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Federal Aviation Administration (FAA), DOT.
Final special conditions.
These special conditions are issued for the XtremeAir GmbH XA42 airplane. The XA42 airplane has a novel or unusual design feature associated with its static stability. This airplane can perform at the highest level of aerobatic competition. To be competitive, the aircraft was designed with positive and, at some points, neutral stability within its flight envelope. Its lateral and directional axes are also decoupled from each other providing more precise maneuvering. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for these design features. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards. These special conditions are only applicable to aircraft certified solely in the acrobatic category.
Mr. Ross Schaller, Federal Aviation Administration, Small Airplane Directorate, Aircraft Certification Service, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone (816) 329-4162; facsimile (816) 329-4090.
On May 3, 2011, XtremeAir GmbH applied for a type certificate for their new model XA42. The XA42 is certified under EASA authority as a dual category (acrobatic/utility) airplane. It has a two-place tandem canopy cockpit and a single-engine. It also features a conventional landing gear, conventional low-wing planform and is of composite construction. The engine is a Lycoming AEIO-580-B1A with a rated power of 315 Hp at 2,700 rpm. The airplane is proposed to be approved for Day-VFR operations with no icing approval.
The maximum takeoff weight is 2,200 pounds in utility category, 1,874 pounds in acrobatic category. V
Acrobatic airplanes previously type certificated by the FAA did comply with the stability provisions of Subpart B of 14 CFR part 23. However, airplanes like the XA42 are considered as “unlimited” acrobatic aircraft because they can perform at the highest level of aerobatic competition and can perform any of the maneuvers listed in the Aresti Catalog. Generally, the evolution of the “unlimited” types of acrobatic airplanes, with very low mass, exceptional roll rates and very high G capabilities, in addition to power to mass ratios that are unique to this type of airplane, have led to airplanes that cannot comply with the stability provisions of the regulations. These airplanes can still be type-certificated, but in the acrobatic category only and with an appropriate set of special conditions and associated limitations.
The FAA will only consider certifying the XA42 in the acrobatic category. XtremeAir GmbH will not be able to offer a utility category operating envelope to accommodate the increased fuel load designed for cross-country operations. The FAA does recognize that fuel exhaustion is one of the top accident causes associated with this class of aircraft. For this reason, the FAA allows XtremeAir to seek certification of a limited acrobatic envelope at a higher weight that will still meet the minimum load requirements of +6/-3 g associated with 14 CFR, part 23, § 23.337. The XA42 airplane would be approved for unlimited maneuvers at or below its designed unlimited acrobatic weight. The airplane would also be approved at some higher weight (for fuel) that would still meet the requirements of § 23.337 for acrobatic category and may have restrictions on the maneuvers allowed.
Under the provisions of 14 CFR, part 21, § 21.17, XtremeAir GmbH must show that the XA42 meets the applicable provisions of part 23, as amended by Amendments 23-1 through 23-59 thereto.
Part 36 of Title 14 of the Code of Federal Regulations, effective December 1, 1969, as amended by Amendments 36-1 through 36-28.
Not approved for ditching; compliance with provisions for ditching equipment in accordance with 14 CFR 23.1415(a)(b) has not been demonstrated.
Approved for VFR-day only. Flight in known icing prohibited.
If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 23) do not contain adequate or appropriate safety standards for the XA42 because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.
In addition to the applicable airworthiness regulations and special conditions, the XA42 must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36 and the FAA must issue a finding of regulatory adequacy pursuant to section 611 of Public Law 92-574, the “Noise Control Act of 1972.”
Special conditions, as defined in § 11.19, are issued in accordance with § 11.38 and become part of the type certification basis in accordance with § 21.17(a)(2).
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of § 21.101.
The XtremeAir GmbH XA42 will incorporate the following novel or unusual design features:
For acrobatic category airplanes with unlimited acrobatic capability:
Neutral longitudinal and lateral static stability characteristics.
The Code of Federal Regulations states static stability criteria for longitudinal, lateral, and directional axes of an airplane. However, none of these criteria are adequate to address the specific issues raised in the flight characteristics of an unlimited aerobatic airplane. Therefore, the FAA has determined after a flight test evaluation that, in addition to the requirements of part 21 and part 23, special conditions are needed to address these static stability characteristics.
Accordingly, these special conditions are for the XtremeAir GmbH XA42 static stability characteristics to be certified solely as an acrobatic category airplane. Other conditions may be developed, as needed, based on further FAA review and discussions with the manufacturer and civil aviation authorities.
A notice of proposed special conditions No. 23-11-02-SC for the XtremeAir GmbH XA42 airplanes was published in the
As discussed above, these special conditions are applicable to the XA42. Should XtremeAir GmbH apply at a later date for a change to the type certificate to include another model on the same type certificate incorporating the same novel or unusual design feature, the special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and it affects only the applicant who applied to the FAA for approval of these features on the airplane.
Aircraft, Aviation safety, Signs and symbols.
49 U.S.C. 106(g), 40113 and 44701; 14 CFR 21.16 and 21.17; and 14 CFR 11.38 and 11.19.
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for XtremeAir GmbH XA42 airplanes.
For unlimited, acrobatic-only category aircraft, XtremeAir GmbH XA42 will comply with the following stability special conditions in lieu of the existing §§ 23.171, 23.173, 23.175, and 23.177:
(A) In place of 14 CFR part 23, § 23.171 Flight—General (stability) requirement, comply with the following:
(B) In place of 14 CFR part 23, § 23.173, Static longitudinal stability requirement, comply with the following:
(a) A pull must be required to obtain and maintain speeds below the specified trim speed and a push required to obtain and maintain speeds above the specified trim speed. This must be shown at any speed that can be obtained, except that speeds requiring a control force in excess of 40 pounds or speeds above the maximum allowable speed or below the minimum speed for steady unstalled flight need not be considered.
(b) The stick force or position must vary with speed so that any substantial speed change results in a stick force or position clearly perceptible to the pilot.
(C) In place of 14 CFR part 23, § 23.175, Demonstration of static longitudinal stability requirement, comply with the following:
(a) Climb. The stick force curve must have, at a minimum, a neutrally stable to stable slope at speeds between 85 and 115 percent of the trim speed, with—
(1) Maximum continuous power; and
(2) The airplane trimmed at the speed used in determining the climb performance required by section 23.69(a).
(b) Cruise. With the airplane in trim with power for level flight at representative cruising speeds at high and low altitudes, including speeds up to V
(1) The stick force curve must, at a minimum, have a neutrally stable to stable slope at all speeds within a range that is the greater of 15 percent of the trim speed plus the resulting free return speed range, or 40 knots plus the resulting free return speed range, above and below the trim speed, except that the slope need not be stable—
(i) At speeds less than 1.3 V
(ii) For airplanes with V
(c) Landing. The stick force curve must, at a minimum, have a neutrally stable to stable slope at speeds between 1.1 V
(1) Landing gear extended; and
(2) The airplane trimmed at—
(i) V
(ii) V
(D) In place of 14 CFR part 23, § 23.177, Static directional and lateral stability requirement, comply with the following:
(a) The static directional stability, as shown by the tendency to recover from a wings level sideslip with the rudder free, must be positive for any landing gear and flap position appropriate to the takeoff, climb, cruise, approach, and landing configurations. This must be shown with symmetrical power up to maximum continuous power, and at speeds from 1.2 V
(b) In straight, steady slips at 1.2 V
Federal Aviation Administration (FAA), DOT.
Final special conditions, request for comments.
These special conditions are issued for the Airbus A350-900 series airplane. These airplanes will have a novel or unusual design feature(s) associated with seats that include non-traditional, large, non-metallic panels that would affect survivability during a post-crash fire event. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
The effective date of these special conditions is March 14, 2012. We must receive your comments by May 10, 2012.
Send comments identified by docket number [FAA-2012-0325] using any of the following methods:
•
•
•
•
Jeff Gardlin, FAA, Airframe/Cabin Safety, ANM-115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington, 98057-3356; telephone (425) 227-2136; facsimile (425) 227-1320.
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions based on the comments we receive.
On August 25, 2008, Airbus applied for a type certificate for their new A350-900 series airplane. Later, Airbus requested and the FAA approved an extension to the application for FAA type certification to June 28, 2009. The A350-900 series has a conventional layout with twin wing-mounted Rolls Royce Trent engines. It features a twin aisle 9-abreast economy class layout, and accommodates side-by-side placement of LD-3 containers in the cargo compartment. The basic A350-900 series configuration accommodates 315 passengers in a standard two-class arrangement. The design cruise speed is Mach 0.85 with a Maximum Take-Off Weight of 591,000 lbs. Airbus proposes the A350-900 series to be certified for extended operations (ETOPS) beyond 180 minutes at entry into service for up to a 420-minute maximum diversion time.
The applicable airplane regulations, Title 14, Code of Federal Regulations (14 CFR) part 25, do not require seats to meet the more-stringent flammability standards required of large, non-metallic panels in the cabin interior. At the time the applicable rules were written, seats were designed with a metal frame covered by fabric, not with large, non-metallic panels. Seats also met the then-recently adopted standards for flammability of seat cushions. With the seat design being mostly fabric and metal, the contribution to a fire in the cabin had been minimized and was not considered a threat. For these reasons, seats did not need to be tested to heat-release and smoke-emission requirements.
Seat designs have now evolved to occasionally include non-traditional, large, non-metallic panels. Taken in total, the surface area of these panels is on the same order as the sidewall and overhead stowage bin interior panels. To provide the level of passenger protection intended by the airworthiness standards, these non-traditional, large, non-metallic panels in the cabin must meet the standards of part 25, Appendix F, parts IV and V, heat-release and smoke-emission requirements.
Under Title 14, Code of Federal Regulations (14 CFR) 21.17, Airbus must
The FAA has determined that Airbus A350-900 series airplanes must comply with the following sections: § 25.853(a) and § 25.853(c), and Amendment 25-61 and Amendment 25-66.
If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the A350-900 series because of a novel or unusual design feature, special conditions are prescribed under § 21.16.
Special conditions are initially applicable to the model or series for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the A350-900 series must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34, the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92-574, the “Noise Control Act of 1972.”
The FAA issues special conditions, as defined in § 11.19, under § 11.38, and they become part of the type-certification basis under § 21.17(a)(2).
The A350-900 series will incorporate the following novel or unusual design features: Passenger seats that incorporate non-traditional, large, non-metallic panels in lieu of the traditional metal frame covered by fabric. The flammability properties of these panels have been shown to significantly affect the survivability of occupants of the cabin in the case of fire. These seats are considered a novel design for transport category airplanes that include Amendment 25-61 and Amendment 25-66 in the certification basis, and were not considered when those airworthiness standards were established.
The existing regulations do not provide adequate or appropriate safety standards for seat designs that incorporate non-traditional, large, non-metallic panels. In order to provide a level of safety that is equivalent to that provided by the balance of the cabin, additional airworthiness standards, in the form of special conditions, are necessary. These special conditions supplement § 25.853. The requirements contained in these special conditions consist of applying the identical test conditions required of all other large panels in the cabin, to seats with non-traditional, large, non-metallic panels.
A non-traditional, large, non-metallic panel, in this case, is defined as a panel with exposed-surface areas greater than 1.5 square feet installed per seat place. The panel may consist of either a single component or multiple components in a concentrated area. Examples of parts of the seat where these non-traditional panels are installed include, but are not limited to: Seat backs, bottoms and leg/foot rests, kick panels, back shells, credenzas and associated furniture. Examples of traditional exempted parts of the seat include: Arm caps, armrest close-outs such as end bays and armrest-styled center consoles, food trays, video monitors and shrouds.
“Exposed” includes those panels directly exposed to the passenger cabin in the traditional sense, plus those panels enveloped such as by a dress cover. Traditional fabrics or leathers currently used on seats are excluded from these special conditions. These materials must still comply with § 25.853(a) and § 25.853(c) if used as a covering for a seat cushion, or § 25.853(a) if installed elsewhere on the seat. Non-traditional, large, non-metallic panels covered with traditional fabrics or leathers will be tested without their coverings or covering attachments.
In the early 1980s the FAA conducted extensive research on the effects of post-crash flammability in the passenger cabin. As a result of this research and service experience, the FAA adopted new standards for interior surfaces associated with large surface area parts. Specifically, the rules require measurement of heat release and smoke emission (part 25, Appendix F, parts IV and V) for the affected parts. Heat release has been shown to have a direct correlation with post- crash fire survival time. Materials that comply with the standards (i.e., Sec. 25.853 entitled “Compartment interiors” as amended by Amendment 25-61 and Amendment 25-66) extend survival time by approximately 2 minutes over materials that do not comply.
At the time these standards were written the potential application of the requirements of heat release and smoke emission to seats was explored. The seat frame itself was not a concern because it was primarily made of aluminum and there were only small amounts of non-metallic materials. It was determined that the overall effect on survivability was negligible, whether or not the food trays met the heat release and smoke requirements. The requirements therefore did not address seats. The preambles to both the Notice of Proposed Rule Making (NPRM), Notice No. 85-10 (50 FR 15038, April 16, 1985) and the Final Rule at Amendment 25-61 (51 FR 26206, July 21, 1986), specifically note that seats were excluded “because the recently-adopted standards for flammability of seat cushions will greatly inhibit involvement of the seats.”
Subsequently, the Final Rule at Amendment 25-83 (60 FR 6615, March 6, 1995) clarified the definition of minimum panel size: “It is not possible to cite a specific size that will apply in all installations; however, as a general rule, components with exposed-surface areas of one square foot or less may be considered small enough that they do not have to meet the new standards. Components with exposed-surface areas greater than two square feet may be considered large enough that they do have to meet the new standards. Those with exposed-surface areas greater than one square foot, but less than two square feet, must be considered in conjunction with the areas of the cabin in which they are installed before a determination could be made.”
In the late 1990s, the FAA issued Policy Memorandum 97-112-39, Guidance for Flammability Testing of Seat/Console Installations, October 17, 1997
In October of 2004, an issue was raised regarding the appropriate flammability standards for passenger seats that incorporated non-traditional, large, non-metallic panels in lieu of the traditional metal covered by fabric. The Seattle Aircraft Certification Office and Transport Standards Staff reviewed this design and determined that it represented the kind and quantity of
As discussed above, these special conditions apply to Airbus A350-900 series airplanes. Should Airbus apply later for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on Airbus A350-900 series airplanes. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
So, by the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Airbus A350-900 series airplanes with passenger seats that have non-traditional, large, non-metallic panels.
1. Compliance with 14 CFR part 25 Appendix F, parts IV and V, heat release and smoke emission, is required for seats that incorporate non-traditional, large nonmetallic panels that may either be a single component or multiple components in a concentrated area in their design.
2. The applicant may designate up to and including 1.5 square feet of non-traditional, nonmetallic panel material per seat place that does not have to comply with No. 1. A triple seat assembly may have a total of 4.5 square feet excluded on any portion of the assembly (e.g., outboard seat place 1 sq. ft., middle 1 sq. ft., and inboard 2.5 sq. ft.).
3. Seats need not meet the test requirements of 14 CFR part 25 Appendix F, parts IV and V when installed in compartments that are not otherwise required to meet these requirements. Examples include:
a. Airplanes with passenger capacities of 19 or less,
b. Airplanes exempted from smoke and heat release requirements.
In rule document 2012-5859 appearing on pages 14679-14681 in the issue of March 13, 2012, make the following correction:
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E airspace at Hastings, NE. Additional controlled airspace is necessary to accommodate new Area Navigation (RNAV) Standard Instrument Approach Procedures at Hastings Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport.
Effective date: 0901 UTC, May 31, 2012. The Director of the
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-7716.
On November 28, 2011, the FAA published in the
This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E airspace extending upward from 700 feet above the surface to accommodate new RNAV standard instrument approach procedures at Hastings Municipal Airport, Hastings, NE. This action is necessary for the safety and management of IFR operations at the airport.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action”
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace in the Hastings, NE., area.
Airspace, Incorporation by reference, Navigation (Air)
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 7.2-mile radius of Hastings Municipal Airport, and within 2 miles each side of the 150° bearing from the airport extending from the 7.2-mile radius to 10.4 miles southeast of the airport.
FR DOC 2012-3390 appearing on pages 11252-11344 in the issue of Friday, February 24, 2012 is being partially republished due to numerous errors.
1. On page 11252, in the first column, the
The Commodity Futures Trading Commission is adopting amendments to its existing part 4 regulations and promulgating one new regulation regarding Commodity Pool Operators and Commodity Trading Advisors. The Commission is also adopting new data collections for CPOs and CTAs that are consistent with a data collection required under the Dodd-Frank Act for entities registered with both the Commission and the Securities and Exchange Commission. The adopted amendments rescind an exemption from registration as a CPO; rescind relief from the certification requirement for annual reports provided to operators of certain pools offered only to qualified eligible persons (“QEPs”); modify the criteria for claiming exclusion from the definition of CPO; and require the annual filing of notices claiming exemptive relief under several sections of the Commision's regulations. Finally, the adopted amendments include new risk disclosure requirements for CPOs and CTAs regarding swap transactions.
2. In 17 CFR Part 4, beginning on page 11283, in the second column, in 31st line of text, amendatory instructions 1-8 and their corresponding amendments to the Code of Federal Regulations are being republished as follows:
7 U.S.C. 1a, 2, 4, 6(c), 6b, 6c, 6l, 6m, 6n, 6o, 12a, and 23.
(c) * * *
(2) * * *
(iii) Furthermore, if the person claiming the exclusion is an investment company registered as such under the Investment Company Act of 1940, then the notice of eligibility must also contain representations that such person will operate the qualifying entity as described in Rule 4.5(b)(1) in a manner such that the qualifying entity:
(A) Will use commodity futures or commodity options contracts, or swaps solely for bona fide hedging purposes within the meaning and intent of Rules 1.3(z)(1) and 151.5 (17 CFR 1.3(z)(1) and 151.5); Provided however, That in addition, with respect to positions in commodity futures or commodity option contracts, or swaps which do not come within the meaning and intent of Rules 1.3(z)(1) and 151.5, a qualifying entity may represent that the aggregate initial margin and premiums required to establish such positions will not exceed five percent of the liquidation value of the qualifying entity's portfolio, after taking into account unrealized profits and unrealized losses on any such contracts it has entered into; and, Provided further, That in the case of an option that is in-the-money at the time of purchase, the in-the-money amount as defined in Rule 190.01(x) (17 CFR 190.01(x)) may be excluded in computing such five percent; or
(B) The aggregate net notional value of commodity futures, commodity options contracts, or swaps positions not used solely for bona fide hedging purposes within the meaning and intent of Rules 1.3(z)(1) and 151.5 (17 CFR 1.3(z)(1) and 151.5), determined at the time the most recent position was established, does not exceed 100 percent of the liquidation value of the pool's portfolio, after taking into account unrealized profits and unrealized losses on any such positions it has entered into. For the purpose of this paragraph:
(
(
(5)
(a) * * *
(3) * * *
(ix) A natural person whose individual net worth, or joint net worth with that person's spouse at the time of either his purchase in the exempt pool or his opening of an exempt account would qualify him as an accredited investor as defined in § 230.501(a)(5) of this title;
(x) A natural person who would qualify as an accredited investor as defined in § 203.501(a)(6) of this title;
(b) * * *
(3)
(A) A Statement of Financial Condition as of the close of the exempt pool's fiscal year (elected in accordance with § 4.22(g));
(B) A Statement of Operations for that year;
(C) Appropriate footnote disclosure and such further material information as may be necessary to make the required statements not misleading. For a pool that invests in other funds, this information must include, but is not limited to, separately disclosing the amounts of income, management and incentive fees associated with each investment in an investee fund that exceeds five percent of the pool's net assets. The income, management and incentive fees associated with an investment in an investee fund that is less than five percent of the pool's net assets may be combined and reported in the aggregate with the income, management and incentive fees of other investee funds that, individually, represent an investment of less than five percent of the pool's net assets. If the commodity pool operator is not able to obtain the specific amounts of management and incentive fees charged by an investee fund, the commodity pool operator must disclose the percentage amounts and computational basis for each such fee and include a statement that the CPO is not able to obtain the specific fee amounts for this fund;
(D) Where the pool is comprised of more than one ownership class or series, information for the series or class on which the financial statements are reporting should be presented in addition to the information presented for the pool as a whole; except that, for a pool that is a series fund structured with a limitation on liability among the different series, the financial statements are not required to include consolidated information for all series.
(ii)
The revisions and additions read as follows:
(a) * * *
(3) * * *
(ii) * * *
(B) * * *
(
(
(b) * * *
(2) * * *
(ii) Contain the section number pursuant to which the operator is filing the notice (
(4)
(e) * * *
(2) If a person operates one or more commodity pools described in paragraph (a)(3) of this section, and one or more commodity pools for which it must be, and is, registered as a commodity pool operator, the person is exempt from the requirements applicable to a registered commodity pool operator with respect to the pool or pools described in paragraph (a)(3) of this section;
(i) Furnishes in written communication physically delivered or delivered through electronic transmission to each prospective participant in a pool described in paragraph (a)(3) of this section that it operates:
(A) A statement that it will operate the pool as if the person was exempt from registration as a commodity pool operator;
(B) A description of the criteria pursuant to which it will so operate the pool;
(ii) Complies with paragraph (c) of this section; and
(iii) Provides each existing participant in a pool that the person elects to operate as described in paragraph (a)(3) of this section a right to redeem the participant's interest in the pool, and informs each such participant of that right no later than the time the person commences to operate the pool as described in paragraph (a)(3) of this section.
The revision and addition read as follows:
(a) * * *
(8) * * *
(i) * * *
(D) A commodity pool operator who has claimed an exemption from registration under § 4.13(a)(3), or, if registered as a commodity pool operator, who may treat each pool it operates that meets the criteria of § 4.13(a)(3) as if it were not so registered; and
(iii) * * *
(D)
(b) * * *
(5) If the pool may engage in swaps, the Risk Disclosure Statement must further state:
SWAPS TRANSACTIONS, LIKE OTHER FINANCIAL TRANSACTIONS, INVOLVE A VARIETY OF SIGNIFICANT RISKS. THE SPECIFIC RISKS PRESENTED BY A PARTICULAR SWAP TRANSACTION NECESSARILY DEPEND UPON THE TERMS OF THE TRANSACTION AND YOUR CIRCUMSTANCES. IN GENERAL, HOWEVER, ALL SWAPS TRANSACTIONS INVOLVE SOME COMBINATION OF MARKET RISK, CREDIT RISK, COUNTERPARTY CREDIT RISK, FUNDING RISK, LIQUIDITY RISK, AND OPERATIONAL RISK.
HIGHLY CUSTOMIZED SWAPS TRANSACTIONS IN PARTICULAR MAY INCREASE LIQUIDITY RISK, WHICH MAY RESULT IN A SUSPENSION OF REDEMPTIONS. HIGHLY LEVERAGED TRANSACTIONS MAY EXPERIENCE SUBSTANTIAL GAINS OR LOSSES IN VALUE AS A RESULT OF RELATIVELY SMALL CHANGES IN THE VALUE OR LEVEL OF AN UNDERLYING OR RELATED MARKET FACTOR.
IN EVALUATING THE RISKS AND CONTRACTUAL OBLIGATIONS ASSOCIATED WITH A PARTICULAR SWAP TRANSACTION, IT IS IMPORTANT TO CONSIDER THAT A SWAP TRANSACTION MAY BE MODIFIED OR TERMINATED ONLY BY MUTUAL CONSENT OF THE ORIGINAL PARTIES AND SUBJECT TO AGREEMENT ON INDIVIDUALLY NEGOTIATED TERMS. THEREFORE, IT MAY NOT BE POSSIBLE FOR THE COMMODITY POOL OPERATOR TO MODIFY, TERMINATE, OR OFFSET THE POOL'S OBLIGATIONS OR THE POOL'S EXPOSURE TO THE RISKS ASSOCIATED WITH A TRANSACTION PRIOR TO ITS SCHEDULED TERMINATION DATE.
(b) * * *
(4) If the commodity trading advisor may engage in swaps, the Risk Disclosure Statement must further state:
SWAPS TRANSACTIONS, LIKE OTHER FINANCIAL TRANSACTIONS, INVOLVE A VARIETY OF SIGNIFICANT RISKS. THE SPECIFIC RISKS PRESENTED BY A PARTICULAR SWAP TRANSACTION NECESSARILY DEPEND UPON THE TERMS OF THE TRANSACTION AND YOUR CIRCUMSTANCES. IN GENERAL, HOWEVER, ALL SWAPS TRANSACTIONS INVOLVE SOME COMBINATION OF MARKET RISK, CREDIT RISK, FUNDING RISK, AND OPERATIONAL RISK.
HIGHLY CUSTOMIZED SWAPS TRANSACTIONS IN PARTICULAR MAY INCREASE LIQUIDITY RISK, WHICH MAY RESULT IN YOUR ABILITY TO WITHDRAW YOUR FUNDS BEING LIMITED. HIGHLY LEVERAGED TRANSACTIONS MAY EXPERIENCE SUBSTANTIAL GAINS OR LOSSES IN VALUE AS A RESULT OF RELATIVELY SMALL CHANGES IN THE VALUE OR LEVEL OF AN UNDERLYING OR RELATED MARKET FACTOR.
IN EVALUATING THE RISKS AND CONTRACTUAL OBLIGATIONS ASSOCIATED WITH A PARTICULAR SWAP TRANSACTION, IT IS IMPORTANT TO CONSIDER THAT A SWAP TRANSACTION MAY BE MODIFIED OR TERMINATED ONLY BY MUTUAL CONSENT OF THE ORIGINAL PARTIES AND SUBJECT TO AGREEMENT ON INDIVIDUALLY NEGOTIATED TERMS. THEREFORE, IT MAY NOT BE POSSIBLE TO MODIFY, TERMINATE, OR OFFSET YOUR OBLIGATIONS OR YOUR EXPOSURE TO THE RISKS ASSOCIATED WITH A TRANSACTION PRIOR TO ITS SCHEDULED TERMINATION DATE.
(a)
(1)
(2)
(3)
(4)
(5)
(6)
(b)
(1) Any commodity pool operator that is registered or required to be registered under the Commodity Exchange Act and the Commission's regulations thereunder; or
(2) Any commodity trading advisor that is registered or required to be registered under the Commodity Exchange Act and the Commission's regulations thereunder.
(c)
(2) All financial information shall be reported in accordance with generally accepted accounting principles consistently applied.
(d)
(e)
(1)(i) Contain an oath and affirmation that, to the best of the knowledge and belief of the individual making the oath and affirmation, the information contained in the document is accurate and complete;
(ii) Each oath or affirmation must be made by a representative duly authorized to bind the CPO or CTA.
(2) Be submitted consistent with the National Futures Association's electronic filing procedures.
(f)
(g)
FR DOC 2012-3390 appearing on pages 11252-11344 in the issue of Friday, February 24, 2012 is being partially republished due to numerous errors.
U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury.
Final rule.
This document adopts as a final rule, without change, the proposed amendments to the CBP regulations that provide that where an owner or master of a vessel documented under the laws of the United States fails to timely pay the duties determined to be due to CBP that are associated with the purchase of equipment for, or repair to, the vessel while it is outside the United States, interest will accrue on the amounts owed to CBP and that person will be liable for interest. The purpose of this document is to ensure that the CBP regulations reflect that CBP collects interest as part of its inherent revenue collection functions in situations where an owner or master of a vessel fails to pay the vessel repair duties determined to be due within 30 days of CBP issuing the bill.
George F. McCray, Chief, Cargo Security, Carriers and Immigration Branch, Regulations and Rulings, Office of International Trade, (202) 325-0082.
On April 1, 2011, U.S. Customs and Border Protection (CBP) published in the
CBP solicited comments on the proposed rulemaking.
One commenter responded to the solicitation of public comment in the proposed rule. The comment was favorable and recommended adoption of the proposed amendments as a final rule.
In light of the fact that a single favorable comment was submitted in response to CBP's solicitation of public comment, CBP has determined to adopt as final the proposed rule published in
Because these amendments merely reflect the agency's revenue collection functions and rights, and impose no additional regulatory burden on the importing public, pursuant to the provisions of the Regulatory Flexibility Act, 5 U.S.C. 601
As there are no new collections of information in this document, the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) are inapplicable.
This rulemaking is being issued in accordance with 19 CFR 0.1(a)(1), pertaining to the authority of the Secretary of the Treasury (or his/her delegate) to approve regulations related to certain CBP revenue functions.
Administrative practice and procedure, Cargo vessels, Customs duties and inspection, Entry, Passenger vessels, Penalties, Repairs, Reporting and recordkeeping requirements, Shipping, Vessels.
Accounting, Claims, Customs duties and inspection, Exports, Imports, Interest, Reporting and recordkeeping requirements, Taxes, User fees, Wages.
For the reasons set forth in the preamble, parts 4 and 24 of title 19 of the CFR (19 CFR Parts 4 and 24) are amended as set forth below.
5 U.S.C. 301; 19 U.S.C. 66, 1431, 1433, 1434, 1624, 2071 note; 46 U.S.C. 501, 60105.
Section 4.14 also issued under 19 U.S.C. 1466, 1498; 31 U.S.C. 9701.
The revisions and additions read as follows:
(i) * * *
(3)
(j) * * *
(1) * * * The owner or master of the vessel who fails to timely pay the duty determined to be due is liable for interest as provided in § 24.3a(b)(1) of this chapter.
5 U.S.C. 301; 19 U.S.C. 58a-58c, 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States, 1505, 1520, 1624; 26 U.S.C. 4461, 4462; 31 U.S.C. 3717, 9701; Pub. L. 107-296, 116 Stat. 2135 (6 U.S.C. 1
The revision reads as follows:
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Metro North (Peck) Bridge across the Pequonnock River, mile 0.3, at Bridgeport, Connecticut. The deviation allows the bridge to remain in the closed position to facilitate miter rail repair.
This deviation is effective from April 15, 2012 through June 30, 2012.
Documents mentioned in this preamble as being available in the docket are part of docket USCG-2012-0153 and are available online at
If you have questions on this rule, call or email Ms. Judy Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 668-7165, email
The Metro North (Peck) Bridge, across the Pequonnock River, mile 0.3, at Bridgeport, Connecticut, has a vertical clearance in the closed position of 26 feet at mean high water and 32 feet at mean low water. The drawbridge operation regulations are listed at 33 CFR 117.219(b).
The operator of the bridge, Metro North Railroad, requested a temporary deviation from the regulations to facilitate scheduled bridge maintenance, miter rail repair, at the bridge.
The waterway users are recreational vessels and commercial lobster boats. The Metro North (Peck) Bridge rarely opens for vessel traffic. The bridge has received no requests to open during the past three years except for bridge testing and repairs.
Under this temporary deviation the Metro North (Peck) Bridge may remain in the closed position from April 15, 2012 through June 30, 2012. Vessels that can pass under the bridge in the closed position may do so at all times.
The waterway users were advised of the requested bridge closure and offered no objection.
In accordance with 33 CFR 117.35(e), the bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Postal Service.
Final rule.
On March 24, 2010, the Board of Governors of the United States Postal Service adopted a number of amendments to the Board's Bylaws. These amendments revised and clarified the provisions concerning the election and terms of office of the Board Chairman and Vice-Chairman. The amendments also formalized the process for notation voting (voting by paper ballot) on routine or administrative matters. This final rule incorporates the changes adopted by the Board.
These amendments to the Code of Federal Regulations are effective March 26, 2012.
Julie S. Moore, Secretary of the Board, U.S. Postal Service, 475 L'Enfant Plaza SW., Washington, DC 20260-1000. Telephone: (202) 268-4800.
This document publishes amendments to 39 CFR Parts 4, 6, and 7, conforming to amendments to the Bylaws of the Board of Governors of the United States Postal Service. In part 4, the Board revised §§ 4.1 and 4.2 to establish December 1 as the regular commencement date of the terms of office of the newly-elected Board Chairman and Vice-Chairman. In part 6 (with a conforming amendment to part 7), the Board added a new § 6.7 to formalize the process for notation voting by paper ballot on routine, non-controversial, and administrative matters.
Administrative practice and procedure, Organization and functions (Government agencies), Postal Service.
Accordingly, for the reasons stated, 39 CFR Parts 4, 6, and 7 are amended as follows:
39 U.S.C. 202-205, 401(2), (10), 402, 1003, 3013, 3686.
(a) The Chairman of the Board of Governors is elected by the Governors from among the members of the Board. The Chairman:
(1) Shall be elected at the Board's regularly scheduled November meeting for a term that commences on December 1 of the calendar year in which the election occurred, or upon the death, departure or resignation of the current Chairman, whichever occurs first, and expires upon the election and installation of a successor Chairman;
(2) Shall preside at all regular and special meetings of the Board, and shall set the agenda for such meetings;
(3) Shall select and appoint the chairman, vice chairman (if any), and members of any committee properly established by the Board.
(b) If the Postmaster General is elected Chairman of the Board, the Governors shall also elect one of their number to preside during proceedings dealing with matters upon which only the Governors may vote.
(c) In the event of the Chairman's death, departure or resignation prior to the election of a successor, the Board, as soon as practicable, shall elect a new Chairman who shall serve a term that commences immediately upon election and expires upon the election and installation of a successor Chairman.
(d)(1) Upon the election and installation of a new Chairman of the Board, the immediate past Chairman shall become Chairman Pro Tempore of the Board, to preside during the absence of the Chairman and Vice Chairman at any meeting of the Board during the year or years following the immediate past Chairman's tenure as Chairman and until another Chairman has been elected.
(2) The Chairman Pro Tempore shall, at the request of the Chairman or Vice Chairman, serve as the representative of the Board of Governors at conferences, trade shows, ceremonial functions and other meetings important to Postal Service business.
The Vice Chairman is elected by the Governors from among the members of the Board and shall perform the duties and exercise the powers of the Chairman during the Chairman's absence or disability. The Vice Chairman is elected at the Board's regularly scheduled November meeting for a term that commences on December 1 of the calendar year in which the election occurred or upon the death, departure or resignation of the current Vice Chairman, whichever occurs first, and expires upon the election and installation of a successor Vice
39 U.S.C. 202, 205, 401(2), (10), 1003, 3622; 5 U.S.C. 552b(e), (g).
As provided by 39 U.S.C. 205(c), and except for routine, non-controversial, and administrative matters considered through the notation voting process described in § 6.7, the Board acts by resolution upon a majority vote of those members who attend a meeting in person or by teleconference. No proxies are allowed in any vote of the members of the Board. Any 6 members constitute a quorum for the transaction of business by the Board, except:
(a)
(b)
(1) Distributing notation voting memoranda and voting sheets;
(2) Establishing deadlines for notation voting sheets to be completed and returned;
(3) Processing and tabulating all notation voting sheets; and
(4) Determining whether further action is required.
(c)
(d)
39 U.S.C. 410; 5 U.S.C. 552b(a)-(m).
(b) * * * The term ”meeting” does not include any procedural deliberations required or permitted by §§ 6.1, 6.2, 7.4, or 7.5 of the bylaws in this chapter, or the notation voting process described in § 6.7 of the bylaws in this chapter.
Environmental Protection Agency (EPA).
Final rule.
EPA is finalizing its approval of most of the Nevada Regional Haze State Implementation Plan (SIP) that implements the Clean Air Act (CAA) Regional Haze Rule requiring states to prevent any future and remedy any existing man-made impairment of visibility in mandatory Class I areas through a regional haze program. EPA proposed to approve all parts of Nevada's SIP revisions on June 22, 2011 (76 FR 36450). This final approval applies to all aspects of Nevada's SIP except for that portion of Nevada's determination regarding the Best Available Retrofit Technology (BART) to reduce nitrogen oxide (NO
EPA has established docket number EPA-R09-OAR-2011-0130 for this action. Generally, documents in the docket are available electronically at
Thomas Webb, U.S. EPA, Region 9, Planning Office, Air Division, Air-2, 75 Hawthorne Street, San Francisco, CA 94105. Thomas Webb can be reached at telephone number (415) 947-4139 and via electronic mail at
Throughout this document, wherever “we,” “us,” or “our,” is used, we mean the United States Environmental Protection Agency (EPA).
Regional haze is the impairment of visibility across a broad geographic area produced by numerous sources and
Data from existing visibility monitors, the “Interagency Monitoring of Protected Visual Environments” (IMPROVE) network, indicate that visibility impairment caused by air pollution occurs virtually all the time at most federally protected national parks and wilderness areas, known as Class I areas. The average visual range in many Class I areas in the western United States is 100 to 150 kilometers, or about one-half to two-thirds of the visual range that would exist without man-made air pollution.
In section 169(A)(1) of the 1977 Amendments to the CAA, Congress established as a national goal the “prevention of any future, and the remedying of any existing, impairment of visibility in mandatory class I Federal areas which impairment results from man-made air pollution.” Visibility was determined by Congress to be an important value in 156 mandatory Class I Federal areas
Congress added section 169B to the CAA in 1990 to conduct scientific research on regional haze. This legislation established the Grand Canyon Visibility Transport Commission (GCVTC), which issued its report, “Recommendations for Improving Western Vistas,” on June 10, 1996. These recommendations informed the regulatory development of a regional haze program, and provided an option for certain western states to address visibility at 16 Class I areas on the Colorado Plateau under 40 CFR 51.309.
EPA promulgated a rule to address regional haze on July 1, 1999 known as the Regional Haze Rule (RHR). See 64 FR 35713 as amended at 70 FR 39156 (July 6, 2005) and 71 FR 60631 (October 13, 2006). The RHR revised the existing visibility regulations to include provisions addressing regional haze impairment and established a comprehensive visibility protection program for Class I areas. The requirements for regional haze, found at 40 CFR 51.308 and 51.309, are included in EPA's visibility protection regulations at 40 CFR 51.300-309.
The requirement to submit a regional haze SIP revision applies to all 50 states, the District of Columbia, and the Virgin Islands. States were required to submit the first SIP addressing regional haze visibility impairment no later than December 17, 2007. 40 CFR 51.308(b). Since most states, including Nevada, did not submit SIPs prior to the deadline, EPA made a Finding of Failure to Submit that under the Clean Air Act had the effect of creating a deadline of January 15, 2011, for EPA to approve a SIP or publish a Federal Implementation Plan (FIP). 74 FR 2392 (January 15, 2009). EPA is publishing this final action to meet this obligation in part.
For a more detailed discussion of the CAA and RHR requirements, please see sections II and III of our proposal dated June 22, 2011 (76 FR 36450). Our evaluation of the Nevada Regional Haze Plan is in section IV of the same proposal.
On June 22, 2011, EPA proposed to approve all portions of Nevada's Regional Haze SIP as meeting the relevant requirements of CAA Section 169A and the Regional Haze Rule. We proposed to find that Nevada appropriately established baseline visibility conditions and a reasonable progress goal for its one Class I area; developed a long-term strategy with enforceable measures to ensure reasonable progress toward achieving the Reasonable Progress Goal in the first planning period ending in 2018; adequately applied Best Available Retrofit Technology to specific stationary sources, including RGGS; developed a regional haze monitoring strategy; provided for periodic progress reports and revisions; provided for consultation and coordination with federal land managers; and provided for the regional haze SIP's future review and revisions. We also proposed to find that emissions from Nevada do not interfere with other states' measures to protect visibility as required by CAA Section 110(a)(2)(D)(i)(II). Our proposed action provides more information about the relevant CAA requirements, EPA guidance, the State's submittals, and our review and evaluation of the SIP revisions.
We are taking no action in today's rule on the portion of the Nevada SIP that contains the BART determination at RGGS for NO
The RHR provides that a BART determination must take into account several factors, which are frequently referred to as the “five-factor analysis.” These factors are listed below (40 CFR 51.308(e)(1)(ii)(A)):
• The cost of compliance for the technically feasible control technologies;
• The energy and non-air quality impacts of the control technologies;
• Any existing air pollution control technologies at the source;
• The remaining useful life of the source; and
• The degree of visibility improvement which may reasonably be anticipated to result from the various control technologies.
RGGS consists of four coal-fired boilers, three of which are BART-eligible units with generating capacity of 100 megawatts (MW) each. A fourth unit (250 MW) is not BART-eligible. Nevada Energy, the owner of RGGS, performed a BART analysis for the three BART-eligible RGGS units and submitted the results of its analysis to NDEP.
In its submittal to NDEP, Nevada Energy determined that low NO
As noted in Section II.B above, NDEP's elimination of control options more stringent than ROFA with Rotamix was based on the incremental cost effectiveness ($/ton) and expected visibility improvement of the various options. EPA received several comments (see Docket Items 0054, 0057, 0061, 0062 and 0062 Attachment 6) alleging flaws in NDEP's analysis and response to comments, and stating that SCR should be BART for NO
Regarding cost effectiveness, several commenters (see Docket Items 0054, 0057, 0061, and 0062) alleged that the total capital and annual cost estimates relied upon by NDEP for the SCR-based control options were overestimated, included several costs not allowed by EPA's Control Cost Manual (CCM) such as owner's costs, surcharge, and allowance for funds used during construction (AFUDC), and used certain variables and values that were either inflated or unreasonable. One commenter (see docket item 0062 Attachment 6) performed a revised analysis of SCR cost effectiveness that adjusted for these alleged issues, and projected a 33 to 40 percent decrease in average and incremental cost effectiveness values as a result of these adjustments. In addition, commenters stated that total capital and annual cost estimates lacked evidentiary support in the administrative record due to the absence of detailed information such as equipment design parameters, equipment lists, and actual cost calculations. Finally, commenters also stated that the level of SCR performance relied upon by NDEP is not supported in the administrative record by site-specific information such as vendor quotes or specifications (see Docket Items 0054 and 0061 to 0063).
Regarding visibility improvement, commenters (see Docket Items 0054 and 0062) noted that while baseline visibility modeling indicated that RGGS currently causes or contributes to visibility impairment at multiple Class I areas, control scenario visibility modeling results were only provided for the single closest Class I area, Grand Canyon National Park. They asserted that the potential visibility benefit at all affected Class I areas should be accounted for when considering control technology options. In addition, as described in Section II.B above, NDEP estimated larger NO
After reviewing the public comments, we performed additional analysis of the cost effectiveness and visibility improvement associated with the various NO
Therefore, EPA is taking no action on the portion of the SIP containing the BART determination for NO
EPA's proposed approval published on June 22, 2011 (76 FR 36450) included a 30-day public comment period, which ended on July 22, 2011. We subsequently extended the comment period by 30 days until August 22, 2011 (76 FR 43963). We received comments from WildEarth Guardians, a consortium of environmental and conservation organizations
In addition to extensive comments addressing NDEP's BART determination for NO
In arguing for further reductions in these BART limits, WildEarth Guardians notes that, “according to Clean Air Markets data from the EPA, units 1-3 are meeting annual sulfur dioxide emission rates of between 0.054 and 0.064 lbs/MMbtu and have for at least the last two years.” However, while the units' current annual average emission rates may be less than 0.15 lb/MMbtu, these figures are not directly comparable to the 24-hour rolling average emissions limits set by NDEP in its BART determination for RGGS. The more relevant points of comparison are the units' current Title V permit limits of 0.40 lbs/MMbtu, based on a 10-day rolling average period, which are more than twice the limit that NDEP has set for each of the three BART units in its Regional Haze SIP.
In response to commenters' concerns regarding potential increases in SO
NDEP's baseline emissions for SO
From a broader perspective, NDEP's BART determination for SO
Under section 110(k)(3) of the CAA, EPA is fully approving most portions of the Nevada Regional Haze SIP as satisfying all of the relevant requirements of CAA Section 169A and the Regional Haze Rule. For the portions of the SIP establishing BART for NO
We find that Nevada has met the following Regional Haze Rule requirements: The State established baseline visibility conditions and reasonable progress goals for each of its Class I areas; the State developed a long-term strategy with enforceable measures ensuring reasonable progress towards meeting the reasonable progress goals for the first ten-year planning period, through 2018; the State has adequately addressed the application of Best Available Retrofit Technology to specific stationary sources, except for NO
In addition, under section 110(k)(3) of the CAA, we are fully approving the Nevada Regional Haze SIP as satisfying the CAA Section 110(a)(2)(D)(i)(II) requirement to prohibit emissions that will interfere with measures to protect visibility in another state for the 1997 8-hour ozone and 1997 PM
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not interfere with Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) because EPA lacks the discretionary authority to address environmental justice in this rulemaking.
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 25, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Sulfur dioxide, Particulate matter, Reporting and recordkeeping requirements, Visibility, Volatile organic compounds.
Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(e) * * *
(e)
(a)
(b)
Environmental Protection Agency (EPA).
Final rule.
EPA is making two determinations regarding the Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE 8-hour ozone moderate nonattainment area (the Philadelphia Area). First, EPA is determining that the Philadelphia Area has attained the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS). This determination is based upon complete, quality assured, and certified ambient air monitoring data that show the area has monitored attainment of the 1997 8-hour ozone NAAQS for the 2008-2010 monitoring period. In accordance with EPA's applicable ozone implementation rule, this clean data determination suspends the requirement for the Philadelphia Area to submit an attainment demonstration, reasonably available control measures (RACM), a reasonable further progress (RFP) plan and contingency measures related to attainment of the 1997 8-hours ozone NAAQS. These requirements shall be suspended for so long as the area continues to attain the 1997 8-hour ozone NAAQS. Second, EPA is determining that the Philadelphia Area has attained the 1997 8-hour ozone NAAQS by its attainment date of June 15, 2011. These actions are being taken under the Clean Air Act (CAA).
EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2011-0713. All documents in the docket are listed in the
If you have questions concerning EPA's proposed action related to Delaware, Maryland or Pennsylvania, please contact Maria A. Pino (215) 814-2181, or by email at
The following outline is provided to aid in locating information in this action.
EPA published a notice of proposed rulemaking (NPR) for the States of Delaware, Maryland, and New Jersey
The December 9, 2011 NPR also proposed to make a clean data determination that the Philadelphia Area has attained the 1997 8-hour ozone NAAQS. This proposed clean data determination was based upon complete, quality assured, and certified ambient air monitoring data that show the Philadelphia Area has monitored attainment of the 1997 8-hour ozone NAAQS for the 2008-2010 monitoring period. As a result of this determination, the requirement for the Philadelphia Area to submit an attainment demonstration, a RACM analysis, an RFP plan, contingency measures, and other planning requirements related to attainment of the 1997 8-hours ozone NAAQS shall be suspended for so long as the area continues to attain the 1997 8-hour ozone NAAQS.
In that same December 9, 2011 rulemaking notice, EPA withdrew the May 8, 2009 proposed disapprovals of the attainment demonstrations for the Philadelphia Area, based on the ambient air quality monitoring data demonstrating attainment. The Docket ID Numbers for the proposed disapprovals are EPA-R03-OAR-2008-0930, EPA-R03-OAR-2008-0929, EPA-R02-OAR-2008-0497, and EPA-R03-OAR-2008-0928, respectively.
Moderate areas are required to attain the 1997 8-hour ozone NAAQS by no later than six years after designation, or June 15, 2010.
EPA is making a determination that the Philadelphia Area has attained the 1997 ozone NAAQS by its applicable attainment date of June 15, 2011. As a result of this action, EPA has met its requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the standard by that date. The effect of this final determination of attainment by the area's attainment date is to discharge EPA's obligation under CAA section 181(b)(2)(A)
EPA is making a clean data determination, finding that the Philadelphia Area is attaining the 1997 8-hour ozone NAAQS. Under the provisions of EPA's ozone implementation rule (
The clean data determination suspends the requirements to submit an attainment demonstration, RACM, RFP, contingency measures, and other planning elements related to attainment of the 1997 8-hour ozone NAAQS. This suspension continues until such time, if any, that EPA (i) redesignates the area to attainment at which time those requirements no longer apply, or (ii) subsequently determines that the area has violated the 1997 8-hour ozone NAAQS. This clean data determination is separate from, and does not influence or otherwise affect, any future designation determination or requirements for the area based on any new or revised ozone NAAQS. This clean data determination remains in effect regardless of whether EPA designates the Philadelphia Area as a nonattainment area for purposes of any new or revised ozone NAAQS.
Although these requirements are suspended, EPA is not precluded from acting upon these elements. The States of Delaware and Maryland, and the Commonwealth of Pennsylvania submitted these SIP elements for their portions of the Philadelphia Area to EPA for review and approval in June 2007. The State of New Jersey submitted these SIP elements for its portion of the Philadelphia Area to EPA for review and approval in October 2007. EPA approved each state's RFP plans, RFP contingency measures, and RACM analyses for the Philadelphia Area in separate rulemaking actions. Therefore, these requirements have been fulfilled. EPA approved the RFP plans, RFP contingency measures, and RACM analyses from Delaware, Maryland, New Jersey, and Pennsylvania on April 8, 2010, June 11, 2010, May 15, 2009, and February 7, 2011, respectively.
Complete, quality assured, certified 8-hour ozone air quality monitoring data for 2008 through 2010 show that the Philadelphia Area has attained the 1997 8-hour ozone NAAQS. Additional information on air quality data for the Philadelphia Area can be found in the Technical Support Document (TSD) prepared for this action. The TSD can be viewed at
EPA is making two determinations regarding the Philadelphia Area. First, EPA is making a clean data determination, finding that the Philadelphia Area has attained the 1997 8-hour ozone NAAQS. This clean data determination is based upon complete, quality assured, and certified ambient air monitoring data that show the area has monitored attainment of the 1997 8-
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 25, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This determination that the Philadelphia Area has attained the 1997 8-hour ozone NAAQS may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
Based upon EPA's review of the air quality data for the 3-year period 2008 to 2010, EPA determined that Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE 8-hour ozone moderate nonattainment area (the Philadelphia Area) attained the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS) by the applicable attainment date of June 15, 2011. Therefore, EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the standard. EPA also determined that the Philadelphia Area nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).
(i)
(x)
(d) Based upon EPA's review of the air quality data for the 3-year period 2008 to 2010, EPA determined that Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE 8-hour ozone moderate nonattainment area (the Philadelphia Area) attained the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS) by the applicable attainment date of June 15, 2011. Therefore, EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the standard. EPA also determined that the Philadelphia Area nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).
Based upon EPA's review of the air quality data for the 3-year period 2008 to 2010, EPA determined that Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE 8-hour ozone moderate nonattainment area (the Philadelphia Area) attained the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS) by the applicable attainment date of June 15, 2011. Therefore, EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the standard. EPA also determined that the Philadelphia Area nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).
(r)
(f) Based upon EPA's review of the air quality data for the 3-year period 2008 to 2010, EPA determined that Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE 8-hour ozone moderate nonattainment area (the Philadelphia Area) attained the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS) by the applicable attainment date of June 15, 2011. Therefore, EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the standard. EPA also determined that the Philadelphia Area nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).
Environmental Protection Agency.
Direct final rule.
The U.S. Environmental Protection Agency (EPA) is taking direct final action to revise one of the use conditions required for use of hydrofluoroolefin (HFO)-1234yf (2,3,3,3-tetrafluoroprop-1-ene), a substitute for ozone-depleting substances (ODSs) in the motor vehicle air conditioning end-use within the refrigeration and air conditioning sector, to be acceptable subject to use conditions under EPA's Significant New Alternatives Policy (SNAP) program. The revised use condition incorporates by reference a revised standard from SAE International.
This rule is effective on May 21, 2012 without further notice, unless EPA receives adverse comment or receives a request for a public hearing by April 23, 2012. If we receive adverse comment or a request for a public hearing, we will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA- HQ-OAR- 2011-0776 by one of the following methods:
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EPA has established a public docket for this action under Docket ID No. EPA-HQ-OAR-2011-0776. All documents in the docket are listed on the
Margaret Sheppard, Stratospheric Protection Division, Office of Atmospheric Programs; Environmental Protection Agency, Mail Code 6205J, 1200 Pennsylvania Avenue NW., Washington DC 20460; telephone number (202) 343-9163, fax number, (202) 343-2338; email address at
EPA is publishing this rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. We are revising an existing use condition for hydrofluoroolefin (HFO)-1234yf (2,3,3,3-tetrafluoroprop-1-ene) in motor vehicle air conditioning (MVAC) by incorporating by reference an updated edition of a standard from SAE International and clarifying the scope of the use condition. EPA previously listed HFO-1234yf as acceptable, subject to use conditions, for use in MVAC systems in new passenger cars and light-duty trucks (March 29, 2011; 76 FR 17488). This action does not place any significant burden on the regulated community and ensures consistency with standard industry practices.
In the “Proposed Rules” section of today's
You may claim that information in your comments is confidential business information (CBI), as allowed by 40 CFR Part 2. If you submit comments and include information that you claim as CBI, we request that you submit them directly to Margaret Sheppard at the address under
This final rule regulates the use of the chemical HFO-1234yf (2,3,3,3-tetrafluoroprop-1-ene, Chemical Abstracts Service Registry Number [CAS Reg. No.] 754-12-1) as a refrigerant in new motor vehicle air conditioning (MVAC) systems in new passenger cars and light-duty trucks. Businesses in this end-use that might want to use HFO-1234yf in new MVAC systems in the future include:
Regulated entities may include:
EPA's Significant New Alternatives Policy (SNAP) program has a long-standing approach of requiring unique fittings for use with each refrigerant substitute for CFC-12 in MVAC systems. This is intended to prevent cross-contamination of different refrigerants, preserve the purity of recycled refrigerants, and ultimately to avoid venting of refrigerant. In the 1996 SNAP rule requiring the use of fittings on all refrigerants submitted for the use in MVAC systems, EPA urged industry to develop mechanisms to ensure that the refrigerant venting prohibition under Clean Air Act (CAA) Section 608 and 40 CFR 82.154 is observed (61 FR 54032; October 16, 1996). EPA has issued multiple rules codified in the Code of Federal Regulations (CFR) requiring the use of fittings unique to a refrigerant for use on “containers of the refrigerant, on can taps, on recovery, recycling, and charging equipment, and on all [motor vehicle] air conditioning system service ports.” (See, e.g., appendices C and D to subpart G of 40 CFR part 82)
On March 29, 2011, EPA listed HFO-1234yf as acceptable, subject to use conditions, for use in MVAC systems in new passenger cars and light-duty trucks (76 FR 17488). The use conditions contain two requirements for unique fittings to be used with the refrigerant containers for HFO-1234yf. First, the rule requires the use of the unique fittings, specified in SAE International
In this direct final rule, we are revising the requirement for the unique fitting (also known as a connection or coupler) to be used with large refrigerant containers. The new requirement is that containers of HFO-1234yf for use in professional servicing
EPA recognizes that the fitting in the October 2011 edition of SAE J2844 is not “unique” in its direction and diameter, as per the criteria for uniqueness mentioned in appendix H to subpart G of 40 CFR part 82. However, the Acme thread has a trapezoidal shape that makes it impossible to cross-connect this fitting with others already identified with the same thread direction and diameter which use different shaped thread. Therefore, we find this fitting to be unique, and we are allowing its use on refrigerant containers of HFO-1234yf used for professional servicing.
SAE International first established the standard SAE J2844, “R-1234yf (HFO-1234yf) New Refrigerant Purity and Container Requirements for Use in Mobile Air-Conditioning Systems” in February 2011. Shortly thereafter, the committee responsible for this standard decided that revisions to the standard were appropriate (June 13, 2011 Letter from K. Horen, Honeywell). In particular, the committee decided that the original “quick-connect” type fitting addressed in the February 2011 edition of SAE J2844 for refrigerant containers for servicing should be replaced by a screw-type valve. Quick-connect fittings are more likely to become dislodged and to release refrigerant without warning to the service technician. In contrast, if a screw-type valve is not properly
We believe that incorporating the revised industry standard is consistent with the Clean Air Act and, as described above, we believe that the fitting in the revised industry standard is unique even though it does not meet all of the criteria specified in appendix H to subpart G of 40 CFR part 82. Further, the new fittings adopted in the revised standard may have an environmental benefit by reducing the chance that an entire container of refrigerant could leak without detection. Therefore, we are revising the use condition to reference the October 2011 edition of the SAE J2844 standard for purposes of the fittings for large containers of HFO-1234yf for use in professional servicing.
During implementation of the March 2011 final rule, manufacturers of the refrigerant HFO-1234yf contacted EPA, asking for clarification of the fitting requirement for refrigerant containers. One manufacturer stated, based on its understanding, that this requirement was for containers for “professional service or service for consideration” and asked for clarification of this point (June 22, 2011 Letter from S. Bernhardt, Honeywell). Further, the manufacturer stated that, for cylinders greater than 50 lbs, it planned to use a specific fitting approved by the Cylinder Gas Association (CGA 670 fitting), and for cylinders greater than 450 lbs, industrial fittings would be used (June 13, 2011 Letter from K. Horen, Honeywell). Manufacturers expressed concerns that the quick-connect fitting in SAE standard J2844 (February 2011 edition) incorporated by reference in the final rule was not robust enough to use with large refrigerant containers, particularly containers used for industrial transfer or for bulk packing sent to automobile manufacturers for initial filling of MVAC systems.
In this direct final rule, we clarify that the requirement for the unique fittings on refrigerant containers of HFO-1234yf applies to containers for use for professional servicing. In the “Further Information” column of our decision, we state that, for HFO-1234yf, refrigerant containers for use in professional servicing are from 5 lbs to 50 lbs in size. Based on information from the refrigerant manufacturer, containers larger than 50 lbs would not be intended for use in professional servicing (June 13, 2011 Letter from K. Horen, Honeywell). We expect that refrigerant containers for HFO-1234yf larger than 50 lbs, with a volume larger than 23 liters, are used for transport and industrial transfer of refrigerant, rather than for servicing. Under section 4.1.1.2 of SAE J2844 (October 2011 edition), such cylinders are required to “comply with the fitting requirements specified by applicable transportation rules and laws.”
EPA's concerns at the time it first established the requirement for unique fittings for MVAC substitutes were (1) the potential for cross-contamination of refrigerant due to mixing and (2) the need for purity of recycled refrigerant (61 FR 54033). We are also concerned about unintended incentives for intentional venting because contaminated refrigerant would no longer be of economic value and because separation or destruction of cross-contaminated refrigerant costs more than venting. These are concerns that primarily are implicated during servicing of the MVAC system. It is far more likely that a technician might intentionally or unintentionally try to charge equipment with a different refrigerant during servicing of an MVAC system than that someone would transfer a refrigerant to a very large container (i.e., larger than 50 lbs) containing a different refrigerant. Thus, we clarify that the requirement for a unique fitting for containers of HFO-1234yf applies to containers to be used for professional servicing (sizes of 5 to 50 lbs).
Finally, we note that our final rule listing HFO-1234yf as acceptable subject to use conditions did not apply to small containers. The refrigerant manufacturer would need to submit a unique fitting specifically for use with small can taps and small refrigerant containers before EPA could determine whether to find use of such small containers acceptable under SNAP. In addition, such containers could not be sold until a significant new use notice is submitted to EPA, consistent with EPA's final significant new use rule for HFO-1234yf under the Toxic Substances Control Act (October 27, 2010; 75 FR 65987).
CAA Section 612 requires EPA to develop a program for evaluating alternatives to ozone-depleting substances (ODS). EPA refers to this program as the SNAP program. The major provisions of Section 612 are:
Section 612(c) requires EPA to promulgate rules making it unlawful to replace any class I substance (i.e., chlorofluorocarbon, halon, carbon tetrachloride, methyl chloroform, methyl bromide, and hydrobromofluorocarbon) or class II substance (i.e., hydrochlorofluorocarbon) with any substitute that the Administrator determines may present adverse effects to human health or the environment where the Administrator has identified an alternative that (1) reduces the overall risk to human health and the environment, and (2) is currently or potentially available.
Section 612(c) requires EPA to publish a list of the substitutes unacceptable for specific uses and to publish a corresponding list of acceptable alternatives for specific uses. The list of acceptable substitutes is found at
Section 612(d) grants the right to any person to petition EPA to add a substance to, or delete a substance from, the lists published in accordance with Section 612(c). The Agency has 90 days to grant or deny a petition. Where the Agency grants the petition, EPA must publish the revised lists within an additional six months.
Section 612(e) directs EPA to require any person who produces a chemical substitute for a class I substance to notify the Agency not less than 90 days before new or existing chemicals are introduced into interstate commerce for significant new uses as substitutes for a class I substance. The producer must also provide the Agency with the producer's unpublished health and safety studies on such substitutes.
Section 612(b)(1) states that the Administrator shall seek to maximize the use of federal research facilities and resources to assist users of class I and II substances in identifying and developing alternatives to the use of
Section 612(b)(4) requires the Agency to set up a public clearinghouse of alternative chemicals, product substitutes, and alternative manufacturing processes that are available for products and manufacturing processes which use class I and II substances.
On March 18, 1994, EPA published the original rulemaking (59 FR 13044) which established the process for administering the SNAP program and issued EPA's first lists identifying acceptable and unacceptable substitutes in the major industrial use sectors (subpart G of 40 CFR part 82). These sectors—refrigeration and air conditioning; foam blowing; cleaning solvents; fire suppression and explosion protection; sterilants; aerosols; adhesives, coatings and inks; and tobacco expansion—are the principal industrial sectors that historically consumed the largest volumes of ODS.
CAA Section 612 requires EPA to ensure that substitutes found acceptable do not present a significantly greater risk to human health and the environment than other substitutes that are currently or potentially available.
Under the SNAP regulations, anyone who plans to market or produce a substitute to replace a class I substance or class II substance in one of the eight major industrial use sectors must provide notice to the Agency, including health and safety information on the substitute, at least 90 days before introducing it into interstate commerce for significant new use as an alternative. This requirement applies to the persons planning to introduce the substitute into interstate commerce,
The Agency has identified four possible decision categories for substitutes that are submitted for evaluation: acceptable; acceptable subject to use conditions; acceptable subject to narrowed use limits; and unacceptable (40 CFR 82.180(b)). Use conditions and narrowed use limits are both considered “use restrictions” and are explained in the paragraphs below. Substitutes that are deemed acceptable with no use restrictions (no use conditions or narrowed use limits) can be used for all applications within the relevant end-uses within the sector.
After reviewing a substitute, the Agency may determine that a substitute is acceptable only if certain conditions in the way that the substitute is used are met to minimize risks to human health and the environment. EPA describes such substitutes as “acceptable subject to use conditions.” Entities that use these substitutes without meeting the associated use conditions are in violation of EPA's SNAP regulations.
For some substitutes, the Agency may permit a narrowed range of use within an end-use or sector. For example, the Agency may limit the use of a substitute to certain end-uses or specific applications within an industry sector. EPA describes these substitutes as “acceptable subject to narrowed use limits.” The Agency requires the user of a narrowed-use substitute to demonstrate that no other acceptable substitutes are available for the specific application by conducting comprehensive studies. A person using a substitute that is acceptable subject to narrowed use limits in applications and end-uses that are not consistent with the narrowed use limit is using the substitute in an unacceptable manner and is in violation of Section 612 of the CAA and EPA's SNAP regulations.
The Agency publishes its SNAP program decisions in the
In contrast, EPA publishes decisions concerning substitutes that are deemed acceptable with no restrictions in “notices of acceptability,” rather than as proposed and final rules. As described in the March 18, 1994, rule initially implementing the SNAP program, EPA does not believe that rulemaking procedures are necessary to list alternatives that are acceptable without restrictions because such listings neither impose any sanction nor prevent anyone from using a substitute (59 FR 13047).
Many SNAP listings include “Comments” or “Further Information” to provide additional information on substitutes. Since this additional information is not part of the regulatory decision, these statements are not binding for use of the substitute under the SNAP program. However, regulatory requirements so listed are binding under other regulatory programs (e.g., worker protection regulations promulgated by the Occupational Safety and Health Administration (OSHA)). The “Further Information” classification does not necessarily include all other legal obligations pertaining to the use of the substitute. While the items listed are not legally binding under the SNAP program, EPA encourages users of substitutes to apply all statements in the “Further Information” column in their use of these substitutes. In many instances, the information simply refers to sound operating practices that have already been identified in existing industry and/or building codes or standards. Thus many of the statements, if adopted, would not require the affected user to make significant changes in existing operating practices.
For copies of the comprehensive SNAP lists of substitutes or additional information on SNAP, refer to EPA's Ozone Depletion Web site at:
This action is not a “significant regulatory action” under the terms of
This action does not impose any new information collection burden. It contains no new requirements for reporting. However, the Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations in subpart G of 40 CFR part 82 under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statutes unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; for NAICS code 336111 (Automobile manufacturing), a small business has <1000 employees; for NAICS code 336391 (Motor Vehicle Air-Conditioning Manufacturing), a small business has <750 employees; and for NAICS code 811111 (General Automotive Repair), a small business has annual receipts of less than $7.0 million (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of today's final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. The small entities directly regulated by this final rule are small businesses involved in automotive repair. This final rule will not impose any requirements on small entities beyond current industry practices. Today's action effectively ensures consistency with current industry practices, whereas without these revisions, small businesses would need to reconcile differences between EPA regulations and industry standards.
It is not clear that there would be any cost differential between these new unique fittings, those used with the current automotive refrigerant, HFC-134a, or other fittings that the automotive industry could adopt instead. It is possible that the fittings required in the revised use condition will be less expensive than those required in the March 29, 2011 final rule because they are a standard shape and size easily produced in a metal-working shop. Thus, cost impacts of this final rule on small entities are expected to be small. This final rule is expected to relieve burden for some small entities, such as automotive repair shops, by avoiding confusion over which fittings to use and by using a more robust fitting that allows quick detection of any leaks from the valve.
Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this rule on small entities. EPA has worked together with SAE International and with groups representing professional service technicians such as the Mobile Air Conditioning Society Worldwide, which conducts regular outreach with technicians and owners of small businesses such as retail refrigerant suppliers and automobile repair shops.
This rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. This final rule will not impose any requirements beyond current industry practices, and thus, compliance costs are expected to be small. Thus, this rule is not subject to the requirements of sections 202 or 205 of UMRA.
This rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. The requirements of this rule apply to the servicing of motor vehicle air conditioning systems. The requirements of this rule for unique fittings are expected to be comparable in cost to those of current fittings. Requirements would be the same as those imposed on any other entity performing servicing on motor vehicle air conditioning systems.
This final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This regulation applies directly to facilities that use these substances and not to governmental entities. Thus, Executive Order 13132 does not apply to this rule.
This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It does not significantly or uniquely affect the communities of Indian tribal governments, because this regulation applies directly to facilities that use these substances and not to governmental entities. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to EO 13045 (62 FR 19885, April 23, 1997) because it is not economically significant as defined in EO 12866, and because the Agency does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action only concerns allowing use of a specific fitting that may reduce technician's exposure in the course of professional servicing of MVAC systems. Therefore, we did not conduct further health or risk assessments beyond those in the original rulemaking (March 29, 2011; 76 FR 17488).
This action is not subject to Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not a significant
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, Section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
This rulemaking involves technical standards. EPA has decided to use SAE International's SAE J2844 standard, “R-1234yf (HFO-1234yf) New Refrigerant Purity and Container Requirements for Use in Mobile Air-Conditioning Systems”. This standard can be obtained from
Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This final rule requires specific use conditions for unique fittings for use with refrigerant containers for professional servicing of MVAC systems, for those servicing MVAC systems using this low GWP refrigerant alternative. It does not directly affect the amount of exposure to or emissions of HFO-1234yf expected.
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Reporting and recordkeeping requirements, Stratospheric ozone layer.
For the reasons set out in the preamble, 40 CFR part 82 is amended as follows:
42 U.S.C. 7414, 7601, 7671-7671q.
In rule document 2012-4475 appearing on pages 12913 through 12924 in the issue of Friday, March 2, 2012 make the following correction. On page 12918, Part 52—Solicitation Provisions and Contract Clauses, is reprinted in its entirety due to numerous errors. It should appear as follows:
(c) * * *
(6) * * *
(ii) It ☐ is, ☐ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [
(7) * * *
(i) It ☐ is, ☐ is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and
(ii) It ☐ is, ☐ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [
(b) * * *
_ (24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (APR 2012) (15 U.S.C. 637(m)).
_ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (APR 2012) (15 U.S.C. 637(m)).
(b) * * *
(4) * * *
(ii) It ☐ is, ☐ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (b)(4)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [
(5) * * *
(ii) It ☐ is, ☐ is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (b)(5)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [
The revised text reads as follows:
The revised text reads as follows:
(c)
(2) Any award resulting from this solicitation will be made to a WOSB concern eligible under the WOSB Program.
(3) The Contracting Officer will ensure that the apparent successful offeror has provided the required documents to the WOSB Program Repository. The contract shall not be awarded until all required documents are received.
(d)
(e)
(5) The procuring activity executes the contract in the name of the WOSB concern
In rule document 2012-4495 appearing on pages 12935 through 12937 in the issue of Friday, March 2 2012, make the following correction. On page 12936, Part 52—Solicitation Provisions and Contract Clauses, is reprinted in its entirety due to numerous errors. It should appear as follows:
(b) * * *
_ (27) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (MAR 2012) (E.O. 13126).
_ (41) 52.225-5, Trade Agreements (MAR 2012) (19 U.S.C. 2501,
(b) * * *
(1) * * *
(i) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (MAR 2012) (E.O. 13126). (Applies to contracts for supplies exceeding the micro-purchase threshold.)
(b) * * * Those countries are Albania, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Macao China, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan (Chinese Taipei), and the United Kingdom.
Fish and Wildlife Service, Interior.
Final rule.
The U.S. Fish and Wildlife Service (Service or we) establishes migratory bird subsistence harvest regulations in Alaska for the 2012 season. These regulations will enable the continuation of customary and traditional subsistence uses of migratory birds in Alaska and prescribe regional information on when and where the harvesting of birds may occur. These regulations were developed under a co-management process involving the Service, the Alaska Department of Fish and Game, and Alaska Native representatives. The rulemaking is necessary because the regulations governing the subsistence harvest of migratory birds in Alaska are subject to
The amendments to subpart D of 50 CFR part 92 are effective April 2, 2012, through August 31, 2012.
Fred Armstrong, (907) 786-3887, or Donna Dewhurst, (907) 786-3499, U.S. Fish and Wildlife Service, 1011 E. Tudor Road, Mail Stop 201, Anchorage, AK 99503.
These regulations will take effect less than 30 days after publication. If there were a delay in the effective date of these regulations after this final rulemaking, subsistence hunters would not be able to take full advantage of their subsistence hunting opportunities. We therefore find that “good cause” exists justifying the earlier start date, within the terms of 5 U.S.C. 553(d)(3) of the Administrative Procedure Act, and, under authority of the Migratory Bird Treaty Act (July 3, 1918), as amended (16 U.S.C. 703-711).
This rulemaking is necessary because, by law, the migratory bird harvest season is closed unless opened by the Secretary of the Interior, and the regulations governing subsistence harvest of migratory birds in Alaska are subject to public review and annual approval. This rule establishes regulations for the taking of migratory birds for subsistence uses in Alaska during the spring and summer of 2012. This rule establishes a list of migratory bird season openings and closures in Alaska by region.
Background information, including past events leading to this rulemaking, accomplishments since the Migratory Bird Treaties with Canada and Mexico were amended, and a history, was originally addressed in the
The U.S. Fish and Wildlife Service (Service or we) are establishing migratory bird subsistence harvest regulations in Alaska for the 2012 season. These regulations enable the continuation of customary and traditional subsistence uses of migratory birds in Alaska and prescribe regional information on when and where the harvesting of birds may occur. These final regulations were developed under a co-management process involving the Service, the Alaska Department of Fish and Game, and Alaska Native representatives.
We opened the process to establish regulations for the 2012 spring and summer subsistence harvest of migratory birds in Alaska in a proposed rule published in the
The Alaska Migratory Bird Co-management Council (Co-management Council) held a meeting in June 2011, to develop recommendations for changes that would take effect during the 2012 harvest season. These recommendations were presented first to the Flyway Councils and then to the Service Regulations Committee at the committee's meeting on July 27 and 28, 2011.
On November 3, 2011, we published in the
Eligibility to harvest under the regulations established in 2003 was limited to permanent residents, regardless of race, in villages located within the Alaska Peninsula, Kodiak Archipelago, the Aleutian Islands, and in areas north and west of the Alaska Range (50 CFR 92.5). These geographical restrictions opened the initial migratory bird subsistence harvest to about 13 percent of Alaska residents. High populated areas such as Anchorage, the Matanuska-Susitna and Fairbanks North Star boroughs, the Kenai Peninsula roaded area, the Gulf of Alaska roaded area, and Southeast Alaska were excluded from eligible subsistence harvest areas.
Based on petitions requesting inclusion in the harvest, in 2004, we added 13 additional communities based on criteria set forth in 50 CFR 92.5(c). These communities were Gulkana, Gakona, Tazlina, Copper Center, Mentasta Lake, Chitina, Chistochina, Tatitlek, Chenega, Port Graham, Nanwalek, Tyonek, and Hoonah, with a combined population of 2,766. In 2005, we added three additional communities for glaucous-winged gull egg gathering only, based on petitions requesting inclusion. These southeastern communities were Craig, Hydaburg, and Yakutat, with a combined population of 2,459, based on the latest census information at that time.
In 2007, we enacted the Alaska Department of Fish and Game's request to expand the Fairbanks North Star Borough excluded area to include the Central Interior area. This action excluded the following communities from participation in this harvest: Big Delta/Fort Greely, Healy, McKinley Park/Village, and Ferry, with a combined population of 2,812.
Regulations finalized in this rule are identical to those for the 2011 harvest season. However, at the June 2, 2011, Co-Management Council meeting, the Yukon/Kuskokwim Delta and Kodiak Archipelago regional representatives requested to remove their respective regions from 2012 regulations by not approving the consent agenda. Annually, the migratory bird subsistence season in Alaska is closed until regulations are passed that open the upcoming season. If regulations do not change from year to year, the 11 Alaska regions opt to vote a consent agenda whereby regulations from the previous year (2011) are accepted for the following year (2012).
The justification provided at the Co-Management Council Meeting by the Yukon/Kuskokwim Delta representative was that the region could not support regulations that included the duck stamp requirement. The representative indicated that there was a conflict in the application of other federal requirements to the Alaska Migratory Bird Co-Management Council (AMBCC) regulations and that the Federal
The justification provided by the Kodiak Archipelago representative was that the Kodiak Island representative expressed concerns that he was not familiar with the AMBCC process and was not familiar with the history of the regional regulations. The Kodiak Archipelago representative indicated that, based on discussions with local elders, they are not supportive of the closure areas or dates and could not support them. He indicated that there is egg gathering in the Kodiak Island region and that was another reason why he could not support a closure that would stop that activity.
After the Co-Management Council meeting, the Alaska Regional Director and his staff contacted both regional representatives to inform them that the Service Regulations Committee would have to implement regulations to provide harvest opportunities for subsistence users who take migratory birds in those areas and elsewhere. The Service Regulations Committee met on July 28, 2011, and does not support the lack of subsistence regulations in the Yukon/Kuskokwim and Kodiak Archipelago Regions. Therefore, the Service is continuing the 2011 regulations for those two regions through the 2012 season without change. Justification to finalize these regulations is to provide a continuity of the regulations affecting subsistence harvesters in those areas.
We have monitored subsistence harvest for the past 25 years through the use of annual household surveys in the most heavily used subsistence harvest areas, such as the Yukon-Kuskokwim Delta. In recent years, more intensive surveys combined with outreach efforts focused on species identification have been added to improve the accuracy of information gathered from regions still reporting some subsistence harvest of listed or candidate species.
Spectacled eiders
The Service has dual goals and responsibilities for authorizing a subsistence harvest while protecting migratory birds and threatened species. Although these goals continue to be challenging, they are not irreconcilable, providing sufficient recognition is given to the need to protect threatened species, measures to remedy documented threats are implemented, and the subsistence community and other conservation partners commit to working together. With these dual goals in mind, the Service, working with North Slope partners, developed measures in 2009 to further reduce the potential for shooting mortality or injury of closed species. These conservation measures included: (1) Increased waterfowl hunter outreach and community awareness through partnering with the North Slope Migratory Bird Task Force; (2) continued enforcement of the migratory bird regulations that are protective of listed eiders; and (3) in-season Service verification of the harvest to detect Steller's eider mortality.
This final rule continues to focus on the North Slope from Barrow through Point Hope because Steller's eiders from the listed Alaska breeding population are known to breed and migrate there. These regulations were designed to address several ongoing eider management needs by clarifying for subsistence users that (1) Service law enforcement personnel have authority to verify species of birds possessed by hunters, and (2) it is illegal to possess any bird closed to harvest. This rule also describes how the Service's existing authority of emergency closure will be implemented, if necessary, to protect Steller's eiders. We are always willing to discuss regulations with our partners on the North Slope to ensure these protect closed species as well as provide subsistence hunters an opportunity to harvest migratory birds in a way that maintains the culture and traditional harvest of the community. The regulations pertaining to bag checks and possession of illegal birds are deemed necessary to verify compliance with not harvesting protected eider species.
The Service is aware of and appreciates the considerable efforts by North Slope partners to raise awareness and educate hunters on Steller's eider conservation via the bird fair, meetings, radio shows, signs, school visits, and one-on-one contacts. We also recognize that no listed eiders have been documented shot in the last 3 years, even with the first significant breeding season in recent years for Steller's eiders occurring in the Barrow area this past summer. The Service acknowledges progress made with the other eider conservation measures including partnering with the North Slope Migratory Bird Task Force for increased waterfowl hunter awareness, continued enforcement of the regulations, and in-season verification of the harvest. Our primary strategy to reduce the threat of shooting mortality of threatened eiders is to continue working with North Slope partners to conduct education, outreach, and harvest monitoring. In addition, the emergency closure authority provides another level of assurance if an unexpected amount of Steller's eider shooting mortality occurs (50 CFR 92.21 and 50 CFR 92.32).
In-season harvest monitoring information will be used to evaluate the efficacy of regulations, conservation measures, and outreach efforts. During 2009 through 2011, no Steller's eiders were reported being taken on the North Slope, and no Steller's eiders were found shot during in-season verification of the subsistence harvest. Based on these successes, the 2011 conservation measures will also be continued, although there will be some modification of the amount of effort and emphasis each will receive. Specifically, local communities have continued to develop greater responsibility for taking actions to ensure Steller's and spectacled eider conservation and recovery, and based on last year's observations, local hunters have demonstrated greater compliance with hunting regulations.
The longstanding general emergency closure provision at 50 CFR 92.21 specifies that the harvest may be closed or temporarily suspended upon finding that a continuation of the regulation allowing the harvest would pose an imminent threat to the conservation of any migratory bird population. With regard to Steller's eiders, the regulation at 50 CFR 92.32, carried over from the past 2 years, would clarify that we will take action under 50 CFR 92.21 as is necessary to prevent further take of Steller's eiders, and that action could include temporary or long-term closures of the harvest in all or a portion of the geographic area open to harvest. If mortality of threatened eiders occurs, we will evaluate each mortality event by criteria such as cause, quantity, sex, age, location, and date. We will consult with
Yellow-billed loon (
Consistent with the request of the North Slope Borough Fish and Game Management Committee and the recommendation of the Co-management Council, this rule continues through 2012 the provisions originally established in 2005, to allow subsistence use of yellow-billed loons inadvertently entangled in subsistence fishing (gill) nets on the North Slope. Yellow-billed loons are culturally important to the Inupiat Eskimo of the North Slope for use in traditional dance regalia. A maximum of 20 yellow-billed loons may be kept if found entangled in fishing nets in 2012, under this provision. This provision does not authorize intentional harvest of yellow-billed loons, but allows use of those loons inadvertently entangled during normal subsistence fishing activities.
In 2010, the Service Regulations Committee's continued support of this provision was contingent on the North Slope Borough collaborating with the Service and the Co-Management Council to design and implement, in 2011, a scientifically defensible survey to estimate the number of yellow-billed loons entangled in subsistence fishing nets. During June 2011, the North Slope submitted a proposal entitled, “Assessment of Yellow-Billed Loons Inadvertently Entangled in Subsistence Fishing Nets in the North Slope Borough” that has been endorsed by the Alaska Department of Fish and Game and the Service. The Service Regulations Committee met on July 28, 2011, and appreciated the efforts by the North Slope Borough to develop a scientifically defensible yellow-billed loon entanglement survey and therefore supported continuation of the provision to allow subsistence use of up to 20 yellow-billed loons inadvertently caught in subsistence fishing nets.
Section 7 of the Endangered Species Act (16 U.S.C. 1536) requires the Secretary of the Interior to “review other programs administered by him and utilize such programs in furtherance of the purposes of the Act” and to “insure that any action authorized, funded, or carried out * * * is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of [critical] habitat * * *” We conducted an intra-agency consultation with the Fairbanks Fish and Wildlife Field Office on this harvest as it will be managed in accordance with this final rule and the conservation measures. The consultation was completed with a March 14, 2012, biological opinion that concluded the final rule and conservation measures are not likely to jeopardize the continued existence of Steller's eider, spectacled eider, yellow-billed loon, or Kittlitz's murrelet, or result in the destruction or adverse modification of designated critical habitat for Steller's eider or spectacled eider.
On November 3, 2011, we published in the
We derive our authority to issue these regulations from the Migratory Bird Treaty Act of 1918, at 16 U.S.C. 712(1), which authorizes the Secretary of the Interior, in accordance with the treaties with Canada, Mexico, Japan, and Russia, to “issue such regulations as may be necessary to assure that the taking of migratory birds and the collection of their eggs, by the indigenous inhabitants of the State of Alaska, shall be permitted for their own nutritional and other essential needs, as determined by the Secretary of the Interior, during seasons established so as to provide for the preservation and maintenance of stocks of migratory birds.”
The Office of Management and Budget (OMB) has determined that this rule is not significant and has not reviewed this rule under Executive Order 12866 (E.O. 12866). OMB bases its determination upon the following four criteria:
(a) Whether the rule will have an annual effect of $100 million or more on the economy or adversely affect an economic sector, productivity, jobs, the environment, or other units of the government.
(b) Whether the rule will create inconsistencies with other Federal agencies' actions.
(c) Whether the rule will materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients.
(d) Whether the rule raises novel legal or policy issues.
The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:
(a) Will not have an annual effect on the economy of $100 million or more. It legalizes and regulates a traditional subsistence activity. It will not result in a substantial increase in subsistence harvest or a significant change in harvesting patterns. The commodities being regulated under this final rule are migratory birds. This rule deals with legalizing the subsistence harvest of migratory birds and, as such, does not involve commodities traded in the marketplace. A small economic benefit from this final rule derives from the sale of equipment and ammunition to carry out subsistence hunting. Most, if not all, businesses that sell hunting equipment in rural Alaska qualify as small businesses. We have no reason to believe that this final rule will lead to a disproportionate distribution of benefits.
(b) Will not cause a major increase in costs or prices for consumers; individual industries; Federal, State, or local government agencies; or geographic regions. This final rule does not deal with traded commodities and, therefore, does not have an impact on prices for consumers.
(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This final rule deals with the harvesting of wildlife for personal consumption. It does not regulate the marketplace in any way to generate effects on the economy or the ability of businesses to compete.
We have determined and certified under the Unfunded Mandates Reform Act (2 U.S.C. 1501
Under the criteria in Executive Order 12630, this final rule does not have significant takings implications. This final rule is not specific to particular land ownership, but applies to the harvesting of migratory bird resources throughout Alaska. A takings implication assessment is not required.
Under the criteria in Executive Order 13132, this final rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. We discuss effects of this final rule on the State of Alaska in the Unfunded Mandates Reform Act section above. We worked with the State of Alaska to develop these regulations. Therefore, a federalism summary impact statement is not required.
The Department, in promulgating this final rule, has determined that it will not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of Executive Order 12988.
In keeping with the spirit of the President's memorandum of April 29, 1994, “Government-to-Government Relations With Native American Tribal Governments” (59 FR 22951), and Executive Order 13175 (65 FR 67249; November 6, 2000), concerning consultation and coordination with Indian Tribal Governments, we submitted over 413 letters to all tribes, tribal entities, and Native Corporations in Alaska soliciting their input as to whether or not they would like the Service to consult with them on the 2012 migratory bird subsistence harvest regulations. We received 5 responses, of which 3 requested consultation, and one indicated they were happy with the process and did not want consultation. We did follow up with a call to the latter tribe, and they were undecided as to what they wanted to do. We conducted 3 consultations with the tribes on December 4, 2012. All 3 tribes were happy with the information provided and did not have any comments on the regulations.
We implemented the amended treaty with Canada with a focus on local involvement. The treaty calls for the creation of management bodies to ensure an effective and meaningful role for Alaska's indigenous inhabitants in
This final rule has been examined under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The annual regulations and options were considered in the environmental assessment, “Managing Migratory Bird Subsistence Hunting in Alaska: Hunting Regulations for the 2012 Spring/Summer Harvest,” October 25, 2011. Copies are available from either the person listed under
Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This is not a significant regulatory action under this Executive Order; it will allow only for traditional subsistence harvest and will improve conservation of migratory birds by allowing effective regulation of this harvest. Further, this final rule is not expected to significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action under Executive Order 13211, and no Statement of Energy Effects is required.
Hunting, Treaties, Wildlife.
For the reasons set out in the preamble, we amend title 50, chapter I, subchapter G, of the Code of Federal Regulations as follows:
16 U.S.C. 703-712.
The 2012 season dates for the eligible subsistence harvest areas are as follows:
(a)
(1) Northern Unit (Pribilof Islands):
(i) Season: April 2-June 30.
(ii) Closure: July 1-August 31.
(2) Central Unit (Aleut Region's eastern boundary on the Alaska Peninsula westward to and including Unalaska Island):
(i) Season: April 2-June 15 and July 16-August 31.
(ii) Closure: June 16-July 15.
(iii) Special Black Brant Season Closure: August 16-August 31, only in Izembek and Moffet lagoons.
(iv) Special Tundra Swan Closure: All hunting and egg gathering closed in units 9(D) and 10.
(3) Western Unit (Umnak Island west to and including Attu Island):
(i) Season: April 2-July 15 and August 16-August 31.
(ii) Closure: July 16-August 15.
(b)
(1) Season: April 2-August 31.
(2) Closure: 30-day closure dates to be announced by the Service's Alaska Regional Director or his designee, after consultation with field biologists and the Association of Village Council President's Waterfowl Conservation Committee. This 30-day period will occur between June 1 and August 15 of each year. A press release announcing the actual closure dates will be forwarded to regional newspapers and radio and television stations.
(3) Special Black Brant and Cackling Goose Season Hunting Closure: From the period when egg laying begins until young birds are fledged. Closure dates to be announced by the Service's Alaska Regional Director or his designee, after consultation with field biologists and the Association of Village Council President's Waterfowl Conservation Committee. A press release announcing the actual closure dates will be forwarded to regional newspapers and radio and television stations.
(c)
(1) Season: April 2-June 14 and July 16-August 31 (general season); April 2-July 15 for seabird egg gathering only.
(2) Closure: June 15-July 15 (general season); July 16-August 31 (seabird egg gathering).
(d)
(1) Stebbins/St. Michael Area (Point Romanof to Canal Point):
(i) Season: April 15-June 14 and July 16-August 31.
(ii) Closure: June 15-July 15.
(2) Remainder of the region:
(i) Season: April 2-June 14 and July 16-August 31 for waterfowl; April 2-July 19 and August 21-August 31 for all other birds.
(ii) Closure: June 15-July 15 for waterfowl; July 20-August 20 for all other birds.
(e)
(1) Season: April 2-June 30 and July 31-August 31 for seabirds; April 2-June 20 and July 22-August 31 for all other birds.
(2) Closure: July 1-July 30 for seabirds; June 21-July 21 for all other birds.
(f)
(1) Season: April 2-June 9 and August 15-August 31 (hunting in general); waterfowl egg gathering May 20-June 9 only; seabird egg gathering May 20-July 12 only; hunting molting/non-nesting waterfowl July 1-July 31 only.
(2) Closure: June 10-August 14, except for the taking of seabird eggs and molting/non-nesting waterfowl as provided in paragraph (f)(1) of this section.
(g)
(1) Southern Unit (Southwestern North Slope regional boundary east to Peard Bay, everything west of the longitude line 158°30′ W and south of the latitude line 70°45′ N to the west bank of the Ikpikpuk River, and everything south of the latitude line 69°45′ N between the west bank of the Ikpikpuk River to the east bank of Sagavinirktok River):
(i) Season: April 2-June 29 and July 30-August 31 for seabirds; April 2-June 19 and July 20-August 31 for all other birds.
(ii) Closure: June 30-July 29 for seabirds; June 20-July 19 for all other birds.
(iii) Special Black Brant Hunting Opening: From June 20-July 5. The open area would consist of the coastline, from mean high water line outward to include open water, from Nokotlek Point east to longitude line 158°30′ W. This includes Peard Bay, Kugrua Bay, and Wainwright Inlet, but not the Kuk and Kugrua river drainages.
(2) Northern Unit (At Peard Bay, everything east of the longitude line 158°30′ W and north of the latitude line 70°45′ N to west bank of the Ikpikpuk River, and everything north of the latitude line 69°45′ N between the west bank of the Ikpikpuk River to the east bank of Sagavinirktok River):
(i) Season: April 6-June 6 and July 7-August 31 for king and common eiders; April 2-June 15 and July 16-August 31 for all other birds.
(ii) Closure: June 7-July 6 for king and common eiders; June 16-July 15 for all other birds.
(3) Eastern Unit (East of eastern bank of the Sagavanirktok River):
(i) Season: April 2-June 19 and July 20-August 31.
(ii) Closure: June 20-July 19.
(4) All Units: yellow-billed loons. Annually, up to 20 yellow-billed loons total for the region may be inadvertently entangled in subsistence fishing nets in the North Slope Region and kept for subsistence use.
(5) North Coastal Zone (Cape Thompson north to Point Hope and east along the Arctic Ocean coastline around Point Barrow to Ross Point, including Iko Bay, and 5 miles inland).
(i) No person may at any time, by any means, or in any manner, possess or have in custody any migratory bird or part thereof, taken in violation of subparts C and D of this part.
(ii) Upon request from a Service law enforcement officer, hunters taking, attempting to take, or transporting migratory birds taken during the subsistence harvest season must present them to the officer for species identification.
(h)
(1) Season: April 2-June 14 and July 16-August 31; egg gathering May 1-June 14 only.
(2) Closure: June 15-July 15.
(i)
(1) Season: April 15-May 26 and June 27-August 31.
(2) Closure: May 27-June 26.
(3) The Copper River Basin communities listed above also documented traditional use harvesting birds in Unit 12, making them eligible to hunt in this unit using the seasons specified in paragraph (h) of this section.
(j)
(1) Prince William Sound Area (Harvest area: Unit 6[D]), (Eligible Chugach communities: Chenega Bay, Tatitlek):
(i) Season: April 2-May 31 and July 1-August 31.
(ii) Closure: June 1-30.
(2) Kachemak Bay Area (Harvest area: Unit 15[C] South of a line connecting the tip of Homer Spit to the mouth of Fox River) (Eligible Chugach Communities: Port Graham, Nanwalek):
(i) Season: April 2-May 31 and July 1-August 31.
(ii) Closure: June 1-30.
(k)
(1) Season: April 2-May 31—That portion of Unit 16(B) south of the Skwentna River and west of the Yentna River, and August 1-31—That portion of Unit 16(B) south of the Beluga River, Beluga Lake, and the Triumvirate Glacier:
(2) Closure: June 1-July 31.
(l)
(1) Community of Hoonah (Harvest area: National Forest lands in Icy Strait and Cross Sound, including Middle Pass Rock near the Inian Islands, Table Rock in Cross Sound, and other traditional locations on the coast of Yakobi Island. The land and waters of Glacier Bay National Park remain closed to all subsistence harvesting (50 CFR Part 100.3(a)):
(i) Season: glaucous-winged gull egg gathering only: May 15-June 30.
(ii) Closure: July 1-August 31.
(2) Communities of Craig and Hydaburg (Harvest area: small islands and adjacent shoreline of western Prince of Wales Island from Point Baker to Cape Chacon, but also including Coronation and Warren islands):
(i) Season: glaucous-winged gull egg gathering only: May 15-June 30.
(ii) Closure: July 1-August 31.
(3) Community of Yakutat (Harvest area: Icy Bay (Icy Cape to Point Riou), and coastal lands and islands bordering the Gulf of Alaska from Point Manby southeast to Dry Bay):
(i) Season: glaucous-winged gull egg gathering: May 15-June 30.
(ii) Closure: July 1-August 31.
Upon finding that continuation of the subsistence regulations in this subpart would pose an imminent threat to the conservation of threatened Steller's eiders
Executive Office of the President, Office of Management and Budget (OMB).
Advance notice of proposed guidance; extension of comment period.
The Office of Management and Budget (OMB) is extending the comment period for the Advance Notice of Proposed Guidance on Reform of Federal Policies Relating to Grants and Cooperative Agreements; cost principles and administrative requirements (including Single Audit Act). The original comment period was scheduled to end on March 29, 2012. With this document, OMB is extending the time period in which to provide public comments until April 30, 2012. This will allow interested parties additional time to analyze the issues and prepare their comments.
To be assured of consideration, comments must be received by OMB at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time (E.S.T) on April 30, 2012.
In submitting commenting, please refer to file “Grant Reform”. You may submit comments using one of the following three alternatives (please choose only one of these three alternatives):
Comments will be most useful if they are presented in the same sequence (and with the same heading) as the section of this notice to which they apply. Also, if you are submitting comments on behalf of an organization, please identify the organization. Finally, the public comments received by OMB will be posted on OMB's Web site and at
Victoria Collin at (202) 395-7791 for general information.
OMB is extending the comment period for its advance notice of proposed guidance, which published in the
Copies of the OMB Circulars that are discussed in this notice are available on OMB's Web site at
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E Airspace at Memphis, TN, as the West Memphis Non-Directional Beacon (NDB) has been decommissioned and new Standard Instrument Approach Procedures have been developed at Memphis International Airport. This action also would remove West Memphis Municipal Airport, West Memphis, TN from the existing airspace surrounding Memphis International Airport, Memphis, TN. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport.
Effective 0901 UTC, Comments must be received on or before May 10, 2012. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA, Order 7400.9 and publication of conforming amendments.
Send comments on this rule to: U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Ave. SE., Washington, DC 20590-0001; Telephone: 1-800-647-5527; Fax: 202-493-2251. You must identify the Docket Number FAA-2011-1211; Airspace Docket No. 11-ASO-40, at the beginning of your comments. You may also submit and review received
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
Interested persons are invited to comment on this rule by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-2011-1211; Airspace Docket No. 11-ASO-40) and be submitted in triplicate to the Docket Management System (see
Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2011-1211; Airspace Docket No. 11-ASO-40.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded from and comments submitted through
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking distribution System, which describes the application procedure.
The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to amend Class E airspace extending upward from 700 feet above the surface to support new standard instrument approach procedures developed at Memphis International Airport, Memphis, TN. Airspace reconfiguration is necessary due to the decommissioning of the West Memphis NDB and cancellation of the NDB approach, and for continued safety and management of IFR operations at the airport. Also, West Memphis Municipal Airport, West Memphis, AR, would be removed from the Memphis, TN, airspace designation to accommodate the separation of existing Class E airspace surrounding Memphis International Airport, Memphis, TN. The establishment of the new designator for the controlled airspace at West Memphis Municipal Airport, West Memphis, AR, would simultaneously be coordinated with this action.
Class E airspace designations are published in Paragraph 6005 of FAA order 7400.9V, dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This proposed rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This proposed regulation is within the scope of that authority as it would amend Class E airspace at Memphis International Airport, Memphis TN.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR Part 71 as follows:
1. The authority citation for Part 71 continues to read as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9V, Airspace Designations and Reporting Points, dated August 9, 2011, effective September 15, 2011, is amended as follows:
That airspace extending upward from 700 feet above the surface within an 8-mile radius of Memphis International Airport, and within 4 miles north and 8 miles south of the 271º bearing from the Elvis NDB extending from the 8-mile radius to 16 miles west of the Elvis NDB, and within a 7.5-mile radius of Olive Branch Airport, Olive Branch, MS, and within 4 miles west and 8 miles east of the 017º bearing and 4 miles west and 8 miles east of the 170º bearing from the Olive Branch NDB extending from the 7.5-mile radius to 16 miles northeast and south of the airport, and within a 6.4-mile radius of General DeWitt Spain Airport; excluding that airspace within the Millington, TN, Class E airspace area.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify Class D and Class E airspace at Bellingham, WA, to accommodate aircraft departing and arriving under Instrument Flight Rules (IFR) at Bellingham International Airport. This action also would remove Class E airspace designated as an extension to a Class D or E surface area at Bellingham International Airport. This action, initiated by the biennial review of the Bellingham airspace area, would enhance the safety and management of aircraft operations at the airport.
Comments must be received on or before May 10, 2012.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2011-0363; Airspace Docket No. 11-ANM-8, at the beginning of your comments. You may also submit comments through the Internet at
Eldon Taylor, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4537.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA 2011-0363 and Airspace Docket No. 11-ANM-8) and be submitted in triplicate to the Docket Management System (see
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2011-0363 and Airspace Docket No. 11-ANM-8”. The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class D airspace and Class E airspace designated as surface area to meet current standards for IFR departures and arrivals at Bellingham International Airport, Bellingham, WA. This modification eliminates the need for Class E airspace designated as an extension to a Class D or E surface area, and, therefore, would be removed. This action, initiated by a biennial review of the airspace, is necessary for the safety and management of aircraft departing and arriving under IFR operations at the airport.
Class D and E airspace designations are published in paragraph 5000, 6002 and 6004, respectively, of FAA Order 7400.9V, dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR Part 71.1. The Class D and E airspace designation listed in this document will be published subsequently in this Order.
The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation; (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This proposal is within the scope of that authority as it modifies controlled airspace at Bellingham International Airport, Bellingham, WA.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E. “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR Part 71 as follows:
1. The authority citation for 14 CFR Part 71 continues to read as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal Aviation Administration Order 7400.9V, Airspace Designations and Reporting Points, dated August 9, 2011, and effective September 15, 2011 is amended as follows:
That airspace extending upward from the surface to and including 2,700 feet MSL within a 4.1-mile radius of Bellingham International Airport. This Class D airspace is effective during the dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from the surface within a 4.1-mile radius of Bellingham International Airport. This Class E airspace is effective during the dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at West Memphis, AR. Separation of existing Class E airspace surrounding West Memphis Municipal Airport from the Class E airspace of Memphis International Airport, Memphis, TN, has made this action necessary to enhance the safety and management of Instrument Flight Rules (IFR) operations at the airport.
0901 UTC. Comments must be received on or before May 10, 2012.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You must identify the docket number FAA-2012-0155/Airspace Docket No. 12-ASW-1, at the beginning of your comments. You may also submit comments through the Internet at
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: (817) 321-7716.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2012-0155/Airspace Docket No. 12-ASW-1.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), Part 71 by establishing Class E airspace extending upward from 700 feet above the surface at West Memphis, AR, to accommodate the separation of existing Class E airspace surrounding West Memphis Municipal Airport from the Class E airspace of Memphis International Airport, Memphis, TN. The amendment for the existing Class E airspace surrounding Memphis International Airport, Memphis, TN, would be simultaneously coordinated with this action. Controlled airspace is needed for the safety and management of IFR operations at the airport.
Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9V, dated August 9, 2011 and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish controlled airspace at West Memphis Municipal Airport, West Memphis, AR.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR Part 71 as follows:
1. The authority citation for part 71 continues to read as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9V, Airspace Designations and Reporting Points, dated August 9, 2011, and effective September 15, 2011, is amended as follows:
That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of West Memphis Municipal Airport.
U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury.
Notice of proposed rulemaking.
This document proposes amendments to the Customs and Border Protection (CBP) regulations to provide that if certain imports do not comply with applicable energy conservation or labeling standards, CBP will refuse admission when so notified by the Department of Energy (DOE) or the Federal Trade Commission (FTC) and CBP may, upon a recommendation from DOE or FTC, conditionally release the goods so that they may be brought into compliance. Specifically, CBP will refuse admission into the customs territory of the United States to consumer products and industrial equipment deemed noncompliant with the Energy Policy and Conservation Act of 1975 (EPCA) and its implementing regulations, and for which CBP has received written notice from the DOE or the FTC that identifies merchandise as noncompliant with applicable EPCA requirements. In lieu of immediate refusal of admission, and upon written or electronic notice by DOE or FTC, CBP may conditionally release under bond to the importer such noncompliant products or equipment for purposes of reconditioning, re-labeling, or other action so as to bring the subject product or equipment into compliance with applicable energy conservation and labeling admissibility standards. If the subject import is not timely brought into compliance, CBP, at the direction of DOE or FTC, will issue a refusal of admission notice to the importer and
Comments must be received on or before May 25, 2012.
You may submit comments, identified by
•
•
Mike Craig, Chief, Interagency Requirements Branch, Trade Policy and Programs, Office of International Trade, (202) 863-6558. Valarie M. Neuhart, Import Safety & Interagency Requirements Division, Office of International Trade, (202) 863-6223.
Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the proposed rule. Customs and Border Protection (CBP) also invites comments that relate to the economic, environmental, or federalism effects that might result from this proposed rule. If appropriate to a specific comment, the commenter should reference the specific portion of the proposed rule, explain the reason for any recommended change, and include data, information, or authority that support such recommended change.
Title III, Part B of the Energy Policy and Conservation Act of 1975 (EPCA), Public Law 94-163 (42 U.S.C. 6291-6309), as amended, established the Energy Conservation Program for Consumer Products Other Than Automobiles, a program covering most major household appliances. Similarly, Title III, Part C of the EPCA, (42 U.S.C. 6311-6317) as amended, added by Public Law 95-619, Title IV, section 441(a), established the Energy Conservation Program for Certain Industrial Equipment, a program covering industrial equipment.
Section 6302(a) of title 42 of the United States Code (42 U.S.C. 6302(a)), and its implementing regulations, prescribe the specific energy conservation and labeling standards applicable to manufacturers and, in some instances, private labelers, distributors, and retailers. Sections 6301 and 6316 of title 42 of the United States Code (42 U.S.C. 6301 and 6316) require the Secretary of the Treasury to issue regulations refusing admission into the customs territory of the United States to covered products or covered equipment offered for importation in violation of 42 U.S.C. 6302. The statute also provides the Secretary with the discretion to authorize the importation of covered products or covered industrial equipment under such terms and conditions (including the furnishing of a bond) that ensure that the merchandise will not violate 42 U.S.C. 6302.
Pursuant to 42 U.S.C. 6301, this document proposes to amend part 12 of title 19 of the Code of Federal Regulations (19 CFR Part 12) by adding a new § 12.50 which provides that CBP will refuse admission into the customs territory of the United States to covered imports that the Department of Energy (DOE) or the Federal Trade Commission (FTC) has determined to be in violation of 42 U.S.C. 6302, upon receipt of written or electronic notice from the DOE or FTC, as appropriate. The notice will identify a named regulated party as being in violation of 42 U.S.C. 6302 and will describe the subject product or equipment in a manner sufficient to enable CBP to identify the articles.
While refusal of admission will be the norm, there may be instances where reconditioning, re-labeling, or other modification may bring an import into compliance with applicable energy conservation or labeling admissibility standards. Accordingly, this rule proposes a procedure to allow CBP to conditionally release noncompliant imports to the importer under a CBP basic importation and entry bond for purposes of bringing the merchandise into conformity with the applicable standards, upon a recommendation by the DOE or FTC. In any case involving conditional release of a covered import under bond, the CBP port director always retains the discretion to require additional security in any case where he believes that acceptance of a continuous bond would hamper the enforcement of the law.
If the DOE or FTC notifies CBP that the subject imports have been brought into compliance with applicable energy conservation and labeling admissibility standards before the conclusion of the 30-day conditional release period, or any authorized extension thereof, CBP may release the subject goods into the commerce and entry may be completed.
If attempts at modification fail within the 30-day conditional release period, or any authorized extension thereof, the DOE or FTC will notify CBP of that fact, and CBP will issue a notice of refusal of admission to the importer concurrent with a demand for redelivery under the terms and conditions of the CBP bond. A failure to comply with the demand for redelivery will result in the assessment of liquidated damages equal to three times the value of the imports at issue. Moreover, covered imports that are conditionally released will be under the concurrent jurisdiction of DOE and/or FTC.
The proposed amendments are consistent with § 429.5(b) of title 10 of the Code of Federal Regulations (10 CFR 429.5(b)), which is a DOE regulation that further notifies the importing public that any covered product or equipment offered for importation that does not meet the applicable energy
Executive Orders 13563 and 12866 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget.
This section examines the impact of the rule on small entities as required by the Regulatory Flexibility Act (5 U.S.C. 601
The proposed rule, if finalized, will establish a procedure whereby the DOE or the FTC will notify CBP of any imported article that is in violation of 42 U.S.C 6302 and its implementing regulations. Upon notification, CBP will refuse these articles admission into the commerce of the United States. Upon a recommendation by the DOE or FTC, however, CBP will conditionally release noncompliant imported articles under a CBP basic importation and entry bond for the purpose of bringing the merchandise into compliance with 42 U.S.C. 6302 and its implementing regulations. This conditional release is valid for a period of 30 days, but it may be extended by the DOE or FTC.
The DOE has identified only a small number of businesses importing noncompliant articles, of which fewer than five were small entities. When notified of their noncompliance, each of these businesses ceased importation of these articles. Given the small number of small entities identified by DOE as having been noncompliant and that the law prohibiting the importation of these noncompliant articles within the United States was enacted in 1975, CBP does not anticipate a significant number of small entities attempting to import articles which violate 42 U.S.C 6302 and its implementing regulations. If a small entity does import an article in violation of 42 U.S.C 6302 and its implementing regulations, the small entity can request the DOE or the FTC allow CBP to grant the imported article a conditional release. CBP believes that cost associated with this conditional release to be negligible because this request is virtually costless to the small entity and the importer is already required to maintain a CBP basic importation and entry bond.
Accordingly, CBP does not believe this rule will have a significant impact on a substantial number of small entities. CBP welcomes any comments regarding this assessment. If CBP does not receive any comments contradicting this finding, CBP will certify that this rule will not have a significant economic impact on a substantial number of small entities at the final rule stage.
As there is no collection of information proposed in this document, the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) are inapplicable.
This proposed regulation is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his delegate) to approve regulations related to certain customs revenue functions.
Customs duties and inspection, Electronic products, Entry of merchandise, Imports, Prohibited merchandise, Reporting and recordkeeping requirements, Restricted merchandise, Seizure and forfeiture.
For the reasons stated above, it is proposed to amend part 12 of title 19 of the Code of Federal Regulations (19 CFR Part 12) as set forth below.
1. The general authority citation for part 12 continues to read as follows and the specific authority citation is added to read as follows:
5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624;
Section 12.50 also issued under 42 U.S.C. 6301;
2. A new center heading and new § 12.50 are added to read as follows:
(a)
(b)
(c)
(d)
(1)
(i) The date that CBP issues a notice of refusal of admission pursuant to paragraph (c) of this section;
(ii) The date that the DOE or FTC issues a notice to CBP stating that the covered import is in compliance and may proceed; or
(iii) At the conclusion of the 30-day period following the date of release.
(2)
(3)
(4)
U.S. Customs and Border Protection, Department of Homeland Security.
Withdrawal of notice of proposed rulemaking.
This document withdraws a notice of proposed rulemaking, published in the
Effective March 26, 2012, the proposed rule published October 27, 2010, (75 FR 66050), is withdrawn.
Anita Harris, Chief, Broker Compliance Branch, Trade Policy and Programs, Office of International Trade, (202) 863-6069.
On October 27, 2010, Customs and Border Protection (CBP) published a notice of proposed rulemaking in the
CBP received public comment on the proposed rulemaking. The majority of commenters expressed concern that the proposed rule did not serve the interests of the importing public. Specifically, there was opposition to the proposal from brokers due to the condition on sharing the information that CBP included in the document to protect importers' proprietary information.
CBP is withdrawing the notice published in the
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing approval of a revision to the Connecticut State Implementation Plan (SIP) that addresses regional haze for the first planning period from 2008 through
Written comments must be received on or before April 25, 2012.
Submit your comments, identified by Docket ID Number EPA-R01-OAR-2009-0919 by one of the following methods:
1.
2.
3.
4.
5.
In addition, copies of the State submittal are also available for public inspection during normal business hours, by appointment at the Bureau of Air Management, Department of Energy and Environmental Protection, State Office Building, 79 Elm Street, Hartford, CT 06106-1630.
Anne McWilliams, Air Quality Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail Code OEP05-02), Boston, MA 02109-3912, telephone number (617) 918-1697, fax number (617) 918-0697, email
Throughout this document, wherever “we,” “us,” or “our” is used, we mean the EPA.
Regional haze is visibility impairment that is produced by a multitude of sources and activities which are located across a broad geographic area and emit fine particles and their precursors (e.g., sulfur dioxide, nitrogen oxides, and in some cases, ammonia and volatile organic compounds). Fine particle precursors react in the atmosphere to form fine particulate matter (PM
Data from the existing visibility monitoring network, the “Interagency Monitoring of Protected Visual Environments” (IMPROVE) monitoring network, show that visibility impairment caused by air pollution occurs virtually all the time at most national park and wilderness areas. The average visual range in many Class I areas (i.e., national parks and memorial parks, wilderness areas, and international parks meeting certain size criteria) in the Western United States is 100-150 kilometers, or about one-half to two-thirds of the visual range that would exist without manmade air pollution. In most of the eastern Class I areas of the United States, the average visual range is less than 30 kilometers, or about one-fifth of the visual range that would exist under estimated natural conditions. See 64 FR 35715 (July 1, 1999).
In section 169A(a)(1) of the 1977 Amendments to the CAA, Congress created a program for protecting visibility in the nation's national parks and wilderness areas. This section of the CAA establishes as a national goal the “prevention of any future, and the remedying of any existing, impairment of visibility in mandatory Class I Federal areas
Congress added section 169B to the CAA in 1990 to address regional haze issues. EPA promulgated a rule to address regional haze on July 1, 1999 (64 FR 35714), the Regional Haze Rule. The Regional Haze Rule revised the existing visibility regulations to integrate into the regulation provisions addressing regional haze impairment and established a comprehensive visibility protection program for Class I areas. The requirements for regional haze, found at 40 CFR 51.308 and 51.309, are included in EPA's visibility protection regulations at 40 CFR 51.300-309. Some of the main elements of the regional haze requirements are summarized in Section II. The requirement to submit a regional haze SIP applies to all 50 States, the District of Columbia and the Virgin Islands. In 40 CFR 51.308(b), States are required to submit the first implementation plan addressing regional haze visibility impairment no later than December 17, 2007. On January 15, 2009, EPA found that 37 States, the District of Columbia and the U.S. Virgin Islands failed to submit this required implementation plan. See 74 FR 2392 (Jan. 15, 2009). In particular, EPA found that Connecticut failed to submit a plan that met the requirements of 40 CFR 51.308. See 74 FR 2393. On November 18, 2009, the Bureau of Air Management of the CT DEEP submitted revisions to the Connecticut State Implementation Plan (SIP) to address regional haze as required by 40 CFR 51.308. EPA has reviewed Connecticut's submittal and is proposing to find that it is consistent with the requirements of 40 CFR 51.308 as outlined in Section II.
Successful implementation of the regional haze program will require long-term regional coordination among States, tribal governments and various federal agencies. As noted above, pollution affecting the air quality in Class I areas can be transported over long distances, even hundreds of kilometers. Therefore, to effectively address the problem of visibility impairment in Class I areas, States need to develop strategies in coordination with one another, taking into account the effect of emissions from one jurisdiction on the air quality in another.
Because the pollutants that lead to regional haze can originate from sources located across broad geographic areas, EPA has encouraged the States and Tribes across the United States to address visibility impairment from a regional perspective. Five regional planning organizations (RPOs) were developed to address regional haze and related issues. The RPOs first evaluated technical information to better understand how their States and Tribes impact Class I areas across the country, and then pursued the development of regional strategies to reduce emissions of PM
The Mid-Atlantic/Northeast Visibility Union (MANE-VU) RPO is a collaborative effort of State governments, tribal governments, and various federal agencies established to initiate and coordinate activities associated with the management of regional haze, visibility and other air quality issues in the Northeastern United States. Member State and Tribal governments include: Connecticut, Delaware, the District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Penobscot Indian Nation, Rhode Island, and Vermont.
The Clean Air Interstate Rule (CAIR) required some states to reduce emissions of SO
CAIR was later found to be inconsistent with the requirements of the CAA and the rule was remanded to EPA.
EPA promulgated the Cross-State Air Pollution Rule (CSAPR), to replace CAIR in 2011 (76 FR 48208, August 8, 2011). Connecticut was subject to ozone season NO
On December 30, 2011, the DC Circuit Court issued an order addressing the status of CSAPR and CAIR in response to motions filed by numerous parties seeking a stay of CSAPR pending judicial review. In that order, the D.C. Circuit stayed CSAPR pending the court's resolutions of the petitions for review of that rule in
On December 15, 2011, Connecticut held a public hearing on proposed Regulations of Connecticut State Agencies (RCSA) section 22a-174-22d. This regulation, once adopted, will permanently maintain the ozone season NO
RCSA 22a-174-22d is a replacement for RCSA 22a-174-22c, “The Clean Air Interstate Rule (CAIR) Nitrogen Oxides (NO
Regional haze SIPs must assure reasonable progress towards the national goal of achieving natural visibility conditions in Class I areas. Section 169A of the CAA and EPA's implementing regulations require States to establish long-term strategies for making reasonable progress toward meeting this goal. Implementation plans must also give specific attention to certain stationary sources that were in existence on August 7, 1977, but were not in operation before August 7, 1962, and require these sources, where appropriate, to install Best Available Retrofit Technology (BART) controls for the purpose of eliminating or reducing visibility impairment. The specific regional haze SIP requirements are discussed in further detail below.
The RHR establishes the deciview (dv) as the principal metric for measuring visibility. This visibility metric expresses uniform changes in haziness in terms of common increments across the entire range of visibility conditions, from pristine to extremely hazy conditions. Visibility is determined by measuring the visual range (or deciview), which is the greatest distance, in kilometers or miles, at which a dark object can be viewed against the sky. The deciview is a useful measure for tracking progress in improving visibility, because each deciview change is an equal incremental change in visibility perceived by the human eye. Most people can detect a change in visibility at one deciview.
The deciview is used in expressing Reasonable Progress Goals (RPGs) (which are interim visibility goals towards meeting the national visibility goal), defining baseline, current, and natural conditions, and tracking changes in visibility. The regional haze SIPs must contain measures that ensure “reasonable progress” toward the national goal of preventing and remedying visibility impairment in Class I areas caused by manmade air pollution by reducing anthropogenic emissions that cause regional haze. The national goal is a return to natural conditions, i.e., manmade sources of air pollution would no longer impair visibility in Class I areas.
To track changes in visibility over time at each of the 156 Class I areas covered by the visibility program and as part of the process for determining reasonable progress, States must calculate the degree of existing visibility impairment at each Class I area within the State at the time of each regional haze SIP submittal and periodically review progress every five years midway through each 10-year planning period. To do this, the RHR requires States to determine the degree of impairment (in deciviews) for the average of the 20 percent least impaired (“best”) and 20 percent most impaired (“worst”) visibility days over a specified time period at each of their Class I areas. In addition, States must also develop an estimate of natural visibility conditions for the purposes of comparing progress toward the national goal. Natural visibility is determined by estimating the natural concentrations of pollutants that cause visibility impairment and then calculating total light extinction based on those estimates. EPA has provided guidance to States regarding how to calculate baseline, natural and current visibility conditions in documents entitled,
For the first regional haze SIPs that were due by December 17, 2007, “baseline visibility conditions” were the starting points for assessing “current” visibility impairment. Baseline visibility conditions represent the degree of impairment for the 20 percent least impaired days and 20 percent most impaired days at the time the regional haze program was established. Using monitoring data from 2000 through 2004, States are required to calculate the average degree of visibility impairment for each Class I area within the State, based on the average of annual values over the five year period. The comparison of initial baseline visibility conditions to natural visibility conditions indicates the amount of improvement necessary to attain natural visibility, while the future comparison of baseline conditions to the then current conditions will indicate the amount of progress made. In general, the 2000-2004 baseline period is considered the time from which improvement in visibility is measured.
The vehicle for ensuring continuing progress towards achieving the natural visibility goal is the submission of a series of regional haze SIPs from the States that establish RPGs for Class I areas for each (approximately) 10-year planning period. The RHR does not mandate specific milestones or rates of progress, but instead calls for States to establish goals that provide for “reasonable progress” toward achieving natural (i.e., “background”) visibility conditions for their Class I areas. In setting RPGs, States must provide for an improvement in visibility for the most impaired days over the (approximately) 10-year period of the SIP, and ensure no degradation in visibility for the least impaired days over the same period.
States have significant discretion in establishing RPGs, but are required to consider the following factors established in the CAA and in EPA's RHR: (1) The costs of compliance; (2) the time necessary for compliance; (3) the energy and non-air quality environmental impacts of compliance; and (4) the remaining useful life of any potentially affected sources. States must demonstrate in their SIPs how these factors are considered when selecting the RPGs for the best and worst days for each applicable Class I area. See 40 CFR 51.308(d)(1)(i)(A). States have considerable flexibility in how they take these factors into consideration, as noted in EPA's July 1, 2007 memorandum from William L. Wehrum, Acting Administrator for Air and Radiation, to EPA Regional Administrators, EPA Regions 1-10, entitled
Section 169A of the CAA directs States to evaluate the use of retrofit controls at certain larger, often uncontrolled, older stationary sources in order to address visibility impacts from these sources. Specifically, the CAA requires States to revise their SIPs to contain such measures as may be necessary to make reasonable progress towards the natural visibility goal, including a requirement that certain categories of existing stationary sources built between 1962 and 1977 procure, install, and operate the “Best Available Retrofit Technology” as determined by the State. (CAA 169A(b)(2)a)).
On July 6, 2005, EPA published the
States must address all visibility impairing pollutants emitted by a source in the BART determination process. The most significant visibility impairing pollutants are sulfur dioxide (SO
The RPOs provided air quality modeling to the States to help them in determining whether potential BART sources can be reasonably expected to cause or contribute to visibility impairment in a Class I area. Under the BART Guidelines, States may select an exemption threshold value for their BART modeling, below which a BART eligible source would not be expected to cause or contribute to visibility impairment in any Class I area. The State must document this exemption threshold value in the SIP and must state the basis for its selection of that value. Any source with emissions that model above the threshold value would be subject to a BART determination review. The BART Guidelines acknowledge varying circumstances affecting different Class I areas. States should consider the number of emission sources affecting the Class I areas at issue and the magnitude of the individual sources' impacts. Any exemption threshold set by the State should not be higher than 0.5 deciviews. See 70 FR 39161 (July 6, 2005).
In their SIPs, States must identify potential BART sources, described as “BART-eligible sources” in the RHR, and document their BART control determination analyses. The term “BART-eligible source” used in the
A regional haze SIP must include source-specific BART emission limits and compliance schedules for each source subject to BART. Once a State has made its BART determination, the BART controls must be installed and in operation as expeditiously as practicable, but no later than five years after the date of EPA approval of the regional haze SIP, as required by CAA (section 169(g)(4)) and the RHR (40 CFR 51.308(e)(1)(iv)). In addition to what is required by the RHR, general SIP requirements mandate that the SIP must also include all regulatory requirements related to monitoring, recordkeeping, and reporting for the BART controls on the source. States have the flexibility to choose the type of control measures they will use to meet the requirements of BART.
In 40 CFR 51.308(d)(3) of the RHR, States are required to include a LTS in their SIPs. The LTS is the compilation of all control measures a State will use to meet any applicable RPGs. The LTS must include “enforceable emissions limitations, compliance schedules, and other measures as necessary to achieve the reasonable progress goals” for all Class I areas within, or affected by emissions from, the State. See 40 CFR 51.308(d)(3).
When a State's emissions are reasonably anticipated to cause or contribute to visibility impairment in a Class I area located in another State, the RHR requires the impacted State to coordinate with the contributing States in order to develop coordinated emissions management strategies. See 40 CFR 51.308(d)(3)(i). In such cases, the contributing State must demonstrate that it has included in its SIP all measures necessary to obtain its share of the emission reductions needed to meet the RPGs for the Class I area. The RPOs have provided forums for significant interstate consultation, but additional consultations between States may be required to sufficiently address interstate visibility issues. This is especially true where two States belong to different RPOs.
States should consider all types of anthropogenic sources of visibility impairment in developing their LTS, including stationary, minor, mobile, and area sources. At a minimum, States must describe how each of the seven factors listed below is taken into account in developing their LTS: (1) Emission reductions due to ongoing air pollution control programs, including measures to address RAVI; (2) measures to mitigate the impacts of construction activities; (3) emissions limitations and schedules for compliance to achieve the RPG; (4) source retirement and replacement schedules; (5) smoke management techniques for agricultural and forestry management purposes including plans as currently exist within the State for these purposes; (6) enforceability of emissions limitations and control measures; (7) the anticipated net effect on visibility due to projected changes in point, area, and mobile source emissions over the period addressed by the LTS. See 40 CFR 51.308(d)(3)(v).
As part of the RHR, EPA revised 40 CFR 51.306(c) regarding the LTS for RAVI to require that the RAVI plan must provide for a periodic review and SIP revision not less frequently than every three years until the date of submission of the State's first plan addressing regional haze visibility impairment, which was due December 17, 2007, in accordance with 40 CFR 51.308(b) and (c). On or before this date, the State must revise its plan to provide for review and revision of a coordinated LTS for addressing reasonably attributable and regional haze visibility impairment, and the State must submit the first such coordinated LTS with its first regional haze SIP. Future coordinated LTS's, and periodic progress reports evaluating progress towards RPGs, must be submitted consistent with the schedule for SIP submission and periodic progress reports set forth in 40 CFR 51.308(f) and 51.308(g), respectively. The periodic reviews of a State's LTS must report on both regional haze and RAVI impairment and must be submitted to EPA as a SIP revision.
In 40 CFR 51.308(d)(4), the RHR requires a monitoring strategy for measuring, characterizing, and reporting of regional haze visibility impairment that is representative of all mandatory Class I Federal areas within the State. The strategy must be coordinated with the monitoring strategy required in 40 CFR 51.305 for RAVI. Compliance with this requirement may be met through participation in the Interagency Monitoring of Protected Visual Environments (IMPROVE) network. The monitoring strategy is due with the first regional haze SIP, and it must be reviewed every five years. The monitoring strategy must also provide for additional monitoring sites if the IMPROVE network is not sufficient to determine whether RPGs will be met.
The SIP must also provide for the following:
• Procedures for using monitoring data and other information in a State with mandatory Class I areas to determine the contribution of emissions from within the State to regional haze visibility impairment at Class I areas both within and outside the State;
• Procedures for using monitoring data and other information in a State with no mandatory Class I areas to determine the contribution of emissions from within the State to regional haze visibility impairment at Class I areas in other States;
• Reporting of all visibility monitoring data to the Administrator at least annually for each Class I area in the State, and where possible, in electronic format;
• Developing a statewide inventory of emissions of pollutants that are reasonably anticipated to cause or contribute to visibility impairment in any Class I area. The inventory must include emissions for a baseline year, emissions for the most recent year for which data are available, and estimates of future projected emissions. A State must also make a commitment to update the inventory periodically; and
• Other elements, including reporting, recordkeeping, and other measures necessary to assess and report on visibility.
Pursuant to 40 CFR 51.308(f) of the RHR, state control strategies must cover an initial implementation period extending to the year 2018, with a comprehensive reassessment and revision of those strategies, as appropriate, every 10 years thereafter. Periodic SIP revisions must meet the core requirements of 40 CFR 51.308(d) with the exception of BART. The BART
The RHR requires that States consult with FLMs before adopting and submitting their SIPs. See 40 CFR 51.308(i). States must provide FLMs an opportunity for consultation, in person and at least 60 days prior to holding any public hearing on the SIP. This consultation must include the opportunity for the FLMs to discuss their assessment of impairment of visibility in any Class I area and to offer recommendations on the development of the RPGs and on the development and implementation of strategies to address visibility impairment. Further, a State must include in its SIP a description of how it addressed any comments provided by the FLMs. Finally, a SIP must provide procedures for continuing consultation between the State and FLMs regarding the State's visibility protection program, including development and review of SIP revisions, five-year progress reports, and the implementation of other programs having the potential to contribute to impairment of visibility in Class I areas.
On November 18, 2009, February, 24, 2012, and March 12, 2012, CT DEEP's Bureau of Air Management submitted revisions to the Connecticut SIP to address regional haze as required by 40 CFR 51.308. EPA has reviewed Connecticut's submittal and is proposing to find that it is consistent with the requirements of 40 CFR 51.308 as outlined in Section II. A detailed analysis follows.
Connecticut is responsible for developing a regional haze SIP which addresses Connecticut's impact on any nearby Class I areas. As Connecticut has no Class I areas within its borders, Connecticut is not required to address the following Regional Haze SIP elements: (a) Calculation of baseline and natural visibility conditions; (b) establishment of reasonable progress goals; (c) monitoring requirements; and d) RAVI requirements.
Connecticut is a member of the MANE-VU RPO. The MANE-VU RPO contains seven Class I areas in four States: Moosehorn Wilderness Area, Acadia National Park, and Roosevelt/Campobello International Park in Maine; Presidential Range/Dry River Wilderness Area and Great Gulf Wilderness Area in New Hampshire; Brigantine Wilderness Area in New Jersey; and Lye Brook Wilderness Area in Vermont.
Through source apportionment modeling, MANE-VU assisted States in determining their contribution to the visibility impairment of each Class I area in the MANE-VU region. Connecticut and the other MANE-VU States adopted a weight-of-evidence approach which relied on several independent methods for assessing the contribution of different sources and geographic source regions to regional haze in the northeastern and mid-Atlantic portions of the United States. Details about each technique can be found in the Northeast States for Coordinated Air Use Management (NESCAUM) document
The source apportionment modeling demonstrated that the contribution of Connecticut emissions to total sulfate (the main contributor to visibility impairment in the Northeast, see Section III.C.3) was consistently determined to be no more than 0.76% of the total sulfate at any Class I area. This finding was consistently predicted by different assessment techniques that are based on the application of disparate chemical, meteorological and physical principles. The greatest modeled contribution from Connecticut for each of the MANE-VU Class I areas was 0.76% sulfate at Acadia National Park, 0.56% sulfate at Moosehorn Wilderness Area and Roosevelt Campobello International Park, 0.48% sulfate at Great Gulf Wilderness Area and Presidential Range—Dry River Wilderness Area, 0.55% sulfate at Lye Brook Wilderness Area, and 0.53% at Brigantine Wilderness Area. The impact of sulfate on visibility is discussed in greater detail below.
The MANE-VU Class I States determined that any State contributing at least 2.0% of the total sulfate observed on the 20 percent worst visibility days in 2002 were contributors to visibility impairment at the Class I area. Connecticut, Rhode Island, Vermont, and the District of Columbia were determined to contribute less than 2.0% of sulfate at any of the Class I areas in the Northeast.
EPA is proposing to find that CT DEEP has adequately demonstrated that emissions from Connecticut sources do not cause or contribute to visibility impairment in nearby Class I Areas.
According to 51.308(e), “The State must submit an implementation plan containing emission limitations representing BART and schedules for compliance with BART for each BART-eligible source that may reasonably be anticipated to cause or contribute to any impairment of visibility in any Class I Federal area, unless the State demonstrates that an emissions trading program or other alternative will achieve greater reasonable progress toward natural visibility conditions.” On October 13, 2006, EPA's “Regional Haze Regulations to Provisions Governing Alternative to Source-Specific Best Available Retrofit Technology (BART) Determinations; Final Rule” (hereinafter known as the “Alternative to BART Rule”) was published in the
(1) A list of all BART-eligible sources within the State.
(2) A list of all BART-eligible sources and all BART source categories covered by the alternative program.
(3) Determination of the BART benchmark. If the alternative program has been designed to meet a requirement other than BART, as in the case of Connecticut, the State may determine the best system of continuous emission control technology and associated emission reductions for similar types of sources within a source category based on both source specific and category-wide information, as appropriate.
(4) An analysis of the projected emission reductions achieved through the alternative program.
(5) A determination based on a clear weight of evidence that the alternative program achieves greater reasonable progress than would be achieved through the installation and operation of BART at the covered sources.
Determining BART-eligible sources is the first step in the BART process. BART-eligible sources in Connecticut were identified in accordance with the methodology in Appendix Y of the Regional Haze Rule,
• The unit falls into one of the listed source categories;
• The unit was constructed or reconstructed between 1962 and 1977; and
• The unit has the potential to emit over 250 tons per year of sulfur dioxide, nitrogen oxides, particulate matter, volatile organic compounds, or ammonia.
The BART Guidelines require States to address SO
The identification of BART sources in Connecticut was undertaken as part of a multi-State analysis conducted by the NESCAUM. NESCAUM worked with CT DEEP licensing engineers to review all sources and determine their BART eligibility. CT DEEP identified ten sources as BART-eligible. Pfizer Inc. Boilers No. 5, No. 8, and the Organic Synthesis Plant 2 (OSP2) were originally included in the list of BART-eligible units. On March 10, 2006, the CT DEEP issued Consent Order No. 8262 to Pfizer Inc. which caps the actual aggregated emissions from the boilers and OSP2 to less than 250 tons per year for each of the air pollutants NO
In crafting Connecticut's alternative to BART demonstration, the State relied on SO
According to the Alternative to BART Rule, in developing the BART benchmark, with one exception, States must follow the approach for making BART determinations under section 51.308(e)(1). The one exception to this general approach is where the alternative program has been designed to meet requirements other than BART; in this case, States are not required to make BART determinations under 51.308(e)(1) and may use a simplifying assumption in establishing a BART benchmark based on an analysis of what BART is likely to be for similar types of sources within a source category. Under either approach to establishing a BART
RCSA section 22a-174-19a (Control of Sulfur Dioxide Emissions from Power Plant and Other Large Stationary Sources of Air Pollution) was submitted to EPA as part of Connecticut's November 18, 2008 PM
• Combust liquid fuel, gaseous fuel or a combination of each, provided that each fuel possesses a fuel sulfur limit of equal to or less than 0.5% sulfur, by weight;
• Meet an average emission rate of equal to or less than 0.55 pounds of SO
• Meet an average emission rate of equal to or less than 0.5 pounds of SO
• Combust liquid fuel, gaseous fuel or a combination of each, provided that each fuel possesses a fuel sulfur limit of equal to or less than 0.3% sulfur, by weight;
• Meet an average emission rate of equal to or less than 0.33 pounds of SO
• Meet an average emission rate of equal to or less than 0.3 pounds of SO
The first phase of Connecticut's SO
Presumptive BART potential emission levels for 2012 (tons per year) in Table 3 were calculated by multiplying the MANE-VU BART workgroup and EPA recommended BART emission rates in lb/MMBtu by the design capacity of the unit in MMBtu/hr by 8760 hrs/year as follows:
• For Bridgeport Harbor 3, the sole coal-burning unit, 0.15 lb/MMBtu, the MANE-VU BART workgroup's and EPA's recommended SO
• For the five oil-burning EGUs, the MANE-VU BART workgroup's and
• MANE-VU BART workgroup post-BART SO
Table 4 lists the actual 2001, 2002, and 2006 SO
As detailed in Attachment X of Connecticut's SIP submittal, potential emissions from all sources subject to RCSA 22a-174-19a was 89,537 tons in 2002 and 60,304 tons in 2006. As shown in Table 5, by comparing SO
In addition, Table 6 shows the reductions in actual SO
Furthermore, Attachment X of Connecticut's November 18, 2009 Regional Haze SIP submittal contains maps of the facility reductions in actual SO
Most of the BART-eligible units in Connecticut installed NO
Pursuant to the ozone reasonably available control technology (RACT) provisions of the 1990 Clean Air Act Amendments, in 1995, CT DEEP adopted NO
Since 1999, CT DEEP has adopted several NO
On December 23, 2008, CAIR was remanded without vacatur.
RCSA section 22a-174-22d limits Connecticut's ozone season NO
In addition to the ozone season requirements for NO
Connecticut noted that between 1994 and 2006 NO
Connecticut cites three elements of its BART alternative program to support a finding that the clear weight of evidence demonstrates that its NO
While CAIR is currently still in place, it is only effective pending review of CSAPR. However, Connecticut has proposed parallel processing of its replacement to CAIR, RCSA section 22a-174-22d. This regulation as proposed maintains a cap of 2,691 tons per ozone season and allocates emissions credits to EGUs based in part on their megawatt generation.
Furthermore, Attachment X of Connecticut's November 18, 2009 Regional Haze SIP submittal contains maps of the facility reductions in actual NO
EPA is proposing to find that Connecticut has adequately demonstrated that the potential and actual SO
As part the NO
Had
An additional piece of evidence for Connecticut's alternative to BART program demonstration is that, while Connecticut does not have a firm state-wide, year-round cap on emissions from EGUs, the firm cap during ozone season acts as an impediment to emissions growth during non-ozone season.
In EPA's Alternative to BART Rule, the included scenario was only intended to be demonstrative of those situations where a weight of evidence approach would be appropriate. Connecticut's NO
EPA's BART Guidelines for 750 MW and greater power plants do not contain presumptive emission limits for PM. The MANE-VU BART workgroup's recommended BART emission limits for PM
Table 9 shows the visibility impact and existing PM controls at BART-eligible units in Connecticut. Several units have electrostatic precipitators (ESP) already in place.
Middletown Unit 3, Norwalk Unit 2, PSEG Bridgeport Harbor Unit 3, and PSEG New Haven Harbor Unit 1 have existing ESP control. PSEG Bridgeport Harbor Unit 3 also installed a baghouse for mercury control in July 2008, thereby achieving concomitant PM reduction benefits.
MANE-VU's 2002 individual unit modeling shows that none of Connecticut's PM emissions from BART-eligible sources have a significant visibility impact on any Class I area. As can be seen in Table 9, the highest individual PM visibility impact (0.0035 dv) is significantly less than the 0.1 deciview individual impact MANE-VU warrants worthy of consideration of BART controls.
Table 10 shows the cost of PM controls per year for those BART-eligible units without PM controls as well as actual PM emissions for 2005. Numbers were calculated by using the range of control technologies and cost per actual cubic feet per minute (ACFM) of gas flow values provided in NESCAUM's
The MANE-VU BART workgroup's recommendation for sources which rely on the remaining useful life factor for the determination of BART is that these sources should either control emissions from the BART-eligible sources prior to 2013 or accept a federally enforceable permit limitation or retirement date prior to each state's public notice and hearing processes and FLM review of BART SIP elements. Similar to the other New England States, the Connecticut analysis did not weight this factor.
No significant energy or non-air quality environmental benefits or dis-benefits associated with PM controls were identified.
Given the very high cost per ton reduced for the remaining BART-eligible units without PM controls along with the lack of PM contribution evidence from MANE-VU's modeling, Connecticut determined that the existing conditions with respect to PM control are equivalent to BART.
EPA is proposing to approve Connecticut's determination that further primary PM control beyond the controls already implemented by Connecticut's BART-eligible units is not warranted at this time as such measures are not cost-effective and the visibility contribution from Connecticut's BART-eligible units with respect to PM is insignificant.
EPA is proposing to approve RCSA Section 22a-174-19a and revisions to RCSA Section 22a-174-22, including new subdivision 22a-174-22(e)(3), with this rulemaking. In addition, pursuant to CT DEEP's request for parallel processing, EPA is proposing approval of Connecticut's proposed RCSA Section 22a-174-22d. After the State submits the adopted State Regulation RCSA 22a-174-22d (including a response to all public comments raised during the State's public participation process), EPA will prepare a final rulemaking notice. If the State's formal SIP submittal contains changes which occur after EPA's notice of proposed rulemaking, such changes must be described in EPA's final rulemaking action. If the State's changes are significant, then EPA must decide whether it is appropriate to re-propose our action with regard to the State's SIP submittal.
As described in Section II.E of this action, the LTS is a compilation of State-specific control measures relied on by the State to obtain its share of emission reductions to support the RPGs established by Maine, New Hampshire, Vermont, and New Jersey, the nearby Class I area States. Connecticut's LTS for the first implementation period addresses the emissions reductions from federal, State, and local controls that take effect in the State from the baseline period starting in 2002 until 2018. Connecticut participated in the MANE-VU regional strategy development process and supported a regional approach towards deciding which control measures to pursue for regional haze, which was based on technical analyses documented in the following reports: (a) The Contribution Report; (b)
The State-wide emissions inventories used by MANE-VU in its regional haze technical analyses were developed by MARAMA for MANE-VU with assistance from Connecticut. The 2018 emissions inventory was developed by projecting 2002 emissions forward based on assumptions regarding emissions growth due to projected increases in economic activity and emissions reductions expected from federal and State regulations. MANE-VU's emissions inventories included estimates of NO
MANE-VU developed emissions inventories for four inventory source classifications: (1) Stationary point sources, (2) stationary area sources, (3) non-road mobile sources, and (4) on-road mobile sources. The New York Department of Environmental Conservation also developed an inventory of biogenic emissions for the entire MANE-VU region. Stationary point sources are those sources that emit greater than a specified tonnage per year, depending on the pollutant, with data provided at the facility level. Stationary area sources are those sources whose individual emissions are relatively small, but due to the large number of these sources, the collective emissions from the source category could be significant. Non-road mobile sources are equipment that can move but do not use the roadways. On-road mobile source emissions are automobiles, trucks, and motorcycles that use the roadway system. The emissions from these sources are estimated by vehicle type and road type. Biogenic sources are natural sources like trees, crops, grasses, and natural decay of plants. Stationary point sources emission data is tracked at the facility level. For all other source types, emissions are summed on the county level.
There are many federal and State control programs being implemented that MANE-VU and Connecticut anticipate will reduce emissions between the baseline period and 2018. Emission reductions from these control programs in the MANE-VU region were projected to achieve substantial visibility improvement by 2018 at all of the MANE-VU Class I areas. To assess emissions reductions from ongoing air pollution control programs, BART, and reasonable progress goals, MANE-VU developed 2018 emissions projections called “Best and Final.” The emissions inventory provided by the State of Connecticut for the Best and Final 2018 projections is based on expected control requirements.
Connecticut relied on emission reductions from the following ongoing and expected air pollution control programs as part of the State's long term strategy. For electrical generating units (EGUs), Connecticut relied on RCSA sections 22a-174-19a which limits SO
On July 30, 2007, the U.S. Court of Appeals for the District of Columbia vacated and remanded the Industrial Boiler MACT Rule.
On December 2, 2011, EPA issued a proposed reconsideration of the MACT standards for existing and new boilers at major (76 FR 80598) and area (76 FR 80532) source facilities, and for Commercial and Industrial Solid Waste Incinerators (76 FR 80452). On January 9, 2012, the U.S. District Court for the District of Columbia vacated EPA's stay of the effectiveness date of the Industrial Boiler MACT, reinstating the original effective date and therefore requiring compliance with the current rule in 2014.
Even though Connecticut's modeling is based on the old Industrial Boiler MACT limits, Connecticut's modeling conclusions are unlikely to be affected because the expected reductions in SO
Controls on area sources expected by 2018 include: the OTC VOC rules for consumer products (RCSA 22a-174-40); VOC control measures for architectural and industrial maintenance coatings (RCSA 22a-174-41) and solvent cleaning (RCSA 22a-174-20(l)); VOC control measures for adhesive and sealants (RCSA 22a-174-44); VOC control measures for emulsified and cutback asphalt paving (RCSA 22a-174-20(k)); and VOC control measures for portable fuel containers (contained in EPA's Mobile Source Air Toxics rule).
Controls on mobile sources expected by 2018 include: On-board diagnostics testing for 1979 and new vehicles (RCSA 22a-174-27); Federal On-Board Refueling Vapor Recovery (ORVR) Rule; Federal Tier 2 Motor Vehicle Emissions Standards and Gasoline Sulfur Requirements; Federal Heavy-Duty Diesel Engine Emission Standards for Trucks and Buses; and Federal Emission Standards for Large Industrial Spark-Ignition Engines and Recreation Vehicles.
Controls on non-road sources expected by 2018 include the following federal regulations: Control of Air Pollution: Determination of Significance for Nonroad Sources and Emission Standards for New Nonroad Compression Ignition Engines at or above 37 kilowatts (59 FR 31306, June 17, 1994); Control of Emissions of Air Pollution from Nonroad Diesel Engines (63 FR 56967, Oct. 23, 1998); Control of Emissions from Nonroad Large Spark-Ignition Engines and Recreational Engines (67 FR 68241, Nov. 8, 2002); and Control of Emissions of Air Pollution from Nonroad Diesel Engines and Fuels (69 FR 38958, June 29, 2004).
Tables 11 and 12 are summaries of the 2002 baseline and 2018 estimated emissions inventories for Connecticut. The 2018 estimated emissions include emissions growth as well as emission reductions due to ongoing emission control strategies and reasonable progress goals.
MANE-VU performed modeling for the regional haze LTS for the 11 Mid-Atlantic and Northeast States and the District of Columbia. The modeling analysis is a complex technical evaluation that began with selection of the modeling system. MANE-VU used the following modeling system:
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•
•
•
•
CMAQ modeling of regional haze in the MANE-VU region for 2002 and 2018 was carried out on a grid of 12x12 kilometer (km) cells that covers the 11 MANE-VU States (Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, and Vermont) and the District of Columbia and States adjacent to them. This grid is nested within a larger national CMAQ modeling grid of 36x36 km grid cells that covers the continental United States, portions of Canada and Mexico, and portions of the Atlantic and Pacific Oceans along the east and west coasts. Selection of a representative period of meteorology is crucial for evaluating baseline air quality conditions and projecting future changes in air quality due to changes in emissions of visibility-impairing pollutants. MANE-VU conducted an in-depth analysis which resulted in the selection of the entire year of 2002 (January 1-December 31) as the best period of meteorology available for conducting the CMAQ modeling. The MANE-VU States' modeling was developed consistent with EPA's
MANE-VU examined the model performance of the regional modeling for the areas of interest before determining whether the CMAQ model results were suitable for use in the regional haze assessment of the LTS and for use in the modeling assessment. The modeling assessment predicts future levels of emissions and visibility impairment used to support the LTS and to compare predicted, modeled visibility levels with those on the uniform rate of progress. In keeping with the objective of the CMAQ modeling platform, the air quality model performance was evaluated using graphical and statistical assessments based on measured ozone, fine particles, and acid deposition from various monitoring networks and databases for the 2002 base year. MANE-VU used a diverse set of statistical parameters from the EPA's Modeling Guidance to stress and examine the model and modeling inputs. Once MANE-VU determined the model performance to be acceptable, MANE-VU used the model to assess the 2018 RPGs using the current and future year air quality modeling predictions, and compared the RPGs to the uniform rate of progress.
In accordance with 40 CFR 51.308(d)(3), the State of Connecticut provided the appropriate supporting documentation for all required analyses used to determine the State's LTS. The technical analyses and modeling used to develop the glide path and to support the LTS are consistent with EPA's RHR, and interim and final EPA Modeling Guidance. EPA is proposing to find the MANE-VU technical modeling to support the LTS and determine visibility improvement for the uniform rate of progress acceptable because the modeling system was chosen and used according to EPA Modeling Guidance. EPA agrees with the MANE-VU model performance procedures and results, and that CMAQ, REMSAD, and CALPUFF are appropriate tools for the regional haze assessments for the Connecticut LTS and regional haze SIP.
An important step toward identifying reasonable progress measures is to identify the key pollutants contributing to visibility impairment at each Class I area. To understand the relative benefit of further reducing emissions from different pollutants, MANE-VU developed emission sensitivity model runs using CMAQ to evaluate visibility and air quality impacts from various groups of emissions and pollutant scenarios in the Class I areas on the 20 percent worst visibility days.
Regarding which pollutants are most significantly impacting visibility in the MANE-VU region, MANE-VU's contribution assessment demonstrated that sulfate is the major contributor to PM
The emissions sensitivity analyses conducted by MANE-VU predict that reductions in SO
Since the State of Connecticut does not have a Class I area, it is not required to establish RPGs. However, as a MANE-VU member State, Connecticut adopted the “Statement of MANE-VU Concerning a Request for a Course of Action by States Within MANE-VU Toward Assuring Reasonable Progress” on June 7, 2007. This document included four emission management strategies that will provide for reasonable progress towards achieving natural visibility at the MANE-VU Class I areas. These emission management strategies are collectively known as the MANE-VU “Ask,” and include: (a) Timely implementation of BART requirements; (b) a 90 percent reduction in SO
Connecticut will be controlling its BART sources with Connecticut's alternative to BART program. This program is discussed in detail in Section III.B. Connecticut does not have any EGU stacks identified by MANE-VU as a top contributor to visibility impairment in any of the MANE-VU Class I areas.
The MANE-VU low sulfur fuel oil strategy includes: Phase I reduction of distillate oil to 0.05% sulfur by weight (500 parts per million (ppm)) by no later than 2014; Phase II reductions of #4 residual oil to 0.25% sulfur by weight by no later than 2018; #6 residual oil to 0.5% sulfur by weight by no later than 2018; and further reduction of the sulfur content of distillate oil to 15 ppm by 2018.
The expected reduction in SO
EPA is today proposing approval of the Connecticut Regional Haze SIP for the first implementation period without Connecticut's implementation of a low sulfur fuel oil strategy.
Despite our conclusion that a low sulfur fuel oil strategy is not a necessary component of its Regional Haze SIP for this first implementation period, Connecticut has adopted a partial low sulfur fuel oil strategy that is contingent on its neighboring states adopting similar policies. Section 16a-21a of the Connecticut General Statutes (CGS) limits sulfur content of heating distillate oil and off road diesel to 500 ppm as of the date on which the last of the States of New York, Massachusetts, and Rhode Island limit the sulfur content of such fuels. Currently, all three States have yet to adopt these measures. Connecticut has submitted CGS Section16a-21a for approval into its SIP.
In 40 CFR 51.308(d)(3)(v), States are required to consider the following factors in developing the long term strategy:
a. Emission reductions due to ongoing air pollution control programs, including measures to address reasonably attributable visibility impairment;
b. Measures to mitigate the impacts of construction activities;
c. Emission limitations and schedules for compliance to achieve the reasonable progress goal;
d. Source retirement and replacement schedules;
e. Smoke management techniques for agricultural and forestry management purposes including plans as currently exist within the State for these purposes;
f. Enforceability of emissions limitations and control measures; and
g. The anticipated net effect on visibility due to projected changes in point area, and mobile source emissions over the period addressed by the long term strategy.
Since Connecticut does not contain any Class I areas, the State is not required to address RAVI, nor has any Connecticut source been identified as subject to RAVI. A list of Connecticut's ongoing air pollution control programs is included in Section III.B.1.
The Regional Haze Rule requires Connecticut to consider measures to mitigate the impacts of construction activities on regional haze. MANE-VU's consideration of control measures for construction activities is documented in
The construction industry is already subject to requirements for controlling pollutants that contribute to visibility impairment. For example, federal regulations require the reduction of SO
MANE-VU's Contribution Report found that, from a regional haze perspective, crustal material generally does not play a major role. On the 20 percent best-visibility days during the 2000-2004 baseline period, crustal material accounted for 6 to 11 percent of the particle-related light extinction at the MANE-VU Class I Areas. On the 20 percent worst-visibility days, however, the contribution was reduced to 2 to 3 percent. Furthermore, the crustal fraction is largely made up of pollutants of natural origin (e.g., soil or sea salt) that are not targeted under the Regional Haze Rule. Nevertheless, the crustal fraction at any given location can be heavily influenced by the proximity of construction activities; and construction activities occurring in the immediate vicinity of MANE-VU Class I area could have a noticeable effect on visibility.
For this regional haze SIP, Connecticut concluded that its current regulations are currently sufficient to mitigate the impacts of construction activities. Any future deliberations on potential control measures for construction activities and the possible implementation will be documented in the first regional haze SIP progress report in 2014. EPA proposes to find that Connecticut has adequately addressed measures to mitigate the impacts of construction activities.
In addition to the existing CAA control requirements discussed in Section III.C.1, Connecticut has legislation to implement a low sulfur fuel oil strategy consistent with the MANE-VU “Ask” at such time that New York, Massachusetts, and Rhode Island adopt a comparable sulfur in fuel oil limit. As described in Section III.C.4 above, we do not believe inclusion of the low sulfur oil strategy is a necessary component of an approvable Regional Haze SIP for Connecticut. Therefore, EPA is proposing to determine that Connecticut has satisfactorily considered emission limitations and schedules as part of the LTS.
Pursuant to 40 CFR 51.308(d)(3)(v)(D) of the Regional Haze Rule, Connecticut is required to consider source retirement and replacement schedules in developing the long term strategy. Source retirement and replacement were considered in developing the 2018 emissions. The sources in Connecticut that were shut down after the 2002 base year and therefore were not included in the 2018 inventory are: Devon Unit 7 (109 MW EGU) and Devon Unit 8 (109 MW EGU). The modeling used to develop the 2018 emission inventories, EPA's Integrated Planning Model (IPM), projected that several large EGUs in Connecticut, including five of the six BART-eligible EGUs would retire by 2018 and be replaced by newer units to meet future electric growth. However, Connecticut did not directly rely on the closures of any particular plant in establishing the 2018 inventory upon which the reasonable progress goals were set. EPA is proposing to determine that Connecticut has satisfactorily considered source retirement and replacement schedules as part of the LTS.
The Regional Haze Rule requires States to consider smoke management techniques related to agricultural and forestry management in developing the long-term strategy. MANE-VU's analysis of smoke management in the context of regional haze is documented in
Connecticut currently regulates outdoor wood burning through a statute at CGS 22a-174(f) and a regulation at RCSA 22a-174-17. The open burning requirements limit the locations and times when open burning can take place. Although CT DEEP does not have a formal smoke management program (SMP), as a smoke management policy, CT DEEP's Division of Forestry can only initiate prescribed burns when such activity has less significant impacts on air quality.
Source apportionment results show that wood smoke is a moderate contributor to visibility impairment at some Class I areas in the MANE-VU region; however, smoke is not a large contributor to haze in MANE-VU Class I areas on either the 20% best or 20% worst visibility days. Moreover, most of wood smoke is attributable to residential wood combustion. Therefore, it is unlikely that fires for agricultural or forestry management cause large impacts on visibility in any of the Class I areas in the MANE-VU region. On rare occasions, smoke from major fires degrades air quality and visibility in the MANE-VU area. However, these fires are generally unwanted wildfires that are not subject to SMPs. EPA proposes to approve Connecticut's decision that an Agricultural and Forestry Smoke Management Plan to address visibility impairment is not required at this time.
Connecticut has asked, and we are proposing to process approval of RCSA Section 22a-174-22d in parallel with the approval of Connecticut's Regional Haze SIP. Connecticut indicated that they plan to have a final adopted regulation by June 2012, prior to the finalization of this action. EPA will review the final regulation and determine whether it differs significantly from the proposed regulation. At the same time we take final action on Connecticut's Regional Haze SIP, we will then take final action on RCSA 22a-174-22d, at which point it will be federally enforceable. Therefore, once today's action is finalized, all emission limitations included as part of Connecticut's Regional Haze SIP will be federally enforceable. EPA is proposing to find that Connecticut has adequately addressed the enforceability of emission limitations and control measures.
MANE-VU used the best and final emission inventory to model progress expected toward the goal of natural visibility conditions for the first regional haze planning period. All of the MANE-VU Class I areas are expected to achieve greater progress toward the natural visibility goal than the uniform rate of progress, or the progress expected by extrapolating a trend line from current visibility conditions to natural visibility conditions.
In summary, EPA is proposing to find that Connecticut has adequately addressed the LTS regional haze requirements.
On May 10, 2006, the MANE-VU State Air Directors adopted the Inter-RPO State/Tribal and FLM Consultation Framework that documented the consultation process within the context of regional phase planning, and was intended to create greater certainty and understanding among RPOs. MANE-VU States held ten consultation meetings and/or conference calls from March 1, 2007 through March 21, 2008. In addition to MANE-VU members attending these meetings and conference calls, participants from the Visibility Improvement State and Tribal Association of the Southeast (VISTAS) RPO, Midwest RPO, and the relevant Federal Land Managers were also in attendance. In addition to the conference calls and meeting, the FLMs were given the opportunity to review and comment on each of the technical documents developed by MANE-VU.
On February 4, 2009, Connecticut submitted a draft Regional Haze SIP to the relevant FLMs for review and comment pursuant to 40 CFR 51.308(i)(2). The FLMs provided comments on the draft Regional Haze SIP in accordance with 40 CFR 51.308(i)(3). The comments received from the FLMs were addressed and incorporated in Connecticut's SIP revision. Most of the comments were requests for additional detail as to various aspects of the SIP. These comments and Connecticut's response to comments can be found in the docket for this proposed rulemaking.
On July 17, 2009, Connecticut proposed its Regional Haze SIP for public hearing. Comments were received from U.S. EPA, the National Park Service, the U.S. Department of Agriculture and a private citizen.
EPA is proposing to find that Connecticut has addressed the requirements for consultation with the Federal Land Managers.
Consistent with the requirements of 40 CFR 51.308(g), Connecticut has committed to submitting a report on reasonable progress (in the form of a SIP revision) to the EPA every five years following the initial submittal of its regional haze SIP. The reasonable progress report will evaluate the progress made towards the RPGs for the MANE-VU Class I areas, located in Maine, New Hampshire, Vermont, and New Jersey.
Pursuant to 40 CFR 51.308(f), CT DEEP is required to submit periodic revisions to its Regional Haze SIP by July 31, 2018, and every ten years thereafter. CT DEEP acknowledges and agrees to comply with this schedule.
Pursuant to 40 CFR 51.308(d)(4)(v), CT DEEP will also make periodic updates to the Connecticut emissions inventory. CT DEEP proposes to complete these updates to coincide with the progress reports. Actual emissions will be compared to projected modeled emissions in the progress reports.
Lastly, pursuant to 40 CFR 51.308(h), CT DEEP will submit a determination of adequacy of its regional haze SIP revision whenever a progress report is submitted. Connecticut's regional haze SIP states that, depending on the findings of its five-year review, Connecticut will take one or more of the following actions at that time, whichever actions are appropriate or necessary:
• If Connecticut determines that the existing State Implementation Plan requires no further substantive revision in order to achieve established goals for visibility improvement and emissions reductions, CT DEEP will provide to the EPA Administrator a negative declaration that further revision of the existing plan is not needed.
• If CT DEEP determines that its implementation plan is or may be inadequate to ensure reasonable progress as a result of emissions from sources in one or more other State(s)
• If Connecticut determines that its implementation plan is or may be inadequate to ensure reasonable progress as a result of emissions from sources in another country, Connecticut will provide notification, along with available information, to the EPA Administrator.
• If Connecticut determines that the implementation plan is or may be inadequate to ensure reasonable progress as a result of emissions from sources within the State, Connecticut will revise its implementation plan to address the plan's deficiencies within one year from this determination.
EPA is proposing approval of Connecticut's November 18, 2009 SIP revision as meeting the applicable requirements of the Regional Haze Rule found in 40 CFR 51.308. In addition, EPA is proposing approval of Connecticut's RCSA Section 22a-174-19a, “Control of sulfur dioxide emissions from power plants and other large stationary sources of air pollution” and revisions to RCSA Section 22a-174-22, “Control of Nitrogen Oxides Emissions,” including subdivision 22a-174-22(e)(3), and CGS 16a-21a, “Sulfur content of home heating oil and off-road diesel fuel. Suspension of requirements for emergency.” Furthermore, pursuant to CT DEEP's request under parallel processing, EPA is proposing approval of Connecticut's proposed RCSA Section 22a-174-22d, “Post-2011 Connecticut Ozone Season NO
RCSA 22a-174-22d is a replacement for RCSA 22a-174-22c, “The Clean Air Interstate Rule (CAIR) Nitrogen Oxides (NO
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical substances: Hexabromocyclododecane (Chemical Abstracts Service Registry Number (CASRN) 25637-99-4) and 1,2,5,6,9,10-hexabromocyclododecane (CASRN 3194-55-6), hereinafter collectively referred to as HBCD. This proposed rule would designate “use in consumer textiles, other than for use in motor vehicles” as a significant new use. This action would require persons who intend to manufacture (including import) or process HBCD for use in covered consumer textiles to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if appropriate, to prohibit or limit that activity before it occurs. For this proposed rule, the general SNUR article exemption for persons who
Comments must be received on or before May 25, 2012.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2011-0489, by one of the following methods:
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You may be potentially affected by this action if you manufacture (defined by statute to include import) or process HBCD for consumer textiles. Potentially affected entities may include, but are not limited to organizations identified by the following North American Industry Classification System (NAICS) codes:
• Chemical Manufacturing (NAICS code 325).
• Painting and Wall Covering Contractors (NAICS code 238320).
• Textile and Fabric Finishing (except Broadwoven Fabric) Mills (NAICS code 313312).
• Curtain and Drapery Mills (NAICS code 314121).
• Other Household Textile Product Mills (NAICS code 314129).
• All Other Miscellaneous Textile Product Mills (NAICS code 314999).
• Upholstered Household Furniture Manufacturing (NAICS code 337121).
• Household Furniture (except Wood and Metal) Manufacturing (NAICS code 337125).
• Mattress Manufacturing (NAICS code 337910).
• Blind and Shade Manufacturing (NAICS code 337920).
• Furniture Merchant Wholesalers (NAICS code 423210).
• Home Furnishing Merchant Wholesalers (NAICS code 423220).
• Reupholstery and Furniture Repair (NAICS code 811420).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in § 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under
In addition, chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR part 707, subpart B). Chemical importers must certify that shipments of chemical substances comply with all applicable rules and orders under TSCA, including SNURs. In addition, any persons who export or intend to export a chemical substance that is the subject of a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
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2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
EPA is proposing a SNUR for HBCD which would require persons to notify EPA at least 90 days before commencing the manufacture (including import) or processing of HBCD for use in consumer textiles other than for use in motor vehicles. EPA is considering future regulatory action on additional uses of HBCD.
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering “all relevant factors including:
• The projected volume of manufacturing and processing of a chemical substance,
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance,
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance, and
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.”
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.
Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)). As described in Unit II.C., the general SNUR provisions are found at 40 CFR part 721, subpart A.
General provisions for SNURs appear under 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. Additional provisions appear at § 721.1(c) which describe how persons subject to SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, the Agency may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities on which it has received the SNUN. If EPA does not take action, the Agency is required under TSCA section 5(g) to explain in the
EPA proposes that a person who imports or processes HBCD as part of an article for use in consumer textiles (except for use in motor vehicles) would not be exempt from submitting a SNUN. (See rationale at Unit VI.C.) For this reason, § 721.45(f), which exempts persons importing or processing a chemical substance as part of an article, would not apply to this proposed SNUR.
Persons who export or intend to export a chemical substance(s) identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons who import chemical substances are subject to the TSCA section 13 import certification requirements, codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Such persons must certify that the shipment of the chemical substance(s) comply with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B.
This proposed SNUR would apply to two chemical substances: Hexabromocyclododecane (CASRN 25637-99-4) and 1,2,5,6,9,10-hexabromocyclododecane (CASRN 3194-55-6). Hexabromocyclododecane is manufactured by adding bromine to technical grade 1,5,9-cyclododecatriene to make a chemical substance where the positions of the six bromine atoms are not specified on the cyclododecane ring, corresponding to CASRN 25637-99-4. The specific 1,2,5,6,9,10-hexabromocyclododecane isomer (CASRN 3194-55-6) is the major component of CASRN 25637-99-4. Throughout this proposed rule, the term “HBCD” represents both chemical substances, unless a specific CASRN is also noted.
The Inventory Update Rule (IUR)
Based on information gathered from research, industry, and government, EPA believes that HBCD is not used in consumer textiles other than for use in motor vehicles. The major use of HBCD is in polystyrene foam insulation boards used in construction. It is also used to a minor extent in high-impact polystyrene in electronic products and in textile coatings in carpets, vehicles, furniture, and upholstery, such as draperies (Posner, 2006). In the IUR data, one manufacturer/importer of HBCD (CASRN 3194-55-6) reported the use of the chemical substance under the NAICS code for textile and fabric finishing mills (EPA, 2006). For this use, 1% of the total production volume of the chemical substance was in consumer and commercial products. However, the reporting does not distinguish between commercial and consumer use (EPA, 2006).
Information available to EPA indicates that the use of HBCD in textiles is as a backcoating to function as a flame retardant. EPA conducted preliminary research to determine whether HBCD was used in textile applications for end products sold to consumers. In 2010, an HBCD expert with the Consumer Product Safety Commission (CPSC) expressed to EPA his understanding that HBCD is used only in non-consumer textiles such as firefighters' suits (CPSC, 2010). In 2011, EPA requested information from current and former manufacturers of HBCD. The responses indicate that only one manufacturer sells HBCD for textile uses. The company does not know whether the end use of any of those textiles is a consumer article. (ACC, 2011). Additionally, a representative of the furniture manufacturing company Herman Miller told EPA that HBCD is not in their products (Herman Miller, 2011). EPA also received information from a group of textile formulators that the end uses of HBCD-containing textiles are for military, institutional, and aviation uses only (EPP, 2011). EPA solicits comment on whether any of these uses could be considered consumer textile uses. (See definition of “consumer textile” at § 721.10281 in the regulatory language of this proposed rule).
EPA found that a small amount of HBCD is used in floor mats, headliners, and possibly other interior fabrics in motor vehicles made in the United States, including passenger vehicles. The automotive industry plans to phase out these uses in 2015. This phase-out is consistent with the addition of HBCD to the Annex XIV List of Substances Subject to Authorisation under the European Union's Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) regulations (REACH, 2011). See
Based on the sum of available information, EPA believes HBCD is not used in consumer textiles other than those used in motor vehicles. The Agency also believes HBCD could potentially be used in the future in consumer textiles in the United States because the chemical substance:
1. Is used in non-consumer textile applications in the United States including institutional, military, and aviation uses.
2. Is used in textiles in motor vehicles in the United States.
3. Has been used in residential consumer textile applications.
See more information on uses of HBCD in EPA's “Economic Analysis of the Proposed Significant New Use Rule for Hexabromocyclododecane (HBCD)” (EPA, 2011).
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In a recently conducted, more robust, 2-generation reproductive toxicity study in rats conducted according to established OECD test guidelines, HBCD showed treatment-related reproductive effect (a significant decrease in the number of primordial follicles in the F1 females) (Ema,
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Because HBCD is not chemically bound to its substrate (the protected textile material), there is potential for HBCD to be released at any point in the lifecycle. There is potential for release when the HBCD is initially manufactured, when it is being formulated into the material that is commonly used in textile back coatings, as well as when it is being combined with the textile material to which it is added. In addition, HBCD can be released during the service life of the textile material containing it, including release into water used to wash the treated textiles or into the air via dust particulates. Workers and the general population can be exposed to HBCD through direct contact as it migrates across land, in air, and in water by diffusion or environmental transport.
Evidence strongly suggests there is potential for exposure to the general population from HBCD in the environment and also from products and dust in the home and workplace. HBCD is found world-wide in the environment and wildlife. Human exposure is evidenced from its presence in breast milk, adipose tissue, and blood (Covaci,
To the extent HBCD is present in household applications (e.g., building foam, furniture upholstery, carpeting), children could be exposed, especially given children's increased exposure via dust and the hand-to-mouth ingestion pathway.
HBCD has been measured in air and sediment in Scandinavian countries, North America and Asia (Covaci,
For more information on HBCD concerning its physical-chemical properties, fate, releases, and human and environmental exposure, see EPA's “Hexabromocyclododecane (HBCD) Action Plan” dated August 18, 2010 (HBCD Action Plan, 2010).
EPA is proposing to designate as a significant new use any use of HBCD in consumer textiles other than for use in motor vehicles. EPA believes the only current use of HBCD for consumer textiles is in motor vehicles. Thus any use of HBCD in consumer textiles (other than for textiles in motor vehicles) would be a significant new use. A proposed definition of “consumer textile” can be found at § 721.10281 of the regulatory text of this proposed rule. The proposed definition of “motor vehicle” refers to 40 CFR 85.1703.
(1) The vehicle cannot exceed a maximum speed of 25 miles per hour over level, paved surfaces; or
(2) The vehicle lacks features customarily associated with safe and practical street or highway use, such features including, but not being limited to, a reverse gear (except in the case of motorcycles), a differential, or safety features required by state and/or federal law; or
(3) The vehicle exhibits features which render its use on a street or highway unsafe, impractical, or highly unlikely, such features including, but not being limited to, tracked road contact means, an inordinate size, or features ordinarily associated with military combat or tactical vehicles such as armor and/or weaponry.”
40 CFR 85.1703 is available online at:
This proposed rule would add a section to 40 CFR part 721 to require persons who intend to manufacture (including import) or process HBCD for an activity preliminarily designated as a significant new use by this action to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if appropriate, to prohibit or limit that activity before it occurs. For this proposed rule, the general SNUR exemption for persons that import or process chemical substances as part of an article at § 721.45(f) would not apply. (See discussion at Unit VI.C.)
As summarized in Unit III.D. and E., EPA has concerns regarding the potential exposure to and human health and environmental effects of HBCD. EPA believes that HBCD could be manufactured or processed for consumer textiles other than for use in motor vehicles in the future. Accordingly, EPA wants the opportunity to evaluate and control, where appropriate, activities associated with that use, if such manufacturing or processing were to be commenced in the future. The required notification provided by a SNUN would provide EPA with the opportunity to evaluate activities associated with the significant new use and an opportunity to protect against unreasonable risks, if any, from exposure to HBCD.
Consistent with EPA's past practice for issuing SNURs under TSCA section 5(a)(2), EPA's decision to propose a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use. Rather, the Agency's action is based on EPA's determination that if the use begins or resumes, it may present a risk that EPA should evaluate before the manufacturing or processing for that use begins. Since the new use does not currently exist, deferring a detailed consideration of potential risks or hazards related to that use is an effective use of resources. If a person decides to begin manufacturing or processing the chemical for the new use, the SNUN to EPA allows EPA to evaluate the use according to the specific parameters and circumstances surrounding that intended use.
Based on the considerations in Unit V.A., EPA has the following objectives with regard to the significant new use that is preliminarily designated in this proposed rule:
1. EPA would receive notification of any person's intent to manufacture (including import) or process HBCD for the described significant new use before that activity begins.
2. EPA would have an opportunity to review and evaluate data submitted in a SNUN before the SNUN submitter begins manufacturing or processing of HBCD for the described significant new use.
3. EPA would be able to regulate prospective manufacturers or processors of HBCD before the described significant new use of the chemical substance(s) occur, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including those listed at TSCA section 5(a)(2) (see list at Unit II.B.). EPA has preliminarily determined that manufacturing or processing of HBCD for use in consumer textiles other than
EPA welcomes comment on all aspects of this proposed rule, including:
1. The basis for the significant new use determination presented for this proposed rule.
2. Information about any ongoing manufacture, import, or processing of HBCD for use in consumer textiles.
Before proposing this SNUR, EPA considered the following alternative regulatory actions:
Under a TSCA section 8(a) rule, EPA could, among other things, generally require persons to report information to the Agency when they intend to manufacture or process a listed chemical for a specific use or any use. However, for HBCD in consumer textiles, the use of TSCA section 8(a) rather than SNUR authority would have several limitations. First, if EPA were to require reporting under TSCA section 8(a) instead of TSCA section 5(a), EPA would not have the opportunity to review human and environmental hazards and exposures associated with the use in consumer textiles and, if necessary, take immediate follow-up regulatory action under TSCA sections 5(e) or 5(f) to prohibit or limit the activity before it begins, if warranted. In addition, EPA might not receive important information from small businesses, because such firms generally are exempt from TSCA section 8(a) reporting requirements. In view of health and environmental concerns related to HBCD, if used for the proposed significant new use, EPA believes that a TSCA section 8(a) rule for these chemical substances would not meet EPA's regulatory objectives.
EPA may regulate under TSCA section 6 if “the Administrator finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use or disposal of a chemical substance or mixture . . . presents or will present an unreasonable risk of injury to health or the environment.” (TSCA section 6(a)). EPA concluded that risk management action under TSCA section 6 is not necessary at this time because EPA:
1. Believes HBCD is not being used in consumer textiles in the United States, other than for use in motor vehicles.
2. Has not determined as of this date that use of HBCD in motor vehicles presents unreasonable risk.
3. Expects the use in motor vehicles to end within a few years. This proposed SNUR would allow the Agency to address the potential risks associated with the proposed significant new use.
Under the SNUR exemption provision at § 721.45(f), a person who imports or processes a chemical substance covered by a SNUR identified in 40 CFR part 721, subpart E, as part of an article is not generally subject to the notification requirements of § 721.25 for that chemical substance. However, EPA is concerned that exempting HBCD as part of articles would render the SNUR less effective because of the possibility that consumer textile articles containing HBCD, the primary concern of EPA associated with this proposed rule, could be imported or processed for uses subject to this proposed SNUR without the submission of a SNUN. This proposed rule would not include the exemption at § 721.45(f).
As discussed in the
EPA recognizes that TSCA section 5 does not require the development of any particular test data before submission of a SNUN. There are two exceptions:
1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (TSCA section 5(d); 40 CFR 720.50 and 40 CFR 721.25). However, as a general matter, EPA recommends that SNUN submitters include data that would permit a reasoned evaluation of risks posed by the chemical substance during its manufacture, processing, use, distribution in commerce, or disposal. EPA encourages persons to consult with the Agency before submitting a SNUN. As part of this optional pre-SNUN consultation, EPA would discuss specific data it believes may be useful in evaluating a significant new use. SNUNs submitted for significant new uses without any test data may increase the likelihood that EPA will take action under TSCA section 5(e) to prohibit or limit activities associated with this chemical.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on:
• Human exposure and environmental releases that may result from the significant new use of the chemical substance.
• Potential benefits of the chemical substance.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 40 CFR 721.25. The e-PMN software is available electronically at
EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers and processors of HBCD in consumer textiles. The evaluation is in the “Economic Analysis of the Proposed Significant New Use Rule for Hexabromocyclododecane (HBCD)” (EPA, 2011). It is briefly summarized here and is available in the docket for this proposed rule.
Because there appears to be no use of HBCD in consumer textiles in the United States at the current time, other than for use in motor vehicles, EPA expects very few, if any, entities would submit a SNUN. As a result, the economic impact of this rule is anticipated to be either zero or very low.
In the event that a SNUN is submitted, costs are estimated at approximately $8,300 per SNUN submission for large businesses and $5,900 for small businesses, and include the cost to prepare and submit the SNUN and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $2,500 user fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than $40 million when combined with those of the parent company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). In its evaluation of this proposed rule, EPA also considered the potential costs a company might incur by avoiding or delaying the significant new use in the future, but these costs have not been quantified.
The following documents are specifically referenced in the preamble for this proposed rule. In addition to these documents, other materials may be available in the docket established for this proposed rule under docket ID number EPA-HQ-OPPT-2011-0489, which you can access through
1. EPA. 2006. Inventory Update Reporting (IUR): Non-Confidential 2006 TSCA Inventory Update Rule (IUR) Records. Available online at:
2. Posner. 2006. Survey and technical assessment of alternatives to TBBPA and HBCDD. Kemi Report. January 2006.
3. CPSC. 2010. Personal communication with Dr. Michael Babich, Chemist, United States Consumer Product Safety Commission (CPSC). March 16, 2010.
4. ACC. 2011. Personal communication with Jackson Morrill, Director of Chemical Products of the American Chemistry Council (ACC). February 16, 2011.
5. Herman Miller. 2011. Personal communication with Gabe Wing of Herman Miller, Inc. March 30, 2011.
6. EPP. 2011. Personal communication with John Friddle, President of Eagle Performance Products. March 3, 2011.
7. REACH. 2011. Available online at:
8. EPA. 2011. Economic Analysis of the Proposed Significant New Use Rule for Hexabromocyclododecane (HBCD). Washington, DC. OPPT/Environmental Economics and Technology Division (EETD)/Economic and Policy Analysis Branch (EPAB). February 6, 2012.
9. Chengelis. 2001. An oral (gavage) 90 day toxicity study of HBCD in rats. Study No. WIL-186012. WIL Research Laboratories, Inc. Ashland, Ohio, USA.
10. Eriksson,
11. Ema, M.,
12. Desjardins,
13. Deng,
14. Palace,
15. Kling,
16. Zhang,
17. Ronisz,
18. Drottar,
19. Schriks,
20. Oetken,
21. Crump,
22. Fernie,
23. Covaci,
24. UNEP. 2007. Stockholm Convention on Persistent Organic Pollutants. Persistent Organic Pollutants Review Committee, Third meeting, Geneva. pp. 19-23, November 2007, Item 7 of the provisional agenda, Presentation on environmental transport and modeling. The OECD screening tool for overall persistence and long-range transport potential. UNEP/POPS/POPRC.3/INF/7.
25. Ghanem, R. 2009. Kinetics of Thermal and Photolytic Segregation of Hexabromocyclododecane in Backcoated Textile Samples.
26. EC. 2008. European Commission (EC). Risk Assessment: Hexabromocyclododecane CAS-No.: 25637-99-4 EINECS-No.: 247-148-4, Final Report. Office for Official Publications of the European Communities: Luxembourg. May 2008.
27. Arnot,
28. UNEP. 2009. Stockholm Convention on Persistent Organic Pollutants. Summary of the proposal for the listing of hexabromocyclododecane (HBCDD) in Annex A to the Convention. July 2009.
29. HBCD Action Plan. 2010. EPA's Hexabromocyclododecane (HBCD) Action Plan. August 2010. Available online at http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/hbcd.html (accessed March 8, 2012).
Under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this action has been designated a “significant regulatory action.” Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563, entitled “Improving Regulation and Regulatory Review” (76 FR 3821, January 21, 2011), and any changes made in response to OMB recommendations have been documented in the docket for this action as required by section 6(a)(3)(E) of the Executive Order.
EPA has prepared an economic analysis of this action, entitled “Economic Analysis of the Proposed Significant New Use Rule for Hexabromocyclododecane (HBCD)” (EPA, 2011). A copy of the document is available in the docket for this proposed rule and is summarized in Unit X.
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0038 (EPA ICR No. 1188). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average 97 hours per response. This burden estimate includes the time needed to review instructions; search existing data sources; gather and maintain the data needed; and complete, review, and submit the required SNUN.
Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
Under RFA, small entities include small businesses, small organizations, and small governmental jurisdictions. Small entity is defined in accordance with section 601 of RFA as: A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. For purposes of assessing the impacts of this proposed rule on small entities, EPA has determined that this proposed rule is not expected to impact any small not-for-profit organizations or small governmental jurisdictions. As such, the Agency estimated potential impacts on small business.
A SNUR applies to any person (including small or large entities) who intends to manufacture, import, or process a chemical substance for a use the EPA has designated as a “significant new use.” By definition of the word “new,” and based on information currently available to EPA, it appears that no small or large entities presently engage in such activity. Since this proposed SNUR would require a person who intends to engage in such activity in the future to first notify EPA by submitting a SNUN, no economic impact will occur unless someone files a SNUN to pursue a significant new use in the future or forgoes profits by avoiding or delaying the significant new use. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemical substances, the Agency receives only a handful of SNUNs per year. For example, the number of SNUNs was four in Federal fiscal year 2005, eight in FY2006, six in FY2007, eight in FY2008, and seven in FY2009. During this 5-year period, three small entities submitted a SNUN. Therefore, EPA believes that the potential economic impact of complying with a SNUR is not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4), the Agency presented its general determination that proposed
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reason to believe that any State, local, or Tribal government would be impacted by this proposed rule. As such, EPA has determined that this regulatory action would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531-1538).
This action would not have federalism implications because it is not expected to have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).
This action would not have tribal implications as specified in Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). This action is not expected to have substantial direct effects on Indian Tribes, would not significantly or uniquely affect the communities of Indian Tribal governments, and would not involve or impose any requirements that affect Indian Tribes. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.
This action is not a “significant energy action” as defined in Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this action is not likely to have a significant adverse effect on the supply, distribution, or use of energy.
Because this action would not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note), does not apply to this action.
This action would not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Therefore, it is proposed that 40 CFR part 721 be amended as follows:
1. The authority citation for part 721 continues to read as follows:
15 U.S.C. 2604, 2607, and 2625(c).
2. Add § 721.10281 to subpart E to read as follows:
(a)
(2) The significant new use is use in consumer textiles, other than for use in motor vehicles.
(b)
(1)
(2)
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of proposed rulemaking (NPRM).
In this NPRM, PHMSA is proposing to revise the Hazardous Materials Regulations applicable to air bag inflators, air bag modules, and seat-belt pretensioners. The proposed changes would incorporate the provisions of two special permits into the regulations. In addition, PHMSA proposes to revise the current approval and documentation requirements for a material appropriately classified as a
Comments must be submitted by May 25, 2012. To the extent possible, PHMSA will consider late-filed comments as a final rule is developed.
You may submit comments identified by the docket number (PHMSA-2010-0201 (HM-254)) by any of the following methods:
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Matthew Nickels, Standards and Rulemaking Division, Office of Hazardous Materials Safety, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, telephone (202) 366-8553.
The Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) are issued by the Pipeline and Hazardous Materials Safety Administration (PHMSA) and govern the safe transportation of hazardous materials by highway, rail, vessel, and air. The scope of the HMR includes hazardous materials classification, packaging, hazard communication, emergency response information, and training, etc. Furthermore, included within these provisions are the regulations for the transportation of air bag inflators, air bag modules, and seat-belt pretensioners in § 173.166.
Found in § 173.166(a), PHMSA provides definitions for an air bag inflator (a gas generator used to inflate an air bag in a supplemental restraint system in a motor vehicle), an air bag module (the air bag inflator plus an inflatable bag assembly), and a seat-belt pretensioner (containing similar hazardous materials and is used in the operation of a seat-belt restraining system in a motor vehicle). In § 173.166(b)-(f), PHMSA also provides the regulatory requirements for the classification, EX number assignments, exceptions, packagings, and labeling requirements for these air bag inflators, air bag modules, and seat-belt pretensioners.
In a petition dated June 24, 2008 (P-1523) and two addendums submitted on February 26, 2009 and June 14, 2011, the North American Automotive Hazmat Action Committee (NAAHAC), representing numerous automobile manufacturers and component suppliers located in North America as well as in Asia and Europe, requested revisions to requirements in the HMR applicable to safety restraint systems (e.g., air bag inflators, air bag modules, and seat-belt pretensioners). NAAHAC suggests that subjecting Class 9, UN3268 safety restraint systems to the EX approval process in accordance with § 173.56 imposes an unnecessary burden on the industry that does not advance safety.
In addition, NAAHAC suggests that PHMSA incorporate the following long-standing special permits into the HMR:
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a. Non-specification steel drums with a wall and lid thickness not less than 20 gauge. The lid must be securely affixed with a lever-locking or bolted-ring assembly. The threaded bung closure in the top of the drum must be removed prior to shipment and the bung opening covered with waterproof plastic tape or a waterproof soft plastic cap that must easily provide ventilation of the drum contents in the event of a fire. The drum may be filled with any combination of air bag inflators, air bag modules, or seat-belt pretensioner devices to a capacity not greater than fifty (50) percent of the drum's total volume; inner packagings are not necessary; or
b. Outer packagings that are UN Standard 4H2 solid plastic boxes or non-specification rugged reusable plastic containers with either trays or cushioning material in the containers to prevent movement of articles during transportation. Inner packagings are static-resistant plastic bags or trays, as appropriate.
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As stated above, in addition to NAAHAC's petition suggesting that subjecting Class 9, UN3268 safety restraint systems to the EX approval process in accordance with § 173.56 imposes an unnecessary burden on the industry that does not advance safety, the petition also suggests that PHMSA incorporate these two long-standing special permits into the HMR. PHMSA agrees with the petition and proposes to amend the HMR to incorporate certain requirements based on these two existing special permits issued under 49 CFR Part 107, Subpart B (§§ 107.101 to 107.127). These special permits set forth alternative requirements (variances) to the requirements in the HMR by means that achieve a safety level that at the least corresponds to the safety level required under the regulations and that is consistent with the public interest. Congress expressly authorized DOT to issue variances in the Hazardous Materials Transportation Act of 1975, when appropriate.
The HMR generally are performance-oriented regulations that provide the regulated community a certain amount of flexibility in meeting safety requirements. Even so, not every transportation situation can be anticipated and built into the regulations. The hazardous materials community is particularly strong at developing new materials and technologies and innovative ways of moving materials. Special permits enable the hazardous materials industry to quickly, effectively and safely integrate new products and technologies into the production and transportation stream. Thus, special permits allow developing products and technologies to move in commerce for testing and other purposes, promote increased transportation efficiency and productivity, and support global competitiveness.
A special permit must achieve at least an equivalent level of safety to that specified in the HMR. Implementation of new technologies and operational techniques can enhance safety because the authorized operations or activities achieve a greater level of safety than currently required under the regulations. Special permits also reduce the volume and complexity of the HMR by addressing unique or infrequent transportation situations that would be difficult to accommodate in regulations intended for use by a wide range of shippers and carriers. PHMSA conducts ongoing reviews of special permits to identify widely-used and longstanding special permits with established safety records for incorporation into the HMR for broader applicability.
Incorporating these two special permits into regulations reduces paperwork burdens and facilitates commerce while maintaining an acceptable level of safety. Additionally, adoption of special permits as rules of general applicability provides wider access to the benefits and regulatory flexibility of the provisions granted in the special permits. Factors that influence whether a specific special permit is a candidate for regulatory action include: The safety record for hazardous materials transported; transportation operations conducted under a special permit; the potential for broad application of a special permit; suitability of provisions in the special permit for incorporation into the HMR; rulemaking activity in related areas; and agency priorities.
Regarding the proper classifying of air bag inflators, air bag modules, and seat-belt pretensioners, NAAHAC notes that it is the responsibility of the device manufacturer to ensure that testing, verification, and classification of its products has been conducted in accordance with the HMR. Special Provision 160 (see § 172.102 of the HMR) requires the manufacturer to get the air bag inflators, air bag modules, and seat-belt pretensioners tested by a DOT explosives test lab, in accordance with Test series 6(c) of Part I of the UN Manual of Tests and Criteria (incorporated by reference; see § 171.7 of the HMR), and then the manufacturer must submit a hazard classification recommendation from that DOT explosives test lab to the DOT. This test is performed to ensure that air bag inflators, air bag modules, and seat-belt pretensioners meet the criteria for classification as Class 9 materials. To pass the test there must be no fragmentation of the device casing or pressure vessel, and no projection hazard or thermal effect that would significantly hinder emergency response efforts in the immediate vicinity. Failure of Test series 6(c) necessitates treatment as an explosive in Class 1, including the EX approval process and inclusion of the EX number on the shipping documentation.
NAAHAC indicates that the current requirement to reference the EX number on the shipping paper for Class 9, UN3268 safety restraint systems is a burden that offers little in terms of hazard communication or transportation safety. In fact, NAAHAC states that the requirement imposes unnecessary costs to obtain, record, and transfer the EX number to shipping documents. According to NAAHAC, the industry-wide costs associated with first verifying and then transferring the EX number to the shipping paper is in excess of $890,000.00 annually.
PHMSA agrees with the petitioner that requiring Class 9 air bag inflators, air bag modules, and seat-belt pretensioners to be subjected to the EX approval process is unnecessarily burdensome and that eliminating the approval requirement will not adversely affect safety. Further, PHMSA agrees that incorporating the terms of DOT-SP 12332 and DOT-SP 13996 into the HMR will promote compliance and safety. As a result, PHMSA proposes to revise § 173.166 to address the concerns highlighted in NAAHAC's petition. PHMSA believes changes proposed by this NPRM will promote the safe transportation of Class 9 air bag inflators, air bag modules, and seat-belt pretensioners, while significantly reducing the financial burden on the automotive industry for shipping these devices. The changes proposed by this NPRM are described in detail below.
In this NPRM, PHMSA proposes to allow manufacturers of air bag inflators, air bag modules, or seat-belt pretensioners to receive a classification of Class 9 (UN3268) to new designs that pass Test series 6(c) of the UN Manual of Tests and Criteria—currently required by Special Provision 160. As proposed, an air bag inflator, air bag module, or seat-belt pretensioner may be classed as Class 9 (UN3268) if the air bag inflator, air bag module, or seat-belt pretensioner design is examined and successfully tested by a person or agency (authorized testing agency) who is authorized by the Associate Administrator to perform such examination and testing of explosives under 173.56(b)(1).
As proposed in this NPRM, persons who test and examine air bag inflators, air bag modules, or seat-belt pretensioners will be required to provide a detailed report on each tested design to the manufacturer. Key components of the report include a description of the design; explanation of the tests performed and results; and a recommended classification for tested designs. The manufacturer must retain the report for as long as the design is in production and for 15 years thereafter. Additionally, the manufacturer must make the report available to Department officials upon request. This record retention requirement ensures that a detailed test report of each air bag inflator, air bag module, or seat-belt pretensioner design is maintained and available for the useful life of the device. These records may be used to verify the accuracy and validity of the tests and classification recommendation.
In summary, the proposed amendment provides manufacturers of air bag inflators, air bag modules, or seat-belt pretensioners with the option to utilize new designs that are proven to meet the criteria of a Class 9 through established test criteria, without receiving an EX approval from PHMSA. The result is a significant cost savings and no change in the level of safety. Additionally, we propose to permit manufacturers to continue to receive EX approval by submitting their designs for examination and testing in accordance with § 173.56(b) if they so choose.
Air bag inflators, air bag modules, or seat-belt pretensioners that meet the criteria for a Division 1.4G explosive, (e.g., a device that fails Test series 6(c) of the UN Manual of Tests and Criteria, as provided by Special Provision 160) must continue to be approved by
PHMSA is proposing in this NPRM to except Class 9 air bag inflators, air bag modules, or seat-belt pretensioners assigned to UN3268 from the requirement to provide the EX number on the shipping paper. As suggested by NAAHAC, the documentation requirement imposes a cost burden, but does not provide a safety benefit.
In this NPRM, PHMSA proposes to clarify that a safety restraint device that is installed in a vehicle or vehicle component is not subject to the HMR. This change makes it clear that the exception will continue to apply to Class 9, UN3268 materials that are not approved by the Associate Administrator.
In this NPRM, PHMSA is also proposing to authorize the use of non-DOT specification, reusable containers manufactured from high strength plastic, metal, or other suitable material, or other dedicated handling devices, for transportation of air bag inflators, air bag modules, and seat-belt pretensioners. This change would incorporate the provisions of Special Permit DOT-SP 13996 into the HMR. The special permit has been in effect since 2005, and has been utilized by 31 grantees with no known safety problems. A review of the Hazardous Materials Incident Data library did not reveal any incidents related to this special permit since the date of its issuance.
Special Permit DOT-SP 13996 allows the specified packaging to be used for transportation from the manufacturing facility to an intermediate handling location; from an intermediate handling location to the assembly facility; from the assembly facility to an intermediate handling location; from the intermediate handling location back to the manufacturing facility; or from the assembly facility directly to the manufacturer with no intermediate facility involved. As proposed in this NPRM, there would be no limit on the use of the authorized packaging to transportation between specific destinations. However, no modifications or changes may be made to the original package and the transportation must be made by private or contract carrier. By requiring no modifications to the original package, this will ensure that adequate packaging and handling considerations are maintained.
In this NPRM, PHMSA also proposes to authorize additional packaging alternatives for air bag inflators, air bag modules, and seat-belt pretensioners that have been removed from, or were intended to be used in, a motor vehicle that meets the requirements for use in the United States. The proposed change would incorporate the provisions of Special Permit DOT-SP 12332 into the HMR. The special permit has been in effect since 2000, and has been utilized by more than 2,100 grantees with no known safety problems. A review of the Hazardous Materials Incident Data library did not reveal any incidents related to this special permit since the date of its issuance. In accordance with the special permit, this additional packaging option would be limited to devices that are offered for transportation and transported domestically by highway.
In this NPRM, we did not propose any changes to the requirements for shipping air bag modules or seat-belt pretensioners for recycling. In the current HMR, when offered for domestic transportation by highway, rail freight, cargo vessel or cargo aircraft, a serviceable air bag module or seat-belt pretensioner removed from a motor vehicle that was manufactured as required for use in the U.S. may be offered for transportation and transported without compliance with the shipping paper requirement prescribed in § 173.166(c), but the word “Recycled” must be entered on the shipping paper immediately after the basic description prescribed in § 172.202. However, we believe that the word “Reuse” might be a more appropriate description for the actual action that is taking place. We request comments regarding a potential change from the word “Recycled” to “Reuse” that would appear on shipping papers in accordance with an altered § 173.166(d)(4).
To maintain alignment of the HMR with international requirements, in this NPRM, we are proposing to incorporate changes based on the Seventeenth revised edition of the UN Model Regulations. Specifically, in addition to the packagings authorized currently in § 173.166(e)(1), (e)(2), and (e)(3), we propose to permit 1N2 and 1D drums, 3B2 jerricans, and 4A, 4B, 4N, and 4H1 boxes.
This notice of proposed rulemaking is published under the authority of 49 U.S.C. 5103(b) which authorizes the Secretary to prescribe regulations for the safe transportation, including security, of hazardous material in intrastate, interstate, and foreign commerce. 49 U.S.C. 5117(a) authorizes the Secretary of Transportation to issue a special permit from a regulation prescribed in 5103(b), 5104, 5110, or 5112 of the Federal Hazardous Materials Transportation Law to a person transporting, or causing to be transported, hazardous material in a way that achieves a safety level at least equal to the safety level required under the law, or consistent with the public interest, if a required safety level does not exist. If adopted as proposed, the final rule would amend the regulations incorporating a petition and provisions from certain widely-used and longstanding special permits that have established a history of safety and which may, therefore, be converted into the regulations for general use.
This notice of proposed rulemaking is not considered a significant regulatory action under section 3(f) of Executive Order 12866 and, therefore, was not reviewed by the Office of Management and Budget. Furthermore, this rule is not significant under the Regulatory Policies and Procedures of the Department of Transportation (44
Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review that were established in Executive Order 12866 Regulatory Planning and Review of September 30, 1993. By building off of each other, these two Executive Orders 12866 and 13563 require agencies to regulate in the “most cost-effective manner,” to make a “reasoned determination that the benefits of the intended regulation justify its costs,” and to develop regulations that “impose the least burden on society.”
In this NPRM, the proposed amendments to the HMR will not impose increased compliance costs on the regulated industry. Rather, the proposed rule incorporates current approval procedures for the transportation of air bag inflators, air bag modules, and seat-belt pretensioners into the HMR and provides additional
This proposed rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). This proposed rule would preempt State, local, and Indian tribe requirements but does not propose any regulation that has substantial direct effects on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.
The Federal hazardous materials transportation law, 49 U.S.C. 5101-5127, contains an express preemption provision (49 U.S.C. 5125(b)) that preempts State, local, and Indian tribe requirements on the following subjects:
(1) The designation, description, and classification of hazardous materials;
(2) The packing, repacking, handling, labeling, marking, and placarding of hazardous materials;
(3) The preparation, execution, and use of shipping documents related to hazardous materials and requirements related to the number, contents, and placement of those documents;
(4) The written notification, recording, and reporting of the unintentional release in transportation of hazardous material; and
(5) The design, manufacture, fabrication, marking, maintenance, recondition, repair, or testing of a packaging or container represented, marked, certified, or sold as qualified for use in transporting hazardous material.
This proposed rule addresses subject areas (1), (3), and (5), above. If adopted as final, this rule would preempt any State, local, or Indian tribe requirements concerning these subjects unless the non-Federal requirements are “substantively the same” as the Federal requirements. Furthermore, this proposed rule is necessary to update, clarify, and provide relief from regulatory requirements.
Federal hazardous materials transportation law provides at § 5125(b)(2) that, if DOT issues a regulation concerning any of the covered subjects, DOT must determine and publish in the
This NPRM has been analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this NPRM does not significantly or uniquely affect the communities of the Indian tribal governments and does not impose substantial direct compliance costs, the funding and consultation requirements of Executive Order 13175 do not apply.
The Regulatory Flexibility Act (5 U.S.C. 601
This notice has been developed in accordance with Executive Order 13272 (“Proper Consideration of Small Entities in Agency Rulemaking”) and DOT's procedures and policies to promote compliance with the Regulatory Flexibility Act to ensure that potential impacts of draft rules on small entities are properly considered.
PHMSA currently has an approved information collection under Office of Management and Budget (OMB) Control Number 2137-0051, entitled “Rulemaking, Special Permits, and Preemption Requirements,” with an expiration date of April 30, 2014. This NPRM may result in a decrease in the annual burden and costs under OMB Control Number 2137-0051 due to proposed changes to incorporate provisions contained in certain widely-used or longstanding special permits that have an established safety record.
PHMSA also has an approved information collection under OMB Control Number 2137-0557, entitled “Approvals for Hazardous Materials,” with an expiration date of May 31, 2014. While this NPRM may result in a slight increase in the annual burden and cost to OMB Control Number 2137-0557 for proposed minor recordkeeping requirements under § 173.166, this NPRM should result in an overall decrease in the annual burden and cost to OMB Control Number 2137-0557 due to the larger cost savings of reducing the number of approvals required by testers of air bags and air bag modules.
PHMSA has an approved information collection under OMB Control Number 2137-0034, entitled “Hazardous Materials Shipping Papers and Emergency Response.” This NPRM may result in a decrease in the annual burden and cost due to shippers no longer being required to put the EX numbers on shipping papers for air bag modules.
Under the Paperwork Reduction Act of 1995, no person is required to respond to an information collection unless it has been approved by OMB and displays a valid OMB control number. Section 1320.8(d), title 5, Code of Federal Regulations requires that PHMSA provide interested members of the public and affected agencies an opportunity to comment on information and recordkeeping requests.
This notice identifies revised information collection requests that PHMSA will submit to OMB for
OMB Control No. 2137-0051:
OMB Control No. 2137-0557:
OMB Control No. 2137-0034:
PHMSA specifically requests comments on the information collection and recordkeeping burdens associated with developing, implementing, and maintaining these requirements for approval under this proposed rule.
Requests for a copy of this information collection should be directed to Steven Andrews or T. Glenn Foster, Office of Hazardous Materials Standards (PHH-12), Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, Telephone (202) 366-8553.
Address written comments to the Dockets Unit as identified in the
A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.
This proposed rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It does not result in costs of $141.3 million or more to either state, local or tribal governments, in the aggregate, or to the private sector, and is the least burdensome alternative that achieves the objective of the rule.
The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321-4347), and implementing regulations by the Council on Environmental Quality (40 CFR part 1500) require Federal agencies to consider the consequences of Federal actions and prepare a detailed statement on actions that significantly affect the quality of the human environment.
The hazardous materials regulatory system is a risk management system that is prevention oriented and focused on identifying a hazard and reducing the probability and quantity of a hazardous materials release. Hazardous materials are categorized by hazard analysis and experience into hazard classes and packing groups. The regulations require each shipper to classify a material in accordance with these hazard classes and packing groups; the process of classifying a hazardous material is itself a form of hazard analysis. Further, the regulations require the shipper to communicate the material's hazards by identifying the hazard class, packing group, and proper shipping name on shipping papers and with labels on packages and placards on transport vehicles. Thus, the shipping paper, labels, and placards communicate the most significant findings of the shipper's hazard analysis. Most hazardous materials are assigned to one of three packing groups based upon its degree of hazard, from a high hazard Packing Group I material to a low hazard Packing Group III material. The quality, damage resistance, and performance standards for the packagings authorized for the hazardous materials in each packing group are appropriate for the hazards of the material transported.
Hazardous materials are transported by aircraft, vessel, rail, and highway. The potential for environmental damage or contamination exists when packages of hazardous materials are involved in transportation incidents. The need for hazardous materials to support essential services means transportation of highly hazardous materials is unavoidable. However, these shipments frequently move through densely populated or environmentally sensitive areas where the consequences of an incident could be loss of life, serious injury, or significant environmental damage. The ecosystems that could be affected by a hazardous materials release during transportation include atmospheric, aquatic, terrestrial, and vegetal resources (for example, wildlife habitats). The adverse environmental impacts associated with releases of most hazardous materials are short-term impacts that can be greatly reduced or eliminated through prompt clean-up of the incident scene. In this NPRM, we are requesting comments on the potential environmental impacts of the proposals.
In this NPRM, PHMSA proposes to incorporate the terms of two special permits into the HMR. Further, all of the proposals in this NPRM involve the transportation of air bag inflators, air bag modules, or seat-belt pretensioners that have been classed as UN3268, miscellaneous hazardous materials (Class 9). While this classification indicates that the material presents a hazard during transportation (but which does not meet the definition of any other hazard class in the HMR), a Class 9 material ranks last in all items regulated by the U.S. DOT in terms of hazard precedence and risk. The proposals in this NPRM reflect that fact and if finalized, would reduce the unnecessary burdens on not just the offerors of these UN3268 materials, but reduce PHMSA's own administrative costs from reviewing unnecessary approvals and special permits.
The purpose and need of this rulemaking is to incorporate widely-used special permits or those with an established safety record into the HMR for universal use. More information about the advantages of the proposed action can be found in the preamble (i.e., Summary Review of Proposed Amendments) to this rulemaking. The alternatives considered in the analysis include: (1) The proposed action, that is, incorporation of the proposed special permits as amendments to the HMR; and (2) the “no action” alternative, meaning that none of the proposed special permits would be incorporated into the HMR. PHMSA believes that either of these alternatives would result in equal environmental risk and/or impact because special permits are intended to offer equivalent safety and environmental protection as the HMR.
In considering the potential environmental impacts of the proposed
Given that this rulemaking proposes to amend the HMR to incorporate provisions contained in certain widely-used or longstanding special permits that have an established safety record, these proposed changes in regulation should increase safety and environmental protections.
The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing any standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standards have a legitimate domestic objective, such as the protection of safety, and do not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. PHMSA notes the purpose is to ensure the safety of the American public, and has assessed the effects of this rule to ensure that it does not exclude imports that meet this objective. As a result, this proposed rule is not considered as creating an unnecessary obstacle to foreign commerce.
Hazardous materials transportation, Packaging and containers, Radioactive materials, Reporting and recordkeeping requirements, and Uranium.
In consideration of the foregoing, we propose to amend 49 CFR Chapter I as follows:
1. The authority citation for part 173 continues to read as follows:
49 U.S.C. 5101-5128, 44701; 49 CFR 1.45, 1.53.
2. Section 173.166 is proposed to be revised as follows:
(a)
(b)
(i) Does not manufacture or market explosives, air bag inflators, air bag modules, or seat-belt pretensioners, is not owned in whole or in part, or is not financially dependent upon any entity that manufactures or markets explosives, air bag inflators, air bag modules, or seat-belt pretensioners;
(ii) Performs all examination and testing in accordance with the applicable requirements as specified in Special Provision 160 (see § 172.102); and
(iii) Maintains records in accordance with paragraph (g) of this section.
(iv) By adhering to all the provisions specified in § 173.166(b)(1), the Class 9 (UN3268) air bag inflator, air bag module, or seat-belt pretensioner design is not required to be submitted to the Associate Administrator for approval or assigned an EX number.
(2) An air bag inflator, air bag module, or seat-belt pretensioner may be classed as Division 1.4G if it has been examined and successfully tested by a person or agency (authorized testing agency) who is authorized by the Associate Administrator to perform such examination and testing of explosives under 173.56 of this subchapter. For domestic transport, air bag inflators, air bag modules or seat-belt pretensioners that meet the criteria for a Division 1.4G explosive must be transported using the description, “UN0431, Articles, pyrotechnic
(3) The manufacturer has submitted an application, including a classification issued by the competent authority of a foreign government to the Associate Administrator, and received written notification from the Associate Administrator that the device has been approved for transportation and assigned an EX number.
(c)
(2) An air bag inflator, air bag module, or seat-belt pretensioner when classed as a Class 9 (UN3268), is excepted from the EX number requirements of paragraph (c).
(d)
(2) An air bag module containing an inflator that has been previously approved by the Associate Administrator for transportation is not required to be submitted for further examination or approval.
(3) An air bag module containing an inflator that has previously been approved by the Associate Administrator as a Division 2.2 material is not required to be submitted for further examination to be reclassed as a Class 9 material.
(4)
(e)
(1) 1A2, 1B2, 1N2, 1D, 1G, or 1H2 drums.
(2) 3A2, 3B2, or 3H2 jerricans.
(3) 4A, 4B, 4N, 4C1, 4C2, 4D, 4F, 4G, 4H1, or 4H2 boxes.
(4)
(A) The gross weight of the containers or handling devices may not exceed 1000 kg (2205 pounds). Containers or handling devices must provide adequate support to allow stacking at least three units high with no resultant damage;
(B) If not completely enclosed by design, the container or handling device must be covered with plastic, fiberboard, metal, or other suitable material. The covering must be secured to the container by banding or other comparable methods; and
(C) Internal dunnage must be sufficient to prevent movement of the devices within the container.
(ii) Reusable containers manufactured from high-strength plastic, metal, or other suitable material, or other dedicated handling devices are authorized for shipment of air bag inflators, air bag modules, and seat-belt pretensioners to, between, and from, intermediate handling locations, provided they meet the conditions specified in paragraph (e)(4)(i)(A)-(C) of this section and:
(A) No modifications or changes are made to the packagings; and
(B) Transportation must be made by private or contract carrier.
(5) Packagings which were previously authorized in an approval issued by the Associate Administrator may continue to be used until January 1, 2018, provided a copy of the approval is maintained while such packaging is being used.
(6)
(i) Specification and non-specification steel drums with a wall and lid thickness not less than 20 gauge. The lid must be securely affixed with a lever-locking or bolted-ring assembly. The lid of the drum must provide ventilation of the drum contents in a fire. The drum may be filled with any combination of air bag inflators, air bag modules, or seat-belt pretensioner devices to a capacity not greater than fifty (50) percent of the drum's total volume. In addition, inner packagings are not required; or
(ii) Outer packaging consisting of 4H2 solid plastic boxes or non-specification rugged reusable plastic outer packaging and inner static-resistant plastic bags or trays, as appropriate. If not completely enclosed by design, the container or handling device must be covered with plastic, fiberboard, metal or other suitable material. The covering must be secured to the container by banding or other comparable methods. The articles must be packed to prevent movement within the container during transportation.
(f)
(g)
(i) Name and address of the test facility;
(ii) Name and address of the applicant;
(iii) Manufacturer of the device. For a foreign manufacturer, the U.S. agent or importer must be identified;
(iv) A test report number, drawing of the device, and description of the air bag inflator, air bag module, or seat-belt pretensioner in sufficient detail to ensure that the test report is traceable (e.g. a unique product identifier) to a specific inflator design;
(v) The tests conducted and the results; and
(vi) A certification that the air bag inflator, air bag module, or seat-belt pretensioner is properly classed as a Class 9 (UN3268).
(2) For as long as any air bag inflator, air bag module, or seat-belt pretensioner design is being manufactured, and for at least fifteen (15) years thereafter, a copy of each test report must be maintained by the authorized testing agency that performed the examination and testing, and by the manufacturer of the product.
(3) Test reports must be made available to a representative of the Department upon request.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Forest Service, USDA.
Revised notice of intent to call for nominations for membership to the Black Hills National Forest Advisory Board.
The U.S. Department of Agriculture, Forest Service has re-established the Black Hills National Forest Advisory Board (Board). The purpose is to obtain advice and recommendations on a broad range of forest issues such as forest plan revisions or amendments, forest health including fire management and mountain pine beetle infestations, travel management, forest monitoring and evaluation, recreation fees, and site-specific projects having forest wide implications. In an earlier notice, the Forest Service indicated it was seeking nominations for individuals to be considered as committee members, and the public was invited to submit nominations for membership. That notice, “Notice of intent to re-establish the Black Hills National Forest Advisory Board and call for nominations,” was published in the
Written nominations must be received by April 30, 2012. Instructions for submitting a nomination package may be found in the section below entitled, “Advisory Committee Organization”.
Send nominations and applications to Craig Bobzien, Forest Supervisor, Black Hills National Forest, 1019 North 5th Street, Custer, SD 57730.
Marie Curtin, Planning and Public Affairs, USDA, Forest Service, Black Hills National Forest, telephone: 605-673-9324, fax: 605-673-9208, or email:
USDA 16565-Black Hills National Forest Advisory Board is a non-scientific program advisory Board established by the Secretary of Agriculture in 2003 to provide advice and counsel to the U. S. Forest Service, Black Hills National Forest, in the wake of increasingly severe and intense wild fires and mountain pine beetle epidemics.
The purpose of the Board is to provide advice and recommendations on a broad range of forest issues such as forest plan revisions or amendments, travel management, forest monitoring and evaluation, and site-specific projects having forest-wide implications. The Board also serves to meet the needs of the Recreation Enhancement Act of 2005 as a recreation resource advisory board (RRAC) for the Black Hills of South Dakota. The Board provides timely advice and recommendations to the regional forester through the forest supervisor regarding programmatic forest issues and project-level issues that have forest-wide implications for the Black Hills National Forest.
The Board meets approximately ten times a year, with one month being a field trip, held in August and focusing on both current issues and the educational value of seeing management strategies and outcomes on the ground. This Board has been established as a truly credible entity and a trusted voice on forest management issues and is doing often astonishing work in helping to develop informed consent for forest management.
For years, the demands made on the Black Hills National Forest have resulted in conflicts among interest groups resulting in both forest-wide and site-specific programs being delayed due to appeals and litigation. The Board provides a forum to resolve these issues to allow for the Black Hills National Forest to move forward in its management activities. The Board is believed to be one of the few groups with broad enough scope to address all of the issues and include all of the jurisdictional boundaries.
The Board's most significant accomplishments include:
1. A 2004 report on the Black Hills Fuels Reduction Plan, a priority following the major fires including the 86,000 acre Jasper Fire in 2000;
2. A 2004 initial Off-Highway Vehicle Travel Management Subcommittee report;
3. A report on their findings regarding the thesis, direction, and assumptions of Phase II of our Forest Plan produced in 2005;
4. The Invasive Species Subcommittee Report in 2005 covering recommendations to better stop invasive species from infiltrating the Forest;
5. A final Travel Management Subcommittee Report in 2006 in which the Board made 11 recommendations regarding characteristics of a designated motor vehicle trail system, the basis for our initial work to prepare our Motor Vehicle Use Map in 2010-2011;
6. The Board's annual work to attract funding through grants based on the Collaborative Landscape Forest Restoration Program (CFLRP), a program of the Secretary of Agriculture CFLR Program to encourage the collaborative, science-based ecosystem restoration of priority forest landscapes;
7. A letter to the Secretary and the Chief of the Forest Service to work, restore and maintain open space for wildlife habitat and recreation needs like snowmobile trails; and
8. The annual reports to the Secretary detailing the Board's activities, issues, and accomplishments.
The Board is deemed to be among the most effective public involvement strategies in the Forest Service and continues to lead by example for Federal, State, and local government agencies working to coordinate and cooperate in the Black Hills of South Dakota and Wyoming.
Pursuant to the Federal Advisory Committee Act (5 U.S.C. App. II), notice is hereby given that the Secretary of Agriculture intends to calls for nominations for membership to the Black Hills National Forest Advisory Board. The Board provides advice and recommendations on a broad range of forest planning issues and, in accordance with the Federal Lands Recreation Enhancement Act (Pub. L. 108-447 (REA)), more specifically will provide advice and recommendations on Black Hills National Forest recreation fee issues (serving as the RRAC for the Black Hills National Forest). The Board membership consists of individuals representing commodity interests, amenity interests, and State and local government.
The Board has been determined to be in the public interest in connection with the duties and responsibilities of the Black Hills National Forest. National forest management requires improved coordination among the interests and governmental entities responsible for land management decisions and the public that the agency serves.
The Board consists of 16 members that are representative of the following interests (this membership is similar to the membership outlined by the Secure Rural Schools and Community Self Determination Act for Resource Advisory Committees (16 U.S.C. 500,
1. Economic development;
2. Developed outdoor recreation, off-highway vehicle users, or commercial recreation;
3. Energy and mineral development;
4. Commercial timber industry;
5. Permittee (grazing or other land use within the Black Hills area);
6. Nationally recognized environmental organizations;
7. Regionally or locally recognized environmental organizations;
8. Dispersed recreation;
9. Archeology or history;
10. Nationally or regionally recognized sportsmen's groups, such as anglers or hunters;
11. South Dakota State-elected offices;
12. Wyoming State-elected offices;
13. South Dakota or Wyoming county-or local-elected officials;
14. Tribal government elected or- appointed officials;
15. South Dakota State natural resource agency official; and
16. Wyoming State natural resource agency official.
No individual who is currently registered as a Federal lobbyist is eligible to serve as a member of the Committee. The Committee will meet approximately nine times, and will attend at least one summer field tour as designated by the Designated Federal Officer (DFO).
The appointment of members to the Board will be made by the Secretary of Agriculture. Any individual or organization may nominate one or more qualified persons to serve on the Board. Individuals may also nominate themselves. To be considered for membership, nominees must submit a:
1. Resume describing qualifications for membership to the Committee;
2. Cover letter with rationale for serving on the committee and what you can contribute; and
3. Complete form AD-755, Advisory Committee Membership Background Information.
Letters of recommendations are welcome. The AD-755 may be obtained from Forest Service contact person or from the following Web site:
The members of the Board will elect and determine the responsibilities of the Chairperson and the Vice-Chairperson. In absence of the Chairperson, the Vice-Chairperson will act in the Chairperson's stead. The Forest Supervisor of the Black Hills National Forest serves as the Designated Federal Official under sections 10(e) and (f) of the Federal Advisory Committee Act (5 U.S.C. App. II).
Members will serve without compensation, but may be reimbursed for travel expenses while performing duties on behalf of the Board, subject to approval by the DFO.
Equal opportunity practices are followed in all appointments to the Board in accordance with USDA policies. To ensure that the recommendations of the Board have been taken into account the needs of diverse groups, served by the Black Hills National Forest, membership shall include, to the extent practicable, individuals with demonstrated ability to represent minorities, women, and persons with disabilities.
National Agricultural Statistics Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection, the Agricultural Resources Management Survey and Chemical Use Surveys. A revision to burden hours will be needed due to changes in the size of the target population, sampling design, and/or questionnaire length.
Comments on this notice must be received by May 25, 2012 to be assured of consideration.
You may submit comments, identified by docket number 0535-0218, by any of the following methods:
•
•
•
•
Joseph T. Reilly, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-4333.
ARMS is the only source of information available for objective evaluation of many critical issues related to agriculture and the rural economy, such as: Whole farm finance data, including data sufficient to construct estimates of income for farms by: type of operation, loan commodities, income for operator households, credit, structure, and organization; marketing information; and other economic data on input usage, production practices, and crop substitution possibilities.
Data from ARMS are used to produce estimates of net farm income by type of commercial producer as required in 7 U.S.C. 7998 and estimates of enterprise production costs as required in 7 U.S.C. 1441(a). Data from ARMS are also used as weights in the development of the Prices Paid Index, a component of the Parity Index referred to in the Agricultural Adjustment Act of 1938. These indexes are used to calculate the annual federal grazing fee rates as described in the Public Rangelands Improvement Act of 1978 and Executive Order 12548 and as promulgated in regulations found at 36 CFR 222.51.
In addition, ARMS is used to produce estimates of sector-wide production expenditures and other components of income that are used in constructing the estimates of income and value-added which are transmitted to the U.S. Department of Commerce, Bureau of Economic Analysis, by the USDA Economic Research Service (ERS) for use in constructing economy-wide estimates of Gross Domestic Product. This transmittal of data, prepared using the ARMS, is undertaken to satisfy a 1956 agreement between the Office of Management and Budget and the Departments of Agriculture and Commerce that a single set of estimates be published on farm income.
NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),” 72 FR 33362 (June 15, 2007).
Copies of this information collection and related instructions can be obtained without charge from the NASS Clearance Officer, at (202) 690-2388 or at:
National Agricultural Statistics Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intent of the National Agricultural Statistics Service (NASS) to seek reinstatement of an information collection, the National Childhood Injury and Occupational Injury Survey of Farm Operators.
Comments on this notice must be received by May 25, 2012 to be assured of consideration.
You may submit comments, identified by docket number 0535-0235, by any of the following methods:
•
•
•
•
Joseph T. Reilly, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-4333.
Data will be collected by telephone from all 50 states. Questions will relate to farm injuries occurring during the reference calendar year. These data will update and enhance existing data series used by the National Institute of Occupational Safety and Health (NIOSH) to: (1) Establish a measure of the number and rate of childhood injuries associated with farming operations and study the specific types of injuries sustained and (2) describe the scope and magnitude of occupational injuries associated with farming operations. The collection combines the youth and occupational injury studies to reduce the number of contacts on the targeted farm population. Reports will be generated and information disseminated to all interested parties concerning the findings from this study.
NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential
Copies of this information collection and related instructions can be obtained without charge from David Hancock, NASS—OMB Clearance Officer, at (202) 690-2388 or at
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
Copies of the above information collection proposal can be obtained by calling or writing Jennifer Jessup, Departmental Paperwork Clearance Officer, (202) 482-0336, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to Jasmeet Seehra, Office of Management and Budget (OMB), by email to
Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of open public meeting.
This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the DoC NOAA National Climate Assessment and Development Advisory Committee (NCADAC).
The meeting is scheduled for: Tuesday, April 10, 2012 from 2-4 p.m. Eastern Time.
Conference call. Public access will be available at the office of the U.S. Global Change Research Program, Conference Room A, Suite 250, 1717 Pennsylvania Avenue NW., Washington, DC 20006. Please check the National Climate Assessment Web site for additional information at
Please refer to the Web page
Dr. Cynthia Decker, Designated Federal Official, National Climate Assessment and Development Advisory Board, NOAA, Rm. 11230, 1315 East-West Highway, Silver Spring, Maryland 20910. (Phone: 301-734-1156, Fax: 301-713-1459, Email:
The National Climate Assessment and Development Advisory Committee was established in December 2010. The committee's mission is to synthesize and summarize the science and information pertaining to current and future impacts of climate change upon the United States; and to provide advice and recommendations toward the
U.S. Census Bureau, Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
To ensure consideration, written comments must be submitted on or before May 25, 2012.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, (202) 482-0336, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Jeremy Phillips, U.S. Census Bureau, Governments Division, 4600 Silver Hill Road, Washington, DC 20233-6800; (301) 763-5653.
The United States Census Bureau plans to request an extension to the current Office of Management and Budget clearance for the Annual Survey of School System Finances.
The Annual Survey of School System Finances is the only comprehensive source of public elementary-secondary school system finance data collected on a nationwide scale using uniform definitions, concepts, and procedures. The collection covers the revenues, expenditures, debt, and assets of all public elementary-secondary school systems. This data collection has been coordinated with the National Center for Education Statistics (NCES). The NCES uses this collection to satisfy its need for school finance data.
Fiscal data provided by respondents aid data users in measuring the effectiveness of resource allocation. The products of this data collection make it possible for data users to search a single database to obtain information on such things as per pupil expenditures and the percent of state, local, and federal funding for each school system. Elementary-secondary education related spending is the single largest financial activity of state and local governments. Education finance statistics provided by the Census Bureau allow for analyses of how public elementary-secondary school systems receive their funding and how they are spending their funds.
The forms and survey announcement used in the school finance portion of the survey are:
The Census Bureau collects almost all of the finance data for local school systems from state education agency databases through central collection arrangements with the state education agencies. The states transfer most of this information in electronic format over the Internet via file transfer protocol. The Census Bureau has facilitated central collection of school system finance data by accepting data in multiple formats.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
An application has been submitted to the Foreign-Trade Zones (FTZ) Board (the Board) by the Tri-Cities Airport Commission, grantee of FTZ 204, requesting authority to reorganize the zone under the alternative site framework (ASF) adopted by the Board (74 FR 1170, 1/12/09 (correction 74 FR 3987, 1/22/09); 75 FR 71069-71070, 11/22/10). The ASF is an option for grantees for the establishment or reorganization of general-purpose zones and can permit significantly greater flexibility in the designation of new “usage-driven” FTZ sites for operators/users located within a grantee's “service area” in the context of the Board's standard 2,000-acre activation limit for a general-purpose zone project. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally filed on March 20, 2012.
FTZ 204 was approved by the Board on October 18, 1994 (Board Order 706, 59 FR 54432, 10/31/94) and expanded on June 7, 2002 (Board Order 1233, 67 FR 41393-41394, 06/18/02) and on June 22, 2010 (Board Order 1691, 75 FR 38979-38980).
The current zone project includes the following sites:
The grantee's proposed service area under the ASF would be the Counties of Sullivan, Hawkins, Greene, Washington, Unicoi, Carter, Hamblen, and Johnson, Tennessee and the Counties of Buchanan, Dickenson, Wise, Lee, Russell, Scott and Washington, Virginia and the Cities of Norton and Bristol, Virginia as described in the application. If approved, the grantee would be able to serve sites throughout the service area based on companies' needs for FTZ designation. The proposed service area is within/adjacent to the Tri-Cities Customs and Border Protection port of entry.
The applicant is requesting authority to reorganize its existing zone project under the ASF as follows: Sites 1 through 11 would become magnet sites. The ASF allows for the possible exemption of one magnet site from the “sunset” time limits that generally apply to sites under the ASF, and the applicant proposes that proposed magnet Site 1 be so exempted. Because the ASF only pertains to establishing or reorganizing a general-purpose zone, the application would have no impact on FTZ 204's authorized subzone.
In accordance with the Board's regulations, Kathleen Boyce of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the Board.
Public comment is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is May 25, 2012. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to June 11, 2012.
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 2111, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via
An application has been submitted to the Foreign-Trade Zones (FTZ) Board (the Board) by the Findlay/Hancock County Chamber of Commerce, grantee of FTZ 151, requesting authority to reorganize the zone under the alternative site framework (ASF) adopted by the Board (74 FR 1170, 1/12/09 (correction 74 FR 3987, 1/22/09); 75 FR 71069-71070, 11/22/10). The ASF is an option for grantees for the establishment or reorganization of general-purpose zones and can permit significantly greater flexibility in the designation of new “usage-driven” FTZ sites for operators/users located within a grantee's “service area” in the context of the Board's standard 2,000-acre activation limit for a general-purpose zone project. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally filed on March 20, 2012.
FTZ 151 was approved by the Board on July 6, 1988 (Board Order 389, 53 FR 27058, 7/18/1988) and expanded on February 10, 1999 (Board Order 1023, 64 FR 8542, 2/22/1999) and April 4, 2004 (Board Order 1332, 69 FR 26067, 5/11/2004).
The current zone project includes the following sites:
The grantee's proposed service area under the ASF would be Hardin, Putnam, Seneca, Allen and Hancock Counties, Ohio, as described in the application. If approved, the grantee would be able to serve sites throughout the service area based on companies' needs for FTZ designation. The proposed service area is within and adjacent to the Toledo Customs and Border Protection port of entry.
The applicant is requesting authority to reorganize its existing zone project to include both of the existing sites as “magnet” sites. The ASF allows for the possible exemption of one magnet site from the “sunset” time limits that generally apply to sites under the ASF, and the applicant proposes that Site 1 be so exempted. No usage-driven sites are being requested at this time. Because the ASF only pertains to establishing or reorganizing a general-purpose zone, the application would have no impact on FTZ 151's authorized subzones.
In accordance with the Board's regulations, Elizabeth Whiteman of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the Board.
Public comment is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is May 25, 2012. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to June 11, 2012.
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 2111, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via
On December 22, 2011, the Port of Portland, grantee of Foreign-Trade Zone (FTZ) 45, requested to expand the scope of manufacturing authority approved within Subzone 45F, on behalf of Epson Portland, Inc. (EPI), in Hillsboro, Oregon. The request involved the use of privileged foreign (PF) status (19 CFR 146.41) inputs in manufacturing of ink for inkjet printer cartridges. Notice was given in the
Section 400.32(b)(1) of the FTZ Board's regulations (15 CFR part 400) allows the Assistant Secretary for Import Administration to act for the Board in making decisions on new manufacturing authority when the zone benefits sought do not involve the election of non-privileged foreign status on items involving inverted tariffs. Pursuant to that regulatory provision, on March 8, 2012, the Assistant Secretary for Import Administration approved authority to include the use of certain PF status inputs in the manufacturing of ink for inkjet printer cartridges within Subzone 45F, subject to the FTZ Act (19 U.S.C. 81a-81u) and the Board's regulations, including Section 400.28.
The applicant's request for broader authority, including the manufacturing of inkjet ink involving foreign-sourced inputs that would be admitted to the subzone under nonprivileged foreign (NPF) status (19 CFR 146.42), will continue to be reviewed and processed under FTZ Docket 7-2012 (77 FR 4006, 1/26/2012).
Import Administration, International Trade Administration, Department of Commerce.
Lingjun Wang, AD/CVD Operations, Office 6, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2316.
On October 20, 2011, the Department published partial preliminary results of the administrative review.
In antidumping duty administrative reviews, section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), requires the Department to make a final determination in an administrative review of an antidumping duty order within 120 days after the day on which the preliminary results are published. However, if it is not practicable to complete the review within this time period, section 751(a)(3)(A) of the Act allows the Department to extend the 120-day period to 180 days after publication of the preliminary results.
The Department has determined that it is not practicable to complete the review within the 120-day time period
This notice is published in accordance with sections 751(a) and 777(i) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
Dustin Ross or Minoo Hatten, AD/CVD Operations, Office 1, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0747 or (202) 482-1690, respectively.
At the request of interested parties, the Department of Commerce (the Department) initiated an administrative review of the antidumping duty order on solid urea from the Russian Federation for the period July 1, 2010, through June 30, 2011.
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), requires the Department to complete the preliminary results within 245 days after the last day of the anniversary month of an order for which a review is requested. If it is not practicable to complete the review within this time period, section 751(a)(3)(A) of the Act allows the Department to extend the time limit for the preliminary results to a maximum of 365 days after the last day of the anniversary month.
We determine that it is not practicable to complete the preliminary results of this review by the current deadline of April 1, 2012, because we require additional time to analyze a detailed response to a supplemental questionnaire that was submitted on March 7, 2012. In addition, the numerous extensions we have granted for filing various responses has contributed to us requiring additional time to complete the preliminary results.
Therefore, we are extending the time period for issuing the preliminary results of this review by 75 days, until June 15, 2012.
This notice is published in accordance with section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(2).
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) determines that countervailable subsidies are being provided to producers and exporters of bottom mount combination refrigerator-freezers (bottom mount refrigerators) from the Republic of Korea (Korea). For information on the estimated subsidy rates, see the “Suspension of Liquidation” section of this notice.
Myrna L. Lobo, Justin M. Neuman, or Milton Koch, AD/CVD Operations, Office 6, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2371, (202) 482-0486, and (202) 482-2584, respectively.
The U.S. producer that filed the petition for this investigation is Whirlpool Corporation (hereafter, Whirlpool, or “petitioner”). This investigation covers 41 programs. The mandatory respondents in this investigation are: (1) Samsung Electronics Co., Ltd. (SEC), and its cross-owned affiliates Samsung Gwangju Electronics Co., Ltd. (SGEC) and Samsung Electronics Logitech (SEL); (2) LG Electronics (LGE) and its cross-owned affiliate, ServeOne Co., Ltd., and (3) Daewoo Electronics Corporation (DWE).
The period of investigation for which we are measuring subsidies is January 1, 2010, through December 31, 2010.
The following events have occurred since the Department published the
In September and October 2011, the petitioner filed comments on the supplemental responses of LGE and SEC, on the NSA questionnaire responses, and on cross-ownership of respondents. On October 17, 2011, the Government of Korea (GOK) submitted to the record the public version of a verification report from a prior investigation. Also in October, SEC filed pre-verification corrections. On October 27, 2011, the Department placed independent research on the record. On October 31, 2011, the Department placed on the record the Preliminary Scope Memorandum,
In November 2011, the petitioner filed new information and comments on the NSA supplemental responses of the GOK and DWE, and on suppliers and verification issues for LGE and SEC. On November 28, 2011, the petitioner met with the Department and filed pre-verification comments.
The Department conducted verification from December 5, 2011, through December 16, 2011. On December 21, 2011, the Department issued its Post-Preliminary Analysis of Cross-ownership and its Post-Preliminary Analysis of New Subsidy Allegations. On that date, the Department also issued its Post-Preliminary Analysis Regarding the Restructuring of Daewoo Electronics Corporation.
On February 2, 2012, the Department issued verification reports for LGE and SEC. On February 3, 2012, the Department issued verification reports for the GOK and DWE. Also on February 3, 2012, the Department met with counsel for SEC.
In the
The products covered by the investigation are all bottom mount combination refrigerator-freezers and certain assemblies thereof from Korea. For purposes of the investigation, the term “bottom mount combination refrigerator-freezers” denotes freestanding or built-in cabinets that have an integral source of refrigeration using compression technology, with all of the following characteristics:
• The cabinet contains at least two interior storage compartments accessible through one or more separate external doors or drawers or a combination thereof;
• An upper-most interior storage compartment(s) that is accessible through an external door or drawer is either a refrigerator compartment or convertible compartment, but is not a freezer compartment;
• There is at least one freezer or convertible compartment that is mounted below an upper-most interior storage compartment(s).
For purposes of the investigation, a refrigerator compartment is capable of storing food at temperatures above 32 degrees F (0 degrees C), a freezer compartment is capable of storing food at temperatures at or below 32 degrees F (0 degrees C), and a convertible compartment is capable of operating as either a refrigerator compartment or a freezer compartment, as defined above.
Also covered are certain assemblies used in bottom mount combination refrigerator-freezers, namely: (1) Any assembled cabinets designed for use in bottom mount combination refrigerator-freezers that incorporate, at a minimum: (a) An external metal shell, (b) a back panel, (c) a deck, (d) an interior plastic liner, (e) wiring, and (f) insulation; (2) any assembled external doors designed for use in bottom mount combination refrigerator-freezers that incorporate, at a minimum: (a) An external metal shell, (b) an interior plastic liner, and (c) insulation; and (3) any assembled external drawers designed for use in bottom mount combination refrigerator-freezers that incorporate, at a minimum: (a) An external metal shell, (b) an interior plastic liner, and (c) insulation.
The products subject to the investigation are currently classifiable under subheadings 8418.10.0010, 8418.10.0020, 8418.10.0030, and 8418.10.0040 of the Harmonized Tariff System of the United States (HTSUS). Products subject to this investigation may also enter under HTSUS subheadings 8418.21.0010, 8418.21.0020, 8418.21.0030, 8418.21.0090, and 8418.99.4000, 8418.99.8050, and 8418.99.8060. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to this scope is dispositive.
The subsidy programs under investigation and the issues raised in the case and rebuttal briefs by parties in this investigation are discussed in Memorandum to Paul Piquado, Assistant Secretary for Import Administration, Issues and Decision Memorandum for the Final Determination in the Countervailing Duty Investigation of Bottom Mount Combination Refrigerator-Freezers from the Republic of Korea (Decision Memorandum), which is hereby adopted by this notice. A list of the subsidy programs and the issues that parties raised and to which we responded in the Decision Memorandum is attached to this notice as an Appendix. The Decision Memorandum is a public document, which is on file electronically via Import Administration's Antidumping and Countervailing Duty Centralized Electronic Service System (IA ACCESS). Access to IA ACCESS is available in the Central Records Unit (CRU), room 7046 of the main Department of Commerce
For purposes of this final determination, we relied, in part, on adverse facts available (AFA), as provided for in sections 776(a) and (b) of the Tariff Act of 1930, as amended (Act), to determine the countervailable subsidy rate for one program under investigation. A full discussion of our decision to apply AFA is presented in the Decision Memorandum in the section “Application of Facts Available, Including the Application of Adverse Inferences.”
Because Korea is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, the International Trade Commission (ITC) is required to determine pursuant to section 701(a)(2) of the Act whether imports of the subject merchandise from Korea materially injure, or threaten material injury to, a U.S. industry. On May 23, 2011, the ITC published its affirmative preliminary determination that there is a reasonable indication that an industry in the United States is materially injured by reason of allegedly subsidized imports from Korea of subject merchandise.
In accordance with section 705(c)(1)(B)(i)(I) of the Act, we have calculated an individual countervailable subsidy rate for each respondent. Section 705(c)(5)(A)(i) of the Act states that for companies not individually investigated, we will determine an “all others” rate equal to the weighted average of the countervailable subsidy rates established for exporters and producers individually investigated, excluding any zero and
Notwithstanding the language of section 705(c)(5)(A)(i) of the Act, we have not calculated the “all others” rate by weight averaging the rates of DWE and SEC, because doing so risks disclosure of proprietary information. Therefore, we have calculated an average rate using other information on the record.
Because the
If the ITC issues a final affirmative injury determination, we will issue a CVD order. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.
In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order, without the written consent of the Assistant Secretary for Import Administration. In accordance with section 705(b)(3) of the Act, because our preliminary determination was negative and our final determination is affirmative, the ITC will make its final determination within 75 days after the Department makes its final determination.
In the event that the ITC issues a negative final injury determination, this notice will serve as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
We determine that imports of narrow bottom mount combination refrigerator-freezers (bottom mount refrigerators) from the Republic of Korea (Korea) are being, or are likely to be, sold in the United States at less than fair value (LTFV), as provided in section 735 of the Tariff Act of 1930, as amended (the Act). In addition, we determine that there is no reasonable basis to believe or suspect that critical circumstances exist with respect to the subject merchandise exported from Korea.
Based on our analysis of the comments received, we have made changes in the margin calculations. Therefore, the final determination differs from the preliminary determination. The final weighted-average dumping margins for the investigated companies are listed below in the section entitled “Final Determination Margins.”
Elizabeth Eastwood or Henry Almond, AD/CVD Operations, Office 2, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3874 and (202) 482-0049, respectively.
On November 2, 2011, the Department published in the
In November 2011, we issued supplemental questionnaires to two respondents, LG Electronics, Inc. (LG), and Samsung Electronics Co., Ltd. (Samsung), and we received responses to these supplemental questionnaires in this same month.
In November and December 2011, we verified the questionnaire responses of three respondents in this case, Daewoo Electronics Corporation (Daewoo), LG, and Samsung, in accordance with section 782(i) of the Act.
In January 2012, the Government of Korea submitted comments on certain aspects of the Department's preliminary determination.
In February 2012, Whirlpool Corporation (hereafter, the petitioner) and two of the three respondents submitted case and rebuttal briefs. Daewoo submitted only a rebuttal brief. Also in February 2012, the Department held a public hearing at the request of the petitioner and the three respondents.
Subsequent to the
The period of investigation (POI) is January 1, 2010, through December 31, 2010.
The products covered by the investigation are all bottom mount combination refrigerator-freezers and certain assemblies thereof from Korea. For purposes of the investigation, the term “bottom mount combination refrigerator-freezers” denotes freestanding or built-in cabinets that have an integral source of refrigeration using compression technology, with all of the following characteristics:
• The cabinet contains at least two interior storage compartments accessible through one or more separate external doors or drawers or a combination thereof;
• An upper-most interior storage compartment(s) that is accessible through an external door or drawer is either a refrigerator compartment or convertible compartment, but is not a freezer compartment;
• There is at least one freezer or convertible compartment that is mounted below an upper-most interior storage compartment(s).
For purposes of the investigation, a refrigerator compartment is capable of storing food at temperatures above 32 degrees F (0 degrees C), a freezer compartment is capable of storing food at temperatures at or below 32 degrees F (0 degrees C), and a convertible compartment is capable of operating as either a refrigerator compartment or a freezer compartment, as defined above.
Also covered are certain assemblies used in bottom mount combination refrigerator-freezers, namely: (1) Any assembled cabinets designed for use in bottom mount combination refrigerator-freezers that incorporate, at a minimum: (a) An external metal shell, (b) a back panel, (c) a deck, (d) an interior plastic liner, (e) wiring, and (f) insulation; (2) any assembled external doors designed for use in bottom mount combination refrigerator-freezers that incorporate, at a minimum: (a) An external metal shell, (b) an interior plastic liner, and (c) insulation; and (3) any assembled external drawers designed for use in bottom mount combination refrigerator-freezers that incorporate, at a minimum: (a) An external metal shell, (b) an interior plastic liner, and (c) insulation.
The products subject to the investigation are currently classifiable under subheadings 8418.10.0010, 8418.10.0020, 8418.10.0030, and 8418.10.0040 of the Harmonized Tariff System of the United States (HTSUS). Products subject to this investigation may also enter under HTSUS subheadings 8418.21.0010, 8418.21.0020, 8418.21.0030, 8418.21.0090, and 8418.99.4000, 8418.99.8050, and 8418.99.8060. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to this scope is dispositive.
In the
As discussed in the preliminary determination, we conducted an investigation to determine whether the respondents made comparison market sales of the foreign like product during the POI at prices below their COP within the meaning of section 773(b) of the Act.
We found that 20 percent or more of each respondent's sales of a given product during the POI were at prices less than the weighted-average COP for this period. Thus, we determined that these below-cost sales were made in “substantial quantities” within an extended period of time and at prices which did not permit the recovery of all costs within a reasonable period of time in the normal course of trade.
Therefore, for purposes of this final determination, we found that each respondent made below-cost sales not in the ordinary course of trade. Consequently, we disregarded these sales and used the remaining sales as the basis for determining normal value for each respondent pursuant to section 773(b)(1) of the Act.
The Act allows the Department to employ the average-to-transaction margin calculation methodology under the following circumstances: (1) There is a pattern of export prices that differ significantly among purchasers, regions or periods of time; and (2) the Department explains why such differences cannot be taken into account using the average-to-average or transaction-to-transaction methodology.
In the
Further, for both Samsung and LG, we found that the standard average-to-average methodology did not take into account the price differences because the alternative average-to-transaction methodology yielded a material difference in the margin. Accordingly, we preliminarily applied the average-to-transaction methodology to all U.S. sales made by LG and Samsung.
For purposes of the final determination, we performed our targeted-dumping analysis following the methodology employed in the
In the
For the final determination, we relied on updated shipment data provided by Daewoo, LG, and Samsung, which we examined at verification. Based on our analysis of these data and the comments submitted by the parties, we continue to find that critical circumstances do not exist with respect to imports of bottom mount refrigerators from Korea, as explained below.
Section 735(a)(3) of the Act provides that the Department will determine that critical circumstances exist if there is a reasonable basis to believe or suspect that: (A)(i) There is a history of dumping and material injury by reason of dumped imports in the United States or elsewhere of the subject merchandise; or (ii) the person by whom, or for whose account, the merchandise was imported knew or should have known that the exporter was selling the subject merchandise at less than its fair value and that there was likely to be material injury by reason of such sales; and (B) there have been massive imports of the subject merchandise over a relatively short period. Section 351.206(h)(1) of the Department's regulations provides that, in determining whether imports of the subject merchandise have been “massive,” the Department normally will examine: (i) The volume and value of the imports; (ii) seasonal trends; and (iii) the share of domestic consumption accounted for by the imports. In addition, 19 CFR 351.206(h)(2) provides that an increase in imports of 15 percent during the “relatively short period” of time may be considered “massive.” Section 351.206(i) of the Department's regulations defines “relatively short period” as normally being the period beginning on the date the proceeding begins (
In determining whether the above criteria have been satisfied, we examined: (1) The evidence placed on the record by the respondents and the petitioner; and (2) the International
To determine whether there is a history of injurious dumping of the merchandise under investigation, in accordance with section 735(a)(3)(A)(i) of the Act, the Department normally considers evidence of an existing antidumping duty order on the subject merchandise in the United States or elsewhere to be sufficient.
To determine whether the person by whom, or for whose account, the merchandise was imported knew or should have known that the exporter was selling the subject merchandise at LTFV, and that there was likely to be material injury by reason of such sales in accordance with section 735(a)(3)(A)(ii) of the Act, the Department normally considers margins of 25 percent or more for export price (EP) sales or 15 percent or more for constructed export price (CEP) transactions sufficient to impute knowledge of dumping.
The final dumping margin calculated for LG exceeds the threshold sufficient to impute knowledge of dumping (
In determining whether an importer knew or should have known that there was likely to be material injury by reason of dumped imports, the Department normally will look to the preliminary injury determination of the ITC. If the ITC finds a reasonable indication of present material injury to the relevant U.S. industry, the Department will determine that a reasonable basis exists to impute importer knowledge that material injury is likely by reason of such imports.
In determining whether there are “massive imports” over a “relatively short period,” pursuant to section 735(a)(3)(B) of the Act, the Department normally compares the import volumes of the subject merchandise for at least three months immediately preceding the filing of the petition (
Specifically, the Department requested and obtained from each of the respondents monthly shipment data from January 2008 to October 2011. To determine whether imports of subject merchandise have been massive over a relatively short period, we compared, pursuant to 19 CFR 351.206(h)(1)(i), the respondents' export volumes for the seven months before the filing of the petition (
For purposes of our “massive imports” determination, we also considered the impact of seasonality on imports of bottom mount refrigerators based on interested party comments and information contained in the ITC's preliminary determination. In order to determine whether the seasonality factor accounted for the increase in imports observed for each of the respondents in the post-petition filing period (the comparison period), we analyzed company-specific shipment data for a historical three-year period, where possible, using the same base and comparison time periods noted above. As a result of this analysis, we found that there is a consistent pattern of seasonality in the industry, and that seasonal trends account for the increase in imports subsequent to the filing of the petition from each of the respondents. Specifically, with respect to LG, we found that the percentage increase in shipments during the comparison period is not related to the filing of the petition but rather to the consistent seasonal trends in the industry because shipments during the April-October time period were consistently higher than those in the September-March time period, and the shipment increases observed in the April-October time period from year to
In summary, we find that there is a reasonable basis to believe or suspect importers had knowledge of dumping and the likelihood of material injury with respect to bottom mount refrigerators produced and exported from Korea by LG. However, we do not find that there have been massive imports of bottom mount refrigerators over a relatively short period from LG due to seasonality. Therefore, for the reasons stated above, the Department finds that critical circumstances do not exist for imports of the subject merchandise from Korea. For a complete discussion of our final critical circumstances analysis, see the Decision Memorandum at Comment 2 and the March 16, 2012, Memorandum to James P. Maeder, Jr., Director, Office 2, from The Team entitled, “Antidumping Duty Investigation of Certain Bottom Mount Refrigerator Freezers from Korea—Final Determination of Critical Circumstances.”
All issues raised in the case and rebuttal briefs by parties in this investigation are addressed in the Decision Memorandum, which is adopted by this notice. Parties can find a complete discussion of the issues raised in this investigation and the corresponding recommendations in this public memorandum, which is on file in the Central Records Unit, room 7046 of the main Department building.
In addition, a complete version of the Decision Memorandum can be accessed directly on the Web at
Based on our analysis of the comments received and our findings at verification, we have made certain changes to the margin calculations. For a discussion of these changes, see the “Margin Calculations” section of the Decision Memorandum.
As provided in section 782(i) of the Act, we verified the sales and cost information submitted by the respondents for use in our final determination. We used standard verification procedures including an examination of relevant accounting and production records, and original source documents provided by the respondents.
Pursuant to 735(c)(1)(B) of the Act, we will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all entries of subject merchandise from Korea, entered, or withdrawn from warehouse, for consumption on or after November 2, 2011, the date of publication of the preliminary determination in the
Accordingly, for cash deposit purposes, we are subtracting from the applicable cash deposit rate that portion of the rate attributable to the export subsidies found in the affirmative countervailing duty determination for each respondent with a final dumping margin above
The weighted-average dumping margins are as follows:
In accordance with section 735(c)(5)(A) of the Act, we have based the “All Others” rate on the simple average of the dumping margins calculated for the exporters/manufacturers investigated in this proceeding. The “All Others” rate is calculated exclusive of all
We will disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
In accordance with section 735(d) of the Act, we have notified the ITC of our final determination. As our final determination is affirmative, the ITC will determine within 45 days whether imports of the subject merchandise are causing material injury, or threat of material injury, to an industry in the United States. If the ITC determines that material injury or threat of injury does not exist, the proceeding will be terminated and all securities posted will be refunded or canceled. If the ITC determines that such injury does exist, the Department will issue an antidumping duty order directing CBP to assess antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation.
This notice will serve as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing this determination and notice in accordance with sections 735(d) and 777(i) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) determines that countervailable subsidies are being provided to producers and exporters of galvanized steel wire (galvanized wire) from the People's Republic of China (the PRC). For information on the estimated subsidy rates, see the “Suspension of Liquidation” section of this notice.
Nicholas Czajkowski or David Lindgren, AD/CVD Operations, Office 6, Import Administration, U.S. Department of Commerce, Room 7866, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: 202-482-1395 or 202-482-3870, respectively.
The U.S. producers that filed the petition for this investigation are Davis Wire Corporation, Johnstown Wire Technologies, Inc., Mid-South Wire Company, Inc., National Standard, LLC, and Oklahoma Steel & Wire Company, Inc. (collectively, Petitioners). This investigation covers 40 programs. The mandatory respondents in this investigation are: (1) M&M Industries Co. Ltd. (M&M); (2) Shandong Hualing Hardware and Tool Co., Ltd. (Hualing); (3) Shanghai Bao Zhang Industry Co. Ltd. and its cross-owned affiliated companies Anhui Bao Zhang Metal Products Co., Ltd. and Shanghai Li Chao Industry Co., Ltd. (collectively, the Bao Zhang Companies); and, (4) Tianjin Huayuan Metal Wire Products Co., Ltd. and its cross-owned affiliated companies Tianjin Tianxin Metal Products Co., Ltd. and Tianjin Mei Jia Hua Trade Co., Ltd. (collectively, the Huayuan Companies).
The period of investigation for which we are measuring subsidies is January 1, 2010, through December 31, 2010.
The following events have occurred since the Department published the
Between September 15 and October 21, 2011, the GOC, Petitioners, the Bao Zhang Companies and the Huayuan Companies filed factual information submissions. Except for the Bao Zhang Companies' October 21, 2011 wire rod benchmark submission, all were rejected by the Department as untimely under 19 CFR 351.301(c). The Department informed Petitioners they could re-file certain portions of their rejected material, which they did on October 31, 2011. On September 19, 2011, the Department issued supplemental questionnaires to the GOC, the Bao Zhang Companies, and the Huayuan Companies, which, in turn, submitted responses between September 28 and October 3, 2011. On October 7, 2011, the Department issued additional supplemental questionnaires to the Bao Zhang Companies and the GOC, with responses filed on October 13 and 14, 2011, respectively. Moreover, on October 14, 2011, Department issued a supplemental questionnaire to the Huayuan Companies, which filed a response on October 24, 2011.
Between October 21 and November 2, 2011, the Department issued verification outlines to the GOC, the Bao Zhang Companies, the Huayuan Companies and M&M. On October 24, 2011, Petitioners filed pre-verification comments. The Department conducted verification of the Bao Zhang Companies and the GOC from October 31 to November 8, 2011. Although scheduled for verification, the Huayuan Companies and M&M verbally informed the Department on November 3, 2011 that they would not participate in verification; a letter filed on November 9, 2011 stated the reasons for their decision not to participate. The Bao Zhang Companies filed minor corrections on November 4, 2011, and on November 10 and 15, 2011, the Bao Zhang Companies and the GOC, respectively, timely filed verification exhibits. The Department issued verification reports for the Bao Zhang Companies and the GOC on December 22, 2011.
With respect to scope issues, on November 2, 2011, Qingdao Ant Hardware Manufacturing Co., Ltd. (AHM) placed on the record physical samples and other information pertaining to the scope of the investigation, and, on November 16, 2011, a public viewing of the physical samples was held at the Department. On December 15, 2011, the Department placed on the record of this investigation the preliminary determinations in the corresponding antidumping duty (AD) investigations of galvanized wire from the PRC and Mexico
On January 9, 2012, the GOC requested that the Department terminate this investigation based on the U.S. Court of Appeals for the Federal Circuit December 19, 2011 ruling in
The Department issued a post-preliminary analysis memorandum regarding three programs on January 17, 2012.
As referenced in the “Case History” section above, the Department placed the preliminary determinations of the companion galvanized wire AD investigations from Mexico and the PRC on the record of this investigation. In those preliminary determinations, the Department found that galvanized wire with a diameter less than one millimeter was subject to the scope of the investigation. We invited parties to comment on this issue. No additional comments were made on this issue. Thus, the Department continues to find, specifically, that galvanized wire with a diameter less than one millimeter but equal to or greater than 0.5842 millimeters is covered by the scope.
Also, as noted in the “Case History” section above, all scope-related comments submitted by parties in all three investigations in their case and rebuttal briefs are on the record of all three investigations. Petitioners and AHM provided comments on the scope and merchandise that is to be covered under the scope. Based on our analysis of these comments, the Department continues to find that hobby wire, which is galvanized steel wire, in lengths of more than 15 feet, is properly included in the scope of this investigation.
The merchandise covered by this investigation is galvanized steel wire.
The subsidy programs under investigation and the issues raised in the case and rebuttal briefs by parties in this investigation are discussed in Memorandum to Paul Piquado, Assistant Secretary for Import Administration, Issues and Decision Memorandum for the Final
For purposes of this final determination, we have continued to rely on facts available and have continued to apply adverse inferences in accordance with sections 776(a) and (b) of the Tariff Act of 1930, as amended (the Act) with regard to: (1) The CVD rate to be applied to the non-cooperative mandatory company respondent, Hualing; (2) whether the wire rod and zinc input producers at issue are government authorities that provide wire rod and zinc for less than adequate remuneration (LTAR); and, (3) the GOC's provision of electricity for LTAR. In addition, for the purposes of this final determination, we are also applying adverse facts available (AFA) to (1) determine the CVD rate to be applied to the non-cooperating mandatory respondents the Huayuan Companies and M&M, and (2) determine that the Zhabei District “Save Energy Reduce Emission Team” award is specific pursuant to sections 776(a) and (b) of the Act. A full discussion of our decision to apply AFA is presented in the Decision Memorandum under the section “Use of Facts Otherwise Available and Adverse Inferences.”
In accordance with section 703(d)(1)(A)(i) of the Act, we have calculated a rate for each individually investigated producer/exporter of the subject merchandise. Section 705(c)(5)(A)(i) of the Act states that for companies not investigated, we will determine an “all-others” rate equal to the weighted average countervailable subsidy rates established for exporters and producers individually investigated, excluding any zero and
In this investigation, the only rate not based entirely on AFA is the rate calculated for the Bao Zhang Companies. Consequently, the rate calculated for the Bao Zhang Companies is also assigned as the “all-others” rate. For those non-cooperative companies that did not fully participate in this investigation, we have determined rates based solely on AFA, in accordance with sections 776(a) and (b) of the Act.
As a result of our
We will issue a CVD order and reinstate the suspension of liquidation under section 706(a) of the Act if the U.S. International Trade Commission (ITC) issues a final affirmative injury determination, and will require a cash deposit of estimated CVDs for such entries of merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.
In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Import Administration.
In the event that the ITC issues a final negative injury determination, this notice will serve as the only reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.
The scope of this investigation covers galvanized steel wire which is a cold-drawn carbon quality steel product in coils, of circular or approximately circular, solid cross section with any actual diameter of 0.5842 mm (0.0230 inch) or more, plated or coated with zinc (whether by hot-dipping or electroplating).
Steel products to be included in the scope of this investigation, regardless of Harmonized Tariff Schedule of the United States (HTSUS) definitions, are products in which: (1) iron predominates, by weight, over each of the other contained elements; (2) the carbon content is two percent or less, by weight; and (3) none of the elements listed below exceeds the quantity, by weight, respectively indicated:
Specifically excluded from the scope of this investigation is galvanized steel wire in coils of 15 feet or less which is pre-packed in individual retail packages. The products subject to this investigation are currently classified in subheadings 7217.20.30, 7217.20.45, or 7217.90.10 of the HTSUS which cover galvanized wire of all diameters and all carbon content. Galvanized wire is reported under statistical reporting numbers 7217.20.3000, 7217.20.4510, 7217.20.4520, 7217.20.4530, 7217.20.4540, 7217.20.4550, 7217.20.4560, 7217.20.4570, 7217.20.4580, and 7217.90.1000. These products may also enter under HTSUS subheadings 7229.20.0015, 7229.20.0090, 7229.90.5008, 7229.90.5016, 7229.90.5031, and 7229.90.5051. Although the HTSUS subheadings are provided for convenience and Customs purposes, the written description of the merchandise is dispositive.
Import Administration, International Trade Administration, Department of Commerce.
We determine that imports of bottom mount combination refrigerator-freezers (bottom mount refrigerators) from Mexico are being, or are likely to be, sold in the United States at less than fair value (LTFV), as provided in section 735 of the Tariff Act of 1930, as amended (the Act). In addition, we determine that critical circumstances exist with respect to the subject merchandise exported from Mexico by Samsung Electronics Mexico, S.A. de C.V. (Samsung).
Based on our analysis of the comments received, we made changes in the margin calculations. Therefore, the final determination differs from the preliminary determination. The final weighted-average dumping margins for the investigated companies are listed below in the section entitled “Final Determination Margins.”
David Goldberger or Katherine Johnson, AD/CVD Operations, Office 2, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4136 and (202) 482-4929, respectively.
On November 2, 2011, the Department published in the
In November 2011, we issued supplemental questionnaires to, and received responses from, all four respondents: Electrolux Home Products Corp. NV/Electrolux Home Products De Mexico, S.A. de C.V. (Electrolux), LG Electronics Monterrey Mexico, S.A. de C.V. (LGEMM), Controladora Mabe, S.A. de C.V./Mabe, S.A. de C.V. (Mabe), and Samsung. Also, in November 2011, we received updated shipment information for our critical circumstances analysis from Electrolux, LGEMM, and Samsung.
On December 5, 2011, Whirlpool Corporation (hereafter, the petitioner) amended its targeted dumping allegation with respect to Samsung to reflect the revised U.S. sales data submitted by Samsung in response to the Department's November 2011, supplemental questionnaire.
In November and December 2011, we verified the questionnaire responses of the four respondents in this case, in accordance with section 782(i) of the Act. In December, January and February 2012, we issued our verification findings for each respondent.
In February 2012, the Department requested, and the respondents submitted, revised U.S. and/or comparison-market sales listings to reflect certain verification findings.
Also, in February 2012, the petitioner and the respondents (except for Electrolux) submitted case and rebuttal briefs. On February 22, 2012, the Government of Mexico submitted comments on certain aspects of the Department's preliminary determination. On February 24, 2012, the Department held a hearing in this case.
Subsequent to the
The period of investigation (POI) is January 1, 2010, through December 31, 2010.
The products covered by the investigation are all bottom mount combination refrigerator-freezers and certain assemblies thereof from Mexico. For purposes of the investigation, the term “bottom mount combination refrigerator-freezers” denotes freestanding or built-in cabinets that have an integral source of refrigeration using compression technology, with all of the following characteristics:
• The cabinet contains at least two interior storage compartments accessible through one or more separate external doors or drawers or a combination thereof;
• An upper-most interior storage compartment(s) that is accessible through an external door or drawer is either a refrigerator compartment or convertible compartment, but is not a freezer compartment;
• There is at least one freezer or convertible compartment that is mounted below an upper-most interior storage compartment(s).
For purposes of the investigation, a refrigerator compartment is capable of storing food at temperatures above 32 degrees F (0 degrees C), a freezer compartment is capable of storing food at temperatures at or below 32 degrees F (0 degrees C), and a convertible compartment is capable of operating as either a refrigerator compartment or a freezer compartment, as defined above.
Also covered are certain assemblies used in bottom mount combination refrigerator-freezers, namely: (1) Any assembled cabinets designed for use in bottom mount combination refrigerator-freezers that incorporate, at a minimum: (a) an external metal shell, (b) a back panel, (c) a deck, (d) an interior plastic liner, (e) wiring, and (f) insulation; (2) any assembled external doors designed for use in bottom mount combination refrigerator-freezers that incorporate, at a minimum: (a) an external metal shell, (b) an interior plastic liner, and (c) insulation; and (3) any assembled external drawers designed for use in bottom mount combination refrigerator-freezers that incorporate, at a minimum: (a) an external metal shell, (b) an interior plastic liner, and (c) insulation.
The products subject to the investigation are currently classifiable under subheadings 8418.10.0010, 8418.10.0020, 8418.10.0030, and 8418.10.0040 of the Harmonized Tariff System of the United States (HTSUS). Products subject to this investigation may also enter under HTSUS subheadings 8418.21.0010, 8418.21.0020, 8418.21.0030, 8418.21.0090, and 8418.99.4000, 8418.99.8050, and 8418.99.8060. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to this scope is dispositive.
In the
All issues raised in the case and rebuttal briefs by parties in this investigation are addressed in the Issues and Decision Memorandum (Decision Memorandum), which is adopted by this notice. A list of the issues raised is attached to this notice as Appendix I. The Decision Memorandum is a public document and is on file electronically via Import Administration's Antidumping and Countervailing Duty Centralized Electronic Service System (IA ACCESS). Access to IA ACCESS is available in the Central Records Unit (CRU), room 7046 of the main Department of Commerce building. In addition, a complete version of the Decision Memorandum can be accessed directly on the internet at
As provided in section 782(i) of the Act, we verified the sales and cost information submitted by the respondents for use in our final determination. We used standard verification procedures including an examination of relevant accounting and production records, and original source documents provided by the respondents.
Based on our analysis of the comments received and our findings at verification, we made certain changes to the margin calculations for each respondent. For a discussion of these changes, see the “Margin Calculations” section of the Decision Memorandum.
As discussed in the
We found that 20 percent or more of each respondent's sales of a given product during the POI were at prices less than the weighted-average COP for this period. Thus, we determined that these below-cost sales were made in “substantial quantities” within an extended period of time and at prices which did not permit the recovery of all costs within a reasonable period of time in the normal course of trade.
Therefore, for purposes of this final determination, we found that each respondent made below-cost sales not in the ordinary course of trade. Consequently, we disregarded these sales and used the remaining sales as the basis for determining normal value for each respondent pursuant to section 773(b)(1) of the Act.
As we discussed in the
We have continued to apply the MNC Provision to the calculation of LGEMM's NV for purposes of the final determination because all three criteria enumerated in the Act have been met. Specifically, we verified that LGEMM is owned in part by LGE, which produces bottom mount refrigerators, and that LGEMM's home market sales are not viable for comparison to its U.S. sales. Furthermore, using the same methodology as that employed in the
The Act allows the Department to employ the average-to-transaction margin calculation methodology under the following circumstances: (1) There is a pattern of export prices that differ significantly among purchasers, regions or periods of time; and (2) The Department explains why such differences cannot be taken into account using the average-to-average or transaction-to-transaction methodology.
In the
Furthermore, for Samsung, we found that the standard average-to-average methodology took into account the price differences because the alternative average-to-transaction methodology yielded no difference in the margin or yielded a difference in the margin that was so insignificant relative to the size of the resulting margin as to be immaterial. Accordingly, we preliminarily applied the standard average-to-average methodology to all U.S. sales made by Samsung. For LGEMM, we found that that the standard average-to-average methodology did not take into account the price differences because the alternative average-to-transaction methodology yielded a material difference in the margin. Accordingly, we preliminarily applied the average-to-transaction methodology to all U.S. sales made by LGEMM. For Electrolux, because we did not find a pattern of prices that differed significantly for certain time periods, we applied our standard average-to-average price comparison methodology to all U.S. sales made by Electrolux.
For purposes of the final determination, we performed our targeted-dumping analysis following the methodology employed in the
In the
In conducting our critical circumstances analysis for the final determination, we relied on updated shipment data provided by Electrolux, LGEMM, and Samsung which we examined at verification. Based on our analysis of these data and the criteria enumerated under section 735(a)(3) of the Act, we continue to find that critical circumstances exist only with respect to imports of bottom mount refrigerators from Samsung, as explained below.
Section 735(a)(3) of the Act provides that the Department will determine that critical circumstances exist if there is a reasonable basis to believe or suspect that: (A)(i) There is a history of dumping and material injury by reason of dumped imports in the United States or elsewhere of the subject merchandise; or (ii) the person by whom, or for whose account, the merchandise was imported knew or should have known that the exporter was selling the subject merchandise at less than its fair value and that there was likely to be material injury by reason of such sales; and (B) there have been massive imports of the subject merchandise over a relatively short period. Section 351.206(h)(1) of the Department's regulations provides that, in determining whether imports of the subject merchandise have been “massive,” the Department normally will examine: (i) the volume and value of the imports; (ii) seasonal trends; and (iii) the share of domestic consumption accounted for by the imports. In addition, 19 CFR 351.206(h)(2) provides that an increase in imports of 15 percent during the “relatively short period” of time may be considered “massive.”
In determining whether the above criteria have been satisfied, we examined: (1) The evidence placed on the record by the respondents and the petitioner; and (2) the International Trade Commission's (ITC's) preliminary determination of injury (
To determine whether there is a history of injurious dumping of the merchandise under investigation, in accordance with section 735(a)(3)(A)(i) of the Act, the Department normally considers evidence of an existing antidumping duty order on the subject merchandise in the United States or elsewhere to be sufficient.
To determine whether the person by whom, or for whose account, the merchandise was imported knew or should have known that the exporter was selling the subject merchandise at LTFV, and that there was likely to be material injury by reason of such sales in accordance with section 735(a)(3)(A)(ii) of the Act, the Department normally considers margins of 25 percent or more for export price (EP) sales or 15 percent or more for constructed export price (CEP) transactions sufficient to impute knowledge of dumping.
Electrolux made only CEP sales and the vast majority of LGEMM's sales are CEP. Samsung had both EP and CEP sales, a majority of which are CEP sales. The final dumping margins calculated for Electrolux, LGEMM, and Samsung exceed the threshold sufficient to impute knowledge of dumping (
In determining whether there are “massive imports” over a “relatively short period,” pursuant to section 735(a)(3)(B) of the Act, the Department normally compares the import volumes of the subject merchandise for at least three months immediately preceding the filing of the petition (
Specifically, the Department requested and obtained from each of the respondents monthly shipment data from January 2008 to October 2011. To determine whether imports of subject merchandise have been massive over a relatively short period, we compared, pursuant to 19 CFR 351.206(h)(1)(i), the respondents' export volumes for the seven months before the filing of the petition (
For purposes of our “massive imports” determination, we also considered the impact of seasonality on imports of bottom mount refrigerators based on interested party comments and information contained in the ITC's preliminary determination. In order to determine whether the seasonality factor accounted for the increase in imports observed for each of the respondents in the post-petition filing period (the comparison period), we analyzed company-specific shipment data for a historical three-year period, where possible, using the same base and comparison time periods noted above. As a result of this analysis, we found that there is a consistent pattern of seasonality in the industry, and that seasonal trends account for the increase in imports subsequent to the filing of the petition from each of the respondents except one. Specifically, with respect to Electrolux and LGEMM, we found that the percentage increase in shipments during the comparison period is not related to the filing of the petition but rather to the consistent seasonal trends in the industry because shipments during the April-October time period were consistently higher than those in the September-March
In summary, we find that there is a reasonable basis to believe or suspect importers had knowledge of dumping and the likelihood of material injury with respect to bottom mount refrigerators produced and exported from Mexico by Electrolux, LGEMM, and Samsung. In addition, we find that there have been massive imports of bottom mount refrigerators over a relatively short period from Samsung, irrespective of seasonality. However, we do not find that there have been massive imports of bottom mount refrigerators over a relatively short period from Electrolux and LGEMM due to seasonality. Therefore, for the reasons stated above, the Department finds that critical circumstances do not exist for imports of the subject merchandise from Electrolux and LGEMM, but continues to find that critical circumstances exist for imports of the subject merchandise from Samsung in the final determination. For a complete discussion of our final critical circumstances analysis, see the Decision Memorandum at Comment 34 and the March 16, 2012, Memorandum to James P. Maeder, Jr., Director, Office 2, from The Team entitled, “Antidumping Duty Investigation of Certain Bottom Mount Refrigerator Freezers from Mexico—Final Determination of Critical Circumstances.”
Pursuant to 735(c)(1)(B) of the Act, we will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all entries of subject merchandise from Mexico, produced/exported by Electrolux, LGEMM, Mabe, and “All Others” and entered, or withdrawn from warehouse, for consumption on or after November 2, 2011, the date of publication of the preliminary determination in the
The weighted-average dumping margins are as follows:
In accordance with section 735(c)(5)(A) of the Act, we based the “All Others” rate on the weighted average of the dumping margins calculated for the exporters/manufacturers investigated in this proceeding. The “All Others” rate is calculated exclusive of all
We will disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
In accordance with section 735(d) of the Act, we notified the ITC of our final determination. As our final determination is affirmative, the ITC will determine within 45 days whether imports of the subject merchandise are causing material injury, or threat of material injury, to an industry in the United States. If the ITC determines that material injury or threat of injury does not exist, the proceeding will be terminated and all securities posted will be refunded or canceled. If the ITC determines that such injury does exist, the Department will issue an antidumping duty order directing CBP to assess antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation.
This notice will serve as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing this determination and notice in accordance with sections 735(d) and 777(i) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
On November 4, 2011, the Department of Commerce (the Department) published its preliminary determination in the investigation of sales at less than fair value of galvanized steel wire (galvanized wire) from Mexico.
The Department has determined that galvanized wire from Mexico is being, or is likely to be, sold in the United States at less than fair value, as provided in section 735 of the Tariff Act of 1930, as amended (the Act). The final margins of sales at less than fair value are listed below in the section entitled “Final Determination of Investigation.”
Patrick Edwards or Ericka Ukrow, AD/CVD Operations, Office 7, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-8029 or (202) 482-0405, respectively.
The preliminary determination in this investigation was published on November 4, 2011.
On November 10 and 23, 2011, the Department issued Deacero supplemental questionnaires.
On December 5, 2011, the Department released its memorandum addressing Deacero's ministerial error allegations, finding that no amendment to the preliminary determination was warranted.
On December 5, 2011, Deacero submitted its response to the November 23, 2011, questionnaire.
We conducted cost and sales verifications of the responses submitted by Deacero and Camesa (collectively, respondents).
Based on the Department's findings at verification, as well as the minor corrections presented by Deacero and Camesa at the start of their respective verifications, we requested respondents to submit revised sales databases.
Subsequent to the release of the verification reports in this investigation, parties timely filed case and rebuttal briefs. We received a case brief from Petitioners, Deacero, and Camesa on February 23, 2012; Petitioners and Deacero filed rebuttal briefs on February 28, 2012. No public hearing was held because all requests for a hearing were withdrawn.
On March 2, 2012, at the Department's request, respondents in the companion galvanized wire investigations involving the People's Republic of China (both antidumping and countervailing duty) filed on the record of this investigation certain scope comments that were raised in those proceedings' case and rebuttal briefs. We allowed a period of time for parties in the instant proceeding to comment on those submissions, and we received no comments.
All issues raised in the case and rebuttal briefs by parties to this antidumping investigation are addressed in the “Issues and Decision Memorandum for the Final Determination of the Antidumping Duty Investigation of Galvanized Steel Wire from Mexico” (Decision Memorandum) from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Import Administration, dated March 19, 2012, which is hereby adopted by this notice. A list of the issues which parties have raised and to which we have responded, all of which are in the Decision Memorandum, is attached to this notice as an appendix. Parties can find a complete discussion of all issues raised in this investigation and the corresponding recommendations in the Decision Memorandum which is on file and available electronically via IA ACCESS, which is accessible in the CRU, room 7046 of the main Department of Commerce building. In addition, a complete version of the Decision Memorandum can be accessed directly on the Web at
The scope of this investigation covers galvanized steel wire which is a cold-drawn carbon quality steel product in coils, of circular or approximately circular, solid cross section with any actual diameter of 0.5842 mm (0.0230 inch) or more, plated or coated with zinc (whether by hot-dipping or electroplating).
Steel products to be included in the scope of this investigation, regardless of Harmonized Tariff Schedule of the United States (HTSUS) definitions, are products in which: (1) Iron predominates, by weight, over each of the other contained elements; (2) the carbon content is two percent or less, by weight; and (3) none of the elements listed below exceeds the quantity, by weight, respectively indicated:
Specifically excluded from the scope of this investigation is galvanized steel wire in coils of 15 feet or less which is pre-packed in individual retail packages. The products subject to this investigation are currently classified in subheadings 7217.20.30, 7217.20.45, and 7217.90.10 of the HTSUS which cover galvanized wire of all diameters and all carbon content. Galvanized wire is reported under statistical reporting numbers 7217.20.3000, 7217.20.4510, 7217.20.4520, 7217.20.4530, 7217.20.4540, 7217.20.4550, 7217.20.4560, 7217.20.4570, 7217.20.4580, and 7217.90.1000. These products may also enter under HTSUS subheadings 7229.20.0015, 7229.20.0090, 7229.90.5008, 7229.90.5016, 7229.90.5031, and 7229.90.5051. Although the HTSUS subheadings are provided for convenience and Customs purposes, the written description of the merchandise is dispositive.
In their case and rebuttal briefs, Petitioners, respondents, and other interested parties provided comments on the scope and merchandise that is to be covered under the scope. We have discussed these comments fully in the Decision Memorandum.
In addition, in the
The period of investigation (POI) is January 1, 2010, to December 31, 2010.
As provided in section 782(i) of the Act and noted above, we verified the information submitted by the respondents for use in our final determination. We used standard verification procedures, including examination of relevant accounting and production records, and original source documents provided by the respondents.
Based on our analysis of the comments received and our findings at verification, we have made certain changes to the margin calculation for both Deacero and Camesa. For a discussion of these changes,
Section 735(c)(5)(A) of the Act provides that the estimated “all others” rate shall be an amount equal to the weighted average of the estimated weighted average dumping margins established for exporters and producers individually investigated, excluding any zero or
We determine that the following weighted-average dumping margins exist for the period January 1, 2010, through December 31, 2010:
Pursuant to section 735(c)(1)(B) of the Act and 19 CFR 351.211(b)(1), we will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all entries of subject merchandise from Mexico entered, or withdrawn from warehouse, for consumption on or after November 4, 2011, the date of the publication of the
In accordance with section 735(d) of the Act, we have notified the International Trade Commission (ITC) of our final determination. As our final determination is affirmative and in accordance with section 735(b)(2) of the Act, the ITC will determine, within 45 days, whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports or sales (or the likelihood of sales) for importation of the subject merchandise. If the ITC determines that material injury or threat of material injury does not exist, the proceeding will be terminated and all securities posted will be refunded or canceled. If the ITC determines that such injury does exist, the Department will issue an antidumping duty order directing CBP to assess antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
This determination is issued and published pursuant to sections 735(d) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
On November 4, 2011, the Department of Commerce (the “Department”) published the
Irene Gorelik, Katie Marksberry or Kabir Archuletta, AD/CVD Operations, Office 9, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC, 20230; telephone: (202) 482-6905, (202) 482-7906, or 482-2593, respectively.
On November 4, 2011, Shanghai Bao Zhang Industry Co., Ltd., Anhui Bao Zhang Metal Products Co., Ltd., and B&Z Galvanized Wire Industry (collectively, “Baozhang”), one of the three respondents selected for individual examination in this investigation, notified the Department that it would not participate in any the scheduled verifications.
On November 2, 2011, Qingdao Ant Hardware Manufacturing Co., Ltd. (“AHM”), one of the non-individually examined exporters that received a separate rate, placed on the record samples of products which it believes should be excluded from the scope of the investigation. On November 9, 2011, the Department notified all interested parties that it would allow any interested parties to physically view the samples.
Between December 9 and 14, 2011, we received case and rebuttal briefs from Petitioners,
On March 2, 2012, at the Department's request, interested parties in the companion galvanized wire investigations involving Mexico filed on the record of this investigation certain scope comments that were raised in that proceeding's case and rebuttal briefs. We allowed a period of time for parties in the instant proceeding to comment on those submissions. We received no comments.
All issues raised in the case and rebuttal briefs by parties to this investigation are addressed in the “Antidumping Duty Investigation of Galvanized Steel Wire from the People's Republic of China: Issues and Decision Memorandum for the Final Determination” (“Decision Memo”), dated concurrently with this notice and which is hereby adopted by this notice. A list of the issues which parties raised, and to which we respond in the Decision Memo, are attached to this notice as Appendix I. The Decision Memo is a public document and is on file electronically via Import Administration's Antidumping and Countervailing Duty Centralized Electronic Service System (“IA ACCESS”). Access to IA ACCESS is available in the Central Records Unit (“CRU”), room 7046 of the main Department of Commerce building. In addition, a complete version of the Decision Memo can be accessed directly on the internet at
Based on our analysis of information on the record of this investigation, we have made changes regarding Honbase and Baozhang for the final determination. Specifically, for the final determination, we have applied total adverse facts available (“AFA”) for Honbase's and Baozhang's failure to participate and their subsequent inclusion as part of the PRC-wide entity.
The scope of this investigation covers galvanized steel wire which is a cold-drawn carbon quality steel product in coils, of circular or approximately circular, solid cross section with any actual diameter of 0.5842 mm (0.0230 inch) or more, plated or coated with zinc (whether by hot-dipping or electroplating).
Steel products to be included in the scope of this investigation, regardless of Harmonized Tariff Schedule of the United States (“HTSUS”) definitions, are products in which: (1) Iron predominates, by weight, over each of the other contained elements; (2) the carbon content is two percent or less, by weight; and (3) none of the elements listed below exceeds the quantity, by weight, respectively indicated:
Specifically excluded from the scope of this investigation is galvanized steel wire in coils of 15 feet or less which is pre-packed in individual retail packages. The products subject to this investigation are currently classified in subheadings 7217.20.30, 7217.20.45, and7217.90.1000 of the HTSUS which cover galvanized wire of all diameters and all carbon content. Galvanized wire is reported under statistical reporting numbers 7217.20.3000, 7217.20.4510, 7217.20.4520, 7217.20.4530, 7217.20.4540, 7217.20.4550, 7217.20.4560, 7217.20.4570, 7217.20.4580, and 7217.90.1000. These products may also enter under HTSUS subheadings 7229.20.0015, 7229.20.0090, 7229.90.5008, 7229.90.5016, 7229.90.5031, and 7229.90.5051. Although the HTSUS subheadings are provided for convenience and Customs purposes, the written description of the merchandise is dispositive.
In their case and rebuttal briefs, interested parties provided comments on the scope and merchandise that is to be covered under the scope. We have discussed these comments fully in the Decision Memo.
In addition, in the
In proceedings involving non-market-economy (“NME”) countries, the Department begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is the Department's policy to assign all exporters of merchandise subject to an investigation in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.
No parties commented on the above companies' eligibility for separate rate status. Consequently, for the final determination, we continue to find that these companies demonstrated both a
The Department received comments from Huayuan and Petitioners regarding the Department's preliminary determination with respect to Huayuan's separate rate status. The Department has addressed the arguments in Comment 1 of the Decision Memo. For the final determination, we continue to find that Huayuan has not overcome the presumption of government control with respect to its exports of the merchandise under investigation.
Additionally, as discussed in the “PRC-wide Entity and Facts Available” section below and in Comment 2 of the Decision Memo, Honbase and Baozhang failed to demonstrate their eligibility for a separate rate by preventing the Department from verifying the accuracy of their information and will, therefore, be considered part of the PRC-wide entity for this final determination.
In the
In the
Further, as stated above, in the
Section 776(a)(2) of the Act provides that if an interested party: (A) Withholds information that has been requested by the Department; (B) fails to provide such information in a timely manner or in the form or manner requested, subject to subsections 782(c)(1) and (e) of the Act; (C) significantly impedes a determination under the antidumping statute; or (D) provides such information but the information cannot be verified, the Department shall, subject to subsection 782(d) of the Act, use facts otherwise available in reaching the applicable determination.
Section 782(c)(1) of the Act provides that if an interested party “promptly after receiving a request from {the Department} for information, notifies {the Department} that such party is unable to submit the information in the requested form and manner, together with a full explanation and suggested alternative form in which such party is able to submit the information,” the Department may modify the requirements to avoid imposing an unreasonable burden on that party.
Section 782(d) of the Act provides that, if the Department determines that a response to a request for information does not comply with the request, the Department will inform the person submitting the response of the nature of the deficiency and shall, to the extent practicable, provide that person the opportunity to remedy or explain the deficiency. If that person submits further information that continues to be unsatisfactory, or this information is not submitted within the applicable time limits, the Department may, subject to section 782(e) of the Act, disregard all or part of the original and subsequent responses, as appropriate.
Section 782(e) of the Act states that the Department shall not decline to consider information deemed “deficient” under section 782(d) if: (1) The information is submitted by the established deadline; (2) the information can be verified; (3) the information is not so incomplete that it cannot serve as a reliable basis for reaching the applicable determination; (4) the interested party has demonstrated that it acted to the best of its ability; and (5) the information can be used without undue difficulties.
Furthermore, section 776(b) of the Act states that if the administering authority finds that an interested party has not acted to the best of its ability to comply with a request for information, the administering authority may, in reaching its determination, use an inference that is adverse to that party. The adverse inference may be based upon: (1) The Petition, (2) a final determination in the investigation under this title, (3) any previous review under section 751 or determination under section 753, or (4) any other information placed on the record.
Information on the record of this investigation indicates that the PRC-
Since the
Because we begin with the presumption that all companies within a NME country are subject to government control, and because only the companies listed under the “Final Determination Margins” section, below, have overcome that presumption, we are applying a single antidumping rate (
In the
In the
Section 776(a)(2) of the Act provides that, if an interested party (A) withholds information requested by the Department, (B) fails to provide such information by the deadline, or in the form or manner requested, (C) significantly impedes a proceeding, or (D) provides information that cannot be verified, the Department shall use, subject to sections 782(d) and (e) of the Act, facts otherwise available in reaching the applicable determination. Because the PRC-wide entity (now including Honbase and Baozhang) did not respond to our requests for information, withheld information requested by the Department, and did not allow their information to be verified, pursuant to sections 776(a)(2)(A), (C), and (D) of the Act, we determine, as in the
Section 776(c) of the Act provides that, when the Department relies on secondary information, rather than on information obtained in the course of an investigation as facts available, it must, to the extent practicable, corroborate that information from independent sources reasonably at its disposal. Secondary information is described in the SAA as “information derived from the petition that gave rise to the investigation or review, the final determination concerning subject merchandise, or any previous review under Section 751 concerning the subject merchandise.”
At the
For the final determination, because there were no margins calculated for the mandatory respondents, to corroborate the 235.00 percent margin used as AFA for the PRC-wide entity, to the extent appropriate information was available, we are affirming our pre-initiation analysis of the adequacy and accuracy of the information in the Petition.
In the
We determine that the below percentage margins exist for the following entities for the POI:
We will
In accordance with section 735(c)(1)(B) of the Act, we are directing U.S. Customs and Border Protection (“CBP”) to continue to suspend liquidation of all imports of merchandise subject to the investigation entered or withdrawn from warehouse, for consumption for the PRC-wide entity and the Separate Rate Recipients on or after November 4, 2011. We will instruct CBP to require a cash deposit or the posting of a bond equal to the weighted-average amount by which the NV exceeds U.S. price, as follows: (1) The rate for the exporter/producer combinations listed in the chart above will be the rate we have determined in this final determination; (2) for all PRC exporters of subject merchandise which have not received their own rate, the cash-deposit rate will be the PRC-wide rate; and (3) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash-deposit rate will be the rate applicable to the PRC exporter/producer combination that supplied that non-PRC exporter. These suspension of liquidation instructions will remain in effect until further notice.
Additionally, the Department found in its final determination for the companion countervailing duty (“CVD”) investigation that Baozhang's merchandise benefited from export subsidies.
With respect to M&M Industries Co., Ltd., a separate rate recipient in this case, but a mandatory respondent in the companion CVD case to which total AFA was assigned, the Department
Further, with respect to the other companies receiving a separate rate in the instant investigation, excluding M&M Industries Co., Ltd., these companies are subject to the all-others rate in the companion CVD investigation. Moreover, as noted above, all companies were found to have the same amount of export subsidies, the amount found for the cooperative respondent in the CVD case. Therefore, for companies receiving a separate rate, we will instruct CBP to require a cash deposit or posting of a bond equal to the amount by which normal value exceeds U.S. price for the separate rate recipients, as indicated above, reduced by the export subsidy rate (0.21%) found for all companies.
This notice also serves as a reminder to the parties subject to administrative protective order (“APO”) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
This determination and notice are issued and published in accordance with sections 735(d) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
On November 3, 2011, the Department of Commerce (the “Department”) published its preliminary determination of sales at less than fair value (“LTFV”) in the antidumping investigation of certain stilbenic optical brightening agents (“stilbenic OBAs”) from the People's Republic of China (“PRC”).
Shawn Higgins or Maisha Cryor, AD/CVD Operations, Office 4, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0679, or (202) 482-5831, respectively.
The Department published its
The period of investigation (“POI”) is July 1, 2010, through December 31, 2010. This period corresponds to the two most recent fiscal quarters prior to the month of the filing of the petition, which was March 2011.
All issues raised in the case and rebuttal briefs by parties to this investigation are addressed in the Issues and Decision Memorandum.
• The Department changed the surrogate value (“SV”) for ocean freight to reflect shipping rates that actually occurred during the POI. In addition, the Department included certain additional charges (
• The Department changed the SV for ice blocks from Global Trade Atlas import data to a value reported in the publication
• The Department made changes based on minor corrections presented at verification.
The stilbenic OBAs covered by this investigation are all forms (whether free acid or salt) of compounds known as triazinylaminostilbenes (
Excluded from this investigation are all forms of 4,4'-bis[4-anilino-6-morpholino-1,3,5-triazin-2-yl]
These stilbenic OBAs are classifiable under subheading 3204.20.8000 of the Harmonized Tariff Schedule of the United States (“HTSUS”), but they may also enter under subheadings 2933.69.6050, 2921.59.4000 and 2921.59.8090. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise is dispositive.
As provided in section 782(i) of the Act, the Department verified the information submitted by Transfar and Hongda for use in its final determination. The Department used standard verification procedures, including examination of relevant accounting and production records and original source documents provided by the respondents.
The Department considers the PRC to be a non-market economy (“NME”) country. In accordance with section 771(18)(C)(i) of the Act, any determination that a foreign country is an NME country shall remain in effect until revoked by the administering authority. The Department has not revoked the PRC's status as an NME country. No party has challenged the designation of the PRC as an NME country in this investigation. Therefore, the Department continues to treat the PRC as an NME for purposes of the final determination.
In the preliminary determination, the Department selected Thailand as the appropriate surrogate country for use in this investigation pursuant to section 773(c)(4) of the Act based on the following: (1) It is at a similar level of economic development as the PRC; (2) it is a significant producer of merchandise comparable to the merchandise under consideration; and (3) the record contains reliable data from Thailand that the Department can use to value the factors of production.
Section 776(a) of the Act provides that the Department shall apply facts available (“FA”) if (1) necessary information is not on the record, or (2) an interested party or any other person (A) withholds information that has been requested, (B) fails to provide information within the deadlines established, or in the form and manner requested by the Department, subject to subsections (c)(1) and (e) of section 782 of the Act, (C) significantly impedes a proceeding, or (D) provides information that cannot be verified as provided by section 782(i) of the Act.
Section 776(b) of the Act further provides that the Department may use an adverse inference in applying FA when a party has failed to cooperate by not acting to the best of its ability to comply with a request for information. Such an adverse inference may include
In the
Because the PRC-wide entity did not respond to our request for information, the Department has determined that the PRC-wide entity has failed to cooperate to the best of its ability. Therefore, pursuant to section 776(b) of the Act, the Department has found that, in selecting from among the FA, an adverse inference is appropriate for the PRC-wide entity.
Because the Department begins with the presumption that all companies within an NME country are subject to government control and only the mandatory respondents have overcome that presumption, the Department is applying a single antidumping rate to all other exporters of merchandise under consideration from the PRC. Such companies have not demonstrated entitlement to a separate rate.
In selecting a rate for adverse facts available (“AFA”), the Department selects a rate that is sufficiently adverse “as to effectuate the purpose of the adverse facts available rule to induce respondents to provide the Department with complete and accurate information in a timely manner.”
The dumping margin for the PRC-wide entity applies to all entries of the merchandise under investigation except for entries of merchandise under investigation from the exporter/manufacturer combinations listed in the chart in the “Final Determination” section below.
In the
The Department determines that the following dumping margins exist for the period July 1, 2010, through December 31, 2010:
The Department intends to disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
In accordance with section 735(c)(1)(B) of the Act, the Department will instruct U.S. Customs and Border Protection (“CBP”) to continue to suspend liquidation of all appropriate entries of stilbenic OBAs from the PRC as described in the “Scope of Investigation” section, entered, or withdrawn from warehouse, for consumption on or after November 3, 2011, the date of publication of the
In accordance with section 735(d) of the Act, we have notified the International Trade Commission (“ITC”) of the final affirmative determination of sales at LTFV. As the Department's final determination is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will determine, within 45 days, whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports, or sales (or the likelihood of sales) for importation, of the merchandise under consideration. If the ITC determines that such injury does exist, the Department will issue an antidumping duty order directing CBP to assess, upon further instruction by the Department, antidumping duties on all imports of the merchandise under consideration entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation.
This notice also serves as a reminder to the parties subject to administrative protective order (“APO”) of their responsibility concerning the disposition of propriety information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of return or distruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
This determination is issued and published in accordance with sections 735(d) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that countervailable subsidies are being provided to producers and exporters of crystalline silicon photovoltaic cells, whether or not assembled into modules (solar cells) from the People's Republic of China (PRC). For information on the estimated subsidy rates,
Gene Calvert, Jun Jack Zhao, or Emily Halle, AD/CVD Operations, Office 6, Import Administration, U.S. Department of Commerce, Room 7866, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3586, (202) 482-1396, or (202) 482-0176, respectively.
The Department initiated a countervailing duty (CVD) investigation of solar cells from the PRC on November 8, 2011.
On November 29, 2011, the Department completed its respondent selection analysis. Given available resources, the Department determined it could examine no more than two producers/exporters and selected Changzhou Trina Solar Energy Co., Ltd. (Trina Solar) and Wuxi Suntech Power Co., Ltd. (Wuxi Suntech) as mandatory respondents.
On December 5, 2011, the petitioner, Solar World Industries, America, Inc. (Petitioner), submitted an additional subsidy allegation, claiming that the government of the PRC (GOC), through state-owned enterprises (SOEs),
On January 3, 2012, Wuxi Suntech requested an extension of the January 13 deadline for responding to the Department's December 7, 2011 questionnaire. On January 5, 2012, the GOC and Trina Solar each requested an extension of the January 13 deadline for responding to the questionnaire. The Department extended the deadline until January 23, 2012.
On January 3, 2012, the GOC requested that the Department terminate the CVD investigation, stating that, in a recent decision, the U.S. Court of Appeals for the Federal Circuit found that the Department does not have the authority to apply the CVD law to countries the Department considers non-market economies (NMEs).
On January 9, 2012, Trina Solar and Wuxi Suntech each requested that the Department further extend the deadline for the preliminary determination by an additional 35 days, noting the Department had the authority to do so in extraordinary circumstances. In these same submissions, both Trina Solar and Wuxi Suntech also requested an additional extension of the deadline for responding to the Department's December 7, 2011 questionnaire. Also on January 9, 2012, the GOC reiterated its January 5, 2012 request for additional time to respond to the Department's December 7, 2011 questionnaire, requesting the deadline be extended to February 3, 2012. On January 19, 2012, Petitioner requested that the Department extend the deadline for submitting additional subsidy allegations. Based on this request from Petitioner, the Department extended this deadline until February 10, 2012. Also on January 19, 2012, Petitioner requested that the preliminary determination be further extended until March 2, 2012. On January 23, Petitioner re-submitted its allegation that the GOC provided solar cells producers with glass for LTAR. On January 19, 2012, the Department extended the deadline until January 31, 2012, for the GOC, Trina Solar, and Wuxi Suntech to respond to the Department's December 7, 2011 questionnaire. On January 31, 2012, the Department published in the
On February 9, 2012, Petitioner submitted a request to extend further the deadline for submitting additional subsidy allegations. Based on this request from Petitioner, the Department extended the deadline until February 14, 2012, for submitting additional subsidy allegations. Also on February 9, 2012, the Department issued supplemental questionnaires to Trina Solar and Wuxi Suntech. On February 14, 2012, Trina Solar and Wuxi Suntech each requested that the Department extend the deadline until February 29, 2012, for responding to the February 9, 2012 supplemental questionnaire. In its submission, Wuxi Suntech also reiterated its January 9, 2012 request to extend fully the deadline for the preliminary determination. The Department extended the supplemental questionnaire response deadline to February 27, 2012, for Trina Solar and Wuxi Suntech. On February 14, 2012, Petitioner submitted five additional new subsidy allegations. The Department has not yet reached a determination of whether to include these five additional allegations, or the uncreditworthiness allegations noted above, in the investigation, but intends to do so after the issuance of this preliminary determination.
On February 15, 2012, the Department issued a supplemental questionnaire to the GOC. On February 17, 2012, the GOC requested an extension until March 5, 2012, for responding to the Department's February 15, 2012 supplemental questionnaire. The Department extended the deadline until March 1, 2012. On February 22, 2012, the Department published in the
In accordance with the preamble to the Department's regulations, in our
The merchandise covered by this investigation are crystalline silicon photovoltaic cells, and modules, laminates, and panels, consisting of crystalline silicon photovoltaic cells, whether or not partially or fully assembled into other products, including, but not limited to, modules, laminates, panels and building integrated materials.
This investigation covers crystalline silicon photovoltaic cells of thickness equal to or greater than 20 micrometers, having a p/n junction formed by any means, whether or not the cell has undergone other processing, including, but not limited to, cleaning, etching, coating, and/or addition of materials (including, but not limited to, metallization and conductor patterns) to collect and forward the electricity that is generated by the cell.
Subject merchandise may be described at the time of importation as parts for final finished products that are assembled after importation, including, but not limited to, modules, laminates, panels, building-integrated modules, building-integrated panels, or other finished goods kits. Such parts that otherwise meet the definition of subject merchandise are included in the scope of this investigation.
Excluded from the scope of this investigation are thin film photovoltaic products produced from amorphous silicon (a-Si), cadmium telluride (CdTe), or copper indium gallium selenide (CIGS).
Also excluded from the scope of this investigation are crystalline silicon photovoltaic cells, not exceeding 10,000mm
Modules, laminates, and panels produced in a third-country from cells produced in the PRC are covered by this investigation; however, modules, laminates, and panels produced in the PRC from cells produced in a third-country are not covered by this investigation.
Merchandise covered by this investigation is currently classified in the Harmonized Tariff System of the United States (HTSUS) under subheadings 8501.61.0000, 8507.20.80, 8541.40.6020 and 8541.40.6030. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this investigation is dispositive.
Because the PRC is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, the U.S. International Trade Commission (ITC) is required to determine whether imports of the subject merchandise from the PRC materially injure, or threaten material injury to, a U.S. industry. On December 16, 2011, the ITC published its preliminary determination that there is a reasonable indication that an industry in the United States is materially injured by reason of imports of solar cells from the PRC.
On October 25, 2007, the Department published its final determination on coated free sheet paper from the PRC.
Additionally, for the reasons stated in the CWP from the PRC Decision Memorandum, we are using the date of December 11, 2001, the date on which the PRC became a member of the World Trade Organization (WTO), as the date from which the Department will identify and measure subsidies in the PRC for purposes of CVD investigations.
On January 27, 2012, the Department determined that critical circumstances exist with respect to imports of solar cells from the PRC for Trina Solar, Wuxi Suntech, and all other PRC producers or exporters, finding that there have been massive imports of subject merchandise over a relatively short period of time by these entities.
On November 17, 2011, CNPV Dongying Solar Power Company Limited requested that it be selected as a voluntary respondent, if the company was not selected as a mandatory respondent. Also on November 17, 2011, Yingli Green Energy Holding Company Limited and Yingli Green Energy Americas, Inc. requested that they be selected collectively as a voluntary respondent. On November 22, 2011, both Trina Solar and Wuxi Suntech requested that they be selected as voluntary respondents. Jiangsu Green Power PV Co., Ltd. requested that it be selected as a voluntary respondent on November 28, 2011. On December 23, 2011, Motech (Suzhou) Renewable Energy Co., Ltd. requested that it be a selected as a voluntary respondent.
In the Respondent Selection Memorandum, the Department explained that it did not have resources available to examine any of the several parties, noted above, requesting to be investigated as voluntary respondents.
Sections 776(a)(1) and (2) of the Act provide that the Department shall apply “facts otherwise available” if necessary information is not on the record or if an interested party or any other person: (A) Withholds information that has been requested; (B) fails to provide information within the deadlines established, or in the form and manner requested by the Department, subject to subsections (c)(1) and (e) of section 782 of the Act; (C) significantly impedes a proceeding; or (D) provides information that cannot be verified as provided by section 782(i) of the Act.
Section 776(b) of the Act further provides that the Department may use an adverse inference in applying the facts otherwise available when a party has failed to cooperate by not acting to the best of its ability to comply with a request for information. Section 776(b) of the Act also authorizes the Department to use as adverse facts available (AFA), information derived from the petition, the final determination, a previous administrative review, or other information placed on the record.
Section 776(c) of the Act provides that, when the Department relies on secondary information rather than on information obtained in the course of an investigation or review, it shall, to the extent practicable, corroborate that information from independent sources that are reasonably at its disposal. Secondary information is defined as “{i}nformation derived from the petition that gave rise to the investigation or review, the final determination concerning the subject merchandise, or any previous review under section 751 concerning the subject merchandise.”
As discussed below under the section “Programs Preliminarily Determined to be Countervailable,” the Department is investigating the provision of polysilicon for LTAR by the GOC. We requested information from the GOC regarding the specific companies that produced this input product that Trina Solar and Wuxi Suntech purchased during the period of investigation (POI). Specifically, we sought information from the GOC that would allow us to determine whether the producers are “authorities” within the meaning of section 771(5)(B) of the Act. In our original and supplemental questionnaires, we requested detailed information from the GOC that would be needed for this analysis.
For each producer in which the GOC was a majority owner, we stated that the GOC needed to provide the following information that is relevant to our analysis of whether that producer is an “authority.”
• Translated copies of source documents that demonstrate the producer's ownership during the POI, such as capital verification reports, articles of association, share transfer agreements, or financial statements.
• The names of the ten largest shareholders and the total number of shareholders.
• The identification of any government ownership or other affiliations between the ten largest shareholders and the government.
• Total level of state ownership of the company's shares and the names of all government entities that own shares in the producer
• Any other relevant evidence the GOC believes demonstrates that the company is not controlled by the government.
For each producer that the GOC claimed was privately owned by individuals or companies during the POI, we requested the following.
• Translated copies of source documents that demonstrate the producer's ownership during the POI, such as capital verification reports, articles of association, share transfer agreements, or financial statements.
• Identification of the owners, members of the board of directors, or managers of the producers who were also government or Chinese Communist Party (CCP) officials or representatives during the POI.
• A statement regarding whether the producer had ever been an SOE, and, if so, whether any of the current owners, directors, or senior managers had been involved in the operations of the company prior to its privatization.
• A discussion of whether and how operational or strategic decisions made by the management or board of directors are subject to government review or approval.
Finally, for producers owned by other corporations (whether in whole or in part) or with less-than-majority state ownership during the POI, we requested information tracing the ownership of the producer back to the ultimate individual or state owners. For such producers, we requested the following information.
• The identification of any state ownership of the producer's shares; the names of all government entities that own shares, either directly or indirectly, in the producer; the identification of all owners considered “SOEs” by the GOC; and the amount of shares held by each government owner.
• For each level of ownership, identification of the owners, directors, or senior managers of the producer who were also government or CCP officials during the POI.
• A discussion of whether and how operational or strategic decisions made by the management or board of directors are subject to government review or approval.
• A statement regarding whether any of the shares held by government entities have any special rights, priorities, or privileges with regard to voting rights or other management or decision-making powers of the company; a statement regarding whether there are restrictions on conducting, or acting through, extraordinary meetings of shareholders; a statement regarding whether there are any restrictions on the shares held by private shareholders; and a discussion of the nature of the private shareholders' interests in the company (
In its questionnaire response on January 31, 2012, the GOC provided incomplete ownership information for nearly all of the companies that produced polysilicon purchased by Trina Solar and Wuxi Suntech. For the vast majority of these producers, it provided none of the information requested in the standard “input producers” appendix the Department issues to determine the individual owners of producers and to determine the extent of GOC control, if any, over the producers.
In its March 1, 2012 response, the GOC did not provide any information regarding the role of GOC and CCP officials and representatives, nor did the GOC explain the efforts it undertook to obtain the requested information. The GOC provided further ownership information, but the information provided was still incomplete in that no ownership information was provided for some companies, and, in other instances, the ownership information provided was not sufficient to determine the ultimate individual owners.
In addition to not providing all of the requested information regarding government and CCP officials and representatives, the GOC also declined to answer questions about the CCP's structure and functions that are relevant to our determination of whether the producers of polysilicon are “authorities” within the meaning of section 771(5)(B) of the Act. In its initial questionnaire response, the GOC objected to our questions, stating that the CCP, along with other related organizations, is not a government organization and that the involvement of CCP officials in the management or operations of the input producers “does not lead to interference by the Chinese government in the management and operation of the input supplier.”
Regarding the GOC's objection to the Department's questions about the role of CCP officials in the management and operations of the polysilicon producers, we have explained our understanding of the CCP's involvement in the PRC's economic and political structure in a past proceeding.
Because the GOC did not respond to our requests for information on this issue, we have no further basis for evaluating the GOC's claim that the role of the CCP is irrelevant. Thus, the Department finds, as it has in past investigations, that the information requested regarding the role of CCP officials in the management and operations of the polysilicon producers, and in the management and operations of the producers' owners, is necessary to our determination of whether these producers are authorities within the meaning of section 771(5)(B) of the Act. In addition, the GOC did not promptly notify the Department, in accordance with section 782(c), that it was unable to submit the information requested in the requested form and manner, nor did it suggest any alternative forms for submitting this information. Further, the GOC did not provide any information regarding the attempts it undertook to obtain this information, despite the fact that we provided the GOC with a second opportunity to provide the information
Therefore, we preliminarily determine that the GOC has withheld necessary information that was requested of it and, thus, that the Department must rely on “facts otherwise available” in making our preliminary determination.
The Department asked the GOC to provide a list of industries in the PRC that purchase polysilicon directly and to provide the amounts (volume and value) purchased by each of the industries, including the solar cells industry.
Therefore, we preliminarily determine that the GOC has withheld necessary information that was requested of it and, thus, that the Department must rely on “facts available” in making our preliminary determination.
In the initial questionnaire, the Department stated that if the GOC claimed that the provision of land or land-use rights to the respondents was not contingent upon any particular status or activity (
Because the GOC did not provide complete responses to either the Department's initial or supplemental questions regarding the derivation of the prices paid by Trina Solar for land-use rights, the Department is unable to determine whether or not the provision of these land use rights was specific. Therefore, we preliminarily determine that the GOC has withheld necessary information that was requested of it and, thus, that the Department must rely on facts available in making our preliminary determination for all of Trina Solar's tracts. Moreover, we preliminarily determine that the GOC has failed to cooperate by not acting to
In supplemental questionnaires to the respondents and the GOC, we identified a number of grants that the companies appeared to have received based on information from the financial statements and filings with the U.S. Securities and Exchange Commission (SEC) that parties had placed on the record. Respondents had not reported these grants nor did they complete appropriate appendices, despite the Department's request in its initial questionnaire that the respondents should report all subsidies used during the POI, not merely those related to allegations under investigation. In the supplemental questionnaire, we requested that Trina Solar and Wuxi Suntech provide more information about these grants and that the GOC coordinate with the companies to provide information concerning the programs under which these grants were provided, including complete responses to the questions on specificity in our “standard appendix.” While both companies provided a listing of their grants and the names of the projects or programs under which they themselves classified these grants, the GOC only confirmed the amounts of the grants reported by one respondent. The GOC did not provide any other information but instead noted: “The GOC objects to inquiries concerning purported subsidies as to which no timely allegations have been filed, and as to which the Department has not initiated any investigation.”
The Department, however, has the authority pursuant to section 775 of the Act to examine subsidies discovered during the course of an investigation. Because the GOC has declined to provide information necessary for our analysis of whether these grants are specific, we find that the GOC has withheld information that was requested and has impeded our investigation. Further, the GOC has not cooperated to the best of its ability in responding to our request for information and therefore, we find the use of AFA is warranted in determining the specificity of the grants the respondents reported. Accordingly, as AFA, we are finding all grant programs for these subsidies to be specific (hereinafter, referred to as the “Discovered Grants” to distinguish them from other grants provided under programs named in the petition). A list of all Discovered Grants identified publicly by the respondents and found to be used in the POI is included below in the section “Programs Preliminarily Determined to be Countervailable.” Most grants provided prior to the POI did not pass the “0.5 percent test” provided for in 19 CFR 351.524(b)(2) (discussed below) and, thus, no benefit is allocable to the POI from these grants. A list of the grants provided prior to the POI that can be identified publicly is included below in the section “Programs Preliminarily Determined to be Not Used By Respondents.” Because the names of some of the grants were bracketed by the respondents, a full list of the Discovered Grants can only be found in the business-proprietary Preliminary Calculations Memoranda.
The POI for which we are measuring subsidies is January 1, 2010, through December 31, 2010.
The Department normally allocates the benefits from non-recurring subsidies over the average useful life (AUL) of renewable physical assets used in the production of subject merchandise. The Department finds the AUL in this proceeding to be 10 years, pursuant to 19 CFR 351.524(d)(2) and the U.S. Internal Revenue Service's 1977 Class Life Asset Depreciation Range System.
Furthermore, for non-recurring subsidies, we have applied the “0.5 percent test,” as described in 19 CFR 351.524(b)(2). Under this test, we divide the amount of subsidies approved under a given program in a particular year by the relevant sales value (
In accordance with 19 CFR 351.525(b)(6)(i), the Department normally attributes a subsidy to the products produced by the company that received the subsidy. However, 19 CFR 351.525(b)(6)(ii)-(v) provides additional rules for the attribution of subsidies received by respondents with cross-owned affiliates. Subsidies to the following types of cross-owned affiliates
According to 19 CFR 351.525(b)(6)(vi), cross-ownership exists between two or more corporations where one corporation can use or direct the individual assets of another corporation in essentially the same ways it can use its own assets. This standard will normally be met where there is a majority voting interest between two corporations, or through common ownership of two (or more) corporations. The Court of International Trade (CIT) has upheld the Department's authority to attribute subsidies based on whether a company could use or direct the subsidy benefits of another company in essentially the same ways it could use its own subsidy benefits.
Based on information on the record, we preliminarily determine that cross-ownership exists, in accordance with 19 CFR 351.525(b)(6)(vi), among the following companies.
As discussed above, we selected Changzhou Trina Solar Energy Co., Ltd. (
Wuxi Suntech has responded to the Department's original and supplemental questionnaires on behalf of itself and five cross-owned affiliates: Luoyang Suntech Power Co., Ltd. (Luoyang Suntech), Suntech Power Co., Ltd. (Shanghai Suntech), Yangzhou Rietech Renewal Energy Co., Ltd. (Yangzhou Rietech), Zhenjiang Huantai Silicon Science & Technology Co., Ltd. (Zhenjiang Huantai), and Kuttler Automation Systems (Suzhou) Co., Ltd. (Suzhou Kuttler). In its annual Form 20-F SEC filing for the year ending December 31, 2010,
Wuxi Suntech, Luoyang Suntech, and Shanghai Suntech are producers of subject merchandise. Accordingly, we are attributing subsidies received by Wuxi Suntech, Luoyang Suntech, and Shanghai Suntech to the combined sales of the three companies, excluding inter-company sales, in accordance with 19 CFR 351.525(b)(6)(ii). Yangzhou Rietech, Zhenjiang Huantai and Suzhou Kuttler provide either inputs or equipment for the production of subject merchandise. With regard to the inputs, we preliminarily determine that these inputs are primarily dedicated to the production of solar cells in accordance with 19 CFR 351.524(b)(6)(iv).
Hereinafter, we refer to Wuxi Suntech, Luoyang Suntech, Shanghai Suntech, Yangzhou Rietech, Zhenjiang Huantai, and Suzhou Kuttler collectively as Wuxi Suntech, unless otherwise indicated.
When selecting an appropriate denominator for use in calculating the
Consistent with 19 CFR 351.524(d)(3)(i)(C) and the Department's practice over multiple PRC CVD investigations, we have used as our discount rates the long-term interest rate benchmarks calculated according to the methodology described below for the years in which the government provided non-recurring subsidies.
Section 771(5)(E)(ii) of the Act explains that the benefit for loans is the “difference between the amount the recipient of the loan pays on the loan and the amount the recipient would pay on a comparable commercial loan that the recipient could actually obtain on the market,” indicating that a benchmark must be a market-based rate. Normally, the Department uses comparable commercial loans reported by the company for benchmarking purposes.
In past proceedings involving imports from the PRC, we calculated the external benchmark using the methodology first developed in
After identifying the appropriate interest rates, the next step in constructing the benchmark has been to incorporate an important factor in interest rate formation, the strength of governance. These indicators measure the quality of the countries' institutions and they have been built into the analysis by using a regression analysis that relates the interest rates to the governance indicators. In each of the years from 2001-2009, the results of the regression analysis reflected the intended, common sense result: stronger institutions meant relatively lower interest rates, while weaker institutions meant relatively higher interest rates. For 2010, however, the regression does not yield that outcome for the PRC's income group.
This contrary result for a single year in ten does not lead us to reject the strength of governance as a determinant of interest rates. As confirmed by the Federal Reserve, “there is a significant negative correlation between institutional quality and the real interest rate, such that higher quality institutions are associated with lower real interest rates.”
With the following exceptions, we have used the interest and inflation rates reported in the International Financial Statistics (IFS), collected by the International Monetary Fund, for the countries identified as “upper middle income” by the World Bank for 2010 and “lower-middle income” for 2001-2009.
For loans denominated in U.S. dollars, we are again following the methodology developed over a number of successive PRC investigations. Specifically, for U.S. dollar loans, the Department used as a benchmark the one-year dollar London Interbank Offering Rate (LIBOR), plus the average spread between LIBOR and the one-year corporate bond rates for companies with a BB rating. Likewise, for loans denominated in other foreign currencies, we used as a benchmark the one-year LIBOR for the given currency plus the average spread between the LIBOR rate and the one-year corporate bond rate for companies with a BB rating.
The lending rates reported in the IFS represent short-term and medium-term lending, and there are not sufficient, publicly available long-term interest rate data upon which to base a robust benchmark for long-term loans. To address this problem, the Department previously developed an adjustment to the short-term rates described above to convert them to long-term rates using BB-rated corporate bond rates.
Section 351.511(a)(2) of the Department's regulations sets forth the basis for identifying comparative benchmarks for determining whether a government good or service is provided for LTAR. These potential benchmarks are listed in hierarchical order by preference: (1) Market prices from actual transactions within the country under investigation; (2) world market prices that would be available to purchasers in the country under investigation; or (3) an assessment of whether the government price is consistent with market principles. As explained in detail in previous investigations, the Department cannot rely on the use of so called “first-tier” and “second-tier” benchmarks to assess the benefits from the provision of land for LTAR in the PRC.
Consistent with the prior determinations, we have preliminarily determined that measuring the extent by which land is provided for LTAR is best achieved by comparing prices for land-use rights in the PRC with comparable market-based prices in a country at a comparable level of economic development that is within the geographic vicinity of the PRC. In previous PRC investigations,
For this investigation, we have obtained updated data from the same independent and internationally recognized real estate agency for all four quarters of 2010. These are updated versions of the same reports, relied on in the prior determinations, which include industrial land values for plots in industrial estates, parks, and zones in Thailand, the Philippines, and other Asian countries. We are placing all four of the
Based on our analysis, we preliminarily determine that a simple average of all land values for industrial property in Thailand provides the closest match, among options on the record, to the PRC in terms of per capita GNI and population density. The per capita GNI of Thailand is $3,760, compared to $3,590 for the PRC, while the per capita GNI for the Philippines is $2,840.
We are continuing to use the 2007 benchmark calculated in the investigations of laminated woven sacks and new pneumatic off-the-road tires cited above as the land benchmark for any land that may have been purchased in 2007 or earlier years. As mentioned, this benchmark was calculated using the same source,
We have selected the benchmark for measuring the adequacy of the remuneration for polysilicon in accordance with 19 CFR 351.511(a)(2). In its supplemental questionnaire response, the GOC confirmed that there were 47 producers in the PRC of polysilicon during the POI, but the GOC did not provide the production volume
As explained in the “Application of AFA: Polysilicon Producers are `Authorities'” section above, the Department has preliminarily determined that all the producers of polysilicon purchased by the respondents during the POI are “authorities” within the meaning of section 771(5)(B) of the Act. Because the GOC did not provide the production volumes for any of the polysilicon producers in the PRC, the Department cannot determine, on the basis of production volumes, what percentage of total domestic production or total domestic consumption is accounted for by the producers determined to be “authorities.”
Therefore, we determine that the GOC is the predominant provider of polysilicon in the PRC and that its significant presence in the market distorts all transaction prices. As such, we cannot rely on domestic prices in the PRC as a “tier-one” benchmark. For the same reasons, we determine that import prices into the PRC cannot serve as a benchmark. Turning to tier-two benchmarks,
We note that Petitioner submitted alternative polysilicon benchmark data in its pre-preliminary determination comments. It argued that these data were more appropriate because they represent values for long-term contracts in 2008, which might cover shipments in 2010, according to the SEC filings of Trina Solar. Trina Solar's SEC filings, however, state that it purchased polysilicon in 2007 and 2008 “through a combination of multi-year supply agreements, short-term supply arrangements and spot market purchases.”
The GOC reported that six programs used by the respondents have been terminated. However, the GOC did not request a program wide change adjustment to the cash deposit rate under 19 CFR 351.526(a), nor did it provide all of the documentation necessary to conduct such an evaluation. In addition, several of the programs the GOC claims were terminated have residual benefits in the POI. For example, certain parties continue to enjoy benefits from the “Two Free, Three Half” income tax program for Foreign Invested Enterprises (FIEs). Therefore, we are not making any adjustments to the cash deposit rates in this preliminary determination for terminated programs.
Based upon our analysis of the petition, the responses to our questionnaires, and other information on the record, we preliminarily determine the following.
The Golden Sun Demonstration Program (Golden Sun program) is a combination of financial assistance, technological support, and market approaches developed to accelerate the industrialization and development of the PRC's domestic photovoltaic power industry and to promote the progress of photovoltaic power generation. According to the GOC, the central government has allocated renewable energy funds to support the implementation of the Golden Sun program under Article 20 of the GOC's “Renewable Energy Law.” As detailed in the “Notice concerning the Implementation of the Golden Sun Demonstration Project,” (CaiJian {2009} No. 397), the program was established in 2009, and was designed to provide one-time assistance to recipients over the course of its two-year term.
The GOC states that the Golden Sun program was created to assist constructive investment in photovoltaic electricity-generation projects, with the goal of narrowing the gap between the costs of photovoltaic electricity generation and the costs of fossil fuel electricity generation. Financial assistance through this program includes support for,
To be eligible for financial support for this program, the GOC states that projects must: (1) Be included in the Golden Sun program within the local geographic region; (2) have an installed capacity of not less than 300 kWh; (3) have a construction period of not more than one year, and an operation period
To receive funding under this program, the GOC states that an operator of an eligible project must complete any preparation work beforehand, which includes inviting bids for necessary equipment, finalizing plans for the project's construction, and submitting application documents to the GOC. Once these documents are approved by the GOC, the Ministry of Finance will allocate the funds to the project's operator.
Wuxi Suntech reported that it did not participate in this program in 2009 (the year this program was established) or during the POI. Trina Solar, however, reported that it received a grant during the POI from the Jiangsu Reform and Development Committee for installing a photovoltaic energy-generating project.
In accordance with 19 CFR 351.504(c)(1) and 19 CFR 351.524(b)(2), we have treated the grant as a non-recurring subsidy and performed the “0.5 percent test” for the year the grant was provided to Trina Solar. Specifically, we divided the total amount of the grant by the appropriate total sales denominator, as discussed in the “Subsidies Valuation Information” section above, and in the Preliminary Calculations Memoranda. Because the resulting percentage was less than 0.5 percent, we have expensed the full amount of the grant in the POI. To determine Trina Solar's subsidy rate from the grant, we divided the benefit expensed in the POI by the appropriate total sales denominator, as discussed in the “Subsidies Valuation Information” section above, and in the Preliminary Calculations Memoranda. On this basis, we preliminarily determine a countervailable subsidy rate of 0.09 percent
Petitioner alleged that the GOC subsidizes solar cells producers through the provision of policy loans. According to Petitioner, the GOC provides for preferential policy lending to solar cells producers through the Renewable Energy Law, the Medium- and Long-Term Development Plan for Renewable Energy in China, the “Interim Measures for the Administration of Financial Subsidy Fund for Renewable and Energy Saving-Building Materials,” and a “multitude of other Chinese central government programs and measures, notably including the PRC's Twelfth Five-Year Plan.”
Both respondents reported having loans outstanding during the POI. The Department finds that the loans to both respondents are countervailable. The information on the record indicates the GOC has placed great emphasis on targeting the renewable energy industry, including solar cells producers, for development in recent years.
Renewable energy is also among the projects listed in the “Directory Catalogue on Readjustment of Industrial Structure” of the National Development and Reform Commission (NDRC) (Catalogue No. 40), which contains a list of encouraged projects the GOC develops through loans and other forms of assistance,
Therefore, given the evidence demonstrating the GOC's objective of developing the renewable energy sector, and solar cells producers in particular, through loans and other financial incentives, we preliminarily determine there is a program of preferential policy lending specific to solar cells producers, within the meaning of section 771(5A)(D)(i) of the Act. We also preliminarily find that loans from state owned commercial banks (SOCBs) under this program constitute financial contributions, pursuant to sections 771(5)(B)(i) and 771(5)(D)(i) of the Act, because SOCBs are “authorities.”
Petitioners have alleged that the respondents received countervailable subsidies in the form of the provision of polysilicon for LTAR. For the reasons explained in the “Use of Facts Otherwise Available and Adverse Inferences” section above, we are basing our determination regarding the government's provision of polysilicon, in part, on AFA. Specifically, we have determined as AFA that the producers of the polysilicon purchased by both respondents are “authorities” within the meaning of section 771(5)(B) of the Act and, as such, the provision of polysilicon constitutes a financial contribution under section 771(5)(D)(iii) of the Act. Further, we have determined as AFA that the provision of polysilicon at LTAR is specific to solar cells producers. Lastly, a benefit is being conferred because the polysilicon is being provided for LTAR, as explained below.
As discussed above under the “Subsidies Valuation Information” section, the Department is selecting for polysilicon benchmarks contemporaneous monthly world market prices from Photon Consulting's “Silicon Price Index.” This information was placed on the record of this investigation in the petition. The Department has adjusted the benchmark price to include delivery charges, import duties, and value added tax (VAT) pursuant to 19 CFR 351(a)(2)(iv).
Based on this comparison, we preliminarily determine that polysilicon was provided for LTAR and that a benefit exists for each respondent in the amount of difference between the benchmark prices and the prices each respondent paid.
Petitioner has alleged that Trina Solar and Wuxi Suntech benefited from the provision of land to solar cells producers by the GOC at either a discounted rate or for free. The sale of land-use rights constitutes a financial contribution from a government authority in the form of providing goods or services pursuant to section 771(5)(D)(iii) of the Act. As discussed above in the “Application of AFA: Land Provided to Trina Solar is Specific to the Solar Cells Industry” section, the Department has preliminarily determined as AFA that the provision of land to Trina Solar was specific.
In order to calculate the benefit, we first multiplied the Thailand industrial land benchmarks discussed above under the “Land Benchmark” section, by the total area of Trina Solar's countervailed tracts. As noted above, we have benchmarks for 2007 and 2010. For other years in which land was provided, we deflated either the 2007 or 2010 figure, depending on which was closer in time to the year of the relevant land-use agreement. We then subtracted the price actually paid for each tract to derive the total unallocated benefit. We next conducted the “0.5 percent test” of 19 CFR 351.524(b)(2) for the year of the relevant land-use agreement by dividing the total unallocated benefit for each tract by the appropriate sales denominator. If more than one tract was provided in a single year, we combined the total unallocated benefits from the tracts before conducting the “0.5 percent test.” As a result, we found that the benefits were greater than 0.5 percent of relevant sales and that allocation was appropriate for all tracts. We allocated the total unallocated benefit amounts across the terms of the land-use agreements, using the standard allocation formula of 19 CFR 351.524(d), and determined the amount attributable to the POI. We then summed all of the benefits attributable to the POI and divided this amount by the appropriate total sales denominator, as discussed in the “Subsidies Valuation Information” section above, and in the Preliminary Calculations Memoranda, to derive a subsidy rate of 0.63 percent
As discussed below under the section “Programs for Which Additional Information is Required,” we will be requesting additional information regarding land-use rights provided to Wuxi Suntech.
Under Article 8 of the “Income Tax Law of the People's Republic of China for Enterprises with Foreign Investment and Foreign Enterprises,” an FIE that is “productive” and scheduled to operate for more than ten years may be exempted from income tax in the first two years of profitability and pay income taxes at half the standard rate for the next three years. According to the GOC, the program was terminated effective January 1, 2008, by the Enterprise Income Tax Law, but
The Department has previously found the “Two Free, Three Half” program to confer a countervailable subsidy.
To calculate the benefit, we treated the income savings by Luoyang Suntech and Zhenjiang Huantai as a recurring benefit, consistent with 19 CFR 351.524(c)(1). To compute the amount of the tax savings, we compared the two companies' tax rates to the rates they would have paid in the absence of the program. We divided Luoyang Suntech's and Zhenjiang Huantai's tax savings for their returns filed during the POI by the appropriate total sales denominator, as discussed in the “Subsidies Valuation Information” section above, and in the Preliminary Calculations Memoranda, in accordance with 19 CFR 351.525(b)(6)(ii) and 19 CFR 351.525(b)(6)(iv), respectively. We then summed the two companies'
According to the GOC, this program became effective in January 2008 as part of the Enterprise Income Tax Law of the PRC (Decree 63 of the PRC, 2007). Article 28.2 of the Enterprise Income Tax Law of the PRC provides for the reduction of the income tax rate to 15 percent, from 25 percent, for enterprises that are recognized as high or new technology enterprises (HNTEs), regardless of whether the enterprise is an FIE or domestic company. The “Circular of the Ministry of Science and Technology, the Ministry of Finance and the State Administration of Taxation on Printing and Distributing the Administrative Measures for Certification of New and High Technology Enterprises” (Guo Ke Fa Huo {2008} No. 172), of April 14, 2008, identifies HNTEs as enterprises that have been registered for more than one year within the PRC and that have been engaged in continuous research and development and in the transformation of their scientific and technological achievements. This circular also specifically identifies the HNTEs that qualify for key state support, which includes renewable, clean energy technologies such as solar photovoltaic technologies.
To apply as an HNTE, Chinese companies must complete a self-assessment process regarding whether they can meet the criteria for an HNTE, and they must submit the requisite application form, business license and tax registration forms, and documents that establish that the company has been conducting high technological or innovative activities. Enterprises that meet the eligibility criteria will be certified as HNTEs by the approving GOC authority, and this designation remains effective for three years. Both Trina Solar and Wuxi Suntech were recognized as HNTEs by the GOC during the POI, and their income tax rates were therefore reduced from 25 percent to 15 percent for tax returns filed during the POI as a result.
We preliminarily determine that the reduction in income tax paid by HNTEs under this program confers a countervailable subsidy. The income tax reduction is a financial contribution in the form of revenue forgone by the government, and it provides a benefit to the recipients in the amount of the tax savings, pursuant to section 771(5)(D)(ii) of the Act and 19 CFR 351.509(a)(1). We also preliminarily determine that the income tax reduction afforded by this program is limited as a matter of law to certain enterprises,
To calculate the benefit from this program to Trina Solar and Wuxi Suntech, we treated the income tax reductions claimed by Trina Solar and Wuxi Suntech as recurring benefits, consistent with 19 CFR 351.524(c)(1). To compute the amount of the tax savings, we compared their tax rates (15 percent) to the rate that would have been paid by Trina Solar and Wuxi Suntech otherwise (the standard income tax rate of 25 percent). We multiplied the difference by the taxable income of each company. We then divided these amounts by the appropriate total sales denominator, as discussed in the “Subsidies Valuation Information” section above, and in the Preliminary Calculations Memoranda. On this basis, we preliminarily determine a countervailable subsidy rate of 1.25 percent
Enacted in 1997, the “Circular of the State Council on Adjusting Tax Policies on Imported Equipment” (GUOFA No. 37), exempts both FIEs and certain domestic enterprises from VAT and tariffs on imported equipment used in projects identified in related catalogues. The NDRC, or its provincial branch, provides a certificate to enterprises that receive the exemption. The objective of the program is to encourage foreign investment and to introduce foreign advanced technology equipment and industry technology upgrades. Trina Solar, Wuxi Suntech, Luoyang Suntech, Shanghai Suntech, Zhenjiang Huantai, and Suzhou Kuttler received VAT and tariff exemptions under this program as FIEs. The Department has previously found VAT and tariff exemptions under this program to confer countervailable subsidies.
Consistent with the earlier cases, we preliminarily determine that VAT and tariff exemptions on imported equipment confer a countervailable subsidy. The exemptions are a financial contribution in the form of revenue forgone by the GOC and they provide a benefit to the recipient in the amount of VAT and tariff savings.
Normally, we treat exemptions from indirect taxes and import charges, such as VAT and tariff exemptions, as recurring benefits, consistent with 19 CFR 351.524(c)(1), and allocate the benefits to the year in which they were received. However, when an indirect tax or import charge exemption is provided for, or tied to, the capital structure or capital assets of a firm, the Department normally treats it as a non-recurring benefit and allocates the benefit to the firm over the AUL.
To calculate the countervailable subsidy, we used our standard methodology for non-recurring grants.
As outlined in GUOSHUIFA (1999) No. 171, “Trial Administrative Measures on Purchase of Domestically Produced Equipment by FIEs,” the GOC refunds the VAT on purchases of certain Chinese produced equipment to FIEs if the equipment is used for certain encouraged projects identified in related catalogues.
Trina Solar reported using this program from 2005 through 2009; Louyang Suntech reported using this program in 2008; and Zhenjiang Huantai reported using this program from 2004 through 2008. We preliminarily determine that the rebate of the VAT paid on purchases of Chinese-made equipment by FIEs confers a countervailable subsidy. The rebates are a financial contribution in the form of revenue forgone by the GOC and they provide a benefit to the recipients in the amount of the tax savings.
Normally, we treat rebates from indirect taxes and import charges, such as VAT rebates, as recurring benefits, consistent with 19 CFR 351.524(c)(1), and expense these benefits in the year they were received. However, when an indirect tax or import charge exemption is provided for, or tied to, the capital structure or capital assets of a firm, the Department normally treats it as a non-recurring benefit and allocates the benefit to the firm over the AUL.
For those companies that received benefits under this program, we applied the “0.5 percent test,” pursuant to 19 CFR 351.524, for each of the years in which rebates were received. For the years in which the rebate amount was less than 0.5 percent of the relevant sales figure, we expensed the rebates in the year of receipt, consistent with 19 CFR 351.524(a). For those years in which the VAT rebates were greater than or equal to 0.5 percent, we allocated the rebate amount over the AUL. We used the discount rates described above in the “Subsidies Valuation Information” section to calculate the amount of the benefit allocable to the POI. On this basis, we preliminarily determine that Trina Solar received a countervailable subsidy rate of 0.01 percent
According to the “Implementation Opinion on Further Promoting the Development of Brand Economy” (XIZHENGFA {2006} No. l06), the government of Wuxi City provides a lump sum award to enterprises that receive a “famous brands” certificate. The award is jointly provided by the city, county, and district finance bureaus. Though this program is operated at the local level, the GOC issued the circular titled “Measures for the Administration of Chinese Top-Brand Products,” which requires that firms provide information in their “famous brands” applications concerning their export ratios as well as the extent to which their product quality meets international standards.
We preliminarily determine that the grant that Wuxi Suntech received under this program constitutes a financial contribution and a benefit under sections 771(5)(D)(i) and 771(5)(E) of the Act, respectively. Regarding specificity, section 771(5A)(B) of the Act states that an export subsidy is a subsidy that is, in law or in fact, contingent upon export performance, alone or as one of two or more conditions. Consistent with prior determinations regarding grants under
As explained above, the Department has determined that numerous grants provided to respondents are countervailable based upon AFA. Pursuant to 19 CFR 351.524(c) the Department normally treats grants as non-recurring subsidies. As such, the Department applied the “0.5 percent test” of 19 CFR 351.524(b) to each grant, individually, to determine whether it should be allocated. None of the Discovered Grants received during the POI passed the 0.5 percent test and, therefore, all such grants were attributed to the POI. In addition, some of the Discovered Grants received prior to the POI passed the 0.5 percent test and have been allocated to the POI. We calculated the subsidy from each grant separately by dividing the entire amount of the grant by the appropriate sales figure for the POI. Respondents' program descriptions indicate certain grants were export contingent. We determined such grants were export subsidies and used total export sales as the denominator. If the subsidy rate calculated for any particular grant was less than 0.005 percent
We preliminarily determine that Trina Solar and Wuxi Suntech did not apply for or receive benefits during the POI under the programs listed below. Because of the complicated cross-ownership issues in this investigation, we are continuing to gather information concerning the reported non-use of these programs by all companies that may be cross-owned within each company's corporate structure.
Petitioner's allegation focused on primary aluminum.
Certain cross-owned affiliates of the respondents reported receiving tax reductions under this program prior to the POI. Because the Department has treated this program as a recurring subsidy program in prior investigations, we preliminarily determine the reductions to be recurring in this investigation as well. Therefore, no benefits were received during the POI by the respondents.
After analyzing the responses of Trina Solar and Wuxi Suntech, the Department preliminarily determines that neither of the respondents received benefits under this program during the POI.
As explained above, the Department has determined, as AFA, that numerous grants provided to the respondents are countervailable. Pursuant to 19 CFR 351.524(c) the Department normally treats grants as non-recurring subsidies. As such, the Department applied the “0.5 percent test” of 19 CFR 351.524(b) to each grant, individually, to determine whether it should be allocated. Most of the Discovered Grants received prior to the POI failed the 0.5 percent test and were therefore expensed prior to the POI. Thus, all such grants are preliminarily found to have been not used during the POI by the respondents. None of these grants were publicly identified by the respondents. Therefore, these “non-used” grants are all listed in the business-proprietary Preliminary Calculations Memoranda.
The Department finds that additional information is needed in order to determine whether the following programs are countervailable. After gathering and analyzing the additional information, the Department intends to issue a post-preliminary analysis regarding whether these programs are countervailable.
As discussed above, the GOC did not provide all of the information requested regarding how prices paid by respondents for land-use rights were determined and the information provided requires further clarification.
The questionnaire responses were not complete regarding the alleged provision of electricity for LTAR. These questions requested information needed by the Department to determine whether such a provision was specific with the meaning of section 771(5A) of the Act, and whether a benefit within the meaning of section 771(5)(E) of the Act was provided. The Department intends to request further information from the GOC after the issuance of this preliminary determination.
According to the GOC, Article 30.1 of the Enterprise Income Tax Law of the PRC created a new program regarding the deduction of research and development expenditures for all enterprises.
In accordance with section 782(i)(1) of the Act, the Department will verify the information submitted by the GOC, Trina Solar, and Wuxi Suntech, prior to making our final determination.
In accordance with section 705(c)(1)(B)(i)(I) of the Act, we have calculated an individual countervailable subsidy rate for each respondent. Section 705(c)(5)(A)(i) of the Act states that for companies not individually investigated, we will determine an all others rate equal to the weighted average of the countervailable subsidy rates established for exporters and producers individually investigated, excluding any zero and
Notwithstanding the language of section 705(c)(5)(A)(i) of the Act, we have not calculated the “all others” rate by weight averaging the rates of Trina Solar and Wuxi Suntech, because doing so risks disclosure of proprietary information. Therefore, we have calculated an average rate using other information on the record.
We preliminarily determine the total countervailable subsidy rates to be as follows.
In accordance with sections 703(d)(1)(B) and (2), and 703(e)(2)(A) of the Act, in light of our preliminary affirmative determination of critical circumstances, we are directing CBP to suspend liquidation of all entries of the subject merchandise from the PRC that are entered or withdrawn from warehouse, for consumption on or after the date 90 days prior to the date of publication of this notice in the
In accordance with section 703(f) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order, without the written consent of the Assistant Secretary for Import Administration.
In accordance with section 705(b)(2) of the Act, if our final determination is affirmative, the ITC will make its final determination within 45 days after the Department makes its final determination.
In accordance with 19 CFR 351.224(b), we will disclose to the parties the calculations for this preliminary determination within five days of its announcement. We will notify parties of the schedule for submitting case briefs and rebuttal briefs, in accordance with 19 CFR 351.309(c) and 19 CFR 351.309(d)(1), respectively. A list of authorities relied upon, a table of contents, and an executive summary of issues should accompany any briefs submitted to the Department. Executive summaries should be limited to five pages total, including footnotes. Section 774 of the Act provides that the Department will hold a public hearing to afford interested parties an opportunity to comment on arguments raised in case or rebuttal briefs, provided that such a hearing is requested by an interested party.
Interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Import Administration, U.S. Department of Commerce, Room 1870, within 30 days of the publication of this notice, pursuant to 19 CFR 351.310(c). Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations will be limited to issues raised in the briefs. If a request for a hearing is made in this investigation, we intend to hold the hearing two days after the deadline for submission of the rebuttal briefs, pursuant to 19 CFR 351.310(d). Any such hearing will be held at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230. Parties should confirm by telephone, the date, time, and place of the hearing 48 hours before the scheduled time.
This determination is issued and published pursuant to sections 703(f) and 771(i) of the Act.
National Institute of Standards and Technology, U.S. Department of Commerce.
The Department of Commerce, National Institute of Standards and Technology is providing notice of a determination of an exception to the Buy American Provisions of the American Recovery and Reinvestment Act of 2009 (ARRA or Recovery Act), for inverters necessary for the construction of a solar array system at NIST's WWVH radio station in Kauai, HI.
Jason Gerloff, Contracting Officer, Acquisition Management Division, 303-497-6320, National Institute of Standards and Technology, 325 Broadway, Boulder, CO 80305.
Section 1605 of the Recovery Act (Pub. L. 111-5) prohibits use of recovery funds “for a project for the construction, alteration, maintenance, or repair of a public building or public work unless all of the iron, steel, and manufactured goods
In May 2010, NIST awarded a Recovery Act contract in the amount of $1,415,000.00 to Adon Construction for the construction of a 120kw photovoltaic solar array system to be built in eight 15kw sub-arrays at NIST's WWVH radio station in Kauai, HI. The objective of the solar array project is to produce power for the radio station and feed electricity back to the local grid. By doing this, the NIST radio station will be able to cut its utility costs and show a cost savings for future years on electricity.
The contract specifications required that all exterior photovoltaic equipment be in stainless steel or PVC enclosures that carried a minimum National Electrical Manufacturers Association (NEMA) 3R rating. An inverter is an essential piece of electrical equipment that converts DC electrical power to AC electrical power; without the inverters, the solar array could not be used for site operations. In July of 2010, the contractor proposed using three 5kw, 208V AC, single phase inverters inside of NEMA 3R, 6060 aluminum enclosures for each 15kw sub-array. The contractor notified NIST that its research indicated there were no American-made products that met the project specifications. NIST completed a review of the contractor's findings and concurred that neither the 5kw nor 15kw inverters in stainless steel, PVC, or aluminum 6060 enclosures were produced or manufactured in the U.S. in sufficient and reasonably available quantities of a satisfactory quality in July 2010. NIST also determined that the aluminum enclosures were an acceptable alternative to the stainless steel or PVC materials originally specified because they would be able to withstand the rigors of outdoor use in a tropical climate.
Based on NIST and the contractor's review of the market place and various vendors' product availability, NIST determined there were no inverters manufactured in the United States that met the contract specifications or NIST's requirements.
Pub. L. 111-5, section 1605.
National Institute of Standards and Technology, Commerce.
Notice.
The National Institute of Standards and Technology (NIST) is forming a Work Group (WG) to examine alternative methods for testing the accuracy of commercial measuring devices including, but not limited to retail motor-fuel dispensers. The WG will investigate the current methodology and standards (
An initial WG meeting will be held on Tuesday, April 24, 2012, from 10 a.m. to 5 p.m. Subsequent meeting dates will be determined based on the concurrence of the WG members.
An initial meeting of the WG will be at NIST, 100 Bureau Drive, Gaithersburg, MD 20899. Subsequent locations for WG meetings may include NIST as well as sites suggested by WG members offering to host meetings. WG meetings will also be conducted via Web conferencing. Please note admittance instructions under the
Ms. Carol Hockert, Chief, NIST, Office of Weights and Measures, 100 Bureau Drive, Stop 2600, Gaithersburg, MD 20899-2600. You may also contact Ms. Hockert by telephone (301) 975-5507 or by email at
The formation of this WG and its associated meetings is intended to bring together government officials and representatives of business, industry, trade associations, and consumer organizations on the subject of standards and test procedures used in the testing of commercial measuring devices by regulatory officials and service companies. NIST participates to promote uniformity among the states in laws, regulations, methods, and testing equipment that comprises the regulatory control of commercial weighing and measuring devices and other trade and commerce issues.
Included among the topics to be discussed by the WG for current and proposed device technologies used in testing commercial measuring devices are: metrology laboratory standards and test procedures; uncertainties; measurement traceability; tolerances and other technical requirements for commercial measuring devices; existing standards for testing equipment; field implementation; data analysis; field test procedures; field enforcement issues; training at all levels; and other relevant issues identified by the WG. WG recommendations may result in the revision of current standards or the development of new standards for testing equipment, including documents such as the NIST Handbook 105 Series for field standards; NIST Handbook 44,
All visitors to the NIST site are required to pre-register to be admitted. Anyone wishing to attend this meeting must register by close of business Tuesday, April 17, 2012, in order to attend. Please submit your full name, email address, and phone number to Ms. Hockert. Non-U.S. citizens must also submit their country of citizenship, title, and employer/sponsor. Ms. Hockert's email address is
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before May 25, 2012.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Chris Rilling, (301) 427-8168, (
The National Oceanic and Atmospheric Administration (NOAA), National Marine Fisheries Service (NMFS) deploys fishery observers on United States (U.S.) commercial fishing vessels and to fish processing plants in order to collect biological and economic data. NMFS has at least one observer program in each of its six Regions. These observer programs provide the most reliable and effective method for obtaining information that is critical for the conservation and management of living marine resources. Observer programs primarily obtain information through direct observations by employees or agents of NMFS; and such observations are not subject to the Paperwork Reduction Act (PRA). However, observer programs also collect the following information that requires clearance under the PRA: (1) Standardized questions of fishing vessel captains/crew or fish processing plant managers/staff, which include gear and performance questions, safety questions, and trip costs, crew size and other economic questions; (2) questions asked by observer program staff/contractors to plan observer deployments; (3) forms that are completed by observers and that fishing vessel captains are asked to review and sign; (4) questionnaires to evaluate observer performance; and (5) a form to certify that a fisherman is the permit holder when requesting observer data from the observer on the vessel. NMFS seeks to renew OMB PRA clearance for these information collections.
The information collected will be used to: (1) Monitor catch and bycatch in federally-managed commercial fisheries; (2) understand the population status and trends of fish stocks and protected species, as well as the interactions between them; (3) determine the quantity and distribution of net benefits derived from living marine resources; (4) predict the biological, ecological, and economic impacts of existing management action and proposed management options; and (5) ensure that the observer programs can safely and efficiently collect the information required for the previous four uses. In particular, these biological and economic data collection programs contribute to legally mandated analyses required under the Magnuson-Stevens Fishery Conservation and Management Act (MSA), the Endangered Species Act (ESA), the Marine Mammal Protection Act (MMPA), the National Environmental Policy Act (NEPA), the Regulatory Flexibility Act (RFA), Executive Order 12866 (EO 12866), as well as a variety of state statutes. The confidentiality of the data will be protected as required by the MSA, Section 402(b).
The information will be collected by (1) NMFS observers while they are deployed on a vessel to observe a particular fishing trip; questions will be asked in-person to the captain, crew and/or owner (if on board the vessel) during the course of the observed trip; (2) via mail through a follow up surveys of economic information not available during the trip; (3) via telephone or mail survey by the observer program staff or contractor planning to deploy observers; or (4) via feedback questionnaires mailed to the vessel owners or captains to evaluate observer performance.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Simon Nash, Parthenon Entertainment Ltd, 34 Whiteladies Road, Bristol, BS8 2LG, United Kingdom, has applied in due form for a permit to conduct commercial or educational photography
Written, telefaxed, or email comments must be received on or before April 25, 2012.
These documents are also available upon written request or by appointment in the following offices:
Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376; and
Pacific Islands Region, NMFS, 1601 Kapiolani Blvd., Rm. 1110, Honolulu, HI 96814-4700; phone (808) 944-2200; fax (808) 973-2941.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Carrie Hubard or Kristy Beard, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant is requesting authorization to film spinner dolphins near Midway Atoll in the Pacific Ocean. Dolphins would be approached during morning and late afternoon when they are typically active, but would not be approached during their mid-day resting period. Filming techniques include above water from a vessel, a pole-mounted underwater camera, and a waterproof camera used by a snorkeling cameraman. Up to 1,300 dolphins could be approached annually during filming activities. Footage would be used primarily for a television documentary about Hawaiian wildlife that would be aired on Animal Planet in the U.S. and elsewhere internationally. The initial filming period is scheduled for two weeks in June/July 2012. The permit would be valid for five years.
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Pacific Council will convene a meeting of the Ecosystem Plan Development Team (EPDT) which is open to the public.
The EPDT will meet on Thursday, April 12, 2012 from 9 a.m. to 5 p.m., or when business for the day is completed.
The meeting will be held at the Hilton Seattle Airport, Mercer B Room, 17620 International Boulevard, Seattle, WA 98188-4001; telephone: (206) 244-4800.
Mike Burner, Staff Officer; telephone: (503) 820-2280.
Please note, this is not a public hearing; it is a work session for the primary purpose of drafting a report and recommendations to the Council on the Development of a Fishery Ecosystem Plan (FEP). The primary purpose of the meeting is to address Council requests from and since the November 2011 Council meeting, revise and expand sections of the Council's developing Fishery Ecosystem Plan, discuss the content and format of an annual ecosystem report, explore mechanisms for incorporating ecosystem science into stock assessments, and revisit the need and mechanisms for expanding protective measures for unexploited forage species. The EPDT may also develop recommendations for the June 2012 Council meeting.
Although non-emergency issues not contained in the meeting agenda may come before the EPDT for discussion, those issues may not be the subject of formal EPDT action during this meeting. EPDT action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2280 at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Whiting Oversight Committee on April 17, 2012 to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Tuesday, April 17, 2012 at 10 a.m.
The meeting will be held at the Hotel Providence, 139 Mathewson Street, Providence, RI 02903; telephone: (401) 861-8000; fax: (401) 454-4306.
Paul J. Howard, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Oversight Committee will choose final alternatives for Draft Amendment 19, based on public hearing input and analysis of impacts. The draft alternatives include annual limits on catch and landings by fishery program and/or stock, in-season and post-season accountability measures including incidental possession limits, year-round red hake possession limits, and monitoring and specification procedures. These final alternatives will be recommended for approval at the April 24-26 Council meeting. Other matters relative to whiting or skate management may also be discussed.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice; Extension of Comment Period.
The National Telecommunications and Information Administration (NTIA) announces that the closing deadline for submitting comments responsive to the March 5, 2012 request for public comments on the multistakeholder process to develop consumer data privacy codes of conduct has been extended until 5 p.m. Eastern Daylight Time (EDT) on April 2, 2012.
Comments are due by 5 p.m. EDT on April 2, 2012.
Written comments may be submitted by email to
For general questions about this amended Notice contact Aaron Burstein, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Room 4725, Washington, DC 20230; telephone (202) 482-1055; email
On February 23, 2012, the Executive Office of the President released
Office of the Under Secretary of Defense (Personnel and Readiness), DoD.
Notice.
In compliance with Section 3506(c)(2)(A) of the
Consideration will be given to all comments received by May 25, 2012.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Defense Manpower Data Center (DMDC) ATTN: Ms. Kristin Williams, 4800 Mark Center Drive, Ste 04E25, Alexandria, VA, 22350, or call at (571) 372-1102.
UOCAVA requires the States to allow Uniformed Services personnel, their family members, and overseas citizens to use absentee registration procedures and to vote by absentee ballot in general, special, primary, and runoff elections for Federal offices. The Act covers members of the Uniformed Services and the merchant marine to include the commissioned corps of the National Oceanic and Atmospheric Administration and Public Health Service and their eligible dependents, Federal civilian employees overseas, and overseas U.S. citizens not affiliated with the Federal Government. Local Election Officials (LEO) process voter registration and absentee ballot applications, send absentee ballots to voters, and receive and process the voted ballots in counties, cities, parishes, townships and other jurisdictions within the U.S. LEOs, independently and in relation to their respective State election officicals, are often one of the most important pieces in the absentee voting process for UOCAVA citizens. The Federal Voting Assistance Program (FVAP) conducts the post-election survey of State and Local Election Officials to determine participation rates that are representative of all citizens covered by the Act, to measure State-Federal cooperation, and to evaluate the effectiveness of the overall absentee voting program. By design, the information collected be both quantitative (collected from both the State and Local Election Officials) and qualitative (collected from the Local Election Officials), and will be used for overall program evaluation, management and improvement, and to compile the congressionally-mandated report to the President and Congress.
Defense Logistics Agency, DoD.
Notice.
In compliance with Section 3506(c)(2)(A) of the
Consideration will be given to all comments received by May 25, 2012.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Defense Logistics Agency, ATTN: U.S./Canada Joint Certification Office, DLA Logistics Information Service-LFT, Attn: Stephen G. Riley, Federal Center, 74 Washington Ave. N., Battle Creek, MI 49017-3084, or call (269) 961-5464.
Use of DD Form 2345 permits U.S. and Canada defense contractors to certify their eligibility to obtain certain unclassified technical data with military and space applications. Non-availability of this information prevents defense contractors from accessing certain restricted databases and obstructs conference attendance where restricted data will be discussed.
Office of the Administrative Assistant to the Secretary of the Army, (OAA-AAHS), DoD.
Notice.
In compliance with Section 3506(c)(2)(A) of the
Consideration will be given to all comments received by May 25, 2012.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write Arlington National Cemetery (ANC), Communications Director, ATTN: Kennon Artis, Arlington, Virginia 22211, or call Department of the Army reports clearance officer at (703) 428-6440.
Arlington National Cemetery (ANC) is the preeminent institution for interring our nation's heroes. ANC cares about the families (friends) of those laid to rest there. ANC represents a good destination to Explore the Nation's history. In an area of 624 acres veterans and military casualties from each of the nation's wars are interred in the cemetery ranging from the American Civil War through to the military actions in Afghanistan and Iraq.
The National Center for Education Statistics (NCES) Quick Response Information System (QRIS) consists of the Fast Response Survey System (FRSS) and the Postsecondary Education Quick Information System (PEQIS). The QRIS currently conducts surveys under OMB generic clearance 1850-0733, which expires in June 2012. This submission requests approval to continue the current clearance conditions through 2015. FRSS primarily conducts surveys of the elementary/secondary sector (districts, schools) and public libraries. PEQIS conducts surveys of the postsecondary education sector.
Interested persons are invited to submit comments on or before April 25, 2012.
Written comments regarding burden and/or the collection activity requirements should be electronically mailed to
Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that Federal agencies provide interested parties an early opportunity to comment on information collection requests. The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, publishes this notice containing proposed information collection requests at the beginning of the Departmental review of the information collection. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
The National Assessment of Educational Progress (NAEP) is a federally authorized survey of student achievement at grades 4, 8, and 12 in various subject areas, such as mathematics, reading, writing, science, U.S. history, civics, geography, economics, and the arts.
Interested persons are invited to submit comments on or before April 25, 2012.
Written comments regarding burden and/or the collection activity requirements should be electronically mailed to
Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35) requires that Federal agencies provide interested parties an early opportunity to comment on information collection requests. The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, publishes this notice containing proposed information collection requests at the beginning of the Departmental review of the information collection. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
U.S. Department of Energy, DOE.
Notice and Request for OMB Review and Comment.
The Department of Energy (DOE) has submitted to the Office of Management and Budget (OMB) for clearance, a proposal for collection of information under the provisions of the Paperwork Reduction Act of 1995. The proposed collection will be used to report the progress of participants in the DOE Better Buildings Challenge (BBC) program. The Better Buildings Challenge is a presidential leadership initiative intended to drive greater energy efficiency in the commercial and industrial marketplace to create cost savings and jobs. This will be accomplished by highlighting the ways participants overcome market barriers and persistent obstacles with replicable, marketplace solutions. The program will showcase real solutions and partner with industry leaders to better understand policy and technical opportunities. President Obama launched the Better Buildings Challenge on December 2, 2011.
Comments regarding this collection must be received on or before April 25, 2012. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, please advise the DOE Desk Officer at OMB of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at 202-395-4650.
Written comments should be sent to the DOE Desk Officer, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10102, 735 17th Street NW., Washington, DC 20503.
And to Monica Neukomm, 202-586-8177,
Monica Neukomm, 202-586-8177,
This information collection request contains: (1) OMB No. {“New”}; (2) Information Collection Request Title: Department of Energy Better Buildings Challenge Information Collection Request; (3) Type of Request: New collection; (4) Purpose: The collected information will be used to report the progress of participants in the DOE Better Buildings Challenge (BBC) program; (5) Annual Estimated Number of Respondents: 130; (6) Annual Estimated Number of Total Responses: 1,714; (7) Annual Estimated Number of Burden Hours: 788; (8) Annual Estimated Reporting and Recordkeeping Cost Burden: $0.
Section 421 of the Energy Independence and Security Act of 2007 (42 U.S.C. 17081); Section 911 of the Energy Policy Act of 2005, as amended (42 U.S.C. 16191).
U.S. Energy Information Administration (EIA), Department of Energy.
Agency Information Collection Activities: Information Collection Extension; Notice and Request for Comments.
The EIA intends to extend for three years, Form EIA-851A “Domestic Uranium Production Report (Annual),” Form EIA-851Q “Domestic Uranium Production Report (Quarterly),” and Form EIA-858 “Uranium Marketing Annual Survey,” with the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments regarding this proposed information collection must be received on or before May 25, 2012. If you anticipate difficulty in submitting comments within that period, contact the person listed in
Send comments to Douglas Bonnar. The mailing address is Department of Energy, U.S. Energy Information Administration, Attn: Douglas Bonnar, EI-23, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585. To ensure receipt of the comments by the due date, submission by email (
Requests for additional information or copies of the forms and instructions should be directed to Douglas Bonnar at the contact information given above. Forms and instructions are also available on the Internet at:
This information collection request contains:
(1) OMB No. 1905-0160;
(2)
(3)
(4)
The Federal Energy Administration Act of 1974 (Pub. L. 93-275, 15 U.S.C. 761
The EIA, as part of its effort to comply with the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 3501
Form EIA-851A collects annual data from the U.S. uranium industry on
Form EIA-851Q collects monthly data from the U.S. uranium industry on uranium production and sources (mines and other) on a quarterly basis. The data are used by Congress and the public. The data collected may appear in the following EIA publications:
Form EIA-858 collects annual data from the U.S. uranium market on uranium contracts, deliveries, inventories, enrichment services purchased, uranium use in fuel assemblies, feed deliveries to enrichers, and unfilled market requirements. Uranium deliveries, feed deliveries to enrichers, and unfilled market requirements are reported both for the current reporting year and for the following ten years. The data are used by Congress and the public. The data collected may appear in the following EIA publications:
(4a) Proposed Changes to Information Collection:
The EIA proposes the following changes:
For Form EIA-851A, EIA proposes two minor changes to clarify the instructions for Item 8, Reserve (Reasonably Assured Resource) Estimate. The proposed instructions are:
For each property, provide:
For Form EIA-851Q, EIA purposes to collect supervisor information in addition to the responding company, the parent company, and the contact/preparer information.
For Form EIA-858, EIA proposes changes to clarify the instructions for Item 5, Uranium Feed Deliveries to U.S. and Foreign Enrichers in the Survey Year. The proposed instructions are:
(5)
(6)
(7)
(8)
Section 13(b) of the Federal Energy Administration Act of 1974, Pub. L. 93-275, codified at 15 U.S.C. 772(b).
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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j. Deadline for filing comments, motions to intervene, and protests: April 19, 2012.
All documents may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. Description of Application: Georgia Power Company seeks approval to construct a 615-foot-long rock and concrete weir, with top elevation of 225.5 feet, in the existing tailrace of the North Highland Dam of the Middle Chattahoochee Project. The proposed weir will act to support the tailwater elevation required to continue operating the North Highlands Development once the downstream City Mills Dam licensed by Uptown Columbus is breached. In addition, Georgia Power Company also seeks to construct a permanent access road to the weir and a staging area reserved for future plant
l. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
Any filings must bear in all capital letters the title “COMMENTS,” “PROTEST,” or “MOTION TO INTERVENE,” as applicable, and the Project Number of the particular application to which the filing refers. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
o. Agency Comments: Federal, state, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives.
Take notice that the following hydrokinetic pilot project license application has been filed with the Commission and is available for public inspection.
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j. This application is not ready for environmental analysis at this time.
k. With this notice, we are asking federal, state, local, and tribal agencies with jurisdiction and/or expertise with respect to environmental issues to cooperate with us in the preparation of the environmental document. Agencies who would like to request cooperating status should follow the instructions for filing described below.
All documents may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site
l. The proposed Admiralty Inlet Pilot Tidal Project would consist of (1) two 19.7-foot-diameter Open-Centre Turbines supplied by OpenHydro Group Ltd., mounted on completely submerged gravity foundations; (2) two transmission cables, which run from the turbines to the cable termination vault; (3) two transmission cables from the cable termination vault to the proposed cable control building; (4) a proposed cable control building housing the power conditioning and monitoring equipment; (5) a transmission cable bringing power from the cable control building to an existing 12.47-kV transmission line; and (6) appurtenant facilities for operation and maintenance. The estimated average annual generation of the project is 216,000 kilowatt-hours.
m.
n. You may also register online at
o. Procedural Schedule:
The application will be processed according to the following preliminary Hydro Licensing Schedule. Revisions to the schedule may be made as appropriate.
p. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, and service can be found at:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on March 19, 2012, OREG 1, Inc., OREG 2, Inc., OREG 3, Inc., and OREG 4, Inc filed compliance refund reports, pursuant to the Federal Energy Regulatory Commission's (Commission) Orders issued in this proceeding on May 19, 2011, 135 FERC ¶ 61,150 (2011), and February 16, 2012, 138 FERC ¶ 61,110 (2012) and the Notice Extending the Date to Make Refunds, issued on June 15, 2011.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) for the Choctaw Hub Expansion Project (Project) proposed by PetroLogistics Natural Gas Storage, LLC (PetroLogistics) in the above-referenced docket. PetroLogistics requests authorization to build and operate high-deliverability, multi-cycle natural gas storage facilities in order to increase the total working capacity of the Choctaw Hub from 16 billion cubic feet (bcf) to 26.6 bcf. The proposed facilities would be adjacent to PetroLogistics' existing natural gas storage, compression and pipeline facilities within the Choctaw Salt Dome located approximately 4 miles northwest of the City of Plaquemine, Louisiana.
The EA assesses the potential environmental impacts of the construction and operation of the Project in accordance with the requirements of the National Environmental Policy Act of (NEPA). The FERC staff concludes that approval of the Project, with appropriate mitigating measures, would not constitute a major federal action significantly affecting the quality of the human environment.
The U.S. Army Corps of Engineers participated as a cooperating agency in the preparation of the EA. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by the proposal and participate in the NEPA analysis.
The Project includes the following:
• A change in service of one existing underground storage cavern to natural gas storage: Cavern 28, currently used for commercial brine service;
• Addition of two compressor units totaling 27,000 horsepower to the existing PetroLogistics Compressor Station;
• One 0.67-mile-long, 30-inch-diameter cavern injection/withdrawal pipeline from the compressor station expansion site to the Cavern 28 wellhead (30-Inch Lateral to Cavern 28); and
• One 0.06-mile-long, 10-inch-diameter cavern injection/withdrawal pipeline extending from the 30-Inch-Lateral to Cavern 28 to the existing certificated Cavern 24 wellhead (10-Inch Lateral to Cavern 24).
• One 13-mile-long, 30-inch-diameter expansion header pipeline (30-Inch Expansion Header) looping PetroLogistics' existing pipelines,
• One 0.90-mile-long, 20-inch-diameter pipeline to the proposed Texas Eastern Transmission, LP (TETCO) Station Expansion (20-Inch TETCO Lateral);
• One 0.11-mile-long, 12-inch-diameter interconnect pipeline to CrossTex LIG Pipeline Company's (Crosstex) existing system (12-Inch CrossTex Lateral);
• One 0.04-mile-long, 12-inch diameter interconnect pipeline to Florida Gas Transmission Company, LLC (FGT) (12-Inch FGT Lateral);
• A 0.23-acre expansion of the meter station interconnect to Bridgeline Pipeline System (Bridgeline) at Station Number (SN) 381+00 (Milepost (MP) 7.21) (Bridgeline Station Expansion);
• A 0.68-acre expansion of the existing Southern Natural Gas Company (SONAT) Station at SN 684+50 (MP 12.95) (SONAT Station Expansion);
• A 0.52-acre expansion of the TETCO Station at SN 47+74 of the 20-Inch TETCO Lateral (TETCO Station Expansion);
• A 0.05-acre expansion of the TETCO-future Gulf South Pipeline Company, LP (Gulf South) Interconnect Station at SN 384+00 (MP 7.27) (TETCO-future Gulf South Interconnect Station Expansion);
• Expansion of two valve sites on the existing PetroLogistics mainline to accommodate the 30-Inch Expansion Header, at SN 228+40 (MP 4.33) and SN 292+42 (MP 5.54) (Expanded Mainline Valve Sites 1 and 2);
• Three side valves on the 30-Inch Expansion Header for future lateral interconnects to Gulf South's, Cypress Pipeline Company's (Cypress'), and Enterprise Products Partners' (Enterprise's) natural gas systems at SN 83+50 (MP 1.58) (Cypress Valve Set); and
• A 5.5-acre non-jurisdictional electrical substation (Sawmill Substation) along with a 200-foot-long 69-kilovolt (kv) electrical supply line to Entergy LLC's (Entergy's) powerline.
The FERC staff mailed copies of the EA to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; newspapers and libraries in the project area; and parties to this proceeding. In addition, the EA is available for public viewing on the FERC's Web site (
Any person wishing to comment on the EA may do so. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that the Commission has the opportunity to consider your comments prior to making its decision on this project, it is important that we receive your
For your convenience, there are three methods you can use to file your comments with the Commission. In all instances please reference the project docket number (CP11-50-000) with your submission. The Commission encourages electronic filing of comments and has dedicated eFiling expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the
(2) You can also file your comments electronically using the
(3) You can file a paper copy of your comments by mailing them to the following address: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214).
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's regulations, 18 CFR Part 380 (Order No. 486, 52 FR 47879), the Office of Energy Projects has reviewed the application for exemption from licensing for the Cargill Falls Hydroelectric Project, to be located on the Quinebaug River, in the Town of Putnam in Windham County, Connecticut, and has prepared an Environmental Assessment (EA). In the EA, Commission staff analyzes the potential environmental effects of the project and conclude that issuing an exemption for the project, with appropriate environmental measures, would not constitute a major federal action significantly affecting the quality of the human environment.
A copy of the EA is on file with the Commission and is available for public inspection. The EA may also be viewed on the Commission's Web site at
You may also register online at
For further information, contact Jeff Browning at (202) 502-8677.
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a final environmental impact statement (EIS) for the New Jersey-New York Expansion Project (NJ-NY Project or Project), proposed by Texas Eastern Transmission, LP (Texas Eastern) and Algonquin Gas Transmission, LLC (Algonquin), both Spectra Energy Corporation natural gas pipeline companies, in the above-referenced docket. Texas Eastern and Algonquin request authorization to expand their natural gas pipeline systems in New Jersey, New York, and Connecticut, to deliver up to 800,000 dekatherms per day of natural gas from multiple receipt points on the Texas Eastern and Algonquin pipeline systems to new delivery points in New Jersey and New York.
The final EIS assesses the potential environmental effects of the construction and operation of the NJ-NY Project in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that approval of the proposed Project would have some adverse environmental impact; however, these impacts would be reduced to less-than-significant levels with the implementation of Texas Eastern's and Algonquin's proposed
The U.S. Environmental Protection Agency (EPA), U.S. Department of Transportation, U.S. Army Corps of Engineers, New York City Mayor's Office, and New York City Department of Environmental Protection participated as cooperating agencies in the preparation of the EIS. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by the proposal and participate in the NEPA analysis. Although the cooperating agencies provided input to the conclusions and recommendations presented in the EIS, the agencies will present their own conclusions and recommendations in their respective Records of Decision for the project.
The final EIS addresses the potential environmental effects of the following project facilities:
• Construction and operation of approximately 15.2 miles of new 30-inch-diameter pipeline and 4.8 miles of 42-inch-diameter pipeline;
• Abandonment of 8.95 miles of existing 12-, 20-, and 24-inch-diameter pipeline;
• Installation of seven new metering and regulating (M&R) stations;
• Modifications to four existing compressor stations and one existing M&R station; and
• Modifications and installations of associated valves and piping.
The FERC staff mailed copies of the EIS to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; local newspapers and libraries in the Project area; intervenors to the FERC's proceeding; and potentially affected landowners and other interested individuals and groups. Paper copy versions of the EIS were mailed to those specifically requesting them; all others received a CD version. In addition, the EIS is available for public viewing on the FERC's Web site (
In accordance with the Council on Environmental Quality's (CEQ) regulations implementing NEPA, no agency decision on a proposed action may be made until 30 days after the EPA publishes a notice of availability of the final EIS in the
Additional information about the Project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
This is a supplemental notice in the above-referenced proceeding of Wellhead Power Delano, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR Part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR Part 34, of future issuances of securities and assumptions of liability, is April 9, 2012.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
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j. Qualified Hydro 24 filed its request to use the Traditional Licensing Process on January 3, 2012. Qualified Hydro 24 provided public notice of its request on January 27, 2012. Qualified Hydro 24's request to use the Traditional Licensing Process was denied by letter dated March 15, 2012.
k. With this notice, we are initiating informal consultation with: (a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR, Part 402; (b) NOAA Fisheries under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920; and (c) the Washington State Historic Preservation Officer, as required by section 106, National Historical Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.
l. With this notice, we are designating Qualified Hydro 24 as the Commission's non-federal representative for carrying out informal consultation, pursuant to section 7 of the Endangered Species Act, section 305 of the Magnuson-Stevens Fishery Conservation and Management Act, and section 106 of the National Historic Preservation Act.
m. Qualified Hydro 24 filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
n. A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site (
Register online at
On December 6, 2011, Natural Currents Energy Services, LLC filed an application, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the Orient Point Tidal Energy Project, which would be located on the eastern end of the Long Island Sound in Suffolk County, New York. The proposed project would not use a dam or impoundment. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of: (1) Installation of 45 NC Sea Dragon tidal turbines at a rated capacity of 110 kilowatts, (2) an estimated 2,500 meters in length of additional transmission infrastructure, and (3) appurtenant facilities. Initial estimated production will be a minimum of 5 megawatt hours per year with the installation of 45 units.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and competing applications may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's Web site at
On January 11, 2012, Southern Energy, Inc. filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Walker Lake Hydroelectric Project (Walker Lake Project or project) to be located on Walker Lake, near Haines, Haines Borough, Alaska. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would utilize the existing Walker Lake and would consist of the following new features: (1) Two rockfilled dams approximately 15-foot-wide, 250- and 325-foot-long, respectively making usable capacity of Walker Lake to be 4,300 acre-feet at a normal maximum operating elevation of 1,195 feet mean sea level (msl); (2) a concrete spillway and diversion channel for controlled releases to Walker Creek; (3) a freestanding concrete intake and reservoir outlet works at elevation 1,170 feet msl diverting flow from the southeast dam into the penstock; (4) a 24-inch-diameter, 12,000-foot-long penstock, of which approximately 10,000 feet will be buried and 2,000 feet will be aboveground; (5) a powerhouse containing one generating unit rated for one megawatt at 780 feet of net head; (6) a 50-foot-long tailrace connecting the powerhouse with the Little Salmon River; (7) an underground 4-mile-long, 12.5-kilovolt (kV) transmission line extending from the project to a transmission line owned by Inside Passage Electric Cooperative (the point of interconnection); and (8) appurtenant facilities. The estimated annual generation of the Walker Lake Project would be 3,615 megawatt-hours.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and competing applications may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office announces public teleconferences of the SAB Environmental Economics Advisory Committee to conduct a review of EPA's Draft White Paper “Retrospective Study of the Costs of EPA Regulations: An Interim Report” (March 2012).
The public teleconferences will be held on Thursday, April 19, 2012 from 11 a.m. to 3 p.m. (Eastern Daylight Time), Friday, April 20, 2012 from 11 a.m. to 3 p.m. (Eastern Daylight Time) and Thursday, July 12, 2012 from 11 a.m. to 3 p.m. (Eastern Daylight Time).
The teleconferences will be conducted by telephone only.
Any member of the public who wants further information concerning the meeting may contact Dr. Holly Stallworth, Designated Federal Officer (DFO), EPA Science Advisory Board (1400R), U.S. Environmental Protection Agency, 1300 Pennsylvania Avenue NW, Washington, DC 20460; via telephone/voice mail (202) 564-2073; fax (202) 565-2098; or email at
Background: Pursuant to the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C., App., notice is hereby given that the SAB Environmental Economics Advisory Committee (EEAC) will hold a public teleconferences to review the EPA draft report “Retrospective Study of the Costs of EPA Regulations: An Interim Report” (March 2012). The SAB was established pursuant to 42 U.S.C. 4365 to provide independent scientific and technical advice to the Administrator on the technical basis for Agency positions and regulations. The SAB is a Federal Advisory Committee chartered under FACA. The SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies.
The U.S. Environmental Protection Agency (EPA) conducts benefit-cost analyses of its rules and regulations. EPA strives to use the best available information to conduct its analyses. Benefit-cost analyses are by definition predictive, relying on
Technical Contacts: Any questions concerning EPA's White Paper should be directed to Dr. Nathalie Simon, NCEE at (202) 566-2347 or
Availability of Meeting Materials: A meeting agenda, charge questions, and other materials for the teleconferences will be placed on the SAB Web site at
Procedures for Providing Public Input: Public comment for consideration by EPA's federal advisory committees and panels has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office. Federal advisory committees and panels, including scientific advisory committees, provide independent advice to EPA. Members of the public can submit relevant comments pertaining to the group conducting this advisory activity, EPA's charge, or meeting materials. Input from the public to the SAB will have the most impact if it consists of comments that provide specific scientific or technical information or analysis for the SAB to consider. Members of the public wishing to provide comment should contact the Designated Federal Officer for the relevant advisory committee directly.
Accessibility: For information on access or services for individuals with disabilities, please contact Dr. Stallworth at the phone number or email address noted above, preferably at least ten days prior to the meeting, to give EPA as much time as possible to process your request.
Federal Communications Commission.
Notice and request for comments.
The Federal Communications Commission (FCC), as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act (PRA) of 1995. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before May 25, 2012. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to the Federal Communications Commission via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Board of Governors of the Federal Reserve System.
Notice is hereby given of the final approval of a proposed information collection by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling Paperwork Burdens on the Public). Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Federal Reserve Board Clearance Officer—Cynthia Ayouch—Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202-452-3829). Telecommunications Device for the Deaf (TDD) users may contact (202-263-4869), Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than April 10, 2012.
A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528:
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B. Federal Reserve Bank of Minneapolis (Jacqueline G. King, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:
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Board of Governors of the Federal Reserve System, March 21, 2012.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than April 9, 2012.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
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The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than April 19, 2012.
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The companies listed in this notice have given notice under the Home Owners' Loan Act (HOLA) (12 U.S.C. 1461
Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 10a(c)(4)(B) of HOLA (12.U.S.C. 1467a(c)(4)(B)).
Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than April 19, 2012.
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Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before April 20, 2012.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Linda M. Holleran (202-326-2267), FTC, Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and 3.25(f) the Commission Rules of Practice, 16 CFR 3.25(f), notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for March 20, 2012), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before April 20, 2012. Write “Star Pipe, Docket No. 9351” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Star Pipe, Docket No. 9351” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission (“Commission: or “FTC”) has accepted, subject to final approval, an agreement containing a proposed consent order (“Agreement”) from Star Pipe Products, Ltd. (“Star”). The Agreement seeks to resolve in part an administrative complaint issued by the Commission on January 4, 2012. The complaint charges that Star and certain of its competitors violated Section 5 of the Federal Trade Commission Act, 15 U.S.C. 45, by engaging in collusive acts and practices in the market for ductile iron pipe fittings (“DIPF”).
The Commission anticipates that, with regard to Star, the competitive issues described in the complaint will be resolved by accepting the proposed order, subject to final approval, contained in the Agreement. The Agreement has been placed on the public record for 30 days for receipt of comments from interested members of the public. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the Agreement and any comments received, and will decide whether it should withdraw from the Agreement or make final the proposed order contained in the Agreement.
The purpose of this Analysis to Aid Public Comment is to invite and facilitate public comment concerning the proposed order. It is not intended to constitute an official interpretation of the Agreement and proposed order or in any way to modify its terms.
The proposed order is for settlement purposes only and does not constitute an admission by Star that it violated the law, or that the facts alleged in the complaint, other than jurisdictional facts, are true.
The following allegations are taken from the complaint and publicly available information.
The largest sellers of DIPF in the United States are Star, McWane, Inc. (“McWane”), and Sigma Corporation (“Sigma”). DIPF are used in municipal water distribution systems to change pipe diameter or pipeline direction. There are no widely available substitutes for DIPF. Both imported and domestically produced DIPF are commercially available.
DIPF suppliers distribute these products through wholesale distributors, known as waterworks distributors, which specialize in distributing products for water infrastructure projects. The end users of DIPF are typically municipal and regional water authorities.
DIPF prices are based off of published list prices and discounts, with customers negotiating additional discounts off of those list prices and discounts on a transaction-by-transaction basis. DIPF suppliers also offer volume rebates.
Between January 2008 and January 2009, Star allegedly conspired with McWane and Sigma to increase the prices at which DIPF were sold in the United States. In furtherance of the conspiracy, and at the request of McWane, Star changed its business methods to make it easier to coordinate price levels, first by limiting the discretion of regional sales personnel to offer price discounts, and later by exchanging information documenting the volume of its monthly sales, along with sales by McWane and Sigma, through an entity known as the Ductile Iron Fittings Research Association (“DIFRA”).
The January and June 2008 price restraints among Star, McWane, and Sigma alleged in the complaint are naked restraints on competition that are
The June 2008 agreement, which was allegedly reached after a public invitation to collude by McWane, illustrates how price fixing agreements may be reached in public. Here, McWane's invitation to collude was conveyed in a letter sent to waterworks distributors, the common customers of Star, McWane, and Sigma. McWane's letter contained a section that was meaningless to waterworks distributors, but was intended to inform Star and Sigma of the terms on which McWane desired to fix prices.
The DIFRA information exchange was a component of the illegal price fixing agreement. Specifically, the complaint alleges that the DIFRA information exchange played a critical role in the 2008 price fixing conspiracy, first as the
Evaluated apart from the price fixing conspiracy, Star's participation in the information exchange is an independent violation of the antitrust laws because this concerted action facilitated price coordination among the three competitors.
The proposed order is designed to remedy the unlawful conduct charged against Star in the complaint and to prevent the recurrence of such conduct.
Paragraph II.A of the proposed order prohibits Star from participating in or maintaining any combination or conspiracy between any competitors to fix, raise or stabilize the prices at which DIPF are sold in the United States, or to allocate or divide markets, customers, or business opportunities.
Paragraph II.B of the proposed order prohibits Star from soliciting or inviting any competitor to participate in any of the actions prohibited in Paragraphs II.A.
Paragraph II.C of the proposed order prohibits Star from participating in or facilitating any agreement between competitors to exchange “Competitively Sensitive Information” (“CSI”), defined as certain types of information related to the cost, price, output or customers of or for DIPF. Paragraph II.D of the proposed order prohibits Star from unilaterally disclosing CSI to a competitor, except as part of the negotiation of a joint venture, license or acquisition, or in certain other specified circumstances. Paragraph II.E of the proposed order prohibits Star from attempting to engage in any of the activities prohibited by Paragraphs II.A, II.B, II.C, or II.D.
The prohibitions on Star's communication of CSI with competitors contained in Paragraphs II.C and II.D of the proposed order are subject to a proviso that permits Star to communicate CSI to its competitors under certain circumstances. Under the proposed order, Star may participate in an information exchange with its competitors in the DIPF market provided that the information exchange is structured in such a way as to minimize the risk that it will facilitate collusion among Star and its competitors. Specifically, the proposed order requires any exchange of CSI to occur no more than twice yearly, and to involve the exchange of aggregated information more than six months old. In addition, the aggregated information that is exchanged must be made publicly available, which increases the likelihood that an information exchange involving Star will simultaneously benefit consumers. The proposed order also prohibits Star's participation in an exchange of CSI involving price, cost or total unit cost of or for DIPF when the individual or collective market shares of the competitors seeking to participate in an information exchange exceed specified thresholds. The rationale for this provision is that in a highly concentrated market the risk that the information exchange may facilitate collusion is high. Due to the highly concentrated state of the DIPF market as currently structured, an information exchange involving Star and relating to price, output or total unit cost of or for DIPF is unlikely to reoccur in the foreseeable future.
Paragraph III of the proposed order requires Star to cooperate with Commission staff in the still-pending administrative litigation against McWane.
The proposed order has a term of 20 years.
By direction of the Commission.
Office of Acquisition Policy, GSA.
Notice of request for comments regarding a extension of a previously existing OMB clearance.
Under the provisions of the Paperwork Reduction Act the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding identification of products with environmental attributes.
Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; and ways to enhance the quality, utility, and clarity of the information to be collected.
Submit comments on or before: May 25, 2012.
Ms. Dana Munson, Procurement Analyst, General Services Acquisition Policy Division, GSA, at telephone (202) 357-9652 or via email to
Submit comments identified by Information Collection 3090-0262, Identification of Products with Environmental Attributes, by any of the following methods:
•
•
•
General Services Administration (GSA) requires contractors submitting Multiple Award Schedule Contracts to identify in their GSA price lists those products that they market commercially that have environmental attributes. The identification of these products will enable Federal agencies to maximize the use of these products to meet the responsibilities expressed in statutes and executive orders.
Administration on Aging, HHS.
Notice.
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments on the collection of information by April 25, 2012.
Submit written comments on the collection of information by fax 202.395.6974 or by mail to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., Rm. 10235, Washington, DC 20503, Attn: Brenda Aguilar, Desk Officer for AoA.
Louise Ryan, telephone: (202) 357-3503; email:
In compliance with 44 U.S.C. 3507, AoA has submitted the following proposed collection of information to OMB for review and clearance.
States provide the following data and narrative information in the report:
1. Numbers and descriptions of cases filed and complaints made on behalf of long-term care facility residents to the statewide ombudsman program;
2. Major issues identified impacting on the quality of care and life of long-term care facility residents;
3. Statewide program operations; and
4. Ombudsman activities in addition to complaint investigation.
The report form and instructions have been in continuous use, with minor modifications, since they were first approved by OMB for the FY 1995 reporting period. This request is for approval to extend use of the current form and instructions, with no modifications, for three years, covering the FY 2012-2014 reporting periods.
The data collected on complaints filed with ombudsman programs and narrative on long-term care issues provide information to Centers for Medicare and Medicaid Services and others on patterns of concerns and major long-term care issues affecting residents of long-term care facilities. Both the complaint and program data collected assist the states and local ombudsman programs in planning strategies and activities, providing training and technical assistance and developing performance measures.
A reporting form and instructions may be viewed in the ombudsman section of the AoA Web site,
AoA estimates the burden of this collection and entering the report information as follows: Approximately 8,569 hours, with 52 State Agencies on Aging responding annually.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by April 25, 2012.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 12.45 (21 CFR 12.45), issued under section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. This section also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in 21 CFR 12.85, or, in the case of a hearing before a Public Board of Inquiry, concerning disclosure of data and information by participants (21 CFR 13.25). In accordance with § 12.45(e), the presiding officer may omit a participant's appearance.
The presiding officer and other participants will use the collected information in a hearing to identify specific interests to be presented. This preliminary information serves to expedite the pre-hearing conference and commits participation.
The respondents are individuals or households, State or local governments, not-for-profit institutions and businesses, or other for-profit groups and institutions.
In the
The burden estimates for this collection of information are based on Agency records and experience over the past 3 years.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by April 25, 2012.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(e) and (f), 360d(b), 360e(b), and 360j(l)) and part 860 (21 CFR part 860), subpart C, FDA has responsibility to collect data and information contained in reclassification petitions. The reclassification provisions of the FD&C Act allow any person to petition for reclassification of a device from any of the three classes i.e., I, II, and III, to another class. The reclassification procedure regulation requires the submission of specific data when a manufacturer is petitioning for reclassification. This includes a “Supplemental Data Sheet,” Form FDA 3427, and a “Classification Questionnaire,” Form FDA 3429. Both forms contain a series of questions concerning the safety and effectiveness of the device type. Further, the reclassification content regulation (§ 860.123) requires the submission of valid scientific evidence demonstrating that the proposed reclassification will provide a reasonable assurance of safety and effectiveness of the device type for its indications for use. Thus, the reclassification provisions of the FD&C Act serve primarily as a vehicle for manufacturers to seek reclassification from a higher to a lower class, thereby reducing the regulatory requirements applicable to a particular device type, or
In the
FDA estimates the burden of this collection of information as follows:
Based on the last 3 years, and actual reclassification petitions received, FDA anticipates that six petitions will be submitted each year. The time required to prepare and submit a reclassification petition, including the time needed to assemble supporting data, averages 500 hours per petition. This average is based upon estimates by FDA administrative and technical staff who: (1) Are familiar with the requirements for submission of a reclassification petition, (2) have consulted and advised manufacturers on these requirements, and (3) have reviewed the documentation submitted.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by April 25, 2012.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7651,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Requirements for drug establishment registration and drug listing are set forth in section 510 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360); section 351 of the Public Health Service Act; and part 207 (21 CFR part 207). Fundamental to FDA's mission to protect the public health is the collection of this information, which is used for important activities such as postmarket surveillance for serious adverse drug reactions, inspection of drug manufacturing and processing facilities, and monitoring of drug products imported into the United States. Comprehensive, accurate, and up-to-date information is critical to conducting these activities with efficiency and effectiveness.
Under section 510 of the FD&C Act, FDA is authorized to establish a system for registration of producers of drugs and for listing of drugs in commercial distribution. To implement section 510 of the FD&C Act, FDA issued part 207.
Under current § 207.21, establishments, both domestic and foreign, must register with FDA within 5 days after beginning the manufacture of drugs or biologicals, or within 5 days after the submission of a drug application or biological license application (BLA). In addition, establishments must register annually. Changes in individual ownership, corporate or partnership structure, location, or drug-handling activity must be submitted as amendments to registration under current § 207.26 within 5 days of such changes. Under § 207.20(b), private label distributors may request their own labeler code and elect to submit drug listing information to FDA. In such instances, at the time of submitting or updating drug listing information, private label distributors must certify to the registered establishment that manufactured, prepared, propagated, compounded or processed (which includes, among other things, repackaging and relabeling) the listed drug that the drug listing submission was made. Establishments must, within 5 days of beginning the manufacture of drugs or biologicals, submit to FDA a listing for every drug or biological product in commercial distribution at that time. Private label distributors may elect to submit to FDA a listing of every drug product they place in commercial distribution. Registered establishments must submit to FDA drug product listing for those private label distributors who do not elect to submit listing information.
Under § 207.25, product listing information submitted to FDA by domestic and foreign manufacturers must, depending on the type of product being listed, include any new drug application (NDA) number or biological establishment license number, copies of current labeling and a sampling of advertisements, a quantitative listing of the active ingredient for each drug or biological product not subject to an approved application or license, the NDC number, and any drug imprinting information.
In addition to the product listing information required, FDA may also require, under § 207.31, a copy of all advertisements and a quantitative listing of all ingredients for each listed drug or biological product not subject to an approved application or license; the basis for a determination, by the establishment, that a listed drug or biological product is not subject to marketing or licensing approval requirements; and a list of certain drugs or biological products containing a particular ingredient. FDA may also request, but not require, the submission of a qualitative listing of the inactive ingredients for all listed drugs or biological products, and a quantitative listing of the active ingredients for all listed drugs or biological products subject to an approved application or license.
Under § 207.30, establishments must update their product listing information every June and December or, at the discretion of the establishment, when any change occurs. These updates must include the following information: (1) A listing of all drug or biological products introduced for commercial distribution that have not been included in any previously submitted list; (2) all drug or biological products formerly listed for which commercial distribution has been discontinued; (3) all drug or biological products for which a notice of discontinuance was submitted and for which commercial distribution has been resumed; and (4) any material change in any information previously submitted. No update is required if no changes have occurred since the previously submitted list.
Historically, drug establishment registration and drug listing information have been submitted in paper form using Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label Distributors) (collectively referred to as FDA Forms).
Changes in the FD&C Act resulting from enactment of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) (FDAAA) require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted. Before the enactment of FDAAA, section 510(p) of the FD&C Act expressly provided for electronic submission of drug establishment registration information upon a finding that electronic receipt was feasible, and section 510(j) of the FD&C Act provided that drug listing information be submitted in the form and manner prescribed by FDA. Section 224 of FDAAA, which amends section 510(p) of the FD&C Act, now expressly, requires electronic drug listing in addition to drug establishment registration. In certain cases, if it is unreasonable to expect a person to submit registration and listing information electronically, FDA may grant a waiver from the electronic format requirement.
In the
In addition to the information that previously was collected by the FDA Forms, the guidance addresses electronic submission of other required information as follows:
• For registered foreign drug establishments, the name, address, and telephone number of its U.S. agent (§ 207.40(c));
• The name of each importer that is known to the establishment (the U.S. company or individual in the United States that is an owner, consignee, or recipient of the foreign establishment's drug that is imported into the United States. An importer does not include the consumer or patient who ultimately purchases, receives, or is administered the drug, unless the foreign establishment ships the drug directly to the consumer or the patient) (section 510(i)(1)(A) of the FD&C Act); and
• The name of each person who imports or offers for import (the name of each agent, broker, or other entity, other than a carrier, that the foreign drug establishment uses to facilitate the import of their drug into the United States) (section 510(i)(1)(A) of the FD&C Act).
FDA also recommends the voluntary submission of the following additional information, when applicable:
• To facilitate correspondence between foreign establishments and FDA, the email address for the U.S. agent, and the telephone number(s) and email address for the importer and person who imports or offers for import their drug;
• A site-specific Data Universal Numbering System (DUNS) number for each entity (e.g., the registrant, establishments, U.S. agent, importer);
• The NDC product code for the source drug that is repacked or relabeled;
• Distinctive characteristics of certain listed drugs, i.e., the flavor, the color, and image of the actual solid dosage form; and
• Registrants may indicate that they view as confidential the registrant's business relationship with an establishment, or an inactive ingredient.
In addition to the collection of information, there is additional burden for the following activities:
• Preparing a standard operating procedure (SOP) for the electronic submission of drug establishment registration and drug listing information;
• Creating the SPL file, including accessing and reviewing the technical specifications and instructional documents provided by FDA (accessible at
• Reviewing and selecting appropriate terms and codes used to create the SPL file (accessible at
• Obtaining the digital certificate used with FDA's electronic submission gateway and uploading the SPL file for submission (accessible at
• Requests for waivers from the electronic submission process as described in the draft guidance.
When FDA published the 2009 guidance on submitting establishment registration and drug listing information in electronic format, the Agency also amended its burden estimates for OMB control number 0910-0045 to include the additional burden for collection of information that had not been submitted using the FDA Forms, and to create and upload the SPL file. The amended burden estimates included the one-time preparation of an SOP for creating and uploading the SPL file. Although most firms will already have prepared an SOP for the electronic submission of drug establishment registration and drug listing information, each year additional firms will need to create an SOP. As provided in table 2 of this document, FDA estimates that approximately 1,000 firms will have to expend a one-time burden to prepare, review, and approve an SOP, and the Agency estimates that it will take 40 hours per recordkeeper to create 1,000 new SOPs for a total of 40,000 hours. The information collection requirements of the Drug Listing and Establishment Registration regulations have been grouped according to the information collection areas of the regulations.
In the
The comment raised two issues and asked for several procedural clarifications. The first issue raised suggested that the burden to industry might be greater than the 4.5-hour average provided in the estimate. The next issue questioned the process by which FDA issued a guidance to address the electronic submissions process without changing the regulation that still describes a paper submission process, which would have allowed for public comment on that change. The comment then sought several procedural clarifications on: (1) How to submit changes in ownership of an establishment, (2) how to select a business function, (3) how to ensure that an establishment is represented consistently between a vendor's registration and the client's drug establishment registration, (4) how to link an importer with a particular product, (5) how to list bulk tablets that will be imported for packaging, and (6) how to certify to the registered establishment that the private label distributor has listed the product.
FDA acknowledges that the 2009 guidance is different from the process described in the current part 207. As was stated in the
The following paragraphs are intended to clarify one of the commenter's issues mentioned previously in this document:
1. Changes to the establishment name, registrant name, or other registration information can be made by submitting an updated registration submission via SPL. Changes in corporate ownership or officers that do not affect names, addresses, or the DUNS number(s) for a registered establishment should be made with Dun and Bradstreet. That data is then referenced as needed by FDA using the DUNS number. Information about submitting SPL can be found at the link at the end of the FDA response. It should be noted that changes in ownership may also require the submission of updates to listing information, labeler code name and DUNS, and application data for NDAs, abbreviated new drug applications (ANDAs), BLAs, new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs).
2. For selecting a business operation, a current list of valid business functions and their associated codes can be found at the link at the end of this response. Please note that if more than one business function apply, a registrant should select all that apply and include them in the registration SPL.
3. FDA has implemented an automated validation of all drug product listing submissions to ensure that each establishment referenced in the product listing is registered under the same business operation. For example, a product listing SPL that references a particular facility as a packer of the product will be rejected if that establishment has not chosen Pack as a business operation in its registration. FDA expects vendors and clients to communicate this information directly to each other and, if necessary, coordinate their submissions in order to avoid issues with this validation.
4. The importer information is submitted via the registration of the foreign establishment. Any product listing referencing that foreign establishment should therefore provide the necessary link from importer to product. Information about submitting SPL can be found at the link at the end of the FDA response.
5. A product listing for bulk tablets intended for further processing or packaging should be listed using the SPL product/document type of Bulk Ingredient and a marketing category of Drug for Further Processing. Information about submitting SPL can be found at the link at the end of the FDA response.
6. For finished dosage forms, appearance in the NDC Directory is proof of submission of listing. Note that unfinished products and active pharmaceutical ingredient listings will not appear in the NDC Directory.
Instructions and SPL resources may be found on the SPL Resources Web page at
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Yvette Waples at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
The 60-day
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of a meeting of the PubMed Central National Advisory Committee.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the meetings.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of a meeting of the Literature Selection Technical Review Committee.
The meeting will be open to the public as indicated below, with
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended because the premature disclosure of journals as potential titles to be indexed by the National Library of Medicine and the discussions would likely to significantly frustrate implementation of recommendations.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of meetings of the Board of Regents of the National Library of Medicine.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Closed: 2:30 p.m. to 4 p.m.
Open: May 8, 2012, 9 a.m. to 4:10 p.m.
Closed: May 8, 2012, 4:10 p.m. to 4:30 p.m.
Open: May 9, 2012, 9 a.m. to 12 p.m.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of meetings of the Board of Regents of the National Library of Medicine.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
United States Coast Guard, Department of Homeland Security.
Committee Management; Notice of Federal Advisory Committee Meetings.
The National Offshore Safety Advisory Committee (NOSAC) will meet on April 11 and 12, 2012, in New Orleans, Louisiana to discuss various issues related to safety of operations and other matters affecting the oil and gas offshore industry. These meetings are open to the public.
NOSAC will meet Wednesday, April 11, 2012 from 12 p.m. to 5 p.m. and Thursday, April 12, 2012, from 8:30 a.m. to 5 p.m. Three subcommittees will meet the afternoon of April 11. Please note that the meetings may close early if the committee has completed its business or be extended based on the level of public comments.
The meetings will be held at the Renaissance New Orleans Arts Hotel, 700 Tchoupitoulas Street, New Orleans, Louisiana 70130,
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the person listed in
To facilitate public participation, we are inviting public comment on the issues to be considered by the committee as listed in the “AGENDA” section below. Comments must be submitted in writing no later than April 1, 2012, and must be identified by USCG-2012-0091 and may be submitted by
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A public comment period will be held during the meeting on April 12, 2012, and speakers are requested to limit their comments to 3 minutes. Please note that the public comment period may end before the time indicated, following the last call for comments. Contact the individual listed below to register as a speaker.
Commander Rob Smith, Designated Federal Officer of NOSAC, Commandant (CG-5222), U.S. Coast Guard, 2100 Second Street SW., Stop 7126, Washington, DC 20593-0001 or Mr. Kevin Pekarek, Alternate Designated Federal Officer of NOSAC, Commandant (CG-5222), U.S. Coast Guard, 2100 Second Street SW., Stop 7126, Washington, DC 20593-0001; telephone (202) 372-1386, fax (202) 372-1926. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826.
Notice of this meeting is given under the
NOSAC's three subcommittees will meet on April 11, 2012 between 12 p.m. and 5 p.m., to discuss its ongoing work. Times for these meetings are as follows: (1) Standards for Dynamic Positioning (DP) Operating Personnel (12 p.m. to 2:30 p.m.); (2) Medical Evacuation of Injured Divers (2 p.m. to 4 p.m.); and (3) Review of the Mississippi Canyon Incident Reports stemming from the Deepwater Horizon casualty event (2:30 p.m. to 5 p.m.).
The NOSAC will meet on April 12, 2012 to review and discuss reports and recommendations received from the three subcommittees from their deliberations on April 11. The Committee will then use this information to formulate recommendations to the agency. The meeting will be open for public comment at the end of the day, see Agenda item (17).
A complete agenda for April 12th is as follows:
(1) Roll call of committee members and determination of a quorum.
(2) Approval of minutes from the February 15, 2012, meeting.
(3) Committee Administration.
The swearing in of new members from fiscal year 2009, 2010 and 2011 (if seated) slates of candidates.
(4) Welcoming comments from Eighth District Commander; Director of Commercial Regulations and Standards (CG-52); and Commander, Sector New Orleans.
(5) Presentation and discussion of reports and recommendations from the subcommittees and subsequent actions on:
(a) Standards for DP Operating Personnel.
(b) Medical Evacuation of Injured Divers.
(c) Mississippi Canyon Incident Reports.
(6) An update and discussion on recent U.S. Coast Guard regulations and
(7) Offshore Operators Committee (OOC) update regarding medical evacuations from the Outer Continental Shelf (OCS).
(8) Present a capsulation of the industry comments received from the Mobile Offshore Drilling Unit Guidance Policy, Notice of Availability, request for comments and public meeting published in the
(9) U.S. Coast Guard National Center of Expertise (NCOE) Outer Continental Shelf Inspections will lead discussions on where and how can the USCG improve on training.
(10) Update from the Bureau of Safety and Environmental Enforcement (BSEE) concerning the status of their Deepwater Horizon Investigation Recommendations.
(11) Updates on International Maritime Organization (IMO) activities of interest to the OCS community.
(12) Statistical discussion on commercial diving casualties and analysis of OCS casualties.
(13) Update on alternatives and enforcement policy concerning the Notice of Arrival on the Outer Continental Shelf rulemaking, published in the
(14) Discussion on the state of the industry: Well Control Training and current issues to be resolved to improve training for persons with Well Control responsibilities.
(15) Task Statement discussion of Safety and Environmental Management System: A joint regulatory effort between the U.S. Coast Guard and BSEE.
(16) A progress report from the U.S. Coast Guard on the last 5 years of NOSAC's submitted final reports and the disposition/actions the U.S. Coast Guard has taken regarding these reports.
(17) Period for Public comment.
(18) Adjournment of meeting.
A copy of each report is available at the
The meeting will be recorded by a court reporter. A transcript of the meeting and any material presented at the meeting will be made available through the
The committee will review the information presented on each issue, deliberate on any recommendations presented in the subcommittees' reports, and formulate recommendations for the Department's consideration.
The committee will also receive tasking from CDR Rob Smith, Designated Federal Officer, on one proposed task statements: Safety and Environmental Management System and to make recommendations to the U.S. Coast Guard on same.
U.S. Customs and Border Protection; Department of Homeland Security.
General notice.
U.S. Customs and Border Protection (CBP) has established an international trusted traveler program, referred to as Global Entry, at twenty major U.S. airports. Global Entry allows pre-approved, low-risk participants expedited entry into the United States using Global Entry kiosks located at designated airports. This document announces the expansion of the program to include four additional airports.
Global Entry will be available at all four airport locations on or before September 22, 2012. The exact starting date for each airport location will be announced on the Web site at
Larry Panetta, Office of Field Operations, (202) 344-1253,
Global Entry is a voluntary program that allows for the expedited clearance of pre-approved, low-risk travelers arriving in the United States at Global Entry kiosks located at designated airports. The Global Entry final rule, published on February 6, 2012, promulgated the regulation to establish Global Entry as a permanent regulatory program and contains a detailed description of the program, the eligibility criteria, the application and selection process, and the initial airport locations.
The twenty airports initially chosen for Global Entry were those facilities which typically experience the largest numbers of travelers arriving from outside of the United States. They include:
• John F. Kennedy International Airport, Jamaica, New York (JFK);
• The George Bush Intercontinental Airport, Houston, Texas (IAH);
• The Washington Dulles International Airport, Sterling, Virginia (IAD);
• Los Angeles International Airport, Los Angeles, California (LAX);
• Hartsfield-Jackson Atlanta International Airport, Atlanta, Georgia (ATL);
• Chicago O'Hare International Airport, Chicago, Illinois (ORD);
• Miami International Airport, Miami, Florida (MIA);
• Newark Liberty International Airport, Newark, New Jersey (EWR);
• San Francisco International Airport, San Francisco, California (SFO);
• Orlando International Airport, Orlando, Florida (MCO);
• Detroit Metropolitan Wayne County Airport, Romulus, Michigan (DTW);
• Dallas Fort Worth International Airport, Dallas, Texas (DFW);
• Honolulu International Airport, Honolulu, Hawaii (HNL);
• Boston—Logan International Airport, Boston, Massachusetts (BOS);
• Las Vegas—McCarran International Airport, Las Vegas, Nevada (LAS);
• Sanford—Orlando International Airport, Sanford, Florida (SSB);
• Seattle—Tacoma International Airport-SEATAC, Seattle, Washington (STT);
• Philadelphia International Airport, Philadelphia, Pennsylvania (PHL);
• San Juan—Luis Munos Marin International Airport, San Juan, Puerto Rico (SAJ);
• Ft. Lauderdale Hollywood International Airport, Fort Lauderdale, Florida (FLL), including the General Aviation Facility private aircraft terminal.
The preamble to the final rule states that when CBP is ready to expand Global Entry to additional airports and has selected the airports, CBP will publish an announcement in the
CBP is expanding the Global Entry program to include the following four additional airports: St. Paul International Airport, Minneapolis, Minnesota (MSP); Charlotte Douglas International Airport, Charlotte, North Carolina (CLT); Phoenix Sky Harbor International Airport, Phoenix, Arizona (PHX); and Denver International Airport, Denver, Colorado (DEN). Global Entry will become operational at all four airports on or before September 22, 2012. The exact starting dates of the expansion of Global Entry to each airport location will be announced on the Web site at
Department of the Interior.
30-Day notice of submission of information collection to the Office of Management and Budget and request for comments.
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the U.S. Department of the Interior has submitted a Generic Information Collection Request (Generic ICR): “DOI Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Comments must be submitted by April 25, 2012.
Written comments may be submitted to the Desk Officer for the Department of the Interior (DOI) at the Office of Management and Budget (OMB) via email to
Don Bieniewicz (202) 208-4915. You may also review the submitted ICR online at
The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.
Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: the target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study.
No comments were received in response to the 60-day notice published in the
A Federal agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.
Fish and Wildlife Service, Interior.
Notice of receipt of applications for permit.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
We must receive comments or requests for documents on or before April 25, 2012.
Brenda Tapia, Division of Management Authority, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Room 212, Arlington, VA 22203; fax (703) 358-2280; or email
Brenda Tapia, (703) 358-2104 (telephone); (703) 358-2280 (fax);
Send your request for copies of applications or comments and materials concerning any of the applications to the contact listed under
Please make your requests or comments as specific as possible. Please confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Include sufficient information with your comments to allow us to authenticate any scientific or commercial data you include.
The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) Those that include citations to, and analyses of, the applicable laws and regulations. We will not consider or include in our administrative record comments we receive after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the address listed under
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The applicant requests a permit to import biological specimens of loggerhead sea turtles (
The applicant requests a renewal of their permit to import tissue or blood samples of any avian species (class Aves), reptile species (class Reptilia), and any fish (within the taxonomic phylum Chordata), from worldwide locations for the purpose of diagnostic testing for infectious diseases/scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the Eld's deer (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the scimitar-horned oryx (
The applicant requests a permit authorizing interstate and foreign commerce, export, and cull of excess scimitar-horned oryx (
The applicant requests renewal and amendment of their captive-bred wildlife registration under 50 CFR 17.21(g) to add the family Bovidae to the families Equidae, and Felidae. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests renewal of their captive-bred wildlife registration under 50 CFR 17.21(g) for radiated tortoise (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the scimitar-horned oryx (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the jackass penguin (
The applicant requests renewal of their captive-bred wildlife registration under 50 CFR 17.21(g) for the following families, genus, and species, to enhance their propagation or survival. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the addax (
The applicant requests a permit authorizing interstate and foreign commerce, export, and cull of excess addax (
The applicant requests renewal of their captive-bred wildlife registration under 50 CFR 17.21(g) for golden parakeet (
The applicant requests amendment of their captive-bred wildlife registration under 50 CFR 17.21(g) to add scimitar-horned oryx (
The applicant requests a permit authorizing interstate and foreign commerce, export, and cull of excess scimitar-horned oryx (
The applicant request permits to export, re-export, and re-import captive-born tigers (
The following applicants each request a permit to import the sport-hunted trophy of one male bontebok (
Fish and Wildlife Service, Interior.
Notice of availability.
We, the U.S. Fish and Wildlife Service (Service), announce the availability of the final voluntary Land-Based Wind Energy Guidelines (Guidelines). These Guidelines supersede the Service's 2003 voluntary interim guidelines for land-based wind energy development. They respond to accelerated development of land-based wind energy generation projects in the United States. These voluntary Guidelines provide developers and agency staff with an iterative process to make sound decisions in selecting sites to avoid, minimize and compensate for adverse effects to wildlife, particularly birds and bats, and their habitats resulting from construction, operation, and maintenance of land-based wind energy facilities.
These voluntary Guidelines are effective March 26, 2012.
The Guidelines may be downloaded from
Christy Johnson-Hughes, Division of Habitat and Resource Conservation, U.S. Fish and Wildlife Service, Department of the Interior, (703) 358-1922. Individuals who are hearing-impaired or speech-impaired may call the Federal Relay Service at 1-800-877-8337 for TTY assistance, 24 hours a day, 7 days a week.
The mission of the U.S. Fish and Wildlife Service is to work with others to conserve, protect, and enhance fish, wildlife, plants, and their habitats for the continuing benefit of the American people. As part of this mission, we implement statutes including the Endangered Species Act (ESA; 16 U.S.C. 1531
Increased energy demands and the nationwide goal to increase energy production from renewable sources have intensified the development of renewable energy facilities, including wind energy. The Service supports renewable energy development that is compatible with wildlife conservation.
The voluntary Guidelines will provide Service staff, developers, landowners and other stakeholders with a tool to assist in avoiding, minimizing, and compensating for significant adverse impacts to wildlife and their habitats. Adherence to the Guidelines is voluntary and does not relieve any individual, company, or agency of the responsibility to comply with laws and regulations. However, if a violation of law occurs, the Service will consider a developer's documented efforts to communicate with the Service and adhere to the Guidelines. The Guidelines include a Communications Protocol that provides guidance to both developers and Service personnel regarding expectations of appropriate communication and documentation.
The Service anticipates that these Guidelines, when used in concert with appropriate regulatory tools and other existing policies, provide the best practical approach for wildlife conservation.
In July 2003, the Service released voluntary interim guidelines for land-based wind energy projects to assist developers in avoiding, minimizing, and/or compensating for effects to wildlife and their habitats related to land-based wind energy facilities. In 2007, the Secretary of the Interior (Secretary) established the Wind Turbine Guidelines Advisory Committee (Committee) under the Federal Advisory Committee Act (5 U.S.C. App.). The Committee submitted final recommendations to the Secretary on March 4, 2010. The Service appreciates all the time and effort that members of the Committee devoted to developing their recommendations, as well as since that time, as the Service developed these final Guidelines. The Service used the recommendations as a basis to develop the Service's draft Guidelines, which we circulated for comment in February 2011 (76 FR 9590, February 18, 2011).
We announced several opportunities for the public to attend Committee meetings and to submit comments or otherwise participate in the development of the Guidelines as follows:
The Service received more than 30,000 comments (summarized below) on the draft Guidelines from a wide range of interests, including Federal, State, and local agencies; tribes; wind energy developers; utilities; national and local wildlife conservation organizations; universities; and concerned citizens. The Service made
The final Guidelines incorporate elements from the Committee's recommendations, the draft Guidelines, as well as extensive public comment received during comment periods and the public Committee meetings. The majority of the comments focused on either the need to make the Guidelines mandatory or to keep them strictly voluntary. The following is a succinct summary of comments received and our responses.
The final Guidelines preserve many elements from the previous drafts including descriptions of the information needed to identify, assess, mitigate, and monitor the potential adverse effects of wind energy projects on wildlife and their habitats; and flexibility to accommodate the unique circumstances of each project. The framework helps developers understand how to avoid or minimize effects to certain species, which is important for compliance with a number of laws, including MBTA, BGEPA, and ESA.
The levels of surveying, monitoring, assessing, and collecting other information will vary among different wind-energy projects due to the diverse geographic, climatological, and ecological features of potential wind development sites. Founded upon a “tiered approach” for assessing potential effects to species of concern and their habitats, the guidelines are intended to promote: Compliance with relevant laws and statutes; the use of scientifically rigorous survey, monitoring, assessment, and research designs proportionate to the potential risk to affected species; the accumulation of comparable data across the landscape; the identification of trends and patterns of effects; and, ultimately, the improved ability to predict and resolve effects locally, regionally, and nationally.
The authorities for this action are the Endangered Species Act of 1973 as amended (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of document availability.
We, the Fish and Wildlife Service, announce the availability of the final recovery plan for
You may obtain a copy of the recovery plan by contacting the Panama City Field Office (PCFO), by U.S. mail at U.S. Fish and Wildlife Service, 1601 Balboa Ave, Panama City, FL 32405, or by telephone at (850) 769-0552. Alternatively, you may visit the Fish and Wildlife Service's recovery plan Web site at
Dr. Vivian Negrón-Ortiz, at the above address, or by telephone at (850) 769-0552, ext. 231.
We listed
Restoring an endangered or threatened animal or plant to the point where it is again a secure, self-sustaining member of its ecosystem is a primary goal of the endangered species program. To help guide the recovery effort, we are preparing recovery plans
The Act requires the development of recovery plans for listed species, unless such a plan would not promote the conservation of a particular species. Section 4(f) of the Act requires us to provide a public notice and an opportunity for public review and comment during recovery plan development. We made the draft of this recovery plan available for public comment from March 23 through May 23, 2011 (76 FR 16439). We considered information we received during this public comment period and information from peer reviewers in our preparation of this final recovery plan. Some sections of the recovery plan were edited based on peer reviewer and public comments. However, no substantial changes were made to the final plan.
The goal of this plan is to provide a framework to conserve and recover
• Extant populations and newly discovered sites are identified and mapped;
• Inventories have been conducted across the species' historic sites and/or on new locations;
• Monitoring programs and management protocols on selected populations are established for 15 years to track threats to the species and its habitat;
• Extant populations located on public land are stable;
• The minimum viable population (MVP) size has been determined for each variety;
• Research on key aspects related to demography, reproductive biology, and seed ecology is accomplished; and
• Collect viable seeds from at least 50 percent of the populations for each variety and store them
In addition, the following specific actions must be completed for each variety:
○ Var.
Sizes of populations # 1 to # 4 (out of 5) are increased via prescribed burns until plant numbers are stabilized;
At least one new population is found; and
At least one population is re-established within the historic range.
○ Var.
Fifty percent of the Bibb County glades known to support the variety on private land are protected through conservation agreements, easements, or land acquisition.
As reclassification criteria are met the status of the species will be reviewed, and the species will be considered for reclassification to threatened status.
Defining delisting criteria is not possible at this time, given the current low numbers of populations and individuals, lack of information about the species' biology, and the magnitude of current threats from development. Reclassification criteria will be reevaluated and delisting criteria will be created as new scientific data and information become available and recovery actions are implemented.
The authority for this action is section 4(f) of the Endangered Species Act, 16 U.S.C. 1533(f).
Bureau of Land Management, Interior.
Notice of filing of plats; Colorado.
The Bureau of Land Management (BLM) Colorado State Office is publishing this notice to inform the public of the intent to file the land survey plats listed below, and to afford all affected parties a proper period of time to protest this action, prior to the plat filing.
Unless there are protests of this action, the filing of the plats described in this notice will happen on April 25, 2012.
BLM Colorado State Office, Cadastral Survey, 2850 Youngfield Street, Lakewood, Colorado 80215-7093.
Randy Bloom, Chief Cadastral Surveyor for Colorado, (303) 239-3856.
The plat and field notes of the dependent resurvey in Township 10 South, Range 70 West, Sixth Principal Meridian, Colorado, were accepted on January 13, 2012.
The plat and field notes of the dependent resurvey and survey in Township 9 South, Range 71 West, Sixth Principal Meridian, Colorado, were accepted on January 13, 2012.
The plat and field notes of the dependent resurvey and survey in Township 10 South, Range 71 West, Sixth Principal Meridian, Colorado, were accepted on January 13, 2012.
The supplemental plat, in 4 sheets, of Section 8, in Township 1 North, Range 71 West, Sixth Principal Meridian, Colorado, was accepted on January 20, 2012.
The supplemental plat of Section 13, in Township 1 North, Range 72 West, Sixth Principal Meridian, Colorado, was accepted on January 27, 2012.
The plat incorporating the field notes, in 2 sheets, of the dependent resurvey in Township 51 North, Range 5 East, New Mexico Principal Meridian, Colorado, was accepted on February 3, 2012.
The plat and field notes of the section subdivision and survey in Township 7 South, Range 95 West, Sixth Principal Meridian, Colorado, were accepted on February 8, 2012.
The plat and field notes of the corrective dependent resurvey in Township 36 North, Range 11 West, New Mexico Principal Meridian, Colorado, were accepted on February 21, 2012.
Bureau of Land Management, Interior.
Notice of Filing of Plats; Colorado.
The Bureau of Land Management (BLM) Colorado State Office is publishing this notice to inform the public of the filing of the land survey plats listed below.
The plats described in this notice were filed on March 12, 2012.
BLM Colorado State Office, Cadastral Survey, 2850 Youngfield Street, Lakewood, Colorado 80215-7093.
Randy Bloom, Chief Cadastral Surveyor for Colorado, (303) 239-3856.
The supplemental plat of Sections 32 and 33, in Township 12 South, Range 90 West, Sixth Principal Meridian, Colorado, was accepted and filed on March 12, 2012.
The supplemental plat of Section 5, in Township 13 South, Range 90 West, Sixth Principal Meridian, Colorado, was accepted and filed on March 12, 2012.
Bureau of Land Management, Interior.
Notice.
Under the provisions of the Mineral Leasing Act of 1920, as amended, the Bureau of Land Management (BLM) received a petition for reinstatement from Larry Napolitano, Twylla Napolitano, Michael K. Smith, and Patricia J. Smith for competitive oil and gas lease WYW163161 for land in Niobrara County, Wyoming. The petition was filed on time and was accompanied by all the rentals due since the date the lease terminated under the law.
Bureau of Land Management, Julie L. Weaver, Chief, Fluid Minerals Adjudication, at (307) 775-6176. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
The lessees have agreed to the amended lease terms for rentals and royalties at rates of $10 per acre or fraction thereof, per year and 16
30-Day Notice of Information Collection Under Review: Federal Coal Lease Request.
The Department of Justice (DOJ), Antitrust Division (ATR), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
The purpose of this notice is to allow for an additional 30 days for public comment until April 25, 2012. This process is conducted in accordance with 5 CFR 1320.10.
If you have comments (especially regarding the estimated public burden or associated response time), suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Jill Ptacek, Antitrust Division, United States Department of Justice, 450 5th Street NW., Suite 8000, Washington, DC 20530.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required, contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution
30-Day Notice of Information Collection.
The Department of Justice (DOJ), Criminal Division, Child Exploitation and Obscenity Section (CEOS) will be submitting the following information collection renewal to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection renewal is published to obtain comments from the public and affected agencies. This information collection renewal was previously published in the
The purpose of this notice is to allow for an additional 30 days for public comment until April 25, 2012. This process is conducted in accordance with 5 CFR 1320.10.
If you have comments especially on the estimated number of respondents, estimated public burden or associated response time, suggestions, or need additional information, please contact Andrew G. Oosterbaan, Chief, Child Exploitation and Obscenity Section, Criminal Division, United States Department of Justice, Washington, DC 20530, email:
Written comments and suggestions from the public and affected agencies concerning the collection of information are encouraged. Your comments should address one or more of the following four points:
(1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3) How to enhance the quality, utility, and clarity of the information to be collected; and
(4) How to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
(1)
(2)
(3)
(4)
The information collection documents the recordkeeping, labeling, and inspection requirements for producers of visual depictions of actual and simulated sexually explicit conduct, and the certification regime for the exemption from these requirements, in certain circumstances, for producers of visual depictions of simulated sexually explicit conduct and visual depictions of actual sexually explicit conduct constituting the lascivious exhibition of the genitals or pubic area of a person. These statutory requirements of 28 CFR part 75, codified at 18 U.S.C. 2257 and 2257A, are designed to ensure that visual depictions of sexually explicit conduct are produced in accordance with laws and regulations, and without the involvement of minors under 18 years of age.
(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The Department is unable to estimate with any precision the number of entities producing visual depictions of simulated sexually explicit conduct. As a partial indication, the Department's 2008 regulatory review, including the information collection request and PRA Supporting Statement (RIN 1105-AB19), cited data collected by the U.S. Census Bureau in 2002. Employing the same method of analysis, according to data collected by the U.S. Census Bureau in 2007, there were 11,974 establishments engaged in motion picture and video production in the United States. Based on a rough assumption that 10% of the establishments are engaged in the production of visual depictions of simulated sexually explicit conduct, the Department estimates that approximately 1,974 motion picture and video producing establishments are required to comply with these statutory requirements. (The Department does not Additionally, the statute provides an exemption from these requirements applicable in certain circumstances, and it requires producers to submit certifications to qualify for this exemption. From March 18, 2009, the effective date of the certification regime, to the present, the Department has received approximately 865 certification letters. For the entities that qualify for the exemption, the Department estimates that it would take less than 20 hours per year to prepare the biennial certification required for the exemption.
(6) An estimate of the total public burden (in hours) associated with the collection: If OMB were to assume that 3,000,000 visual depictions of simulated sexually explicit conduct are created each year and that it requires 6 minutes to complete the recordkeeping requirement for each depiction, the recordkeeping requirements would impose a burden of 300,000 hours. If, however, OMB were to assume that producers of 90% of these depictions qualify for the statutory exemption from these requirements, the requirements would only impose a burden of 30,000 hours (These estimates were included in the Department's 2008 regulatory review, including the information collection request and PRA Supporting Statement (RIN 1105-AB19). The Department does not certify the accuracy of these numbers.)
If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, Department of Justice, Two Constitution Square, Room 2E-508, 145 Street NE., Washington, DC 20530.
60-Day Notice of Information Collection Under Review.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for “sixty days” until May 25, 2012. This process is conducted in accordance with 5 CFR 1320.10.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Stuart Lowrey, Chief, Firearms Operations Division at
Request written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information collection:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, Department of Justice, Two Constitution Square, Room 2E-508, 145 N Street NE., Washington, DC 20530.
60-Day Notice of Information Collection Under Review:
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for “sixty days” until May 25, 2012. This process is conducted in accordance with 5 CFR 1320.10.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Jacqueline Pitts, Office of Strategic Management, 99 New York Avenue NE.,Washington, DC 20226.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, Department of Justice, Two Constitution Square, Room 2E-508, 145 N Street NE., Washington, DC 20530.
60-Day Notice of Information Collection Under Review.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for “sixty days” until May 25, 2012. This process is conducted in accordance with 5 CFR 1320.10.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Ben Hayes, Chief, Law Enforcement Support Branch, National Tracing Center, 244 Needy Road, Martinsburg, WV 25405.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information collection:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, Department of Justice, Two Constitution Square, Room 2E-508, 145 N Street NE., Washington, DC 20530.
30-Day Notice of Information Collection.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
The purpose of this notice is to allow for an additional 30 days for public comment until April 25, 2012. This process is conducted in accordance with 5 CFR 1320.10.
Written comments concerning this information collection should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attn: DOJ Desk Officer. The best way to ensure your comments are
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
Each licensed firearms manufacturer or licensed importer must legibly identify each firearm by engraving, casting, stamping (impressing), or otherwise conspicuously placing on the frame or receiver an individual serial number. Also, ATF requires minimum height and depth requirements for identification markings placed on firearms.
(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: There will be an estimated 2,962 respondents who will take 5 seconds to mark the firearm.
(6) An estimate of the total burden (in hours) associated with the collection: There are an estimated 2,500 total burden hours associated with this collection.
If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, Department of Justice, Two Constitution Square, Room 2E-508, 145 N Street NE., Washington, DC 20530.
60-Day Notice of Information Collection Under Review.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for “sixty days” until May 25, 2012. This process is conducted in accordance with 5 CFR 1320.10.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact William Miller, Chief, Explosives Industry Programs Branch at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, Department of Justice, Two Constitution
On September 22, 2010, I, the then-Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Morris W. Cochran, M.D. (Respondent), of Birmingham, Alabama. The Order proposed the revocation of Respondent's DEA Certificate of Registration BC1701184, and the denial of any pending applications to renew or modify his registration, on the ground that his “continued registration is inconsistent with the public interest.” 21 U.S.C. 824(a)(4).
More specifically, the Order alleged that while Respondent is authorized to prescribe Suboxone and Subutex “for maintenance or detoxification treatment pursuant to 21 U.S.C. 823(g)(2) under DEA identification number XC1701184,” he had “prescribed methadone,” a schedule II controlled substance, “to patients for the purpose of drug addiction treatment” without the registration required under 21 U.S.C. 823(g)(1). ALJ Ex.1, at 1-2.
Next, the Order alleged that Respondent had prescribed both methadone and Suboxone, the latter being a Schedule III controlled substance, to numerous patients whose charts show that he “did not obtain a prior medical history,” that he “did not perform an initial physical exam,” that he “established little or no basis for the diagnoses,” and that he “offered no other treatment other than prescribing controlled substances.”
Based on the above, I concluded that Respondent's continued registration during the pendency of the proceeding “constitute[d] an imminent danger to the public health and safety.”
Respondent requested a hearing on the allegations and the matter was placed on the docket of the Agency's Administrative Law Judges (ALJs). On November 2-4, 2010, an ALJ conducted a hearing in Birmingham, Alabama. ALJ Decision (also ALJ), at 3.
On January 5, 2011, the ALJ issued her decision which recommended that Respondent's registration be revoked.
With respect to factors two (Respondent's experience in dispensing controlled substances) and four (Respondent's compliance with applicable laws related to controlled substances), the ALJ made extensive findings. First, the ALJ found that Respondent violated DEA regulations because he prescribed drugs other than Suboxone or Subutex on prescription forms that used only his Data Waiver (or X) number. ALJ at 43. The ALJ also found that Respondent “improperly prescribed Suboxone for substance abuse using his regular DEA registration number rather than the required “X” number.”
Next, the ALJ found that Respondent prescribed methadone for detoxification and maintenance treatment without holding the separate registration required to do so under Federal law. ALJ at 43-45. The ALJ specifically rejected Respondent's testimony that he had prescribed methadone to nine patients to treat pain (which does not require a separate registration), noting that Respondent had initially told a DEA Investigator that he was prescribing methadone for detoxification purposes, that several patients who had received methadone had told the Investigator that they were being treated for substance abuse, and that several of the patients had come to Respondent's clinic “directly after” being treated by a methadone clinic “where the prescription of methadone for pain is prohibited” and had been diagnosed by Respondent as being substance abusers.
Next, the ALJ found that Respondent violated both Federal and State regulations because his medical charts “fail[ed] to list the source and severity of pain when chronic pain [wa]s the diagnosis. ALJ at 47 (citing Ala. Admin. Code 540-X-4.08; 21 CFR 1306.04(a) and 1306.07(c)). The ALJ further found that Respondent's charts “fail[ed] to record when medical examinations were conducted and the specific results of those examinations in support of diagnoses,” and that “[i]n some instances, patients actually reported that no examination was conducted.”
The ALJ further found that Respondent had post-dated prescriptions for schedule II controlled substances in violation of Federal regulations.
With respect to factor five—such other conduct which may threaten public health or safety—the ALJ found that Respondent lacked candor. More
The ALJ then turned to Respondent's evidence as to his remedial measures. The ALJ noted that Respondent had stopped using his X number improperly (to prescribe drugs other than Suboxone and for purposes other than substance abuse treatment), that he had stopped prescribing methadone, and that at the hearing, he had “apologized for the issuance of prescriptions for controlled substances without a proper DEA registration.”
The ALJ thus concluded that Respondent had failed to rebut the Government's
Neither party filed exceptions to the ALJ's decision. Thereafter, the record was forwarded to this Office for Final Agency Action. Having considered the record as a whole, I adopt the ALJ's findings of fact and conclusions of law except as otherwise noted herein. I further adopt the ALJ's recommendation that Respondent's registration be revoked and that any pending application be denied. I make the following findings.
Respondent is a physician licensed by the Alabama State Board of Medical Examiners (hereinafter, State Board or Medical Board) and is board certified in family practice. As of the date of the hearing, Respondent's state license remains current and unrestricted. Tr. 259. The State Board, however, has an open investigation of Respondent.
Respondent is also the holder of DEA Certificate of Registration BC1701184, which prior to the issuance of the Immediate Suspension Order, authorized him to dispense controlled substances as a practitioner in schedules II through V, with the registered location of Narrows Health & Wellness, 151 Narrows Parkway, Suite 110, Birmingham, Alabama.
Respondent is also authorized to dispense Suboxone and Subutex, under the Drug Addiction Treatment Act of 2000 (DATA), for the purpose of treating opiate addicted patients and is authorized to treat up to 100 patients; Respondent has been assigned identification number XC1701184 for this purpose.
Respondent is not, however, authorized to dispense methadone, a schedule II narcotic, for the purpose of treating opiate addiction as he does not have the registration required by 21 U.S.C. 823(g)(1). GXs 1 & 2. Respondent can, however, lawfully dispense methadone for the purpose of treating pain.
Respondent first came to the attention of the authorities when several pharmacies complained to a State Board Investigator that he was prescribing large amounts of methadone using his X number. Tr. 35-36. The State Investigator passed this information on to a DEA Diversion Investigator (DI); on February 28, 2010, which was a Sunday morning, the two Investigators went to Respondent's Red Bay Clinic and arrived there at 6:30 a.m.
Respondent did not arrive at the office until shortly before 11 a.m., by which time “close to 50 people” were waiting to see him.
With respect to his chronic pain patients, Respondent told the State Investigator that he would look for surgical scars on the patient's body and that he sent some of his patients for X-Rays and MRIs.
Respondent also maintained that he knew the requirements for using his X number and that he was not prescribing any other drugs under this number.
The DI then asked Respondent how many patients he was treating under his X number.
During the visit, the DI encountered JKB in Respondent's waiting room and asked to speak with him.
Following this interview, the DI resumed his interview of Respondent. Respondent now maintained that he was prescribing methadone for pain.
Upon leaving the clinic, the Investigators observed “approximately 50 patients inside of [the] office and probably another 50 to 60 . . . in the parking lot.”
On May 17, 2010, the Investigators (along with a Supervisory DI) went to Respondent's Russellville office and obtained various patients' files through either an administrative subpoena or a warrant. Tr. 48-50, 62-63. The Investigators again interviewed Respondent who stated that he was mainly seeing pain patients.
During the interview, Respondent identified AK as a chronic pain patient who he was treating with Suboxone and who was waiting to see him.
The DI also interviewed another patient, SH, who was in the parking lot.
The DIs seized 114 patient files which were selected on the basis of pharmacy records showing that Respondent had prescribed either Suboxone or methadone to the patients.
On June 1, 2010, the DI spoke with TP. TP told him that Respondent did not physically examine her, that she paid $100.00 for the visit and that he prescribed methadone to her. Tr. 103-105; GX 5X. TP went to Respondent because she had heard that he was using methadone to treat addiction. Tr. 105.
TP saw Respondent on three occasions (Feb. 7 and 21, and Mar. 7, 2010). GX 5X. TP completed an intake form on which she listed her medications as “methadone 12 10s a day” and wrote that her pharmacy was the “methadone clinic.”
However, Respondent did not document the nature and intensity of the pain, current and past treatments for the pain, and its effect on TP's physical and psychological functioning.
Moreover, while TP indicated that she had previously gone to a methadone clinic, Respondent did not know the name of the clinic and did not even attempt to obtain her treatment records.
At each of TP's three visits, Respondent prescribed a daily dose of eleven tablets of methadone 10 mg, with the first two prescriptions being written under his X number for 154 tablets each.
When asked on cross-examination if the methadone clinic which TP had previously gone to was treating her for abusing narcotics, Respondent testified that while the only purpose of a methadone clinic is to treat “substance abuse,” she was “going for pain.”
DG first saw Respondent on January 3, 2010. GX 5O. On the intake form, DG listed his medications as “methadone.” Respondent made a diagnosis of chronic pain even though he checked “NO” for whether DG had pain and the progress note for the visit does not document the nature and intensity of the pain, whether any treatments had been previously tried, and the pain's effect on his psychological and physical function. GX 5O, at 4. While Respondent noted that he performed a physical exam, he found each of the areas of the examination to be normal.
On July 9, 2010, the lead DI interviewed DG. Tr. 106. DG stated that Respondent had told him on February 28, 2010, that he would no longer prescribe methadone, but that he would prescribe Suboxone to DG if he was having trouble getting off of the methadone.
Respondent testified that on January 19, 2010, he diagnosed DG as having a substance abuse problem, yet the medical chart does not document the basis for that diagnosis.
DG testified at the hearing. The ALJ found credible his testimony that he was also seeing the Respondent for pain in his shoulder and lower back. ALJ at 23. While DG believed this pain was a result of masonry work he had done since he was a teenager, as well as a snowboarding accident he had when he had lived in Utah, DG's chart does not reflect any of this information. Tr. 367, 374; GX 5O.
According to DG, Respondent examined him and would spend about 7 to 10 minutes with him during his visits. Tr. 370. DG also denied having told the DI that Respondent did not perform a physical exam on him and that he was seeing Respondent for substance abuse. Tr. 371.
Respondent used his X number to prescribe methadone for DG. GX 5O, at 5, 7, 9, 11. The methadone prescriptions were for lesser and lesser amounts. GX 5O, at 1. In March of 2010, Respondent proposed to offer DG an alternative medication treatment plan.
On July 20, 2010, the lead DI interviewed MB. Tr. 108; GX 5A. MB stated that she was seeing Respondent for an addiction to Lorcet and not for chronic pain, that she paid cash for her prescriptions, and that Respondent did not perform any physical examinations. Tr. 109-110. MB also commented that she thought there were too many people waiting inside and outside the office to see Respondent.
On the progress note for MB's first visit, Respondent circled “YES” for whether she had pain and diagnosed her as having chronic pain due to headaches. GX 5A, at 7. At the hearing, Respondent testified that MB was being treated for both periodic headaches and substance abuse. Respondent did not, however, further document the nature and intensity of the pain, how it affected MB's ability to function, and any prior treatments for her pain.
Respondent described his treatment of MB as tapering her down on her methadone prescriptions, and the prescriptions show that Respondent was gradually reducing her daily dosage from 150 mg to 130 mg over the course of the slightly more than two months in which he treated her.
Respondent issued MB two methadone prescriptions on his X prescription pad. Tr. 541-42; GX 5A, at 6. MB's file has no entry for her visits of February 28 and March 14, even though MB's drug log notes that a methadone prescription was issued on each date for 182 and 106 dosage units of methadone respectively. GX 5A, at 2-3.
Respondent saw JC1 three times in February and March of 2010. GX 5N. On his intake form, JC1 listed his medications as methadone and Xanax. GX 5N, at 2. On the progress note for JC1's first visit (Feb. 9), Respondent noted that he had been in an automobile accident and wrote “back” on the chart.
At JC1's next visit (Feb. 23), Respondent again indicated that he had “NO” pain and did a physical exam at which he found all areas normal.
On March 9, Respondent wrote JC1 two more prescriptions, one for another 210 tablets of methadone with the same daily dose “for pain” as before, and one for twenty-eight tablets of Valium.
Respondent testified that JC1 had been in an automobile accident and had fractured his back, that he had developed a tolerance for pain medicine and was taking more and more, and thus went to a methadone clinic. Tr. 486. Respondent further testified that JC1 had come from either the Shoal's clinic or a narcotic treatment program in Hamilton because he “wanted to take a cleaner medicine for his pain.”
As for the basis of the substance abuse diagnosis which he made at JC1's second visit, Respondent testified that “we probably got our February 9 drug screen back. And he probably had some [illicit] drug in there.”
Respondent prescribed methadone at a lower dosage amount than the dosage JC1 reported he had been on.
Respondent treated JB in February and March of 2010.
On February 28, 2010, JB again saw Respondent. Respondent circled “YES” for whether JB had pain and insomnia, and made a further notation that his pain was worse, although the precise area is illegible.
At JB's final visit (Mar. 14), Respondent noted that his “pain persists” and that he was “anxious about stopping methadone.”
Respondent testified that JB had been asked to leave a drug treatment program before he saw the Respondent. Tr. 482. Respondent testified that he had done a drug screen on JB and that he did not “see anything that bothered [him], such as cocaine * * * or marijuana at that time.”
According to Respondent, JB had been in a four-wheeler accident, took narcotics, and went to the drug treatment program because his other physician would not write anymore prescriptions for narcotics. Tr. 696. Respondent did not, however obtain JB's records from the drug treatment program and Respondent maintained that the fact that JB was being treated at a methadone clinic did not tell him that JB was being treated for opiate addiction.
Respondent also testified that he had provided JB with the option of other treatment medications, but that he elected to go to another methadone clinic. Tr. 483. Respondent annotated in the medical chart that he was treating JB for back and knee pain. GX 5L, at 5-6. Respondent did not document the severity of the pain. GX 5L. Respondent stated that his treatment of JB was appropriate. Tr. 483-84.
Respondent saw NB three times in February and March of 2010. GX 5M. At her first visit (Feb. 7), Respondent diagnosed her as having chronic pain even though he indicated that she had “NO” pain. GX 5M, at 3. Respondent did not document any further information regarding NB's condition (such as the nature and intensity of the pain, its history, whether any treatments had been previously tried, and the pain's effect on her psychological and physical functioning) at any of her three visits.
The progress note for NB's first visit indicates that Respondent performed a physical exam.
On Feb. 21, Respondent issued NB additional prescriptions for methadone and Xanax under his X number.
Respondent testified that NB told her at the initial visit that she had been on 180 mg of methadone and that “she was taking it for pain.” Tr. 484. He then testified that “she also had some anxiety” and that she was a “troubling patient” because she was “on a combination of methadone and Xanax” which caused him great concern, especially if “those two drugs get mixed with alcohol.”
Respondent also testified that he gave her “150 methadone,” which was “much less methadone than she was on,” and that he “gave her 28 tablets of the Xanax in fear of seizure potential if we went below that.”
Respondent saw KI four times in February and March of 2010. GX 5T. On the intake form, KI noted that her medications included “methadone, Xanex[sic], [and] Ambien.”
According to Respondent, KI was being treated at Shoals, a narcotic treatment facility, and she wanted out of the clinic. Tr. 494. Respondent testified that KI had back pain; however, Respondent indicated that she had “NO” pain on the progress note for her first visit. Tr. 494, GX 5T, at 3. Although Respondent wrote “Back” as the location, once again, he did not document the nature and intensity of the pain, the history of the pain, what treatments had been used, and the pain's effect on KI's physical and psychological functioning. GX 5T, at 3; Tr. 494, 718.
Respondent performed a physical examination but did not note any abnormalities; he also did not document
Respondent did not obtain treatment records from the narcotic treatment facility and did not know what substance KI was abusing; he also did not obtain any records related to her back pain. Tr. 715-16. Respondent testified that KI began taking narcotics to treat her pain, became addicted to those narcotics, but then denied that she had told him that she then entered the methadone clinic to treat her addiction.
On June 1, 2010, the DI spoke with SS by phone. Tr. 96. SS said that he was being treated for opiate addiction, that he received a Suboxone prescription from Respondent, and that he was not being treated for chronic pain. He also stated that he paid $100.00 cash directly to Respondent for his prescription and that Respondent did not conduct any examination on him. Tr. 95-98; GX 5H.
SS saw Respondent only on May 2, 2010. GX 5H, at 2-3. On the intake form, SS listed methadone as his medication and Respondent noted on the progress note that he was on 120 mg.
Respondent testified that SS was on methadone, which he was getting “off the street,” but that fact is not annotated in his chart. Tr. 672. Respondent, however, refused to prescribe methadone to SS. Instead, he prescribed Suboxone and offered SS the choice of an alternative medical treatment program for getting off of methadone.
On May 17, 2010, the DI interviewed AG.
According to her chart, Respondent diagnosed AG as having chronic pain and substance abuse as a secondary condition. GX 5P, at 3; Tr. 488-89. However, the chart does not specify the basis for this diagnosis and Respondent checked “NO” for whether AG had pain. Tr. 704; GX 5P, at 3. In addition, Respondent did not record any vital signs at this or any subsequent visit.
Respondent prescribed Suboxone to AG at both the initial and several subsequent visits. Tr. 488; GX 5P, at 1, 4, 6, 8, 9. Moreover, at subsequent visits, Respondent continued to diagnose AG as having both chronic pain and substances abuse while checking “NO” for whether she had pain.
On June 1, 2010, DI Michael Jones interviewed LM by telephone.
LM completed a form in which she listed her medications as Adderall and Oxycontin, the latter being a schedule II narcotic. Tr. 193; GX 5V, at 2. At LM's first visit, Respondent diagnosed LM as having chronic pain, substance abuse, and bipolar disorder. GX 5, at 3. While Respondent checked “YES” for whether LM had pain and listed her “back” as the location, the chart does not document the nature and intensity of the pain, current and past treatments for pain, and its effect on her physical and psychological functioning.
At subsequent visits, Respondent continued to list chronic pain as a diagnosis while checking “NO” for whether LM had pain.
LM's progress notes do not, however, indicate what substance(s) she was abusing. GX 5V, at 3 & 5. Moreover, notwithstanding his testimony that her substance abuse was based in part on her use of Adderall, Respondent prescribed this drug to LM at four of her subsequent visits.
On June 1, 2010, the DI interviewed ET by telephone. ET explained that the Respondent was treating him for an addiction to pain killers. Tr. 83-84. Respondent prescribed Suboxone to ET on an X pad on four occasions between December 2009 and March 2010; in
The first two progress notes (one of which is undated but which is above the note for January 5, 2010
On June 2, 2010, a DI spoke with CT. CT stated that Respondent was treating her for opiate addiction with Suboxone. Tr. 87-88. On the intake form, CT listed her medications as “Suboxone, methadone, and Zanex [sic].” GX 5Y, at 2.
At CT's first visit, Respondent diagnosed her as having both substance abuse and chronic pain. GX 5Y, at 3. However, Respondent did not indicate in the chart what substance she was abusing.
In his testimony, Respondent admitted that he did not know what substance(s) CT was abusing, but added that “usually they're on multiple medicines to get whatever desired effect they want.” Tr. 729-30. Respondent did not obtain any prior treatment records for CT, whether for pain or substance abuse.
Respondent wrote CT prescriptions for Suboxone on a pad which contained only his X number, as well as on a pad which contained both his X number and his regular DEA registration number. GX 5Y, at 4, 6. Respondent believed his treatment of CT was within the standard of care. Tr. 502.
On June 2, 2010, the lead DI spoke with JH. JH stated that Respondent was treating him for “a bad addiction to Oxycontin” with Suboxone and that he was not being treated for chronic pain. Tr. 89-90; GX 5R. JH listed his medications as “OXY 80 mg x4.” GX 5R, at 9. According to Respondent, JH was taking “four [Oxycontin] a day for his pain,” which he was getting off the street because “his doctors fired him.” Tr. 710.
At JH's first visit, Respondent diagnosed him as having substance abuse, attention deficit disorder and chronic pain. GX 5R, at 10. While in his testimony, Respondent maintained that JH had told him that he needed OxyContin “to get by with his pain,” on JH's chart, Respondent indicated that JH had “NO” pain and did not document a cause of the pain.
Respondent obtained a printout of JH's prescriptions from the State's prescription monitoring program.
On June 2, 2010, the lead DI spoke with KP. KP stated that Respondent was prescribing Suboxone to treat her opiate addiction and that she was not being treated for chronic pain. Tr. 92-94. While Respondent testified that KP was on a narcotic which she wanted off of, KP did not list any medications she was on. GX 5W, at 2. Moreover, Respondent did not document the name of the narcotic in KP's record. Tr. 499.
Respondent testified that KP had “a complaint of pain.”
Respondent did not make a diagnosis of substance abuse until her third visit (Jan. 19, 2010); however, none of the progress notes for KP's subsequent visits list a diagnosis of substance abuse.
KP stated that she had to pay cash for her prescriptions as Respondent would not file a claim with Medicare for her. Tr. 94. She also stated that the Respondent did not perform any medical examinations on her, although Respondent indicated on the progress notes that he had done so and noted that the various parts of the examinations were normal (by either checking or lining through them). Tr. 95,
Respondent prescribed Suboxone and Xanax for KP on an X prescription pad.
On June 10, 2010, the lead DI spoke with TB. TB stated that Respondent was prescribing Suboxone to him for both pain and addiction. Tr. 98-99; GX 5B. TB wrote on the intake sheet that he had used Suboxone, but Respondent did not know who prescribed it, and he commented that he could not tell from TB's chart if the Suboxone had been prescribed for substance abuse. GX 5B, at 1; Tr. 580-81.
At the first visit (Dec. 20, 2009), Respondent diagnosed TB as having chronic pain and substance abuse. Tr.
The chart indicates that Respondent performed an examination at which all areas including TB's back were found to be normal. GX 5B, at 6. However, no vital signs were recorded.
Respondent also saw TB on January 19, February 16,
SW's chart indicates that he was being treated for chronic pain and substance abuse. While the chart for SW's first visit indicates that he was on Oxy 160 mg, Respondent checked “NO” for whether SW had pain and did not document the cause or severity of SW's pain. GX 5J at 3, 5. Respondent did not identify a potential source of SW's pain until his third and final visit, when he noted that SW had a herniated disc in his back and had undergone surgery.
SW testified at the hearing and the ALJ found credible his testimony that he had a herniated disc in his back, that he had been taking Oxycontin for the pain, and that he had begun treatment with the Respondent in order to get a different pain medication. Tr. 346. The ALJ also found credible SW's testimony that he told a DI that Respondent was treating him for chronic pain and that the Respondent had performed a physical examination on him.
Respondent did not know who had prescribed Oxycontin to SW, and SW's chart does not contain any prior medical records. Tr. 684-85; GX 5J. SW testified that he was addicted to his pain medications. Tr. 355. Respondent spent 15 to 20 minutes with SW and prescribed Suboxone to him.
SW saw Respondent three times.
CL first saw Respondent on December 20, 2009.
Respondent saw CL again on January 17, 2010.
Respondent provided CL with prescriptions for Suboxone on February 14, March 14, April 10, and May 9, 2010.
The earliest progress note for CP is dated December 20, 2009, which also corresponds with the earliest date listed on the record of CP's Suboxone prescriptions. GX 23, at 5, 10. The progress note indicates a diagnosis of chronic pain, even though Respondent checked that CP had “NO” pain and contains no other documentation (such as the nature and intensity of the pain, its history, and its effect on CP's functioning) to support this diagnosis.
At the next visit, Respondent again noted that CP had chronic pain while indicating that he had “NO” pain.
At CP's next visit (Feb. 16), Respondent again diagnosed him as having chronic pain while noting that he had “NO” pain.
Respondent issued CP prescriptions for Suboxone on Dec. 20, 2009, Jan. 17, Feb. 16, Mar. 16, April 10, and May 9, 2010; he also wrote CP prescriptions for Xanax on each of these dates except for April 10. GX 23. Respondent wrote both the Suboxone and Xanax prescriptions on Dec. 20, 2009, as well as the Jan. 17, Feb. 16, and March 16, under his X number.
On June 23, 2010, another DI interviewed CML and asked whether she was “being treated for pain or addiction.” Tr. 266-67. CML stated that she was being treated for addiction to controlled substances and that the Respondent was prescribing Suboxone to her.
On the progress note for CML's first visit (Dec. 8, 2009), Respondent checked that she had both pain and chronic pain, as well as insomnia. GX 5F, at 7. While Respondent noted that her physical exam was normal in all areas, he did not record any vital signs and did not document the nature and intensity of the pain, the history of the pain, whether any treatments had been previously tried, and the pain's effect on her psychological and physical function at any of her subsequent visits.
Indeed, several of the progress notes for CML's visits contain no medical information whatsoever. With respect to this, Respondent testified, “In fact, there's some entries I didn't even put in on February and March of 2010 and I don't know why that's the case.” Tr. 472.
At CML's second visit, Respondent noted a diagnosis of substance abuse. GX 5F, at 7. However, Respondent did not note this diagnosis at any of CML's subsequent visits.
Respondent admitted that the chart fails to adequately document CML's pain. Tr. 472. Respondent also testified that he was tapering CML's dosages of Suboxone to find the appropriate levels to treat her chronic pain.
On December 29, 2009, SJW made her initial visit to Respondent.
Respondent did, however, prescribe Suboxone (and Xanax) to SJW at her second visit, which occurred one week later.
While SJW's chart shows that she received prescriptions for Suboxone (and Xanax) in February and March, the progress notes for this period contain no information regarding her medical condition(s).
On May 9, 2010, SJW made her final visit to Respondent. GX 5I, at 3. At this visit, Respondent again diagnosed her as having chronic pain while indicating that she had “NO” pain and that her physical examination was normal in all areas.
On June 23, 2010, a DI phoned SJW and interviewed her. SJW told the DI that Respondent was treating her for her addiction to controlled substances and that she paid $100 cash for each visit. Tr. 268-69. On two occasions (Jan. 5 and Feb. 2), Respondent prescribed both Suboxone and Xanax to SJW under his X number. Tr. 269; GX 5I, at 6, 8. Respondent testified that he was treating SJW for pain and anxiety. Tr. 477, 679.
As for how he made his diagnosis of substance abuse, Respondent testified that “[i]t could be in her history with me; it could be a drug screen.”
On her intake form, LMJ listed her medications as “Loricets” [sic]. GX 5E. At her first visit (Feb. 16, 2010), Respondent made diagnoses of both chronic pain and substance abuse.
On June 24, 2010, a DI interviewed LMJ by phone. Tr. 270. The DI asked LMJ whether she was seeing Respondent for pain or for addiction to controlled substances; LMJ said that she was seeing Respondent for addiction for which he was prescribing Suboxone.
The ALJ found that Respondent credibly testified that he did not “have a good grasp on her history and physical as to, is this chronic pain or substance abuse, so we put the differential as both of these right now.”
MR first saw Respondent on December 15, 2009. GX 5G, at 7. Respondent diagnosed MR as having chronic pain even though he noted that MR had “NO” pain.
On both the January 17 and March 30 progress notes, Respondent also listed a diagnosis of substance abuse.
When asked whether MR's tooth pain “was no longer an issue in the subsequent visits”; Respondent maintained that “I just didn't enter it.”
On June 24, 2010, a DI phoned MR and interviewed him.
SHY first saw Respondent on December 13, 2009. GX 5D, at 8. On the intake form, SHY listed his medications as Suboxone and Zyprexa.
At SHY's subsequent visits, Respondent continued to document that SHY had chronic pain even though he repeatedly noted that he had “NO” pain, never found anything that was not normal during the physical exams, and never listed a location of any pain.
On June 22, 2010, a DI called SHY, and asked him why he was seeing Respondent. Tr. 288. SHY said that he was being treated for opiate addiction and that he was not being treated for chronic pain.
At the hearing, Respondent testified that he thought SHY was probably abusing either Lorcet or Oxycontin.
Respondent treated JC2 for chronic pain, substance abuse, attention deficit disorder, and extreme anxiety. Tr. 458; GX 5C. Respondent acknowledged that JC2 was “a tough patient,” who had been “fired” by other doctors and had abused Xanax. Tr. 458-60. A note in JC2's chart dated “9-1-09” indicates that a friend of JC2 had stated that he was taking twelve Xanax pills at a time. GX 5C, at 3.
Respondent noted in the chart that JC2 was abusing Xanax and “MUST STOP XANAX.”
The ALJ found that Respondent credibly testified that he could not just cease prescribing Xanax to JC2 because he could have seizures.
Respondent testified that he prescribed Suboxone to treat JC2's substance abuse and that substance abuse was JC2's primary diagnosis.
Respondent also testified that JC2 had been in a narcotic treatment program in 2007 or 2008 and had left against medical advice.
DA saw Respondent three times: in December 2009, and in January and February of 2010. GX 5K. According to the progress note for the first visit, Respondent diagnosed DA with chronic pain and anxiety.
On June 1, 2010, the lead DI interviewed DA by phone. Tr. 85. DA told the DI that he was addicted to pain killers and that Respondent was treating him for this condition and not for chronic pain.
Respondent saw AH four times beginning on December 13, 2009, and ending on March 28, 2010. GX 5S. Respondent noted that AH was taking 12 Lortab 10 mg a day, which she was getting “from doctors, friends, [and] off the street.” Tr. 493. Respondent diagnosed AH with both substance abuse and chronic pain as a secondary diagnosis. GX 5S, at 3. While Respondent noted “YES” for whether AH had pain, he did not document the nature, intensity and location of the pain; the history of the pain; what treatments had been used; and the pain's effect on her physical and psychological functioning.
At AH's second visit (Feb. 1), Respondent noted that she had “NO” pain and did not make any other findings about her pain; he also indicated that she did not demonstrate withdrawal, that she was not agitated or moody and did not have insomnia or a positive MDQ. GX 5S, at 7. Respondent did not note any abnormalities in the physical exam and did not document having taken AH's vital signs.
On Feb. 28, Respondent issued AH a third prescription for Suboxone, again using his X number.
On March 28, AH again saw Respondent.
Respondent testified that AH had some neck and back pain, but “appeared to be functional.” Tr. 493. He was also “not convinced that [he] could not add the substance abuse potential to her.”
NK saw Respondent three times during February and March 2010. GX 5U. On the intake form, NK listed his medications as Suboxone and Xanax.
On March 9, Respondent issued NK a second prescription for Suboxone, and on March 21, he issued NK prescriptions for both Suboxone and Xanax.
On May 25, 2010, the lead DI interviewed NK. Tr. 78. NK stated that Respondent was treating him for opiate addiction, and not for any other medical problem including chronic pain.
On September 27, 2010, Respondent was personally served with the Order to Show Cause and Immediate Suspension of Registration. At that time, the lead DI explained to Respondent that, as of that date, he was no longer authorized to prescribe or handle any controlled substances. Tr. 112-13. Respondent told the DI that “he was not going to abide by this order and that (the DI) didn't have the authority to tell him that he couldn't prescribe any controlled substances.”
Thereafter, the lead DI discovered that Respondent had issued controlled-substance prescriptions which were dated September 29, October 3 and October 4, 2010. Tr. 114; GX 6. While the ALJ found that there were a total of four post-suspension prescriptions, two of the prescription forms contained prescriptions for two controlled substances. ALJ at 34;
The first prescription, which was issued to CW and dated September 29, 2010, was for the drug Adderall, a schedule II controlled substance. GX 6, at 1. CW told the lead DI that Respondent wrote the prescription after she had been seen by Respondent's Physician's Assistant, CC. CW picked up the prescription the next day, September 30. Tr. 115-118; GX 6, at 1. Respondent admitted to signing this prescription. Tr. 506-07;
The second prescription, which was issued to JB and dated October 3, 2010, was also for Adderall. Tr. 118-19, 200-01; GX 6, at 2. However, the evidence showed that Respondent had issued the prescription on September 3, 2010. Tr. 119-20, 508, 733-34. This prescription did not, however, include Respondent's registration number and listed only his X number. GX 6, at 2.
The lead DI contacted the pharmacist who filled the prescription, and was told that the pharmacy would not accept a post-dated prescription for a scheduled drug. Tr. 123. The pharmacist remembered this prescription and further stated that it had actually been presented for filling on October 3, 2010. Tr. 123-24, 158-59. The lead DI testified that while it would have been permissible to write a prescription and sign it on September 3, 2010, with the annotation of “do not fill until October 3, 2010,” it was not permissible for Respondent to sign a schedule II prescription on September 3 but date the prescription for October 3rd. Tr. 124.
The evidence also included two prescriptions issued (on a single prescription form) to MK and dated October 4, 2010; the prescriptions were for 60 Adderall and 90 Lortab 10 mg, another schedule III narcotic. GX 6, at 3. The lead DI contacted MK about the prescriptions; MK confirmed that the prescriptions were written and received on October 4, 2010. Tr. 124-25. While Respondent testified that the prescriptions had been post-dated, he admitted to having written the prescriptions on September 29, two days after he was served with the Immediate Suspension Order. Tr. 508-09; 740-41. Respondent maintained that the prescription was given to MK by mistake.
The evidence also included two prescriptions which were issued to DH and also dated October 4, 2010. GX 6, at 4. The prescriptions were for 90 Lortab 10 mg and 90 Xanax 1 mg. Tr. 126, 509; GX 6, at 4.
Respondent testified that he thought that he had seen DH in September but that he did not know “exactly which day I saw him.” Tr. 509. Respondent admitted, however, that the prescription was in his handwriting and that he “signed it.” Continuing, he maintained that he did not have an explanation for it, that “[t]his was an accident,” and that he “would never do anything to violate an order.”
According to DH's patient file, DH saw Respondent on September 29, 2010.
Respondent maintained that some of the patients did not know what they were being treated for. Tr. 743-44. However, Respondent did not document any patient's lack of understanding of his diagnosis in the patient files. Tr. 745. Moreover, the ALJ did not find this testimony credible. ALJ at 49.
As noted above, Respondent provided evidence that he had stopped prescribing methadone to his patients. Moreover, Respondent established that he had stopped using his X number to write prescriptions for drugs other than Suboxone and when prescribing Suboxone to treat pain. However, on September 3, 2010, Respondent wrote a further controlled substance prescription for Adderall (which was post-dated) under his X number. GX 6, at 2.
Respondent also testified that he maintained the drugs screens he ordered on his patients in a separate file which he called the “Drug Screen Book.” Tr. 687. Respondent testified that when the
Respondent agreed that his patient charts were incomplete. Tr. 452. In one case Respondent testified that his record keeping was incorrect and he had mistakenly written the wrong primary diagnosis for the patient.
Section 304(a) of the Controlled Substances Act provides that a “registration pursuant to section 823 of this title to * * * dispense a controlled substance * * * may be suspended or revoked by the Attorney General upon a finding that the registrant * * * has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a)(4). In determining the public interest, Congress directed that the following factors be considered:
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
21 U.S.C. 823(f). In addition, pursuant to 21 U.S.C. 824(d), “[t]he Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to public health or safety.”
The public interest factors are considered in the disjunctive.
The Government has “the burden of proving that the requirements for * * * revocation or suspension pursuant to section 304(a) * * * are satisfied.” 21 CFR 1301.44(e);
Having considered all of the factors, I conclude that the Government's evidence pertinent to factors two (Respondent's experience in dispensing controlled substances) and four (Respondent's compliance with applicable laws related to controlled substances), establishes that Respondent has committed acts which render his registration “inconsistent with the public interest.” 21 U.S.C. 824(a)(4). I further conclude that Respondent has not rebutted the Government's
The record establishes that the State Board has an open investigation of Respondent. However, the Board has not made a recommendation in this matter, and it is undisputed that Respondent's medical license remains active and unrestricted. Accordingly, this factor does not support a finding either for, or against, the continuation of Respondent's registration.
There is also no evidence in the record that Respondent has been convicted of an offense related to the manufacture, distribution or dispensing of controlled substances. While this factor supports the continuation of Respondent's registration, DEA has long held that this factor is not dispositive.
The record establishes that Respondent violated numerous provisions of Federal law and DEA regulations. These include: (1) The prescribing of methadone for substance abuse treatment without being registered to do so under 21 U.S.C. 823(g)(1), in violation of 21 U.S.C. 841(a)(1); (2) the prescribing of methadone for substance abuse treatment, in violation of 21 CFR 1306.04(c) and 1306.07; (3) prescribing controlled substances without a legitimate medical purpose, in violation of 21 CFR 1306.04(a); (4) the post-dating of prescriptions, in violation of 21 CFR 1306.05(a); and (5) prescribing controlled substances when his registration had been suspended, in violation of 21 U.S.C. 843(a)(2).
Under 21 U.S.C. 823(g)(1), “practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment shall obtain annually a separate registration [from their practitioner's registration] for that purpose.”
Methadone is, however, a schedule II narcotic, and thus, except for where a patient presents with acute withdrawal symptoms (and then for no more than a total of three days), cannot be lawfully dispensed for the purpose of maintenance or detoxification treatment absent the practitioner's holding a registration under section 823(g)(1).
Also relevant here is the definition of the term “maintenance treatment.” 21 U.S.C. 802(29). Under the CSA, the term “means the dispensing, for a period in excess of twenty-one days, of a narcotic drug in the treatment of an individual for dependence upon heroin or other morphine-like drugs.”
Finally, Respondent claimed that most of the patients whose files were introduced into evidence (including some of the methadone patients) were chronic pain patients. Under a longstanding DEA regulation, to be effective, “[a] prescription for a controlled substance * * * must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). As the Supreme Court has explained, “the prescription requirement * * * ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.”
Under the CSA, it is fundamental that a practitioner must establish and maintain a bonafide doctor-patient relationship in order to act “in the usual course of * * * professional practice” and to issue a prescription for a “legitimate medical purpose.”
By regulation, the Alabama Board of Medical Examiners has adopted
A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.
The Guidelines also provide that:
The physician should keep accurate and complete records to include
1. The medical history and physical examination;
2. Diagnostic, therapeutic and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. Discussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage and quantity prescribed);
8. Instructions and agreements;
9. Periodic reviews.
The record contains substantial evidence that Respondent prescribed methadone to opiate addicted patients for the purpose of providing maintenance treatment. During his initial interview (on Feb. 28, 2010) with the Investigators, Respondent told them that “he was operating a detox clinic where he was using methadone to get his patients onto Suboxone.” Tr. 43. It was not until later that day, when the Investigators interviewed Respondent for the second time, that he claimed that he prescribed methadone for pain and that he had previously misspoken.
Other evidence supports the conclusion that Respondent was prescribing methadone to provide maintenance or detoxification treatment to opiate addicted patients. On the date of the visit, Investigators interviewed JKB, who told them that he was being treated by Respondent with methadone for opiate addiction.
The Government introduced into evidence seven files of patients who received methadone prescriptions from Respondent. GXs 5X; 5O; 5A; 5N; 5L; 5M; and 5T. The Government also elicited the testimony of the DIs to the effect that they had interviewed several of the patients to determine what condition they were being treated for.
Patient TP related that she had gone to Respondent because she had heard that he was using methadone to treat addiction; TP also noted on her intake form that she had previously gone to a methadone clinic and was taking twelve tablets of methadone 10 mg strength a day. Respondent issued her prescriptions for methadone on three separate dates over the course of a month, and ultimately TP returned to a methadone clinic.
While Respondent maintained that TP had been going to the methadone clinic for pain, he conceded that the purpose of a methadone clinic is to treat addiction. Moreover, while Respondent noted diagnoses of both chronic pain and substance abuse on TP's progress
I thus conclude that Respondent prescribed methadone to TP for maintenance or detoxification purposes and not to treat chronic pain. In doing so, he violated the CSA because he did not have the registration required under section 823(g)(1) to dispense methadone for this purpose; he also violated DEA regulations which prohibit the prescribing of narcotic drugs for this purpose except for those drugs in schedules III through V which have been specifically approved by the FDA to provide maintenance or detoxification treatment. 21 CFR 1306.04(c).
The DIs also interviewed MB, who stated that she was being treated by Respondent for an addiction to Lorcet and not for chronic pain. Respondent testified, however, that he was treating MB both for chronic pain cause by headaches and substance abuse. Respondent prescribed methadone to her on six different dates.
Notably, the Government did not produce any evidence corroborating MB's statement that she was not being treated for chronic pain.
Notably, Respondent did not document the nature and intensity of her pain, its effect on both her physical and psychological function, any prior or current treatment for it, and her history of substance abuse.
Respondent issued three methadone prescriptions (on Feb. 9, 23, and Mar. 9) to JC1 (GX 5N), each of which was for 210 tablets with a daily dose of 150 mg. Respondent admitted that JC1 had come from another methadone clinic even though he denied that JC1 had gone to the clinic to be treated for addiction and maintained that he had gone there for pain management. Moreover, while Respondent also maintained that JC1 had come to him because “he wanted to take a cleaner medicine for his pain,” when Respondent stopped writing methadone prescriptions, JC1 decided to go to another treatment facility.
In addition, notwithstanding Respondent's claim that he was treating JC1 for pain, at his first two visits (and at which Respondent prescribed methadone), Respondent noted that JC1 had “NO” pain; and at the third visit, where he issued a further methadone prescription, Respondent did not even make a progress note. Respondent also failed to document any of the findings set forth in Alabama's Guideline 2(a). Accordingly, I conclude that Respondent prescribed methadone to JC1 for maintenance/detoxification purposes without the required registration and violated DEA regulations which prohibit the prescribing of schedule II narcotics for this purpose. 21 U.S.C. 823(g)(1); 21 CFR 1306.04(c).
JB also came to Respondent from a narcotic treatment program, which he had been kicked out of. Respondent noted this in the chart and that JB “desire[d] to get off methadone.” Respondent asserted that the fact that JB had been treated at a methadone clinic did not mean that the clinic was treating him for addiction, even though that is the purpose of a methadone clinic; moreover, he admitted that he did not obtain JB's records from the clinic. After Respondent stopped prescribing methadone to JB, the latter went to another methadone clinic.
While Respondent documented that JB had foot and knee pain, and the progress notes include a few additional statements regarding his pain such as the location and that JB had been in an accident, the notes do not document the nature and intensity of pain, any prior treatments for it, and its effect on JB's functioning. Moreover, Respondent noted that he planned to put JB on his alternative medication program. Given JB's prior history of substance abuse treatment and his express “desire to get off methadone,” I conclude that Respondent's primary purpose in prescribing methadone to him (which he did on three occasions over a month) was to provide maintenance/detoxification treatment. I thus conclude that Respondent violated the CSA and DEA regulations in doing so. 21 U.S.C. 823(g)(1); 21 CFR 1306.04(c).
Respondent testified that NB told him at the initial visit that she had been on 180 mg of methadone which she was taking for pain. He also testified that she was a “troubling patient” because she was on both methadone and Xanax and that this was a great concern, especially if she mixed the drugs with alcohol. Respondent diagnosed NB as having chronic pain even though he noted on her chart that she had “NO” pain, and he did not document any further findings to support a diagnosis of chronic pain. Moreover, notwithstanding his express concern that NB was on both methadone and Xanax, Respondent prescribed Xanax to her and did not document that she had anxiety, although he maintained in his testimony that she “had some anxiety.”
The evidence is insufficient to support the conclusion that NB sought treatment from Respondent for a substance abuse problem. However, the evidence does support the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing methadone to her. 21 CFR 1306.04(a). Having noted on NB's chart that she had “NO” pain, and having failed to document any further findings as required by the Guidelines to support his chronic pain diagnosis (and to explain the inconsistency between his diagnosis and his notation that she had no pain), it is clear that Respondent lacked a legitimate medical purpose in prescribing methadone to her.
KI noted on her intake form that she was using three controlled substances: methadone, Xanax and Ambien. Respondent also acknowledged that KI had previously been treated at a narcotic treatment facility and that she had taken narcotics and become addicted to them. However, he denied that KI had told her that she had gone to the methadone clinic to treat her addiction—as if there was any other reason a person would seek treatment from a methadone clinic. While Respondent maintained that KI had diagnoses of both substance abuse and chronic pain, on the progress note for her initial visit, he noted that she had “NO” pain although he wrote “Back” as the location. Respondent did not document any findings that would explain the inconsistency between his diagnosis and his having noted that KI had “NO” pain; he also did not document the history of any pain, what
Respondent issued three methadone prescriptions to KI. I conclude that Respondent's purpose in doing so was not to treat pain, but to provide maintenance/detoxification treatment to her. I thus conclude that Respondent violated Federal law by prescribing methadone to KI for maintenance/detoxification treatment without the required registration and violated DEA regulations which prohibit the prescribing of schedule II narcotics for this purpose. 21 U.S.C. 823(g)(1); 21 CFR 1306.04(c).
As found above, Respondent also prescribed Suboxone, a schedule III controlled substance, to numerous patients. The Government elicited the testimony of the DIs as to phone interviews they conducted with sixteen of these patients, the majority of whom said that Respondent was treating them for substance abuse and not chronic pain.
As found above, Respondent testified that many of these patients were actually being treated for chronic pain in addition to substance abuse, or were just being treated for chronic pain. Moreover, Respondent frequently noted both diagnoses on the patient's charts, although in some instances he did not note a substance abuse diagnosis until after the first visit (and sometimes not until after several visits).
However, even if it is the case that most of the Suboxone patients were being treated only for substance abuse, the Government did not offer any evidence (whether in the form of clinical standards or expert testimony) establishing what the appropriate course of professional practice requires of a physician treating patients for substance abuse.
Respondent, however, testified that many of the Suboxone patients were actually being treated for chronic pain, and he noted this as his primary diagnosis in many of their charts. As explained above, the Alabama Guidelines require that a physician who prescribes controlled substances to treat pain, obtain “[a] complete medical history” and document this in the patient's medical record. Moreover, the Guidelines state that the record “should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse.” Ala. Admin. Code r. 540-X-4-.08(2)(A).
As found above, at the initial visits of nine of the Suboxone patients, Respondent diagnosed them as having chronic pain but not substance abuse.
Tellingly, in the charts, Respondent frequently noted that the patients had “NO” pain, yet nonetheless diagnosed them as having chronic pain.
The Government further argues, and the ALJ agreed, that Respondent violated 21 CFR 1306.07(c), because his “charts failed to show the use of any treatment options besides the prescribing of controlled substances.” ALJ at 47. The ALJ further explained that “[s]uch lack of attempts of alternative modalities prior to determining that the patient suffers from chronic pain violates” this regulation.
Both the Government and the ALJ clearly misread the regulation. This provision, which is part of the regulation setting forth the requirements for dispensing narcotic controlled substances “to a narcotic dependant[sic] person for the purpose of maintenance or detoxification treatment” states:
This section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none had been found after reasonable efforts.
The Government's and the ALJ's construction of this regulation as imposing—by implication no less—an affirmative obligation for a physician to engage in alternative treatment modalities cannot be squared with the purpose of the CSA, which “manifests no intent to regulate the practice of medicine generally,” an authority which remains vested in the States.
The ALJ found that “[t]he parties do not dispute that Respondent improperly used his `X' prescription registration to prescribe controlled and non-controlled substances other than Suboxone or Subutex.” ALJ at 43. The problem with the ALJ's reasoning is that an X number is not a registration at all, but only an identification number.
As the statute states: “Upon receiving a notification under subparagraph (B) [of a practitioner's intent to prescribe narcotic drugs in schedules III through V for maintenance or detoxification treatment], the Attorney General shall assign the practitioner involved
Moreover, under DEA's regulations,
[a]ll prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address and
21 CFR 1306.05(a).
As found above, Respondent issued numerous controlled substance prescriptions (for both Suboxone and other drugs) on forms that listed only his X number. The Suboxone prescriptions issued in this manner violated DEA's regulation because Respondent was required to include both his X number and his practitioner's registration number on them.
The ALJ also concluded that “Respondent improperly prescribe Suboxone for substance abuse using his regular DEA registration number rather than the required X number.” ALJ at 43. Apparently, this was because Respondent eventually started listing both numbers on his prescription blanks. However, as set forth above, DEA's regulation expressly requires that a practitioner include both his registration number and his X number when issuing a prescription for Suboxone for maintenance or detoxification treatment under the authority of 21 CFR 1301.28.
Moreover, while a “practitioner must include the identification number * * * on all prescriptions when prescribing narcotic drugs” for the purpose of providing maintenance or detoxification treatment,
The evidence also shows that Respondent violated the Immediate Suspension Order by issuing multiple prescriptions after he was served with the Order. Under 21 U.S.C. 843(a)(2), it is “unlawful for any person knowingly or intentionally * * * to use in the course of the distribution[] or dispensing of a controlled substance, a registration number which is * * * suspended[.]”
The evidence clearly shows that Respondent was personally served with the Immediate Suspension Order on September 27, 2010, at which time he told the Investigator that “he was not going to abide by this order and that [the DI] didn't have the authority to tell him that he couldn't prescribe any controlled substances.” Tr. 113. True to his word, two days later, however, he issued prescriptions to CW for Adderall, to MK for Adderall and Lortab, and to DH for Lortab and Xanax. Respondent's explanation that these prescriptions were just mistakes or accidents is totally unpersuasive.
The prescriptions to MK and DH, as well as a further Adderall prescription which was issued to JB, were unlawful for the further reason that they were post-dated. As set forth above, under 21 CFR 1306.05(a), “[a]ll prescriptions for controlled substances shall be dated as of, and signed on, the day when issued.” Respondent admitted that on September 3, 2010, he issued CW a prescription for Adderall, a schedule II controlled substance which he dated October 3, 2010. Moreover, both Respondent's testimony and documentary evidence establish that Respondent wrote the prescription to MK and DH on September 29, while post-dating them to October 4. Accordingly, I also find that Respondent violated DEA regulations in writing these prescriptions.
I further find that Respondent lacked a legitimate medical purpose in prescribing Xanax to JC2. The evidence shows that Respondent knew that JC2 was abusing Xanax and that he had been jailed for distribution. While Respondent testified that he could not simply stop prescribing the drug to JC2 because JC2 could have seizures, and that he planned to taper JC2 off the drug, Respondent actually increased the daily dose of JC2's Xanax prescriptions. Given the inconsistency between the medical justification Respondent offered for his continuing to prescribe Xanax to JC2 and the actual prescriptions he issued, I conclude that Respondent lacked a legitimate medical purpose and acted outside the usual course of professional practice in prescribing Xanax to JC2. 21 CFR 1306.04(a).
The record thus establishes that Respondent's experience in dispensing controlled substances (factor two) and his record of compliance with applicable laws related to controlled substances (factor four) is characterized by his multiple violations of Federal law. These include his prescribing of methadone for maintenance or detoxification purposes without being registered to do so and in violation of DEA regulations prohibiting the prescribing of methadone for this
While I agree with the ALJ that Respondent lacked candor, and appreciate that she personally observed his testimony, I do so based on different evidence. First, during the initial interview on Feb. 28, 2010, Respondent told the investigators that he was operating a detox clinic and was using methadone to transfer his patients to Suboxone. Tr. 43. Yet later that day, he claimed that he was prescribing methadone only for pain and had previously misspoken.
Under Agency precedent, where, as here, the Government has made out a
The ALJ found, and the record supports the conclusion, that Respondent eventually ceased prescribing methadone for maintenance and detoxification purposes. ALJ at 49-50. The record generally supports the conclusion that Respondent stopped writing controlled substance prescriptions which did not include his registration number, as required by DEA regulations. However, as found above, in September 2010, Respondent issued a further Adderall prescription to JB and did not include his registration number.
The ALJ further noted that Respondent expressed remorse for some of his wrongdoing. ALJ at 50. However, while Respondent maintained that he had mistakenly issued the post-suspension prescriptions, and “would never do anything to violate an order,” Tr. 509, his testimony is belied by the evidence that upon being served with the Immediate Suspension Order, he stated his intention not to comply with it. Indeed, his testimony is patently disingenuous, given that he wrote the prescriptions only two days after he was served with the Order. In short, Respondent's conduct manifests a deliberate and egregious disregard for his obligations as a DEA registrant.
Finally, while the ALJ noted that “Respondent testified passionately about the prevalence of narcotic abuse in Red Bay and his want to eliminate it,” she further concluded that he “likely facilitated some of that abuse.”
Accordingly, I hold that Respondent has not rebutted the Government's
Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 824(a)(4), as well as by 28 CFR 0.100(b) & 0.104, I order that DEA Certificate of Registration, BC1701184, and Identification Number XC1701184, issued to Morris W. Cochran, M.D., be, and they hereby are, revoked. I further order that any application for renewal or modification of such registration be, and it hereby is, denied. This Order is effective immediately.
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• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
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60-day Notice of Information Collection Under Review.
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for “sixty days” until May 25, 2012. This process is conducted in accordance with 5 CFR 1320.10.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Lynn Langton, Statistician, Bureau of Justice Statistics, Office of Justice Programs, Department of Justice, 810 7th Street NW., Washington, DC 20531, or facsimile (202) 616-1351.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information:
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If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 2E-508, Washington, DC 20530.
By application dated February 29, 2012, a company official requested administrative reconsideration of the negative determination regarding workers' eligibility to apply for Trade Adjustment Assistance (TAA) applicable to workers and former workers of Roseburg Forest Products, Composite Panels Division, Missoula, Montana (subject facility). The Notice of Determination was issued on February 2, 2012 and published in the
The workers engage in activities related to the production of particleboard. The initial determination was based on the findings that worker separations were not attributable to increased imports by the subject firm or its declining customers of articles like or directly competitive with particleboard or a shift/acquisition of these articles to/from a foreign country by the workers' firm.
In the request for reconsideration, the petitioner supplied additional information regarding possible import competition.
The Department of Labor has carefully reviewed the request for reconsideration and the existing record, and has determined that the Department will conduct further investigation to determine if the workers meet the eligibility requirements to apply for TAA.
After careful review of the application, I conclude that the claim is of sufficient weight to justify reconsideration of the U.S. Department of Labor's prior decision. The application is, therefore, granted.
In accordance with Section 223 of the Trade Act of 1974, as amended (“Act”), (19 U.S.C. 2273), the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on February 3, 2012, applicable to workers of Lexis Nexis, Quality & Metrics Division, Miamisburg, Ohio. The workers are engaged in
At the request of a company official, the Department reviewed the certification for workers of the subject firm. New information shows that worker separations occurred within Lexis Nexis, Quality & Metrics Department in states other than Ohio, including but not limited to Colorado, and within the State of Ohio, including but not limited to Miamisburg.
These employees provide various activities related to the supply of quality and metric services. The acquisition of these services from Manila, Philippines contributed importantly to worker separations at these locations of the subject firm.
Based on these findings, the Department is amending this certification to include workers of Lexis Nexis, Quality & Metrics Department located throughout the United States who report to the Miamisburg, Ohio facility (TA-W-80,502) and to include workers of Lexis Nexis, Quality & Metrics Department located throughout the United States who report to the Colorado Springs, Colorado facility (TA-W-80,502A).
The intent of the Department's certification is to include all workers of the subject firm who were adversely affected by the acquisition of quality and metric services from Manila, Philippines.
The amended notice applicable to TA-W-80,502 is hereby issued as follows:
All workers of Lexis Nexis, Quality & Metrics Department, including employees throughout the United States who report to, Miamisburg, OH (TA-W-80,502) and Lexis Nexis, Quality & Metrics Department, including employees throughout the United States who report to, Colorado Springs, CO (TA-W-80,502), who became totally or partially separated from employment on or after October 6, 2010, through February 3, 2014, and all workers in the group threatened with total or partial separation from employment on the date of certification through two years from the date of certification, are eligible to apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, as amended.
In accordance with Section 223 of the Trade Act of 1974, as amended (“Act”), 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on February 3, 2012, applicable to workers of Cinram Distribution, LLC, a subsidiary of Cinram International Income Fund, including on-site leased workers from Good People, Aurora, Illinois. The workers are engaged in the supply of optical media distribution services. The notice was published in the
At the request of Illinois State, the Department reviewed the certification for workers of the subject firm. New information shows that workers leased from Good People employed on-site at the Aurora, Illinois location of Cinram Distribution, LLC, a subsidiary of Cinram International Income Fund had their wages reported through a separate unemployment insurance (UI) tax account under the name Real Time Staffing.
Accordingly, the Department is amending this certification to properly reflect this matter.
The intent of the Department's certification is to include all workers of the subject firm who were adversely affected by increased company imports of the supply of optical media distribution.
The amended notice applicable to TA-W-81,260 is hereby issued as follows:
All workers from Cinram Distribution, LLC, a subsidiary of Cinram International Income Fund, including on-site leased workers from Good People, including workers whose unemployment insurance (UI) wages are reported through Real Time Staffing, Aurora, Illinois, who became totally or partially separated from employment on or after January 20, 2011 through February 3, 2014, and all workers in the group threatened with total or partial separation from employment on date of certification through two years from the date of certification, are eligible to apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1074, as amended.
In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on January 18, 2012, applicable to workers and former workers of Stimson Lumber Company, Arden Division, Colville, Washington. The workers are engaged in activities related to the production of cedar lumber. The Department's Notice was published in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm and the new information supplied by the State.
The Department determines that workers from Securitas Security Services USA and Briteway Janitorial were employed on-site at the Colville, Washington location of Stimson Lumber Company and were sufficiently under the control of Stimson Lumber Company to be considered leased workers.
The intent of the Department's certification is to include all workers of the subject firm adversely affected by customer imports of articles from Canada.
Based on these findings, the Department is amending this certification to include workers leased from Securitas Security Services USA and Briteway Janitorial working on-site
The amended notice applicable to TA-W-80,487 is hereby issued as follows:
All workers of Stimson Lumber Company, Arden Division, including on-site leased workers from Securitas Security Services USA and Briteway Janitorial, Colville, Washington, who became totally or partially separated from employment on or after September 27, 2010, through January 18, 2014, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974.
In accordance with Section 223 of the Trade Act of 1974, as amended (19 U.S.C. 2273) the Department of Labor herein presents summaries of determinations regarding eligibility to apply for trade adjustment assistance for workers by (TA-W) number issued during the period of
In order for an affirmative determination to be made for workers of a primary firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(a) of the Act must be met.
I. Under Section 222(a)(2)(A), the following must be satisfied:
(1) A significant number or proportion of the workers in such workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) The sales or production, or both, of such firm have decreased absolutely; and
(3) One of the following must be satisfied:
(A) Imports of articles or services like or directly competitive with articles produced or services supplied by such firm have increased;
(B) Imports of articles like or directly competitive with articles into which one or more component parts produced by such firm are directly incorporated, have increased;
(C) Imports of articles directly incorporating one or more component parts produced outside the United States that are like or directly competitive with imports of articles incorporating one or more component parts produced by such firm have increased;
(D) Imports of articles like or directly competitive with articles which are produced directly using services supplied by such firm, have increased; and
(4) The increase in imports contributed importantly to such workers' separation or threat of separation and to the decline in the sales or production of such firm; or
II. Section 222(a)(2)(B) all of the following must be satisfied:
(1) A significant number or proportion of the workers in such workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) One of the following must be satisfied:
(A) There has been a shift by the workers' firm to a foreign country in the production of articles or supply of services like or directly competitive with those produced/supplied by the workers' firm;
(B) There has been an acquisition from a foreign country by the workers' firm of articles/services that are like or directly competitive with those produced/supplied by the workers' firm; and
(3) The shift/acquisition contributed importantly to the workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected workers in public agencies and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(b) of the Act must be met.
(1) A significant number or proportion of the workers in the public agency have become totally or partially separated, or are threatened to become totally or partially separated;
(2) The public agency has acquired from a foreign country services like or directly competitive with services which are supplied by such agency; and
(3) The acquisition of services contributed importantly to such workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected secondary workers of a firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(c) of the Act must be met.
(1) A significant number or proportion of the workers in the workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) The workers' firm is a Supplier or Downstream Producer to a firm that employed a group of workers who received a certification of eligibility under Section 222(a) of the Act, and such supply or production is related to the article or service that was the basis for such certification; and
(3) Either—
(A) The workers' firm is a supplier and the component parts it supplied to the firm described in paragraph (2) accounted for at least 20 percent of the production or sales of the workers' firm; or
(B) A loss of business by the workers' firm with the firm described in paragraph (2) contributed importantly to the workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected workers in firms identified by the International Trade Commission and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(f) of the Act must be met.
(1) The workers' firm is publicly identified by name by the International Trade Commission as a member of a domestic industry in an investigation resulting in—
(A) An affirmative determination of serious injury or threat thereof under section 202(b)(1);
(B) An affirmative determination of market disruption or threat thereof under section 421(b)(1); or
(C) An affirmative final determination of material injury or threat thereof under section 705(b)(1)(A) or 735(b)(1)(A) of the Tariff Act of 1930 (19 U.S.C. 1671d(b)(1)(A) and 1673d(b)(1)(A));
(2) The petition is filed during the 1-year period beginning on the date on which—
(A) A summary of the report submitted to the President by the International Trade Commission under section 202(f)(1) with respect to the affirmative determination described in paragraph (1)(A) is published in the
(B) Notice of an affirmative determination described in subparagraph (1) is published in the
(3) The workers have become totally or partially separated from the workers' firm within—
(A) The 1-year period described in paragraph (2); or
(B) Notwithstanding section 223(b)(1), the 1- year period preceding the 1-year period described in paragraph (2).
The following certifications have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination.
The following certifications have been issued. The requirements of Section 222(a)(2)(A) (increased imports) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(a)(2)(B) (shift in production or services) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(c) (supplier to a firm whose workers are certified eligible to apply for TAA) of the Trade Act have been met.
In the following cases, the investigation revealed that the eligibility criteria for worker adjustment assistance have not been met for the reasons specified.
The investigation revealed that the criterion under paragraph (a)(1), or (b)(1), or (c)(1)(employment decline or threat of separation) of section 222 has not been met.
The investigation revealed that the criteria under paragraphs (a)(2)(A) (increased imports) and (a)(2)(B) (shift in production or services to a foreign country) of section 222 have not been met.
After notice of the petitions was published in the
The following determinations terminating investigations were issued because the petitioner has requested that the petition be withdrawn.
I hereby certify that the aforementioned determinations were issued during the period of
Petitions have been filed with the Secretary of Labor under Section 221(a) of the Trade Act of 1974 (“the Act”) and are identified in the Appendix to this notice. Upon receipt of these petitions, the Director of the Division of Trade Adjustment Assistance, Employment and Training Administration, has instituted investigations pursuant to Section 221(a) of the Act.
The purpose of each of the investigations is to determine whether the workers are eligible to apply for adjustment assistance under Title II, Chapter 2, of the Act. The investigations will further relate, as appropriate, to the determination of the date on which total or partial separations began or threatened to begin and the subdivision of the firm involved.
The petitioners or any other persons showing a substantial interest in the subject matter of the investigations may request a public hearing, provided such request is filed in writing with the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than April 5, 2012.
Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than April 5, 2012.
The petitions filed in this case are available for inspection at the Office of the Director, Office of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, Room N-5428, 200 Constitution Avenue NW., Washington, DC 20210.
Legal Services Corporation.
Notice; request for comments.
The Legal Services Corporation seeks public comment on a draft program letter discussing minimum screening requirements for LSC recipients to apply when determining financial eligibility of applicants based on information collected through online systems.
Written comments will be accepted until April 25, 2012.
Written comments may be submitted by mail, fax or email to Mark Freedman, Senior Assistant General Counsel, Legal Services Corporation, 3333 K St. NW., Washington, DC 20007; 202-295-1623 (phone); 202-337-6519 (fax);
Mark Freedman, Senior Assistant General Counsel, Legal Services Corporation, 3333 K St. NW., Washington, DC 20007; 202-295-1623 (phone); 202-337-6519 (fax);
The Legal Services Corporation (“LSC” or “Corporation”) was established by the United States Congress “for the purpose of providing financial support for legal assistance in noncriminal matters or proceedings to persons financially unable to afford such assistance.” 42 U.S.C. 2996b(a). LSC performs this function primarily through providing federal funding to civil legal aid programs providing legal services to low-income persons throughout the United States and its possessions and territories in geographic areas determined by LSC. Each LSC recipient must screen all applicants for LSC funded legal assistance to determine if they meet the recipient's financial eligibility requirements, which themselves must comply with the LSC financial eligibility requirements set forth at 45 CFR part 1611.
Over the last several years, LSC has seen a marked increase in the number of LSC grant recipients implementing online systems as part of their client-eligibility screening systems to improve efficiency in their intake processes. LSC has received a corresponding increase in compliance-related inquiries pertaining to these systems. LSC has prepared this draft program letter to assist LSC recipients in complying with eligibility screening requirements for all methods of intake, including online intake systems. It reflects LSC's obligation to ensure compliance with statutory and regulatory requirements governing the use of LSC funds, as well as LSC's recognition of the realities of practices in the field.
The draft program letter can be found in the “Matters for Comment” section of LSC's Web site at:
LSC recognizes the importance of input from the public and from LSC recipients. It is LSC's intention that the Program Letter balance recognition of the advancements in technology with LSC's obligation to ensure compliance with the statutory and regulatory requirements governing the use of LSC funds. LSC encourages all interested parties and program staff whose work involves screening applicants to review the draft Program Letter and provide input to LSC. Interested parties may submit comments to LSC within thirty (30) days of the date of publication of this notice.
U.S. Nuclear Regulatory Commission.
This notice is to announce the renewal of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) for a period of two years.
The U.S. Nuclear Regulatory Commission (NRC) has determined that the renewal of the Charter for the Advisory Committee on the Medical Uses of Isotopes for the two year period commencing on March 14, 2012 is in the public interest, in connection with duties imposed on the Commission by law. This action is being taken in accordance with the Federal Advisory Committee Act, after consultation with the Committee Management Secretariat, General Services Administration.
The purpose of the ACMUI is to provide advice to NRC on policy and technical issues that arise in regulating the medical use of byproduct material for diagnosis and therapy. Responsibilities include providing guidance and comments on current and proposed NRC regulations and regulatory guidance concerning medical use; evaluating certain non-routine uses of byproduct material for medical use;
Members of this Committee have demonstrated professional qualifications and expertise in both scientific and non-scientific disciplines including nuclear medicine; nuclear cardiology; radiation therapy; medical physics; nuclear pharmacy; State medical regulation; patient's rights and care; health care administration; and Food and Drug Administration regulation.
Ashley Cockerham, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555; Telephone (240) 888-7129; email
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (the “Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget for extension and approval.
Rule 23c-1 (17 CFR 270.23c-1) under the Investment Company Act of 1940 (15 U.S.C. 80a), among other things, permits a closed-end fund to repurchase its securities for cash if in addition to the other requirements set forth in the rule: (i) Payment of the purchase price is accompanied or preceded by a written confirmation of the purchase; (ii) the asset coverage per unit of the security to be purchased is disclosed to the seller or his agent; and (iii) if the security is a stock, the fund has, within the preceding six months, informed stockholders of its intention to purchase stock. Commission staff estimates that approximately 29 closed-end funds rely on Rule 23c-1 annually to undertake 261 repurchases of their securities. Commission staff estimates that, on average, a fund spends 2.5 hours to comply with the paperwork requirements listed above each time it undertakes a security repurchase under the rule. Commission staff thus estimates the total annual burden of the rule's paperwork requirements is 653 hours.
In addition, the fund must file with the Commission a copy of any written solicitation to purchase securities given by or on behalf of the fund to 10 or more persons. The copy must be filed as an exhibit to Form N-CSR (17 CFR 249.331 and 274.128). The burden associated with filing Form N-CSR is addressed in the submission related to that form.
The estimate of average burden hours is made solely for the purposes of the Paperwork Reduction Act, and is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules and forms.
Please direct your written comments to Thomas Bayer, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312; or send an email to:
By letter dated December 5, 2011, counsel for Edward Jones & Co., L.P. (“Edward Jones”) requested that the Securities and Exchange Commission (“Commission”) issue to Edward Jones an exemption from Section 11(d)(1) of the Securities Exchange Act of 1934 (“Exchange Act”) pursuant to Section 36(a) of the Exchange Act. Specifically, the letter requested that the Commission exempt Edward Jones from the prohibitions of Section 11(d)(1) of the Exchange Act if Edward Jones extends to a customer margin on newly-purchased shares of mutual funds not managed or sponsored by Edward Jones or any affiliate of Edward Jones (“non-proprietary mutual funds”) in instances in which the customer makes a dollar-for-dollar substitution by selling an already-margined non-proprietary mutual fund and buying another non-proprietary mutual fund on margin without incurring any fees, commissions or other costs for the transactions and without Edward Jones otherwise charging the respective customers any fees, commissions or other costs to effect the transactions.
We find that it is appropriate and in the public interest and consistent with the protection of investors to grant Edward Jones a conditional exemption from Section 11(d)(1) of the Exchange Act.
This exemption is subject to the conditions that
• Edward Jones does not receive any sales commissions, Rule 12b-1 fees, revenue sharing or any other compensation, directly or indirectly, from the mutual fund complexes in which investments are made, and Edward Jones does not charge or receive any compensation, fees, expenses or other costs as a result of its effecting transactions in the funds; and
• Edward Jones, its affiliates, associates, related persons, management and employees have no affiliation with the mutual funds subject to the request, other than that Edward Jones will effect transactions in the funds for its customers.
The foregoing exemption is subject to modification or revocation if at any time the Commission determines that such action is necessary or appropriate in furtherance of the purposes of the Exchange Act.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend its rules regarding the Short Term Option Series Program. The text of the proposed rule change is available on the Exchange's Web site
In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B and C below, of the most significant aspects of such statements.
The purpose of this proposed rule change is to amend ISE Rules 504 and 2009 regarding the Short Term Option Series Program (“STOS Program”).
Currently, ISE may select up to 30 currently listed option classes on which short term option series may be opened in the STOS Program. The Exchange may also match any option classes that are selected by other securities exchanges that employ a similar program under their respective rules. For each option class eligible for participation in the STOS Program, the Exchange may open up to 30 short term option series for each expiration date in that class.
This proposal seeks to allow the Exchange to open short term option series that are opened by other securities exchanges in option classes selected by other exchanges under their respective short term option rules. This change is being proposed notwithstanding the current cap of 30 series per class under the STOS Program. This is a competitive filing and is based on approved filings and existing rules of The NASDAQ Stock Market LLC for the NASDAQ Options Market (“NOM”) and NASDAQ OMX PHLX, Inc. (“PHLX”).
ISE is competitively disadvantaged since it operates a substantially similar STOS Program as NOM and PHLX but is limited to listing a maximum of 30 series per options class that participates in its STOS Program (whereas PHLX and NOM are not similarly restricted).
The Exchange is not proposing any changes to the STOS Program other than the ability to open short term option series that are opened by other securities exchanges in option classes selected by other exchanges under their respective short term option rules.
ISE notes that the STOS Program has been well-received by market participants, in particular by retail investors. ISE believes that the current proposed revision to the STOS Program will permit the Exchange to meet increased customer demand and provide market participants with the ability to hedge in a greater number of option classes and series.
With regard to the impact of this proposal on system capacity, ISE has analyzed its capacity and represents that it and the Options Price Reporting Authority (“OPRA”) have the necessary systems capacity to handle the potential additional traffic associated with trading of an expanded number of series for the classes that participate in the STOS Program.
The proposed increase to the number of series per classes eligible to participate in the STOS Program is required for competitive purposes as well as to ensure consistency and uniformity among the competing
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Securities Exchange Act of 1934
ISE does not believe that this proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Exchange Act. In this regard and as indicated above, the Exchange notes that the rule change is being proposed as a competitive response to existing NOM and PHLX rules. ISE believes this proposed rule change is necessary to permit fair competition among the options exchanges with respect to their short term options programs.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from members or other interested parties.
Because the foregoing proposed rule change does not significantly affect the protection of investors or the public interest, does not impose any significant burden on competition, and, by its terms, does not become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has requested that the Commission waive the 30-day operative delay. The Commission believes that waiver of the operative delay is consistent with the protection of investors and the public interest because the proposal is substantially similar to those of other exchanges that have been approved by the Commission and permit such exchanges to open short term option series that are opened by other securities exchanges under their respective short term option rules.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 24, 2012, ICE Clear Europe Limited (“ICE Clear Europe”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change SR-ICEEU-2012-01 pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed changes were set out in revisions to the Rules and CDS Procedures that were described in circular no. C11/170 published on November 25, 2011 (available on the Internet Web site of ICE Clear Europe at:
Specifically, these changes can be grouped into three categories:
First, under ICE Clear Europe's current rule framework, CDS Contracts that arise following the end-of-day pricing process give rise to non-cleared transactions that may later be submitted for clearing. However, since the applicable CDS Contract is typically intended to be cleared between the parties, and since trades that arise following end-of-day pricing arise at the direction of the clearing house, ICE Clear Europe believes that it is more efficient and reduces risk for such CDS Contract to arise upon notice by ICE Clear Europe, rather than to require the applicable parties to submit the CDS Contract later. Accordingly, the first change establishes Rule 401(a)(xi) to permit ICE Clear Europe to specify the time and terms of entry into a CDS Contract arising following the submission of end-of-day prices by a Clearing Member. Once ICE Clear Europe has notified the two affected clearing members of a contract under Rule 401(a)(xi), the contract will stand, unless it is voidable under Rule 404 (for example due to illegality or manifest error). This change gives rise to the majority of the proposed rule changes in the text of the ICE Clear Europe Rules and the CDS Procedures. As a practical matter, this change operationalizes a technical service by which the terms of a CDS Contract entered into following submission of end-of-day prices can be promptly cleared by ICE Clear Europe. In order to operationalize this change, certain conforming changes are required. For example, various Rules establishing procedures for other automatically effective CDS Contracts are amended to include new Rule 401(a)(xi).
In addition, a new paragraph (c) has been added to Rule 602 which deems Clearing Members not to be in violation of Position Limits (as defined in the Rules) as a result of CDS Contracts that arise by notice of ICE Clear Europe. Rule 602(c) provides a procedure under which the Clearing Member can close out such a position within five business days of the applicable Position Limit adoption or determination date. In this manner, both the policy of ensuring the pricing process through automatically effective trades and the policy of ensuring Position Limits are respected. ICE Clear Europe notes that these provisions relating to accommodation of Clearing Members in respect of Position Limits that may be applicable to CDS Contracts that are automatically effective applies not only to Rule 401(a)(xi), but also to Rules 401(a)(v), (vi), and (x). In the case of Rule 401(a)(v), new Rule 602(c) would apply to CDS Contracts that arise from transactions generated by ICE Futures Europe or the ICE OTC Operator as a result of the operation of their contra trade, error trade, invalid trade, cancelled trade, error correction or similar policies and rules and procedures relating thereto or otherwise. In the case of Rule 401(a)(vi), new Rule 602(c) would apply to CDS Contracts that form as a result of another Contract being invoiced back by ICE Clear Europe. Finally, in the case of Rule 401(a)(x), new Rule 602(c) would apply to CDS Contracts arising pursuant to Rule 903(a)(xii), which generally governs the creation of new CDS Contracts between ICE Clear Europe and non-defaulting Clearing Members to replace any remaining CDS Contracts of a defaulting Clearing Member.
Under the second category of changes, settlement and coupon payments under CDS Contracts will take place through the ICE Clear Europe's payment banking network used for other cleared products, and not through the CLS Bank International (“CLS”) system. At present, Section 8.9 of the CDS Procedures provides that where a CDS Contract is to be settled in circumstances in which Rule 1514 (CDS Alternative Delivery or Settlement Procedure) does not apply, relevant cash payments between ICE Clear Europe and CDS Clearing Members will take place through The Depository Trust and Clearing Corporation using CLS, unless otherwise specified by ICE Clear Europe in a circular prior to the date on which such cash payments are due. However, following consultation with Clearing Members, ICE Clear Europe has determined it is more efficient if settlement and coupon payments are effected through ICE Clear Europe's current payment system (which is also permitted by the current CDS Procedures). ICE Clear Europe has determined to harmonize the system described at Section 8.9 of the CDS Procedures into a single payment system. This is achieved through the deletion of Section 8.9 of the CDS Procedures.
The third category of changes involves various cross-reference and typographical amendments to the processes for submission of CDS Contracts. The typographical changes are as follows: (i) Section 4.2 of the CDS Procedures, the words “Bilateral CDS Contract” are changed to “Bilateral CDS Transaction”, and (ii) Section 8.4 of the CDS Procedures, the words “submission of” are added. According to ICE Clear Europe, these changes are made solely to correct typographical and cross-reference drafting in the text of the Rules and make no substantive changes to the Rules.
In its filing with the Commission, ICE Clear Europe indicated that it has engaged in extensive private consultation with its CDS Clearing Members involving both operational and legal consultation groups and has presented the changes to its CDS Risk Committee, which approved the changes. ICE Clear Europe has also engaged in a public consultation process in relation to all the changes, pursuant to the Circulars referred to above, and as required under applicable U.K. legislation. This public consultation involved the publication of such Circulars on a publicly accessible portion of the Internet Web site of ICE Clear Europe. ICE Clear Europe has received no opposing views from its Clearing Members in relation to the proposed rule amendments and received no responses to its public consultations during the consultation period.
Section 19(b)(2)(B) of the Act directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to such organization.
If approved, the proposed rule change would allow ICE Clear Europe to implement certain operational changes related to the processing of CDS contracts, including with respect to (i) CDS Contracts that arise as a result of the end-of-day pricing process and (ii) and the process by which settlement and coupon payments under CDS Contracts will be made. After considering these changes, the Commission believes that the proposed rule change is consistent with Section 17A(b)(3)(F) of the Act, including ICE Clear Europe's obligation to ensure that its rules be designed to remove impediments to and perfect the mechanism of a national system for the prompt and accurate clearance and settlement of securities transactions.
On the basis of the foregoing, the Commission finds that the proposal is consistent with the requirements of the Act and in particular with the requirements of Section 17A of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The purpose of DTC's proposed rule change is to amend DTC's Settlement Service Guide to change certain deadlines associated with processing issuances and maturity presentments of money market instruments.
In its filing with the Commission, DTC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. DTC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
The Maturity Presentment
MMI issuers and IPAs commonly view the primary source of funding for payments of MMI maturity presentments as flowing from new issuances of MMIs in the same program by that MMI issuer on that day. If the MMI issuer issues more new MMIs than the number of MMIs maturing, there would be no net funds payment to the IPA on that day. When an issuer has more maturing MMIs than new issuances, it will have an obligation to pay to the IPA the net amount of the MMIs maturing that day over the new issuance. When net maturity presentments exceed issuances on a day, IPAs at their discretion may provide significant intraday credit to issuers for the excess. However, the IPA as an agent of an issuer is not obligated to fund the presentments unless payment is received from the issuer.
The business relationships between IPAs and their MMI issuers play a key role in determining if an IPA will execute a refusal to pay at DTC with respect to an MMI issuance. Because maturity presentments of an issuer's MMIs for which the IPA acts are processed automatically and randomly against the IPA's account, IPAs are permitted to refuse to pay for all of an issuer's maturities in an MMI program.
In late 2009, DTC and the Securities Industry and Financial Markets Association (“SIFMA”) formed the MMI Blue-Sky Task Force (“Task Force”) to address systemic and unique market risks associated with the MMI process, including those related to DTC's maturity presentment processing. The Task Force, along other money market industry members,
1. Making all MMI issuance and deliver order transactions subject to DTC's Receiver Authorized Delivery (“RAD”) function for approval regardless of transaction value.
2. Adjusting the MMI valued new issuance cut-off time from 3:20 p.m. E.T. to 2 p.m. E.T.
3. Creating a new MMI RAD approval of new valued issuance transactions at 2:45 p.m. E.T. instead of 3:30 p.m. E.T.
DTC believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to DTC because the earlier cutoffs and the elimination of MMI matched reclaims should reduce potential late day reversals due to non-payment instructions from IPAs, which should in turn allow IPAs to determine before the 3 p.m. RTP deadline if there is a funding shortfall with respect to an issuer. Additionally, the changes to the Settlement Service Guide, as proposed, should serve to reinforce consistent MMI business practices by implementing earlier deadlines for issuances processing and receiver approvals. DTC expects these proposed changes to make the processing of MMI issuances and maturities more efficient. Finally, the proposed rule change is consistent with the CPSS/IOSCO Recommendations for Securities Settlement Systems applicable to DTC.
DTC does not believe that the proposed rule change would impose any burden on competition.
The proposed rule change was developed in consultation with the Task Force and other securities industry organizations. Written comments relating to the proposed rule change have not been solicited or received. DTC will notify the Commission of any written comments received by DTC.
Within forty-five days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The purpose of the proposed rule change (
As discussed in more detail in Item II below, Modification #1 reduces the level of default resources held in the mutualized ICC guaranty fund and significantly increases the level of resources held in initial margin. Modification #2 modifies the initial margin risk model by removing the conditional Recovery Rate stress-scenarios and adding a new Recovery Rate sensitivity component that is computed by considering changes in Recovery Rate assumptions that impact the Net Asset Value of the portfolio.
In its filing with the Commission, ICC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
The counterparty risk brought to ICC by any of its clearing participants is “collateralized” in the first instance by the clearing participant counterparty through its initial margin. In the event that any defaulting clearing participant's initial margin and guaranty fund contributions are insufficient to cover its obligations, any such deficit is mutualized across all non-defaulting clearing participants through their respective guaranty fund contributions.
Since its launch, ICC has maintained a very high percentage of its default resources in the mutualized guaranty fund. On average, the size of the guaranty fund has been roughly 50% of the initial margin held by ICC. Whereas, historically, traditional futures clearinghouse have maintained guaranty funds in an amount equal to roughly 5-7% of the initial margin held. In other words, at ICC, the clearing participant resources available to be mutualized in the guaranty fund versus the resources available as initial margin have been approximately ten times greater on a
Modification #1 reduces the level of default resources held in the mutualized ICC guaranty fund and increases the level of resources held in initial margin (collateral).
The ICC guaranty fund is relatively much larger, as compared to traditional futures clearinghouses, in part because the guaranty fund model is currently designed to cover the uncollateralized losses that would result from the three single names that would cause the greatest losses when entering a state of default. Modification #1 incorporates into the initial margin risk model the single name that causes the greatest loss when entering a state of default (i.e., the single name that results in the greatest amount of loss when stress-tested). This change effectively collateralizes the loss that would occur from the single name that causes the greatest loss entering a state of default. Consequently, the amount of uncollateralized loss that would result from the three single names causing the greatest losses when entering a state of default is reduced, thereby reducing the amount of required guaranty fund contributions.
This change to the guaranty fund and initial margin risk model will, as noted above, result in a reduction of the guaranty fund requirements and an increase in the initial margin requirements. However, it is important to note that the decrease in the guaranty fund and the increase in initial margin requirements are not symmetrical. Instead, based upon current portfolios, for every $1 decrease to the guaranty fund there will be a corresponding increase to the initial margin requirements of approximately $5.
Modification #2 modifies the initial margin risk model by removing the conditional Recovery Rate stress-scenarios and adding a new Recovery Rate sensitivity component that is computed by considering changes in the Recovery Rate assumptions and their impact on the Net Asset Value of the Credit Default Swap portfolio. This modification will make it easier for market participants to measure their risk.
ICC believes that the proposed rule change is consistent with the requirements of Section 17A of the Act and the rules and regulations thereunder applicable to it. ICC believes that by reducing the level of default resources held in the guaranty fund and increasing the level of default resources held as initial margin and by modifying the initial margin risk model as described above, it is able to safeguard securities and funds in its custody or control or for which it is responsible.
ICC does not believe the proposed rule change would have any impact, or impose any burden, on competition.
Written comments relating to the proposed rule change have not been solicited or received. ICC will notify the Commission of any written comments received by ICC.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICC-2012-03 and should be submitted on or before April 16, 2012.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
ICE Clear Europe proposes rule and CDS procedural amendments that are intended to modify the terms of the calculation and payment of interest on mark-to-market margin for CDS transactions. The amendments would provide further detail for calculation of interest on mark-to-market margin for CDS at the position level, but would not change the overall calculation of that interest. The amendments would also move payment of such interest from a monthly to a daily basis.
In its filing with the Commission, ICE Clear Europe included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICE Clear Europe has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
As noted above, the proposed rule changes consist of operational changes to the Rules, CDS Procedures and Finance Procedures ICE Clear Europe has consulted with its CDS Risk Committee, which supports the proposed amendment.
ICE Clear Europe submits proposed amendments to its CDS Procedures, Finance Procedures and Rules in relation to the calculation and payment of interest on the mark-to-market margin for CDS transactions on a daily basis. The amendments also clarify, consistent with ICE Clear Europe's current practice, mark-to-market margin and variation margin may be required to be provided by the clearing member to the clearing house or vice versa.
ICE Clear Europe proposes to update Parts 1 and 3 of its CDS Procedures to state more clearly the daily calculation of interest on mark-to-market margin for CDS transactions and to provide further detail about such calculations. The new definitions of “Daily Aggregate MTM Interest Amount,” “Mark-to-Market Interest” and “Mark-to-Market Margin Balance” and the provisions of Part 3 of the CDS Procedures reflect these changes. “Daily Aggregate MTM Interest Amount” means for any Clearing Member for a currency on any day the sum of the Mark-to-Market Margin Balances in such currency for that day in respect of that Clearing Member. The Daily Aggregate MTM Interest Amount will be determined separately in respect of the Clearing Member's Proprietary Account and any relevant customer account. Where the Daily Aggregate MTM Interest Amount is positive, it will be owed by ICE Clear Europe to the relevant Clearing Member; where it is negative, the relevant Clearing Member will owe the absolute value of the Daily Aggregate MTM Interest Amount to ICE Clear Europe. “Mark-to-Market Interest” will mean interest calculated daily in accordance with the market convention for the relevant currency by applying the applicable overnight rate. “Mark-to-Market Margin Balance” will mean the sum of all Mark-to-Market Margin delivered up to, but excluding that day, by the relevant Clearing Member in respect of such CDS Contract to ICE Clear Europe less all Mark-to-Market Margin delivered up to, but excluding that day, by ICE Clear Europe in respect of such CDS Contract to such Clearing Member, as determined at the close of business on such day. Pursuant to the amendments to Section 3.1 of the CDS Procedures and 6.11(h)(iv) of the Finance Procedures, interest on Mark-to-Market Margin will be payable on a daily, rather than a monthly basis, although the interest calculation is substantially unchanged.
ICE Clear Europe believes that the proposed rule change is consistent with the requirements of Section 17A of the Act
ICE Clear Europe does not believe the proposed rule and procedural changes would have any impact, or impose any burden, on competition.
Written comments relating to the proposed rule change have not been solicited or received. ICE Clear Europe will notify the Commission of any written comments received by ICE Clear Europe.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2012-05 and should be submitted on or before April 16, 2012.
For the Commission by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to list and trade shares of the APMEX Physical—1 oz. Gold Redeemable Trust (the “Trust”) pursuant to NYSE Arca Equities Rule 8.201. The text of the proposed rule change is available at the Exchange, the Commission's Public Reference Room, and
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to list and trade Units (“Units”) of the Trust under NYSE Arca Equities Rule 8.201.
APMEX Precious Metals Management Services, Inc. is the manager of the Trust (“Manager”),
According to the Registration Statement, the investment objective of the Trust is to invest and hold substantially all of its assets in 1 oz. gold coins. The assets of the Trust will consist of 1 oz. American Gold Eagle bullion coins and 1 oz. Canadian Gold Maple Leaf bullion coins, although the Trust is also permitted to purchase 1 oz. gold bullion bars and rounds. The Trust seeks to provide a secure, convenient and exchange-traded investment alternative for investors interested in holding 1 oz. gold coins. The Trust believes that investing in 1 oz. gold coins has several advantages over investing in bullion, including (i) 1 oz. gold coins contain a known quantity of gold that is guaranteed by the government issuing them, whereas gold bullion has no such guarantee; (ii) it is a crime to tamper with 1 oz. gold coins, so those receiving them have more confidence as to the amount of gold the coin contains; (iii) because the amount of gold contained in each unit is small (1 oz.), redemptions for the underlying precious metal can be done at lower amounts than similar investments in gold bullion; and (iv) if an investor chooses to redeem the investor's interests in the Trust, the investor would receive 1 oz. gold coins, the value of which is known since the precious metals it contains are of a known and fixed quantity, as opposed to bullion, the value of which would have to be re-determined for the benefit of a transferee when the investor wanted to transfer it. The Trust does not anticipate making regular cash distributions to unitholders. The Trust is neither an investment company registered under the Investment Company Act of 1940
The Exchange represents that the Units satisfy the requirements of NYSE Arca Equities Rule 8.201 and thereby qualify for listing on the Exchange.
According to the Registration Statement, the global gold market is influenced by several industries, organizations and activities which may be categorized as banking, governmental, mining, manufacturing and investment. For example:
• Multi-national bullion banks provide a variety of bullion-related products and services to the global gold market, including physical purchases and sales, gold leasing, hedging and gold deposits.
• Governments, through central bank activities for each nation, buy, sell and hold gold reserves.
• Mining companies produce gold directly and combine with other companies that produce gold as a by-product and companies that are scrap merchants and gold recyclers to provide a supply of gold.
• Manufacturers which use gold in the process of making or constructing a final product, including products in the industrial community, electronic products, dental applications and jewelry, combine to provide demand for gold.
• Investment activities of individuals, corporations, pooled accounts, exchange traded funds and other investment oriented trading activity combine to provide demand for gold.
Gold can be purchased in a physical form in almost every country in the world. The most popular forms of gold ownership include coins, most commonly in one ounce gold coins of a known fineness, struck by sovereign governments including the United States, Canada, South Africa, Australia, Austria and others, along with bars and rounds also commonly containing one ounce or less in a known or expressed fineness, provided by major gold refiners including Johnson & Matthey, Produits Artistiques Métaux Précieux, Credit Suisse and others. Physical gold can be purchased in the United States through most precious metal or coin dealers and over the Internet, while in Europe and other parts of the world, purchases can also be made through banks and other financial institutions.
Physical gold is paid at the time of delivery and generally the prices track the world price of gold directly plus a small premium for manufacturing and distribution costs. The owner of the gold has a responsibility to store and insure the gold, but that is at the discretion of the owner. Private depositories and bank safe deposit vaults are available for annual fees.
Sources of gold supply include both mine production and recycling of existing previously mined gold. Gold mine production constitutes the largest portion of gold supplied into the market annually. Gold scrap, from jewelry and other manufactured products, is the second largest source of annual gold supply. Although many central banks have recently been purchasing gold rather than selling, central bank sales have historically accounted for a significant supply of gold coming into the marketplace.
Mine production includes gold produced from a primary or a secondary deposit. For the five years ended December 31, 2010, gold from net mining activity (gold from mining producers less hedging by producers) has been relatively stable at a level of between approximately 2,031 metric tons and approximately 2,686 metric tons per year. Notwithstanding this steady production, this supply represents only approximately 58% to 63% of the total annual demand for gold. During the seven quarters ended September 30, 2011, with rising prices and, accordingly, greater incentive for mining, net mining activity is providing from 57% to 75% of the total demand for gold.
According to the Registration Statement, central banks, as well as other governmental agencies, have historically retained gold as a strategic asset. However, since 1989, the governmental segment has been a net seller of gold to the private sector until the fourth quarter of 2010. For the five years ended December 31, 2010, central bank sales of gold have declined from approximately 370 metric tons in 2006, or approximately 10% of total annual supply of 3,574 metric tons, turning to negative supply, or otherwise a factor in demand, to approximately 77 metric tons in 2010, a significant turnaround from a source of supply to a source of demand. In the seven quarters ended September 30, 2011, central bank sales have provided a source of demand, not a source of supply, except for the fourth quarter of 2010, ranging from the provision of demand of as much as approximately 148 metric tons in the third quarter of 2011, to a swing as a source of supply of approximately 18 metric tons in the fourth quarter of 2010. Overall for 2010, central banks provided a net of approximately 77 metric tons of demand, not supply, in the global market.
According to the Registration Statement, as a result of the swing from net seller in 2006 to a net buyer in 2010, these central banks have ceased providing a supply of gold to the market and have become a consumer of gold in the market. This dramatic shift may have significant impact on supply and demand relationships in the future.
Industrial gold demand includes production for electronic devices, dental applications and other uses. Gold has manufacturing properties that include malleability, resistance to corrosion and conductivity that make the metal ideal for a variety of electronic components such as smartphones and notebooks and in emerging technology such as nanoparticles. During the five years ended December 31, 2010, industrial demand has been as high as 466 metric tons per year to as low as 410 metric tons per year and has represented as much as 13% of total annual demand and as low as 11% of total annual demand. For the seven quarters ended September 30, 2011, industrial demand has increased from 114 metric tons in the first quarter of 2010 to 120 metric tons in the third quarter of 2011, with a high of 120 metric tons in the third quarters of 2010 and 2011.
Gold jewelry continues to be the primary source of gold demand worldwide, although in 2009, institutional demand exceeded jewelry demand. India is the most significant market for gold jewelry demand followed by China, the United States and Saudi Arabia. For the five years ended December 31, 2010, jewelry demand has been between 50% and 69% of the total annual demand. For the seven quarters ended September 30, 2011, jewelry demand has varied from 418 metric tons in the second quarter of 2010 to 558 metric tons in the first quarter of 2011. As a portion of total demand during the seven quarters ended September 30, 2011, jewelry has represented between 38% and 60% of total demand.
Retail and institutional investment demand includes government gold coin production, medals and other coin and bar production, gold bar hoarding, increases in gold on deposit for exchange traded funds and other gold fund investments and other physical investment demand. For the five years ended December 31, 2010, investment demand has grown from 830 metric tons in 2006 to 1,518 metric tons in 2010. During the seven quarters ended September 30, 2011, investment demand has fluctuated from 248 metric tons in the first quarter of 2010 to a high of 575 metric tons in the second quarter of 2010. For the seven quarters ended September 30, 2011, investment demand has provided from 27% to 52% of total demand.
Gold is traded around the world daily on a 24 hour basis. Gold can be owned directly or indirectly in several ways and traded in several different markets depending on the form of gold ownership or rights to own the underlying gold.
According to the Registration Statement, the Valuation Agent will determine the fair market value of the 1 oz. American Gold Eagle bullion coins
1 oz. gold coins are manufactured and distributed by the United States Mint and the Royal Canadian Mint.
Each of the mints offers the 1 oz. gold coins to a group of authorized distributors, which are approved by the respective mint.
Based on the supply chain from the respective mints, the authorized distributors set their prices based on current market conditions, creating a spread between the purchase price of the 1 oz. gold coins from the mints and the selling price of such distributors with such selling price based on current market demand. Since the market value of the 1 oz. gold coins are primarily based on the price of 1 oz. of gold, and, further, since all of the coins from the respective mints are identical, the selling price of all the authorized distributors is substantially similar in what is a competitive commodity market. Generally, these authorized distributors (or “primary dealers”) offer the 1 oz. gold coins to wholesalers and to larger retail sellers.
The Trust will hold substantially all of its assets in the 1 oz. American Gold Eagle bullion coin and the 1 oz. Canadian Gold Maple Leaf bullion coin.
The United States Mint charges the authorized purchasers a premium of 3% over the price of gold on the 1 oz American Gold Eagle. The Royal Canadian Mint does not disclose or publish the premium for the 1 oz. Gold Maple Leaf.
Each of the mints has established a set of criteria that must be met by prospective and current authorized distributors. The United States Mint publishes the application to become an authorized purchaser online at
According to the Registration Statement, the correlation of the market value of the 1 oz. American Gold Eagle coin to the gold spot, as reported by Bloomberg Finance L.P., for the period from January 2009 to August 2011 as of the last trading day each month, is 0.978. The correlation of the market value of the 1 oz. Canadian Gold Maple Leaf coin to the gold spot, as reported by Bloomberg Finance L.P., for the period from January 2009 to August 2011 as of the last trading day each month, is 0.976. The data provided by Bloomberg Finance L.P. for the value of the 1 oz. American Gold Eagle Coin and the 1 oz. Canadian Gold Maple Leaf Coin is the same data that will be used by the Trust to calculate the NAV.
There are several commodity exchanges around the world that provide the ability to purchase a contract for delivery of a fixed amount of gold in a specified purity, or fineness, with delivery at a specific time in the future. Commodity exchange contracts can be satisfied either financially or by physical delivery. The current delivery month contract trades at a price that approximates the current value of the underlying amount of gold while future delivery months trade at a premium to the current delivery month. Generally, the longer the time until the contract delivery month, the higher the premium per ounce of gold the contract trades relative to the current delivery month. Because the contracts expire and must be satisfied either financially or by physical delivery, there is some action required by the contract owner every month for the current contract.
Stock exchanges around the world trade the equities of gold mining companies. These publicly traded gold mining companies may or may not have profitable operations and may or may not have ownership or rights to gold mines. The gold mines in which the gold mining companies have exploration rights may or may not be producing gold. The public disclosure of the details and explanations of the operations of the gold mining companies that trade on the exchanges vary in each country and in each trading exchange.
There are several worldwide exchanges that trade gold derivatives. Gold derivatives include options to purchase or sell gold, forwards and other forms of trading rights to buy or sell gold. Such gold derivatives usually carry a fixed price of gold at which the gold must be bought or sold and have a tenor, or fixed timeframe when the right to buy or sell expires. Settlement of the derivative trade is most often completed financially and no physical gold is generally ever bought, sold or delivered. The owner of a derivative holds a right to buy or sell gold and not the physical gold and prices at which these derivatives trade are not directly related to the price of gold, but trade at prices that include the price of gold, the premium of the option, the remaining time before expiration of the option and other factors. Gold futures are traded on the COMEX, an affiliate of the Chicago
There are several gold funds operating around the world with the majority of the funds traded on public exchanges in the form of open or closed end funds, or alternatively, in exchange traded funds. These publicly traded funds are a form of asset backed securities where the owner of the security holds an undivided interest in the pool of gold that the public fund holds. Generally, the public funds hold gold in safekeeping, and the value of the securities is directly related to the value of the gold that the public fund holds. However, there can be some trading premium or discount to the value of the underlying gold based on current market conditions, the need for liquidity by the owners of the public funds, temporary imbalances of buy or sell orders for the securities, tax treatments of the public funds, or other factors. Generally, the interest in the public funds is bought or sold through brokerage firms with official access to the exchanges on which the securities of the public funds trade.
According to the Registration Statement, the Trust will not hold or trade in commodity futures contracts regulated by the Commodity Exchange Act, as administered by the U.S. Commodity Futures Trading Commission (“CFTC”). According to the Registration Statement, the Trust is not a commodity pool for purposes of the Commodity Exchange Act,
The Trust intends to invest in long-term holdings of 1 oz. gold coins but intends to hold highly liquid investments (consisting of short term certificates of deposit or any U.S. Government Security) or cash [sic] an amount equal to approximately 3% of its total net assets generally to pay expenses and cash redemptions. The Trust does not intend to speculate in gold. The Trust may be required to sell some of its 1 oz. gold coins from time to time in order to replenish the amount held in cash. The Trust is authorized to issue an unlimited number of Units.
Except with respect to cash and highly liquid investments that the Trust will hold to pay expenses and anticipated redemptions, the Trust expects to own only 1 oz. gold coins. While the Trust, pursuant to its investment guidelines (“Investment Guidelines”), will be permitted to invest up to 20% of its assets in securities other than 1 oz. gold coins, the Manager intends to invest and hold approximately 97% of the total net assets of the Trust in 1 oz. gold coins.
The Manager will not buy and sell 1 oz. gold coins for the Trust through its current parent company, APMEX Precious Metals Exchange, Inc., of which the Manager's officers and directors are officers, or its affiliates.
To purchase all of the 1 oz. gold coins pursuant to the Trust's investment guidelines using the initial public offering proceeds, the Manager will negotiate on behalf of the Trust for multiple transactions with certain authorized distributors; all of such distributors are independent of the Manager and any affiliate of the parent company. These negotiations and related transactions will include the pricing of the 1 oz. gold coins, the proposed terms of payment and certain delivery requirements in each transaction for the 1 oz. gold coins to be received at the gold custodian.
The process of determining the worldwide price of gold occurs twice daily in London, once in the morning and once in the afternoon, by a committee of five internationally recognized bullion dealers, all of which are members of the London Bullion Market Association. Once the Manager identifies an offer of price and terms as acceptable for a transaction, it will prepare a purchase order for the transaction that specifies the Trust as the buyer and the seller as the identified distributor and will set forth in reasonable detail the price and terms. The Manager will sign the purchase order on behalf of the Trust and deliver it to the selling distributor. In accordance with the terms of the purchase order, funds will be delivered to the selling distributor directly from the Trust. As the physical delivery of the 1 oz. gold coins is completed at the gold custodian, a representative of the Manager will be present. At delivery, the Manager will inspect the 1 oz. gold coins and complete a random review of the count and authenticity of the gold content. Once the Manager is satisfied with the completeness and accuracy of the delivery of the 1 oz. gold coins, the gold custodian will put the 1 oz. gold coins in storage and provide a written report to the Custodian of the details of such receipt.
The Units may trade in the secondary market on the Exchange at prices that are lower or higher relative to their NAV per Unit. The amount of the discount or premium in the trading price relative to the NAV may be influenced by non-concurrent trading hours between the COMEX, which is the U.S. exchange on which gold for physical delivery is traded, and NYSE Arca and the Toronto Stock Exchange (“TSX”). While the Units will trade on NYSE Arca and the TSX until 4 p.m. Eastern time, liquidity in the global gold market will lessen after the close of the COMEX at 1:30 p.m. Eastern time. As a result, during this time, trading spreads, and the resulting premium or discount to the NAV may widen.
The Trust pays the Manager a monthly management fee. Fees payable to the Manager are calculated and accrued daily and will be paid monthly in arrears. Except as otherwise described in the Registration Statement, the Trust is responsible for all costs and expenses incurred in connection with
The Trust will offer at a minimum, 1,000,000 Units in its initial public offering. Each Unit will represent an equal, undivided ownership interest in the net assets of the Trust attributable to the Units. The Trust may not issue additional Units following the completion of this offering (i) unless the per Unit offering price, after deducting underwriting fees, commissions and offering expenses, will not yield proceeds less than the NAV per Unit, as determined on the business day prior to the pricing of the units to be sold in the offering, or (ii) except by way of Unit distribution in connection with an income distribution.
Unitholders may redeem their Units on a weekly basis, as described below.
Subject to the terms of the amended and restated trust agreement, a unitholder may redeem Units at its option for 1 oz. gold coins on each Thursday. Unitholders who redeem their Units for 1 oz. gold coins are entitled to receive a redemption price equal to 100% of the aggregate NAV of the redeemed Units determined at 4 p.m., Eastern time, on the Thursday on which NYSE Arca and/or the TSX is open for trading for the week in respect of which the redemption request is processed, or the weekly redemption date and time, less the redemption expenses, or the gold redemption amount. Such redemption requests must be for a minimum redemption amount of at least $10,000 (the “gold redemption minimum”).
A unitholder that owns a sufficient number of Units (a number of Units equal to the gold redemption minimum) who desires to exercise his, her or its redemption privileges for 1 oz. gold coins must do so by instructing the unitholder's broker, who must be a direct or indirect participant of Depository Trust Company in the United States (“DTC”), or CDS Clearing and Depository Services, Inc. in Canada (“CDS”), to deliver to the registrar and transfer agent, on behalf of the unitholder a written notice (the “gold redemption notice”) of the unitholder's intention to redeem Units for 1 oz. gold coins. The Trust's registrar and transfer agent must receive a gold redemption notice no later than 4 p.m., Eastern time, on the third day on which NYSE Arca or the TSX is open for trading prior to the weekly redemption date and time. The Trust will process any gold redemption notice that it receives after that time on the next weekly redemption date, following the date on which the unitholder gives timely notice.
A common carrier will deliver the 1 oz. gold coins to be delivered to a unitholder as a result of a redemption of Units, and the shipping provider will fully insure the 1 oz. gold coins during transit. The Trust will engage the shipping service provider in connection with a redemption. The 1 oz. gold coins can be delivered to any physical address (subject to approval by the Trust). In the event that a redeeming unitholder does not provide an acceptable physical address for delivery of its 1 oz. gold coins in its gold redemption notice, such unitholder may elect to either have up [sic] its 1 oz. gold coins delivered to the Manager for pickup by the unitholder at the office of the Manager or redeem its Units for cash as described below. If the unitholder requests that the 1 oz. gold coins be delivered to the Manager, the risk of loss transfers to the unitholder upon delivery to the Manager. Once the Trust places the 1 oz. gold coins representing the redeemed Units with the shipping service provider, which will fully insure the shipment, the Trust will have completed its responsibilities with respect to the redemption and the redeeming unitholder will bear the risk of loss of, and damage to, such 1 oz. gold coins and seek any redress for any loss or damage from the shipping service provider or the insurance provider, as the case may be. The shipping service provider will receive 1 oz. gold coins in connection with a redemption of Units approximately seven business days after the redemption is processed by the registrar and transfer agent.
According to the Registration Statement, subject to the terms of the amended and restated trust agreement, a unitholder may redeem Units at its option for cash on a monthly basis. Units redeemed for cash will receive a redemption price equal to 95% of the lesser of (i) the volume-weighted average trading price of the Units traded on NYSE Arca or, if trading has been suspended on NYSE Arca, the trading price of the Units traded on the TSX, for the last five days on which the respective exchange is open for trading during the month in which the redemption request is processed by the registrar and transfer agent, and (ii) the NAV of the redeemed Units as of 4 p.m., Eastern time, on the last day of the month on which NYSE Arca is open for trading during the month in which the redemption request is processed (in each case, less any applicable taxes). A redeeming unitholder will receive cash redemption proceeds approximately three business days after the end of the month in which the redemption notice is processed. The Trust will retain the remaining 5% of the value of the Units.
The Trust's registrar and transfer agent must receive a redemption notice no later than 4 p.m., Eastern time, on the 15th day of the month in order for the Manager to process such redemption notice that month or, if such day is not a business day, then on the immediately following day that is a business day. The Manager will process any redemption notice to redeem Units for cash that it receives after such time in the next month.
According to the Registration Statement, the Trust may suspend the right of unitholders to request a redemption of their Units or postpone the date of delivery or payment of the redemption proceeds (whether 1 oz. gold coins and/or cash, as the case may be) for any period during which the Trust determines that conditions exist which render impractical the sale of assets of the Trust or which impair the ability of the Trust or the Valuation Agent to determine the value of the assets of the Trust and the NAV or the redemption amount for the Units. Pursuant to Sections 5.7(2) and 5.7(3) of National Instrument 81-102, the Trust must apply to the Ontario Securities Commission, the securities regulatory authority for the jurisdiction in which the head office of the Trustee is located, for approval to suspend redemptions and must concurrently file a copy of the application with the securities regulatory authority in each of the other Canadian jurisdictions in which the Units will be offered. The Trust may suspend redemptions only after the application is approved by the Ontario Securities Commission and has not been disallowed by any of the other relevant Canadian jurisdictions.
In the event of any such suspension, the Trust will issue a press release, and publicly file such press release with the Commission via the Edgar system, with the TSX and with the Canadian securities regulatory authorities on SEDAR, announcing the suspension and will advise all agents of the Trust, as applicable. The suspension may apply to all requests for redemption received prior to the suspension, but as for which payment has not been made, as well as to all requests received while the suspension is in effect. All unitholders making such requests will be advised of the suspension and that the redemption will be effected at a price determined on the first valuation date that the value of the net assets of the Trust per Unit is calculated following the termination of the suspension. All such unitholders will have, and will be advised that during such suspension of redemptions that they have, the right to withdraw their requests for redemption. The suspension will terminate in any event on the first business day on which the condition giving rise to the suspension has ceased to exist or when the Trust has determined that such condition no longer exists, provided that no other condition under which a suspension is authorized then exists, at which time the Trust will issue a press release announcing the termination of the suspension and will advise all agents of the Trust, as applicable. Subject to applicable Canadian and U.S. securities laws, any declaration of suspension made by the Trust will be conclusive.
During any period in which the right of unitholders to request a redemption of their Units for 1 oz. gold coins and/or cash is suspended, the Trust will direct the Trust's Valuation Agent to suspend the calculation of the value of the net assets of the Trust and the NAV. During any such period of suspension, the Trust will not issue or redeem any Units.
Termination Events
The Trust does not have a fixed termination date but will dissolve and be subsequently terminated in the event that:
• There are no Units outstanding;
• The Trustee resigns or is removed and no successor trustee is appointed within the time limit prescribed in the amended and restated trust agreement;
• The Manager resigns and no successor manager is appointed and approved by unitholders within the time limit prescribed in the amended and restated trust agreement;
• The Manager is, in the opinion of the Trustee, in material default of its obligations under the amended and restated trust agreement and such default continues for 120 days from the date that the Manager receives notice of such default from the Trustee and no successor manager has been appointed by the unitholders;
• The Manager has been declared bankrupt or insolvent or has entered into liquidation or winding-up, whether compulsory or voluntary (and not merely a voluntary liquidation for the purposes of amalgamation or reconstruction), and no successor manager has been appointed by the unitholders within 90 days from such date;
• The Manager makes a general assignment for the benefit of its creditors or otherwise acknowledges its insolvency, and no successor manager has been appointed by the unitholders within 90 days of such date; or
• The assets of the Manager have become subject to seizure or confiscation by any public governmental authority, and no successor manager has been appointed by the unitholders within 90 days from such date.
In addition, the Trustee may at any time terminate and dissolve the Trust if, in the opinion of the Trustee, after consulting with the Manager and the independent review committee, the value of the net assets of the Trust has been reduced such that it is no longer economically feasible to continue the Trust and would be in the best interests of the unitholders to terminate the Trust, by giving each holder of Units at the time at least 90 days' notice. To the extent such termination in the discretion of the Manager may involve a matter that would be a “conflict of interest matter” as set forth in applicable Canadian laws, the Manager will refer the matter to the independent review committee established by the Manager for its recommendation. In connection with the termination of the Trust, the Trust will, to the extent possible, convert its assets to cash and, after paying or making adequate provision for all of the Trust's liabilities and expenses, distribute the net assets of the Trust to unitholders, on a pro rata basis, as soon as practicable after the termination date.
The Valuation Agent will determine the value of the net assets of the Trust and the NAV on each business day, unless the Trust determines that its assets cannot be valued as frequently as a result of the occurrence of a force majeure event, such as a war, earthquake, hurricane, civil disturbance or terrorist act. The value of the net assets of the Trust as of the valuation time on each business day will be the amount obtained by deducting from the aggregate fair market value of the assets of the Trust as of such date an amount equal to the value of the liabilities of the Trust (excluding all liabilities represented by outstanding Units, if any) as of such date. The NAV will be determined by dividing the value of the net assets of the Trust on a date by the total number of Units then outstanding on such date. Registration or transfers of the Units may be made through the book-based system of CDS and/or DTC, each of which hold the Units on behalf of its participants (i.e., brokers), which in turn may hold the Units on behalf of their customers.
The Trust Web site will provide an intraday indicative value (“IIV”) per share for the Units, as calculated by a third party financial data provider during the Exchange's Core Trading Session (9:30 a.m. to 4 p.m. Eastern time).
1. Subtracting the closing spot price of gold for the prior business day from the current applicable spot price of gold (the “Spread”);
2. Multiplying the Spread by the aggregate number of the Trust's 1 oz. gold coins for the prior business day (the “Adjustment”);
3. Dividing the Adjustment by the aggregate number of units of the Trust outstanding for the prior business day (the “Per Unit Adjustment”); and
4. Adding the Per Unit Adjustment to the NAV per Unit of the Trust for the prior business day.
The Web site for the Trust, which the Trust will launch upon the closing of the initial public offering, will contain the following information, on a per Unit basis, for the Trust:
(a) The midpoint of the bid-ask price at the close of trading in relation to the NAV as of the time the NAV is
(b) Data in chart format displaying the frequency distribution of discounts and premiums of the Bid/Ask Price against the NAV, within appropriate ranges, for each of the four previous calendar quarters. The Web site for the Trust will also provide the Trust's prospectus, as well as the two most recent reports to stockholders.
The Trust Web site also will provide the last sale price of the Units as traded in the U.S. market, as well as a breakdown of the holdings of the Trust by coin type.
Currently, the Consolidated Tape Plan does not provide for dissemination of the spot price of a commodity, such as gold, over the Consolidated Tape. However, there will be disseminated over the Consolidated Tape the last sale price for the Units, as is the case for all equity securities traded on the Exchange. In addition, there is a considerable amount of gold price and gold market information available on public Web sites and through professional and subscription services. The IIV relating to the Units will be widely disseminated by one or more major market data vendors at least every 15 seconds during the Core Trading Session.
Investors may obtain on a 24-hour basis gold pricing information based on the spot price for an ounce of gold from various financial information service providers, such as Reuters and Bloomberg. Reuters and Bloomberg provide at no charge on their Web sites delayed information regarding the spot price of gold and last sale prices of gold futures, as well as information about news and developments in the gold market. Reuters and Bloomberg also offer a professional service to subscribers for a fee that provides information on gold prices directly from market participants. An organization named EBS provides an electronic trading platform to institutions such as bullion banks and dealers for the trading of spot gold, as well as a feed of live streaming prices to Reuters and Moneyline Telerate subscribers. Gold coin price information is widely available for free from many precious metals dealers. For example, it is free at
Complete real-time data for gold futures and options prices traded on the COMEX are available by subscription from Reuters and Bloomberg. The NYMEX also provides delayed futures and options information on current and past trading sessions and market news free of charge on its Web site. There are a variety of other public Web sites providing information on gold, ranging from those specializing in precious metals to sites maintained by major newspapers, such as The Wall Street Journal. In addition, the London AM Fix and London PM Fix are publicly available at no charge at
The Trust's daily (or as determined by the Manager in accordance with the amended and restated trust agreement) NAV is posted on the Trust's Web site as soon as practicable. The Exchange will provide on its Web site (
The Trust will be subject to the criteria in NYSE Arca Equities Rule 8.201(e) for initial and continued listing of the Units.
It is anticipated that a minimum of 1,000,000 Units will be required to be outstanding at the start of trading. The minimum number of Units required to be outstanding is comparable to requirements that have been applied to previously listed shares of the Sprott Physical Gold Trust.
The Exchange deems the Units to be equity securities, thus rendering trading in the Fund subject to the Exchange's existing rules governing the trading of equity securities. Trading in the Units on the Exchange will occur in accordance with NYSE Arca Equities Rule 7.34(a). The Exchange has appropriate rules to facilitate transactions in the Units during all trading sessions. As provided in NYSE Arca Equities Rule 7.6, Commentary .03, the minimum price variation (“MPV”) for quoting and entry of orders in equity securities traded on the NYSE Arca Marketplace is $0.01, with the exception of securities that are priced less than $1.00 for which the MPV for order entry is $0.0001.
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Units. Trading on the Exchange in the Units may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Units inadvisable. These may include: (1) The extent to which conditions in the underlying gold market have caused disruptions and/or lack of trading, or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. In addition, trading in Units will be subject to trading halts caused by extraordinary market volatility pursuant to the Exchange's “circuit breaker” rule.
The Exchange intends to utilize its existing surveillance procedures applicable to derivative products (including Commodity-Based Trust Shares) to monitor trading in the Units. The Exchange represents that these procedures are adequate to properly monitor Exchange trading of the Units in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws.
NYSE Arca Equities Rule 8.201 sets forth certain restrictions on ETP Holders acting as registered Market Makers in the Units to facilitate surveillance. Pursuant to NYSE Arca Equities Rule 8.201(g), an ETP Holder acting as a registered Market Maker in the Units is required to provide the Exchange with information relating to its trading in the underlying gold, related futures or options on futures, or any other related derivatives. Commentary .04 of NYSE Arca Equities Rule 6.3 requires an ETP Holder acting as a registered Market Maker, and its affiliates, in the Units to establish, maintain and enforce written policies and procedures reasonably designed to prevent the misuse of any material nonpublic information with respect to such products, any components of the related products, any physical asset or commodity underlying the product, applicable currencies, underlying indexes, related futures or
As a general matter, the Exchange has regulatory jurisdiction over its ETP Holders and their associated persons, which include any person or entity controlling an ETP Holder. A subsidiary or affiliate of an ETP Holder that does business only in commodities or futures contracts would not be subject to Exchange jurisdiction, but the Exchange could obtain information regarding the activities of such subsidiary or affiliate through surveillance sharing agreements with regulatory organizations of which such subsidiary or affiliate is a member.
The Exchange's current trading surveillance focuses on detecting securities trading outside their normal patterns. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations. Also, pursuant to NYSE Arca Equities Rule 8.201(g), the Exchange is able to obtain information regarding trading in the Units and the underlying gold, gold futures contracts, options on gold futures, or any other gold derivative, through ETP Holders acting as registered Market Makers, in connection with such ETP Holders' proprietary or customer trades through ETP Holders which they effect on any relevant market. In addition, the Exchange may obtain trading information via the Intermarket Surveillance Group (“ISG”) from other exchanges who are members of the ISG, including the COMEX.
The Exchange also has a general policy prohibiting the distribution of material, non-public information by its employees.
Prior to the commencement of trading, the Exchange will inform its ETP Holders in an Information Bulletin of the special characteristics and risks associated with trading the Units. Specifically, the Information Bulletin will discuss the following: (1) The procedures for purchases and redemptions of Units; (2) NYSE Arca Equities Rule 9.2(a), which imposes a duty of due diligence on its ETP Holders to learn the essential facts relating to every customer prior to trading the Units; (3) the requirement that ETP Holders deliver a prospectus to investors purchasing newly issued Units prior to or concurrently with the confirmation of a transaction; (4) the possibility that trading spreads and the resulting premium or discount on the Units may widen as a result of reduced liquidity of gold trading during the Core and Late Trading Sessions after the close of the major world gold markets; and (5) trading information. For example, the Information Bulletin will advise ETP Holders, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Trust. The Exchange notes that investors purchasing Units directly from the Trust will receive a prospectus. ETP Holders purchasing Units from the Trust for resale to investors will deliver a prospectus to such investors.
In addition, the Information Bulletin will reference that the Trust is subject to various fees and expenses described in the Registration Statement. The Information Bulletin will also reference the fact that there is no regulated source of last sale information regarding physical gold, that the Commission has no jurisdiction over the trading of gold as a physical commodity, and that the CFTC has regulatory jurisdiction over the trading of gold futures contracts and options on gold futures contracts.
The Information Bulletin will also discuss any relief, if granted, by the Commission or the staff from any rules under the Act.
The basis under the Act for this proposed rule change is the requirement under Section 6(b)(5)
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in NYSE Arca Equities Rule 8.201. The Exchange has in place surveillance procedures that are adequate to properly monitor trading in the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws. The Exchange may obtain information via ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement, including COMEX.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that there is a considerable amount of gold price and gold market information available on public Web sites and through professional and subscription services. Investors may obtain on a 24-hour basis gold pricing information based on the spot price for an ounce of gold from various financial information service providers. Complete real-time data for gold futures and options prices traded on the COMEX are available by subscription from Reuters and Bloomberg. In addition, the London AM Fix and London PM Fix are publicly available at no charge at
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of an additional type of exchange-traded product that will enhance competition among market participants, to the benefit of investors and the marketplace. As noted above, the Exchange has in place surveillance procedures relating to trading in the Shares and may obtain information via ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement. In addition, as noted above, investors will have ready access to information regarding gold pricing and gold futures information.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Exchange Act”)
The MSRB is filing with the SEC a proposed rule change consisting of (i) proposed MSRB Rule G-43 governing the municipal securities activities of broker's brokers and certain alternative trading systems (“Proposed Rule G-43”), (ii) proposed amendments to MSRB Rule G-8 (on recordkeeping by broker's brokers and certain alternative trading systems), MSRB Rule G-9 (on record retention), and MSRB Rule G-18 (on agency trades and trades by broker's brokers) (collectively, the “Proposed Amendments”); and (iii) a proposed interpretive notice on the duties of brokers, dealers, and municipal securities dealers (“dealers”) that use the services of broker's brokers (the “Proposed Notice”). The MSRB requests that the proposed rule change be made effective six months after approval by the Commission.
The text of the proposed rule change is available on the MSRB's Web site at
In its filing with the Commission, the MSRB included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The MSRB has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The MSRB decided to consider additional rulemaking concerning broker's brokers and the dealers that use their services due to the important role that broker's brokers play in the provision of secondary market liquidity for retail investors in municipal
A frequent scenario in large intra-day price differentials occurs when a single block of securities moves through a “chain” of transactions during the day. The securities involved in these scenarios often are infrequently traded issues with credits that are relatively unknown to most market participants. In a typical case, the transaction chain starts with a dealer buying securities from a customer, usually in a “retail” size block of $5,000 to $100,000. The securities are then sold through a broker's broker. Two or more inter-dealer transactions follow, with a final sale of the securities being made by a dealer to a customer. In certain cases, the difference between the price received by the selling customer and the price received by the purchasing customer is abnormally large, exceeding 10% or more. In reviewing such transaction chains, it often appears that the two dealers effecting trades with customers at each end of the chain—one dealer purchasing from a customer and the other selling to a customer—did not make excessive profits on their trades. Instead, the abnormally large intra-day price differentials can be attributed in major part to the price increases found in the inter-dealer trading occurring after the broker's broker's trade.
The MSRB deferred its rulemaking on the subject of broker's brokers until the completion of Commission and Financial Industry Regulatory Authority (“FINRA”) enforcement actions, which subsequently highlighted broker's broker activities that constitute clear violations of MSRB rules.
The MSRB recognizes that some broker's brokers make considerable efforts to comply with MSRB rules. However, given the nature of the rule violations brought to light by Commission and FINRA enforcement actions and the important role of broker's brokers in the provision of secondary market liquidity for retail investors, the MSRB determined that additional guidance and/or rulemaking concerning the activities of broker's brokers was warranted.
The role of the broker's broker is that of intermediary between selling dealers and bidding dealers. Proposed Rule G-43(a) would set forth the basic duties of a broker's broker to such dealers.
Proposed Rule G-43(a)(ii) would provide that a broker's broker that undertook to act for or on behalf of another dealer in connection with a transaction or potential transaction in municipal securities could not take any action that would work against that dealer's interest to receive advantageous pricing. Under Proposed Rule G-43(a)(iii), a broker's broker would be presumed to act for or on behalf of the seller
Proposed Rule G-43(b) would create a safe harbor. The safe harbor would provide that a broker's broker that conducted bid-wanteds in the manner described in Proposed Rule G-43(b) would satisfy its pricing duty under Proposed Rule G-43(a)(i).
Proposed Rule G-43(b)(i) and (ii) would require a broker's broker to disseminate a bid-wanted widely and, in the case of securities of limited interest, to make a reasonable effort to reach dealers with specific knowledge of the issue or known interest in comparable securities.
Proposed Rule G-43(b)(iii) would require that each bid-wanted have a deadline for the acceptance of bids to assist in measuring compliance with the safe harbor.
Proposed Rule G-43(c)(i)(F) would require broker's brokers that availed themselves of the safe harbor to use predetermined parameters designed to identify possible off-market bids in the conduct of bid-wanteds. For example, the predetermined parameters could be based on yield curves, pricing services, recent trades reported to the MSRB's Real-Time Trade Reporting System (RTRS), or bids submitted to a broker's broker in previous bid-wanteds or offerings. Broker's brokers would be required to test the predetermined parameters periodically to see whether they were achieving their designed purpose.
Proposed Rule G-43(b)(iv) would permit a broker's broker that availed itself of the safe harbor to contact the high bidder in a bid-wanted about its bid price prior to the deadline for bids without the seller's consent, if the bid was outside of the predetermined parameters described above and the broker's broker believed that the bid might have been submitted in error. If the high bid was within the predetermined parameters, yet the broker's broker believed it might have been submitted in error (
Under Proposed Rule G-43(b)(v), a broker's broker would be required to notify the seller if the highest bid received in a bid-wanted was below the predetermined parameters and receive the seller's oral or written consent
Proposed Rule G-43(c) is designed to ensure that bid-wanteds and offerings are conducted in a fair manner. Many of the requirements of Proposed Rule G-43(c) would address behavior that would also be a violation of Rule G-17 (
Proposed Rule G-43(d) would contain the definitions of terms used in Proposed Rule G-43. Under Proposed Rule G-43(d)(iii), the term “broker's broker” would mean a dealer, or a separately operated and supervised division or unit of a dealer, that principally effects transactions for other dealers or that holds itself out as a broker's broker, whether a separate company or part of a larger company. Certain alternative trading systems would be excepted from the definition of “broker's broker.” To be excepted, the alternative trading system would be required, with respect to its municipal securities activities, to utilize only automated and electronic means to communicate with bidders and sellers in a systematic and non-discretionary fashion (with certain limited exceptions), limit any customers to sophisticated municipal market professionals, and operate in accordance with most of the provisions of Proposed Rule G-43(c). In essence, an alternative trading system qualifying for the exception from the definition of “broker's broker” would be subject to most
The proposed amendments to Rule G-8 would require recordkeeping designed to assist in the enforcement of Proposed Rule G-43. Records would be required to be kept of bids, offers, changed bids and offers, the time of notification to the seller of the high bid, the policies and procedures of the broker's broker concerning bid-wanteds and offerings, and any agreements by which bidders and sellers agreed to joint representation by the broker's broker.
Proposed Rule G-8(a)(xxv)(D) would require broker's brokers to keep the following records of communications with bidders and sellers regarding possibly erroneous bids: The date and time of the communication; whether the bid deviated from the predetermined parameters and, if so, the amount of the deviation; the full name of the person contacted at the bidder; the full name of the person contacted at the seller, if applicable; the direction provided by the bidder to the broker's broker following the communication; the direction provided by the seller to the broker's broker following the communication, if applicable; and the full name of the person at the bidder, or seller, if applicable, who provided that direction.
Under Proposed Rule G-8(a)(xxv)(E), the broker's broker would be required to keep records of the date and time it notified the seller that the high bid was below the predetermined parameters; the amount by which the bid deviated from the predetermined parameters; the full name of the person contacted at the seller; the direction provided by the seller to the broker's broker following the communication; and the full name of the person at the seller who provided that direction.
Proposed Rule G-8(a)(xxv)(J) would require that each broker's broker keep a record of its predetermined parameters, its analysis of why those predetermined parameters were reasonably designed to identify most bids that might not represent the fair market value of municipal securities that were the subject of bid-wanteds to which the parameters were applied, and the results of the periodic tests of such predetermined parameters required by Proposed Rule G-43(c)(i)(F).
Proposed Rule G-8(a)(xxvi) would impose comparable recordkeeping requirements on alternative trading systems.
In the case of broker's brokers or alternative trading systems that are separately operated and supervised divisions of other dealers, separately maintained or separately extractable records of the municipal securities activities of the broker's broker or alternative trading system would be required to be maintained to assist in enforcement of Proposed Rule G-43.
The proposed amendments to Rule G-9 would provide for the retention of the records described above for six years.
The proposed amendment to Rule G-18 would eliminate duplication, as the deleted text would be moved to Proposed Rule G-43(a)(i).
The Proposed Notice would discuss the duties of dealers that use the services of broker's brokers.
Under the Proposed Notice, selling dealers would be reminded that the high bid obtained in a bid-wanted or offering is not necessarily a fair and reasonable price and that such dealers have an independent duty under Rule G-30 to determine that the prices at which they purchase municipal securities as a principal from their customers are fair and reasonable. Selling dealers would be cautioned that any direction they provided to broker's brokers to “screen” other dealers from their bid-wanteds or offerings could affect whether the high bid represented a fair and reasonable price and should be limited to valid business reasons, not anti-competitive behavior. Selling dealers would be urged not to assume that their customers needed to liquidate their securities immediately without inquiring as to their customers' particular circumstances and discussing with their customers the possible improved pricing benefit associated with taking additional time to liquidate their securities. The Proposed Notice also would provide that, depending upon the facts and circumstances, the use of bid-wanteds by selling dealers solely for price discovery purposes, without any intention of selling the securities through the broker's brokers might be an
Under the Proposed Notice, bidding dealers that submitted bids to broker's brokers that they believed were below the fair market value of the securities or that submitted “throw-away” bids to broker's brokers would violate MSRB Rule G-13. The Proposed Notice would provide that, while Rule G-30 provides that bidders are entitled to make a profit, Rule G-13 does not permit them to do so by “picking off” other dealers at off-market prices.
The MSRB believes that the proposed rule change is consistent with Section 15B(b)(2) of the Securities Exchange Act (“Exchange Act”), which provides that:
The Board shall propose and adopt rules to effect the purposes of this title with respect to transactions in municipal securities effected by brokers, dealers, and municipal securities dealers and advice provided to or on behalf of municipal entities or obligated persons by brokers, dealers, municipal securities dealers, and municipal advisors with respect to municipal financial products, the issuance of municipal securities, and solicitations of municipal entities or obligated persons undertaken by brokers, dealers, municipal securities dealers, and municipal advisors.
be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in municipal securities and municipal financial products, to remove impediments to and perfect the mechanism of a free and open market in municipal securities and municipal financial products, and, in general, to protect investors, municipal entities, obligated persons, and the public interest.
The proposed rule change is consistent with Sections 15B(b)(2) and 15B(b)(2)(C) of the Exchange Act for the following reasons. Enforcement agencies have informed the MSRB that they continue to observe the same kinds of series of transactions in municipal securities that prompted the MSRB's 2004 pricing guidance. They have also informed the MSRB about their observations of other trading patterns that indicate some market participants may misuse the role of the broker's broker in the provision of secondary market liquidity and may cause retail customers who liquidate their municipal securities by means of broker's brokers to receive unfair prices. Proposed Rule G-43 is designed to improve pricing in the secondary market for retail investors in municipal securities by increasing the likelihood that bid-wanteds and offerings made through broker's brokers will result in fair and reasonable prices. It would do that by encouraging the wide dissemination of bid-wanteds to those who are likely to have interest in the securities, drawing potential below market prices to the attention of selling dealers, and discouraging the type of fraudulent and unfair conduct that may result in prices that are lower than they would otherwise have been. At the same time, Proposed Rule G-43 is structured in a manner that should not impede the operation of the secondary market for municipal securities. The MSRB has worked extensively with broker's brokers and other dealers to refine the proposed rule so that it targets abuses without reducing liquidity. The proposed amendments to Rules G-8 and G-9 would assist the Commission and FINRA in the enforcement of Rule G-43. The proposed amendment to Rule G-18 would eliminate unnecessary duplication as the broker's brokers pricing obligation would be transferred to Proposed Rule G-43. The Proposed Notice would remind dealers that use the services of broker's brokers of their own pricing obligations, as sellers and as bidders. In order for retail investors to receive fair and reasonable prices for their municipal securities, all dealers in the secondary market (whether sellers, broker's brokers, or bidders) must satisfy their pricing obligations.
The MSRB does not believe that the proposed rule change would impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Exchange Act, since it would apply equally to all broker's brokers and all alternative trading systems would have the opportunity to qualify for the exception from the definition of “broker's broker.” The MSRB notes that alternative trading systems that have voice brokerage components would be subject to all of the provisions of Proposed Rule G-43 and would not be given a competitive advantage over voice brokers. The MSRB also does not believe that the provisions of the proposed rule change would be unduly burdensome to broker's brokers or would have the effect of reducing the number of broker's brokers.
On September 8, 2011, the MSRB requested comment on a draft of the proposed rule change.
References in this section to “Draft Rule G-43” and “Draft Rule G-8(a)(xxv)” are to the draft version of Proposed Rule G-43 and the draft amendments to Rule G-8 upon which comment was requested in MSRB Notice 2011-50. The underlined rule text in this section does not reflect amendments agreed to by the MSRB's Board that are now included in the proposed rule change. This text has been included in this filing for the convenience of the reader because a number of the sections of the draft rule were reordered in the proposed rule change, although not substantively changed.
Draft Rule G-43(a)(iii): A broker's broker will be presumed to act for or on behalf of the seller in a bid-wanted or offering, unless both the seller and bidders agree otherwise in writing in advance of the bid-wanted or offering.
Hartfield Titus also suggested restricting this section to bid-wanteds. It said that broker's broker activity in offerings is not consistent with the requirement of Draft Rule G-43(a)(iii). It said that a broker's broker works for either the seller or buyer in the negotiation, depending on which side initiates the negotiation.
RBI said that Draft Rule G-43(a)(iii) should be revised to indicate the difference between “bid-wanteds” and “offerings.” It agreed that the broker's broker represents the seller in the operation of a bid-wanted auction, but did not agree that the broker's broker will always work for the seller in an “offering” as it represents the bidder and seller equally.
Wolfe & Hurst said that a broker's broker is a “dual-agent for the seller and the buyer of securities.” It stated that it is not practicable to require a broker's broker to get written consent from both the buyer and seller in advance of the bid-wanted or offering. Wolfe & Hurst suggested that the definition of a broker's broker be revised to reflect the dual nature of their business. If not modified, it suggested that the provision clarify that “the clients of a broker's broker could consent to a dual-agency relationship either through an initial service agreement or through Terms of Use on the firm's Web site.”
SIFMA noted that, in offerings, a broker's broker will typically approach a dealer with known interest in the securities being offered or comparable securities, rather than reaching out to a wide universe of dealers.
SIFMA agreed with Draft Rule G-43(b)(iv), which prohibits broker's brokers from giving preferential treatment to bidders during a bid-wanted. However, it suggested that broker's brokers be allowed to inform a bidder whether their bid is being used before a bid-wanted is completed. Wolfe & Hurst agreed with SIFMA.
Hartfield Titus suggested restricting Draft Rule G-43(b)(iv) to bid-wanteds. It said that offerings are traded through negotiation rather than an auction. It also suggested that broker's brokers “be allowed to give a bidder information on whether their bid is being used and subsequently prohibit them from any further bidding on the item.”
TMC noted that Draft Rule G-43, by its definition, includes all of the electronic trading platforms. It said that Draft Rule G-43(b)(vii) would be meaningless as all alternative trading systems would be required to inform every registered firm that every price they post will be changed, and in multiple ways, as each recipient firm defines its own matrix. Current guidelines already prohibit unfair dealing. TMC suggested that Draft Rule G-43(b)(vii) be removed or modified to accommodate private label Web sites that allow customers and registered reps to view inventory.
The MSRB does not agree with TMC's comment. Under the proposal, a seller's consent would be required before an offered price could be changed by a broker's broker. The same would be true for alternative trading systems excepted from the rule. However, that consent could be obtained in advance (
Hartfield Titus suggested restricting Draft Rule G-43(b)(v) to apply only to bid-wanteds and not to offerings. It said that current industry practices have no time limits on offerings. Hartfield Titus agreed with SIFMA that “the deadline for accepting bids on an `around time' item be when the bonds are marked `FOR SALE'.”
RBI said that the imposition of a deadline could drastically deny the retail customer from receiving the highest bid available. RBI also noted that, in MSRB Notice 2011-18 (February 24, 2011), the MSRB stated that it “believes that most retail customers would prefer a better price to a speedy trade.” RBI agreed with this and said the imposition of an arbitrary “deadline” does the opposite. “RBI believes that any deadline that is imposed upon its ability to accept bids, especially on odd-lot bid-wanted items that are being advertised as an `around time', will be vastly detrimental to the ability of broker's brokers to provide the best price, and therefore the best execution, for the retail seller who is trying to get the best price for their municipal bonds.” RBI also commented that the MSRB has not provided guidelines regarding the procedures that should be taken when late, high bids are returned to the broker's broker that cannot be reported to the seller because of this “deadline.” Like SIFMA and Hartfield Titus, RBI proposed that instead of the bid deadline ending at the time that a bid is “put up” to the seller, that the bid deadline should end when the bonds are marked “for sale.”
Wolfe & Hurst objected to Draft Rule G-43(b)(v). It said that the rule currently applies to both “sharp” and “around time” deadlines. It argued that the “requirement restricts the broker's broker from getting the best bid for its client, which will ultimately have a negative impact on smaller retail clients and the market as a whole. Wolfe & Hurst suggested that the “rule be modified in the case of `around time' bid-wanteds only. Specifically, where a selling dealer requests an `around time' deadline, the broker's broker should be permitted to accept and change bids up until the point that the trade is marked for sale. Prohibiting modification at the point where the high bid is `put up' to the seller is restricting liquidity in the market. This rule change would be detrimental to the industry.”
TMC said, “The requirement of a broker's broker to contact a seller for permission to contact a bidder, when the bid itself is within the parameters of the safe harbor is neither practical nor realistic. A selling dealer, who is acting in the best interest of its selling client, is not likely to give such approval.” TMC also said that “the requirement to document the communication, the original bid, and the changed bid is superfluous and an added regulatory burden.”
BDA expressed concern that “if a broker's broker set the parameters too broadly on the upper end, erroneous bids would not be identified, the bidder would not be notified and might, in future dealings with that broker's broker, bid more conservatively or not at all. The result would be reduced liquidity in the market and lower prices for investors. Similarly, if the broker's broker set the parameters too narrowly on the lower end, the selling broker would receive a notice and quite likely not go through with the trade, or risk litigation if it did.”
Wolfe & Hurst objected to the use of predetermined parameters for bid-wanteds. It said that erroneous bids typically occur due to human error and should not be permitted to reach the marketplace as they do not reflect an accurate bid. Wolfe & Hurst also said
The concept of “predetermined parameters” has two purposes. First, if the high bid in a bid-wanted is below the predetermined parameters, a broker's broker using the safe harbor must notify the seller of that fact, thus alerting the seller that the bid may be off market. Second, if the high bid is outside of the parameters, the broker's broker may inquire of the bidder whether its bid was in error. Considerable abuse has occurred previously when some broker's brokers signaled to bidders that they could lower their bids to be closer to cover bids. This practice resulted in less favorable prices for retail investors. Cover bids are, therefore, under the proposal not permitted to be taken into account in the pricing parameters of a broker's broker.
The MSRB has modified Proposed Rule G-43(b)(vi) to clarify that a broker's broker need only inform the seller of changes in the winning high bidder's bids and in cover bids, rather than changes to other bids. Additionally, the MSRB has clarified that the permission of a seller to contact a bidder need not be in writing, although a broker's broker must keep a written record of such communication.
BDA also said that it is not a function of a broker's broker to determine a fair price or a range of fair prices. It also noted a practical problem if the draft rule is applied to alternative trading systems (“ATSs”). BDA suggested that “the Proposal should not be applied to ATSs, which allow for the wide and impartial distribution of bids.”
Hartfield Titus suggested restricting Draft Rule G-43(c)(i)(F) to apply only to bid-wanteds. It said that offer and bid information on offerings should be made available to interested parties throughout the negotiation process. Hartfield Titus also suggested that a definition of when a bid-wanted is “completed” be any of the following: “1) the item traded, i.e., the sell is executed and the buy is executed; 2) the item is `Traded Away' (it was traded by the seller to another dealer or customer); and 3) the item is identified as `No Trade' (we are told by the seller that the item will not trade).”
TMC supported the notion that brokers' brokers should prominently disclose the types of firms that constitute its client base but does not agree with disclosing to a seller information about the buyer of an item at the time of trade stating this to be
TMC said that “providing users with useful market and security specific tools should suffice to satisfy the Board's desire to improve bid quality. If a firm uses the same systematic approach for each posted bid-wanted and has a set of tools that helps traders establish value, then there should be no need for a safe harbor.”
BDA argued that the inclusion of ATSs within the definition of broker's broker is not warranted.
Wolfe & Hurst suggested a more detailed definition of broker's broker to include the nature and role of a broker's broker as well as the duties and responsibilities of a broker's broker. It argued that this would eliminate the need to include the phrase, “or that holds itself out as a broker's broker” in Draft Rule G-43(d)(iii).
TMC said that the language in Draft Rule G-43(d)(iii) on whether a firm “holds itself out as a broker's broker” discourages dealers from competitive (“in-comp”) bidding. TMC requested clarification regarding the following questions: (1) As a dealer's business is not usually “principally effecting transactions for other dealers” but for its client, would a broker-dealer be exempt from the definition or is acting like a broker's broker the equivalent of “holds itself out as a broker's broker?” (2) Many dealers post the same bid-wanted with multiple broker's brokers. Does the use of multiple broker's brokers create an unfair practice with respect to G-17? (3) If a dealer uses multiple brokers, should that be disclosed to the broker so that the broker can disclose that fact to potential bidders? (4) If the same bond is out for the bid with multiple broker's brokers, and the bond can only trade once, would that be viewed negatively by the regulators, barring disclosure to the marketplace? (5) If a broker's broker receives a bid-wanted that has been posted to multiple firms, does the broker need to use the same level of care as if the item were for its own account?
The MSRB continues to be of the view that a function-based definition of “broker's broker” is appropriate, rather than a detailed list such as that proposed by Wolfe & Hurst.
The MSRB has determined that it is appropriate to except certain alternative trading systems from the definition of “broker's broker,” because they do not engage in the types of voice communications that have led to abuses in the past. Nevertheless, in order to qualify for the exception, under Proposed Rule G-43(d)(iii) such systems would be subject to the same prohibitions on abusive behavior to which a broker's broker would be subject.
Hartfield Titus said that the majority of negotiations on municipal offerings are performed through “voice brokering.” Price may change many times. It suggested that the time and price record be limited to when the offering is first received, when it is updated for display or distribution, and displaying the offering as it was given to the brokers' broker or updated, by the seller. Hartfield Titus also said that there should be no requirement to record the reason.
RBI agreed that the requirements are reasonable for bid-wanteds, but said they are not workable or necessary for offerings. Negotiated offerings involve back and forth communications between a potential buyer and seller, not always resulting in a trade. RBI said the requirement would impose a significant recordkeeping burden on broker's brokers while adding no significant compliance benefits.
(E)
TMC said that “[r]equiring brokers' brokers to document price changes would be of no value to the market, as traders know that offering prices are always subject to change.” It also added that “documenting tens of thousands of price changes on a daily basis would be cost prohibitive.”
The MSRB issued two other requests for comment on the regulation of broker's brokers prior to the request for comment described above. On September 9, 2010, the MSRB published “Request for Comment on MSRB Guidance on Broker's Brokers” (“MSRB Notice 2010-35”). In MSRB Notice 2010-35, the MSRB requested comment on an interpretive notice reviewing the fair pricing requirements of MSRB Rules G-18 and G-30 and the fair practice requirements of MSRB Rule G-17 as they applied to transactions effected by broker's brokers. It also proposed to discuss the recordkeeping and record retention requirements for broker's brokers. On February 24, 2011, the MSRB published “Request for Comment on Draft Broker's Brokers Rule (Rule G-43) and Associated Recordkeeping and Transaction Amendments” (“MSRB Notice 2011-18”). In MSRB Notice 2011-18, the MSRB requested comment on the original version of Draft Rule G-43 (on broker's brokers), as well as associated draft amendments to Rule G-8 (on books and records), G-9 (on records preservation), and G-18 (on execution of transactions). Copies of MSRB Notices 2010-35 and 2011-18 and associated comment letters are included in Attachment 2 hereto. Each subsequent request for comment has included a summary of the comments received on the previous request for comment, as well as the MSRB's responses to those comments.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-MSRB-2012-04. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Web site
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 20, 2012, the Municipal Securities Rulemaking Board (“MSRB”) filed with the Securities and Exchange Commission (“SEC” or “Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”),
The proposed rule change consists of amendments to Rule G-14, Reports of Sales or Purchases, including the Rule G-14 RTRS Procedures, and amendments to the Real-Time Transaction Reporting System (“RTRS”) information system and subscription service (the “RTRS Facility”; collectively, “proposed rule change”). The proposed changes to Rule G-14 would remove certain outdated information. The proposed changes to the RTRS Facility would (A) remove certain outdated information and amend certain definitions to reflect current system operating hours and business days; (B) add an RTRS-calculated yield to the information disseminated for inter-dealer transactions; (C) remove certain infrequently used data reporting requirements; (D) require dealers to submit dollar prices for certain trades; and (E) reduce the number of customer trades suppressed from dissemination because of potentially erroneous price/yield calculations. The MSRB proposes that the proposed rule change be implemented in three phases, as further described herein.
The proposed rule change would amend Rule G-14 and the Rule G-14 RTRS Procedures to update certain references (such as references to the National Association of Securities Dealers, the predecessor of FINRA); eliminate certain provisions that are no longer relevant (such as provisions relating to testing during the original RTRS start-up period) or that, by their original terms, have expired; and conform terms in certain definitions.
To facilitate yield-based comparisons of transaction data across securities, the proposed rule change would cause RTRS to be reprogrammed to perform this calculation so that a yield for most inter-dealer transactions would be added to the information disseminated from RTRS, thereby improving the usefulness of the inter-dealer data disseminated to subscribers and displayed on the MSRB's Electronic Municipal Market Access (EMMA®) Web site.
The first of these two requirements relates to inter-dealer transactions and requires the identity of an “intermediate dealer,” or correspondent of a clearing broker that passes data to the clearing broker about transactions effected by a third dealer (“effecting dealer”), to be included on applicable trade reports. One of the original purposes of having the intermediate dealer included in a trade report was to assist market surveillance staff by having an additional dealer associated with a transaction reported in the event that the effecting dealer's identity was erroneously reported. However, few transaction reports contain such an intermediate dealer and, since the November 2009 enhancement to transaction reporting to add the effecting broker to the matching criteria in RTTM, the identity of the effecting dealer is rarely, if ever, erroneous. The proposed rule change would delete the requirement for dealers to identify the intermediate dealer. This amendment to the RTRS Facility is reflected by the deletion of the penultimate paragraph under the heading “RTRS Facility—Enhancement of Information Available to Regulators,” and conforming changes to the RTRS Users Manual will be made.
The second requirement applies to any transaction effected at a price that substantially differs from the market price as a result of the parties to the transaction agreeing to significantly deviate from a normal settlement cycle. For such transactions, dealers are required to include an identifier on the trade report that allows the trade report to be entered into the RTRS audit trail yet suppressed from price dissemination. Since a small number of transactions are reported with this identifier, for example only .01% of trade reports were identified with this indicator in August 2011, these transactions could be reported using the generic “away from market” indicator used for reporting any transaction at a price that differs from the current market price for the security to simplify transaction reporting requirements. Thus, concurrently with the elimination of the intermediate dealer reporting requirement, the RTRS Users Manual would be revised to delete the “away from market—extraordinary settlement” special condition indicator from RTRS and require that such transactions be reported using the generic “away from market” indicator.
Since MSRB transaction reporting for inter-dealer transactions began in 1994, a very small portion of inter-dealer transactions have been in securities with a non-standard $1,000 par
To ensure that the dollar price disseminated for inter-dealer transactions remains accurate and to minimize the impact on dealer operations as well as the clearance and settlement use of the data submitted to DTCC, the MSRB proposes to require dealers to report—in addition to the information currently reported for inter-dealer transactions—the contractual dollar price at which the transaction was executed.
In 2010, of those trades receiving this error, over 75% of the reported dollar prices disagreed with the RTRS-calculated dollar price by less than one dollar. To increase the number of customer transactions disseminated, the proposed rule change would cause RTRS to be reprogrammed to adjust the tolerance of the error code so that the error would continue to be returned to dealers for customer transactions where the reported dollar price disagrees with the RTRS calculated price but allow the trade report to be disseminated so long as the dealer and RTRS-calculated dollar prices are within $1 of each other. Further, since the disseminated dollar price would be unable to be exactly verified, RTRS would also be programmed to include with the disseminated trade report an indicator that the dollar price of these trades was unable to be verified. Thus, concurrently with the amendment to require dollar price reporting for all inter-dealer transactions, the RTRS Users Manual would be revised to reflect these changes in programming.
The Commission has carefully considered the proposed rule change and finds that the proposed rule change is consistent with the requirements of the Exchange Act and the rules and regulations thereunder applicable to the MSRB.
The Commission believes that the proposed rule change is consistent with the Exchange Act because the proposed rule change would remove impediments to and perfect the mechanism of a free and open market in municipal securities by improving trade reporting and market transparency. The proposed rule change would facilitate comparison of trade data across securities and within data for a security, thereby contributing to fairer pricing, improve the reliability and accuracy of price information disseminated for inter-dealer
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of Missouri dated 03/15/2012.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 13041B and for economic injury is 130420.
The States which received an EIDL Declaration # are Missouri, Arkansas.
Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Kentucky (FEMA-4057-DR), dated 03/16/2012.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416
Notice is hereby given that as a result of the President's major disaster declaration on 03/16/2012, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 13050C and for economic injury is 13051C.
Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of Tennessee (FEMA-4060-DR), dated 03/16/2012.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 03/16/2012, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 13048C and for economic injury is 130490.
Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of West Virginia (FEMA-4059-DR), dated 03/16/2012.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 03/16/2012, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 13044C and for economic injury is 130450.
Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of West Virginia (FEMA-4059-DR), dated 03/16/2012.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 03/16/2012, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 13044C and for economic injury is 130450.
Small Business Administration.
Amendment 5.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Texas (FEMA-1999-DR), dated 08/15/2011.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Texas, dated 08/15/2011, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
Small Business Administration.
Notice of Open Federal Advisory Committee Meeting.
The SBA is issuing this notice to announce the location, date, time, and agenda for the next meeting of the Advisory Committee on Veterans Business Affairs. The meeting will be open to the public.
March 26, 2012 from 9 a.m. to 5 p.m. in the Eisenhower Conference room, side B, located on the 2nd floor.
U.S. Small Business Administration, 409 3rd Street SW., Washington, DC 20416.
Pursuant to section 10(a) (2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the Advisory Committee on Veterans Business Affairs. The Advisory Committee on Veterans Business Affairs serves as an independent source of advice and policy recommendation to the Administrator of the U.S. Small Business Administration.
The purpose of this meeting is scheduled as a full committee meeting. It will focus on strategic planning, updates on past and current events, and the ACVBA's objective for 2012. For information regarding our veterans' resources and partners, please visit our Web site at www.sba.gov/vets.
If you require accommodations because of a disability, please contact the Office of Veterans Business Development at (202) 205-6773 at least two weeks in advance.
Department of State.
Notice of the CAFTA-DR Environmental Affairs Council meeting and request for comments on the meeting agenda.
The Department of State and the Office of the United States Trade Representative are providing notice that the government parties to the Dominican Republic-Central America-United States Free Trade Agreement (CAFTA-DR) intend to hold the sixth meeting of the Environmental Affairs Council (Council) established under Chapter 17 of that agreement in San Pedro Sula, Honduras on April 12, 2012 at the Hilton Princess Hotel, 10 Calle y Ave. Circunvalación, S.O. Col. Trejo. All interested persons are invited to attend a public session beginning at 2:30 p.m. on April 12.
During the meeting, each Council Member will present their country's progress in implementing Chapter 17 obligations and on the impacts of environmental cooperation in their countries. The Council will also receive a presentation from the CAFTA-DR Secretariat for Environmental Matters (SEM) and discuss the Organization of
All interested persons are invited to attend a public session where they will have the opportunity to ask questions and discuss implementation of Chapter 17 and environmental cooperation with Council Members. In addition, the SEM will present on the citizen submission process established under Chapter 17. More information on the Council is included below under
The Department of State and Office of the United States Trade Representative invite written comments or suggestions regarding the meeting agenda. In preparing comments, we encourage submitters to refer to Chapter 17 of the CAFTA-DR, the Final Environmental Review of the CAFTA-DR and the Agreement among the CAFTA-DR countries on Environmental Cooperation (ECA) (all documents available at
To be assured of timely consideration, all written comments or suggestions are requested no later than April 6, 2012.
Written comments or suggestions should be submitted to both: (1) Rebecca Slocum, U.S. Department of State, Bureau of Oceans and International Environmental and Scientific Affairs, Office of Environmental Policy by email to
Rebecca Slocum, (202) 647-4828 or Kelly Milton, (202) 395-9590.
Article 17.5 of the CAFTA-DR establishes an Environmental Affairs Council (the Council). Article 17.5 requires the Council to meet to oversee the implementation of, and review progress under, Chapter 17. Article 17.5 further requires, unless the governments otherwise agree, that each meeting of the Council include a session in which members of the Council have an opportunity to meet with the public to discuss matters relating to the implementation of Chapter 17.
In Article 17.9 of the CAFTA-DR, the governments recognize the importance of strengthening capacity to protect the environment and to promote sustainable development in concert with strengthening trade and investment relations and state their commitment to expanding their cooperative relationship on environmental matters. Article 17.9 also references the ECA, which sets out certain priority areas of cooperation on environmental activities that are also reflected in Annex 17.9 of the CAFTA-DR. These priority areas include, among other things: Reinforcing institutional and legal frameworks and the capacity to develop, implement, administer, and enforce environmental laws, regulations, standards and policies; conserving and managing shared, migratory and endangered species in international trade and management of protected areas; promoting best practices leading to sustainable management of the environment; and facilitating technology development and transfer and training to promote clean production technologies. The public is advised to refer to the State Department Web site at
State Justice Institute.
Notice of meeting.
The SJI Board of Directors will be meeting on Monday, April 23, 2012 at 1 p.m. The meeting will be held at the National Center for State Courts Headquarters in Williamsburg, Virginia. The purpose of this meeting is to consider grant applications for the 2nd quarter of FY 2012, and other business. All portions of this meeting are open to the public.
National Center for State Courts Headquarters, 300 Newport Avenue, Williamsburg, VA 23185, 800-616-6164.
Jonathan Mattiello, Executive Director, State Justice Institute, 11951 Freedom Drive, Suite 1020, Reston, VA 22314, 571-313-8843,
Susquehanna River Basin Commission.
Notice.
As part of its regular business meeting held on March 15, 2012, in Harrisburg, Pennsylvania, the Susquehanna River Basin Commission (Commission) approved the release of a proposed Low Flow Protection Policy (Policy) for public review and comment. The Policy can be accessed on the Commission's Web site at
The deadline for the submission of written comments is May 16, 2012.
Comments may be mailed to: Mr. John Balay, Susquehanna River Basin Commission, 1721 N. Front Street, Harrisburg, PA 17102-2391, or electronically submitted through
John Balay, Manager of Planning and Operations, telephone: (717) 238-0423; fax: (717) 238-2436.
On March 15, 2012, the Commission approved the release of a proposed Low Flow Protection Policy for public review and comment. The Policy was developed over the past year in coordination with the Commission's Water Resources
Public Law 91-575, 84 Stat. 1509
Federal Aviation Administration, DOT.
Notice of intent of waiver with respect to land.
The Federal Aviation Administration (FAA) is considering a proposal to authorize the release of 18 acres of the airport property at the Jackson Municipal Airport, Jackson MN. The City is proposing a land swap to exchange this 18 acre parcel for another parcel of 24.72 acres.
The acreage being released is not needed for aeronautical use as currently identified on the Airport Layout Plan.
The acreage comprising this parcel was originally acquired in 1976 with an Airport Development Aid Program (ADAP) grant (76-5-27-0045-01). In exchange for the 18 acres the airport will receive a new parcel of land in the approach to the crosswind runway 4/22. The appraised fair market value of the proposed release parcel is $130,500, the fair market value of the proposed acquire parcel is $165,000. The FAA approved a Categorical Exclusion for environmental requirements on May 13, 2010. Approval does not constitute a commitment by the FAA to financially assist in the disposal of the subject airport property nor a determination of eligibility for grant-in-aid funding from the FAA. The disposition of proceeds from the disposal of the airport property will be in accordance with FAA's Policy and Procedures Concerning the Use of Airport Revenue, published in the
In accordance with section 47107(h) of title 49, United States Code, this notice is required to be published in the
Comments must be received on or before April 25, 2012.
Ms. Sandra E. DePottey, Program Manager, Federal Aviation Administration, Airports District Office, 6020 28th Avenue South, Room 102, Minneapolis, MN 55450-2706. Telephone Number (612) 253-4642/FAX Number (612) 253-4611. Documents reflecting this FAA action may be reviewed at this same location or at the Minnesota Department of Transportation, 222 East Plato Blvd., St. Paul, MN 55107.
Ms. Sandra E. DePottey, Program Manager, Federal Aviation Administration, Airports District Office, 6020 28th Avenue South, Room 102, Minneapolis, MN 55450-2706. Telephone Number (612) 253-4642/FAX Number (612) 253-4611. Documents reflecting this FAA action may be reviewed at this same location or at the Minnesota Department of Transportation, 222 East Plato Blvd., St. Paul, MN 55107.
Following is a description of the subject airport property to be released at Jackson Municipal Airport in Jackson, Minnesota and described as follows:
A parcel of land located in the westerly 18.00 acres of that part of the North Half of the Northeast Quarter (N1/2NE1/4) of Section 13, Township 102 North, Range 35 West.
Said parcel subject to all easements, restrictions, and reservations of record.
Federal Highway Administration (FHWA), DOT.
Notice of Limitation on Claims for Judicial Review of Actions by FHWA and other Federal agencies.
This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed transportation corridor project (Cottonwood Street; 4500 South to Vine Street in Murray City, Salt Lake County in the State of Utah). These actions grant licenses, permits, and approvals for the project.
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the FHWA actions on the highway project will be barred unless the claim is filed on or before September 22, 2012. If the Federal law that authorizes judicial review of a claim provides a time period of less than 180 days for filing such claim, then that shorter time period still applies.
For FHWA: Mr. Edward Woolford, Environmental Program Manager, Federal Highway Administration, 2520 West 4700 South, Suite 9A, Salt Lake City, Utah 84129; telephone (801) 955-3524; email:
Notice is hereby given that the FHWA and other Federal agencies have taken final agency actions subject to 23 U.S.C. 139(l)(1) by issuing licenses, permits, and approvals for the following highway project in the State of Utah: Cottonwood Street; 4500 South to Vine Street in Murray City, Salt Lake County, project number S-LC35(198). The project will be a one-way couplet with southbound traffic on Box Elder Street and northbound traffic on Hanauer Street. The project includes construction of a new section of Hanauer Street between 4800 South and Vine Street. The project will improve connectivity and reduce pedestrian and auto travel distances between the planned Murray City Center District, transit stations, neighborhoods, and nearby arterials; and it supports Murray City's plans for economic redevelopment and a more livable, walkable community in the year 2040.
The actions by the FHWA and the laws under which such actions were taken, are described in the Environmental Assessment (EA) for the project, approved on August 17,2011, in the FHWA Finding of No Significant Impact (FONSI) issued on March 1,
This notice applies to all Federal agency decisions, actions, approvals, licenses and permits on the project as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1. General: National Environmental Policy Act (NEPA) [42 U.S.C. 4321- 4347]; Federal-Aid Highway Act [23 U.S.C. 109];
2. Air: Clean Air Act [42 U.S.C. 7401- 7671(q)];
3. Land: Section 4(f) of the Department of Transportation Act of 1966 [49 U.S.C. 303];Wildlife: Endangered Species Act [16 U.S.C. 1531-1544]; Migratory Bird Treaty Act [16 U.S.C. 703-712];
4. Historic and Cultural Resources: Section 106 of the National Historic Preservation Act of 1966, as amended [16 U.S.C. 470f.];
5. Social and Economic: Civil Rights Act of 1964 [42 U.S.C. 2000(d)- 2000(d)(1)]; Farmland Protection Policy Act (FPPA) [7 U.S.C. 4201-4209];
6. Wetlands and Water Resources: Clean Water Act, 33 U.S.C. 1251-1377 [Section 404, Section 401, Section 319]; Safe Drinking Water Act [42 U.S.C. 300f et seq.]; TEA-21 Wetlands Mitigation [23 U.S.C. 103(b)(6)(m), 133(b)(11)]; Flood disaster Protection Act [42 U.S.C. 4001-4129].
Executive Orders: E.O. 11990, Protection of Wetlands; E.O. 11988, Floodplain Management; E.O. 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations; E.O. 13175, Consultation and Coordination with Indian Tribal Governments; E.O. 13112, Invasive Species. Nothing in this notice creates a cause of action under these Executive Orders. (Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.)
23 U.S.C. 139(l)(1).
Federal Highway Administration (FHWA), DOT.
Notice of Limitation on Claims for Judicial Review of Actions by FHWA and Other Federal Agencies.
This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to the proposed interchange and roadway improvement project (Bangerter 600 West Project) in Draper, Salt Lake County in the State of Utah. These actions grant licenses, permits, and approvals for the project.
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filed on or before September 22, 2012. If the Federal law that authorizes judicial review of a claim provides a time period of less than 180 days for filing such claim, then that shorter time period still applies.
For FHWA: Mr. Edward Woolford, Environmental Program Manager, Federal Highway Administration, 2520 West 4700 South, Suite 9A, Salt Lake City, Utah 84129; telephone: (801) 955-3500; email:
Notice is hereby given that the FHWA and other Federal agencies have taken final agency actions by issuing licenses, permits, and approvals for the following highway project in the State of Utah: The Bangerter 600 West Project in Draper, Salt Lake County, Utah, project number FHWA-UT-EIS-11-01-F. Federal Lead Agency: Federal Highway Administration. Project Description: The project consists of improvements to Bangerter Highway between Interstate 15 (I-15) and the Union Pacific Railroad (UPRR) line at about 900 West in the city of Draper in Salt Lake County. The Selected Alternative (600 West Interchange with Right Turns Only at 200 West Alternative (Alternative 4F)) implements a transportation project consisting of: (1) A new interchange on Bangerter Highway at about 600 West; (2) eliminates the signals from the intersection at 200 West; (3) allows only right turns at the 200 West intersection. Left turns would not be permitted; (4) adds an additional west travel lane on Bangerter Highway between I-15 and the 600 West interchange; (5) adds an additional lane on the southbound I-15 off ramp; (6) adds a dedicated right-turn lane on westbound Bangerter Highway between I-15 and 200 West; (7) adds an acceleration lane from 200 West onto westbound Bangerter Highway to 600 West; (8) builds a connecting five-lane arterial from the 600 West interchange to the intersection of 13490 South and 200 West; (9) builds a connecting five-lane arterial to tie into 13800 South; (10) makes improvements to the 13490 South/200 West intersection to improve traffic flow. This would include providing double left-turn lanes from eastbound 13490 South to northbound 200 West; (11) relocates the Jordan and Salt Lake City Canal or place it in a pipe; (12) relocates utilities (fiber optic and drainage features) along Bangerter Highway; (13) includes stormwater drainage and passive water quality treatment.
The actions by the FHWA and other Federal agencies, and the laws under which such actions were taken, are described in the Final Environmental Impact Statement (FEIS) for the project, approved on November 18, 2011, in the FHWA Record of Decision (ROD) issued on March 7, 2012, and other key documents. The FEIS and ROD are available by contacting FHWA at the address provided above. The FHWA FEIS and ROD can be viewed and downloaded from the project Web site at
This notice applies to all Federal agency decisions on the project as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1.
2.
3.
4.
5.
6.
7.
Executive Orders: E.O. 11990, Protection of Wetlands; E.O. 11988, Floodplain Management; E.O. 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations; E.O. 13175, Consultation and Coordination with Indian Tribal Governments; E.O. 13112, Invasive Species. Nothing in this notice creates a cause of action under these Executive Orders.
23 U.S.C. 139(l)(1).
Federal Transit Administration (FTA), DOT.
Notice of proposed Buy America waiver and request for comment.
The purpose of this notice is to solicit comment a request from Allison Transmission, Inc. to renew a waiver for its hybrid electric propulsion system, Energy Storage Unit subsystem H 49.40 EPSystem, until December 31, 2013 so they may complete their ongoing process to secure a domestic supplier of Lithium Ion batteries. FTA seeks public comment before deciding whether to grant Allison's request.
Comments must be received by April 2, 2012. Late filed comments will be considered to the extent practicable.
Please submit your comments by only one of the following means, identifying your submissions by docket number FTA-2012-0006. All electronic submissions must be made to the U.S. Government electronic site at
(1)
(2)
(3)
(4)
Jayme L. Blakesley at (202) 366-0304 or
The purpose of this notice is to seek public comment on whether the Federal Transit Administration (FTA) should waive its Buy America requirements of 49 U.S.C. 5323(j), as implemented at 49 CFR Part 661, until December 31, 2013, for an Energy Storage Unit (ESU) manufactured by Allison Transmission, Inc. (Allison). The purpose of the waiver is to allow Allison until December 2013 to complete its ongoing process to secure and qualify a domestic supplier of Lithium Ion batteries.
The ESU is one of five subsystems of Allison's hybrid-electric propulsion system known as the H 40/50 EP System. The ESU supplies and stores energy for the H 40/50 EP System during normal motor-generator operation and during regenerative braking. The ESU is a packaged subsystem comprised of proprietary batteries, a battery management system, thermal management equipment and containment. It is manufactured to Allison's specifications and is functionally critical and specific to the H 40/50 EP System. The company currently procures the ESU completely assembled from a supplier that cannot comply with FTA's Buy America requirements.
With few exceptions, FTA's Buy America rules require that all steel, iron and manufactured goods used in FTA-funded projects be produced in the United States. One exception to Buy America is non-availability—that in some instances certain steel, iron, and manufactured goods are not produced in the United States in sufficient and reasonably available quantities or are not of a satisfactory quality. When this is the case, FTA may waive its Buy America requirements and allow the use of foreign-produced goods in an FTA-funded project.
On April 3, 2009, FTA granted a limited non-availability waiver to Allison. The waiver allowed Allison to produce its ESU outside the United States. While the waiver was in effect, FTA instructed Allison to identify and qualify a domestic manufacturer capable of producing ESUs for Allison's H 40/50 EP System. The waiver expired and, despite its best efforts, Allison has not identified and qualified a U.S. manufacturer.
Allison asked FTA to renew and extend the waiver until December 31, 2013, to allow it to complete the qualification process. According to Allison, since the issuance of the 2009 waiver, Allison has utilized competitive assessments, technical reviews, and independent market studies with U.S. based Lithium Ion suppliers. The company compared its current Nickel Metal Hydride (NiMH) batteries with Lithium Ion and determined Lithium Ion was appropriate for transit bus applications. In addition, Allison is changing from NiMH to Lithium Ion because no NiMH supplier is producing within the U.S. to meet Allison's requirements (design, reliability, quality, pricing, etc). Most domestic suppliers who expressed interest in starting production of the ESU subsystem quoted Lithium Ion technologies. Five companies have started or are starting cell production in the United States. Five additional companies are starting pack production in the Unites States.
After contacting and surveying a number of potential suppliers, Allison has chosen a domestic supplier. The selection and approval of this supplier
FTA proposes to grant Allison a waiver through December 31, 2013. Unlike other requests for non-availability waivers, the granting of which would enable otherwise non-compliant materials to be utilized until a U.S. producers comes forward, this waiver would allow Allison to maintain its position in the market while continuing the process of securing a domestic manufacturer for its ESU subsystems. Without a waiver extension, Allison faces a potential loss of volume, market share, and revenue, and a potential loss of U.S. Jobs. In addition, Allison's bus manufacturing customers would be limited in their ability to offer buses utilizing hybrid propulsion technology, without furthering the goals of Buy America.
Before deciding whether to grant Allison's request, FTA seeks comment from all interested parties. In the interest of transparency, FTA has published copies of Allison's request to the docket. Interested parties may access these materials by visiting the docket comments by April 2, 2012. Late-filed comments will be considered to the extent practicable.
National Highway Traffic Safety Administration, DOT.
Notice of receipt of petition.
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that right-hand drive (RHD) 2000-2003 Jeep Wrangler multi-purpose passenger vehicles (MPVs) that were not originally manufactured to comply with all applicable Federal Motor Vehicle Safety Standards (FMVSS) are eligible for importation into the United States because they have safety features that comply with, or are capable of being altered to comply with, all such standards.
The closing date for comments on the petition is April 25, 2012.
Comments should refer to the docket and notice numbers above and be submitted by any of the following methods:
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Follow the online instructions for accessing the dockets. The docket ID number and title of this notice are shown at the heading of this document notice. Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically search the Docket for new material.
George Stevens, Office of Vehicle Safety Compliance, NHTSA (202-366-5308).
Under 49 U.S.C. 30141(a)(1)(B), a motor vehicle that was not originally manufactured to conform to all applicable FMVSS, and has no substantially similar U.S.-certified counterpart, shall be refused admission into the United States unless NHTSA has decided that the motor vehicle has safety features that comply with, or are capable of being altered to comply with, all applicable FMVSS based on destructive test data or such other evidence as NHTSA decides to be adequate.
Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR Part 592. As specified in 49 CFR 593.7, NHTSA publishes notices in the
US SPECS of Havre de Grace, Maryland (Registered Importer 03-321) has petitioned NHTSA to decide
In its petition, US SPECS notes that Chrysler Corporation certified an RHD 2003 Jeep Wrangler MPV to all applicable FMVSS and offered that vehicle for sale in the United States. US SPECS contends that the non-U.S certified RHD 2000-2003 Jeep Wrangler MPV shares the same platform with the U.S.-certified RHD 2003 model, and on that basis compares the non-U.S. certified models to that vehicle to establish their conformity with many applicable FMVSS. Because there is no U.S.-certified counterpart for the RHD 2000, 2001, and 2002 Jeep Wrangler MPV, the petitioner acknowledged that it could not base its petition on the substantial similarity of those vehicles to the U.S.-certified RHD 2003 Jeep Wrangler MPV in light of the petitioning requirements of 49 U.S.C. 30141(a)(1)(A), as set forth in 49 CFR Part 593. Instead, the petitioner chose to establish import eligibility on the basis that the vehicles have safety features that comply with, or are capable of being modified to comply with, the FMVSS based on destructive test data or such other evidence that NHTSA decides to be adequate as set forth in 49 U.S.C. 30141(a)(1)(B). Nevertheless, the petitioner contends that the non-U.S. certified RHD 2000-2003 Jeep Wrangler MPV utilizes the same components as the U.S.- certified RHD 2003 Jeep Wrangler MPV in virtually all of the systems subject to the applicable FMVSS.
US SPECS submitted information with its petition intended to demonstrate that non-U.S. certified RHD 2000-2003 Jeep Wrangler MPVs conform to many FMVSS and are capable of being altered to comply with all other standards to which they were not originally manufactured to conform.
Specifically, the petitioner claims that non-U.S. certified RHD Jeep Wrangler MPVs, as originally manufactured, conform to: Standard Nos. 102
The petitioner also contends that the vehicles are capable of being altered to meet the following standards, in the manner indicated:
Standard No. 101
Standard No. 108
Standard No. 111
Standard No. 114
Standard No. 118
Standard No. 120
Standard No. 201
Standard No. 208
Standard No. 209
Standard No. 225
Standard No. 301
In addition, the petitioner states that a vehicle identification number plate must be installed in the area of the left windshield post to meet the requirements of 49 CFR Part 565 if the vehicle is not already so equipped.
All comments received before the close of business on the closing date indicated above will be considered, and will be available for examination in the docket at the above addresses both before and after that date. To the extent possible, comments filed after the closing date will also be considered. Notice of final action on the petition will be published in the
49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8; delegations of authority at 49 CFR 1.50 and 501.8.
National Highway Traffic Safety Administration, DOT.
Notice of receipt of petition.
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that 2005 Ifor Williams LM85G trailers that were not originally manufactured to comply with all applicable Federal Motor Vehicle Safety Standards (FMVSS) are eligible for importation into the United States because they have safety features that
The closing date for comments on the petition is April 25, 2012.
Comments should refer to the docket and notice numbers above and be submitted by any of the following methods:
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George Stevens, Office of Vehicle Safety Compliance, NHTSA (202-366-5308).
Under 49 U.S.C. 30141(a)(1)(B), a motor vehicle, including a trailer, that was not originally manufactured to conform to all applicable FMVSS, and has no substantially similar U.S.-certified counterpart, shall be refused admission into the United States unless NHTSA has decided that the motor vehicle has safety features that comply with, or are capable of being altered to comply with, all applicable FMVSS based on destructive test data or such other evidence as NHTSA decides to be adequate.
Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR Part 592. As specified in 49 CFR 593.7, NHTSA publishes notices in the
J.K. Technologies, LLC of Baltimore, Maryland (J.K.) (Registered Importer 90-006) has petitioned NHTSA to decide whether nonconforming 2005 Ifor Williams LM85G trailers are eligible for importation into the United States. J.K. believes these vehicles are capable of being modified to meet all applicable FMVSS.
J.K. submitted information with its petition intended to demonstrate that 2005 Ifor Williams LM85G trailers conform to one FMVSS and are capable of being altered to comply with all other standards to which they were not originally manufactured to conform.
Specifically, the petitioner claims that 2005 Ifor Williams LM85G trailers, as originally manufactured, are equipped with DOT-compliant tires, as required by Standard No. 119
The petitioner contends that the nonconforming 2005 Ifor Williams LM85G trailers are capable of being readily altered to meet the following standards, in the manner indicated:
Standard No. 108
Standard No. 120
In addition, the petitioner states that a vehicle identification number plate or label must be installed to meet the requirements of 49 CFR part 565 if the vehicle is not already so equipped.
All comments received before the close of business on the closing date indicated above will be considered, and will be available for examination in the docket at the above addresses both before and after that date. To the extent possible, comments filed after the closing date will also be considered. Notice of final action on the petition will be published in the
49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8; delegations of authority at 49 CFR 1.50 and 501.8.
Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation.
Notice of request for stakeholder input.
This notice is a request for comments and suggestions relative to the draft work plan of the Transportation—Dangerous Goods Working Group, of the United States-Canada Regulatory Cooperation Council (RCC). Comments will be accepted from all interested stakeholders.
Comments must be received by April 25, 2012.
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Mr. Shane Kelley or Mr. Vincent Babich, Office of Hazardous Materials Safety, Department of Transportation, Washington, DC 20590; (202) 366-0656.
President Barack Obama and Prime Minister Stephen Harper created the U.S.-Canada Regulatory Cooperation Council (RCC) on February 4, 2011. After private sector consultations and bilateral negotiations, the RCC released the Joint Action Plan on Regulatory Cooperation on December 7, 2011. The Joint Action Plan is a practical first step to increased regulatory cooperation between the United States and Canada.
In order to address the dangerous goods (hazardous materials) transportation opportunities identified in the Joint Action Plan, the Transportation—Dangerous Goods Working Group led by senior officials of regulatory agencies from both countries has developed a work plan with concrete objectives, deliverables and milestones for tangible progress within the RCC's two-year mandate. When available, the work plan will be posted at
The purpose of this request is to invite all interested stakeholders to provide comments relative to the plan and the RCC. The draft work plan has also been posted and is available for viewing under this docket number. All stakeholders including those who may not have participated in the United States-Canada Regulatory Cooperation Council (RCC) stakeholder engagement session on January 31, 2012 in Washington, DC are welcome to submit additional comments. Comments that were submitted prior to the publication date of this notice will be posted to this docket and do not need to be resubmitted.
PHMSA is particularly soliciting comments and suggestions in the following areas:
• The development of ongoing cooperation frameworks and alignment mechanisms in the work plan.
• Technical input relevant to issues identified in the work plan or otherwise in relation to the transportation of hazardous materials between the U.S. and Canada.
• Your preferred method and frequency of stakeholder engagement for the working group.
• Overall United States-Canada regulatory cooperation and the RCC process with respect to the transportation of hazardous materials.
Notice; correction.
The Department of the Treasury published a document in the
In the
• Page 6858, in the third column, under
• Page 6858, in the third column, under
• Page 6859, in the first column, fourth line of text beginning with “caused by”, replace “caused by severe storms, tornadoes, straight-line winds and flooding in Alabama beginning on April 15, 2011.” with “in the State of New York caused by either Hurricane Irene during the period of August 26, 2011, to September 5, 2011, or the remnants of Tropical Storm Lee during the period of September 7, 2011, to September 11, 2011.”
• Page 6859, in the first column, under
• Page 6859, in the first column, under
Internal Revenue Service, Treasury.
Notice of Closed Meeting of Art Advisory Panel.
Closed meeting of the Art Advisory Panel for Fine Art will be held in New York, NY.
The meeting will be held April 19, 2012.
The closed meeting of the Art Advisory Panel will be held on April 19, 2012, beginning at 9:30 a.m.,
Ruth M. Vriend, C:AP:P&V:ART, 999 N. Capitol Street NE., Washington, DC 20003. Telephone (202) 435-5739 (not a toll free number).
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App., that a closed meeting of the Art Advisory Panel will be held on April 19, 2012, beginning at 9:30 a.m., at 290 Broadway, Foley Square, New York, NY 10007.
The agenda will consist of the review and evaluation of the acceptability of fair market value appraisals of works of art involved in Federal income, estate, or gift tax returns. This will involve the discussion of material in individual tax returns made confidential by the provisions of 26 U.S.C. 6103.
A determination as required by section 10(d) of the Federal Advisory Committee Act has been made that this meeting is concerned with matters listed in section 552b(c)(3), (4), (6), and (7), and that the meeting will not be open to the public.
Occupational Safety and Health Administration (OSHA), DOL.
Final rule.
In this final rule, OSHA is modifying its Hazard Communication Standard (HCS) to conform to the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS). OSHA has determined that the modifications will significantly reduce costs and burdens while also improving the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. Consistent with the requirements of Executive Order 13563, which calls for assessment and, where appropriate, modification and improvement of existing rules, the Agency has concluded this improved information will enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they may be exposed, and in reducing the incidence of chemical-related occupational illnesses and injuries.
The modifications to the standard include revised criteria for classification of chemical hazards; revised labeling provisions that include requirements for use of standardized signal words, pictograms, hazard statements, and precautionary statements; a specified format for safety data sheets; and related revisions to definitions of terms used in the standard, and requirements for employee training on labels and safety data sheets. OSHA is also modifying provisions of other standards, including standards for flammable and combustible liquids, process safety management, and most substance-specific health standards, to ensure consistency with the modified HCS requirements. The consequences of these modifications will be to improve safety, to facilitate global harmonization of standards, and to produce hundreds of millions of dollars in annual savings.
This final rule becomes effective on May 25, 2012 Affected parties do not need to comply with the information collection requirements in the final rule until the Department of Labor publishes in the
The incorporation by reference of the specific publications listed in this final rule is approved by the Director of the Federal Register as of May 25, 2012.
In compliance with 28 U.S.C. 2112(a), the Agency designates Joseph M. Woodward, Associate Solicitor for Occupational Safety and Health, Office of the Solicitor, Room S-4004, U.S. Department of Labor; 200 Constitution Avenue NW., Washington, DC 20210, as the recipient of petitions for review of this final standard.
This final rule modifies the Hazard Communication standard (HCS) and aligns it with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) as established by the United Nations (UN). This action is consistent with Executive Order 13563 and, in particular, with its requirement of “retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome.” The preamble to the final rule provides a synopsis of the events leading up to the establishment of the final rule, a detailed description of OSHA's rationale for the necessity of the modification, and final economic and voluntary flexibility analyses that support the Agency's determinations. Also included are explanations of the specific provisions that are modified in the HCS and other affected OSHA standards and OSHA's responses to comments, testimony, and data submitted during the rulemaking. The discussion follows this outline:
The HCS requires that chemical manufacturers and importers evaluate the chemicals they produce or import and provide hazard information to downstream employers and employees by putting labels on containers and preparing safety data sheets. This final rule modifies the current HCS to align with the provisions of the UN's GHS. The modifications to the HCS will significantly reduce burdens and costs, and also improve the quality and consistency of information provided to employers and employees regarding chemical hazards by providing harmonized criteria for classifying and labeling hazardous chemicals and for preparing safety data sheets for these chemicals.
OSHA is required by the Occupational Safety and Health (OSH) Act of 1970 to assure, as far as possible, safe and healthful working conditions for all working men and women. Section 3(8) of the OSH Act (29 U.S.C. 652(8)) empowers the Secretary of Labor to promulgate standards that are “reasonably necessary or appropriate to provide safe or healthful employment and places of employment.” This language has been interpreted by the Supreme Court to require that an OSHA standard address a significant risk and reduce this risk significantly.
Section 6(b)(7) of the Act (29 U.S.C. 655(b)(7)) allows OSHA to make appropriate modifications to its hazard communication requirements as new knowledge and techniques are developed. The GHS system is a new approach that has been developed through international negotiations and embodies the knowledge gained in the field of chemical hazard communication since the current rule was first adopted in 1983. As indicated in Section IV of this preamble, OSHA finds that modifying the HCS to align with the GHS will enhance worker protections significantly. As noted in Section VI of this preamble, these modifications to HCS will also result in less expensive chemical hazard management and communication. In this way, the modifications are in line with the requirements of Executive Order 13563 and its call for streamlining of regulatory burdens.
OSHA is also required to determine if its standards are technologically and economically feasible. As discussed in Section VI of this preamble, OSHA has determined that this final standard is technologically and economically feasible.
The Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), requires OSHA to determine if a regulation will have a significant impact on a substantial number of small entities. As discussed in Section VI, OSHA has determined and certified that this rule will not have a significant impact on a substantial number of small entities.
Executive Orders 13563 and 12866 require OSHA to assess the benefits and costs of final rules and of available regulatory alternatives. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This rule has been designated an economically significant regulatory action under section 3(f)(1) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget, and the remainder of this section summarizes the key findings of the analysis with respect to the costs and benefits of the final rule.
Because this final rule modifies the current HCS to align with the provisions of the UN's GHS, the available alternatives to the final rule are somewhat limited. The Agency has qualitatively discussed the two major alternatives to the proposed rule—(1) voluntary adoption of GHS within the existing HCS framework and (2) a limited adoption of specific GHS components—in Section III of this preamble, but quantitative estimates of the costs and benefits of these alternatives could not reasonably be developed. However, OSHA has determined that both of these alternatives would eliminate significant portions of the benefits of the rule, which can only be achieved if the system used in the U.S. is consistently and uniformly applied throughout the nation and in conformance with the internationally harmonized system.
Table SI-1, derived from material presented in Section VI of this preamble, provides a summary of the costs and benefits of the final rule. As shown, the final rule is estimated to prevent 43 fatalities and 521 injuries and illnesses annually. Also as shown, OSHA estimates that the monetized health and safety benefits of the final rule are $250 million annually and that the annualized cost reductions and productivity gains are $507 million annually. In addition, OSHA anticipates that the final rule will generate substantial (but unquantified) savings from simplified hazard communication training and from expanded opportunities for international trade due to a reduction in trade barriers.
The estimated cost of the rule is $201 million annually. As shown in Table SI-1, the major cost elements associated with the final rule include the classification of chemical hazards in accordance with the GHS criteria and the corresponding revision of safety data sheets and labels to meet new format and content requirements ($22.5 million); training for employees to become familiar with new warning symbols and the revised safety data sheet format ($95.4 million); management familiarization and other management-related costs as may be necessary ($59.0 million); and costs to purchase upgraded label printing equipment and supplies or to purchase pre-printed color labels in order to include the hazard warning pictogram enclosed in a red-bordered diamond on the product label ($24.1 million).
The final rule is estimated to generate net monetized benefits of $556 million annually, using a discount rate of 7 percent to annualize costs and benefits. Using a 3 percent discount rate instead would have the effect of lowering the costs to $161 million per year and increasing the gross benefits to $839 million per year. The result would be to increase net benefits from $556 million to $678 million per year.
These estimates are for informational purposes only and have not been used by OSHA as the basis for its decision concerning the requirements for this final rule.
In the preamble, OSHA refers to supporting materials. References to these materials are given as “Document ID #” followed by the last four digits of the document number. The referenced materials are posted in Docket No. OSHA-H022K-2006-0062, which is available at
The HCS was first promulgated in 1983 and covered the manufacturing sector of industry (48 FR 53280, Nov. 25, 1983). (Please note: The Agency's HCS (29 CFR 1910.1200; 1915.1200; 1917.28; 1918.90; and 1926.59) will be referred to as the “current HCS” throughout this rule.) In 1987, the Agency expanded the scope of coverage to all industries where employees are potentially exposed to hazardous chemicals (52 FR 31852, Aug. 24, 1987). Although full implementation in the non-manufacturing sector was delayed by various court and administrative actions, the rule has been fully enforced in all industries regulated by OSHA since March 17, 1989 (54 FR 6886, Feb. 15, 1989) (29 CFR 1910.1200; 1915.1200; 1917.28; 1918.90; and 1926.59). In 1994, OSHA made minor changes and technical amendments to the HCS to help ensure full compliance and achieve better protection of employees (59 FR 6126, Feb. 9, 1994). The development of the HCS is discussed in detail in the preambles to the original and revised final rules (
The current HCS requires chemical manufacturers and importers to evaluate the chemicals they produce or import to determine if they are hazardous. The standard provides definitions of health and physical hazards to use as the criteria for determining hazards in the evaluation process. Information about hazards and protective measures is then required to be conveyed to downstream employers and employees through labels on containers and through material safety data sheets, which are now called “safety data sheets” (SDS) under the final rule and in this preamble. All employers with hazardous chemicals in their workplaces are required to have a hazard communication program, including container labels, safety data sheets, and employee training. Generally, under the final rule, these obligations on manufacturers, importers, and employers remain, but how hazard communication is to be accomplished has been modified.
To protect employees and members of the public who are potentially exposed to hazardous chemicals during their production, transportation, use, and disposal, a number of countries have developed laws that require information about those chemicals to be prepared and transmitted to affected parties. The laws vary on the scope of chemicals covered, definitions of hazards, the specificity of requirements (
Within the U.S., several regulatory authorities exercise jurisdiction over chemical hazard communication. In addition to OSHA, the Department of Transportation (DOT) regulates chemicals in transport; the Consumer Product Safety Commission (CPSC) regulates consumer products; and the Environmental Protection Agency (EPA) regulates pesticides, as well as exercising other authority over the labeling of chemicals under the Toxic Substances Control Act. Each of these regulatory authorities operates under different statutory mandates, and all have adopted distinct hazard communication requirements.
Tracking and complying with the hazard communication requirements of different regulatory authorities is a burden for manufacturers, importers, distributors, and transporters engaged in commerce in the domestic arena. This burden is magnified by the need to develop multiple sets of labels and safety data sheets for each product in international trade. Small businesses have particular difficulty in coping with the complexities and costs involved. The problems associated with differing national and international requirements were recognized and discussed when the HCS was first promulgated in 1983. At that time, OSHA committed to periodically reviewing the standard in recognition of an interagency trade policy that supported the U.S. pursuing international harmonization of requirements for chemical classification and labeling. The potential benefits of harmonization were noted in the preamble of the 1983 standard:
* * * [O]SHA acknowledges the long-term benefit of maximum recognition of hazard warnings, especially in the case of containers leaving the workplace which go into interstate and international commerce. The development of internationally agreed standards would make possible the broadest recognition of the identified hazards while avoiding the creation of technical barriers to trade and reducing the costs of dissemination of hazard information by elimination of duplicative requirements which could otherwise apply to a chemical in commerce. As noted previously, these regulations will be reviewed on a regular basis with regard to similar requirements which may be evolving in the United States and in foreign countries. (48 FR at 53287)
OSHA has actively participated in many such efforts in the years since that commitment was made, including trade-related discussions on the need for harmonization with major U.S. trading partners. The Agency issued a Request for Information (RFI) in the
In June 1992, the United Nations Conference on Environment and Development issued a mandate (Chapter 19 of Agenda 21), supported by the U.S., calling for development of a globally harmonized chemical classification and labeling system:
A globally harmonized hazard classification and compatible labeling system, including material safety data sheets and easily understandable symbols, should be available, if feasible, by the year 2000.
A coordinating group comprised of countries, stakeholder representatives, and international organizations was established to manage the work. This group, the Inter-Organization Programme for the Sound Management of Chemicals Coordinating Group for the Harmonization of Chemical Classification Systems, established overall policy for the work and assigned tasks to other organizations. The Coordinating Group then took the work of these organizations and integrated it to form the GHS. OSHA served as chair of the Coordinating Group.
The work was divided into three main parts: classification criteria for physical hazards; classification criteria for health and environmental hazards (including criteria for mixtures); and hazard communication elements, including requirements for labels and safety data sheets. The criteria for physical hazards were developed by a United Nations Sub-committee of Experts on the Transport of Dangerous Goods/International Labour Organization working group and were based on the already harmonized criteria for the transport sector. The criteria for classification of health and environmental hazards were developed under the auspices of the Organization for Economic Cooperation and Development. The ILO developed the hazard communication elements. OSHA participated in all of this work, and served as U.S. lead on classification of mixtures and hazard communication.
Four major existing systems served as the primary basis for development of the GHS. These systems were the requirements in the U.S. for the workplace, consumers, and pesticides; the requirements of Canada for the workplace, consumers, and pesticides; European Union directives for classification and labeling of substances and preparations; and the United Nations Recommendations on the Transport of Dangerous Goods. The requirements of other systems were also examined as appropriate, and taken into account as the GHS was developed. The primary approach to reconciling these systems involved identifying the relevant provisions in each system; developing background documents that compared, contrasted, and explained the rationale for the provisions; and undertaking negotiations to find an agreed approach that addressed the needs of the countries and stakeholders involved. Principles to guide the work were established, including an agreement that protections of the existing systems would not be reduced as a result of harmonization. Thus, countries could be assured that the existing protections of their systems would be maintained or enhanced in the GHS.
An interagency committee under the auspices of the Department of State coordinated U.S. involvement in the development of the GHS. In addition to OSHA, DOT, CPSC, and EPA, other agencies were involved that had interests related to trade or other aspects of the GHS process. Different agencies took the lead in various parts of the discussions. Positions for the U.S. in these negotiations were coordinated through the interagency committee. Interested stakeholders were kept informed through email dissemination of information, as well as periodic public meetings. In addition, the Department of State published a notice in the
OSHA published an Advance Notice of Proposed Rulemaking (ANPR) on the GHS in September of 2006 (71 FR 53617, Sept. 12, 2006). At the same time the ANPR was published, OSHA made available on its Web site a document summarizing the GHS (
This final rule is based on Revision 3 of the GHS. The adoption of the GHS will improve OSHA's current HCS standard by providing consistent, standardized hazard communication to downstream users. However, even after the U.S. and other countries implement the GHS, it will continue to be updated in the future. These updates to the GHS will be completed as necessary to reflect new technological and scientific developments as well as provide additional explanatory text. Any future changes to the HCS to adopt subsequent changes to the GHS would require OSHA's rulemaking procedures.
OSHA will remain engaged in activities related to the GHS. The U.S. is a member of the United Nations Committee of Experts on the Transport of Dangerous Goods and the Globally Harmonized System of Classification and Labelling of Chemicals, as well as the Sub-committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals, where OSHA is currently the Head of the U.S. Delegation. These permanent UN bodies have international responsibility for maintaining, updating as necessary, and overseeing the implementation of the GHS. OSHA and other affected Federal agencies actively participate in these UN groups. In addition, OSHA will also continue to participate in the GHS Programme Advisory Group under the United Nations Institute for Training and Research (UNITAR). UNITAR is
Based on consideration of the record as a whole, OSHA has modified the HCS to make it consistent with the GHS. OSHA finds that harmonizing the HCS with the GHS will improve worker understanding of the hazardous chemicals they encounter every day. Such harmonization will also reduce costs for employers.
OSHA believes that adopting the GHS will result in a clearer, more effective methodology for conveying information on hazardous chemicals to employers and employees. Commenters overwhelmingly supported the revision, and their submissions form a strong evidentiary basis for this final rule. The American Health Care Association stated that the GHS “would enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they might be exposed” (Document ID #0346). The National Institute of Environmental Health Sciences concurred, and added that adopting the GHS “would provide better worker health and safety protections” (Document ID #0347). (
Consistent with Executive Order 13563, OSHA has concluded that the revision significantly improves the current HCS standard. Moreover, there is widespread agreement that aligning the HCS with the GHS would establish a valuable, systematic approach for employers to evaluate workplace hazards, and provide employees with consistent information regarding the hazards they encounter. A member of the United Steel Workers aptly summed up the revision by stating that “the HCS in 1983 gave the workers the `right to know' but the GHS will give the workers the `right to understand' ” (Document ID #0403). The American Society of Safety Engineers (ASSE) concurred, stating that adoption of the HCS was “necessary to help this nation's workers deal with the increasingly difficult challenge of understanding the hazards and precautions needed to handle and use chemicals safely in an increasingly connected workplace” (Document ID #0336). Phlymar, ORC, BCI, 3M, American Iron & Steel Institute, and the North American Metals Council (NAMC) all agreed that the adoption of the GHS would improve the quality and consistency of information and the effectiveness of hazard communication (Documents ID #0322, 0336, 0339, 0370, 0377, 0390, 0405, and 0408). (
This section of the preamble provides an overview of the current HCS and how the adoption of the GHS will change this standard. Moreover, this section will also discuss the alternatives to mandatory implementation and the benefits of the final rule. The specific issues for which OSHA solicited comments in the NPRM will be discussed within their respective sections.
The HCS requires a comprehensive hazard evaluation and communication process, aimed at ensuring that the hazards of all chemicals are evaluated, and also requires that the information concerning chemical hazards and necessary protective measures is properly transmitted to employees. The HCS achieves this goal by requiring chemical manufacturers and importers to review available scientific evidence concerning the physical and health hazards of the chemicals they produce or import to determine if they are hazardous. For every chemical found to be hazardous, the chemical manufacturer or importer must develop a container label and an SDS, and provide both documents to downstream users of the chemical. All employers with employees exposed to hazardous chemicals must develop a hazard communication program, and ensure that exposed employees are provided with labels, access to SDSs, and training on the hazardous chemicals in their workplace.
There are three information communication components in this system—labels, SDSs, and employee training, all of which are essential to the effective functioning of the program. Labels provide a brief, but immediate and conspicuous, summary of hazard information at the site where the chemical is used. SDSs provide detailed technical information and serve as a reference source for exposed employees, industrial hygienists, safety professionals, emergency responders, health care professionals, and other interested parties. Training is designed to ensure that employees understand the chemical hazards in their workplace and are aware of protective measures to follow. Labels, SDSs, and training are complementary parts of a comprehensive hazard communication program—each element reinforces the knowledge necessary for effective protection of employees. Information required by the HCS reduces the incidence of chemical-related illnesses and injuries by enabling employers and employees to implement protective measures in the workplace. Employers can select less hazardous chemical alternatives and ensure that appropriate engineering controls, work practices, and personal protective equipment are in place. Improved understanding of chemical hazards by supervisory personnel results in safer handling of hazardous substances, as well as proper storage and housekeeping measures.
Employees provided with information and training on chemical hazards are able to fully participate in the protective measures instituted in their workplaces. Knowledgeable employees can take the steps required to work safely with chemicals, and are able to determine what actions are necessary if an emergency occurs. Information on chronic effects of exposure to hazardous chemicals helps employees recognize signs and symptoms of chronic disease and seek early treatment. Information provided under the HCS also enables health and safety professionals to provide better services to exposed employees. Medical surveillance, exposure monitoring, and other services are enhanced by the ready availability of health and safety information. The modifications that make up this final rule build on these core principles by establishing a more detailed and consistent classification system and requiring uniform labels and SDSs, which will better ensure that workers are informed and adequately protected from chemical exposures.
The current HCS covers a broad range of health and physical hazards. The standard is performance-oriented, providing definitions of hazards and parameters for evaluating the evidence to determine whether a chemical is considered hazardous. The evaluation is based upon evidence that is currently available, and no testing of chemicals is required.
The current standard covers every type of health effect that may occur, including both acute and chronic effects. Definitions of a number of adverse health effects are provided in the standard. These definitions are indicative of the wide range of coverage, but are not exclusive. Mandatory Appendix A of the current standard lists criteria for specific health effects; however, it also notes that these criteria are not intended to be an exclusive categorization scheme, but rather any available scientific data on the chemical must be evaluated to determine whether the chemical presents a health hazard. Any adverse health effect that is substantiated by a study conducted according to established scientific principles, and reporting a statistically significant outcome, is sufficient for determining that a chemical is hazardous under the rule.
Most chemicals in commerce are not present in the pure state (
The current HCS establishes requirements for minimum information that must be included on labels and SDSs, but does not provide specific language to convey the information or a format in which to provide it. When the current HCS was issued in 1983, the public record strongly supported this performance-oriented approach (
The GHS is an internationally harmonized system for classifying chemical hazards and developing labels and safety data sheets. However, the GHS is not a model standard that can be adopted verbatim. Rather, it is a set of criteria and provisions that regulatory authorities can incorporate into existing systems, or use to develop new systems.
The GHS allows a regulatory authority to choose the provisions that are appropriate to its sphere of regulation. This is referred to as the “building block approach.” The GHS includes all of the regulatory components, or building blocks, that might be needed for classification and labeling requirements for chemicals in the workplace, transport, pesticides, and consumer products. This rule only adopts those sections of the GHS that are appropriate to OSHA's regulatory sector. For example, while the GHS includes criteria on classifying chemicals for aquatic toxicity, these provisions were not adopted because OSHA does not have the regulatory authority to address environmental concerns. The building block approach also gives regulatory agencies the authority to select which classification criteria and provisions to adopt. OSHA is adopting the classification criteria and provisions for labels and SDSs, because the current HCS covers these elements. Broad criteria were established for the GHS in order to allow regulatory bodies to apply the same standards to a wide array of hazards. The building block approach may also be applied to the criteria for defining hazard categories. As a result, the GHS criteria are more comprehensive than what was in the current HCS, and OSHA did not need to incorporate all of the GHS hazard categories into this final rule.
Under the GHS, each hazard or endpoint (
Hazard communication requirements under the GHS are directly linked to the hazard classification. For each class and category of hazard, a harmonized signal word (
Precautionary statements are also required on GHS labels. The GHS provides precautionary statements; while they have been codified (numbered), they are not yet considered formally harmonized. In other words, regulatory authorities may choose to use different language for the precautionary statements and still be considered to be harmonized with the GHS. The GHS has codified these statements (
The GHS establishes a standardized 16-section format for SDSs to provide a consistent sequence for presentation of information to SDS users. Items of
The GHS uses an integrated, comprehensive process of identifying and communicating hazards, and the GHS modifications improve the HCS by providing more extensive criteria for defining the hazards in a consistent manner, as well as standardizing label elements and SDS formats to help to ensure that the information is conveyed consistently. The GHS does not include requirements for a written hazard communication program, and this final rule does not make substantive changes to the current HCS requirements for a written hazard communication program. Nor does the GHS impose employee training requirements; however, OSHA believes that additional training will be necessary to ensure that employees understand the new elements, particularly on the new pictograms. Therefore, modified training requirements have been included in the final rule in order to address the new label elements and SDS format required under this revised standard.
The revised HCS primarily affects manufacturers and importers of hazardous chemicals. Pursuant to the final rule, chemical manufacturers and importers are required to re-evaluate chemicals according to the new criteria in order to ensure the chemicals are classified appropriately. For health hazards, this will involve assigning the chemical both to the appropriate hazard category and subcategory (called hazard class). For physical hazards, these new criteria are generally consistent with current DOT requirements for transport. Therefore, if the chemicals are transported (
Preparation and distribution of modified labels and safety data sheets by chemical manufacturers and importers will also be required. However, those chemical manufacturers and importers following the ANSI Z400.1 standard for safety data sheets should already have the appropriate format, and will only be required to make some small modifications to the content of the sheets to be in compliance with the final rule.
Using the revised criteria, a chemical will be classified based on the type, the degree, and the severity of the hazard it poses. This information will help employers and employees understand chemical hazards and identify and implement protective measures. The detailed criteria for classification will result in greater accuracy in hazard classification and more consistency among classifiers. Uniformity will be a key benefit; by following the detailed criteria, classifiers are less likely to reach different interpretations of the same data.
Based on comments from the rulemaking effort, OSHA has made some modifications from the proposal to the final rule. These changes were the result of OSHA's analysis of the comments and data received from interested parties who submitted comments or participated in the public hearings. The major changes are summarized below and are discussed in the Summary and Explanation Section of this Preamble (Section XIII).
In the proposal, OSHA asked interested parties to comment on whether OSHA's permissible exposure limits (PELs) should be included on SDSs, as well as any other exposure limit used or recommended by the chemical manufacturer, importer, or employer who prepares SDSs. After reviewing and analyzing the comments and testimony, OSHA has decided not to modify the HCS with regard to the American Conference of Government Industrial Hygienists (ACGIH) Threshold Limit Values (TLVs) and so will continue to require ACGIH TLVs on SDSs. We have also retained the classification listings of the International Agency for Research on Cancer (IARC) and the National Toxicology Program (NTP) on SDSs. As explained more fully in the Summary and Explanation, OSHA finds that requiring ACGIH TLVs as well as the IARC and NTP classification listings on the SDS will provide employers and employees with useful information to help them assess the hazards presented by their workplaces.
As discussed in the NPRM, the GHS gives individual countries the option of using black, rather than red, borders around pictograms for labels used in domestic commerce. OSHA proposed requiring red frames for all labels, domestic and international. The final rule carries forward this requirement. As discussed in Sections IV and XIII, studies showed that there is substantial benefit to the use of color on the label. The color red in particular will make the warnings on labels more noticeable, because red borders are generally perceived to reflect the greatest degree of hazard. Further, while commenters who objected to this requirement cited the cost of printing in red ink as a reason to allow domestic use of black borders, OSHA was unconvinced that the costs involved made the provision infeasible, excessively burdensome, or warranted the diminished protection provided by black borders. (
One option suggested by commenters was requiring a red label but allowing manufacturers and importers to use preprinted labels with multiple red frames. This would save costs because the preprinted label stock could be used for different products requiring different pictograms. Use of this option, however, would mean that the label for a particular chemical might have empty red frames if the chemical did not require as many pictograms as there were red frames on the label stock.
As explained in Sections IV and XIII, OSHA has concluded that a red border without a pictogram can create confusion and draw worker attention away from the appropriate hazard warnings (
Another change to the final rule is the inclusion of the IARC and NTP as resources for determining carcinogenicity. Commenters generally supported this modification, and OSHA believes the inclusion of this information will assist evaluators with the classification process. Therefore, descriptions of both the IARC and NTP classification criteria have been added to Appendix F, and IARC and NTP classifications may be used to determine
OSHA has made several modifications to clarify and specify the definition for unclassified hazards, based on the comments provided. Executive Order 13563 states that our regulatory system “must promote predictability and reduce uncertainty,” and these efforts at clarification are designed to achieve that goal. OSHA included this definition to preserve existing safeguards under requirements of the HCS for chemical manufacturers and importers to disseminate information on hazardous chemicals to downstream employers, and for all employers to provide such information to potentially exposed employees. Inclusion of the definition does not create new requirements. OSHA has made certain changes to clarify application of the definition, and to ensure that the relevant provisions do not create confusion or impose new burdens.
In order to minimize confusion, OSHA has renamed unclassified hazards, “hazards not otherwise classified.” More fundamentally, and in response to the majority of the comments on this issue, OSHA has removed from the coverage of the general definition the hazards identified in the NPRM as not currently classified under the GHS criteria. These hazards are: pyrophoric gases, simple asphyxiants, and combustible dust. As described below, OSHA has added definitions to the final rule for pyrophoric gases and simple asphyxiants, and provided guidance on defining combustible dust for purposes of complying with the HCS. In addition, the Agency has also provided standardized label elements for these hazardous effects.
In response to concerns by commenters that, on occasion, a specified precautionary statement might not be appropriate, OSHA modified mandatory Appendix C to provide some added flexibility. Where manufacturers, importers, or responsible parties can show that a particular statement is inappropriate for the product, that precautionary statement may be omitted from the label. This is discussed in more detail in section XIII below.
Changing the HCS to conform to the GHS requires modification of other OSHA standards. For example, modifications have been made to the standards for Flammable and Combustible Liquids in general industry (29 CFR 1910.106) and construction (29 CFR 1926.152) to align the requirements of the standards with the GHS hazard categories for flammable liquids. Modifications to the Process Safety Management of Highly Hazardous Chemicals standard (29 CFR 1910.119) will ensure that the scope of the standard is not changed by the revisions to the HCS. In addition, modifications have been made to most of OSHA's substance-specific health standards, ensuring that requirements for signs and labels and SDSs are consistent with the modified HCS.
In the proposal, OSHA solicited comments regarding whether it would be feasible for employers to train employees regarding the new labels and SDSs within two years after publication of the final rule. Additionally, OSHA inquired as to whether chemical manufacturers, importers, distributors, and employers would be able to comply with all the provisions of the final rule within three years, and whether a phase-in period was necessary.
OSHA received many comments and heard testimony regarding the effective dates which are discussed in detail in Section XIII below. First, after analysis of the record, the Agency has determined that covered employers must complete all training regarding the new label elements and SDS format by December 1, 2013 since, as supported by record, employees will begin seeing the new style labels considerably earlier than the compliance date for labeling. Second, OSHA is requiring compliance with all of the provisions for preparation of new labels and safety data sheets by June 1, 2015. However, distributors will have an additional six months (by December 1, 2015) to distribute containers with manufacturers' labels in order to accommodate those they receive very close to the compliance date. Employers will also be given an additional year (by June 1, 2016) to update their hazard communication programs or any other workplace signs, if applicable.
Additionally, OSHA has decided not to phase in compliance based on whether a product is a substance or a mixture. OSHA has concluded that adequate information is available for classifiers to use to classify substances and mixtures. Finally, as discussed in the NPRM, employers will be considered to be in compliance with the HCS during the transition period as long as they are complying with either the existing HCS (as it appears in the CFR as of October 1, 2011) or this revised HCS. A detailed discussion regarding the effective dates is in Section XIII.
In the NPRM, OSHA proposed several alternatives to mandatory implementation of the GHS in response to concerns raised by commenters through the ANPR (74 FR at 50289). Commenters generally supported the concept of adopting the GHS as it was proposed. However, a few commenters indicated that they were concerned with what they saw as the cost burden on small businesses that are not involved in international trade. To address these concerns, OSHA solicited comments in the NPRM on several options proposed by the Agency regarding alternatives to mandatory harmonization. The following is a discussion of these alternatives; the potential impact and the response from participants in the rulemaking regarding the relative benefit, feasibility, impact on small business; and the impact on worker safety and health.
The first alternative OSHA proposed was to facilitate voluntary adoption of GHS within the existing HCS framework, and give manufacturers and importers the option to use the current HCS or the GHS system. This option would have permitted companies to decide whether they wanted to comply with the existing standard or with the GHS. A variation of this alternative was also proposed that would have adopted the GHS with an exemption allowing small chemical producers to continue to use the HCS, even after this GHS-modified HCS is promulgated.
The second alternative was a limited adoption of specific GHS components. Under this approach, producers could either comply with the GHS or a modified HCS that would retain the current HCS hazard categories, but require standardized hazard statements, signal words, and precautionary statements. A variation of this alternative would have omitted mandatory precautionary statements.
Commenters almost universally objected to both of the alternatives listed above (Document ID #0324, 0328, 0329, 0330, 0335, 0338, 0339, 0341, 0344, 0351, 0352, 0355, 0365, 0370, 0377, 0381, 0382, 0385, 0387, 0389, 0393, 0495, 0403, 0404, and 0412). American Industrial Hygiene Association (AIHA), in a representative comment, stated that “permitting voluntary use of some of the system * * * or exempting certain sectors based on business size or other criteria [would] defeat the purpose of revising this standard and of the GHS” (Document ID #0365). Additionally, the
Many commenters argued that a dual system that permitted businesses to opt out of complying with the GHS would undermine the key benefits of implementation. For example, Ferro Corporation stated that “for GHS to be effective and efficient in the U.S., implementation should be consistent and congruent” (Document ID #0363). DuPont Company argued “dual systems would be confusing for employers” (Document ID #0329). ORC also rejected voluntary implementation, reasoning that “consistent requirements for all manufacturers and importers of chemicals [are] needed to maximized efficiency in the chemical supply chain” (Document ID #0370). Additionally, the AFL-CIO cited consistent hazard information for workers and employers as the core objective of this rulemaking (Document ID #0340).
The commenters who supported GHS as proposed indicated that consistency was an essential aspect of this rule. Stericycle, Inc., stated that SDSs which “do not follow a consistent format would cause issues in understanding and implementing the controls to limit exposure and protect employee safety and health,” and argued that exemptions from GHS requirements would “shift the burden from the chemical industry to all employers” (Document ID #0338). Additionally, commenters did not support exempting small businesses from adopting the GHS. Ecolab argued that “large and small businesses use each others' products” and are inextricably linked, and they indicated that voluntary adoption “could cause confusion about product hazards if two identical products are labeled differently due solely to the size of the business from which [they are] obtained” (Document ID #0351).
OSHA agrees that the first alternative is unworkable as even one business's adoption of one of the alternatives would affect other companies. As stated in the comments above, if small businesses do not adopt the GHS, then large businesses or distributors will either have to generate GHS classifications for chemicals purchased, or request that small businesses supply data and labels using GHS classifications. Likewise, chemical producers often provide their products to distributors who then sell them to customers who are unknown to the original producer. This would lead to a plethora of product labels, a situation that is bound to make hazard communication far more difficult.
Commenters specifically cited issues with safety as their basis for rejecting the first proposed alternative. The AIHA (Document ID #0365) stated:
If employers and employees cannot have confidence that labels and MSDSs provide a consistent safety message superficial standardization will not improve safety. Safety is also seriously compromised if different hazard communication systems are present in the work area. Effective training is not possible if pictograms and hazard statements are not used in a consistent manner * * *. All of the approaches discussed will create competitive pressures that can affect classification decisions and make good and consistent hazard communication more difficult.
Moreover, commenters asserted that the benefits derived from the harmonized labeling of chemicals would be significantly diluted if employers were not uniformly required to adopt the GHS. United Steel Workers Union aptly reiterated that the primary benefit of adopting the GHS is not the facilitation of international trade, but rather is the protection of workers, which is “best accomplished through a uniform system of classification leading to comprehensible hazard information” (Document ID #0403). (
Several commenters supported the voluntary adoption of the GHS (Document ID #0355, 0389, and 0502). For example, Intercontinental Chemical Corporation supported voluntary adoption for companies not involved in international trade (Document ID #0502). Additionally, Betco supported allowing “small businesses that market domestically” to retain the current HCS and suggested that “voluntary adoption would not be any less protective for employees or create confusion” (Document ID #0389).
OSHA acknowledges that small chemical manufacturers will have some burdens associated with the adoption of GHS. However, employees who use products produced by small employers are entitled to the same protections as those who use products produced by companies engaged in international trade. The confusion created by two or more competing systems would undermine the consistency of hazard communication achievable by a GHS-modified HCS. Moreover, whether or not a product will wind up in international trade may not be known to the manufacturer or even the first distributer. A producer may provide a chemical to another company, which then formulates it into a product that is sold internationally. Thus, the original producer is involved in international trade without necessarily realizing it. For these reasons, OSHA has determined that, in order to achieve a national, consistent standard, all businesses must be required to adhere to the revised HCS.
OSHA concludes that the rulemaking record does not support adoption of the first alternative. The majority of private industry, unions, and professional organizations did not support this approach, arguing persuasively that piecemeal adoption would undermine the benefits of harmonization. As discussed above, while improvements to international trade are a benefit of this rulemaking; they are not the primarily intended benefit. OSHA believes that implementation of the GHS, without exceptions based on industry or business size, will enhance worker safety through providing consistent hazard communication and, consequently, safe practices in the workplace. However, as indicated above, OSHA does recognize that there are burdens with any change and as discussed in Section XIII, OSHA will use the input OSHA has received to the record to develop an outreach plan for additional guidance.
The second alternative, a halfway measure allowing businesses to adopt some of the features of a GHS-modified HCS but not requiring adoption of others, drew little interest or comment from the participants. OSHA has concluded that this alternative, which would have led to even more inconsistencies in hazard communication, is not a viable alternative. OSHA's conclusion is supported by the overwhelming number of commenters who spoke out against the first option and strongly supported the proposed standard. Allowing employers to adopt, say, only the provisions for the labels or safety data sheets will result in inconsistent use of the standardized hazard statement, signal word, and precautionary statement without clear direction on when they would be required, a situation that is sure to compromise safety in the workplace. Therefore, OSHA has concluded that implementation of the GHS is also preferable to the second alternative.
Pursuant to its analysis of the entire rulemaking record, OSHA has decided to adopt the GHS as proposed and is not incorporating any of the alternatives into this final rule. The adoption of any of the alternatives would undermine the key benefits associated with the GHS. OSHA has concluded, as discussed in Section V, that the adoption of GHS as proposed will strengthen and refine OSHA's hazard communication system, leading to safer workplaces.
Chemical exposure can cause or contribute to many serious adverse health effects such as cancer, sterility, heart disease, lung damage, and burns. Some chemicals are also physical hazards and have the potential to cause fires, explosions, and other dangerous incidents. It is critically important that employees and employers are apprised of the hazards of chemicals that are used in the workplace, as well as the associated protective measures. This knowledge is needed to understand the precautions necessary for safe handling and use, to recognize signs and symptoms of adverse health effects related to exposure when they do occur, and to identify appropriate measures to be taken in an emergency.
OSHA established the need for disclosure of chemical hazard information when the Hazard Communication Standard (HCS) was issued in 1983 (48 FR 53282-53284, Nov. 25, 1983). As noted in the NPRM (74 FR 50291, Sept. 30, 2009), this need continues to exist. The Agency estimates that 880,000 hazardous chemicals are currently used in the U.S., and over 40 million employees are now potentially exposed to hazardous chemicals in over 5 million workplaces. During the September 29, 2009, press conference announcing the publication of the HCS NPRM, Deputy Assistant Secretary of Labor for Occupational Safety and Health, Jordan Barab, discussed the impact that the HCS has had on reducing injury and illness rates. Mr. Barab stated that, since the HCS's original promulgation in 1983, “OSHA estimates that chemically-related acute injuries and illness [have] dropped at least 42%.” Reiterating information from OSHA's preliminary economic analysis in the NPRM, Mr. Barab also stated:
[T]here are still workers falling ill or dying from exposure to hazardous chemicals. OSHA estimates, based on BLS data, that more than 50,000 workers became ill and 125 workers died due to acute chemical exposure in 2007. These numbers are dwarfed by chronic illnesses and fatalities that are estimated in the tens of thousands.
OSHA believes that aligning the Hazard Communication Standard with the provisions of the GHS will improve the effectiveness of the standard and help to substantially improve worker safety and health. The GHS will provide a common system for classifying chemicals according to their health and physical hazards and it will specify hazard communication elements for labeling and safety data sheets.
Data collected and analyzed by the Agency also reflect this critical need to improve hazard communication. Chemical exposures result in a substantial number of serious injuries and illnesses among exposed employees. The Bureau of Labor Statistics estimates that employees suffered 55,400 illnesses that could be attributed to chemical exposures in 2007, the latest year for which data are available (BLS, 2008). In that same year, 17,340 chemical-source injuries and illnesses involved days away from work (BLS, 2009).
The BLS data, however, do not indicate the full extent of the problem, particularly with regard to illnesses. As noted in the preamble to the HCS in 1983, BLS figures probably only reflect a small percentage of the incidents occurring in exposed employees (48 FR 53284, Nov. 25, 1983). Many occupational illnesses are not reported because they are not recognized as being related to workplace exposures, are subject to long latency periods between exposure and the manifestation of disease, and other factors (
While the current HCS serves to ensure that information concerning chemical hazards and associated protective measures is provided to employers and employees, the Agency has determined that the revisions adopted in this final rule will substantially improve the quality and consistency of the required information. OSHA believes these revisions to the HCS, which align it with the GHS, will enhance workplace protections significantly. Better information will enable employers and employees to increase their recognition and knowledge of chemical hazards and take measures that will reduce the number and severity of chemical-related injuries and illnesses.
A key foundation underlying this belief relates to the comprehensibility of information conveyed under the GHS. All hazard communication systems deal with complicated scientific information being transmitted to largely non-technical audiences. During the development of the GHS, in order to construct the most effective hazard communication system, information about and experiences with existing systems were sought to help ensure that the best approaches would be used. Ensuring the comprehensibility of the GHS was a key principle during its development. As noted in a
As was discussed in the proposal (74 FR 50291), to help in the development of the GHS, OSHA had a review of the literature conducted to identify studies on effective hazard communication, and made the review and the analysis of the studies available to other participants in the GHS process. One such study, prepared by researchers at the University of Maryland, entitled “Hazard Communication: A Review of the Science Underpinning the Art of Communication for Health and Safety” (Sattler
Further work related to comprehensibility was conducted during the GHS negotiations by researchers in South Africa at the University of Cape Town—the result is an annex to the GHS on comprehensibility testing (
Another principle that was established to guide development of the GHS was the agreement that levels of protection offered by an existing hazard communication system should not be reduced as a result of harmonization. Following these principles, the best aspects of existing systems were identified and included in a single, harmonized approach to classification, labeling, and development of SDSs.
The GHS was developed by a large group of experts representing a variety of perspectives. Over 200 experts provided technical input on the project. The United Nations Sub-Committee of Experts on the GHS, the body that formally adopted the GHS and is now responsible for its maintenance, includes 35 member nations as well as 14 observer nations. Authorities from these member states are able to convey the insight and understanding acquired by regulatory authorities in different sectors, and to relate their own experiences in implementation of hazard communication requirements. In addition, over two dozen international and intergovernmental organizations, trade associations, and unions are represented, and their expertise serves to inform the member nations. The GHS consequently represents a consensus recommendation of experts with regard to best practices for effective chemical hazard communication, reflecting the collective knowledge and experience of regulatory authorities in many nations and in different regulatory sectors, as well as other organizations that have expertise in this area.
United States-based scientific and professional associations have endorsed adoption of the GHS since publication of the Advance Notice of Proposed Rulemaking (ANPR) in 2006 (71 FR 53617, Sept. 12, 2006). For example, the American Chemical Society (ACS) indicated its support for the GHS, stating: “The American Chemical Society strongly supports the adoption of the GHS for hazard communication in general and specifically as outlined in the ANPR” adding that “* * * ACS anticipates that OSHA implementation of GHS in the U.S. will enhance protection of human health and the environment through warnings and precautionary language that are consistent across different products and materials as well as across all workplaces” (Document ID #0165). The American Industrial Hygiene Association (AIHA) affirmed its support for modification of the HCS to adopt the GHS. AIHA maintained that standardized labels and safety data sheets will make hazard information easier to use, thereby improving protection of employees (Document ID #0034). While acknowledging that the GHS presents a number of concerns and challenges, the Society of Toxicology has also expressed its support for the GHS, stating that “a globally harmonized system for the classification of chemicals is an important step toward creating consistent communications about the hazards of chemicals used around the world” (Document ID #0304). The American Association of Occupational Health Nurses joined these organizations in advocating adoption of the GHS, arguing that standardization of chemical hazard information is critical to protecting the safety and health of employees (Document ID # 0099). Responders to the 2009 NPRM reiterated their support or, in the case of new commenters, echoed the comments from other scientific and professional associations to the ANPR (
Stakeholders representing a wide range of sectors and interests agreed with OSHA that aligning the HCS with the GHS will improve comprehensibility, and thus lead to reductions in chemical source illnesses and injuries. American Society of Safety Engineers, Dow Chemical, and ORC all voiced their support for the proposed rule, citing improved comprehensibility and quality of transmitted information as key benefits (Document ID #0336, 0353, and 0370). Representing union labor, the American Federation of State, County and Municipal Employees (AFSCME) stated that this rulemaking would “allow critical communication about the hazards of chemicals to be understood by all workers, regardless of their literacy level or primary language * * * [and] will in turn lead to safer, more productive workplaces” (Document ID #0414). Many stakeholders asserted that adopting the GHS would lead to safer workplaces. The Chamber of Commerce provided its support for the rulemaking, stating that the GHS could “improve worker safety, and facilitate business growth and international trade” (Document ID #0397). The American Subcontractors Association, Inc. added that consistent hazard communication is critical to having a safe work program (Document ID #0322). Additionally, North American Metals Council (NAMC), which represents the interests of the metals and mining industry, stated that a single, globally harmonized classification and labeling system is of vital interest to its members (Document ID #0233). The position that GHS would increase worker protection was also raised in testimony during the hearings. Elizabeth Treanor of Phylmar Regulatory Roundtable testified that adopting the GHS would “enhance the effectiveness of the hazard communication standard by improving the quality and consistency of chemical hazard information that is provided to employees and employers” (Document ID #0497 Tr. 92).
In addition to the endorsement of the GHS by a group of experts with extensive knowledge and experience in chemical hazard communication, support from scientific and professional associations with expertise in this area, and support from industry and labor stakeholders, a substantial body of evidence indicates that the modifications to the HCS will better protect employees. Specifically, this evidence supports OSHA's findings that: (1) Standardized label elements—signal words, pictograms, hazard statements and precautionary statements—will be more effective in communicating hazard information; (2) standardized headings and a consistent order of information will improve the utility of SDSs; and (3) training will support and enhance the effectiveness of the new label and SDS requirements.
This evidence was obtained from sources predating the ANPR and from more recent data. OSHA commissioned several studies to examine the quality of information on SDSs (Karstadt, 1988, Document ID #0296; Kearney/Centaur 1991a, 1991b, Document ID #0309 and 0310; Lexington Group, 1999, Document ID #0257); the General Accounting Office (GAO) has issued two reports based on its evaluation of certain aspects of the HCS (GAO 1991 and 1992, Document ID #0271 and 0272); a National Advisory Committee on Occupational Safety and Health (NACOSH) workgroup conducted a review of hazard communication and published a report of its findings (NACOSH, 1996, Document ID #0260); and a substantial amount of scientific literature relating to hazard communication has been published. As mentioned previously, OSHA
No commenters questioned the validity of studies presented in the NPRM. Similarly, commenters did not question OSHA's analysis or interpretation of the study findings. Only one commenter suggested that OSHA should adopt more “conservative expectations for the effects that warning format changes can have on the behavior of end users,” adding that “real-world conditions” must be accounted for when determining the actual responses of users (Document ID #0396). However, the commenter did not disagree with OSHA's overall conclusion that this final rule would improve safety. OSHA agrees that external factors may influence the overall benefits of label elements (this will be addressed in Section VI).
The studies discussed in the NPRM formed the evidentiary basis for the revised HCS. As such, OSHA infers that commenters generally found the studies, as well as OSHA's analysis, to be sound. OSHA's rationale for adopting the GHS is tied to anticipated improvements in the quality and consistency of the information that would be provided to employers and employees. Hazard classification is the foundation for development of this improved information. Indeed, hazard classification is the procedure of identifying and evaluating available scientific evidence in order to determine if a chemical is hazardous, and the degree of hazard, pursuant to the criteria for health and physical hazards set forth in the standard. Hazard classification provides the basis for the hazard information that is provided in labels, SDSs, and employee training. As such, it is critically important that classification be performed accurately and consistently.
The GHS provides detailed scientific criteria to direct the evaluation process. The specificity and detail provided help ensure that different evaluators would reach the same conclusions when evaluating the same chemical. Moreover, the GHS refines the classification process by establishing categories of hazard within most hazard classes. These categories indicate the relative degree of hazard, and thereby provide a basis for determining precise hazard information that is tailored to the level of hazard posed by the chemical. The classification criteria established in the GHS thus provide the necessary basis for development of the specific, detailed hazard information that would enhance the protection of employees.
Labels serve as immediate visual reminders of chemical hazards, and complement the information presented in training and on SDSs. The current HCS requires that labels on hazardous chemical containers include the identity of the hazardous chemical; appropriate hazard warnings that convey the specific physical and health hazards, including target organ effects; and the name and address of the chemical manufacturer, importer, or other responsible party. The HCS does not specify a standard format or design elements for labels.
In the NPRM, OSHA proposed to improve the HCS by changing the performance requirements for labels to the GHS-specific requirements that labels include four standardized elements: a signal word; hazard statement(s); pictogram(s); and precautionary statement(s) (
This requirement is different from the current HCS in that it will require consistent and detailed information regarding a chemical based on the hazard classification. The current rule does not specify a standard format or design elements for labels. Rather, all that is required in the current HCS is that the label of the hazardous chemical containers include the identity of the hazardous chemical; appropriate hazard warnings that convey the specific physical and health hazards, including target organ effects; and the name and address of the chemical manufacturer, importer, or other responsible party.
Additionally, as discussed in the proposal (74 FR 50291, Sept. 30, 2009), a great deal of literature has been developed that examines the effectiveness of warnings on labels. These studies support OSHA's adoption of standardized warnings on the labels of hazardous chemicals. Although the studies discussed below pertain to prescription and non-prescription medications, alcoholic beverages, or consumer products rather than hazardous chemicals, it does not diminish the importance or relevance of the data. This literature provides a substantial body of information directly applicable and analogous to workplace chemical labels. In spite of the differences in affected populations, workplace chemical labels have many characteristics that are comparable to those found in other sectors. Pharmaceutical labels, for example, are similar to chemical labels in that they often have explicit instructions for use which, if not followed, can cause adverse health effects or death. Designers of pharmaceutical labels also encounter many of the same challenges faced by those who design chemical labels, such as container space limitations and the need to convey information to low-literate or non-English-literate users. In addition, some of the research is not directly related to any particular sector or type of product. Some findings related to use of color, for example, could reasonably be applied to a wide variety of label applications. The studies are discussed below in the specific labeling sections.
A signal word is a word that typically appears near the top of a warning, sometimes in all capital letters. Common examples include DANGER, WARNING, CAUTION, and NOTICE. The signal word is generally understood to serve a dual purpose: Alerting the user to a hazard and indicating a particular level of hazard. For example, users generally perceive the word DEADLY to indicate a far greater degree of hazard than a term like NOTICE.
This final rule requires the use of one of two signal words for labels—DANGER or WARNING—depending on the hazard classification of the substance in question. These are the same two signal words used in the GHS. DANGER is used for the more severe hazard categories, while WARNING denotes a less serious hazard. These signal words are similar to those in other established hazard communication systems, except that some other systems have three or more tiers. For example, ANSI Z129.1 (the American National Standard for Hazardous Industrial Chemicals—Precautionary Labeling) uses DANGER, WARNING, and CAUTION, in descending order of severity (ANSI, 2006, Document ID #0280).
A number of studies have examined how people perceive signal words and,
Wogalter
Seeking to test warning signs in realistic settings, Adams
Laughery
Several studies have tested the arousal strength or perceived hazard of different signal words.
Griffith and Leonard asked 80 female undergraduates (who were unlikely to have already received industrial safety training) to rate signal words. Results included a list of terms in order of “meaningfulness,” representing conceptual “distance” from the neutral term NOTICE (Griffith and Leonard, 1997, Document ID #0250). From most to least meaningful, these terms were reported to be DANGER, URGENT, BEWARE, WARNING, STOP, CAUTION, and IMPORTANT.
Wogalter
In more of a free-form experiment, Young asked 30 subjects to produce warning signs for a set of scenarios, using different sign components available on a computer screen (Young, 1998, Document ID #0289). In roughly 80 percent of the signs, the participant chose to use a signal word. DANGER, DEADLY, and LETHAL were more likely to be used for scenarios with severe hazards; CAUTION and NOTICE for non-severe scenarios. WARNING was used equally in both types of scenarios. The author suggests that these results support a two-tiered system of signal words. In a separate task, users ranked the perceived hazard of signal words, resulting in the following list from most to least severe: DEADLY, LETHAL, DANGER, WARNING, CAUTION, and NOTICE.
While these studies have focused on the relative perceptions of signal words, others have sought to evaluate how the absolute meaning of common signal words is perceived. Drake
Signal word perceptions are reported to be consistent among some non-U.S. populations, as well. Hellier
Similar results were found among workers in Zambia. Banda and Sichilongo tested GHS-style labels using four different signal words (as well as other variables) (Banda and Sichilongo, 2006, Document ID #0237). Among workers in the industrial and transport sectors, DANGER was generally perceived as the most hazardous signal word. WARNING was one of a group of terms that were largely indistinguishable from one another, but distinct from DANGER. The authors support adoption of the GHS, suggesting that having just two possible signal words will lead to “more impact and less confusion about the extent of hazard.”
In addition, comparable results were found in South Africa (London, 2003, Document ID #0311). In a large study on SDS and label comprehensibility conducted for South Africa's National Economic Development and Labour
Cumulatively, these studies provide a clear indication that signal words are effective in alerting readers that a hazard exists, and in conveying the existence of a particular level of hazard. The studies found a generally consistent hierarchy of signal words with respect to perceived hazard. DANGER and WARNING appear to connote different levels of hazard, while the perceived difference between WARNING and CAUTION is often insignificant.
In response to the NPRM, OSHA received a comment from Croplife America about the impact of using a two-tiered signal word system on pesticide labels (Document ID #0387). Croplife America explained that they believe a three-tiered system (DANGER, WARNING and CAUTION) provides “a little more distinction in the relative toxicity of a compound” and “if everything says `warning,' we run the risk of diluting the effectiveness of the signal word” (Document ID #0495 Tr. 251). During the informal public hearings, OSHA requested that Croplife America support their position on why a three-tiered warning system is better than a two-tiered system. To support this assertion, Croplife America submitted a late comment containing an additional paper by Hellier
This paper discusses two studies performed in 2007 to analyze if alternative information is communicated with signal words (Hellier
Even if it had been timely submitted, OSHA is not convinced that this study supplies sufficient evidence that using a two-tiered signal word approach will diminish the chemical user's ability to distinguish hazard severity. In OSHA's opinion, if anything, the Hellier study provides additional support for the use of signal words on labels to attract attention and to identify levels of hazard. Indeed, its results show that the signal word “caution” was substantially less connected by participants with communicating hazards than “warning” and “danger,” which supports OSHA's decision not to use “caution” as a signal word. The record supports OSHA's determination that using the signal word in combination with the hazard statement alerts the chemical user to the hazard and allows him or her to distinguish the level of hazard severity posed by hazardous chemicals in the workplace.
Commenting on the studies presented in the proposal, Applied Safety and Ergonomics (ASE) agreed that there are benefits associated with the standardization of warning elements. However, they also urged “OSHA to adopt more conservative expectations for the effect that warning format changes can have on the behavior of end users” (Document ID #0396).
Comments received from stakeholders support the revision of the HCS to include the use of standardized signal words (Document ID #0321, 0338, 0339, and 0349). For example, the Communications Workers of America (CWA) stated: “Clearly, the Rule's requirements regarding revised SDSs and labeling provisions requiring the use of standardized signal words, pictograms, and hazard and precautionary statements would prove invaluable to affected CWA members whom have been exposed to hazardous chemicals and chemical products that have produced negative health effects and medical problems” (Document ID #0349). These comments support OSHA's conclusion that signal words alert chemical users to a hazard and indicate a particular level of hazard.
After reviewing the comments received and the evidence presented in the record, OSHA has determined that, in this revised rule, use of the signal words “DANGER” and “WARNING” is appropriate.
A pictogram is a graphical composition that may include a symbol along with other graphical elements, such as a border or background color. A pictogram is a communication tool and is intended to convey specific information. The proposed rule included requirements for use of eight different pictograms. Each of these pictograms consists of a different symbol in black on a white background within a red square frame set on a point (
A study by Kalsher
Symbols may be more salient than text because of visual differentiations of shape, size, and color. Usually symbols have unique details and possess more differences in appearance than do the letters of the alphabet. Letters are highly familiar and are more similar to one another than most graphical symbols.
Other investigators have examined the benefits of pictograms for those with low literacy levels and those who do not understand the language in which the
Several researchers have sought to evaluate how people comprehend symbols, including the symbols that were proposed to be required. Several studies have found that the skull and crossbones icon—one of the symbols proposed and included in the final rule—is among the most recognizable of safety symbols. For example, Wogalter
Several studies have examined other pictograms included in the final rule. As part of an experiment to see how individuals comprehend warnings on household chemical labels, Akerboom and Trommelen asked 60 university students whether they understood the meaning of several pictograms, including four that are included in the final rule (Akerboom and Trommelen, 1998, Document ID #0236). The authors reported the following levels of comprehension for these pictograms:
Flame: 93 percent comprehension;
Skull and crossbones: 85 percent comprehension;
Corrosion: 20 percent comprehension; and
Flame over circle: 13 percent comprehension.
Only the flame and skull and crossbones pictograms met the 85 percent comprehension criteria suggested by ANSI Z535.3 (the American National Standard Criteria for Safety Symbols) (ANSI, 2002a, Document ID #0276). The authors recommend that labels present the hazard phrase [statement] and symbol together, along with corresponding precautions, as has been included as a requirement in the final rule.
Banda and Sichilongo tested comprehension of labels among 364 workers in four sectors in Zambia (transport, agriculture, industrial, and household consumers) (Banda and Sichilongo, 2006, Document ID #0237). Within this population, the skull and crossbones symbol was widely understood, as was the “flame” symbol. Based on these results, the authors suggest a preference for symbols that depict familiar, meaningful, and recognizable images.
London performed a similar study among the same four sectors in South Africa, finding that the skull and crossbones was understood by at least 96 percent of each sector and “flame” by at least 89 percent (London, 2003, Document ID #0311). “Exploding bomb” was correctly comprehended by 44 to 71 percent of each sector. On the other hand, many health-related symbols did not fare well, and six symbols had less than 50 percent comprehension across all four sectors. Outside the transport sector, “Gas cylinder” was the least comprehended symbol.
These findings indicate that some of the pictograms included in the final rule are already widely recognized by a general audience. Others, however, are not commonly understood. Therefore, simply adding some of the pictograms on labels will not provide useful information unless efforts are also undertaken to ensure that employees understand the meaning of the pictograms. As Wogalter
Where pictograms are used and understood, communication of hazards can be improved. Houts
Another body of literature focuses on the utility of symbols in general. Ganier found that people generally construct mental representations faster with pictures than they do with text, supporting earlier findings on the usefulness of symbols (Ganier, 2001, Document ID #0275). Evans
In a follow-up article on the South African study mentioned previously, Dowse and Ehlers found that patients receiving antibiotics adhered to instructions much better when the instructions included pictograms—(54 percent with high adherence, versus 2 percent when given text-only instructions) (Dowse and Ehlers, 2005, Document ID #0243).
Pictograms also serve to attract attention to the hazard warnings on a label. To examine factors that influence the effectiveness of pharmaceutical labels, Kalsher
Laughery
Where chemical labels are concerned, London found that symbols tend to be the most easily recalled label elements (London, 2003, Document ID #0311). In the comprehensibility test of labels
Wogalter
Meingast asked subjects to recall warning content after viewing labels that were considered either high quality (with color signal icons, pictorials, and organized text conforming to ANSI Z535.4, the American National Standard for Product Safety Signs and Labels) or low quality (text only) (Meingast, 2001, Document ID #0210). Pictorials were the items remembered most often, accounting for 48 percent of what viewers of high-quality labels recalled. The author suggests that these pictorials also served the role of dual coding, meaning that they help to improve the retention of corresponding text.
Other studies support this dual-coding function of pictorials, finding that symbols tend to be most effective when paired with redundant or reinforcing text. For example, Sojourner and Wogalter asked 35 participants to rate several prescription label formats in terms of ease of reading, ease of understanding, overall effectiveness, likelihood of reading, overall preference, pictorial understanding, and how helpful pictorials are in helping to remember the instructions (Sojourner and Wogalter, 1997, Document ID #0288). The authors found that people prefer fully redundant text and pictorials, which they judged easiest to read, most effective, and preferred overall. Dual-coded pictorials aided understanding and memory more than labels with pictorials only (no text).
In a follow-up study, Sojourner and Wogalter gave undergraduates, young adults, and older adults a free recall test after viewing medication labels (Sojourner and Wogalter, 1998, Document ID #0288). Fully redundant text and pictorials led to significantly greater recall than other formats, and were rated most effective by all age groups.
Similarly, Sansgiry
Some evidence links use of pictograms directly to safer behavior. Jaynes and Boles investigated whether different warning designs, specifically those with symbols, affect compliance rates (Jaynes and Boles, 1990, Document ID #0290). Five conditions were tested: a verbal warning, a pictograph warning with a circle enclosing each graphic, a pictograph warning with a triangle on its vertex enclosing each graphic, a warning with both words and pictographs, and a control (no warning). Participants performed a chemistry laboratory task using a set of instructions that contained one of the five conditions. The warnings instructed them to wear safety goggles, mask, and gloves. All four warning conditions had significantly greater compliance than the no-warning condition. A significant effect was also found for the “presence of pictographs” variable, suggesting that the addition of pictographs will increase compliance rates.
NIOSH submitted an additional study at the informal public hearings that analyzed the use of pictograms on labels. In 1997, Wilkinson
Stakeholders on the whole supported the inclusion of pictograms on the labels of hazardous substances. During the hearings, Chris Trahan of the AFL-CIO voiced support for including pictograms on the labels of hazardous chemicals, and cited construction workers as a group whose safety and health conditions would be greatly improved by OSHA's adoption of “a system of symbols [workers] can then readily use to make decisions on a daily basis” (Document ID #0494 Tr. 8).
As discussed in the proposal, a considerable amount of evidence shows that pictograms can serve as useful and effective communication tools. In the final rule, OSHA has decided to adopt the eight GHS pictograms initially proposed in the NPRM. Each of these pictograms consists of a different symbol in black on a white background within a red square frame set on a point (
OSHA finds, based on scores of supporting studies and persuasive testimony that the pictograms will make warnings on labels more noticeable and easier for employees to understand. In particular, symbols will improve comprehension among people with low literacy levels and those who are not literate in the English language. Moreover, pictograms will be used not only in conjunction with other label elements, but also in the context of the hazard communication program as a whole. Training that includes an explanation of labels (included in the final rule) will ensure that the pictograms are understood by employees.
GHS allows regulatory authorities the option of permitting black pictogram borders for labels on domestic products, and in the proposal OSHA requested comment on this issue. Mandating the use of red borders was supported by stakeholders, who argued persuasively that red borders would make labels more noticeable and would make the warnings appear to be more important (Document ID #0339, 0341, 0365, 0383, 0408, 0410, 0412, and 0456). The National Association of Chemical Distributers, in supporting the use of red borders, reasoned that they would be consistent with the overall goal of the
Several commenters raised economic concerns, suggesting that because red ink is more expensive, the use of black borders should be permitted (Document ID #0318, 0328, 0370, 0377, 0382, 0393, and 0411). Dow Chemical, Troy Corporation, and several other commenters recommended that red borders should only be required on products that were being exported (Document ID #0352, 0353, 0399, 0405, and 0389). Similarly, API argued that in order to remain consistent with the GHS, OSHA should only require exported chemicals to have a red border (Document ID #0376).
OSHA finds this argument to be unpersuasive. In order to reap the benefits of consistency in warnings, labels must have a degree of sameness and that includes the colors used. Moreover, OSHA analyzed the impact that the use of red borders would have on production costs. While the use of red borders may increase the cost of printing, OSHA has determined that the cost does not render the rule infeasible. This issue is discussed in greater detail in Section VI. Finally, the GHS does not even state a preference for black borders on labels of domestic products; it simply gives the competent authority discretion to allow black borders when the product will not enter into international commence.
Numerous studies have found that substantial benefits exist when color is used on labels. Due to the extensive amount of information that needs to be displayed, warning labels can become cluttered. Swindell found that searching for needed information on a cluttered label is very challenging for the user (Swindell, 1999, Document ID #0284). Her study concluded that minor changes to an extensive warning label, such as the addition of color, can greatly improve the noticeability of the warning, grab the attention of the user faster, and produce quicker reaction times.
Swindell also researched the effect that different colors (red, blue, and black) had on the time it took users to locate and respond to a warning. Red was perceived to indicate the highest degree of hazard and was shown to increase the perceived hazard of a word presented in that color (
Swindell's findings echo the results reported by Laughery
The primacy of red as an understandable color denoting danger is also supported by these studies.
• Smith-Jackson and Wogalter asked English-speaking community members to rate the perceived hazard of ten ANSI safety colors (Smith-Jackson and Wogalter, 2000, Document ID #0196). Red, yellow, black, and orange were rated the highest (in descending order). Differences were statistically significant except the difference between yellow and black.
• Among 80 college students asked to rate colors by Griffith and Leonard, red was rated the most “meaningful” color (
• Wogalter
• Dunlap
• Wogalter
• London asked workers in four sectors in South Africa to rank the colors red, yellow, green, and blue in terns of perceived hazard; 95 percent said red represents the greatest hazard, and 58 percent said yellow is the second greatest hazard (London, 2003; Document ID #0311).
• Banda and Sichilongo asked workers in Zambia to rate the perceived hazard of various colors used in chemical labels (Banda and Sichilongo, 2006, Document ID #0237). Red was associated with the greatest hazard, followed by yellow.
• Among a sample of 30 undergraduates who rated the perceived hazard of 105 signal word/color combinations, Braun
These reports are consistent in showing that red is commonly understood to be associated with a high level of hazard—the highest of any color.
After reviewing stakeholder comments and studies investigating the benefits of using the color red to signal a hazard, OSHA has decided to require all pictograms to have red borders. OSHA finds that these labels will be more effective in communicating hazards to employees—both by drawing the attention of employees to the label and by indicating the presence of a hazard through non-verbal means. Consistently applying red borders to all labels, regardless of the final destination, will ensure that workers are protected. OSHA has determined that red pictogram borders will maximize recognition of the warning label and ensure consistency; therefore the final rule requires red borders for both domestic and international labeling.
The final rule requires that all red diamonds printed on a label have one of the eight pictograms printed inside the diamond. The prohibition of blank diamonds on labels will ensure that users do not get desensitized to warnings placed on labels. Two commenters proposed alternatives to the prohibition of blank diamonds. The American Chemical Council (ACC) suggested that, because the red diamond border for pictograms are often pre-printed on shipping labels, OSHA allow printing the word “BLANK” on, or writing “pictogram intentionally left blank” in, the unused diamond (Document ID #0393). Additionally, Michelle Sullivan also suggested writing “intentionally left blank” in the empty diamonds (Document ID #0382).
OSHA acknowledges that prohibiting blank diamonds on labels may require an adjustment in practice for entities that use pre-printed labels or require businesses to inventory additional blank stock. OSHA analyzed the impact that prohibiting the use of blank diamonds on labels would have on production costs. While this requirement may
Including diamonds on labels only when a pictogram is required will ensure that such warnings stand out to users. Prohibiting the use of blank diamonds will improve the likelihood that users will notice and react to the warning on the label. Therefore, OSHA has determined that prohibiting the use of blank diamonds on labels is necessary to provide the maximum recognition and impact of warning labels and to ensure that users do not get desensitized to the warnings placed on labels.
Hazard statements describe the hazards associated with a chemical. Precautionary statements describe recommended measures that should be taken to protect against hazardous exposures, or improper storage or handling of a chemical. This revised rule replaces the current performance-oriented requirement for “appropriate hazard warnings” on labels with a requirement for specific hazard and precautionary statements on labels. The statements are prescribed, based on the hazard classification of the chemical.
Standardized requirements for hazard and precautionary statements provide a degree of consistency that is lacking among current chemical labels. This lack of consistency among current labels makes it difficult for users to understand the nature and degree of hazard associated with a chemical, and to compare chemical hazards. For example, in an article reviewed for the record, Dr. Beach relates experiences from the perspective of a doctor treating occupationally exposed patients (Beach, 2002, Document ID #0238). The author noted that different suppliers use different risk phrases for the same chemical, making it difficult for users to compare relative risks.
ANSI standard Z129.1, Hazardous Industrial Chemicals—Precautionary Labeling (Document ID #0610), was developed to provide a consistent approach to labeling of hazardous chemicals. This standard gives manufacturers and importers guidance on how to provide information on a label, including standardized phrases and other information that can improve the quality of labels. Because it is a voluntary standard, however, not all chemical manufacturers and importers have adopted the ANSI approach. As a result of the diverse formats and language used in the past, a consistent and understandable presentation of information was not fully achieved.
A preference for hazard statements was shown in EPA's Consumer Labeling Initiative (Abt Associates, 1999, Document ID #0209). This study asked consumers about their attitudes toward labels on household chemical products. Overall, consumers indicated that they like to have information that clearly connects consequences with actions, and they prefer to know why they are being instructed to take a particular precaution. A clear hazard statement provides this information.
In some cases, clear and concise precautionary information is necessary to enable employees to identify appropriate protective measures. For example, Frantz
Other reports indicate that users prefer information that includes both an indication of the hazard and the recommended action (
Explicit precautionary statements make it more likely that employees will take appropriate precautions. Bowles
Evidence indicates that using key label elements together improves warning performance, compared with labels that only contain a subset of these elements. This is the approach taken in the revised rule, which requires the signal word, pictogram(s), hazard statement(s), and precautionary statement(s) together on the label. In one study, Meingast asked students to recall information from two variations of warning labels: Enhanced warnings with color, signal icons, pictorials, and organized text (following the ANSI Z535.4 standard, American National Standard for Product Safety Signs and Labels); and warnings with text only (Meingast, 2001, Document ID #0246). The authors reported that the enhanced warnings were more noticeable, led to significantly greater recall, and made people report a higher likelihood of compliance.
Other findings agree that improving all label elements can improve warning performance. For example, Lehto tested information retrieval from three chemical label formats and found that subjects generally did best with an “extensive” format that included pictograms, paragraphs, and horizontal bars indicating the degree of hazard (Lehto, 1998, Document ID #0258). Subjects were able to answer more questions correctly when the label included a range of content—particularly information on first aid and spill procedures.
Wogalter
The effectiveness of a combination of elements was also investigated in a study of warnings on alcoholic beverage containers (Laughery
The findings of these reports support OSHA's belief that the combined label elements,
Overall, the record shows that the presentation of information on labels through standardized signal words, hazard statements, pictograms, and precautionary statements would provide clearer, more consistent, and more complete information to chemical users. Comments received in response to the ANPR support this view (
Employers and employees would be given the same information on a chemical regardless of the supplier. This consistency should improve communication of the hazards. It may also improve communication for those who are not functionally literate, or who are not literate in the language written on the label. In addition, having the core information developed already, translated into multiple languages, and readily available to whomever wishes to access it, should eliminate the burden on manufacturers and users to develop and maintain their own such systems. Thus the specification approach should be beneficial both to the producers and the users of chemicals.
The majority of comments received in response to the proposal support the use of hazard and precautionary statements on labels (
In response to the proposal, stakeholders commented on the importance of being able to comprehend hazard and precautionary statements (
Labels are intended to provide an immediate visual reminder of chemical hazards. Whereas labels in the past could be presented in a variety of formats using inconsistent terminology and visual elements, labels prepared in accordance with the requirements in this final rule will be consistent. Standardized signal words and hazard statements attract attention and communicate the degree of hazard. Pictograms reinforce the message presented in text and enhance communication for low-literacy populations. Precautionary statements provide useful instructions for protecting against chemical-source injuries and illnesses.
A number of stakeholders submitted comments in support of standardized labeling for hazardous chemical containers. Several commenters stated that standardized label elements would better convey critically important hazard warnings, and provide useful information regarding precautionary measures that would serve to better protect employees (Document ID #0313, 0341, 0344, 0365, 0381, 0382, 0402, and 0405). The studies contained in the record reinforce OSHA's position on the use standardized label elements—including the use of standardized pictograms, signal words, and hazard and precautionary statements—to alert and inform chemical users of the hazards posed by hazardous chemicals in the workplace.
OSHA concludes, based on the studies discussed above and supported by the comments submitted to the record that standardizing the labels for hazardous chemicals is an essential step in harmonizing the HCS with the GHS. In addition, OSHA concludes that the labeling requirements in this revised final rule will result in more effective transmittal of information to employees. Therefore, OSHA has adopted the labeling requirements set forth in the NPRM in this final rule.
The HCS requires chemical manufacturers and importers to develop an SDS for each hazardous chemical they produce or import. SDSs serve as a source of detailed information on chemical hazards and protective measures. Each SDS must indicate the identity of the chemical used on the label; the chemical and common name(s) of hazardous ingredients; physical and chemical characteristics; physical and health hazards; the primary route(s) of entry; exposure limits; generally applicable precautions for safe handling and use; generally applicable control measures; emergency and first aid procedures; the date of preparation of the SDS; and the name, address and telephone number of the party preparing or distributing the SDS. Prior to this final standard, the information was not required to be presented in any particular order or to follow a specific format.
While the effectiveness of SDSs is evident, there are concerns regarding the quality of information provided. In particular, concerns have been raised regarding the accuracy (
Since the HCS was promulgated in 1983, access to chemical information has improved dramatically due to the availability of SDSs. OSHA believes that adopting a standardized format will build on the demonstrated benefits that have already clearly been established from the use of SDSs. As discussed in the proposal, the General Accounting Office (GAO) issued a report in May 1992 that addressed issues employers had with complying with the HCS (GAO, 1992, Document ID #0292). The findings were based on the results of a national survey of construction, manufacturing, and personal services
One very important finding of the GAO survey was that almost 30% of employers reported that they had replaced a hazardous chemical with a less hazardous substitute because of information presented on an SDS. With regard to the HCS as a whole, GAO found that over 56% of employers reported “great” or “very great” improvement in the availability of hazard information in the workplace and in management's awareness of workplace hazards. Forty-five percent of those in compliance with the HCS considered the standard to have a positive effect on employees, compared with only 9% who viewed the effect as negative. The results indicate that when chemical hazard information is provided, the result is generally recognized as beneficial to employees. A number of other studies support this conclusion.
Conklin demonstrated the utility of SDSs among employees of a multinational petrochemical company (Conklin, 2003; Document ID #0245). Across three countries (the U.S., Canada, and the United Kingdom), 98 percent felt that the SDS is a satisfactory information source (the percentage was similar across all three countries). Seventy-two percent said they would request an SDS all or most of the time when introduced to a new chemical, although 46 percent of workers said that SDSs are too long. The author notes that this sample did not include any workers with low literacy.
However, while these studies show a clear benefit related to the use of SDS in the workplace, a number of investigations raise concerns that the information on SDSs is not comprehensible to employees. In 1991, OSHA commissioned a study that evaluated the comprehensibility of SDSs by a group of unionized employees in manufacturing industries located in the state of Maryland (Kearney/Centaur, 1991a, 1991b, Document ID #0309 and 0310). The study assessed the ability of these employees to understand information regarding the route of entry of the substance, the type of health hazard present, appropriate protective measures, and sources of additional help.
Each of the 91 participating workers was provided with and tested on four different SDSs. The workers answered the test questions based on information supplied on each of the SDSs. It should be noted that the employees who volunteered for this study understood that it relied on reading comprehension. This created a selection bias, as employees with reading difficulties would not be likely to volunteer for the study.
The results of the tests indicated that workers on average understood about two-thirds of the health and safety information on the SDSs. The best comprehension was associated with information providing straightforward procedures to follow (
Conklin reported a similar result in a study involving employees of a multinational petrochemical company (Conklin, 2003, Document ID #0245). After viewing information on an unfamiliar chemical in a variety of SDS formats, a questionnaire was administered to workers to gauge their comprehension of the material presented. The workers reportedly answered 65 percent of the questions correctly.
The Printing Industries of America reported a study that examined the comprehensibility of SDSs to master printers in 1990 (PIA, 1990, Document ID #0295). The subjects had an average of 13.9 years of formal education, or approximately two years beyond high school. In this study, 27 SDSs were selected and analyzed for reading levels using a software program, finding an average reading grade level of 14. The investigators found that employees with 15 years of education or more understood 66.2% of the information presented.
Some of the difficulty workers experience in understanding information presented on SDSs may be due to the vocabulary used in the document. Information presented at a reading level that exceeds the capability of the user is unlikely to be well understood. An example of this situation was reported by Frazier
Other reports substantiate the belief that many SDS users have difficulty understanding the information on the documents. For example, in a study evaluating the comprehensibility of SDSs at a large research laboratory, 39 percent of the workers found SDSs “difficult to understand” (Phillips, 1997, Document ID #0263). The study also indicated that a third of the information provided on SDSs was not understood. These results were obtained from a study population of literate, trained workers who spoke English as their first language.
Smith-Jackson and Wogalter corroborated this finding in a study involving 60 undergraduates and community volunteers (Smith-Jackson and Wogalter, 1998, Document ID #0188). The subjects were asked to sort SDS data into a logical order. After completing the task, subjects were asked for their opinions on the difficulty of the content. Overall, 43 percent found the information easy to understand, 42 percent said it was not easy, and the remaining 15 percent felt that only scientists, experts, or very experienced workers would be able to understand the information.
These studies are consistent in reporting that workers have difficulty understanding a substantial portion of the information presented on SDSs. This finding can be explained at least in part by the fact that not all of the information on SDSs is intended for workers. SDSs are intended to provide detailed technical information on a hazardous chemical. While they serve as a reference source for exposed employees, SDSs are meant for other audiences as well. SDSs provide information for the benefit of emergency responders, industrial hygienists, safety professionals, and health care providers. Much of this information may be of a technical nature and would not be readily understood by individuals who do not have training or experience in these areas. For example, language that may be readily understood by a population of firefighters may be poorly understood by chemical workers.
In addition, Title III of the Superfund Amendments and Reauthorization Act (SARA, also known as the Emergency Response and Community Right-to-Know Act of 1986) mandated that SDSs be made available to state emergency response commissions, local emergency planning committees, and fire departments in order to assist in planning and response to emergencies, as well as to provide members of the
Product liability concerns also play a role in the comprehensibility of SDSs. Producers of chemicals may be subject to “failure to warn” lawsuits that can have significant financial implications. Attempts to protect themselves against lawsuits can affect the length and complexity of SDSs, as well as the way in which information is presented. In some cases the length and complexity of SDSs reportedly make it difficult to locate desired information on the documents. For example, in testimony before the U.S. Senate Subcommittee on Employment, Safety, and Training, one hospital safety director described a situation in which an employee was unable to find critical information on an SDS in an emergency situation (Hanson, 2004, Document ID #0200):
* * * two gallons of the chemical xylene spilled in the lab of my hospital. By the time an employee had noticed the spill, the ventilation had already sucked most of the vapors into the HVAC. This, in turn, became suspended in the ceiling tile over our radiology department. Twelve employees were sent to the emergency room. To make the matter worse, the lab employee was frantically searching through the MSDS binder in her area for the xylene MSDS. Once she found it, she had difficulty locating the spill response section. After notifying our engineering department, she began to clean up the spill with solid waste rags, known for spontaneous combustion, and placing the rags into a clear plastic bag for disposal. She did not know that xylene has a flash point of 75 degrees Fahrenheit. She then walked the bag down to our incinerator room and left it there, basically creating a live bomb. Twelve people were treated from this exposure. The lab employee was very upset and concerned about the safety of the affected employees and visitors, and hysterically kept stating that she could not find the necessary spill response information.
To accommodate the needs of the diverse groups who rely on SDSs, a standardized format has been viewed as a way to make the information on SDSs easier for users to find, and to segregate technical sections of the document from more basic elements. A standardized format was also thought to facilitate computerized information retrieval systems and to simplify employee training.
The first attempt to establish a format for SDS was made in 1985, when OSHA established a voluntary format to assist manufacturers and importers who desired some guidance in organizing SDS information. This two-page form (OSHA Form 174) includes spaces for each of the items included in the SDS requirements of the standard, to be filled in with the appropriate information as determined by the manufacturer or importer. However, some members of the regulated community desired a more comprehensive, structured approach for developing clear, complete, and consistent SDSs.
In order to develop this structure, the Chemical Manufacturers Association (now known as the American Chemistry Council) formed a committee to establish guidelines for the preparation of SDSs. This effort resulted in the development of American National Standards Institute (ANSI) standard Z400.1, a voluntary consensus standard for the preparation of SDSs. Employers, workers, health care professionals, emergency responders, and other SDS users participated in the development process. The standard established a 16-section format for presenting information as well as standardized headings for sections of the SDS. In 2004, an updated version of the ANSI standard that was consistent with the GHS format was published. This ANSI standard has since been combined with the ANSI Z129 consensus standard on precautionary labeling preparation. The ANSI Z400.1/Z129.1 standard was issued in 2010.
By following the recommended format, the information of greatest concern to employees is featured at the beginning of the document, including information on ingredients and first aid measures. More technical information that addresses topics such as the physical and chemical properties of the material and toxicological data appears later in the document. The ANSI standard also includes guidance on the appearance and reading level of the text in order to provide a document that can be easily understood by readers.
OSHA currently allows the ANSI format to be used as long as the SDS includes all of the information required by the HCS. Because it is a voluntary standard, however, the ANSI format has not been adopted by all chemical manufacturers and importers. As a result, different formats are still used on many SDSs.
The International Organization for Standardization (ISO) has published its own standard for SDS preparation. This standard, ISO 11014-1, has been revised for consistency with the GHS (new version issued in 2009). The standard includes the same 16 sections as the GHS, as well as similar data requirements in each section. These two consensus standards, ANSI Z400.1-2004 and ISO 11014-1 (2009), have essentially the same provisions and are consistent with GHS. There are minor differences, such as units of measure recommended in the national ANSI standard versus the international ISO standard.
Another development has been the creation of International Chemical Safety Cards (ICSCs). The documents, developed by the International Programme on Chemical Safety, summarize essential health and safety information on chemicals for use at the “shop floor” level by workers and employers (Niemeier, 1997, Document ID #0191). ICSCs are intended to present information in a concise and simple manner, and they follow a standardized format that is shorter (one double-sided page) and less complex than the ANSI approach. The ICSCs were field tested in their initial stages of development, and new ICSCs are verified and peer reviewed by internationally recognized experts (
A study by Phillips compared the effectiveness of different SDS formats as well as ICSCs among workers at a large national laboratory (Phillips, 1997, Document ID #0191). The employees represented a variety of trades, including painters, carpenters, truck drivers, and general laborers. Each worker was tested for knowledge regarding a hazardous chemical before and after viewing an SDS or ICSC. Three designs were tested: a 9-section OSHA form, the 16-section ANSI Z400.1 format (an earlier and slightly different version of the current ANSI Z400.1 format), and the 9-section ICSC. A subsequent paper described the final results of this study (Phillips, 1999, Document ID #0263). All three formats led to significant improvements in subjects' knowledge, and there was no statistically significant difference among the three formats in terms of total test score. However, there were a few significant differences in how well readers of each SDS format answered specific types of questions:
The ICSC performed better than the OSHA form regarding chronic and immediate health effects.
The other two formats performed better than the ANSI format on fire-related questions.
The OSHA form performed better than the other two formats on spill response questions.
The OSHA form performed better than the ANSI format regarding carcinogenic potential.
The ANSI Z400.1 template has been used by a wide number of employers for creating SDSs. By following the recommended format, the information of greatest concern to employees is featured at the beginning of the document, including information on ingredients and first aid measures. More technical information that addresses topics such as the physical and chemical properties of the material and toxicological data appears later in the document. The ANSI standard also includes guidance on the appearance and reading level of the text in order to provide a document that can be easily understood by readers.
The ANSI format is commonly used. However, because it is a voluntary standard, not all chemical manufacturers and importers have adopted it. As a result, different formats are still used on many SDSs. Of the comments received regarding SDS, none were in favor of allowing voluntary adoption of the SDS format. The California Industrial Hygiene Council (CIHC) (Document ID #0463) reiterated its support for a uniform format, and specifically the implementation of the ANSI format for SDSs. The CIHC also stated that a mandatory format would establish a harmonized structure for all “global target audiences” (Document ID #0463).
In a separate comparison, Conklin also found similarities in the overall performance of several standard SDS formats (Conklin, 2003, Document ID #0245). In this study, employees of a multinational petrochemical company were given one of three versions of an SDS for an unfamiliar chemical: A U.S. version (OSHA's required content within an ANSI Z400.1-1998 16-part structure); a Canadian version following the 9-part structure prescribed by Canada's Workplace Hazardous Materials Information System (WHMIS); and a version following the European Union's content and 16-part structure. SDSs were controlled for font, layout, and reading level. Overall, Conklin found no statistically significant difference in mean post-test scores using the three different formats, although there were significant differences on 5 out of 10 questions (no one format was consistently better).
OSHA also examined several studies addressing what sequence of information would prove to be most beneficial for users. Because extensive searching can be a barrier to SDS use, researchers have examined whether there is a preferred order of information that more closely matches users' cognitive expectations. Smith-Jackson and Wogalter asked 60 undergraduates and community volunteers to arrange portions of six SDSs in the order they considered most usable (Smith-Jackson and Wogalter, 1998; Document ID #0188). The authors found a few consistent results:
Information about health hazards, protective equipment, and fire and explosion data tended to be placed toward the beginning.
Physical and reactivity data tended to be placed near the end.
Spill or leak procedures were placed near the beginning or the middle, depending on the type of chemical.
A majority of subjects reported that they had attempted to prioritize the hazard information that needed to be communicated. The participants' suggested order of information generally did not match either the original SDS order or the order listed in the HCS—particularly the subjects' emphasis on health hazard information near the beginning.
In the previously discussed 1991 study that evaluated the comprehensibility of SDSs by a group of 91 unionized workers in manufacturing industries in the state of Maryland, a subset of the group (18 workers) was also tested on an ICSC (Kearney/Centaur, 1991a, 1991b, Document ID #0309 and 0310). While the results indicated that workers on average understood about two-thirds of the health and safety information on SDSs, ICSCs provided better results. The average ICSC test score ranged from 6% to 23% higher than the average test score on the four SDSs evaluated. This finding was considered by the authors to suggest that an improved format for SDSs may serve to increase user comprehension of the information presented.
OSHA believes that a standardized format will improve the effectiveness of SDSs for the following reasons: A consistent format makes it easier for users to find information on an SDS. Headings for SDS sections are standardized, so SDS users know which section to consult for the information they desire. The sections are presented in a consistent, logical sequence to further facilitate locating information of interest. Information commonly desired by exposed employees and of greatest interest to emergency responders (
Specifically, the revised SDS format now segregate more complex information from information that is generally easier to understand. This order of information places basic information in the first sections, allowing SDS users to find basic information about hazardous chemicals without having to sift through a great deal of technical information that may have little meaning to them. In emergency situations, rapid access to information such as first-aid measures, fire-fighting measures, and accidental release measures can be critically important.
Several stakeholders expressed dissatisfaction with the degree that current SDSs vary from manufacturer to manufacturer (Document ID #0330 and 0351). The International Brotherhood of Teamsters stated that the quality and usefulness of SDSs has been grossly inconsistent in terms of content and format, adding that such discrepancies ultimately result “in a failure to achieve the objective of the standard” (Document ID #0357). John Schriefer, head of Local 9477, indicated that workers often didn't bother to request SDSs, because they are so complicated (Document ID #0494 Tr. 54-55). He suggested that a simplified, standard format for SDSs would go a long way toward improving worker safety (Document ID #0494 Tr. 63).
Commenters supported putting information targeted to the employees first on the SDS in order to improve how emergency situations are addressed (Document ID #0332, 0386 and 0414). Stericycle, Inc. supported placing hazard identification information in one location rather than “sprinkling it through the documents, as is sometimes the case with [SDSs]” (Document ID #0338). United Steelworkers stated that the difficulty in locating information on current SDSs “is bad enough with routine assessments, but in an emergency situation like a spill, splash or fire it can be deadly” (Document ID #0402). Additionally, the American Wind Energy Association argued that requiring hazard identification and first aid information to be placed in the first sections of the SDS would serve to “better assist emergency response teams to more efficiently recognize hazards during incidents” (Document ID #0386). American Federation of State, County and Municipal Employees (AFSCME) also supported the adoption of a standardized SDS, reasoning that it would enable workers to better understand SDSs, and could ultimately lead to faster responses as well as a reduction in the number of incidents altogether (Document ID #0386).
A standardized format does not address all issues affecting SDS comprehensibility. Reading level and some design elements would continue to vary. In many respects, this is inevitable given the different target audiences that SDSs have, and the varying qualifications of those who prepare SDSs. Nevertheless, OSHA believes that the revisions will result in a substantial improvement in the quality and ease of comprehension of information provided on SDSs.
In addition to the issues regarding comprehensibility, researchers raised concerns that some SDSs may be incomplete or contain erroneous information. The magnitude of the problem is unclear, because only very limited numbers of SDSs have been evaluated in these studies, and in some cases the investigations were performed so long ago that the results may not reflect current practices. Nevertheless, the evidence appears to indicate that a substantial number of SDSs may not contain complete and correct information.
An initial examination of the accuracy of SDSs was commissioned by OSHA shortly after the scope of the rule was expanded to cover all industries in 1987 (Karstadt, 1988, Document ID #0296). The report, which analyzed the content of 196 SDSs for products used in auto repair and body shops, provided a general indication that the content and presentation of information was inconsistent on the SDSs examined. In 1991, OSHA commissioned an additional study that examined the accuracy of SDSs (Kearney/Centaur, 1991a, 1991b, Document ID #0309 and 0310). The study examined information presented in five areas considered crucial to the health of workers potentially exposed to hazardous substances. The five areas assessed were: Chemical identification of ingredients; reported health effects of ingredients; recommended first aid procedures; use of personal protective equipment; and exposure level regulations and guidelines. The evaluation indicated that 37% of the SDSs examined accurately identified health effects data, 76% provided complete and correct first aid procedures, 47% accurately identified proper personal protective equipment, and 47% correctly noted all relevant occupational exposure limits. Only 11% of the SDSs were accurate in all four information areas, but more (51%) were judged accurate, or considered to include both accurate and partially accurate information, than were judged inaccurate (10%). The study also concluded that the more recent SDSs examined (those prepared between 1988 and 1990) appeared to be more accurate than those prepared earlier.
This belief that some SDSs are not complete and correct was corroborated by an examination of SDSs for lead and ethylene glycol ethers (Paul and Kurtz, 1994, Document ID #0302). Although these substances are known reproductive and developmental toxicants, researchers found that 421 of 678 SDSs examined (62%) made no mention of effects on the reproductive system. OSHA also commissioned a study, completed in 1999, focusing specifically on the accuracy of first aid information provided on SDSs (Lexington Group, 1999, Document ID #0257). A total of 56 SDSs for seven chemicals were examined. First aid information on the SDSs was compared with information from established references. The researchers reported that nearly all of the SDSs reviewed had at least minor inaccuracies.
A standardized format does not directly address the concerns that have been raised regarding the accuracy of information present on SDSs. However, standardization would improve the accuracy of chemical hazard information indirectly. With consistent presentation of information, the task of reviewing SDSs and labels to ensure accuracy will be simplified. Individuals preparing and reviewing these documents should find it easier to identify any missing elements and compare information presented on an SDS to reference sources and other SDSs. OSHA enforcement personnel will be able to more efficiently examine SDSs when conducting inspections. The detailed entries for SDSs are particularly noteworthy in this regard. The sub-headings provide an organized and detailed list of pertinent information to be included under the headings on the SDS. For example, while the HCS currently requires physical and chemical characteristics of a hazardous chemical to be included on the SDS, the final rule provides a list of 18 properties for Section 9 of the SDS. The party preparing the SDS must either include the relevant information for these entries, or indicate that the information is not available or not applicable. This approach provides both a reminder to the party preparing the SDS regarding the information required and a convenient means of reviewing the section to ensure that relevant information is included and is accurate.
Additionally, several stakeholders agreed that standardization would result in improved accuracy of the information on SDSs. For example, Ecolab, Inc. stated that a uniform approach to hazard classification and labeling would improve the accuracy of the information presented on labels and SDSs and reduce “the currently observed variability among suppliers in chemical classification and presentation of that information” (Document ID #0351). Additionally, American Iron and Steel Works noted that “standardized criteria to evaluate and communicate hazards via SDSs * * * should assure consistent communication and lower the likelihood of miscommunication and misinterpretation” (Document ID #0408). Alliance for Hazardous Materials Professionals also indicated that the standardization of SDSs is likely to “resolve language and content inconsistencies among similar product providers” (Document ID #0327).
OSHA concludes that the classification criteria included in the final rule will also improve the accuracy and precision of information on SDSs. The detailed criteria provided will direct evaluators to the appropriate classification for a chemical. For example, while directing the evaluator to use expert judgment in taking all existing hazard information into account, the criteria for serious eye damage/eye irritation is tied to specific results found in animal testing. In addition, assignment to hazard categories would lead to provision of detailed information that would be specific to the degree of hazard presented by the chemical.
Classification of hazards will play an important role in increasing the usefulness of SDSs under the final rule. By including the classification of the substance on the SDS, employers will be in a much better position to compare the hazards of different chemicals. Hazard categories generally give an indication of the severity of the hazard associated with a chemical. For example, all other things being equal, a chemical classified for skin corrosion/irritation in category 1 as a skin corrosive would be more hazardous than a chemical classified in category 2 as a skin irritant. If chemicals are classified into hazard categories, this information can be used to simplify the process of comparing chemicals. As noted previously, employers use SDSs as a means of comparing chemical hazards to select less hazardous alternatives. Thus, it is reasonable to conclude that this final rule will result in more effective use of the SDS as an instrument for identifying less hazardous substitutes for hazardous chemicals.
Stakeholders have expressed support for a standard SDS format. The development of an industry consensus standard for preparation of SDSs, ANSI
A report drafted by the GAO recommended that OSHA clearly specify the language and presentation of information on SDSs (GAO, 1991, Document ID #0292). In addition, the report of the National Advisory Committee for Occupational Safety and Health Review of Hazard Communication (September 12, 1996) indicated that during the public presentations and workgroup discussions, there was general agreement that a uniform format should be encouraged, and most workgroup members agreed that OSHA should endorse use of the ANSI Z400.1 format (NACOSH, 1996, Document ID #0260).
Comments received in response to the ANPR indicated widespread support for a standard format for SDS (
Moreover, stakeholder response to the NPRM also overwhelmingly supported requiring a consistent, standardized format for SDSs (Document ID #0307, 0313, 0321, 0322, 0328, 0329, 0330, 0335, 0341, 0344, 0349, 0352, 0357, 0365, 0372, 0374, 0381, 0382, 0383, 0386, 0389, 0392, 0393, 0403, 0404, 0405, 0410, 0415, 0456, and 0463). American Subcontractors of America stated that a standardized format would make SDSs a more effective resource and better educational tool (Document ID #0322). Additionally, the Communications Workers of America asserted that standardizing SDSs would be an invaluable solution for addressing current inconsistencies and quality issues on SDSs (Document ID #0349).
Based on the studies and comments in the record, OSHA has concluded that not only will the standardized SDS format indirectly improve the quality of information provided on SDSs, but that it is in the format that stakeholders already know and overwhelmingly prefer.
Along with labels on containers and SDSs, employee training is one of three core components of a comprehensive hazard communication program. Training is needed to explain and reinforce the information presented on labels and SDSs, to ensure that employees understand the chemical hazards in their workplace and are aware of the protective measures they need to follow. The final rule includes a relatively minor revision to the existing HCS training requirements for employers to train employees on the label elements and SDS format. This revision is intended to ensure that labels and SDSs are adequately explained to employees (
Training is necessary to ensure that employees understand the standardized headings and sequence of information on SDSs. Likewise, employees must be able to understand the meaning of the standardized label elements in order for them to be effective. In certain instances, label elements already appear to be fairly well understood. For example, “Danger” appears to be generally recognized to represent a higher degree of hazard than “Warning.” Other label elements, particularly some pictograms, are less well understood. This finding is not surprising given the limited amount of exposure that most of the population has had to some of these pictograms.
A relatively high level of understanding is generally recommended for pictograms. For example, ANSI Z535.3, the American National Standard that addresses criteria for safety symbols (Document ID #0276), contains a test method for determining the effectiveness of a pictogram. The criterion for a successful, effective pictogram is 85% correct responses, with no more than 5% critical confusion. (Critical confusion refers to when the message conveyed is the opposite of the intended message.) A score below 85% does not mean the pictogram should not be used, but rather that it should not be used without some additional element, such as written text. The International Standards Organization has similar criteria in ISO 9186, Procedures for the Development and Testing of Public Information Symbols (Document ID #0255). This standard recommends testing methodologies to evaluate symbols intended to be used internationally. It sets a somewhat lower level of acceptability (66%) than the ANSI standard.
While initial understanding of some pictograms may not be satisfactory, research shows that training can improve comprehension. In one study, Wogalter
Lesch conducted a similar study, testing how well workers recognized a set of 31 chemical and physical safety symbols before and after training (Lesch, 2002, Document ID #0246; Lesch, 2003, Document ID #0282). Training significantly improved comprehension, which remained higher up to 8 weeks later. As in the Wogalter
In a survey of South African workers, London examined the impact of brief training on the meaning of symbols and hazard phrases (London, 2003, Document ID #0311). Here, the author found no statistical difference in comprehensibility of four familiar hazard symbols, but did find that training improved comprehension of one symbol (the GHS health hazard symbol), and it also reduced the overall incidence of critical confusion. This study also found that workers with previous workplace training were more likely to understand label text and some pictograms, and were better able to identify the active ingredient. Banda and Sichilongo reported a similar result in their evaluation of GHS labels in Zambia. The authors found that “correct responses to label elements were not a result of social class and/or age but appeared to be influenced by extent of duration of exposure either through specialized training or acquaintance” (Banda and Sichilongo, 2006, Document ID #0237). Recognizing that symbols are the items most often recalled from a label, London advised a strong emphasis on training for GHS symbols, particularly the “flame over circle” and
NIOSH, in its post-hearing comments, provided the following additional studies. These studies support OSHA's position that training ensures the understanding of standardized label elements (pictograms, signal words, hazard statement, and precautionary statements) and is an essential part of an effective hazard communication program.
Burt
In 2007, Lesch (Document ID #0480.3) conducted a study looking at different training conditions. During the training, warning symbols with labels (to better explain the meaning of the symbol) were paired with accident scenarios. The accident scenarios illustrated the nature of the hazard, the required or prohibited actions, and the possible consequences of failing to comply with the warning. The participants were tested before and following the training (immediately after and two weeks later). The results showed the benefits of training—improved comprehension, reduced reaction times, and an improved confidence in their responses—and illustrated that, by strengthening the connections between the warning symbol and its associated meaning, accident scenario training can be used to prevent accidents and injuries.
In 2007, Su and Hsu (Document ID #0480.5) tested 1,000 college students on their perception of GHS labels and traffic safety signs. The study found that students who had taken training did better in perceiving various traffic safety signs than those who did not. With regards to chemical labeling, students who had taken hazard communication training had better perception ratings than those without training. Analysis showed that 17 out of 27 hazards had perception ratings lower than 66%, the ISO suggested acceptable rate for a good sign. The statistical analysis used in the study indicated that pictograms should not be used alone but accompanied by warning statements or other kinds of textual materials. The study also suggested that training on pictograms and warning statements should be integrated into school curriculum.
Rother (2008, Document ID #0480.4) conducted a study to assess how South African farm workers interpret the pictograms used in the pesticide industry. Administered to 115 farm workers from commercial vineyards in Western Cape, South Africa, this study used a questionnaire designed to interpret the workers' understanding of 10 pictograms commonly used in the pesticide industry. Fifty percent or more of the study participants had misleading, incorrect, or critically confused interpretations of the label pictograms. The study identified a response as critically confused when a farm worker incorrectly interpreted a pictogram to require an action or behavior that would increase his or her health risks. OSHA agrees with NIOSH's interpretation that the study “found that lack of training severely affected farm worker's abilities to correctly interpret pesticide pictogram warning labels” (Document ID #0470).
These reports reinforce OSHA's longstanding belief that labels, SDSs, and training are complementary parts of a comprehensive hazard communication program—each element reinforces the knowledge necessary for effective protection of employees. The need for training to ensure comprehension of hazard information is widely recognized. Annex A of ANSI Z535.2 (the American National Standard for Environmental and Facility Safety Signs) (Document ID #0277), for example, recommends training on the meaning of standard safety symbols and signal words, and ANSI Z535.4 (Document ID #0278) contains similar guidance.
OSHA received many comments supporting the importance of training (
Training is key to ensuring effective hazard communication. Although written information is important, training is an opportunity to explain the data and helps to ensure that the messages are being received accurately so they can be acted on appropriately.
The USW stated that “there is no question good training greatly improves the ability to understand chemical labeling and safety data sheets. Unfortunately, the OSHA standard is vague * * *” (Document ID #0403). Several organizations, including Western Region Universities Consortium, ORC Worldwide, SOCMA, NIOSH, Building & Construction Trades Department of AFL-CIO, NIEHS, and USW (
Others, such as DuPont, API, Michelle Sullivan, ACC, and American Iron and Steel Institute/American Coke & Coal Chemicals Institute, stated that the standardized SDS and label format should facilitate training efforts and the overall effectiveness of hazard communication in industry (Document ID #0329, 0376, 0382, 0393, and 0408). The American Iron and Steel Institute stated: “Standardized criteria to evaluate chemicals should facilitate training. With a single teaching format for SDSs and Labels, understanding, regardless of an employee's educational background, should be improved” (Document ID #0408).
OSHA not only received many comments indicating that the training requirements in the HCS are not adequate, several organizations requested that OSHA either add regulatory text or a mandatory appendix specifying training content, frequency, and methods of evaluation (Document ID #0331, 0340, 0347, 0349, 0357, 0403, 0414, 0456, 0640, and 0647). For example, the National Institute of Environmental Health Sciences Worker Education and Training Program (NIEHS WETP) (Document ID #0347 and, 0516) provided training information, including a training program guidance manual, and an outline detailing specific training topics for the HCS.
OSHA agrees that training is important for ensuring effective hazard communication. However, OSHA did not propose to change the training provisions in the HCS other than initial training on the new GHS elements.
It is a longstanding Agency position that employees have the “right to know” and understand the hazards of chemicals they are exposed to in the workplace (53 FR 29826, Aug. 8, 1988; 59 FR 6126, Feb. 9, 1994). This knowledge is needed in order to take the precautions necessary for safe handling and use, to recognize adverse health effects associated with chemical exposure, and to respond appropriately in emergency situations.
Equally important in terms of employee protection is that employers have access to chemical hazard information as well. Chemical information is the foundation of workplace chemical safety programs—without it, sound management of chemicals is impossible. By ensuring that emergency responders, physicians, nurses, industrial hygienists, safety engineers and other professionals have the information they need, the HCS reduces the likelihood of chemical source illnesses and injuries. Selection of appropriate engineering controls, work practices, and personal protective equipment is predicated upon knowing the chemicals that are present, the form they are present in, and their hazardous properties.
In his testimony at the informal public hearings, Mr. David Irby, a union safety representative at the Severstal Steel Plant in Sparrows Point, Maryland, expressed the importance of the right to understand SDSs, stating that employees “need an easy-to read format written in a clear, precise and understandable manner in our workplace” (Document ID #0494 Tr. 55-57). OSHA agrees that employees must be able to read and comprehend the information presented on both labels and SDSs so that they can respond accordingly. Therefore, OSHA has determined that the provisions in this final rule—the standardized label elements (including pictograms, signal words, and hazard and precautionary statements), a standardized 16-section SDS, and the requisite training provisions—provide the necessary conventions to support understanding the hazards posed by chemicals in the workplace and that this final rule provides employees not only with the “right to know” but also the “right to understand.”
OSHA concludes that aligning the HCS with the GHS will improve the quality and consistency of the chemical hazard information provided to employers and employees. A combination of label elements—signal word, hazard statement(s), pictogram(s), and precautionary statement(s)—is expected to make label warnings more noticeable and easier to understand, and will better communicate hazard and precautionary information. Standardized headings and a consistent order of information are anticipated to make it easier for users to find information on SDSs, improve their accuracy, and better enable users to compare the relative hazards of different substances. Along with effective training in the context of a comprehensive chemical hazard communication program, OSHA has determined that these revisions will more adequately inform employees of chemical hazards, and lead to better protections in the workplace.
The primary purpose of the Occupational Safety and Health Act (the “OSH Act” or “Act”) (29 U.S.C. 651
An occupational safety and health standard is defined under the Act as:
[A] standard which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment and places of employment.
OSH Act § 3(8), 29 U.S.C. 652(8). The Supreme Court has interpreted this provision as requiring OSHA to determine, before promulgating a permanent standard under section 6(b) of the Act, that the standard is reasonably necessary and appropriate to remedy a significant risk of material health impairment.
Section 6(b)(5) provides that:
The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. Development of standards under this subsection shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addition to the attainment of the highest degree of health and safety protection for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws. Whenever practicable, the standard promulgated shall be expressed in terms of objective criteria and of the performance desired.
Thus, once OSHA determines that a significant risk due to a health hazard is present and that such risk can be reduced or eliminated by a proposed standard, section 6(b)(5) requires it to issue the standard, based on the best available evidence, that “most adequately assures” employee protection, subject only to feasibility considerations. As the Supreme Court has explained, in passing section 6(b)(5) “Congress * * * plac[ed] the `benefit' of worker health above all other considerations save those making attainment of this `benefit' unachievable.”
In addition, section 6(b)(7) of the Act provides in part that:
Any standard promulgated under this subsection shall prescribe the use of labels or other appropriate forms of warning as are necessary to insure that employees are apprised of all hazards to which they are exposed, relevant symptoms and appropriate emergency treatment, and proper conditions and precautions of safe use or exposure.
In promulgating a standard under the Act, OSHA's determinations will be deemed conclusive if they are “supported by substantial evidence in the record considered as a whole.” OSH Act § 6(f), 29 U.S.C. 655(f). When the standard deals with toxic materials or harmful physical agents, OSHA must use the “best available evidence.” Such evidence includes “the latest scientific data in the field,” “research, demonstrations, experiments, and such other information as may be appropriate,” and “experience gained under this and other health and safety laws.” OSH Act § 6(b)(5), 29 U.S.C. 655(b)(5). The Supreme Court has held that OSHA is not required to support its finding of significant risk of material health impairment “with anything approaching scientific certainty” and that the determination of whether a level of particular risk is “`significant' will be based largely on policy considerations.”
The OSH Act allows the Secretary to “modify” and “revoke” existing occupational safety or health standards. OSH Act § 6(b)(2); 29 U.S.C. 655(b)(2). In passing the Act, Congress recognized that OSHA should revise and replace its standards as “new knowledge and techniques are developed.” S. Rep. 91-1282 at 6 (1970). The Supreme Court has observed that administrative agencies “do not establish rules of conduct to last forever, and * * * must be given ample latitude to adapt their rules and policies to the demands of changing circumstances.”
OSHA's Hazard Communication Standard (“HCS”) is a standard promulgated under the authority of sections 6(b)(5) and 6(b)(7) of the Act (29 U.S.C. 655(b)(5) and 655(b)(7)).
As a 6(b)(5) standard, OSHA was required to establish that the HCS would substantially reduce a significant risk of material harm. Some OSHA standards protect employees from exposure to a concentration of a hazardous substance that OSHA has found to create a significant risk of material health impairment. Thus, in making the significant risk determination in these cases, OSHA is concerned with determining the level at which a significant risk arises.
OSHA took a different approach to its significant risk determinations in promulgating the HCS in 1983 and revising it in 1994. The agency relied on NIOSH data showing that about 25 million, or about 25% of, American employees were potentially exposed to one or more of 8,000 NIOSH-identified chemical hazards and that, for the years 1977 and 1978, more than 174,000 illnesses were likely caused by workplace exposure to hazardous chemicals. 48 FR 53280, 53282 (Nov. 25, 1983). It then noted the consensus evident in the record among labor, industry, health professionals, and government that an “effective federal standard requiring employers to identify workplace hazards, communicate hazard information to employees, and train employees in recognizing and avoiding those hazards” was necessary to protect employee health.
Thus, OSHA found that because:
* * * inadequate communication about serious chemical hazards endangers workers and that the practices required by this standard are necessary or appropriate to the elimination or mitigation of these hazards, the Secretary is hereby able to make the threshold “significant risk” determination that is an essential attribute of all permanent standards.
A characteristic of hazard communication that OSHA confronted in adopting the HCS is that information about the hazards associated with a particular chemical, and the exposures associated with its use, is not uniformly distributed across industry. That is, chemical manufacturers and importers tend to have greater knowledge and scientific expertise with respect to the composition of the chemicals they make or import than do downstream employers.
OSHA's approach in promulgating the HCS reflects this reality. It places the duty to ascertain and disclose chemical hazards on manufacturers and importers, so that downstream users can use this information to avoid harmful exposures to chemical hazards. But because manufacturers and importers will often have less information about the particular exposures of downstream users, their hazard assessment and communication obligations are imposed only for all normal conditions of use of
In previous rulemakings, OSHA rejected suggestions that the hazard assessment and communication obligations should arise only where the downstream use creates a significant risk because it is difficult, if not impossible, for OSHA or manufacturers and importers to know where these risks might occur before the fact. 48 FR at 53295, 53296, 53307 (Nov. 25, 1983; 59 FR at 6132 (Feb. 9, 1994). Further, it is only by the provision of hazard information that downstream employers and employees can determine how to use the chemical so that exposure and risk may be minimized.
For these reasons, hazard communication—as opposed to risk communication—“most adequately assures” employee protection from the significant risk of material impairment of health arising from the use of hazardous chemicals in the workplace for purposes of OSHA's authority under section 6(b)(5) of the Act. In addition, the HCS is authorized under section 6(b)(7), which requires OSHA to prescribe “labels or other appropriate forms of warning as are necessary to insure that employees are apprised of all hazards to which they are exposed, relevant symptoms and appropriate emergency treatment, and proper conditions and precautions of safe use or exposure.” 29 U.S.C. 655(b)(7). As noted above, the
The Secretary, in consultation with the Secretary of Health and Human Services, may by rule promulgated pursuant to section 553 of title 5, United States Code, make appropriate modifications in the foregoing requirements relating to the use of labels or other forms of warning, monitoring or measuring, and medical examinations as may be warranted by experience, information, or medical or technological developments acquired subsequent to the promulgation of the relevant standard.
This provision exempts modifications to hazard communication, monitoring, and medical examination requirements from the standard-setting requirements of section 6(b), and so evidences Congress's intent to provide OSHA with an expedited procedure to update these requirements. OSHA believes that exercise of this authority does not require a new finding of significant risk. As noted above, the “backstop” 6(b)(7) requirements of hazard communication, exposure monitoring, and medical surveillance may be imposed even in the absence of a significant risk finding.
Rather than requiring a finding of significant risk, the last sentence of section 6(b)(7) provides other assurances that OSHA is exercising its authority appropriately: by requiring the involvement of the Secretary of Health and Human Services, and by limiting the authority only to modifications that are based on “experience, information, or medical or technological developments” acquired since the promulgation of the standard in the limited areas of hazard communication, monitoring, and medical examinations. Therefore, OSHA need not make any new significant risk findings; rather, the final rule is supported by the significant risk findings that OSHA made when it adopted the current HCS.
OSHA has used the authority of section 6(b)(7) in the past to revise its standards.
The final rule fits well within the authority granted by the last sentence of section 6(b)(7). Adoption of GHS provisions constitutes a “modification[]” of the HCS regarding “the use of labels or other forms of employee warning.” For the reasons summarized above and explained more fully elsewhere in this preamble, OSHA believes that the adoption of GHS is “appropriate” based on “experience, information, or medical or technological developments acquired subsequent to the promulgation of the relevant standard.” The formulation of GHS may also be considered a “technological development” that has occurred since the promulgation of the original standard in 1983. GHS was negotiated and drafted through the involvement of labor, industry, and governmental agencies, and thus represents the collective experience and information on hazard communication gathered by the participants in these sectors over the last several decades.
The last sentence of section 6(b)(7) also requires consultation with the Secretary of Health and Human Services. As detailed in the NPRM, NIOSH was involved in the development of the proposal through briefings and review of the proposed rule before publication.
Paul A. Shulte, Ph.D., testified on behalf of NIOSH that:
[A] significant advantage of the proposed standard is the detailed technically sound criteria for classification that will improve accuracy and consistency in the information provided to employers and employees on chemical hazards and protective measures * * *. In summary, the proposed standard will serve as a powerful tool for the protection of working people.
HCS is a 6(b)(5) standard since it acts to mitigate the significant health risk of using dangerous chemicals without adequate hazard communication.
Standards adopted under the authority of section 6(b)(5) must be supported by a finding of significant risk. However, as explained elsewhere, the GHS is an improved method of communicating chemical hazards to employers and employees over the current standard, and therefore the final rule, which incorporates the GHS, is now the “standard that most adequately assures” worker protection. OSH Act § 6(b)(5); 29 U.S.C. 655(b)(5). Adoption of GHS will substantially reduce the significant risk of inadequate communication workers face. As discussed above, OSHA supported the current rule with a finding, affirmed by the Third Circuit, that “inadequate communication about serious chemical hazards endangers workers” and that the HCS will mitigate this risk. 48 FR 53321 (Nov. 25, 1983);
As discussed in Section IV, several studies show that employees do not understand approximately one-third of the safety and health information listed on SDSs prepared in accordance with the current standard (Document ID #0245, 0263, 0295, 0309, and 0310). Studies also report that roughly 40% of persons reviewing SDSs found them difficult to understand (Document ID #0188 and 0262). The results from these studies probably overstate the level of comprehension in the workforce, because the studies had a selection bias towards employees who have stronger English reading skills. These findings are corroborated by worker testimony stating that they and their coworkers find SDSs “difficult and confusing,” “inadequate and incomprehensible,” and a “nightmare.” One witness stated that employees he works with would not ask to see SDSs because they were too complicated, and as a result, the employees unwittingly expose themselves to chemical hazards (Document ID #0494 Tr. 50, 54-55; and 0499 Tr. 134, 147-48, 151, 162, 165-66, and 167).
Moreover, the evidence in the record shows workers who read SDSs prepared in a standardized format have substantially improved comprehension of the information they present (Document ID #0191, 0263, 0309, and 0310). Indeed, standards specifying uniform formats for SDSs have been adopted by ANSI and other standards bodies, indicating a consensus that standardized SDSs will more effectively communicate chemical hazards to workers and employers. Moreover, commenters overwhelmingly agreed that standardizing SDSs would improve hazard communication. (
Likewise, the record shows that the current HCS's performance-oriented labeling requirements result in inadequate communication. Research conducted over the last twenty years and summarized in section IV of this preamble shows that use of the signal words “Danger” and “Warning,” pictograms, red borders, and standardized hazard warnings and precautionary statements better convey information about chemical hazards. Studies show that the information conveyed by these techniques is better understood, especially among low literacy populations, better remembered, and more likely to be acted upon. Again, commenters agreed that the current performance-oriented labeling requirement leads to worker confusion, and that the standardized GHS labeling requirements would minimize that confusion. (
Finally, employees still continue to suffer chemical-related injuries, illnesses and deaths. As discussed in more detail in Section VI, Final Economic Analysis, of the preamble, OSHA estimates that over 40 million employees are potentially exposed to hazardous chemicals. BLS data show that in 2007, there were approximately 55,400 illnesses related to hazardous chemical exposures and 125 chemical-related fatalities. These statistics probably represent only a small portion of the illnesses experienced by exposed employees; most occupational illnesses are not reported because they are not recognized as being related to workplace exposures and are subject to long
These data corroborate the idea that currently there is inadequate communication of chemical hazards in the workplace. Further, they show that the use of chemical hazards in the workplace creates a significant risk to employees. For the reasons explained above and in sections IV and XIII of the preamble, OSHA believes that the final rule will reduce the risk to employees by providing better and more easily understood information to employees and employers about the hazards of the chemicals they use, which in turn will allow precautionary measures to be taken.
In its post-hearing comment, the Styrene Information and Research Council (SIRC) argued that OSHA should also have examined injury and illness rates in the EU. It states that “the GHS is substantially the system that has been in place in the EU for the last 40 years” for substances covered by the EU Dangerous Substances Directive and for the 10 years for mixtures covered by the EU Dangerous Preparations Directive (Document ID #0642). OSHA disagrees with SIRC's premise. There are significant differences between the GHS and the relevant EU directives. These differences include the criteria for classifying hazards, as well as the label elements used to communicate the hazardous effects. In addition, even if the EU's hazard communications obligations were substantially similar to the GHS, there are technical hurdles that would have to be overcome before such a study could yield useful information. There are significant differences in the way that statistics for occupational illness and injuries collected by the US and the EU (and its members) that make direct comparisons difficult. Furthermore, the regulatory structure for mitigating the hazards identified and communicated in varying systems also differ significantly, and this would confound any effort to compare illness and injury rates in the two jurisdictions. In any event, OSHA need not wait for scientific certainty to update its regulations, but rather it must rely on the best available evidence, and may use conservative assumptions in interpreting the evidence. OSH Act § 6(b)(5), 29 U.S.C. 655(b)(5);
OSHA standards must be feasible, which means “capable of being done, executed or effected.”
In addressing feasibility in the 1994 HCS revisions, OSHA found that:
The feasibility question raised by the HCS is not difficult to resolve. This standard does not relate to activities on the frontiers of scientific knowledge; the requirements are not the sorts of obligations that approach the limits of feasibility.
As discussed below and in section VI.E of this preamble, OSHA believes the final rule poses no technological feasibility issues. The most important resource employers will need in order to comply with the GHS modifications to HCS is technical expertise in hazard classification and the communication of those hazards. OSHA found that such expertise was already available in promulgating the initial HCS rule in 1983. 48 FR at 53296-99 (Nov. 25, 1983). OSHA believes that the availability of professionals with this expertise has only increased in the intervening time. The GHS has already been implemented, in whole or in part, by a number of major U.S. trading partners, including Japan and the EU. Companies that export to these jurisdictions should already have developed expertise in the GHS, and there are a number of GHS training resources developed on the international level (Document ID #0405, 0410, and 0514). At least one professional organization currently provides GHS training in hazard communication to professionals and businesses in the United States (Document ID #0021 and 0145). Through OSHA's Alliance with the Society for Chemical Hazard Communication, training to small businesses in the requirements of hazard communication and information about the GHS modifications has been made available.
Likewise, for the reasons more fully discussed in Section VI, Final Economic Analysis, OSHA believes that the adoption of GHS will not pose economic feasibility issues. Again, OSHA previously found that the implementation of HCS would have no such effect.
OSHA is required by the Occupational Safety and Health (OSH) Act of 1970 to ensure and demonstrate that standards promulgated under the Act are reasonably necessary and appropriate, as well as technologically and economically feasible. Executive Orders 12866 and 13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act also require OSHA to estimate the costs, assess the benefits, and analyze the impacts of certain rules that the Agency promulgates. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. OSHA has determined that this action is “economically significant” within the meaning of 3(f)(1) of the executive order because it is likely to have an effect on the economy of $100 million or more in any one year. Accordingly, the rule has been reviewed by OMB.
Accordingly, OSHA has prepared this Final Economic Analysis (FEA), including a Final Regulatory Flexibility Screening Analysis (FRFSA), for the modifications to the Hazard Communication Standard (HCS). The OSHA FEA is based largely on research conducted for the Preliminary Economic Analysis (PEA) by Policy, Planning, and Evaluation, Inc. (PP&E), as presented in its revised final report, “Data and Analysis in Support of an Economic Analysis of Proposed Changes to the OSHA Hazard Communication Standard,” prepared under contract to OSHA, and on research conducted for purposes of completing this FEA by Eastern Research Group (ERG). ERG and OSHA analyses updated both costs and benefits. The materials prepared by PP&E, 2009 (Document ID #0273) and ERG (2010, 2011, and 2012)
Eastern Research Group (ERG, 2012). Excel Spreadsheets in Support of OSHA Final Economic Analysis for GHS Rule. Submitted to Occupational Safety And Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis, Contract No. GS-10-F-0125P. January 20, 2012.
Employees in work environments covered by the HCS are exposed to a variety of significant hazards that can and do cause serious injury and death. The HCS serves to ensure that both employers and employees are provided needed information about chemical hazards that was not provided by markets in the absence of such a standard. The HCS also facilitates interstate commerce by promoting consistency among federal and individual state requirements.
The changes to the HCS will create a uniformity standard for the presentation of hazard information and, as such, will serve to improve the efficiency and effectiveness of the existing hazard communication system in the U.S., and to reduce unnecessary barriers to trade. Hazard communication is currently addressed by many different international, national, and State authorities. As described in Section IV of this preamble, these existing requirements are not always consistent and often contain different definitions of hazards and varying provisions for what information is required on labels and safety data sheets. Complying with these different rules results in increased costs for employers with hazardous chemicals in their workplace and for chemical manufacturers, distributors, and transporters involved in international trade. In addition to these effects on businesses, the different existing requirements result in workplaces receiving chemicals with varying information, with potential adverse impacts on the safety and health of employees. The revisions to the OSHA HCS will standardize the hazard communication requirements for products used in U.S. workplaces, and thus provide employees with uniform and consistent hazard communication information. Secondarily, because these revisions will harmonize the U.S. system with international norms, they will facilitate international trade.
The revisions would affect employers and employees in many different industries across the economy. Based on ERG (2012), OSHA estimates that the HCS covers over five million workplaces in which employees are potentially exposed to hazardous chemicals (
For establishments with employees whose only exposures to hazardous chemicals result from their use of the chemical products, the revisions to the HCS would generally involve minor effects, such as familiarization with new warning labels. For establishments producing hazardous chemicals, which are generally part of the chemical manufacturing industry, the revisions to the standard would involve reclassifying chemicals in accordance with the new classification system and revising safety data sheets (SDSs) and labels associated with hazardous chemicals. OSHA has judged that SDSs for imported chemicals would normally be produced in the country of origin, and thus would not represent expenses for importers. OSHA solicited comment on this judgment in the PEA and did not receive any contrary testimony or evidence.
There is ample evidence of the substantial risks of chemical exposure in the workplace. In 2007, according to the Bureau of Labor Statistics, employees suffered an estimated 55,400 illnesses attributable to chemical exposures (BLS, 2008), and some 17,340 chemical-source injuries and illnesses involved days away from work (BLS, 2009). However, as noted in the preamble to the HCS in 1983, BLS
Section IV of this preamble describes some of the incidents that may have been related to the non-standardized approach to SDSs in the current HCS, including xylene exposure at a hospital when an employee was unable to find critical information on an SDS in an emergency spill situation (Document ID #0251). As a result, twelve employees required emergency room treatment. Were the information on SDSs more uniformly formatted and comprehensible, as required under the modifications to HCS, incidents such as this would be less likely to occur.
In general, the modifications to the HCS are expected to result in increased safety and health for the affected employees and to reduce the numbers of accidents, fatalities, injuries, and illnesses associated with exposures to hazardous chemicals.
It is difficult to quantify precisely how many injuries, illnesses, and fatalities would be prevented due to the revisions to the HCS.
The harmonization of hazard classifications, safety data sheet formats, and warning labels for affected chemicals and products would also yield substantial savings to businesses. Fewer different SDSs would have to be produced for affected chemicals, and many SDSs would be able to be produced at lower cost due to harmonization and standardization. The benefits represented by these cost reductions would primarily affect businesses involved in chemical manufacturing. In addition, businesses that purchase or use hazardous chemicals can expect reductions in operating costs as a result of the promulgation and implementation of the modifications to the HCS due the standardization of SDSs, which will make it easier to locate information and determine handling requirements, and other factors related to simplification and uniformity which will improve workplace efficiency.
In 2008, in preparation for OSHA's Notice of Proposed Rulemaking, PP&E conducted extensive research on the processes that companies use to classify chemical hazards, to develop SDSs and labels, and to handle, store, and use hazardous chemicals. PP&E evaluated how these processes would be affected by the revisions to the HCS and analyzed the potential savings that would be realized as a result of adopting these revisions. Using the parameters estimated by PP&E through its research and employing updated data on wages and the number of affected establishments and employees, OSHA has concluded that the annual cost savings for these companies would be an estimated $507.4 million.
OSHA also expects the revised HCS will reduce the costs of providing hazard communication training to employees in future periods. Stakeholders largely corroborated that expectation. Standardized SDS and label formats will reduce the amount of time needed to familiarize employees with the HCS, which will reduce the training time for all employees once the final rule is fully implemented. OSHA did not monetize these estimated cost savings, but anticipates that they will be substantial.
As an additional benefit, the modification of the HCS by the inclusion of the globally harmonized system (GHS) of classification and labeling of chemicals would be expected to facilitate international trade, increasing competition, increasing export opportunities for U.S. businesses, reducing costs for imported products, and generally expanding the selection of chemicals and products available to U.S. businesses and consumers. As a result of both the direct savings resulting from harmonization and the increased competitiveness, prices for the affected chemicals and products, and the corresponding goods and services using them, would be lowered.
Finally, the GHS modifications to the OSHA HCS would meet the international goals for adoption and implementation of the GHS that have been supported by the U.S. government. Implementing GHS in U.S. federal laws and policies through appropriate legislative and regulatory action was anticipated by the U.S. support of international mandates regarding the GHS in the Intergovernmental Forum on Chemical Safety, the World Summit on Sustainable Development, and the United Nations. It is also consistent with the established goals of the Strategic Approach to International Chemicals Management, a policy framework that the U.S. helped to craft (
The estimated compliance costs for the revisions to the HCS represent the additional costs necessary for employers to achieve full compliance. They do not include costs associated with current compliance that has already been achieved; nor do they include costs necessary to achieve compliance with existing requirements, to the extent that some employers may currently not be fully complying with applicable regulatory requirements.
The majority of the costs associated with compliance with the revisions to the HCS would generally be incurred by the affected industries as one-time transitional costs over the phase-in period of four years including the costs to reclassify chemical hazards and revise SDSs and labels, to train workers, and for management to familiarize itself with the requirements of the final rule. There will be additional ongoing annual compliance costs associated with the revisions to the HCS due to the cost to purchase and maintain color printing ink or cartridges or to purchase pre-printed color labels in order to comply
The compliance costs are expressed as an annualized cost for purposes of assessing the cost-effectiveness of the revisions, in order to be able to compare the economic impact of the rulemaking with other regulatory actions, and to be able to add and track federal regulatory compliance costs and economic impacts in a consistent manner. Annualized costs also represent a better measure for assessing the longer-term potential impacts of the rulemaking. A seven percent discount rate was applied to costs incurred in future years to calculate the present value of these costs for the base year in which the standard becomes effective, and the same discount rate was then applied to the total present value costs, over a 20-year period,
The total annualized cost of compliance with the final rule is estimated to be about $201 million. The major cost elements associated with the revisions to the standard include the classification of chemical hazards in accordance with the GHS criteria and the corresponding revision of safety data sheets and labels to meet new format and content requirements ($22.5 million); training for employees to become familiar with new warning symbols and the revised safety data sheet format ($95.4 million); management familiarization and other management-related costs as may be necessary ($59.0 million); and costs to purchase upgraded label printing equipment and supplies or to purchase pre-printed color labels in order to include the hazard warning pictogram enclosed in a red-bordered diamond on the product label ($24.1 million).
Table VI-1 provides a summary of the costs and benefits of the modifications to the OSHA HCS, and it shows the net benefits of the modifications to the standard are estimated to be $556 million annually, using a discount rate of 7 percent to annualize costs and benefits. (Using a 3 percent discount rate instead would have the effect of lowering the costs to $161 million per year and increasing the gross benefits to $839 million per year. The result would be to increase net benefits from $556 million to $674 million per year.) Because compliance with the standard would result in cost savings that exceed costs, OSHA has not provided estimates of costs per life saved or other metrics of cost-effectiveness. However, it should be noted that the estimated benefits exceed costs by more than a factor of three.
In response to comments on the proposed rule, OSHA has made the following changes to the economic analysis from the PEA to the FEA:
(1) Increased by 100 percent the amount of training time necessary to train employees on the revised HCS during the transition period—from 30 minutes to 60 minutes;
(2) Increased by over 60 percent the number of SDSs (with corresponding labels) covered by the rule—from approximately 0.9 million to over 1.4 million;
(3) Added annualized costs of $24.1 million to print product labels in color; and
(4) Incorporated updated economic data on the number of establishments, number of employees, annual revenues, annual profits, etc. and adjusted estimates from 2007 dollars to 2010 dollars.
The change from 2007 to 2010 dollars using the GDP deflator (for non-wage-related costs and benefits) increased affected costs and benefits by about 4 percent. The rule changes that increased the phase-in period reduced the annualization factors and the associated costs and benefits by about 9.6 percent. All other changes to costs and benefits were the result of updated economic data, including wages, and revised cost factors (e.g., number of SDSs, number of affected employees) in response to comments on the proposed rule.
As discussed in Section III of this preamble, the available alternatives to the final rule are somewhat limited since this final rule modifies the current HCS in order to align with the provisions of the UN's GHS. In Section III, the Agency qualitatively discussed the two major alternatives presented during this rulemaking process—(1) voluntary adoption of GHS within the existing HCS framework and (2) a limited adoption of specific GHS components and a variation on (1) that would require compliance with GHS but allow an exemption for small businesses to comply with either the current HCS or with the GHS-compliant HCS. All of these alternatives were soundly rejected by stakeholders. To allow certain parties to follow an alternative system or to allow voluntary adoption of the elements of a uniformity standard does nothing to reduce confusion, improve efficiency, or simplify processes. In order for those benefits to be realized, all elements must apply to all affected parties. OSHA has determined that both of the alternatives presented above would eliminate significant portions of the benefits of the rule.
OSHA did not attempt to evaluate the costs and benefits for the regulatory alternatives that involved partial or voluntary adoption of the GHS. The Agency did evaluate two alternatives where the effective dates were altered. In the first alternative considered, all elements of the revised HCS would be required to be implemented within two years. Under this alternative, all transitional costs would be incurred in two years and benefits would be realized beginning in the third year. The second alternative that OSHA evaluated extended the timeline for training to be completed. For this alternative, all elements of the revised HCS (including training) would be required to be implemented by June 1, 2016. Under this alternative, training costs would not be realized for four and a half years (as opposed to the two year requirement for training in the final version of this rule) while benefits would not be realized for five years (unchanged from the final rule). The results of these evaluations are presented in Table VI-2 below and are discussed in further detail,
To assess the nature and magnitude of the economic impacts associated with compliance with the final rule, OSHA developed quantitative estimates of the potential economic impact of the new requirements on entities in each of the affected industry sectors. The estimated compliance costs were compared with industry revenues and profits to provide an assessment of the economic feasibility of complying with the final rule and an evaluation of the potential economic impacts.
Only the compliance costs were considered for purposes of assessing the potential economic impacts and economic feasibility of the revisions. As described in Section VI.G: Net Benefits, Cost-effectiveness, and Regulatory Alternatives, in this preamble, the overall economic impacts associated with this rulemaking are expected to result in significant net benefits to employers, employees, and the economy generally.
As described in greater detail in Section VI.F: Costs of Compliance in this preamble, the costs of compliance with the rulemaking are not large in relation to the corresponding annual financial flows associated with each of the affected industry sectors. The estimated costs of compliance represent about 0.001 percent of revenues and about 0.011 percent of profits, on average, across all entities; compliance costs represent less than 0.09 percent of revenues or, with the exception of three chemical manufacturing industries, less than 0.9 percent of profits in any individual industry sector. These three chemical manufacturing industries are NAICS 325181 Alkalies & chlorine manufacturing, NAICS 325191 Gum & wood chemical manufacturing, and NAICS 325992 Photographic film, paper, plate, & chemical manufacturing, and their compliance costs as a percentage of profits are 4.3 percent, 2.1 percent, and 2.4 percent, respectively. The higher percentage of profits for these three industries are mainly the result of low profit margins, low baseline estimates of the number of color printers currently employed in these industries (causing higher costs of compliance with the color printing requirements), and a large estimated number of labels produced by these industries.
The economic impact of achieving compliance with the final rule, without considering the associated benefits, is most likely to consist of an extremely small increase in prices of about 0.001 percent, on average, for affected hazardous chemicals. It is highly unlikely that a price increase of this magnitude would significantly alter the types or amounts of goods and services demanded by the public or any other affected customers or intermediaries. If the compliance costs of the final rule can be substantially recouped with a minimal increase in prices, there may be little or no effect on profits.
In general, for most establishments, it would be very unlikely that none of the compliance costs could be passed along in the form of increased prices. In the event that a price increase of 0.001 percent were not possible, profits in the affected industries would be reduced by an average of about 0.011 percent.
Given the minimal potential impact on prices or profits in the affected industries, OSHA has concluded that compliance with the requirements of the rulemaking would be economically feasible in every affected industry sector.
In addition, based on an analysis of the costs and economic impacts associated with this rulemaking, OSHA concludes that the effect of the final rule on employment, wages, and economic growth for the United States would be negligible. The effect on international trade is likely to be beneficial and similar to the effect of a small reduction in non-tariff trade barriers.
OSHA has analyzed the potential impact of the final rule on small entities, and has prepared a Final Regulatory Flexibility Screening Analysis (FRFSA) in conjunction with this rulemaking to describe the potential effects on small entities. The FRFSA is included as a part of this preamble in Section VI:I.
As a result of the analysis of the potential impact on small entities, OSHA concludes and certifies that the rulemaking would not have a significant impact on a substantial number of small entities. Therefore, a Final Regulatory Flexibility Analysis (FRFA) is not required for this rulemaking. Nevertheless, OSHA has voluntarily provided the elements of the FRFA as part of the FRFSA presented in Section VI:I: Final Regulatory Flexibility Screening Analysis in this preamble. As part of this rulemaking, OSHA has fulfilled its requirements under the Regulatory Flexibility Act and under the Small Business Regulatory Enforcement Fairness Act, as applicable, to ensure that no unnecessary burdens are imposed on small businesses.
The remainder of this FEA includes the following sections:
Employees in work environments addressed by OSHA's hazard communication standard (HCS) are exposed to a variety of significant hazards associated with chemicals used in the workplace that can and do cause serious injury and death. OSHA's HCS was designed to ensure that employers and employees are provided the information they need about the hazards in chemical products both to make informed purchases and to provide for safe use. The current HCS contains a set of requirements for chemical products, including mandatory hazard determination, labeling, and detailed information (in safety data sheets). Based on evidence presented in the record,
The standard, through conformance with GHS (as explained in Section IV and XIII of this preamble), contains a number of changes to improve the performance of the U.S. hazard communication system:
• Revised criteria for more consistent classification of chemical hazards;
• Standardized signal words, pictograms, hazard statements, and precautionary statements on labels; and
• A standardized format for SDSs.
In short, GHS is a “uniformity standard” for the presentation of hazard information (Hemenway, 1975, Document ID #0293, Tr. 8). And much
It is also worth noting that, for uniformity standards with technological implications, the benefits of reduced information costs, economies of uniformity, and facilitation of exchange may need to be weighed against possible losses of flexibility, experimentation, and innovation. However, because GHS is limited to the presentation of hazard information and does not involve other than incidental technological or strategic considerations, the possible costs of uniformity here would be non-existent or minuscule.
Since publication of the current HCS, there has been some movement by industry toward standardization, consistent with the revisions. However, OSHA does not believe that full and comprehensive standardization as required under the revisions, or the goal of harmonizing the U.S. system with the international one, can be achieved voluntarily in the absence of regulation.
First, in a basic sense, GHS cannot simply be implemented by the market. Some aspects of GHS, such as the reorganization of SDSs, would be allowed under the current OSHA standard, but other aspects, such as the classifications system, would not be. Use of differing classification criteria would lead to label warnings that are not consistent with current HCS requirements in some situations. Thus, at a minimum, OSHA would need to modify HCS to allow the use of GHS in the U.S. OSHA cannot simply provide a compliance interpretation that labels and safety data sheets prepared in accordance with the GHS meet the HCS requirements because the requirements of a standard cannot be changed through a compliance interpretation. While there is considerable overlap between the HCS and the GHS in terms of coverage, there are differences in the criteria used to classify both substances and mixtures that can result in different hazards being covered in some situations. This is particularly true in the area of acute toxicity, where OSHA is covering more substances under the modified rule than the current HCS, but potentially fewer mixtures.
Second, it is important to understand that while the costs of creating SDSs and labels under GHS are borne directly by the chemical producers, the bulk of the benefits of adopting GHS accrue to the users. The set of all users includes employers who are direct customers of a chemical manufacturer, employees who use or are exposed to workplace chemicals, and emergency responders who typically have no market relationship with the producers of the chemical. Even if one thought that market forces might ensure the socially optimal approach to SDSs between manufacturers of chemicals and their customers, there are limited market forces at work between the chemical manufacturer and these two other sets of users—the employees and the emergency response community. Therefore, the benefits achieved by a uniformity standard, such as GHS, cannot be obtained in the private market, without regulation.
OSHA does anticipate that there will be some increased market pressure to comply with GHS that will affect some firms that may think that they have no need to switch to the GHS system because they do not ship their products internationally. Many small firms do not realize the extent to which they are involved in international trade. There are probably few companies who have products that are never involved in international trade, or who never import chemical products and need hazard communication information for them. Many chemical producers ship their products to distributors and are unaware of where their products are ultimately used. OSHA can envision a likely scenario in which these distributors put pressure on their suppliers to become GHS-compliant. Further, small companies sell products to larger companies. The larger companies may use those products to prepare goods that are exported. These larger companies might also be expected to pressure their small-firm suppliers to be GHS-compliant. Nevertheless, such an approach would surely involve a long transition period, with attendant losses in worker protection and production efficiencies, and it is doubtful that market pressure alone would achieve full compliance.
The changes made by GHS will involve costs for all parties. Producers of chemicals will incur substantial costs, but will also achieve benefits—in part because they themselves benefit as both producers and users, and in part, as a result of foreign trade benefits that OSHA has not quantified. Some producers may not see these types of trade benefits unless they engage in chemical export. However, many small companies are currently prevented from engaging in international trade because of the substantial burdens of complying with many different countries' requirements. International harmonization of hazard communication requirements would enable these small companies to become involved in international trade if they so desire.
Of more significance to the concerns of the OSH Act, the changes also provide substantial benefits to users, including:
• Fewer worker illnesses, injuries, fatalities, and accidents due to a more consistent and comprehensible system that does not require English literacy to obtain some minimal hazard information;
• Greater ease of use of SDSs; and
• Less time needed to train workers due to a clearer and more uniform system.
Because many of these benefits require uniformity, and the benefits are dispersed throughout a network of producers and users, only some of which have direct market relationships with each other, OSHA believes that only a single, uniform standard can achieve the full net benefits available to a hazard communications system.
The revisions to the HCS would affect establishments in a variety of different industries in which employees are exposed to hazardous chemicals or in which hazardous chemicals are produced. Every workplace in OSHA's jurisdiction in which employees are exposed to hazardous chemicals is covered by the HCS and is required to have a hazard communication program.
The revisions to the HCS are not anticipated to either increase or
For establishments with employees exposed to hazardous chemicals, the revisions to the HCS will generally involve management becoming familiar with and employees receiving training on the new warning labels and the new format of the SDSs. For establishments producing or importing hazardous chemicals, generally as part of the chemical manufacturing industry, these revisions to the standard will involve reclassifying chemicals in accordance with the new classification system and revising safety data sheets and labels associated with hazardous chemicals.
OSHA's estimates of the number of employees covered by the standard are based on the determination that all production employees in manufacturing will be covered, and that, in addition, employees in other industries working in any of the occupations specified in the PP&E (2009) report would also be exposed to hazardous chemicals.
Table VI-3 provides an overview of the industries and estimated numbers of employees potentially affected by the HCS. The data in this table update the estimates provided in the PEA in support of the proposed rule. They rely on the most recent data from the U.S. Census Bureau (2007a, 2007b).
The industries and establishments affected by the revisions can be divided into two categories. The first category contains establishments that are required to produce labels and SDSs; the second category contains establishments that do not produce labels or SDSs but are required to provide employee access to labels and SDSs, supplied by others, for the chemicals to which their employees may be exposed in the workplace. As noted in the introduction to this FEA, OSHA has judged that SDSs and labels for imported chemicals would normally be produced in the country of origin, and thus would not represent expenses for importers or other US firms.
As shown in Table VI-3, approximately 75,000 firms, in over 90,000 establishments, create hazardous chemicals (
In many instances, firms may be already producing several different versions of SDSs and labels for the same product to satisfy different regulatory requirements in different jurisdictions, including SDSs and labels consistent with GHS criteria. For these products, the revisions to the OSHA HCS will be satisfied relatively easily and may result in a reduction in overall compliance costs by reducing the number of different labels and SDSs needed for each affected product.
The second category of industries and establishments affected by the revisions contains those that do not produce labels or SDSs but are required to provide their employees with access to SDSs supplied by others as part of a hazard communication program covering chemicals to which employees may be exposed in the workplace. The effects on these establishments will generally involve promoting employee awareness of and management familiarization with the revisions to SDSs and labels.
As shown in Table VI-3, an estimated 41 million employees are potentially exposed to hazardous chemicals in these workplaces and are covered by the OSHA HCS. Including employees working in establishments that produce labels and SDSs, a total of 44 million employees would potentially need to become familiar with the revisions to SDSs and labels. The estimated number of employees to be trained, as shown in Table VI-3, is equal to the number of production employees in all affected industries. As also shown in Table VI-3, OSHA estimates that there are over five million workplaces where employees may be potentially exposed to hazardous chemicals.
OSHA received comment from the American Wind Energy Association and Duke Energy Business Services, LLC that asserted that the Agency had underestimated the number of employees that would need to be trained in the electric power generation industry (Document ID #0386 and 0453). OSHA estimated that approximately 49 percent of employees were production employees in this industry who would need to be trained to familiarize them with the revisions to the HCS and that an additional 11,000 managers and logistic personnel would receive training as well. The commenters felt that 60 to 70 percent of employees would need to be trained. OSHA evaluated the concerns of the AWEA and Duke Energy and has decided to defer to their expertise on the subject and adopt their recommendation (by changing the percentage of employees who would need to be trained in NAICS 2211 Electric power generation, transmission and distribution to 65 percent). The change from 49 percent of employees to 65 percent of employees to be trained results in a negligible change to the costs to this industry. Increasing the number of production employees needing training from 245,715 to 315,623 results in an increase of about $39 per firm in annualized costs to this industry, and the costs as a percent of revenues would increase from 0.0052 percent to 0.0060 percent.
OSHA estimates that the promulgation of the revisions to the HCS will result in substantial benefits from a variety of sources. OSHA's estimates of the benefits include improvements in occupational safety and health and a corresponding reduction in the annual number of injuries, illnesses, and fatalities sustained by employees from exposure to hazardous chemicals; cost reductions for producers of hazardous chemicals; increased efficiencies in the handling and use of hazardous chemicals; reduced costs to provide HCS training to new employees; and other benefits as described in this section.
OSHA expects the revisions to the HCS will result in an increased degree of safety and health for affected employees and a reduction in the numbers of accidents, fatalities, injuries, and illnesses associated with exposures to hazardous chemicals.
As explained in detail in Sections IV and XIII of this preamble, the design of GHS was based on years of extensive research that demonstrated the effectiveness of pictograms, specific signal words, and a standardized format.
In addition, the standardized format of the safety data sheets would enable critical information to be accessed more easily and quickly during emergencies. This can reduce the risk of injury, illness, and death to exposed employees and to rescue personnel and can also reduce property damage.
It is difficult to quantify precisely how many injuries, illnesses, and fatalities will be prevented due to the revisions to the HCS. The benefits associated with the current HCS may help provide a general sense of the potential magnitude of the benefits of these revisions. A discussion and analysis of the benefits that would result from the implementation of the current OSHA HCS were included as part of the rulemaking process for the promulgation of the current standard in the 1980s.
The current HCS was originally promulgated in two parts. First, a final rule covering the manufacturing industry was published in the
For both of these final rules, OSHA conducted research specifically
The information, data sources, analyses, and findings related to the estimation of the benefits associated with these standards are included in the public records for the rulemakings. The complete rulemaking records for these standards can be found in OSHA public dockets H-022B and H-022D.
The estimated benefits associated with the Hazard Communication Standards were published in the
Using a willingness-to-pay approach for valuing these benefits, OSHA determined that the annual safety and health benefits would be over $18.2 billion annually, expressed in 1985 dollars. Applying the BLS inflation calculator, the $18.2 billion of benefits in 1985 is equivalent to $36.7 billion of benefits in 2010 after adjusting for inflation of 102 percent of the period.
Based on the material presented in this preamble, OSHA expects that the revisions to the HCS will result in incremental improvements in employee health and safety above that already achieved under the current HCS. In the PEA, OSHA estimated that compliance with the revisions to the HCS would result in benefits equal to 1 percent of the health and safety benefits attributed to the current HCS. It is conceivable that actual benefits might be somewhat lower, but because GHS is expected to result, in some situations, in more timely and appropriate treatment of exposed workers, OSHA expects that actual benefits may be larger, perhaps several times larger.
The emergency planning and first responder community depends upon MSDS information for life and safety. The ability to immediately examine an MSDS and glean hazard and response information at the scene of an incident is critically important. The lives of first responders, employees of the facility and the public depend upon the accuracy and ease of use of the MSDS.
OSHA prepared a sensitivity analysis to test the effect of variations in its estimates and found that, even if the estimated health and safety benefits were overstated by a factor of 2 (or even if the health and safety benefits were omitted altogether—see Table VI-1), the benefits would still exceed the costs of the final rule. Those results can be seen in Section VI.L: Sensitivity Analysis in this preamble.
Using the 1 percent estimate, OSHA anticipates that once all requirements take effect for the final rule, they would result in the prevention of an additional 318 non-lost-workday injuries and illnesses, 203 lost-workday injuries and illnesses, 64 chronic illnesses, and 43 fatalities annually. The monetized value of these health and safety benefits is an estimated $367 million annually in 2010 dollars.
In order to obtain a sense of how realistic these estimated safety and health benefits are in light of the current level of occupational injuries, illnesses, and fatalities that are chemically related, OSHA reviewed relevant BLS data for the periods 1992-2007. OSHA's examination of these data shows a 42 percent decline in chemically related acute injuries and illnesses over the period, but both remain significant problems—55,400 chemically related illnesses and 125 chemically related fatalities in 2007. However these readily measurable reported acute illnesses and fatalities are dwarfed by chronic illnesses and fatalities. For chronic illness fatalities, there is little information available, and certainly no annual time-series data. The most recent estimate is that there were 46,900 to 73,700 fatalities due to occupational illnesses in 1992 (Document ID #0274). OSHA believes these more recent data from 1992-2007 suggest that the HCS has had a desirable effect on chemically related illnesses and injuries, but there remains a very significant role for further and better hazard information, as would be provided by aligning the current HCS with the GHS.
The annual health and safety benefits associated with the revisions to the OSHA HCS are estimated to begin after full implementation of the changes and associated employee training. The phase-in period for the main provisions of the final rule is approximately four years from the date of publication. Thus, in order to calculate the estimated annualized health and safety benefits over a twenty-year period associated with this rule in a manner that would be comparable to the corresponding annualized costs, the delay in the realization of the benefits was incorporated into the calculation. Using a discount rate of 7 percent, the estimated annual benefits of $367 million, beginning four years after the effective date of the final rule, were multiplied by 0.6803 to calculate the annualized benefits over a twenty-year period beginning with the effective date of the final rule.
Other substantial benefits, in addition to the improved occupational safety and health of affected employees, are also expected to result from this rulemaking, as discussed in the following paragraphs.
The harmonization of hazard classifications, safety data sheet formats, and warning labels for affected chemicals and products would yield substantial savings to the businesses involved in these activities. Fewer different SDSs would have to be produced for affected chemicals, and many SDSs would be able to be produced at lower cost due to harmonization and standardization. The record supports these savings with comment from Stericycle, Inc. stating that they anticipate that “less time will be spent in reviewing new chemicals due to the changed format and better characterizations of the hazard” (Document ID #0338), from the Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD), which felt that these revisions to the HCS would “ultimately increase efficiency and reduce time needed to prepare labels and SDSs” (Document ID #0374), and from ORC Worldwide, which said that the “use of one harmonized classification system is expected to significantly reduce the time needed to classify global products” (Document ID #0123). The American Chemistry Council reported that they would “expect a positive economic and time impact on developing and reviewing SDSs” (Document ID #0393) as a result of these revisions to the HCS. Troy Corporation reported that they believed that “providing harmonized SDSs will reduce development and maintenance time” (Document ID #0352) and that there “will be tangible savings when materials only have to be classified once instead of multiple times” (Document ID #0128). Two commenters suggested that harmonization could lead to a 50 percent time savings in classification (Document ID #0313 and 0327). The benefits represented by these cost reductions would primarily affect businesses involved in chemical manufacturing.
In addition, reductions in operating costs are also expected as a result of the promulgation of the revisions to the HCS for many businesses that purchase or use hazardous chemicals. The current non-uniformity of SDSs and labels received by establishments in many industries requires employees and managers to spend additional time on a daily basis to ascertain the appropriate way to handle and store the hazardous chemicals in their workplaces. Under the revised standard, the presence of uniform and consistent information would help employers and employees to make decisions more efficiently and save substantial time. There is ample evidence in the record that stakeholders anticipate that the revisions to the HCS will improve the quality of the SDSs and labels and that the standardization of the SDS and label elements will increase the consistency of the hazard information and better communicate the hazards to users (
For the benefits estimated in the PEA, PP&E worked closely with stakeholders, conducting multiple interviews and extensive research on the processes that companies use to classify chemical hazards, to develop SDSs and labels, and to handle, store, and use hazardous chemicals. Based on interviews with hazardous materials professionals in more than a dozen affected establishments, PP&E evaluated how these processes would be affected by the proposed revisions to the HCS and analyzed the potential savings that could reasonably be expected as a result of adopting these revisions.
For the PEA, OSHA used the PP&E 2009 report (Document ID #0273) to develop estimates of the cost reductions that the affected companies would expect to obtain as a result of the revisions to the OSHA HCS.
In the PEA (74 FR 50280, 50322, Sept. 30, 2009), OSHA estimated the number of hours that each industry would save by improving the efficiency and productivity of personnel who use SDSs in performing their job functions. OSHA estimated that the amount of time spent during affected activities in the manufacturing sector could be reduced by 3 percent for health and safety supervisors and by 15 percent for logistics personnel specializing in handling hazardous chemicals.
As part of the PEA (
Combining the improved productivity of personnel who use SDSs and the improved efficiency of those who revise SDSs and labels, OSHA concluded that the annualized productivity savings for companies would be an estimated $507 million.
Another area in which the final rule is likely to provide cost savings to industry is in the provision of hazard communication training to new employees after the transition period. Both the current HCS and the revised HCS require employers to provide training on the safe handling of chemicals, on understanding SDSs and labels, and on being familiar with other information crucial to worker safety. Employers are permitted to offer training for categories of hazards (such as flammability or carcinogenicity) rather than training individually on each chemical. The primary sources of information for this training are the SDSs supplied by manufacturers, and the primary method for employees to determine the hazard associated with a specific chemical they are using is through the manufacturer's HCS-compliant label.
Under the revised HCS, SDSs and labels produced in the United States will all be formatted in the same way. As more countries and regions adopt the GHS, fewer variations of SDSs and labels will be seen in the workplace. Information will be located in the same place on every SDS and label an employee will encounter. Employers will no longer have to train on as many SDS formats; nor will they need to devote as many resources to gather information on work practices, PPE, etc. SDSs and labels will be required to provide complete hazard information, and the language that the hazard information is presented in will be uniform across labels and section 2 of the SDSs. The inclusion of the pictograms and standardized hazard statement removes or, at least reduces, training time spent on interpreting various—and in some cases ambiguous—hazard warnings that current SDSs and labels may bear. The standardized labels and elements based on the detailed criteria for each hazard also greatly simplify training by facilitating training on “categories of hazard” rather than having to cover every chemical individually where the hazard determination is based on broad definitions. All of these changes can be expected to reduce the costs of training employees to recognize chemical hazards in the workplace.
The rulemaking record included numerous descriptions of the difficulties for both employees and
An additional benefit of the adoption of GHS is that it would facilitate international trade, increasing competition, increasing export opportunities for U.S. businesses, reducing costs for imported products, and generally expanding the selection of chemicals and products available to U.S. businesses and consumers. The Society for Chemical Manufacturers and Affiliates, for example, stated in their comment that while “SOCMA member companies do not foresee significant savings from the change * * * for companies that do business globally there will be” (Document ID #0402). While OSHA did not take quantitative benefits for these savings, the Agency believes that firms that operate globally may realize a cost savings as a result of the adoption of the GHS (Document ID #0336, 0339, 0361, and 0405). As a result of the direct savings resulting from the harmonization and the associated increase in international competition, prices for the affected chemicals and products, and the corresponding goods and services using them, should decline, although perhaps only by a small amount.
Finally, the GHS modifications to the OSHA HCS would meet the international goals for adoption and implementation of the GHS that have been supported by the U.S. government. Implementing GHS in U.S. federal laws and policies through appropriate legislative and regulatory action was anticipated by the U.S. support of international mandates regarding the GHS in the Intergovernmental Forum on Chemical Safety, the World Summit on Sustainable Development, and the United Nations. It is also consistent with the established goals of the Strategic Approach to International Chemical Management that the U.S. helped to craft.
A number of commenters suggested that the benefits OSHA estimated will result from this rule were incorrect or overstated. The National Association of Homebuilders expressed a belief that OSHA's “assumption that the proposed revisions to the HCS [would] result in cost reductions * * * due to productivity gains is false” (Document ID #0372), while the American Composites Manufacturers Association voiced concern that the benefits OSHA had estimated were speculative (Document ID #0407). Southern Company submitted that “the benefits of adopting the GHS are minimal at best” (Document ID #0378). Applied Safety and Ergonomics, Inc., urged OSHA to adopt a more conservative view of the expected benefits as they asserted that “it is possible that many of the implied or expected benefits of the proposed changes to the HCS may not materialize” (Document ID #0396). OSHA takes these comments seriously and evaluated all concerns raised by stakeholders on the estimated benefits of this standard. Unfortunately, most commenters did not include adequate detail or data that would allow the Agency to evaluate alternative benefits estimates. While future benefits (or costs) cannot be estimated with scientific precision, OSHA believes that the estimated benefits associated with this standard are based on sound data and that the resulting estimates are reasonable and have largely been supported by testimony and comment from stakeholders. It should be noted that many commenters who raised questions or concerns over OSHA's benefits estimates still largely supported the overall aim of the rulemaking and wished to see OSHA proceed with promulgation. The Agency addresses the inherent uncertainty in the economic analysis in Section VI.L Sensitivity Analysis in this preamble. In that section, various parameters are adjusted to evaluate the impact on the overall cost and benefits of the rule, and OSHA finds that even if estimated benefits were grossly overstated, this standard's benefits would still exceed costs.
In accordance with the OSH Act, OSHA is required to demonstrate that occupational safety and health standards promulgated by the Agency are technologically feasible. OSHA has reviewed the requirements that would be imposed by the rule, and has assessed their technological feasibility. As a result of this review, OSHA has determined that compliance with the requirements of the rule is technologically feasible for all affected industries.
The revisions to OSHA's HCS would require employers that produce chemicals to reclassify chemicals in accordance with the new classification criteria and revise safety data sheets and labels associated with hazardous chemicals. Compliance with these requirements is not expected to involve any technological obstacles. A comment in the record indicated that “[s]ome of the work [* * *] has already been done in order to comply with GHS implementation in Asian countries” (Document ID #0405; see also Document ID #0352, 0377, and 0410). In addition to stakeholder comments, a January 4, 2011 press release from the European Chemicals Agency (ECHA) announced that the ECHA had received 3,114,835 notifications of 24,529 substances for the Classification and Labelling Inventory. Industry was required to notify the classification and labeling of all chemical substances that are hazardous or subject to registration under the Registration, Evaluation and Authorization of Chemicals (REACH) regulation and placed on the EU market in accordance with the GHS criteria. NIOSH is also currently working to update its International Chemical Safety Cards and Pocket Guide to incorporate the GHS classifications, which will further reduce the technological burdens of reclassification borne by manufacturers. (For a more detailed discussion of the EU implementation of the GHS and NIOSH's classification work,
The revisions to the HCS will require establishments that package or label hazardous chemicals to affix labels that include hazard warning pictograms enclosed in a red bordered diamond. While some establishments may not currently be printing labels in colors other than black and white, color printing technology is widely available
Compliance with all of the requirements of the rule can be achieved with readily and widely available technologies. Businesses in the affected industries have long been required to be in compliance with the existing HCS, which includes similar requirements. The revised HCS would simply require modifying the labels and SDSs for hazardous chemicals, adding some training to ensure employees are familiar with these changes, and upgrading printing technology with widely available color printers or purchasing preprinted color labels. No new technologies are required for compliance with the modifications to the HCS. OSHA is aware that many U.S. businesses in the affected industries have already begun implementing many of the requirements of the GHS in order to meet the new foreign requirements for exported products. Therefore, OSHA believes that there are no technological constraints associated with compliance with any of the requirements of the revisions to the HCS.
This section presents the estimated costs of compliance for the revisions to the OSHA HCS. The estimated costs of compliance represent the additional costs necessary for employers to achieve full compliance with the new requirements of the final rule. They do not include costs associated with firms whose current practices are already in compliance with the new requirements.
The costs of compliance with the revisions to the HCS consist of four main categories: (1) The cost of reclassification and revision of SDSs and labels, (2) the cost of management familiarization and other management costs associated with the administration of hazard communication programs, (3) the cost of training employees, and (4) the cost of printing labels for hazardous chemicals in color. The first three categories are considered to be one-time transitional costs and were included in the PEA in support of the proposed rule. The fourth category is new and was developed in response to comments on the proposed rule. It includes both one-time transitional costs and costs that recur throughout the life of the rule.
The estimated compliance costs are based on a determination made by the Agency that the revisions would not significantly change the number of chemicals or products for which an SDS will be required. This also means that there will be no change in the number of establishments that are required to implement a hazard communication program. OSHA received no comments as part of the rulemaking record for this standard challenging this determination.
Other than the direct costs of reclassification and relabeling, the estimated compliance costs do not include any further costs or impacts that may result from the reclassification or relabeling of chemicals and products already subject to the HCS, such as possible changes in production or demand for products. Theoretically, such impacts, if any, with regard to possible changes in the uses and applications of affected chemicals, could be positive as well as negative. OSHA has determined that such effects, if any, will not be significant, and received no comment from stakeholders disputing this determination.
In addition to the revisions to the HCS, the rulemaking also includes related revisions to other OSHA standards. The revisions to the other standards generally ensure that all OSHA requirements related to hazard communication remain consistent with each other and become consistent with the revised HCS. OSHA has determined that the revisions to the other standards would not impose significant costs beyond those reflected in the compliance cost estimates for this rulemaking.
In order to have compliance costs presented on a consistent and comparable basis across various regulatory activities, the costs of compliance for this rule are expressed in annualized terms. Annualized costs represent the more appropriate measure for assessing the longer-term potential impacts of the rulemaking and for purposes of comparing compliance costs and cost-effectiveness across diverse regulations with a consistent metric. In addition, annualized costs are often used for accounting purposes to assess the cumulative costs of regulations on the economy or specific parts of the economy across different regulatory programs or across years. Annualized costs also permit costs and benefits to be presented in a comparable manner.
A seven percent discount rate was applied to costs incurred in future years to calculate the present value of these costs for the base year in which the standard becomes effective, and the same discount rate was then applied to the total present value costs, over a 20-year period, to calculate the annualized cost.
Table VI-4 shows the estimated annualized compliance cost by cost category and by industry sector. All costs are reported in 2010 dollars. As shown in Table VI-4, the total annualized cost of compliance with the rulemaking is estimated to be about $201 million. Of this amount, the annualized cost of chemical hazard reclassification and revision of SDSs and labels is an estimated $22.5 million, the annualized cost of training employees is an estimated $95.4 million, the annualized cost of management familiarization and other management costs is an estimated $59.0 million, and the additional annualized label printing costs, incurred to comply with the requirement of a black pictogram surrounded by a red-bordered diamond, is an estimated $24.1 million.
As shown at the bottom of Table VI-4, most of the compliance cost associated with chemical hazard reclassification and revision of SDSs and labels would be borne by the chemical manufacturing industry (shown as the total for industries that produce SDSs and labels). Table VI-4 also shows that compliance costs are spread across all industries in the U.S. economy subject to OSHA jurisdiction, reflecting the fact that employee exposures to hazardous chemicals occur in almost every industry sector.
Other than the costs of printing labels in color, OSHA expects that all compliance costs would be incurred over a period of four years, as the rule would incorporate a four-year transition
In the appendix to this cost section, Table VI-8 shows, by industry and by cost element, total non-annualized (non-discounted) compliance costs of about $2.1 billion estimated to be incurred during the four-year phase-in of the revisions to the HCS.
OSHA received numerous comments on additional costs that had not been considered as part of the PEA. OSHA has carefully evaluated those comments on costs and prepared the following responses.
Stakeholders were concerned about the costs associated with relabeling current inventory. Procter & Gamble reported that they felt “the largest economic impact of GHS compliance to our business will be in the area of re-labeling” (Document ID #0381) and numerous other commenters echoed those concerns (Document ID #0386, 0392, 0393, 0400, and 0402). OSHA anticipates that the four-year phase-in for the revisions to the OSHA HCS (increased from three years in the proposed rule) will provide adequate time for companies to deplete inventory and replace in-house containers that are labeled in accordance with the original OSHA HCS and therefore will mitigate any costs associated with relabeling in-house containers or products in inventory.
The Society of Chemical Manufacturers and Affiliates was concerned that OSHA had not considered the costs associated with mailing revised labels, stating that “a large portion of label revisions will go via the mail service. If a chemical manufacturer produces 75 chemicals and has 50 customers at 70 cents a mailing, it could cost the company as much as $2625.00” (Document ID #0402). The revisions to the HCS do not require that establishments mail revised labels to customers. Manufacturers are only required to provide products labeled in accordance with the GHS criteria by the effective date. OSHA did consider the costs associated with mailing updated SDSs and determined that manufacturers are currently providing updated paper or electronic SDSs to customers as they are revised and would not incur additional costs associated with this standard.
Some comments felt that OSHA had overlooked the time and costs associated with relabeling in-house containers with GHS compliant labels (Document ID #0378 and 0386). The phase-in period for the revisions to the HCS provides adequate time for firms to deplete products in inventory that are not labeled with GHS-compliant labels and to replace workplace containers or signs/permanent labels (such as regulated area signs) in the course of the normal cycle for wear-and-tear replacement. OSHA believes that any costs incurred that are outside the costs that would normally be incurred to replace in-house containers would be negligible and has not estimated a cost for this activity.
Some stakeholders anticipated costs associated with translating labels and SDSs into Spanish (Document ID #0381 and 0393). While some companies may find it necessary, based on customer demand, to provide products with labels and SDSs printed in Spanish, the revisions to the OSHA HCS do not contain any requirement for translating labels or SDSs into Spanish. OSHA has not taken costs related to translating labels and SDSs as part of this FEA.
OSHA received comment that firms will incur costs associated with managing multiple SDSs during the transition period. For example, the Society of Plastics Industry, Inc., reported that “multiple suppliers of the same chemical [may] switch over to the GHS on different schedules” and that “additional time will be required for personnel to sort out and implement appropriate measures for managing this situation” (Document ID #0392, 0402, 0415, and 0452). OSHA appreciates that there may be some time during the transition period where some SDSs are GHS-compliant while others are not. However, given the non-uniformity of SDSs currently circulating to firms, the Agency feels that users will already have a system in place for managing multiple SDSs for identical products and that no additional costs will be incurred as a result of the transition to new SDSs.
The U.S. Chamber of Commerce expressed concern that “employers will also incur legal costs for counsel to review and analyze the revised SDSs to make sure the SDSs provide appropriate explanations and protection from liability” (Document ID #0397). However, the final rule primarily changes the format of SDSs, and generally does not make substantial changes to the categories of information that must be included in the SDS. OSHA does not see why a new legal review to protect against tort liability would be necessary in such circumstances. In addition, the Agency believes that such legal costs would be relatively rare and not representative of the vast majority of employers. Furthermore, such legal costs as occur may simply be an alternative to other in-house professional review services that OSHA has already included in the costs. Finally, employers incurring such legal costs for SDS review arguably have been regularly incurring these costs under the existing HCS as part of periodic SDS changes; in that case, they are costs not attributable to this final rule.
The Society of Chemical Manufacturers and Affiliates felt that costs would be incurred because “someone will have to inventory all of the MSDSs, make the required changes and then communicate those changes to customers and other affected personnel” (Document ID #0402). The revisions to the OSHA HCS do not require manufacturers to provide new SDSs to customers who have purchased a product and received an SDS in the past. This final rule also includes a four-year phase-in period for firms to update their SDSs and requires only that those updated, GHS-compliant SDSs be provided to users who purchase a company's product after the effective date. OSHA realizes that some firms may choose to provide updated SDSs to past purchasers of their products, but the updates to the OSHA HCS do not require that they do so. Subsequently, OSHA has not taken any costs related to this activity.
Ferro Corporation's comment in the rulemaking record expressed concern that OSHA did not take into account conversion costs for “MSDSs and labels for experimental products that are being resampled” (Document ID #0363). OSHA's analysis does not make a distinction between commercial and experimental products, but it does not exclude costs associated with experimental products. The Agency feels that this economic analysis captures those costs as well as the transitional costs for products that are sold commercially.
The Society of Plastics Industry, Inc. expressed concern that the revisions to the OSHA HCS would require employers “to perform new personal protective equipment (PPE) hazard assessments, select new PPE or select PPE for workers who did not previously use it” or “to add or modify ventilation systems or to have their employees use respiratory protection to address newly discovered hazards, and to implement respiratory protection programs” (Document ID #0392). The scope of hazards covered by the GHS is very similar to what is covered by the current HCS as discussed in Section XIII Summary and Explanation. While the revisions to the OSHA HCS could, theoretically, result in some chemicals that were not considered hazardous being classified as such now, OSHA does not expect any significant change in chemicals covered under this final rule and did not receive any specific examples from stakeholders, despite
Multiple stakeholders questioned whether OSHA had taken into account the cost to update workplace signs to come into compliance with the revised OSHA HCS. Southern Company reported that the cost to purchase signs for their 29 affected plants would be $58,000 plus the cost of employee time to install the signs (Document ID #0378), and API reported that one of its member companies recently updated the signs at its small refinery at a cost of $200,000 (Document ID #0376). OSHA feels that the four-year phase-in time for these revisions to the HCS, combined with the limited number of affected workplace signs, will minimize any cost that firms may incur. The phase-in period will allow firms to update their signs during the normal replacement lifecycle of three to five years for those signs and will result in minimal costs.
Commenters felt that “costs for re-classification and modification of SDS and labels would need to include substantial consulting fees” (Document ID #0392). OSHA maintains that any firm preparing labels and SDSs under the current OSHA HCS will not find it significantly burdensome to prepare labels and SDSs under the revised HCS. On the contrary, OSHA expects that the revisions to the HCS would be able to prepare SDSs and labels at lower cost in the future (for which the Agency earlier, in Section VI.D: Benefits, estimated productivity savings). In addition, much reclassification work has already been done by firms that sell to the EU or to Asian markets.
The remainder of this section explains how the compliance costs arising from the final rule were calculated by describing the data and methodology used to estimate each of the major cost elements. A more complete and detailed description of the estimation of compliance costs can be found in the revised final version of the PP&E 2009 report (Document ID #0273), the ERG (2010, 2011) reports focusing on the costs of printing labels in color, and the updated cost estimates for the final rule in ERG (2012).
The major elements of the revisions to the HCS that involve compliance costs include (1) the classification of chemicals in accordance with the GHS criteria, and the revisions to the safety data sheets and labels corresponding to the affected hazardous chemicals; (2) even though it is not directly a result of any specific requirement included in the revisions to the HCS, the cost for managers and administrators of hazard communication programs to become familiar with the revisions to the standard and to manage, update, and revise their programs as may be necessary to ensure compliance with the revised standard; (3) incremental training for employees already trained under the existing OSHA hazard communication programs to ensure their familiarization with the new formats, information, and symbols that would be introduced into the workplace as a result of the revisions to the HCS; and (4) costs to upgrade label printing technology or purchase labels preprinted in multiple colors in order to comply with the requirement that the pictogram on the label be enclosed in a red-bordered diamond.
The estimated compliance costs presented in this analysis of the revisions to the HCS are largely based on research conducted by PP&E (2009), which was expanded and updated for the FEA by ERG (2010, 2011, and 2012). Both PP&E and ERG performed this research under contract to the Department of Labor specifically for the purpose of developing estimates of compliance costs for, and assessing the potential impacts that may be associated with, revisions to the OSHA HCS in order to implement the GHS.
The estimated costs of compliance with many of the provisions of the final rule involve wages paid for the labor hours required to fulfill the requirements. In some cases, compliance could be achieved by purchasing services or products in lieu of paying employees directly. The estimated compliance costs are intended to capture the resources required for compliance, regardless of how individual establishments may choose to achieve compliance.
The revisions to the OSHA HCS continue to require firms that sell hazardous chemicals to employers to provide information about the associated hazards. Information is required to be presented in a safety data sheet (SDS) in the format specified in the revised standard, and some information is also required to be presented on product labels.
The existing OSHA HCS already requires information about hazardous chemicals to be provided in SDSs and on labels. In addition, under the existing standard, SDSs are to be revised within three months after a manufacturer or employer becomes aware of any significant new information about a chemical hazard.
The final rule requires chemicals to be classified into the appropriate hazard classes and categories based on the information about the chemicals that the manufacturers currently have. This information would have been assembled for purposes of conducting a hazard determination under the current HCS. In addition, the current HCS requires chemical manufacturers and importers to remain aware of developments regarding the hazards of the chemicals they produce or import in order to update the labels and SDSs for the chemicals in a timely manner. The classification of the chemicals into the hazard classes and categories under the revised provisions does not require any additional testing, studies, or research to be conducted. Manufacturers would be able to rely on the information they already have in determining how to properly classify their chemicals.
Generally, chemical manufacturers and importers periodically review, revise, and update SDSs and labels. Changes are made as necessary as information regarding specific hazards develops, new information about protective measures is ascertained, or changes are made to product information and marketing materials. Labels and SDSs must also be produced or modified when products are introduced or changed. Therefore, there is a regular cycle of change for these documents for a variety of reasons. The final rule may require more extensive change than would normally occur, but the phase-in period is such that the chemical manufacturers and importers can take advantage of the normal cycle of change to phase in the revisions for all their products over a reasonable time period. This should have less impact on normal operations than a short time period that would require all SDSs and labels to be revised at the same time.
The transition period that would be allowed by the delayed effective date for the requirement to adopt the new format should help ensure that the transition can be completed in conjunction with revisions and updates that would normally be expected to occur even without the implementation of the final rule. In addition, the format for SDSs required by the final rule is consistent with the format adopted by the American National Standards Institute (ANSI) and therefore has already been implemented by many of the affected businesses.
Based on ERG (2012), OSHA developed estimates of the costs that would be associated with the
The revisions to the HCS would allow for a transition period of four years following the publication of a final rule. During this period, even in the absence of any pertinent OSHA rulemaking, producers of affected chemicals would presumably be ensuring that the information provided in their SDSs and labels remains accurate and current. Producers of hazardous chemicals are generally expected to regularly review the available information regarding any hazards that may be associated with their products and to revise SDSs and labels accordingly.
In addition, for every affected product that is newly created, reformulated, mixed with new ingredients, modified with new or different types of additives, or has any changes made in the proportions of the ingredients used, the chemical producer would be required under existing OSHA and other applicable standards to review the available hazard information, to classify the chemical in accordance with applicable hazard criteria, and to develop corresponding SDSs and labels.
The estimated costs of compliance with the final rule do not include the costs associated with activities such as those described in the above paragraphs, but rather reflect only the additional costs that chemical producers would not already be expected to incur.
The estimated compliance costs associated with the reclassification of hazards and changes to SDSs and labels are directly related to the numbers of SDSs affected. Based on ERG (2012), OSHA developed estimates of the number of potentially affected SDSs by industry, for each of the industries producing the corresponding chemicals and products (as shown in Table VI-3). Downstream users, distributors, and wholesalers are generally expected to continue to rely on SDSs provided by manufacturers to fulfill their obligations under the OSHA standard, as has been the practice for decades.
The costs of compliance associated with the classification of chemicals in accordance with the criteria specified in the final rule and with the revisions to the corresponding SDSs and labels for those chemicals were based on PP&E industry interviews and, as described below, are based on the same time and software estimates as those presented in the proposed rule.
Generally, for smaller establishments with relatively few chemicals affected, OSHA estimated the incremental compliance costs to be the equivalent of the cost of seven hours of time of a professional with the requisite expertise for each affected chemical, on average. Based on ERG's (2012) updates to the PP&E 2009 report (Document ID #0273), OSHA estimated the cost of hourly compensation for a professional for this purpose to be $66. As a result, a small establishment (with fewer than 100 employees) with 20 SDSs for 20 chemicals, for example, would have estimated incremental compliance costs of $9,240 (7 hours times 20 SDSs times $66).
In larger establishments with more affected chemicals, the incremental compliance costs were estimated to consist of two parts. First, labor costs were estimated according to the size of the establishment. OSHA, based on PP&E interviews with stakeholders, estimated that entities with 100 to 499 employees would incur, on average, the equivalent of five hours of time of a professional with the requisite expertise for each affected chemical, and that entities with 500 or more employees would incur the equivalent of three hours of professional time per chemical. Again, OSHA estimated the hourly compensation for a professional for this purpose to be $66.
The rulemaking record presented a wide range of estimates for the time required to update SDSs with a low estimate of four hours per SDS (Document ID #0119 and 0123), a few estimates in the range of 25-30 hours per SDS (Document ID #0134 and 0402), and upper bound estimates as high as 150 hours per SDS (Document ID #0341). OSHA evaluated these estimates and felt that the upper estimates are not defensible for the following reasons: (1) Firms will not be required to gather or evaluate additional data; (2) firms currently must update their SDSs periodically, and there was no evidence presented in the record that suggested that updates under the current HCS take anywhere near 150 hours per SDS; and (3) the Agency does not feel that it is clear that these estimates account for only the incremental time needed to prepare an updated SDS, taking into account any time that would be spent updating SDSs during the transition period in the absence of any revisions to the OSHA HCS. The Agency acknowledges that some SDS updates may take longer than the average listed above, but also feels that many chemicals—especially pure substances which will likely already have been classified according to the GHS for the EU or Asian markets—will take less than the estimated time used in the economic analysis. Therefore, OSHA feels that the estimated time to update SDSs used in this analysis represents a reasonable average for most chemicals.
The labor cost per SDS was estimated to be lower for larger companies based on the determination that larger companies produce more SDSs, and would therefore experience efficiencies associated with producing them. These efficiencies include economies of scale, the use of software specifically designed to classify hazards and produce SDSs, and the generally lower cost per SDS associated with many mixtures.
In addition to labor costs, many of these larger establishments may incur additional expenditures to purchase or modify software that can be used to classify chemicals and to produce corresponding SDSs and labels. Such software is available from a variety of vendors; the software can be purchased or used on a subscription basis. Publicly available information about the products and services being offered and sold to businesses for purposes of complying with hazard communication requirements indicates that most of the relevant vendors are aware of and prepared for an upcoming alignment with the GHS. Therefore, their products and services are or will be adapted to enable compliance with the revisions to the HCS. In addition, some firms may purchase custom or proprietary software from private vendors to achieve compliance with existing requirements or future revisions to hazard communication requirements or for other purposes.
Regardless of the particular approach individual companies may choose to most efficiently fulfill their obligations under the existing HCS, OSHA expects that a part of the costs associated with achieving compliance with the final rule would involve costs attributable to software modifications. Based on industry data obtained by PP&E, OSHA apportioned these costs on a per-SDS basis and estimated the cost per SDS to be $208, on average. Numerous stakeholders raised the issue of software updates and modifications in their comments submitted to the rulemaking record (Document ID #0018, 0105, 0114, 0363, 0371, and 0389). In response to the ANPR, the American Chemistry Council reported that their members estimated anticipated software update and conversion costs of up to $70,000. The ACC also reported that their
Based on ERG's (2012) updates to the PP&E 2009 report (Document ID #0273), OSHA estimated the numbers of SDSs produced in each industry that would potentially need to be revised under the final rule. As shown in Table VI-3, a total of about 1.4 million SDSs, one for each type of chemical produced by an individual manufacturer in the United States, were estimated to be in potential need of revision.
In developing estimates of the compliance costs associated with the rule, PP&E also considered the extent to which many firms have already performed the necessary reclassifications of chemical hazards and revisions to SDSs. Some chemical hazards have already been reclassified as would be required by the OSHA final rule because the U.S. Department of Transportation has required such classifications as part of their regulations for the transportation of hazardous chemicals (49 CFR Parts 171-180). The criteria for physical hazard classifications for purposes of transport have been internationally harmonized for some years, and these criteria formed the basis for the physical hazard criteria in the GHS. Therefore, many products intended for transport have already been classified under the new physical hazard criteria as well as the existing criteria in the HCS.
Many current SDSs are already produced to varying degrees in accordance with the requirements of the OSHA final rule because the widely followed ANSI industry consensus standard already reflects many of these requirements in its relevant criteria. In addition, many firms have implemented or are beginning to implement hazard reclassifications, SDS revisions, software modifications, and other changes in accordance with the requirements of the final rule, because these provisions are generally anticipated to be adopted as part of the implementation of the GHS in countries and regions around the world. Since some other countries are already implementing the GHS, companies in the U.S. that ship to those countries are already having to comply with the GHS for products being exported. Stakeholder comment in the docket suggested that some of the work related to reclassification has already been done (
Research conducted by PP&E indicates that all of these factors contribute to a substantial degree of current compliance with the requirements of the final rule, even if the existing OSHA HCS standard remains unchanged.
Based on the preceding analysis, OSHA estimates an annualized cost of approximately $22.5 million for the classification of chemicals in accordance with the criteria specified in the final rule and for revisions to the corresponding SDSs and labels for those chemicals.
[(
where the first term in brackets reflects the fact that these costs are assumed to be spread equally over the first four years; the second term in brackets calculates the present value of the costs, and the third term in brackets annualizes the present value of the costs over a 20-year period.
As discussed below, OSHA received some comments from the public regarding the estimated costs associated with chemical classifications and revisions to safety data sheets in response to the ANPR published by OSHA in the
Some commenters provided examples of cost estimates that generally support the estimates of the preliminary economic analysis. Information from other commenters provided a wide range of cost estimates. The figures presented in some comments appeared to correspond to gross costs of creating SDSs, and in other cases it was not clear whether gross or incremental costs were being presented. In general, commenters did not provide the rationale underlying their cost estimates.
Comment from the Fragrance Materials Association of the United States (Document ID #0061) and the Flavor and Extract Manufacturers Association of the United States (Document ID #0062) stated that these Associations' best assessment is that it would take anywhere from two to eight hours to review information and prepare new labels and safety data sheets for each hazardous chemical
One company that produces and distributes about 4,000 different hazardous chemicals estimated that it will take four to six hours per product to prepare a GHS SDS. (Document ID #0026).
The National Paint and Coatings Association stated that it would take approximately five hours to research the information for a product SDS/label at a small company, at a cost of about $300 per product; it also estimated that, at a medium-sized company, this same task would take from 3-5 days to 3 weeks at a cost of approximately $1,000 to $1,800, and that at a larger company, the task would be even more expensive (Document ID #0050).
The National Association of Chemical Distributors estimated that converting an existing SDS to the new GHS format would require about 150 hours as
Another commenter, Merck, which produces, imports, or distributes about 500 hazardous chemicals annually, estimated that, on average, it takes approximately 3 weeks to generate a single safety data sheet at an average cost of $1,500. Merck also stated that with a sufficient transition period of three to six years, the costs of moving to GHS would be minimal. Merck noted that the time and cost for additional changes to the GHS format should be minimal because it had already converted its SDSs to the 16-section ANSI/GHS format several years ago (Document ID #0072).
One trade association estimated that the costs associated with revising SDSs and labels for the 1,600 firms in the cleaning product formulator industry would total $575 million, not including the time needed to review changes to hazard classifications. The total numbers of SDSs per establishment are generally higher for the establishments represented by the trade association than the OSHA estimates for the industry category as a whole (Document ID #0032).
This trade association also provided some of the details underlying its cost estimates for individual companies. Cost estimates provided by the trade association for individual companies included costs per SDS as low as $30 and $80, and as high as $600 or more. One company (identified as Company #11) estimated the cost to revise the label and SDS would be $120 per product; another company (Company #2) estimated that this cost would be $2,600 per product. Some of the higher compliance cost estimates appear to be unrealistically high; for example, the estimated costs associated only with revising labels for company #3 appear to represent about 3 percent of total annual sales. While acknowledging that some firms may incur higher costs than others to revise SDSs and labels, these data generally appear to support that, at least for several firms in the industry, the costs minimally necessary to achieve compliance would be close to or less than the costs estimated by OSHA.
Ameren, an electric and gas services provider, estimated that all 9,000 of their employees would need one hour of training initially at a total cost of $450,000. The company estimated that it would take 100 hours to update their SDSs (fewer than 25) at a total cost of $6,500 and that updating the 25,000 SDSs in their database would take five minutes per SDS for a total cost of $102,700 (Document ID #0330).
The Independent Lubricant Manufacturers Association surveyed their members and reported that, with one SDS per product, their members could be expected to incur costs of $340,000 to $559,000 ($329 or $200 per SDS multiplied by 1700 SDSs per firm) to update SDSs. One member company estimated costs associated with update software at $200,000 in the first year and $1,000 per SDS in subsequent years to maintain the software and SDSs. Another company estimated that software would cost $50,000 and would include an additional $300,000 in staff time (Document ID #0371).
Another trade organization, The Society of Chemical Manufacturers and Affiliates, felt that it would take ten hours to revise a label or an SDS (Document ID #0402).
Several other commenters provided cost estimates related to the adoption of GHS requirements for chemical classifications and revisions to safety data sheets and labels. (
The implementation of GHS as part of the OSHA HCS would require that employees currently covered by the standard become familiar with the new system. The nature and extent of the familiarization required would vary depending on an employee's job and business. OSHA considered separately various training needs that may be imposed by the revisions.
Although it would not be explicitly required by the final rule, some establishments may choose to provide training to managers and other employees that are not directly covered by the training requirements of the HCS. Other management-related costs may include making revisions, if necessary, to existing hazard communication programs; promoting awareness of and providing information about the revisions to hazard communication programs; coordinating and integrating changes to hazard communication programs with other programs, processes, and functions; serving as an in-house resource for supporting the general adoption of the revised HCS; creating supplemental capacity for providing training and assistance to affected employees; and other ancillary costs for company-specific changes and general hazard communication program administration that may be incurred at some establishments.
These management costs could be considered discretionary since they are not explicitly required by the regulatory provisions. However, OSHA recognizes that these costs may be incurred in practice due to the manner in which some companies have implemented and integrated hazard communication programs in their facilities. These costs reflect the fact that hazard communications programs often are not implemented solely for purposes of complying with the OSHA standard, but may serve a variety of other purposes that are part of and that benefit the overall production process.
In some cases, health and safety supervisors, logistics personnel, and other personnel involved in administering, implementing, and ensuring compliance with the requirements of the HCS in affected establishments would be expected by company managers to become familiar with the revisions to the HCS. The responsibilities of these employees may include modifying written hazard communication programs as necessary, reviewing and preparing training materials, and training new and existing employees regarding the changes. A commenter asserted that OSHA had overlooked the cost to train the employees who would be providing training to production workers (Document ID #0392), and the American Chemistry Council also questioned whether OSHA had considered the necessary training for fire, EMS, or other emergency workers (Document ID #0393). The Agency has included these occupations in the cost estimates, allocating eight hours for training on the revised HCS elements, and included employees responsible for providing training as part of the management training and familiarization costs and has continued to include them in estimated the costs of the rule for this FEA.
In the PEA, OSHA estimated 8 hours of time, or an equivalent cost, would be associated with the necessary familiarization and implementation of
In many potentially affected establishments that do not produce SDSs, and that have few affected chemicals or few affected employees, a very basic hazard communication program may achieve compliance with the OSHA standard. For these establishments, outside of the manufacturing sector, that have a health and safety supervisor, the incremental management and administrative costs associated with the revisions to the OSHA standard were estimated to be two hours per establishment. For establishments outside of the manufacturing sector that do not have a health and safety supervisor, OSHA estimated that these costs would be negligible.
Based on the preceding analysis, OSHA estimates an annualized cost of approximately $59 million for management familiarization and other related management activities in response to GHS.
The annualization factor, 0.085332, is equal to:
[(
where the first term in brackets reflects the fact that these costs are assumed to be spread equally over the first two years; the second term in brackets calculates the present value of the costs, and the third term in brackets annualizes the present value of the costs over a 20-year period.
Production employees who are currently covered by and trained under the provisions of the existing HCS would need to receive some additional training to become familiar with the changes to SDSs and labels.
In many potentially affected establishments that do not produce SDSs, and that have few affected chemicals or few affected employees, a very basic hazard communication program may achieve compliance with the OSHA final rule. In these establishments, the incremental employee training costs associated with the revisions to the HCS may be relatively small. In other cases, employers may be able to integrate the necessary training into existing training programs and other methods of distributing safety and health information to employees, and thus may not incur much additional cost. Nevertheless, in general, employers will need to devote real time and resources to provide the necessary training in order to ensure that workers are familiar with the new hazard communication system.
In response to comments in the rulemaking record, the training time associated with the revisions to the OSHA HCS has been increased from those presented in the PEA. OSHA increased the estimated training time from 30 minutes to 60 minutes for most employees; from 15 minutes to 30 minutes for employees with minimal contact with hazardous chemicals; and from 5 to 10 minutes for employees in certain occupations in the transportation sector, where GHS pictograms are already in use. A complete occupation-by-occupation summary of OSHA's estimates is provided in the ERG (2012) revisions to the PP&E (2009) report.
The United Parcel Service, Inc. submitted comment supporting this increase, reporting that “[i]nitial training takes about 15 minutes currently but will [* * *] double during the phase-in process” and that “training time (
Based on the preceding analysis, OSHA estimates that the annualized cost of training employees in response to GHS would be approximately $95.4 million.
The revisions to the HCS may result in reductions in the costs associated with providing training for employees as required by the existing OSHA HCS. Affected companies could save considerable time and effort in training new employees in the future. The savings may be attributable in part to reducing or eliminating the need to explain the different types of formats used to convey hazard information and the different types of information included in the contents of SDSs and labels. OSHA did not quantify these potential savings in training costs as part of this FEA but, based on stakeholder comment and testimony in the rulemaking record, OSHA anticipates that companies will realize cost savings in future time periods from simplified hazard communication training facilitated by the final rule. A qualitative discussion of these cost savings was presented in Section VI.D: Benefits in this preamble and an estimate of the possible magnitude of these cost savings is presented in the sensitivity analysis in Section VI.L in this preamble.
The revisions to OSHA's HCS include a requirement that labels include a pictogram enclosed in a red-bordered diamond. The rulemaking record showed widespread (although not unanimous) support for requiring the red-bordered diamond. One commenter felt that “the use of color to draw attention to a potential hazard is a useful tool and is likely to enhance the communication of safety information” (Document ID #0327), another stated that “the color red has been universally accepted as indicating a potential danger or hazard” (Document ID #0339), and others showed general support for requiring red borders in order to achieve the highest level of harmonization (Document ID #0351 and 0383). Many stakeholders raised concerns that this requirement would result in additional costs to firms since many do not currently print labels in multiple colors or purchase pre-printed labels in multiple colors (Document ID #0120, 0327, 0328, 0344, 0363, 0383, 0389, and 0402). Requiring the red-bordered diamond on the label would mean that some firms would have to upgrade their printer technology or purchase more expensive pre-printed label stock that included the red-bordered diamond.
OSHA estimated the cost impacts of the rule's requirement that pictogram borders be printed in red based on a report on the subject prepared by ERG (2011). That report is based on data provided in an earlier report prepared by ERG (2010). The full ERG reports are available in the rulemaking docket on regulations.gov. To estimate costs for this provision, OSHA estimated the number of hazard labels printed per year, the number of establishments that would incur costs to upgrade their printing technology, and the cost to those establishments to upgrade their printing technology. OSHA estimates that approximately 949 million hazard labels are printed each year and the total incremental cost for establishments to comply with this provision of the OSHA standard is $24.1 million per year. The following section explains how OSHA, using ERG (2010 and 2011), developed estimates of the number of hazard labels printed per establishment, the number of establishments that would need to upgrade printer technology, and the cost to those establishments to comply with this provision of the final rule.
ERG (2011) used data on
For each of the SCTG commodity codes, the U.S. Census data present shipments of basic chemicals by shipment weight. In order to establish the types of shipments that might fall into each weight class, OSHA relied on preliminary research conducted by ERG (2010) on the weight and capacity of various shipping container units and the weight per gallon of various chemicals. Information was gathered on the types of containers typically used by specific industries and whether those containers would typically ship inside a labeled exterior container. OSHA calculated shipment weights for various chemicals shipped in various container types by multiplying the product weight per gallon by container capacity and adding the weight of the shipping container. As shown in Table VI-5, minimum, maximum, and simple average weights per full container were estimated for the different commodities evaluated in this test case using the Census-reported commodity shipments by shipment weight to establish some bounds on possible shipment types.
Based on these calculations, OSHA was able to estimate the number of each type of container that would fall into each of the U.S. Census weight classes. The number of containers that would require a label under the OSHA HCS was refined by estimating the percentage of each commodity that was comprised of nonhazardous products and the percentage of the remaining products that would be sold to consumers. Neither of these types of products fall under the scope of OSHA's HCS and would not require a hazard warning label under the revised rule. For the remaining hazardous non-consumer shipments, assuming one label per container and one label on the outer packaging where applicable, ERG estimated that approximately 949 million hazard labels are applied annually to containers of all sizes.
In most cases one SCTG maps to multiple NAICS industries. In order to divide the number of labels for each SCTG among its constituent NAICS industries, OSHA used receipts data from the U.S. Census Bureau's Statistics of U.S. Businesses to calculate receipts for a particular NAICS industry as a percentage of receipts for all NAICS industries that map to one SCTG. This percentage was used to allocate the estimated number of labels printed for each SCTG among its constituent NAICS industries.
The labels printed per NAICS industry were then distributed among the various size classes based on each size class's share of receipts. In cases where receipts data were not available from the Statistics of U.S. Business (a situation found exclusively within the chemical manufacturing industry in the affected industries for this rule), OSHA calculated the average total receipts and average receipts for each establishment size class for six-digit NAICS in the 325 (Chemical Manufacturing) subsector and the ratio of average receipts for size class to total receipts for six-digit NAICS in 325. This ratio was multiplied by total receipts for the appropriate size class for each industry where receipts data were not available.
Having estimated the number of hazard labels used per year for each NAICS code, OSHA next estimated the costs associated with printing those labels with red pictogram borders. Affected establishments were assigned to one of four categories:
Category 1: Companies printing only in black who don't own a color printer
Category 2: Companies printing in black but who own a color printer
Category 3: Companies using pre-printed stock or labels
Category 4: Companies printing color labels
Establishments in Category 1 and Category 2 will have to buy new color printers (although Category 2 establishments will have to buy fewer new printers), as well as either color cartridges for laser printers or red ribbons for thermal transfer printers. Establishments in Category 3 will face higher costs for pre-printed stock or labels with red pictogram borders. Establishments in Category 4 will not face higher costs. Relying on conversations with companies and label printers/vendors, ERG allotted establishments into these four categories on the basis of establishment size (as shown in Table VI-6).
Using the estimates of the percentage of establishments per category by size and the data presented in the industry profile, OSHA was able to estimate the number of establishments per category by size. OSHA used the ratio of SDSs produced by size class to the ratio of total SDSs produced and used that ratio to estimate the number of labels produced per size class per NAICS industry. The results are shown in Table VI-7.
The number of establishments per category per size class and the number of labels per establishment were then combined with the incremental costs to print in color as opposed to black only to arrive at an estimate of the cost of this provision.
The unit costs by category were estimated as follows.
A low-end laser printer was estimated to cost only a few hundred dollars while a higher-end laser printer can cost upwards of $1,000 to $5,000. OSHA estimates that on average, the incremental cost of buying a color printer instead of a black and white printer is $50 for a low-end laser printer, $100 for a high-end laser printer, $100 for a low-end thermal transfer printer, and $1,000 for a high-end thermal transfer printer. In this analysis, OSHA considers the cost of printers to be a one-time cost that establishments will incur during the four year transition period. The one-time, non-annualized cost to establishments to upgrade printer technology was estimated to be $11.8 million. Printer costs were annualized using a 7 percent interest rate over a five-year period.
The incremental cost of color cartridges for laser printers is a significant driver of costs under the rule. Black cartridges cost approximately $300, while printing in color requires buying four cartridges (cyan, magenta, yellow, and black) at an estimated cost of $1,200. Additionally, printers using black cartridges can print 20,000 labels, while color cartridges can print only 6,000 labels. This results in a per-label cost of $0.015 for black cartridges and $0.20 for color cartridges, for an incremental cost of $0.185.
For companies using thermal transfer printers, the cost of ribbons varies depending on the label material, but is approximately $30 per ribbon for black ribbons and $40 per ribbon for red ribbons. Since both black and red ribbons will be required to print labels under the final rule, the incremental cost of printing in color is the cost of the red ribbon or $40. Both types of ribbons will print approximately 1,000 labels, for a per-label cost of $0.034 for black ribbons and $0.04 for red ribbons, for an incremental cost of $0.01 per label.
For companies using pre-printed stock/labels, the cost of all black labels is estimated to be $0.10 per label while the cost of labels with red pictograms is estimated to be $0.15 per label. This results in an incremental cost of $0.05 per label.
For the purposes of this analysis, OSHA estimated that for those establishments in category 1 (those currently printing labels only with black ink who don't own a color printer) very small establishments will purchase one low-end laser printer, small establishments will purchase two high-end laser printers, medium establishments will purchase three low-end thermal transfer printers, and large establishments will purchase four high-end thermal transfer printers. For establishments in category 2 (those currently printing labels only in black ink but who own a color printer), OSHA estimated that very small establishments will purchase one low-end laser printer, small establishments will purchase one high-end laser printer, medium establishments will purchase two low-end thermal transfer printers, and large establishments will purchase three high-end thermal transfer printers. OSHA estimates that establishments in categories 3 and 4 (those purchasing preprinted black and white labels and those currently printing labels in color) will incur no costs to procure new printers.
Using the estimates described above, OSHA was able to determine the current costs of printing and the cost of printing labels with red-bordered pictograms.
For establishments in Category 1 (those printing black and white labels), the current average cost per label is $0.02 and the average cost per establishment is $132, and for establishments in Category 2 (those printing black and white labels but who own a color printer), the current average cost per label is $0.03 and the average cost per establishment is $344. Establishments in Category 1 and Category 2 will have to buy new color printers (although those in Category 2 will have to buy fewer printers). These establishments will also face higher costs for purchasing color cartridges and ribbons. For these establishments, the cost of purchasing a color printer becomes insignificant when annualized (at a 7 percent interest rate over five years) and when considered on a per-label basis. The main driver of overall costs is the incremental cost of purchasing color cartridges for those establishments using laser printers (establishments that OSHA estimates are small and very small). For very small and small establishments using a laser printer, the cost of cartridges goes from under $0.02 per label for a black cartridge to $0.20 per label for color cartridges. Cost increases are more modest for medium and large establishments using thermal transfer printers, with ribbon costs only increasing from $0.03 to $0.04 per label.
For establishments in Category 3 (those who use pre-printed stock or labels) the current average cost per label is $0.10 and the average cost to purchase labels per establishment is $1,148. Establishments in Category 3 will have to pay more for pre-printed stock or pre-printed labels with red pictograms than for their current hazard labels. OSHA estimates that costs will increase from $0.10 per label to $0.15 per label, increasing printing costs by 50 percent for all establishments in this category.
For establishments in Category 4 (those currently printing in color) the current average cost per label is $0.15 and the average cost per establishment is $1,880. Establishments in Category 4 will not have to pay any more to print red borders as they are already printing color labels.
The annualized cost of printers was calculated by finding the present value of the incremental printer cost incurred four years after the rule is published (to account for the compliance time for the labeling provisions of the rule). This present value was annualized over five years at a 7 percent interest rate to account for the life of the printer. In the cases of printing supplies (
For all establishments in all categories, the total costs associated with the requirement to print red pictogram borders are approximately $24.1 million per year, which includes the annualized cost of new printers (approximately $2.4 million) and of 16 years' worth of annual printing supply costs. OSHA feels this estimate is in line with the comments received on the subject as part of the rulemaking record. Betco Corporation estimated that requiring color printing would increase printing costs by 25 percent (Document ID #0389), Dow Chemical estimated that black and white printing was 40 percent less expensive than color printing (Document ID #0353), and The National Paint & Coatings Association, Inc. estimated an increase of 15 percent to 47 percent to print in color depending on the size of the label (Document ID #0328). The Agency also feels that the four-year phase-in period allows adequate time for establishments to exhaust their current stock of labels, which will help ameliorate some cost concerns expressed by stakeholders.
The following list provides a summary of the input estimates underlying the calculation of the compliance costs. It should be noted that these costs are intended to reflect only the incremental costs that would be incurred in addition to the associated costs that would be incurred in the absence of the revisions to the HCS. Except for employee training and color printing, these costs would apply only to those businesses not already in compliance with the revisions.
Reclassifying chemicals and modifying SDSs and labels:
• Large establishments (over 500 employees): an average of 3 hours per SDS; in addition, for 95 percent of establishments, an average of $208 per SDS for software modifications.
• Medium establishments (100-499 employees): an average of 5 hours per SDS; in addition, for 25 percent of establishments, an average of $208 per SDS for software modifications.
• Small establishments (1-99 employees): an average of 7 hours per SDS. Management familiarization and other costs:
• Eight hours for health and safety managers and logistics personnel in the manufacturing sector.
• Two hours for each hazard communication program manager not in the manufacturing sector.
Employee training:
• One hour per production employee in most industries;
• 30 minutes in occupations exposed to few hazardous chemicals and types of hazards;
• 10 minutes per employee in some occupations where GHS-type pictograms are already in use.
• Category 1 establishments (those currently printing only in black & white who do not own color printers): Large establishments $0.02 per label, medium establishments $0.01 per label, small establishments $0.13 per label, and very small establishments $0.14 per label.
• Category 2 establishments (those currently printing only in black & white but who own color printers): large establishments $0.02 per label, medium establishments $0.01 per label, small establishments $0.13 per label, and very small establishments $0.14 per label.
• Category 3 establishments (those currently purchasing pre-printed label stock): large establishments $0.03 per label, medium establishments $0.03 per label, small and very small establishments $0.03 per label.
• Category 4 establishments (those currently producing labels printed in multiple colors): No additional costs related to this provision.
Table VI-8 shows the total non-annualized (non-discounted) compliance costs by industry and by cost element that are estimated to be incurred during the four-year phase-in of the revisions. Except for employee training and color printing, these estimates include no costs for businesses already in compliance with the revisions.
As shown in Table VI-8, the total cost of compliance with the rulemaking over the course of the transition period of four years is estimated to be about $2.1 billion. Of this amount, the cost of chemical hazard reclassification and revision of SDSs and labels is an estimated $281 million, the cost of training employees is an estimated $1,118 million, the cost of management familiarization and other costs such as updates to hazard communication programs is an estimated $692 million, and the one-time printer costs for companies needing to upgrade printing technology to print labels in color is an estimated $12 million.
Table VI-9 summarizes OSHA's estimates for printing costs. It shows annualized per-label costs by category and establishment size ranging from $0.01 to $0.14 and total annualized costs by category and establishment size. Total annualized costs include the cost of printers annualized over five years and the cost of printing supplies incurred over a 20-year period beginning four years after the rule is published.
Table VI-1 provides a summary of the costs and benefits of the revisions to the OSHA HCS, and it shows the net benefits and cost-effectiveness of the revisions to the standard. Net monetized benefits are estimated to be $556 million annually, expressed in 2010 dollars and using a 7 percent discount rate. (Using a 3 percent discount rate instead would have the effect of lowering the costs to $161 million per year and increasing the gross benefits to $839 million per year. The result would be to increase net benefits from $556 million to $678 million per year.) The cost-effectiveness of the standard can be expressed as more than three dollars of benefits for every dollar of cost.
Some qualitative evidence of the cost-effectiveness of the standard was provided by comments submitted in response to the ANPR published by OSHA in the
The available alternatives to the final rule are somewhat limited since this rule modifies the current HCS in order to align with the provisions of the UN's GHS. In Section III, the Agency qualitatively discussed the two major alternatives presented during this rulemaking process—(1) voluntary adoption of GHS within the existing HCS framework and (2) a limited adoption of specific GHS components and a variation on (1) that would require compliance with GHS but allow an exemption for small businesses to comply with either the current HCS or with the GHS-compliant HCS. All of these alternatives were soundly rejected by stakeholders. To allow certain parties to follow an alternative system or to allow voluntary adoption of the elements of a uniformity standard does nothing to reduce confusion, improve efficiency, or simplify processes. In order for those benefits to be realized, all elements must apply to all affected parties. OSHA has determined that both of the alternatives presented above would eliminate significant portions of the benefits of the rule.
OSHA did not attempt to evaluate the costs and benefits for the regulatory alternatives that involved partial or voluntary adoption of the GHS. The Agency did evaluate two alternatives where the effective dates were altered. For both alternatives, OSHA re-estimated the costs, benefits, and net benefits simply by adjusting the effective dates in its formulas. The results are summarized in Table VI-10.
In the first alternative considered, all elements of the revised HCS would be required to be implemented within two
The second alternative that OSHA evaluated extended the timeline for training to be completed. For this alternative, all elements of the revised HCS (including training) would be required to be implemented by June 1, 2016. Under this alternative, training costs would not be realized for four and a half years (as opposed to the two-year requirement for training in the final version of this rule) while benefits would not be realized for five years (unchanged from the final rule). OSHA estimated that annualized costs under this second alternative would decrease by $12 million, from $201 million to $189 million, while annualized benefits would be unchanged. Estimated net benefits would therefore increase by $12 million, from $556 million to $568 million. However, these estimates fail to recognize that workers will be exposed to (some) GHS-compliant labels and SDS formats well before the 4
In summary, although both alternatives show greater net benefits, the Agency concludes that the timing of the final rule is preferable because of additional (but unquantified) compliance costs and reduced (but unquantified) benefits under the first alternative and because of reduced (but unquantified) worker health and safety benefits under the second alternative. In addition, OSHA expects that the final rule offers coordination benefits in that its requirements will fully take effect at the same time as the EU completes its transition.
This section presents OSHA's analysis of the potential economic impacts of the final rule and an assessment of economic feasibility. A separate analysis of the potential economic impacts on small entities (as defined in accordance with the criteria established by the Small Business Administration) and on very small entities (those with fewer than 20 employees) is presented in the following section as part of the Final Regulatory Flexibility Screening Analysis, conducted in accordance with the criteria laid out in the Regulatory Flexibility Act.
To determine whether a rule is economically feasible, OSHA begins with two screening tests to consider minimum threshold effects of the rule under two extreme cases: (1) All costs are passed through to customers in the form of higher prices (consistent with a price elasticity of demand of zero), and (2) all costs are absorbed by the firm in the form of reduced profits (consistent with an infinite price elasticity of demand).
In the former case, the immediate impact of the rule would be observed in increased industry revenues. While there is no hard and fast rule, in the absence of evidence to the contrary, OSHA generally considers a standard to be economically feasible for an industry when the annualized costs of compliance are less than a threshold level of one percent of annual revenues. Common-sense considerations indicate that potential impacts of such a small magnitude are unlikely to eliminate an industry or significantly alter its competitive structure, particularly since most industries have at least some ability to raise prices to reflect increased costs and normal price variations for products typically exceed three percent a year (OSHA, 2011, Chapter VI). Of course, OSHA recognizes that even when costs are within this range, there could be unusual circumstances requiring further analysis.
In the latter case, the immediate impact of the rule would be observed in reduced industry profits. OSHA uses the ratio of annualized costs to annual profits as a second check on economic feasibility. Again, while there is no hard and fast rule, in the absence of evidence to the contrary, OSHA generally considers a standard to be economically feasible for an industry when the annualized costs of compliance are less than a threshold level of ten percent of annual profits. This is a fairly modest threshold level, given that normal year-to-year variations in profit rates in an industry can exceed 40 percent or more (OSHA, 2011, Chapter VI).
For this final rule, all hazardous chemicals distributed in the United States have to be in compliance with the SDS and labeling revisions to the HCS, and chemical producers and users in most advanced economies will be under comparable GHS requirements (encompassing training, etc.) specific to their own country or economic union. For this reason, affected domestic establishments should not be susceptible to foreign competitors not bound by the requirements of the revisions to the HCS or similar GHS requirements. As a result, OSHA expects that the costs of this final rule will be passed on in higher prices rather than absorbed in lost profits, and therefore the Agency will tend to be primarily concerned with the ratio of industry costs to industry revenues rather than with the ratio of industry costs to industry profits.
In order to assess the nature and magnitude of the economic impacts associated with compliance with the final rule, OSHA developed quantitative estimates of the potential economic impact of the requirements on each of the affected industry sectors. The estimated costs of compliance presented in Section VI.F of this preamble were compared with industry revenues and profits to provide a measure of potential economic impacts. Although Section VI.G also contains estimates of substantial productivity benefits arising from this final rule that more than offset the estimated costs, these cost savings have not been included in estimating the economic impacts of the final rule.
Table VI-11 presents data on revenues and profits for each affected industry sector at the six digit NAICS industry level, along with the corresponding estimated annualized costs of compliance in each sector. Potential impacts in the table are represented by the ratios of compliance costs to revenues and compliance costs to profits.
As is evident from the data and estimates presented in Table VI-6, the costs of compliance for the final rule are not large in relation to the corresponding revenues and profits in each of the industry sectors. The estimated costs of compliance represent about 0.001 percent of revenues and about 0.011 percent of profits on average across all entities; compliance costs represent less than 0.09 percent of revenues or, with the exception of three chemical manufacturing industries, less than 0.9 percent of profits in any individual industry sector. These three chemical manufacturing industries are NAICS 325181 Alkalies & chlorine manufacturing, NAICS 325191 Gum & wood chemical manufacturing, and NAICS 325992 Photographic film, paper, plate, & chemical manufacturing, and their compliance costs as a percentage of profits are 4.3 percent, 2.1 percent, and 2.4 percent, respectively. The cost of printing labels in color is the main cost driver for these industries.
Based on the Agency's two screening tests to determine if the economic impacts of the final rule exceed some minimum threshold level (
The economic impact of the final rule is most likely to consist of a very small increase in prices for affected hazardous chemicals, of about 0.001 percent on average. Chemical manufacturing companies, all of whom must incur the costs of compliance unless they are already doing so, should be able to pass through costs to customers. The additional costs of a one-time revision to SDS and labeling criteria and one-time investments in printing technology are extremely small in relation to the value of the corresponding products, and there are generally no economic substitutes, or alternatives, that would not be subject to the same requirements. It is unlikely that a price increase of this magnitude would significantly alter the types or amounts of goods and services demanded by the public or any other affected customers or intermediaries. If the compliance costs of the final rule can be substantially recouped with a minimal increase in prices, there would be little or no effect on profits.
In profit-earning entities, compliance costs can generally be expected to be absorbed through a combination of increases in prices and reductions in profits. The extent to which the impacts of cost increases affect prices or profits depend on the price elasticity of demand for the products or services produced and sold by the entity.
The price elasticity of demand refers to the relationship between changes in the price charged for a product and the resulting changes in the demand for that product. A larger price elasticity of demand implies that an entity or industry is less able to pass increases in costs through to its customers in the form of a price increase and must absorb more of the cost increase through a reduction in profits.
In the case of cost increases that may be incurred due to the requirements of the final rule, all businesses within each of the covered industry sectors would be subject to the same requirements. Thus, to the extent potential price increases correspond to costs associated with achieving compliance with the standards, the elasticity of demand for each entity will approach that faced by the industry as a whole.
Given the small increases in prices potentially resulting from compliance with the final rule and the lack of readily available substitutes for the products and services provided by the covered industry sectors, demand is expected to be sufficiently inelastic in each affected industry to enable entities to substantially offset compliance costs through minor price increases without experiencing any significant reduction in revenues or profits.
OSHA expects the overall economic impact of the final rule to be both an increase in the efficiency of production of goods and services and an improvement in the welfare of society.
First, as demonstrated by the analysis of costs and benefits associated with compliance with the requirements of the final rule, OSHA expects that societal welfare will increase as a result of the revisions to the HCS, as the benefits far exceed compliance costs. The final rule is estimated to yield net annualized benefits of over $800 million.
Second, until now, many of the costs associated with the injuries, illnesses, and fatalities resulting from the risks addressed by the final rule have been externalized. For example, the costs incurred by society to supply certain products and services that are accompanied by injuries, illnesses, or fatalities from employee exposure to hazardous chemicals have not been fully reflected in the prices of those products and services. To the extent that fewer of these costs are externalized because of improved employer and employee information about hazardous chemicals in the workplace, the price mechanism will enable the market to produce a more efficient allocation of resources. However, reductions in externalities by themselves do not necessarily increase efficiency or social welfare unless the costs of achieving the reductions (including indirect and unintended consequences of regulatory approaches) are outweighed by the associated benefits, as they are in this instance.
In addition, based on an analysis of the costs and economic impacts associated with this rulemaking, OSHA concludes that the effects of the final rule on employment, wages, and economic growth for the United States would be negligible. This final rule is expected to result in increased import and export opportunities with U.S. trading partners due to the harmonization of the U.S. system with GHS. Hence, the primary effect on international trade, for businesses of all size, is likely to be favorable. This determination was supported by comment in the rulemaking record. For example, the Society of Chemical Manufacturers and Affiliates reported that companies that do business globally would see benefits related to the revisions to the OSHA HCS (Document ID #0402). Other stakeholders anticipate benefits related to global harmonization (Document ID #0382, 0388, 0393, and 0405) and mention that the standardization of the HCS will benefit those who are involved in international trade (Document ID #0410).
As required by Executive Order 13211, and in accordance with the guidance for implementing Executive Order 13211 and with the definitions provided therein as prescribed by the Office of Management and Budget (OMB), OSHA has analyzed the standard with regard to its potential to have a significant adverse effect on the supply, distribution, or use of energy.
As a result of this analysis, OSHA has determined that this action is not a significant energy action as defined by the relevant OMB guidance.
The Regulatory Flexibility Act (5 U.S.C. 601-612), as amended in 1996, requires the preparation of a Final Regulatory Flexibility Analysis (FRFA) for rules where there would be a significant economic impact on a substantial number of small firms. Under the provisions of the law, each such analysis shall contain:
1. A description of the impact of the rule on small entities;
2. A statement of the need for, and objectives of, the rule;
3. The response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments;
4. A statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments;
5. A description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available;
6. A description of the projected reporting, recordkeeping and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirements and the type of professional skills necessary for preparation of the report or record; and
7. A description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of the applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.
The Regulatory Flexibility Act further states that the required elements of the FRFA may be performed in conjunction with or as part of any other agenda or analysis required by any other law if such other analysis satisfies the relevant provisions (5 U.S.C. 605(a)).
As explained below, OSHA believes that the final rule will not have a significant economic impact on a substantial number of small entities, and therefore a FRFA is not required by the Regulatory Flexibility Act. Nonetheless, OSHA has prepared this voluntary FRFA to assure the regulated community that the agency has considered the impacts of the final rule on small entities. While a full understanding of OSHA's analysis and conclusions with respect to costs and economic impacts on small businesses requires a reading of the complete FEA
The final regulation requires classification of chemicals, especially chemical mixtures, somewhat different from current hazard determination methods; a standardized format for the organization of MSDSs (now called SDSs); standardized labels and standardized pictograms; and training for affected employees on these changes. (Some commenters argued that GHS would also impose more stringent testing requirements, but as explained in Section III: Need and Support in this preamble, the HCS does not currently require testing of chemicals, and will not require testing with adoption of the GHS.
For the purpose of its cost analysis, OSHA estimated four types of cost:
(1) Costs to chemical producers of classifying chemicals, reformatting SDSs, and developing new labels;
(2) Costs for safety and health managers and logistics personnel to familiarize themselves with the standard (although not required by the regulation, this is a necessary step in its implementation);
(3) Costs of training affected employees on how to find the information they need on SDSs and to comprehend pictograms and standard labels; and
(4) Costs to upgrade printing technology or purchase multi-colored labels to comply with the requirement that the pictograms be presented in a red-bordered diamond.
OSHA believes that, with the exception of the cost of color printing ink or printing cartridges or the cost of purchasing color pre-printed labels, these costs are a one-time cost that would be incurred during the four-year transition period after the final rule is published. OSHA anticipates that, once the final rule is implemented, the costs under the revised OSHA HCS will be only marginally higher than the costs under the existing HCS system and consist solely of the costs associated with color printing supplies. Once chemical producers, distributors, and users set up for and shift to the GHS system, OSHA expects there will be no additional costs arising from the final rule for classification, SDSs, and labeling.
OSHA also anticipates that, after the four-year transition period, the revisions to the HCS—resulting in more consistent chemical classifications and more uniform SDSs and labels—will yield production efficiencies for health and safety managers, logistics personnel, and others who handle hazardous chemicals. These cost savings (in addition to the health benefits for affected workers arising from this final rule) are considered in Section VI.D: Benefits in this preamble.
OSHA's criteria for determining whether there are significant economic impacts on a substantial number of small firms are that, for small entities in any given industry, the annualized costs exceed 1 percent of revenues or 5 percent of profits. All of OSHA's calculations of the economic impacts on small firms totally ignore any offsetting benefits of any kind, even though OSHA estimates that, for most small firms, the benefits of this rule will actually exceed the costs.
OSHA's industry-by-industry analysis, both for small firms (as defined by SBA) and for very small firms (defined by OSHA as those with fewer than 20 employees), shows that in no industry size class do the annualized costs exceed 0.28 percent of revenues or 3.3 percent of profits, and in almost all cases the annualized costs for small and very small firms are below 0.01 percent of revenues and 0.1 percent of profits. For affected small firms as defined by SBA, the average annualized cost per firm of the final rule would be $52 per year, which is equal to 0.001 percent of annual revenue and 0.03 percent of annual profit for the average firm. In terms of chemical-producing industries only, the average annualized cost per small firm as defined by SBA would be $544 per year, which is equal to 0.004 percent of annual revenue and 0.03 percent of annual profit for such a firm. For affected firms with fewer than 20 employees, the average annualized cost per firm of the final rule would be $35 per year (or 0.002 percent of annual revenue and 0.04 percent of annual profit), and the average annualized cost per firm that produces chemicals would be $255 per year (or 0.02 percent of annual revenue and 0.2 percent of annual profit).
Given these results, OSHA concludes that the final rule will not have a significant economic impact on a substantial number of small entities. Thus, a FRFA is not required for this rulemaking. However, recognizing the possible value that such an analysis may provide, OSHA has voluntarily included the elements of the FRFA as part of this Regulatory Flexibility Analysis (RFA) and has analyzed the potential impact of the revisions to OSHA's HCS on small entities. As described in Section VI.D Benefits in this preamble, the revisions to the HCS, on the whole, are expected to result in significant net benefits to employers, as the associated cost savings outweigh the corresponding compliance costs. This same conclusion generally applies to the small entities affected by the final rule.
In order to ensure that any potential significant adverse impact on a substantial number of small entities would be appropriately considered, OSHA also specifically evaluated the impact on small entities of the costs of compliance alone, without regard to the associated cost savings and health and safety benefits.
The total annualized cost of compliance with the final rule for small entities is estimated to be approximately $119 million, as shown by industry in Table VI-12.
To assess the potential economic impact of the final rule on small entities, OSHA calculated the ratios of compliance costs to profits and to revenues. These ratios are presented for each affected industry in Table VI-12. OSHA expects that among small entities potentially affected by the final rule, the average increase in prices necessary to completely offset the compliance costs would be 0.0013 percent. The average price increase necessary to completely offset compliance costs would not exceed 0.18 percent among small entities in any single affected industry sector.
In the event that no costs could be passed through, the compliance costs could be completely absorbed through an average reduction in profits of less than 0.03 percent for affected small entities. For small entities in most affected industries, the compliance costs could be completely absorbed through an average reduction in profits of less than 0.3 percent; the reduction in profits would be no more than 3.3 percent among small entities in any of the affected industries.
To further evaluate the potential for any adverse effects on small entities resulting from the final rule, OSHA assessed the short-term impacts that may be associated with the compliance costs during the transition period.
The total non-annualized compliance costs for small entities during the four-year transition period are estimated to be $1,330 million, or about $333 million per year for four years. Thus, the potential temporary impact would be about 0.004 percent of revenues or about 0.07 percent of profits, on average, per year for four years for affected small entities.
In order to further ensure that potential impacts on small entities were fully analyzed and considered, OSHA also separately examined the potential impacts of the final rule on very small entities, defined as those with fewer than 20 employees. As shown in Table VI-13, the total annualized costs for entities in this size class would be an estimated $67 million. The annualized costs represent about 0.002 percent of revenues and 0.04 percent of profits, on average, for affected very small entities. The annualized costs did not exceed 0.3 percent of revenues or 3.3 percent of profits for very small entities in any affected industry.
The total non-annualized compliance costs for very small entities during the four-year transition period are estimated to be $789 million, or about $197 million per year for four years. Thus, the potential temporary impact on very small entities would be about 0.005 percent of revenues or 0.1 percent of profits, on average, per year for four years.
In order to more carefully focus on the industry sectors most likely to have significant economic impacts, OSHA carefully examined those industries in the chemical manufacturing and petroleum and coal products manufacturing sectors (“chemical and petroleum producers”) that produce chemicals and SDSs. OSHA examined the extent to which these firms might have significant economic impacts if they produced an unusually high number of chemical products requiring SDSs.
To examine this issue, OSHA examined all small chemical and petroleum producers with respect to their costs as a percentage of revenues and profits. Using the same cost estimation methods as the base analysis, OSHA estimated how many separate chemical products a small firm would have to produce for its annualized costs of compliance with the final rule to exceed 5 percent of profits. OSHA found that the firm would have to produce 7,065 distinct chemical products, each requiring its own SDS. OSHA thinks it very unlikely that there are substantial numbers of small firms (with an average of 27 employees) that produce 7,065 or more distinct chemical products. Swedish data show that less than 0.1 percent of all firms (including large firms) in Sweden produce more than 500 distinct chemical products. (Swedish Chemical Agency,
OSHA conducted a similar analysis for very small firms with fewer than twenty employees. This analysis found that such firms, with an average of 4.7 employees, would need to produce more than 310 distinct chemical products for costs to exceed 5 percent of profits. OSHA estimates that this would be a very rare situation.
Further, even if small firms could be found that produce more than 7,065 chemical products and very small firms that produce more than 310 chemical products, the costs would probably be much lower than OSHA estimates. First, firms producing this many distinct products probably would not produce SDSs and labels without the assistance of specialized computer software, which OSHA assumes most small firms do not use, but would instead invest in appropriate software to lower their costs, as most larger firms do. Second, firms producing large numbers of chemical products commonly do so because they sell a variety of different mixtures with similar ingredients. Once appropriate data for the ingredients of these mixtures had been developed, using the bridging principles outlined in Appendix A of this preamble, small firms developing SDSs and labels for each mixture would take far less than the 7 hours per chemical product that OSHA has estimated for small firms to convert to the GHS system.
OSHA therefore concludes that there are not a substantial number of small entities or very small entities that would have significant economic impacts from this rule as a result of producing a very large number of distinct chemical products.
OSHA's HCS was first adopted in 1983 for manufacturing (48 FR 53280, Nov. 25, 1983). Later the Agency expanded the scope of coverage to include all industries where employees are potentially exposed to hazardous chemicals (52 FR 31852, Aug. 24, 1987).
The HCS requires chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import. The current rule provides definitions of health and physical hazards to use as the criteria for determining hazards in the evaluation process. Information about chemical hazards and appropriate protective measures is then required to be conveyed to downstream employers and employees by putting labels on containers and preparing and distributing safety data sheets. All employers with hazardous chemicals in their workplaces are required to have a hazard communication program, including container labels, safety data sheets, and employee training.
Ensuring that this information is available in workplaces helps employers design and implement appropriate controls for chemical exposures, provides employees the knowledge of the hazards and identities of the chemicals, and gives employees the opportunity to participate actively in the successful control of exposures. Together employers and employees can use this information to reduce the potential for adverse effects to occur. The information transmitted under the HCS requirements provides the foundation upon which a workplace chemical safety and health program is built. Without this information, appropriate controls could not be identified and implemented.
OSHA's HCS is designed to disseminate information on chemicals, which will precipitate changes in handling methods and thus protect those potentially exposed to the chemical from experiencing adverse effects. To protect employees and members of the public who are potentially exposed to chemicals during their production, transportation, use, and disposal, a number of countries have developed laws that require information about those chemicals to be prepared and transmitted to affected parties. These laws vary with regard to the scope of chemicals covered, definitions of hazards, the specificity of requirements (
Development of multiple sets of labels and safety data sheets for each product shipped to different countries is a major compliance burden for chemical manufacturers, distributors, and transporters involved in international trade. Small businesses may have particular difficulty in coping with the complexities and costs involved, and it has been argued that these differing requirements may be a technical (non-tariff) barrier to trade.
These concerns led, in June 1992, to a mandate from the United Nations Conference on Environment and Development (UNCED)(Chapter 19 of Agenda 21), supported by the U.S., calling for development of a globally harmonized chemical classification and labeling system. The negotiations were extensive and spanned a number of years. The product resulting from this effort, the Globally Harmonized System of Classification and Labeling of Chemicals, was formally adopted by the new United Nations Committee of Experts on the Transport of Dangerous Goods and the Globally Harmonized System of Classification and Labelling of Chemicals in December 2002.
The final rule incorporates the GHS's requirements into the HCS. They require chemical manufacturers to apply new hazard classification criteria to their chemicals and to prepare and distribute new labels and safety data sheets. Further, these SDSs and labels will be standardized in a way that they are not under the existing HCS. OSHA's current performance-based approach to SDSs and labeling can create confusion among those who seek to use hazard information effectively. For example, labels and safety data sheets may include symbols and hazard statements that are unfamiliar to readers or not well understood. This lack of standardization and the absence of pictograms are particularly a problem for U.S. workers not literate in English. Containers may be labeled with such a large volume of information that important statements are not easily recognized.
OSHA believes that adoption of these new requirements will benefit employers and enhance employee safety. Employers who use chemicals and employees exposed to those chemicals will benefit from receiving the revised labels and safety data sheets prepared in a consistent format. OSHA believes that the information will be easier to comprehend and access in the new approach, allowing it to be used more effectively for the protection of employees. The primary effect in workplaces where chemicals are used but not produced will be to integrate the new approach into the workplace hazard communication program, including ensuring that both employers and employees understand the pictograms and other information provided on the chemicals' labels and SDSs.
OSHA believes that adoption of the GHS will improve labels and SDS comprehensibility through implementation of a uniform approach. The current regulatory system includes a performance-oriented approach to labels and SDSs, allowing the producers to use whatever language or format they choose to provide the necessary information. This result in a lack of consistency makes it difficult for users of chemicals to properly identify their hazards and recommended protective measures, particularly when purchasing the same product from multiple suppliers. Having the information provided in the same words and pictograms on labels, as well as having a standardized order of information on SDSs, will help all users, including employers, employees, and emergency responders, to more easily identify the critical information necessary to protect employees.
In addition, OSHA believes that American employees and employers will receive benefits from the international adoption of GHS. Development of the GHS system required extensive work by a great number of people and resources from many countries and organizations. The reason it received such support is the belief that there are significant benefits associated with implementation of a globally harmonized approach to hazard communication. Countries, international organizations, chemical producers, users of chemicals, and employees working with chemicals would all benefit. There are at least four reasons to expect that GHS will be adopted globally.
First and foremost, the GHS modifications of the HCS will enhance protection of workers and the environment. Occupationally related injuries, illnesses, and fatalities remain a serious problem in the U.S. For example, although likely to contain very
Second, OSHA believes that the final rule will facilitate international trade in chemicals. It will reduce the burdens caused by having to comply with differing requirements for the same product and facilitate small business participation in international trade.
Third, one of the initial reasons this system was pursued internationally involved concerns about animal welfare and the proliferation of requirements for animal testing and evaluation. Existing systems with different definitions of hazards often result in duplicative testing to produce data related to the varying cut-offs in the different systems. Having one agreed definition will reduce the need for this duplicative testing. It should be noted, however, that OSHA's HCS has never had testing requirements. The HCS is based on collecting and evaluating the best available existing evidence on the hazards of each chemical.
Fourth, information transmittal systems provide the underlying infrastructure for the sound management of chemicals in a country. Those countries that do not have the resources to develop and maintain such a system can use the GHS to build their chemical safety and health programs. Since it has been developed, and will be maintained, through an international approach, national resources used to achieve chemical safety and health can be streamlined. Unlike some other issues, a country's approach to the sound management of chemicals definitely affects others countries. In some cases, bordering countries may experience their neighbors' pollution and other effects of uncontrolled chemical exposures. In all countries, there is a need to acquire sufficient information to properly handle chemicals when they are imported from other countries. Thus having a coordinated and harmonized approach to the development and dissemination of information about chemicals would be mutually beneficial to importing and exporting countries.
In the U.S., there are four primary regulatory agencies that exercise jurisdiction over chemical hazard communication: OSHA; the Department of Transportation, which regulates chemicals in transport; the Consumer Product Safety Commission, which regulates consumer products; and the Environmental Protection Agency, which regulates pesticides and has other labeling authority under the Toxic Substances Control Act. These agencies are not domestically harmonized in terms of definitions of hazards and other requirements. If all four agencies adopt the GHS, the U.S. will have the additional benefit of harmonizing the overall U.S. approach to classification and labeling. Since most chemicals are produced in a workplace and shipped elsewhere, many employers deal with at least two sets of federal requirements. Thus these employers would be likely to obtain some benefits from domestic harmonization.
OSHA has made a determination that the revisions to the HCS will improve the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. The Agency anticipates this improved information will enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they are exposed, and in reducing the incidence of chemical-related occupational illnesses and injuries. OSHA estimates that (1) savings in benefits from improved employee health and safety exceed the costs of the final rule, and (2) cost savings to chemical users exceed the costs of the final rule.
An additional and more complete discussion of the reasons why this standard is being promulgated by the Agency is provided in other sections of this preamble.
The primary objective of aligning the HCS with the GHS is to achieve the benefits of the OSHA HCS in a more comprehensive, efficient, and effective manner. The revisions are expected to provide an increased degree of occupational safety and health for employees potentially exposed to hazardous chemicals in the workplace and to provide updated, clear, and comprehensive standards regarding the classification of chemical hazards and the manner in which relevant information about chemical hazards is disseminated to affected employees.
The intent of the HCS is to ensure that all chemical hazards are properly evaluated and that information concerning chemical hazards and associated protective measures is transmitted to employers and employees. The standard achieves this goal by requiring chemical manufacturers and importers to review available scientific evidence concerning the physical and health effects of the chemicals they produce or import to determine if they are hazardous.
For every chemical found to be hazardous, the chemical manufacturer or importer must develop a container label and an SDS and provide both to downstream users of the chemical. All employers with employees exposed to hazardous chemicals must develop a hazard communication program and ensure that exposed employees are provided with labels, access to SDSs, and training on the hazardous chemicals in their workplace.
The three information components in this system—labels, SDSs, and employee training—are all essential to the effective functioning of the program. Labels provide a brief, conspicuous summary of hazard information at the site where the chemical is used. SDSs provide detailed technical information and serve as a reference source for exposed employees, industrial hygienists, safety professionals, emergency responders, health care professionals, and other interested parties. Training is designed to ensure that employees understand the chemical hazards in their workplace and are aware of recommended protective measures. Labels, SDSs, and training are complementary parts of a comprehensive hazard communication program—each element reinforces the knowledge necessary for effective protection of employees.
Information provided in accordance with the HCS serves to reduce the incidence of chemical-related illnesses and injuries in the workplace. This is accomplished by modifying the behavior of both employers and employees. For example, the information contained in the HCS enables employers to implement protective measures in the workplace. Employers will also have information to choose less hazardous alternatives or select appropriate engineering controls, work practices, and personal protective equipment. Improved understanding of chemical hazards by supervisory
Employees provided with information and training on chemical hazards are able to fully participate in the protective measures instituted in their workplaces. Knowledgeable employees can take the steps required to work safely with chemicals in their workplace and are able to determine what actions are necessary if an emergency occurs. Information on chronic effects of exposure to hazardous chemicals helps employees recognize signs and symptoms of chronic disease and seek early treatment. Information provided under the HCS also enables health and safety professionals to provide better services to exposed employees. Medical surveillance, exposure monitoring, and other services are enhanced by the ready availability of health and safety information.
OSHA believes that the comprehensive approach adopted in the HCS, which includes requiring evaluation of chemicals and the transmittal of information through labels, SDSs, and training, is sound. This final rule does not alter that approach. Rather, the final rule is intended to improve the effectiveness of the HCS by enhancing the quality and consistency of the information provided to employers and employees. OSHA believes this can be accomplished by revising the requirements of the standard to conform to the more specific and detailed provisions of the GHS for classification, labeling, and SDSs.
The Office of Advocacy in the SBA did not submit any comments to OSHA in response to the proposed rule.
OSHA received numerous comments in the record about the impact of this rulemaking on small entities. There were concerns about OSHA's preliminary cost estimates and concerns that this rule would have a substantial impact on small manufacturers. OSHA carefully evaluated these concerns and has addressed them below as well as in Section VI.F: Costs of Compliance in this preamble.
Some stakeholders felt that OSHA should convene a Small Business Regulatory Enforcement Fairness Act (SBREFA) panel for this rulemaking (Document ID #0361, 0372, 0397, 0407, and 0411). OSHA evaluated this rule under the provisions of the Regulatory Flexibility Act, which requires that OSHA hold a SBREFA (or SBAR—Small Business Advocacy Review) panel when a rule is expected to have a significant impact on a substantial number of small entities. The modifications to the hazard communication standard do affect a substantial number of small entities, but the costs per firm do not rise to the level where they would impose a significant economic impact on a substantial number of small entities. OSHA defines a significant economic impact on small entities as costs that exceed one percent of revenues or five percent of profits for small entities in any affected industry. The Regulatory Flexibility Act does not define the term “significant economic impact.” Instead, as noted in the RFA's legislative history, Congress suggested that agencies refer to SBA guidelines for measuring the impact of rules on small businesses.
OSHA's two thresholds have long been a part of the Agency's published SBREFA procedures (
Furthermore, in employing a dual threshold, based on either revenue or profit impacts, OSHA has taken special pains to identify potentially significant impacts on small entities.
While this rule will be costly in the aggregate, it is not aggregate costs but the significance of impacts on small entities that triggers the need for a SBREFA panel. No panel was or is needed for this rulemaking because costs per small entity do not meet the threshold that OSHA uses to define a significant economic impact on a substantial number of small entities.
Stakeholders also expressed concerns that costs were underestimated and that costs to small entities would be considerable. The U.S. Chamber of Commerce asserted that “the imposition of a completely new system of classification of chemicals represents huge burdens on small employers with significant costs” (Document ID #0397). OSHA acknowledges that there will be transitional costs for small businesses but feels that the additional transition time OSHA has incorporated into the final rule and discussed in more detail elsewhere in the FEA, combined with OSHA compliance assistance and the fact that many firms have already made the transition to GHS, should allow small employers to adopt the GHS criteria without overwhelming challenges. The U.S. Chamber of Commerce did not provide additional details, which were solicited as part of both the ANPR and the NPRM, on what types of costs small businesses would incur or the possible magnitude of those costs. Without detailed estimates, OSHA cannot fully evaluate alternative costs for small businesses; nor can OSHA adopt alternative cost estimates without persuasive evidence in the record.
Wacker Chemical Company felt that the changes to the HCS would have a large impact on small businesses “result[ing] from the lack of personnel and financial resources to implement changes of this magnitude which may involve reclassification of the companies' products, reauthoring SDSs
Many comments expressed general concern that OSHA underestimated the compliance burden on small businesses (Document ID #0336, 0372, 0397, and 0407), and OSHA has increased some costs (for instance, doubling the time required for training) in response to these comments. The comments, while appreciated and insightful, did not contain the level of detail that OSHA would need in order to make a case for changing many of the estimates in the PEA. For the most part, comments received on the issue of costs to and impacts on small businesses simply stated that (in general) costs to small businesses were understated in the PEA or asserted that impacts would be significant without providing data to support alternative estimates. In order to assess the impacts on the cost effectiveness of this standard of possible underestimation of cost parameters, the Agency has included a sensitivity analysis in Section VI.L: Sensitivity Analysis in this preamble. Additional concerns about costs that are not specific to small businesses are addressed further in Section VI.F: Costs of Compliance in this preamble.
Many commenters, including some who voiced concerns about costs, did not support a voluntary adoption approach or any other exemption or modified system for small businesses (Document ID #0324, 0327, 0328, 0329, 0335, 0338, 0351, 0352, 0370, 0376, 0377, 0381, 0382, 0393, and 0410). DuPont felt that dual systems would “undermine the goal of harmonization [* * * and] be very confusing for employees” (Document ID #0329). Ferro Corporation expressed the view that “failure to implement [the requirements of the rule] across-the-board will cause confusion; negate main benefits; and potentially be less protective” (Document ID #0363).
Many of the commenters who addressed small business issues felt that the benefits to small businesses would be negligible (Document ID #0372, 0378, 0385, 0396, 0397, 0400, 0402, and 0407). Commenters who viewed the primary benefits of adopting the GHS as facilitating international trade were likely to favor an alternative of less than full compliance with GHS. As has been addressed throughout the FEA, however, OSHA's estimates of the benefits of this final rule reflect fewer worker injuries and illnesses, efficiency improvements in the safe handling of hazardous chemicals, and less costly and more effective hazard communication training of new workers. While OSHA recognizes the significant potential trade benefits of this final rule, the Agency did not quantify or monetize these benefits.
In response to numerous comments received in the record, OSHA has extended the phase-in period for this rulemaking and aligned the phase-in of this rule to correspond to the EU's deadline for classification of mixtures. Some of these comments asserted that more time would be especially beneficial to small businesses, reducing the compliance burden significantly (Document ID #0399, 0405, and 0408). For example, the National Association of Chemical Distributors suggested a timeline of 3 years plus 18 months for distributors and downstream users (Document ID #0341). The effective dates in the final rule take these (and other suggestions) into account and provide substantial additional time for implementation. Where the proposal required all labels and SDSs to be in compliance with the new requirements in three years after publication (or August 2014), the final rule requires manufacturers and importers to modify labels and SDSs by June 1, 2015. The final rule also gives distributors an additional six months, until December 1, 2015, to sell stock labeled under the current standard. In addition, employers are given another six months, until June 1, 2016, to update their training and their hazard communication program with any new hazard information received because of the final rule. Finally, the proposal required that exposed employees receive initial training two years after adoption (or August 2013), whereas the final rule gives employers until December 1, 2013 to complete this training.
OSHA has completed an analysis of the economic impacts associated with this final rule, including an analysis of the type and number of small entities to which the final rule applies. In order to determine the number of small entities potentially affected by this rulemaking, OSHA used the definitions of small entities developed by the Small Business Administration (SBA) for each industry.
The final standard impacts firms that are the primary producers or distributors of hazardous chemicals, and firms whose employees are exposed to hazardous chemicals. Based on the definitions of small entities developed by SBA for each industry, the final rule is estimated to potentially affect a total of 4,093,543 small entities, as shown in Table VI-12. The rule has its greatest impacts on the 72,040 small firms that produce chemicals that require SDSs and labels.
The final standard includes revised criteria for classification of chemical hazards; revised labeling provisions that include requirements for use of standardized signal words, pictograms, and hazard statements; a specified format for safety data sheets; and related revisions to definitions of terms used in the standard, employee information and training requirements, and other sections of HCS. The final rule also modifies other OSHA standards that contain hazard communication requirements to harmonize them with the requirements of GHS. In addition, certain OSHA standards use HCS terms, and OSHA is making changes to ensure that the scope of those standards is not changed by the GHS revisions.
The preamble to the final standard provides a comprehensive description of, and further detail regarding, the compliance requirements of the rulemaking. A description of the types
Reclassifying chemicals and modifying SDSs and labels:
• Medium establishments (100-499 employees): An average of 5 hours per SDS; in addition, for 25 percent of establishments, an average of $208 per SDS for software modifications.
• Small establishments (1-99 employees): An average of 7 hours per SDS. Management familiarization and other costs:
• Eight hours for health and safety managers and logistics personnel in the manufacturing sector;
• Two hours for each hazard communication program manager not in the manufacturing sector.
Employee training:
• One hour per production employee in most industries;
• Thirty minutes in occupations exposed to few hazardous chemicals and types of hazards;
• Ten minutes per employee in some occupations where GHS-type pictograms are already in use.
Color Printing
• Category 1 establishments (those currently printing only in black & white who do not own color printers): Medium establishments $0.01 per label, small establishments $0.13 per label, and very small establishments $0.14 per label.
• Category 2 establishments (those currently printing only in black & white but who own color printers): Medium establishments $0.01 per label, small establishments $0.13 per label, and very small establishments $0.14 per label.
• Category 3 establishments (those currently purchasing pre-printed label stock): Medium establishments $0.03 per label, small and very small establishments $0.03 per label.
• Category 4 establishments (those currently producing labels printed in multiple colors): No additional costs related to this provision.
OSHA has extended the phase-in period for this rulemaking in response to stakeholder concern. The Agency believes that the additional time granted to manufacturers, distributors, and users of chemicals will serve to reduce the transitional costs associated with this rule. Chemical manufacturers currently revise SDSs and labels periodically to include new or updated hazard information, and the extended time frame will allow firms to adopt the GHS criteria into their hazard communication program and to modify SDSs, warning labels, and workplace signs within the normal flow of their operations.
OSHA will be offering guidance materials such as quick cards and fact sheets to aid firms in developing and implementing the training requirements of this rule. OSHA will also be releasing a small business compliance guide to provide additional guidance to small businesses, which will ease the economic impact and compliance burden. The Agency solicited comment from stakeholders as part of the ANPR and NPRM on what compliance assistance tools would be most helpful and has incorporated the suggestions received in the record in the development of guidance materials.
OSHA has reviewed the provisions of this final rule in accordance with the requirements of the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321
Section 3 of the Occupational Safety and Health Act makes clear that OSHA cannot enforce compliance with its regulations or standards on the U.S. government “or any State or political subdivision of a State.” Under voluntary agreement with OSHA, some States enforce compliance with their State standards on public sector entities, and these agreements specify that these State standards must be equivalent to OSHA standards. Thus, although OSHA may include compliance costs for affected public sector entities in its analysis of the expected impacts associated with the final HCS rule, the rule does not involve any unfunded mandates being imposed on any State or local government entity.
Based on the analysis presented in this economic analysis, OSHA concludes that the final rule would impose a Federal mandate on the private sector in excess of $100 million in expenditures in any one year. Accordingly, this economic analysis of the final rule, concerning revisions to the HCS, constitutes the written statement containing a qualitative and quantitative assessment of the anticipated costs and benefits of the Federal mandate, as required under Section 202(a) of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532(a)).
In this section, OSHA provides a sensitivity analysis of the major assumptions underlying the Agency's estimates of the annualized costs and annualized benefits of the final rule. The purpose is to determine whether OSHA's conclusion that the final rule yields net benefits is vulnerable to a reasonable change in any one of these assumptions. OSHA's choice of how much to increase unit cost parameters in the sensitivity analysis was intended to reflect an upper bounds (or more) of reasonableness, based on comments, as well as on professional experience and common sense. (As a result, there are almost no estimates provided by commenters of higher unit costs than we used in the sensitivity analysis, and we rejected those few outliers as being unrealistically large and certainly not representative of the average establishment covered by this rule.) OSHA's choice of how much to decrease unit benefit parameters was more subjective and reflected the fact that few commenters provided alternative quantitative estimates. Broadly, the Agency cut unit benefit parameters by at least half in all cases for the sensitivity analysis, which OSHA believes is consistent with the spirit of comments that either supported OSHA's estimates of benefits or thought benefits were somewhat overestimated—the exception being those few commenters who disputed the existence of health and safety benefits or productivity benefits arising from the proposed rule. However, it should be carefully noted that any given benefit category could be reduced to zero and the net benefits would still be positive. This can be seen in Table VI-1, which shows that the estimated net positive annualized benefits of the final rule ($556 million)
The sensitivity analysis below shows that OSHA's conclusion that the final rule produces net benefits is not dependent on any particular assumption. In fact, the estimated annualized health and safety benefits of the rule alone, independent of any productivity benefits, exceed the estimated annualized cost of the rule. Further, the broad support from industry for this rule, even from those commenters critical of some of OSHA's estimates of costs and benefits, suggests that industry believes the productivity benefits of the rule exceed the costs.
The methodology and calculations underlying the estimation of the compliance costs, benefits, and economic impacts associated with this rulemaking are generally linear and additive in nature. Thus, the sensitivity of the results and conclusions of the analysis will generally be proportional to variations in the relevant input parameters.
For example, if the estimated time that companies need to reclassify chemical hazards and revise SDSs and labels were doubled, the corresponding labor costs (but not software costs) of reclassification and revision of SDSs and labels would double as well.
OSHA evaluated a series of such changes in input parameters to test whether and to what extent the general conclusions of the economic analysis held up. On the whole, OSHA found that the conclusions of the analysis are reasonably robust, as changes in any of the input parameters tend not to produce disproportionately large changes in the results. The results also show significant net annualized benefits for the rule regardless of the individual revisions to costs, benefits, or discount rate. The results of the individual sensitivity tests are summarized in Table VI-14 and are described in more detail below.
In the sensitivity test on costs where OSHA doubled the estimated time that companies need to reclassify chemical hazards and revise SDSs and labels, and estimates of other input parameters remained unchanged, as shown in Table VI-14, the estimated total costs of compliance would increase by $18 million annually, or by about 9 percent, while net benefits would also decline by $18 million, from $556 million to $538 million annually.
In a second sensitivity test, OSHA doubled the estimated total number of affected SDSs addressed by this rulemaking, which increased the estimated total cost of reclassification and revision of SDSs and labels. As shown in Table VI-14, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $23 million annually, or by about 11 percent, while net benefits would also decline by $23 million annually, from $556 million to $533 million annually.
In a third sensitivity test, when OSHA increased by 50 percent the estimated number of employees required to be covered by hazard communication programs and to be trained on GHS, the corresponding estimate of the total costs associated with training employees increased by 50 percent. As shown in Table VI-14, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $48 million annually, or by about 24 percent, while net benefits would also decline by $48 million annually, from $556 million to $508 million annually.
In a fourth sensitivity test, when OSHA doubled the estimated incremental amount of time necessary for training employees on GHS, the corresponding estimate of the total costs associated with training employees also doubled. As shown in Table VI-14, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $96 million annually, or by about 48 percent, while net benefits would also decline by $96 million annually, from $556 million to $460 million annually.
OSHA performed a fifth sensitivity test where the estimated incremental per-label cost of printing labels in color was doubled. As shown in Table VI-14, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $24 million annually, or by about 12 percent, while net benefits would also decline by $24 million annually, from $556 million to $532 million annually
OSHA also performed sensitivity tests on several input parameters used to estimate the benefits of the final rule. In one sensitivity test on benefits, OSHA reduced its estimate of health and safety benefits of the final rule from 1 percent to 0.5 percent of the benefits estimated for the existing HCS. As shown in Table VI-14, if OSHA's estimates of other input parameters remained unchanged, the total estimated benefits of the final rule would decline by $125 million annually, or by about 17 percent, while net benefits would also decline by $125 million annually, from $556 million to $431 million annually.
In a second, parallel sensitivity test on benefits, OSHA increased its estimate of health and safety benefits of the final rule from 1 percent to 5 percent of the benefits estimated for the existing HCS. As shown in Table VI-14, if OSHA's estimates of other input parameters remained unchanged, the total estimated benefits of the final rule would increase by $1,000 million annually, or by about 132 percent, while net benefits would also increase by $1,000 million annually, from $556 million to $1,556 million annually.
In a third sensitivity test on benefits, OSHA reduced its estimate of savings due to the improved efficiency in creating and revising SDSs under GHS by 50 percent. As shown in Table VI-14, if OSHA's estimates of other input parameters remained unchanged, the total estimated benefits of the final rule would decline by $17 million annually, or by about 2 percent, while net benefits would also decrease by $17 million annually, from $556 million to $539 million annually.
In a fourth sensitivity test on benefits, OSHA reduced its estimate of savings due to the improved efficiency of safety and health managers and logistics personnel by 67 percent. As shown in Table VI-14, if OSHA's estimates of other input parameters remained unchanged, the total estimated benefits of the final rule would decline by $315 million annually, or by about 42 percent, while net benefits would also decrease by $315 million annually, from $556 million to $241 million annually.
And finally, in the fifth sensitivity test on benefits, OSHA tested the effect of including cost savings from simplified hazard communication training in future periods made possible by the final rule.
OSHA also examined the effect of a change in the discount rate on the annualized costs and benefits. Changing the discount rate from 7 percent, used in the base case, to 3 percent would have the effect of lowering the costs to $161 million per year and increasing the gross benefits to $839 million per year. The result, as shown in Table VI-14, would be to increase net benefits by
OSHA also considered the sensitivity of its findings that the final rule is economically feasible and does not have a significant economic impact on a substantial number of small entities. For example, even if all of the estimated annualized costs of compliance were to increase by 50 percent, these costs would still represent less than 0.005 percent of annual revenues and less than 0.1 percent of annual profit for the average establishment, small entity, or very small entity, and no small entity or very small entity would have costs in excess of 1 percent of revenues or 5 percent of profits.
In conclusion, the sensitivity analysis demonstrates that even with relatively large variations in the input parameters, there would not be any disproportionately large changes in the estimates of compliance cost or benefits. Further, even if there were a 50 percent increase in all of the compliance cost estimates, there would still be a relatively high confidence in OSHA's finding concerning economic feasibility, the certification that the standard will not have significant economic impacts on a substantial number of small entities, and the conclusion that the benefits of the final rule exceed the costs.
The final rule revises existing Hazard Communication collection of information (paperwork) requirements that are currently approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA-95), 44 U.S.C. 3501
The final rule standardizes the hazard communication requirements for hazardous chemical products used in U.S. workplaces, and thus provides employees with consistent hazard communication information. Hazard communication is currently addressed by many different international, national, and State authorities. These existing requirements are not always consistent and often contain different definitions of hazards and varying provisions for what information is required on labels and safety data sheets (SDSs). The final standard harmonizes the U.S. system with international norms and as a result would enhance worker safety and facilitate international trade. The final rule's modifications to the Hazard Communication Standard's collection of information requirements include: (1) Revised criteria for classification of chemical hazards; (2) revised labeling provisions that include requirements for use of standardized signal words, pictograms, hazard statements, and precautionary statements; (3) a specified format for SDSs; and (4) related revisions to definitions of terms used in the Standard and to requirements for employee training on labels and SDSs.
Paragraph (d), “hazard classification,” requires chemical manufacturers and importers to evaluate chemicals produced in their workplaces or imported by them to classify the chemicals' health and physical hazards in accordance with the Standard. For each chemical, the chemical manufacturer or importer must determine the hazard classes, and the category of each hazard class, that apply to the chemical being classified. Employers are not required to classify chemicals unless they choose not to rely on the classification performed by the chemical manufacturer or importer for the chemical. Chemical manufacturers, importers or employers classifying chemicals must identify and consider the full range of available scientific literature and other evidence concerning the potential hazards. There is no requirement to test the chemical to determine how to classify its hazards. Mandatory Appendix A to § 1910.1200 shall be consulted for classification of health hazards, and Mandatory Appendix B to § 1910.1200 shall be consulted for the classification of physical hazards.
For mixtures, chemical manufacturers, importers, or employers evaluating chemicals also must follow the procedures described in Appendixes A and B to § 1910.1200 to classify the hazards of the chemicals, including determinations regarding when mixtures of the classified chemicals are covered by the Standard. When classifying mixtures they produce or import, chemical manufacturers and importers of mixtures may rely on the information provided on current SDSs of the individual ingredients except where the chemical manufacturer or importer knows, or in the exercise of reasonable diligence should know, that the SDS misstates or omits information required by the provisions in the final HCS.
Pursuant to paragraph (e), employers are required to develop, implement, and maintain at each workplace a written hazard communication program which at least describes how the criteria specified in paragraphs (f), (g), and (h) of the standard on labels and other forms of warning, SDSs, and employee information and training will be met, and which also includes the following: (i) a list of the hazardous chemicals known to be present using a product identifier that is referenced on the appropriate SDS (the list may be compiled for the workplace as a whole or for individual work areas); and (ii) the methods the employer will use to inform employees of the hazards of non-routine tasks (for example, the cleaning of reactor vessels) and the hazards associated with chemicals contained in unlabeled pipes in their work areas. The final rule makes no changes to this requirement.
Paragraph (f) modifies existing label requirements by requiring more specific information. Paragraph (f)(1) requires chemical manufacturers, importers, or distributors to ensure that each shipped container of classified hazardous chemicals leaving the workplace is labeled, tagged, or marked with the following information:
(i) Product identifier;
(ii) Signal word;
(iii) Hazard statement(s);
(iv) Pictogram(s);
(v) Precautionary statement(s); and
(vi) Name, address, and telephone number of the chemical manufacturer,
importer, or other responsible party.
The chemical manufacturer, importer, or distributor must ensure that the information provided under (i) through (v) above must be in accordance with the mandatory Appendix C,
For labels in the workplace, except as provided in paragraphs (f)(7) and (f)(8) of the Standard, employers must ensure that each container of hazardous chemicals in the workplace is labeled, tagged, or marked with either (i) the information specified under (f)(1)(i) through (v) for labels on shipped containers; or (ii) product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals, and which, in conjunction with the other information immediately available to employees under the hazard communication program, will provide employees with the specific information regarding the physical and health hazards of the hazardous chemical.
OSHA has also updated the language for workplace signs and labels to incorporate the GHS hazard statement and the applicable precautionary statement(s), where required. Most OSHA substance-specific heath standards require hazard warning signs, usually for regulated areas, and the language required on the signs varies. With the GHS revision, these standards retain the requirements for specific warning language for specific signs; however, OSHA has modified the language to be compatible with GHS and consistent throughout the OSHA standards. The GHS classification process for a specific substance dictates the hazard warnings and the precautionary statements that will be required on the new GHS-compliant product labels. OSHA believes that having signs and labels in the same formats and containing identical warnings for the same health effects will make it far easier for employers and employees to quickly recognize the hazard and the degree of danger of a hazard, thus enhancing communication.
The final rule modifies the language requirements for signs and labels found in the Agency's health standards listed below in Table VII-1. Since the final rule provides specific language for signs and for labels on containers of contaminated clothing, waste and debris, the Agency is exempted from taking burden hours and costs for these provisions. (
Pursuant to paragraph (f)(11), chemical manufacturers, importers, distributors, or employers who become newly aware of any significant information regarding the hazards of a chemical shall revise the labels for the chemical within six months of becoming aware of the new information, and shall ensure that labels on containers of hazardous chemicals shipped after that time contain the new information. If the chemical is not currently produced or imported, the chemical manufacturer, importer, distributor, or employer shall add the information to the label before the chemical is shipped or introduced into the workplace again.
Paragraph (g)(2) requires the chemical manufacturer or importer preparing the SDS to ensure that it is in English (although the employer may maintain copies in other languages as well), and include the following section numbers and headings, and associated information under each heading, in the order listed (
Section 1, Identification;
Section 2, Hazard(s) identification;
Section 3, Composition/information on ingredients;
Section 4, First-aid measures;
Section 5, Fire-fighting measures;
Section 6, Accidental release measures;
Section 7, Handling and storage;
Section 8, Exposure controls/personal protection;
Section 9, Physical and chemical properties;
Section 10, Stability and reactivity;
Section 11, Toxicological information; and
Section 16, Other information, including date of preparation or last revision.
Although not required by the final rule, an employer may include the following sections to be consistent with the GHS:
Section 12, Ecological information;
Section 13, Disposal considerations;
Section 14, Transport information; and
Section 15, Regulatory information.
Paragraph (g)(5) requires the chemical manufacturer, importer or employer preparing the SDS to ensure that the information provided accurately reflects the scientific evidence used in making the hazard classification. If the chemical manufacturer, importer or employer preparing the SDS becomes newly aware of any significant information regarding the hazards of a chemical, or ways to protect against the hazards, this new information must be added to the SDS within three months. If the chemical is not currently being produced or imported, the chemical manufacturer or importer must add the information to the SDS before the chemical is introduced into the workplace again.
Paragraph (g)(11) requires that employers ensure the SDSs are readily available, upon request, to designated representatives, the Assistant Secretary, and the Director, in accordance with the requirements of 29 CFR 1910.1020(e).
The Agency reviewed this final rule according to the most recent Executive Order (“E.O.”) on Federalism (E.O. 13132, 64 FR 43255, August 10, 1999). This E.O. requires that Federal agencies, to the extent possible, refrain from limiting State policy or local
In Section 18 of the Occupational Safety and Health Act (the OSH Act), Congress expressly provides that States may adopt, with Federal OSHA approval, a plan for the development and enforcement of occupational safety and health standards. States that obtain Federal approval for such plans are referred to as “State Plan States” (29 U.S.C. 667). Occupational safety and health standards developed by such State Plan States, among other things, must be at least as effective in providing safe and healthful employment and places of employment as Federal OSHA standards.
OSHA intends to closely scrutinize amendments to previously approved State hazard communication standards submitted under current or future State plans to ensure equal or greater effectiveness, including assurance that any additional requirements do not conflict with, or adversely affect, the effectiveness of the national application of OSHA's standard. OSHA must also determine in its review whether any State plan standard provisions that differ from the Federal provisions, when applicable to products distributed or used in interstate commerce, are “required by compelling local conditions and do not unduly burden interstate commerce.” OSH Act section 18(c), 29 U.S.C. 667(c).
This final rule complies with E.O. 13132. In States that do not have OSHA-approved State Plans, this rule limits State policy options in the same manner as all OSHA standards.
OSHA also reviewed this final rule in accordance with E.O. 13,175 on Consultation and Coordination with Indian Tribal Governments (65 FR 67,249 (Nov. 9, 2000)), and determined that it does not have “tribal implications” as defined in that order. The final rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
When federal OSHA promulgates a new standard or more stringent amendment to an existing standard, the 27 States or U.S. territories with their own OSHA-approved occupational safety and health plans must revise their standards to reflect the new standard or amendment, or show OSHA why there is no need for action, e.g., because an existing state standard covering this area is already “at least as effective” as the new federal standard or amendment. 29 CFR 1953.5(a). The state standard must be at least as effective as the final federal rule, must be applicable to both the private and public (state and local government employees) sectors, and must be completed within six months of the publication date of the final federal rule. When OSHA promulgates a new standard or a standards amendment which does not impose additional or more stringent requirements than an existing standard, states are not required to revise their standards, although OSHA may encourage them to do so.
The 27 States and U.S. territories with OSHA-approved occupational safety and health plans are: Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. Connecticut, Illinois, New Jersey, New York and the Virgin Islands have OSHA approved State Plans that apply to public-sector employees only.
This final rule modifies OSHA's hazard communication standard to conform to the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS). It requires chemical manufacturers to use revised criteria for classification of chemical hazards, revised labeling provisions, and a specified format for safety data sheets. There are also revised requirements for employers to train their employees regarding labels and safety data sheets for hazardous chemicals. This GHS rule will also increase worker protection by improving the quality and consistency of information provided to employers and employees regarding chemical hazards and protective measures. Therefore, State Plan States must adopt comparable provisions within six months of publication of the final rule. Each State's existing requirements will continue to be in effect until it adopts the required revisions.
OSHA reviewed this final rule according to the Unfunded Mandates Reform Act of 1995 (“UMRA”; 2 U.S.C. 1501
Under Section 202 of the UMRA, an agency must prepare a written “qualitative and quantitative assessment” of the anticipated costs and benefits of any Federal regulation creating a mandate that “may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more” in any one year. 2 U.S.C. 1532(a). As discussed in section VI of this preamble (“Final Economic and Voluntary Regulatory Flexibility Analysis”), the Agency estimates that this final rule will require private sector employers annualized expenditures of $201 million per year. However, OSHA's final rule does not place a mandate on State or local governments, for purposes of the UMRA, because OSHA cannot enforce its regulations or standards on State or local governments. (
Based on the analysis presented in the Final Economic Analysis (section VI above), OSHA has determined that this final rule will impose a Federal mandate on the private sector in excess of $100 million in expenditures in any one year, and is thus subject to the requirements under UMRA for review of private sector costs. The Final Economic Analysis in section VI, satisfies these requirements, and provides a written statement containing the qualitative and quantitative assessment of costs and benefits as is required under Section 202(a) of UMRA (2 U.S.C. 1532).
E.O.13045 requires that Federal agencies submitting covered regulatory actions to OMB's Office of Information and Regulatory Affairs (OIRA) for review pursuant to E.O.12866 must provide OIRA with (1) an evaluation of the environmental health or safety effects that the planned regulation may have on children, and (2) an explanation of why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency. E.O.13045 defines “covered regulatory actions” as rules that may (1) be economically significant under E.O.12866 (
The Agency reviewed this final rule according to the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321
As a result of this review, OSHA has determined that this final rule will have no impact on air, water, or soil quality; plant or animal life; or the use of land or aspects of the external environment. Therefore, OSHA concludes that this final rule will have no significant environmental impacts.
This final rule is based on the public record developed during the rulemaking. As described in Section II, an advance notice of proposed rulemaking (ANPR) was published by OSHA on September 12, 2006 (71 FR 53617). The ANPR included a series of questions to solicit information on a number of specific topics. The responses from more than 100 commenters were used by the Agency to help prepare the required analyses for the proposed rulemaking, as well as to make determinations regarding the proposed text. The notice of proposed rulemaking (NPRM) was published by OSHA on September 29, 2009 (74 FR 50280). Public comments were received during a 90-day comment period that ended on December 29, 2009. Subsequently, public hearings were convened in March 2010 in Washington, DC, and Pittsburgh, PA, for the Agency to receive oral testimony from interested parties. Following completion of the hearings, participants were given an opportunity to provide additional information to OSHA during a post-hearing comment period, as well as submit briefs summarizing their views for the record. The public record upon which OSHA is basing the final standard includes all of the comments, testimony, and supporting information submitted by rulemaking participants, as well as by OSHA.
Support for implementation of the GHS by OSHA was expressed by both users and producers of chemicals who responded to the ANPR (
In addition to those who supported implementation, but raised areas of concern regarding the way in which it is pursued, there were others who did not support implementation (Document ID #0004, 0065, 0068, and 0108). These commenters argued that it would be too burdensome (Document ID #0004); delegates power to an international body, which can only be accomplished through a treaty, if at all (Document ID #0065); would change the current hazard communication scheme and thus potentially impair safety (Document ID #0065); and should not be applied to pesticides because they are already heavily regulated (Document ID #0108).
In the NPRM, OSHA addressed each of these concerns and concluded that evidence, arguments, and accompanying analyses supported pursuing the modifications to the HCS. OSHA preliminarily determined that these modifications would enhance employee protection and facilitate compliance for all workplaces that produce or use hazardous chemicals.
While OSHA did not include questions regarding the support of stakeholders for adoption of the GHS, it was clear that a majority of those responding to the ANPR supported moving forward with the rulemaking. The arguments presented by those few who actively objected to adoption were addressed in the NPRM and the analyses for the rule, and were not found by OSHA to be persuasive. Other issues raised by supporters as concerns, or suggestions for addressing concerns, were also addressed in the proposed rule.
OSHA indicated in the NPRM (74 FR 50281, Sept. 30, 2009) that the Agency had made a “preliminary determination that the proposed modifications to the HCS would increase the quality and consistency of information provided to employers and employees.” OSHA also indicated that the “standardized label elements would be more effective in communicating hazard information;
Many participants responded, and the vast majority agreed with OSHA's preliminary determination that the proposed modifications would be effective in protecting employees, as well as the conclusions as to the reasons why it would be effective, and thus supported the rulemaking (
AISI and ACCCI support OSHA's assessment that modifications to the Hazard Communication Standard (HCS) would increase the quality and consistency of information provided to employers and employees. Two improvements are expected with the changes OSHA has proposed:
a. Standardized criteria to evaluate chemicals and communicate the hazards via Safety Data Sheets (SDSs) and labeling should assure consistent communication and lower the likelihood of miscommunication and misinterpretation.
b. Standardized criteria to evaluate chemicals should facilitate training. With a single teaching format for SDSs and Labels, understanding, regardless of an employee's educational background, should be improved.
SOCMA members are generally very supportive of the implementation of GHS for workplace hazard communication in the United States, and for over the past forty years, we have spent millions of dollars and dedicated an insurmountable amount of time towards evaluating potential chemical hazards, communicating hazard information and protecting workers. The proposed rule may have a disproportionate economic impact on small business chemical manufacturers, particularly companies that are already struggling in these unstable economic times. A majority of these burdens can be mitigated, though, if the most affected entities are given adequate time to transition and proper compliance assistance is provided.
* * * Once overcome though, the potential benefits of implementing GHS in the United States are highly anticipated by SOCMA members, some of which include: The harmonization of incompatibilities and inconsistencies in labeling and classification, more uniformity in both substance and format, the elimination of language and reading barriers through pictograms, and the facilitation of control banding.
The National Institute for Occupational Safety and Health (NIOSH) has extensive experience in another international effort to harmonize information on chemicals—development of International Chemical Safety Cards under the auspices of the World Health Organization (WHO) and the International Program on Chemical Safety (IPCS). In their comments, they highlighted the advantages of internationally-harmonized classification criteria (Document ID #0412):
NIOSH recognizes OSHA's Hazard Communication Standard (HCS) as one of the most important U.S. regulations in occupational safety and health and concurs with OSHA on the need for a revised HCS. A significant advantage of the proposed standard is the detailed criteria for classification will improve accuracy and consistency in the information provided to employers and employees on chemical hazards and protective measures. Those criteria will reduce the likelihood of differing interpretations of the same data. In addition, the specified hazard categories will convey the severity of the effect, unlike the hazard classes in the current HCS.
Worker representatives also supported the proposed rulemaking. For example, comments on behalf of the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union (AFL/CIO.CLC), stated (Document ID #0403.2):
The committees which designed the GHS agreed on an important principle early in the work: The final harmonized system should not weaken the protection afforded by any existing system. That in itself was a significant accomplishment. However, in the United States, adopting the GHS will go a step further—the revised, GHS-compliant Hazard Communication rule will greatly improve the comprehensibility of labels and safety data sheets, giving workers and employers—especially employers in small business—information they can more easily understand and use.
While stakeholder support for the rule was extensive, there were some stakeholders who did not support pursuing a final rule to modify the HCS, sought to exempt their constituents from its provisions, or supported a different approach. For example, the American Composite Manufacturers Association (ACMA) argued that the protections of the current rule are sufficient, and implementation of the revisions would be too burdensome for their industry (Document ID #0407). No data were provided to support these contentions. The North American Insulation Manufacturers Association (NAIMA) indicated they support harmonization, but argued that the proposed standard will not achieve global harmonization for a number of reasons, including conflicting domestic requirements (
OSHA does not find any of these arguments persuasive. With regard to NAIMA, OSHA indicated in the NPRM how it plans to maintain the necessary consistency with the GHS through the various rulemaking options available to the Agency, and that it continues to participate in the international GHS activities in order to be involved in maintenance of the system itself. We do not agree that these are insurmountable concerns that argue against adopting the provisions, or changing the approach in a significant way.
OSHA agrees with ACMA and ICC that the existing standard provides extensive protections to exposed employees. However, the analyses presented in support of the proposed and final rules demonstrate that these
* * * OSHA can help minimize the cost to businesses by only modifying those sections of the OSHA Hazard Communication Standard (HCS) that must be changed to be consistent with GHS. Therefore, we strongly support OSHA's stated intent to maintain the current scope, application, and interpretations of the HCS, and only modify those sections of the standard necessary for consistency with the GHS. Not only will this help minimize the implementation burden on industry, it should also serve to minimize confusion among employers and employees during the implementation period.
OSHA agreed with these commenters, and made every effort in the NPRM to maintain the framework of the current HCS in the proposed revisions. The modifications proposed were believed by OSHA to be those that were required to align the current HCS with the GHS, but did not address provisions of the current standard that are not addressed in the GHS. Thus, for example, the scope and application paragraph remained largely unchanged, as did the paragraph addressing trade secret protection. The primary modifications proposed in those paragraphs were changes in terminology required to ensure consistency.
A number of commenters addressed this issue in their NPRM comments and testimony as well. For example, Dow Chemical Corporation indicated (Document ID #0353) that OSHA should follow two overarching principles as it revises the HCS. The first is to “implement the GHS with as little US customization as possible,” and the second is to “make only those changes to the HCS that are necessary to facilitate GHS implementation.” (
Others commenters recognized this was OSHA's approach, and supported it. For example, the Defoamer Industry Trade Association (DITA) noted (Document ID #0367):
DITA applauds the fact that OSHA did not modify the GHS definitions to a great degree. These definitions reflect a consensus scientific process for the review of the hazards that chemicals can present and the toxicology data that predicts the likelihood of hazard occurring. Accordingly, this should lead to a high level of harmonization on the classification of chemical substances between the EU and the US. A high degree of harmonization is desirable so that manufacturers do not need different SDSs that satisfy the requirements of different countries.
Many commenters to the ANPR also suggested that OSHA should coordinate implementation of the GHS with other Federal agencies. These included primarily EPA, DOT, and CPSC (
SDA urges OSHA to coordinate implementation of revisions to the HCS related to the GHS with the Environmental Protection Agency (EPA), Department of Transportation (DOT), and the Consumer Product Safety Commission (CPSC), which all have announced their intentions to implement GHS provisions in their regulations. Workplace hazard communication occurs in a stage of the overall life cycle of chemicals and finished products. Coordination and synchronization of implementation timing could greatly improve the efficiency of implementation of the GHS by industry.
Similar comments were received in responses to the NPRM (
A number of commenters to the ANPR also argued that OSHA should coordinate implementation with major U.S. trading partners (
API strongly recommends that OSHA ensure that timing and coordination of GHS implementation schedules are in line with those of other countries, allowing sufficient time for companies to organize and accomplish necessary work. In order to achieve international harmonization of hazard communication materials and to avoid undue burden on companies, OSHA must stay engaged with all other actors to encourage even and consistent implementation of GHS by individual countries. Further, API recommends that OSHA work closely with other government agencies and countries to ensure alignment to the UN endorsed version of the GHS. As the implementation of the GHS by countries deviates from the UN version of GHS, the perceived benefits of harmonization substantially decrease.
3M agrees that the potential benefits identified in the proposed NPRM may be achieved through global implementation of GHS. However, 3M emphasizes that the potential benefits of GHS will depend on countries around the world aligning as closely as possible with the GHS. The potential benefits of GHS will be substantially undercut by country-specific differences or additions that would require companies to have multiple SDSs and labels for the same product.
Consistent implementation among the major trading partners of the world is crucial to realize the benefits of the GHS system. For this reason, the alignment, insofar as possible, of all national and regional GHS systems with the UN GHS system is critical. In addition, any national or regional GHS implementation effort must retain enough flexibility to continually adapt the system as necessary to harmonize as closely as possible with the UN GHS system.
OSHA agrees with these commenters that coordination among trading partners would enhance harmonization and facilitate implementation. The Agency remains active in the UN process, participating in the Sub-committee of Experts on the GHS (UNSCEGHS), as well as the United Nations Institute for Training and Research (UNITAR) Programme Advisory Group. There is increased emphasis in the Sub-committee on implementation issues as well as coordination. OSHA is leading a correspondence group of interested members established by the Sub-committee that is reviewing practical classification and hazard communication issues, and proposing modifications to the Sub-committee to clarify such provisions when identified. There are also other correspondence groups that are addressing implementation issues as they are raised to the Sub-committee. OSHA tries to participate in all of this work in the Sub-committee to help ensure that any U.S.-identified issues are raised and addressed. Essentially all of the countries involved in implementation participate in the Sub-committee, so this is OSHA's best opportunity to coordinate with them.
The Agency has also had bilateral discussions with Canada, as well as the European Union (EU), on issues related to implementation. These discussions continue periodically to address mutual issues of concern.
Canada has not yet proposed modifications to their system to achieve harmonization, but they are planning to in the near future. The EU has adopted the GHS, and according to a press release on January 4, 2011, from the European Chemicals Agency (ECHA), recently reached a significant implementation milestone for its Classification, Labelling and Packaging (CLP) regulation. (
By 3 January 2011, ECHA received 3,114,835 notifications of 24,529 substances for the Classification and Labelling Inventory. By this deadline, industry had to notify the classification and labelling of all chemical substances that are hazardous or subject to registration under the REACH regulation and placed on the EU market. * * *
The Classification, Labelling and Packaging regulation relates to chemical substances and mixtures. It introduces into the EU the criteria of the United Nations' Globally Harmonised System for classifying and labelling chemicals. One of the aims of the CLP regulation is to improve the protection of human health and the environment by providing criteria for defining when a substance or mixture displays properties that lead to its classification as hazardous.
CLP applies to manufacturers, importers, users or distributors of chemical substances or mixtures. They must classify, label and package any substance or mixture, regardless of its annual tonnage, in accordance with the Regulation.
The largest number of the notifications, over 800,000, came from Germany. Over 500,000 notifications were submitted from the United Kingdom and nearly 300,000 from France. All together over 6,600 companies notified at least one substance.
Canada and the EU are two of the major trading partners for the U.S. When OSHA prepared the NPRM, it examined the CLP to coordinate where possible on approaches to implementation. However, the primary principles followed by OSHA in developing this proposal were to ensure that the modifications maintain or enhance the protections of the current standard, and that the modifications are consistent with the negotiated provisions of the GHS.
One of the issues of concern regarding implementation by some other countries has been deviation from the GHS itself. Because GHS is intended to be globally implemented, efforts by countries to deviate in a collective manner from the GHS, rather than maintaining consistency, defeats the purpose and, consequently, lessens the benefits of the GHS. OSHA will continue to seek opportunities to ensure coordination of implementation and promote harmonization, both internationally and bilaterally.
It should also be noted that the GHS is a living document, and the UN actively reviews it and considers possible changes based on implementation experiences and other information. These changes are made on a two-year cycle, referred to as a biennium. The OSHA proposal and the final rule are based on Revision 3 of the GHS. Revision 3 was adopted by the UN Committee and Sub-Committee of Experts on the GHS in December 2008, and is available as a publication and on the UN Web site. In December 2010, the UN Committee and Sub-committee of Experts on the GHS adopted additional changes that will be issued as Revision 4.
It is expected that as the UNSCEGHS fulfills its mandate to ensure that the GHS is up-to-date and relevant, further changes will be adopted on a biennium basis. If the change(s) is substantive and controversial, OSHA will have to engage in notice-and-comment rulemaking in order to amend the HCS. However, for non-substantive or clarification changes, other rulemaking options are available that can be utilized to implement the changes more quickly than the full notice-and-comment rulemaking process.
Two possible means are the Standards' Improvement Process (SIPs) or a Direct Final Rule (DFR). Each of these options gives the public notice and opportunity to comment, but has the advantage of a faster process. Either method could be used to ensure that the HCS remains current with the GHS.
A number of NPRM participants commented that OSHA should establish a stakeholder process for input into U.S. government positions on issues raised at
In the NPRM (74 FR 50288, Sept. 30, 2009), OSHA noted that one advantage of adopting a system with harmonized hazard statements is that it would facilitate the use of “control banding” in the U.S. Control banding is an approach to selecting control measures for workplace chemical exposures. Basically, the employer can, with the use of information readily available in the workplace, use the approach to determine the appropriate control measures for a chemical. The harmonized hazard statements are key to assessing the hazards, and the degree of severity of the hazards. In combination with data about physical and chemical characteristics, quantities used, and the types of processing, the employer can access recommended control measures. It is particularly helpful in situations with common operations (
There is considerable international interest in this approach, and there have been a number of research studies conducted to refine the approach and determine its applicability. Both OSHA and NIOSH have taken part in activities to further investigate its utility in the U.S. NIOSH has extensive information available on its Web site at
The use of control banding to provide guidance for chemical safety and health approaches in U.S. workplaces cannot be accomplished until harmonized hazard statements are readily available. Adoption of the GHS and its phrases would open up the possibility that control banding guidance can be used in the United States to help small- and medium-sized employers select and implement appropriate control measures [NIOSH 2009].
* * * ASSE believes OSHA should update the HCS to incorporate elements of control banding. Assuming that most elements of GHS will be adopted and a national database for safety data sheets (SDSs) and chemical classifications will be established to support the transition to GHS from current practice, building a system that would allow guided review of materials and processes such as control banding would be a relatively small additional step. We encourage OSHA to take that step now and avoid revisiting this issue when it becomes unavoidable as control banding grows in use internationally as well among leading employers in this nation.
OSHA solicited additional ideas for outreach or compliance assistance in the NPRM, and many commenters provided such information (
Similarly, as OSHA indicated in the NPRM, the Agency's approach was also to be as consistent as possible with the GHS itself. Editing was limited to what was required to make the provisions mandatory in the context of OSHA rulemaking, and using the regulatory language required for that purpose. Additionally, as described in the NPRM, OSHA did not propose adopting language from the GHS that was strictly provided for guidance purposes (such as the decision logics in the chapters in the GHS that describe the physical and health hazard criteria). There is no question that other changes could be made to the language to make it more readable, or to state it in American English. However, introducing different terminology also introduces the possibility that readers will believe that OSHA means something different than the GHS because we have used different language. Since this is not the intent, the Agency has avoided doing this.
Nevertheless, many such editorial changes were suggested. While OSHA has reviewed all of them, and adopted a few that seemed appropriate or necessary, in general the Agency did not engage in extensive editing of agreed text for fear of changing the meaning, or giving the impression that the meaning has changed. In particular, Dow Chemical submitted extensive suggested edits in both its initial comments on the NPRM and in post-hearing comments (Document ID #0353 and 0526). Most of these issues were not raised by any other participants. Given the large number of such editorial suggestions from Dow, OSHA does not discuss each one in this preamble, but simply notes where changes have been made to the text. OSHA, however, gave each of Dow's suggestions full consideration.
The second part of the paragraph addresses the preemption of State or local laws by this Federal standard. It indicates that OSHA is addressing comprehensively the issues described, and thus the standard preempts States, and political subdivisions of States, from addressing these issues except under the authority of a Federally-approved State plan under Section 18 of the OSH Act. While Section 18 applies to every occupational safety and health standard that OSHA promulgates, the HCS raises particular issues because of the nature of the provisions. It requires chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import, and to prepare labels and safety data sheets based on those evaluations to transmit hazard information and appropriate precautionary advice to users downstream. This is a unique but highly appropriate approach for an OSHA standard, as it recognizes that chemical manufacturers and importers are in the best position to assess the hazards of their products and develop appropriate information for labels and SDSs.
There is a national, indeed international, marketplace for industrial chemicals, and thus chemical manufacturers and importers affect commerce within the meaning of the OSH Act and therefore fall under OSHA's jurisdiction. If a State, or a political subdivision of a State, were to establish different requirements for labels and safety data sheets, such requirements would have an impact on chemical manufacturers and importers that are not located in that State. This is a burden that the HCS eliminates by establishing national requirements.
The proposed revisions to the HCS had essentially the same purposes, and thus the NPRM included only minor modifications to this paragraph. OSHA proposed to modify paragraph (a)(1) to change the language regarding the assessment of hazards to indicate that the hazards will be “classified” rather than simply assessed or evaluated. This is consistent with the approach in the GHS. In addition, OSHA proposed to modify this paragraph to clearly indicate that the standard is intended to be consistent with the GHS, Revision 3. That change is a reflection of the purpose of this rulemaking to harmonize the existing requirements with the provisions of the GHS, which is the international instrument that includes globally harmonized provisions on hazard communication. In addition, in this paragraph and succeeding paragraphs of the revised rule, the term “material safety data sheet” was modified to “safety data sheet” to reflect the terminology of the GHS.
The only modifications proposed to paragraph (a)(2) also addressed terminology, using “classifying” instead of “evaluating”, and “safety data sheet” instead of “material safety data sheet”.
There were a few comments that were related to the Purpose paragraph provisions. One comment suggested that the standard should be limited to a purpose of international communication so as not to trigger hazard assessments under other OSHA standards that address respiratory protection, personal protective equipment, or process safety management (Document ID #0049). There were several other comments that indicated that new assessments would have to be done for these standards (Document ID #0111, 0134, 0164, and 0178). Arguments were made that this would lead to extensive additional costs for new engineering controls, respirators, or other personal protective equipment.
As discussed above, there is no identified link to these other standards in the stated purpose of the HCS either currently or with the proposed modifications in the NPRM. While the current HCS and this final standard require the provision of information on recommended control measures, including respiratory protection, personal protective equipment, and engineering controls, there is no requirement for employers to implement the recommended controls. An employer should use all available information when designing an appropriate protective program, but a recommendation on a safety data sheet by itself would not trigger the need to implement new controls.
Furthermore, these comments seem to imply that there will be major changes in the classification of the hazards of chemicals as a result of implementation of the GHS provisions. Both the HCS and the GHS are based on identifying and communicating the inherent hazards of chemicals. Thus the biggest change for most chemicals under the final rule will be in categorizing the chemical's hazards. Under the current standard, for example, a chemical either is, or is not, a carcinogen. Under the revised HCS, if a chemical is a carcinogen, it would be categorized as a Category 1 or a Category 2 carcinogen. Such a change would provide additional information for the downstream user, but would not generally result in a need to change engineering controls or respiratory protection.
It is possible that a chemical may be classified under the final rule as having a hazard it did not have before, but OSHA believes that this is not likely to happen frequently given the broad coverage of the current rule. Furthermore, the physical and chemical characteristics of the chemical—which
Several commenters to the ANPR noted what they believed to be the continued need to address the preemption of State standards (
It was also indicated that changes in State laws should be coordinated with the Federal changes to facilitate implementation (Document ID #0146).
There were a number of comments received in response to the NPRM that addressed the Purpose paragraph provisions. For example, the Styrene Information and Research Center (Document ID #0361) indicated that OSHA should revise paragraph (a)(1) to say that it is intended to be consistent with the GHS “with some exceptions,” since there are some deviations from the GHS. OSHA does not agree with this suggestion. The language proposed, and in the final rule, is accurate—it is consistent with the provisions of the GHS. The GHS is not a model regulation, and it is not intended that countries will adopt the actual text of the GHS. Furthermore, there is allowance for flexibility and differences where necessary to accommodate a country's specific needs. There was nothing in the NPRM that was inconsistent with the GHS, and neither is the final rule inconsistent.
Dow Chemical (Document ID #0353), argued that paragraph (a)(2) should state that OSHA is preempting personal injury suits alleging that labels provided inadequate warnings. The Industrial Minerals Association-North America (Document ID #0394) indicates that the new rule must make clear that it preempts state law tort claims alleging failure to warn. OSHA declines these invitations. As recently explained in the Solicitor of Labor's letter to Stephen Wodka, dated October 18, 2011, in general the HCS does not preempt state tort failure to warn lawsuits, and OSHA does not intend to change that position in the final rule. Indeed, the OSH Act's “savings clause” explicitly preserves, rather than preempts, State tort law. OSH Act § 4(b)(4), 29 U.S.C. 653(b)(4);
Similarly, DuPont (Document ID #0329) says OSHA should convince States to voluntarily rescind their “right-to-know” laws, or make them consistent with the HCS final rule. And the National Paint and Coatings Association (NPCA) (Document ID #0328) believes that OSHA should not allow States to promulgate a standard that is different from the Federal rule. As indicated in paragraph (a)(2), States with OSHA-approved State Plans will have to adopt standards that are at least as effective as this final rule. (
Therefore, OSHA has concluded that the changes it proposed to Paragraph (a) are appropriate, and those changes are being incorporated into the final rule. No other revisions are being made.
The provisions of paragraph (b)(2) in the HCS address the overall scope of the standard as applying to “any chemical which is known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency.” This provision addresses many questions that are raised about the application of the standard.
In general, OSHA does not expect significant changes in the chemicals covered by the HCS under the final rule as compared to the current standard. The scope of hazards covered by the GHS is very similar to what is covered by the current HCS. Additional chemicals may be considered to be acutely toxic due to the proposed adoption of Category 4 in acute toxicity, which would expand the criteria for inclusion from the current definition (
In addition to the overall scope statement, the final rule, like the current rule, provides for limited coverage in workplace situations that have special circumstances, including laboratories (paragraph (b)(3)) and work operations where employees only handle chemicals in closed containers (paragraph (b)(4)).
OSHA also addresses the interface with other Federal agency requirements by either exempting the products covered from additional OSHA labeling (such as pesticides required to be labeled by the EPA) (paragraph (b)(5)), or completely exempting the product (such as hazardous waste regulated by EPA) (paragraph (b)(6)). These accommodations help to ensure that
Under the GHS, such provisions are left under the purview of the “competent authority.” In developing the GHS, it was recognized that countries' regulatory authorities would need to have the discretion to address such national circumstances in ways that are suited to the regulatory perspective of the country. Thus authorities such as OSHA are free to make determinations about scope and application issues while still being harmonized with the primary provisions of the GHS.
OSHA reviewed the current provisions of paragraph (b), and determined that no significant changes were required to be consistent with the GHS. Several minor changes to revise terminology were retained from the proposal (
Several commenters to the ANPR indicated that OSHA should adopt exemptions included by the European Union in its requirements. Specifically, these exemptions address non-isolated intermediates, chemicals involved in research and development, and waste (Document ID #0049, 0134, and 0164). In response to the NPRM, the Society of the Plastics Industry (SPI) (Document ID #0392) continued to argue that the EU exemptions should be adopted. All of these situations are already addressed in paragraph (b), and OSHA does not agree that it is appropriate or necessary to change them.
In terms of non-isolated intermediates, the overall scope provision in paragraph (b)(2) adequately addresses this situation. This was described in the preamble to the 1983 final rule (48 FR 53335, Nov. 25, 1983):
That is, the term “known” means the employer need not analyze intermediate process streams, for example, to determine the presence or quantity of trace contaminants. However, where the employer knows of such contaminants, and they are hazardous, then they fall under the provisions of the standard.
With regard to chemicals involved in research and development, paragraph (b)(3) limits coverage in laboratories, and partially addresses this situation. Where there is no knowledge of the hazards of such chemicals, the HCS does not apply at all since there is no requirement to generate new hazard information. Where information is available, it must be provided to exposed employees, consistent with paragraph (b)(3) when it is in a laboratory situation. Therefore, it appears to OSHA that this situation is also adequately addressed under the current provisions. Hazardous waste as regulated by EPA is already exempted under paragraphs (b)(6)(i) and (ii).
The North American Metals Council (NAMC) (Document ID #0377) argued in response to the NPRM that OSHA should use the EU approach to exempt metals in their massive form, alloys, and other preparations that do not present a hazard. Provisions already exist in the current HCS, and are included in the final rule, that address these issues (
There were commenters who suggested that OSHA maintain current exemptions or limitations in the revised GHS, including the consumer product exemption (Document ID #0064), guidance on byproducts (Document ID #0064), the relative roles of manufacturers and employers (Document ID #0064), and the article exemption (Document ID #0160). OSHA agrees and all of these accommodations remain the same in the revised rule. The Agency is not changing those parts of the HCS that are not affected by the GHS.
There were also a few comments regarding the scope of the revised rule in terms of provisions of the GHS that affect the environment or transportation (
Few comments were received on this paragraph in the NPRM. Dow Chemical (Document ID #0353) suggested that paragraph (b)(5)(iv) be updated to reflect the changed name of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (the word “Explosives” has been added to their name). This has been done. In addition, two typographical errors in (b)(6)(ii) have been corrected.
The North American Insulation Manufacturers Association (NAIMA) (Document ID #0411) states that OSHA has given unwarranted exemption by ceding authority for products regulated by other agencies. In particular, NAIMA is concerned about coverage by CPSC, and indicates that CPSC addresses the fire hazards of cellulose insulation, but not the health hazards, in its label requirements. NAIMA argues that OSHA should not allow consumer product labels to supersede OSHA requirements.
OSHA considered this issue at length in previous amendments to the HCS (53 FR 29822, 29834-38, Aug. 8, 1988; 59 FR 6126, 6150-52, Feb. 9, 1994;
OSHA nevertheless decided to permit the CPSC labels to suffice so as not to disrupt the extensive labeling conducted in accordance with those rules. OSHA believed that this could be justified on the basis that some information is provided on the labels that would be useful to workers, and that the requirement for MSDSs would provide what information is necessary to supplement the labels. 48 FR 53289. This additional information is critical to ensuring that training can be properly conducted, and that adequate protective measures are used in the workplace.
A few comments were received in response to the ANPR regarding EPA labels for pesticides, noting that signal words in these labels would change if GHS is adopted (Document ID #0178), and noting that the requirements for these labels are dictated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which also controls the SDS content (Document ID #0108). A commenter also argued that FIFRA pesticide labels are more useful because they are risk-based rather than hazard-based (Document ID #0108). These concerns were not related to the proposal which maintained the exemption for additional labels on containers that are labeled in accordance with EPA requirements. If EPA decides to adopt the GHS, then labels for pesticides would be consistent with OSHA labels on other types of products. With regard to SDSs, these are required by the HCS, not FIFRA, and therefore such SDSs must be consistent with GHS provisions as adopted in this final standard.
A number of additional comments, and oral testimony, were received in response to the NPRM from representatives of the pesticide industry regarding potential conflicts between OSHA and EPA requirements (
The principal reasons for this are: (i) Requiring GHS compliant SDS's but not pesticide labels will result in significant confusion in workplaces in which pesticides are used; (ii) imposing GHS-based SDS's would be inconsistent with EPA's interpretation of FIFRA, which includes all material that may be shipped with a pesticide, including SDS's, as part of its definition of labeling; and (iii) applying GHS to pesticide SDS's will not provide any additional substantive information, as EPA's evaluation of pesticides before approving them for sale includes all aspects of potential occupational exposures.
OSHA considered exempting pesticides from the final rule. However, exempting pesticides would reduce protections for those workers under OSHA's jurisdiction. For example, OSHA's jurisdiction extends to employees in pesticide manufacture and formulation. While EPA approves the label on the final product shipped out of these facilities, and that label includes information needed when the products are used by applicators, EPA does not have hazard communication requirements for the protection of workers in production facilities. Such protection is covered by OSHA, and OSHA requires labels on containers that are not subject to EPA labeling, as well as SDSs and training. The workplace exposures of these workers are of great concern. The chemicals are generally designed to be biologically active, and the exposures can be quite different than they would be for applicators, for example, who may use them only on an intermittent basis.
In testimony during the public hearing, representatives from the ACC Biocides Panel and CropLife America, Inc., agreed that EPA does not cover workers in pesticide manufacturing or formulating facilities (
As a result of receiving these comments, and the concerns about removing current protections from the final rule, OSHA considered several options. OSHA considered allowing the SDS preparer to use the EPA classification in section 2 of the SDS to ensure consistency with the FIFRA label. However, in doing this the SDS would then be inconsistent with other chemicals in the production of pesticides. In the pesticide manufacturing workplace the pesticide chemical “active” ingredients would bear a FIFRA label but would have an OSHA SDS, however other chemicals in the workplace such the “inactive” ingredients or cleaning products might still be considered hazardous under the HCS would contain an OSHA label and an OSHA SDS. An added complication is that an identical chemical (for example, chlorine) could potentially be in a pesticide manufacturing workplace where in one situation it could contain a FIFRA label and another it could bear an OSHA style label depending on its end use (e.g., a disinfectant). Adding a different SDS would create additional confusion not only for the worker handling the chemicals but also the personnel in charge of chemical management as well. Therefore, OSHA and EPA met to discuss what would be an appropriate resolution. First, with regard to the argument that SDSs are part of labels, and therefore preempted, EPA has long had an interpretation that they will not apply their review requirements to SDSs (US EPA Pesticide Registration Notices 92-04). Based on our discussions, OSHA does not anticipate that this policy will change. Secondly, EPA has indicated that they are committed to working with OSHA to develop an approach that will provide both appropriate protection for employees, as well as the environment, through workable guidance for the pesticide industry. OSHA anticipates that EPA will provide guidance to their regulated community (such as through a Pesticide Registration Notice) on how to develop an OSHA GHS-compliant SDS that will not be in conflict with the pesticide label. Therefore, pesticides will continue to be covered in the same manner as has been done under the HCS since its inception, and the exemption requested by pesticides industry rulemaking participants for such products is not granted.
Although the OSHA ICR (OMB Control No. 1218-0072) that is currently pending review and approval by OMB addresses the information collection activities associated with preparing the entire SDS as prescribed by the OSHA final rule, the approach OSHA anticipates will be provided in the EPA guidance for pesticide registrants was not considered by OSHA at the proposed rule stage. While OSHA preliminarily believes it has taken sufficient time in its paperwork estimate to cover compliance with the anticipated EPA guidance, the public has not had the opportunity to comment
In the proposed revisions, OSHA retained as many definitions as possible from the current HCS. Changes were proposed only when there was a new term used that needed to be defined, or there is a different definition in the GHS, and consistency with the international definition was needed for harmonization purposes. As with the preceding paragraphs, minor modifications were proposed to ensure terminology is appropriate—primarily the use of terms related to classification and safety data sheets. These modifications were retained in the final rule. There were relatively few comments submitted on the proposed revisions to the definitions, other than those referring to the new definition OSHA proposed to address “unclassified hazards” and the definition for “pictogram” that references a red border frame.
One important difference between the HCS and GHS in terminology involves the use of the term “chemical.” The HCS has used this term since it was originally promulgated, and defines it to include elements, chemical compounds, and mixtures of elements and/or compounds. It has been a convenient way to describe the coverage of the rule. The GHS, like some other international standards, uses the terms “substance” and “mixture”. OSHA has decided to retain a definition of “chemical” in the revised standard, which minimizes the number of terminology changes that have to be made to the regulatory text, as well as providing a shorthand way to define the scope to include both individual substances and mixtures of substances. This term is used in the body of the regulatory text of the final standard, similar to its use in the current HCS. However, the modifications also include definitions for “substance” as well as “mixture” to align with the GHS, and both of these terms are used as well. In particular, in the appendixes that are adopting GHS language, the separate terms “substance” and “mixture” are used consistent with the GHS.
“Substance” means “chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurities deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.” Dow Chemical (Document ID #0353) objected to this definition, and suggested that it should be “chemical elements and compounds in their natural state or obtained by any production process.” OSHA has concluded that it is appropriate to maintain the GHS language for this definition to help to ensure consistent application, and thus the revised rule includes the definition of substance that was proposed.
A “mixture” is defined as a “combination or a solution composed of two or more substances in which they do not react.” This is consistent with the GHS definition—and while slightly different than the definition in the current HCS, means the same thing. Dow Chemical (Document ID #0353) suggested that OSHA maintain part of its current definition in order to avoid inadvertently changing the scope of coverage by adding “if the combination is not, in whole or in part, the result of a chemical reaction.” OSHA does not believe that the scope is changed by the GHS definition, and has retained the GHS-consistent language that was proposed.
OSHA also proposed to maintain the term “hazardous chemical” in this revised standard as used in the current standard (a chemical which is a physical or health hazard), except to add the term “classified” to indicate how it is determined that it is a physical or health hazard. OSHA also proposed to include unclassified hazards in this definition, but, as will be described below, has chosen a different approach in the final rule. Instead, the definition of “hazardous chemical” in this final rule is “any chemical which is classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, pyrophoric gas, or hazard not otherwise classified.” The term is used throughout the standard to indicate that the classification process is completed, and the chemical manufacturer has determined that the chemical poses a hazard. Most of the substantive requirements of the rule apply to hazardous chemicals.
Dow Chemical (Document ID #0353) indicated that OSHA should drop the use of the word “substance” altogether, and instead use the word “chemical.” As noted in the definition of “chemical,” however, it is to be used when a reference is to both substances and mixtures. Where a provision or statement refers only to a substance, or only to a mixture, those terms are used in lieu of “chemical” or “hazardous chemical.” These individual designations are used most commonly in the appendixes, particularly in the classification criteria. OSHA has maintained consistency in the criteria with the GHS insofar as is possible with regard to this terminology.
Another proposed modification to the definitions paragraph was to move the specific physical hazard definitions to an appendix. In the current HCS, health hazard definitions are addressed specifically in Appendix A, but the physical hazard definitions were included in paragraph (c). In the final standard, health hazard definitions continue to be addressed in Appendix A, but a new Appendix B addresses physical hazards. Both of these appendixes are discussed below under the summary and explanation of paragraph (d) “Hazard Classification.”
As noted in Section III above, the physical hazard definitions in the GHS are drawn from the United Nations' Recommendations on the Transport of Dangerous Goods. Since DOT has already adopted this international approach, the GHS definitions are substantially harmonized with the U.S. requirements for labeling of dangerous goods in transport. All chemicals that are shipped in the U.S. have already been classified according to DOT's physical hazard definitions. This will reduce the burdens associated with classifying physical hazards under the revised HCS. The primary differences involve exceptions that make the definitions more applicable to workplace situations (for example, coverage of flammable liquids that are currently defined as combustible under the HCS). Modifying the HCS to align with the GHS thus serves the purpose of harmonizing many of these definitions domestically, and results in shippers only having to classify their chemicals once for most physical hazards.
OSHA also has updated the definition of the term “classification” to reflect the additional hazards in this final rule (simple asphyxiant, combustible dust, and pyrophoric gas). The definition for classification will now read: “Classification means to identify the relevant data regarding the hazards of a chemical; review those data to ascertain the hazards associated with the chemical; and decide whether the chemical will be classified as hazardous according to the definition of hazardous chemical in this section. In addition, classification for health and physical hazards include the determination of the degree of hazard, where appropriate, by comparing the data with the criteria for health and physical hazards,” Dow Chemical (Document ID #0353) suggested that the language be changed to read “for health hazards and for physical hazards.” OSHA does not find this to be a necessary revision, and has adopted the definition as proposed. This definition is very similar to the process of hazard determination that is currently in the HCS, with the exception of determining the degree of hazard where appropriate. This reflects the GHS approach of having categories for each class of hazard. Under the current HCS, there are some definitions that have categories in a hazard class (
OSHA has also retained in the final rule the proposed definitions for “hazard class” and “hazard category” to further explain the approach of breaking down the hazardous effects into levels of severity. A “hazard class” is defined as “the nature of the physical or health hazards,
OSHA has retained the proposed definition of “health hazard” to reflect the specific hazards defined in the GHS. While the overall scope of what is covered is essentially the same as the current HCS, the hazards may be identified slightly differently. For example, the current HCS covers reproductive toxicity as a target organ effect, and includes all aspects of the effect under that hazard. The GHS has a separate definition for germ cell mutagenicity, which is considered part of reproductive toxicity in the current HCS. The definition of “health hazard” was thus proposed to be “a chemical which is classified as posing one of the following hazardous effects: acute toxicity (any route of exposure); skin corrosion or irritation; serious eye damage or eye irritation; respiratory or skin sensitization; germ cell mutagenicity; carcinogenicity; reproductive toxicity; specific target organ toxicity (single or repeated exposure); or aspiration hazard. The criteria for determining whether a chemical is classified as a health hazard are detailed in Appendix A to § 1910.1200—Health Hazard Criteria.”
Both the American Chemistry Council (ACC) (Document ID #0393) and Dow Chemical (Document ID #0353) suggested that OSHA modify the phrase “any route of exposure,” which refers to “acute toxicity.” ACC suggested it list the three specific routes of exposure in the criteria, and Dow suggested that it include “relevant” to modify routes of exposures. OSHA does not believe either of these changes is necessary. The definition already uses the term “classified” to refer to each of the health hazards listed, and the acute toxicity criteria include three routes of exposure for classification. Dow further suggested that “serious eye damage” be modified to say “by chemical action.” Again, the classification process is for chemicals, and the definition already indicates that it is covered as a health hazard when classified. Similarly, Dow suggested that “aspiration hazard” be modified to say “aspiration toxicity hazard.” The proposed language is consistent with the GHS, and OSHA is maintaining it for harmonization purposes in the final standard.
A revised definition of “physical hazard” was proposed to reflect the physical hazards covered in the GHS. While these are similar to the coverage of the HCS, they are in some cases described differently. The definition proposed for “physical hazard” is “a chemical that is classified as posing one of the following hazardous effects: Explosive; flammable (gases, aerosols, liquids, or solids); oxidizer (liquid, solid or gas); self-reactive; pyrophoric (liquid or solid); self-heating; organic peroxide; corrosive to metal; gas under pressure; or in contact with water, emits flammable gas.
Procter & Gamble (Document ID #0381) noted that the definition for “flashpoint” was missing from the NPRM and suggested that it should be put back into the rule. However, the meaning of the term “flashpoint” is already addressed in the criteria for “flammable liquid” in Appendix B by specifying the test methods to determine it. OSHA has also included a definition for flashpoint in the criteria chapter, rather than in the definitions paragraph.
The definition of “label” in the GHS is slightly different than what is currently in the HCS, and OSHA proposed to modify the HCS to be consistent with the GHS. The proposed definition of “label,” which has been retained in the final rule, is “an appropriate group of written, printed or graphic information elements concerning a hazardous chemical that is affixed to, printed on, or attached to the immediate container of a hazardous chemical, or to the outside packaging.” The GHS label is more specific than what is required in the current HCS, and includes certain core information that must be presented. Thus, a definition for “label elements” was also proposed and adopted in the final rule as “the specified pictogram, hazard statement,
“Safety data sheet (SDS)” is defined in both the NPRM and the final rule as “written or printed material concerning a hazardous chemical which is prepared in accordance with paragraph (g) of this section.”
Definitions for terms that describe information required to be provided on labels were also proposed to be added to the HCS and are included in the final rule. These terms include “hazard statement,” “pictogram,” “precautionary statement,” “product identifier,” and “signal word.” These new definitions will help to clarify the specific requirements for labels under the revised HCS, and are consistent with similar definitions in the GHS.
“Hazard statement” is “a statement assigned to a hazard class and category that describes the nature of the hazards of a chemical, including, where appropriate, the degree of hazard.” This is essentially what is defined as a hazard warning under the current rule. An example of a hazard statement under the GHS is: “Causes serious eye damage.” These statements have been codified, meaning that numbers have been assigned to them. They are available in all of the official languages of the United Nations, and thus translation will not be a problem when shipping to countries using those languages. Having standardized statements is expected to facilitate translation into other languages as well. The definition for “hazard statement” is being adopted as proposed.
There were a few comments about specific hazard statements, such as an objection from the National Propane Gas Association (Document ID #0400) indicating the statement for flammable gas is ambiguous, and lacks substantiation and scientific credence. They object to labeling propane as “extremely flammable,” which is the required statement for Category 1 for flammability hazards. This objection was also raised in a comment to the ANPR (Document ID #0068). OSHA responded in the NPRM that it would not be making chemical-specific changes to hazard statements (74 FR 50399, Sept. 30, 2009). The point of having harmonized statements is that all chemicals with the same degree of hazard have the same statement. OSHA also indicated that some in the industry already use the “extremely flammable” terminology. NPGA responded that not everyone is familiar with it, or uses it. That is why OSHA is establishing a standardized approach, so everyone in an industry with a common product like propane uses the same language to convey the hazard. This consistency will help people understand what the hazards are, and simplify the process of conveying them since everyone will use the same approach. As noted previously, examples of where the hazard statement “extremely flammable” are currently being used for propane are readily found (
A few commenters suggested that where hazard statements include two hazards, separating them should be permitted when data indicate that only one is applicable to the product involved (for example, it causes infertility but not developmental hazards) (Document ID #0344, 0376, 0377, 0381, 0382, and 0393). OSHA agrees that such separation should be permitted. The following provision has been added to Appendix C.2.2.2: “If the chemical manufacturer, importer, or responsible party can demonstrate that all or part of the hazard statement is inappropriate to a specific substance or mixture, the corresponding statement may be omitted from the label.”
Additionally, OSHA permits chemical manufacturers and importers to combine hazard statements where the information is related and the combination can shorten the text required on the label. Appendix C.2.2.1 states: “Hazard statements may be combined where appropriate to reduce the information on the label and improve readability, as long as all of the hazards are conveyed as required.” OSHA also allows additional hazard statements under supplementary information, as long as they are accurate and do not conflict with the required statements. “Pictogram” is defined as a “composition that may include a symbol plus other graphic elements, such as a border, background pattern, or color, that is intended to convey specific information about the hazards of a chemical.” This definition covers both pictograms in the transport sector, and those in other sectors covered by the GHS. The pictograms are required as part of the core information provided on a label to describe the hazards of a chemical. ACC (Document ID #0393) and Procter & Gamble (Document ID #0381) noted that the proposed definition of pictogram, which was retained in the final rule, is slightly different than what is in the GHS: “a graphical composition that may include a symbol plus other graphic elements, such as a border, background pattern, or color, that is intended to convey specific information.” OSHA added “about the hazards of a chemical” because that is the only type of information that will be conveyed by the pictograms in the HCS. The definition is being adopted as proposed.
The workplace pictograms proposed were a black symbol on a white background with a red diamond border frame. Some ANPR commenters noted that the frame should be permitted to be black for domestic shipments as allowed under the GHS (
Many of the rulemaking participants recognized the communication benefits of the red border, and supported the proposed requirement for a red border frame for all shipments (
OSHA requests comment on whether pictogram borders should be required to be in red or should be allowed to be printed in black. While the use of a red border may increase the cost of printing some labels, the use of color to draw attention to a potential hazard is a useful tool and is likely to enhance the communication of safety information. As products may also be exported to other countries, the use of the red border would be consistent with the establishment of a globally recognized hazard symbol. Imported products likewise, would have to contain the red symbol border and this would have to be made abundantly clear to Customs Agents and others responsible for monitoring the importation of chemical products.
However, others argued that black frames should be permitted on domestic shipments, and that the use of red borders is too costly and burdensome in terms of printing costs in particular (
If OSHA were to require only the red frame for pictograms, it would require those formulators that presently print single color labels to utilize different systems for producing labels of this nature, requiring a substantial capital investment which in turn will add greatly to the cost of transitioning to the revised HCS. OSHA must keep in mind, that small and medium sized formulators handle hundreds of products, each of which in turn are sold under multiple private labels. Thus a change in color requirements for labels generally will literally require a formulator to revise hundreds, if not thousands, of individual labels.
Further, we believe the use of a black frame will not present a threat to worker health and safety. ISSA disagrees with OSHA's conclusion that a red frame would significantly enhance the communicative value of the label. In citing studies, OSHA does not take into account that the use of the new labels will be the subject of intensive employee training that will more than mitigate the use of a black frame over a red frame.
In the NPRM regulatory analyses, OSHA did not assess the specific costs associated with red versus black borders, but has done so in the analyses for the final rule.
OSHA believes that the increased comprehension that will be provided by the red border frame is compelling. The red color will clearly delineate the hazard symbols from the other information on the label, and the prominence will lead to increased attention and recognition of the hazards. The transport labels and placards that have been in use for many years have multiple colors in their pictograms, and yet compliance has been achieved. Plus most product labels have various colors related to their logos, brands, etc., so clearly it can be done.
There are also some logistical issues that would make compliance more difficult with two different colored frames. First, it is unlikely that it would always be known whether a product would be exported at the point of labeling it at the end of the manufacturing process. Many containers are simply shipped to distributors, and the original manufacturer does not know where they will be sent after that—thus raising the question of whether a manufacturer or importer would know when to apply a black versus a red frame. In addition, workers exposed to chemicals purchased from different sources might have different frames, requiring additional training to avoid potential confusion. The final rule remains as proposed, and requires pictograms to have a red frame, with a black symbol on a white background, for all shipped chemicals regardless of destination.
Several commenters (Document ID #0318, 0382, and 0393) also raised issues regarding whether pre-printed labels with blank red frames could be used. The manufacturer would simply add the symbols to the frames when printing the required label information. If a manufacturer or importer took this approach, a particular label might have one or more empty red diamonds in addition to any required pictograms. OSHA does not believe that this would be appropriate. Blank frames would still attract attention, but workers could be confused about what they mean and whether something is missing from the information. While blank frames could be marked to indicate they are intentionally left blank, they will still contribute to clutter on the label and distract from the primary messages (
Under the GHS, a symbol is generally assigned to each hazard class and category. There are nine agreed symbols under the GHS to convey the health, physical and environmental hazards. Eight of these symbols were proposed for adoption in this rulemaking, the exception being the environmental symbol. Six of these symbols have been used for many years in the international transport requirements, so some employers and employees will already be familiar with them.
The symbols in the proposed rule are adopted in the final rule. Dow Chemical (Document ID #0353) noted that the pictograms are not entirely self-evident. While this may be true, the rule requires training workers so they will know what the symbols mean and how to respond.
It should be noted that in the NPRM, the pictogram for C.4.17 (oxidizing gases) was published with a “flame” symbol, rather than the “flame over circle” symbol that was appropriate, and was described. OSHA has corrected this error in the final rule, and has inserted the appropriate “flame over circle” symbol in Appendix C.4.17 for oxidizing gases.
The “precautionary statement” is “a phrase that describes recommended measures that should be taken to minimize or prevent adverse effects resulting from exposure to a hazardous chemical, or improper storage or handling.” The precautionary statements specified in Appendix C will be required on containers under the final rule. An example of a precautionary statement is: “Wear protective gloves.” The precautionary statements in the GHS are assigned to certain hazard classes and categories.
Precautionary statements are not required under the current HCS, although many chemical manufacturers include them on their labels for safe handling and use. These statements are codified under the GHS, meaning that numbers have been assigned to them. The precautionary statements in the GHS are not harmonized like the hazard statements are, and the regulatory authority is free to use the statements in the GHS annex or to use alternative statements when adopting the current version of the GHS. Using the GHS statements has the advantage of adopting statements that have undergone expert review by the UN Sub-committee, are assigned to the appropriate hazard class and category, and have been translated into six languages. Work continues on them in the Sub-committee to combine or edit the precautionary statements to reduce repetition and the complexity of the label. The precautionary statements may be considered harmonized in the future.
Other countries are already using them (
While the definition of precautionary statement itself did not seem to raise questions with rulemaking participants, there were a number of comments on the proposal to make the GHS precautionary statements mandatory. Many commenters agreed with OSHA that the statements should be on the label, and should be mandatory (Document ID #0328, 0329, 0335, 0336, 0347, 0352, 0365, 0370, 0372, 0377, 0379, 0389, 0402, 0408, 0410, 0412, and 0456). Commenters mentioned increased comprehensibility, as well as available translations, as some of the reasons why they support this approach. It was also noted by a number of commenters that OSHA should permit additional precautionary statements to cover situations without an available statement in Appendix C (Document ID #0313, 0324, 0327, 0329, 0335, 0352, 0365, 0370, 0376, and 0402). Others supported making them mandatory when they are harmonized in the GHS (Document ID #0351 and 0405). And at least one participant argued that precautionary statements should not appear on labels, just SDSs (Document ID #0338).
Other commenters did not support the mandatory approach, and thought that manufacturers should be able to continue to use their own precautionary statements (Document ID #0321, 0330, 0344, 0353, 0363, 0376, 0381, 0382, 0393, and 0399). It was also suggested that the UN needs to provide further guidance on when precautionary statements can be combined or omitted (Document ID #0328, 0370, and 0376), or that the number of phrases appearing on a label should be limited (Document ID #0329 and 0405).
In the final standard, OSHA has maintained the proposed provision to require the precautionary statements in the GHS to be used on labels. As noted previously, the use of prescribed precautionary statements is consistent with the other label elements, and provides the significant benefits of improved communication of information through increased comprehensibility and familiarity. In terms of flexibility, chemical manufacturers and importers are free to put additional precautionary statements on the label from other sources in the supplementary information area. As long as the information provided is accurate, and does not conflict with the required information, this is permitted.
OSHA will also permit the statements to be combined as appropriate, and states in Appendix C.2.4.6: “Precautionary statements may be combined or consolidated to save label space and improve readability. For example, “Keep away from heat, sparks and open flame,” “Store in a well-ventilated place,” and “Keep cool” can be combined to read “Keep away from heat, sparks and open flame and store in a cool, well-ventilated place.”
In addition, where there are concerns, supported by evidence, about the applicability of a statement to a particular product, the chemical manufacturer or importer may revise the statements as appropriate for the situation. Appendix C.2.4.8 states: “If the chemical manufacturer, importer, or responsible party can demonstrate that a precautionary statement is inappropriate to a specific substance or mixture, the precautionary statement may be omitted from the label.”
Thus, the final rule adopts the precautionary statements, which are taken from the GHS. However, it allows the use of additional statements where necessary, as long as they are accurate, do not conflict, and are placed in supplementary information. Additionally, chemical manufacturers and importers can use their judgment to combine related statements to shorten the amount of information on a label, as well as omit any statements that can be demonstrated to be inapplicable to the particular chemical involved. OSHA believes this approach maximizes the comprehensibility of the precautionary statements, as well as simplifies compliance for employers. Nevertheless, there are allowances for unique situations, and thus assurances that the information will be accurate.
It was suggested that the precautionary statements should be written in plain language (Document ID #0321). There were some specific changes to particular statements that were suggested (such as a statement regarding fighting fires near explosives, Document ID #0353). OSHA is not going to modify any of the statements as published in the GHS in terms of technical information. These have been reviewed by many experts. Changes should only be made to them through the UN Sub-committee process at this point, as they are close to being harmonized.
However, OSHA has made a few minor changes to precautionary statements in this final rule to address clarity and related issues. These changes were adopted by the Sub-committee of Experts on the GHS at its December 2010 meeting, and are expected to be included in Revision 4 of the GHS. Most changes simply amend the precautionary statement to clarify its meaning by making the statement more concise, or stating it in plain language. Others either provide added flexibility in applying the precautionary statement, or provide instructions for the classifier on the conditions relating to use of the precautionary statement. Examples of each type are presented below.
Examples of precautionary statements for physical hazards that were clarified in the final rule are presented below:
An example of a precautionary statement providing instructions for the classifier on the conditions relating to use of the precautionary statement is provided below for the health hazard class Skin corrosion/irritation, Category 1A to 1C (for the illustration, the instructions for use are provided in italics). In this example, note that the precautionary statement was clarified and the conditions relating to use of the precautionary statement were added.
The final example of the precautionary statement changes is provided below for instructions for the classifier on the conditions relating to use of the precautionary statement. In certain situations, text in a precautionary statement may not be appropriate. To address this issue, a new paragraph C.2.4.5 has been added to explain the use of text provided in square brackets ([ ]). Paragraph C.2.4.5 states: “Where square brackets ([ ]) appear around text in a precautionary
OSHA has included these non-substantive, minor changes approved by the UN Sub-committee, because they make the statements more readable, allow added flexibility, and are consistent with the latest version of the GHS.
Container labels will also be required to include a “product identifier.” The proposed definition for this term, which was retained in the final rule with a clarifying change (discussed below), was “the name or number used for a hazardous chemical on a label and in the SDS. It provides a unique means by which the user can identify the chemical. The product identifier used shall permit cross references to be made among the required list of hazardous chemicals, the label, and the SDS.” In other words, the product identifier is essentially the same as the “identity” under the current HCS. The GHS allows competent authorities for workplace requirements to choose not to require specific chemical identities of ingredients to be listed on the label, as long as they are on the SDS. This is the approach OSHA currently uses in the HCS, and it has been effective. OSHA will continue to require chemical identities only on SDSs, and has proposed a definition for “product identifier” that is consistent with the current definition for “identity” (which has been deleted from the final rule) to maintain this approach. ACC (Document ID #0393) and Procter & Gamble (Document ID #0381) suggested that OSHA should clarify what the “required list of hazardous chemicals” refers to in the definition. This terminology has been in the HCS since the original standard was published in 1983, and refers to the only list of chemicals required by the HCS, which is in the written hazard communication program. Therefore, OSHA has modified the language in the final rule to read: “among the list of hazardous chemicals required in the written hazard communication program, the label and the SDS.”
Another new concept in the NPRM for HCS labels is inclusion of a “signal word” to bring attention to the hazardous effects, as well as to contribute to the recognition of the severity of the hazard. Signal words have been used for many years in the United States on consumer and pesticide labels. The proposed definition is “a word used to indicate the relative level of severity of hazard and alert the reader to a potential hazard on the label. The signal words used in this section are `danger' and `warning.' `Danger' is used for the more severe hazards, while `warning' is used for the less severe.” OSHA received no objections to the proposed definition of “signal word” and it is being carried through to the final rule.
OSHA proposed to add a definition to the HCS for “unclassified” hazards. As has been noted, the current HCS is performance-oriented, and takes a very broad approach to defining hazards covered by the rule. The GHS is similarly broad in approach, but includes very specific definitions of criteria to apply when determining whether a chemical poses a physical or health hazard. This specification approach has significant benefits associated with it, including providing more guidance to help ensure a consistent approach to determining hazards. It also allows more information to be developed that provides an indication of the severity of effect.
OSHA proposed to add a definition to the HCS for “unclassified” hazards. As has been noted, the current HCS is performance-oriented, and takes a very broad approach to defining hazards covered by the rule. The GHS is similarly broad in approach, but includes very specific definitions of criteria to apply when determining whether a chemical poses a physical or health hazard. This specification approach has significant benefits associated with it, including providing more guidance to help ensure a consistent approach to determining hazards. It also allows more information to be developed that provides an indication of the severity of effect.
In the ANPR, OSHA asked for comment on whether the GHS criteria are sufficient to cover the hazards present in the workplace. While the Agency believed the scope of coverage is similar between the two approaches, OSHA wanted to be sure that the new approach is as comprehensive as the existing standard. In the NPRM (74 FR 50390, Sept. 30, 2009), OSHA noted two hazards of concern—combustible dust and simple asphyxiants. Both of these are mentioned in the GHS in the SDS annex as examples of hazards not classified that should be addressed on the SDS.
It is possible that there are other hazards that may not yet be specifically defined. Rulemaking participants have mentioned several (
OSHA proposed to require the chemicals posing unclassified hazards to be treated as hazardous chemicals under the rule. The Agency anticipated that this information would appear in Section 2 of the SDS (Hazard Identification)—the GHS already identifies this as the appropriate place in its guidance on the contents of SDSs (A4.3.2.3,
It is important to understand that the Agency anticipated that there would be relatively few situations where there would be scientific evidence or data indicating an effect that is not currently classified, and merely wanted to ensure that this information is captured and conveyed to employers and employees. OSHA also indicated that it would be appropriate to establish a feedback mechanism, where classifiers could inform OSHA of situations where the current criteria are insufficient, and the Agency can then suggest to the United Nations that appropriate criteria be developed and added to the GHS. This is consistent with the overall approach to hazard classification in the GHS that OSHA proposed to adopt—that specific criteria be provided to help ensure that classification is appropriate, and information transmittal is consistent from company to company. Therefore, the use of the definition of unclassified hazard was to be a temporary situation for these hazards, ensuring information is provided until such time as the criteria are added to the rule.
There were many comments received regarding the NPRM definition and concept of “unclassified hazards.” A number of participants agreed with OSHA that there is a need to cover some hazardous effects that have not yet been spelled out in the GHS with criteria (Document ID #0313, 0327, 0347, 0363, 0365, 0366, 0367, 0410, and 0412). Others suggested that it was an appropriate interim step, while working with the UN to get criteria added to the GHS (Document ID #0329, 0330, 0335, 0339, 0352, 0370, 0376, 0383, 0405, and 0414). Some argued that these hazardous effects should have specific criteria so employers would know with certainty what is covered (Document ID #0327, 0361, 0366, 0377, and 0392).
With regard to the actual definition, some thought it was too broad and ambiguous (Document ID #0344, 0379, 0381, and 0399). The U.S. Chamber of Commerce (Document ID #0397) argued that the definition should be withdrawn, or substantially revised, and that OSHA was exceeding its authority. There were other commenters who thought the effects should be called “hazards not otherwise classified” or “additional hazards” rather than “unclassified hazards.”
OSHA has considered all of these comments, and the need to provide sufficient protection for exposed employees, in devising an approach for the final rule. First, OSHA agrees with commenters that using the term “hazards not otherwise classified” is a better designation. Secondly, OSHA has revised the language to clarify the intent and address what was perceived as ambiguity. The definition in the final rule, which replaces and amends the proposed definition of “unclassified hazard,” now reads: “`Hazard not otherwise classified (HNOC) means an adverse physical or health effect identified through evaluation of scientific evidence during the classification process that does not meet the specified criteria for the physical or health hazard classes addressed in this section. This does not extend coverage to adverse physical and health effects for which there is a hazard class addressed in this section, but the effect either falls below the cut-off value/concentration limit of the hazard class or is under a GHS hazard category that has not been adopted by OSHA
Additionally, and importantly, OSHA has deleted proposed paragraph (f)(2), which specified information to include on labels for the HNOC chemicals. Given that there are no harmonized label elements available for these effects, it appears that this could be confusing to both the label preparers and the users of the chemicals. However, provision of an SDS for HNOC chemicals is required under the final rule, and information regarding their hazards is to be included in Section 2.
The U.S. Chamber of Commerce objected to the inclusion of “unclassified hazards” in the final rule because, in its view, the proposed definition is “broad,” “expansive,” and will “impose new requirements on employers without undertaking all of the steps in a full OSHA rulemaking” (Document ID #0397). OSHA appreciates the concerns and has carefully considered (and in some respects revised) the provision with those concerns in mind. OSHA does not intend to impose new requirements, or to bypass rulemaking, but includes the definition to continue the longstanding requirements that such hazards be disclosed. As finalized and clarified, the relevant provision does not expand on those requirements or add new burdens; on the contrary, it preserves requirements in the current rule. The following discussion is designed to clarify these points.
As noted above, the final rule retains the proposed requirement, using the term “hazard not otherwise classified” (HNOC) instead of unclassified hazard. In essence, this definition requires classifiers who find “scientific evidence” that a chemical can cause death, illness, or injury to workers in a way not currently covered by the GHS classification criteria to disclose that fact on the SDS. This is meant to be a modest and narrow requirement. It is triggered only when the classifier has objective, scientific evidence of the hazard. OSHA believes that there are likely to be few such hazards outside those covered by the specific criteria in the final rule, which are the product of over thirty years of international experience in hazard communication.
It is important to understand that the HNOC definition essentially preserves (and does not expand) the scope of the current rule, which is not as tightly bound to specific criteria as the GHS. The HNOC definition should be interpreted and understood with this preservative goal in mind. For example, under the current rule, “health hazard” means a chemical for which there is at least one statistically significant scientific study showing that “acute or chronic health effects may occur to exposed employees.” Indeed, while mandatory Appendix A of the current standard lists criteria for specific health effects, it also notes that these criteria are not intended to be an exclusive categorization scheme, but rather any available scientific data on the chemical must be evaluated to determine whether the chemical presents a health hazard. Likewise, though the current definition of physical hazard is tied to a specific list of effects, some of these can also be quite broad. For example, under the current rule, “flammable solid” includes a material “which can be ignited readily and when ignited burns so vigorously and persistently as to create serious hazard.”
The essential point is that the HNOC definition is designed so as to prevent the final rule from being less protective than the current standard by picking up any hazards that might fall within the definitions of the current rule, but might fall outside the GHS hazard classes. As discussed above, it is OSHA's intent that the HNOC classification would be an interim measure, used until harmonized criteria for a hazard can be adopted at the UN Sub-committee level, and subsequently incorporated into the HCS through rulemaking.
If the provision is understood in light of the foregoing points, this rulemaking is all the OSH Act and the Administrative Procedures Act (APA)
With regard to the three hazards specifically mentioned during the rulemaking (pyrophoric gases, simply asphyxiants, and combustible dust), OSHA is handling them as follows in the final rule.
OSHA inadvertently removed the definition of pyrophoric gases from the proposal when it removed the generic definition for pyrophorics. The American Chemistry Council (ACC) correctly pointed out that excluding the pyrophoric gases, even though there is no corresponding definition in GHS, would mean that they would not be labeled or classified appropriately (Document ID #0393). OSHA agrees and has included the definition of pyrophoric gas in the current HCS in this final rule. Pyrophoric gases must therefore be addressed both on container labels and SDSs, and in worker training programs. Therefore, OSHA has retained the definition for pyrophoric gases from the current HCS and has added pyrophoric gases to the definition of “hazardous chemical”. Label elements are provided in C.4.30. The signal word will be danger; the pictogram is the flame; and the hazard statement is “Catches fire spontaneously if exposed to air.”
For the two examples of effects not addressed in the GHS that were raised in the proposal (simple asphyxiants and combustible dust), OSHA is addressing them specifically in the final rule rather than covering them under the HNOC definition. Using comments in the record, and commonly applied voluntary industry consensus standards, the Agency has designated chemicals with these properties under the definition of “hazardous chemical.” The chemicals posing such effects must therefore be both labeled where appropriate, and addressed on SDSs and in training. In addition, OSHA has added C.4.30 to Appendix C to provide the label elements for OSHA defined hazards.
With regard to simple asphyxiants, OSHA had indicated in Issue #8 (74 FR 50282, Sept. 30, 2009) that it believed it might be more appropriate to simply add a definition of this effect to the final rule rather than covering it under the “unclassified hazard” approach. A definition was proposed as follows:
“Simple asphyxiants” are substances that displace oxygen in the ambient atmosphere, and can thus cause oxygen deprivation in exposed workers that leads to unconsciousness and death. They are of particular concern in confined spaces. Examples of asphyxiants include: nitrogen, helium, argon, propane, neon, carbon dioxide, and methane.
OSHA also solicited comments on proposed specific label elements. No symbol would be required, but the signal word “warning” would be used, with the hazard statement “may be harmful if inhaled.” In addition, a precautionary statement such as the following would be required: “May displace oxygen in breathing air and lead to suffocation and death, particularly in confined spaces.”
A number of commenters agreed with the definition and the approach (Document ID #0339, 0347, 0351, 0365, 0366, 0370, 0405, 0408, and 0456). Others had specific comments on what was proposed, such as arguing for simplification of the language (Document ID #0414); proposing to replace the definition with the NFPA 704 definition of “simple asphyxiant” (Document ID #0330); suggesting a reference to “suffocation” (Document ID #0329 and 0335), or indicating that the hazard statement is really a precautionary measure, or vice versa (Document ID #0376, 0382, 0393, and 0405). Procter & Gamble suggested it should not be covered since it is not an inherent toxicity (Document ID #0381).
OSHA disagrees with Procter & Gamble's argument. Chemicals with certain properties can displace oxygen and cause asphyxiation. Not every chemical has those properties, so the asphyxiation hazard is inherent and chemical-dependent. Moreover, OSHA has provided longstanding interpretations that indicate simple asphyxiants are covered under the current HCS (
OSHA believes that coverage of simple asphyxiants is very important to the HCS. Such substances result in fatalities in the workplace, particularly in confined spaces, and need to be warned about effectively. The definition has been revised based on the comments received, and included in paragraph (c): “ ‘Simple asphyxiant means a substance or mixture that displaces oxygen in the ambient atmosphere, and can thus cause oxygen deprivation in those who are exposed, leading to unconsciousness and death.” Label elements are provided for simple asphyxiants in Appendix C.4.30. Simple asphyxiants will require the signal word “warning” and the hazard statement “may displace oxygen and cause rapid suffocation.” In addition, OSHA has added “simple asphyxiant” to the definition of “hazardous chemical.” Thus all of the provisions of the rule that apply to hazardous chemicals will apply to simple asphyxiants as well.
OSHA will continue to work with the UN to add this hazard to the GHS. (The U.S. has raised this issue in the UN Sub-committee, but it has not yet been resolved. Some of the Sub-committee members share the view that it should not be covered since, according to them, it is not an inherent hazard.) We will evaluate the need for additional rulemaking to change the definition and label elements if the UN incorporates simple asphyxiants into the GHS.
For combustible dust, OSHA has also already provided considerable guidance on the nature and definition of combustible dust in a variety of materials, including OSHA's
The CSB therefore recommends that OSHA amend the HCS to explicitly address the fire and explosion hazards of combustible dusts, and those materials that could reasonably be expected to produce combustible dusts, among the substances covered by the standard, and also that the Agency require inclusion of dust fires and explosions among the physical hazards that must be addressed in Material Safety Data Sheets. The CSB also requests that OSHA advocate similar changes to the GHS through appropriate international mechanisms.
OSHA has introduced this issue to the UN Sub-committee as well, and is leading a correspondence group on it. However, one of the problems in pursuing this approach is that some countries' systems are limited to supply chain requirements, and do not cover hazard communication issues that arise in the workplace as a result of processing. OSHA's rule does cover such workplace hazards, and requires the provision of information to downstream customers when known processing approaches will result in a hazard. Therefore, discussions continue, but the Sub-committee will not resolve this for at least two years.
In light of the important nature of the issue, a number of public comments, and the need to provide clarity sooner than the UN Sub-committee will complete its work, OSHA is including combustible dust in the definition of “hazardous chemical” in this final rule. We have noted that many commenters agreed that there was a need to provide hazard communication on combustible dust, as has been required by OSHA under the current rule. But there were also suggestions that criteria and greater clarity were needed in order to avoid confusion. A few commenters argued that OSHA should not cover combustible dust since it is not an intrinsic hazard of a product (
It is true that a separate rulemaking is ongoing on this topic in OSHA, and some commenters suggested that the combustible dust issue should therefore not be addressed in this rulemaking. Such an approach would, however, eliminate safeguards that have long been in place (since 1983). Similar to the situation with simple asphyxiants, OSHA has provided longstanding interpretations that indicate combustible dusts are covered under the current HCS (
While OSHA is currently in the preliminary stages of developing a proposed rule to address combustible dust, the new standard is not expected to be completed for some time. It is also important to note that there is a clear distinction between coverage under the HCS, and potential provisions promulgated under a specific rulemaking for combustible dust. The rulemaking on combustible dust is a much broader approach to the issue, and will likely establish methods to control and address such dusts in the workplace. The HCS is an information transmittal standard. Provision of information to downstream employers is critical now, as it can alert them to the need to have a protective program. This is a fundamental purpose of the HCS—to provide employers and employees with information about hazards so they can take steps to protect their employees and themselves. A failure to continue to address the combustible dust issue in the HCS at this time would eliminate current protections. Therefore, the Agency is clarifying its position that it will continue to regard combustible dust as a serious hazard for which chemical manufacturers and importers must provide information to downstream employers.
The Agency is not adding a definition for combustible dust to the final rule given ongoing activities in the specific rulemaking, as well as in the UN Sub-committee. However, guidance is being provided through existing documents, including the Combustible Dust National Emphasis Program Directive CPL 03-00-008. This directive includes an operative definition, as well as provides information about current responsibilities in this area. In addition, there are a number of voluntary industry consensus standards (particularly those of the NFPA) that address combustible dust, and were noted by commenters as providing further guidance in this area. (
Label elements are also provided for combustible dust in C.4.30 requiring, when appropriate, the signal word “warning” and the hazard statement “May form combustible dust concentrations in air” (similar to ANSI Z400.1/Z129.1—2010 statements).
Concerns were raised by commenters that labels with a signal word and hazard statement may not be appropriate in some situations, because the combustible dust is created through processing downstream, and the product may not present a hazard in its shipped form. (
OSHA has already addressed a similar situation under paragraph (f)(4) of the final standard, which addresses solid metal, solid wood, plastic, and shipments of whole grain that present no hazard in shipping, but which are used in such a way in downstream operations that employees can be exposed to hazards. In this situation, the downstream employer needs label information about the hazards to protect employees, but OSHA determined that such label information does not need to accompany the product. Therefore, paragraph (f)(4) allows the chemical manufacturer or importer to transmit the label to the customer at the time of the initial shipment, but the label does not need to be included with subsequent shipments unless it changes. This provides the needed information to the downstream users on the potential hazards in the workplace, while acknowledging that the solid metal or other materials do not present the same hazards that are produced when these materials are processed under normal conditions of use.
Many products that are a combustible dust hazard when processed are similar in nature, and therefore paragraph (f)(4) would apply. A shipment of grain, for example, does not present a combustible dust hazard in the shipped form. But when processed downstream in a plant, such hazards are a concern, and the employer needs the label information to properly address the hazard in the workplace. Since this is a normal condition of use for the grain, the chemical manufacturer or importer must provide the information at the time of the initial shipment, and in the future if there is new information regarding the hazards or protective measures. An SDS must always be provided.
In other situations where the material is shipped in a dust form that is potentially combustible without further processing, the chemical manufacturer or importer must have appropriate labels on the containers when shipped under the requirements of paragraph (f)(1). If the chemical manufacturer
Combustible dust has been added to the definition for hazardous chemical, and thus all of the provisions of the standard as amended by the final rule that apply to hazardous chemicals will also apply to combustible dusts, including safety data sheets and worker training. Employers with workplaces where combustible dusts are generated must comply with the workplace labeling requirements in paragraph (f)(6).
As with simple asphyxiants, OSHA will continue to encourage the UN Sub-committee to deal with combustible dusts and develop criteria to be adopted by countries such as ours where workplace exposures are a key part of the hazard communication system.
In order to ensure the broadest dissemination of information, and to reduce the number of situations where conflicting determinations may be made for the same chemical by different suppliers, the current HCS considers one study, conducted according to established scientific principles and producing a statistically significant result consistent with the definitions of hazard in the standard, to be sufficient for a finding of health hazard under the rule.
Most of the definitions under the current HCS simply lead to a conclusion that the chemical involved poses that hazard or it does not. For example, a chemical might be found to be a carcinogen under the rule based on one study indicating that it poses a carcinogenic effect. The current standard does not generally address the degree of severity of the hazardous effect in most of the definitions—so a chemical is either a carcinogen, or it is not. However, while a one-study determination leads to providing information about that hazardous effect on a safety data sheet, it may not lead to a hazard warning on a label. The current HCS requires such warnings to be “appropriate,” and there are situations where the data do not support warning about the hazard on the label because of other negative studies or information.
This hazard evaluation process is consistent with product stewardship processes that have evolved in the chemical industry. (
The current HCS requires chemical manufacturers to remain vigilant regarding new information about their chemicals, and to add significant new information about hazards or protective measures to their hazard communication documents within three months of learning about them.
At the time the HCS was promulgated, the standard's provisions and approach were quite novel, and there were concerns that chemical manufacturers and importers would need more guidance regarding what chemicals to consider hazardous. Thus OSHA included provisions in the hazard determination paragraph that established certain chemicals as being hazardous. Chemical manufacturers and importers still had to complete a hazard evaluation and determination of what hazards were posed, but for these designated chemicals, there was no decision to be made as to whether they were hazardous or not. These chemicals were considered to be a “floor” of chemicals covered by the rule, and included those for which OSHA has permissible exposure limits in 29 CFR Part 1910, as well as those for which the American Conference of Governmental Industrial Hygienists (ACGIH) has recommended Threshold Limit Values (TLVs). In addition, given that carcinogenicity was the most controversial and difficult health effect to address, OSHA indicated that, at a minimum, chemicals found to be carcinogenic in the National Toxicology Program's biennial Report on Carcinogens (RoC), or in monographs published by the International Agency for Research on Cancer, were to be considered to be carcinogens in addition to those regulated by OSHA as carcinogens.
The current HCS also includes provisions regarding hazard determinations for mixtures. 29 CFR 1910.1200(d)(5). Where such mixtures have been tested to determine their hazardous effects, the data on the mixture as a whole are used. Where testing has not been done, OSHA promulgated an approach based on the percentage of a hazardous chemical in a mixture to determine if the mixture is hazardous. Therefore, if a mixture contains one percent (by weight or volume) or more of a chemical determined to present a health hazard, the mixture is assumed to have the same effect. The one exception is
In all cases, a mixture will still be considered to be hazardous if there is evidence that it poses a health risk when the hazardous chemical is present in concentrations below the cut-offs. This was included to ensure that chemicals that can have effects at very low concentrations, such as sensitizers, will be adequately addressed.
For physical hazards, the evaluator must determine based on whatever objective evidence is available whether the hazardous effect is still possible in smaller concentrations. This recognizes that, for physical effects, such a determination may be made based on factors such as dilution, and there are readily available means to make an appropriate assessment.
The approach in the current HCS is considered to be a self-classification system. In other words, the chemical manufacturer or importer reviews the available information, and makes the determination as to whether the product presents a potential hazardous effect. This is different than some other systems where the regulatory authority makes the determination, and publishes a list of hazardous chemicals that must be used by the chemical manufacturer or importer.
The hazard determination is to be completed based on available information. The current HCS does not require testing of chemicals to produce information where it is not available.
The hazard determination approach in the current HCS recognizes that information about chemicals changes, new chemicals are introduced, others cease to be used—in other words, the world of chemicals in the workplace changes constantly, and the standard is designed to ensure that employees receive the most up-to-date information available regarding the chemicals to which they are currently being exposed.
Employers who simply use chemicals, rather than producing or importing them, are permitted to rely on the information received from their suppliers. 29 CFR 1910.1200(d)(1). This downstream flow of information recognizes that the chemical manufacturers and importers have access to information about the chemicals they sell that is not available to those who only use them. It also reduces duplication of effort by focusing the hazard determination process at the source, rather than having everyone who uses a chemical trying to complete such a process.
The current HCS requires chemical manufacturers and importers to maintain a copy of the procedures they follow to make hazard determinations. 29 CFR 1910.1200(d)(6). If OSHA finds errors in a label or SDS, the chemical manufacturer or importer that prepared the document will be held responsible—not the employer using the chemical.
The hazard determination procedures in the current HCS, including the definitions and Appendixes A and B, have been in place since the standard was promulgated in 1983.
To accommodate these refinements, and improve protection for employees exposed to chemicals in the U.S., the final rule modifies the current HCS as follows. First, paragraph (d) is re-named “hazard classification” rather than the current “hazard determination.” This re-naming is consistent with the approach and terminology used in the GHS.
Similarly, final paragraph (d)(1), like the proposal, modifies the current HCS to indicate that chemical manufacturers and importers are required to classify the chemicals' health and physical hazards in accordance with this section. For each chemical, the chemical manufacturer or importer must determine the hazard classes, and the category of each class, that apply to the chemical being classified.
Final paragraph (d)(1) allows employers to rely on information received from suppliers (
Final paragraph (d)(2), which is identical to the proposal, similarly modifies the current HCS's terminology regarding classification. However, the final paragraph also includes modifications to address the evaluation process and the role of testing. The paragraph specifically states that evaluation of the hazards of chemicals requires the evaluator to “identify and consider the full range of available scientific literature and other evidence concerning the potential hazards.” This is consistent with the current HCS, but re-emphasizes the responsibility to fully characterize the hazard of the chemicals. To clarify that available evidence is to be used, final paragraph (d)(2) specifically states that there is no requirement to test a chemical to classify its hazards under the modified provisions—just as there is no such requirement under the current HCS. Dow Chemical Company (Document ID #0353) suggested that OSHA revert to the current text of paragraph (d)(2), which simply referred to Appendix B for the parameters of the hazard determination. This would not be appropriate since Appendix B no longer exists in its current form. But OSHA does not believe that what is written in paragraph (d)(2) is inconsistent with what is currently required in Appendix B. It is not intended to mean (and does not say) that an evaluator must identify every “shred” of information as Dow has indicated in its comment, but rather that the evaluator cannot, for example, only review acute toxicity data and consider that a complete evaluation. The extent of the literature search must be what the reasonably prudent classifier would do to assure themselves that evidence for the range of hazards covered by the rule has been identified, and a thorough evaluation has been done of the potential effects. That is
On the other hand, the Styrene Information and Research Center (SIRC) (Document ID #0361) commented on the same paragraph as follows:
SIRC supports hazard classification for carcinogenicity and other endpoints based on a comprehensive assessment of the “full range of available scientific literature and other evidence concerning the potential hazards,” within a best available science framework. This approach should provide optimum precision assessing potential hazards and a sound basis for maintaining a safe and healthy workplace.
Final paragraph (d)(2) refers to Appendixes A and B for further information on classification as in the current standard. However, the Appendixes have been completely changed from the current text. New Appendix A includes the criteria for classification of health hazards, and new Appendix B includes the criteria for classification of physical hazards. These mandatory appendixes have to be used for the hazard classification process under the revised standard. The Appendixes have been adopted in the final rule, with some changes as described below.
Reference to these appendixes is also included in final paragraph (d)(3), which addresses mixtures. Final paragraph (d)(3)(i), like the proposal, states that chemical manufacturers and importers must follow the procedures in Appendixes A and B to classify hazards for mixtures as well as for individual chemicals. Proposed paragraph (d)(3)(ii) stated that the chemical manufacturer or importer “shall be responsible for the accuracy of the classification even when relying on the classifications for individual ingredients received from the ingredient manufacturers or importers on the safety data sheets.” SIRC expressed reservations about this proposed paragraph (Document ID #0494 Tr. 128-29;
In reconsidering the language proposed, OSHA wanted to ensure that chemical manufacturers and importers know that, in most cases, they can continue to rely on their suppliers' SDS information for ingredients they will be using in formulations. However, where they know information is incomplete or wrong, they have some responsibility for ensuring they have the correct information before using it for their own evaluations.
During implementation of the current HCS, OSHA allowed formulators of chemicals to develop an SDS by simply providing the SDSs for all the ingredients rather than compiling a specific SDS for the product. OSHA does not believe that this practice of providing the SDSs for all the ingredients is widely pursued, but it will not be permitted under the final rule. The revisions to the approach to classifying mixtures do not lend themselves to such a practice. Hazard classification requires consideration and application of bridging principles based on the constituents, as well as the application of a formula when there are multiple ingredients with acute toxicity. These approaches require the evaluator to determine a classification for the mixture as a whole. In addition, this practice places more of a burden on the user of the product to sort out the relevant information for protection of their employees. The formulator is in a better position to assess the information and provide what is needed to their customers.
Under the current HCS, paragraph (d)(6) requires chemical manufacturers, importers, or employers performing hazard determinations to keep a copy of the procedures they follow in the hazard determination process. This provision has been deleted in the final rule because the hazard classification procedures have been specified, and thus all evaluators are following the same process.
Final paragraph (d) is thus much shorter and less detailed than paragraph (d) in the existing standard. This is largely due to the approach in the GHS to include the details regarding classification in hazard-specific discussions that address both the individual substance and that substance in mixtures. Given the volume of these criteria, it appeared to OSHA that presenting the relevant information in mandatory appendixes was a more efficient way to describe the criteria than including it all in the primary text of the standard. This is particularly true for those many employers reading the standard who do not have to perform hazard classification—the revisions only apply to chemical manufacturers and importers, unless an employer chooses not to rely on information received from them.
With the detailed criteria, and the weight of evidence approach in the GHS, OSHA indicated in the NPRM that it appeared to no longer be necessary to have such a floor or the one study rule. Many commenters agreed with OSHA (
Elimination of the “floor” definition of hazardous (as consistent with the GHS) would require producers and users to more closely examine the properties of the materials they produce or handle. While this would increase the effort necessary to determine that some substances are hazardous, it would also force a more careful examination of the underlying reasons that the substance is hazardous.
There were few comments that questioned taking the floor out of the requirements given the detailed nature of the criteria to evaluate hazards. It was noted that the lack of a floor may result in some inconsistencies in evaluations (Document ID #0352). There were also some concerns about removing IARC and NTP as sources to evaluate chemicals (Document ID #0321). Conversely, others supported elimination of these resources because inclusion violated the Data Quality Act (Document ID #0417)—a conclusion that OSHA does not believe is accurate. Evaluation of carcinogens will be
As OSHA indicated in the proposed rule (74 FR 50282, Sept. 30, 2009), the Agency planned to adopt all of the health and physical hazard classes in the GHS, but not all of the hazard categories. In keeping with its intent to maintain the scope of coverage of the existing rule to the extent possible, as well as to be as consistent as possible with the scope of the European implementation of the GHS, OSHA did not propose to adopt Acute Toxicity, Category 5; Skin Corrosion/Irritation, Category 3; and Aspiration Hazard, Category 2.
Many commenters agreed that the categories selected in the proposal were appropriate (
While the decision logics for the health and physical hazard criteria were omitted from the regulatory text, OSHA indicated that it would consider publishing them as guidance. Commenters agreed with this concept (
There were also comments that OSHA should publish guidance on its interpretation of criteria application, and indicate whether it agrees or disagrees with interpretations published by other countries (Document ID #0382). OSHA is considering many different types of guidance documents, but has not made final decisions in this regard.
The text of Appendixes A and B is the bulk of what was proposed to be adopted essentially verbatim from the GHS. While some of the provisions of the GHS have been adopted into the final rule with OSHA-developed language that is specific to the regulatory system of the U.S., OSHA has strived in these appendixes to retain the text of the GHS intact. In order to understand the context of this language, and OSHA's approach to its inclusion, a brief history of its development is necessary.
Most people think of the labels and SDSs as the products of the GHS that are harmonized since they are the system's “output” that are seen most frequently. But harmonization of these documents cannot occur unless the underlying criteria are harmonized, and countries adopting them implement them similarly. The health hazard criteria were developed in the Organization for Economic Cooperation and Development (OECD)—an organization of 34 countries that “provides a forum in which governments can work together to share experiences and seek solutions to common problems.”
It was this expertise and recognition that led to the OECD being the “focal point” for development of the health hazard criteria. The OECD also uses a process of consensus to develop their documents, requiring agreement from all countries to move forward rather than a simple majority vote. Working on a consensus basis is much more difficult to accomplish, but is advantageous in other ways since it helps to ensure that the concerns of all parties are taken into consideration, and thus are more likely to remain consistent with the results.
A disadvantage is that the text must satisfy all parties, and thus it is not always written in the clearest fashion. The text was also reviewed further when it was submitted to the UN Sub-committee, and additional editing was done to address concerns. Therefore, it is fair to say that it was written by expert committees, and reflects the involvement of many different people and ideas.
The criteria in Appendix B, unlike those in Appendix A, were not developed “from scratch,” but were based on the harmonized criteria developed to classify the physical hazards of chemicals involved in transport by the UN Sub-committee of Experts on the Transport of Dangerous Goods (TDG). The TDG Sub-committee includes many subject experts in areas such as explosives and flammability. The TDG Sub-committee and the International Labor Organization (ILO) were jointly tasked to review the TDG criteria for application to other sectors such as the workplace. This review not only took advantage of the UN and ILO expertise, but also created a system that is harmonized with transport in terms of criteria.
When OSHA developed the proposed rule, it considered editing the text of the criteria for purposes of improving the language. However, the trade-off is inconsistency with the GHS, and the potential for people to believe that OSHA means something different because the text has been revised. Thus, as noted in the NPRM (74 FR 50392, Sept. 30, 2009), OSHA chose to take the approach of adopting the language as stated in the GHS. Editing of the criteria focused on what needed to be changed for purposes of putting it into mandatory regulatory language, including deleting what was clearly identified as guidance.
Therefore, while we have reviewed every suggestion that was made to the text of the Appendixes, our general approach was not to make changes unless they were truly necessary. Editorial changes for purposes of clarification are more appropriately made through the UN Sub-committee process, and OSHA participates actively in that activity, and chairs the primary correspondence group. Those changes that were suggested that OSHA believes have merit in terms of clarifying
In general, there were very few substantive technical comments provided on the approaches in the criteria, and OSHA assumes that reflects the fact that the criteria were developed by technical experts from countries and stakeholder organizations. There were some suggestions received that certain parts of Appendix A be withdrawn so OSHA can consult with toxicologists (Document ID #0353). Numerous toxicologists and other health professionals from the U.S., as well as many other countries, have been involved in the development and review of the text in Appendix A, and it has been subject to extensive scientific and policy discourse. Furthermore, this rulemaking was also the opportunity for others who have not been involved to provide input. If OSHA had received significant comments on the technical aspects of the criteria that indicated a systemic concern about the criteria, it may have been cause for reconsideration. But most of the comments that were received were more reflective of differences on policy positions than truly technical issues. Therefore, there are relatively few changes to Appendixes A and B as a result of record input. These changes are discussed below.
As described in the NPRM and this document, in Appendixes A and B OSHA has maintained its general approach (supported by stakeholders) of: (a) Limiting changes to the HCS to those that are required to align with the GHS; and (b) remaining as consistent with the GHS as possible within the need to use appropriate regulatory language and maintain or enhance current protections. OSHA has also remained mindful of the approaches of its trading partners, although it notes that some proponents of that principle were quite inconsistent themselves when using this particular argument. Therefore, while this argument was used to support choosing higher cut-offs for mixtures, for example, some of these same commenters also suggested not covering hazard classes or categories that are both covered by the EU and currently addressed by OSHA (
Any test that determines hazardous properties, which is conducted according to recognized scientific principles, can be used for purposes of a hazard determination for health hazards. Test conditions need to be standardized so that the results are reproducible with a given substance, and the standardized test yields `valid' data for defining the hazard class of concern.
As mentioned below in the discussion on mixtures, OSHA has also revised Appendix A to use “cut-offs/concentration limits” everywhere one of these terms was formerly used in order to be consistent, and make clear the terms are interchangeable.
The remainder of Appendix A is taken from Chapter 3 of the GHS on Health Hazards. OSHA has included the specific discussions of all of the health hazards covered by the HCS in proposed Appendix A, extracted from Chapter 3 of the GHS. OSHA removed the decision logics that are in the GHS from the criteria, and is considering including them in a guidance document to be made available at the time the final rule is published. As discussed above, stakeholders generally supported this approach. The hazard communication portions of the criteria chapters have also been removed since all of this information is already available in Appendix C and would thus be duplicative. In addition, edits have been made where OSHA is not adopting all of the categories of a particular hazard class.
The chapters on Skin Corrosion/Irritation (Chapter A.2) and Serious Eye Damage/Irritation (Chapter A.3) have been modified more extensively than the other chapters on health hazards in the GHS. In these chapters, the GHS leads the evaluator to conduct additional testing on the chemical when information is not available. While the GHS does not require such testing, the criteria for these effects imply that it should be conducted to complete an evaluation. The HCS is based solely on available information, and no testing is ever required. Therefore, OSHA has modified these chapters to eliminate any references to additional testing and limit the evaluation to what is known based on available information. It should be noted that the UNSCEGHS has initiated work to edit these chapters and make them easier to follow. OSHA will continue to participate in this activity.
The coverage of mixtures in terms of health hazards is addressed in two places in the revised rule. First, general principles that apply to multiple effects are addressed in the introductory part of Appendix A in Chapter A.0, “General Classification Considerations.” Second, each hazard class discussion includes the criteria for classifying a substance or a mixture. Unlike the current HCS, which defines across-the-board percentage cut-offs for all health hazard classes, the GHS employs a tiered approach to classification. Like the HCS, classification would be based on test data for a mixture as a whole for most hazard classes where it is available. However, where it is not available, but there are data on ingredients and similar mixtures, the GHS allows extrapolation or bridging of data to classify a mixture. This allows greater use of available data before resorting to a percentage cut-off or similar approach. Where such data are not available, the criteria address how to classify mixtures based on cut-offs specific to that hazard. In the case of acute toxicity, this includes calculations based on the acute toxicity of each ingredient in the mixture.
The tiered scheme is somewhat different for certain hazard classes. As described, usually the evaluation is based first on test data available on the complete mixture, followed by the applicable bridging principles and, lastly, cut-offs/concentration limits or additivity. The criteria for Germ Cell Mutagenicity, Carcinogenicity, and Reproductive Toxicity take a different approach by considering the cut-off levels as the primary tier and allowing the classification to be modified on a case-by-case basis based on available test data for the mixture as a whole. This approach is related to the sensitivity of available test methods to detect these types of effects at small
The approach to mixture classification may result in some mixtures that are currently considered to pose a particular hazard not being so classified under the GHS. OSHA believes that the protections of the GHS approach are appropriate, and that these changes will not result in an inappropriate reduction in protection. For example, if there is a mixture that is comprised of 1% of an acutely toxic material, regardless of the severity of that effect, and 99% water, the current HCS would require that mixture to be considered acutely toxic. Under the GHS, it is unlikely to be considered as such. Based on the dilution effect of the water, the acute toxicity is no longer a concern. Thus the bridging principles under the GHS allow for a more accurate assessment of the potential harm of the mixture, whereas the strict cut-off approach under the current HCS may provide hazard information in cases where the exposure is minimal and the occurrence of an adverse effect is unlikely. In the example described, the presence of the water in the mixture as used by the workers reduces the potential for exposure to the hazardous ingredient to such a small amount that no effect is expected to result. The GHS approach is not as simple to apply as the current HCS, but the resulting approximation of the hazards of the mixture will be more accurate.
The GHS uses both the term “cut-off” (which is what is used in the current HCS), and “concentration limit” (which is used in the EU requirements). The terms are used interchangeably and often appear together (
Several commenters indicated that language in A.0.5.1.1(a), in the bridging principle that addresses dilution, was inappropriately changed from “may” to “shall” in the NPRM (
In another part of the bridging principles, the term “commercial product” is used in the GHS, and was thus used by OSHA in the NPRM (A.0.5.1.2). Commenters asked that this term be defined (Document ID #0344 and 0381). OSHA reviewed the text, and has changed the term to “mixture” instead of “commercial product”. This is accurate, and the term is already defined.
There are several hazard classes in the GHS that give competent authorities such as OSHA a choice of cut-offs/concentration limits to apply when classifying a mixture containing ingredients that pose these effects (
In North America, Canada and the U.S. do not have such consequences linked to label statements, and their requirements are based on giving workers the right-to-know about the hazards and identities of the chemicals in their workplaces. Additionally, Canada has the lower cut-offs in most cases in their current requirements, and OSHA already has the 0.1% cut-off for carcinogenicity. Adoption of the lower cut-offs for both labels and SDSs was supported by both Canada and the U.S. from the outset.
As has been described, OSHA has used consistent cut-offs for purposes of hazard determination for mixtures since the HCS was promulgated in 1983. OSHA described the proposal as follows in the 1983 final rule preamble (48 FR 53290, Nov. 25, 1983):
The rationale of the proposal was that when the hazard of a mixture is unknown, all hazardous ingredients should be indicated on the material safety data sheet. The user would then have the most complete information available to predict the potential hazards of the mixture. The one percent exclusion was included to absolve the employer from having to evaluate and list chemicals in small quantities, which are not likely to result in substantial exposures.
In the 1982 proposal, the one percent cut-off would have applied to all health and physical hazards. As a result of the comments submitted to the record, OSHA took a different approach to physical hazards in the final rule (no percentage cut-off applies to physical hazards), and also lowered the cut-off for carcinogenicity to 0.1 percent. In addition, a provision that required inclusion of chemicals below these cut-offs in certain situations was also part of the 1983 final rule.
In proposing the one percent cut-off, OSHA noted that “there was no scientifically correct delineation, but that the one percent cut-off is apparently considered reasonable by a number of parties” (47 FR 12102, Mar. 19, 1982). OSHA's intent was “to absolve the employer from having to evaluate and list chemicals present in mixtures in small quantities, which are not likely to result in substantial exposures” (48 FR 53290, Nov. 25, 1983). These cut-offs were practical accommodations, had been used in other regulatory settings (
That being said, however, the scientific knowledge about these health effects has increased significantly since the HCS was first adopted, as has the concern about their occurrence in the work force. At that time, carcinogenicity was the primary concern in terms of chronic and/or significant health effects, and this concern was reflected in the lower cut-off value adopted by OSHA for that effect. Most of OSHA's substance-specific rulemakings were done for the purpose of addressing carcinogenicity. Now, however, there is more evidence that raises significant concerns about other types of effects.
Sensitization is a key example. Respiratory sensitization leads to asthma, and substantial evidence has
Further, the most recent science shows that respiratory and skin sensitization can be caused at very low concentrations. A 2006 paper by Arts
If the components of a mixture could be released in concentrations which would exceed an OSHA PEL, an ACGIH TLV, or could present a health risk to employees, information on these components must be included on the MSDS regardless if their final concentration in the mixture is less than 1% (or 0.1% for carcinogens). For instance, TDI is a sensitizer at very small concentrations and despite its low concentration in a mixture, can be offgassed in quantities which may present a health risk that must be noted on the MSDS.
But sensitization is not the only effect of concern. Reproductive toxicity is a serious hazard that includes both fertility and effects on the offspring. Recent research concerning endocrine disruptors suggests that these chemicals can have adverse reproductive effects at very low levels (Document ID #0583, 0584, and 626). Likewise, occupational disease mortality and morbidity statistics indicate a number of cases related to target organ effects as well (Document ID #0291,
OSHA proposed to use the most protective of the GHS concentration limits for these hazard classes. For sensitizers and reproductive toxins, the final rule requires information to be provided on labels and safety data sheets at concentrations above 0.1%. Other countries may choose to only provide the information on SDSs when the concentration is higher. However, as indicated, these particular health effects are among the most significant to employees, and OSHA believes the provision of information on labels will help both employers and employees ensure that appropriate protective measures are followed. (On the other hand, it should be noted that OSHA was persuaded that the current 1% cut-off may be too conservative for many acute toxins and Category 3 Single Target Organ Toxicants, and the final rule is likely to result in fewer mixtures being covered for these effects than under the current approach.)
In addition to concerns regarding protection for these health effects, there is also a concern about the communication difficulties of having different hazard information on a label versus a safety data sheet. As indicated, the GHS negotiators agreed that all countries would use the lower levels in the criteria for providing information on SDSs. Using a different cut-off for labels would create a situation where there may be hazards on the SDS that do not appear on a label. This inconsistency makes training more difficult, and creates confusion for downstream employers as well when they are deciding about appropriate protective measures. Under the current rule, the mixture cut-offs apply to both the label and the SDS. Several commenters indicated that OSHA should provide guidance indicating specific threshold cut-offs (Document ID #0344, 0381, and 0399). The table below indicates what the cut-offs are for different health hazards. These commenters also suggested OSHA provide guidance on opting out of the cut-offs if data override the threshold. This is already addressed in A.0.4.3.2 (if the classifier has information that the hazard of an ingredient will be evident (
During the hearing, worker representatives were asked to comment on whether consistency between the information on the label and the SDS was important for worker protection. They all indicated that it was important. For example, Mr. Platner, who represented the Building and Construction Trades Department of the
Oh, absolutely. An example of a sensitizer that's very common is isocyanate components or polyurethane spray foams or coatings. They're potent sensitizers, and that information very rarely gets to the label. It's usually appropriately in the MSDS, but it rarely makes it to the label.
Similarly, Mr. Kojola of the AFL-CIO, commented (Document ID #0494 Tr. 33):
Oh, absolutely. What it does is it provides a consistent message that workers are getting both in labels and on safety data sheets. And I think it enhanced the ability to, for example, translate that information into other languages, so I think that alone is a major step forward in enhancing worker protection.
Some commenters argued that OSHA should adopt the higher cut-off levels where given a choice by the GHS (Document ID #0344, 0361, 0367, 0371, 0376, 0381, 0392, and 0393). They questioned whether there was a scientific justification for the lower levels, and suggested that the U.S. should harmonize with the EU approach.
As OSHA described above, there are two primary reasons for the lower levels. First, OSHA believes it is important for effective communication to have the same hazards on the label and SDS to as great a degree as possible. Labels are in an employee's work area, and thus provide the most immediate source of information. While SDSs must be available, they are longer and more complicated, and workers are less likely to review them on a regular basis. For downstream employers, it is also important to maintain consistency and reduce confusion where possible by having the information on hazards the same on the label and SDS.
Secondly, as discussed above, increased knowledge of these health effects in the scientific literature, as well as studies indicating that they are often not reported when they should be, or the information is lacking, has led OSHA to the conclusion that communication at the lower levels is appropriate and necessary for worker protection. It is particularly critical in the area of sensitizers since the incidence of occupational asthma is increasing, and sensitization can occur at lower levels as it progresses. But with the advent of information on effects like those of endocrine disruptors, and the increased awareness of the possible effects of low levels of exposure, it is necessary for all of these effects.
As for the argument regarding consistency with the EU, OSHA has sought to be consistent where possible. However, the EU has a different regulatory structure for dealing with these effects downstream, and what is appropriate for their classification and labeling system is not necessarily appropriate for ours in the U.S. (
There are relatively few chemicals for which there are data indicating the types of effects of concern with regard to these lower cut-offs (
The American Chemistry Council asked during the hearing why OSHA adopted the cut-off levels 25 years ago if the Agency thought they weren't protective, or whether there is information to indicate that they have not been protective (Document ID # 0494 Tr. 174). In response to questions from OSHA as to what the scientific basis would be for communicating a hazard on an SDS and not a label, they responded (Document ID # 0494 Tr. 177): “A scientific basis? Well, most of these are obligatory regulatory cut-offs for mixtures. There really is not much scientific basis for any of the mixture cut-offs.” In other words, ACC concedes that there is also no scientific basis for the higher cut-offs it advocates—rather the EU cut-offs are simply policy choices made by a different authority with a distinct regulatory structure. As described previously, OSHA believes there is evidence that these cut-offs are no longer sufficiently protective in light of additional information developed since the HCS was adopted in 1983. Furthermore, having inconsistencies in information on a label versus a safety data sheet impacts the effectiveness of the communication to workers and downstream employers. The cut-offs/concentration levels in the final rule are the same as proposed, and are the lower levels of those the GHS allows countries to choose from when implementing.
The Styrene Information and Research Center (SIRC) argues that OSHA may not lower the mixture cut-off thresholds for sensitizers and reproductive toxicants without establishing that a significant risk exists at that lower threshold (Document ID #0361, 0467, and 0642). OSHA disagrees.
As discussed in Section V, Pertinent Legal Authority, OSHA has found that inadequate hazard communication creates a significant risk and that the final rule will reduce that risk. Contrary to what the SIRC says, OSHA need not support each requirement in a standard with its own significant risk finding.
Indeed, a contrary rule would impose an unworkable burden on OSHA. As the Third Circuit held
The holdings in
Rather, once OSHA makes a general significant risk finding in support of a standard, the next question is whether a particular standard's requirements are reasonably related to the purpose of the standard as a whole.
In addition, SIRC seems to challenge only the reduction of the threshold for disclosure on labels, not the identical reduction of the threshold for disclosing the hazard on SDS for these hazards. Under the final rule, the same information for sensitizers and reproductive toxicants must appear on both the label and the SDS, avoiding the potential for confusion. The reproductive toxicant and sensitizer cut-offs are reasonably related to the purposes of the Hazard Communication Standard.
The courts have upheld similar requirements even in the absence of a significant risk finding, provided the requirements were reasonable. In
As explained in the Pertinent Legal Authorities section, the mixture cut-off levels are part of the HCS's general approach of providing prophylaxis against the exposure to significant risks, similar to the medical monitoring requirement in
A related issue is the cut-off in Category 3 of Specific Target Organ Toxicity, both in Single Exposure and Repeat Exposure. Under the GHS, a cut-off/concentration limit of 20% is suggested as guidance. It is an additive cut-off, meaning that the percentages of the ingredients that meet the definition for Category 3 would be added together and compared to the cut-off. Consistent with other revisions to the GHS language that are appropriate for a mandatory standard versus a non-mandatory recommendation, OSHA proposed to make the 20% cut-off mandatory, but requested comment on it. (74 FR 50282, Sept. 30, 2009; see also A.8.3.4.5 and A.9.3.4.4.) A limit that is not mandatory will be difficult for chemical manufacturers to know how to comply with, and it will also be difficult for OSHA to enforce. Furthermore, OSHA views this provision as relaxing the current requirement, which is a cut-off of one percent for each of the ingredients in the mixture that are in and of themselves hazardous. However, consistent with A.0.4.3.2, if the classifier has information that the hazard will be evident below the specified concentration limit, the mixture is to be classified accordingly. Therefore, where the 20% is too high, the classifier will nevertheless be required to classify it appropriately below that level.
There were a number of commenters who supported making the 20% level mandatory, suggesting that it was reasonable for the U.S., promoted consistency, and that the level could be lower if data warrant (
Adopting Category 5 would not only expand coverage significantly, it would lead to inconsistency with Europe and with the current national consensus standard. OSHA also believes that exposures of this magnitude are not likely to be encountered in the occupational setting, and that such coverage would be excessive.
Since OSHA raised this issue for comment in the ANPR, a number of respondents specifically addressed acute toxicity. The responses varied, although a number supported the approach proposed to cover through Category 4 (Document ID #0021, 0046, 0047, 0077, 0104, 0123, 0135, 0145, 0155, 0163, and 0171). For example, Dow (Document ID #0047) stated:
Dow believes that OSHA should adopt all health hazard criteria and categories, except Acute Toxicity Category 5. While this category may be useful for characterizing consumer products, its use with the substances characterized under the HCS would be confusing and unnecessary. Dow understands that the EU and Australia have both chosen not to include Acute Toxicity Category 5 in their implementation of the GHS and that Canada is currently considering doing the same. Dow believes that the U.S. should be consistent with these other major trading partners by not including this category when it adopts the GHS.
Others suggested that OSHA propose to adopt Categories 1 through 3 (Document ID #0034, 0128, and 0141). Some argued that all categories should be adopted to ensure harmonization (
OSHA believes that coverage provided by Categories 1 through 4 is appropriately protective for the workplace, and leads to the greatest harmonization with workplace authorities in other countries. With regard to coverage provided by Category 5, OSHA does not preclude inclusion of information on Category 5 on the label or the SDS. Thus chemical manufacturers or importers who wish to have one label that suffices for the workplace and the consumer sector, for example, could do that and still be in compliance with the HCS. As noted earlier, commenters on the NPRM supported the categories chosen by OSHA, except for a few who thought OSHA should adopt all categories in the GHS to promote complete harmonization. However, OSHA believes that this concern is addressed by permitting such categories to be addressed on labels and SDSs with no penalty.
OSHA did not propose to adopt Category 5. The final standard does not adopt Category 5, nor include it in Table A.1.1, which describes the criteria for acute toxicity. However, calculations for the acute toxicity of mixtures that are comprised of one or more ingredients that fall into Category 5 must include the acute toxicity estimate for the Category 5 ingredients. Proposed Paragraph A.1.3.6.1(a) indicated that the calculation of the acute toxicity of mixtures would “[i]nclude ingredients with a known acute toxicity, which fall into any of the acute toxicity categories.” This is consistent with the GHS (Subparagraph 3.1.3.6.1(a)).
As discussed in the Proposal, OSHA believes that the exclusion of Category 5 from the criteria Table A.1.1 may lead to classifiers overlooking substances falling into this category in the mixture calculation, which could result in a higher (less protective) classification. This could also mean a lack of harmonization within the U.S. if other Federal agencies adopt Category 5, potentially requiring inclusion of these data in the calculation. To avoid this situation, OSHA has clarified the text for the mixture calculation to ensure that the ingredients that would be classified as Category 5, and thus would not be classified under the HCS, are included in the mixture calculation. Paragraph A.1.3.6.1(a) has been modified to indicate the calculation must “[i]nclude ingredients with a known acute toxicity, which fall into any of the acute toxicity categories, or which have an oral or dermal LD
OSHA has modified the text of Note (d) to Table A.1.1 to help clarify the requirements. This was done in response to a comment from Dow (Document ID #0526), which stated that they were “confused about the table,” and that OSHA should revisit the table and the definitions to properly harmonize the provisions.
Several commenters noted that there were errors in Table A.1.2 in the NPRM (Document ID #0376, 0393, and 0405). The errors have been corrected in the final rule.
One commenter stated that the criteria seem to assume that acute lethality data are available in all situations, and they are not (Document ID # 0321). As with all other health hazard criteria in the standard, the HCS does not require data to be generated to comply with the standard. And the final rule recognizes that many chemicals have not been tested to ascertain their hazards. For example, the formula used to calculate the acute toxicity of a mixture makes an adjustment for ingredients whose acute toxicity is unknown. In addition, the fact that a mixture contains an ingredient of unknown toxicity must be indicated on the label and SDS. This is important because in some mixtures the unknown percentage could be significant, and therefore the estimation of toxicity for the mixture has less credibility than in a situation where the majority of the ingredients have data available.
It was also suggested that the formula used for acute toxicity be displayed in a way that is more commonly used for such equations (Document ID #0641). OSHA agrees that it could be displayed in a different way, but wanted to ensure it appeared the same in the regulatory text as it appears in the GHS. However, in guidance for application of the final rule, OSHA will include the formula in the alternative format as well to assist in understanding it.
The Styrene Information and Research Center (SIRC) challenged the proposal's requirement to disclose the concentration of ingredients in a mixture whose acute toxicity was unknown (Document ID #0361). It argued that “[i]t is unclear how that requirement would pass a significant risk test” and that “[i]t seems unlikely to make the user more cautious.” However, the record shows the contrary. Both workers and union representatives testified at the public hearing on this rulemaking that workers would be more cautious when dealing with chemicals of unknown toxicity and would look for substitutes where possible (Document ID #0494). Further, Cathy Cole, President of the American Industrial Hygiene Association, testified that industrial hygienists use the fact that a chemical's acute toxicity is unknown when they perform qualitative risk
[W]e would take that information and use it to weigh it against all the other information within that mixture. If there's an unknown, then we would most likely provide a safety factor as we did our risk assessment * * *. If there's a mixture that has a number of unknowns, then we would treat that very carefully and we would have a high risk ranking for it.
The final rule's hazard classification scheme for mixtures presenting acute toxicity hazards treats unknown toxicity in a similar way. When testing data on the mixture as a whole are not available, the acute toxicity of the mixture is determined by assuming that the nontoxic ingredients dilute the toxicity of the acutely toxic ingredients. (
OSHA has also made two minor, clarifying changes to paragraph A.1.3.6.2.4 that are consistent with changes that were approved by the UN Sub-committee in December. The word “relevant” has been added in front of “ingredient,” and the word “total” was deleted before “percentage.” Therefore, A.1.3.6.2.4 in the final rule requires that if the total concentration of the relevant ingredient(s) with unknown acute toxicity is ≤10% then the following formula must be used:
However, if the total concentration of the relevant ingredient(s) with unknown acute toxicity is >10%, the formula presented above is corrected to adjust for the percentage of the unknown ingredient(s) as follows:
The above discussion shows that SIRC's concerns about the unknown toxicity requirement are unfounded. Employers use the fact that a chemical's acute toxicity is unknown in determining how chemicals should be handled. As such, the disclosure requirement is reasonably related to the purpose of hazard communication and, therefore, within OSHA's authority. In addition, by providing the worker with information about the limits of the known information, the requirement provides the sort of prophylactic function that has been upheld even in situations where the Agency has not made a significant risk finding. The unknown toxicity requirement is consistent with the OSH Act.
Another commenter suggested the trade secret provisions should apply to the requirement for disclosing the concentration of ingredients with unknown toxicity (Document ID #0353). The revised rule (and the GHS) do not suggest that the names of the components be disclosed—simply the aggregate percentage of the total composition that has unknown acute toxicity. So if there are three ingredients in a mixture that have no acute toxicity data available, and they comprise 20% of the mixture, the label and SDS must indicate that 20% of the mixture has unknown acute toxicity. The names of the chemicals do not have to be disclosed, and neither does the number of chemicals involved. Therefore, there should be no trade secret issue.
As OSHA noted in the preamble to the NPRM (74 FR 50392-93, Sept. 30, 2009), significant editing was done to the GHS text for this health hazard. The criteria in the GHS lead the evaluator to conduct additional testing when information is not available. While the GHS does not require testing, the criteria imply that it should be done to complete an evaluation. This implication is not acceptable under the HCS, which is based solely on available evidence.
As noted in the NPRM discussion, work had already been initiated in the UN Sub-committee to modify the chapter on skin corrosion/irritation to address inconsistencies and clarify provisions. That work has proceeded since the NPRM, and is on the work program for the next two years as well. OSHA has made modifications to the HCS criteria to reflect discussions in the Sub-committee, and clarify areas of concern. In particular, Chapter A.2 of Appendix A, “Skin Corrosion/Irritation,” was reorganized in the final rule so that text and figures are consistent. Paragraph A.2.1's title was changed to “Definitions and general considerations.” Paragraph A.2.1.2 was added to introduce a tiered approach to follow when classifying for skin corrosion/irritation. Paragraph A.2.2, “Classification criteria for substances using test data,” has been modified to reflect that it covers animal test data. In Paragraph A.2.3, “Irritation,” the factors used to determine the corrosion/irritation potential of a substance were deleted, and the text was reorganized to follow the tiered approach to classify substances using other data elements. Figure A.2.1 was updated to make it consistent with the text, and to show the tiered evaluation scheme instead of a testing scheme. Comments had been received that indicated this figure was confusing (Document ID #0344 and 0381). Another commenter noted that the criteria are provided without indicating how they were derived (Document ID #0321). The criteria were developed by a group of experts in the OECD and were derived from the existing criteria of the countries involved. They do not specify a test method because the GHS is test method neutral, but the OECD testing guidelines are generally agreed to provide the type of information needed for classification under the GHS.
There were also several comments that pH criteria are not appropriate to use in some situations (for example, the pH of the ingredients in a mixture may not predict the pH of the mixture) (Document ID #0321, 0335, and 0381). The criteria recognize that test data for these effects provide better information
OSHA believes the edits and changes make the chapter less confusing and clarify that testing is not required to achieve compliance. The basic provisions and approach remain the same as the GHS. The Agency is participating in the continuing work of the UN Sub-committee on this topic, and will revise the HCS if any additional clarifications are made in the criteria for these hazards that will help classifiers follow the provisions.
The text for GHS Chapter 3.3, “Serious Eye Damage/Eye Irritation,” posed similar issues to those described above for skin corrosion/irritation. The criteria in the GHS implied that testing might be needed to complete classification in the absence of data. This is required by neither the GHS nor the HCS. OSHA made a number of modifications to the parallel text in Appendix A, Chapter A.3, of the HCS proposal to address the perception that testing might be required when it is not. And the UN Sub-committee is also reviewing this chapter for purposes of clarifying the requirements.
As with the skin chapter, in the final rule OSHA has reorganized Chapter A.3 so that the text and figures are consistent, and so that it is clear that what must be followed is a tiered approach. The title of A.3.1 was modified to indicate it covers definitions and general considerations, and paragraph A.3.1.2 was added to introduce the tiered approach for classification. Paragraph A.3.2 (“Classification criteria for substances using animal test data”) was modified to indicate it addresses animal data. Table A.3.1 was modified to indicate that Category 1 corresponds to Serious Eye Damage and not to eye irritants, and Table A.3.2 adds the criteria for Category 2B. In A.3.3 (“Classification criteria for substances using other data elements”), the classification criteria for substances were reorganized using other data elements to make it consistent with Figure A.3.1, and to show the tiered evaluation strategy for classification. Figure A.3.1 was updated to make it consistent with the text. And Table A.3.3 now has a note to indicate that a mixture may be classified as Category 2B in cases when all relevant ingredients are classified as Category 2B. As with skin corrosion/irritation, OSHA will continue to monitor work in the UN Sub-committee to clarify these criteria, and will modify the rule to update the chapter as necessary if changes are made.
One additional issue was raised concerning the coverage of the GHS criteria for eye irritation in comparison to current criteria used by CPSC and EPA. The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) (Document ID #0384) suggests that the GHS criteria are not as protective as the current criteria used by CPSC and EPA. OSHA uses the CPSC criteria in the current HCS, but does not use EPA criteria. NICEATM did an analysis of a group of chemicals to determine what their classifications would be under the different criteria, and concluded that at least 14 of 149 chemicals it reviewed (17%) would not be classified under the GHS criteria, but would have been under current HCS criteria.
OSHA asked a consulting toxicologist familiar with the GHS criteria to review the comment and the analysis, and the results of his review have been entered into the public record (Document ID #0576, 0577, and 0578). The results of this review show that all of the 14 chemicals are differently classified because they present transitory effects that resolve in 72 hours or less; the difference in classification results from the way each method accumulates transitory positive results across test animals. While there may be some differences in conclusions made under the differing criteria, the differences are less pronounced when variance in transient effects is considered (as it is under the criteria as proposed). This is explained as follows in the toxicologist's report:
In order to compensate for this difference in approaches, OSHA has proposed to also adopt the GHS concept of “pronounced variability”. Under this concept, for those chemicals where there is pronounced variability among animal responses, such information may be taken into account in determining the classification. As discussed specifically under OSHA's proposed criteria for Classification and Categorization of Skin Corrosion/Irritation, but only mentioned in passing under Serious Eye Damage/Eye Irritation, this notion would allow for classification in cases where there are very definite, positive irritant effects related to chemical exposure in a single animal, but the overall data set does not support classification. In cases where the response is borderline but persistent or severe but transient, the Assessor would likely classify a substance as irritating. It is noted that there are at least two chemicals among those under examination where “pronounced variability” would likely cause the Assessor to classify them as irritants (see data for ethyl thioglycolate and glycidyl methacrylate; fomesafen, 2,2-dimethyl-3-pentanol, and cellosolve acetate might also be classified as irritants under this concept).
Finally, a quick search of secondary and tertiary sources available on-line indicates that 12 of the 14 chemicals in question would be classified as hazardous materials under both the current and proposed classification criteria. Those that would not be classified are N,N-dimethylguanidine sulfate (sub-EU classification eye and skin irritation responses; not a sensitizer; no other data found); and tetraaminopyrimidine sulfate (not an acute or chronic toxicant; identified as non-irritating by EU Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP)).
While OSHA appreciates the concerns raised by NICEATM, the criteria are being finalized as proposed, other than the modifications made for clarification purposes. It appears that the pronounced variability considerations will address some of the concerns raised, and that the primary remaining differences involve transient effects of relatively low concern. Both CPSC and EPA were involved in the development of the criteria in the GHS, and were aware of the differences between their existing systems and the agreed harmonized criteria. In harmonizing between the existing systems, the criteria selected were between what currently exists in the U.S. and in the EU. The classification criteria in each existing system is not a bright line determined by science, but rather a scientifically influenced policy determination, and as discussed elsewhere, an inevitable part of adopting harmonized criteria is that a few borderline chemicals might be dropped. No other stakeholders have raised the issue of whether the criteria are protective enough. OSHA is proceeding with the final rule because it believes that in this situation,
The GHS criteria for respiratory and skin sensitizers have one category for each type of sensitization, but also give the option of dividing that one category into two sub-categories, which involves a differentiation in the type of evidence available. In the NPRM, OSHA proposed to adopt the sub-categories for classification. One commenter strongly supported adopting sub-categories for these sensitizers (Document ID #0381), while another did not support it because the EU has not adopted sub-categories (Document ID #0376). OSHA is adopting the sub-categories as proposed. However, the Agency recognizes that there are situations where data are not available to place the chemical into one of the sub-categories. The GHS itself addresses this in 3.4.2.1.1.1 (respiratory sensitization), and 3.4.2.2.1.1 (skin sensitization). Therefore, under the revised HCS, simply classifying the chemical as Category 1 will be sufficient in cases where data are insufficient to assign a subcategory. The American Chemistry Council (Document ID #0393) suggested that more guidance is needed to differentiate potential and severe sensitizers for placement into the sub-categories. OSHA believes that this type of guidance should be developed through the Sub-committee process, rather than by countries independently developing guidance for application. The Agency will consider requesting the Sub-committee to develop such guidance.
OSHA disagrees. First, while the current HCS does not define mutagenicity as a separate health hazard, it is covered by the reproductive toxin definition. Under the GHS, mutagenicity is not covered by reproductive toxicity, and OSHA's failure to adopt the mutagenicity category would render the final less protective than the current HCS. The hazard class will have to be adopted to maintain coverage. Secondly, though mutagenicity data are used to predict carcinogenicity, the mutagenicity hazard is not covered by the carcinogenicity criteria. Furthermore, little additional burden for training can be claimed for what is already covered under reproductive toxicity in the current HCS.
All of these commenters argue that the HCS should be as consistent with the EU as possible. The EU has already adopted these criteria, so excluding them would not be consistent with the EU. OSHA is maintaining the hazard class as part of the HCS, and including both categories. It is OSHA's understanding that at present there are no chemicals that meet the criteria for Category 1A, so currently this has no burden associated with it—although there may be minimal burdens if new data in the future place chemicals in this category. (
OSHA included a new heading in A.5.4 entitled “Examples of scientifically validated test methods.” In the interest of maintaining current protections, as well as being consistent with implementation in the EU, germ cell mutagenicity is adopted in the final rule as proposed.
The current Hazard Communication standard includes a reference to several lists of chemicals automatically presumed to be hazardous, such as the lists of carcinogens published by the National Toxicology Program (NTP) and the International Agency for Research on Cancer (IARC). The proposal removes references to such lists, in favor of a more detailed and complicated classification system. While that classification system is required by the GHS, the lists provide useful guidance and should not be removed altogether.
We suggest the following compromise: OSHA should state in the regulatory text that a classifier may presume that the presence of a chemical on one or more of those lists is sufficient to classify the chemical as hazardous with respect to the hazard covered by the list. (OSHA should also state that the inverse is not true: The absence from a list does not indicate the lack of a hazard.) This does not mean that the classifier is required to classify a chemical as hazardous based solely on the list, only that he or she is free to do so. OSHA should also indicate in the preamble that the Agency will use the lists as guidance in enforcement, and that a classifier who ignores the lists should be prepared to show why his or her judgment is better than the judgment of, for example, NTP or IARC.
For example, IARC, NTP and other qualified organizations assess carcinogenicity and come to published conclusions. We do not understand why the proposed Hazard Communication Standard establishes procedures for chemical suppliers to conduct such assessments, seemingly asking them to conduct their own evaluations in the manner
OSHA agrees with these commenters that allowing evaluators to rely on IARC and NTP could make classification easier for them, as well as lead to greater consistency. Therefore, A.6.4.1 has been added to the criteria in the final rule to indicate that classifiers may treat these sources as establishing that a chemical is a carcinogen without applying the criteria themselves. And A.6.4.2 reiterates that OSHA-regulated carcinogens are covered under the HCS.
In order to facilitate the use of IARC and NTP determinations as sources for purposes of classification, non-mandatory Appendix F has been significantly modified. In the NPRM, Appendix F was simply a verbatim quote of guidance from IARC on determining carcinogenicity. In the final rule, Appendix F has been updated to reflect the latest version of that IARC text, but also includes additional guidance on how to use IARC and NTP to make carcinogenicity classifications. The inclusion of this guidance should make classification easier for chemicals addressed by these sources, and should also provide parameters for the type of weight-of-evidence decisions that are appropriate under the GHS-aligned criteria.
The following table is included in Part D of Appendix F, and may be used to perform hazard classifications for carcinogenicity under the HCS. It relates the approximated GHS hazard categories for carcinogenicity to the classifications provided by IARC and NTP, as described in Parts B and C of Appendix F:
While the criteria for carcinogenicity (as well as other health effects) are largely based on weight of evidence evaluations, there are also provisions in the GHS for countries that want to ensure that all potential carcinogens are adequately captured by the criteria. Thus paragraph 3.6.2.6 of the GHS chapter on carcinogenicity states:
* * * For inclusion into Safety Data Sheets, positive results in any carcinogenicity study performed according to good scientific principles with statistically significant results may be considered.
Positive results in any carcinogenicity study performed according to good scientific principles with statistically significant results qualifies for referencing the chemical as, at the least a Category 2 carcinogen.
The Styrene Information and Research Council (SIRC) (Document ID #0361) argues that the “one positive study” criterion is inconsistent with the weight of evidence approach. In fact, it is not part of the weight of evidence approach, but rather reflects the Agency's decision to ensure that the current level of protection in terms of identifying potential carcinogens in the workplace is maintained in the HCS as permitted by the GHS provisions.
SIRC also indicated that it is not clear what is meant by “referencing” the chemical as, at the least, a Category 2 carcinogen. OSHA agrees that the inclusion of this language in Figure A.6.1 is not as clear as it could be in terms of what is required. In the final rule, OSHA has separated this requirement from Category 2, and added a new heading of “Other considerations” to the table. The text for the “Other considerations” is: “Where the weight of evidence for the carcinogenicity of a substance does not meet the above criteria, any positive study conducted in accordance with established scientific principles, and which reports statistically significant findings regarding the carcinogenic potential of the substance, must be noted on the safety data sheet.” Categories 1 and 2 will remain based on weight of evidence, but the data that meet the definition of “other considerations” must also be provided on the SDS for the chemical. This will maintain the protections of the current rule and provide information to downstream users so they can determine the appropriate protective measures to be taken in these situations.
In paragraph A.6.3.2 of the NPRM, OSHA included the mixture approach in GHS paragraph 3.6.3.1 regarding use of test data as a whole to characterize the carcinogenic potential of a mixture:
A mixture may be classified based on the available test data for the mixture as a whole. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations and analysis (
Again, the use of the word “conclusive” appears to be an inappropriate attempt to apply the European Precautionary Principle to this issue. It is inconsistent with the fundamental principle that hazard communication is to be based on the application of expert judgment to known information and not require chemical testing (either explicitly or as an inevitable practical requirement to avoid unacceptable economic consequences). The word “conclusive” should be replaced with the word “adequate” or “persuasive.”
In addition to the technical considerations, SIRC (Document ID #0361) (as well as SPI, Document ID #0392), repeatedly suggests that the precautionary principle, or European approaches, are the genesis of various provisions. First, OSHA does not agree that the precautionary principle had any part in the GHS, or the HCS, provisions. The HCS is an information transmittal standard, not a standard that requires the implementation of controls or other risk management approaches. The precautionary principle generally applies to competent authorities, and allows them to regulate or establish controls in situations where complete information is not available about the situation. That certainly does not apply to this provision in the HCS, which requires definitive data before allowing a chemical manufacturer or importer to designate a mixture as not being carcinogenic, although it contains an ingredient that clearly has a carcinogenic potential. The HCS is a standard that is intended to provide information to users of chemicals so they can make their own determinations as to what controls are needed to prevent adverse health effects or the effects of physical hazards. The better information they have about the chemicals in their workplaces, the more likely they will be able to make their own risk assessments, and choose appropriate risk management measures. The provisions of the HCS—as well as the GHS—are designed to ensure that such information is available to users.
The criteria proposed are adopted in the final standard, with the addition of the paragraphs referring to NTP, IARC, and OSHA-regulated substances, and supplemented by the revised non-mandatory Appendix F.
The only change OSHA has made in the final rule is to change “should” to “shall” in A.7.2.5.4, since it is mandatory in the HCS. Otherwise, the criteria are adopted as proposed in the text of the final rule.
There are also a significant difficulty and potential unintended outcome that weigh against applying Category 2. Animal studies may be done for a variety of purposes, some of which are not relevant to consumer product uses, and the interpretations of animal data from these types of studies often yield conclusions not relevant to consumer products. Using the outcomes from animal studies for classification into Category 2, especially studies at exposures near the point of morbidity, requires an unusual level of expertise that many classifiers would not possess. In addition, classification into Category 2 relies on interpretation of the phrase “relevant to human health,” which would involve an additional expertise. Therefore, Category 2 should not be adopted.
There are a number of difficulties with this argument. First, this section addresses protection of workers exposed to chemicals, and not the assessment of consumer products and exposures. Many consumer products are not covered by the HCS, although provisions in the scope and application cover those products where they are used in the workplace in a manner different than consumers would use them, or with a more extensive duration and frequency of use.
In devising the Category 1/Category 2 approach to classifying specific target organ toxicity after single (and repeated) exposure, the framers of the STOT-SE (and STOT-Repeated Exposure) criteria sought to establish a means by which the chemical manufacturers and importers could communicate to the worker information as to both the nature and the severity of adverse systemic and target organ effects. The final rule provides detailed criteria to clarify what would be considered an “adverse” effect (
Using these criteria and examples, classifiers will be able to consider whether a change was, as required by Category 2, “of
Additionally, the GHS-based STOT criteria proposed for adoption by OSHA sought to introduce the concept of dose response to the communication of specific target organ toxicity hazards. Such a concept has long been part of the assessment of acute toxicity hazards, but has been missing from the communication of many other health hazard endpoints. Adoption of both Categories 1 and 2, as proposed, allows the chemical manufacturer/importer of a chemical to convey to the worker additional information as to the
P&G also suggests that Category 2 is inconsistent with paragraph 3.8.1.3 of the GHS in that “it does not rely primarily on human data * * *.” However, while GHS 3.8.1.3 (A.8.1.3 in the final rule) does say that human data will be the “primary source for classification,” it also specifically states that classification in this hazard class may also be made on reliable evidence “in experimental animals, toxicologically significant changes * * *.” Thus, P&G's contention is not accurate. In addition, animal data are used or referred to throughout the criteria in the GHS for health hazards, and the use of such data to predict effects in exposed humans is a standard toxicological approach.
In addition to its appropriateness for protection of workers, Category 2 has been adopted by the EU, and adopting it in the final rule will thus maintain consistency with the EU as well.
Several commenters on the NPRM also argued that aspiration hazard should be completely excluded from the revised HCS (
The primary proponent for complete exclusion of aspiration as a hazard in the revised GHS was the Hydrocarbon Solvents Panel (the Panel) of the American Chemistry Council. In their post-hearing comments, the Panel summarized their position as follows (Document ID #0528):
(1) OSHA should not adopt the Aspiration Toxicity class under the GHS because, as demonstrated by data submitted to the record, aspiration as a route of exposure is not common in the industrial setting, and is not a significant cause of occupationally related severe or fatal poisonings.
(2) Should OSHA include Aspiration Toxicity as one of the Health Hazard classes, the Panel urged that OSHA not require the Health Hazard Symbol be used as part of the pictogram because it does not accurately symbolize the nature of the hazard represented by the aspiration route of entry, and could be potentially misleading.
(3) Should OSHA include Aspiration Toxicity and a symbol, the Exclamation Mark symbol is more appropriate for the Aspiration Hazard Pictogram. Of the existing symbols in the proposed rule, the Exclamation Mark symbol is more representative of an actual aspiration episode. The Exclamation Mark would be a better choice to connote the hazard endpoints and response necessary in an aspiration event, due to the immediate need for intervention in an aspiration episode.
(4) If OSHA is unwilling to adopt the Exclamation Mark symbol for Aspiration Toxicity, we request that OSHA forward the concern to the UNSCEGHS for its consideration.
With regard to the symbol, the application of the more severe health hazard symbol to a Category 1 hazard category is consistent with how the symbols are applied to all of the health hazards. Adopting the exclamation mark in the U.S. for aspiration Category 1 would make the HCS inconsistent with other countries' rules regarding aspiration hazard, which would present difficulties for countries exporting to the U.S., and potentially create inconsistencies in what workers see on labels and SDSs. This would not be an effective communication approach to aspiration hazards. Therefore, OSHA does not agree that the exclamation mark should be permitted for Category 1 aspiration hazards. In terms of presenting it to the UN Sub-committee as an issue, OSHA will take that suggestion under advisement. However, industry stakeholders are free to make this suggestion to the Sub-committee themselves through submission of a paper.
With regard to the contention that drowning in water could conceivably be read as being covered by the aspiration hazard criteria, OSHA assures stakeholders that drowning in water is not covered and that the HCS will not be interpreted as addressing drowning in water as an effect covered by the rule.
Aspiration Hazard, Category 1, is included in the final rule as proposed.
As with Appendix A and the health hazard criteria, OSHA edited Chapter 2 of the GHS (“Physical Hazards”) to shorten the discussions and focus only on the criteria in the proposed revisions. Decision logics and hazard communication information are not included. As with health hazards, OSHA tried to maintain the current scope of the HCS for physical hazards in the proposal, as well as being as consistent as possible with trading partners, particularly the European Union. One exception may be flammable gases, where it appears that more flammable gases will be covered by OSHA adopting Category 2 than are currently covered by the HCS. OSHA is adopting all of the physical hazards in the GHS.
The one deviation from the approach adopted by the European Union is in the proposed adoption of Categories 1 through 4 for flammable liquids. The European system only addresses Categories 1 through 3. The current HCS covers flammable liquids in Category 4, and exclusion of this category would result in reduced protection, which OSHA does not believe is appropriate. Thus Category 4 is included in the revised HCS.
One edit that should be noted occurs in the criteria for explosives. The GHS criteria currently use the term “article” in a manner that is inconsistent with that term as used in the workplace in the U.S. OSHA has changed the term to “item” in these criteria. This modification was supported by stakeholders (
While OSHA believes that harmonizing with DOT provides significant benefits, there were some concerns regarding this approach that arose in reviewing the physical hazard criteria. These concerns involved the test methods referred to in the GHS criteria, which are based on issues related to the packaging and volume in transportation. Packaging is obviously a major concern in transport, and is used to address or mitigate the risk of conveying certain types of chemicals. These chemicals may or may not be present in the workplace in the same size or type of packaging and the relevance of these factors in the test methods are questionable in terms of workplace exposures. OSHA invited comment on these factors, including comments on the appropriateness of the criteria (including the test methods and references to packaging or volume) when applied to the workplace, and any suggestions that interested parties have to address these issues. Of particular interest were criteria for self-reactive chemicals, organic peroxides, self-heating chemicals, and explosives. Commenters indicated that the criteria could be applied to the workplace (
The classification, labeling, handling and storage of chemicals related to transport concerns should remain aligned with the principles of HCS. OSHA should seek where possible to reduce incompatibilities between HCS criteria and US DOT transportation requirements.
Accordingly, OSHA has decided to carry through these requirements to the final rule as proposed. OSHA is satisfied that, in this respect, the criteria proposed are appropriate.
The Society of the Plastics Industry, Inc. (SPI) (Document ID #0392) contends that the requirements will not be possible to implement for organic peroxides:
The GHS would require that the SDS for organic peroxide include:
(1) Recommended use of the chemical and restrictions on use;
(2) Precautions for safe handling;
(3) Conditions for safe storage, including any incompatibilities, and
(4) Appropriate engineering controls.
Compliance with these requirements, which include principles from the EU regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), presents a particular concern for organic peroxide producers following transportation and initial storage in the DOT-regulated transport container. As written, compliance would present unreasonable difficulties and appears to be infeasible for suppliers of these chemicals. Customers are likely to handle and use these materials under significantly different conditions once they remove the organic peroxides from the packages in which they were transported.
SPI indicates that these requirements for information on SDSs originate with REACH requirements in Europe. In fact, OSHA has always required such information on SDSs (with the exception of intended use of the chemical, and restrictions on use), and these requirements preceded REACH by many years—as did the negotiated text of the GHS. In § 1910.1200 (g)(2)(viii) and (ix) of the HCS promulgated in 1983, the preparer of the MSDS is required to provide any generally applicable precautions for safe handling and use, and any generally applicable control measures such as engineering controls, which are known to the chemical manufacturer, importer or employer. OSHA also notes that the manual supplied and written by SPI: “SAFETY AND HANDLING OF ORGANIC PEROXIDES: A Guide” (dated August 1999), recommends that downstream users consult labels and MSDSs for handling information (Document ID #0392). OSHA does not agree that the SDS requirements in the NPRM, and the final rule, are infeasible or even substantially different than what has been required by OSHA since 1983. The Agency does not agree that the suggested statement should be required by OSHA regarding organic peroxides. Chemical manufacturers and importers of organic peroxides are free to provide whatever advice they deem appropriate in the supplementary information part of the label, or on the SDS, to guide downstream users for appropriate handling, as long as the advice does not conflict with the required hazard communication information.
With regard to harmonizing with DOT, the criteria in the final rule are the criteria that DOT adopted from the UN Transport recommendations. Therefore, OSHA is harmonizing with DOT through this rulemaking.
One commenter indicated that there was concern that criteria based on transport classification may confuse workplace application, and guidance would be needed (Document ID #0339):
Concerns have been expressed that the criteria developed for transport concerns, as stated in the GHS, express very specific constraints, or “worse case scenarios”, which can be confusing to suppliers and users of chemicals who are reading the Safety Data Sheets (SDSs)/labels, etc., without benefit of the context. PRR believes this is an area in which OSHA could develop informational materials to help chemical suppliers and users understand the rationale behind physical hazard classifications.
Only minor editorial revisions have been made to Appendix B after reviewing all of the comments received. While a great number of changes were suggested by one commenter (Document ID #0353), most have not been adopted, consistent with the discussion above on
The modifications made in the final rule include changing metric references to units used in the U.S., and modifying references to documents incorporated by reference to make them consistent with OSHA's requirements for such references. There are no technical changes to the criteria. Therefore, Appendix B in the final rule is substantially the same as proposed.
One interesting comment that was submitted by a number of respondents to the ANPR involved development of a classification database (Document ID #0047, 0050, 0053, 0054, 0038, 0155, 0160, and 0165). Opinions as to who would develop and maintain such a database varied (OSHA, U.S. industry, and an international body were all mentioned). It appears that the European Union will be making such a database available for compliance with its requirements, as have Japan, Taiwan, South Korea, and New Zealand. Concerns have been raised by stakeholders that classifications in these databases are different for the same chemical. OSHA invited additional comment on this issue in the NPRM (74 FR 50284, Sept. 30, 2009), and received a number of responses.
Many supported the concept of having such a database (Document ID #0328, 0329, 0330, 0335, 0336, 0339, 0341, 0352, 0365, 0366, 0379, 0383, 0389, 0408, 0410, and 0453). There were also various comments about how a database might be done. Some thought OSHA should do the classifications and maintain them online, or that the classifications should be considered “official” (Document ID #0330, 0341, and 0453). Others were concerned about the Agency's ability to develop and maintain a database (Document ID #0339), or said it should only be done if resources were provided to maintain it (Document ID #0365). Alternatively, resources could be provided for classifiers to help improve the quality of their classifications (Document ID #0365).
Others suggested that NIOSH could be tasked with developing and maintaining the database (Document ID #0341 and 0408). NIOSH commented that funding is not currently available, and that OSHA may wish to partner with the EU database efforts (Document ID #0412). Additionally, NIOSH and another commenter (Document ID #0383) suggested alternatives to developing a database using existing information such as the Department of Homeland Security's database; using International Chemical Safety Cards that currently cover 1,650 substances and are translated into many languages; or adding GHS classifications to the National Library of Medicine, including its Hazardous Substances Data Bank. NIOSH is also updating its Pocket Guide to include GHS classifications.
Another suggestion was to have the UN develop a database so there is a globally harmonized list, and the Department of Labor could help support it (Document ID #0328 and 0335). The National Fire Protection Association (NFPA) (Document ID #0366) suggested that its database of 2,500 chemicals could be useful in the transition. Other commenters suggested that suppliers can provide classifications to a central repository (Document ID #0352, 0408, and 0410), but one commenter warned that if left to manufacturers, there would be differences that would have to be resolved downstream (Document ID #0328). Another comment raised a concern that, while a common database might be useful, it could also interfere with weight-of-evidence determinations (Document ID #0379). However, such a database could prove useful for substances, which would provide the basis for mixture classifications (Document ID #0335).
Other commenters did not support having a classification database (Document ID #0324, 0344, 0351, 0370, and 0377), or indicated that if OSHA were to develop a classification list, it should be non-binding guidance, and include stakeholder input and global accessibility (Document ID #0344, 0381, 0393, and 0405). Others were concerned that a common database would create another unharmonized list of classifications compared to lists in other countries (Document ID #0344), and that manufacturers should have the responsibility for classification (Document ID #0324 and 0405). Also, a company could have valid data that contradicts a classification assigned in a database, and should be allowed to use its own information (Document ID #0351). There was also a concern that such a list might impede progress by not using the best available data (Document ID #0377). Another commenter argued that the database would need to be internationally developed and maintained to be useful, which would result in the elimination of national or regional lists (Document ID #0376).
OSHA is very interested in whether an international database of classifications could be developed and maintained. It is not likely to be feasible for OSHA to develop and maintain a U.S.-based database, which, as some have noted, would be less useful than an internationally harmonized approach that preempts countries and regions from developing their own approaches. The subject has been raised and discussed in the UN Sub-committee, and a correspondence group has been established to explore the issue further. OSHA has volunteered to lead that group and to help form a consensus position in the Sub-committee on options to address this issue. In the meantime, some of the suggested sources can provide extensive information to assist businesses with GHS classifications, particularly small businesses with fewer technical resources. The International Chemical Safety Cards—which are linked on both OSHA and NIOSH Web pages—are one such resource. The OECD has also established a global chemical portal that includes extensive information on chemicals (
The written hazard communication program requirements in paragraph (e) are intended to ensure that hazard communication in a given workplace is coordinated and comprehensive. An employer's program must include a list of the hazardous chemicals known to be present in the workplace (paragraph (e)(1)(i)). This list is basically an inventory of the chemicals the employer must have safety data sheets for, and must be available to employees so they, too, can determine what chemicals should be included under the hazard communication programs in their workplace. The list can be maintained by work area or for the workplace as a whole, and must be kept by an “identity” of the chemicals (which will be the “product identifier” under the final rule). In other words, the inventory can be common names or product names, rather than individual chemical ingredients of each product by specific chemical identity or chemical name.
The employer's hazard communication program must also include how the standard's requirements for labels, SDSs, and training will be met (paragraph (e)(1)); how the hazards of non-routine tasks will be addressed (paragraph (e)(1)(ii)); and how hazard communication will be
Several comments to the ANPR were received from the Small Business Administration (SBA) and others that suggested there would be significant burdens associated with revising the written program as a result of implementing the GHS (
The most likely differences resulting from re-classification under the final rule are that a chemical would be placed in a category under a hazard class that does not currently include categories. It may also be possible that a chemical may fall into a different category where there are already defined categories (such as flammability). Neither of these differences would necessitate a change in the inventory.
With regard to other changes in an employer's program, it does not appear likely there would be many, if any at all. Written hazard communication programs usually include provisions such as who in the organization is responsible for implementing different parts of the program, or the type of in-plant labeling system used. The final HCS will not affect those provisions. OSHA does not believe that extensive revisions would have to be made to written programs, including the inventory, under the final rule.
OSHA did not propose any substantive modifications to the written hazard communication program, and it does not anticipate any significant new burdens associated with revising the program as a result of other modifications in the final rule.
While the written hazard communication program was mentioned several times in relation to the costs of compliance, or the burdens on small businesses, it was generally not discussed in a substantive way by rulemaking participants. The Building and Construction Trades Department of the AFL-CIO (Document ID #0359) expressed concerns about the challenges associated with implementation of the HCS on multi-employer worksites, a subject that is addressed in the written hazard communication program requirements. They suggested that the controlling employer on a site coordinate hazard communication activities. This is not a subject related to adopting the GHS, and no changes are being made to the rule to address it. The written program must address how the exchange of information will be accomplished, and that will continue under the final rule.
In the current HCS, the requirements for labels are performance-oriented. At the time the standard was promulgated, there were many different types of labels in use. A common label format used by industry was that provided by the ANSI Z129, Hazardous Industrial Chemicals—Precautionary Labeling standard. Employers following this format at the time provided a number of different types of information on the chemicals involved. However, there were two areas where employers were inconsistent or did not necessarily provide what was needed when following the national consensus standard. The first was provision of an identity on the label that could lead a chemical user to the specific chemical identities for the hazardous ingredients. It was common practice to provide a trade name for a product, but not the names of ingredients, on either the label or the safety data sheet. The second was provision of specific information on the hazards involved, such as the target organ affected.
The current HCS label provisions focus on this typically missing information. On shipped containers, chemical manufacturers or importers are required to include an identity, and appropriate hazard warnings, as well as their name and address or that of a responsible party. The term “identity” is defined in the current HCS definitions (paragraph (c)) as “any chemical or common name which is indicated on the material safety data sheet (MSDS) for the chemical. The identity used shall permit cross-references to be made among the required list of hazardous chemicals, the label and the MSDS.” The hazard warning is to provide specific information about the health or physical hazards posed by the chemical. The term is defined as “any words, pictures, symbols, or combination thereof appearing on a label or other appropriate form of warning which convey the specific physical and health hazard(s), including target organ effects, of the chemical(s) in the container(s). (
The current HCS similarly requires identity and appropriate hazard warnings for in-plant containers. OSHA has taken a flexible approach to in-plant labeling, allowing a wide variety of systems to be used as long as all of the required information is readily available to employees when they are in their work areas. Thus the current standard allows employers to continue to use systems such as the Hazardous Materials Information System (HMIS) and the National Fire Protection Association (NFPA) labeling systems that use numerical rankings of hazard.
The labeling provisions of the current HCS exemplify the overall performance orientation of the rule. They establish the basic information requirements for chemical manufacturers and importers, but do not specify a format, or any particular label elements to be used. As a result, labels are often quite different when the same chemical is addressed by different suppliers, creating the potential for employee confusion. While many manufacturers follow the ANSI national consensus standard, others do
This performance-oriented approach also did not lend itself to harmonization. Other countries often use more specific approaches, including assignment of standard phrases to certain hazardous effects, symbols, and other label elements. It was clear that the performance orientation of HCS, with its many acceptable varieties of labels, could not be standardized through agreement on content to achieve harmonization.
Given that a more specified approach would also lead to consistency among manufacturers, as well as helping to ensure the same message is received by all exposed employees, OSHA agreed to negotiate a harmonized approach that was more specific than the current standard. This was also agreed to by stakeholder representatives involved in the negotiations. Thus once a chemical is classified as to its hazard classes and corresponding categories, the GHS specifies exactly what information is to appear on a label for that chemical. As described in Part IV of this preamble, OSHA believes that these specific labeling requirements will be more protective of employee health and safety than the current performance-oriented standard.
The NPRM proposed more modifications for paragraph (f) than most of the other paragraphs of the existing standard. It changed the title of paragraph (f)(1) to indicate it addresses labels on shipped containers. OSHA also proposed adding a number of new types of information to the label: Product identifier, signal word, hazard statement(s), pictogram(s), precautionary statement(s), and the name, address, and telephone number of the chemical manufacturer, importer, or other responsible party. One commenter (Document ID #0520) proposed a different format for the requirements in paragraph (f). While OSHA appreciates the suggestion, the format followed by OSHA is dictated to a large extent by document drafting requirements of the
The final rule requires that labels on shipped containers contain much more information than required by the current standard. However, much of this additional information has already been included by manufacturers, particularly when following the ANSI standard for precautionary labeling. In addition, the OSHA requirements are intended to be the minimum information to be provided by manufacturers and importers. Under the GHS, as well as the current HCS and the final rule, chemical manufacturers and importers are free to provide additional information regarding the hazardous chemical and precautions for safe handling and use. The GHS and the final rule refer to this as supplemental information. Several commenters requested that this be permitted (Document ID #0132 and 0145). As has already been discussed above with regard to the definitions for hazard statements and precautionary statements, such additional information is permitted in Appendix C of the rule as long as it is accurate and does not conflict with the required label elements. Paragraph (f)(1) is adopted in the final rule as proposed except to provide clarity in light of OSHA deleting the requirement for labeling for hazards not otherwise classified. OSHA has modified paragraph (f)(1) to explicitly state that hazards not otherwise classified do not have to be addressed on container labels. Paragraph (f)(1) in this final rule now requires that chemical manufacturers, importers, or distributors ensure that each container of hazardous chemical leaving the workplace is labeled, tagged, or marked. Hazards not otherwise classified do not have to be addressed on the container. The paragraph also includes the information that the chemical manufacturer or importer must provide on the label, tag, or mark.
Paragraph (f)(2) of the proposal addressed labeling for unclassified hazards. As noted in the discussion on definitions, this has been changed to Hazards Not Otherwise Classified in the final rule. In addition to the change in the definition, OSHA has removed the proposed requirement for labeling unclassified hazards. Since there are no label elements in the rule to address these hazards, the Agency decided to cover them in a more limited fashion, and removed the requirement for labeling them from the final rule. Hazards not otherwise classified will still be addressed on the SDS.
Paragraph (f)(3) in the proposal elaborated the label requirements by stating that the required information would be taken from new Appendix C of the standard on Allocation of Label Elements, which incorporates the GHS labeling requirements. This Appendix specifies the signal word, hazard statement, pictogram, and precautionary statements for each hazard class and category. It also includes a few basic rules about preparing labels that address precedence of hazards and other topics. Thus once a hazard classification is completed, the chemical manufacturer or importer can refer to Appendix C to determine what information must be included on the label. Since paragraph (f)(2) of the proposal has been deleted from the final standard, paragraph (f)(3) of the proposal is now paragraph (f)(2) in the final rule. Each of the subsequent paragraph numbers have changed accordingly. New paragraph (f)(2) also requires that the label be prominently displayed, and in English (although other languages may also be included).
New paragraph (f)(3) requires the harmonized information to be located together on the label, tag, or mark. This paragraph has been adopted in the final standard as it was proposed.
The rest of paragraph (f) in the current standard remained largely the same in the proposed modified text, although conforming changes to terminology were made throughout the paragraph. The current standard's accommodation for labels associated with solid metal was maintained in the revised text, although OSHA has added a heading of “Solid materials” to it. The provision regarding conflicts with the requirements of DOT has also been maintained. In fact, since transport rules have been harmonized with the other sectors under the GHS, the possibility of a conflict in information is less likely when the HCS is consistent with the international approach. Two ANPR commenters specifically noted that OSHA should avoid conflict with DOT (Document ID #0064 and 0066). This is already addressed in paragraph (f)(5) in the final standard. NPRM commenters further noted that the exterior package should be for displaying DOT labels, rather than for OSHA labels (Document ID #0345). In general, this would be
The American Trucking Association (ATA) also raised the issue as to whether a GHS-compliant label might lead to a carrier's violation under DOT based on the carrier's “constructive knowledge” that a shipment contains a hazardous material (Document ID #0345). ATA suggested that OSHA and DOT need to work together to address this issue. OSHA contacted DOT and was told that this issue is addressed in 49 CFR 172.401, Prohibited Labeling. Specifically, GHS labels are exempted under 49 CFR 172.401(c)(5).
Under proposed paragraph (f)(7) (paragraph (f)(6) in the final rule), OSHA addressed workplace labeling. As noted previously, the current standard provides employers with flexibility regarding the type of system to be used in their workplaces. Some ANPR comments suggested that OSHA maintain this flexibility in the proposed standard (
OSHA did not propose to modify the remaining paragraphs on labels in the current HCS, including those that deal with alternatives to affixing labels to stationary containers; labeling of portable containers where the materials are transferred from a labeled container, used within a work shift, and under the control of the employee who performs the transfer; ensuring that all containers in the workplace have a label; a requirement for workplace labels to be in English and prominently displayed, while allowing the information to be in other languages as well; and the requirement for updating label information when there is new and significant information regarding the hazards of a chemical.
The only one of these provisions that received significant comment was the one regarding updating of label information within three months of receiving new and significant information regarding the hazards of a chemical. This provision ((f)(11) in the final rule) has been in the HCS since the 1994 revisions, but an administrative stay was placed on it shortly after it was promulgated in response to manufacturers' concerns. That administrative stay was never reconsidered or removed by OSHA, so the provision was not enforced. OSHA noted in the NPRM (74 FR 50283, Sept. 30, 2009) its intent to lift the stay, and requested comment and input on whether the time frame is appropriate. It should also be noted that an administrative stay is a tool available to OSHA to cease enforcement for reasons the Agency finds appropriate. It is not, as some appeared to assume, something that is adjudicated by an outside body, nor does it involve publication or documentation based on any type of record. It is usually a short-term solution to a problem that can be resolved through discussions with affected parties.
The current HCS requires that SDSs be updated within three months of learning of significant new hazard information, and that requirement has been enforced since the standard first went into effect in 1983. 29 CFR 1910.1200(g)(5). It is important to ensure that labels are similarly updated in a timely fashion, particularly since they provide the most immediate information in the workplace.
It appears that some commenters thought this provision was the effective date for updating the labels with the new GHS-aligned provisions (Document ID #0400, 0502, and 0513). This is not the case. Paragraph (j) of the final rule gives a much longer time period to implement the new GHS label requirements. Paragraph (f)(11), by contrast, addresses situations when a label must be changed because there is new and significant information about the hazards of the chemical. For example, there may be new studies that indicate an ingredient of the product is a potential carcinogen. This happens infrequently, so it is not anticipated that this provision would apply in many cases.
The key concern of commenters is what to do about stockpiles of chemicals that are already labeled. As noted by one commenter (Document ID #0370), new technology is available that links labels and SDSs, making new label generation more efficient. Stockpiles and distribution are now managed through computer programs that were not widely available in 1983. These programs can affect the amount of product kept in stockpiles, as well as the distribution of products in the supply chain, and thus the ability to deal with this updating issue. Consequently, a number of participants agreed that three months was an acceptable time frame (Document ID #0330, 0335, 0336, 0339, 0349, 0351, 0370, 0383, 0408, and 0410). Other commenters suggested that it was reasonable to allow sales to continue of products that are already labeled (Document ID #0313, 0323, 0327, 0328, 0329, 0344, 0351, 0361, 0375, 0377, 0381, 0399, and 0410). For example, Ecolab (Document ID #0351) stated:
Ecolab agrees that three months for labels to be updated with significant changes to the hazards is acceptable. However, it would also be reasonable to allow the sell-through of product that is already produced and labeled. By three months, we agree new production of that product should occur with the significant new information, as long as existing date-coded inventory can be sold without modification. * * *
Others thought the administrative stay should be continued (Document ID #0353 and 0405). Of those who suggested alternative time frames, a number thought twelve months would be appropriate (Document ID #0328, 0352, 0372, 0376, 0382, 0399, 0402, and 0405). Others indicated three months was not enough (Document ID #0379); updating at some time interval is needed (Document ID #0365); six months would be the minimum (Document ID #0324, 0344, and 0361); or a range of six or seven to twelve months would be appropriate (Document ID #0411).
The North American Insulation Manufacturers Association (NAIMA) detailed some of the factors that influence the ability of a manufacturer to update a label: (1) Identification of the products whose labels need to be changed; (2) drafting new label language, which might require redesign of the packaging; (3) the ability to obtain new label or packing stock for printing; (4) the availability of printers to print the new material within the required time; (5) and transportation time for stock to the printer, from the printer to the manufacturer, and from the manufacturer through the supply chain (Document ID #411). NAIMA argues that many of these factors may be beyond the control of the manufacturer.
OSHA will not maintain the stay. It is necessary that labels be updated to
One commenter suggested that OSHA add a new requirement that importers, distributors, and employers inform the chemical manufacturer in writing, within three months, when they become aware of significant information about the hazards of a chemical (unless they have already received this information from the chemical manufacturer) (Document ID #0520). The HCS has always been designed on the premise that the chemical manufacturer is in the best position to know what information is available about the chemicals produced. This information is then to be disseminated downstream to distributors and users of the chemical. This suggestion would create a very extensive new burden on parties in the distribution chain who are not responsible for the chemical or the information regarding it as required under the GHS. It is not consistent with the approach in the rule, and is not the most effective and efficient way to identify and distribute information. Therefore, OSHA rejects this suggestion. However, downstream users are free to inform manufacturers of new hazards of which they learn, and OSHA encourages the sharing of such information.
A few commenters on the ANPR also argued that a small package exemption, or some type of prioritization of information on small packages, should be permitted (Document ID #0043, 0046, and 0080). The current HCS does not have such an exemption or limitation, but the Agency has allowed practical accommodations in enforcement policies for those situations where an issue has occurred. (
In Revision 3 of the GHS, some provisions regarding small package labels have been included (1.4.10.5.4.4, Labelling of small packagings). The competent authority is given the discretion to implement changes that allow label preparers to reduce the required information to accommodate a small package size. OSHA did not propose to adopt such a provision, and has retained its current approach regarding small packages in the final rule. Very small packages are less frequent in the workplace than in consumer settings, and it is difficult to argue that employees should get less information just because of the size of the package. The practical accommodation approach OSHA has been utilizing addresses those situations where there is a valid issue, and ensures that workers receive all of the required information.
Following the NPRM, further comments were received on the issue of labeling small packages. Some suggested that OSHA should provide clear guidance for small containers, including perhaps a suggested priority for the label information (Document ID #0313, 0327, and 0339). Others thought the manufacturer should be permitted to pick the most important hazard and precautionary statements to include on small packages (Document ID #0405), or that OSHA should use the GHS guidance on the issue (Document ID #0342). Particular problems were noted, such as labeling small containers for reference standards (Document ID #0342). Phylmar Regulatory Roundtable testified during the hearing, and suggested that OSHA should either establish a priority for information on a small package label, or clarify what is meant by practical accommodations (Document ID #0497 Tr. 113).
The guidance in the GHS (1.4.10.5.4.4) basically allows countries to introduce a consideration of risk by determining that small quantities of the chemical are not a concern, or that information may be omitted because of the small volume. This approach is not consistent with the HCS, or with the concept of right-to-know. It is also unacceptable to OSHA to allow manufacturers to decide which information is the most important. Essentially, all of the suggested solutions result in less information being available to exposed employees than other employees would receive when exposed to the same chemical packaged in a larger container.
The concept of practical accommodations is difficult to define, since it entails a judgment by OSHA staff when confronted with the details of a specific situation. The point, however, is to find a way to provide the required information in every situation, and not to start with the premise that the solution is to omit such information. Ensuring that workers receive the required information may be accomplished in ways other than simply attaching it directly to each small container. OSHA will examine the situation to make sure that the information is associated with the proper containers, and that it is complete. OSHA is not adopting any regulatory requirements for small packages, but will consider whether any additional guidance is needed as the standard is implemented.
While the GHS specifies the information to be placed on a label, it does not provide a specific format for placement, which is similar to current HCS requirements. At least one commenter noted that the GHS does not specify a location or size of core information on a shipment (Document ID #0066). OSHA believes that the performance-oriented approach of paragraphs (f)(3) and (f)(10) is preferable. The Agency will allow accommodations to be made as long as the information is located together, and is prominently displayed as required.
A number of commenters endorsed the overall approach or specific parts of the label requirements. Comments included adopting the GHS labels (Document ID #0324 and 0339), supporting the flexibility of the in-plant labeling (Document ID #0392), and the use of signal words (Document ID #0321). Others wanted to ensure that hazards are conveyed accurately to all levels of education in the work force (Document ID #0331); supported allowing other languages on labels (Document ID #0381); suggested OSHA should allow flexibility of format and placement of required label elements (Document ID #0405); and suggested that OSHA should follow Revision 3 of the GHS for label requirements (Document ID #0382). OSHA believes that the final standard incorporates all of these concepts.
Appendix C details how the specified label elements apply to each hazard class and hazard category. OSHA has made some modifications to the
In C.2.1, “Precedence of hazard information,” addressing precedence of symbols, OSHA indicated that where the skull and crossbones is on a label, the exclamation point should not be included for acute toxicity. In the GHS, the statement simply says the exclamation point should not be included where the skull and crossbones is on the label. This is followed in the GHS by two other statements about not using the exclamation point for specific hazards when there is already a symbol for the more severe category of the same hazard. OSHA received a comment that the phrase “where it is used for acute toxicity” should be deleted since it is not in the GHS (Document ID #0393). OSHA believes that this phrase is appropriate for clarity and parallel construction with the other provisions of the paragraph. The skull and crossbones symbol only addresses acute toxicity, and does not convey other types of effects.
One commenter indicated that paragraph C.2.3.3 should not be mandatory (Document ID #0335). The paragraph indicates that when there is a DOT pictogram for a hazard on a label, an additional GHS pictogram for the same hazard must not appear. The reason it is mandatory is that having two different pictograms addressing the same hazard may lead to confusion for people handling the chemical.
OSHA also indicated that it was proposing to exclude ammunition and ammunition components under Division 1.4S from having the exploding bomb symbol and precautionary statements normally used for explosives (74 FR 50283, Sept. 30, 2009). This proposed exclusion was based on discussions during OSHA's rulemaking to update the explosives standard, and the issue of ammunition being sold in retail establishments. The Agency asked for input on whether the exclusion of the symbol was sufficiently protective, and whether any adjustments needed to be made. Several people thought the symbol should be included on ammunition and components since they are explosive (Document ID #0313, 0327, and 0328). However, others thought it was appropriate to treat ammunition and components differently, and that the exploding bomb does not represent the hazards of ammunition (Document ID #0330, 0336, 0338, 0370, and 0376). OSHA agrees with these commenters that the exploding bomb does not represent the hazards of ammunition, implying that there is a mass explosion hazard when handling these items, although that is not the case. Therefore, the Agency is maintaining the proposed provisions in the final standard, and will not be requiring a symbol or precautionary statements for ammunition and ammunition components.
A question was raised by the National Propane Gas Association (Document ID #0400) regarding signal words for propane if both simple asphyxiant and flammability hazards are covered since they have different signal words (warning and danger, respectively). Appendix C explains the precedence rules for signal words. Only one is ever required on a label. If one of the hazards warrants a “danger” signal word, then that will be the only one required on the label.
A few comments were also received about the interface of the new OSHA label requirements with the requirements of other agencies. For example, it was noted that it would be difficult to use one label to comply with both OSHA and CPSC (Document ID #0405), and that EPA and CPSC should accept GHS labels until they adopt the system themselves (Document ID #0328). OSHA does not have authority to determine the policies of other agencies with regard to accepting the new GHS-aligned labels. Another commenter noted that fireworks are regulated by other agencies, and therefore additional requirements are burdensome (Document ID #0355). The new OSHA requirements will be essentially harmonized with DOT's requirements, which will facilitate compliance with both agencies. Lastly, it was noted that OSHA should coordinate label implementation with Canada's Workplace Hazardous Material Information System (WHMIS) (Document ID #0461). As was noted earlier, OSHA does have bilateral discussions with Canada on implementation issues—however, Canada has not yet adopted the GHS or initiated implementation by regulation.
While this performance orientation was supported by chemical manufacturers when the standard was originally promulgated, it was largely based on the positions of those who were already providing SDSs and did not want to change their format. As the scope of the standard was expanded to cover other industries, it became clear that SDS users preferred a uniform order of information or a format. In particular, stakeholders such as emergency responders were concerned that information not being located in the same place on every SDS could create an increased risk in situations where the information was needed quickly.
Several years after the HCS was adopted, the chemical manufacturers themselves responded to these concerns by developing a national voluntary industry consensus standard that included a 16-section SDS (ANSI Z400, Hazardous Industrial Chemicals—Material Safety Data Sheets—Preparation). This consensus standard establishes the titles of each section and the order of presentation. It addresses concerns raised by also putting information of most use to those exposed in the beginning of the SDS, with the more technical data required by health and safety professionals in later sections. ANSI Z400 also responded to comments indicating that the SDS should be essentially “one stop shopping” in terms of information on a chemical, and should include other information such as how it is regulated by other Federal agencies, including transport requirements and environmental information by having sections for each of those categories of information.
In 1990, OSHA published a Request for Information (RFI) that addressed the issues of comprehensibility of labels and SDSs (55 FR 20580, May 17, 1990). Nearly 600 comments were received, and the majority of respondents sought an order of information or format for SDSs. Since the international harmonization process had begun at that point, OSHA thought it would be useful to wait until a globally harmonized SDS was available before changing the
The 16-section format continued to be recognized in different countries and organizations over the years, including an International Labour Organization (ILO) recommendation on chemical safety, the European SDS requirements, and an International Standards Organization standard on SDSs. When the GHS was developed, it was decided that this 16-section format was already a
Since the 16-section SDS was initiated in the U.S. by industry, many companies have been using it. This adoption by industry will reduce the impact of the harmonized GHS requirements. Others who continued to use different formats will need to change their SDSs to conform. There is already software available to assist in developing SDSs in the 16-section format, and it is expected that more tools will be available as the dates for SDS compliance approach.
OSHA proposed to modify paragraph (g)(2) to establish the section numbers and title headings of the sections of the SDS to be consistent with the GHS. Furthermore, a new Appendix D was proposed to be added to the standard to address safety data sheets, and it indicates what information must be included in each section.
As OSHA indicated in the ANPR and the NPRM, sections 12 through 15 of the SDS require information on subjects that are outside the Agency's jurisdiction (
The revised SDS would require the following sections:
Section 1. Identification.
Section 2. Hazard(s) identification.
Section 3. Composition/Information on ingredients.
Section 4. First-aid measures.
Section 5. Fire-fighting measures.
Section 6. Accidental release measures.
Section 7. Handling and storage.
Section 8. Exposure controls/personal protection.
Section 9. Physical and chemical properties.
Section 10. Stability and reactivity.
Section 11. Toxicological information.
Section 16. Other information, including date of preparation of the last revision.
A note in the revised text addresses the other sections that are not mandatory for OSHA:
Section 12. Ecological information.
Section 13. Disposal considerations.
Section 14. Transport information.
Section 15. Regulatory information.
The remainder of the paragraph on SDSs remains the same as the current HCS. The final rule, like the proposal, retains the current HCS design, ensuring the downstream flow of information from the chemical manufacturer or importer to the distributor and ultimately the employer. Other provisions (completion of all sections of the SDS; provisions for complex mixtures; the requirement for information to be accurate and reflect the scientific evidence; the need to update the SDS when new and significant information is available; maintenance of SDSs so they are accessible to employees; accommodations for situations where employees travel between workplaces during a work shift; and access for OSHA and NIOSH) remain in this final standard as they are in the current standard, although they have been re-numbered.
As was the case with labels, relatively few comments were submitted in response to the ANPR or the NPRM on the specific provisions for SDSs. The final provisions are generally consistent with the current HCS, with the exception of the standardized approach described above that OSHA proposed and adopted in the final rule.
The only text changes that were made to the provisions that follow (g)(2) in the standard were to revise the terminology to be consistent with the new approach. However, there were some editorial suggestions for other changes (Document ID #0353). Consistent with OSHA's stated intent to not change anything that does not require change to align with the GHS, these suggestions have not been implemented in the final rule.
A number of rulemaking participants stated that they support the standardization of SDSs, and some noted that standardization would facilitate training (Document ID #0307, 0321, 0322, 0349, 0456, and 0463). It was suggested that OSHA update (g)(8) to (g)(10) to indicate that electronic distribution is acceptable (Document ID #0376 and 0395). It is already stated in (g)(8) that electronic access is acceptable for employees (although OSHA has removed “microfiche” from this provision since that technology is outdated and rarely used and in any event is captured under the broader term “other alternatives,” which is retained in the final rule). Electronic distribution is not precluded, although the employer on the receiving end of the information must be able to access it in that form. The general issue of electronic distribution and access is addressed in the compliance directive for the standard (CPL 02-02.038), and is based on recommendations made by the National Advisory Committee on Occupational Safety and Health (NACOSH). As explained in the directive, electronic distribution is permitted, but the appropriateness of its implementation will be judged as follows:
MSDSs must be readily accessible and there must be no barriers to employee access during the work shift. The Agency interprets the term “readily accessible” to mean immediate access to MSDSs. The employer has flexibility to determine how this will be accomplished. The use of electronic means such as computers with printers, microfiche machines, the Internet, CD-ROMS, fax machines, etc., is acceptable. Employers using electronic means to supply MSDSs to their employees must ensure that reliable devices are readily accessible in the workplace at all times; that workers are trained in the use of these devices, including specific software; that there is an adequate back-up system for rapid access to MSDSs in the event of an emergency, including power outages, equipment, and on-line access delays; and that the system is part of the overall hazard communication program of the workplace. Additionally, employees must be able to access hard copies of the MSDSs, and in the event of medical emergencies, employers must be able to immediately provide copies of MSDSs to medical personnel. Mere transmission of the requested information orally via telephone is not acceptable.
Employers may use off-site MSDS management services to meet the requirements of the HCS only if MSDSs are readily available to employees, either as hard copies in the workplace or through electronic means and as long as the provisions outlined
When immediate access to paper or hard copy MSDSs does not exist, CSHOs should evaluate the performance of the employer's system by requesting a specific MSDS. Ultimately, the evaluation of an adequate system will rely on the professional judgment of the CSHO. Factors that may be appropriate to consider when determining if MSDSs are readily accessible include:
(1) Are the sheets or alternative methods maintained at a location and under conditions where employees can access them during each work shift, when they are in their work areas?
(2) If an electronic system is used for MSDS access (computer, fax, etc.) do employees know how to operate and obtain information from the system? (CSHOs should request an employee to retrieve MSDSs using the electronic system.)
(3) Was there an emergency/accident where immediate access was critical?
(4) How quickly did the employer respond to the employee's request?
Employees must have immediate access to MSDSs and be able to get information when they need it in order for an employer to be in compliance.
On multi-employer job sites, employers who produce, use or store hazardous chemicals in such a way that other employers' employees are exposed or potentially exposed, must communicate to other employers how the means of access to MSDSs will be accomplished.
Various suggestions were made for improvements to SDSs. For example, it was suggested that the SDS be limited to five pages (Document ID #0415); that a one-page, eighth-grade reading level summary of its contents should be provided (Document ID #0306); and that SDSs be written in plain and simple language (Document ID #0347). OSHA agrees that SDS preparers should try to ensure the SDSs are written clearly, and preparers should consider the audience in determining how the information may be best communicated. As originally designed by ANSI, the sections in the beginning of the SDS are intended to be written in plain language, with fewer technical terms where possible. This information should be of immediate use in emergency situations, and addresses information that exposed workers are most likely to need (summary of hazards for example). But many of the remaining sections of the SDS require technical information, and they are intended to be of use primarily to professionals designing protective measures or providing services such as medical surveillance to exposed employees. These sections need to retain their technical terminology in order to be useful to the professionals for these purposes. It is difficult to regulate those aspects of preparing documents that are intended to convey technical information, and no specific requirements of this type have been included in the final standard.
There was also a comment that the Superfund Amendments and Reauthorization Act (SARA) refers to material safety data sheets (
One commenter suggested that OSHA add to the SDS the date the chemical was produced, where chemical testing occurred to determine SDS data, and the manufacturer's Web site (Document ID #0346). OSHA rejects this suggestion, noting that the final rule does not require adding information to the SDS that would make it significantly different from the GHS harmonized information requirements. Furthermore, it would not be practical to require either the date the chemical was produced (which would result in a costly requirement to revise SDSs for every day the chemical was produced), or where chemical testing occurred (which may not be known, given that such information is obtained from many different sources, and studies do not frequently indicate where the testing occurred). However, suppliers are free to provide this information on their Web sites, and often do.
In the NPRM, OSHA noted that mixture safety data sheets could no longer be prepared by attaching multiple SDSs for the ingredients, but rather would have to be an SDS for the mixture as a whole (74 FR 50392, Sept. 30, 2009). One commenter (Document ID #0334) thought the multiple SDSs practice should continue to be allowed, particularly to minimize burdens for small businesses. OSHA believes that this approach is not in compliance with the GHS-aligned requirements. It also does not provide the best information for those downstream, including small business users.
New mandatory Appendix D, “Safety Data Sheets,” provides additional requirements for the information to be included under each section heading. The sub-headings used to indicate the additional information were lettered (
Another commenter indicated concern that Appendix D does not refer to ANSI Z400.1 or Annex 4 of the GHS (Document ID #0336). OSHA does not believe that reference to either of these documents is necessary since Appendix D is self-contained. As Appendix D is mandatory, those documents would have to be incorporated by reference to be referred to, and that is not necessary for purposes of compliance with the standard. However, both ANSI Z400.1 and Annex 4 would be useful references for SDS preparers since they provide additional guidance for completing an SDS.
In the final rule, a small modification has been made to the introduction to Appendix D to indicate that a subheading “within a section” needs to be marked when no relevant information is available. Also, OSHA has added column identifiers of “heading” and “sub-heading” to clarify what is being referred to by that terminology.
Additional comments were received on specific sections of the SDS. For example, in section 1, “Identification,” the American Chemistry Council wanted clarification of subheading (c), “Recommended use of the chemical and restrictions on use” (Document ID #0393). As explained in Annex 4 of the GHS, A4.3.1.3, the SDS preparer should “provide the recommended or intended use of the substance or mixture,
On Section 2 of the SDS, “Hazard identification,” the Soap and Detergent Association argued that the requirement for precautionary statements in subheading (b) should not be included because they are not mandatory in the GHS (Document ID #0344). However, the GHS requires that precautionary statements appear on a label (1.4.10.5.2(c)), and Annex 4 (A.4.3.2.2) indicates that the GHS label elements, including precautionary statements, should be included in Section 2 of the SDS. As has already been discussed, OSHA is adopting the GHS precautionary statements, so they are mandatory for purposes of complying with this standard.
Other commenters questioned what was meant by “unknown toxicity” in Section 2, subheading (d) (Document ID #0367 and 0371). This term refers to the criteria for determining the acute toxicity of a mixture where there are ingredients that have no available acute toxicity data. In this case, the percentage of ingredients that have no data to consider in the calculations must be indicated in Section 2. In the final rule, OSHA has slightly modified sub-heading (d) to clarify this reference.
In addition to this clarification, two other changes have been made in Section 2. First, references to paragraphs (d) and (f) said “paragraph (d)[(f)] of this section,” which is the normal regulatory reference since the entire standard is called a “section” of the Code of Federal Regulations. However, since parts of the SDS under the “Headings” column are also referred to as sections, it was confusing. Section 2 now refers to the section number of the standard, 1910.1200. This change is tracked in other parts of Appendix D as well. Second, subheading (c) has been revised to refer to hazards not otherwise classified, rather than unclassified hazards, consistent with modifications to the regulatory text.
In Section 3, “Composition/information on ingredients,” commenters indicated that OSHA had left out a phrase that appears in the GHS with regard to identification of ingredients in a mixture (Document ID #0344 and 0393). This was an oversight, and OSHA has added the language “and are present above their concentration limits/cut-off levels” into Section 3. To ensure consistency with the classification criteria, OSHA has also clarified that ingredients that present a health risk below the cut-off/concentration limits would also need to be disclosed in section 3 of the SDS. It was also suggested that where the SDS discloses only the range of concentrations, the narrowest range possible should be permitted (Document ID #0395). Neither the GHS provisions for information on SDSs, nor the guidance for completing them, address specific limits for concentration limits. Under the current rule, concentrations of chemicals in a mixture are not required to be disclosed at all. OSHA agrees with the commenter that when SDS preparers use ranges rather than a specific percentage composition, the range must be limited in terms of the percentage concentration variation, and the variation in concentration must have no effect on the hazard of the mixture.
In order to help ensure that use of concentration ranges is understood, OSHA has added the term “concentration” in parentheses after the “exact percentage” terminology used in paragraph (i)(1) regarding trade secret protection. Similarly, the term “exact percentage” has been added in parentheses after “concentration” in Section 3 requirements for the SDS. These terms refer to situations where the mixture has a set formula, and the amount of a substance in the mixture is consistent from batch-to-batch. OSHA recognizes that there are some very small variances in this situation that have no impact on the hazard of the overall mixture. “Exact percentage” is the terminology used in the GHS guidance for preparation of SDSs, but these small variations or tolerances are expected and acceptable when reporting the anticipated percentage based on the formula.
Concentration ranges, rather than concentrations, may be used in other situations. For example, the final standard includes the longstanding provision that addresses the use of a single SDS for complex mixtures in paragraph (g)(4). Under this provision, where complex mixtures have similar hazards and contents (the ingredients are essentially the same, but the specific composition varies from mixture to mixture), one SDS may be used for all of these similar mixtures. Petroleum streams would be an example of a type of complex mixture to which this provision applies. In this situation, concentration ranges may be used for the ingredients that vary from stream to stream.
A chemical manufacturer or importer may also have a line of products that are very similar, but can be varied slightly in composition to meet the needs of customers. For example, toner colors may be changed by varying the amount of pigment. The variances are small, and the hazard remains the same. In these situations, concentration ranges may be used for multiple, similar products.
Trade secret status may be claimed for exact percentage composition but not for concentration ranges. Where a trade secret claim is made for exact percentage, the chemical manufacturer or importer may choose to provide a concentration range to assist downstream users in providing appropriate protections and, at the same time, potentially eliminating requests from users for disclosure of the trade secret in accordance with § 1910.1200. However, Section 3 must indicate that a trade secret claim is being made and information has been withheld.
Section 8 addresses exposure controls and personal protection. Some commenters noted that the information provided should have more detail than what was proposed in Appendix D, such as requiring information on specific PPE materials that provide protection (Document ID #0359 and 0456). OSHA agrees that SDS preparers should provide the most specific information available for the material so that the appropriate protective measures can be implemented. Annex 4 of the GHS, guidance for preparing the SDS, addresses the specific type of information on personal protective equipment that should be provided in Section 8 of the SDS in paragraph A4.3.8.3. OSHA will be making additional guidance available when the rule is implemented.
Section 8 also addresses inclusion of occupational exposure limits (OELs) on the SDS. Comments were received on inclusion of exposure limits on SDSs in response to the ANPR, and a number of different opinions were expressed, particularly regarding TLVs being required. Many ANPR commenters argued that TLVs should be included on the SDSs, as is currently required under the HCS (
In the NPRM, OSHA proposed to maintain the requirement to include its mandatory permissible exposure limits
First, many people agreed that the PEL should be on the SDS (although some acknowledged that they are out-of-date) (
Our industry generally supports the requirement to include OSHA PELs, but not require the other recommended limits on SDSs. In particular, the American Conference of Industrial Hygienists (ACGIH)_TLVs, while able to provide useful information often lack credibility. As the result of a sometimes flawed development process, the TLVs can be misleading and their use can reduce clarity of communication. For certain materials, some manufacturers may choose to include TLVs on an SDS, or include other non-mandatory exposure values, including their own recommendations, but this should not be mandatory. The relevance of such other non-mandatory guidelines should be determined by the manufacturer who can best explain the meaning, context and limitations of such values.
Others specifically supported the approach proposed (
Clariant supports the recommendation to “include other occupational exposure limits used or recommended”. Clariant would also support a non-mandatory appendix to the HCS to include reference to the TLVs and other occupational exposure limits such as the AIHA WEELs. Many companies already include other occupational exposure limits on their SDS. In most cases, those other limits are more up-to-date than the OSHA PELs.
Many commenters supported mandatory disclosure of applicable TLVs on the SDS in Section 8 (
For example, the Center for Regulatory Effectiveness argued that OSHA's decision to require the disclosure of ACGIH TLVs on SDSs is inconsistent with the requirements of the Information Quality Act, Public Law 106-554, § 1(a)(3), Title V, § 515, 114 Stat. 2763 (2000). That act required OMB and DOL to issue guidelines “ensuring and maximizing the quality, objectivity, utility, and integrity of information * * * disseminated by the agency.” 44 U.S.C. 3516, note, at (b)(2)(A). Both OMB and DOL have issued such guidelines, and in addition OMB issued the “Peer Review Bulletin,” citing the authority of the Information Quality Act. OMB,
All three documents except from the definition of information “opinions, where the agency's presentation makes it clear that what is being offered is someone's opinion rather than fact or the agency's views.” (OMB Guidelines V.5; DOL Guidelines at 5, 13-14; Peer Review Bulletin I.5.) OSHA understands this to mean that the guidelines do not apply unless the public could reasonably understand the information being disseminated as the official view of the agency. This understanding is supported by a number of statements by OMB and DOL. In the preamble to the Peer Review Bulletin, for example, OMB states that “[a]n information product is not covered by the Bulletin unless it represents an official view of one or more departments or agencies of the federal government.” 70 FR at 2667/2. Likewise, DOL's guidelines do not apply to information “clearly represented as opinion and not an official agency or Departmental representation.” DOL Guidelines at 3. Hyperlinks on an agency's Web site to information on non-governmental Web sites are not an agency dissemination of information, nor is a private researcher's publication and communication of the results of a government-funded study, where an appropriate disclaimer appears. OMB Guidelines V.5; 67 FR 8454/1; DOL Guidelines at 5, 13-14.
Users of hazardous chemicals could not reasonably think that ACGIH TLVs listed on an SDS are OSHA's dissemination of information as to the correct or feasible level of exposure to the chemical. As explained on the ACGIH Web site, TLVs are the ACGIH's statements of “scientific opinion” (Document ID #0529). The SDS is prepared by the manufacturer and represents the manufacturer's understanding of the hazards of the chemical, the appropriate conditions of use, and the necessary protective measures to be employed. It is hard to see, in that context, how a user of the SDS could understand that the TLVs listed on the SDS represent information disseminated by OSHA. The TLV will be identified as such on the SDS. Indeed, in the many cases where there is an applicable OSHA PEL, the PEL will also be listed in addition to the TLV.
Further, if TLVs are “information” for purposes of the IQA, then so too is everything in the SDS. If that were true, it would render the approach of the HCS unworkable because it would require OSHA to review and approve every manufacturer's label and SDS. OSHA does not believe Congress intended such a result in enacting the IQA.
The Center for Regulatory Effectiveness and the AFL-CIO's Building and Construction Trades Department suggested that OSHA could
There are other reasons the IQA guidelines do not apply here. The OMB and DOL guidelines only apply to information “first disseminated after October 1, 2002” (OMB Guidelines III.4; DOL Guidelines at 2), and OSHA has required TLVs to be disclosed on MSDSs since 1983. Moreover, the guidelines are “not intended to impose any binding requirements on DOL or the public or * * * to provide any right to judicial review” (DOL Guidelines at 2). Rather, “information quality [is] an important management objective.” (
At least one commenter suggested that requiring disclosure of the TLV would violate the Administrative Procedure Act's notice and comment requirements, to the extent that the SDSs were required to disclose TLVs that the ACGIH might adopt after the final rule is published (Document ID #0361). That contention was rejected in
Finally, a number of commenters expressed concerns about the procedures ACGIH uses in adopting TLVs (Document ID #0083, 0084, 0361, 0371, 0372, and 0529). Typical of these is the comment from the Independent Lubricant Manufacturers Association:
TLVs are developed by way of ACGIH committees that operate in secret with
As explained on its Web site, ACGIH TLVs “represent conditions under which ACGIH believes that nearly all workers may be repeatedly exposed without adverse health effects. They are not fine lines between safe and dangerous exposures” (Document ID #0529). TLVs are to be used by industrial hygienists in determining safe exposures in workplace, according to the ACGIH, but “are only one of multiple factors to be considered in evaluating specific workplace situations and conditions.” (
The record evidence shows that the ACGIH uses a reliable and open method to develop TLVs with ample opportunity for public input. ACGIH TLVs are set by the Threshold Limit Value Chemical Substances Committee (Document ID #0536). Members of this committee are chosen for their expertise in industrial hygiene, occupational medicine, epidemiology, toxicology, or related fields such as statistics or chemistry, and members are selected to maintain a balance between these specialties. (
The ACGIH has a conflict of interest policy, requiring that members disclose, both orally and in writing, “potential, real, or perceived conflict[s] of interest” with respect to a substance under consideration (Document ID #0536). The Committee chair is required to conduct a conflict of interest presentation annually, and Sub-committee chairs will typically inquire at the beginning of meetings as to whether members' conflict status has changed. (
Once the relevant ACGIH sub-committee decides to consider a new TLV, it is included on an “Under Study” list that the ACGIH publishes each February 1. (
The author and the sub-committee review the public comments received, and the draft documentation is amended if necessary. (
NIOSH, the Kentucky Labor Cabinet, the American Industrial Hygiene Association, the American Society of Safety Engineers, the Alliance of Hazardous Materials Professionals, and several occupational safety and health consulting firms support the TLV requirement, stating that ACGIH TLVs are useful in developing health and safety programs and are widely used in industry (Document ID #0313, 0323, 0327, 0336, 0354, 0365, 0410, 0412, 0496, and 0521). A number of manufacturers and manufacturer associations also support the TLV requirement (Document ID #0328, 0330, 0332, 0353, 0413, and 495). The International Chemical Safety Cards, prepared under the auspices of the UN, list TLVs (Document ID #0497). TLVs are currently required to be disclosed under the HCS, and witnesses testified that failure to include TLVs on SDSs in the final rule would render the standard less protective of worker health because TLVs are more up to date and cover more substances than OSHA's PELs (Document ID #494 Tr. 28-29, 94; Document ID #496 Tr. 368, 382).
Based on this record, OSHA finds that commenters' objections to TLVs are without merit. TLVs are set through an open process with ample opportunity for public input through the comment and symposium process; the fact that the ACGIH does not hold public hearings on proposed TLVs does not undermine the fairness of the process. While OSHA agrees that TLVs do not address feasibility concerns, it finds that TLVs are useful information for employers and employees to use in evaluating the hazards presented by chemicals used in their workplaces. OSHA finds that the record does not support the contention that TLVs have “compromised scientific value” because of the process used by the ACGIH. Each TLV is supported by a documentation explaining the evidence and assumptions on which it relies; these documentations are subjected to public comment and approved at several levels within the organization. It is certainly possible that a manufacturer or importer might disagree with the scientific judgments embodied in a TLV, but the final rule allows them to set forth their own recommendations about an appropriate exposure level on the SDS. Based on the ACGIH's procedures and the evidence of TLV use by industry, occupational safety and health professionals, and NIOSH, OSHA reaffirms its position that, in general, TLVs provide useful information that should be disclosed to employers and employees using hazardous chemicals.
Some commenters supported requiring other limits to be on the SDS in addition to the TLVs, such as the NIOSH Recommended Exposure Limits (RELs); the AIHA Workplace Environmental Exposure Limits (WEELs); and the German maximum allowable concentrations (MAKs) (
Providing occupational exposure limits (OELs) helps workers and employers understand the relationship between exposure concentration and adverse health effects. NIOSH supports the requirement of including PELs on the SDSs and further suggests that OSHA consider adding additional exposure limits, whenever available, such as NIOSH recommended exposure limits (RELs), American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values (TLVs), American Industrial Hygiene Association (AIHA) Workplace Environmental Exposure Limits (WEELs), and German maximum allowable concentrations (MAKs) * * *.
There were a number of other comments on the issue of exposure limits in Section 8 of the SDSs, such as asking for an explanation of “any other exposure limit used or recommended” by the SDS preparer (Document ID #0329, 0351, 0382, 0381, and 0393), including whether this means exposure limits from other countries. There was also a suggestion to delete “used or” from the requirement (Document ID #0339). This language is in the current HCS, and is intended to include any exposure limits developed by the producer to protect their own employees, as well as other exposure limits commonly available such as the TLV or REL. It may also include exposure limits from other countries, but there is no intent to require that every known exposure limit in the world be provided. OSHA does not agree that it is appropriate to delete “used or” since companies often have exposure limits to protect their own employees, and this information can help their customers to determine what is needed to protect downstream employees as well. Others thought inclusion of exposure limits in addition to the PELs would confuse small businesses (Document ID #0372), or be detrimental to harmonization (Document ID #0464).
The AFL-CIO summarized their view of the record on this issue, as well as that of other worker representatives, in their post-hearing brief (Document ID #0645):
We believe that OSHA needs to issue a final rule that restores the requirement to list the TLV on the SDS and strong record evidence supports our position. There is broad support for this position, covering a wide range of organizations including NIOSH (Ex. 0412.1) unions (AFL-CIO, Ex. 340.1; Building and Construction Trades Department, Ex. 0359.1; and the Steelworkers, Ex. 0403.2); safety and health professional associations (American Society of Safety Engineers, Ex. 0336.1); employers and their representatives (Dow Chemical Company, Ex. 03353.1); Patton Boggs, Ex. 0413.1); and individual experts (Adam Finkel, Ex. 0401.1; Harry Ettinger, Ex. 0319.1).
In Section 8 of the SDS in the final rule, OSHA has included the language used in the current rule to describe what exposure limits are to be addressed: “OSHA permissible exposure limit (PEL), American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV), and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the safety data sheet, where available.”
As noted in the NPRM, OSHA took the reference to TLVs out of Section 8 of the SDS in the interest of limiting country-specific deviations from the GHS. However, based on many comments in the record, OSHA has concluded that the TLVs provide useful information for those designing
With regard to the recommendations for other exposure limits to be included on the SDS, OSHA agrees that referring to those exposure limits could also be useful, and would encourage SDS preparers to include them where available. However, the Agency is still concerned about including additional country-specific deviations, especially for limits that are less available than the TLVs. Providing too many different exposure limits may also be confusing to employers. Publication of a non-mandatory appendix would require OSHA to continually update it, as these different lists are prepared by various organizations. Since the Code of Federal Regulations is only updated annually, the Appendix would always be out-of-date. We do not believe this would be helpful in the long term, and that resources would be better put to other purposes than updating a non-mandatory appendix.
In the NPRM, OSHA did not propose to continue to require specific mention of IARC, NTP, and OSHA as sources of determinations regarding carcinogenicity. The requirement to consider these sources definitive in terms of a carcinogen determination was not included in the NPRM since it was not part of the GHS approach. However, as was discussed above, OSHA has modified Appendix F to allow classifiers to use these sources when assessing carcinogenicity, rather than applying the criteria to the data themselves. In order to facilitate this, OSHA has provided a table in Appendix F that aligns the GHS criteria with those of IARC and NTP. In addition, OSHA has decided to retain the requirement to include this information on the SDS in Section 11. This information will be of use to classifiers, as well as to employers and employees, when ascertaining potential hazards and determining appropriate control measures. This was supported by some commenters (
OSHA indicated in the NPRM that Sections 12 through 15 of the SDS were not going to be mandatory since they involved information that is outside OSHA's jurisdiction. With regard to Section 12 on environmental effects, some commenters expressed concern about the lack of harmonization with trading partners on environmental issues, or suggested that OSHA should work with EPA on this issue (
Similarly, comment was received suggesting that Section 14 on transport information should be required, and producers should indicate whether the product is, or is not, covered by DOT's Hazardous Material Regulations (Document ID #0345). While OSHA does not have authority to require this to be included in Section 14, we certainly agree that it would be useful information for users of the chemical, and encourage producers to complete Section 14.
In the final rule, non-mandatory Section 15 of the SDS is intended to provide other regulatory information. OSHA raised as an issue for comment whether this section should be made mandatory by requiring regulatory information on OSHA's substance-specific standards be included in it. Employers can, of course, voluntarily list information about other OSHA standards (Document ID #0376), but voluntarily provided information is not subject to enforcement. Many of the respondents commented that Section 15 should not be made mandatory (
While OSHA agrees that there is merit in including the substance-specific standards in Section 15 to inform chemical users of their existence and applicability, it is difficult to make completion of Section 15 mandatory since there is likely to be considerable other information in the section that would not be enforceable by OSHA. Having a section that includes both mandatory and non-mandatory information is potentially confusing to the regulated community. Additionally, the PELs will already be indicated in Section 8, and will thus inform the user when there is a substance-specific standard of concern. Therefore, while OSHA encourages additional information in Section 15, it remains non-mandatory in the final rule.
One suggestion received for Section 16 indicated that the preparer should identify the exact changes made to the SDS when revising it so the user can determine if re-training is needed (Document ID #0469). Presumably, the user would review the changes to decide whether re-training is needed. However, the success of such an approach would depend on how often the chemical is purchased, and a new SDS is received. If the chemical has not been purchased for a while, and a new SDS only indicates what changes have been made since the last update, the user could have missed versions of the SDS in the interim, and thus would not know all of the changes that had been made since the last SDS was received. In addition, adding such a requirement would make the OSHA provisions internationally inconsistent.
In the workplace, it is expected that all of the GHS elements will be adopted, including labels that have the harmonized core information under the GHS, and safety data
OSHA agrees that training is key to ensuring effective hazard communication. Under the current HCS, training is used to explain the label and SDS systems used in a workplace, and to address the hazards of chemicals and protective measures. While the written information provided is clearly important, training is an opportunity to explain the data and helps to ensure that the messages are being received accurately so they can be acted on appropriately. (
The training provisions in the HCS do not need to be modified to be consistent with the GHS since it does not include such requirements. However, OSHA proposed small revisions to track terminology used in other paragraphs, as well as to clarify the requirement to train on the details of the hazard communication program in (h)(3)(iv). While training on the program has always been required in the HCS, OSHA believed that modifying the text slightly would convey the need to address both the labels that will arrive on shipped containers, as well as any workplace-specific system that the employer uses. In addition, the training on SDSs must include the order of information. The final rule requires that training include the details of the hazard communication program developed by the employer, including an explanation of the labels received on shipped containers and the workplace labeling system used by their employer; the safety data sheets, including the order of information and how employees can obtain and use the appropriate hazard information.
OSHA proposed that employers train or re-train employees regarding the new labels and safety data sheets within two years after the rule is promulgated. The Agency believes that the training needs to be completed by the time employees begin to see labels and safety data sheets with the new information on them, rather than waiting until after the transition has been completed.
Some commenters to the ANPR noted that training would be required to ensure employees understand, in particular, the symbols and pictograms that will be used on labels. Some argued that the burden would be substantial given that all training would have to be revised, and the time and resources required would be significant (
Marshfield Clinic (Document ID #0028) noted that communication of information about chemicals and other hazardous substances:
* * * is one of the more difficult to get across to workers. It is very appreciated that OSHA is revisiting this. Standardization will greatly assist in giving workers a better understanding of the hazards they may encounter when working with chemicals and other hazardous substances.
Similarly, Alcoa (Document ID #0042) suggested: “A standardized format will simplify hazard communication training and the use of pictograms will alleviate some of the problems presented by poor language skills.”
There were a few commenters who argued that the standardized approach either would not simplify training, or they did not know if it would (
The majority of the comments made on the training provisions suggested additions to the existing requirements to further specify what is expected, and to improve the training. These comments were submitted primarily by worker representatives, or by the National Institute of Environmental Health Sciences (NIEHS) (
* * * Given the significance of education and training, OSHA should develop a mandatory appendix to the Proposed Rule that sets forth the elements (including an evaluative component) of an acceptable education and training program.
As noted above, OSHA agrees with these commenters that effective training is a key part of hazard communication. While the GHS does not include such requirements, the developers also recognized the importance of including training in national programs, and encouraged countries to do that. In addition, the United Nations Institute for Training and Research (UNITAR), which is the international focal point for capacity building on the GHS, is developing training courses to be made available to developing countries, in particular to assist them in adopting the GHS.
As described, OSHA proposed a slight modification to ensure that employers are aware that they need to train specifically on the new label elements and SDS format. This modification is in the final rule, and the training on these aspects is to be completed prior to other provisions going into full effect. OSHA does not agree that other changes should be made to the training provisions of the HCS at this time. As also indicated in this document, the changes to the HCS being promulgated are focused on what is necessary to comply with the GHS. Since the GHS does not have any training requirements, the modification proposed and adopted by OSHA is what is necessary to ensure appropriate compliance with the revised standard, and does not introduce any new approaches or requirements.
OSHA is planning to provide additional guidance to help ensure appropriate training is conducted when complying with the revised HCS. A draft Model Training Program was posted for comment on OSHA's Web page some years ago. It includes many of the concepts addressed in the comments received, but was never finalized. While it was designed to provide an array of tools from which employers could choose what they needed based on their workplaces (lesson plans and slides), there were comments received at the time that it was too long for small employers. OSHA believes that the model program includes important information about conducting appropriate training (which was also the view of other commenters on the program). It is being revised and updated to be consistent with the revised rule, and will be made available on OSHA's Web page. A shorter guidance document for small employers is also being developed.
In addition to these training-specific tools, OSHA has other tools under development that could be used in training (
Based on the above reasons, the final rule adopts the training provisions in the proposal. OSHA will address other comments provided through guidance and compliance assistance materials, rather than through further revisions to the rule.
OSHA has made minor changes to the training provisions to reflect the new definition of hazardous chemical in the final rule. In (h)(1), OSHA is replacing the phrase “new physical or health hazard” with the broader term “chemical hazard.” Final paragraph (h)(1) requires that employers provide employees with effective information and training on hazardous chemicals in their work area at the time of their initial assignment, and whenever a new chemical hazard the employees have not
Similarly in paragraph (h)(3)(ii), OSHA is replacing the phrase “The physical and health hazards” with all of the hazards identified as well as the hazards not otherwise classified. Final paragraph (h)(3)(ii) requires that the training include the physical, health, simple asphyxiation, combustible dust, and pyrophoric gas hazards, as well as hazards not otherwise classified, of the chemicals in the work area. This change was necessary because the final rule covers simple asphyxiants, pyrophoric gas, combustible dust, and hazards not otherwise classified, in addition to what falls under the new definitions for physical and health hazards. The modification to paragraph (h)(3)(ii) requires employers to train employees on all of the chemical hazards in the workplace, rather than only physical and health hazards as defined in the final rule.
The negotiations for development of the GHS recognized at the outset that trade secrets—generally referred to internationally as confidential business information—would be an issue of concern. Guiding principles included the following (
In relation to chemical hazard communication, the safety and health of workers, consumers and the public in general, as well as the protection of the environment, should be ensured while protecting confidential business information, as prescribed by the competent authorities.
The type of information that can be considered confidential or trade secret is limited to the names of chemicals and their concentrations in mixtures. Under the current HCS, OSHA did not require that concentrations in mixtures be disclosed, and thus limited trade secret claims to specific chemical identities. This was the primary difference between the current rule and the proposed revisions to the HCS. To be consistent with GHS, OSHA proposed to add percentage composition information to the SDS. This introduces the possibility that trade secret claims will be made for this type of information, as well as specific chemical identities. Thus the proposal revised the text of the current rule to add consideration of percentage composition everywhere specific chemical identity is addressed in the provisions.
The GHS further suggests that SDSs indicate when information has been withheld as confidential; that the information be disclosed to the competent authority upon request and under condition of confidentiality; that the information must be disclosed in a medical emergency, with mechanisms to protect it while ensuring timely disclosure; that the information be disclosed in non-emergency situations, also under conditions of protecting confidentiality; and that the competent authority have procedures to deal with challenges to this process. All of these principles have already been included in the trade secret provisions of the HCS, and are maintained in the final rule as previously promulgated. The proposed revisions simply conformed terminology, and added text regarding percentage composition being subject to the same provisions as specific chemical identity.
Very few comments on trade secrets or confidential business information were received in response to the ANPR. It was suggested that protection of confidential business information should be an implementation principle for the GHS modifications to HCS (Document ID #0072 and 0179), and that the current trade secret position should be retained (Document ID #0049). There was also a comment that indicated that full disclosure of all ingredients should be required on the SDS unless the employer provides a justification to the Agency showing that a particular ingredient is a trade secret, and demonstrating that the economic damage of disclosure exceeds the damage associated with the potential health effects to exposed employees (Document ID #0044). In addition, the National Paints and Coatings Association (NPCA) argued that the approaches to protection of confidential business information need to be harmonized (Document ID #0050). As NPCA stated, different approaches may lead to development of different SDSs for various authorities.
As noted above, laws regarding confidential business information are generally not specific to classification and labeling requirements, but rather reflect an overall approach of a country. It was not possible to change such laws through the harmonization of classification and labeling, and thus the limit of the agreement was to establish the principles already described. Those principles are consistent with law in the United States, and do not require any modifications to the current HCS approach to be consistent with the GHS.
There were a few comments on the trade secret provisions proposed. Some expressed their support for maintaining the current approach, with the small revisions to conform to the GHS (Document ID #0353, 0367, and 0371). Several indicated that the trade secret provisions should be extended to labels because the name of unclassified hazards was proposed to be included on labels, and when there is an ingredient of unknown toxicity, this must be indicated as well. For example, the American Petroleum Institute (Document ID #0376) indicated:
Under certain conditions both the SDS and label can require text such as:
With regard to the inclusion of the name of unclassified hazards on a label, this requirement has been deleted from the final rule. Therefore, listing unclassified hazards on the label no longer raises a trade secret concern. It should be noted that there was never a
With regard to the statement regarding unknown toxicity, OSHA does not find that this statement merits a change to allow the trade secret provisions to apply to labels. It is noted in paragraph A.1.3.6.2.3 that, where there is one or more ingredient of unknown toxicity in a mixture of other ingredients known to be acutely toxic, the calculation for predicting the acute toxicity cannot be completely accurate. Therefore, as suggested in the GHS, OSHA has indicated that a statement must be on the label and SDS indicating that a percentage of the mixture has unknown acute toxicity. There is no requirement to relate that general statement to specific ingredients, and specific chemical identities are not required on the label. Therefore, no trade secret information is required to be disclosed, and protection of the information under the trade secret provisions is not necessary.
There were also comments that OSHA should allow for flexibility in terms for indicating information is being withheld as a trade secret, such as “confidential,” “confidential business information,” or “proprietary” (Document ID #0376 and 0393). OSHA has never indicated specific terminology for claiming that information is subject to the trade secret provisions of the HCS, and would accept language such as “confidential,” “confidential business information,” or “proprietary” when indicating on an SDS that information is being withheld. This has never been an issue in OSHA enforcement of the HCS.
As implementation moves forward in different countries and regions, conformance to the GHS principles should lead to increased harmonization of approaches. This is an area that should be monitored to determine if further action can be defined and implemented. OSHA does not believe it would be prudent to implement changes in the approach to trade secret protection and disclosure before that time. Therefore, the final maintains the proposed language for the trade secret provisions.
It should be noted that due to requirements of the
Many comments were received in response to the ANPR on the issue of phasing in the requirements of the GHS, as well as on current practices and time frames required for various activities. There was a wide variety of opinions, as well as a number of factors that commenters suggested should be considered in establishing effective dates.
OSHA specifically requested input on the possibility of phasing in requirements based on the size of the business. While a few commenters supported this approach (
There were also those who thought the phasing should be coordinated with other trading partners, particularly the European Union (Document ID #0024, 0072, 0080, 0081, 0163, 0171, and 0179). The European phasing is taking place over a long period of time because of the REACH requirements for chemicals that are going into effect and not necessarily because of the amount of time needed just for compliance with GHS. Another suggestion that had support from commenters was to phase in substances first, and then cover mixtures, or to have a three-step phase-in that includes intermediates before mixtures (
There were also suggestions for a specific number of years, or a range of years, for phase-in. Some of these suggested less than 3 years (
OSHA decided on the three-year proposal based on a consideration of the widely diverse viewpoints expressed, as well as information provided by commenters about stockpiles and other issues. It is clear that activities have already begun by a number of vendors of software programs for hazard classification and labeling to convert to the GHS, and make programs available for companies to use to comply with requirements around the world as countries adopt the GHS.
Stakeholders provided many comments, as well as testimony, on the proposed effective dates. As with the record submitted in response to the ANPR described above, the opinions ranged over a wide variety of effective date options.
As noted, OSHA proposed that employers provide training regarding the new labels and safety data sheets two years after publication of the final rule. The intent of this training is to ensure that when employees begin to see such labels and SDSs in their workplaces, they understand how to use them and access the information effectively. Given the number of chemicals imported into American workplaces, as well as the number of employers who are already beginning to change over to the new formats, OSHA believes it is important to have this introductory training done before all of the labels and SDSs will be changed. It is not possible to pick a time frame that would ensure that such training is done before employees see any of these documents, but two years is a reasonable period of time and helps to ensure that employees will be trained before the new formats become the standard practice.
This training is not required to address the specific hazards of the chemicals, or the protective measures. Employees will have already been trained on hazards and protective
Some commenters thought two years would not be enough time, or who appeared to misunderstand what training was to be done by this date (
The three-year time frame for compliance with all other requirements generated significant comment. Many commenters supported this time frame as being appropriate and feasible (
OSHA should consider an additional 18-month phase in period for chemical distributors after the 3-year implementation date expires. This would allow for a more effective GHS while reducing any potential negative economic impact on small chemical distributors. NACD members have expressed concern that a three-year transition time for the entire value chain (suppliers, distributors, customers) presents the possibility of a bottleneck in the supply of chemicals * * *
Many commenters indicated that the time frame should be longer and tiered, with either substances first, and then mixtures, or a three-tiered system with substances, intermediate mixtures, and complex mixtures. The latter approach has been used by the EU. (
Therefore, SDA and CPSA support either a sequenced approach of substance suppliers first and formulators last, or a longer overall timeframe in order to minimize the impact of undertaking this significant effort to reclassify substances and mixtures, develop revised labeling, while allowing time to deplete inventories of labels and products with a current label. Any consideration of business size for a phase-in approach would be unacceptable as businesses large and small use each other's products in their end-use products; each one may rely on the upstream supplier for information in hazard classification.
While the Agency wants to provide sufficient time for compliance, there is also a concern about the effect on employees of dealing with multiple systems during a transition period. While some time period when the currently required labels and SDSs, and the new GHS labels and SDSs, will co-exist in workplaces is inevitable, hazard communication during this transition period will be confusing and less effective. It is therefore important to minimize the effects of the transition on the effectiveness of hazard communication by ensuring that it is completed in a timely fashion, while allowing adequate time for an orderly changeover.
Requiring the phasing in of substances first, and then mixtures, clearly has some persuasive logic as an approach. However, the supply chain is not always orderly and logical. It cannot be assumed, for example, that no mixtures can be completed until all substances are done. Mixtures that are comprised of substances that are widely available, and their hazards are well known, do not need an extensive time period to complete. Some mixtures are comprised of other mixtures rather than substances, and producers of such mixtures will need information on the component mixtures before they can comply. If manufacturers of mixtures wait until the end of an extensive time period to complete their work, their customers might not meet the compliance dates. These types of issues are generally addressed by the market, and the needs of a manufacturer's customers, and cannot be individually addressed in a phasing-in period.
OSHA is also mindful of the fact that the initial HCS had a two-year phase-in period for completion and distribution of all labels and SDSs, and an additional six months for all other provisions of the rule to be completed. There was no tiered approach to substances and mixtures. In that situation, the requirements for labels and safety data sheets were completely new, and yet timely compliance was achieved by most employers. Where there were situations that needed special consideration (such as an employer not receiving the required information from suppliers), the Agency made adjustments through enforcement policies. It should also be noted that this took place nearly thirty years ago, and pre-dated many of the resources available today that can facilitate compliance—such as access to extensive information online.
As was the case in the comments to the ANPR, a number of NPRM participants referenced the timeline for compliance with European CLP requirements (
That being said, however, nearly two years have elapsed since the NPRM was published, and the EU requirements for notifications regarding classification of substances are now in effect. In January 2011, the European Chemicals Agency (ECHA) indicated that it had received over three million such classifications (
Taking into consideration all of the information received from the public during the comment periods and in hearing testimony, as well as the results of the economic analysis which examines the effects of different compliance dates on the overall costs of compliance, the following effective dates have been included in the final rule. Rather than specifying a time frame related to the publication date of the final rule, OSHA is establishing dates certain for these activities to be completed. The following table summarizes the requirements in the final rule:
First, final paragraph (j)(1) requires training regarding the new label and SDS formats to be completed by all covered employers by December 1, 2013. OSHA has concluded that it is necessary and appropriate to complete this training prior to all of the new labels and SDSs being completed and received in workplaces so that employees know how to access and use the information appropriately. Most of those who commented on this issue agreed with that position, and with the timing proposed. Those who didn't may have misunderstood exactly what training is being required, but we have clarified that in this document.
Secondly, OSHA has not found the arguments regarding phasing in based on whether the product is a substance or a mixture to be convincing. There are many variations in the supply chain that impact the logic of this approach. In addition, given the current situation where substance classifications for the GHS have already had to be completed for both the EU countries, as well as other countries such as Japan, many suppliers involved in international trade have already had to complete substance evaluations. For those who have not, there is extensive information available as a result of these classifications having been done for the purpose of compliance with other authorities' requirements. Thus little time should be necessary to complete this part of the work.
Final paragraph (j)(2) requires compliance with all of the provisions for preparation of new labels and safety data sheets by June 1, 2015. This compliance date is consistent with the EU requirements for classification of mixtures. It also provides almost a year more time for compliance than was proposed. Thus it addresses a number of the suggestions received, but is still a reasonable time frame in terms of employee protections. There are two exceptions to this date. First, final paragraph (j)(2)(i) gives distributors an additional six months to distribute containers received from chemical manufacturers and importers with the new labels and SDSs in order to accommodate those they receive very close to the compliance date. Accordingly, by December 1, 2015, all their distributed containers must be appropriately labeled, and have the new SDS. Second, final paragraph (j)(2)(ii) gives employers until June 1, 2016, to make sure that their workplace labels and training programs reflect any new information received as a result of the final rule.
As was proposed, final paragraph (j)(3) states that employers will be considered to be in compliance with the HCS during the transition period as long as they are complying with either the existing HCS as of October 1, 2011, or this revised HCS.
Employers are encouraged to work with their suppliers to ensure they get the information they need by the dates they need it. While the final rule gives distributors and employers extra time to ensure they have the information before they have to be in compliance with all requirements, coordination will still be key to ensure everything is done on time. For example, mixture formulators need to make sure their suppliers are aware of their need to receive substance classifications as soon as possible. Employers would be best served to start evaluating their workplaces long before the year after suppliers must be in compliance to assess what they will need to do to bring their programs in line with the new requirements. As with the original rule, OSHA will handle individual problems through enforcement policies that recognize difficult issues or situations that impede compliance. Nevertheless, given the long time frame involved, and recognition of different players in the supply chain of the needs of others, OSHA expects that these situations will be minimal.
In this final standard, OSHA has modified its current standards in General Industry (29 CFR Part 1910), Construction (29 CFR Part 1926), and Maritime (Shipyards, Marine Terminals, and Longshoring (29 CFR Parts 1915, 1917, and 1918, respectively)) that contain hazard classification and communication provisions so that they will be internally consistent and aligned with the GHS modifications to the HCS. OSHA proposed to do so on the basis of the strong support in the record of comments on the ANPR. The majority of commenters who addressed the impact of the GHS on other OSHA standards recommended the Agency review all its standards and update them for consistency with GHS (71 FR 53617, Sept. 12, 2006) (Document ID #0031, 0038, 0046, 0050, 0054, 0072, 0077, 0107, 0116, 0145, 0147, 0154, 0155, 0163, 0165, 0171, and 0179). OSHA did so, and this rule contains the updates to the requirements in OSHA standards affected by the GHS modifications to HCS. Commenters also urged OSHA to complete these revisions in one rulemaking (Document ID #0079, 0123, 0137, 0154, and 0157). The comments on the proposed standard and testimony at the hearing also strongly supported modifying these standards for consistency with the GHS (Document ID #0313, 0327, 0328, 0329, 0336, 0338, 0352, 0359, 0365, 0370, 0372, 0405, 0408, 0410, 0412, and 494 Tr. 91, 162). Of the commenters who specifically addressed adopting GHS provisions on physical hazards, many urged the
Several other commenters to the ANPR pointed out some of the difficulties with adoption of the GHS physical hazards criteria in OSHA standards (Document ID #0031, 0034, 0038, 0077, 0145, and 0166). BASF was concerned that modifying OSHA standards to conform to the GHS will cause them to deviate from the national consensus standards they were based on (Document ID #077). In addition, some ANPR commenters recommended that OSHA limit changes only to standards that directly refer to the HCS (Document ID #0047, 0064, 0077, 0104, and 0115). OSHA acknowledged these concerns when developing the NPRM.
OSHA's NPRM reflected the advantages of harmonizing OSHA's standards, but also took into account the places where harmonization might be too difficult at this time because it would substantially change the scope of coverage of a current standard or make OSHA's standards incompatible with other widely accepted standards (74 FR 50280, Sept. 30, 2009). OSHA proposed modifying requirements in primarily the substance-specific health standards and in physical hazards definitions and terminology for the purposes of internal consistency and compatibility with the GHS-modified Hazard Communication Standard (HCS).
Building and Trades Construction Department of AFL-CIO (BTCD) and Northrup Grumman Shipbuilding, in response to the NPRM, requested that OSHA again review the standards, and the Agency has done so (Document ID #0359 and 0395). OSHA reviewed all its standards, the comments, and the entire record and has decided to maintain the modifications to the substance-specific standards as proposed, except for some minor changes that are explained below.
In the NPRM, OSHA updated the substance-specific health standards in General Industry, Construction, and Maritime, whether they specifically referenced HCS or contained their own hazard communication requirements. OSHA proposed to modify these standards as follows:
Revise the provisions covering workplace signs to require warning statements that are consistent with the GHS modifications to HCS;
Revise all standards to reference the modified HCS for labels, safety data sheets, and training, and identify the hazards that need to be addressed;
Maintain the requirement to avoid creating dust currently in some substance-specific health standards for which GHS modifications contain no equivalent statements at this time;
Maintain or specify language for contaminated clothing and debris;
Update definitions in § 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories, to maintain compatibility with the modified HCS; and
Change the name Material Safety Data Sheets to Safety Data Sheets and require information on them to be compliant with GHS in content, format, and order.
OSHA proposed to update the language for workplace signs and labels to incorporate the GHS hazard statement and the applicable precautionary statement(s), where required. Most OSHA substance-specific heath standards require hazard warning signs, usually for regulated areas, and the language required on the signs varies greatly (
The vast majority of persons and entities who commented on the issue in response to the NPRM supported OSHA's harmonization of the signage and labeling currently required in its substance-specific standards with the modifications to HCS (Document ID #0313, 0315, 0327, 0328, 0329, 0330, 0336, 0338, 0344, 0365, 0370, 0372, 0376, 0381, 0382, 0383, 0405, 0408, and 0410). NIOSH pointed out that the consistent language on signs, labels, and SDSs would avoid confusion and allow for easy translation into other languages (Document ID #0414). AIHA, in supporting the modification of language for signs and labels, noted that the action was consistent with GHS and the goal of harmonization. They envisioned clearer warnings, improved comprehension, and better self-protection by workers (Document ID #0365). Companies such as Ecolab, Product Safety Solutions, DuPont Company, Phylmar Group, Stericycle, Procter & Gamble, Clariant Corporation, 3M, Industrial Health and Safety Consultants, and Wacker Chemical specifically addressed the issue of affected standards and stressed that aligning the standards with GHS would bring needed consistency and aid employee understanding (Document ID #0313, 0329, 0335, 0338, 0339, 0351, 0381, 0383, 0405, and 0410). Lawrence R. Klein of DuPont (Document ID #0329) commented that:
* * * hazard communication regardless of whether * * * general chemicals or substance specific chemicals regulated under other OSHA standards, will prove to be beneficial for industry. Through adequate training * * * and consistent, easily comprehensible hazard and precautionary statements, via workplace signs or chemical labels, the safety and protection of employees will be enhanced.
Ameren added that the language proposed for the substance-specific standards accurately conveyed the hazards (Document ID #0330). Associations that addressed this issue also provided strong support. ORC, ASSE, NAHB, API, Alliance of Hazardous Materials Professionals, National Paint and Coatings Association, Soap and Detergent Association, ACC, and AISI agreed with OSHA that modifying the standards will provide consistency and aid in employee understanding (Document ID #0327, 0328, 0336, 0344, 0370, 0376, 0393, and 0408). Many commenters followed up with testimony at the informal public hearings. NIOSH testified that there would be better identification of what was a hazard and the nature of the hazard (Document ID #0494 Tr. 50). BCTD AFL-CIO testified that the specific format and vocabulary for labels would facilitate hazard communication across a range of English literacy, as one in four construction workers speaks a language other than English, and two in three entering workers speak Spanish. They said that the signs, symbols, and phrases will make it easier for employees to work safely with hazardous products
It's imperative that the information on the labels is consistent from product to product. Incorporating the GHS labeling system with pictograms and single-word hazard statements will assist workers to quickly recognize hazards.
Several commenters to the NPRM, while supporting the modifications, raised potential problems with warnings for substance-specific health standards' labels and regulated area signs. Northrop Grumman agreed with the wording of the regulated area signs and that it would enhance employee information, although there was concern that this was a change in OSHA's policy of allowing supplemental language on labels and signs that would enhance the information (Document ID #0395). OSHA has not changed its policy on regulated area signs with this rulemaking and will continue to allow supplemental language on labels and signs. ASSE suggested that, under the proposal, the term “Cancer Agent” would be retained in the thirteen identified carcinogens standard, though the ASSE did not believe the problems caused by this inconsistency would be significant (Document ID #0336). OSHA notes that all cancer warnings, including “Cancer Agent” and “Cancer Suspect Agent,” have been changed to “May Cause Cancer,” so there is no inconsistency. NAHB addressed the issue of the cancer warning in a comment to the ANPR, positing that the different signal words (“Danger” versus “Warning”) and different hazard statements (“May Cause Cancer” versus “Suspected of Causing Cancer”) may create confusion (Document ID #0065). Like other commenters, NIEHS supported consistency, but thought “May Cause Cancer” may not be strong enough, and recommended “Causes Cancer” be retained. The International Chemical Workers Union Council agreed that “May Cause Cancer” was not strong enough; they preferred “Causes Cancer” because it was a more definite statement about the health hazard. They were concerned that some workers might not see the warning as a clear indication of the material causing cancer and act accordingly (Document ID #0456). Dr. Michelle Sullivan also supported consistency among SDSs, labels, and in-plant warning signs, but cautioned that training would be needed especially on “May Cause Cancer” (Document ID #0382). OSHA agrees that training will be needed and that appropriately trained workers who see the phrase “May Cause Cancer” will be well warned and benefit from the use of a consistent hazard statement for all carcinogens.
The current substance-specific health standards that are regulated as carcinogens have varying hazard statements on signs and labels, as, for example, from “Cancer Hazard” for inorganic arsenic (29 CFR 1910.1018) to “Cancer-Suspect Agent” for vinyl chloride (29 CFR 1910.1017) to “May Cause Cancer” for methylenedianiline (MDA) (29 CFR 1910.1050). As stated in the preamble to the proposed standard, these warnings appeared to suggest gradations of cancer hazards, but they were not intended that way. The standards were promulgated over many years, and the differences in the warning language reflect the language widely used for each cancer warning at the time of promulgation, not the degree of hazard (74 FR 50405, Sept. 30, 2009). This inconsistency has long been a problem, especially in workplaces where two or more OSHA-regulated carcinogens are used. The final rule's revision to the substance-specific health standards will solve the problem of different warning statements by standardizing the carcinogen warning language to “May Cause Cancer” for each standard. This will lead to clearer and more timely recognition of the hazard and, with training, better understanding of the potential for developing cancer.
OSHA understands the points made by commenters who argued for another warning for cancer that might appear stronger, but any other warning would not be consistent with GHS and thus workers would not benefit from the global consistency of a single hazard statement for carcinogenicity. Moreover, OSHA believes that, with training, workers will understand the seriousness of the warning and benefit from seeing only one warning on carcinogens in the workplace. OSHA has concluded that the signal words and hazard statements, including “May Cause Cancer,” in its substance-specific health standards will provide better hazard information to employers, and has carried through the changes proposed in the NPRM to the final rule.
OSHA's proposal to change the signage requirements in the substance-specific standards was nearly universally supported by commenters. Product Safety Solutions, AHMP, National Paint and Coatings Association, Ameren, Wacker Chemical Corp, ASSE, Stericycle, Phylmar Regulatory Roundtable, Soap and Detergent Association/Consumer Specialty Products Association, Ecolab, Inc., AIHA, ORC Worldwide, National Association of Homebuilders, API, Procter & Gamble Company, Dr. Michelle Sullivan, Clariant Corporation, American Chemical Council, 3M, AISI (American Coke and Coal Chemicals Institute), Industrial Health and Safety Consultants, and NIOSH, in their comments to the NPRM, specifically supported the harmonization of signage required in the substance-specific standards (Document ID #0313, 0327, 0328, 0330, 0335, 0336, 0338, 0339, 0344, 0351, 0365, 0370, 0372, 0376, 0381, 0382, 0383, 0393, 0405, 0408, 0410, and 0412). USSE, agreeing with the commenters above, testified that having the same wording on regulated-areas signs would be helpful to workers as they move around and it is better for them to see the same information they have been trained on (Document ID #0499 Tr. 165).
Commenters raised several signage issues. Dow Chemical advocated the elimination of signs in substance-specific health standards, arguing that there was no need for signs since the chemical will be labeled and workers can also refer to an SDS (Document ID #0353). OSHA disagrees. The substance-specific standards' sign requirements cover regulated areas of facilities that are by definition high-exposure or potentially high-exposure areas. They are among the most dangerous areas in a facility, which is why OSHA requires signs. Moreover, contrary to what Dow assumes, product labels may not always be available in these circumstances. Thus, OSHA disagrees with Dow Chemical and believes the signs convey crucial information about the chemical hazard in a regulated area and that the signs benefit not only the well-trained worker but also other workers who might be near, or inadvertently enter, the regulated area.
The Battery Council International (Document ID #0390) had suggestions for language on regulated area signs for the lead standard, 29 CFR 1910.1025. First, they requested that OSHA change the language from “Causes Damage to the Central Nervous System” to “May Cause Damage to the Central Nervous System,” since nerve damage may or may not occur depending on whether or not the facility has taken proper precautions. However, as discussed above, OSHA has updated the signs to be consistent with GHS labeling to ensure that the worker is receiving the same message and this would provide better identification of the hazard. Therefore, OSHA has retained the proposed language for lead regulated area signs in the final.
The Battery Council International also requested that OSHA retain the original language § 1910.1025(m)(2) so that it would be clear that other signage may also be used in places where required (Document ID #0390). For example, it reported that California has such a signage requirement under Proposition 65. OSHA agrees that, in some very specific cases, other warnings may be necessary for lead. Thus, the current requirement that, “The employer may use signs required by other statutes, regulations or ordinances in addition to, or in combination with, signs required by this paragraph,” has been retained in the final rule for the lead standard at § 1910.1025(m)(2)(iv).
OSHA concludes that the proposed changes, which are as close as possible to the GHS terminology, are essential in order to make the warnings on signs consistent with each other, as well as labels, to the extent possible. These consistent warning signs will provide the best hazard communication in the relevant workplace regulated areas. The proposed changes to the signage requirements of the substance-specific standards have been carried through to the final rule.
OSHA's current substance-specific standards are inconsistent in that some have their own communication of hazards requirements, while other standards reference the HCS, and still other standards have no requirements for labels and safety data sheets in their sections. Although these latter standards are missing requirements, they still are covered by HCS. Similarly for labels, while most substance-specific standards require labels on containers of raw materials, mixtures, and products, some specify specific language while others reference the HCS. As proposed, and as carried forward in this final rule, OSHA has standardized the language for hazard communication and has removed the requirements for specific language labels from the “Communications of hazards” paragraphs of the substance-specific standards. The new paragraph in each substance-specific standard uses the following model format:
(i) Chemical manufacturers, importers, distributors and employers shall comply with all requirements of the Hazard Communication Standard (HCS) (29 CFR 1910.1200) for [chemical name].
(ii) In classifying the hazards of [chemical name] at least the following hazards are to be addressed: [hazard information].
(iii) Employers shall include [chemical name] in the hazard communication program established to comply with the HCS. Employers shall ensure that each employee has access to labels on containers of [chemical name] and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph [Training paragraph] of this section.
By adding this paragraph in each substance-specific health standard, OSHA achieves consistency across standards and with GHS principles. Some commenters indicated that the chemicals covered by the substance-specific standards should not be classified any differently than any other chemical in regard to the health hazards included on a label or SDS (
OSHA believes that requiring standards to reference HCS will ensure consistency with the GHS revisions and across the standards and consistency when the specific chemical is part of a mixture. Removal of the current specific warning language was essential for adoption of the GHS language. Retention of these provisions in the standards would result in the untenable situation of two potentially conflicting requirements, only one of which (the reference to HCS) would be in accord with the GHS-modified HCS. Moreover, as OSHA noted in the preamble to the proposed standard, the hazard statements specified for the chemical in the standard might not be correct when the chemical is part of a mixture. As for the current standards that simply referenced HCS, employers could choose any language and format that conveyed the necessary information. This approach is no longer allowed because, as OSHA has found in adopting the GHS approach, consistency in labeling is key to effective communication of hazards. The vast majority of commenters agreed. For example, AHMP noted that eliminating language inconsistent with established hazard statements will facilitate hazard communication and should not result in lower protection (Document ID #0327). Others, including NIOSH, DuPont,
For classification purposes, OSHA proposed to provide guidance on the potential health outcomes that must be addressed when classifying a substance by setting forth the health end-points (outcomes) for each substance-specific health standard. The Agency did not attempt to formally classify each substance; rather, OSHA provided a proposed list of health effects to assist the classifier in determining what must be considered for inclusion on the new labels. The GHS classification process for a specific substance dictates the actual hazard warnings and precautionary statements that are required on the new GHS-compliant labels and SDSs. In determining the hazards to include for each substance-specific health standard, the Agency's primary sources on health effects were the information gained in its own rulemakings and subsequent experience, the NIOSH Pocket Guide to Chemical Hazards (2005), and the International Chemical Safety Cards (ICSCs). The ICSCs are an undertaking of the International Programme on Chemical Safety (IPCS) (a joint activity of three cooperating International Organizations, namely, the United Nations Environment Programme (UNEP), the International Labour Office (ILO), and the World Health Organization (WHO)) and are peer reviewed by a group of internationally recognized experts (Document ID #0412.2). As a secondary source, OSHA also considered the European Union's (EU) “Proposal for a Regulation of the European Parliament and of the Council on Classification, Labeling and Packaging of Substances and Mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006.” From these sources, OSHA developed hazard endpoints to be considered for hazard classification in the substance-specific health standards based on either of two criteria: (1) The health hazard was the basis for the original rulemaking; or (2) the health hazard was asserted by OSHA, NIOSH, or IPCS, and confirmed by a second source. For example, acrylonitrile (AN) (§ 1910.1045) was regulated by OSHA based on its carcinogenicity. Skin sensitization was acknowledged by OSHA, IPCS, and EU; skin irritation by OSHA, NIOSH, and EU; respiratory tract irritation by IPCS and EU; eye irritation by OSHA, NIOSH, and IPCS; liver effects and central nervous system effects by IPCS and NIOSH; acute toxicity by OSHA, IPCS, and EU; and flammability by IPCS, NIOSH, and EU. Because all these effects met the criteria for inclusion, skin sensitization, skin irritation, respiratory irritation, eye irritation, liver effects, central nervous system effects, acute toxicity, and flammability were listed as potential hazards in the acrylonitrile standard.
OSHA's approach, including its choice of sources for health effects, was generally supported by many commenters to the proposal (Document ID #0329, 0339, 0351, 0370, and 0376). However, some, including NIOSH, AIHA, ASSE, Ameren, Stericycle, Wacker Chemical Corporation, and 3M Corporation, wanted OSHA to add other sources (Document ID #0233, 0330, 0338, 0365, 0405, and 0412). NIOSH suggested OSHA look at OECD SIDS, ESIS, NOAA, NLM, NLM-TOXSEEK, NLM-TOXNET, IPCS, CCOHS, and GESTIS (Document ID #0412). AIHA commented that substance-specific health standards should be classified the same as other chemicals and that other references such as ATSDR Toxicological Profiles, IRIS Toxicological Reviews, WHC Monographs, CICADS, OECD SIDS, and Patty's Toxicology should be used (Document ID #0365). Wacker Chemical Corporation recommended IARC be included and that one recognized body's determination of a hazard should be sufficient (Document ID #0335). ASSE urged inclusion of ACGIH documentation of TLVs and RELs and precautions developed by manufacturers from testing and epidemiological studies. ASSE submitted a long list of sources including NSC's Fundamentals of Industrial Hygiene, The Industrial Environment—Its Evaluation and Control, Patty's Industrial Hygiene and Toxicology, Casarett & Doull's Toxicology, The Dose Makes the Poison, Quick Selection Guide to Chemical Protective Clothing, U.S. DHHS Seventh Annual Report on Carcinogens, AIHA Engineering Field Reference Manual, and 17 others (Document ID #0336). AIHA urged OSHA to have the hazards for the substance-specific standards considered, but not be mandatory. It recommended additional references such as ATSDR Toxicological Profiles, IRIS Toxicological Reviews, EHC Monographs, CICADS, OECD SIDS, and Patty's Toxicology (Document ID #0365). Ameren would have OSHA add ACHIS and AIHA sources (Document ID #0330). Stericycle advocated adding Industrial Chemical Safety Cards, European Commission, and ACGIH as secondary sources (Document ID #0338). Still others, such as ASSE, API, AHMP, Product Safety Solutions, National Paint and Coatings Association, and Industrial Minerals Association—North America, deemed OSHA's choice of sources inadequate (Document ID #0313, 0327, 0328, 0338, 0376, and 0379). USSW (Document ID #0403) found lists such as IARC's and NTP's useful, but wanted OSHA to state in the regulatory text that a chemical on one or more of these lists was sufficient to classify it as hazardous (although the absence of a chemical on a list does not mean it is not hazardous). It also wanted OSHA to use lists in enforcement.
Commenters also raised other issues in this regard. API believed OSHA should just reference the GHS criteria, while ASSE wanted OSHA to use other authoritative references (Document ID #0336 and 0376). Both AHMP and Product Safety Solutions were concerned the NIOSH Pocket Guide and International Chemical Safety Cards had not been subject to rulemaking and could be overly conservative, even though they felt these sources could be used as information, but not as precedent if significant contradictory information is presented (Document ID #0313 and 0327). National Paint and Coatings Association commented that the substance-specific standards' health
OSHA believes these comments reflect a misunderstanding of what OSHA proposed for its substance-specific health standards and how the sources were used to yield health effects to be considered in classifying all health hazards but not to perform a formal classification. (
In complying with the HCS, as discussed above, classifiers must take into account available scientific information about the hazards of the chemical being classified, which could include information found in the other sources noted by the commenters. The manufacturer, distributor, or importer must still classify and categorize each regulated chemical (in the substance-specific health standards) in compliance with the GHS-modified HCS and its appendices. The lists of endpoints for each substance-specific standard are the minimum that must be considered. The manufacturer or importer has leeway to use additional primary studies and sources to evaluate the substance-specific chemical and is free to add health effects' endpoints as appropriate according to the studies or sources. As discussed previously in this section, the HCS generally uses a weight-of-evidence approach in classifying health hazards. Therefore, a superior source or significant and compelling contradictory information to a particular source usually must be weighed with the total body of evidence.
IMA-NA suggested that OSHA's methodology for determining the list of health effects to be considered by classifiers does not meet the requirements of the Information Quality Act (Document ID #0233). OSHA disagrees. That statute, and the guidelines published under it (discussed in more detail above), require that agencies take steps to ensure the “quality, objectivity, utility, and integrity” of information they disseminate. Similar to its response to the concern regarding TLVs, discussed above, OSHA does not believe that it is disseminating information for purposes of the IQA when it merely requires that manufacturers and importers consider specific health effects listed for each substance-specific standard in classifying the chemical under the HCS. However, even if it were disseminating information in the final rule, OSHA believes that it has complied with the applicable requirements of the IQA. OSHA has fully described the methods by which it determined the listed health effects for each substance, relied only on respected health compilations prepared by governmental agencies or subject to peer review, and subjected its analysis to notice and comment in this rulemaking. This adequately assures the quality, objectivity, utility, and integrity of any dissemination of information involved in these provisions of the final rule.
OSHA received no comments on the particular hazards proposed for each substance-specific health standard, and retained them in the final rule. The endpoints for each substance-specific standard are listed in Table XIII-5, “Health Effects Determined for the Substance-Specific Standards.”
The NPRM retained specific language for labels in the substance-specific health standards for containers of contaminated clothing or waste and debris to ensure that protection gained from communicating these hazards to the downstream recipients of the materials would not be lessened. The proposal, however, updated the language to be consistent with the GHS. The labeling requirements in these standards are part of broad protections, resulting from PELs and ancillary provisions such as exposure monitoring, personal protective equipment, and medical surveillance. These requirements for labeling containers of contaminated clothing, PPE, and waste and debris have been an integral part of the standards since their promulgation. To simply conform the labeling requirements for these kinds of containers to the GHS-modified HCS rule would not offer the extra protection currently provided in these standards; because of the variation in the quantity of chemicals in the containers of contaminated clothing, PPE, and waste and debris, the chemical concentration may be lower than the specified cut-off values/concentration limits. In such a case, if OSHA only relied on the GHS-modified HCS labeling requirement, labeling for these containers may not be triggered and protections would be lessened.
Commenters agreed that specific language for labels on containers of contaminated clothing and waste and debris should be maintained. For example, Ameren and 3M Corporation commented that maintaining specific language for labels on contaminated clothing and waste/debris containers for the substance-specific health standards will provide adequate warnings to all (Document ID #0330 and 0405). AIHA, in supporting the specific labels, noted that the workplace-contaminated materials are not hazardous chemicals in commerce; thus, these special labels are not inconsistent with GHS. Further, AIHA said that because recipients of these containers are accustomed to specific warnings, a change, such as elimination of the specific warning language because it might not be required by GHS, might be perceived as a change in hazard (Document ID #0365). The Battery Council International urged OSHA not to eliminate the label language requiring the disposal of lead-contaminated waste water in accordance with applicable local, state, or federal regulations in § 1910.1025(m)(2) for contaminated clothing. OSHA agrees that this information is important and is not inconsistent with GHS labeling. Therefore, OSHA has retained this language for the labels for contaminated clothing and equipment in the final rule. AISI and Industrial Health and Safety Consultants urged OSHA to require that the language on containers of contaminated clothing and waste/debris be in accord with the GHS guidelines. Such harmonization would maintain consistency with other labeling and minimize confusion of downstream handlers (Document ID #0408). In addition, Industrial Health and Safety Consultants felt that containers of contaminated clothing and waste/debris should be classified according to the HCS and the specific language on the label should be eliminated (Document ID #0410). As discussed below, OSHA does not agree. Industrial Health and Safety Consultants also suggested that OSHA require HCS classification and labeling of contaminated waste clothing and waste for all chemicals (Document ID #0410). OSHA did not propose such extensive new requirements for containers of chemically contaminated clothing and waste and debris. These requirements were not part of HCS and would be a significant addition to the final rule.
OSHA agrees with the commenters who advocate retaining the warnings and harmonizing these labels for contaminated clothing and waste and
OSHA is adding two warnings to the Cadmium standard, which were left out of one paragraph of the proposal, through an error. In the NPRM, OSHA proposed that the warning labels for waste, scrap, or debris be required to include “Danger”; “Contains Cadmium”; and “May Cause Cancer” in paragraph 1910.1027(m)(3)(ii). The warnings “Causes Damage to Lungs and Kidneys” and “Avoid Creating Dust” were inadvertently left out of this paragraph. (The NPRM properly included these two warnings in paragraph 1910.1027(i)(2)(iv) for bags and containers of contaminated protective clothing and equipment.) OSHA is correcting this error by adding these warnings in this final standard, making the Cadmium standard consistent with the other substance-specific standards and, to the extent possible, with GHS.
In addition, for labels of bags or containers of contaminated clothing and equipment, OSHA has determined precautionary statements that address creating dust in the current substance-specific health standards must be retained even though there is no GHS equivalent. At this time, a work group formed under the UN Sub-Committee of Experts for the GHS (UN Sub-committee) is working to finalize issues related to hazard and precautionary statements. OSHA has recommended to the UN Sub-committee to adopt the phrase “avoid creating dust” as a precautionary statement, if this statement is adopted as a precautionary statement, then this statement will be consistent with the GHS. However, if the UN Sub-committee does not adopt such a statement, OSHA intends to continue to require the dust statements in those paragraphs for labels of bags and containers of contaminated clothing and equipment since OSHA has concluded that removing these statements would be a lessening of protection. An example of requirements for those statements can be found in OSHA's Cadmium standard, § 1910.1027(i), (k), and (m). OSHA also inadvertently removed the term “Avoid Creating Dust” from the Asbestos labeling requirements in § 1910.1001(j) and § 1926.1101(l) of the proposal. As discussed above, OSHA believes that this is a unique statement and should be retained. OSHA is correcting this error by reinstating this phrase in the asbestos labeling requirements in § 1910.1001(j) and § 1926.1101(l).
OSHA proposed to modify most of paragraph (b), Definitions, in § 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories (the laboratory standard), in order to maintain compatibility with HCS. In particular, OSHA removed the definitions of Combustible liquid, Compressed gas, Explosive, Flammable, Flashpoint, Organic peroxide, Oxidizer, Unstable (reactive), and Water-reactive from paragraph (b). In addition, in the NPRM, OSHA revised the definitions of Hazardous chemical, Physical hazard, and Reproductive toxins in paragraph (b) and added definitions for Health hazard and Mutagen
The term “hazardous chemical” used in this final rule relies on the definition of “health hazard” found in the OSHA Hazard Communication Standard. As discussed in the scope and application section above, commenters urged OSHA to maintain consistency in terms between the Hazard Communication Standard and this final standard since laboratories are subject to both regulations.
Ameren agreed with OSHA that “combustible liquid” should be removed from paragraph (b) (Document ID #0330). However, the company recommended that OSHA replace the term with specific flashpoint criteria. OSHA disagrees that a definition for combustible liquid with specific flashpoint criteria differing from GHS-modified HCS should be contained in the laboratory standard. OSHA's intention is to harmonize the laboratory standard with the GHS-modified HCS. The final HCS rule contains definitions of flammable liquids with flashpoint criteria in Appendix B, and these flashpoint criteria include what are currently the combustible liquid classes. The laboratory standard does not contain specific requirements for physical hazards, including flammable or combustible liquids. Rather, this program standard contains requirements for such things as a chemical hygiene plan, employee exposure determination, training, medical consultation and examinations, and recordkeeping. Thus, OSHA does not see a need for including separate flashpoint criteria for flammable or combustible liquids and believes that reference to the flammable liquid categories in HCS is appropriate for § 1910.1450.
OSHA proposed to maintain the current definition of “select carcinogens” in the laboratory standard since the original purpose of the standard was to deviate from the HCS definition and narrow the scope of the standard. As noted in the preamble to the final rule for the laboratory standard, the scope was set for “select carcinogens” based on the small, often minute, quantities of substances handled. OSHA stated its reasons for this deviation in that preamble, and those reasons remain persuasive:
This final rule, however, modifies the carcinogen definition and the obligatory action so that special provisions must be explicitly considered by the employer, but need only be implemented when the employer deems them appropriate on the basis of the specific conditions existing in his/her laboratory. Moreover, the term, “carcinogen” has been replaced by “select carcinogen” which covers a narrower range of substances * * *
OSHA has thus incorporated in the final rule its proposed changes to the definitions in the laboratory standard.
OSHA reviewed the appendices to each of its substance-specific health standards and made the following minor changes necessary to align the appendices with their GHS-harmonized standards.
The language in Appendix B, “Employee Standard Summary,” chapter XI, “Signs,” in both the general industry and the construction standards for lead (§ 1910.1025 and § 1926.62, respectively) has been made consistent
In Asbestos § 1910.1001, Appendix F, “Work Practices and Engineering Controls for Automotive Brake and Clutch Inspection, Disassembly, Repair and Assembly (Mandatory),” a reference to paragraph (j)(4) of the standard has been redesignated as paragraph (j)(5) to be consistent with the changes in the regulatory text for § 1910.1001. No changes were made to the construction Asbestos standard § 1926.1101, as none were needed.
OSHA has changed the term “material safety data sheets” when it appears to “safety data sheets” in both the substance-specific health standards and their appendices. As discussed above, this change reflects the GHS terminology.
OSHA proposed to require implementation of all but one of the revisions to the HCS in three years following completion or promulgation of the final rule. Training was proposed to be required in two years. OSHA noted that during the transition period, an employer could be in compliance with either the current HCS or the revised HCS (the final rule), but there could not be a lapse in compliance. For the final standard, OSHA has decided to align implementation of GHS with the final implementation of GHS in the EU for labeling and SDSs. A full explanation of the information and comments and the Agency's reasoning is set out above in this section.
The proposed changes to the substance-specific health standards required compliance with the HCS, thus incorporating the proposed compliance dates for the revised HCS. One commenter suggested that the proposed sign and label updates be done in accordance with the facility's normal replacement schedule (Document ID #0376). OSHA finds that this is too indefinite a period, because it essentially leaves the compliance date in the hands of each employer. OSHA has concluded that the administration of HCS programs by employers and the communication and comprehension of the hazards by employees will be most effective if the requirement for completion of changes for the substance-specific health standards is the same as for all other chemicals. In a sense, this is just another example of the consistency that was approved by so many of the commenters and hearing witnesses.
Thus, the final rule keeps the compliance dates for the new substance-specific health standard requirements in line with those for the revisions to the HCS. Employers must be using new labels for contaminated clothing and waste and debris by June 1, 2015, the date by which manufacturers and importers must comply with the labeling and SDS requirements of the revised HCS. Employers must post the new signs by June 1, 2016, the same date by which employers must also update their hazard communication plans for any new hazard information they receive as a result of the final rule. In the meantime, as with the revised HCS, employers must comply with either the old or new labeling and signage requirements. Provisions to this effect are inserted for each substance-specific standard in this final rule.
OSHA proposed modifying safety standards that either directly reference the HCS or provide information pertinent to the SDSs, in particular regarding the storage and handling of chemicals. As noted above, many commenters supported standardizing physical hazard criteria across all applicable OSHA standards (Document ID #0034, 0104, 0105, 0155, 0170, 0171, 0313, 0324, 0327, 0328, 0329, 0336, 0338, 0359, 0365, 0376, 0382, 0395, 0405, 0408, 0410, and 0494 Tr. 91, 162). For example, the Compressed Gas Association (CGA) (Document ID #0324) stated:
CGA agrees with the harmonization to GHS to align the definitions of the physical hazards to the requirements of the GHS categories in safety standards for general industry, construction, and maritime standards, which either directly reference the Hazard Communication Standard * * * or provide information pertinent to the SDS.
However, some other commenters, and even some who supported applying physical hazard criteria across all standards, raised concerns about storage and handling requirements; degree of impact; potential effects on the scope of the Process Safety Management of Highly Hazardous Chemicals (PSM) standard; and potential conflicts with widely accepted consensus standards (Document ID #0038, 0077, 0104, 0163, 0329, 0335, 0336, 0339, 0366, 0370, 0381, 0383, 0393, 0399, 0414, 0500, 0514, 0530, 0643, 0494 Tr. 91, 162, and 0497 Tr. 81-84).
OSHA agrees with the commenters who supported standardizing physical hazard criteria and is doing so except in some standards, such as OSHA's electrical standards, where conflicts with referenced consensus standards make harmonization inappropriate at this time. OSHA proposed to:
• Incorporate the current HCS definitions of flammable liquid and gas into PSM and health hazard into Hazardous Waste Operations and Emergency Response (HAZWOPER) standards;
• Modify the Welding standard (§ 1910.252) requirements on labeling welding consumables to be consistent with GHS modifications to HCS;
• Amend paragraphs on flammable and combustible liquids to conform categories, terminology, flashpoints (FP), and boiling points to the GHS modifications to HCS;
• Incorporate the modified-HCS definition of flammable aerosols into the Flammable and Combustible Liquids standard, § 1910.106. (In § 1910.106, OSHA is also correcting a rounding error in the conversion from 12 feet to meters. The change is from 3.648 meters to 3.658 meters); and
• Update the acceptable methods for determining flashpoints; but
• Leave unchanged electrical standards in Subpart S for general industry and Subpart K for construction, and explosive standards for general industry (§ 1910.109) and for construction (§ 1926.914).
Commenters overwhelmingly supported ensuring consistency in OSHA standards, while maintaining scope of coverage. (Document ID # 0049, 0050, 0077, 0105, 0123, 0145, 0163, 0170, 0313, 0324, 0327, 0328, 0351, 0359, 0365, 0376, and 0494 Tr. 91, 162). Organization Resource Counselors (ORC) (Document ID # 0494 Tr. 91) testified:
ORC supports concurrent harmonization of hazard definitions in most OSHA standards. ORC agrees with OSHA's proposal to harmonize hazardous communication components across most other OSHA standards in this rulemaking. ORC believes this is the most efficient way to address this necessary step in ensuring consistent hazard information and eliminating conflicting requirements.
Many comments to the ANPR and the NPRM supported OSHA exempting certain standards such as electrical and explosive standards from harmonization at this time (Document ID # 0047, 0075, 0076, 0104, 0113, 0145, 0163, 0328, 0330, 0336, 0370, 0393, and 0408). For example, the standards in Subpart S contain requirements such as internal design criteria that, if changed, would impact their scope. OSHA's reasons for excluding these standards are explained below. In testimony at the hearing, the ACC (Document ID # 0494 Tr. 162) agreed, stating:
We agree with this approach and therefore would expect that there would be no impact on electrical area classification, facility [s]iting, mechanical integrity, electrical classification, storage quantities, unloading and storage location, ventilation requirements, spill protection, grounding and bonding, tank and vessel design, interlocks and safety devices and process hazard analysis.
As discussed in detail below, in the final rule PSM retains its current scope; HAZWOPER's definition of “health hazard” is modified; the definitions in the Flammable and Combustible Liquids standards are aligned with the GHS modifications to HCS; Welding, Cutting and Brazing labeling requirements were also modified to be consistent with HCS; and a few technical amendments have been made to other safety standards that currently use the term “combustible” in order to keep their scope the same. Also, no changes were made to standards that OSHA proposed to exclude from this rulemaking.
PSM standards for general industry and construction reference the HCS for their scopes, which are currently set forth in § 1910.119(a)(1)(ii) and § 1926.64(a)(1)(ii) as covering a process which involves a flammable liquid or gas (as defined in § 1910.1200(c) [§ 1926.59(c)] on site in one location, in a quantity of 10,000 pounds (4535.9 kg) or more, followed by the listed exceptions in the paragraph.
If OSHA did not modify this provision in this rulemaking, the scope of PSM would expand since the HCS's definition of flammable liquid changes from liquids with a flashpoint below 100 °F (37.8 °C) to the new GHS definition of liquids with a flashpoint at or below 199.4 °F (93 °C) (though, as discussed above, the scope of the HCS is unaffected). Keeping the reference to the HCS definition would mean that many more processes would have been covered by the PSM standards than when those standards were promulgated. OSHA does not intend to expand the scope of the PSM standards. Therefore, to maintain the scope of those standards, OSHA proposed to modify the language in the scope paragraphs § 1910.119(a)(1)(ii) and § 1926.64(a)(1)(ii) to read:
A process which involves a Category 1 flammable gas (as defined in § 1910.1200(c)) or flammable liquid with a flashpoint below 100 °F (37.8 °C) on site in one location, in a quantity of 10,000 pounds (4535.9 kg) or more * * *
In other words, for PSM, “flammable gas” includes Category 1 flammable gases and liquids only if they have flashpoints below 100 °F (37.8 °C) to be consistent with the criteria specified in the current HCS.
Commenters who considered the issue differed on what should be done (Document ID #0324, and 0402). For example, ACC, in responding the NPRM, supported OSHA's approach (Document ID # 0393). ACC noted that OSHA's proposed regulatory language for § 1910.119, the general industry PSM, appropriately reflected the new cut-off without changing the scope of the regulation (Document ID #0393). However, CGA requested that OSHA update paragraph (a)(1)(ii) of § 1910.119 to use GHS Category 1 flammable liquids as a cutoff for PSM coverage, stating, “This would maintain consistency throughout the OSHA standards and harmonization with the GHS” (Document ID #0324). The Society of Chemical Manufacturers and Affiliates (SOCMA) (Document ID #0402) was concerned that the change in the flashpoint trigger for flammable liquids from “the current 100 °F to the new 140 °F * * * would significantly expand the number of products subject to OSHA 1910.106 (flammable liquids), and OSHA 1910.119 (Process Safety Standards).”
While OSHA agrees with CGA that using GHS Category 1 flammable liquids would maintain consistency throughout the OSHA standards, to do so would change the scope of the PSM standard by making it applicable only to flammable liquids with flashpoints below 73 °F (23 °C). This would significantly narrow the scope of PSM and lessen worker protection by eliminating from coverage flammable liquids with flashpoints from 73 °F to below 100 °F. However, to set the coverage of PSM to 140 °F (flammable liquid categories 1, 2 and 3 which require the hazard warning “flammable” to appear on labels), as SOCMA noted, would expand the coverage beyond the scope of the original standard.
OSHA has concluded that setting the flashpoint below 100 °F (37.8 °C), the previous HCS level, properly maintains the scope of the PSM standards as they were promulgated. As explained in the proposal, OSHA's approach to the other affected standards is to “modify provisions of the standards that reference the HCS definitions to maintain coverage or consistency with the modified HCS” (74 FR 50404, Sept. 30, 2009). It is beyond the scope of this rulemaking to consider whether, as a substantive matter, the scope of the PSM standards should be changed. Thus, OSHA is neither increasing nor decreasing the scope of the PSM standard; consequently, the same products in the same quantities will be covered. The final rule adopts the proposed changes to the PSM standards noted above.
In the NPRM, OSHA updated the definition of health hazard in its HAZWOPER standards, § 1910.120(a)(3) for general industry and § 1926.65(a)(3) for construction, so that the terminology is aligned with the GHS health hazards in § 1910.1200, Appendix A. The final rule retains the proposed definition.
In proposing this change, OSHA was concerned that some of the terminology in HAZWOPER, such as neurotoxin and nephrotoxin, which were partly defined by reference to the HCS, would no longer be consistent with the GHS-modified HCS. For consistency, the proposal removed such terms from HAZWOPER and are now subsumed within the HCS specific target organ toxicity category, thus maintaining the same hazard communication requirements in both HAZWOPER and HCS. By updating the definition of “health hazard” in the HAZWOPER standards to clearly reference HCS, employers will have the proper reference to HCS and, in there, the proper guidance on how to classify the health hazards. OSHA received no contrary comment, and the final rule adopts the definition of health hazard as proposed.
The ACC requested that OSHA clarify how the HAZWOPER standards would be affected by OSHA's adoption of the GHS flammable and combustible liquid classifications in § 1910.106, § 1926.152, and § 1926.155 (Document ID # 0393 and 0530). ACC seems to be asking why OSHA did not reference the new definitions (GHS categories) of flammable liquids in HAZWOPER. OSHA believes the HAZWOPER standards would not be directly affected by the GHS-harmonized categories of flammable liquids, and therefore ACC's concern is misplaced. The HAZWOPER standards are program standards, and they do not contain any specific references to flammable or combustible liquids. It is true that the HAZWOPER standards state that all requirements of Parts 1910 and 1926 of CFR title 29 apply to hazardous waste and emergency response (§ 1910.120(a)(2) and § 1926.65(a)(2)). Thus, where HAZWOPER-covered employees are responding to an emergency situation where flammable liquids have been stored or need to be temporarily stored during clean-up, the flammable liquid standards might apply. OSHA believes that even in those situations, GHS harmonization of flammable liquids will
OSHA is harmonizing the requirements in the Welding, Cutting and Brazing standard, § 1910.252, by adding a Hazard Communication paragraph and bringing in line with the GHS and OSHA's substance-specific health standards the terminology in the labeling requirements for filler metals and fusible granular materials, filler metals containing cadmium, and fluxes containing fluorine compounds.
The final rule retains the proposed text of the Hazard Communication paragraph at § 1910.252(c)(1)(iv). Similar to the substance-specific standards, the welding standard's hazard communication paragraph requires employers to include welding contaminants in a program established to comply with the HCS (§ 1910.1200). Also, similar to the substance-specific standards, OSHA has added a date paragraph requiring employers to be using new labels by June 1, 2015, the date by which manufacturers and importers must comply with the labeling and SDS requirements of the revised HCS.
In addition to adding the general Hazard Communication paragraph, OSHA reorganized some of the paragraphs in § 1910.252 so as to place the general reference to HCS in the correct position in the standard, § 1910.252(c)(1)(iv). To accomplish this, OSHA moved the “Additional considerations for hazard communication in welding, cutting, and brazing,” including filler and fusible granular materials, materials containing cadmium, and materials containing fluorine compounds, from paragraphs (c)(1)(iv)(A) through (C) to new paragraphs (c)(1)(v)(A) through (D).
The proposal inserted a cross reference to § 1910.1200 in the welding standards hazard determination section. In addition, as with the substance-specific standards, the proposal deleted specific label language requirements for welding materials containing cadmium and fluorine and instead listed specific health endpoints to be considered in the classification.
OSHA received one comment on the proposed changes from the Gases and Welding Distributors Association, Inc. (GAWDA). While GAWDA generally supported OSHA's rulemaking effort, GAWDA requested that OSHA change “suppliers” of welding materials to “manufacturers” in § 1910.252(c)(1)(v)(A) of the proposal (Document ID # 0388). GAWDA stated the term “supplier” is undefined and might include different entities in the supply chain; furthermore, elsewhere OSHA places the responsibility of hazard determination on manufacturers, importers, and distributors. However, OSHA would like to point out that the term “supplier” is used in the current standard, which requires suppliers to determine the hazards in § 1910.252(1)(c)(iv): “The suppliers of welding materials shall determine the hazard, if any, associated with the use of their materials in welding, cutting, etc.” OSHA assumes that “suppliers” will continue to use the same method that they are currently using to determine the hazards of their materials. To change this term could result in a substantive change in the scope of this standard and would be beyond the scope of this rulemaking. Therefore OSHA will retain the word “suppliers” as proposed.
In addition, as discussed in the preamble to the proposal,
The changes to this standard were predicated on achieving consistency with the GHS modifications to HCS and other OSHA substance-specific standards, and OSHA has concluded that the modifications as proposed and as explained in the previous paragraphs will effectuate harmonizing the standard's terminology with HCS. In addition, this action also contributes to internal consistency by making the Welding, Cutting, and Brazing standard similar to the substance-specific health standards.
OSHA proposed to align the definitions of flammable and combustible liquids in both the general industry and construction standards to conform to the GHS modifications to the HCS. In particular, the proposal changed the definitions of flammable liquid categories and deleted the term and definition of combustible liquids (
OSHA proposed to drop the current rules' classifications of flammable and combustible liquids in favor of the GHS flammable liquid classifications. This meant that all liquids under the proposal would fall into GHS flammable liquid Categories 1 through 4, and that the term “Combustible Liquids” in §§ 1910.106, 1910.107, 1910.123, 1910.125, 1926.152, and 1926.155 was proposed to be deleted since the GHS does not have a hazard class titled “Combustible liquids.” However, the GHS does require the hazard statement “combustible liquid” on the label for Category 4 Flammable liquids (flashpoint greater than 60 °C (140 °F) but not greater than 93 °C (199.4°F)).
In addition, the current general industry Spray Finishing standard, § 1910.107, relies on the current § 1910.106 definition of Class IIIB liquids (liquids with a flashpoint over 93 °C). Therefore the proposal amends § 1910.107 to replace its use of the term “combustible liquids,” which has no corresponding GHS category, with the phrase “Liquids with a Flashpoint Greater than 93 °C (199.4 °F).” With the new terminology, the protection provided by the original standards remains the same.
OSHA believed that most of the proposed changes in the definitions were not significant. The move to GHS categories entails nominal changes to the flashpoint values for flammable and combustible liquids from 22.8 °C (73 °F) (current Class IA/B cut-off) to 23 °C (73.4 °F) (GHS Category 1/2 cut-off) and from 93.3 °C (200 °F) (current Class IIIB cut-off) to 93 °C (199.4 °F) (GHS Category 4). OSHA believes these changes in flash point represent simple rounding to the closest significant value
However, OSHA requested comment in the proposal on one change that was potentially significant. Under the proposal, the boiling points used to define the threshold for the current Flammable Class IA in § 1910.106 shifted from the cut-off value of 37.8 °C (100 °F) to a cut-off value of 35 °C (95 °F) for GHS Category 1. Likewise, the boiling points in the proposed definition of Flammable Class IB (§ 1910.106) shift from equal to or greater than (≥) 37.8 °C (100 °F) to greater than (≥) 35 °C (95 °F) in GHS Category 2 (
Most agreed with OSHA that resulting reclassifications of liquids with borderline flashpoints from the old Class IA to the GHS Category 2 was not significant (Document ID #0313, 0324, 0327, 0328, 0338, 0352, 0365, 0366, 0370, 0376, 0382, 0383, 0393, 0405, 0408, 0410, and 0494 Tr. 56). National Association of Chemical Distributers (NACD) stated that “Several NACD members handle flammable liquids under Category 1 and 2. However, the proposed changes would result in few operational changes” (Document ID # 0341). Several commenters pointed out that aligning the definitions for flammable liquids is consistent with the single worldwide definition for these hazards (Document ID #0313 and 0327). ORC (Document ID #0370) stated:
The American Petroleum Institute (API) urged OSHA to be consistent across all standards (Document ID #0376). Further, the ACC commented that in reference to the boiling point cut-off for Category 1 and 2 flammable liquids, they believe the language (in the NPRM) is sufficient to reflect the cut-off without changing the scope of the regulation (Document ID #0393).
However, some commenters expressed concern that the shift in flammability criteria would require facilities to modify their storage facilities to maintain compliance with § 1910.106, and consequently storage receptacles would have to be smaller, leading to less storage and greater costs (ISSA, Document ID # 0399). That concern is misplaced because the change from OSHA's old flammable and combustible classes to GHS categories involves a
The American Society of Safety Engineers (ASSE) agreed with OSHA's assessment of the storage issue. ASSE noted that the differences in boiling points from the original § 1910.106 to the GHS Categories could increase the number of gallons allowed to be stored in rooms and cabinets as well as the size of containers for certain liquids. However, in its opinion, the “slightly” increased boiling point would be of “little significance” (Document ID #0336). Therefore, based on the analysis discussed above and the comments received, OSHA has concluded that the shift in boiling point and the minor changes in temperatures and the re-categorizing of flammable liquids are insignificant and will have a negligible impact on the protection provided by the standards that use these terms.
Most commenters supported OSHA's proposal to incorporate the GHS definitions for flammable liquids into its safety standards (Document ID #0313, 0327, 0328, 0338, 0365, 0376, 0405, 0408, and 0410). Some stressed the “consistency” benefits from harmonization (Document ID #0338, 0405, and 0408). ASSE (Document ID #0336) said:
Although there was considerable support for the changes OSHA made in the proposal to the flammable and combustible liquid categories, OSHA also received comments suggesting that the deletion of the “combustible” designation and the combining of NFPA Class 1C flammable and Class II combustible liquids into new Category Flammable 3, would lead to confusion among engineers, employers, and employees, which could result in potential accidents (Document ID #0344, 0366, 0381, 0399, 0402, 0498, 0500, 0514, and 0643). In addition, some commenters questioned whether the OSHA standards that address flammable liquids that are not covered by GHS (Combustible Class IIIB) are best handled by replacing the term “combustible” with a quantitative definition so as to maintain their coverage (Document ID #0336, 0366, and 0497 Tr. 56-58 and 68).
Some organizations, though they supported the proposed changes in general, had some specific concerns, particularly with how the OSHA GHS harmonization works with other national standards, including consensus standards. Clariant Corporation opined that eliminating the term “combustible liquid” will likely cause some confusion since it is still used by NFPA and DOT but urged OSHA to adopt the GHS criteria to maintain global consistency (Document ID #0383). However, OSHA points out that, as mentioned above by NPCA, the GHS criteria are consistent with DOT. The American Federation of State, County and Municipal Employees (AFSCME) favored OSHA's GHS harmonization, but sought clarification or additional guidance on how secondary labeling systems such as NFPA's 704 Diamond or the Hazardous Materials Information System (HMIS) would be used once GHS was in effect (Document ID #0414).
NFPA testified that the GHS categories would conflict with NFPA's established hazard ratings in NFPA 704, which has been in effect since the 1950s. NFPA recommended that the term “combustible liquid” not be deleted (Document ID #0497 Tr. 59-64). In addition, NFPA expressed concern that there may be additional confusion since the rating system in NFPA 704 expresses the most hazardous as a “4” while the GHS classification criteria expresses the most hazardous as Category “1”. The International Fire Marshals Association (IFMA), echoing the sentiments of the NFPA, agreed that users have been relying on the NFPA 704 Hazard Rating and the Hazardous Material Information System (HMIS) systems for a long time and would be confused by the change (Document ID #0497 Tr. 80-84).
These commenters were concerned that the proposed realignment of the flammable liquid categories would result in confusion among employees, emergency responders, authorities having jurisdiction, and others who have been used to the distinction between flammable and combustible liquids (Document ID #0344, 0366, 0381, 0399, 0402, 0498, 0500, 0514, 0643, and 0497 Tr. 56-58). NFPA (Document ID #0366) stated:
As an initial matter, OSHA notes liquids with a flashpoint greater than or equal to 60 °C (140 °F) and less than 93.3 °C (200 °F), which are currently classified as “combustible,” will be labeled as “combustible liquids” under the final rule. Thus this minimizes the potential for the confusion that NFPA suggests for these chemicals.
In any event, OSHA believes that there is currently confusion and inconsistency in this area. For example, OSHA standards have several cutoff values for flammable and combustible liquids. In OSHA's general industry standard at § 1910.106, 100 °F is the cut-off between flammable liquids and combustible liquids, but in construction, § 1926.155, 140 °F is the cut-off between flammable and combustible. Even the NFPA's standards are confusing. In NFPA 30, the hazard levels are structured from Ia/b/c to III b, with Ia being the highest, while in NFPA 704 the hazard levels range from 1 to 4, where the highest hazard category is 4 and the lowest is 1. NFPA classification and rating systems have been in existence since the 1950s and while the NFPA rating system is widely used, it is still not universally used or understood. Testimony from Mr. Frederick of the United Steelworkers indicated that NFPA is a good quick reference although (he believed) it does not cover all hazards, but it is used to alert workers that they must look elsewhere for additional information (Document ID #0499 Tr. 155-169).
In addition, OSHA reviewed randomly chosen SDSs for liquids classified under the current standard to determine how NFPA ratings correlated to hazard warnings. As shown in Table XIII-7, the hazard warnings were inconsistent, while the MSDSs were all technically correct for physical properties. For example, the hazard warning for flammable liquids with a
OSHA believes that this rulemaking will promote greater harmonization of hazard warnings in the future. Now, when a chemical falls in a particular flammable liquid hazard category, the HCS requirements will dictate the appropriate hazard warning. At least one comment alleges this has already happened in the United States. Dr. Michele Sullivan pointed out that the U.S. Department of Transportation (DOT) is already aligned with the GHS physical hazard criteria (the GHS criteria for physical hazard was based on the DOT physical hazard criteria); thus is already aligned with GHS flammable liquid criteria. Therefore, OSHA is aligning with DOT with this rulemaking (49 CFR 173.120 and Document ID #0382).
Neither the proposal nor final rule prohibits the use of NFPA or HMIS rating systems. They do not prohibit the use of NFPA definitions for employers taking preventive measures in designing facilities or implementing fire protection systems such as automatic sprinklers to ensure a safer situation. OSHA's requirements, even with the substitution of the term “flammable” for “combustible,” do not prohibit safer workplace designs or installations. Furthermore, OSHA expects that engineers and other professionals will use the actual flashpoints and other properties of the liquids themselves in design and installation of controls rather than a designation of a liquid as “flammable” or “combustible.” IFMA agreed with this premise (Document ID #0497 Tr. 84-85). In any event, even if the engineer, facility designer, or employer is somehow misled by § 1910.106's use of the term “flammable,” which has traditionally connoted a higher level of hazard, the result should be an error on the side of safety, rather than of less protection.
During the public hearings, ORC Worldwide commented on OSHA's review of the standards affected by this rulemaking, stating support for the “concurrent harmonization of hazard definitions in most OSHA standards.” However, ORC also “agrees with member concern that changes to definitions in § 1910.106, Flammable and Combustible Liquids, while not increasing the scope of the standard, may cause confusion to workers who are familiar with NFPA nomenclature for these materials” (Document ID #0494 Tr. 91-92). OSHA asked ORC to elaborate on this concern and provide support for their testimony. In response, ORC (Document ID #0643) provided two hypothetical situations it believes show that confusion over the realignment of flammable and combustible liquid categories could be significant:
OSHA thanks ORC Worldwide for their testimony and for providing examples of where revisions to standards affected by this rulemaking might cause confusion. With regard to the situations presented by ORC, OSHA understands that the engineer designing the sprinkler system would be required to follow local and state building codes, along with NFPA codes or other building codes, such as NFPA 1 (Fire Code), NFPA 13 (Standard for the Installation of Sprinkler Systems), NFPA 30 (Flammable and Combustible Liquids Code), NFPA 32 (Standard for Dry Cleaning Plants), NFPA 5000 (Building Construction and Safety Code), and the International Building Code (published by the International Code Council) as well as any OSHA standards that would apply.
The design of a system is not predicated on one physical property, and a prudent engineer or sprinkler designer should be aware that there are special requirements for the storage of combustible and flammable liquids. The codes and standards mentioned above all refer to NFPA 30 for requirements related to the storage and use of flammable and combustible liquids. There are restrictions on maximum container size, maximum storage height, and maximum total quantity stored based on flashpoint.
With regard to the change in solvent used at a dry cleaning facility, the argument remains the same as for the design engineer mentioned above. The flashpoint determines the classification of the chemical. The automatic sprinkler system design would be based on the flashpoint and not the class of chemical being used. OSHA concludes that commenters' concerns about confusion are not well founded and has decided to retain the GHS definition for flammable liquids as proposed in the final rule.
Two commenters, Procter & Gamble and ISSA, believed OSHA was adopting the 140 °F flashpoint cut-off as the definition of a flammable liquid and that this would conflict with the current flashpoint cut-off of 100 °F in § 1910.106 (Document ID #0381 and 0399). Procter & Gamble, arguing that the GHS was designed for hazard communications and not intended to regulate design criteria and that aligning
As an initial matter, Procter & Gamble misunderstood how OSHA incorporated the GHS flammable liquid definitions into the safety standards. This change was made only to align terminology. In fact, OSHA agrees that the GHS was not intended to regulate design criteria. Therefore, OSHA proposed to leave the standard's design criteria intact by using the actual measurable flashpoint as the defining criterion. The proposal, adopted by the final rule, is similar to Procter & Gamble's Option 2 and accomplishes both harmonization with GHS and retention of OSHA's long-established and effective risk management practice.
Finally, there were concerns that realigning the flammability criteria could affect contracts. Phylmar Regulatory Roundtable (PRR), which did not oppose OSHA's alignment of definitions of flammable and combustible liquids with the GHS categories, was concerned the reclassification of chemicals may cause conflicts in contracts with customers. PRR stated that the contracts require specifications in products manufactured, engineering controls, personal protective equipment, and specified instructions. PRR claimed that in such a situation the manufacturer by contract is permitted no deviation from the contract or process standards (Document ID #0514). However, as stated above, OSHA has not changed the scope or the requirements of its standards. Therefore, OSHA has concluded there is unlikely to be any interference with contracts. Moreover, where distinctions must be made in the OSHA requirements between the former Class 1C flammable liquids and Class II combustible liquids, the OSHA requirements have specified such distinctions with specific flashpoints. The contents and scopes of the regulatory paragraphs are not affected by GHS reclassifications or terminology changes, nor are OSHA's ventilation, respiratory protection, and personal protective equipment standards. In addition, OSHA did not change standards, like its electrical standards, that address internal design criteria.
OSHA has decided to remain consistent with GHS and not create additional flammable liquid categories. However, § 1910.106(18)(ii)(b) defines Combustible Class IIIB liquids as liquids with flashpoints at or above 200 °F (93.3 °C). While Class IIIB liquids are not included in the scope of § 1910.106, there is no such exemption in the Spray Finishing standard, § 1910.107 (OSHA letter of interpretation, Aug. 15, 2006). In order to preserve coverage in standards such as Spray Finishing, these liquids are now called “Liquids with a Flashpoint of >93 °C (199.4 °F).” Similar to § 1910.106, the use of the flashpoint cut-off is the best way to stay as close to the GHS and maintain scope and consistency within the standards. The Soap and Detergent Association (SDA) and the Consumer Specialty Products Association (CSPA) in a joint comment stated that OSHA should “correct” § 1910.107(e) and (e)(4) and § 1910.124(c)(2) to read “Liquids with a Flashpoint at or below 199.4 °F” to be consistent with the GHS criteria (Document ID #0344). However, if OSHA were to adhere strictly to GHS in this instance and drop the higher flashpoint category, protection from this hazard would be lost and safety compromised.
Several commenters addressed this issue. ASSE stated that their “members do not see the need for the fifth category of `Flammable Liquids Over a Flash Point of 93.3 °C.' Specific flash point criteria should be used” (Document ID #0336). NFPA expressed general concern about the elimination of the Class IIIB liquids by the adoption of the GHS categorization system, though they acknowledged that OSHA had proposed to extend liquids as “flammable liquid with flash point greater than 93 °C” (Document ID #0366 and 0497 Tr. 56-58). The point was further clarified upon questioning at the hearing where NFPA agreed that by extending the liquids to flashpoints greater than 199.4 °F, OSHA was providing the coverage for § 1910.107 that had always been there. In addition, NFPA recommended it be further clarified that these liquids with the higher flashpoints belong to § 1910.107 and are not part of GHS Category 4 (Document ID #0497 Tr. 68).
In addition, Intercontinental Chemical Corporation recommended that OSHA create six new categories matching the six classes in the original § 1910.106 (Document ID #0500). The Agency believes that this approach would be inconsistent with GHS, since the GHS classifications and categories, including flammable liquid Categories 1-4, were established by international committees and are in place. OSHA's intent in this rulemaking is to harmonize the HCS with the existing GHS classifications and categories, not to make new categories.
In summary, OSHA views this rulemaking as a step towards eliminating current inconsistencies. OSHA believes the potential confusion with other agency policies, standards, consensus standards, and traditional practices suggested by the commenters are not likely to occur for several reasons. First, the changes in the final rule will bring internal consistency to the OSHA standards covered. OSHA standards currently have several cut-off values for flammable and combustible liquids. In OSHA's general industry standard (§ 1910.106), 100 °F is the cut-off between the flammable and combustible liquids, but in construction, § 1926.155, 140 °F is the cut-off between flammable and combustible. Harmonizing these standards, which have been out of sync for many years, will bring needed consistency to the safety standards. In addition, as noted above, substantive requirements have not changed, and therefore designs are not affected.
Second, the changes to the standards do not require changes in work practices. Rather, what have changed are a few regulatory terms used in the standards. Commenters who thought that such changes in definitions and terminology would result in significant and costly modifications to facility design and operation are incorrect, as the old requirements in the standards remain and no facility design and operation changes are required (Document ID #0344, 0381, and 0399). The requirements for what were known formerly as combustible liquids remain the same even though they are now categorized as flammable liquids.
Third, there is growing awareness of the GHS “flammable liquids” definition. Other agencies, such as DOT, are already aligned with the GHS definition for flammable liquids (49 CFR 173.120), and OSHA believes that its ANPR and NPRM have raised awareness of the definition.
Change occurs in every area of employment, and employers and workers get trained and adjust to the change; OSHA believes these minor changes will be accepted and adopted. OSHA's flammable and combustible liquid storage requirements have always been based on the flashpoint and boiling point of the liquid; OSHA does not
OSHA will be doing outreach to affected parties and working with professional and trade associations to help users become familiar with and competent in applying these modifications. ORC testified that the changes may cause confusion to workers familiar with NFPA nomenclature, and agreed with OSHA that, with training, any confusion resulting from the change from NFPA definitions and terminology to GHS definitions and terminology would be overcome. ORC (Document ID #0494 Tr. 100-101) further stated that potential confusion would not be a reason to delay moving forward with finalizing the standard:
OSHA agrees and believes users of the new GHS flammable liquid categories will implement its new terminology in their work.
The note in the PSM construction standard, § 1926.64(d)(1)(vii), has been changed. In the current standard, paragraph (d)(1)(vii), the note states, “Material Safety Data Sheets meeting the requirements of 29 CFR 1926.59(g) may be used to comply with this requirement to the extent they contain the information required by this subparagraph.” The note has been changed to “Safety Data Sheets (SDSs) meeting the requirements of 29 CFR 1910.1200(g) . * * *”
To correct a technical error and to complete alignment across standards, § 1910.106(j), Scope, has been made consistent with § 1910.106(a)(19) and § 1910.1200, Appendix B. Proposed § 1910.106(j) stated that it “applie[d] to the handling, storage, and use of flammable liquids with a flashpoint
In § 1926.155, OSHA proposed to harmonize the definitions of flammable and combustible liquids to be consistent with the GHS categories of flammable liquids (
The Soap and Detergent Association and Consumer Specialty Products Association, in a joint comment (Document ID #0344), suggested that OSHA change the term “pilot light” to “indicating light.” As discussed previously, this type of change is outside of the scope of this rulemaking since it does not pertain to hazard communication or GHS harmonization. Therefore, OSHA is not adopting that suggestion at this time.
OSHA proposed to update the methods that may be used to determine flashpoints in the NPRM. These methods include updated ASTM methods, ISO methods, and British, French, and German national standards for the testing. The methods are listed in Appendix B.6 of § 1910.1200 and are also referenced in Revision 3 of the GHS (2009), Chapter 2.6.
In the definitions of § 1910.106, the current standard allowed only ASTM D-56-70 and ASTM D-93-71 as testing methods to determine flashpoints. In § 1926.155, which applies to Subpart F of the construction standards (Fire Protection and Prevention), OSHA currently allows only ASTM D-56-69 and ASTM D-93-69 for such determinations. The current HCS allows only ASTM D 56-79, ASTM D 93-79, and ASTM D 3278-78. The methods allowed in § 1910.155 were adopted in the late 1960s, and the methods for § 1910.106 and § 1926.1200 were adopted in the 1970s.
The NPRM updated the methods in § 1910.1200 to conform to the GHS. However, flashpoint methods in § 1910.1200 had always differed from methods in § 1910.106 and § 1926.155. Instead of revamping the older test methods in OSHA's other standards, the proposal allowed a broader test selection. OSHA kept the tests currently permitted in § 1910.106 and § 1926.155 because they were in the original OSHA standards, but allowed methods in the GHS-modified HCS be used as well. The final rule adopts these changes.
Thus, the final rule amends § 1910.106 and § 1926.155 to allow ASTM D-56-70 and ASTM D-93-71 for § 1910.106; ASTM D-56-69 and ASTM D-93-69 for § 1910.155; and the equivalent testing methods permitted in the HCS, § 1910.1200, Appendix B.6, Physical Hazard Criteria. For example, as amended by the final rule, § 1910.106(a)(14)(i) states that for a liquid which has a viscosity of less than 45 SUS at 100 °F (37.8 °C), does not
By equivalent test method, OSHA means employers can select any of the test methods in Appendix B.6 or in Chapter 2.6 of Revision 3 of the GHS (2009).
The only comments on this issue recommended additional methods for determining flashpoints (Document ID #0344 and 0381). The Soap and Detergent Association/Consumer Specialty Products Association (Document ID #0344) and the Procter & Gamble Company (Document ID #0381) recommended OSHA include ASTM D6450 on the list of approved methods for determining the flashpoints of liquids in the “incorporation by reference” list in § 1910.106. OSHA is not prepared to adopt this method at this time. The determination of flashpoint test methods for GHS falls under a Sub-committee of the United Nations Economic and Social Council's Committee of Experts on the Transport of Dangerous Goods (UNCEDTG). Commenters who wish the GHS to incorporate ASTM D6450 should direct their requests to that body, and if the method is incorporated into the GHS, OSHA will consider the matter at that time.
OSHA currently defines the term “flammable aerosol” in § 1910.106 and in § 1910.1200 by reference to a definition developed by the Consumer Product Safety Commission under the Federal Hazardous Substances Act.
The current § 1910.106 definitions for “aerosol” and “flammable aerosol” are provided in (§ 1910.106(a)(1)) and (§ 1910.106(a)(13)) and are different from those in the revised Hazard Communication Standard. In the current § 1910.106, an aerosol is defined as a material which is dispensed from its container as a mist, spray, or foam by a propellant under pressure. However, in the current § 1910.106, a flammable aerosol is defined as an aerosol which is required to be labeled “Flammable” under the Federal Hazardous Substances Labeling Act (15 U.S.C. 1261). For the purposes of § 1910.106(d), such aerosols are considered Class IA liquids.
OSHA proposed to remove the definitions of “aerosol” and “flammable aerosol” from § 1910.106 and instead insert its GHS-consistent definitions along with references to Appendix B.3 of the GHS-modified HCS. In response to OSHA's proposed action, National Paint and Coatings Association and Alliance of Hazardous Materials Professionals both said that, while they were not prepared to offer specific impact information on operations, “to align OSHA definitions for * * * Flammable Aerosols is fully consistent with the concept of a `single world-wide' definition for these hazards.” (Document ID #0313 and 0327).
OSHA agrees with these comments and has included the revised definition of “flammable aerosols” in the final rule. The revised definition in the Flammable liquids standard, § 1910.106, duplicates the flammable aerosols definition contained in Appendix B to § 1910.1200—Physical Hazard Criteria. For the purposes of § 1910.106(d), such aerosols are considered Category 1 flammable liquids.
The GHS-modified definition and classification criteria for flammable aerosols can be found in Appendix B.3 of HCS.
OSHA's decision to change the definition of aerosols to be consistent with the GHS-modified HCS is based not only upon harmonizing its own standards with those followed by other countries who have or are considering adopting GHS, but also to harmonize with DOT's definition for flammable aerosols, which is also consistent with the GHS.
Dr. Michelle Sullivan (Document ID #0382), alluding to flammable aerosols, pointed out that flammable categories will differ among regulatory authorities. She stated:
Regarding Dr. Sullivan's comment, OSHA acknowledges that other regulatory bodies, when adopting GHS, may choose different building blocks. However, the basis for classification will still be based on the same criteria and will lead to harmonization of similarly covered materials. This does not affect OSHA's decision to strive for both domestic and international harmonization.
Finally, OSHA believes that the GHS classification criteria are similar enough to the current § 1910.106 and § 1910.1200 criteria that all aerosols currently regulated by OSHA would continue to be so, and that few, if any, new aerosols would be subject to OSHA regulation. Indeed, OSHA raised this issue in the NPRM and received no comments to the contrary.
OSHA did not propose to change standards that incorporate by reference other consensus standards, such as NFPA codes, or are based on consensus standards when those consensus standards are used for internal design criteria only and do not reference the HCS for applicable scope or incorporation into the SDS. These standards include Subpart S—Electrical, in Part 1910 (General Industry), and Subpart K—Electrical, in Part 1926 (Construction). Many commenters on the ANPR were particularly concerned that a change in OSHA's definitions would create an incompatibility with local building codes (Document ID #0047, 0075, 0076, 0104, 0113, 0145 and 0163). They alleged that, in many cases, this would require extensive rewiring to meet the Subpart S requirements on hazardous locations and would lead to conflicts with local electrical codes.
Many commenters on the NPRM supported OSHA's exemption of these standards (Document ID #0328, 0330, 0336, 0370, 0393, and 0408). Ameren expressed concern that if OSHA harmonized the electrical and blasting agents standards (Part 1910 Subpart S, § 1910.109, and Part 1926 Subpart K, § 1926.914) with the GHS, such changes would require training of affected employees on the changes (Document ID #0330). ASSE agreed with OSHA's decision not to propose updates to the electrical standards (general industry 1910 Subpart S and construction 1926 Subpart K) or explosives and blasting agents (general industry § 1910.109 and construction § 1926.914), since these subparts are “self-contained” in that they do not rely on other OSHA standards for regulatory scope or definitions but reference external organizations such as the National Fire Protection Association (NFPA) (Document ID #0336). The American Iron and Steel Institute agreed (Document ID #0408). ORC strongly
Wacker Chemical Company, PRR, and ACC urged OSHA to update electrical and explosive and blasting agents standards if the consensus organizations could come to agreement, and they expressed their concerns regarding potential conflicts with local codes and regulations (Document ID #0335, 0339, and 0393). Wacker Chemical Corporation encouraged OSHA to work closely with organizations (NFPA and others) that develop fire and electrical codes to ensure there is consistent application of these codes to area classification, building construction, equipment electrical ratings, etc. (Document ID #0335). Wacker Chemical suggested that OSHA could make progress with the consensus organizations (Document ID #0335). PRR recommended harmonization updates of electrical and explosive standards if the updates would enhance safety and the ease of doing business in the global market (Document ID #0339). The ACC agreed with OSHA's decision not to change standards that incorporate consensus standards by reference (
OSHA agrees with those comments that expressed the desire to harmonize but also expressed concern over the potential effects of internal codes. OSHA concluded that exempting those standards where conflicts with internal codes could occur at this time was appropriate. OSHA agrees with ACC that impacting electrical area classification, facility siting, and wiring configuration is not appropriate. Therefore, because of these potential conflicts with internal design criteria, OSHA is not harmonizing the electrical and other standards that depend on internal design criteria and local building codes.
OSHA did not propose to harmonize the Explosive and Blasting Agents standards, § 1910.109 (general industry) and § 1926, Subpart U (construction). At the time of the proposal, a separate rulemaking to revise them was in progress. That rulemaking has since been terminated (75 FR 5545, Feb. 3, 2010). However, the HCS has always covered hazardous chemicals regulated by OSHA's Explosive and Blasting Agents standards. Although the rulemaking on explosives and blasting agents has ceased, the general requirements in the GHS-modified HCS and specific requirements in its appendices still apply to explosives and blasting agents that can be considered hazardous chemicals. Manufacturers and importers must evaluate chemicals to classify their health and physical hazards in accordance with paragraph (d) of the HCS, must affix labels in accordance with paragraph (f) in HCS, and must provide SDSs in accordance with paragraph (g) of the HCS. Appendix B.1 of the GHS-modified HCS contains specific classification criteria for explosives. Furthermore, labels are required by the Department of Transportation (DOT) for the transportation of packages or containment devices that contain hazardous materials meeting one or more of DOT's hazard class definitions.
The few commenters who addressed the issue supported OSHA's decision not to include the Explosive and Blasting Agents standards (§ 1910.109 and § 1926.914) in the proposal (Document ID #0328, 0330, 0336, 0362, and 0370).
As to the continuing coverage of HCS, a representative from Institute Makers of Explosives stated that the commercial explosives industry understands the importance of GHS, has been prepared for several years to implement GHS, and would not experience any impacts to explosives operations that were not already anticipated (Document ID #0362).
Galaxy Fireworks noted that § 1910.109(k)(1) excludes the sale and “use (public display)” of pyrotechnics (fireworks) from the explosives standard (Document ID #0355). Galaxy Fireworks' concern was the potential for the proposal to create a regulation that overlaps with the existing requirements of the Department of Transportation and the Consumer Product Safety Commission. Galaxy urged OSHA to work with these other agencies in amending the HCS to develop regulations that would apply uniformly to the fireworks industry and with other organizations to further harmonization (Document ID #0335). OSHA agrees and believes its global harmonization efforts embodied in this rulemaking go a long way toward the overall goal of consistency.
OSHA received one comment, from Northrop Grumman Shipbuilding, which stated that OSHA had omitted modification of the shipyard Part 1915 safety standards for GHS harmonization (Document ID # 0395). More specifically, Northrop Grumman believed that the maritime standards that contain requirements for flammable and combustible liquids required review and updating to be GHS harmonized, just as the flammable and combustible liquids the General Industry Part 1910 and Construction Part 1926 standards were proposed to be reviewed and updated.
OSHA did not propose to update the maritime standards, other than the substance-specific standards mentioned above, in this rulemaking. Unlike the standards in general industry and construction, the maritime standards (Shipyard Employment, Part 1915; Marine Terminals, Part 1917; and Longshoring, Part 1918) have always addressed flammables and combustibles in their own unique way, reflecting the special conditions of maritime work. These parts do not use flashpoint criteria to distinguish between flammable and combustible liquids. The terminology in the maritime standards that addresses flammable and combustible materials, including liquids, differs from the general industry and construction standards. For example, § 1915.12(b)(1) (Flammable atmospheres) and § 1915.54 (Welding, cutting and heating of hollow metal containers not covered by § 1915.12) require competent-person testing and contain detailed instructions on the specific maritime work covered.
There are a few paragraphs in the maritime standards where flammable and combustible liquids requirements reference flashpoint criteria but in these cases, flashpoints are not used for the purpose of distinguishing flammable from combustible liquids. Examples include Subpart P, Fire Protection, § 1915.501 through § 1915.509, where flammable liquid is defined as liquids with flashpoints below 100 °F (37.8 °C). Combustible liquids are neither defined nor mentioned in this Subpart, although combustible materials are mentioned and not defined. Other maritime standards such as § 1915.14 (Hot work)
OSHA has issued a maritime compliance tool, “Tool Bag Directive for the Part 1915 Shipyard Employment Standards,” that includes specific interpretations of the maritime standards. The Tool Bag Directive references specific general industry standards in order to provide further guidance related to some of the more general maritime requirements. A specific case is how general industry standard § 1910.106 is used. The Tool Bag Directive informs users that if specific Part 1915 shipyard requirements give flashpoint criteria, those requirements take precedence. However, where definitions of flammable and combustible liquids are not specified in the Part 1915 shipyard standards, the definitions of § 1910.106 are to apply. The final rule's changes do not significantly modify the substantive requirements of § 1910.106, and the Tool Bag Directive's interpretive policy will continue after the final rule becomes effective, using the new definitions in § 1910.106.
In a similar manner, OSHA has a compliance tool for Parts 1917 “Marine Terminals” and 1918 “Longshoring” called the Tool Shed Directive. This Directive notes that the requirements of § 1910.1200 apply to operations covered by Parts 1917 and 1918.
The Building and Construction Trades Department (BCTD) requested that OSHA clarify inconsistencies in the construction standards, particularly by updating the Part 1926 standards to conform to the proposed requirements for and definitions of “flammable” and the related deletion of the term “combustible” liquids (Document ID # 0359). BCTD gave examples of §§ 1926.152, 1926.155, 1926.66 and Subpart K of Part 1926 and requested that OSHA conduct a thorough review of the Part 1926 construction standards. Though it had done so once in preparing the NPRM, OSHA again conducted a thorough review of Part 1926. OSHA had already proposed to modify § 1926.152 (Flammable and combustible liquids) and § 1926.155 (Definitions) as well as § 1926.64 (Process Safety Management), § 1926.65 (HAZWOPER), and the substance-specific health standards in construction in the NPRM. As explained above, OSHA has made further revisions in the construction regulations regarding process safety management (§ 1926.64(d)(1)(vii)) and fire protection and prevention (§ 1926.150(c)(vi), § 1926.151(a)(4)), and § 1926.151(b)(3)) in this final rule.
Like Subpart S in general industry, § 1926.66 (Criteria for design and construction of spray booths) belongs to the category of construction standards that incorporate other consensus standards by reference, such as NFPA codes, or are based on consensus standards when those consensus standards are used for internal design criteria only and do not reference HCS for applicable scope or incorporation into the SDS. Clearly, there is no reason to change the terminology in § 1926.66. As noted above, Part 1926, Subpart K (Electrical), belongs in this category. Other similar standards are § 1926.351 (Arc Welding and Cutting), and Part 1926, Subpart V (Power Transmission and Distribution). OSHA is not modifying these standards for the same reasons listed above for general industry.
Similar to the discussion regarding the Maritime standards, OSHA did not propose modifications of standards that do not contain definitions that are applicable to standards in the Subpart or explicitly reference standards that contain the definitions. The standards may contain phrases with the terms “flammable liquid” or “combustible liquid,” but the definitions of the terms are absent. Standards belonging to this category of undefined terms include § 1926.66(c)(9)(i) (Criteria for design and construction of spray booths), § 1926.252(e) (Disposal of waste materials), § 1926.307(p)(2)(ii) (Mechanical power-transmission apparatus), § 1926.352(c) and (h) (Fire prevention), § 1926.803(l)(13) (Compressed air), and § 1926.1101, Appendix B (Sampling and Analysis for Asbestos). In addition, some of these standards' requirements use the term “flammable liquid” without the term “combustible liquid,” and some of the requirements use the term “combustible liquid” without the term “flammable liquid.” As with the maritime standards, since OSHA has not changed the actual requirements of § 1910.106 or § 1926.155, OSHA does not anticipate that the final rule will affect the requirements of other OSHA standards that use some of the same terminology.
In addition, OSHA did not modify standards that refer to flammable and combustible materials, storage piles, etc. that are not liquids. Examples are § 1926.550(a)(15)(vii)(C) (Cranes and derricks), which refers to combustible and flammable materials; § 1926.956(b)(3) (Underground lines), which refers to combustible gases; and § 1926.352(c) (Fire prevention), which refers to flammable compounds. In addition, § 1926.154(e)(1) (Temporary heating devices) mentions “flammable liquids,” but the term was not the focus of the standard. The requirement mentions flammable liquid-fired heaters, but the focus is on safety controls for the particular piece of equipment. Safety training and education, § 1926.21(b)(5), is another example that contains some of the terminology, but its focus is on safety training. Flammable liquids are treated in a general sense,
A commenter from the International Chemical Workers Union Council recommended OSHA include a conversion formula for Centigrade and Fahrenheit or, at a minimum, provide the equivalent degrees when addressing flammable and combustible liquids, since in general employers and employees in the U.S. are more familiar with degrees Fahrenheit (Document ID # 456). OSHA proposed to provide temperature equivalents, and in the final standard equivalents are included where there are requirements for flammable and combustible liquids. The formulas for conversion are:
Since the formulas for conversion are standard formulas found in textbooks, and since equivalents have been provided wherever possible for flammable and combustible liquids, OSHA has determined that it is not necessary to state the formulas for conversion in the actual regulations.
This document was prepared under the direction of David Michaels, Assistant Secretary of Labor for Occupational Safety and Health, U.S.
Asbestos, Blood, Chemicals, Diving, Fire prevention, Gases, Hazard communication, Hazardous substances, Health records, Incorporation by reference, Labeling, Labels, Laboratories, Occupational safety and health, Reporting and recordkeeping requirements, Safety data sheets, Signs and symbols, and Training.
Hazard communication, Hazardous substances, Labels, Longshore and harbor workers, Occupational safety and health, Reporting and recordkeeping requirements, Safety data sheets, Signs and symbols, Training, and Vessels.
Chemicals, Construction industry, Diving, Fire prevention, Gases, Hazard communication, Hazardous substances, Health records, Labels, Lead, Occupational safety and health, Reporting and recordkeeping requirements, Safety data sheets, Signs and symbols, and Training.
For the reasons discussed in the preamble, the Occupational Safety and Health Administration amends 29 CFR parts 1910, 1915 and 1926 as set forth below:
Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355) or 1-2012 (77 FR 3912), as applicable.
Section 1910.6 also issued under 5 U.S.C. 553. Sections 1910.6, 1910.7, and 1910.8 also issued under 29 CFR Part 1911. Section 1910.7(f) also issued under 31 U.S.C. 9701, 29 U.S.C. 9a, 5 U.S.C. 553; Pub. L. 106-113 (113 Stat. 1501A-222); Pub. L. 111-8 and 111-317 and OMB Circular A-25 (dated July 8, 1993) (58 FR 38142, July 15, 1993).
(a) * * *
(4) Copies of standards listed in this section and issued by private standards organizations are available for purchase from the issuing organizations at the addresses or through the other contact information listed below for these private standards organizations. In addition, these standards are available for inspection at any Regional Office of the Occupational Safety and Health Administration (OSHA), or at the OSHA Docket Office, U.S. Department of Labor, 200 Constitution Avenue NW., Room N-2625, Washington, DC 20210; telephone: 202-693-2350 (TTY number: 877-889-5627). They are also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of these standards at NARA, telephone: 202-741-6030, or go to
(h) Copies of the standards listed below in this paragraph (h) are available for purchase from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959; Telephone: 610-832-9585; Fax: 610-832-9555; Email:
(1) ASTM A 47-68, Malleable Iron Castings, IBR approved for § 1910.111.
(2) ASTM A 53-69, Welded and Seamless Steel Pipe, IBR approved for §§ 1910.110 and 1910.111.
(3) ASTM A 126-66, Gray Iron Casting for Valves, Flanges and Pipe Fitting, IBR approved for § 1910.111.
(4) ASTM A 391-65 (ANSI G61.1-1968), Alloy Steel Chain, IBR approved for § 1910.184.
(5) ASTM A 395-68, Ductile Iron for Use at Elevated Temperatures, IBR approved for § 1910.111.
(6) ASTM B 88-66A, Seamless Copper Water Tube, IBR approved for § 1910.252.
(7) ASTM B 88-69, Seamless Copper Water Tube, IBR approved for § 1910.110.
(8) ASTM B 117-64, Salt Spray (Fog) Test, IBR approved for § 1910.268.
(9) ASTM B 210-68, Aluminum-Alloy Drawn Seamless Tubes, IBR approved for § 1910.110.
(10) ASTM B 241-69, Standard Specifications for Aluminum-Alloy Seamless Pipe and Seamless Extruded Tube, IBR approved for § 1910.110.
(11) ASTM D 5-65, Test for Penetration by Bituminous Materials, IBR approved for § 1910.106.
(12) ASTM D 56-70, Test for Flash Point by Tag Closed Tester, IBR approved for § 1910.106.
(13) ASTM D 56-05, Standard Test Method for Flash Point by Tag Closed Cup Tester, Approved May 1, 2005, IBR approved for Appendix B to § 1910.1200.
(14) ASTM D 86-62, Test for Distillation of Petroleum Products, IBR approved for §§ 1910.106 and 1910.119.
(15) ASTM D 86-07a, Standard Test Method for Distillation of Petroleum Products at Atmospheric Pressure, Approved April 1, 2007, IBR approved for Appendix B to § 1910.1200.
(16) ASTM D 88-56, Test for Saybolt Viscosity, IBR approved for § 1910.106.
(17) ASTM D 93-71, Test for Flash Point by Pensky Martens, IBR approved for § 1910.106.
(18) ASTM D 93-08, Standard Test Methods for Flash Point by Pensky-Martens Closed Cup Tester, Approved Oct. 15, 2008, IBR approved for Appendix B to § 1910.1200.
(19) ASTM D 240-02 (Reapproved 2007), Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter, Approved May 1, 2007, IBR approved for Appendix B to § 1910.1200.
(20) ASTM D 323-68, Standard Test Method of Test for Vapor Pressure of Petroleum Products (Reid Method), IBR approved for § 1910.106.
(21) ASTM D 445-65, Test for Viscosity of Transparent and Opaque Liquids, IBR approved for § 1910.106.
(22) ASTM D 1078-05, Standard Test Method for Distillation Range of Volatile Organic Liquids, Approved May 15, 2005, IBR approved for Appendix B to § 1910.1200.
(23) ASTM D 1692-68, Test for Flammability of Plastic Sheeting and Cellular Plastics, IBR approved for § 1910.103.
(24) ASTM D 2161-66, Conversion Tables for SUS, IBR approved for § 1910.106.
(25) ASTM D 3278-96 (Reapproved 2004) E1, Standard Test Methods for Flash Point of Liquids by Small Scale Closed-Cup Apparatus, Approved November 1, 2004, IBR approved for Appendix B to § 1910.1200.
(26) ASTM D 3828-07a, Standard Test Methods for Flash Point by Small Scale Closed Cup Tester, Approved July 15, 2007, IBR approved for Appendix B to § 1910.1200.
(27) ASTM F-2412-2005, Standard Test Methods for Foot Protection, IBR approved for § 1910.136.
(28) ASTM F-2413-2005, Standard Specification for Performance Requirements for Protective Footwear, IBR approved for § 1910.136.
(q) The following material is available for purchase from the National Fire Protection Association (NFPA), 1 Batterymarch Park, Quincy, MA 02269; Telephone: 800-344-3555 or 617-770-3000; Fax: 1-800-593-6372 or 1-508-895-8301; Email:
(37) NFPA 30B, Code for the Manufacture and Storage of Aerosol Products, 2007 Edition, Approved August 17, 2006, IBR approved for Appendix B to § 1910.1200.
(y)(1) The following materials are available for purchase from the International Standards Organization (ISO) through ANSI, 25 West 43rd Street, Fourth Floor, New York, NY 10036-7417; Telephone: 212-642-4980; Fax: 212-302-1286; Email:
(2) Documents not available in the ANSI store may be purchased from:
(i) Document Center Inc., 111 Industrial Road, Suite 9, Belmont, 94002; Telephone: 650-591-7600; Fax: 650-591-7617; Email:
(ii) DECO—Document Engineering Co., Inc., 15210 Stagg Street, Van Nuys, CA 91405; Telephone: 800-645-7732 or 818-782-1010; Fax: 818-782-2374; Email:
(iii) Global Engineering Documents, 15 Inverness Way East, Englewood, CO 80112; Telephone: 1-800-854-7179 or 303-397-7956; Fax: 303-397-2740; Email:
(iv) ILI Infodisk, Inc., 610 Winters Avenue, Paramus, NJ 07652; Telephone: 201-986-1131; Fax: 201-986-7886; Email:
(v) Techstreet, a business of Thomson Reuters, 3916 Ranchero Drive, Ann Arbor, MI 48108; Telephone: 800-699-9277 or 734-780-8000; Fax: 734-780-2046; Email:
(3) ISO 10156:1996 (E), Gases and Gas Mixtures—Determination of Fire Potential and Oxidizing Ability for the Selection of Cylinder Valve Outlets, Second Edition, Feb. 15, 1996, IBR approved for Appendix B to § 1910.1200.
(4) ISO 10156-2:2005 (E), Gas cylinders—Gases and Gas Mixtures—Part 2: Determination of Oxidizing Ability of Toxic and Corrosive Gases and Gas Mixtures, First Edition, Aug. 1, 2005, IBR approved for Appendix B to § 1910.1200.
(5) ISO 13943:2000 (E/F), Fire Safety—Vocabulary, First Edition, April, 15, 2000, IBR approved for Appendix B to § 1910.1200.
(z)(1) The following document is available for purchase from United Nations Publications, Customer Service, c/o National Book Network, 15200 NBN Way, PO Box 190, Blue Ridge Summit, PA 17214; telephone: 1-888-254-4286; fax: 1-800-338-4550; email:
(i) Bernan, 15200 NBN Way, Blue Ridge Summit, PA 17214; telephone: 1-800-865-3457; fax: 1-800-865-3450; email:
(ii) Renouf Publishing Co. Ltd., 812 Proctor Avenue, Ogdensburg, NY 13669-2205; telephone: 1-888-551-7470; Fax: 1-888-551-7471; email:
(2) UN ST/SG/AC.10/Rev.4, The UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Fourth Revised Edition, 2003, IBR approved for Appendix B to § 1910.1200.
Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), or 5-2007 (72 FR 31159), 4-2010 (75 FR 55355) or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.
Sections 1910.103, 1910.106 through 1910.111, and 1910.119, 1910.120, and 1910.122 through 1910.126 also issued under 29 CFR part 1911.
Section 1910.119 also issued under Section 304, Clean Air Act Amendments of 1990 (Pub. L. 101-549), reprinted at 29 U.S.C.A. 655 Note.
Section 1910.120 also issued under Section 126, Superfund Amendments and Reauthorization Act of 1986 as amended (29 U.S.C.A. 655 Note), and 5 U.S.C. 553.
The revisions read as follows:
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(13) Flammable aerosol shall mean a flammable aerosol as defined by Appendix B to § 1910.1200—Physical Hazard Criteria. For the purposes of paragraph (d) of this section, such aerosols are considered Category 1 flammable liquids.
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(i) For a liquid which has a viscosity of less than 45 SUS at 100 °F (37.8 °C), does not contain suspended solids, and does not have a tendency to form a surface film while under test, the procedure specified in the Standard Method of Test for Flashpoint by Tag Closed Tester (ASTM D-56-70), which is incorporated by reference as specified in § 1910.6, or an equivalent test method as defined in Appendix B to § 1910.1200—Physical Hazard Criteria, shall be used.
(ii) For a liquid which has a viscosity of 45 SUS or more at 100 °F (37.8 °C), or contains suspended solids, or has a tendency to form a surface film while under test, the Standard Method of Test for Flashpoint by Pensky-Martens Closed Tester (ASTM D-93-71) or an equivalent method as defined by Appendix B to § 1910.1200—Physical Hazard Criteria, shall be used except that the methods specified in Note 1 to section 1.1 of ASTM D-93-71 may be used for the respective materials specified in the Note. The preceding ASTM standard is incorporated by reference as specified in § 1910.6.
(iii) For a liquid that is a mixture of compounds that have different volatilities and flashpoints, its flashpoint shall be determined by using the procedure specified in paragraph (a)(14)(i) or (ii) of this section on the liquid in the form it is shipped.
(18) [Reserved]
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(i) Category 1 shall include liquids having flashpoints below 73.4 °F (23 °C) and having a boiling point at or below 95 °F (35 °C).
(ii) Category 2 shall include liquids having flashpoints below 73.4 °F (23 °C) and having a boiling point above 95 °F (35 °C).
(iii) Category 3 shall include liquids having flashpoints at or above 73.4 °F (23 °C) and at or below 140 °F (60 °C). When a Category 3 liquid with a flashpoint at or above 100 °F (37.8 °C) is heated for use to within 30 °F (16.7 °C) of its flashpoint, it shall be handled in accordance with the requirements for a Category 3 liquid with a flashpoint below 100 °F (37.8 °C).
(iv) Category 4 shall include liquids having flashpoints above 140 °F (60 °C) and at or below 199.4 °F (93 °C). When a Category 4 flammable liquid is heated for use to within 30 °F (16.7 °C) of its flashpoint, it shall be handled in accordance with the requirements for a Category 3 liquid with a flashpoint at or above 100 °F (37.8 °C).
(v) When liquid with a flashpoint greater than 199.4 °F (93 °C) is heated for use to within 30 °F (16.7 °C) of its flashpoint, it shall be handled in accordance with the requirements for a Category 4 flammable liquid.
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(
(4) * * *
(i) Tank vehicle and tank car loading or unloading facilities shall be separated from aboveground tanks, warehouses, other plant buildings or nearest line of adjoining property which may be built upon by a distance of 25 feet for Category 1 or 2 flammable liquids, or Category 3 flammable liquids with a flashpoint below 100 °F (37.8 °C), and 15 feet for Category 3 flammable liquids with a flashpoint at or above 100 °F (37.8 °C) and Category 4 flammable liquids, measured from the nearest
(6) * * *
(ii)
(7) * * *
(i) * * *
(
(f) * * *
(1) * * *
(i)
(ii)
(2) * * *
(ii)
(iii) * * *
(
(
(
(3) * * *
(i)
(ii)
(iv) * * *
(
(
(
(
(
(v)
(vi)
(4) * * *
(viii) * * *
(
(5) * * *
(i)
(6)
(8)
(g) * * *
(1) * * *
(i) * * *
(
(
(
(iii) * * *
(
(
(
(v)
(3) * * *
(iv) * * *
(
(
(
(
(v) * * *
(
(vi) * * *
(
(4) * * *
(iii) * * *
(
(5) * * *
(i)
(6) * * *
(iv)
(7)
(h) * * *
(3) * * *
(i) * * *
(
(iii) * * *
(
(iv)
(5)
(7) * * *
(i) * * *
(
(iii) * * *
(
(j)
(e)
(4)
(a) * * *
(1) * * *
(ii) A process which involves a Category 1 flammable gas (as defined in 1910.1200(c)) or a flammable liquid with a flashpoint below 100 °F (37.8 °C) on site in one location, in a quantity of 10,000 pounds (4535.9 kg) or more except for:
(B) Flammable liquids with a flashpoint below 100 °F (37.8 °C) stored in atmospheric tanks or transferred which are kept below their normal boiling point without benefit of chilling or refrigeration.
(b) * * *
(a) * * *
(3) * * *
(d) * * *
(c) * * *
(2) You must ensure that any exhaust air re-circulated from a dipping or coating operation using flammable liquids or liquids with flashpoints greater than 199.4 °F (93 °C) is:
If you use flammable liquids, you must comply with the requirements of this section as well as the requirements of §§ 1910.123, 1910.124, and 1910.126, as applicable.
Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, and 657); Secretary of Labor's Orders Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.
(c) * * *
(1) * * *
(iv)
(v)
(B) In addition to any requirements imposed by § 1910.1200, all filler metals and fusible granular materials shall carry the following notice, as a minimum, on tags, boxes, or other containers:
Do not use in areas without adequate ventilation.
(C) Where brazing (welding) filler metals contain cadmium in significant amounts, the labels shall indicate the hazards associated with cadmium including cancer, lung and kidney effects, and acute toxicity effects.
(D) Where brazing and gas welding fluxes contain fluorine compounds, the labels shall indicate the hazards associated with fluorine compounds including eye and respiratory tract effects.
(vi) Prior to June 1, 2015, employers may include the following information on labels in lieu of the labeling requirements in paragraph (c)(1)(v) of this section:
(A) All filler metals and fusible granular materials shall carry the following notice, as a minimum, on tags, boxes, or other containers:
Welding may produce fumes and gases hazardous to health. Avoid breathing these fumes and gases. Use adequate ventilation.
(B) Brazing (welding) filler metals containing cadmium in significant amounts shall carry the following notice on tags, boxes, or other containers:
Do not breathe fumes. Use only with adequate ventilation such as fume collectors, exhaust ventilators, or air-supplied respirators.
(C) Brazing and gas welding fluxes containing fluorine compounds shall have a cautionary wording to indicate that they contain fluorine compounds. One such cautionary wording recommended by the American Welding
This flux when heated gives off fumes that may irritate eyes, nose and throat.
1. Avoid fumes—use only in well-ventilated spaces.
2. Avoid contact of flux with eyes or skin.
3. Do not take internally.
Sections 4, 6, 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.
All of subpart Z issued under section 6(b) of the Occupational Safety and Health Act of 1970, except those substances that have exposure limits listed in Tables Z-1, Z-2, and Z-3 of 29 CFR 1910.1000. The latter were issued under section 6(a) (29 U.S.C. 655(a)).
Section 1910.1000, Tables Z-1, Z-2 and Z-3 also issued under 5 U.S.C. 553, but not under 29 CFR part 1911 except for the arsenic (organic compounds), benzene, cotton dust, and chromium (VI) listings.
Section 1910.1001 also issued under section 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3704) and 5 U.S.C. 553.
Section 1910.1002 also issued under 5 U.S.C. 553, but not under 29 U.S.C. 655 or 29 CFR part 1911.
Sections 1910.1018, 1910.1029, and 1910.1200 also issued under 29 U.S.C. 653.
Section 1910.1030 also issued under Pub. L. 106-430, 114 Stat. 1901.
Section 1910.1201 also issued under 49 U.S.C. 1801-1819 and 5 U.S.C. 533.
The revisions and additions read as follows:
(h) * * *
(2) * * *
(iv) The employer shall ensure that containers of contaminated protective devices or work clothing, which are to be taken out of change rooms or the workplace for cleaning, maintenance or disposal, bear labels in accordance with paragraph (j) of this section.
(3) * * *
(vi) The employer shall ensure that contaminated clothing is transported in sealed impermeable bags, or other closed, impermeable containers, and labeled in accordance with paragraph (j) of this section.
(j) * * *
(1)
(ii) In classifying the hazards of asbestos at least the following hazards are to be addressed: Cancer and lung effects.
(iii) Employers shall include asbestos in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of asbestos and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (j)(7) of this section.
(4)
(ii)
(A) The warning signs required by paragraph (j)(4)(i) of this section shall bear the following legend:
(B) In addition, where the use of respirators and protective clothing is required in the regulated area under this section, the warning signs shall include the following:
(C) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (j)(4)(ii)(A) of this section:
(D) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (j)(4)(ii)(B) of this section:
(iii) The employer shall ensure that employees working in and contiguous to regulated areas comprehend the warning signs required to be posted by paragraph (j)(4)(i) of this section. Means to ensure employee comprehension may include the use of foreign languages, pictographs and graphics.
(iv) At the entrance to mechanical rooms/areas in which employees reasonably can be expected to enter and which contain ACM and/or PACM, the building owner shall post signs which identify the material which is present, its location, and appropriate work practices which, if followed, will ensure that ACM and/or PACM will not be disturbed. The employer shall ensure, to the extent feasible, that employees who come in contact with these signs can comprehend them. Means to ensure employee comprehension may include the use of foreign languages, pictographs, graphics, and awareness training.
(5)
(ii)
(iii) Prior to June 1, 2015, employers may include the following information on raw materials, mixtures or labels of bags or containers of protective clothing and equipment, scrap, waste, and debris containing asbestos fibers in lieu of the labeling requirements in paragraphs (j)(1)(i) and (j)(5)(ii) of this section:
(6) The provisions for labels and for safety data sheets required by paragraph (j) of this section do not apply where:
The revisions read as follows:
(e)
(ii) In classifying the hazards of carcinogens listed in paragraph (e)(1)(iv) of this section, at least the hazards listed in paragraph (e)(1)(iv) are to be addressed.
(iii) Employers shall include the carcinogens listed in paragraph (e)(1)(iv) of this section in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of the carcinogens listed in paragraph (e)(1)(iv) and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (e)(4) of this section.
(iv) List of Carcinogens:
(A) 4-Nitrobiphenyl: Cancer.
(B) alpha-Naphthylamine: Cancer; skin irritation; and acute toxicity effects.
(C) Methyl chloromethyl ether: Cancer; skin, eye and respiratory effects; acute toxicity effects; and flammability.
(D) 3,3′-Dichlorobenzidine (and its salts): Cancer and skin sensitization.
(E) bis-Chloromethyl ether: Cancer; skin, eye, and respiratory tract effects; acute toxicity effects; and flammability.
(F) beta-Naphthylamine: Cancer and acute toxicity effects.
(G) Benzidine: Cancer and acute toxicity effects.
(H) 4-Aminodiphenyl: Cancer.
(I) Ethyleneimine: Cancer; mutagenicity; skin and eye effects; liver effects; kidney effects; acute toxicity effects; and flammability.
(J) beta-Propiolactone: Cancer; skin irritation; eye effects; and acute toxicity effects.
(K) 2-Acetylaminofluorene: Cancer.
(L) 4-Dimethylaminoazo-benzene: Cancer; skin effects; and respiratory tract irritation.
(M) N-Nitrosodimethylamine: Cancer; liver effects; and acute toxicity effects.
(2)
(ii) The employer shall post signs at entrances to regulated areas containing operations covered in paragraph (c)(5) of this section. The signs shall bear the legend:
(iii) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (e)(2)(i) of this section:
(iv) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (e)(2)(ii) of this section:
(v) Appropriate signs and instructions shall be posted at the entrance to, and exit from, regulated areas, informing employees of the procedures that must be followed in entering and leaving a regulated area.
(l)
(ii) In classifying the hazards of vinyl chloride at least the following hazards are to be addressed: Cancer; central nervous system effects; liver effects; blood effects; and flammability.
(iii) Employers shall include vinyl chloride in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of vinyl chloride and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (j) of this section.
(2)
(ii) The employer shall post signs at areas containing hazardous operations or where emergencies currently exist. The signs shall be legible and bear the legend:
(iii) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (l)(2)(i) of this section:
(iv) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (l)(2)(ii) of this section:
(3)
(ii) Prior to June 1, 2015, employers may include the following information on labels of containers of polyvinyl chloride resin waste from reactors or other waste contaminated with vinyl
(4) Prior to June 1, 2015, employers may include the following information for containers of polyvinyl chloride in lieu of the labeling requirements in paragraphs (l)(1)(i) of this section:
(5)(i) Prior to June 1, 2015, employers may include either the following information in either paragraph (l)(5)(i) or (l)(5)(ii) of this section on containers of vinyl chloride in lieu of the labeling requirements in paragraph (l)(1)(i) of this section:
(ii) In accordance with 49 CFR Parts 170-189, with the additional legend applied near the label or placard:
(6) No statement shall appear on or near any required sign, label, or instruction which contradicts or detracts from the effect of any required warning, information, or instruction.
(j) * * *
(2) * * *
(vii) Labels on contaminated protective clothing and equipment.
(A) The employer shall ensure that the containers of contaminated protective clothing and equipment in the workplace or which are to be removed from the workplace are labeled and that the labels include the following information:
(B) Prior to June 1, 2015, employers may include the following information on containers of protective clothing and equipment in lieu of the labeling requirements in paragraphs (j)(2)(vii) of this section:
(p)
(ii) In classifying the hazards of inorganic arsenic at least the following hazards are to be addressed: Cancer; liver effects; skin effects; respiratory irritation; nervous system effects; and acute toxicity effects.
(iii) Employers shall include inorganic arsenic in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of inorganic arsenic and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (o) of this section.
(iv) The employer shall ensure that no statement appears on or near any sign or label required by this paragraph (p) which contradicts or detracts from the meaning of the required sign or label.
(2)
(ii) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (p)(2)(i) of this section:
(iii) The employer shall ensure that signs required by this paragraph (p) are illuminated and cleaned as necessary so that the legend is readily visible.
(3)(i) Prior to June 1, 2015, in lieu of the labeling requirements in paragraphs (p)(1)(i) of this section, employers may apply precautionary labels to all shipping and storage containers of inorganic arsenic, and to all products containing inorganic arsenic, bearing the following legend:
(ii) Labels are not required when the inorganic arsenic in the product is bound in such a manner so as to make unlikely the possibility of airborne exposure to inorganic arsenic. (Possible examples of products not requiring labels are semiconductors, light emitting diodes and glass.)
The revisions read as follows:
(g) * * *
(2) * * *
(vii) Labeling of contaminated protective clothing and equipment.
(A) The employer shall ensure that labels of bags or containers of contaminated protective clothing and equipment include the following information:
(B) Prior to June 1, 2015, employers may include the following information on bags or containers of contaminated protective clothing and equipment in lieu of the labeling requirements in paragraphs (g)(2)(vii)(A) of this section:
(m)
(ii) In classifying the hazards of lead at least the following hazards are to be addressed: Reproductive/developmental
(iii) Employers shall include lead in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of lead and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (l) of this section.
(2)
(ii) The employer shall ensure that no statement appears on or near any sign required by this paragraph (m)(2) which contradicts or detracts from the meaning of the required sign.
(iii) The employer shall ensure that signs required by this paragraph (m)(2) are illuminated and cleaned as necessary so that the legend is readily visible.
(iv) The employer may use signs required by other statutes, regulations, or ordinances in addition to, or in combination with, signs required by this paragraph (m)(2).
(v) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (m)(2)(ii) of this section:
The standard requires that the following warning sign be posted in the work areas when the exposure to lead exceeds the PEL:
However, prior to June 1, 2016, employers may use the following legend in lieu of that specified above:
(h) * * *
(2) * * *
(iv) The employer shall ensure that bags or containers of contaminated protective clothing or equipment that are removed from change rooms for laundering, cleaning, maintenance, or disposal are labeled in accordance with the requirements of the Hazard Communication Standard, § 1910.1200.
(l) * * *
(1)
(ii) In classifying the hazards of chromium (VI) at least the following hazards are to be addressed: Cancer, eye irritation, and skin sensitization.
(iii) Employers shall include chromium (VI) in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of chromium (VI) and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (l)(2) of this section.
(k) * * *
(7) Waste, scrap, debris, bags, containers, personal protective equipment, and clothing contaminated with cadmium and consigned for disposal shall be collected and disposed of in sealed impermeable bags or other closed, impermeable containers. These bags and containers shall be labeled in accordance with paragraph (m) of this section.
(m) * * *
(1)
(ii) In classifying the hazards of cadmium at least the following hazards are to be addressed: Cancer; lung effects; kidney effects; and acute toxicity effects.
(iii) Employers shall include cadmium in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of cadmium and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (m)(4) of this section.
(2)
(ii) Warning signs required by paragraph (m)(2)(i) of this section shall bear the following legend:
(iii) The employer shall ensure that signs required by this paragraph (m)(2) are illuminated, cleaned, and maintained as necessary so that the legend is readily visible.
(iv) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (m)(2)(ii) of this section:
(3)
(ii) The warning labels for containers of contaminated protective clothing, equipment, waste, scrap, or debris shall include at least the following information:
(iii) Prior to June 1, 2015, employers may include the following information on shipping and storage containers containing cadmium, cadmium compounds, or cadmium contaminated clothing, equipment, waste, scrap, or debris in lieu of the labeling
(iv) Where feasible, installed cadmium products shall have a visible label or other indication that cadmium is present.
(j)
(ii) In classifying the hazards of benzene at least the following hazards are to be addressed: Cancer; central nervous system effects; blood effects; aspiration; skin, eye, and respiratory tract irritation; and flammability.
(iii) Employers shall include benzene in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of benzene and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (j)(3) of this section.
(2)
(ii) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (j)(2)(i) of this section:
(iii) The employer shall ensure that labels or other appropriate forms of warning are provided for containers of benzene within the workplace. There is no requirement to label pipes. The labels shall comply with the requirements of paragraph (j)(1) of this section and § 1910.1200(f).
(iv) Prior to June 1, 2015, employers shall include the following legend or similar language on the labels or other appropriate forms of warning:
(l)
(2)
(ii) In addition, the employer shall post signs in the areas where the permissible exposure limit is exceeded bearing the legend:
(iii) The employer shall ensure that no statement appears on or near any sign required by this paragraph (l) which contradicts or detracts from the effects of the required sign.
(iv) The employer shall ensure that signs required by this paragraph (l)(2) are illuminated and cleaned as necessary so that the legend is readily visible.
(v) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (l)(2)(i) of this section:
(vi) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (l)(2)(ii) of this section:
(3)
(ii) Prior to June 1, 2015, employers may include the following information on contaminated protective clothing and equipment in lieu of the labeling requirements in paragraph (l)(3)(i) of this section:
(j)
(2) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (j)(1) of this section:
(j) * * *
(2) * * *
(v) Containers of DBCP-contaminated protective devices or work clothing which are to be taken out of change rooms or the workplace for cleaning, maintenance or disposal shall bear
(k) * * *
(1) * * *
(iii) * * *
(
(o)
(ii) In classifying the hazards of DBCP at least the following hazards are to be addressed: Cancer; reproductive effects; liver effects; kidney effects; central nervous system effects; skin, eye and respiratory tract irritation; and acute toxicity effects.
(iii) Employers shall include DBCP in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of DBCP and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (n) of this section.
(iv) The employer shall ensure that no statement appears on or near any sign or label required by this paragraph (o) which contradicts or detracts from the meaning of the required sign or label.
(2)
(ii) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (o)(2) of this section:
(3)
(ii) The employer shall ensure that the precautionary labels required by this paragraph (o)(3) are readily visible and legible.
(iii) Prior to June 1, 2015, employers may include the following information on containers of DBCP or products containing DBCP, DBCP-contaminated protective devices or work clothing or DBCP-contaminated portable vacuums in lieu of the labeling requirements in paragraphs (j)(2)(v), (k)(l)(iii)(b) and (o)(1)(i) of this section:
(p)
(ii) In classifying the hazards of AN and AN-based materials at least the following hazards are to be addressed: Cancer; central nervous system effects; liver effects; skin sensitization; skin, respiratory, and eye irritation; acute toxicity effects; and flammability.
(iii) Employers shall include AN and AN-based materials in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of AN and AN-based materials and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (o) of this section.
(iv) The employer shall ensure that no statement appears on or near any sign or label required by this paragraph (p) that contradicts or detracts from the required sign or label.
(2)
(ii) The employer shall ensure that signs required by this paragraph (p)(2) are illuminated and cleaned as necessary so that the legend is readily visible.
(iii) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (p)(2)(i) of this section:
(3)
(ii) Prior to June 1, 2015, employers may include the following information on precautionary labels required by this paragraph (p)(3) in lieu of the labeling requirements in paragraph (p)(1) of this section:
(iii) The employer shall ensure that the precautionary labels required by this paragraph (p)(3) are readily visible and legible.
(j)
(ii) In classifying the hazards of EtO at least the following hazards are to be addressed: Cancer; reproductive effects; mutagenicity; central nervous system; skin sensitization; skin, eye and respiratory tract irritation; acute toxicity effects; and flammability.
(iii) Employers shall include EtO in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of EtO and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (j)(3) of this section.
(2)
(B) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (j)(2)(i)(A) of this section:
(ii)
(B) Prior to June 1, 2015, employers may include the following information on containers of EtO in lieu of the labeling requirements in paragraph (j)(1)(i) of this section:
(C) The labeling requirements under this section do not apply where EtO is used as a pesticide, as such term is defined in the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), when it is labeled pursuant to that Act and regulations issued under that Act by the Environmental Protection Agency.
(e) * * *
(1)
(ii) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (e)(1)(i) of this section:
(h) * * *
(2) * * *
(ii) When formaldehyde-contaminated clothing and equipment is ventilated, the employer shall establish storage areas so that employee exposure is minimized.
(A)
(B)
(C) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (h)(2)(ii)(A) of this section:
(D) Prior to June 1, 2015, employers may include the following information on containers of protective clothing and equipment in lieu of the labeling requirements in paragraphs (h)(2)(ii)(B) of this section:
(j) * * *
(4) Formaldehyde-contaminated waste and debris resulting from leaks or spills shall be placed for disposal in sealed containers bearing a label warning of formaldehyde's presence and of the hazards associated with formaldehyde. The employer shall ensure that the labels are in accordance with paragraph (m) of this section.
(m)
(ii) In classifying the hazards of formaldehyde at least the following hazards are to be addressed: Cancer; skin and respiratory sensitization; eye, skin and respiratory tract irritation; acute toxicity effects; and flammability.
(iii) Employers shall include formaldehyde in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of formaldehyde and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (n) of this section.
(iv) Paragraphs (m)(1)(i), (m)(1)(ii), and (m)(1)(iii) of this section apply to chemicals associated with formaldehyde gas, all mixtures or solutions composed of greater than 0.1 percent formaldehyde, and materials capable of releasing formaldehyde into the air at concentrations reaching or exceeding 0.1 ppm.
(v) In making the determinations of anticipated levels of formaldehyde release, the employer may rely on objective data indicating the extent of potential formaldehyde release under reasonably foreseeable conditions of use.
(2)(i) In addition to the requirements in paragraphs (m)(1) through (m)(1)(iv) of this section, for materials listed in paragraph (m)(1)(iv) capable of releasing formaldehyde at levels above 0.5 ppm, labels shall appropriately address all hazards as defined in paragraph (d) of § 1910.1200 and Appendices A and B to § 1910.1200, including cancer and respiratory sensitization, and shall
(ii) As a minimum, for all materials listed in paragraph (m)(1)(i) and (iv) of this section capable of releasing formaldehyde at levels of 0.1 ppm to 0.5 ppm, labels shall identify that the product contains formaldehyde; list the name and address of the responsible party; and state that physical and health hazard information is readily available from the employer and from safety data sheets.
(iii) Prior to June 1, 2015, employers may include the phrase “Potential Cancer Hazard” in lieu of “May Cause Cancer” as specified in paragraph (m)(2)(i) of this section.
The revisions and additions read as follows:
(k)
(i) Chemical manufacturers, importers, distributors and employers shall comply with all requirements of the Hazard Communication Standard (HCS) (§ 1910.1200) for MDA.
(ii) In classifying the hazards of MDA at least the following hazards are to be addressed: Cancer; liver effects; and skin sensitization.
(iii) Employers shall include MDA in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of MDA and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (k)(4) of this section.
(2)
(B) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (k)(2)(i)(A) of this section:
(ii)
(A) For pure MDA:
(B) For mixtures containing MDA:
(3)
(l) * * *
(1)
(ii) In classifying the hazards of BD at least the following hazards are to be addressed: Cancer; eye and respiratory tract irritation; center nervous system effects; and flammability.
(iii) Employers shall include BD in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of BD and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (l)(2) of this section.
The revisions read as follows:
(k)
(ii) In classifying the hazards of MC at least the following hazards are to be addressed: Cancer, cardiac effects (including elevation of carboxyhemoglobin), central nervous system effects, liver effects, and skin and eye irritation.
(iii) Employers shall include MC in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of MC and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (l) of this section.
(2) [Reserved]
The revisions and additions read as follows:
(a)
(2) This occupational safety and health standard is intended to address comprehensively the issue of classifying the potential hazards of chemicals, and communicating information concerning hazards and appropriate protective measures to employees, and to preempt any legislative or regulatory enactments of a state, or political subdivision of a state, pertaining to this subject. Classifying the potential hazards of chemicals and communicating information concerning hazards and appropriate protective measures to employees, may include, for example, but is not limited to, provisions for: developing and maintaining a written hazard communication program for the workplace, including lists of hazardous chemicals present; labeling of containers of chemicals in the workplace, as well as of containers of chemicals being shipped to other workplaces; preparation and distribution of safety data sheets to employees and downstream employers; and development and implementation of employee training programs regarding hazards of chemicals and protective measures. Under section 18 of the Act, no state or political subdivision of a state may adopt or enforce any requirement relating to the issue addressed by this Federal standard, except pursuant to a Federally-approved state plan.
(b) * * *
(1) This section requires chemical manufacturers or importers to classify the hazards of chemicals which they produce or import, and all employers to provide information to their employees about the hazardous chemicals to which they are exposed, by means of a hazard communication program, labels and other forms of warning, safety data sheets, and information and training. In addition, this section requires distributors to transmit the required information to employers. (Employers who do not produce or import chemicals need only focus on those parts of this rule that deal with establishing a workplace program and communicating information to their workers.)
(3) * * *
(iv) Laboratory employers that ship hazardous chemicals are considered to be either a chemical manufacturer or a distributor under this rule, and thus must ensure that any containers of hazardous chemicals leaving the laboratory are labeled in accordance with paragraph (f) of this section, and that a safety data sheet is provided to distributors and other employers in accordance with paragraphs (g)(6) and (g)(7) of this section.
(5) * * *
(iv) Any distilled spirits (beverage alcohols), wine, or malt beverage intended for nonindustrial use, as such terms are defined in the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) and regulations issued under that Act, when subject to the labeling requirements of that Act and labeling regulations issued under that Act by the Bureau of Alcohol, Tobacco, Firearms and Explosives;
(6) * * *
(ii) Any hazardous substance as such term is defined by the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) (42 U.S.C. 9601 et seq.) when the hazardous substance is the focus of remedial or removal action being conducted under CERCLA in accordance with Environmental Protection Agency regulations.
(c) * * *
(d)
(2) Chemical manufacturers, importers or employers classifying chemicals shall identify and consider the full range of available scientific literature and other evidence concerning the potential hazards. There is no requirement to test the chemical to determine how to classify its hazards. Appendix A to § 1910.1200 shall be consulted for classification of health hazards, and Appendix B to § 1910.1200 shall be consulted for the classification of physical hazards.
(3)
(ii) When classifying mixtures they produce or import, chemical manufacturers and importers of mixtures may rely on the information provided on the current safety data sheets of the individual ingredients, except where the chemical manufacturer or importer knows, or in the exercise of reasonable diligence should know, that the safety data sheet misstates or omits information required by this section.
(e) * * *
(1) * * *
(i) A list of the hazardous chemicals known to be present using a product identifier that is referenced on the appropriate safety data sheet (the list may be compiled for the workplace as a whole or for individual work areas); and,
(f)
(i) Product identifier;
(ii) Signal word;
(iii) Hazard statement(s);
(iv) Pictogram(s);
(v) Precautionary statement(s); and,
(vi) Name, address, and telephone number of the chemical manufacturer, importer, or other responsible party.
(2) The chemical manufacturer, importer, or distributor shall ensure that the information provided under paragraphs (f)(1)(i) through (v) of this section is in accordance with Appendix
(3) The chemical manufacturer, importer, or distributor shall ensure that the information provided under paragraphs (f)(1)(ii) through (iv) of this section is located together on the label, tag, or mark.
(4
(ii) The label may be transmitted with the initial shipment itself, or with the safety data sheet that is to be provided prior to or at the time of the first shipment; and,
(iii) This exception to requiring labels on every container of hazardous chemicals is only for the solid material itself, and does not apply to hazardous chemicals used in conjunction with, or known to be present with, the material and to which employees handling the items in transit may be exposed (for example, cutting fluids or pesticides in grains).
(5) Chemical manufacturers, importers, or distributors shall ensure that each container of hazardous chemicals leaving the workplace is labeled, tagged, or marked in accordance with this section in a manner which does not conflict with the requirements of the Hazardous Materials Transportation Act (49 U.S.C. 1801
(6) Workplace labeling. Except as provided in paragraphs (f)(7) and (f)(8) of this section, the employer shall ensure that each container of hazardous chemicals in the workplace is labeled, tagged or marked with either:
(i) The information specified under paragraphs (f)(1)(i) through (v) of this section for labels on shipped containers; or,
(ii) Product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals, and which, in conjunction with the other information immediately available to employees under the hazard communication program, will provide employees with the specific information regarding the physical and health hazards of the hazardous chemical.
(7) The employer may use signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu of affixing labels to individual stationary process containers, as long as the alternative method identifies the containers to which it is applicable and conveys the information required by paragraph (f)(6) of this section to be on a label. The employer shall ensure the written materials are readily accessible to the employees in their work area throughout each work shift.
(8) The employer is not required to label portable containers into which hazardous chemicals are transferred from labeled containers, and which are intended only for the immediate use of the employee who performs the transfer. For purposes of this section, drugs which are dispensed by a pharmacy to a health care provider for direct administration to a patient are exempted from labeling.
(9) The employer shall not remove or deface existing labels on incoming containers of hazardous chemicals, unless the container is immediately marked with the required information.
(10) The employer shall ensure that workplace labels or other forms of warning are legible, in English, and prominently displayed on the container, or readily available in the work area throughout each work shift. Employers having employees who speak other languages may add the information in their language to the material presented, as long as the information is presented in English as well.
(11) Chemical manufacturers, importers, distributors, or employers who become newly aware of any significant information regarding the hazards of a chemical shall revise the labels for the chemical within six months of becoming aware of the new information, and shall ensure that labels on containers of hazardous chemicals shipped after that time contain the new information. If the chemical is not currently produced or imported, the chemical manufacturer, importer, distributor, or employer shall add the information to the label before the chemical is shipped or introduced into the workplace again.
(g)
(2) The chemical manufacturer or importer preparing the safety data sheet shall ensure that it is in English (although the employer may maintain copies in other languages as well), and includes at least the following section numbers and headings, and associated information under each heading, in the order listed (
(i) Section 1, Identification;
(ii) Section 2, Hazard(s) identification;
(iii) Section 3, Composition/information on ingredients;
(iv) Section 4, First-aid measures;
(v) Section 5, Fire-fighting measures;
(vi) Section 6, Accidental release measures;
(vii) Section 7, Handling and storage;
(viii) Section 8, Exposure controls/personal protection;
(ix) Section 9, Physical and chemical properties;
(x) Section 10, Stability and reactivity;
(xi) Section 11, Toxicological information;
(xii) Section 12, Ecological information;
(xiii) Section 13, Disposal considerations;
(xiv) Section 14, Transport information;
(xv) Section 15, Regulatory information; and
(xvi) Section 16, Other information, including date of preparation or last revision.
Note 1 to paragraph (g)(2): To be consistent with the GHS, an SDS must also include the headings in paragraphs (g)(2)(xii) through (g)(2)(xv) in order.
Note 2 to paragraph (g)(2): OSHA will not be enforcing information requirements in sections 12 through 15, as these areas are not under its jurisdiction.
(3) If no relevant information is found for any sub-heading within a section on the safety data sheet, the chemical manufacturer, importer or employer preparing the safety data sheet shall mark it to indicate that no applicable information was found.
(5) The chemical manufacturer, importer or employer preparing the safety data sheet shall ensure that the information provided accurately reflects the scientific evidence used in making the hazard classification. If the chemical manufacturer, importer or employer preparing the safety data sheet becomes newly aware of any significant information regarding the hazards of a chemical, or ways to protect against the hazards, this new information shall be added to the safety data sheet within three months. If the chemical is not
(8) The employer shall maintain in the workplace copies of the required safety data sheets for each hazardous chemical, and shall ensure that they are readily accessible during each work shift to employees when they are in their work area(s). (Electronic access and other alternatives to maintaining paper copies of the safety data sheets are permitted as long as no barriers to immediate employee access in each workplace are created by such options.)
(11) Safety data sheets shall also be made readily available, upon request, to designated representatives, the Assistant Secretary, and the Director, in accordance with the requirements of § 1910.1020(e).
(h) * * *
(1) Employers shall provide employees with effective information and training on hazardous chemicals in their work area at the time of their initial assignment, and whenever a new chemical hazard the employees have not previously been trained about is introduced into their work area. Information and training may be designed to cover categories of hazards (e.g., flammability, carcinogenicity) or specific chemicals. Chemical-specific information must always be available through labels and safety data sheets.
(3) * * *
(ii) The physical, health, simple asphyxiation, combustible dust, and pyrophoric gas hazards, as well as hazards not otherwise classified, of the chemicals in the work area;
(iv) The details of the hazard communication program developed by the employer, including an explanation of the labels received on shipped containers and the workplace labeling system used by their employer; the safety data sheet, including the order of information and how employees can obtain and use the appropriate hazard information.
(i) * * *
(1) The chemical manufacturer, importer, or employer may withhold the specific chemical identity, including the chemical name, other specific identification of a hazardous chemical, or the exact percentage (concentration) of the substance in a mixture, from the safety data sheet, provided that:
(iii) The safety data sheet indicates that the specific chemical identity and/or percentage of composition is being withheld as a trade secret; and,
(iv) The specific chemical identity and percentage is made available to health professionals, employees, and designated representatives in accordance with the applicable provisions of this paragraph (i).
(2) Where a treating physician or nurse determines that a medical emergency exists and the specific chemical identity and/or specific percentage of composition of a hazardous chemical is necessary for emergency or first-aid treatment, the chemical manufacturer, importer, or employer shall immediately disclose the specific chemical identity or percentage composition of a trade secret chemical to that treating physician or nurse, regardless of the existence of a written statement of need or a confidentiality agreement. The chemical manufacturer, importer, or employer may require a written statement of need and confidentiality agreement, in accordance with the provisions of paragraphs (i)(3) and (4) of this section, as soon as circumstances permit.
(3) In non-emergency situations, a chemical manufacturer, importer, or employer shall, upon request, disclose a specific chemical identity or percentage composition, otherwise permitted to be withheld under paragraph (i)(1) of this section, to a health professional (i.e. physician, industrial hygienist, toxicologist, epidemiologist, or occupational health nurse) providing medical or other occupational health services to exposed employee(s), and to employees or designated representatives, if:
(iii) The request explains in detail why the disclosure of the specific chemical identity or percentage composition is essential and that, in lieu thereof, the disclosure of the following information to the health professional, employee, or designated representative, would not satisfy the purposes described in paragraph (i)(3)(ii) of this section:
(7) If the chemical manufacturer, importer, or employer denies a written request for disclosure of a specific chemical identity or percentage composition, the denial must:
(iii) Include evidence to support the claim that the specific chemical identity or percent of composition is a trade secret;
(v) Explain in detail how alternative information may satisfy the specific medical or occupational health need without revealing the trade secret.
(9) * * *
(i) The chemical manufacturer, importer, or employer has supported the claim that the specific chemical identity or percentage composition is a trade secret;
(10) * * *
(i) If OSHA determines that the specific chemical identity or percentage composition requested under paragraph (i)(3) of this section is not a “bona fide” trade secret, or that it is a trade secret, but the requesting health professional, employee, or designated representative has a legitimate medical or occupational health need for the information, has executed a written confidentiality agreement, and has shown adequate means to protect the confidentiality of the information, the chemical manufacturer, importer, or employer will be subject to citation by OSHA.
(ii) If a chemical manufacturer, importer, or employer demonstrates to OSHA that the execution of a confidentiality agreement would not provide sufficient protection against the potential harm from the unauthorized disclosure of a trade secret, the Assistant Secretary may issue such orders or impose such additional limitations or conditions upon the disclosure of the requested chemical information as may be appropriate to assure that the occupational health services are provided without an undue risk of harm to the chemical manufacturer, importer, or employer.
(11) If a citation for a failure to release trade secret information is contested by the chemical manufacturer, importer, or employer, the matter will be adjudicated before the Occupational Safety and Health Review Commission in accordance with the Act's enforcement scheme and the applicable Commission rules of procedure. In accordance with the Commission rules, when a chemical manufacturer, importer, or employer continues to withhold the information during the contest, the Administrative Law Judge may review the citation and supporting documentation “in camera” or issue appropriate orders to protect the confidentiality of such matters.
(j)
(2) Chemical manufacturers, importers, distributors, and employers
(i) After December 1, 2015, the distributor shall not ship containers labeled by the chemical manufacturer or importer unless the label has been modified to comply with paragraph (f)(1) of this section.
(ii) All employers shall, as necessary, update any alternative workplace labeling used under paragraph (f)(6) of this section, update the hazard communication program required by paragraph (h)(1), and provide any additional employee training in accordance with paragraph (h)(3) for newly identified physical or health hazards no later than June 1, 2016.
(3) Chemical manufacturers, importers, distributors, and employers may comply with either § 1910.1200 revised as of October 1, 2011, or the current version of this standard, or both during the transition period.
A.0.1.1 The term “hazard classification” is used to indicate that only the intrinsic hazardous properties of chemicals are considered. Hazard classification incorporates three steps:
(a) Identification of relevant data regarding the hazards of a chemical;
(b) Subsequent review of those data to ascertain the hazards associated with the chemical;
(c) Determination of whether the chemical will be classified as hazardous and the degree of hazard.
A.0.1.2 For many hazard classes, the criteria are semi-quantitative or qualitative and expert judgment is required to interpret the data for classification purposes.
A.0.2.1 There is no requirement for testing chemicals.
A.0.2.2 The criteria for determining health hazards are test method neutral, i.e., they do not specify particular test methods, as long as the methods are scientifically validated.
A.0.2.3 The term “scientifically validated” refers to the process by which the reliability and the relevance of a procedure are established for a particular purpose. Any test that determines hazardous properties, which is conducted according to recognized scientific principles, can be used for purposes of a hazard determination for health hazards. Test conditions need to be standardized so that the results are reproducible with a given substance, and the standardized test yields “valid” data for defining the hazard class of concern.
A.0.2.4 Existing test data are acceptable for classifying chemicals, although expert judgment also may be needed for classification purposes.
A.0.2.5 The effect of a chemical on biological systems is influenced, by the physico-chemical properties of the substance and/or ingredients of the mixture and the way in which ingredient substances are biologically available. A chemical need not be classified when it can be shown by conclusive experimental data from scientifically validated test methods that the chemical is not biologically available.
A.0.2.6 For classification purposes, epidemiological data and experience on the effects of chemicals on humans (e.g., occupational data, data from accident databases) shall be taken into account in the evaluation of human health hazards of a chemical.
A.0.3.1 For some hazard classes, classification results directly when the data satisfy the criteria. For others, classification of a chemical shall be determined on the basis of the total weight of evidence using expert judgment. This means that all available information bearing on the classification of hazard shall be considered together, including the results of valid
A.0.3.2 The quality and consistency of the data shall be considered. Information on chemicals related to the material being classified shall be considered as appropriate, as well as site of action and mechanism or mode of action study results. Both positive and negative results shall be considered together in a single weight-of-evidence determination.
A.0.3.3 Positive effects which are consistent with the criteria for classification, whether seen in humans or animals, shall normally justify classification. Where evidence is available from both humans and animals and there is a conflict between the findings, the quality and reliability of the evidence from both sources shall be evaluated in order to resolve the question of classification. Reliable, good quality human data shall generally have precedence over other data. However, even well-designed and conducted epidemiological studies may lack a sufficient number of subjects to detect relatively rare but still significant effects, or to assess potentially confounding factors. Therefore, positive results from well-conducted animal studies are not necessarily negated by the lack of positive human experience but require an assessment of the robustness, quality and statistical power of both the human and animal data.
A.0.3.4 Route of exposure, mechanistic information, and metabolism studies are pertinent to determining the relevance of an effect in humans. When such information raises doubt about relevance in humans, a lower classification may be warranted. When there is scientific evidence demonstrating that the mechanism or mode of action is not relevant to humans, the chemical should not be classified.
A.0.3.5 Both positive and negative results are considered together in the weight of evidence determination. However, a single positive study performed according to good scientific principles and with statistically and biologically significant positive results may justify classification.
A.0.4.1 For most hazard classes, the recommended process of classification of mixtures is based on the following sequence:
(a) Where test data are available for the complete mixture, the classification of the mixture will always be based on those data;
(b) Where test data are not available for the mixture itself, the bridging principles designated in each health hazard chapter of this appendix shall be considered for classification of the mixture;
(c) If test data are not available for the mixture itself, and the available information is not sufficient to allow application of the above-mentioned bridging principles, then the method(s) described in each chapter for estimating the hazards based on the information known will be applied to classify the mixture (e.g., application of cut-off values/concentration limits).
A.0.4.2 An exception to the above order or precedence is made for Carcinogenicity, Germ Cell Mutagenicity, and Reproductive Toxicity. For these three hazard classes, mixtures shall be classified based upon information on the ingredient substances, unless on a case-by-case basis, justification can be provided for classifying based upon the mixture as a whole. See chapters A.5, A.6, and A.7 for further information on case-by-case bases.
A.0.4.3 Use of cut-off values/concentration limits.
A.0.4.3.1 When classifying an untested mixture based on the hazards of its ingredients, cut-off values/concentration limits for the classified ingredients of the mixture are used for several hazard classes. While the adopted cut-off values/concentration limits adequately identify the hazard for most mixtures, there may be some that contain hazardous ingredients at lower concentrations than the specified cut-off values/concentration limits that still pose an identifiable hazard. There may also be cases where the cut-off value/concentration limit is considerably lower than the established non-hazardous level for an ingredient.
A.0.4.3.2 If the classifier has information that the hazard of an ingredient will be evident (i.e., it presents a health risk) below the specified cut-off value/concentration limit, the mixture containing that ingredient shall be classified accordingly.
A.0.4.3.3 In exceptional cases, conclusive data may demonstrate that the hazard of an ingredient will not be evident (i.e., it does not present a health risk) when present at a level above the specified cut-off value/concentration limit(s). In these cases the mixture may be classified according to those data. The data must exclude the possibility that the ingredient will behave in the mixture in a manner that would increase the hazard over that of the pure substance. Furthermore, the mixture must not contain ingredients that would affect that determination.
A.0.4.4 Synergistic or antagonistic effects.
When performing an assessment in accordance with these requirements, the evaluator must take into account all available information about the potential occurrence of synergistic effects among the ingredients of the mixture. Lowering classification of a mixture to a less hazardous category on the basis of antagonistic effects may be done only if the determination is supported by sufficient data.
A.0.5.1 Where the mixture itself has not been tested to determine its toxicity, but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data shall be used in accordance with the following bridging principles, subject to any specific provisions for mixtures for each hazard class. These principles ensure that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture.
A.0.5.1.1 Dilution.
For mixtures classified in accordance with A.1 through A.10 of this Appendix, if a tested mixture is diluted with a diluent that has an equivalent or lower toxicity classification than the least toxic original ingredient, and which is not expected to affect the toxicity of other ingredients, then:
(a) The new diluted mixture shall be classified as equivalent to the original tested mixture; or
(b) For classification of acute toxicity in accordance with A.1 of this Appendix, paragraph A.1.3.6 (the additivity formula) shall be applied.
A.0.5.1.2 Batching.
For mixtures classified in accordance with A.1 through A.10 of this Appendix, the toxicity of a tested production batch of a mixture can be assumed to be substantially equivalent to that of another untested production batch of the same mixture, when produced by or under the control of the same
A.0.5.1.3 Concentration of mixtures.
For mixtures classified in accordance with A.1, A.2, A.3, A.8, A.9, or A.10 of this Appendix, if a tested mixture is classified in Category 1, and the concentration of the ingredients of the tested mixture that are in Category 1 is increased, the resulting untested mixture shall be classified in Category 1.
A.0.5.1.4 Interpolation within one toxicity category.
For mixtures classified in accordance with A.1, A.2, A.3, A.8, A.9, or A.10 of this Appendix, for three mixtures (A, B and C) with identical ingredients, where mixtures A and B have been tested and are in the same toxicity category, and where untested mixture C has the same toxicologically active ingredients as mixtures A and B but has concentrations of toxicologically active ingredients intermediate to the concentrations in mixtures A and B, then mixture C is assumed to be in the same toxicity category as A and B.
A.0.5.1.5 Substantially similar mixtures.
For mixtures classified in accordance with A.1 through A.10 of this Appendix, given the following set of conditions:
(a) Where there are two mixtures:
(i) A + B;
(ii) C + B;
(b) The concentration of ingredient B is essentially the same in both mixtures;
(c) The concentration of ingredient A in mixture (i) equals that of ingredient C in mixture (ii);
(d) And data on toxicity for A and C are available and substantially equivalent; i.e., they are in the same hazard category and are not expected to affect the toxicity of B; then
If mixture (i) or (ii) is already classified based on test data, the other mixture can be assigned the same hazard category.
A.0.5.1.6 Aerosols.
For mixtures classified in accordance with A.1, A.2, A.3, A.4, A.8, or A.9 of this Appendix, an aerosol form of a mixture shall be classified in the same hazard category as the tested, non-aerosolized form of the mixture, provided the added propellant does not affect the toxicity of the mixture when spraying.
A.1.2.1 Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric cut-off criteria as shown in Table A.1.1. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). See the footnotes following Table A.1.1 for further explanation on the application of these values.
A.1.2.3 The preferred test species for evaluation of acute toxicity by the oral and inhalation routes is the rat, while the rat or rabbit are preferred for evaluation of acute dermal toxicity. Test data already generated for the classification of chemicals under existing systems should be accepted when reclassifying these chemicals under the harmonized system. When experimental data for acute toxicity are available in several animal species, scientific judgment should be used in selecting the most appropriate LD
A.1.3.1 The approach to classification of mixtures for acute toxicity is tiered, and is dependent upon the amount of information available for the mixture itself and for its ingredients. The flow chart of Figure A.1.1 indicates the process that must be followed:
A.1.3.2 Classification of mixtures for acute toxicity may be carried out for each route of exposure, but is only required for one route of exposure as long as this route is followed (estimated or tested) for all ingredients and there is no relevant evidence to suggest acute toxicity by multiple routes. When there is relevant evidence of acute toxicity by multiple routes of exposure, classification is to be conducted for all appropriate routes of exposure. All available information shall be considered. The pictogram and signal word used shall reflect the most severe hazard category; and all relevant hazard statements shall be used.
A.1.3.3 For purposes of classifying the hazards of mixtures in the tiered approach:
(a) The “relevant ingredients” of a mixture are those which are present in concentrations ≥1% (weight/weight for solids, liquids, dusts, mists and vapors and volume/volume for gases). If there is reason to suspect that an ingredient present at a concentration <1% will affect classification of the mixture for acute toxicity, that ingredient shall also be considered relevant. Consideration of ingredients present at a concentration <1% is particularly important when classifying untested mixtures which contain ingredients that are classified in Category 1 and Category 2;
(b) Where a classified mixture is used as an ingredient of another mixture, the actual or derived acute toxicity estimate (ATE) for that mixture is used when calculating the classification of the new mixture using the formulas in A.1.3.6.1 and A.1.3.6.2.4.
(c) If the converted acute toxicity point estimates for all ingredients of a mixture are within the same category, then the mixture should be classified in that category.
(d) When only range data (or acute toxicity hazard category information) are available for ingredients in a mixture, they may be converted to point estimates in accordance with Table A.1.2 when calculating the classification of the new mixture using the formulas in A.1.3.6.1 and A.1.3.6.2.4.
Where the mixture itself has been tested to determine its acute toxicity, it is classified according to the same criteria as those used for substances, presented in Table A.1.1. If test data for the mixture are not available, the procedures presented below must be followed.
A.1.3.5.1 Where the mixture itself has not been tested to determine its acute toxicity, but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following bridging principles as found in paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration of mixtures, Interpolation within one toxicity category, Substantially similar mixtures, and Aerosols.
A.1.3.6.1 Data available for all ingredients.
The acute toxicity estimate (ATE) of ingredients is considered as follows:
(a) Include ingredients with a known acute toxicity, which fall into any of the acute toxicity categories, or have an oral or dermal LD
(b) Ignore ingredients that are presumed not acutely toxic (e.g., water, sugar);
(c) Ignore ingredients if the data available are from a limit dose test (at the upper threshold for Category 4 for the appropriate route of exposure as provided in Table A.1.1) and do not show acute toxicity.
Ingredients that fall within the scope of this paragraph are considered to be ingredients with a known acute toxicity estimate (ATE). See note (b) to Table A.1.1 and paragraph A.1.3.3 for appropriate application of available data to the equation below, and paragraph A.1.3.6.2.4.
The ATE of the mixture is determined by calculation from the ATE values for all relevant ingredients according to the following formula below for oral, dermal or inhalation toxicity:
A.1.3.6.2 Data are not available for one or more ingredients of the mixture.
A.1.3.6.2.1 Where an ATE is not available for an individual ingredient of the mixture, but available information provides a derived conversion value, the formula in A.1.3.6.1 may be applied. This information may include evaluation of:
(a) Extrapolation between oral, dermal and inhalation acute toxicity estimates. Such an evaluation requires appropriate pharmacodynamic and pharmacokinetic data;
(b) Evidence from human exposure that indicates toxic effects but does not provide lethal dose data;
(c) Evidence from any other toxicity tests/assays available on the substance that indicates toxic acute effects but does not necessarily provide lethal dose data; or
(d) Data from closely analogous substances using structure/activity relationships.
A.1.3.6.2.2 This approach requires substantial supplemental technical information, and a highly trained and experienced expert, to reliably estimate acute toxicity. If sufficient information is not available to reliably estimate acute toxicity, proceed to the provisions of A.1.3.6.2.3.
A.1.3.6.2.3 In the event that an ingredient with unknown acute toxicity is used in a mixture at a concentration ≥1%, and the mixture has not been classified based on testing of the mixture as a whole, the mixture cannot be attributed a definitive acute toxicity estimate. In this situation the mixture is classified based on the known ingredients only. (Note: A statement that × percent of the mixture consists of ingredient(s) of unknown toxicity is required on the label and safety data sheet in such cases; see Appendix C to this section, Allocation of Label Elements and Appendix D to this section, Safety Data Sheets.)
Where an ingredient with unknown acute toxicity is used in a mixture at a concentration ≥1%, and the mixture is not classified based on testing of the mixture as a whole, a statement that X% of the mixture consists of ingredient(s) of unknown acute toxicity is required on the label and safety data sheet in such cases; see Appendix C to this section, Allocation of Label Elements and Appendix D to this section, Safety Data Sheets.)
A.1.3.6.2.4 If the total concentration of the relevant ingredient(s) with unknown acute toxicity is ≤10% then the formula presented in A.1.3.6.1 must be used. If the total concentration of the relevant ingredient(s) with unknown acute toxicity is >10%, the formula presented in A.1.3.6.1 is corrected to adjust for the percentage of the unknown ingredient(s) as follows:
A.2.1.1
A.2.1.2 Skin corrosion/irritation shall be classified using a tiered approach as detailed in figure A.2.1. Emphasis shall be placed upon existing human data (See A.0.2.6), followed by other sources of information. Classification results directly when the data satisfy the criteria in this section. In case the criteria cannot be directly applied, classification of a substance or a mixture is made on the basis of the total weight of evidence (See A.0.3.1). This means that all available information bearing on the determination of skin corrosion/irritation is considered together, including the results of appropriate scientifically validated in-vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations.
A.2.2.1.1 A corrosive substance is a chemical that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 of 3 tested animals after exposure up to a 4-hour duration. Corrosive reactions are typified by ulcers, bleeding, bloody scabs and, by the end of observation at 14 days, by discoloration due to blanching of the skin, complete areas of alopecia and scars. Histopathology should be considered to discern questionable lesions.
A.2.2.1.2 Three sub-categories of Category 1 are provided in Table A.2.1, all of which shall be regulated as Category 1.
A.2.2.2.1 A single irritant category (Category 2) is presented in the Table A.2.2. The major criterion for the irritant category is that at least 2 tested animals have a mean score of ≥2.3 ≤4.0.
A.2.2.2.2 Animal irritant responses within a test can be quite variable, as they are with corrosion. A separate irritant criterion accommodates cases when there is a significant irritant response but less than the mean score criterion for a positive test. For example, a substance might be designated as an irritant if at least 1 of 3 tested animals shows a very elevated mean score throughout the study, including lesions persisting at the end of an observation period of normally 14 days. Other responses could also fulfil this criterion. However, it should be ascertained that the responses are the result of chemical exposure. Addition of this criterion increases the sensitivity of the classification system.
A.2.2.2.3 Reversibility of skin lesions is another consideration in evaluating irritant responses. When inflammation persists to the end of the observation period in 2 or more test animals, taking into consideration alopecia (limited area), hyperkeratosis, hyperplasia and scaling, then a chemical should be considered to be an irritant.
A.2.3.1 Existing human and animal data including information from single or repeated exposure should be the first line of analysis, as they give information directly relevant to effects on the skin. If a substance is highly toxic by the dermal route, a skin corrosion/irritation study may not be practicable since the amount of test substance to be applied would considerably exceed the toxic dose and, consequently, would result in the death of the animals. When observations are made of skin corrosion/irritation in acute toxicity studies and are observed up through the limit dose, these data may be used for classification provided that the dilutions used and species tested are equivalent.
A.2.3.2 A
A.2.3.3 The tiered approach explains how to organize information on a substance and to make a weight-of-evidence decision about hazard assessment and hazard classification.
A.2.3.4 All the above information that is available on a substance shall be evaluated. Although information might be gained from the evaluation of single parameters within a
A.2.4.1.1 The mixture shall be classified using the criteria for substances (See A.2.3).
A.2.4.2.1 Where the mixture itself has not been tested to determine its skin corrosion/irritation, but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following bridging principles, as found in paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration of mixtures, Interpolation within one toxicity category, Substantially similar mixtures, and Aerosols.
A.2.4.3.1 For purposes of classifying the skin corrosion/irritation hazards of mixtures in the tiered approach:
The “relevant ingredients” of a mixture are those which are present in concentrations >1% (weight/weight for solids, liquids, dusts, mists and vapors and volume/volume for gases.) If the classifier has reason to suspect that an ingredient present at a concentration <1% will affect classification of the mixture for skin corrosion/irritation, that ingredient shall also be considered relevant.
A.2.4.3.2 In general, the approach to classification of mixtures as irritant or corrosive to skin when data are available on the ingredients, but not on the mixture as a whole, is based on the theory of additivity, such that each corrosive or irritant ingredient contributes to the overall irritant or corrosive properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for corrosive ingredients when they are present at a concentration below the concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as an irritant. The mixture is classified as corrosive or irritant when the sum of the concentrations of such ingredients exceeds a cut-off value/concentration limit.
A.2.4.3.3 Table A.2.3 below provides the cut-off value/concentration limits to be used to determine if the mixture is considered to be an irritant or a corrosive to the skin.
A.2.4.3.4 Particular care shall be taken when classifying certain types of chemicals such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in A.2.4.3.1 and A.2.4.3.2 might not work given that many of such substances are corrosive or irritant at concentrations <1%. For mixtures containing strong acids or bases the pH should be used as classification criteria since pH will be a better indicator of corrosion than the concentration limits of Table A.2.3. A mixture containing corrosive or irritant ingredients that cannot be classified based on the additivity approach shown in Table A.2.3, due to chemical characteristics that make this approach unworkable, should be classified as Skin Category 1 if it contains ≥1% of a corrosive ingredient and as Skin Category 2 when it contains ≥3% of an irritant ingredient. Classification of mixtures with ingredients for which the approach in Table A.2.3 does not apply is summarized in Table A.2.4 below.
A.2.4.3.5 On occasion, reliable data may show that the skin corrosion/irritation of an ingredient will not be evident when present at a level above the generic concentration cut-off values mentioned in Tables A.2.3 and A.2.4. In these cases the mixture could be classified according to those data (See
A.2.4.3.6 If there are data showing that (an) ingredient(s) may be corrosive or irritant at a concentration of <1% (corrosive) or <3% (irritant), the mixture shall be classified accordingly (See
A.3.1.1
A.3.1.2 Serious eye damage/eye irritation shall be classified using a tiered approach as detailed in Figure A.3.1. Emphasis shall be placed upon existing human data (See A.0.2.6), followed by animal data, followed by other sources of information. Classification results directly when the data satisfy the criteria in this section. In case the criteria cannot be directly applied, classification of a substance or a mixture is made on the basis of the total weight of evidence (See A.0.3.1). This means that all available information bearing on the determination of serious eye damage/eye irritation is considered together, including the results of appropriate scientifically validated
A.3.2.1 Irreversible effects on the eye/serious damage to eyes (Category 1).
A single hazard category is provided in Table A.3.1, for substances that have the potential to seriously damage the eyes. Category 1, irreversible effects on the eye, includes the criteria listed below. These observations include animals with grade 4 cornea lesions and other severe reactions (e.g. destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight. In this context, persistent lesions are considered those which are not fully reversible within an observation period of normally 21 days. Category 1 also contains substances fulfilling the criteria of corneal opacity ≥3 and/or iritis >1.5 detected in a Draize eye test with rabbits, because severe lesions like these usually do not reverse within a 21-day observation period.
A.3.2.2 Reversible effects on the eye (Category 2).
A single category is provided in Table A.3.2 for substances that have the potential to induce reversible eye irritation.
A.3.2.3 For those chemicals where there is pronounced variability among animal responses, this information may be taken into account in determining the classification.
A.3.3.1 Existing human and animal data should be the first line of analysis, as they give information directly relevant to effects on the eye. Possible skin corrosion shall be evaluated prior to consideration of serious eye damage/eye irritation in order to avoid testing for local effects on eyes with skin corrosive substances.
A.3.3.2 A tiered approach to the evaluation of initial information shall be used where applicable, recognizing that all elements may not be relevant in certain cases (Figure A.3.1).
A.3.3.3 The tiered approach explains how to organize existing information on a substance and to make a weight-of-evidence decision, where appropriate, about hazard assessment and hazard classification.
A.3.3.4 All the above information that is available on a substance shall be evaluated. Although information might be gained from the evaluation of single parameters within a tier, consideration should be given to the totality of existing information and making an overall weight-of-evidence determination. This is especially true when there is conflict in information available on some parameters.
A.3.4.1.1 The mixture will be classified using the criteria for substances.
A.3.4.1.2 Unlike other hazard classes, there are alternative tests available for skin corrosivity of certain types of chemicals that can give an accurate result for classification purposes, as well as being simple and relatively inexpensive to perform. When considering testing of the mixture, chemical manufacturers are encouraged to use a tiered weight of evidence strategy as included in the criteria for classification of substances for skin corrosion and serious eye damage and eye irritation to help ensure an accurate classification, as well as avoid unnecessary animal testing. In the absence of any other information, a mixture is considered to cause serious eye damage (Eye Category 1) if it has a pH ≤2 or ≥11.5. However, if consideration of acid/alkaline reserve suggests the substance or mixture may not have the potential to cause serious eye damage despite the low or high pH value, then further evaluation may be necessary.
A.3.4.2.1 Where the mixture itself has not been tested to determine its skin corrosivity or potential to cause serious eye damage or eye irritation, but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following bridging principles, as found in paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration of mixtures, Interpolation within one toxicity category, Substantially similar mixtures, and Aerosols.
A.3.4.3.1 For purposes of classifying the eye corrosion/irritation hazards of mixtures in the tiered approach:
The “relevant ingredients” of a mixture are those which are present in concentrations >1% (weight/weight for solids, liquids, dusts, mists and vapors and volume/volume for gases). If the classifier has reason to suspect that an ingredient present at a concentration <1% will affect classification of the mixture for eye corrosion/irritation, that ingredient shall also be considered relevant.
A.3.4.3.2 In general, the approach to classification of mixtures as seriously damaging to the eye or eye irritant when data are available on the ingredients, but not on the mixture as a whole, is based on the theory of additivity, such that each corrosive or irritant ingredient contributes to the overall irritant or corrosive properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for corrosive ingredients when they are present at a concentration below the concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as an irritant. The mixture is classified as seriously damaging to the eye or eye irritant when the sum of the concentrations of such ingredients exceeds a threshold cut-off value/concentration limit.
A.3.4.3.3 Table A.3.3 provides the cut-off value/concentration limits to be used to determine if the mixture should be classified as seriously damaging to the eye or an eye irritant.
A.3.4.3.4 Particular care must be taken when classifying certain types of chemicals such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in A.3.4.3.1 and A.3.4.3.2 might not work given that many of such substances are corrosive or irritant at concentrations <1%. For mixtures containing strong acids or bases, the pH should be used as classification criteria (See A.3.4.1) since pH will be a better indicator of serious eye damage than the concentration limits of Table A.3.3. A mixture containing corrosive or irritant ingredients that cannot be classified based on the additivity approach applied in Table A.3.3 due to chemical characteristics that make this approach unworkable, should be classified as Eye Category 1 if it contains ≥1% of a corrosive ingredient and as Eye Category 2 when it contains ≥3% of an irritant ingredient. Classification of mixtures with ingredients for which the approach in Table A.3.3 does not apply is summarized in Table A.3.4.
A.3.4.3.5 On occasion, reliable data may show that the reversible/irreversible eye effects of an ingredient will not be evident when present at a level above the generic cut-off values/concentration limits mentioned in Tables A.3.3 and A.3.4. In these cases the mixture could be classified according to those data (See also A.0.4.3
A.3.4.3.6 If there are data showing that (an) ingredient(s) may be corrosive or irritant at a concentration of <1% (corrosive) or <3% (irritant), the mixture should be classified accordingly (See also paragraph A.0.4.3,
A.4.1.1
A.4.1.2 For the purpose of this chapter, sensitization includes two phases: the first phase is induction of specialized immunological memory in an individual by exposure to an allergen. The second phase is elicitation, i.e., production of a cell-mediated or antibody-mediated allergic response by exposure of a sensitized individual to an allergen.
A.4.1.3 For respiratory sensitization, the pattern of induction followed by elicitation phases is shared in common with skin sensitization. For skin sensitization, an induction phase is required in which the immune system learns to react; clinical symptoms can then arise when subsequent exposure is sufficient to elicit a visible skin reaction (elicitation phase). As a consequence, predictive tests usually follow this pattern in which there is an induction phase, the response to which is measured by a standardized elicitation phase, typically involving a patch test. The local lymph node assay is the exception, directly measuring the induction response. Evidence of skin sensitization in humans normally is assessed by a diagnostic patch test.
A.4.1.4 Usually, for both skin and respiratory sensitization, lower levels are necessary for elicitation than are required for induction.
A.4.1.5 The hazard class “respiratory or skin sensitization” is differentiated into:
(a) Respiratory sensitization; and
(b) Skin sensitization.
A.4.2.1.1 Hazard Categories.
A.4.2.1.1.1 Effects seen in either humans or animals will normally justify classification in a weight of evidence approach for respiratory sensitizers. Substances may be allocated to one of the two sub-categories 1A or 1B using a weight of evidence approach in accordance with the criteria given in Table A.4.1 and on the basis of reliable and good quality evidence from human cases or epidemiological studies and/or observations from appropriate studies in experimental animals.
A.4.2.1.1.2 Where data are not sufficient for sub-categorization, respiratory sensitizers shall be classified in Category 1.
A.4.2.1.2 Human evidence.
A.4.2.1.2.1 Evidence that a substance can lead to specific respiratory hypersensitivity will normally be based on human experience. In this context, hypersensitivity is normally seen as asthma, but other hypersensitivity reactions such as rhinitis/conjunctivitis and alveolitis are also considered. The condition will have the clinical character of an allergic reaction. However, immunological mechanisms do not have to be demonstrated.
A.4.2.1.2.2 When considering the human evidence, it is necessary that in addition to
(a) The size of the population exposed;
(b) The extent of exposure.
A.4.2.1.2.3 The evidence referred to above could be:
(a) Clinical history and data from appropriate lung function tests related to exposure to the substance, confirmed by other supportive evidence which may include:
(i)
(ii)
(iii) Studies that may indicate other specific hypersensitivity reactions where immunological mechanisms of action have not been proven, e.g., repeated low-level irritation, pharmacologically mediated effects;
(iv) A chemical structure related to substances known to cause respiratory hypersensitivity;
(b) Data from positive bronchial challenge tests with the substance conducted according to accepted guidelines for the determination of a specific hypersensitivity reaction.
A.4.2.1.2.4 Clinical history should include both medical and occupational history to determine a relationship between exposure to a specific substance and development of respiratory hypersensitivity. Relevant information includes aggravating factors both in the home and workplace, the onset and progress of the disease, family history and medical history of the patient in question. The medical history should also include a note of other allergic or airway disorders from childhood and smoking history.
A.4.2.1.2.5 The results of positive bronchial challenge tests are considered to provide sufficient evidence for classification on their own. It is, however, recognized that in practice many of the examinations listed above will already have been carried out.
A.4.2.1.3 Animal studies.
A.4.2.1.3.1 Data from appropriate animal studies
(a) Measurements of Immunoglobulin E (IgE) and other specific immunological parameters, for example in mice
(b) Specific pulmonary responses in guinea pigs.
A.4.2.2.1 Hazard categories.
A.4.2.2.1.1 Effects seen in either humans or animals will normally justify classification in a weight of evidence approach for skin sensitizers. Substances may be allocated to one of the two sub-categories 1A or 1B using a weight of evidence approach in accordance with the criteria given in Table A.4.2 and on the basis of reliable and good quality evidence from human cases or epidemiological studies and/or observations from appropriate studies in experimental animals according to the guidance values provided in A.4.2.2.2.1 and A.4.2.2.3.2 for sub-category 1A and in A.4.2.2.2.2 and A.4.2.2.3.3 for sub-category 1B.
A.4.2.2.1.2 Where data are not sufficient for sub-categorization, skin sensitizers shall be classified in Category 1.
A.4.2.2.2 Human evidence.
A.4.2.2.2.1 Human evidence for sub-category 1A may include:
(a) Positive responses at ≤500 μg/cm
(b) Diagnostic patch test data where there is a relatively high and substantial incidence of reactions in a defined population in relation to relatively low exposure;
(c) Other epidemiological evidence where there is a relatively high and substantial incidence of allergic contact dermatitis in relation to relatively low exposure.
A.4.2.2.2.2 Human evidence for sub-category 1B may include:
(a) Positive responses at >500 μg/cm
(b) Diagnostic patch test data where there is a relatively low but substantial incidence of reactions in a defined population in relation to relatively high exposure;
(c) Other epidemiological evidence where there is a relatively low but substantial incidence of allergic contact dermatitis in relation to relatively high exposure.
A.4.2.2.3 Animal studies
A.4.2.2.3.1 For Category 1, when an adjuvant type test method for skin sensitization is used, a response of at least 30% of the animals is considered as positive. For a non-adjuvant Guinea pig test method a response of at least 15% of the animals is considered positive. For Category 1, a stimulation index of three or more is considered a positive response in the local lymph node assay.
A.4.2.2.3.2 Animal test results for sub-category 1A can include data with values indicated in Table A.4.3 below:
A.4.2.2.3.3 Animal test results for sub-category 1B can include data with values indicated in Table A.4.4 below:
A.4.2.2.4 Specific considerations.
A.4.2.2.4.1 For classification of a substance, evidence shall include one or more of the following using a weight of evidence approach:
(a) Positive data from patch testing, normally obtained in more than one dermatology clinic;
(b) Epidemiological studies showing allergic contact dermatitis caused by the substance. Situations in which a high proportion of those exposed exhibit characteristic symptoms are to be looked at with special concern, even if the number of cases is small;
(c) Positive data from appropriate animal studies;
(d) Positive data from experimental studies in man (See paragraph A.0.2.6 of this Appendix);
(e) Well documented episodes of allergic contact dermatitis, normally obtained in more than one dermatology clinic;
(f) Severity of reaction.
A.4.2.2.4.2 Evidence from animal studies is usually much more reliable than evidence from human exposure. However, in cases where evidence is available from both sources, and there is conflict between the results, the quality and reliability of the evidence from both sources must be assessed in order to resolve the question of classification on a case-by-case basis. Normally, human data are not generated in controlled experiments with volunteers for the purpose of hazard classification but rather as part of risk assessment to confirm lack of effects seen in animal tests. Consequently, positive human data on skin sensitization are usually derived from case-control or other, less defined studies. Evaluation of human data must, therefore, be carried out with caution as the frequency of cases reflect, in addition to the inherent properties of the substances, factors such as the exposure situation, bioavailability, individual predisposition and preventive measures taken. Negative human data should not normally be used to negate positive results from animal studies. For both animal and human data, consideration should be given to the impact of vehicle.
A.4.2.2.4.3 If none of the above-mentioned conditions are met, the substance need not be classified as a skin sensitizer. However, a combination of two or more indicators of skin sensitization, as listed below, may alter the decision. This shall be considered on a case-by-case basis.
(a) Isolated episodes of allergic contact dermatitis;
(b) Epidemiological studies of limited power, e.g., where chance, bias or confounders have not been ruled out fully with reasonable confidence;
(c) Data from animal tests, performed according to existing guidelines, which do not meet the criteria for a positive result described in A.4.2.2.3, but which are sufficiently close to the limit to be considered significant;
(d) Positive data from non-standard methods;
(e) Positive results from close structural analogues.
A.4.2.2.4.4 Immunological contact urticaria.
A.4.2.2.4.4.1 Substances meeting the criteria for classification as respiratory sensitizers may, in addition, cause immunological contact urticaria. Consideration shall be given to classifying these substances as skin sensitizers.
A.4.2.2.4.4.2 Substances which cause immunological contact urticaria without meeting the criteria for respiratory sensitizers shall be considered for classification as skin sensitizers.
A.4.2.2.4.4.3 There is no recognized animal model available to identify substances which cause immunological contact urticaria. Therefore, classification will normally be based on human evidence, similar to that for skin sensitization.
When reliable and good quality evidence, as described in the criteria for substances, from human experience or appropriate studies in experimental animals, is available for the mixture, then the mixture shall be classified by weight of evidence evaluation of these data. Care must be exercised in evaluating data on mixtures that the dose used does not render the results inconclusive.
A.4.3.2.1 Where the mixture itself has not been tested to determine its sensitizing properties, but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging principles as found in paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration of mixtures, Interpolation, Substantially similar mixtures, and Aerosols.
The mixture shall be classified as a respiratory or skin sensitizer when at least one ingredient has been classified as a respiratory or skin sensitizer and is present at or above the appropriate cut-off value/concentration limit for the specific endpoint as shown in Table A.4.5.
A.5.1.1 A
A.5.1.2 The more general terms
A.5.1.3 This hazard class is primarily concerned with chemicals that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, mutagenicity/genotoxicity tests
A.5.2.1 The classification system provides for two different categories of germ cell mutagens to accommodate the weight of evidence available. The two-category system is described in the Figure A.5.1.
A.5.2.2 Specific considerations for classification of substances as germ cell mutagens:
A.5.2.2.1 To arrive at a classification, test results are considered from experiments determining mutagenic and/or genotoxic effects in germ and/or somatic cells of exposed animals. Mutagenic and/or genotoxic effects determined in
A.5.2.2.2 The system is hazard based, classifying chemicals on the basis of their intrinsic ability to induce mutations in germ cells. The scheme is, therefore, not meant for the (quantitative) risk assessment of chemical substances.
A.5.2.2.3 Classification for heritable effects in human germ cells is made on the basis of scientifically validated tests. Evaluation of the test results shall be done using expert judgment and all the available evidence shall be weighed for classification.
A.5.2.2.4 The classification of substances shall be based on the total weight of evidence available, using expert judgment. In those instances where a single well-conducted test is used for classification, it shall provide clear and unambiguously positive results. The relevance of the route of exposure used in the study of the substance compared to the route of human exposure should also be taken into account.
A.5.3.1.1 Classification of mixtures shall be based on the available test data for the
A.5.3.1.2 The mixture will be classified as a mutagen when at least one ingredient has been classified as a Category 1A, Category 1B or Category 2 mutagen and is present at or above the appropriate cut-off value/concentration limit as shown in Table A.5.1 below for Category 1 and 2 respectively.
The classification may be modified on a case-by-case basis based on the available test data for the mixture as a whole. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of germ cell mutagenicity test systems.
A.5.3.3.1 Where the mixture itself has not been tested to determine its germ cell mutagenicity hazard, but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following bridging principles as found in paragraph A.0.5 of this Appendix: Dilution, Batching, and Substantially similar mixtures.
Classification of a substance or mixture as posing a carcinogenic hazard is based on its inherent properties and does not provide information on the level of the human cancer risk which the use of the substance or mixture may represent.
A.6.2.1 For the purpose of classification for carcinogenicity, substances are allocated to one of two categories based on strength of evidence and additional weight of evidence considerations. In certain instances, route-specific classification may be warranted.
A.6.2.2 Classification as a carcinogen is made on the basis of evidence from reliable and acceptable methods, and is intended to be used for substances which have an intrinsic property to produce such toxic effects. The evaluations are to be based on all existing data, peer-reviewed published studies and additional data accepted by regulatory agencies.
A.6.2.3
A.6.2.4
A.6.2.5
A.6.2.5.1 These factors can be viewed as either increasing or decreasing the level of concern for human carcinogenicity. The relative emphasis accorded to each factor depends upon the amount and coherence of evidence bearing on each. Generally there is a requirement for more complete information to decrease than to increase the level of concern. Additional considerations should be used in evaluating the tumor findings and the other factors in a case-by-case manner.
A.6.2.5.2 Some important factors which may be taken into consideration, when assessing the overall level of concern are:
(a) Tumor type and background incidence;
(b) Multisite responses;
(c) Progression of lesions to malignancy;
(d) Reduced tumor latency;
Additional factors which may increase or decrease the level of concern include:
(e) Whether responses are in single or both sexes;
(f) Whether responses are in a single species or several species;
(g) Structural similarity or not to a substance(s) for which there is good evidence of carcinogenicity;
(h) Routes of exposure;
(i) Comparison of absorption, distribution, metabolism and excretion between test animals and humans;
(j) The possibility of a confounding effect of excessive toxicity at test doses; and,
(k) Mode of action and its relevance for humans, such as mutagenicity, cytotoxicity with growth stimulation, mitogenesis, immunosuppression.
A.6.2.5.3 A substance that has not been tested for carcinogenicity may in certain instances be classified in Category 1A, Category 1B, or Category 2 based on tumor data from a structural analogue together with substantial support from consideration of other important factors such as formation of common significant metabolites, e.g., for benzidine congener dyes.
A.6.2.5.4 The classification should also take into consideration whether or not the substance is absorbed by a given route(s); or whether there are only local tumors at the site of administration for the tested route(s), and adequate testing by other major route(s) show lack of carcinogenicity.
A.6.2.5.5 It is important that whatever is known of the physico-chemical, toxicokinetic and toxicodynamic properties of the substances, as well as any available relevant information on chemical analogues, i.e., structure activity relationship, is taken into consideration when undertaking classification.
A.6.3.1 The mixture shall be classified as a carcinogen when at least one ingredient has been classified as a Category 1 or Category 2 carcinogen and is present at or above the appropriate cut-off value/concentration limit as shown in Table A.6.1.
A mixture may be classified based on the available test data for the mixture as a whole. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations and analysis (e.g., statistical analysis, test sensitivity) of carcinogenicity test systems.
Where the mixture itself has not been tested to determine its carcinogenic hazard, but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following bridging principles as found in paragraph A.0.5 of this Appendix: Dilution; Batching; and Substantially similar mixtures.
A.6.4.1 Chemical manufacturers, importers and employers evaluating chemicals may treat the following sources as establishing that a substance is a carcinogen or potential carcinogen for hazard communication purposes in lieu of applying the criteria described herein:
A.6.4.1.1 National Toxicology Program (NTP), “Report on Carcinogens” (latest edition);
A.6.4.1.2 International Agency for Research on Cancer (IARC) “Monographs on the Evaluation of Carcinogenic Risks to Humans” (latest editions)
A.6.4.2 Where OSHA has included cancer as a health hazard to be considered by classifiers for a chemical covered by 29 CFR part 1910, Subpart Z, Toxic and Hazardous Substances, chemical manufacturers, importers, and employers shall classify the chemical as a carcinogen.
A.7.1.1
For classification purposes, the known induction of genetically based inheritable effects in the offspring is addressed in
A.7.1.2
A.7.1.3
A.7.1.4 Adverse effects on or via lactation are also included in reproductive toxicity, but for classification purposes, such effects are treated separately (See A.7.2.1).
A.7.2.1 For the purpose of classification for reproductive toxicity, substances shall be classified in one of two categories in accordance with Figure A.7.1(a). Effects on sexual function and fertility, and on development, shall be considered. In addition, effects on or via lactation shall be classified in a separate hazard category in accordance with Figure A.7.1(b).
A.7.2.2.1 Classification is made on the basis of the criteria, outlined above, an assessment of the total weight of evidence, and the use of expert judgment. Classification as a reproductive toxicant is intended to be used for substances which have an intrinsic, specific property to produce an adverse effect on reproduction and substances should not be so classified if such an effect is produced solely as a non-specific secondary consequence of other toxic effects.
A.7.2.2.2 In the evaluation of toxic effects on the developing offspring, it is important to consider the possible influence of maternal toxicity.
A.7.2.2.3 For human evidence to provide the primary basis for a Category 1A classification there must be reliable evidence of an adverse effect on reproduction in humans. Evidence used for classification shall be from well conducted epidemiological studies, if available, which include the use of appropriate controls, balanced assessment, and due consideration of bias or confounding factors. Less rigorous data from studies in humans may be sufficient for a Category 1A classification if supplemented with adequate data from studies in experimental animals, but classification in Category 1B may also be considered.
A.7.2.3.1 Classification as a reproductive toxicant is made on the basis of an assessment of the total weight of evidence using expert judgment. This means that all available information that bears on the determination of reproductive toxicity is considered together. Included is information such as epidemiological studies and case reports in humans and specific reproduction studies along with sub-chronic, chronic and special study results in animals that provide relevant information regarding toxicity to reproductive and related endocrine organs. Evaluation of substances chemically related to the material under study may also be included, particularly when information on the material is scarce. The weight given to the available evidence will be influenced by factors such as the quality of the studies, consistency of results, nature and severity of effects, level of statistical significance for intergroup differences, number of endpoints affected, relevance of route of administration to humans and freedom from bias. Both positive and negative results are considered together in a weight of evidence determination. However, a single, positive study performed according to good scientific principles and with statistically or biologically significant positive results may justify classification (See also A.7.2.2.3).
A.7.2.3.2 Toxicokinetic studies in animals and humans, site of action and mechanism or mode of action study results may provide relevant information, which could reduce or increase concerns about the hazard to human health. If it is conclusively demonstrated that the clearly identified mechanism or mode of action has no relevance for humans or when the toxicokinetic differences are so marked that it is certain that the hazardous property will not be expressed in humans then a chemical which produces an adverse effect on reproduction in experimental animals should not be classified.
A.7.2.3.3 In some reproductive toxicity studies in experimental animals the only effects recorded may be considered of low or minimal toxicological significance and classification may not necessarily be the outcome. These effects include, for example, small changes in semen parameters or in the incidence of spontaneous defects in the fetus, small changes in the proportions of common fetal variants such as are observed in skeletal examinations, or in fetal weights, or small differences in postnatal developmental assessments.
A.7.2.3.4 Data from animal studies shall provide sufficient evidence of specific reproductive toxicity in the absence of other systemic toxic effects. However, if developmental toxicity occurs together with other toxic effects in the dam (mother), the potential influence of the generalized adverse effects should be assessed to the extent possible. The preferred approach is to consider adverse effects in the embryo/fetus first, and then evaluate maternal toxicity, along with any other factors which are likely to have influenced these effects, as part of the weight of evidence. In general, developmental effects that are observed at maternally toxic doses should not be automatically discounted. Discounting developmental effects that are observed at maternally toxic doses can only be done on a case-by-case basis when a causal relationship is established or refuted.
A.7.2.3.5 If appropriate information is available it is important to try to determine whether developmental toxicity is due to a specific maternally mediated mechanism or to a non-specific secondary mechanism, like maternal stress and the disruption of homeostasis. Generally, the presence of maternal toxicity should not be used to negate findings of embryo/fetal effects, unless it can be clearly demonstrated that the effects are secondary non-specific effects. This is especially the case when the effects in the offspring are significant, e.g., irreversible effects such as structural malformations. In some situations it is reasonable to assume that reproductive toxicity is due to a secondary consequence of maternal toxicity and discount the effects, for example if the chemical is so toxic that dams fail to thrive and there is severe inanition; they are incapable of nursing pups; or they are prostrate or dying.
A.7.2.4.1 Development of the offspring throughout gestation and during the early postnatal stages can be influenced by toxic effects in the mother either through non-specific mechanisms related to stress and the disruption of maternal homeostasis, or by specific maternally-mediated mechanisms. So, in the interpretation of the developmental outcome to decide classification for developmental effects it is important to consider the possible influence of maternal toxicity. This is a complex issue because of uncertainties surrounding the relationship between maternal toxicity and developmental outcome. Expert judgment and a weight of evidence approach, using all available studies, shall be used to determine the degree of influence to be attributed to maternal toxicity when interpreting the criteria for classification for developmental effects. The adverse effects in the embryo/fetus shall be first considered, and then maternal toxicity, along with any other factors which are likely to have influenced these effects, as weight of evidence, to help reach a conclusion about classification.
A.7.2.4.2 Based on pragmatic observation, it is believed that maternal toxicity may, depending on severity, influence development via non-specific secondary mechanisms, producing effects such as depressed fetal weight, retarded ossification, and possibly resorptions and certain malformations in some strains of certain species. However, the limited numbers of studies which have investigated the relationship between developmental effects and general maternal toxicity have failed to demonstrate a consistent, reproducible relationship across species. Developmental effects which occur even in the presence of maternal toxicity are considered to be evidence of developmental toxicity, unless it can be unequivocally demonstrated on a case by case basis that the developmental effects are secondary to maternal toxicity. Moreover, classification shall be considered where there is a significant toxic effect in the offspring, e.g., irreversible effects such as structural malformations, embryo/fetal lethality, or significant post-natal functional deficiencies.
A.7.2.4.3 Classification shall not automatically be discounted for chemicals that produce developmental toxicity only in association with maternal toxicity, even if a specific maternally-mediated mechanism has been demonstrated. In such a case, classification in Category 2 may be considered more appropriate than Category 1. However, when a chemical is so toxic that maternal death or severe inanition results, or the dams (mothers) are prostrate and incapable of nursing the pups, it is reasonable to assume that developmental toxicity is produced solely as a secondary consequence of maternal toxicity and discount the developmental effects.
A.7.2.4.4 Some of the endpoints used to assess maternal toxicity are provided below. Data on these endpoints, if available, shall be evaluated in light of their statistical or biological significance and dose-response relationship.
(a) Maternal mortality: An increased incidence of mortality among the treated dams over the controls shall be considered evidence of maternal toxicity if the increase occurs in a dose-related manner and can be attributed to the systemic toxicity of the test material. Maternal mortality greater than 10% is considered excessive and the data for that dose level shall not normally be considered to need further evaluation.
(b) Mating index (Number of animals with seminal plugs or sperm/Number of mated × 100)
(c) Fertility index (Number of animals with implants/Number of matings × 100)
(d) Gestation length (If allowed to deliver)
(e) Body weight and body weight change: Consideration of the maternal body weight change and/or adjusted (corrected) maternal body weight shall be included in the evaluation of maternal toxicity whenever such data are available. The calculation of an adjusted (corrected) mean maternal body weight change, which is the difference between the initial and terminal body weight minus the gravid uterine weight (or alternatively, the sum of the weights of the fetuses), may indicate whether the effect is maternal or intrauterine. In rabbits, the body weight gain may not be a useful indicator of maternal toxicity because of normal fluctuations in body weight during pregnancy.
(f) Food and water consumption (if relevant): The observation of a significant decrease in the average food or water consumption in treated dams (mothers) compared to the control group may be useful in evaluating maternal toxicity, particularly when the test material is administered in the diet or drinking water. Changes in food or water consumption must be evaluated in conjunction with maternal body weights when determining if the effects noted are reflective of maternal toxicity or more simply, unpalatability of the test material in feed or water.
(g) Clinical evaluations (including clinical signs, markers, and hematology and clinical chemistry studies): The observation of increased incidence of significant clinical signs of toxicity in treated dams (mothers) relative to the control group is useful in evaluating maternal toxicity. If this is to be used as the basis for the assessment of maternal toxicity, the types, incidence, degree and duration of clinical signs shall be reported in the study. Clinical signs of maternal intoxication include, but are not limited to: coma, prostration, hyperactivity, loss of righting reflex, ataxia, or labored breathing.
(h) Post-mortem data: Increased incidence and/or severity of post-mortem findings may be indicative of maternal toxicity. This can include gross or microscopic pathological findings or organ weight data, including absolute organ weight, organ-to-body weight ratio, or organ-to-brain weight ratio. When supported by findings of adverse histopathological effects in the affected organ(s), the observation of a significant change in the average weight of suspected target organ(s) of treated dams (mothers), compared to those in the control group, may be considered evidence of maternal toxicity.
A.7.2.5.1 A number of scientifically validated test methods are available, including methods for developmental toxicity testing (e.g., OECD Test Guideline 414, ICH Guideline S5A, 1993), methods for peri- and post-natal toxicity testing (e.g., ICH S5B, 1995), and methods for one or two-generation toxicity testing (e.g., OECD Test Guidelines 415, 416)
A.7.2.5.2 Results obtained from screening tests (e.g., OECD Guidelines 421—Reproduction/Developmental Toxicity Screening Test, and 422—Combined Repeated Dose Toxicity Study with Reproduction/Development Toxicity Screening Test) can also be used to justify classification, although the quality of this evidence is less reliable than that obtained through full studies.
A.7.2.5.3 Adverse effects or changes, seen in short- or long-term repeated dose toxicity studies, which are judged likely to impair reproductive function and which occur in the absence of significant generalized toxicity, may be used as a basis for classification, e.g., histopathological changes in the gonads.
A.7.2.5.4 Evidence from
A.7.2.5.5 It is preferable that animal studies are conducted using appropriate routes of administration which relate to the potential route of human exposure. However, in practice, reproductive toxicity studies are commonly conducted using the oral route, and such studies will normally be suitable for evaluating the hazardous properties of the substance with respect to reproductive toxicity. However, if it can be conclusively demonstrated that the clearly identified mechanism or mode of action has no relevance for humans or when the toxicokinetic differences are so marked that it is certain that the hazardous property will not be expressed in humans then a substance which produces an adverse effect on reproduction in experimental animals should not be classified.
A.7.2.5.6 Studies involving routes of administration such as intravenous or intraperitoneal injection, which may result in exposure of the reproductive organs to unrealistically high levels of the test substance, or elicit local damage to the reproductive organs, e.g., by irritation, must be interpreted with extreme caution and on their own are not normally the basis for classification.
A.7.2.5.7 There is general agreement about the concept of a limit dose, above which the production of an adverse effect may be considered to be outside the criteria which lead to classification. Some test guidelines specify a limit dose, other test guidelines qualify the limit dose with a statement that higher doses may be necessary if anticipated human exposure is sufficiently high that an adequate margin of exposure would not be achieved. Also, due to species differences in toxicokinetics, establishing a specific limit dose may not be adequate for situations where humans are more sensitive than the animal model.
A.7.2.5.8 In principle, adverse effects on reproduction seen only at very high dose levels in animal studies (for example doses that induce prostration, severe inappetence, excessive mortality) do not normally lead to classification, unless other information is available, for example, toxicokinetics information indicating that humans may be more susceptible than animals, to suggest that classification is appropriate.
A.7.2.5.9 However, specification of the actual “limit dose” will depend upon the test method that has been employed to provide the test results.
A.7.3.1.1 The mixture shall be classified as a reproductive toxicant when at least one ingredient has been classified as a Category 1 or Category 2 reproductive toxicant and is present at or above the appropriate cut-off value/concentration limit specified in Table A.7.1 for Category 1 and 2, respectively.
A.7.3.1.2 The mixture shall be classified for effects on or via lactation when at least one ingredient has been classified for effects on or via lactation and is present at or above the appropriate cut-off value/concentration limit specified in Table A.7.1 for the additional category for effects on or via lactation.
Available test data for the mixture as a whole may be used for classification on a case-by-case basis. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations and analysis (e.g., statistical analysis, test sensitivity) of reproduction test systems.
A.7.3.3.1 Where the mixture itself has not been tested to determine its reproductive toxicity, but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data shall be used in accordance with the following bridging principles as found in paragraph A.0.5 of this Appendix: Dilution, Batching, and Substantially similar mixtures.
A.8.1.1
A.8.1.2 Classification identifies the chemical as being a specific target organ toxicant and, as such, it presents a potential for adverse health effects in people who are exposed to it.
A.8.1.3 The adverse health effects produced by a single exposure include consistent and identifiable toxic effects in humans; or, in experimental animals, toxicologically significant changes which have affected the function or morphology of a tissue/organ, or have produced serious changes to the biochemistry or hematology of the organism, and these changes are relevant for human health. Human data is the primary source of evidence for this hazard class.
A.8.1.4 Assessment shall take into consideration not only significant changes in a single organ or biological system but also generalized changes of a less severe nature involving several organs.
A.8.1.5 Specific target organ toxicity can occur by any route that is relevant for humans, i.e., principally oral, dermal or inhalation.
A.8.1.6 The classification criteria for specific organ systemic toxicity single exposure are organized as criteria for substances Categories 1 and 2 (See A.8.2.1), criteria for substances Category 3 (See A.8.2.2) and criteria for mixtures (See A.8.3). See also Figure A.8.1.
A.8.2.1.1 Substances shall be classified for immediate or delayed effects separately, by the use of expert judgment on the basis of the weight of all evidence available, including the use of recommended guidance values (See A.8.2.1.9). Substances shall then be classified in Category 1 or 2, depending upon the nature and severity of the effect(s) observed, in accordance with Figure A.8.1.
A.8.2.1.2 The relevant route(s) of exposure by which the classified substance produces damage shall be identified.
A.8.2.1.3 Classification is determined by expert judgment, on the basis of the weight of all evidence available including the guidance presented below.
A.8.2.1.4 Weight of evidence of all available data, including human incidents, epidemiology, and studies conducted in experimental animals is used to substantiate specific target organ toxic effects that merit classification.
A.8.2.1.5 The information required to evaluate specific target organ toxicity comes either from single exposure in humans (e.g., exposure at home, in the workplace or environmentally), or from studies conducted in experimental animals. The standard animal studies in rats or mice that provide this information are acute toxicity studies which can include clinical observations and detailed macroscopic and microscopic examination to enable the toxic effects on target tissues/organs to be identified. Results of acute toxicity studies conducted in other species may also provide relevant information.
A.8.2.1.6 In exceptional cases, based on expert judgment, it may be appropriate to place certain substances with human evidence of target organ toxicity in Category 2: (a) when the weight of human evidence is not sufficiently convincing to warrant Category 1 classification, and/or (b) based on the nature and severity of effects. Dose/concentration levels in humans shall not be considered in the classification and any available evidence from animal studies shall be consistent with the Category 2 classification. In other words, if there are also animal data available on the substance that warrant Category 1 classification, the chemical shall be classified as Category 1.
A.8.2.1.7 Effects considered to support classification for Category 1 and 2
A.8.2.1.7.1 Classification is supported by evidence associating single exposure to the substance with a consistent and identifiable toxic effect.
A.8.2.1.7.2 Evidence from human experience/incidents is usually restricted to reports of adverse health consequences, often with uncertainty about exposure conditions, and may not provide the scientific detail that can be obtained from well-conducted studies in experimental animals.
A.8.2.1.7.3 Evidence from appropriate studies in experimental animals can furnish much more detail, in the form of clinical observations, and macroscopic and microscopic pathological examination and this can often reveal hazards that may not be life-threatening but could indicate functional impairment. Consequently all available evidence, and evidence relevance to human health, must be taken into consideration in the classification process. Relevant toxic effects in humans and/or animals include, but are not limited to:
(a) Morbidity resulting from single exposure;
(b) Significant functional changes, more than transient in nature, in the respiratory system, central or peripheral nervous systems, other organs or other organ systems, including signs of central nervous system depression and effects on special senses (e.g., sight, hearing and sense of smell);
(c) Any consistent and significant adverse change in clinical biochemistry, hematology, or urinalysis parameters;
(d) Significant organ damage that may be noted at necropsy and/or subsequently seen or confirmed at microscopic examination;
(e) Multi-focal or diffuse necrosis, fibrosis or granuloma formation in vital organs with regenerative capacity;
(f) Morphological changes that are potentially reversible but provide clear evidence of marked organ dysfunction; and,
(g) Evidence of appreciable cell death (including cell degeneration and reduced cell number) in vital organs incapable of regeneration.
A.8.2.1.8 Effects considered not to support classification for Category 1 and 2
Effects may be seen in humans and/or animals that do not justify classification. Such effects include, but are not limited to:
(a) Clinical observations or small changes in bodyweight gain, food consumption or water intake that may have some toxicological importance but that do not, by themselves, indicate “significant” toxicity;
(b) Small changes in clinical biochemistry, hematology or urinalysis parameters and/or transient effects, when such changes or effects are of doubtful or of minimal toxicological importance;
(c) Changes in organ weights with no evidence of organ dysfunction;
(d) Adaptive responses that are not considered toxicologically relevant; and,
(e) Substance-induced species-specific mechanisms of toxicity, i.e., demonstrated with reasonable certainty to be not relevant for human health, shall not justify classification.
A.8.2.1.9 Guidance values to assist with classification based on the results obtained from studies conducted in experimental animals for Category 1 and 2
A.8.2.1.9.1 In order to help reach a decision about whether a substance shall be classified or not, and to what degree it shall be classified (Category 1 vs. Category 2), dose/concentration “guidance values” are provided for consideration of the dose/concentration which has been shown to produce significant health effects. The principal argument for proposing such guidance values is that all chemicals are potentially toxic and there has to be a reasonable dose/concentration above which a degree of toxic effect is acknowledged.
A.8.2.1.9.2 Thus, in animal studies, when significant toxic effects are observed that indicate classification, consideration of the dose/concentration at which these effects were seen, in relation to the suggested guidance values, provides useful information to help assess the need to classify (since the toxic effects are a consequence of the hazardous property(ies) and also the dose/concentration).
A.8.2.1.9.3 The guidance value (C) ranges for single-dose exposure which has produced a significant non-lethal toxic effect are those applicable to acute toxicity testing, as indicated in Table A.8.1.
A.8.2.1.9.4 The guidance values and ranges mentioned in Table A.8.1 are intended only for guidance purposes, i.e., to be used as part of the weight of evidence approach, and to assist with decisions about classification. They are not intended as strict demarcation values. Guidance values are not provided for Category 3 since this classification is primarily based on human data; animal data may be included in the weight of evidence evaluation.
A.8.2.1.9.5 Thus, it is feasible that a specific profile of toxicity occurs at a dose/concentration below the guidance value, e.g., <2000 mg/kg body weight by the oral route, however the nature of the effect may result in the decision not to classify. Conversely, a specific profile of toxicity may be seen in animal studies occurring at above a guidance value, e.g., ≥2000 mg/kg body weight by the oral route, and in addition there is supplementary information from other sources, e.g., other single dose studies, or human case experience, which supports a conclusion that, in view of the weight of evidence, classification is the prudent action to take.
A.8.2.1.10 Other considerations
A.8.2.1.10.1 When a substance is characterized only by use of animal data the classification process includes reference to dose/concentration guidance values as one of
A.8.2.1.10.2 When well-substantiated human data are available showing a specific target organ toxic effect that can be reliably attributed to single exposure to a substance, the substance shall be classified. Positive human data, regardless of probable dose, predominates over animal data. Thus, if a substance is unclassified because specific target organ toxicity observed was considered not relevant or significant to humans, if subsequent human incident data become available showing a specific target organ toxic effect, the substance shall be classified.
A.8.2.1.10.3 A substance that has not been tested for specific target organ toxicity shall, where appropriate, be classified on the basis of data from a scientifically validated structure activity relationship and expert judgment-based extrapolation from a structural analogue that has previously been classified together with substantial support from consideration of other important factors such as formation of common significant metabolites.
A.8.2.2.1 Criteria for respiratory tract irritation
The criteria for classifying substances as Category 3 for respiratory tract irritation are:
(a) Respiratory irritant effects (characterized by localized redness, edema, pruritis and/or pain) that impair function with symptoms such as cough, pain, choking, and breathing difficulties are included. It is recognized that this evaluation is based primarily on human data;
(b) Subjective human observations supported by objective measurements of clear respiratory tract irritation (RTI) (e.g., electrophysiological responses, biomarkers of inflammation in nasal or bronchoalveolar lavage fluids);
(c) The symptoms observed in humans shall also be typical of those that would be produced in the exposed population rather than being an isolated idiosyncratic reaction or response triggered only in individuals with hypersensitive airways. Ambiguous reports simply of “irritation” should be excluded as this term is commonly used to describe a wide range of sensations including those such as smell, unpleasant taste, a tickling sensation, and dryness, which are outside the scope of classification for respiratory tract irritation;
(d) There are currently no scientifically validated animal tests that deal specifically with RTI; however, useful information may be obtained from the single and repeated inhalation toxicity tests. For example, animal studies may provide useful information in terms of clinical signs of toxicity (dyspnoea, rhinitis etc) and histopathology (e.g., hyperemia, edema, minimal inflammation, thickened mucous layer) which are reversible and may be reflective of the characteristic clinical symptoms described above. Such animal studies can be used as part of weight of evidence evaluation; and,
(e) This special classification will occur only when more severe organ effects including the respiratory system are not observed as those effects would require a higher classification.
A.8.2.2.2 Criteria for narcotic effects
The criteria for classifying substances in Category 3 for narcotic effects are:
(a) Central nervous system depression including narcotic effects in humans such as drowsiness, narcosis, reduced alertness, loss of reflexes, lack of coordination, and vertigo are included. These effects can also be manifested as severe headache or nausea, and can lead to reduced judgment, dizziness, irritability, fatigue, impaired memory function, deficits in perception and coordination, reaction time, or sleepiness; and,
(b) Narcotic effects observed in animal studies may include lethargy, lack of coordination righting reflex, narcosis, and ataxia. If these effects are not transient in nature, then they shall be considered for classification as Category 1 or 2.
A.8.3.1 Mixtures are classified using the same criteria as for substances, or alternatively as described below. As with substances, mixtures may be classified for specific target organ toxicity following single exposure, repeated exposure, or both.
When reliable and good quality evidence from human experience or appropriate studies in experimental animals, as described in the criteria for substances, is available for the mixture, then the mixture shall be classified by weight of evidence evaluation of this data. Care shall be exercised in evaluating data on mixtures, that the dose, duration, observation or analysis, do not render the results inconclusive.
A.8.3.3.1 Where the mixture itself has not been tested to determine its specific target organ toxicity, but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data shall be used in accordance with the following bridging principles as found in paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration of mixtures, Interpolation within one toxicity category, Substantially similar mixtures, or Aerosols.
A.8.3.4.1 Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture shall be classified as a specific target organ toxicant (specific organ specified), following single exposure, repeated exposure, or both when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ toxicant and is present at or above the appropriate cut-off value/concentration limit specified in Table A.8.2 for Categories 1 and 2, respectively.
A.8.3.4.2 These cut-off values and consequent classifications shall be applied equally and appropriately to both single- and repeated-dose target organ toxicants.
A.8.3.4.3 Mixtures shall be classified for either or both single and repeated dose toxicity independently.
A.8.3.4.4 Care shall be exercised when toxicants affecting more than one organ system are combined that the potentiation or synergistic interactions are considered, because certain substances can cause target organ toxicity at <1% concentration when other ingredients in the mixture are known to potentiate its toxic effect.
A.8.3.4.5 Care shall be exercised when extrapolating the toxicity of a mixture that contains Category 3 ingredient(s). A cut-off value/concentration limit of 20%, considered as an additive of all Category 3 ingredients for each hazard endpoint, is appropriate; however, this cut-off value/concentration limit may be higher or lower depending on the Category 3 ingredient(s) involved and the fact that some effects such as respiratory tract irritation may not occur below a certain concentration while other effects such as narcotic effects may occur below this 20% value. Expert judgment shall be exercised. Respiratory tract irritation and narcotic
A.9.1.1
A.9.1.2 Classification identifies the substance or mixture as being a specific target organ toxicant and, as such, it may present a potential for adverse health effects in people who are exposed to it.
A.9.1.3 These adverse health effects produced by repeated exposure include consistent and identifiable toxic effects in humans, or, in experimental animals, toxicologically significant changes which have affected the function or morphology of a tissue/organ, or have produced serious changes to the biochemistry or hematology of the organism and these changes are relevant for human health. Human data will be the primary source of evidence for this hazard class.
A.9.1.4 Assessment shall take into consideration not only significant changes in a single organ or biological system but also generalized changes of a less severe nature involving several organs.
A.9.1.5 Specific target organ toxicity can occur by any route that is relevant for humans, e.g., principally oral, dermal or inhalation.
A.9.2.1 Substances shall be classified as STOT-RE by expert judgment on the basis of the weight of all evidence available, including the use of recommended guidance values which take into account the duration of exposure and the dose/concentration which produced the effect(s), (See A.9.2.9). Substances shall be placed in one of two categories, depending upon the nature and severity of the effect(s) observed, in accordance with Figure A.9.1.
A.9.2.2 The relevant route of exposure by which the classified substance produces damage shall be identified.
A.9.2.3 Classification is determined by expert judgment, on the basis of the weight of all evidence available including the guidance presented below.
A.9.2.4 Weight of evidence of all data, including human incidents, epidemiology, and studies conducted in experimental animals, is used to substantiate specific target organ toxic effects that merit classification.
A.9.2.5 The information required to evaluate specific target organ toxicity comes either from repeated exposure in humans, e.g., exposure at home, in the workplace or environmentally, or from studies conducted in experimental animals. The standard animal studies in rats or mice that provide this information are 28 day, 90 day or lifetime studies (up to 2 years) that include hematological, clinico-chemical and detailed macroscopic and microscopic examination to enable the toxic effects on target tissues/organs to be identified. Data from repeat dose studies performed in other species may also be used. Other long-term exposure studies, e.g., for carcinogenicity, neurotoxicity or reproductive toxicity, may also provide evidence of specific target organ toxicity that could be used in the assessment of classification.
A.9.2.6 In exceptional cases, based on expert judgment, it may be appropriate to place certain substances with human evidence of specific target organ toxicity in Category 2: (a) when the weight of human evidence is not sufficiently convincing to warrant Category 1 classification, and/or (b) based on the nature and severity of effects. Dose/concentration levels in humans shall not be considered in the classification and any available evidence from animal studies shall be consistent with the Category 2 classification. In other words, if there are also animal data available on the substance that warrant Category 1 classification, the substance shall be classified as Category 1.
A.9.2.7.1 Classification is supported by reliable evidence associating repeated exposure to the substance with a consistent and identifiable toxic effect.
A.9.2.7.2 Evidence from human experience/incidents is usually restricted to reports of adverse health consequences, often with uncertainty about exposure conditions, and may not provide the scientific detail that can be obtained from well-conducted studies in experimental animals.
A.9.2.7.3 Evidence from appropriate studies in experimental animals can furnish much more detail, in the form of clinical observations, hematology, clinical chemistry, macroscopic and microscopic pathological examination and this can often reveal hazards that may not be life-threatening but could indicate functional impairment. Consequently all available evidence, and relevance to human health, must be taken into consideration in the classification process. Relevant toxic effects in humans and/or animals include, but are not limited to:
(a) Morbidity or death resulting from repeated or long-term exposure. Morbidity or death may result from repeated exposure, even to relatively low doses/concentrations, due to bioaccumulation of the substance or its metabolites, or due to the overwhelming of the de-toxification process by repeated exposure;
(b) Significant functional changes in the central or peripheral nervous systems or other organ systems, including signs of central nervous system depression and effects on special senses (e.g., sight, hearing and sense of smell);
(c) Any consistent and significant adverse change in clinical biochemistry, hematology, or urinalysis parameters;
(d) Significant organ damage that may be noted at necropsy and/or subsequently seen or confirmed at microscopic examination;
(e) Multi-focal or diffuse necrosis, fibrosis or granuloma formation in vital organs with regenerative capacity;
(f) Morphological changes that are potentially reversible but provide clear evidence of marked organ dysfunction (e.g., severe fatty change in the liver); and,
(g) Evidence of appreciable cell death (including cell degeneration and reduced cell number) in vital organs incapable of regeneration.
Effects may be seen in humans and/or animals that do not justify classification. Such effects include, but are not limited to:
(a) Clinical observations or small changes in bodyweight gain, food consumption or water intake that may have some toxicological importance but that do not, by themselves, indicate “significant” toxicity;
(b) Small changes in clinical biochemistry, hematology or urinalysis parameters and/or transient effects, when such changes or effects are of doubtful or of minimal toxicological importance;
(c) Changes in organ weights with no evidence of organ dysfunction;
(d) Adaptive responses that are not considered toxicologically relevant;
(e) Substance-induced species-specific mechanisms of toxicity, i.e., demonstrated with reasonable certainty to be not relevant for human health, shall not justify classification.
A.9.2.9.1 In studies conducted in experimental animals, reliance on observation of effects alone, without reference to the duration of experimental exposure and dose/concentration, omits a fundamental concept of toxicology, i.e., all substances are potentially toxic, and what determines the toxicity is a function of the dose/concentration and the duration of exposure. In most studies conducted in experimental animals the test guidelines use an upper limit dose value.
A.9.2.9.2 In order to help reach a decision about whether a substance shall be classified or not, and to what degree it shall be classified (Category 1 vs. Category 2), dose/concentration “guidance values” are provided in Table A.9.1 for consideration of the dose/concentration which has been shown to produce significant health effects. The principal argument for proposing such guidance values is that all chemicals are potentially toxic and there has to be a reasonable dose/concentration above which a degree of toxic effect is acknowledged. Also, repeated-dose studies conducted in experimental animals are designed to produce toxicity at the highest dose used in order to optimize the test objective and so most studies will reveal some toxic effect at least at this highest dose. What is therefore to be decided is not only what effects have been produced, but also at what dose/concentration they were produced and how relevant is that for humans.
A.9.2.9.3 Thus, in animal studies, when significant toxic effects are observed that indicate classification, consideration of the duration of experimental exposure and the dose/concentration at which these effects were seen, in relation to the suggested guidance values, provides useful information to help assess the need to classify (since the toxic effects are a consequence of the hazardous property(ies) and also the duration of exposure and the dose/concentration).
A.9.2.9.4 The decision to classify at all can be influenced by reference to the dose/concentration guidance values at or below which a significant toxic effect has been observed.
A.9.2.9.5 The guidance values refer to effects seen in a standard 90-day toxicity study conducted in rats. They can be used as a basis to extrapolate equivalent guidance values for toxicity studies of greater or lesser duration, using dose/exposure time extrapolation similar to Haber's rule for inhalation, which states essentially that the effective dose is directly proportional to the exposure concentration and the duration of exposure. The assessment should be done on a case-by-case basis; for example, for a 28-day study the guidance values below would be increased by a factor of three.
A.9.2.9.6 Thus for Category 1 classification, significant toxic effects observed in a 90-day repeated-dose study conducted in experimental animals and seen to occur at or below the (suggested) guidance values (C) as indicated in Table A.9.1 would justify classification:
A.9.2.9.7 For Category 2 classification, significant toxic effects observed in a 90-day repeated-dose study conducted in experimental animals and seen to occur within the (suggested) guidance value ranges as indicated in Table A.9.2 would justify classification:
A.9.2.9.8 The guidance values and ranges mentioned in A.2.9.9.6 and A.2.9.9.7 are intended only for guidance purposes, i.e., to be used as part of the weight of evidence approach, and to assist with decisions about
A.9.2.9.9 Thus, it is possible that a specific profile of toxicity occurs in repeat-dose animal studies at a dose/concentration below the guidance value, e.g., <100 mg/kg body weight/day by the oral route, however the nature of the effect, e.g., nephrotoxicity seen only in male rats of a particular strain known to be susceptible to this effect, may result in the decision not to classify. Conversely, a specific profile of toxicity may be seen in animal studies occurring at above a guidance value, e.g., ≥100 mg/kg body weight/day by the oral route, and in addition there is supplementary information from other sources, e.g., other long-term administration studies, or human case experience, which supports a conclusion that, in view of the weight of evidence, classification is prudent.
A.9.2.10.1 When a substance is characterized only by use of animal data the classification process includes reference to dose/concentration guidance values as one of the elements that contribute to the weight of evidence approach.
A.9.2.10.2 When well-substantiated human data are available showing a specific target organ toxic effect that can be reliably attributed to repeated or prolonged exposure to a substance, the substance shall be classified. Positive human data, regardless of probable dose, predominates over animal data. Thus, if a substance is unclassified because no specific target organ toxicity was seen at or below the dose/concentration guidance value for animal testing, if subsequent human incident data become available showing a specific target organ toxic effect, the substance shall be classified.
A.9.2.10.3 A substance that has not been tested for specific target organ toxicity may in certain instances, where appropriate, be classified on the basis of data from a scientifically validated structure activity relationship and expert judgment-based extrapolation from a structural analogue that has previously been classified together with substantial support from consideration of other important factors such as formation of common significant metabolites.
A.9.3.1 Mixtures are classified using the same criteria as for substances, or alternatively as described below. As with substances, mixtures may be classified for specific target organ toxicity following single exposure, repeated exposure, or both.
When reliable and good quality evidence from human experience or appropriate studies in experimental animals, as described in the criteria for substances, is available for the mixture, then the mixture shall be classified by weight of evidence evaluation of these data. Care shall be exercised in evaluating data on mixtures, that the dose, duration, observation or analysis, do not render the results inconclusive.
A.9.3.3.1 Where the mixture itself has not been tested to determine its specific target organ toxicity, but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data shall be used in accordance with the following bridging principles as found in paragraph A.0.5 of this Appendix: Dilution; Batching; Concentration of mixtures; Interpolation within one toxicity category; Substantially similar mixtures; and Aerosols.
A.9.3.4.1 Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture shall be classified as a specific target organ toxicant (specific organ specified), following single exposure, repeated exposure, or both when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ toxicant and is present at or above the appropriate cut-off value/concentration limit specified in Table A.9.3 for Category 1 and 2 respectively.
A.9.3.4.2 These cut-off values and consequent classifications shall be applied equally and appropriately to both single- and repeated-dose target organ toxicants.
A.9.3.4.3 Mixtures shall be classified for either or both single- and repeated-dose toxicity independently.
A.9.3.4.4 Care shall be exercised when toxicants affecting more than one organ system are combined that the potentiation or synergistic interactions are considered, because certain substances can cause specific target organ toxicity at <1% concentration when other ingredients in the mixture are known to potentiate its toxic effect.
A.10.1.1
A.10.1.2 Aspiration toxicity includes severe acute effects such as chemical pneumonia, varying degrees of pulmonary injury or death following aspiration.
A.10.1.3 Aspiration is initiated at the moment of inspiration, in the time required to take one breath, as the causative material lodges at the crossroad of the upper respiratory and digestive tracts in the laryngopharyngeal region.
A.10.1.4 Aspiration of a substance or mixture can occur as it is vomited following ingestion. This may have consequences for labeling, particularly where, due to acute toxicity, a recommendation may be considered to induce vomiting after ingestion. However, if the substance/mixture also presents an aspiration toxicity hazard, the recommendation to induce vomiting may need to be modified.
A.10.1.5.1 The classification criteria refer to kinematic viscosity. The following provides the conversion between dynamic and kinematic viscosity:
A.10.1.5.2 Although the definition of aspiration in A.10.1.1 includes the entry of solids into the respiratory system, classification according to (b) in table A.10.1 for Category 1 is intended to apply to liquid substances and mixtures only.
A.10.1.5.3 Classification of aerosol/mist products.
Aerosol and mist products are usually dispensed in containers such as self-pressurized containers, trigger and pump sprayers. Classification for these products shall be considered if their use may form a pool of product in the mouth, which then may be aspirated. If the mist or aerosol from a pressurized container is fine, a pool may not be formed. On the other hand, if a pressurized container dispenses product in a stream, a pool may be formed that may then be aspirated. Usually, the mist produced by trigger and pump sprayers is coarse and therefore, a pool may be formed that then may be aspirated. When the pump mechanism may be removed and contents are available to be swallowed then the classification of the products should be considered.
A mixture shall be classified in Category 1 based on reliable and good quality human evidence.
A.10.3.2.1 Where the mixture itself has not been tested to determine its aspiration toxicity, but there are sufficient data on both the individual ingredients and similar tested mixtures to adequately characterize the hazard of the mixture, these data shall be used in accordance with the following bridging principles as found in paragraph A.0.5 of this Appendix: Dilution; Batching; Concentration of mixtures; Interpolation within one toxicity category; and Substantially similar mixtures. For application of the dilution bridging principle, the concentration of aspiration toxicants shall not be less than 10%.
A.10.3.3.1 A mixture which contains ≥10% of an ingredient or ingredients classified in Category 1, and has a kinematic viscosity ≤20.5 mm
A.10.3.3.2 In the case of a mixture which separates into two or more distinct layers, one of which contains ≥10% of an ingredient or ingredients classified in Category 1 and has a kinematic viscosity ≤20.5 mm
B.1.1.1 An
A
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A
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B.1.1.2 The class of explosives comprises:
(a) Explosive chemicals;
(b) Explosive items, except devices containing explosive chemicals in such quantity or of such a character that their inadvertent or accidental ignition or initiation shall not cause any effect external to the device either by projection, fire, smoke, heat or loud noise; and
(c) Chemicals and items not included under (a) and (b) above which are manufactured with the view to producing a practical explosive or pyrotechnic effect.
Chemicals and items of this class shall be classified as unstable explosives or shall be assigned to one of the following six divisions depending on the type of hazard they present:
(a) Division 1.1—Chemicals and items which have a mass explosion hazard (a mass explosion is one which affects almost the entire quantity present virtually instantaneously);
(b) Division 1.2—Chemicals and items which have a projection hazard but not a mass explosion hazard;
(c) Division 1.3—Chemicals and items which have a fire hazard and either a minor blast hazard or a minor projection hazard or both, but not a mass explosion hazard:
(i) Combustion of which gives rise to considerable radiant heat; or
(ii) Which burn one after another, producing minor blast or projection effects or both;
(d) Division 1.4—Chemicals and items which present no significant hazard: chemicals and items which present only a small hazard in the event of ignition or initiation. The effects are largely confined to the package and no projection of fragments of appreciable size or range is to be expected. An external fire shall not cause virtually instantaneous explosion of almost the entire contents of the package;
(e) Division 1.5—Very insensitive chemicals which have a mass explosion hazard: chemicals which have a mass explosion hazard but are so insensitive that there is very little probability of initiation or of transition from burning to detonation under normal conditions;
(f) Division 1.6—Extremely insensitive items which do not have a mass explosion hazard: items which contain only extremely insensitive detonating chemicals and which demonstrate a negligible probability of accidental initiation or propagation.
B.1.3.1 Explosives shall be classified as unstable explosives or shall be assigned to one of the six divisions identified in B.1.2 in accordance with the three step procedure in Part I of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6). The first step is to ascertain whether the substance or mixture has explosive effects (Test Series 1). The second step is the acceptance procedure (Test Series 2 to 4) and the third step is the assignment to a hazard division (Test Series 5 to 7). The assessment whether a candidate for “ammonium nitrate emulsion or suspension or gel, intermediate for blasting explosives (ANE)” is insensitive enough for inclusion as an oxidizing liquid (See B.13) or an oxidizing solid (See B.14) is determined by Test Series 8 tests.
B.1.3.2 Explosive properties are associated with the presence of certain chemical groups in a molecule which can react to produce very rapid increases in temperature or pressure. The screening procedure in B.1.3.1 is aimed at identifying the presence of such reactive groups and the potential for rapid energy release. If the screening procedure identifies the chemical as a potential explosive, the acceptance procedure (See section 10.3 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6)) is necessary for classification.
B.1.3.3 If a mixture contains any known explosives, the acceptance procedure is necessary for classification.
B.1.3.4 A chemical is not classified as explosive if:
(a) There are no chemical groups associated with explosive properties present in the molecule. Examples of groups which may indicate explosive properties are given in Table A6.1 in Appendix 6 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6); or
(b) The substance contains chemical groups associated with explosive properties which include oxygen and the calculated oxygen balance is less than −200.
The oxygen balance is calculated for the chemical reaction:
or
(c) The organic substance or a homogenous mixture of organic substances contains chemical groups associated with explosive properties but the exothermic decomposition energy is less than 500 J/g and the onset of exothermic decomposition is below 500 °C (932 °F). The exothermic decomposition energy may be determined using a suitable calorimetric technique; or
(d) For mixtures of inorganic oxidizing substances with organic material(s), the concentration of the inorganic oxidizing substance is:
(i) Less than 15%, by mass, if the oxidizing substance is assigned to Category 1 or 2;
(ii) Less than 30%, by mass, if the oxidizing substance is assigned to Category 3.
A flammable gas shall be classified in one of the two categories for this class in accordance with Table B.2.1:
Flammability shall be determined by tests or by calculation in accordance with ISO 10156 (incorporated by reference; See § 1910.6). Where insufficient data are available to use this method, equivalent validated methods may be used.
B.3.2.1 Aerosols shall be considered for classification as flammable if they contain any component which is classified as flammable in accordance with this Appendix, i.e.:
B.3.2.2 A flammable aerosol shall be classified in one of the two categories for this class in accordance with Table B.3.1.
B.3.3.1 To classify a flammable aerosol, data on its flammable components, on its chemical heat of combustion and, if applicable, the results of the aerosol foam flammability test (for foam aerosols) and of the ignition distance test and enclosed space test (for spray aerosols) are necessary.
B.3.3.2 The chemical heat of combustion (ΔHc), in kilojoules per gram (kJ/g), is the product of the theoretical heat of combustion (ΔHcomb), and a combustion efficiency, usually less than 1.0 (a typical combustion efficiency is 0.95 or 95%).
For a composite aerosol formulation, the chemical heat of combustion is the summation of the weighted heats of combustion for the individual components, as follows:
The chemical heats of combustion shall be found in literature, calculated or determined by tests (See ASTM D240-02, ISO 13943, Sections 86.1 to 86.3, and NFPA 30B (incorporated by reference; See § 1910.6)).
B.3.3.3 The Ignition Distance Test, Enclosed Space Ignition Test and Aerosol Foam Flammability Test shall be performed in accordance with sub-sections 31.4, 31.5 and 31.6 of the of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6).
An oxidizing gas shall be classified in a single category for this class in accordance with Table B.4.1:
Classification shall be in accordance with tests or calculation methods as described in ISO 10156 (incorporated by reference; See § 1910.6) and ISO 10156-2 (incorporated by reference; See § 1910.6).
They comprise compressed gases, liquefied gases, dissolved gases and refrigerated liquefied gases.
Gases under pressure shall be classified in one of four groups in accordance with Table B.5.1:
A flammable liquid shall be classified in one of four categories in accordance with Table B.6.1:
The flash point shall be determined in accordance with ASTM D56-05, ASTM D3278, ASTM D3828, ASTM D93-08 (incorporated by reference; See § 1910.6), or any other method specified in GHS Revision 3, Chapter 2.6.
The initial boiling point shall be determined in accordance with ASTM D86-07a or ASTM D1078 (incorporated by reference; See § 1910.6).
B.7.2.1 Powdered, granular or pasty chemicals shall be classified as flammable solids when the time of burning of one or more of the test runs, performed in accordance with the test method described in the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), Part III, sub-section 33.2.1, is less than 45 s or the rate of burning is more than 2.2 mm/s (0.0866 in/s).
B.7.2.2 Powders of metals or metal alloys shall be classified as flammable solids when they can be ignited and the reaction spreads over the whole length of the sample in 10 min or less.
B.7.2.3 Solids which may cause fire through friction shall be classified in this class by analogy with existing entries (e.g., matches) until definitive criteria are established.
B.7.2.4 A flammable solid shall be classified in one of the two categories for this class using Method N.1 as described in Part III, sub-section 33.2.1 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), in accordance with Table B.7.1:
A self-reactive chemical is regarded as possessing explosive properties when in laboratory testing the formulation is liable to detonate, to deflagrate rapidly or to show a violent effect when heated under confinement.
B.8.2.1 A self-reactive chemical shall be considered for classification in this class unless:
(a) It is classified as an explosive according to B.1 of this appendix;
(b) It is classified as an oxidizing liquid or an oxidizing solid according to B.13 or B.14 of this appendix, except that a mixture of oxidizing substances which contains 5% or more of combustible organic substances shall be classified as a self-reactive chemical according to the procedure defined in B.8.2.2;
(c) It is classified as an organic peroxide according to B.15 of this appendix;
(d) Its heat of decomposition is less than 300 J/g; or
(e) Its self-accelerating decomposition temperature (SADT) is greater than 75 °C (167 °F) for a 50 kg (110 lb) package.
B.8.2.2 Mixtures of oxidizing substances, meeting the criteria for classification as oxidizing liquids or oxidizing solids, which contain 5% or more of combustible organic substances and which do not meet the criteria mentioned in B.8.2.1 (a), (c), (d) or (e), shall be subjected to the self-reactive chemicals classification procedure in B.8.2.3. Such a mixture showing the properties of a self-reactive chemical type B to F shall be classified as a self-reactive chemical.
B.8.2.3 Self-reactive chemicals shall be classified in one of the seven categories of “types A to G” for this class, according to the following principles:
(a) Any self-reactive chemical which can detonate or deflagrate rapidly, as packaged, will be defined as self-reactive chemical TYPE A;
(b) Any self-reactive chemical possessing explosive properties and which, as packaged, neither detonates nor deflagrates rapidly, but is liable to undergo a thermal explosion in that package will be defined as self-reactive chemical TYPE B;
(c) Any self-reactive chemical possessing explosive properties when the chemical as packaged cannot detonate or deflagrate rapidly or undergo a thermal explosion will be defined as self-reactive chemical TYPE C;
(d) Any self-reactive chemical which in laboratory testing meets the criteria in (d)(i), (ii), or (iii) will be defined as self-reactive chemical TYPE D:
(i) Detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; or
(ii) Does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement; or
(iii) Does not detonate or deflagrate at all and shows a medium effect when heated under confinement;
(e) Any self-reactive chemical which, in laboratory testing, neither detonates nor deflagrates at all and shows low or no effect when heated under confinement will be defined as self-reactive chemical TYPE E;
(f) Any self-reactive chemical which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows only a low or no effect when heated under confinement as well as low or no explosive power will be defined as self-reactive chemical TYPE F;
(g) Any self-reactive chemical which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows no effect when heated under confinement nor any explosive power, provided that it is thermally stable (self-accelerating decomposition temperature is 60 °C (140 °F) to 75 °C (167 °F) for a 50 kg (110 lb) package), and, for liquid mixtures, a diluent having a boiling point greater than or equal to 150 °C (302 °F) is used for desensitization will be defined as self-reactive chemical TYPE G. If the mixture is not thermally stable or a diluent having a boiling point less than 150 °C (302 °F) is used for desensitization, the mixture shall be defined as self-reactive chemical TYPE F.
B.8.3.1 For purposes of classification, the properties of self-reactive chemicals shall be determined in accordance with test series A to H as described in Part II of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6).
B.8.3.2 Self-accelerating decomposition temperature (SADT) shall be determined in accordance with the UN ST/SG/AC.10, Part II, section 28 (incorporated by reference; See § 1910.6).
B.8.3.3 The classification procedures for self-reactive substances and mixtures need not be applied if:
(a) There are no chemical groups present in the molecule associated with explosive or self-reactive properties; examples of such groups are given in Tables A6.1 and A6.2 in the Appendix 6 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6); or
(b) For a single organic substance or a homogeneous mixture of organic substances, the estimated SADT is greater than 75 °C (167 °F) or the exothermic decomposition energy is less than 300 J/g. The onset temperature and decomposition energy may be estimated using a suitable calorimetric technique (See 20.3.3.3 in Part II of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6)).
A pyrophoric liquid shall be classified in a single category for this class using test N.3 in Part III, sub-section 33.3.1.5 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), in accordance with Table B.9.1:
The classification procedure for pyrophoric liquids need not be applied when experience in production or handling shows that the chemical does not ignite spontaneously on coming into contact with air at normal temperatures (i.e., the substance is known to be stable at room temperature for prolonged periods of time (days)).
A pyrophoric solid shall be classified in a single category for this class using test N.2 in Part III, sub-section 33.3.1.4 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), in accordance with Table B.10.1:
The classification procedure for pyrophoric solids need not be applied when experience in production or handling shows that the chemical does not ignite spontaneously on coming into contact with air at normal temperatures (i.e., the chemical is known to be stable at room temperature for prolonged periods of time (days)).
A
B.11.2.1 A self-heating chemical shall be classified in one of the two categories for this class if, in tests performed in accordance with test method N.4 in Part III, sub-section 33.3.1.6 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), the result meets the criteria shown in Table B.11.1.
B.11.2.2 Chemicals with a temperature of spontaneous combustion higher than 50 °C (122 °F) for a volume of 27 m
B.11.2.3 Chemicals with a spontaneous ignition temperature higher than 50 °C (122 °F) for a volume of 450 liters shall not be classified in Category 1 of this class.
B.11.3.1 The classification procedure for self-heating chemicals need not be applied if the results of a screening test can be adequately correlated with the classification test and an appropriate safety margin is applied.
B.11.3.2 Examples of screening tests are:
(a) The Grewer Oven test (VDI guideline 2263, part 1, 1990, Test methods for the Determination of the Safety Characteristics of Dusts) with an onset temperature 80°K above the reference temperature for a volume of 1
(b) The Bulk Powder Screening Test (Gibson, N. Harper, D. J. Rogers, R. Evaluation of the fire and explosion risks in drying powders, Plant Operations Progress, 4 (3), 181-189, 1985) with an onset temperature 60°K above the reference temperature for a volume of 1
B.12.2.1 A chemical which, in contact with water, emits flammable gases shall be classified in one of the three categories for this class, using test N.5 in Part III, sub-section 33.4.1.4 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), in accordance with Table B.12.1:
B.12.2.2 A chemical is classified as a chemical which, in contact with water emits flammable gases if spontaneous ignition takes place in any step of the test procedure.
The classification procedure for this class need not be applied if:
(a) The chemical structure of the chemical does not contain metals or metalloids;
(b) Experience in production or handling shows that the chemical does not react with water, (e.g., the chemical is manufactured with water or washed with water); or
(c) The chemical is known to be soluble in water to form a stable mixture.
An oxidizing liquid shall be classified in one of the three categories for this class using test O.2 in Part III, sub-section 34.4.2 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), in accordance with Table B.13.1:
B.13.3.1 For organic chemicals, the classification procedure for this class shall not be applied if:
(a) The chemical does not contain oxygen, fluorine or chlorine; or
(b) The chemical contains oxygen, fluorine or chlorine and these elements are chemically bonded only to carbon or hydrogen.
B.13.3.2 For inorganic chemicals, the classification procedure for this class shall not be applied if the chemical does not contain oxygen or halogen atoms.
B.13.3.3 In the event of divergence between test results and known experience in the handling and use of chemicals which shows them to be oxidizing, judgments based on known experience shall take precedence over test results.
B.13.3.4 In cases where chemicals generate a pressure rise (too high or too low), caused by chemical reactions not characterizing the oxidizing properties of the chemical, the test described in Part III, sub-section 34.4.2 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6) shall be repeated with an inert substance (e.g., diatomite (kieselguhr)) in place of the cellulose in order to clarify the nature of the reaction.
An oxidizing solid shall be classified in one of the three categories for this class using test O.1 in Part III, sub-section 34.4.1 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), in accordance with Table B.14.1:
B.14.3.1 For organic chemicals, the classification procedure for this class shall not be applied if:
(a) The chemical does not contain oxygen, fluorine or chlorine; or
(b) The chemical contains oxygen, fluorine or chlorine and these elements are chemically bonded only to carbon or hydrogen.
B.14.3.2 For inorganic chemicals, the classification procedure for this class shall not be applied if the chemical does not contain oxygen or halogen atoms.
B.14.3.3 In the event of divergence between test results and known experience in the handling and use of chemicals which shows them to be oxidizing, judgements based on known experience shall take precedence over test results.
B.15.1.1
(a) Be liable to explosive decomposition;
(b) Burn rapidly;
(c) Be sensitive to impact or friction;
(d) React dangerously with other substances.
B.15.1.2 An organic peroxide is regarded as possessing explosive properties when in laboratory testing the formulation is liable to detonate, to deflagrate rapidly or to show a violent effect when heated under confinement.
B.15.2.1 Any organic peroxide shall be considered for classification in this class, unless it contains:
(a) Not more than 1.0% available oxygen from the organic peroxides when containing not more than 1.0% hydrogen peroxide; or
(b) Not more than 0.5% available oxygen from the organic peroxides when containing more than 1.0% but not more than 7.0% hydrogen peroxide.
B.15.2.2 Organic peroxides shall be classified in one of the seven categories of “Types A to G” for this class, according to the following principles:
(a) Any organic peroxide which, as packaged, can detonate or deflagrate rapidly shall be defined as organic peroxide TYPE A;
(b) Any organic peroxide possessing explosive properties and which, as packaged, neither detonates nor deflagrates rapidly, but is liable to undergo a thermal explosion in that package shall be defined as organic peroxide TYPE B;
(c) Any organic peroxide possessing explosive properties when the chemical as packaged cannot detonate or deflagrate rapidly or undergo a thermal explosion shall be defined as organic peroxide TYPE C;
(d) Any organic peroxide which in laboratory testing meets the criteria in (d)(i), (ii), or (iii) shall be defined as organic peroxide TYPE D:
(i) Detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; or
(ii) Does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement; or
(iii) Does not detonate or deflagrate at all and shows a medium effect when heated under confinement;
(e) Any organic peroxide which, in laboratory testing, neither detonates nor deflagrates at all and shows low or no effect when heated under confinement shall be defined as organic peroxide TYPE E;
(f) Any organic peroxide which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows only a low or no effect when heated under confinement as well as low or no explosive power shall be defined as organic peroxide TYPE F;
(g) Any organic peroxide which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows no effect when heated under confinement nor any explosive power, provided that it is thermally stable (self-accelerating decomposition temperature is 60 °C (140 °F) or higher for a 50 kg (110 lb) package), and, for liquid mixtures, a diluent having a boiling point of not less than 150 °C (302 °F) is used for desensitization, shall be defined as organic peroxide TYPE G. If the organic peroxide is not thermally stable or a diluent having a boiling point less than 150 °C (302 °F) is used for desensitization, it shall be defined as organic peroxide TYPE F.
B.15.3.1 For purposes of classification, the properties of organic peroxides shall be determined in accordance with test series A to H as described in Part II of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6).
B.15.3.2 Self-accelerating decomposition temperature (SADT) shall be determined in accordance with the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), Part II, section 28.
B.15.3.3 Mixtures of organic peroxides may be classified as the same type of organic peroxide as that of the most dangerous ingredient. However, as two stable ingredients can form a thermally less stable mixture, the SADT of the mixture shall be determined.
A
A chemical which is corrosive to metals shall be classified in a single category for this class, using the test in Part III, sub-section 37.4 of the UN ST/SG/AC.10 (incorporated by reference; See § 1910.6), in accordance with Table B.16.1:
The specimen to be used for the test shall be made of the following materials:
(a) For the purposes of testing steel, steel types S235JR+CR (1.0037 resp.St 37-2), S275J2G3+CR (1.0144 resp.St 44-3), ISO 3574, Unified Numbering System (UNS) G 10200, or SAE 1020;
(b) For the purposes of testing aluminium: Non-clad types 7075-T6 or AZ5GU-T6.
C.1 The label for each hazardous chemical shall include the product identifier used on the safety data sheet.
C.1.1 The labels on shipped containers shall also include the name, address, and telephone number of the chemical manufacturer, importer, or responsible party.
C.2 The label for each hazardous chemical that is classified shall include the signal word, hazard statement(s), pictogram(s), and precautionary statement(s) specified in C.4 for each hazard class and associated hazard category, except as provided for in C.2.1 through C.2.4.
C.2.1.1 If the signal word “Danger” is included, the signal word “Warning” shall not appear;
C.2.1.2 If the skull and crossbones pictogram is included, the exclamation mark pictogram shall not appear where it is used for acute toxicity;
C.2.1.3 If the corrosive pictogram is included, the exclamation mark pictogram shall not appear where it is used for skin or eye irritation;
C.2.1.4 If the health hazard pictogram is included for respiratory sensitization, the exclamation mark pictogram shall not appear where it is used for skin sensitization or for skin or eye irritation.
C.2.2.1 The text of all applicable hazard statements shall appear on the label, except as otherwise specified. The information in italics shall be included as part of the hazard statement as provided. For example: “causes damage to organs
C.2.2.2 If the chemical manufacturer, importer, or responsible party can demonstrate that all or part of the hazard statement is inappropriate to a specific substance or mixture, the corresponding statement may be omitted from the label.
C.2.3.1 Pictograms shall be in the shape of a square set at a point and shall include a black hazard symbol on a white background with a red frame sufficiently wide to be clearly visible. A square red frame set at a point without a hazard symbol is not a pictogram and is not permitted on the label.
C.2.4.1 There are four types of precautionary statements presented, “prevention,” “response,” “storage,” and “disposal.” The core part of the precautionary statement is presented in bold print. This is the text, except as otherwise specified, that shall appear on the label. Where additional information is required, it is indicated in plain text.
C.2.4.2 When a backslash or diagonal mark (/) appears in the precautionary statement text, it indicates that a choice has to be made between the separated phrases. In such cases, the chemical manufacturer, importer, or responsible party can choose the most appropriate phrase(s). For example, “Wear protective gloves/protective clothing/eye protection/face protection” could read “wear eye protection”.
C.2.4.3 When three full stops (* * *) appear in the precautionary statement text, they indicate that all applicable conditions are not listed. For example, in “Use explosion-proof electrical/ventilating/lighting/* * */equipment”, the use of “* * *” indicates that other equipment may need to be specified. In such cases, the chemical manufacturer, importer, or responsible party can choose the other conditions to be specified.
C.2.4.4 When text
C.2.4.5 Where square brackets ([ ]) appear around text in a precautionary statement, this indicates that the text in square brackets is not appropriate in every case and should be used only in certain circumstances. In these cases, conditions for use explaining when the text should be used are provided. For example, one precautionary statement states: “[In case of inadequate ventilation] wear respiratory protection.” This statement is given with the condition for use “- text in square brackets may be used if additional information is provided with the chemical at the point of use that explains what type of ventilation would be adequate for safe use”. This means that, if additional information is provided with the chemical explaining what type of ventilation would be adequate for safe use, the text in square brackets should be used and the statement would read: “In case of inadequate ventilation wear respiratory protection.” However, if the chemical is supplied without such ventilation information, the text in square brackets should not be used, and the precautionary statement should read: “Wear respiratory protection.”
C.2.4.6 Precautionary statements may be combined or consolidated to save label space and improve readability. For example, “Keep away from heat, sparks and open flame,” “Store in a well-ventilated place” and “Keep cool” can be combined to read “Keep away from heat, sparks and open flame and store in a cool, well-ventilated place.”
C.2.4.7 In most cases, the precautionary statements are independent (e.g., the phrases for explosive hazards do not modify those related to certain health hazards, and products that are classified for both hazard classes shall bear appropriate precautionary statements for both). Where a chemical is classified for a number of hazards, and the precautionary statements are similar, the most stringent shall be included on the label (this will be applicable mainly to preventive measures). An order of precedence may be imposed by the chemical manufacturer, importer or responsible party in situations where phrases concern “Response.” Rapid action may be crucial. For example, if a chemical is carcinogenic and acutely toxic, rapid action may be crucial, and first aid measures for acute toxicity will take precedence over those for long-term effects. In addition, medical attention to delayed health effects may be required in cases of incidental exposure, even if not associated with immediate symptoms of intoxication.
C.2.4.8 If the chemical manufacturer, importer, or responsible party can demonstrate that a precautionary statement is inappropriate to a specific substance or mixture, the precautionary statement may be omitted from the label.
C.3.1 To ensure that non-standardized information does not lead to unnecessarily wide variation or undermine the required information, supplementary information on the label is limited to when it provides further detail and does not contradict or cast doubt on the validity of the standardized hazard information.
C.3.2 Where the chemical manufacturer, importer, or distributor chooses to add supplementary information on the label, the placement of supplemental information shall not impede identification of information required by this section.
C.3.3 Where an ingredient with unknown acute toxicity is used in a mixture at a concentration ≥1%, and the mixture is not classified based on testing of the mixture as a whole, a statement that X% of the mixture consists of ingredient(s) of unknown acute toxicity is required on the label.
A safety data sheet (SDS) shall include the information specified in Table D.1 under the section number and heading indicated for sections 1-11 and 16. If no relevant information is found for any given subheading within a section, the SDS shall clearly indicate that no applicable information is available. Sections 12-15 may be included in the SDS, but are not mandatory.
The mandatory criteria for classification of a chemical for carcinogenicity under HCS (§ 1910.1200) are found in Appendix A.6 to this section. This non-mandatory Appendix provides additional guidance on hazard classification for carcinogenicity. Part A of Appendix F includes background guidance provided by GHS based on the Preamble of the International Agency for Research on Cancer (IARC) “Monographs on the Evaluation of Carcinogenic Risks to Humans” (2006). Part B provides IARC classification information. Part C provides background guidance from the National Toxicology Program (NTP) “Report on Carcinogens” (RoC), and Part D is a table that compares GHS carcinogen hazard categories to carcinogen classifications under IARC and NTP, allowing classifiers to be able to use information from IARC and NTP RoC carcinogen classifications to complete their classifications under the GHS, and thus the HCS.
As noted in Footnote 6 of Appendix A.6. to this section, the GHS includes as guidance for classifiers information taken from the Preamble of the International Agency for Research on Cancer (IARC) “Monographs on the Evaluation of Carcinogenic Risks to Humans” (2006), providing guidance on the evaluation of the strength and evidence of carcinogenic risks to humans. This guidance also discusses some additional considerations in classification and an approach to analysis, rather than hard-and-fast rules. Part A is consistent with Appendix A.6, and should help in evaluating information to determine carcinogenicity.
The evidence relevant to carcinogenicity from studies in humans is classified into one of the following categories:
(a) Sufficient evidence of carcinogenicity: A causal relationship has been established between exposure to the agent and human cancer. That is, a positive relationship has been observed between the exposure and cancer in studies in which chance, bias and confounding could be ruled out with reasonable confidence.
(b) Limited evidence of carcinogenicity: A positive association has been observed between exposure to the agent and cancer for which a causal interpretation is considered by the Working Group to be credible, but chance, bias or confounding could not be ruled out with reasonable confidence.
In some instances, the above categories may be used to classify the degree of evidence related to carcinogenicity in specific organs or tissues.
The evidence relevant to carcinogenicity in experimental animals is classified into one of the following categories:
(a) Sufficient evidence of carcinogenicity: A causal relationship has been established between the agent and an increased incidence of malignant neoplasms or of an appropriate combination of benign and malignant neoplasms in two or more species of animals or two or more independent studies in one species carried out at different times or in different laboratories or under different protocols. An increased incidence of tumors in both sexes of a single species in a well-conducted study, ideally conducted under Good Laboratory Practices, can also provide sufficient evidence.
Exceptionally, a single study in one species and sex might be considered to provide sufficient evidence of carcinogenicity when malignant neoplasms occur to an unusual degree with regard to incidence, site, type of tumor or age at onset, or when there are strong findings of tumors at multiple sites.
(a) Limited evidence of carcinogenicity: The data suggest a carcinogenic effect but are limited for making a definitive evaluation because, e.g. the evidence of carcinogenicity is restricted to a single experiment; there are unresolved questions regarding the adequacy of the design, conduct or interpretation of the studies; the agent increases the incidence only of benign neoplasms or lesions of uncertain neoplastic potential; or the evidence of carcinogenicity is restricted to studies that demonstrate only promoting activity in a narrow range of tissues or organs.
The weight of evidence analysis called for in GHS and the HCS (§ 1910.1200) is an integrative approach that considers important factors in determining carcinogenic potential along with the strength of evidence analysis. The IPCS “
Various documents on carcinogen assessment all note that mode of action in and of itself, or consideration of comparative metabolism, should be evaluated on a case-by-case basis and are part of an analytic evaluative approach. One must look closely at any mode of action in animal experiments, taking into consideration comparative toxicokinetics/toxicodynamics between the animal test species and humans to determine the relevance of the results to humans. This may lead to the possibility of discounting very specific effects of certain types of substances. Life stage-dependent effects on cellular differentiation may also lead to qualitative differences between animals and humans. Only if a mode of action of tumor development is conclusively determined not to be operative in humans may the carcinogenic evidence for that tumor be discounted. However, a weight of evidence evaluation for a substance calls for any other tumorigenic activity to be evaluated, as well.
Positive responses in several species add to the weight of evidence that a substance is a carcinogen. Taking into account all of the factors listed in A.6.2.5.2 and more, such chemicals with positive outcomes in two or more species would be provisionally considered to be classified in GHS Category 1B until human relevance of animal results are assessed in their entirety. It should be noted, however, that positive results for one species in at least two independent studies, or a single positive study showing unusually strong evidence of malignancy may also lead to Category 1B.
Any case of gender-specific tumors should be evaluated in light of the total tumorigenic response to the substance observed at other sites (multi-site responses or incidence above background) in determining the carcinogenic potential of the substance.
If tumors are seen only in one sex of an animal species, the mode of action should be carefully evaluated to see if the response is consistent with the postulated mode of action. Effects seen only in one sex in a test species may be less convincing than effects seen in both sexes, unless there is a clear patho-physiological difference consistent with the mode of action to explain the single sex response.
Tumors occurring only at excessive doses associated with severe toxicity generally have doubtful potential for carcinogenicity in humans. In addition, tumors occurring only at sites of contact and/or only at excessive doses need to be carefully evaluated for human relevance for carcinogenic hazard. For example, forestomach tumors, following administration by gavage of an irritating or corrosive, non-mutagenic chemical, may be of questionable relevance. However, such determinations must be evaluated carefully in justifying the carcinogenic potential for humans; any occurrence of other tumors at distant sites must also be considered.
Unusual tumor types or tumors occurring with reduced latency may add to the weight of evidence for the carcinogenic potential of a substance, even if the tumors are not statistically significant.
Toxicokinetic behavior is normally assumed to be similar in animals and humans, at least from a qualitative perspective. On the other hand, certain tumor types in animals may be associated with toxicokinetics or toxicodynamics that are unique to the animal species tested and may not be predictive of carcinogenicity in humans. Very few such examples have been agreed internationally. However, one example is the lack of human relevance of kidney tumors in male rats associated with compounds causing α2u-globulin nephropathy (IARC, Scientific Publication N° 147
IARC Carcinogen Classification Categories:
Group 1: The agent is
This category is used when there is
Group 2:
This category includes agents for which, at one extreme, the degree of evidence of carcinogenicity in humans is almost
Group 2A: The agent is
This category is used when there is
Group 2B: The agent is
This category is used for agents for which there is
The criteria for listing an agent, substance, mixture, or exposure circumstance in the Report on Carcinogens (RoC) are as follows:
Known To Be A Human Carcinogen: There is sufficient evidence of carcinogenicity from studies in humans
Reasonably Anticipated To Be A Human Carcinogen: There is limited evidence of carcinogenicity from studies in humans that indicates that a causal interpretation is credible, but that alternative explanations, such as chance, bias, or confounding factors, could not adequately be excluded,
Conclusions regarding carcinogenicity in humans or experimental animals are based on scientific judgment, with consideration given to all relevant information. Relevant information includes, but is not limited to, dose response, route of exposure, chemical structure, metabolism, pharmacokinetics, sensitive sub-populations, genetic effects, or other data relating to mechanism of action or factors that may be unique to a given substance. For example, there may be substances for which there is evidence of carcinogenicity in laboratory animals, but there are compelling data indicating that the agent acts through mechanisms that do not operate in humans and would therefore not reasonably be anticipated to cause cancer in humans.
The following table may be used to perform hazard classifications for carcinogenicity under the HCS (§ 1910.1200). It relates the approximated GHS hazard categories for carcinogenicity to the classifications provided by IARC and NTP, as described in Parts B and C of this Appendix.
The revisions read as follows:
(b) * * *
Safety data sheets are presented in “Prudent Practices” for the chemicals listed below. (Asterisks denote that comprehensive safety data sheets are provided).
Section 41, Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941); Sections. 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; 29 CFR Part 1911.
Section 1915.100 also issued under 49 U.S.C. 1801-1819 and 5 U.S.C. 553.
Sections 1915.120 and 1915.152 of 29 CFR also issued under 29 CFR part 1911.
(i) * * *
(3) The employer shall ensure that contaminated clothing is transported in sealed impermeable bags, or other closed, impermeable containers, and labeled in accordance with paragraph (k) of this section.
(k) * * *
(7)
(ii)
(iii)
(B)(
(
(iv) The provisions for labels required in paragraph (k)(7) of this section do not apply where:
(A) Asbestos fibers have been modified by a bonding agent, coating, binder, or other material, provided that the manufacturer can demonstrate that, during any reasonably foreseeable use, handling, storage, disposal, processing, or transportation, no airborne concentrations of asbestos fibers in excess of the permissible exposure limit and/or excursion limit will be released, or
(B) Asbestos is present in a product in concentrations less than 1.0 percent.
(8)
(ii) The warning signs required by this paragraph (k)(8) shall bear the following legend:
(iii) In addition, where the use of respirators and protective clothing is required in the regulated area under this section, the warning signs shall include the following:
(iv) The employer shall ensure that employees working in and contiguous to regulated areas comprehend the warning signs required to be posted by paragraph (k)(8) of this section. Means to ensure employee comprehension may include the use of foreign languages, pictographs, and graphics.
(v) When a building/vessel owner or employer identifies previously installed PACM and/or ACM, labels or signs shall be affixed or posted so that employees will be notified of what materials contain PACM and/or ACM. The employer shall attach such labels in areas where they will clearly be noticed by employees who are likely to be exposed, such as at the entrance to mechanical room/areas. Signs required by paragraph (k)(6) of this section may be posted in lieu of labels, so long as they contain information required for labeling. The employer shall ensure, to the extent feasible, that employees who come in contact with these signs or labels can comprehend them. Means to ensure employee comprehension may include the use of foreign languages, pictographs, graphics, and awareness training.
(vi) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (k)(8)(ii) of this section:
(vii) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (k)(8)(iii) of this section:
(g) * * *
(2) * * *
(iv) The employer shall ensure that bags or containers of contaminated protective clothing or equipment that are removed from change rooms for laundering, cleaning, maintenance, or disposal are labeled in accordance with the requirements of the Hazard Communication Standard, § 1910.1200.
(j) * * *
(1)
Section 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3704); Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, and 657); and Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912) as applicable; and 29 CFR part 1911.
Sections 1926.58, 1926.59, 1926.60, and 1926.65 also issued under 5 U.S.C. 553 and 29 CFR part 1911.
Section 1926.61 also issued under 49 U.S.C. 1801-1819 and 6 U.S.C. 553.
Section 1926.62 also issued under section 1031 of the Housing and Community Development Act of 1992 (42 U.S.C. 4853).
Section 1926.65 also issued under section 126 of the Superfund Amendments and Reauthorization Act of 1986, as amended (reprinted at 29 U.S.C.A. 655 Note), and 5 U.S.C. 553.
(l) * * *
(1)
(2)
(B) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (l)(2)(i)(A) of this section:
(ii)
(B) Prior to June 1, 2015, employers may include the following information workplace labels in lieu of the labeling requirements in paragraph (l)(2)(ii)(A) of this section:
(
(
(g) * * *
(2) * * *
(vii)(A) The employer shall ensure that the containers of contaminated protective clothing and equipment required by paragraph (g)(2)(v) of this section are labeled as follows:
(B) Prior to June 1, 2015, employers may include the following information on bags or containers of contaminated protective clothing and equipment required by paragraph (g)(2)(v) in lieu of the labeling requirements in paragraph (g)(2)(vii)(A) of this section:
(l)
(1) * * *
(i)
(A) Reproductive/developmental toxicity;
(B) Central nervous system effects;
(C) Kidney effects;
(D) Blood effects; and
(E) Acute toxicity effects.
(m)
(1)
(i) The employer shall post the following warning signs in each work area where an employee's exposure to lead is above the PEL.
(ii) The employer shall ensure that no statement appears on or near any sign required by this paragraph (m) that contradicts or detracts from the meaning of the required sign.
(iii) The employer shall ensure that signs required by this paragraph (m) are illuminated and cleaned as necessary so that the legend is readily visible.
(iv) The employer may use signs required by other statutes, regulations or ordinances in addition to, or in combination with, signs required by this paragraph (m).
(v) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (m)(1)(i) of this section:
The standard requires that the following warning sign be posted in work areas when the exposure to lead is above the PEL:
Prior to June 1, 2016, employers may use the following legend in lieu of that specified above:
(a) * * *
(1) * * *
(ii) A process which involves a Category 1 flammable gas (as defined in § 1910.1200(c)) or flammable liquid with a flashpoint below 100 °F (37.8 °C) on site in one location, in a quantity of 10,000 pounds (4535.9 kg) or more except for:
(B) Flammable liquids with a flashpoint below 100 °F (37.8 °C) stored in atmospheric tanks or transferred that are kept below their normal boiling point without benefit of chilling or refrigeration.
(d) * * *
(1) * * *
(vii) Hazardous effects of inadvertent mixing of different materials that could foreseeably occur.
Safety data sheets meeting the requirements of § 1910.1200(g) may be used to comply with this requirement to the extent they contain the information required by this paragraph (d)(1).
(a) * * *
(3) * * *
Section 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3704); Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736),1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (62 FR 50017), 5-2002 (67 FR 650008), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 1-2012
The revisions read as follows:
(b) * * *
(2) * * *
(iii) Cabinets shall be labeled in conspicuous lettering, “Flammable-Keep Away from Open Flames.”
(3) Not more than 60 gallons of Category 1, 2 and/or 3 flammable liquids or 120 gallons of Category 4 flammable liquids shall be stored in any one storage cabinet. Not more than three such cabinets may be located in a single storage area. Quantities in excess of this shall be stored in an inside storage room.
(h)
(i) * * *
(2) * * *
(iv) * * *
(F) Tanks and pressure vessels storing Category 1 flammable liquids shall be equipped with venting devices that shall be normally closed except when venting to pressure or vacuum conditions. Tanks and pressure vessels storing Category 2 flammable liquids, or Category 3 flammable liquids with a flashpoint below 100 °F (37.8 °C), shall be equipped with venting devices that shall be normally closed except when venting under pressure or vacuum conditions, or with approved flame arresters.
(G) Flame arresters or venting devices required in paragraph (i)(2)(iv)(F) of this section may be omitted for Category 2 flammable liquids or Category 3 flammable liquids with a flashpoint below 100 °F (37.8 °C) where conditions are such that their use may, in case of obstruction, result in tank damage.
(vi) * * *
(B) Where vent pipe outlets for tanks storing Category 1 or 2 flammable liquids, or Category 3 flammable liquids with a flashpoint below 100 °F (37.8 °C), are adjacent to buildings or public ways, they shall be located so that the vapors are released at a safe point outside of buildings and not less than 12 feet (3.658 m) above the adjacent ground level. In order to aid their dispersion, vapors shall be discharged upward or horizontally away from closely adjacent walls. Vent outlets shall be located so that flammable vapors will not be trapped by eaves or other obstructions and shall be at least 5 feet (1.52 m) from building openings.
(viii) * * *
(E) For Category 2 flammable liquids or Category 3 flammable liquids with a flashpoint below 100 °F (37.8 °C), other than crude oils, gasolines, and asphalts, the fill pipe shall be so designed and installed as to minimize the possibility of generating static electricity. A fill pipe entering the top of a tank shall terminate within 6 inches (15.24 cm) of the bottom of the tank and shall be installed to avoid excessive vibration.
(3) * * *
(i)
(iv) * * *
(A) Location and arrangement of vents for Category 1 or 2 flammable liquids, or Category 3 flammable liquids with a flashpoint below 100 °F (37.8 °C). Vent pipes from tanks storing Category 1 or 2 flammable liquids, or Category 3 flammable liquids with a flashpoint below 100 °F (37.8 °C), shall be so located that the discharge point is outside of buildings, higher than the fill pipe opening, and not less than 12 feet (3.658 m) above the adjacent ground level. Vent pipes shall discharge only upward in order to disperse vapors. Vent pipes 2 inches (5.08 cm) or less in nominal inside diameter shall not be obstructed by devices that will cause excessive back pressure. Vent pipe outlets shall be so located that flammable vapors will not enter building openings, or be trapped under eaves or other obstructions. If the vent pipe is less than 10 feet (3.04 m) in length, or greater than 2 inches (5.08 cm) in nominal inside diameter, the outlet shall be provided with a vacuum and pressure relief device or there shall be an approved flame arrester located in the vent line at the outlet or within the approved distance from the outlet.
(C) Location and arrangement of vents for Category 3 flammable liquids with a flashpoint at or above 100 °F (37.8 °C) or Category 4 flammable liquids. Vent pipes from tanks storing Category 3 flammable liquids with a flashpoint at or above 100 °F (37.8 °C) or Category 4
(v) * * *
(D) For Category 2 flammable liquids, or Category 3 flammable liquids with a flashpoint below 100 °F (37.8 °C), other than crude oils, gasolines, and asphalts, the fill pipe shall be so designed and installed as to minimize the possibility of generating static electricity by terminating within 6 inches (15.24 cm) of the bottom of the tank.
(4) * * *
(iv) * * *
(E) For Category 2 flammable liquids, or Category 3 flammable liquids with a flashpoint below 100 °F (37.8 °C), other than crude oils, gasolines, and asphalts, the fill pipe shall be so designed and installed as to minimize the possibility of generating static electricity by terminating within 6 inches (15.24 cm) of the bottom of the tank.
(k) * * *
(3) * * *
(iv) Piping handling Category 1 or 2 flammable liquids, or Category 3 flammable liquids with a flashpoint below 100 °F (37.8 °C), shall be grounded to control stray currents.
The revisions read as follows:
(h)
(1) Category 1 shall include liquids having flashpoints below 73.4 °F (23 °C) and having a boiling point at or below 95 °F (35 °C).
(2) Category 2 shall include liquids having flashpoints below 73.4 °F (23 °C) and having a boiling point above 95 °F (35 °C).
(3) Category 3 shall include liquids having flashpoints at or above 73.4 °F (23 °C) and at or below 140 °F (60 °C).
(4) Category 4 shall include liquids having flashpoints above 140 °F (60 °C) and at or below 199.4 °F (93 °C).
(i) * * *
(1) The flashpoint of liquids having a viscosity less than 45 Saybolt Universal Second(s) at 100 °F (37.8 °C) and a flashpoint below 175 °F (79.4 °C) shall be determined in accordance with the Standard Method of Test for Flash Point by the Tag Closed Tester, ASTM D-56-69 (incorporated by reference;
(2) The flashpoints of liquids having a viscosity of 45 Saybolt Universal Second(s) or more at 175 °F (79.4 °C) or higher shall be determined in accordance with the Standard Method of Test for Flash Point by the Pensky Martens Closed Tester, ASTM D-93-69 (incorporated by reference;
Section107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3704); Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); and Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912) as applicable; and 29 CFR part 1911.
Section 1926.1102 not issued under 29 U.S.C. 655 or 29 CFR part 1911; also issued under 5 U.S.C. 553.
The revisions read as follows:
(k) * * *
(1)
(ii) The employer shall include asbestos in the program established to comply with the Hazard Communication Standard (HCS) (§ 1910.1200). The employer shall ensure that each employee has access to labels on containers of asbestos and safety data sheets, and is trained in accordance with the provisions of HCS and paragraphs (k)(9) and (10) of this section. The employer shall provide information on at least the following hazards: Cancer and lung effects.
(7) * * *
(ii) * * *
(A) The warning signs required by paragraph (k)(7) of this section shall bear the following information.
(B) In addition, where the use of respirators and protective clothing is required in the regulated area under this section, the warning signs shall include the following:
(C) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (k)(7)(ii)(A) of this section:
(D) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (k)(7)(ii)(B) of this section:
(8) * * *
(ii) The employer shall ensure that such labels comply with paragraphs (k) of this section.
(iii) The employer shall ensure that labels of bags or containers of protective clothing and equipment, scrap, waste, and debris containing asbestos fibers bear the following information:
(iv) (A) Prior to June 1, 2015, employers may include the following information on raw materials, mixtures or labels of bags or containers of protective clothing and equipment, scrap, waste, and debris containing asbestos fibers in lieu of the labeling requirements in paragraphs (k)(8)(ii) and (k)(8)(iii) of this section:
(B) Labels shall also contain a warning statement against breathing asbestos fibers.
(g) * * *
(2) * * *
(iv) The employer shall ensure that bags or containers of contaminated protective clothing or equipment that are removed from change rooms for laundering, cleaning, maintenance, or disposal shall be labeled in accordance with the requirements of the Hazard Communication Standard, § 1910.1200.
(j) * * *
(1)
(i) * * *
(2) * * *
(iv) The employer shall ensure that containers of contaminated protective clothing and equipment that are to be taken out of the change rooms or the workplace for laundering, cleaning, maintenance or disposal shall bear labels in accordance with paragraph (m)(3)(ii) of this section.
(k) * * *
(7) Waste, scrap, debris, bags, and containers, personal protective equipment and clothing contaminated with cadmium and consigned for disposal shall be collected and disposed of in sealed impermeable bags or other closed, impermeable containers. These bags and containers shall be labeled in accordance with paragraph (m)(3)(ii) of this section.
(m) * * *
(1)
(2)
(ii) Warning signs required by paragraph (m)(2)(i) of this section shall bear the following legend:
(iii) The employer shall ensure that signs required by this paragraph (m)(2) are illuminated, cleaned, and maintained as necessary so that the legend is readily visible.
(iv) Prior to June 1, 2016, employers may use the following legend in lieu of
(3)
(ii) The warning labels for containers of cadmium-contaminated protective clothing, equipment, waste, scrap, or debris shall include at least the following information:
(iii) Where feasible, installed cadmium products shall have a visible label or other indication that cadmium is present.
(iv) Prior to June 1, 2015, employers may include the following information on shipping and storage containers containing cadmium, cadmium compounds, or cadmium-contaminated clothing, equipment, waste, scrap, or debris in lieu of the labeling requirements specified in paragraphs (m)(3)(i) and (m)(3)(ii) of this section:
Environmental Protection Agency (EPA).
Proposed rule.
The EPA is proposing National Uniform Emission Standards for Storage Vessels and Transfer Operations, Equipment Leaks and Control Devices, herein referred to as Uniform Standards. The EPA is also proposing supplemental revisions to the National Uniform Emission Standards General Provisions, which were proposed with the National Uniform Emission Standards for Heat Exchange Systems, signed by the EPA Administrator on November 30, 2011.
The proposed Uniform Standards would be referenced, as appropriate, in future revisions to new source performance standards and national emission standards for hazardous air pollutants for individual source categories that are part of the chemical manufacturing and refining industries that have storage vessels and transfer operations, equipment leaks or control devices used to control process vents from reactors, distillation and other operations, as well as from emissions from storage vessels, transfer operations and equipment leaks that are routed to control devices. Establishing these Uniform Standards is consistent with the objectives of Executive Order 13563,
• Uniform Standards for Storage Vessels and Transfer Operations should be marked, “Attention Docket ID No. EPA-HQ-OAR-2010-0871.”
• Uniform Standards for Equipment Leaks should be marked, “Attention Docket ID No. EPA-HQ-OAR-2010-0869.”
• Uniform Standards for Control Devices should be marked, “Attention Docket ID No. EPA-HQ-OAR-2010-0868.”
• Uniform Standards General Provisions or General Comments on the Uniform Standards should be marked, “Attention Docket ID No. EPA-HQ-OAR-2010-0870.”
Submit your comments, identified by the appropriate Docket ID No., by one of the following methods:
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For information regarding the proposed General Provisions to the National Uniform Emission Standards, contact Brenda Shine, (919) 541-3608, Sector Policies and Programs Division (E143-01), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; Telephone number: (919) 541-3608; Fax number (919) 541-0246; email address:
For information regarding the proposed National Uniform Emission Standards for Equipment Leaks, contact Jodi Howard, Sector Policies and Programs Division (E143-01), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; Telephone number: (919) 541-4607; Fax number (919) 541-0246; email address:
For information regarding the proposed National Uniform Emission Standards for Storage Vessel and Transfer Operations, contact Nick Parsons, Sector Policies and Programs Division (E143-01), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; Telephone number: (919) 541-5372; Fax number (919) 541-0246; email address:
For information regarding the proposed National Uniform Emission Standards For Control Devices, contact Andrew Bouchard, Sector Policies and Programs Division (E143-01), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; Telephone number: (919) 541-4036; Fax number (919) 541-0246; email address:
We expect, in future rulemaking actions, to propose that new source performance standards (NSPS) and national emission standards for hazardous air pollutants (NESHAP) for other source categories will also reference and require compliance with Uniform Standards, as appropriate, provided that the referencing subpart rulemakings demonstrate that the Uniform Standards meet the statutory stringency requirements that would apply to the referencing subpart source category, such as Clean Air Act (CAA) section 112(d), maximum achievable control technology (MACT), section 112(f), residual risk ample margin of safety (AMOS) and section 111(b), best systems of emission reduction (BSER). Examples of categories and entities potentially affected by the proposed Uniform Standards for Storage Vessels and Transfer Operations, Equipment Leaks and Control Devices include the following:
This table is not intended to be exhaustive; rather, it provides a guide for readers regarding entities the EPA anticipates are likely to be potentially affected by this action through future, separate rulemaking actions.
The table includes source categories currently subject to NESHAP under subparts in 40 CFR part 61 and 40 CFR part 63 and NSPS under subparts in 40 CFR part 60. The entities listed in the above table are not affected by this action unless and until the EPA proposes in a separate notice to apply a Uniform Standard to their source categories. As proposed in 40 CFR part 65, subparts H, I, J and M would apply to owners or operators expressly referenced to part 65 from future rulemakings that may result in new subparts or revisions to current subparts of 40 CFR parts 60, 61 or 63. The list of categories and entities potentially affected by this proposed action in the future is provided solely to inform owners and operators of facilities in those categories of the potential for future rulemaking and to solicit comments from these entities at this time. If, in future rulemakings, the EPA were to propose to apply these Uniform Standards to a particular source category, there would be another opportunity to comment on the application to a specific industry. Because the EPA believes that establishing Uniform Standards for types of emission points found in a variety of industries will be efficient for facilities, state, local and tribal governments and the public, we seek broad input at this time. In the future, you would determine whether your facility, company, business or organization would be regulated by a proposed action by examining the applicability criteria in the referencing subpart. If you have any questions regarding the applicability of this action to a particular entity, consult either the air permitting authority for the entity or your EPA regional representative, as listed in the referencing subpart.
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The docket numbers for the proposed action regarding the Uniform Standards are as follows:
• Uniform Standards for Storage Vessels and Transfer Operations (40 CFR part 65, subpart I) is Docket ID No. EPA-HQ-OAR-2010-0871.
• Uniform Standards for Equipment Leaks (40 CFR part 65, subpart J) is Docket ID No. EPA-HQ-OAR-2010-0869.
• Uniform Standards for Control Devices (40 CFR part 65, subpart M) is Docket ID No. EPA-HQ-OAR-2010-0868.
• Uniform Standards General Provisions or general comments on the Uniform Standards (40 CFR part 65,
To ensure proper receipt by the EPA, be sure to identify the docket ID number(s) assigned to this action in the subject line on the first page of your response.
In addition to being available in the docket, an electronic copy of this proposed action will also be available on the World Wide Web (WWW) through the Technology Transfer Network (TTN). Following signature, a copy of the proposed action will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules at the following address:
If a public hearing is held, it will be held at 10 a.m. at the EPA's Environmental Research Center Auditorium, Research Triangle Park, NC, or an alternate site nearby. Contact Ms. Janet Eck at (919) 541-7946 to request a hearing, to request to speak at a public hearing, to determine if a hearing will be held or to determine the hearing location. If no one contacts the EPA requesting to speak at a public hearing concerning this proposed rule by April 10, 2012, a hearing will not be held.
Consistent with the authority under CAA section 301(a)(1) and CAA sections 111 and 112, we are proposing to establish the Uniform Standards as a set of foundational requirements that may be considered and adopted by future rulemakings under CAA sections 111 and 112. Section 301(a)(1) of the CAA authorizes the Administrator “to prescribe such regulations as are necessary to carry out his functions under [the CAA].” The proposed Uniform Standards, if finalized, would provide a set of common control requirement subparts describing testing, monitoring, recordkeeping and reporting requirements that would, if appropriate, be referenced in future CAA 111 and 112 rulemakings. Future rulemakings would include CAA section 112(d) standards, based on MACT determinations and generally available control technology or management practice (GACT) determinations (for area sources), as well as CAA section 112(d)(6) reviews of existing standards and CAA section 112(f) revisions, which take into account the risk to public health remaining after application of the MACT-based standards. The proposed Uniform Standards could also be referenced during CAA section 111(b) rulemakings to establish NSPS for source categories, and as we periodically review and revise these standards, to reflect improvements in methods for reducing emissions. CAA section 111(b) standards require a level of control that historically has been referred to as “Best Demonstrated Technology.” In order to better reflect that CAA section 111 was amended in 1990 to clarify that “best systems” may or may not be “technology,” the EPA is now using the term “best system of emission reduction” or BSER.
As foundational requirements, the Uniform Standards would become applicable to a particular source category only if a subsequent rulemaking for that source category references the Uniform Standards. We have previously promulgated similar standards, such as the 40 CFR parts 60, 61 and 63 General Provisions (59 FR 12430, March 16, 1994) and the Consolidated Federal Air Rules (CAR) (65 FR 78267, December 14, 2000), which only become applicable to a source category when referenced by another rulemaking. In this preamble, we refer to subparts that would reference the Uniform Standards as “referencing subparts.” The authority for the referencing standards would be provided under the referencing subpart. The rationale for each determination that the Uniform Standards in proposed 40 CFR part 65, subparts H, I, J or M are equivalent to MACT, GACT, AMOS or BSER and comply with all other applicable statutory requirements would be presented in the rulemaking for the individual source category with an opportunity for public comment at that time.
The proposed Uniform Standards are also responsive to Executive Order 13563,
The proposed Uniform Standards for Storage Tanks and Transfer Operations, Equipment Leaks and Control Devices would be codified under 40 CFR part 65 as subparts I, J and M. The General Provisions for the Uniform Standards and Uniform Standards for Heat Exchange Systems were previously proposed in a separate notice signed by the EPA Administrator on November 30, 2011 (77 FR 960, January 6, 2012) and would be codified under 40 CFR part 65 as subparts H and L, respectively. We are proposing supplemental requirements for the General Provisions (subpart H) to include new provisions applicable to all Uniform Standards, as well as new provisions applicable to individual Uniform Standards in subparts I, J and M. As discussed in section VI.A of this preamble, we are maintaining the previously proposed five sections of subpart H and adding eleven new sections. Of the five previously proposed sections, we are proposing to make substantive changes to three sections. The EPA will consider all comments pertaining to the Uniform Standards General Provisions (subpart H) that were submitted in response to the previous proposal (77 FR 960, January 6, 2012), and will address those comments as we address the comments on the supplemental provisions proposed in this action.
In a number of cases, the EPA has established CAA standards for different source categories that regulate the same kinds of emission points. Standards for a given type of emission point may require application of controls with similar control efficiencies and include similar design, component or operating standards, even though these emission points may be located at different types of sources or facilities. To avoid duplicative or disjointed requirements, and to promote consistency among technical requirements for similar emission points in different source categories, the EPA has established several common control requirement subparts describing testing, monitoring, recordkeeping and reporting requirements for certain emission points
Consolidation of compliance requirements under these subparts allows for ease of reference, administrative convenience and consistency in the technical requirements of the air emission control requirements applied to similar emission points under different source category regulations. The 40 CFR part 63, subparts SS, TT, UU and WW are emission point- and emissions control-specific. They specify monitoring, recordkeeping and reporting requirements, but generally do not specify emissions reduction performance requirements or applicability thresholds. Instead, the referencing subpart specifies the emissions reduction performance requirements and applicability thresholds.
By establishing these emission point- and emissions control-specific subparts, other source category-specific regulations were able to reference a common set of design, operating, testing, inspection, monitoring, repair, recordkeeping and reporting requirements for air emissions controls. This reduced the potential for duplicative or conflicting technical requirements, and promoted consistency of the air emission requirements applied to similar emission points, while allowing specific emission standards to be set within the context of the source category-specific regulations. Additionally, creating emission point-specific and emissions control-specific subparts ensured that all regulations that cross-referenced these subparts could be amended in a consistent and timely manner, through one regulatory action.
We intend to establish, through the proposed Uniform Standards, a workable process for consolidation and a more efficient approach to rulemaking. The Uniform Standards have, in general, been modeled after the emission-point and emissions control-specific subparts of the Generic MACT. We are proposing the Uniform Standards in lieu of revising the Generic MACT because it is our intention to provide a set of common compliance monitoring, recordkeeping and reporting requirements that could be applied to emission points referenced from CAA 111 and 112 (NSPS and NESHAP, respectively) rulemakings. The Uniform Standards are designed to apply to chemical and refining facilities regulated under the authority of sections 111 and 112 of the CAA and who may currently be subject to regulation under 40 CFR parts 60, 61 and 63. The Generic MACT is currently referenced by NESHAP under the provisions of 40 CFR part 63 and section 112 of the CAA; revising the current Generic MACT to be referenced by sources regulated under NSPS could create confusion regarding regulatory authority. In addition, the Generic MACT currently affects a large number of source categories and referencing subparts; therefore, a large revision of the Generic MACT could potentially be more confusing for regulated sources. Thus, we are proposing to establish the Uniform Standards under 40 CFR part 65 and anticipate, through future notice-and-comment rulemaking, to cross-reference subparts I, J and M from source category emission standards within at least two different parts of title 40 of the CFR—parts 60 and 63, which establish NSPS and NESHAP standards, respectively. The process of revising individual referencing subparts to reference the Uniform Standards or develop new subparts that reference the Uniform Standards is a clear-cut process that allows for review of the needs of specific source categories.
This action may affect other source categories with similar emission points if the EPA takes action in the future to propose to apply the Uniform Standards to one or more other source categories for storage vessels and transfer operations, equipment leaks or process vents. However, the EPA will determine applicability of these proposed Uniform Standards for another source category through notice-and-comment rulemaking. In such a rulemaking, we will explain that all or a portion of 40 CFR part 65, subparts H, I, J or M are consistent with the CAA requirements at issue for the specific authority in the rulemaking. For example, in the context of an NSPS rulemaking, we could determine that subpart J is BSER for the source category at issue or, alternatively, we could determine that different emission standards should apply, but that recordkeeping, reporting and other requirements of subpart J are appropriate.
We expect to see similar benefits for these Uniform Standards as we have seen for previous emission point- and emissions control-specific subparts, as described above, including the ability to reference a common set of standards for the same type of emission point located at sources within different source categories. This approach will maximize consistency between source categories for each type of emission point.
As with the common control requirement subparts previously promulgated, the proposed Uniform Standards would include technical requirements and would not, in most cases, specify source category-specific applicability thresholds or emissions reduction performance requirements, because these requirements are more properly established in source category-specific rules.
However, we are proposing applicability thresholds, compliance requirements and monitoring frequencies that would apply if the referencing subpart does not specify these parameters. In the rulemaking actions that revise or propose standards to cross-reference 40 CFR part 65, subparts I, J and M, we would address whether the referencing subpart should cross-reference subparts I, J and M in their entirety or cross-reference only a subset of subparts I, J and M. Moreover, we would determine whether the referencing (source category-specific) subpart should include more or less stringent requirements than subparts I, J and M.
As we revise or promulgate source category-specific standards that have emission points addressed by a uniform standard for storage vessels, transfer operations, equipment leaks and/or control devices, we would propose whether and to what extent we would reference the Uniform Standards in the proposed 40 CFR part 65, subparts I, J and M. In making that decision, we would consider the applicable CAA requirements, analyses of the individual source category and the similarity of emission characteristics and applicable controls. We would consider factors such as: (1) The volume and concentration of emissions; (2) the type of emissions; (3) the similarity of emission points; (4) the cost and
In future rulemakings, the referencing subpart would establish the source category-specific requirements, including the regulated materials, appropriate applicability thresholds or tiers, emissions limit requirements (including the format and units of measure) and other source category-specific requirements. Additionally, the referencing subpart would provide rationale for the use of surrogates, if the use of surrogates is appropriate for the source category; for example, the referencing subpart could establish limits on particulate matter (PM) to achieve control of non-volatile metallic hazardous air pollutants (HAP), yet refer to the Uniform Standards for monitoring, recordkeeping and reporting requirements. For any provisions of the Uniform Standards not cross-referenced by a source category-specific subpart, the requirement would be expressly addressed in the source category-specific (referencing) subpart. A portion of 40 CFR part 65, subparts I, J and/or M could be cross-referenced and exceptions could be made within the referencing subpart, as necessary, to ensure that the proposed requirements are appropriate to the source category in light of the applicable CAA requirements. For example, the referencing subpart could specify a monitoring frequency other than that contained in the Uniform Standards if we determine that a different monitoring frequency is appropriate for the regulated emission point in that source category. A referencing subpart with applicability thresholds, for instance, may only direct to a portion of the Uniform Standards or not direct to the Uniform Standards at all for certain thresholds. Because the proposed Uniform Standards could be referenced in this manner, we believe that the requirements in subparts I, J and M would not inhibit the flexibility to address source category-specific needs.
The rationale for each determination that the provisions of 40 CFR part 65, subparts H, I, J or M should be cross-referenced for an individual referencing subpart in light of the applicable CAA requirements, would be addressed in the rulemaking for the individual subpart at the time of proposal, and we would provide an opportunity for public comment at that time. A description of the analyses performed as part of that review would be presented in the rulemaking for the individual subpart and an opportunity for comment would be provided. We would also assess the costs, emission reduction, economic and other impacts as they relate to the specific source category at issue at that time.
In light of these considerations, we have determined that the proposed Uniform Standards would promote the EPA's ability to simplify, clarify and improve implementation of the rules with which source owners or operators must comply, consistent with the objectives of Executive Order 13563,
This action proposes the Uniform Standards for Storage Vessels and Transfer Operations (40 CFR part 65, subpart I), Equipment Leaks (40 CFR part 65, subpart J) and Control Devices (40 CFR part 65, subpart M), and revisions to the General Provisions for the Uniform Standards (40 CFR part 65, subpart H).
This action is based on the EPA's review of the current requirements for equipment leaks, storage tanks and transfer operations and control devices used to control process vents in light of over 20 years of regulatory implementation experience. The benefits of the proposed Uniform Standards include:
• Providing one-stop requirements for equipment leaks, storage tanks and control devices for the chemical manufacturing and refining industries;
• Providing strengthened control and monitoring requirements based on cost-effective advances in technology that could be considered for adoption in future rulemakings;
• Enhancing compliance and enforcement to ensure that the standards achieve the intended emissions reductions required for MACT, GACT or BSER; and
• Reduction of unnecessary and unproductive regulatory burden.
These benefits also support the objectives of Executive Order 13563,
The proposed Uniform Standards provide the benefit of one-stop compliance, monitoring, recordkeeping and reporting requirements for specific emission points that would be referenced in future rulemakings for the chemical manufacturing and refining industries. The EPA desires to facilitate implementation and compliance by making requirements easier to understand, incorporating streamlined compliance approaches and applying these approaches across industry sectors. Currently, the chemical manufacturing and refining industries may be subject to multiple NSPS and NESHAP, including the Generic MACT (40 CFR part 63, subparts SS, TT, UU, and WW); the Miscellaneous Organic Chemical Manufacturing NESHAP (68 FR 63851, November 10, 2003) (MON); the Hazardous Organic NESHAP (59 FR 19402, April 22, 1994) (HON), the Organic Liquids Distribution (OLD) NESHAP (69 FR 5038, February 3, 2004); the Petroleum Refineries NESHAP (60 FR 43260, August 18, 1995); the Synthetic Organic Chemical Manufacturing Industry (SOCMI) rules (Standards of Performance for Volatile Organic Liquid Storage Vessels (52 FR 11429, April 8, 1987); Standards of Performance for Equipment Leaks of VOC in the Synthetic Organic Chemicals Manufacturing Industry (48 FR 48335, October 18, 1983); and SOCMI Reactor Processes (58 FR 45962, August 31, 1993)). Several of these rules cover similar emission points, such as storage tanks, transfer operations, equipment leaks or process vents that route to a control device. As a result, facilities subject to two or more of these rules may have overlapping or confusing compliance requirements for the same emission point. Additionally, facilities may have burdensome recordkeeping and reporting requirements for multiple subparts to which they are subject. The proposed Uniform Standards revise and streamline the compliance approach for future rulemakings by applying a set of control and compliance methods that may be referenced from multiple subparts. In particular, the proposed Uniform Standards are structured so that facilities regulated under NSPS and NESHAP could reference the same cost-effective monitoring, recordkeeping and reporting requirements for storage tanks,
The proposed 40 CFR part 65, subparts I, J and M also provide the groundwork for future rulemakings as a set of strengthened control and monitoring requirements that may be considered for use in future referencing subparts to meet MACT, GACT, AMOS or BSER. The proposed standards are based on a consolidation of existing requirements, but have been augmented where appropriate based on our survey of available technology and a review of existing regulations for each emission point. For example, under the proposed Uniform Standards for Storage Vessels and Transfer Operations, we are proposing to specify situations when landing a floating roof is allowable and the amount of time that a storage vessel with a landed floating roof may be left standing idle. These changes reduce the amount of time during which volatile regulated materials are exposed to the atmosphere and may be released. To improve detection of leaks on fixed roof storage tanks and thereby minimize emissions, we are also proposing to require monitoring for leaks from closure devices, pressure/vacuum vents and other potential leak interfaces on fixed roof storage vessels using Method 21 of 40 CFR part 60, appendix A-7, or optical gas imaging instead of visual inspections for defects. We are also proposing to include different delay of repair provisions in the proposed Uniform Standards for Equipment Leaks which specify that if a valve or connector cannot be repaired within 15 days, “low leak technology” must be used to repair the equipment when it is technically feasible to do so. “Low leak technology” that is available and cost effective includes replacing the valve packing, flange gaskets or the entire valve or connector. These requirements provide additional emissions reductions and could be referenced by future rulemakings as a means to meet applicable CAA requirements. The proposed Uniform Standards for Control Devices include strengthened provisions that require owners and operators of closed vent systems to provide monitoring for each bypass for pressure relief devices (PRD), low leg drains, high point bleeds, analyzer vents and open-ended valves or lines. We are proposing that this equipment is subject to the bypass line requirements to have a flow monitor or a car seal on each bypass line that could divert a vent stream to the atmosphere, thereby minimizing emissions from these points. The proposed requirements under 40 CFR part 65, subparts I, J and M have been designed to reflect advanced practices and control methods and provide robust air emissions control. This allows us to consider these proposed standards as a basis for review in future rulemakings for source categories with similar emission points. Further discussion of these provisions and other strengthened requirements under the Uniform Standards are included in the discussions for each individual subpart in sections III, IV and V of this preamble.
The proposed Uniform Standards also provide the benefits of improved compliance and enforceability. We are proposing to facilitate implementation and compliance by clarifying current requirements that were vague or confusing. For example, current equipment leak rules require facilities to equip open-ended valves or lines with a cap, blind flange, plug or second valve to prevent emissions. We have retained that requirement in the proposed Uniform Standards for Equipment Leaks, but we have added a requirement to check that the cap, blind flange, plug or second valve is installed or closed properly using Method 21 of 40 CFR part 60, appendix A-7 at least once a year to ensure compliance with the standard. The EPA is also proposing to clarify requirements in the Uniform Standards that were confusing during implementation of previous rules, such as the monitoring requirements for small boilers and process heaters that are not part of a fuel gas system (see discussion in section V.B.3 of this preamble). As another example, the proposed Uniform Standards for Equipment Leaks include all the types of equipment for which sensory monitoring is required in one section, which makes clear that the sensory monitoring requirements for all applicable types of equipment are identical. In other current standards, these requirements are spread throughout the rule, and slight differences in wording make it difficult to tell if the requirements are supposed to be the same. These clarifications are intended to improve compliance and enforceability as the Uniform Standards are considered during CAA 111 and 112 rulemakings and incorporated into future referencing subparts. Further clarifications are discussed in the individual subparts in sections III, IV and V of this preamble.
The proposed Uniform Standards also provide benefits as they reduce unproductive burden within the chemical and refining sectors. For example, the proposed Uniform Standards for Equipment Leaks include provisions to use optical imaging to monitor for leaks (where appropriate and allowed by the referencing subpart) instead of instrument monitoring. Because the optical gas imaging device can monitor many more pieces of equipment than conducting instrument monitoring in the same period of time, these provisions are expected to reduce the cost of labor required to meet the proposed Uniform Standards for Equipment Leaks. In particular, we have focused on simplifying recordkeeping and reporting requirements throughout each proposed subpart. For example, under the proposed General Provisions, we have specified that certain reports that are required to be submitted will be done so electronically, as discussed in sections II.F and VI.B.7 of this preamble. We are also proposing a revised record retention policy that allows that records can be maintained in electronic format and accessible within 2 hours of a request for the 5-year record retention period. We have not included different retention periods for onsite and offsite records because the ability to maintain electronic records removes the need for specifying the storage location. An electronic record can be stored either onsite or offsite, but still be quickly accessible from onsite.
Furthermore, we have developed the proposed Uniform Standards in keeping with the objectives of Executive Order 13563,
In keeping with previous emission point-specific and emissions control-specific subparts, we have structured the proposed Uniform Standards for 40 CFR part 65, subparts H, I, J and M to provide a common set of monitoring, testing, recordkeeping and reporting requirements. We intend the proposed Uniform Standards to provide common standards for environmental control that may be referenced from multiple regulations and that may be useful for a broad range of source categories. It is our view that the Uniform Standards will decrease inconsistencies between rulemakings for similar types of industries and reduce burden for both industry and government regulators.
In keeping with the requirements of Executive Order 13563,
As discussed in section II.B of this preamble, we expect that applying a common set of monitoring, testing and recordkeeping and reporting requirements to multiple source categories would be feasible because several source categories within the chemical and refining industries use similar process operations and have similar emission points. Specifically, various industries require the regulation of air emissions from storage vessel and transfer operations, equipment leaks and control devices. Although these industries may have variations in their process operations and the regulated materials used, these emission sources are generally amenable to similar methods for control and demonstration of compliance.
Our review of current regulations for storage vessel and transfer operations, equipment leaks and process vents found that these emission points often have similar requirements for the demonstration of compliance. In general, the mechanisms for release of emissions to the atmosphere from these emission points or emissions controls are similar, regardless of the specific regulated materials involved. With the knowledge of these similarities, we expect that compliance methods that have been determined to be cost effective for control of a specific amount of a given regulated material at one of the proposed emission points would generally be cost effective for the same regulated material at similar emission points, regardless of the source category. Specifically, the compliance methods proposed with the Uniform Standards have been developed with the consideration that they may be applied to emission points in a broad range of source categories. Although we considered how the proposed requirements would apply to petroleum refineries and chemical plants, we have structured the Uniform Standards to provide flexible compliance methods that could be useful for multiple industries. In determining the best and most cost-effective compliance methods, monitoring, and recordkeeping and reporting requirements for the proposed standards, we examined and drew guidance from current rules from many different source categories that contain storage vessel, transfer operations, equipment leaks, process vents, and a variety of control devices. These guiding rules are discussed further in sections III, IV and V of this preamble. While the current rules provide requirements for individual source categories with slight variations for the specific regulated materials and process methods used in the regulated industry, we propose that the Uniform Standards, which would consolidate consistent, cost-effective requirements from a wide range of compliance methods for the same emission points, could be easily and effectively applied to additional industries.
Because the proposed Uniform Standards are intended to supply general requirements for source category-specific subparts, we expect that as current NSPS and NESHAP are periodically reviewed for technology advancements, they may refer to the Uniform Standards for compliance monitoring, recordkeeping and reporting provisions. Review of both NSPS and NESHAP under the CAA authorizes us to consider the cost impacts of control. Therefore, in reviewing the current requirements for these emission points across source categories, we examined the cost effectiveness of the compliance methods. For example, we have considered the cost effectiveness of control methods for equipment leaks on a volatile organic compound (VOC) basis. The majority of the emissions from equipment leaks are the result of gases or vapors escaping through leaks, either because the process fluid itself is a gas or vapor or because the process fluid is a liquid that volatilizes easily. Therefore, VOC are a class of compounds that are representative of these types of emissions. The proposed Uniform Standards, as a whole, reflect our determination of the best and most cost-effective compliance and control options for the regulated materials generally expected at the proposed emission points.
To account for the differences between individual source categories, the proposed standards generally provide limited technical requirements for monitoring, testing, recordkeeping and reporting for the identified emission points. Overall, we have determined that the regulated materials, applicability requirements, emission
Electronic reporting is becoming an increasingly common element of modern life (as evidenced by electronic banking and income tax filing), and the EPA is beginning to require electronic submittal of certain environmental data. Electronic reporting is already common in environmental data collection and many media offices at the EPA are reducing reporting burden for the regulated community by embracing electronic reporting systems as an alternative to paper-based reporting.
One of the major benefits of reporting electronically is standardization, to the extent possible, of the data reporting formats, which provides more certainty to users of the data required in specific reports. For example, electronic reporting software allows for more efficient data transmittal and the software's validation mechanism helps industry users submit fewer incomplete reports. This alone saves industry and regulatory agencies report processing resources and reduces transaction times. Standardization also allows for development of efficient methods to compile and store much of the documentation required to be reported under this rule.
We are proposing that certain reports required to be submitted through the Uniform Standards would be submitted electronically. These reports would include all performance test reports, continuous emission monitoring system (CEMS) performance evaluation reports, the 40 CFR part 65, subparts I and J portions of the Notification of Compliance Status, and semiannual periodic reports specified in 40 CFR part 65, subparts H, I, J and M. All other reports would be submitted in hard copy or other method mutually agreed to between the source and the delegated authority. We have reasoned that reporting elements that are descriptive and contain a high level of detail would not be easily incorporated into the electronic reporting system at this time. For a discussion of each of these various types of reports, see sections III, IV, V and VI of this preamble.
The availability of electronic reporting for sources subject to the Uniform Standards will provide efficiency, improved services, better accessibility of information and more transparency and accountability. Additionally, submittal of these required reports electronically provides significant benefits for regulatory agencies, industry and the public. The compliance data electronic reporting system is being developed such that once a facility's initial data entry into the system is established and a report is generated, subsequent data submittal would only consist of electronic updates to existing information in the system. Such a system would effectively reduce the burden associated with submittal of data and reports by reducing the time, costs and effort required to submit and update hard copies of documentation. State, local and tribal air pollution control agencies could also benefit from more streamlined and accurate electronic data submitted to them. Electronic reporting would allow for an electronic review process rather than a manual data assessment, making review and evaluation of the source-provided data and calculations easier and more efficient. Electronic reporting would also benefit the public by generating a more transparent review process and increasing the ease and efficiency of data accessibility. Furthermore, electronic reporting would reduce the burden on the regulated community by reducing the effort involved in data collection and reporting activities. With the complete information provided in electronic reports, we anticipate there will be a need for fewer and less substantial data collection requests in conjunction with prospective required residual risk assessments or technology reviews. We anticipate that using electronic reporting for the required reports will result in an overall reduction in reporting costs; specifically, we estimated potential savings in reporting costs for an existing chemical plant to be approximately $6,780 (or a 42-percent cost reduction in hard copy reporting required by existing rules). For further discussion of the economic and cost impacts of electronic reporting, see section VII.D of this preamble.
Another benefit of the proposed electronic data submittal is that these data will greatly improve the overall quality of existing and new emissions factors by supplementing the pool of emissions test data for establishing emissions factors and by ensuring that the factors are more representative of current industry operational procedures. A common complaint heard from industry and regulators is that emission factors are outdated or not representative of a particular source category. With timely receipt and incorporation of data from most performance tests, the EPA would be able to ensure that the updated emission factors become available to represent the most current range of operational practices.
We are proposing that data entry of these electronic reports would be through the Compliance and Emissions Data Reporting Interface (CEDRI) that is accessed through the EPA's Central Data Exchange (CDX) (
In addition, we believe that there will be utility in allowing other reporting forms to be developed and used in cases where the other reporting forms can provide an alternate electronic file consistent with the EPA's form output format. This approach has been used successfully to provide alternatives for other electronic forms (
In CEDRI, the user must then upload the ERT file. CEDRI transmits a copy of the ERT project data file directly to WebFIRE, where the data are made available. Where performance test reports are transmitted, WebFIRE notifies the appropriate state, local or tribal agency contact that an ERT project data file was received from the source.
In summary, in addition to supporting regulation development, control strategy development and other air pollution control activities, having an electronic database populated with these reports would save industry, state, local, tribal agencies and the EPA significant time, money and effort while also improving the quality of emission inventories and, as a result, air quality regulations.
We are proposing new Uniform Standards for control of emissions from storage vessels and transfer operations. These Uniform Standards would apply to a storage vessel or transfer operation only if that storage vessel or transfer operation is subject to a regulation that references such standards in proposed 40 CFR part 65, subpart I for control of air emissions from these sources. In section III of this preamble, the term “we” refers to the EPA and the term “you” refers to owners and operators of sources affected by the proposed standards. Additionally, “subpart I” refers to proposed 40 CFR part 65, subpart I. Section III.B provides our rationale for the proposed requirements.
Proposed subpart I would apply to atmospheric storage vessels, pressurized vessels and transfer operations for which another subpart references such standards in this subpart for air emission control. Different vessel size and stored material maximum true vapor pressure (MTVP) thresholds are specified for the different control requirements for storage vessels. Different throughputs and transferred material MTVP thresholds are specified for the different control requirements for transfer operations. We are not proposing to specify a compliance timeline in this subpart, since the compliance period would depend upon the proposal and final rule effective dates of the referencing subpart; thus, the compliance timeline for implementing these standards, as specified in the referencing subpart, would apply for that source category.
As in current storage vessel rules, the proposed rule for storage vessels is based on design requirements, inspection requirements and emission standards. Current rules specify the size and vapor pressure thresholds that define which storage vessels must comply with the requirements. Similar thresholds are specified in proposed subpart I. As in current transfer operations rules, the proposed Uniform Standards for transfer operations are based on loading requirements, inspection requirements and emission standards. Current rules specify the size and vapor pressure thresholds that define which transfer operations must comply with the requirements. Similar thresholds are specified in proposed subpart I.
Your storage vessels and transfer operations would be subject to some or all of the requirements of subpart I when another subpart references the use of such requirements in subpart I for air emission control. In addition, you would be required to meet the general provisions applicable to 40 CFR part 65 (
Transfer operations. If you own or operate a transfer rack that loads regulated material into transport vehicles (
For fixed roof atmospheric storage vessels that are smaller than 20,000 gallons, smaller than 40,000 gallons and store material with a MTVP less than 1.9 psia or greater than or equal to 40,000 gallons and store material with a MTVP less than 0.75 psia, you would have to meet specified equipment, operating, inspection and repair requirements. The proposed equipment requirements are to: (1) Install the fixed roof in a manner that would avoid creating open spaces between roof section joints or between the interface of the roof edge and the tank wall; and (2) equip each opening in the fixed roof with a closure device that, when secured in the closed position, allows no open spaces in the closure device or between the perimeter of the opening and the closure device. You would be required to operate the fixed roof with each closure device secured in the closed position except during those periods when access is needed. A conservation vent or similar device would be allowed to vent to the atmosphere when diurnal temperature changes or filling of the storage vessel cause pressure in the storage vessel to exceed the design range for the storage vessel (i.e., normal breathing and working emissions).
To demonstrate compliance with the equipment and operating requirements, you would be required to conduct initial and periodic monitoring of the fixed roof and its closure devices for leaks. For parts of the fixed roof that you determine are unsafe to monitor, you would have to develop a written plan in which you document why those parts are unsafe to monitor and that specifies a schedule for monitoring when it is safe to do so.
We are proposing two monitoring options. One option would be to use Method 21 of 40 CFR part 60, appendix A-7. This monitoring would be required annually, and you would detect a leak each time you obtain an instrument reading greater than 500 parts per million by volume (ppmv). The second option would be to use optical gas imaging. This monitoring would be required semiannually, and the instrument would have to be capable of detecting at least one of the compounds emitted from the storage vessel. A leak would be detected each time the instrument detects an image. This option also would reference a protocol for other requirements. We are currently developing the protocol and expect to propose it as appendix K to 40 CFR part 60. Public comment on the content of the proposed protocol will be requested in the
If leaks are discovered in a storage vessel during an inspection, you have to either complete repairs or completely empty the storage vessel within 45 days, although you would be allowed up to two extensions of up to 30 days each. If you use an extension, you must maintain records that document your use of the extension. These records must indicate that alternative storage capacity was unavailable and list the actions you took in an effort to repair or empty the tank in the allowed period before the extension.
If you elect to use a floating roof to control emissions from an atmospheric storage vessel that meets the size and MTVP thresholds for such control, you would have to comply with the proposed equipment, operating, inspection and repair requirements for floating roofs specified in this rule.
The proposed rule includes rim seal equipment requirements that are consistent with current rules. If you use an IFR, you would be required to equip the IFR with a liquid-mounted seal, mechanical shoe seal or two seals mounted one above the other. If you use an EFR, you would have to equip the EFR with a liquid-mounted seal and secondary seal, or with a mechanical shoe seal and secondary seal.
The proposed rule includes design and operation specifications for closure devices and other fittings for each type of opening through the deck of the floating roof. Most of these design and operational requirements for deck fittings are consistent with requirements in current rules. One difference is that the proposed rule explicitly specifies requirements for slotted ladder legs that are comparable to requirements for slotted guidepoles. Another difference is that the proposed rule defines automatic bleeder vents (vacuum breaker vent) to include both devices that are activated by pressure and vacuum differences across the floating roof and devices that are activated when an extension leg contacts the floor of the storage vessel. The proposed rule also includes additional control options for slotted guidepoles that were developed for the Storage Tank Emission Reduction Partnership Program (STERPP) (65 FR 19891, April 13, 2000).
The proposed rule would require that you equip each storage vessel with an alarm system that signals when the floating roof: (1) Is about to land on its legs or other support devices; or (2) is close to being overfilled. Each time the floating roof is landed, you would be required to estimate, record and report the amount of regulated material emitted during the time the roof was landed. Similarly, if the storage vessel is ever overfilled, you would be required to estimate, record and report the amount of regulated material spilled and emitted to the atmosphere.
The proposed rule would require that the floating roof be floating on the liquid surface at all times except for certain instances when the floating roof is being supported on leg supports or other support devices (landed). We are proposing to limit both the total amount of time and the circumstances under which the floating roof may be landed to: (1) During the initial fill; (2) when necessary for maintenance, inspection or to support a change to an incompatible liquid, provided you either begin refilling the storage vessel or begin actions to completely empty the storage vessel within 24 hours; (3) when actions to completely empty the storage vessel begin within 24 hours after the roof is landed in order to take the storage vessel out of service; or (4) if the vapors are routed through a closed vent system to a control device from the time the roof is landed until the roof is within 10 percent by volume of being refloated. Typically, once you begin refilling the storage vessel, you would not be allowed to suspend refilling or withdraw liquid until after the roof is refloated. The requirement for continuous refilling until the roof is refloated would not apply to a storage vessel that is used to store product from a batch process if the quantity of product from one batch is insufficient to refloat the roof, and the roof will be refloated when product from additional batches is added to the storage vessel. However, withdrawal of liquid from the storage vessel would still not be permitted until after the roof is refloated.
The proposed rule would require that you inspect the floating roof deck, deck fittings and rim seals. One option would be to conduct visual inspections, measure gaps in rim seals for an EFR and measure gaps between gaskets and the surfaces they are intended to seal for deck fittings on both IFR and EFR. The proposed rule also specifies that Method 21 of 40 CFR part 60, appendix A-7 may be used as an alternative to the deck fittings gap measurement requirements for either type of floating roof and the rim-seal gap measurements on EFR. Another proposed alternative to the deck fittings gap measurement requirements is optical gas imaging. Requirements for monitoring using optical gas imaging would be the same as discussed in section III.A.3 of this preamble for monitoring of fixed roofs. Monitoring using either optical gas imaging or Method 21 of 40 CFR part 60, appendix A-7 would be required while the floating roof is floating on the stored liquid. The proposed rule lists the conditions that would be considered inspection failure (
The proposed rule includes inspection frequency requirements for both IFR and EFR. For IFR, you would have to inspect: (1) Before the initial fill of the storage vessel; (2) at least annually (tank top inspection only); and (3) each time the storage vessel is completely emptied and degassed (but no later than 10 years after the previous such inspection or no later than 5 years for IFR equipped with two rim seals). For EFR, you would have to inspect: (1) The primary and secondary rim seals and deck fittings within 90 days after the initial fill of the storage vessel; (2) the secondary seal, deck fittings and EFR at least annually; and (3) the primary seal no later than 5 years after the previous primary seal gap inspection. Delays in IFR and EFR inspection would be allowed if the storage vessel is out of service on the date 5 or 10 years after the last inspection, as applicable, provided the inspection is conducted prior to filling the storage vessel.
If you determine that it is unsafe to perform the EFR inspections specified in the rule, you would have to either perform the inspections no later than 30 days after making this determination, or remove the storage vessel from service no later than 45 days after making this determination. You may use up to two extensions (up to 30 days each) if the storage vessel cannot be emptied within 45 days, provided you document this decision, explain why it was unsafe to perform the inspection, document that alternative storage capacity is unavailable and provide a schedule of actions taken in an effort to completely empty the storage vessel during the extension period. Not completely emptying the storage vessel before the end of the second extension period would be a deviation.
In the event of an inspection failure, the proposed rule requires repair to correct the failure. In addition, if at times when you are not specifically conducting an inspection as required by the proposed rule, but you notice a condition that constitutes an inspection failure, you would be required to make the necessary repairs just as if the condition had been noted during a scheduled inspection. If you performed the inspection while the storage vessel was not storing liquid, you would have to complete repairs before refilling the storage vessel with liquid. If you performed the inspection while the storage vessel was storing liquid, you would have to complete repairs or remove the vessel from service within 45 days, but you would be allowed up to two extensions (up to 30 days each), as long as you document your decision to use the extension. The documentation would include a description of the failure, documentation that alternative storage capacity is unavailable and a schedule of actions taken in an effort to either repair or completely empty the storage vessel before the end of the applicable extension period. Not repairing or completely emptying the storage vessel before the end of the second extension would be a deviation.
You have the option to request the substitution of an alternate device for any of the seals and fittings specified in the floating roof approach, as long as the alternate device has an emission factor less than or equal to the emission factor for the specified device and the emission factor for the alternate device was determined under tests that accurately simulated the conditions under which the device will operate (
If you elect to control emissions from a fixed roof atmospheric storage vessel by using vapor balancing, you would have to comply with the proposed design, operating, monitoring and repair requirements for vapor balancing specified in this rule. You would have to operate, maintain and inspect the fixed roof, and repair leaks as specified in section III.A.3 of this preamble. Unlike current rules, the proposed rule contains no requirements for offsite facilities that clean and/or reload the transport vehicles and barges.
Under the proposed vapor balancing approach, you would have to design and operate the vapor balancing system to route the vapors displaced from storage vessel loading to the transport vehicle used to fill the storage vessel. Each transport vehicle would have to have a current certification of pressure testing conducted in accordance with U.S. Department of Transportation (DOT) requirements, and you would have to keep records of these certifications. Barges would have to be pressure tested annually in accordance with procedures in the proposed rule; these procedures are consistent with requirements in the Marine Tank Vessel Loading Operations NESHAP (40 CFR part 63, subpart Y) and the Benzene Transfer Operations NESHAP (40 CFR part 61, subpart BB). You would be required to maintain copies of documentation showing that the required testing was performed. The fixed roof would have to meet the design and operating requirements described in section III.A.3 of this preamble.
Under the proposed operating requirements, liquid may be unloaded only when the transport vehicle's vapor-collection equipment is connected to the storage vessel's vapor balancing system. Also, no PRD on the storage vessel, transport vehicle or barge may be open during loading, and PRD on the storage vessel would not be allowed to open at any time as a result of diurnal temperature changes (
Most of the proposed requirements for inspecting, monitoring and repairing equipment in the vapor balancing system and the fixed roof are the same as for closed vent systems as described in section III.A.6 of this preamble. The only difference is that for vapor balancing systems you may elect to
If you elect to vent emissions from a fixed roof storage vessel through a closed vent system to a control device, you would have to comply with the proposed equipment, operating, inspection and repair requirements specified in this rule for these systems.
If your storage vessel and closed vent system are not in vacuum service, you would have to operate, maintain and inspect the fixed roof, and repair leaks as specified in section III.A.3 of this preamble, except that normal breathing and working emissions would not be allowed to vent to the atmosphere. Monitoring would not be required if the storage vessel and closed vent system are in vacuum service, but you would be required to demonstrate that vacuum is maintained by installing a pressure monitoring device and alarm as specified in proposed 40 CFR part 65, subpart J.
For the closed vent system, you would have to comply with the bypass line requirements specified in proposed 40 CFR part 65, subpart M, and you would be required to comply with requirements for equipment in regulated material service in proposed 40 CFR part 65, subpart J. Either equipment controls (
For a non-flare control device, you would be required to comply with the provisions in proposed 40 CFR part 65, subpart M for the applicable control device and reduce regulated organic material emissions by at least 95 percent by weight or to an outlet concentration of regulated material less than 20 ppmv. To demonstrate initial compliance with this emission limit, proposed subpart I would allow you to conduct a design evaluation as an alternative to the performance test (note that the performance test is the default requirement in proposed subpart M). You would be required to comply with the provisions in 40 CFR 63.11(b) of subpart A for flares used to comply with the referencing subpart.
For those periods when you conduct planned routine maintenance of the control devices for your storage vessels, the proposed rule would require that you add no material to the storage vessel during those periods and limit the periods to a total of no more than 360 hr/yr. If you need more than 240 hr/yr, you would have to keep a record that explains why the extension was needed and describes how you minimized the amount of time beyond 240 hours. In addition, you would need to keep records of when the planned routine maintenance periods begin and end and the type of maintenance performed.
If you elect to control storage vessel emissions by routing displaced vapor to a fuel gas system, you would be required to comply with the requirements for fuel gas systems, as specified in proposed 40 CFR part 65, subpart M. Specifically, you would be required to: (1) Submit a statement in your Notification of Compliance Status that the emission stream is connected to the fuel gas system; (2) meet the requirements for equipment in regulated material service in proposed 40 CFR part 65, subpart J for all equipment in the fuel gas system; (3) comply with proposed 40 CFR 65.724 for any small boilers or process heaters in the fuel gas system; and (4) not route halogenated streams to the fuel gas system. In addition, you would be required to operate, maintain and inspect the fixed roof, and repair leaks as specified in section III.A.3 of this preamble. The proposed procedures for inspecting or monitoring the equipment also are the same as for equipment in a closed vent system as described in section III.A.6 of this preamble.
The proposed rule defines a pressure vessel as a storage vessel that is designed not to vent to the atmosphere as a result of compression of the vapor headspace in the vessel during filling of the vessel to its design capacity. The proposed rule would require all openings in a pressure vessel to be equipped with closure devices. In addition, you would be required to conduct annual performance tests using either Method 21 of 40 CFR part 60, appendix A-7, or optical gas imaging to show pressure vessels operate with an instrument reading less than 500 ppmv (for Method 21 of 40 CFR part 60, appendix A-7) or no emissions are imaged by the instrument (for optical gas imaging). Each time you obtain an instrument reading equal to or greater than 500 ppmv (for Method 21 of 40 CFR part 60, appendix A-7) or emissions are imaged (for optical gas imaging), it would be a deviation of the emission limit, and you would be required to estimate, record and report the amount of regulated material emissions during the time the pressure vessel is out of compliance with the emission limit.
The proposed rule would require that all purge streams be routed through a closed vent system to a control device that reduces regulated material emissions by at least 98 percent or to an outlet concentration less than 20 ppmv. Inert material purging is a short duration maintenance procedure required by good engineering practice to ensure proper operation of this type of storage system. The closed vent system would be subject to the same bypass line requirements and monitoring and inspection requirements as for a closed vent system that conveys emissions from an atmospheric storage vessel to a control device; see section III.A.6 of this preamble for details. The proposed compliance requirements for a control device would be the same as for a control device that controls emissions from an atmospheric storage vessel; see section III.A.6 of this preamble for details.
For each transfer rack that you use to load transport vehicles, you would be required to transfer the regulated material to the transport vehicles using submerged loading or bottom loading.
In addition, you would be required to control displacement emissions of regulated materials from the transport vehicles if you transfer more than 35 million gallons per year (gal/yr) of liquids with a weighted average MTVP greater than 4 psia. The proposed rule includes three compliance approaches for these emissions. One approach is to route the displaced emissions from the transport vehicle through a closed vent system to any combination of control devices. In this case, the proposed requirements are the same as those proposed for closed vent systems and control devices used to control emissions from storage vessels; see section III.A.6 of this preamble for details.
A second approach is to route the displaced emissions from the transport vehicle to a fuel gas system. Again, the proposed requirements are the same as the proposed requirements for storage vessels that are controlled by routing emissions to a fuel gas system.
The third approach is to design and operate a vapor balancing system to route vapors that are displaced from loading regulated liquids into transport vehicles back to the storage vessel or to another storage vessel that is connected to a common header. The proposed vapor balancing approach includes the following requirements: (1) Designing the vapor balancing system to prevent any regulated material vapors collected at one transfer rack from passing to another transfer rack; (2) equipping all vapor connections and lines in the vapor-collection equipment and vapor balancing system with closures that seal upon disconnect; (3) ensuring PRD in the system do not open while the transport vehicle is being filled with regulated material; (4) conducting the same LDAR procedures for equipment in the vapor balancing system as for equipment in a closed vent system; and (5) complying with the same bypass line requirements as in the proposed requirements for closed vent systems. You would not be allowed to use the vapor balancing approach if the applicable storage vessel has a floating roof.
Each transport vehicle that you load with regulated material that has a MTVP of regulated material greater than 4 psia would be required to pass an annual vapor tightness test conducted using Method 27 of 40 CFR part 60, appendix A-8. All other transport vehicles that you load with regulated material must either pass an annual vapor tightness test conducted using Method 27 of 40 CFR part 60, appendix A-8 or have a current certification in accordance with DOT pressure test requirements for cargo tanks or tank cars. You would be required to keep records of the DOT certifications and tests conducted using Method 27 of 40 CFR part 60, appendix A-8. You also would be required to take actions to assure that your vapor balancing system, closed vent system or fuel gas system is connected to the transport vehicle's vapor-collection equipment during each transfer of regulated material to transport vehicles.
For each transfer of regulated material to a container at a transfer rack that loads only containers, you would be required, at a minimum, to use either submerged fill or fitted opening/transfer line purging. Whenever a container contains a regulated material, you would also be required to install and secure all covers and closure devices in the closed position, except when you need to access the container (e.g., for adding or removing material, sampling or cleaning). You would also be required to demonstrate annually that containers, 55 gallons and larger, that are loaded and then used for onsite storage are vapor tight by using one of two approaches. One approach is to use Method 27 of 40 CFR part 60, appendix A-8, under the same test conditions specified for testing transport vehicles, and the second approach is to monitor each potential leak interface on the container for leaks using Method 21 of 40 CFR part 60, appendix A-7. When monitoring using Method 21 of 40 CFR part 60, appendix A-7, an instrument reading greater than 500 ppmv would constitute a leak that you would be required to repair within 15 days.
We are proposing three more effective compliance approaches that you may elect to comply with as an alternative to conducting submerged filling. The first approach is to route emissions through a closed vent system to a control device in accordance with the same requirements that apply to closed vent systems and control devices that are used to control emissions from transfers to transport vehicles. The second approach is to design and operate a vapor balancing system that routes displaced vapors back to the storage vessel from which the transferred liquid originated. The requirements would be the same as for the vapor balancing approach for controlling emissions from transfers to transport vehicles. For example, vapor connection and lines in the vapor-collection equipment and vapor balancing system would have to be equipped with closures that seal upon disconnect. Any PRD on the container would have to remain closed while the container is being filled, and you would be required to comply with the same bypass line requirements and LDAR requirements for equipment in the vapor balancing system that are being proposed for closed vent systems. The third approach is to conduct the transfer operations inside a permanent total enclosure (meeting the criteria specified in 40 CFR 52.741, appendix B) that is vented through a closed vent system to a control device. The requirements for the closed vent system and control device would be the same as in the first approach described above.
Other records related to storage vessels would require documentation of: (1) The start and end dates of floating roof landing events and the procedure used to refloat the roof; (2) decisions to use extensions for inspections and repair/removal from service; (3) dates of each overfill event; (4) DOT certifications of vapor tightness tests for transport vehicles used to comply with the vapor balancing approach; (5) vapor tightness test results for barges used to comply with the vapor balancing approach; (6) date and time when periods of planned routine maintenance of a control device begin and end; and (7) identification of each potential source of vapor leakage in a closed vent system that is not defined as a piece of “equipment.” If you comply with closed vent system and control device requirements or fuel gas system
For transfer operations, you would be required to keep records of vapor tightness tests of transport vehicles that are loaded with liquid that has a regulated material vapor pressure greater than 4 psia and DOT certifications of vapor tightness tests for other transport vehicles that are loaded with regulated material. If you comply with the approach to route emissions through a closed vent system to a control device or the fuel gas system approach, you would be required to keep records of monitoring, inspections and leak repairs, as specified in proposed 40 CFR part 65, subpart J, and you would be required to comply with the recordkeeping requirements specified in proposed 40 CFR part 65, subpart M, for the applicable control device. If you comply with the approach to load containers inside an enclosure, you would be required to keep records of the most recent calculations and measurements performed to verify that the enclosure meets the criteria of a permanent total enclosure, as specified in 40 CFR 52.741, appendix B.
We developed the proposed requirements in subpart I based on a review of requirements in current federal and state rules, a survey of technology for controlling and monitoring emissions from storage vessels and transfer operations and an analysis of the cost impacts of various compliance approaches.
The rules listed in Table 2 of this preamble include many provisions that we have developed as the most effective provisions for controlling emissions from storage vessels and transfer operations. These provisions form the backbone of proposed subpart I. In addition, the Generic MACT subparts were already organized to be referenced from source category-specific subparts. One difference between the Generic MACT rules and the proposed rule is how the storage vessel and transfer rack operating condition thresholds for a particular control requirement are specified. The Generic MACT relies on the referencing subpart to specify the range of characteristics that a storage vessel or transfer rack must possess to be subject to a particular control requirement. Conversely, proposed subpart I specifies both the thresholds and control requirements that would apply to storage vessels and transfer racks at any facility that is subject to a referencing subpart that incorporates those Uniform Standards provisions. If, while developing a referencing subpart, we identify a reason to select a different threshold for that source category (such as a difference driven by a prior MACT, AMOS or BSER decision for that subcategory), we would specify that threshold in the referencing subpart and indicate it applies in place of the threshold specified in proposed subpart I. The proposed subpart I thresholds and corresponding control requirements were determined based on the survey of technology and the cost impacts analysis; typically, the proposed requirements represent the best level of emission reduction for which we determined the costs are reasonable for model storage vessels and transfer racks.
Another overarching difference between proposed subpart I and the Generic MACT subparts is that proposed subpart I was organized to be consistent with the “plain language” format that we have adopted since the Generic MACT rules were promulgated. The following sections describe the rationale for the proposed provisions in subpart I.
We are proposing a definition of “storage vessel” that is generally consistent with the definition in the Generic MACT for Tanks Level 2, in that it means “a stationary unit that [* * *] is designed to hold an accumulation of liquids or other materials.” The definition also contains many of the same elements as definitions in many rules in 40 CFR part 63. For example, the proposed definition excludes vessels permanently attached to a motor vehicle, vessels containing regulated material only as impurities and wastewater tanks. Differences between the proposed definition and the definition in the Generic MACT for Tanks Level 2 and most other rules in 40 CFR part 63 are that the proposed definition specifically excludes process tanks, and it does not exclude pressure vessels. We excluded process tanks from the proposed definition because such vessels are in operation only when the process is operating, and they generally operate at process temperatures without the potential for significant emissions due to diurnal temperature changes. As a result, their emissions are more like other process vent emissions than storage tank emissions. We are proposing to include pressure vessels as a subset of storage vessels because we are proposing requirements for pressure vessels that differ from the requirements for atmospheric storage vessels. Proposed 40 CFR part 65, subpart H also defines both “pressure vessel” and “atmospheric storage vessel.”
We request comment on the clarity of this definition and the effect it would have if it were to apply in place of the current definitions in rules that could someday reference proposed subpart I for storage vessel requirements. In particular, we are interested in identification of any types of materials stored that could become subject to a rule that are not currently subject under a current rule's definition.
As discussed in section III.A.2 of this preamble, any one of four specified compliance approaches would be required to control emissions from each atmospheric storage vessel that exceeds any pair of tank capacity and regulated material MTVP thresholds in Table 1 of proposed subpart I. Emissions from all other storage vessels that contain regulated material would have to be controlled using either any of these same four approaches or by equipping the storage vessel with a fixed roof that meets specified design and operation criteria.
As part of our survey of technology, we estimated impacts for several control options for typical fixed roof storage vessels and EFR storage vessels. One purpose of the analysis was to determine applicable thresholds above which the costs for each control option are reasonable. Consistent with requirements in current rules, the thresholds we examined were the vessel size and the vapor pressure of the stored material.
All of the control options that we evaluated involved variations in the requirements for floating roofs or changes to the storage vessel. We focused on floating roof controls because these are the most common controls currently in use, and the only feasible options for baseline EFR storage vessels. We did not estimate costs for the other compliance approaches for fixed roof storage vessels for various reasons. We did not estimate the costs to connect fixed roof storage vessels to a closed vent system and control device because these costs have been shown in previous analyses to exceed the costs of floating roofs (
In the impacts analysis for fixed roof storage vessels, Control Option ST1 was installation of a typical IFR with typical rim seals and deck fittings, except that we varied the type of guide pole (none, solid and slotted). We assumed typical IFR are constructed from bolted aluminum panels, that the deck floats on pontoons and that the rim seal is a mechanical shoe seal. Based on information in AP-42 chapter 7, we assumed that even without a regulatory driver, roof legs, sample wells, stub drains and vacuum breakers typically are controlled in a manner consistent with the requirements in current rules such as 40 CFR part 63, subpart WW. Control Option ST2 was to upgrade other fittings, as necessary, with gasketed covers, wipers and other features needed to meet requirements in current rules such as subpart WW. Additional controls were applied under control Option ST2 only for column wells, ladder wells, guidepoles,
We assumed the baseline EFR storage vessel is equipped with a single rim seal (mechanical shoe) and typical fittings, except that we varied the type of guide pole (either solid or slotted). For such vessels, Control Option ST3 was to install a secondary rim seal, which we assumed would be rim-mounted. Control Option ST4 was to upgrade fittings, like in Control Option ST2 for fixed roof storage vessels. In this case, additional controls were applied under Control Option ST4 only for guidepoles and automatic gauge float wells because other fittings typically would be controlled to current regulatory levels in the absence of a regulatory driver. For this analysis we assumed that controlled slotted guidepoles in EFR storage vessels are equipped with gasketed covers and flexible enclosures. Proposed subpart I would allow a variety of compliance approaches for slotted guidepoles; we elected to evaluate a flexible enclosure in the impacts analysis because it shows a net cost savings even for the most costly approach. Control Option ST5 was to install a dome over storage vessels that meet the Control Option ST4 requirements.
We estimated baseline and controlled emissions using the AP-42 procedures. Inputs for the analysis included meteorological conditions for Houston, Texas, and typical throughputs obtained from a survey of the chemical manufacturing industry (see EPA-450/3-80-025). Costs were obtained from vendors. Table 3 of this preamble summarizes the cost- effectiveness estimates of the two control options for three sizes of model fixed roof storage vessels storing materials with a range of vapor pressures. Table 4 of this preamble shows the cost-effectiveness estimates of the three control options for model EFR storage vessels. Table 4 of this preamble also shows that the cost of Control Option ST5 (adding a dome over an EFR storage vessel that is already complying with Control Options ST3 and ST4) are unreasonable for all model vessels in the analysis; therefore, we rejected this control option from further consideration. Although we evaluated a variety of guide pole scenarios, as discussed above, the results in Table 3 of this preamble are for model storage vessels with a solid guide pole, and the results in Table 4 of this preamble are for model storage vessels with a slotted guide pole; the results for the other guide pole scenarios were not significantly different, and they would not lead to different conclusions. See the memorandum titled
Current rules specify requirements comparable to the combined requirements in Control Options ST1, ST2, ST3 and ST4 for atmospheric storage vessels, but the size and vapor pressure thresholds in the rules vary. For comparison purposes, the HON requires control of emissions from storage vessels with a capacity of at least 40,000 gallons that store material with a vapor pressure of at least 0.75 psia, and storage vessels with a capacity of at least 20,000 gallons that store material with a vapor pressure of at least 1.9 psia. Tables 3 and 4 of this preamble show the incremental cost impacts for storage vessels at these thresholds range from a cost savings for Control Option ST4 to $12,000/ton for storage vessels storing material with a vapor pressure of 0.75 psia under Control Option ST2.
Although cost effectiveness is an important consideration in establishing thresholds for proposed subpart I, we also considered the practicality of setting thresholds less stringent than the thresholds in the HON and other current rules. This would be impractical because, when those rules are amended to reference the Uniform Standards, they would have to override such thresholds in order to satisfy statutory MACT, AMOS and other regulatory requirements. Therefore, we have decided to propose the thresholds that are used in the HON (see Table 1 of this preamble). These thresholds are widely applicable because many current rules reference the HON, and we think they represent the best choice as defaults for the Uniform Standards. We request comment on this decision.
For most chemical manufacturing facilities, the costs to comply with the combined requirements of Control Options ST1, ST2, ST3 and ST4 for atmospheric storage vessels above the proposed thresholds are expected to be zero or minimal because they are already subject to current rules that have the same or similar thresholds and control requirements. However, many storage vessels at petroleum refineries are subject to 40 CFR part 63, subpart CC, which does not require control of deck fittings (
We estimated the current and controlled emissions for each model-refinery storage vessel using the AP-42 procedures and other assumptions, as described above in the discussion of the analysis to establish thresholds for control. We estimated costs to upgrade fittings for each storage vessel using the same information that we used in the analysis to establish thresholds for control. We also applied a product recovery credit of $500/ton of VOC to the prevented emissions. The emission reductions associated with upgrading the deck fittings on EFR storage vessels, particularly slotted guidepoles, resulted in a product recovery credit that exceeded the estimate of all costs associated with Control Options ST2 and ST4. Thus, the nationwide impacts of the control options for petroleum refineries is a cost savings of about $350/ton of VOC controlled. See the memorandum titled
All atmospheric storage vessels below the capacity and MTVP thresholds noted in section III.A.2 of this preamble would have to be equipped with a fixed roof. Although most current rules do not specify standards for such storage vessels, we expect that storage vessels at facilities that may in the future be subject to rules that reference the Uniform Standards already meet this proposed requirement. Thus, we do not expect any cost or emission impacts to meet this requirement. We request comment on the accuracy of this assumption.
The design and operating requirements that we are proposing for fixed roofs are based on the requirements in the Generic MACT for Tanks Level 1. However, we are proposing the seven changes to the requirements in the Generic MACT for Tanks Level 1, described below, to control more effectively fugitive emissions, simplify requirements and enhance consistency with requirements for storage vessels that may be subject to other sections in proposed subpart I.
First, we are not proposing to specify suitable materials for the fixed roof and closure devices. We decided that these decisions are best left to you and the storage vessel manufacturer. You would have the flexibility to choose whatever materials work best in your situation, provided you meet the design and operational requirements in proposed subpart I.
Second, like the Generic MACT for Tanks Level 1, proposed subpart I would allow opening of a closure device or removal of the roof when needed to provide access. The Generic MACT for Tanks Level 1 specifies that the closure devices may be opened to provide access for “performing routine inspection, maintenance, or other activities needed for normal operations” and “to remove accumulated sludge or other residues from the bottom of the tank.” In proposed subpart I, we use an edited version of these statements to clarify that the opening is allowed for “manual operations that require access such as inspections, maintenance, sampling, and cleaning.” A related difference between the Generic MACT for Tanks Level 1 and the proposed rule is that the proposed rule does not explicitly state that the closure device must be secured in the closed position or the roof reinstalled when the activity that requires access is complete. Such a statement is unnecessary, because the inverse of the provision allows openings when access is needed. The proposed rule clearly states that closure devices must be closed at all times except when access is needed.
Third, as in the Generic MACT for Tanks Level 1, proposed subpart I would allow you to route emissions from an opening through a closed vent system to a control device as an alternative to equipping the opening with a closure device. However, the Generic MACT for Tanks Level 1 does not specify compliance procedures for this control option. To ensure that emission reductions are consistent and quantifiable when a control device is used, we are proposing to require compliance with the procedures in proposed 40 CFR 65.325 for closed vent systems and control devices.
Fourth, the Generic MACT for Tanks Level 1 specifies at 40 CFR 63.902(c)(3) that opening of a safety device is allowed at any time. This provision was not included in proposed subpart I because the referencing subparts will address malfunctions.
Fifth, we are proposing delay of repair provisions that differ from the requirements in the Generic MACT for Storage Tanks Level 1. The primary difference between the Generic MACT for Storage Tanks Level 1 and proposed subpart I is the time allowed to complete repair. The Generic MACT for Tanks Level 1 allows delay as long as the owner or operator demonstrates that alternative tank capacity is not available to accept the regulated material from the tank that needs to be repaired, whereas the proposed rule would allow a maximum delay of 105 days (45 days plus up to two extensions of up to 30 days each). We have determined that 105 days is sufficient time to empty the tank, either to other existing tanks on site or to temporary storage, if necessary. Furthermore, current rules (and proposed subpart I) already include such requirements for repair of any floating roof, and applying the same requirements for fixed roof storage tanks would promote consistency and reduce the likelihood of inadvertent compliance errors. Sixth, we are proposing to require periodic monitoring of each potential source of vapor leakage from the fixed roof and fittings on the roof instead of annual visual inspections for defects. The monitoring could be conducted annually using Method 21 of 40 CFR part 60, appendix A-7 or semiannually using optical gas imaging (after promulgation of the protocol that we are developing for 40 CFR part 60, appendix K). See sections III.A.3 and IV.A.5 of this preamble for discussions of the protocol. Repairs would be required for each leak. A leak would be defined as any instrument reading greater than 500 ppmv when monitoring using Method 21 of 40 CFR part 60, appendix A-7, or any emissions imaged when using an optical gas imaging instrument. We are proposing this monitoring change to better control fugitive emissions. As documented in the docket for proposed subpart I, EPA inspectors have often found significant leaks from fittings by sensory means (particularly olfactory) and optical gas imaging when visual inspections indicate the gaskets and other elements of closure devices appear to be sound, and the conservation vent is not actively releasing to relieve increased pressure caused by diurnal temperature changes or filling the storage vessel (see the memorandum titled
The estimated annual costs, emission reductions and cost-effectiveness values for the three monitoring options are shown in Table 5 of this preamble. The estimated cost-effectiveness values for monitoring using either optical gas imaging or Method 21 of 40 CFR part 60, appendix A-7 are less than $230/ton per storage vessel, which we determined is reasonable. Note that the emission reductions for these two options are relative to estimated uncontrolled emissions. We lack the data needed to attempt to quantify the reductions for the visual inspections option, but we expect the reductions to be significantly less than for the other two options given the results of agency inspections noted above.
The impacts were estimated for a representative fixed roof storage vessel with eight fittings on the roof (an access hatch, gauge hatch, conservation vent, emergency pressure relief vent and four other miscellaneous types of valves and instruments). Costs were estimated assuming a visual inspection takes an average of 30 minutes and the other monitoring options take between 40 minutes and an hour, depending on the size of the facility at which the storage vessel is located. Based on the results of agency inspections, we estimated that initial optical gas imaging would find about 0.5 leaking fittings per storage vessel, and that monitoring with Method 21 of 40 CFR part 60, appendix A-7, would find an average of about 1 leaking fitting per storage vessel. We assumed that subsequent monitoring would find about 5-percent leaking fittings if optical gas imaging is conducted semiannually and monitoring with Method 21 of 40 CFR part 60, appendix A-7, is conducted annually. As in equipment leak analyses, repair costs were estimated assuming 75 percent of the leaks could be eliminated by a simple adjustment to the fitting and that 25 percent of the fittings would require a more extensive repair or replacement. Recordkeeping costs were estimated assuming 1 hr/yr to document the results of visual inspections and 0.5 hr/yr to document the results of the other monitoring options. Reporting costs were estimated assuming 0.5 hour per reporting period, to include records in annual periodic reports of inspections of each storage vessel for which a leak was found, and that 40 percent of the storage vessels have one leaking fitting each year (
We request comment, with supporting rationale, on all aspects of the proposed requirements for fixed roof storage vessels that store regulated material. We are particularly interested in comment on the proposed monitoring requirements. For example, itemized cost estimates, data on mass emissions from leaks and information about the types of initial repairs that would be needed and the expected frequency of replacements would be useful. Comparisons of results obtained using both Method 21 of 40 CFR part 60, appendix A-7, and optical gas imaging are requested.
As noted in section III.A.2 of this preamble, we are proposing four different compliance approaches for atmospheric storage vessels that exceed specified capacity and MTVP thresholds. One of these approaches is to use a floating roof. The requirements that we are proposing for this approach in proposed 40 CFR 65.315 are essentially the same as the requirements in the Generic MACT for Tanks Level 2. We are proposing additional requirements and clarifications as described below.
One of the objectives of rim seals is to help fill the annular space between the rim of the floating roof and the wall of the storage vessel thereby minimizing evaporative losses from this area. To meet this objective, rim seals must be constructed of a material that is impermeable to the stored material or any components of the stored material. A rim seal that is saturated with (or has been plasticized by) stored liquid would constitute an inspection failure because the rim seal would not be functioning as designed. In proposed subpart I, this requirement is specified in section 65.315(c)(1)(iii). We request comment on whether explicitly stating in subpart I that rim seal material saturated with (or plasticized by) stored liquid constitutes an inspection failure would help clarify this requirement. We also request comment on other possible approaches for clarifying this requirement. In addition, we are interested in strategies that could minimize repeated use of seal materials that are demonstrated to be less reliable than others. For example, we request comment on the feasibility and potential effectiveness of requiring more frequent inspections if a seal that failed during the first 5 years of use is replaced with a seal made from the same material.
As part of the STERPP, we offered to enter into agreements with companies that have installed or will install controls to reduce their slotted guide pole emissions from storage vessels that
Other rules (e.g., NSPS Kb) allow floating roof landings only if the storage vessel is being completely emptied, and both the emptying and refilling processes must be continuous and as rapid as possible. This requirement has been interpreted as requiring the storage vessel to be emptied each time the floating roof lands. However, as we clarified in the preamble to the CAR (63 FR 57768), emptying the storage vessel every time the roof lands is undesirable because it increases the vapor space, which in turn increases emissions. Thus, emptying the storage vessel when landings are inadvertent or other times when emptying is not needed for operational reasons is counterproductive.
To minimize emissions from landings and clarify the requirements, we are proposing several differences relative to the requirements in current rules. For example, instead of requiring the floating roof to be floating on the liquid surface at all times except when it is landed on its supports, we are proposing to list specific situations under which the floating roof is not required to be floating on the stored liquid (proposed 40 CFR 65.315(b)(1)). We are proposing to allow the roof to be landed during the
We also recognize that landings are required in order to take the storage vessel out of service, and they are often required in order to perform inspections, maintenance or before filling the storage vessel with a liquid that is incompatible with the liquid currently stored in the storage vessel. Therefore, we are proposing to allow roof landings in these situations, provided the time spent standing idle is limited to no more than 24 hours. After 24 hours, you would be required to either begin actions to completely empty (and clean, if necessary) or refill the storage vessel. These requirements clarify that you would not be required to empty a storage vessel when the storage vessel does not need to be empty in order to conduct maintenance or inspections. The limited number of situations when landings are allowed is intended to eliminate unnecessary or convenience landings, and the 24-hour limit is intended to prevent emissions from unnecessary time spent standing idle. We request comment on the suitability of the 24-hour limit. In particular, we request comment on specific situations where a storage vessel does not need to be completely emptied to perform maintenance or inspection, but the maintenance or inspection activity cannot be completed in less than 24 hours. We also request comment on the proposed list of circumstances under which floating roof landings would be allowed, in particular whether there are other circumstances that would require a floating roof landing or whether the list allows landings in situations where they are unnecessary.
We are also proposing to allow landings if you elect to route emissions through a closed vent system to a control device that reduces emissions by at least 90 percent while the roof is landed because this control technique will also reduce standing loss emissions relative to uncontrolled landings. To prevent liquid from being drawn into the closed vent system, control would be required only when the liquid fills less than 90 percent of the volume under the landed roof. We are not proposing to require control of displaced emissions during refill after these events because the cost to control, considering the estimated emissions reduction, would not be reasonable except for very large storage vessels that store highly volatile material. We request comment on the technical feasibility and cost of this control option. In particular, we are interested in test data showing the gas flow rate and inlet mass emissions to a control device that was used as we proposed; please also provide related supporting information, such as the diameter of the storage vessel, the height of the landed roof, the average height of the liquid, the type of material stored and the pressure drop across the floating roof. We also request comment on whether the rule should limit the number of days operating in this manner so that the total controlled emissions do not exceed the standing idle emissions from one day. We also request comment on whether any facilities would have no choice but to comply with this control option because it would not be possible to limit landings to the situations described in the paragraph above; please provide a description of any such facilities and explain why limiting landings would not be possible.
Proposed subpart I would require you to estimate regulated material standing idle emissions from each landing and to submit the results in your next periodic report. As in the Generic MACT for Tanks Level 2, you would also be required to keep records documenting the start and end times of all roof landing events. We have determined that maintaining information on the occurrence, time span and quantity of standing idle emissions for landings is needed to demonstrate compliance with the proposed limits on when landings are allowed. This information will also help inform decisions about where to target compliance inspections. We request comment on the feasibility and burden of estimating emissions from landings.
Second, we are proposing to specify how an inspector is to demonstrate when a gap constitutes an inspection failure for a deck fitting. The Generic MACT for Tanks Level 2 specifies at 40 CFR 63.1063(d)(1)(v) that a gap of more than
Third, we are proposing an editorial change to the language from 40 CFR 63.1063(d)(1)(v) that is incorporated in
Fourth, to increase compliance flexibility and possibly emissions reductions, we are proposing to allow optical gas imaging or monitoring using Method 21 of 40 CFR part 60, appendix A-7 as an alternative to measuring rim seal gaps for EFR and deck fitting gaps for both IFR and EFR. The monitoring would be required on the same schedule as the otherwise applicable gap measurement requirements. An inspection failure would occur if you obtain an instrument reading greater than 500 ppmv when monitoring using Method 21 of 40 CFR part 60, appendix A-7, or when you obtain an image of emissions when using optical gas imaging. Conditions causing an inspection failure would have to be repaired. To ensure consistent and reliable results when using optical gas imaging, we are also proposing two additional requirements: (1) Optical gas imaging would be allowed only if at least one compound in the emissions from the storage vessel can be detected by the optical gas imaging instrument and (2) monitoring would be required in accordance with a new protocol for optical gas imaging. As discussed in sections III.A.3 and III.A.4 of this preamble, we are currently developing a protocol for using optical gas imaging instruments, and we expect that the protocol will be proposed as appendix K in 40 CFR part 60. We anticipate that compliance with either of the proposed monitoring alternatives would result in lower emissions than compliance with the conventional gap measurement requirements because agency personnel using an optical gas imaging instrument have often seen images of emissions from seals and fittings that appear to be in good condition upon visual inspection (see the memorandum titled
Fifth, we are proposing to require inspections of an EFR deck and fittings annually rather than at least every 10 years, as specified in the Generic MACT for Tanks Level 2. The Generic MACT for Tanks Level 2 requires annual secondary seal gap measurements, but complete inspections of the EFR, rim seals and deck fittings are required only when the storage vessel is completely emptied and degassed, or every 10 years, whichever occurs first. A commenter on the proposed changes to storage vessel requirements in 40 CFR part 63, subpart CC (73 FR 66694, November 10, 2008), which would have referenced the Generic MACT for Tanks Level 2, stated that the annual inspection for EFR should be expanded to include inspection of the roof and deck fittings as well as the secondary seal because defects in the roof or fittings are often clearly visible during the secondary seal inspections (see Docket Item No. EPA-HQ-OAR-2003-0146-0176). Furthermore, the commenter noted that, under the current rule, it is unclear whether any such defects noted during the annual inspection are to be repaired, reported or ignored until the next complete inspection. Upon review, we have determined that annual inspections of the EFR deck and fittings are reasonable because: (1) An inspection for other failures can readily be accomplished each time an inspector is measuring secondary seal gaps; (2) conducting such failure inspections annually would more closely align the EFR inspection requirements with the current IFR inspection requirements; and (3) we estimated the additional burden and costs to be minimal. Measurement of gaps between deck fitting gaskets and the surfaces they are intended to seal is not required for IFR. However, given that EFR have a greater potential for emissions due to wind effects, we think the minimal additional time and cost to perform such measurements of EFR fittings is reasonable in light of the potential for reduced emissions. We estimated the additional labor costs for visual inspections, measurement of deck fitting gasket gaps and associated recordkeeping to be about $100/year. The additional burden was estimated to be about 2 hours per storage vessel.
As noted above, we are proposing to allow monitoring using Method 21 of 40 CFR part 60, appendix A-7 and optical gas imaging as alternatives to gap measurement requirements. We estimated the costs and burden to conduct annual monitoring of EFR deck fittings using Method 21 of 40 CFR part 60, appendix A-7 to be about the same as for annual to measurement of gaps at each fitting because an inspector has to check each fitting individually in both cases. Theoretically, costs and burden to conduct optical gas imaging could be slightly less (assuming the facility is using a camera that has already been purchased for monitoring equipment leaks) because several emission points can be monitored simultaneously with an optical gas imaging instrument, but we assumed the same amount of time because time is needed to prepare the camera and to obtain images from multiple locations. See the memorandum titled
We are also proposing to clarify that repair is required any time a condition that constitutes an inspection failure is noted, regardless of whether it was noted as part of a scheduled inspection. Although not stated explicitly, current rules imply that repair is required any time an inspection failure is noted because they state that inspections must be conducted at least once during a specified time period. Any time a condition that constitutes an inspection failure is noted is effectively an inspection, whether or not it was scheduled.
Finally, we are proposing changes to clarify the required frequency of inspections because we received comments on proposed amendments to 40 CFR part 63, subpart CC, that the current requirements could be subject to different interpretations (see docket item EPA-HQ-OAR-2003-0146-0176). For example, the requirement to conduct inspections “every 10 years” could mean in every tenth calendar year, no later than the date 10 years after the previous inspection or in the same month every 10 years. The same uncertainties also apply to the inspection requirements that must be
The second change would clarify terminology. The applicable repair requirements in 40 CFR 63.1063(e) differ depending on whether or not the inspection was conducted while the storage vessel was storing liquid. These requirements could be subject to inconsistent interpretations because the term “storing liquid” is not defined in the rule. The intent of the language was to apply different procedures depending on whether or not the storage vessel was completely empty when the inspection was conducted. The term “completely empty” is defined in the rule. Therefore, rather than define “storing liquid,” we are proposing to replace that term with the term “completely empty” to clarify the requirements.
The third change would clarify the recordkeeping requirements when you use an extension to delay repair or emptying of a storage vessel beyond 45 days. The current requirements in 40 CFR 63.1063(e) imply that documentation of extensions is to be prepared before you use an extension and could be misinterpreted as requiring a request for approval to use an extension. Section 63.1067 of the Generic MACT for Tanks Level 2 also specifies that this documentation be submitted in periodic reports. We have determined that approvals are not necessary; records that document the type of failure, the reasons why an extension was needed, the steps taken to either repair or completely empty the storage vessel during the extension and the date on which repairs were completed or the storage vessel was completely emptied are sufficient to demonstrate compliance. Furthermore, requesting approval via a periodic report is impractical because the schedule of such reports is unlikely to coincide with many extension periods. Therefore, to clarify the reporting requirements, the language in the proposed rule differs from the Generic MACT for Tanks Level 2 in that it clearly requires records of each decision to use an extension.
We are proposing that the second approach for atmospheric storage vessels is vapor balancing (proposed 40 CFR 65.320). Proposed subpart I would require the same design, operating, monitoring and repair requirements for the fixed roof and closure devices that would be required for the closed vent system approach. See section III.B.6 of this preamble for a discussion of our rationale for these requirements. The vapor balancing requirements that we are proposing are similar to requirements in several rules in 40 CFR part 63 (e.g., the MON), except for the following three changes. First, we are proposing to replace the requirement to conduct quarterly monitoring of pressure relief valves on storage vessels using Method 21 of 40 CFR part 60, appendix A-7, with a requirement to conduct applicable LDAR requirements for all equipment in the vapor balancing system. The proposed requirements are nearly identical to the proposed requirements for closed vent systems, as described in section III.B.6 of this preamble. The only difference is that you would have the option to reduce instrument monitoring frequencies (for types of equipment that must be monitored) consistent with the alternative for equipment in batch operations in proposed 40 CFR part 65, subpart J. We proposed this difference because it would be possible to determine the total operating hours for a vapor balancing system, but not for a closed vent system. We are not proposing to limit the monitoring requirement to PRD because such monitoring provides information only for that one piece of equipment. Conducting monitoring of the entire vapor balancing system while the storage vessel is being filled provides more information about the integrity of the entire system, and it is information collected while the system is actually operating and most likely to be emitting vapors.
The second difference from vapor balancing requirements in current rules is that the proposed rule would require design, operation, inspection and repair of openings and closure devices consistent with the requirements for fixed roofs in storage vessels that are controlled by routing emissions through a closed vent system to a control device, as described in section III.B.6 of this preamble. Although current rules and proposed subpart I require PRD be set at levels to prevent breathing losses, we determined that additional requirements are needed to minimize vapor leakage through the roof and fittings regardless of the method for controlling breathing and working losses.
The third difference from vapor balancing requirements in current rules is that the proposed rule would specify no requirements for offsite facilities that reload (and in some cases clean) the transport vehicle or barge. In current rules, these facilities are subject to the same control requirements as the facility that has the affected storage vessel. Both the vapor balancing and closed vent system options were included in current rules in 40 CFR part 63 because they were determined to be at least as effective as using floating roofs, which represented the MACT floors. Based on recent analyses, we determined that requiring control of offsite facilities as part of a vapor balancing option results in better overall control than the other options. Furthermore, the total emissions from a regulated source implementing vapor balancing and an uncontrolled offsite cleaning/reloading facility typically are about the same as the total emissions from both facilities when the regulated source implements the closed vent system approach. The performance of the closed vent system approach relative to vapor balancing will vary depending on the saturation level of the vapor space in the transport vehicle or barge when unloading of liquid to the storage vessel is complete. If the organic compound concentration in the vapor space of the transport vehicle or barge when transfer is complete is approximately the same as the concentration in the vapor space of the storage vessel, then the total mass of organic compounds in the transport
Another issue with the vapor balancing approach, as specified in current rules, is that it imposes a significant burden on the offsite facilities (assuming these facilities are not required to control transfer operations emissions under a rule that currently applies to their source category). Furthermore, because facilities outside the United States are not required to comply with this rule, a regulated source would not be allowed to use the vapor balancing approach if the transport vehicle is cleaned outside of the United States. Therefore, we have decided not to include control requirements for offsite facilities in proposed subpart I because we have determined that such requirements result in greater overall emissions reductions than other storage vessel control approaches. This additional control is not needed to meet regulatory requirements such as MACT in current rules because the performance of vapor balancing without offsite control is at least equivalent to the performance of other control approaches, including those that represent MACT in current rules. As a result, the offsite control requirement also imposes an unnecessary burden on the offsite facilities. Furthermore, the vapor balancing approach without offsite controls imposes clearly enforceable requirements on the regulated facility. We request comment on the differences between the proposed vapor balancing requirements and the vapor balancing requirements in current rules. In particular, we are interested in whether the proposed lack of requirements for offsite facilities could result in significantly higher total emissions under some conditions. We are also interested in test data or theoretical calculations of the organic compound saturation level or concentration in the vapor space of freely vented transport vehicles at the time when unloading of various liquids is complete.
As discussed in section III.A.5 of this preamble, the proposed requirements are based on a combination of the procedures specified in 40 CFR part 65, subpart M and several additional requirements. As discussed in section V.B of this preamble, we have structured the proposed requirements in subpart M to be applicable to any emissions stream that is controlled by routing through a closed vent system to a control device. Referencing these provisions from proposed subpart I promotes consistency for all emissions streams that are routed through a closed vent system to a control device. It is also intended to simplify and reduce the burden of compliance and reduce the potential for inadvertent errors. However, we are also proposing several additional requirements to ensure appropriate control for storage vessels.
In addition to the proposed requirements in 40 CFR part 65, subpart M, we are proposing to require design and operation of the fixed roof and closure devices consistent with the proposed requirements for fixed roof storage vessels, as discussed in section III.B.3 of this preamble, except that breathing and working losses would have to be controlled rather than vented to the atmosphere. We are also proposing to require the same type of monitoring and repair of all potential sources of vapor leakage from the fixed roof and closure devices, as discussed in section III.B.3 of this preamble. We request comment on whether the proposed monitoring frequencies are reasonable and if any changes to operating procedures for the monitoring devices would ensure that the alternative monitoring methods provide similar results.
For equipment in a closed vent system, proposed 40 CFR part 65, subpart M references the compliance requirements in proposed 40 CFR part 65, subpart J. However, in subpart I we are proposing to reference only the bypass line requirements in proposed subpart M and reference directly the applicable equipment leak requirements in proposed subpart J. We selected this approach to specify more easily that certain options in proposed subpart J do not apply to equipment in a closed vent system that conveys emissions from a regulated storage vessel. Specifically, the alternative monitoring frequency requirements for equipment in batch operations would not be allowed for equipment in such closed vent systems because the closed vent system must be in service continuously. Similarly, the provision that specifies sensory monitoring for equipment in service less than 300 hr/yr would not be allowed for equipment in such closed vent systems because determining the amount of time the system actually is conveying emissions is not practical.
The applicable requirements in 40 CFR part 65, subpart J differ depending on whether the equipment is in regulated material service or if it contains or contacts fluid that contains regulated material at levels below the regulated material service threshold. Current rules typically require sensory monitoring of closed vent systems (only closed vent systems constructed of ductwork are subject to monitoring using Method 21 of 40 CFR part 60, appendix A-7). We are proposing instrument monitoring of closed vent systems in regulated material service to be consistent with the requirements for process lines that convey gaseous materials and to ensure that the emission streams reach the control device so that the required level of control is met. As an alternative to using Method 21 of 40 CFR part 60, appendix A-7, we are proposing to allow monitoring using an optical gas imaging device (after the protocol is promulgated, as discussed in section III.A.3 of this preamble), provided at least one compound in the emissions can be detected by the optical gas imaging instrument.
The proposed rule also specifies that all equipment in sections of closed vent systems that convey emissions from storage vessels that meet the thresholds for control (i.e., the thresholds specified in Table 1 of this preamble) are in regulated material service; no additional determination of the composition of gas streams in the closed vent system is required. This approach is being proposed because it provides an easy way for determining when equipment is in regulated material service and because the concentration of organic compounds in vapor that is in equilibrium with a liquid that has a vapor pressure of 0.75 psia (the minimum threshold for control) is approximately 50,000 ppmv, which after conversion to a weight basis, is comparable to or lower than typical 5 percent or 10 percent by weight thresholds in definitions of “in organic HAP service” or “in VOC service” in current rules. We request comment on other approaches that can accurately determine whether equipment is in regulated material service without imposing unreasonable burden.
Current rules for storage vessels generally require non-flare control devices to reduce organic compound emissions by at least 95 percent or to an outlet concentration of regulated material less than 20 ppmv. They also require at least a 99-percent reduction or outlet concentration less than 20 ppmv for acid gases or halogen atoms (the acid gases may be part of the emission stream directly from the storage vessel, or they may be generated by burning halogenated organic compounds in combustion control devices). These levels are achievable by storage vessels storing a wide range of materials in a wide range of source categories, and they are at least equivalent to the reductions that are achieved when using floating roofs. Thus, we are proposing to specify these required control levels in proposed subpart I rather than in each of the individual referencing subparts, thereby improving consistency and simplifying the referencing subparts. The use of flares to control organic emissions from storage vessels is another option that would be allowed in proposed subpart I; all requirements for flares are covered in 40 CFR 63.11(b) of subpart A.
Proposed 40 CFR part 65, subpart M specifies that control performance requirements will be specified in referencing subparts. Because proposed subpart I specifies the required reductions or outlet concentrations for non-flare control devices used to control emissions from storage vessels, subpart I (rather than the rule that references subpart I) would be the referencing subpart for the purpose of complying with proposed subpart M. Therefore, subpart I must specify the provisions for initial compliance determinations (
As in current rules, we are proposing to require different standards for periods of planned routine maintenance of the control device. We are not proposing to require compliance with the same standard at all times because the cost of such a requirement would be unreasonable. Instead, we are proposing to prohibit the addition of material to the storage vessel during periods of planned routine maintenance and to limit the time of planned routine maintenance to less than 360 hr/yr. If you need more than 240 hr/yr, you would be required to keep a record documenting why 240 hours is insufficient and the steps you took to minimize the additional time for planned routine maintenance. In analyses for current rules, 240 hours has been determined as sufficient for most control device rebuilds.
For fuel gas systems that control emissions from storage vessels, proposed subpart I references the fuel gas system requirements in proposed 40 CFR part 65, subpart M and specifies a few additional requirements to ensure appropriate control for storage vessels. See section V.B.4 of this preamble for a discussion of the requirements in subpart M for fuel gas systems. Proposed subpart I also would require the same design operating, monitoring and repair requirements for the fixed roof and closure devices that would be required for the closed vent system approach. See section III.B.6 of this preamble for a discussion of our rationale for these requirements. Proposed subpart I also would require compliance with proposed 40 CFR part 65, subpart J for the equipment in the fuel gas system. As for the closed vent system approach, all equipment in sections of a fuel gas system that convey emissions from an affected storage vessel are in regulated material service and subject to the monitoring and other LDAR requirements for equipment in regulated material service. See section III.B.6 of this preamble for a discussion of the rationale for these requirements.
A pressure vessel is defined in the Uniform Standards as a storage vessel that is designed not to vent to the atmosphere as a result of compression of the vapor headspace in the vessel during filling of the vessel. We are proposing standards for all pressure vessels that contain any regulated material. We are not proposing thresholds for the following reasons. First, materials stored in a pressure vessel are likely to be highly volatile; thus, a low vapor pressure threshold would have little or no impact. Second, we do not expect the operating pressure or frequency of leaks to vary with the size of the storage vessel. Thus, the emissions for the same emission pathway would be the same regardless of the size of the storage vessel. Third, the fittings on the pressure vessel are comparable to the types of equipment (and in the same service as equipment) that would be subject to monitoring under proposed 40 CFR part 65, subpart J.
The proposed requirements for pressure vessels are to equip each opening with a closure device, operate without emissions to the atmosphere at any time, monitor annually all potential leak interfaces using Method 21 of 40 CFR part 60, appendix A-7 (or semiannually when using optical gas imaging), estimate and report emissions from periods when instrument readings exceed 500 ppmv or an image is detected and route purge streams to a control device. Closure devices are an operational necessity for pressure vessels, and they prevent emissions as well. We are proposing periodic monitoring requirements as a means to demonstrate compliance with the requirement to operate without emissions to the atmosphere. We have determined that estimating and reporting emissions is needed to help inform decisions about where to target compliance inspections and to ensure that the pressure vessels are properly operating with no vents to the atmosphere. The burden to conduct monitoring and associated recordkeeping and reporting is estimated to be about 2 hr/yr per storage vessel, at a cost of about $170/year for monitoring with Method 21 of 40 CFR part 60, appendix A-7. The burden is estimated to be about 3.5 hr/yr at a cost of about $260/year for monitoring with an optical gas imaging instrument. The differences in the proposed Uniform Standards are due primarily to the different monitoring frequencies.
We are proposing to include an alternative to the requirement of maintaining a closed system at all times. This alternative would allow you to purge inert materials that build up in the pressure vessel, provided the purge stream is routed through a closed vent system to a control device that achieves the same performance that is being proposed for atmospheric storage vessels (
We are proposing to require you to equip each storage vessel with an overfill detection sensor. A consortium of international oil companies conducted a study that concluded 11 percent of sunken-roof accidents were caused by overfilling the storage vessel (see
In the survey of technology for control of transfer operations that involve loading transport vehicles, we identified several compliance approaches. The most common is submerged loading (or bottom loading). We identified this compliance approach as Control Option TR1. We also identified four additional compliance approaches that are more effective than submerged loading alone: (1) Control Option TR2 is to route displaced emissions through a closed vent system to a flare; (2) Control Option TR3 is to route displaced emissions through a closed vent system to a control device that reduces regulated organic emissions by at least 98 percent or to less than 20 ppmv; (3) Control Option TR4 is to vapor balance the displaced emissions back to the storage vessel from which the transport vehicle is being loaded; and (4) Control Option TR5 is to route displaced emissions to a fuel gas system.
We estimated impacts only for Control Options TR1 and TR2. We did not estimate impacts for the other compliance approaches for several reasons. We did not estimate costs for Control Option TR3 because, as part of the analysis for the OLD NESHAP, we determined that flares are the most common and least costly control device for transfer racks. See the memorandum titled
Regardless of the control option, vapor tightness testing of the transport vehicle is an approach for ensuring that emissions are conveyed to the intended destination. Finally, LDAR for the equipment in the transfer rack is an approach for controlling fugitive emissions from the transfer rack itself. Each of the control options and other compliance approaches and how they have been incorporated into proposed subpart I are discussed in the sections below.
The emissions estimates for the model facilities in Table 7 of this preamble were estimated using procedures in AP-42 Chapter 5.2, assuming the average transfer temperature is 60 °Farenheit and the average vapor molecular weight of transferred materials is 80. The total capital investment was scaled from a quote for converting a rack that has six arms from splash loading to submerged loading; this quote was provided by an industry trade association during development of the gasoline distribution area source rule (see docket item EPA-HQ-OAR-2006-0406-0060). Annual costs were developed for operation, maintenance and indirect costs such as capital recovery. We also included a product recovery credit for the emissions prevented by the change in loading procedures. See the memorandum titled
Based on the results in Table 8 of this preamble, we determined that the costs of Control Option TR2 are reasonable when a facility transfers more than 35 million gal/yr of liquids that contain regulated material, and the weighted-average vapor pressure of the transferred liquids is a little over 3 psia. Using the monthly temperature data in AP-42 Chapter 7.1 to calculate vapor pressures for several cities shows the average true vapor pressure often is about 80 percent of the MTVP. Thus, we are proposing to require control of displaced emissions from transport vehicle loading at facilities that meet thresholds of at least 35 million gal/yr throughput and a weighted average MTVP of at least 4 psia.
As for storage vessels, some current rules specify thresholds for transfer operation control that are more stringent than the thresholds that we determined to be cost effective. For transfer operations, we decided not to propose any of the thresholds from current rules because few current rules require control of transfer operations, and the thresholds in these rules vary. We also have not conducted regulatory analyses for source categories that do not have control requirements for transfer operations. Therefore, we do not know what thresholds would be appropriate in those rules if they were to be amended to include requirements for transfer operations. At a minimum, the current analysis identifies the cost-effective thresholds that could be used as a starting point in more detailed analysis of requirements on a source category-specific basis.
In contrast to some current rules (
The option based on Control Option TR4 is similar to the vapor balancing approach in the OLD NESHAP and other rules in that it includes both design requirements and inspection requirements (
Finally, as in current rules, you would be required to take actions to assure that your closed vent system, vapor balancing system or fuel gas system is connected to the transport vehicle's vapor-collection equipment when regulated material is transferred. These requirements are intended to ensure that the displaced emissions are routed to the required control. Examples of actions to satisfy this requirement include training drivers in the hookup procedures and posting visible reminder signs at the affected transfer racks.
In the survey of technology of emission controls for transfer racks that are used to load containers, we identified several control approaches that have each been included in one or more current rules. For example, one approach is to use controls such as submerged loading or fitted openings in conjunction with transfer line purging. We also identified operational practices to control emissions from containers that are storing transferred regulated
For the impacts analysis, we evaluated two control options: Control Option TR6, which combines submerged fill with the operational practices of using closure devices on stored containers and Control Option TR7, which consists of venting displaced emissions through a closed vent system to a flare. We did not estimate impacts for the enclosure approach (Control Option TR8) because costs for the enclosure are expected to result in higher total costs than for Control Option TR7, and the control device might have to be larger to handle the airflow needed to meet the requirements in 40 CFR 52.741, appendix B. We did not estimate impacts for the vapor balancing approach (Control Option TR9) because we are not aware of any facility that is using this approach, and as with storage vessels, vapor balancing may not be feasible at all facilities due to allowable pressure limits for safe operation.
The impacts of Control Options TR6 and TR7 for a series of model transfer racks are presented in Table 9 of this preamble. The models cover a range of typical throughputs as reported by facilities that responded to an information collection request (ICR) for OLD operations (see the memorandum titled
Capital costs for submerged fill were estimated assuming the capital costs for retrofitting one station that loads containers are about half of the costs for retrofitting one arm that loads transport vehicles. Annual costs for submerged fill were estimated using the same procedures as in the analysis for Control Option TR1. Costs for the closed vent and flare system were scaled from costs developed from vendor information in the analysis for the OLD analysis (see docket item EPA-HQ-OAR-2003-0138-0053).
Uncontrolled emissions were estimated using two approaches. One approach was to use the vehicle refueling equation presented in AP-42 chapter 5.2. This approach was used in the analysis for the OLD NESHAP because surveyed OLD facilities were using nozzles like those used at gasoline service stations. A problem with this approach is that it is not reliable at low vapor pressures. Specifically, as the vapor pressure approaches zero, the emissions are estimated to be negative. Therefore, we also estimated emissions using a second approach, which was to use the transfer rack loss equation in AP-42 chapter 5.2 (
The results of this analysis show the cost impacts for Control Option TR6 are reasonable for throughputs greater than about 1 million gal/yr over the range of vapor pressures specified for the model transfer racks. The analysis also shows
We are also proposing other options that have equal or better performance that may be used instead of submerged loading, or that may be required, if justified, by referencing subparts. These other options include using fitted openings in conjunction with transfer line purging, which is specified in the Gasoline Distribution NESHAP (40 CFR part 63, subpart R). We are also proposing requirements for compliance approaches that are based on Control Options TR8 and TR9. These proposed requirements are a consolidated and streamlined version of the requirements in the Generic MACT for Containers and OLD NESHAP. If you use a closed vent system and control device, the control device would be required to reduce regulated material emissions by 95 percent, as in current rules. Inspection requirements for both closed vent systems and vapor balancing systems would be the same as for such systems used to convey emissions from loading of transport vehicles.
If you load a container 55 gallons or larger with material that has a MTVP greater than 4 psia and use the container for onsite storage of that material, then the container would be subject to either annual vapor tightness testing in accordance with Method 27 of 40 CFR part 60, appendix A-8, or annual monitoring of potential leak interfaces using Method 21 of 40 CFR part 60, appendix A-7. The leak definition for the EPA Method 21 testing would be 500 ppmv. These testing or monitoring requirements are needed to demonstrate that transferred materials with high vapor pressures are not emitted from storage. We request comment on the burden and costs of this proposed requirement to conduct vapor-tightness testing using Method 27 of 40 CFR part 60, appendix A-8. For example, we are interested in estimates of the number of containers that would have to be retrofitted with vapor-collection equipment, the costs of such retrofits and the fraction of the volume stored in such containers that exceeds the 4-psia threshold. In addition, since the MTVP of a given material varies, depending on location, we request comment on whether a threshold based on another parameter would be easier to implement.
As discussed in section VI.B.16 of this preamble, all definitions are located in proposed 40 CFR part 65, subpart H. Most of the definitions that are used in proposed subpart I are unchanged from the definitions in current rules, such as 40 CFR part 63, subpart WW and subpart EEEE. We are also proposing definitions for the terms “barge,” “fittings” and “pressure vessel,” which are not defined in current rules. The vapor balancing requirements for storage vessels specify that emissions from the storage vessel may be vapor balanced to a barge that is providing the liquid to fill the storage vessel. To clarify what type of vessel qualifies as a barge, we are proposing to define a barge as “any vessel that transports regulated material liquids in bulk on inland waterways or at sea.”
We are proposing to add a definition for the term “storage capacity.” This term is intended to take the place of the term “capacity” that is defined in 40 CFR part 63, subpart WW. We are proposing the change to avoid possible confusion because the term capacity is also used in a different context in proposed 40 CFR part 65, subpart M. We are also modifying the definition to specify that storage capacity of a flat-bottomed storage vessel is determined by multiplying the internal cross-sectional area of the storage vessel by the internal height of the shell, but the calculation for storage vessels with a sloped bottom or cone-up or cone-down bottoms need to be adjusted to account for the fact that the floor is not flat.
We are proposing to include a definition for “automatic bleeder vent (vacuum breaker vent).” Vacuum breaker vents equalize the pressure across a landed floating roof when liquid is either being withdrawn or added below the landed roof. Current rules do not include a definition for such devices, but historically vacuum breaker devices have been a covered well opening with a leg attached to the underside of the cover. When the roof lands, the leg opens the vent by lifting the cover off the well. Recently, we learned of a new design that is activated by pressure or vacuum differences across the roof. Theoretical calculations have shown such vents should open only while the roof is landed, not while it is floating. Based on this analysis, we have decided to include both mechanically activated and pressure/vacuum activated devices in the proposed definition of “automatic bleeder vent (vacuum breaker vent).” We request additional information, in particular, any test data that either supports or contradicts the theoretical analysis.
Finally, we are proposing to use a new definition of “maximum true vapor pressure” that excludes the list of methods that may be used to determine MTVP. In proposed subpart I, this list has been moved to 40 CFR 65.306. We also added a new method to the list:
We are proposing new Uniform Standards for control of emissions from equipment leaks. These Uniform Standards for equipment leaks would
In section IV of this preamble, the term “we” refers to the EPA and the term “you” refers to owners and operators affected by the proposed standards. Section IV.A.1 of this preamble identifies the regulated sources under the proposed 40 CFR part 65, subpart J. Sections IV.A.2 through 4 of this preamble summarize the proposed standards for equipment leaks. Section IV.A.5 of this preamble summarizes the proposed standards for using an optical gas imaging instrument to detect leaks. Section IV.A.6 of this preamble summarizes the notification, reporting and recordkeeping requirements. Section IV.B of this preamble presents the rationale behind the development of the proposed standards.
The proposed 40 CFR part 65, subpart J includes requirements for equipment in process units, closed vent systems and fuel gas systems, including valves, pumps, connectors, agitators, PRD, compressors, sampling connection systems, open-ended valves and lines, instrumentation systems and any other types of equipment specified by the referencing subpart that contain or contact regulated material (as defined by the referencing subpart). This subpart also includes requirements for closed-purge and closed-loop systems used to control emissions from certain types of equipment. Proposed 40 CFR part 65, subpart J does not include applicability provisions; instead, the referencing subpart would define what equipment in that source category is subject to the provisions of the Uniform Standards.
Your equipment would be subject to some or all of the requirements of 40 CFR part 65, subpart J when another subpart references the use of provisions of subpart J for air emission control. In addition, you would be required to meet the general provisions applicable to part 65 (
Equipment leak standards consist of techniques to detect leaks based on sensory inspections, instrument monitoring or use of an optical gas imaging instrument, as applicable. Equipment design standards specify requirements regarding the use, design or operation of the equipment. Each of these techniques is summarized in this section.
On December 22, 2008, we published an Alternative Work Practice (AWP) for LDAR that includes a combination of optical gas imaging and instrument monitoring techniques (73 FR 78199). The AWP provisions are located in the General Provisions in 40 CFR parts 60, 61 and 63, so any source subject to LDAR requirements in any current equipment leak rule may elect to comply with this AWP. (This includes the proposed Uniform Standards, as proposed 40 CFR part 65, subpart H specifies that those sections would continue to apply to the referencing subparts.) In addition, we are proposing the optical gas imaging-only provisions described in section IV.A.5 of this preamble. If specifically allowed by your referencing subpart, you would be allowed to use optical gas imaging rather than instrument monitoring to detect leaks from your equipment. You would be required to comply with the leak survey procedures for an optical gas imaging device that will be proposed in 40 CFR part 60, appendix K.
As in current equipment leak rules, the proposed Uniform Standards for equipment leaks are based on a combination of standards, including
For most types of equipment, current rules specify separate requirements for equipment in different types of service (
Section IV.A.4 of this preamble describes proposed standards for specific types of equipment. After you identify indications of a potential leak using sensory monitoring or identify a leak using instrument monitoring, optical gas imaging or other method, the proposed rule would require you to repair the leaking equipment using procedures that also are summarized in section IV.A.4 of this preamble. Finally, alternative equipment leak standards that are provided in the proposed rule are summarized in section IV.A.4 of this preamble.
We are also proposing provisions for subgrouping valves for monitoring purposes. We are proposing specific monitoring and repair requirements for valves located at a plant site with fewer than 250 total valves, valves for which the valve mechanism is not connected to a device that penetrates the valve housing (
We are also proposing specific monitoring and repair requirements for pumps equipped with a dual mechanical seal system that includes a barrier fluid system, pumps with no externally actuated shaft penetrating the pump housing, pumps located within the boundary of an unmanned plant site, unsafe-to-monitor pumps and difficult-to-monitor pumps.
In addition, we are proposing provisions that would apply only if your referencing subpart specifies that no releases to the atmosphere are allowed from any PRD in regulated material service. We are proposing that for each such PRD, you would be required to install and operate a monitor capable of identifying a pressure release, recording the time and duration of each pressure release and notifying operators that a pressure release has occurred. We are also proposing that if the monitor is capable of monitoring concentration of any flow through the PRD, then you would not also be required to conduct separate instrument monitoring no later than 5 calendar days after the PRD returns to regulated material service following a pressure release to confirm that the instrument reading is less than 500 ppm. You would also be required to calculate, record and report the quantity of regulated material released during each pressure relief event. Note that your referencing subpart may include other requirements for releases to the atmosphere as well.
The second option would be to designate that the compressor operates with an instrument reading of less than 500 ppm above background at all times. After you initially confirm that the compressor has an instrument reading less than 500 ppm, you would be required to conduct ongoing instrument monitoring at least annually to demonstrate that the compressor operates with an instrument reading of less than 500 ppm above background. If the instrument reading from any part of the compressor is 500 ppm above background or greater, the compressor would not be in compliance with proposed 40 CFR part 65, subpart J until the next instrument reading of less than 500 ppm above background.
In addition, you would be required to conduct annual instrument monitoring to demonstrate that the open-ended valve or line operates with an instrument reading of less than 500 ppm above background (
Open-ended valves and lines in an emergency shutdown system that are designed to open automatically in the event of a process upset would be exempt from the equipment design and instrument monitoring requirements. However, if your referencing subpart specifies that releases to the atmosphere from these types of open-ended valves and lines are not allowed, then any time an open-ended valve or line of this type does release to the atmosphere, it would not be in compliance with proposed 40 CFR part 65, subpart J. (Note that your referencing subpart may include other requirements for releases to the atmosphere as well.) In addition, open-ended valves and lines containing materials that would auto catalytically polymerize or would present an explosion, serious overpressure or other safety hazard if capped or equipped with a double block and bleed system would be exempt from the equipment and instrument monitoring requirements. Instead, you would be required to conduct sensory monitoring for these open-ended valves and lines.
We are also proposing special requirements for equipment in vacuum service. You would be required to identify equipment operating in vacuum service. You would also be required to demonstrate that the equipment is operating in vacuum service by installing and maintaining a pressure gauge and alarm system that will alert an operator immediately and automatically when the equipment is not operating vacuum service. If the alarm were triggered, you would be required either to initiate procedures immediately to return the equipment to vacuum service or to begin to comply with the applicable requirements of proposed 40 CFR part 65, subpart J (
We are also proposing to allow repairs to be delayed in a few specific situations. First, you would be allowed to delay repair if the repair is technically infeasible within 15 days of detection without a process unit shutdown. We are proposing to require repair of this equipment as soon as practical, but no later than the end of the next process unit shutdown or 5 years after detection, whichever is sooner. Any shutdown of 24 hours or longer would be considered the next process unit shutdown during which you would be required to repair the leak. Second, you would be allowed to delay repair if you determine that repair personnel would be exposed to an immediate danger as a consequence of complying with the repair requirement and you designate the equipment as unsafe-to-repair. Third, a delay in repair would be allowed for equipment that is isolated from the process and that does not remain in regulated material service. Fourth, for valves, connectors and agitators, delay of repair would be allowed if you demonstrate that emissions of purged material resulting from immediate repair would be greater than the fugitive emissions likely to result from delay of repair. When you do repair the valve, connector or agitator, you would be required to ensure the purged material is collected and destroyed, collected and routed to a fuel gas system or process or routed through a closed vent system to a control device. Finally, for pumps, you would be allowed to delay repair up to 6 months after the leak was detected if you demonstrate that repair would require a design change such as replacement of the existing seal design with a new seal system or a dual mechanical seal system, installing a pump with no external shaft or routing emissions through a closed vent system to a control device or to a fuel gas system. Regardless of the reason that you delay repair, you would be required to continue instrument monitoring on the appropriate schedule for that type of equipment.
If you delay repair of a valve or connector beyond 15 days, we are proposing to require that you repair the leaking equipment by replacing the leaking equipment with low leak technology unless it is not technically feasible to do so. You would have several types of “low leak technologies” from which to select. For valves, you could elect to repack the valve, replace the leaking valve with a valve designed to accommodate specific types of packing or replace the existing valve with a bellow seal valve. For connectors, you would have the option to replace the flange gasket or the entire connector. If you cannot replace the leaking equipment with low leak technology, then you would be required to explain why that replacement is technically infeasible in your annual periodic report and to keep records of the demonstration that replacement is technically infeasible. In addition, if that equipment leaks again in the future and you delay the repair beyond 15 days, you would be required to conduct a new analysis of the technical feasibility of using low leak technology (
We anticipate that for some source categories, specific requirements for using an optical gas imaging device to detect leaks without accompanying instrument monitoring could be an
Additionally, we are currently developing a protocol for using optical gas imaging techniques. The protocol will be proposed to be promulgated as appendix K to 40 CFR part 60. Proposed 40 CFR 65.450 specifies that you must follow this protocol if you opt to use optical gas imaging in lieu of EPA Method 21. This protocol will outline specifications of the equipment that must be used, calibration techniques, procedures for conducting surveys and training requirements for optical gas imaging instrument operators. The protocol will not specify the instrument that must be used, but it will provide specifications and performance criteria that must be met. The protocol will contain techniques to verify that your instrument can image the most prevalent chemical in your process unit. Because field conditions greatly impact detection of the regulated material using optical gas imaging, the protocol will describe the impact that these field conditions may have on readings and how to address them, as well as when monitoring with this technique is inappropriate. These field conditions include distance to the target, complex thermal environments, position of the sun, background temperatures, humidity, wind speed, wind direction, angle to the target and time of day. The protocol will also address difficulties with identifying equipment and leaks in dense industrial areas.
We note that, to date, appendix K to 40 CFR part 60 has not been proposed for review and comment. When appendix K to 40 CFR part 60 is proposed, we will request comments on that appendix K. In addition, we intend to provide an opportunity to comment on the application of appendix K to 40 CFR part 60 to the optical gas imaging provisions in these Uniform Standards.
If you elect to comply with 40 CFR 65.450, then we are proposing that, unless your referencing subpart specifies otherwise, you would monitor your equipment bimonthly, and that the optical gas imaging instrument would be required to detect leaks at 60 grams per hour or greater. Any image that appears on the optical gas imaging instrument screen would be considered a leak requiring repair, regardless of the type of equipment leaking. You would be required to follow the repair requirements in proposed 40 CFR 65.432, except that the monitoring to verify repair would be monitoring using the optical gas imaging instrument rather than instrument monitoring. You would be allowed to delay repair of leaks under the same provisions as if you conducted instrument monitoring (proposed 40 CFR 65.432(d)), including leaks that are technically infeasible to repair without a process unit shutdown and leaks in unsafe-to-repair equipment.
We are also proposing that you would keep the following records specific to equipment type: (1) For valves, the monitoring schedule for each process unit, documentation of the percent leaking calculation and documentation of valve subgrouping; (2) for pumps, documentation of visual inspections, documentation of dual mechanical seal pump visual inspections and documentation of the criteria that indicate failure of the seal system or the barrier fluid system; (3) for connectors, the start date and end date of each monitoring period for each process unit and documentation of the percent leaking calculation; (4) for agitators, documentation of visual inspections, documentation of dual mechanical seal agitator visual inspections and documentation of the criteria that indicate failure of the seal system or the barrier fluid system; (5) for PRD, the dates and results of each compliance test conducted for PRD in gas or vapor service after a pressure release and, if applicable, documentation of pressure releases (including duration and quantity of regulated material released); (6) for compressors, documentation of the criteria that indicate failure of the seal system or the barrier fluid system and, if applicable, the dates and results of each compliance test for compressors operating under the alternative compressor standard; (7) for sampling connection systems, documentation of the date and amount of each purge; (8) for open-ended lines and valves, the dates and results of each compliance test; and (9) for equipment in closed vent systems and fuel gas systems, the dates and results of each compliance test.
If you elect to perform instrument monitoring to demonstrate compliance for equipment in batch operations, you would record: (1) A list of equipment added to the batch operation since the last monitoring period; (2) the date and results of the monitoring for equipment added to a batch operation since the last monitoring period; (3) a statement that the inspection was performed if no leaking equipment is found; and (4) the proportion of the time during the calendar year that all the equipment in regulated material service in the batch operation is in use, including documentation that the equipment is in regulated material service the day you conduct monitoring.
For optical gas imaging, you would be required to keep: (1) Identification of the equipment and process units for which you choose to use the optical gas imaging instrument; (2) any records required to be kept by 40 CFR part 60, appendix K; (3) the video record used to document the leak survey results; and (4) the documentation of repairs and repair attempts otherwise required by proposed 40 CFR part 65, subpart J.
The proposed equipment LDAR requirements in the Uniform Standards are based on a survey and analysis of emissions reduction techniques that considered current practices and advances in technology, as well as the emissions reduction impacts and the cost impacts for model plants implementing those practices and technologies. The options considered in this analysis were developed mostly based on current federal rules, such as the National Emission Standards for Equipment Leaks—Control Level 2 Standards (40 CFR part 63, subpart UU; “Level 2 EL Generic MACT”), the Standards of Performance for Equipment Leaks of VOC in the Synthetic Organic Chemicals Manufacturing Industry for Which Construction, Reconstruction, or Modification Commenced After November 7, 2006 (40 CFR part 60, subpart VVa; “NSPS VVa”) and the National Emission Standards for Organic Hazardous Air Pollutants for Equipment Leaks (40 CFR part 63, subpart H; “HON”). Other options were developed from state and local rules and would be additional requirements not yet included in current federal regulations.
The proposed requirements for each type of equipment are the requirements that we determined are the most effective and reasonable for reducing emissions from equipment leaks after reviewing current rules and considering the costs and emissions reductions associated with each option. As noted previously in this preamble, we will determine the nationwide emissions reductions and cost impacts for any source category from which we propose to reference these Uniform Standards in the future to ensure those impacts continue to be reasonable on a nationwide basis, as well as meet any applicable statutory requirements (
We developed six model plants—three to represent chemical manufacturing processes and three to represent petroleum refineries. The chemical manufacturing models represent a range of process sizes, from a simple process with about 1,200 total pieces of equipment to a complex process with nearly 13,000 total pieces of equipment. The refinery models also represent a range of sizes, from a simple topping refinery with a total of about 1,800 pieces of equipment to a complex refinery with over 43,000 total pieces of equipment. These models allowed us to consider the costs and VOC emissions
As a first step, we decided to consider the impacts of implementing a LDAR program at an uncontrolled facility. While we expect that most equipment in regulated material service is already subject to a basic LDAR program, we wanted to evaluate the impacts of that program rather than simply assuming that a basic LDAR program is effective. We determined the costs and VOC emissions associated with implementing a basic LDAR program (hereafter referred to as the “baseline”) for each of the six models. The elements that make up the baseline LDAR program are described in the following paragraphs.
Most current equipment leaks regulations include two types of leak detection methodologies: Instrument monitoring using Method 21 of 40 CFR part 60, appendix A-7, and sensory monitoring. Based on our review of the requirements and the applicability of current rules, including federal, state and local rules, we determined that baseline was implementation of a LDAR program equivalent to the requirements in the National Emission Standards for Equipment Leaks—Control Level 1 (40 CFR part 63, subpart TT; “Level 1 EL Generic MACT”) and Standards of Performance for Equipment Leaks of VOC in the Synthetic Organic Compound Manufacturing Industry for which Construction, Reconstruction, or Modification Commenced After January 5, 1981 but Before November 7, 2006 (40 CFR part 60, subpart VV; “NSPS VV”). These requirements include instrument monitoring using Method 21 of 40 CFR part 60, appendix A-7, for valves and agitators in gas and vapor service and for valves, pumps and agitators in light liquid service. The baseline leak definition for all of the above types of equipment is 10,000 ppm, and each piece of equipment must be monitored monthly, although valves may be transitioned to a less frequent monitoring schedule if they meet certain criteria (
We determined the cost and VOC emissions reduction impacts of the baseline LDAR program described above for each of the six models. We then calculated the cost effectiveness for the six models. The results of these calculations are shown in Table 10 of this preamble.
When we compared the cost effectiveness of the baseline conditions for each model to the number of pieces of equipment in the models, we found that implementing the baseline LDAR program is more cost effective for models with higher equipment counts. This is due to the fact that there are several costs in the analysis that are fixed regardless of the number of pieces of equipment, such as the cost of the monitoring instrument and the number of hours spent on administrative activities and preparing reports. In particular, we note that baseline is the least cost effective for the model with less than 1,500 pieces of equipment.
From baseline, we evaluated a total of five regulatory options, two for valves, two for pumps and one for connectors. In each of these options, we considered the impacts of increasing the stringency of one piece of the LDAR program, each option building on the one before it for that specific piece of equipment. We decided to develop the options in this manner to consider the effectiveness of each piece of the program separately and ensure that the LDAR program proposed for the Uniform Standards included the most appropriate pieces. The calculation methodologies used to develop the cost and emissions reduction impacts for each of the models are described in the technical memorandum,
Throughout the rest of this section of the preamble, we present the impacts and cost effectiveness for each of the models. The costs and VOC emissions associated with each of the regulatory options were compared with the baseline costs and VOC emissions (or the previous option costs and VOC emissions, as appropriate) to determine the incremental costs and VOC emissions reduction impacts.
In Option 1 for valves, we considered the effect of lowering the leak definition from 10,000 ppm to 500 ppm for valves in gas and vapor service and valves in light liquid service. Table 11 of this preamble shows the incremental costs and VOC emissions reductions of lowering the leak definition from 10,000 ppm (baseline) to 500 ppm for valves in gas and vapor service and valves in light liquid service.
In Option 2 for valves, we considered further lowering the leak definition for valves in gas and vapor service and valves in light liquid service to 100 ppm. The leak definition of 100 ppm for valves is required in some state and local regulations, as well as consent decrees. However, we estimate that the incremental costs to reduce a ton of VOC emissions for this option increase significantly for all of the models compared to Option 1 for valves. Table 12 of this preamble shows the incremental costs and VOC emissions reductions of lowering the leak definition from 500 ppm (Option 1 for valves) to 100 ppm for valves in gas and vapor service and valves in light liquid service.
In Option 1 for pumps, we considered the effect of lowering the leak definition from 10,000 ppm to 2,000 ppm for pumps in light liquid service. Table 13 of this preamble shows the incremental costs and VOC emissions reductions of lowering the leak definition from 10,000 ppm (baseline) to 2,000 ppm for pumps in light liquid service. The analysis showed that Option 1 for pumps is more cost effective for the chemical manufacturing models than for the refinery models.
While this particular analysis showed that Option 1 for pumps is less cost effective for the refinery models, we note that there appear to be some anomalies in the values themselves. The large chemical manufacturing model (Model 3) and the small refinery model (Model 5) have a similar number of pumps, and the annualized costs (without VOC recovery credits) for these models is also very similar. However, the VOC recovery credit and VOC emissions reductions per year for Model 3 are over 3.5 times higher than those for Model 5. This trend is due to the fact that the calculated emissions factors for refinery pumps in this analysis range from about 2 to 5 times lower than the emissions factors for chemical manufacturing pumps. Part of that difference is expected and is due to the differences in the emissions equations in the
In Option 2 for pumps, we considered further lowering the leak definition for pumps in light liquid service to 500 ppm. The leak definition of 500 ppm for pumps appears in a few consent decrees. However, we estimated a significantly higher incremental cost to reduce a ton of VOC emissions for all of the models compared to Option 1 for pumps. Table 14 of this preamble shows the incremental costs and VOC emissions reductions of lowering the leak definition from 2,000 ppm (Option 1 for pumps) to 500 ppm for pumps in light liquid service.
In Option 1 for connectors, we considered the impact of adding instrument monitoring for connectors in gas and vapor service and connectors in light liquid service as in Level 2 EL Generic MACT. In this option, the leak definition is 500 ppm. Connectors are monitored annually, but similar to valves, there are provisions for less frequent monitoring if the connectors meet certain conditions. When we evaluated the costs and emission reduction impacts relative to the number of connectors in the models, we again noticed that the option was more cost effective for models with the most connectors. Again, this trend is due to the fact that the number of hours spent on administrative activities and preparing reports is fixed regardless of the number of connectors. Table 15 of this preamble shows the incremental costs and VOC emissions reductions (from baseline) of requiring monitoring of connectors in gas and vapor service and connectors in light liquid service at a leak definition of 500 ppm.
We also considered annual instrument monitoring for open-ended valves and lines. The requirement in nearly all equipment leak standards to equip open-ended valves and lines with a cap, blind flange, plug or a second valve is intended to essentially eliminate emissions from open-ended valves and lines. However, as we noted when we proposed amendments to NSPS VV (71 FR 65302, November 7, 2006), inspections conducted by enforcement agencies have found that many of these closure devices are leaking due to improper installation. Therefore, some states have begun to require instrument monitoring of open-ended valves and lines in addition to requiring a cap, blind flange, plug or a second valve. For example, in the Houston/Galveston/Brazoria area of
We considered the cost of instrument monitoring for open-ended valves and lines separately from the other options in this analysis. Since the cap, blind flange, plug or a second valve is required to seal the open-ended valve or line and eliminate emissions, we do not expect that monitoring would achieve any additional emissions reduction. Rather, the instrument monitoring would ensure compliance with the requirement that the cap, blind flange, plug or second valve seal the open-ended valve or line. The nationwide cost of these monitors would be incorporated into the estimate of monitoring, recordkeeping and reporting burden for the referencing subpart. The costs for the model plants ranged from a capital cost of $810 and an annualized cost of $180 for the simple chemical manufacturing model to a capital cost of $23,000 and an annualized cost of $5,400 for the complex refinery model.
Similarly, we also estimated the costs of requiring electronic monitoring of PRD. This analysis was conducted separately from the options listed above because installation of electronic monitors is not expected to achieve additional emissions reductions. Rather, the electronic monitors would be used to notify operators when there is a pressure release and aid them in ensuring compliance with the requirement that there be no releases from the PRD. The nationwide cost of these monitors would be incorporated into the estimate of monitoring, recordkeeping and reporting burden for the referencing subpart. The costs for the model plants ranged from a capital cost of $11,000 and an annualized cost of $1,600 for the simple chemical manufacturing model to a capital cost of $130,000 and an annualized cost of $19,000 for the complex refinery model. We note that the requirement to install this type of monitor would only apply if a referencing subpart specifically referenced this section.
The analysis of regulatory options described in section IV.B.1 of this preamble provided us with the information needed to determine the appropriate level of stringency for the requirements for the Uniform Standards for equipment leaks from valves, pumps and connectors. The next step was to determine the details for the proposed requirements, as well as determine what other provisions were appropriate to propose as part of the Uniform Standards. Rather than developing all-new regulatory language to describe these requirements, we reviewed the language provided in current equipment leaks regulations. We elected to use the Level 2 EL Generic MACT (40 CFR part 63, subpart UU) as a starting point for developing the Uniform Standards for equipment leaks. We determined that, as one of the most recently promulgated standards for equipment leaks, the Level 2 EL Generic MACT includes many of the provisions that we determined through the analysis described in section VI.B.I of this preamble are the appropriate level of control for the Uniform Standards. In addition, the Level 2 EL Generic MACT was already organized to be referenced from source category-specific subparts. The major overarching change that we made to the format of the Level 2 EL Generic MACT was to rearrange and rephrase all of the provisions to be consistent with our most recent “plain English” regulations.
We note that the Level 2 EL Generic MACT specifies certain types of equipment that are not subject to any of the requirements of that rule, such as equipment in lines with no process fluids. We have elected not to propose this specific provision in 40 CFR part 65, subpart J. Rather, we are proposing the requirements for detecting and repairing leaks in subpart J, and we expect that the referencing subpart will define clearly what equipment must comply with subpart J. Similarly, we are not proposing that equipment in vacuum service would be exempt from subpart J; instead, we are proposing the monitoring and recordkeeping requirements described in section IV.A.3 and section IV.B.5 of this preamble.
We also note that when reviewing the various equipment leak regulations, we noticed that while the requirements themselves are similar, the regulations are not consistent in defining a leak that must be repaired. As a specific example, the Level 2 EL Generic MACT specifies how to handle indications of liquids dripping that you find during a visual pump inspection, but it does not specifically say that indications of liquids dripping is a leak. Conversely, NSPS VVa specifically states that indications of liquids dripping is a leak and that removing the indications of liquids dripping is considered repair (although you are not required to conduct instrument monitoring to confirm repair in that case).
We believe that the standards are clearer if “repair” is defined based on the detection method used to identify the potential leak or leak. For example, for a leak detected using instrument monitoring, repair requires instrument monitoring to confirm that there is no longer a leak, while indications of a potential leak detected using sensory monitoring are considered repaired once you adjust or alter the equipment to eliminate the indications of a potential leak. Therefore, we are proposing in 40 CFR part 65, subpart H that “repaired” has different, specific meanings, depending on how the leak or potential leak is detected. We note that if you observe indications of a potential leak (
We are clarifying in this preamble that the proposed option to maintain certain types of equipment (e.g., such as compressors, PRD, open-ended valves and lines, and equipment in closed vent systems and fuel gas systems) below 500 ppm above background is considered a performance standard and not a leak definition indicating a leak requiring repair. Therefore, the instrument monitoring that we are proposing for those types of equipment is to confirm that the performance standard is being met; it is not instrument monitoring to detect a leak. Additional details regarding these proposed requirements are provided in the equipment-specific paragraphs in section IV.B.4 of this preamble.
As we reviewed the regulatory language of current equipment leak rules, we noticed that the rules include definitions of some types of equipment (
The following sections describe the rationale for specific proposed provisions.
As we noted in section IV.B.1 of this preamble, most current equipment leaks regulations include requirements for sensory monitoring, as well as instrument monitoring using Method 21 of 40 CFR part 60, appendix A-7. Sensory monitoring has traditionally been required for certain equipment for which it is considered not cost effective to require instrument monitoring, such as equipment in heavy liquid service and equipment that is in use a very short time during the year. Our analysis of emissions reduction techniques showed that sensory monitoring is still necessary and appropriate for certain types of equipment. For the specific types of equipment listed in 40 CFR 65.428, we are proposing to require sensory monitoring equivalent to the monitoring required in the Level 2 EL Generic MACT, including equipment in heavy liquid service, equipment in regulated material service less than 300 hr/yr, PRD in light liquid service and instrumentation systems.
The list also includes equipment types that may not be specified in other rules. First, as noted in section IV.B.1 of this preamble, we determined that instrument monitoring at the baseline level (
The change in format (
Based on the analysis described in section IV.B.1 of this preamble, we are proposing requirements mostly equivalent to the Level 2 EL Generic MACT, as well as instrument monitoring for open-ended valves and lines to ensure compliance with the proposed performance standard. We are also proposing several new requirements for delay of leak repair, including a requirement to install low leak technology when a leaking valve or connector is repaired more than 15 days after detection (
We are proposing to clarify how to determine monitoring frequency for valves in 40 CFR 65.420(a)(2)(i). In the
We are also proposing to clarify that the provision for 250 or fewer valves in a process unit in the Level 2 EL Generic MACT is intended to ensure that monthly monitoring is not required and that quarterly is the most frequent monitoring required. Regardless of the number of valves in your process unit, you may monitor valves less frequently than quarterly if the percent leaking calculation qualifies that process unit for less frequent monitoring.
We are proposing to clarify that you are not required to conduct instrument monitoring for valves with a valve mechanism that is not connected to a device that penetrates the valve housing (
We are proposing to retain the requirement found in many current equipment leaks rules to limit the number of difficult-to-monitor valves in a new source to less than 3 percent of the valves in that source. The Uniform Standards would not define a new source; a new source would be defined by the referencing subpart. We are also proposing that you would not have to limit the number of difficult-to-monitor valves in a new source (as defined by the referencing subpart) if all of the difficult-to-monitor valves in that new source meet the description of low leak technology (see sections IV.A.4 and IV.B.5 of this preamble). We also considered requiring all valves in a new source to be designed to meet the description of low leak technology (not just those that you designate as difficult-to-monitor), unless it is technically infeasible to do so. If we included that provision in the Uniform Standards, we would consider removing the 3-percent restriction on difficult-to-monitor valves in a new source, since the potential for leaks from all of the valves would be reduced. We request comment on the proposed provision providing the option of designing difficult-to-monitor valves in a new source to meet the description of low leak technology, as well as the idea of requiring all valves in a new source to be designed to meet the description of low leak technology.
Finally, as we noted in section IV.B.1 of this preamble, we evaluated the impacts of lowering the leak definition from 500 ppm to 100 ppm for valves. Based on our analysis, we concluded that for this proposed rule, 500 ppm is the appropriate leak definition for valves. However, we note that our analysis was general and based on assumptions that may not be applicable to all source categories. We expect that when conducting the analysis to determine whether it is appropriate to reference these Uniform Standards from each source category, we will consider the appropriate leak definition for valves in that source category. If the analysis shows that referencing the Uniform Standards would be appropriate with a lower leak definition than 500 ppm for valves, then the referencing subpart could specify that lower leak definition and override the requirements in the Uniform Standards. We request comment and additional data supporting a different leak definition for valves in the Uniform Standard.
We are proposing to maintain the leak definition of 5,000 ppm for pumps handling polymerizing monomers. This leak definition was set nearly 20 years ago, during the development of the HON, based on the argument that since mechanical seals cannot be used on pumps handling polymerizing monomers, these pumps cannot achieve a 2,000-ppm leak performance level. We request comment and any available data either to support maintaining the 5,000-ppm leak definition for pumps handling polymerizing monomers or to support lowering the leak definition for pumps handling polymerizing monomers.
We are proposing to include the Level 2 EL Generic MACT requirements for weekly inspections of pumps subject to 40 CFR 65.421, including dual mechanical seal pumps. Like the Level 2 EL Generic MACT, we are proposing that if you find indications of liquids dripping during a weekly inspection, you could choose whether to repair the pump, eliminating those indications of liquids dripping or conduct instrument monitoring to determine if there is a leak. We are proposing to add a requirement that if you choose to repair the pump to eliminate the potential leak rather than conducting instrument monitoring, you would be required to do so before the next weekly inspection. This limit of time is similar to the 5 days allowed to repair equipment subject to sensory monitoring requirements. However, if we required repair within 5 days of detection and the next weekly inspection occurred less than 5 days after the inspection in which you observed the indications of liquids dripping (see the “reasonable interval” provisions in the General Provisions), then you would presumably continue to see the indications of liquids dripping that you are already planning to eliminate, and that weekly inspection would not provide any new information. We request comment on the amount of time provided to repair pumps with indications of liquids dripping.
We are also proposing an additional clarification regarding weekly inspections for pumps consistent with NSPS VVa. The aim of an LDAR program is to find and repair leaks. In some instances, the liquids found dripping from pumps are not leaks; for example, the liquids could simply be condensation from the atmosphere. Therefore, we are proposing to clarify in 40 CFR 65.421(c), consistent with NSPS VVa, that if you see liquids dripping during a weekly inspection, you choose to conduct instrument monitoring and
We note that persistent liquids dripping may indicate an operation problem that should be addressed by maintenance. If indications of liquids dripping are noted for one pump during multiple weekly inspections, we encourage you to ensure that the pump is operating properly.
We are not proposing to require you to implement a quality improvement program (QIP) for pumps. In the Level 2 EL Generic MACT, you are required to implement a QIP if “at least the greater of either 10 percent of the pumps in a process unit or three pumps” are leaking. However, evaluation of compliance with current rules that include these provisions has shown that these provisions are complicated and rarely used. We request comment on whether there is need to include QIP provisions for pumps in these Uniform Standards. We also request comment on whether we should substitute the QIP provisions with a similar, but more straightforward requirement. For example, we could include a requirement that if 10 percent of the pumps in a process leak, you would have to replace a certain percentage of those pumps with dual mechanical seal pumps within a set amount of time. A provision like this would achieve similar goals to the QIP, but would be much simpler to understand and implement.
As we noted in section IV.B.1 of this preamble, we evaluated the impacts of lowering the leak definition from 2,000 ppm to 500 ppm for pumps. Based on our analysis, we concluded that for this proposed rule, 2,000 ppm is the appropriate leak definition for pumps. However, as with valves, our analyses were general and were based on assumptions that may not be applicable to all source categories that could reference these Uniform Standards. We expect that when conducting the analysis to determine whether it is appropriate to reference these Uniform Standards from each source category, we will consider the appropriate leak definitions for pumps. If the analysis shows that referencing the Uniform Standards would be appropriate with a lower leak definition for pumps, then the referencing subpart can specify the lower level and override the requirements in the Uniform Standards. We request comment and additional data supporting a different leak definition for pumps in the Uniform Standard.
We expect that we will estimate the costs and emissions reduction impacts of the Uniform Standards for each potential referencing subpart. At that time, we will evaluate the necessary factors (including cost effectiveness, if appropriate) and determine whether to require instrument monitoring for connectors. By including the connector monitoring provisions in the Uniform Standards, we can ensure that the instrument monitoring provisions for connectors will be consistent with the instrument monitoring provisions for other equipment in the Uniform Standards if we determine in the future that instrument monitoring of connectors is appropriate for a particular source category.
Therefore, we are proposing that you would conduct instrument monitoring for connectors in gas and vapor service and connectors in light liquid service, as in Level 2 EL Generic MACT, only if required by your referencing subpart. We did rearrange the paragraphs and make small clarifications to the language, but aside from specifying in the Uniform Standards that connector monitoring and repair is required only if specified by your referencing subpart, there are no substantive differences between the connector requirements in the Level 2 EL Generic MACT and the connector requirements proposed in the Uniform Standards. The differences between the Level 2 EL Generic MACT and the proposed Uniform Standards are described in this section. We request comment on whether there are other requirements for connectors that we should consider.
If your referencing subpart does require connector monitoring, we are proposing two requirements to clarify that the connector requirements are analogous to the requirements for valves. First, connector monitoring data generated less than 12 months before a process unit becomes subject to this subpart would be allowed in determining monitoring frequency (as well as counting as the initial monitoring for connectors). Second, the monitoring that you are required to perform after repairing a leaking connector and within 90 days of detecting the leak is not the same monitoring that you must perform to meet the definition of “repair.”
Finally, we are proposing to limit the types of connectors that can be classified as “inaccessible” connectors in 40 CFR 65.416(b). We are not proposing to include connectors that cannot be reached without elevating personnel (as in the Level 2 EL Generic MACT). These connectors would already be classified as difficult-to-monitor connectors under proposed 40 CFR 65.416(a)(2). In addition, we are not specifically including connectors that cannot be accessed at any time in a safe manner to perform monitoring. Instead, we consider these connectors to be classified as unsafe-to-monitor under proposed 40 CFR 65.416(a)(1). See section IV.B.5 of this preamble for additional detail about unsafe-to-monitor and difficult-to-monitor equipment.
Given the similarities between pumps and agitators in design, operation and current regulatory requirements, we considered lowering the leak definition for agitators from 10,000 ppm. However, we do not currently have sufficient data on agitator monitoring to conduct such an analysis. We request comment and additional data supporting either maintaining the leak definition at 10,000 ppm or lowering the leak definition.
In addition, your referencing subpart may specify that no releases are allowed from any PRD, as release events from PRD have the potential to emit large quantities of regulated material. In that case, it is important to identify and control any releases in a timely manner. Therefore, if your referencing subpart specifies that no releases be allowed from your PRD, we are proposing to require you to install electronic indicators on each PRD that would be able to identify and record the time and duration of each pressure release. In addition to ensuring that significant releases are addressed, these requirements will also alert operators to any operational problems with the PRD seal that could be resulting in emissions to the atmosphere. (We are also proposing that if your electronic indicator can measure the concentration of any flow through the PRD, such that it is capable of verifying that the PRD has reseated properly after any release, you would not be required to conduct additional instrument monitoring to verify that the PRD is operating below 500 ppm above background following a pressure release. You would still be required to keep a record of the concentration provided by this monitor to demonstrate that the concentration is less than 500 ppm above background.)
We request comment on the proposed requirements, including whether the PRD in liquid service should be required to meet the 500-ppm performance standard rather than conducting sensory monitoring. We also request comment on other approaches we could take to reduce leaks and manage releases from PRD.
As noted in section IV.B.2 of this preamble, we are clarifying that the proposed alternative to maintain compressors at an instrument reading below 500 ppm above background is considered a performance standard. We did consider specifying a time frame for repair if you monitor the compressor and get an instrument reading above 500 ppm. However, we determined that since the instrument reading above 500 ppm is a deviation from the standard and not a leak, we should not allow a set number of days for repair or allow delay of repair. Instead, the deviation for that compressor would be continued until you return the compressor to a condition indicated by an instrument reading less than 500 ppm above background. To encourage you to take action as soon as possible to return the compressor to compliance, we are proposing to require that you must provide in your semiannual periodic report the date of the instrument reading 500 ppm above background or greater and the date of the next instrument reading less than 500 ppm above background (
We are also proposing to allow you to collect and recycle the purged process fluid to a process, consistent with NSPS VVa. We are proposing to add this option in 40 CFR 65.426(a)(4) for design of the closed-purge, closed-loop or closed vent system because the Level 2 EL Generic MACT requirement to return the purged process fluid “directly” to a process line could be interpreted to mean that you could not route the process fluid to a process using any method other than direct piping. We intend that use of the word “collect” in this proposed option means the purged fluid should not be allowed to escape. The use of either containers or piping would be an acceptable means of complying with this option. Consistent with the Level 2 EL Generic MACT, we are also proposing to allow you to collect and recycle the purged process fluid to a fuel gas system that meets the requirements of proposed 40 CFR part 65, subpart M.
We are proposing to clarify through the definition of “sampling connection system” in proposed 40 CFR 65.295 that lines that convey samples to analyzers and analyzer bypass lines are considered part of sampling connection systems. You would be required to meet the same requirements for the purged process fluid in these lines that you are required to meet for other purged process fluids. We are also clarifying that, for the purposes of this provision, CEMS are not considered analyzers, as they are typically located on stacks and are analyzing emissions rather than process fluids.
Finally, the Level 2 EL Generic MACT includes three options for collecting, storing and transporting purged process fluids, and consistent with NSPS VVa, we are proposing to add two other options in 40 CFR 65.426(a)(4)(iv).
However, the Level 2 EL Generic MACT includes an exception to the option to collect, store and transport the purged process fluid to a waste management unit that is operated in compliance with the requirements of 40 CFR part 63, subpart G that we are not proposing, consistent with NSPS VVa. Specifically, we are not proposing to allow you to transport purged process fluid that contains regulated material to a waste management unit that has a National Pollution Discharge Elimination System (NPDES) permit instead of to a waste management unit operated in compliance with the requirements of 40 CFR part 63, subpart G, applicable to group 1 wastewater steams because NPDES permits do not require suppression from the wastewater treatment system. Therefore, the emissions from the purged process fluid would not be controlled adequately if we allowed you to send purged process fluid to a waste management unit that has a NPDES permit.
We are proposing to require sensory monitoring for open-ended valves and lines containing materials that would auto catalytically polymerize or would present an explosion, serious overpressure or other safety hazard if capped or equipped with a double block and bleed system. These open-ended valves and lines are exempt from the requirement to install a cap, blind flange, plug or second valve because of the risk of serious overpressure leading to catastrophic failure and, potentially, greater emissions to the atmosphere than if the line is left uncapped. However, we do believe that it is appropriate to require sensory monitoring in this case, as indications of a potential leak from the open-ended valve or line could indicate a leak in the seal of the open-ended valve.
In addition, we are proposing a few clarifications to the definition of “open-ended valve or line.” First, we recognize that the literal interpretation of the phrase “one side of the valve seat in contact with process fluid and one side open to atmosphere, either directly or through open piping” could lead you to the inaccurate conclusion that once you install a cap, plug, blind flange or second valve on the open-ended valve or line, you no longer have one side of the valve seat open to the atmosphere, so it is no longer an “open-ended valve or line.” However, that is not our intended interpretation. Instead, we consider an open-ended valve or line with a cap, plug, blind flange or second valve to be a controlled open-ended valve or line. Therefore, we are proposing to clarify that an open-ended valve or line with a cap, blind flange, plug or second valve on the side that would be otherwise open to the atmosphere is still considered an open-ended valve or line. Second, we are adding the words “any length of” to that phrase, so it reads “or one side open to atmosphere, either directly or through any length of open piping.” This proposed language clarifies that a valve with one side of the valve seat open to the atmosphere through a very long length of pipe is still considered an open-ended valve or line.
Similar to the alternative standard for compressors, we did consider specifying a time frame for repair for an instrument reading of 500 ppm above background or greater. However, we determined that since the instrument reading of 500 ppm above background or greater indicates a deviation from the standard rather than the presence of a leak, we determined that it would not be appropriate to provide a set number of days for repair or allow delay of repair. Instead, we expect you to take action as soon as possible to return the equipment to an instrument reading less than 500 ppm above background. We are proposing to require that you must provide in your semiannual periodic report, the date of
We are proposing several general clarifications and new requirements that are not specific to certain types of equipment. These clarifications and new requirements are described below.
Finally, we evaluated the provisions for inaccessible connectors, and we determined that two of the provisions are more appropriately classified as factors that make the connector either difficult-to-monitor or unsafe-to-monitor. In addition, we saw no reason why these provisions should be limited to connectors rather than applicable to all equipment. Therefore, we are proposing to add “equipment that you cannot access without the use of a motorized man-lift basket in areas where an ignition potential exists” and “equipment in near proximity to hazards such as electrical lines” to the list of examples of unsafe-to-monitor equipment in proposed 40 CFR 65.416(a).
To ensure that the monitoring results are as accurate as possible, we are also proposing in 40 CFR 65.431(a)(3)(ii) to require a calibration drift assessment similar to the requirements in NSPS VVa. At a minimum, you would be required to perform a calibration drift assessment at the end of each monitoring day. Post-test calibration drift assessments constitute good practice and are a useful quality assurance/quality control (QA/QC) tool to validate the proper operation of the monitor during the monitoring period and, hence, the measurement data. We note that the proposed requirement for a calibration drift assessment is not an effort to make the method more accurate than was originally intended; it is intended as an additional quality assurance check.
As proposed, you would be required to check the instrument with the same calibration gases as before use and calculate the percent difference from the most recent calibration value. If the drift assessment shows a negative drift of more than 10 percent, then you would have to calculate the leak definition adjusted for negative drift and re-monitor all equipment monitored since the last calibration with instrument readings below the applicable leak definition and above the leak definition adjusted for negative drift. For example, if your leak definition is 500 ppm and you calculated the negative drift to be 15 percent, you would calculate the leak definition adjusted for negative drift as 425 ppm, and you would have to re-monitor equipment with instrument readings above 425 ppm and below 500 ppm to confirm that those pieces of equipment are not leaking. If the drift assessment shows a positive drift of more than 10 percent, then you would have the option to re-monitor all equipment monitored since the last calibration with instrument readings above the applicable leak definition and above the leak definition adjusted for positive drift. Using the same example, you would calculate the leak definition adjusted for negative drift as 575 ppm, and you could elect to re-monitor equipment with instrument readings above 500 ppm and below 575 ppm to show that those pieces of equipment are not actually leaking.
We are also proposing that if you have a process unit shutdown of longer than 24 hours, planned or unplanned, you would take the time during that shutdown to repair all equipment for which you delayed repair until the next process unit shutdown. We expect that you would purchase the supplies needed to repair the leaks when the leaks are first detected so that you would be prepared to make repairs during an unplanned shutdown. You would not be required to begin making repairs until the shutdown lasts 24 hours, but you would be required to extend the shutdown until all equipment for which you delayed repair until the next shutdown have been repaired. You would not be required to repair leaks detected less than 15 days before the shutdown. While we expect that you would have ordered the supplies needed for repair, they may not arrive in less than 15 days. In addition, the delay of repair requirements are intended for equipment that cannot be repaired in 15 days, so it is not reasonable to expect that you will always know in less than 15 days that a leak cannot be repaired without a process unit shutdown. We request comment on requiring repairs during any shutdown longer than 24 hours.
We are clarifying that you would continue to conduct instrument monitoring on the schedule required by 40 CFR 65.420 through 65.427 while repair of the leak is delayed. The current equipment leaks requirements do not specify clearly that monitoring may be suspended, but we are aware that some owners and operators have interpreted the current regulations to mean that monitoring is not required. However, continuing to conduct instrument monitoring while repair is delayed provides information about the magnitude of the leak during that time. If the leak grows significantly over time, you may determine that it is appropriate to reschedule the next shutdown to repair the leak sooner. You would not be required to report the results of the continued monitoring, but you would be required to keep records of those results. We are also proposing that for a pump or agitator for which you have delayed repair, you may suspend the weekly inspection until the pump or agitator is repaired.
Finally, we are proposing that unless it is technically infeasible for you to do so, when you do repair valves and connectors for which you delayed repair, you must replace leaking valves and connectors with low leak technology (
We recognize that there are situations where replacing the packing, gaskets or entire piece of equipment may not be technically feasible. In that case, you would be required to document the demonstration that such repair was technically infeasible and include the documentation in your annual periodic report. We are proposing that you would be required to evaluate this demonstration each time you delay repair for a piece of equipment. For example, suppose you previously determined that it was technically infeasible to install low leak technology to repair a valve for which you delayed repair. If that valve leaks again in the future and you have to delay repair beyond 15 days again, you would be required to demonstrate that it is still technically infeasible to install low leak technology to repair a valve; you cannot simply refer to your previous determination. We request comment on this proposed requirement, including whether there are other times that we should require installation of low leak technology and whether we should provide specific circumstances for which installation of low leak technology would not be required due to technical infeasibility (and if so, what those circumstances should be).
We note that, as we stated in the preamble to the proposed amendments to NSPS VV (71 FR 65302, November 7, 2006), sealant injection procedures such as drill and tap methods have advanced in recent years to the point that they are a viable on-line repair technique for many leaking valves. Therefore, we are again clarifying in this proposal that if sealant injection procedures such as drill and tap are a technically feasible type of repair for a specific valve, then those procedures should be attempted before you determine that it is necessary to delay repair for that valve.
However, we are not proposing the alternative to route equipment leaks from other pumps and agitators to a fuel gas system or through a closed vent system to a control device. Based on our information, we believe the alternative is rarely, if ever, used for these types of equipment. We request comment on specific situations for which this alternative would apply, particularly from any owners and operators complying with a similar alternative under current equipment leak standards.
As noted in section IV.A.5 of this preamble, we anticipate that for some source categories, specific requirements for using an optical gas imaging device to detect leaks without accompanying instrument monitoring could be an appropriate alternative to the requirements described in section IV.A.4 of this preamble. Therefore, we are proposing to allow the use of optical gas imaging as a standalone technique for detecting equipment leaks in regulated material service. However, as we also noted in section IV.A.5 of this preamble, we believe that this technique is not currently suitable for detection of leaking compounds in all industry sectors, in part, due to the limitation of the number of compounds that can be screened using this technology. Therefore, we are proposing that the provisions for use of an optical gas imaging instrument for leak detection would be allowed as an alternative only if your referencing subpart includes a direct reference to 40 CFR 65.450. We expect that a referencing subpart will include a direct reference to 40 CFR 65.450 only if it is technically feasible for the sources in that source category to follow the protocol proposed in 40 CFR part 60, appendix K. Structuring the requirements in this way ensures that the optical gas imaging techniques are applied consistently over the various source categories, but provides the referencing subpart the flexibility to define clearly when the optical gas imaging provisions may be used.
We are proposing to include a monitoring frequency of bimonthly and a leak detection level of 60 grams per hour in the Uniform Standards that would apply if the referencing subpart allows you to use the optical gas imaging alternative, but does not specify a monitoring frequency and/or leak detection level. We believe that the appropriate monitoring frequency and leak detection level for a given source category is likely to vary depending on the regulated material and other industry-specific factors. However, we currently do not have data to support setting different parameters, so we are proposing to set the levels in the Uniform Standards consistent with the AWP. Unless and until industry-specific and regulated material-specific data can be gathered using the optical gas imaging instrument, it is not reasonable to expect each referencing subpart to set
This section summarizes the requirements proposed under 40 CFR part 65, subpart M in this action. The proposed requirements summarized in this section are based on the EPA's review of current regulations for closed vent systems; control devices used to control process vents from reactors, distillation and other operations, as well as from emissions from storage vessels, transfer and equipment leaks; and fuel gas systems used for air emissions control. These requirements reflect our intent to implement a simplified approach to rulemaking that results in consistent requirements for these emission points across multiple source categories. Subpart M consolidates and simplifies monitoring, recordkeeping and reporting requirements from current NSPS and NESHAP, eliminates duplicative or unnecessarily burdensome requirements and examines advances in control practices and technology that could be considered for control options in future rulemakings.
In section V of this preamble, the term “we” refers to the EPA and the term “you” refers to owners and operators of sources affected by the proposed standards. Section V.B of this preamble provides our rationale for the proposed requirements in 40 CFR part 65, subpart M. Additionally, “subpart M” refers to proposed 40 CFR part 65, Subpart M.
The proposed rule specifies requirements for closed vent systems collecting regulated materials from a regulated source under the referencing subpart; control devices that are used to reduce regulated material emissions from emission points affected by a subpart that references the use of subpart M, including small boilers and process heaters, oxidizers, absorbers, adsorbers, condensers, biofilters, fabric filters, sorbent injection and other control devices; and fuel gas systems used to meet the air emission control requirements of a referencing subpart. The owner or operator would use subpart M to comply with emission standards for any emission unit type (
We are proposing to require that all owners and operators using a control device to comply with a referencing subpart meet the requirements for closed vent systems. For a closed vent system that contains bypass lines that can divert the stream away from the control device to the atmosphere, you would be required to either (1) install, maintain and operate a continuous parameter monitoring system (CPMS) for flow that is capable of recording the volume of gas that bypassed the control device and is equipped with an automatic alarm system that will alert an operator immediately when flow is detected in the bypass line, or (2) to secure the bypass line valve in the non-diverting position with a car-seal or a lock-and-key type configuration. You would be required to inspect the seal or closure mechanism at least once per month to verify the valve is maintained in the non-diverting position. Use of a bypass at any time regulated materials are flowing in the closed vent system that results in a release of regulated materials to the atmosphere is considered an emissions standards deviation under the proposed rule.
The closed vent system equipment collecting regulated material from a regulated source would be subject to the applicable requirements of the equipment leak Uniform Standards of proposed 40 CFR part 65, subpart J (see section IV.A of this preamble).
Under the proposed requirements, you would be required to conduct continuous monitoring for each boiler, process heater, oxidizer, absorber, adsorber, condenser, sorbent injection, biofilter, fabric filter or other control device used to comply with standards in the referencing subpart. The monitoring, recordkeeping and reporting requirements proposed in subpart M are applicable to all control devices. This includes control devices in series with one another (
For each of these control devices, you must install a CEMS capable of measuring regulated material in the exhaust stream of the control device or you may elect to install and operate a CPMS, unless disallowed by a referencing subpart. You would be required to establish operating limits for monitored parameters that indicate the control device is meeting the specified emission standard of the referencing subpart. For fabric filters, we are proposing that you equip your fabric filter with a bag leak detection system with a device able to continuously record the output signal from the sensor. Additionally, the bag leak detection system must be equipped with an alarm system that will sound when an increase in PM emissions is detected and which does not sound more than 5 percent of the operating time during a 6-month period; if the alarm sounds more than 5 percent of the operating time during a 6-month period, it is considered a deviation. The proposed rule provides guidance for calculating the alarm time and directs the corrective actions to be taken.
As part of the proposed general monitoring requirements for control devices, CEMS and CPMS must follow the requirements specified in proposed 40 CFR 65.711 and 40 CFR 65.712. For each CEMS used to comply with the referencing subpart, we are proposing that you operate and maintain each CEMS according to the requirements of your CEMS performance evaluation and monitoring plan. We are proposing that you conduct initial and periodic performance evaluations of each CEMS used to comply with the referencing subpart according to this plan. In addition, for each CPMS used to comply with the referencing subpart, we are proposing that you operate and maintain each CPMS according to the requirements of your CPMS monitoring
All CPMS would be required to meet minimum calibration and quality control requirements, as specified in Table 4 of subpart M. For each monitored parameter, you would establish an operating limit, pursuant to the requirements of proposed 40 CFR 65.713. Table 3 of subpart M specifies the operating parameters, operating limits and data monitoring, recordkeeping and compliance frequencies for each type of control device covered by proposed subpart M. Tables 1 and 2 of subpart M specify the monitoring equipment requirements when using CEMS and CPMS. You would be required to keep monitoring system records for your CEMS or CPMS, as specified in proposed 40 CFR 65.860. Additionally, you would be required to meet the control device-specific monitoring requirements in proposed 40 CFR 65.724 through 65.800 for the specific control measure(s) being used.
In addition to monitoring, we are proposing that for each control device, you must conduct a performance test to determine compliance with the referencing subpart unless you meet the exemptions specified in proposed 40 CFR 65.702(e). You must conduct the performance test for each control device according to the requirements of proposed 40 CFR 65.820 through 65.829 (see section V.A.7 of this preamble). For fabric filters, you would be required to conduct a performance evaluation consistent with the
Owners or operators using a fuel gas system to comply with the requirements of the referencing subpart would be required to submit a statement that the emission stream is connected to the fuel gas system in the Notification of Compliance Status Report. Fuel gas systems used to meet air emissions control would be subject to the applicable proposed equipment leak Uniform Standards of 40 CFR part 65, subpart J (see section IV.A of this preamble) as they apply to the individual equipment components comprising the fuel gas system. These requirements include specific instrument monitoring requirements for equipment in gas and vapor service and equipment in light liquid service, and specific sensory monitoring requirements for equipment in heavy liquid service and other equipment that meets certain criteria. You would also be required to meet the control device provisions in proposed 40 CFR 65.724 for small boilers and process heaters that are a part of the fuel gas system if regulated material is routed to the fuel gas system for control.
For each small boiler or process heater, thermal oxidizer, catalytic oxidizer, absorber, adsorber, condenser, biofilter, sorbent injection system or other control device used to comply with the referencing subpart, you would be required to keep the records described in section V.A.8 of this preamble.
The performance testing requirements for subpart M are included in proposed 40 CFR 65.820 through 65.829. Proposed 40 CFR 65.820 provides requirements for notification, development and submittal of a performance test plan, and specifies the “performance testing facilities” that must be provided by owners and operators required to conduct a performance test (see proposed 40 CFR 65.820(d)).
For each control device controlling regulated materials for which a performance test is required, the proposed standards specify requirements on how to test vent streams from continuous process operations, batch process operations and combined continuous and batch process operations in proposed 40 CFR 65.821. For continuous process operations, we are proposing that you conduct performance tests during “maximum representative operating conditions for the process.” Specifically, we are proposing that you must operate your process during the performance test in such a way that results in the most challenging condition for the control device. The most challenging condition for the control device may include, but is not limited to, the highest HAP mass loading rate to the control device, or the highest HAP mass loading rate of constituents that approach the limits of solubility for scrubbing media.
For batch process operations, performance tests must be conducted at absolute worst-case conditions or hypothetical worst-case conditions. The proposed standards define the criteria for selecting the absolute worst-case and hypothetical worst-case conditions in 40 CFR 65.822 (see section V.B.6 of this preamble). We are also proposing that you develop an emissions profile that would describe the characteristics of the vent stream at the inlet to the control device under those absolute or hypothetical worst-case conditions you selected. You would then be required to control and achieve the emission limit prescribed under the referencing subpart, and conduct your performance tests for those periods of worst-case conditions you selected (see section V.B.6 of this preamble).
For combined continuous and batch process operations, you must conduct performance tests when the batch process operations are operating at absolute worst-case conditions or hypothetical worst-case conditions, and the continuous operations are operating at the maximum representative operating conditions for the process.
Table 5 to proposed subpart M specifies the applicable test methods and procedures for each test run, based on the type of emission limit specified in the referencing subpart. As discussed in section II.E of this preamble, we anticipate that the referencing subpart will establish the emission limit that best represents the level of control needed for the source category. The referencing subpart would provide rationale for the format and units of measure for each limit, or, if applicable, rationale for the use of a surrogate in cases where methods for a specific pollutant are insufficient.
We are proposing that if you make a change to process equipment or operating conditions that would affect the operating parameter values of a control device and render the operating limits ineffective as indicators of compliance with the standard, you must conduct a performance test within 180 days of the date of startup of the change to establish new operating limits and demonstrate that you are in compliance with the applicable emission limit of the referencing subpart.
We have included additional requirements for performance testing, including sampling, duration and calculations for determining compliance
In proposed 40 CFR 65.835, we have included a method for demonstrating compliance with an aggregated percent reduction emission standard. These requirements apply when a referencing subpart allows the owner or operator to show compliance with a percent reduction by aggregating emissions over the full batch process. To demonstrate compliance, the owner or operator would use the proposed engineering evaluation methodologies to calculate uncontrolled emissions from all batch process operations for a given process that they do not want to control. The owner or operator would still determine, through performance testing, uncontrolled and controlled emissions from batch process operations that are controlled. All emissions from all batch process operations (
In addition, we are proposing that you use these engineering evaluation methodologies if you choose to develop an emissions profile by process for determining absolute worst-case conditions of your batch process operations. You would also use these methodologies as part of your condenser design evaluation (see the specific condenser section of section V.B.3 of this preamble).
Except for condensers, under the proposed standards, you may demonstrate compliance for a non-flare control device by conducting a design evaluation in lieu of a performance test, if allowed by the referencing subpart. The design evaluation would require documentation that the control device being used achieves the emission limit required by the referencing subpart. For condensers, we are proposing that you must conduct a design evaluation (see section V.B.3 of this preamble). The evaluation must also include documentation of the composition of the vent stream entering each control device, including flow, regulated material concentration and other site-specific information for each control device, as provided in proposed 40 CFR 65.850. If you choose to do a design evaluation, you would also submit a monitoring description with the Notification of Compliance Status. The monitoring description would contain a description of the parameters to be monitored and the associated operating limit(s), an explanation of the criteria used for selection of that parameter (or parameters) and the operating limit(s), the frequency with which monitoring will be performed, and the averaging time for each operating parameter being measured. Once the design evaluation has been conducted and operating parameters have been established, the non-flare control device must be operated and maintained such that the monitored parameters remain within the established operating limit.
We are proposing that each owner or operator of the affected control device must keep the records in proposed 40 CFR 65.860. These include:
• Continuous records of the monitoring equipment operating parameters or emissions. If certain requirements are met, you have the option of maintaining a record of each measured value, or block hourly average data and the most recent three valid hours of continuous records.
• Records of the daily average value or operating block average value of each continuously monitored parameter or emissions for each operating day.
• Non-continuous records as specified in 40 CFR 65.860(b).
• Records of each operating scenario, each emission episode, and each emission profile you develop as described in proposed 40 CFR 65.860(f) for batch operations.
• Control device monitoring, calibration and maintenance records.
• Records of periods when the regulated source, control equipment or CPMS are out of control, inoperative or are not operating properly.
• For batch process operations, records of whether each batch operation was considered a standard batch, including estimated uncontrolled and controlled emissions for each nonstandard batch.
• Performance test records for each performance test performed, as described in proposed 40 CFR 65.820 through 65.829 (and discussed further in section V.A.7 of this preamble). For control devices for which a performance test is required, you would be required to keep records of the percent reduction of regulated material achieved by the control device or the concentration of regulated material at the outlet of the control device, as applicable.
You would be required to submit the reports in proposed 40 CFR 65.880, 65.882, 65.883 and 65.884; certain reports must be submitted electronically, as specified in the proposed 40 CFR part 65, subpart H (see section II.F and VI.B.7 of this preamble). As specified in proposed 40 CFR 65.880, you would be required to submit the Notification of Compliance Status by the date provided by the referencing subpart. The Notification of Compliance Status would require certifications of compliance with rule requirements, including batch calculations and design evaluation records. The report would also include the established operating limit for each monitored parameter. For halogenated vent streams, you would be required to identify any halogenated vent streams as part of the Notification of Compliance Status. The Notification of Compliance Status would also include a statement about any emissions being routed to a fuel gas system. For existing control devices that may be redirected to the Uniform Standards as current regulations are revised, you would also be required to submit a Notification of Compliance Status. However, in order to reduce burden for transitioning sources, we are providing that you would be allowed to rely on previous performance test reports as part of the submittal, as long as the performance test was conducted within the past 5 years and conducted as specified under proposed subpart M. As discussed in section V.A.4 of this preamble, some transitioning sources may be required to conduct a performance test in cases where new parameter monitoring is required.
You would be required to submit semi-annual and annual periodic reports according to the requirements in proposed 40 CFR 65.882 and 65.883. Generally, semi-annual reporting of deviations is required to submit electronically, and annual reporting of non-deviation elements is required to be submitted in hard copy, as discussed under
We are not proposing to specify a compliance timeline in subpart M, so the compliance timeline specified in the referencing subpart would apply for that source category.
This section provides rationale for the proposed compliance requirements for vent streams that are routed to fuel gas systems or through closed vent systems to control devices. Rationale for the associated monitoring, performance testing, reporting and recordkeeping requirements is also included.
In keeping with our intent to provide a smarter, streamlined process for rulemaking and ensure consistent standards across multiple source categories, we have structured the National Uniform Emission Standards for Control Devices to provide a common set of monitoring, testing, recordkeeping and reporting requirements that may be referenced from multiple regulations, including NSPS and NESHAP. The proposed Uniform Standards in 40 CFR part 65, subpart M are generally based on a review of the Generic MACT standards of 40 CFR part 63, subpart SS. Additionally, we reviewed other recent rules, the applicability determination index database, test reports and recent EPA decisions to identify advances in control technologies, monitoring and compliance approaches. This is in keeping with our intent that the proposed National Uniform Emission Standards for Control Devices would provide a set of supporting requirements that could be considered in future rulemakings under CAA section 111 and 112 to meet the applicable statutory requirements.
The requirements for 40 CFR part 63, subpart SS were chosen as the best starting point for these proposed standards because they were previously developed for the purpose of providing consistent control device requirements that could be referenced by multiple NESHAP subparts, and they already incorporate some improvements based on the EPA's experience with implementation of other subparts, such as the MON (71 FR 40333, issued on July 14, 2006) and the HON (59 FR 19402, issued on April 22, 1994). We have augmented the subpart SS provisions by adding requirements from other subparts to provide additional continuous monitoring options, to better accommodate batch processes and to provide requirements for additional regulated materials (
We have developed the Uniform Standards for Control Devices to create a set of requirements that will ensure continuous compliance with the standards established under a referencing subpart. In developing the proposed requirements, we had the opportunity to review typical compliance methods for control devices controlling vent streams from regulations representing a variety of source categories. From this review, we considered the variation in requirements between rules and identified the most effective requirements for each control device. As such, we are proposing subpart M with more stringent requirements than may currently apply to some source categories; however, this stringency can always be overridden by the referencing subpart if deemed appropriate for the particular source category. These more stringent requirements reflect our intention to provide a consistent set of monitoring, recordkeeping and reporting requirements that reflect the most current control technologies and that are accessible and applicable for the majority of source categories complying with MACT and that would potentially reference the Uniform Standards to meet MACT. These consistent standards, if promulgated, will reduce the current overlapping and inconsistent provisions from multiple NSPS and NESHAP that may apply to a single source into a single set of requirements, thereby reducing the compliance burden for sources and government alike. Providing this common set of requirements also circumvents any undue burden on a single source category (for instance, source categories currently subject to multiple regulations). Furthermore, this approach would reduce the number of requests for alternative monitoring requirements, which are frequently made by sources required to comply with multiple NESHAP and NSPS. The proposed Uniform Standards for Control Devices also provide some additional requirements in places that we discovered, through our regulatory survey, were not adequately addressed by current regulations (
In keeping with the objectives of Executive Order 13563,
Conversely, subpart M provides requirements for control devices that may control a variety of emission
The Uniform Standards for Control Devices assume that the referencing subpart will establish and provide the rationale for the specific emission limits that best support the source category being regulated. The referencing subpart would address and assign applicability thresholds or control levels for any provisions of the Uniform Standards not cross-referenced by the referencing subpart. The referencing subpart could cross-reference or make exceptions, as necessary, to ensure that the proposed requirements of subpart M are appropriate to the source category. For instance, a referencing subpart with multiple applicability thresholds may only direct to a portion of subpart M for sources meeting one of those thresholds. Additionally, the referencing subpart could determine to not direct to subpart M at all for certain applicability thresholds. For example, a referencing subpart may only require CEMS for streams above a defined threshold.
Because the proposed standards contain general monitoring and performance testing requirements that would be applicable to more than one type of control device, we have included separate sections for general monitoring requirements and performance testing requirements to reduce redundancy across rule sections. We additionally congregated the requirements for the correct operation of CEMS and CPMS, as well as requirements for establishing the operating parameters for each CPMS, into individual sections. In addition to the specific control device section that applies to you, you would comply with these proposed general monitoring requirements, located in 40 CFR 65.710 through 65.712. Likewise, you would comply with the proposed general performance testing requirements in 40 CFR 65.820 through 65.829, which include detailed provisions on the methods required for testing. We have also designated a section for general requirements for performing design evaluations. It is our intent that the proposed standards of subpart M, as organized, will have improved clarity and consistency, which will facilitate both reading and compliance as the standards are referenced in future rulemakings.
We revised some provisions included in 40 CFR part 63, subpart SS that are redundant or unclear, including the “route to process” provisions. Subpart SS includes an option to route regulated material emissions from non-process operations (
The proposed subpart M does not contain requirements for flares.
The general monitoring requirements that we are proposing are modeled after specific requirements from 40 CFR part 63, subpart SS, which were based on monitoring and inspection requirements previously developed by the EPA for use in implementing standards for various chemical industry sources. We are supplementing these requirements by proposing continuous monitoring through the installation and operation of either a CEMS or a CPMS. CEMS have been widely used to demonstrate that air pollution control devices are being operated in a manner that ensures that emission limitations are being met, and recent regulations reflect the increasing use of CEMS as a monitoring device across multiple source categories. However, in evaluating the use of CEMS in multiple NESHAP, we determined that monitoring of individual regulated materials may not be reasonable or technically feasible for certain streams. For instance, CEMS may not be available for certain individual HAP species, or may not be economically feasible for smaller sources. In such cases, parameter monitoring provides an alternative option that ensures the control device is operating consistently and continues to achieve the required emission limits. This also provides a more cost-efficient option for some sources, without reducing compliance. Therefore, in order to create a set of standards that could be applied to a broader range of source categories, we have included requirements for both CEMS and CPMS. During the development of referencing subparts that will direct to the Uniform Standards, we will continue to assess the best monitoring option for a given source category from a technical and economic standpoint. We will provide rationale upon proposal or promulgation as to why CEMS or CPMS would be more appropriate for an individual source category, or whether additional flexibility for industry and reduced burden on smaller sources within an individual source category could be granted by allowing either a CEMS or CPMS to be used. We anticipate that in future regulations, the referencing subpart may even override the monitoring options of the proposed subpart M and require a specific monitoring technique.
We have incorporated and updated the CEMS requirements established in the MON, which were developed in consideration of a combination of monitoring requirements from the HON and Pharmaceuticals Production source categories. We have supplemented these requirements with provisions based on the CEMS-specific requirements of 40 CFR part 63, subpart A. These provisions are consolidated under proposed 40 CFR 65.711 in order to establish a set of similar requirements for CEMS in one place that may more generally apply to sources regulated under 40 CFR part 60, 61 or 63 in future rulemakings.
For CPMS, we selected monitoring equipment criteria for overall system accuracy and compatibility. These requirements, which ensure accuracy in measurements and provide confidence for testing results, were inconsistently provided in previous regulations. When these criteria are not established, there is potential that sources could elect to use very costly CPMS equipment, which is inappropriate or ineffective for measuring certain parameters and, therefore, provides inadequate data for the source category. By applying a consistent set of criteria that applies to multiple source categories, we are improving data accuracy, reducing potential costs and removing undue burden for specific source categories. We are requesting comment on whether the proposed approach for establishing CEMS calibration ranges and assessing performance will adequately ensure the accuracy of the reported average emissions that might include measurements at concentrations above the span value. We are also seeking comments on how owners and operators of CPMS are currently employing quality control and calibration methods. Additionally, we welcome information on the lifetime and degradation of CPMS equipment used to measure temperature, liquid or gas volumetric flow, pH, mass flow, pressure and sorbent injection; and whether a “sunset period” for existing CPMS equipment is necessary in cases where the lifetime of the monitoring components is limited.
The requirements for measurement range were selected to ensure that the CPMS could detect and record measurements beyond the normal operating range. We believe that requiring a range of at least 20 percent beyond the normal operating range is reasonable and the minimum measurement range needed to encompass most deviations. Owners and operators may desire to select equipment with even wider ranges if it is likely that measurements beyond 20 percent of the normal operating range will occur. Additionally, we are requiring a resolution of one-half the accuracy requirement or better to ensure that the accuracy of the CPMS can be calculated to at least the minimum number of significant figures for the data accuracy assessment to be meaningful. Selecting a resolution of one-half the required accuracy ensures that measurements made during validation checks can be readily compared to the accuracy requirement. We are soliciting comments on whether the proposed measurement range and accuracy requirements are reasonable and consistent with what is currently being used.
We are proposing calibration and quality control requirements for CPMS to ensure that measured parameter data is accurate to demonstrate compliance with the referencing subpart. These measures, which establish requirements for the design, operation and evaluation of CPMS, are intended to ensure the generation of good quality data both initially and on an ongoing basis and determine that the control device is meeting the required emission limit, as specified in the referencing subpart. The specifications are located in Table 4 to proposed subpart M and would apply if you were to use a temperature, liquid or gas volumetric flow, pH, mass flow, pressure or sorbent injection measurement device to determine compliance with an operating limit. These requirements also reflect the EPA's intention to improve the quality of data collected and disseminated by the agency, which will improve the quality of emission inventories and, as a result, future air quality regulations.
For temperature CPMS, we reviewed rules promulgated under parts 60, 61 and 63 that specify accuracy requirements for temperature. Although there is a wide range of accuracies specified in these rules, the accuracy
Rules promulgated under parts 60, 61 and 63 that require flow rate monitoring specify flow rate accuracy in terms of percent. For liquid flow rate measurement, these rules generally require accuracies of 5 percent, and rules that require steam flow rate monitoring generally require an accuracy of 10 percent or better. We have revised these performance specifications in the proposed subpart M to require accuracies of 2 percent over the normal range of flow measured. Based on our review of vendor literature, we determined a 2-percent accuracy criterion is appropriate and available. Recognizing the differences in the relative magnitudes and the commonly used units of flow rate measurement for liquids and gases, we have specified in the proposed performance standards separate accuracy criteria for liquid and gas flow rates. For liquid flow rate CPMS, which typically are associated with wet scrubber operation, the minimum accuracy would be 1.9 liters per minute (0.5 gallons per minute) or 2 percent, whichever is greater. For gas flow rate CPMS, which often are used to monitor stack gas flow rate, the proposed performance specifications would require a minimum accuracy of 28 liters per minute (10 cubic feet/minute) or 2 percent, whichever is greater. The relative accuracy criterion of 2 percent was selected because the proposed Uniform Standards have been developed to provide the greatest level of air emissions control that may be required by a referencing subpart. As advancements in technology have improved (and are estimated to continue to improve), we have determined that future rulemakings would require more stringent accuracy requirements, and a 2-percent accuracy criterion is reasonable and achievable for the currently available flow CPMS. We note that these requirements could be revised by the referencing subpart, if a higher or lower accuracy is deemed more appropriate for a specific source category.
Although we have incorporated an accuracy criteria for liquid flow rate and gas flow rate as a percent of flow rate and in units of volumetric flow in proposed subpart M, we have concluded that it would not be reasonable to specify accuracy criteria for mass flow in units of mass flow because of the wide range of flow rates that could be monitored (
Manufacturer and vendor literature indicates that pH CPMS generally have accuracies of 0.01 to 0.15 pH units. Based largely on the vendor literature, we have decided to require pH CPMS to have accuracies of 0.2 pH units or better. An accuracy of 0.2 pH units should allow most facilities that currently monitor pH to continue using their pH CPMS, provided the CPMS satisfies the other criteria specified in the proposed Uniform Standards for Control Devices.
For pressure monitoring, we reviewed the existing part 60, 61 and 63 rules that require pressure monitoring. These rules also specify a minimum accuracy. The accuracy specified generally is either 0.25 to 0.5 kilopascals (kPa) (1 to 2 inch water column (in. wc)) or 5 percent for pressure drop, and 5 to 15 percent for liquid supply pressure. A review of vendor literature indicates that most pressure transducers are accurate from 0.25 to 1.0 percent, and all but the lowest grade (Grade D) of American National Standards Institute (ANSI)-rated pressure gauges have accuracies better than 5 percent. For the proposed performance specifications for CPMS, we selected an accuracy requirement of 0.12 kPa (0.5 in. wc) or 1.0 percent, whichever is greater. We believe this level of accuracy is appropriate, considering that some control devices operate with pressure drops of less than 1.2 kPa (5 in. wc). This criterion was selected because the proposed Uniform Standards have been developed to provide the greatest level of air emissions control that may be required by a referencing subpart. The one percent criterion is consistent with vendor literature, which indicates that CPMS that are capable of achieving this accuracy are readily available.
For sorbent injection, we are specifying accuracy requirements of within 5 percent of the normal range for the sorbent injection rate, with annual performance evaluations and 3-month visual checks. These requirements are consistent with the accuracy requirements for other CPMS, including the requirements for carrier gas flow rate monitors (a similar type of monitor) in the Standards of Performance for New Sewage Sludge Incineration Units (76 FR 15404, March 21, 2011).
If your operation could be intermittent, we are requiring that you install and operate a flow indicator to identify periods of flow and no flow at the inlet or outlet of the control device. The proposed requirements are necessary to identify periods when monitored parameter or emission readings are not required or erroneous and should not be included in the daily or operating block average values. It is not necessary to monitor a control device during periods when regulated material is not routed to the control, and monitoring data during these times should not be averaged in calculating the daily or operating block average. We are proposing an annual verification check of the flow indicator to ensure that it is correctly identifying periods of no flow. We are not considering the flow indicator to be a CPMS that must meet all the provisions of proposed 40 CFR 65.712.
We are proposing to include monitoring requirements from the General Provisions of parts 60, 61 and 63 in the monitoring sections of subpart M. This places all the applicable requirements associated with monitoring (including quality checks, monitoring plan requirements, calibration, monitoring data reduction, recordkeeping and reporting) in one place and consolidated using consistent terminology. For instance, we are including provisions for a CEMS performance evaluation and monitoring plan and a CPMS monitoring plan (formerly the “site-specific performance evaluation plan”) from the part 63 General Provisions (40 CFR 63.8) in proposed 40 CFR 65.711 and 65.712,
Under the proposed standards, all closed vent systems would be required to meet the applicable provisions of proposed 40 CFR part 65, subpart J (see section IV.A of this preamble) as they apply to the individual equipment components that comprise the closed vent system. In previous rules, equipment that are in closed vent systems have been subject to annual monitoring and have not been subject to more frequent monitoring. We are proposing these requirements to ensure that a vent stream in regulated material service is properly routed to the closed vent system and delivered to the control device for reduction. The proposed rule also requires you to install and maintain a CPMS for flow through a bypass for each closed vent system bypass line that could divert a vent stream to the atmosphere. The CPMS for flow must be capable of recording the volume of the gas that bypasses the control device and be equipped with an alarm system that will alert an operator immediately and automatically when flow is detected in the bypass. These provisions are to ensure that any flow directed through a bypass is detected and identified by the operator. Alternatively, you may secure the bypass line valve in the non-diverting position with a seal mechanism. For this option, you would be required to inspect the seal or closure mechanism at least once per month to confirm that the valve is in the non-diverting position, or, for a lock-and-key type lock, maintain records that the key has been checked out. If the alarm sounds or if it is determined during the monthly inspection that a bypass has occurred, you would be required to report a deviation and to include an estimate of the resulting emissions of regulated material that bypassed the control device. The EPA's intent is that control devices are not to be bypassed; therefore, use of the bypass at any time to divert a regulated vent stream to the atmosphere would be a deviation from the emissions standards set forth by the referencing subpart.
We have not included requirements from 40 CFR part 63, subpart SS that provided monitoring exclusions for equipment such as PRD, low leg drains, high point bleeds, analyzer vents and open-ended valves or lines needed for safety purposes. This equipment could provide a means of bypassing the control device; therefore, we are proposing bypass monitoring for these devices under subpart M of the proposed standards. It is our intent that analyzer vents should be subject to the control requirements for sampling connection systems in 40 CFR part 63, subpart UU. Additionally, applying the bypass monitoring requirements to PRD, low leg drains, high point bleeds, analyzer vents and open-ended valves or lines are consistent with the District of Columbia Circuit Court's 2008 ruling in
Following the guidance of Executive Order 13563,
For each control device, we are proposing that you meet the continuous monitoring requirements of Table 1 or Table 2 to subpart M. Table 1 to subpart M provides the requirements for facilities who comply with the referencing subpart using CEMS. We have consolidated the specific parametric monitoring requirements for each control device in Table 2 to subpart M to provide the requirements in a simplified, easily referenced format to facilitate compliance.
You must conduct a performance test for each control device according to the requirements of proposed 40 CFR 65.820 through 65.829, unless you meet the general control measures of proposed 40 CFR 65.702(e). A performance test is required because emissions measurement remains the best method to demonstrate initial compliance with regulations and determine control device performance. However, we have made exceptions for: (1) Control devices for which a CEMS is used to monitor the performance, (2) when the referencing subpart allows a design evaluation in lieu of a performance test or (3) if certain provisions have been made for a performance test extension, exemption or waiver. These exemptions allow greater flexibility for referencing subparts and are consistent with our desire to provide workable, consolidated requirements that could apply across multiple source categories.
Additionally, we are not incorporating the requirements of 40 CFR 63.988(a)(3), which stipulate that the vent stream from the boiler or oxidizer must be introduced into the flame zone. Although we are preserving the intent of 40 CFR part 63, subpart SS, we have reasoned that this language is superfluous. We are proposing to clarify the definition of small boilers in this category as having a design such that the vent stream is introduced with the combustion air or as a secondary fuel. It is assumed that secondary fuel and combustion air are introduced into the flame zone and, therefore, the vent gas would be introduced into the flame zone.
In the proposed rule, we have not included the exemptions from conducting a performance test or design evaluation included in 40 CFR part 63, subpart SS for small boilers and process heaters which have been issued a final permit under 40 CFR part 270 and comply with the requirements of 40 CFR part 266, subpart H or which have certified compliance with the interim status requirements of 40 CFR part 266, subpart H. It is our expectation that these facilities are no longer subject to the air emissions requirements under the Resource Conservation and Recovery Act permitting rules (other than requirements that pertain during startup, shutdown and malfunction (SSM)); rather, all boilers and oxidizers previously subject to these requirements are now subject to 40 CFR part 63, subpart EEE. We have included a performance test exemption for small boilers or process heaters burning hazardous waste who have certified compliance with the requirements of 40 CFR part 63, subpart EEE by conducting comprehensive performance tests and submitting a Notification of Compliance Status per 40 CFR 63.1207(j) and 63.1210(d), and who comply with these requirements at all times, even when burning non-hazardous waste. Additionally, we have not included the subpart SS provision allowing owners or operators of small boilers and process heaters with a minimum temperature of 760 degrees Celsius and a minimum residence time of 0.5 seconds to omit the rationale for these design parameters in the design evaluation (40 CFR 63.985(b)(1)(i)(B)) documentation. This minimum temperature and residence time does not necessarily ensure a 95- or 98-percent reduction efficiency for all possible emission stream chemical compositions (see technical memorandum,
For catalytic oxidizers, we are including sampling, analysis and inspection requirements to ensure that the oxidizer is capable of meeting the required emission limits specified in the referencing subpart. We are including a monitoring method for inlet temperature monitoring, provided the difference between the inlet and outlet temperature of the catalytic bed is less than 10 degrees Celsius. A differential of 10 degrees Celsius was chosen based upon the accuracy requirements of temperature monitoring systems specified in this standard, and the typical operating temperature of a catalytic oxidizer. Allowing for measurement error on both sides of the oxidizer (inlet and outlet), 10 degrees Celsius was determined to be a range within measurement capability. The proposed method would allow you to determine a schedule for sampling and analysis of the catalyst activity, based on the degradation rate of the catalyst. If results from the catalyst sampling and analysis indicate that your catalyst will become inactive within the next 18 months, you would be required to replace the catalyst bed or take other corrective action consistent with the manufacturer's recommendations by 3 months before the catalyst is anticipated to become inactive or within half the time available between receiving the catalyst activity report and when the catalyst is expected to become inactive, whichever is less.
Additionally, you would be required to conduct an annual internal inspection of the catalyst bed. The inspection frequency would increase to semiannual or a more stringent frequency, as specified in proposed 40 CFR 65.728(a)(2)(ii), if any issues are found during the annual inspection that require corrective action. These requirements are based on our survey of the MON and the Miscellaneous Metal Parts and Products Surface Coating NESHAP, which included similar alternatives for monitoring the inlet stream temperature. The MON provided an option for monitoring the inlet stream temperature with the requirement of a 12-month check of the catalyst bed; this option was provided to accommodate emissions streams with low flow or diluted concentrations in which it would not always be possible to achieve a measurable temperature differential.
As determined under the MON, when monitoring only the inlet temperature, a catalyst-activity-level check also is needed. This is because catalyst beds can become poisoned and rendered ineffective without any apparent change in operation. The proposed sampling, analysis and inspection requirements discussed above are modeled after the Miscellaneous Metal Parts and Products Surface Coating NESHAP, which expand on the MON's requirement to conduct a 12-month check of the catalyst bed. We are providing the option to determine the schedule for sampling and analysis based on the degradation of the catalyst to provide flexibility for multiple source categories that may reference the Uniform Standards, while ensuring that catalyst beds are replaced or that other corrective actions are taken in a timely manner. A referencing subpart may determine the specific sampling and analysis schedule, in order to ensure compliance, prevent excessive downtime or avoid unreasonable costs to an individual source category.
We have included this option in subpart M only for sources in which the temperature differential between the inlet and outlet of the catalytic oxidizer during normal operating conditions is less than 10 degrees Celsius. We are not proposing this option for sources with a temperature differential of greater than 10 degrees Celsius because inlet and outlet temperature monitoring is a more accurate method of parameter monitoring and should be used, if possible, to measure the temperature differential.
As discussed for
We are proposing the installation and operation of either a CEMS or a CPMS, following the requirements in Tables 1 or 2 of proposed subpart M. As discussed in the general monitoring requirements in section V.B.1 of this preamble, we have included provisions for both CPMS and CEMS to accommodate the variety of sources that may be controlled by a referencing subpart.
The most critical parameter for monitoring absorption systems is liquid flow to the absorber, therefore we are requiring liquid flow be monitored for all absorption systems, but have provided an option for monitoring of the liquid-to-gas ratio. Rather than calculating one minimum flow rate at maximum operating conditions that must be continuously adhered to, this alternative provision allows a facility to optimize the liquid flow for varying gas flow rates. By using a liquid-to-gas ratio, sources may save resources by reducing the liquid rate with reductions in gas flow due to periods of lower production rates.
Pressure drop is also a valuable operating parameter to monitor for absorbers. It can signal abnormal column conditions such as plugging, channeling or mal-distribution of the packing. We are proposing that you monitor the pressure drop for all absorbers as long as the normal pressure drop across the absorber is greater than 5 inches of water. If the pressure drop is typically less than 5 inches of water, it is not a sensitive monitor for absorber performance. We have also included a requirement to monitor pH for acid gas absorbers. For non-water absorbers used for VOC control, we are proposing that the chemical strength and flow rate of the chemical must be monitored. Monitoring the oxidation strength and flow rate of the chemical will ensure that enough chemical is being added to the absorber to attain at least the required amount of absorption. For particulate and metal absorbers, if the pressure drop is normally less than 5 inches of water, the owner or operator will have the choice of monitoring the inlet and outlet gas temperature; the specific gravity and outlet gas temperature; or the liquid feed pressure and outlet gas temperature. These monitoring parameters provide information on whether there has been sufficient contact between the liquid and gas.
Similar choices were provided for VOC absorbers if the normal pressure drop across the absorbers is less than 5 inches of water and the scrubbing liquid is water. The source would monitor the inlet and outlet gas temperatures, or the liquid feed pressure and outlet gas temperature.
Many current regulations address carbon adsorber operation, and the proposed rule has been written to address performance issues that have been identified by the EPA in implementing and enforcing these rules. Known performance issues include: The regeneration frequency of the adsorbent; the effectiveness of regeneration; the life of the adsorbent material before replacement is required; mechanical issues with the system operation including valve sequencing; and for non-regenerative systems, the expected life of the bed before replacement. The proposed rule incorporates different monitoring requirements for adsorption systems based on our review of 40 CFR part 63, subparts G, SS, GGG, MMM, FFFF, GGGGG and BBBBBB, as well as monitoring approaches that have been outlined and approved by the EPA in monitoring alternative requests.
We are proposing the use of CEMS or CPMS to ensure the adsorption system operates consistently; we have included parametric monitoring provisions in Table 2 of subpart M in order to accommodate systems where a CEMS is not used. Because there is no single parameter you can monitor to ensure that all operating aspects are functioning properly, the proposal combines several monitoring approaches, each of which addresses common adsorber system performance issues. These include: (1) Monitoring of the regeneration process, (2) establishing and adhering to a regeneration frequency, (3) daily verification of system operating parameters and (4) routine sampling of the vent stream.
The regeneration process monitoring provisions for non-vacuum systems include regeneration stream flow and adsorber temperature. These are key parameters to ensure the adsorption bed is sufficiently desorbed at the start of an adsorption cycle, and have long been known to influence adsorption performance. We have added the requirement to establish and adhere to a pre-defined interval for regeneration frequency in order to prevent overloading the bed and possibly incurring breakthrough during the adsorption cycle before regeneration is initiated. We considered alternatives to a pre-defined interval that would take into account the organic loading on the bed, but determined that regeneration on a prescribed schedule provides greater assurance that there would be sufficient adsorptive capacity at all times.
Regenerative adsorption processes are typically multiple bed systems with complicated valve and piping arrangements designed to handle the vent streams and desorption streams on a batch basis. Because the consistent operation of the valves in these systems is critical to performance, we have included requirements for daily verification of the adsorber valve sequencing and cycle time. This daily system check will ensure that the adsorber is operating with proper valve sequencing and cycle time.
While adsorption systems can achieve high levels of efficiency for removal of organic compounds from vent streams, performance degrades over time as the adsorption media deteriorates or becomes fouled. Because of this known performance deterioration, and because there are many mechanical elements in the system which can cause performance problems, we are proposing weekly measurements of the adsorber bed outlet VOC or regulated material concentration over the last 5 minutes of an adsorption cycle for each adsorber bed. These measurements are not meant to be a check against the emissions limit established by the referencing subpart; rather, it is a check to determine if the absorber performance is deteriorating and/or has deviated from typical operation. By conducting weekly checks, the owner or operator will establish knowledge of typical operating conditions, so that if performance does degrade, it will become clear based on changes in the weekly measurements. We are proposing that the owner or operator establish a maximum normal concentration to compare to the weekly measurements. If a measurement is obtained that is above the maximum normal concentration, a corrective action process must be initiated within 8 hours. We are proposing that you must develop a corrective action plan that includes investigation of the adsorbent and its efficacy, the valve sequencing system and regeneration process, and additional monitoring, as well as site-specific corrective actions appropriate to the system. This plan is not required to be submitted to the Administrator for approval, but is required to be kept as a record per the requirements of proposed 40 CFR 65.742(j)(1).
Measurements for the weekly checks on each adsorber may be taken with a portable analyzer using Method 21 of 40 CFR part 60, appendix A-7 for open ended lines, or using chromatographic analysis. Acceptable levels for end-of-cycle measurements, the maximum normal concentration will be established based on a statistical evaluation of the last 5 minutes of at least eight adsorption cycles for each adsorber. Because these measurements are taken in the last 5 minutes of the adsorption cycle, they indicate the worst-case emissions over the adsorber cycle. Therefore, they are not indicators of compliance with the emission limit, but instead are indications of non-normal operation, which trigger a corrective action. An adsorber would not be considered to be in deviation unless three consecutive weekly measurements are taken that are above the maximum normal concentration; if the requirement to initiate corrective action within 8 hours is not met; or if a weekly measurement is not performed. See section VII of this preamble for a discussion of the economic and cost impacts of these requirements.
Because the materials desorbed during the regeneration process are regulated materials and are either recovered or disposed of, we are proposing explicit requirements to treat the regulated materials extracted from a regenerative system as process wastewater or vent streams subject to control, as specified by the referencing subpart.
Very few previously published rules have addressed adsorption systems, which are not regenerated onsite. Because there is wide application of non-regenerative adsorption systems, we are including provisions for these systems in the proposed rule. For clarity, we have differentiated the proposed requirements for absorbers generated onsite and the requirements for non-regenerative adsorbers or
As a guideline for the proposed monitoring, we used the National Emission Standards for Site Remediation (40 CFR part 63, subpart GGGGG), as well as monitoring approaches approved by the EPA in alternative requests for monitoring and in enforcement actions to address historical compliance issues with non-regenerated adsorbers. We are proposing CEMS monitoring for the adsorber exhaust. Alternatively, we are proposing requirements for dual adsorbent beds in series and daily monitoring. We have prescribed a dual bed system because the use of a single bed does not ensure continuous compliance unless the bed is replaced significantly before breakthrough. A dual bed system will allow one bed to be saturated before it is replaced and, therefore, makes efficient use of the adsorber bed without exceeding the emission limits. Facilities utilizing non-regenerative adsorbers must typically replace the adsorber bed at the end of the absorbent life and already have a second bed onsite. Therefore, we have determined that these requirements would not impose a cost increase; it would only require a second adsorber bed to be purchased earlier than it would have under previous rules. In addition, once the second adsorber was purchased, the source would need to purchase and install canisters at the same rate they would have under previous rules. In fact, the source could likely reduce costs over time because the adsorber beds can be used to a greater saturation level without risking non-compliance. Under current rules that do not require a second bed, sources must replace the beds, based on temperature readings, the vendor's bed life expectancy estimates or past history, and may replace the bed prematurely in order to avoid non-compliance. The burden of purchasing the initial additional adsorber bed, when compared to the large increase in compliance assurance, is small.
Similar to regenerative adsorbers, in order to monitor performance deterioration, we are proposing measurements of VOC or regulated materials using a portable analyzer or chromatographic analysis for non-regenerative absorbers. We are proposing that these measurements be taken daily on the outlet of the first adsorber bed in series using a sample port. Furthermore, in order to relieve some monitoring burden, we have included the option to reduce the frequency of monitoring with the portable analyzer from daily to weekly or monthly. If you choose this option, you would first be required to establish an average adsorber bed life. For periods when more than 2 months remain on the bed life, monthly monitoring can be conducted, and when more than 2 weeks remain on the bed life, weekly monitoring can be conducted. For a discussion of the economic and cost impacts of these monitoring requirements, see section VII of this preamble.
As part of the design evaluation, we are proposing that you use the engineering evaluation methodologies in 40 CFR 65.835(d) with the temperature of the condensate receiver to determine the outlet organic regulated material concentration. You would then be required to show the concentration meets the emission standard established in the referencing subpart, or to conduct additional calculations to demonstrate a percent reduction or aggregate percent reduction for batch process vents in a referencing subpart was being met.
In the design evaluation for condensers, we have included a provision to consider conditions under which entrainment of the condensing liquid could occur, as well as the other operating conditions traditionally included in a condenser design evaluation, such as the vent stream flow rate, relative humidity and temperature. Entrainment is an important factor in condenser performance that should be considered in a design evaluation in order to document that the condenser achieves the required emission reduction from a referencing subpart.
In biofiltration, microbial activity is the primary means by which the process stream is controlled; the effectiveness of the device is maximized by maintaining preferential conditions for the growth of appropriate microbes. Temperature is a significant factor affecting the growth and maintenance of healthy microbes within the bed—temperatures that are too high or too low will result in reduced microbe colonies and reduced performance for the bed. It is also a good indicator of the health of the microbes since healthy microbes will generate heat themselves. Therefore, we are requiring bed temperature monitoring to ensure that the biofilter can achieve and maintain the emission limits specified in the referencing subpart. For a discussion of the economic and cost impacts of these requirements, see section VII of this preamble.
Given the concerns expressed in the preamble to the final MON rule regarding continuous process operations, we are also proposing requirements to monitor the moisture content of the biofilter bed and pressure drop through the biofilter bed to ensure that the biofilter can achieve the emission limit or percent reduction requirements of the referencing subpart. The moisture content of the biofilter bed
In lieu of these additional monitoring requirements, we are also considering requiring weekly measurements of VOC or regulated material at the outlet of each biofilter bed using a portable analyzer or chromatic analyzer to monitor performance deterioration, similar to those requirements proposed for adsorbers. We are soliciting comment, including the identification or submittal of information or data, as to whether biofilter bed temperature monitoring would be enough for continuous compliance demonstration. Additionally, we are soliciting comments and supporting data or studies that assess the effectiveness of measuring additional parameters to ensure performance and compliance.
The MON does not allow a design evaluation to demonstrate compliance for biofilters; however, we have included provisions for a design evaluation if the referencing subpart allows one. A design evaluation for a biofilter may be adequate to demonstrate compliance for certain source categories; however, this will need to be considered on a source category-specific basis and justified in the referencing subpart rulemaking.
Activated carbon is used in sorbent injection systems where control of mercury or dioxin and furan emissions is required. Lime or other sorbents may also be used in sorbent injection systems to remove acid gasses, such as hydrochloric acid or sulfuric acid. Sorbent injection is used in conjunction with a filtration device designed to collect the sorbent after injection.
As a basis for developing the proposed rule, we have adapted the requirements for sorbent injection systems that were included in the final rule for National Emission Standards for Hazardous Air Pollutants from the Portland Cement Manufacturing Industry (75 FR 54970, September 9, 2010). This recent NESHAP determined monitoring and performance specification requirements for sorbent injection systems and carrier gas systems that reflect the latest technical developments for these control options. In addition, facilities complying with the proposed provisions for sorbent injection would also be required to meet the requirements for fabric filters in proposed 40 CFR 65.762. The Portland Cement NESHAP requires facilities to specify and use the brand and type of sorbent used during the performance test until a subsequent performance test is conducted. We are proposing that you would be required to test if you wanted to substitute a different brand or type of sorbent. Although the Portland Cement NESHAP allows an owner or operator to substitute different brands or types of sorbent without having to do a new performance test (provided that the replacement has equivalent or improved properties compared to the sorbent used in the previous performance test), we have modified the proposed standards to require a new performance test if the sorbent is replaced with a different brand and type of sorbent than was used in the most recent performance test. As we intend the Uniform Standards for Control Devices to be referenced in both NSPS and NESHAP rulemakings across multiple source categories, this change ensures that the control device will continue to meet the emission limits or percent reduction requirements of a referencing subpart when a change of sorbent occurs. A referencing subpart may override this retest requirement if it is determined in its rulemaking to be unnecessary for the source category being regulated.
Provisions for a design evaluation for sorbent collection systems are proposed for this rule in the event that a referencing subpart allows a design evaluation to be conducted in lieu of a performance test. Because this is a relatively new control technology, there were no current rules that provided guidance for a design evaluation of a sorbent collection system. Therefore, we have developed the proposed requirements using recently published articles on activated carbon injection as a control technology. This research indicates that the parameters identified in proposed 40 CFR 65.760(d) provide the best evaluation of sorbent injection system performance.
In consideration of our experience implementing previous rules addressing fuel gas systems as control devices, we are proposing updated standards that clarify the definition of fuel gas system and ensure that these systems are achieving good combustion and control. Under 40 CFR part 63, subpart SS, owners and operators are permitted to route vent streams from storage tanks, transfer equipment and equipment leaks to a fuel gas system as a method of control (this compliance option is not specifically provided for process operations). Fuel gas systems are considered a part of the process, therefore process vent streams that are routed to a fuel gas system are not considered vent streams requiring control because they are not released to the atmosphere. The proposed rule does not specifically state that this control option is only for equipment leaks, storage tanks and transfer operations emissions. It is not necessary to allow this option for only some of the emission unit types, given that the proposed Uniform Standards may be referenced in future NESHAP and NSPS for multiple source categories and industry types, and those rulemakings can determine whether to restrict the control options for specific types of emission units.
As previously discussed for small boilers and process heaters in section V.B.3 of this preamble, small boilers or process heaters receiving vent streams subject to subpart M with a capacity less than 44 MW (in which the vent stream is introduced with combustion air or as a secondary fuel) would be subject to the requirements of proposed 40 CFR 65.724, whether they are part of a fuel gas system or not. If your fuel gas system directs the vent stream to small boilers or process heaters, you would still be required to meet the performance testing and monitoring requirements for small boilers and process heaters. As discussed in section V.B.3 of this preamble, larger boilers and process heaters in which the vent gas stream is introduced with or as the primary fuel have been recognized as units that can be confidently assumed to achieve good combustion. There is not
We expect, in most cases, the vent gas stream of fuel gas systems will be introduced as the primary fuel and/or will be routed to larger units. We want to continue to encourage the use of this otherwise waste gas. However, if small boilers and process heaters are attached to the fuel gas system, then you would be required to conduct performance testing and monitoring. We do not expect this scenario to be common. We also considered defining a fuel gas system such that the vent gas must be introduced with or as a primary fuel, but determined that this would reduce flexibility for sources.
Under the proposed standards, all fuel gas systems that are in regulated material service must perform quarterly LDAR monitoring and would be required to meet the applicable provisions of proposed 40 CFR part 65, subpart J (see section IV.A of this preamble) as they apply to the individual equipment components that comprise the fuel gas system. We are proposing these requirements to ensure that a vent stream in regulated material service is properly routed by the fuel gas system and delivered to the combustion device for destruction. We expect that most fuel gas systems meet the applicability of the LDAR requirements and are already conducting LDAR monitoring; therefore, these requirements are not expected to introduce a new or unnecessary regulatory burden for industry.
The proposed standards revise the definition of
We have incorporated requirements for fabric filters in subpart M with the intent to simplify future rulemakings that would refer to the Uniform Standards. The proposed monitoring, recordkeeping and reporting requirements may be referenced by new or revised NSPS or NESHAP that would establish standards for PM or other regulated materials controlled by fabric filters and not previously covered by other consolidated rulemakings. As such, the consolidation of fabric filter requirements in subpart M facilitates more efficient rulemaking and ensures consistent standards for these control devices across multiple source categories. The monitoring, design evaluation and recordkeeping and reporting requirements for fabric filters were modeled after the Pesticide Active Ingredient Production NESHAP (40 CFR part 63, subpart MMM, as referenced by the MON) and the final rule for National Emission Standards for Hazardous Air Pollutants from the Portland Cement Manufacturing Industry, published on September 9, 2010 (40 CFR part 63, subpart LLL, 75 FR 54970). The proposed requirements include the installation of a bag leak detection system equipped with an alarm that will sound when an increase in relative PM emissions over a preset level is detected.
The Portland Cement Manufacturing NESHAP required that the bag leak detection system be certified by the manufacturer to be capable of detecting PM emissions at concentrations of 10 milligrams per actual cubic meter (mg/acm) or less. Because we intend the proposed Uniform Standards to be applicable for the majority of source categories complying with MACT, we considered that there may be future rulemakings that need to specify lower PM emission limits and would require a lower allowable detection limit for the bag leak detectors. Based on vendor literature, modern bag leak detection systems are capable of detecting baseline emissions as low as 1 mg/acm (see,
We have also added a provision previously included in the Major Source Industrial, Commercial, and Institutional Boilers and Process Heaters NESHAP (76 FR 15608, March 21, 2011), requiring that the bag leak detection system must be operated and maintained such that the alarm does not sound more than 5 percent of the operating time during a 6-month period. We are requiring records of the total alarm time and corrective actions taken following an alarm sounding for demonstration of compliance. These requirements are operation and maintenance requirements that could be adopted in future rulemakings to ensure that the fabric filter is being operated at the conditions for which the control device is meeting the emission limit specified in the referencing subpart.
Additionally, the proposed rule requires that you conduct a performance test on your fabric filter, but provisions have been included for those situations where a design evaluation is acceptable and allowed by the referencing subpart (see sections V.A.9 and V.B.8 of this preamble).
The performance testing requirements that we are proposing are modeled after specific requirements from 40 CFR part 63, subpart SS, which are based on performance testing requirements previously developed by the EPA for use in implementing standards that could apply to a variety of chemical industry sources.
We have organized the performance testing requirements to group similar topics together, and added new methods for performance testing to develop a more generic and inclusive set of control requirements that may be easily referenced in future rulemakings. In addition to using the term “regulated material” (see
Although based on language from 40 CFR part 63, subpart SS, where we propose that you conduct all performance tests at maximum representative operating conditions for continuous process operations, we have defined maximum representative operating conditions to be those conditions that result in the most challenging condition for the control device. In an effort to provide more flexibility to owners and operators regarding the identification of the
For batch process operations, we are proposing consistent requirements to those in 40 CFR part 63, subparts GGG and FFFF, and are requiring that you develop an emissions profile and conduct your performance test at absolute worst-case conditions or hypothetical worst-case conditions. Although continuous operations tend to have products and operations that remain relatively constant, the control devices for batch operations may be subject to a wide variability of products and emission stream characteristics, and a performance test at “maximum representative” conditions for batch operations may not be representative at a later date when the products have changed. Absolute worst-case conditions are based on an emissions profile that shows periods of time when the maximum load, the regulated material loading or stream composition (including non-regulated material) is the most challenging condition for the final control device. To provide flexibility for sources, we are also proposing that you may test under hypothetical worst-case conditions as an alternative. Hypothetical worst-case conditions are simulated test conditions that, at a minimum, contain the highest hourly load of regulated material emissions that would be predicted to vent to the final control device, based on an emissions profile.
The agency's intent, when requiring the development of an emissions profile, is to determine the maximum HAP loading to a control device over time. Therefore, the proposed rule requires that the emissions to the device be evaluated by plotting HAP emissions versus time. To provide multiple options for compliance, we have allowed for the emission profile to be determined by process, by equipment or by capture and control device limitation (this would be dependent on how you choose to characterize your worst-case conditions). When sources test under worst-case conditions, this reduces, and may eliminate, in some cases, the need for any retesting at a later date when conditions change. If a source tested under normal operating conditions, then any change from these conditions would trigger a need to retest the source under the revised normal operating conditions. The concept of worst-case conditions allows sources to anticipate potential changes so that only one (initial) test is generally required, which would reduce the burden on the source. We note that the referencing subpart could require a re-test (
Building off the requirements of 40 CFR part 63, subpart SS, the MON uses a hierarchy to determine applicable requirements for combined emission streams in 40 CFR 63.2450(c)(2). For example, the MON allows you to comply with only the batch process operation requirements for combined batch and continuous process operations. However, for the proposed rule, we are not establishing a hierarchy because the referencing subpart must consider the applicable statutory requirements for the specific type of rulemaking (CAA section 111 or section 112). Instead, we are proposing that you must meet all requirements for each emission stream type in a combined emission stream (
We are proposing that if you make a change to process equipment or operating conditions that would affect the correlation between the operating parameter values of a control device and the emission reduction performance of that control device, and would render the previously established operating limits ineffective, you must conduct a performance test within 180 days of the date of startup of the change. This performance test would be necessary to establish new operating limits and demonstrate that you are in compliance with the applicable emission limit of the referencing subpart. For instance, a facility could institute changes that increase the mass flow to a thermal oxidizer, requiring a higher operating limit for temperature to maintain compliance with the emission standard of the referencing subpart. This proposed requirement is necessary to ensure that the control device remains effective for compliance with the referencing subpart.
We have consolidated the allowed test methods in Table 5 of subpart M for ease of reading. The proposed rule provides test methods based on the types of emissions limits that we anticipate would be specified in a referencing subpart. As was done in the MON (for gas streams containing formaldehyde) and in the Pharmaceuticals Production NESHAP (for gas streams containing carbon disulfide), we have provided specific test methods for determining compliance when formaldehyde or carbon disulfide makes up a significant portion of the vent stream. Consistent with our previous determinations under these rules, we have ascertained that not all methods detect these compounds accurately and these specific methods are necessary in the proposed Uniform Standards.
We also are proposing that you may use Method 320 of 40 CFR part 63, appendix A as an alternative to using Method 18 or Method 26/26A of 40 CFR part 60, appendices A-6 through A-8, to determine compliance with a specific organic regulated material compound outlet concentration or percent reduction emission limit, or a hydrogen halide emission limit specified in the referencing subpart. In response to a public comment, the Method 320 of CFR part 63, appendix A option was added to the MON at final promulgation (68 FR 63852, November 10, 2003). The EPA declared that Method 320 of CFR part 63, appendix A was an acceptable method to demonstrate compliance for any type of batch or continuous vent stream. We have augmented this provision by specifying that EPA Method 320 may only be used to demonstrate compliance with a halogen emission limit if you can show that there are no diatomic-halogen molecules present in the vent stream being tested. For vent streams with diatomic-halogens molecules, we have determined that EPA Method 18 and EPA Method 26/26A are more effective. In addition, we are not allowing EPA Method 18, ASTM D6420-99 and EPA Method 320 to test for total regulated material because these methods only work for determining the quantity of known pollutants; therefore, you could
Because a referencing subpart may have requirements for organic HAP and metal HAP, or requirements for use of a surrogate, such as PM or fine particulate matter (PM
We are proposing language from the MON and the Pharmaceuticals Production NESHAP (40 CFR part 63, subpart GGG) to accommodate batch process operations. The MON primarily references the batch process operation provisions in the Pharmaceuticals Production NESHAP. The proposed standards are intended to be referenced from multiple regulations representing different source categories, and do not set group determinations or levels of control.
We have included provisions in proposed 40 CFR 65.826 and 40 CFR 65.827 explaining how compliance should be demonstrated for the different emission limit formats that a referencing subpart may use for batch process operations. The language accommodates percent reduction or outlet concentration limits for control devices. We have included the emission limit format from the MON that requires the owner or operator to show compliance with a percent reduction by aggregating emissions over the full batch process. These requirements would apply only when a referencing subpart requires the owner or operator to show compliance with a percent reduction using this method (see section V.A.8 of this preamble). We have included language (see equations 29 through 31 of proposed 40 CFR 65.835(a)) clarifying how to determine compliance with a percent reduction where a referencing subpart requires the owner or operator to aggregate batch emissions. The equations illustrate how you would compare the sums of the controlled and uncontrolled emissions for all batch process operations subject to control within the process to calculate the percent reduction achieved. This is a clarification of the MON language, which stated that uncontrolled and controlled emissions should be compared to demonstrate compliance, but did not provide additional details to explain how this should be done.
We are proposing engineering evaluation methodologies that are incorporated by reference from section 3 of the EPA's
With the exception of condensers, the proposed standards under subpart M require performance testing to demonstrate compliance with the applicable standard. However, to provide flexibility, we are including requirements for a design evaluation that could apply to non-flare control devices if it is allowed by the referencing subpart. For condensers, we are proposing that you must conduct a design evaluation (see discussion for condensers in section V.B.3 of this preamble).
Subpart M is structured such that general requirements for conducting a design evaluation are included under one section (proposed 40 CFR 65.850). More specific requirements pertaining to information that must be included in the design evaluation for each type of device are included in the corresponding section for that control device. The requirements for determining the components to include in a design evaluation are based on 40 CFR part 63, subpart SS, which were previously developed by the EPA for use in implementing a generic set of control standards that could be applied for multiple source categories. To ensure that sources can demonstrate compliance with the referencing subpart, we are proposing that you must prepare both a monitoring description and design evaluation. The monitoring description provides documentation that the source is maintaining the continuous monitoring equipment such that the control device can meet the emission limits specified in the referencing subpart. For the monitoring description, you would be required to choose the parameters, the operating limit(s), the monitoring frequency and the averaging time for each operating parameter, based on site-specific information, manufacturer's specifications, engineering judgment or other significant information. Your design evaluation would include documentation demonstrating that the control device being used achieves the required emission limit of a referencing subpart, taking into account the composition of the vent stream entering the control device, flow and regulated material concentration. There were no changes made to the design evaluation provisions except for the changes to: (1) Small boilers and process heaters, (2) oxidizers regarding the minimum temperature and residence time and (3) the inclusion of a design evaluation for biofilters when allowed by the referencing subpart (see previous discussion in section V.B.3 of this preamble).
The notification, recordkeeping and reporting requirements that we are proposing are similar to those required in 40 CFR part 63, subpart SS. However, we have streamlined the periodic
Although some regulations under 40 CFR part 60 and 40 CFR part 61 require 3-hour averaging (
We also do not consider daily averaging a relaxation of the previous NSPS that currently require more frequent averaging. Specifically, the 3-hour averages in NSPS and the daily averages in part 63 should not be compared only considering the averaging time, but one should also consider the meaning of out-of-range results. Under the NSPS, an out-of-range 3-hour average does not necessarily mean the source is out of compliance. Under the 40 CFR part 60 General Provisions, compliance with emission standards is determined by a performance test (see 40 CFR 60.11(a)). Under the 40 CFR part 63 General Provisions, it is clear that deviations from monitoring parameter ranges are direct violations (see 40 CFR 63.6(e)).
Under the proposed Uniform Standards, we have adopted the significance of out-of-range results from 40 CFR part 63; therefore, an out-of-range parameter on a daily average basis is a violation. We would allow the same out-of-range parameter determinations from 40 CFR part 63 to be made in all referencing subparts, including regulations under 40 CFR part 60 and 40 CFR part 61. Therefore, although facilities from 40 CFR part 60 or 40 CFR part 61 referenced to the Uniform Standards may become subject to daily averages in lieu of 3-hour averages, they would also be considered out of compliance if the daily average is out of range, provided this change is adopted in the rulemaking for the referencing subpart.
We anticipate that the referencing subpart may “override” the proposed daily averaging period with a stricter requirement if it is determined that such a requirement would be necessary to maintain the emission standard for the source category covered by the referencing subpart. A good example of such a source category is the proposed PVC Production NESHAP. It was determined for proposal that, for this source category, 3-hour averages are necessary to meet MACT. We consider the development of a referencing subpart at the appropriate time to make these source-category specific decisions.
We are proposing that you must report the daily and operating block averages for each continuously monitored parameter as part of the semiannual periodic report submitted through the CEDRI (see section II.F of this preamble). The EPA relies on the submittal of performance test data and emissions and parametric monitoring data to conduct effective reviews of CAA sections 111 and 112 standards, as well as compliance determinations, emission factor development, residual risk assessments and technology reviews. These emissions averages and parameter averages could supply up-to-date information regarding the capabilities of current industry technology, identify compliance issues and supplement emissions test data for establishing emission factors, improving regulation and improving the quality of emission inventories. Collecting this data on an ongoing basis through CEDRI will greatly reduce or eliminate the burden to industry and EPA from ICR efforts.
The proposed subpart M includes a pre-compliance report for batch processes, as does the MON and Pharmaceuticals Production NESHAP. This report is a combination of data submittals and reports that require the EPA review and approval prior to implementation and is, therefore, due before the compliance date (6 months prior to the compliance date for existing sources and to be submitted with the application for approval of construction or reconstruction for new sources). While we have designed the requirements for batch process operations to provide flexible options for compliance for owners and operators, we must ensure compliance with the MACT, GACT and BSER standards specified in the referencing subpart. We contend that the pre-compliance report is a valuable tool for the regulatory agency responsible for making compliance determinations. The batch pre-compliance requirements include providing details on the test conditions, data, calculations and other information used to establish operating limits for all batch operations, and rationale for why each operating limit indicates the control device is meeting the specified emission limit of the referencing subpart during each specific emission episode. If you used an engineering assessment, as specified in 40 CFR 65.835(b)(2), you would also include data or other information supporting a finding that the emissions estimation equations in the proposed subpart M are inappropriate. These data would include very detailed site-specific information and complex rationale for the selection of operating limits and emissions calculations. It is important that such data are reviewed prior to compliance to provide time to revise the CEMS performance evaluation and monitoring plan or the CPMS monitoring plan and conduct any necessary onsite preparation for revised monitoring requirements, based on the EPA concerns prior to the compliance date. This will ensure that there are no periods of noncompliance resulting from selection of an unacceptable approach. In the proposed Uniform Standards, we are using the term “batch pre-compliance report” rather than
There are several items required in the pre-compliance report for the two previous NESHAP that are not proposed in subpart M because they are not related to the control devices covered by this proposed rule. For example, we are not proposing requirements to determine wastewater characteristics, as required by the Pharmaceuticals Production NESHAP, because we are not proposing requirements for wastewater facilities at this time.
Several source categories, including the Miscellaneous Organic Chemical Manufacturing source category and the Pharmaceuticals Production source category, use non-dedicated, multipurpose equipment that may be configured in numerous ways to accommodate different batch processes. We anticipate that when a NSPS or NESHAP considers referencing subpart M for a batch process operation, there could be a need to anticipate alternate operating scenarios for the batch process. As such, we are proposing these requirements in subpart M in order to accommodate these alternate scenarios.
This section summarizes and provides rationale for the supplemental proposal for 40 CFR part 65, subpart H. This subpart was originally proposed on January 6, 2012 (77 FR 960). This supplemental proposal generally adds new language and sections applicable to proposed subparts H, I, J and M. There are some changes to the language originally proposed, but these are relatively small changes needed to incorporate the additional Uniform Standards subparts.
In section VI of this preamble, the term “we” refers to the EPA and the term “you” refers to owners and operators affected by the proposed standards. All other entities are referred to by their respective names (
In a previous proposal of the National Uniform Emission Standards for Heat Exchangers (40 CFR part 65, subpart L), signed by the EPA Administrator on November 30, 2011 (77 FR 960, January 6, 2012), we proposed general provisions in subpart H that would apply to all sources subject to all Uniform Standards. In that proposal, we specified that 40 CFR parts 60, 61 and 63, subpart A (
Based on this review, we have determined that certain reporting provisions in the 40 CFR parts 60, 61 and 63 General Provisions are not consistent with each other (
As such, we have concluded that the best approach to providing general provisions for the 40 CFR part 65 Uniform Standards is to consolidate some of the part 60, 61 and 63 general provisions, and to include these consolidated general provisions in subpart H. For the current proposal, we are issuing a supplemental proposal for subpart H in order to include additional provisions applicable to all Uniform Standards, as well as provisions applicable to individual Uniform Standards in 40 CFR Part 65, Subparts I, J and M.
For this purpose, we are maintaining five sections of subpart H proposed on January 6, 2012 (77 FR 960), and adding 12 new sections. Of the five previously proposed sections, we are proposing to make changes to three sections, as follows: (1) 40 CFR 65.200 will refer to 40 CFR 65.210, which specifies which general provisions in subpart A of 40 CFR parts 60, 61 and 63 apply to all Uniform Standards; (2) 40 CFR 65.265 will include additional methods incorporated by reference for 40 CFR part 65, subparts I, J and M; (3) 40 CFR 65.295 will include additional definitions of terms used in 40 CFR part 65, subparts I, J and M. The 12 new sections address the following consolidated general provisions applicable to all Uniform Standards: (1) General requirements for complying with the standards, operation and maintenance requirements, recordkeeping and reporting; (2) how to
For those 40 CFR parts 60, 61 and 63 general provisions that would apply to the Uniform Standards and that would not be consolidated into subpart H, you are referred to Table 1 of subpart H, which lists the sections or paragraphs of the 40 CFR parts 60, 61 or 63 general provisions that still apply to the Uniform Standards. In general, Table 1 lists general provisions that are associated with applicability, initial notifications and permit application requirements, and requirements that are not the typical compliance provisions that a source must meet. Examples of the types of 40 CFR part 60, 61 and 63 general provisions listed in Table 1 include: 40 CFR 60.2, 61.02 and 63.2 (definitions); 40 CFR 60.3, 61.03 and 63.3 (abbreviations); 40 CFR 60.12, 61.05, 61.19 and 63.4 (prohibited activities, circumvention and fragmentation); and 40 CFR 60.5, 61.06 and 63.5 (determination of construction or modification; preconstruction review and notification requirements). Regulated sources subject to 40 CFR parts 60, 61 or 63 would remain subject to the provisions in Table 1, as applicable.
40 CFR 65.200 is proposed to be changed from the previously proposed 40 CFR 65.200 to specify that you would be required to comply with the General Provisions, as specified in 40 CFR 65.210 (refers to Table 1), as well as the referencing subpart.
40 CFR 65.205 is proposed to be added to subpart H to make it clear who would be required to comply with the general provisions in subpart H. Subpart H applies to owners and operators who are subject to a referencing subpart and have been expressly directed to comply with the Uniform Standards by a referencing subpart. This section is needed so that you will understand the applicability.
40 CFR 65.206 was added as part of efforts to make consistent the organization of the Uniform Standards. The question of when to comply is addressed in only subpart H.
We are proposing to add 40 CFR 65.210 to subpart H to specify that only some 40 CFR parts 60, 61 and 63 general provisions will apply to you. As discussed in section VI.A of this preamble, we reviewed the 40 CFR parts 60, 61 and 63 General Provisions and concluded that the best approach to providing general provisions for the 40 CFR part 65 Uniform Standards is to consolidate some of the 40 CFR parts 60, 61 and 63 general provisions, and to include these consolidated general provisions in 40 CFR part 65, subparts H and M. Consolidating these provisions will allow us to streamline these general requirements for the Uniform Standards, increasing the clarity of the General Provisions and facilitating the compliance process for all parties. Consolidation will also reduce administrative burden by facilitating our process of amending the referencing subparts in the future.
To consolidate the 40 CFR parts 60, 61 and 63 general provisions, we reviewed each general provision in 40 CFR parts 60, 61 and 63. For each provision, we determined if the general provision should be: (1) Consolidated into one general provision in subpart H that applies to sources complying with any Uniform Standard (you would not comply with the original, unconsolidated part 60, 61 or 63 requirement); (2) consolidated into one general provision in 40 CFR part 65, subpart M that applies to sources complying with 40 CFR Part 65, subpart M (you would not comply with the original, unconsolidated part 60, 61 or 63 requirement); (3) referred to in Table 1 to subpart H and required, as specified in 40 CFR parts 60, 61 or 63; or (4) excluded from the Uniform Standards because the provision does not apply to the types of sources that will be regulated using the Uniform Standards (
Under 40 CFR part 60 and 40 CFR part 61, and as specified in subpart A of both parts, compliance is demonstrated with an emission limit using the results of a performance test; however, under 40 CFR part 63, the General Provisions specify that the Administrator will determine compliance based on performance tests, monitoring data, records, operation and maintenance procedures, and conformance to the procedures. In order to remove undue burden for individual source categories and provide consistent requirements for sources complying with the Uniform Standards, we have consolidated the general operation and maintenance compliance provisions of 40 CFR part 63 in proposed 40 CFR 65.215. These proposed provisions were developed, based on 40 CFR 63.6(e), (f) and (g). The proposed provisions are different from 40 CFR 63.6(e), (f) and (g) in that they include changes in terminology and cross-references, as well as removal of SSM provisions. The consolidated provisions in 40 CFR 65, subparts H and M would apply to all sources subject to referencing subparts.
We have not included provisions for SSM in these Uniform Standards, based on a recent District of Columbia Circuit ruling. The United States Court of Appeals for the District of Columbia Circuit vacated portions of two provisions in the EPA's CAA section 112 regulations governing the emissions of HAP during periods of SSM.
Consistent with
We are proposing to add 40 CFR 65.220 to require that you maintain records for a period of 5 years, as required in 40 CFR part 63, subpart A.
We propose adding 40 CFR 65.225 to subpart H to consolidate and make consistent the reporting provisions in 40 CFR parts 60, 61 and 63. We considered the level of reporting that would be required for sources regulated under the Uniform Standards according to the periodic reporting requirements of the existing rules and the title V program. Many sources are subject to numerous periodic reports under various 40 CFR parts 60, 61 and 63 subparts, as well as under the title V program. Petroleum refineries, for example, are required to prepare periodic reports under multiple regulations. For example, petroleum refineries can be subject to regulations, such as subparts G, R, CC, UU and UUU of 40 CFR part 63, subparts Kb, R, VV, XX, GGG and QQQ of 40 CFR part 60 and subparts V, Y, BB and FF of 40 CFR part 61, in addition to title V reporting requirements. All of these regulations have requirements for periodic reporting, most commonly, semiannual reporting. The NESHAP for petroleum refineries, 40 CFR part 63, subpart CC, includes provisions for emission units that are subject to more than one regulation and the rule provides direction regarding which rule the source should follow to address the overlapping requirements. However, this guidance only applies when more than one rule applies to a given emission unit; the guidance does not address situations when several rules apply to the source, but there is no overlap of requirements for a given emission unit. For example, there is no guidance provided for situations, such as a source with a storage tank subject to 40 CFR part 61, subpart Y, another tank subject to 40 CFR part 60, subpart Kb and third tank subject to 40 CFR part 63, subpart CC. For this example, the source is required to know the details of the recordkeeping and reporting requirements for all three rules and submit periodic reports according to the requirements of each rule.
As discussed in section II.D of this preamble, having the Uniform Standards with different subparts referencing its use provides for a significant burden reduction due to the consolidation of requirements. Although the report content would be the same for a given emission point type, the reporting schedule is dictated by the referencing subpart; therefore, a source subject to the Uniform Standard under multiple referencing subparts applicable to different emission points could still be subject to multiple periodic reports on different reporting schedules. However, we have included in proposed subpart H, provisions modeled from the 40 CFR part 63 General Provisions, allowing adjustments to reporting schedules to arrange the reports on a consistent schedule, including 40 CFR part 70 or 40 CFR part 71 operating permit semiannual reports.
In an effort to streamline the reporting requirements and reduce burden, we are proposing semiannual and annual periodic reports, based on whether the reporting elements are deviations or non-deviations. We considered whether it would be appropriate to eliminate periodic reports under the Uniform Standards because sources are required to document all deviations in 40 CFR part 70 or 40 CFR part 71 operating permit semiannual reports, which must also be documented in reports for the underlying rules. However, some reporting elements in the periodic reports required under existing rules are not reporting deviations. For example, periodic reports include, as applicable, reports on LDAR monitoring (such as number of equipment tested and number of leaking equipment found), new operating scenarios developed for batch operations and the associated parameter monitoring and reports on process changes. In order to address the differences between non-deviation reporting elements and to assure the appropriate level of detail for deviations, we have segregated the reporting elements into deviation and non-deviations. For non-deviation reporting elements, we are proposing that they be submitted annually in hardcopy. We have determined that annual reporting of non-deviation elements is sufficient to ensure compliance under the Uniform Standards, and anticipate that requiring these reporting elements annually, as opposed to semiannually, will create a burden reduction for industry (see section VII.D of this preamble).
Although we have maintained semiannual reporting for the deviation reporting elements in the Uniform Standards, we are proposing that they be electronically entered in the CEDRI (rather than submitted by other means). The electronic reporting system will allow owners and operators to create copies of any deviation reports they would need to submit in a 40 CFR part 70 or 40 CFR part 71 operating permit semiannual report to the permit authority. This would provide an additional burden reduction for industry, as discussed in section VII.D of this preamble.
We are proposing that the Notification of Compliance Status Reports for 40 CFR part 65, subparts I and J be submitted electronically; the Notification of Compliance Status Reports for 40 CFR part 65, subpart M would be submitted in hard copy. We are not requiring electronic submittal of the Notification of Compliance Status Report for subpart M because it contains reporting elements that contain a high level of detail and description. As discussed in section II.F of this preamble, we have determined that these reporting elements would not be easily incorporated into the electronic reporting system at this time.
The category of “other” notifications and reports was created to group together reports that are not part of the Notification of Compliance Status or periodic compliance reports. This group includes notifications and reports: (1) Submitted initially prior to the initial compliance demonstration; (2) that must be submitted only if you request to use alternative methods or procedures from
We have included provisions that would require you to report any changes in CMS, processes or controls, or new operating scenarios for batch operations that differ from what has been previously reported (either in the Notification of Compliance Status or a subsequent report) within 30 days of making the change. We must be notified of these changes because they could be germane to the determination of a deviation, such as a deviation of an operating parameter under a new operating scenario, which was employed following the last report. In this instance, the agency would need to know the parameters against which to evaluate the deviation, as established under the updated operating scenario.
This same approach to standardizing report names has been applied to periodic compliance reports and certain other reports. The proposed Uniform Standards refer to the periodic compliance report as the “annual periodic report” or “semiannual periodic report,” which standardizes the name for the “excess emission and continuous monitoring system performance report” and “summary report” in 40 CFR part 63, the “excess emissions and monitoring systems performance report” and “summary report form” in 40 CFR part 60 and the “compliance status information” form in 40 CFR part 61, appendix A.
Likewise, we propose making consistent, where appropriate, the content of these similar reports in 40 CFR parts 60, 61 and 63 for the semiannual and annual periodic reports and other notifications and reports under the Uniform Standards. For example, the 40 CFR parts 60, 61 and 63 general provisions for periodic compliance reporting include reporting provisions that are similar in intent, but slightly different in content, and this discrepancy between the General Provisions complicates our efforts to specify reporting requirements in 40 CFR part 65, subparts I, J and M. The proposed “semiannual periodic report” and “annual periodic report” incorporate elements of the “excess emission and continuous monitoring system performance report” and “summary report” in 40 CFR part 63, the “excess emissions and monitoring systems performance report” and “summary report form” in 40 CFR part 60 and the “compliance status information” form in 40 CFR part 61, appendix A. We are also updating the contents of the semiannual and annual periodic reports by adding provisions for closed vent systems, batch operations and process changes. Refer to section V.B of this preamble for further discussion on this topic.
We have consolidated the reporting requirement to submit a request for alternative monitoring. The general provisions for 40 CFR parts 60, 61 and 63 all allow alternative monitoring, but 40 CFR part 60 and 40 CFR part 61 do not provide a procedure for submitting such a request. We proposed to apply the procedure specified in the 40 CFR part 63 General Provisions to all sources subject to the Uniform Standards. This proposed revision is discussed further in section VI.B.7 of this preamble. Consolidating these provisions in subpart H would provide a consistent method for requesting monitoring alternatives for all referencing subparts, adding flexibility and simplifying compliance for sources regulated under the Uniform Standards.
Where we have determined that certain reporting requirements in the 40 CFR parts 60, 61 and 63 General Provisions do not apply to the Uniform Standards, we have excluded these provisions from 40 CFR part 65, subparts H through M. For example, the 40 CFR parts 60, 61 and 63 general provisions applicable to opacity and visible emissions are not included in proposed 40 CFR 65.225 because the Uniform Standards do not address opacity and visible emissions standards. We have also not included provisions from 40 CFR part 63 related to the SSM plan and associated recordkeeping and reporting, based on the Court decision that emissions limitations under CAA section 112 must apply at all times, even during periods of SSM (see section VI.B.5 of this preamble). Although the SSM plan and recordkeeping and reporting requirements were not specifically vacated by the Court, they no longer serve the original purpose of making sure the source follows good pollution control measures during periods of SSM in return for not being in violation.
We have removed provisions that required recordkeeping and reporting for actions taken during periods when a deviation occurs. These measures, which were previously included in periodic reports existing under 40 CFR part 60 and 40 CFR part 63, required that sources document and report the corrective actions taken when a
We are proposing that 40 CFR 65.235 be added to subpart H to provide a procedure for sources regulated under 40 CFR part 60 and 40 CFR part 61 (as well as 40 CFR part 63) to apply for and obtain approval for a recordkeeping or reporting waiver request. This proposed procedure for requesting a waiver is currently provided in the General Provisions for 40 CFR part 63, subpart A, but is not provided in the General Provisions for 40 CFR part 60 or 40 CFR part 61. 40 CFR 61.11 does provide provisions for a waiver of compliance, but does not specifically address a waiver of recordkeeping and reporting. We propose that sources regulated under 40 CFR part 61 submit the proposed application for a waiver of recordkeeping or reporting with the application requesting a waiver of compliance under 40 CFR 61.11. Applying this 40 CFR part 63, subpart A procedure to all sources referred to the Uniform Standards would add flexibility and simplify compliance and enforcement for sources regulated under the Uniform Standards.
We propose that 40 CFR 65.240 be added to subpart H to provide a procedure for requesting alternative monitoring methods, including major, minor and intermediate changes to monitoring methods. The allowance to request alternative monitoring is currently provided in the 40 CFR parts 60, 61 and 63 General Provisions, but the 40 CFR part 60 and 40 CFR part 61 General Provisions (
40 CFR 65.245 is proposed to be added to subpart H to provide a procedure for requesting a performance test waiver. This procedure is currently provided in the 40 CFR part 63 General Provisions, but is not provided in the 40 CFR part 60 General Provisions. The 40 CFR part 61 General Provisions (
Applying this 40 CFR part 63 general provisions procedure to all sources referred to the Uniform Standards would update these provisions for sources regulated under 40 CFR part 60 and 40 CFR part 61 and benefit both the public and industry by simplifying compliance for and enforcement of sources regulated under the Uniform Standards.
We propose that 40 CFR 65.250 be added to subpart H to provide a procedure for requesting a different test method than specified in the Uniform Standards, including standard methods not specified, alternative test methods or changes to test methods. The allowance to request alternative test methods is provided in 40 CFR parts 60, 61 and 63, subpart A, but 40 CFR part 60 and 40 CFR part 61, subpart A do not provide a procedure for application and approval of such requests. Applying this 40 CFR part 63, subpart A procedure to all sources referred to the Uniform Standards would provide sources regulated under 40 CFR part 60 and 40 CFR part 61 with more detailed instructions, simplifying compliance and enforcement of sources regulated under the Uniform Standards.
40 CFR 65.260 is proposed to be added to subpart H to specify a procedure for requesting an alternative means of emission limitation. The 40 CFR part 61 and 40 CFR part 63 General Provisions currently include such provisions. The 40 CFR part 60 General Provisions do not include such provisions; however, such provisions are included in the underlying rules of 40 CFR part 60. We are proposing to consolidate the provisions for 40 CFR part 61 and 40 CFR part 63 into proposed subpart H for sources directed to the Uniform Standards and regulated under 40 CFR parts 60, 61 and 63. The consolidated language in proposed subpart H contains the same provisions as the other general provisions requiring the source to submit a request containing information showing that the alternative means of emission limitations achieves equivalent emission reductions to the method specified in the Uniform Standards.
The previously proposed 40 CFR 65.275 describes procedures for determining whether a source is “in regulated material service,” in the event that a referencing subpart does not provide an explanation of how to determine whether a source is “in regulated material service.” These previously proposed requirements are based on the procedures in 40 CFR 63.180(d), which require that you determine the percent organic HAP
We delegate implementation and enforcement authority to a state under sections 111(c) and 112(l) of the CAA. For the Uniform Standards, the delegation of these authorities would be through the referencing subparts because the proposed Uniform Standards are a set of foundational requirements that may be used to demonstrate compliance with the emissions standards specified in the referencing subpart. However, because there are certain requirements that the EPA does not delegate to the states, and some of those requirements are located in the Uniform Standards, it is important to specify their location in the Uniform Standards. 40 CFR 65.275 is proposed to be added to subpart H to specify which authorities located in the Uniform Standards would be retained by the EPA and not delegated to a state. The proposed Uniform Standards in subpart H specify that the EPA retain authority to review and approve the following: alternative means of emission limitation; recordkeeping and reporting waivers; major changes to monitoring requirements; major changes to test methods; and using standard EPA test methods other than those listed in the Uniform Standards. This proposed list of authorities is consistent with the list of retained authorities specified 40 CFR parts 60, 61 and 63.
The proposed National Uniform Emission Standards for Heat Exchangers (40 CFR part 65, subpart L), signed by the EPA Administrator on November 30, 2011 (77 FR 960, January 6, 2012), included guidance on the timing of periodic requirements, including a minimum amount of time that must pass between consecutive instances, or “reasonable intervals.” We provided reasonable intervals for weekly, monthly, quarterly, semiannual and annual requirements in proposed 40 CFR part 65, subpart L, and those intervals have not changed. In the process of developing the Uniform Standards, we have added periodic requirements using additional time frames. Therefore, we are proposing to add additional reasonable intervals for requirements that occur bimonthly, three times per year and biennially (
We are proposing definitions in subpart H for certain types of units that appear in multiple Uniform Standards, so that those terms are defined consistently. Some definitions modeled from subpart SS, UU and WW of part 63 have been revised in the proposed subpart H for clarification or applicability purposes. Refer to sections III through V of this preamble for discussions about issues related to the proposed definitions.
The Uniform Standards provide only operational, compliance monitoring, recordkeeping and reporting requirements that would not apply to any specific source category unless and until made applicable in a subsequent rulemaking for that source category referencing the Uniform Standards; therefore, it is most appropriate to present nationwide impacts for a referencing subpart during proposal or promulgation of that subpart when the emission standards are established for a given source category and when the decision of whether to refer to the Uniform Standards (and with what modifications) is made. The referencing subpart will provide the specific applicability of the Uniform Standards and an estimate of the number of sources and emission units for the given source category. Using the estimated numbers of regulated units, the nationwide impacts can be clearly calculated and presented.
In order to provide sufficient information on the proposed Uniform Standards for comment review, we are presenting costs on a unit basis for the proposed monitoring requirements that have not been included in previous rules. Many of the requirements in the Uniform Standards are the same or are similar to previous rules and do not represent changes that will translate into a cost increase from current rules applicable to the chemical industry. Although the Uniform Standards are intended to reduce the overall burden for facilities, some of the proposed changes could cause an increase in costs. This section provides a discussion of these costs and any cost increases that could be associated with the compliance requirements of the Uniform Standards when they are applied through a referencing subpart.
Generally, costs will be the same or lower for the 40 CFR part 65, subpart I standards. The proposed requirement to control emissions from degassing certain storage vessels will increase costs, as described in section III of this preamble. The proposed requirement to install monitoring devices and alarms to
There are two new provisions in the Uniform Standards for Equipment Leaks that are expected to increase costs compared to current rules. As described in section IV.B.1 of this preamble, the first of these is annual instrument monitoring for open-ended valves and lines to ensure compliance with the requirement that the cap, blind flange, plug or a second valve properly seals the open-ended valve or line. The costs for the model plants ranged from a capital cost of $810 and an annualized cost of $180 for the simple chemical manufacturing model to a capital cost of $23,000 and an annualized cost of $5,400 for the complex refinery model.
The other provision that is expected to increase costs compared to current rules is the requirement to install electronic indicators on each PRD that would be able to identify and record the time and duration of each pressure release. These costs range from a capital cost of $11,000 and an annualized capital cost of $1,600 for the simple chemical manufacturing model to a capital cost of $130,000 and an annualized capital cost of $19,000 for the complex refinery model. Additional details on the calculation of these costs are provided in the technical memorandum entitled
We are providing a summary of the cost impacts of the proposed 40 CFR part 65, subpart M monitoring requirements in which the expected impacts will change from the typical monitoring requirements in past rules, including adsorbers, biofilters, bypasses and reporting requirements. We do not anticipate other cost impacts that would differ from those established in current regulations. We provide a summary of the costs for the proposed monitoring and reporting requirements in sections VII.C.1 through VII.C.3 of this preamble. Additional information regarding monitoring costs for closed vent system and control devices, including small boilers and process heaters, oxidizers, absorbers, adsorbers, condensers, biofilters, sorbent injection and fabric filters can be located in the technical memorandum,
The proposed monitoring for adsorbers, both regenerative and non-regenerative, includes some requirements that are new to the typical chemical sector regulation. Table 16 of this preamble provides a list of the proposed monitoring provisions for adsorbers that have not been typically included in previous chemical sector regulations.
As stated previously in section V.B.3 of this preamble, these monitoring requirements are important to assess whether the adsorbers are operating properly. It is difficult to estimate emissions reductions that can be attributed to these additional costs. Other than the weekly outlet concentration tests, the additional monitoring checks are designed to check for a situation that can occur, but may not for a given adsorber. If, for example, the valve sequencing of a regenerative adsorber is sluggish and the timing is not correct, the emissions reduced by the adsorber could degrade significantly. The weekly checks on the outlet concentration and associated corrective action plan for regenerative adsorbers ensure that degradation of the adsorbent, fouling or channeling is detected in a timely manner. A period of time with inadequate adsorbent would significantly reduce the emissions reductions of the adsorber. Although the degradation of the adsorbent is an anticipated event, the adsorbent life can vary with actual use; therefore, a schedule to check the outlet concentration is important to make sure that the adsorber does not operate with degraded adsorbent and can control emissions to meet the requirements of the referencing subpart.
Few past rules have included provisions for adsorbers regenerated offsite; therefore, any monitoring for non-regenerative adsorbers is additional monitoring or new for chemical sector rules. The proposed monitoring for this type of control, outlet concentration measurement, is low cost, especially considering that this is the only monitoring that is necessary for this control.
Although the MON requires monitoring the temperature of the biofilter bed, we are proposing additional monitoring for moisture and pressure drop. The estimated additional costs for monitoring these parameters are included in Table 17 of this preamble.
Although the MON only allows the biofilter as a control option for batch operations, we are proposing to allow the control option for emissions from either a batch or continuous operation. To meet the additional emissions reductions usually associated with continuous operations, we have added monitoring for moisture and pressure drop to ensure good performance of the biofilter. The costs for the additional monitoring are reasonable given the added assurance of good performance achieved by including this monitoring.
Bypass monitoring has been a requirement of closed vent system provisions in many past regulations. However, PRD needed for safety purposes, low leg drains, high point bleeds, analyzer vents and open-ended valves or lines were previously not subject to the bypass line requirements to have a flow monitor or a car seal on each bypass line that could divert a vent stream to the atmosphere. Given the recent
In our survey of existing regulations for the development of the Uniform Standards, we determined that many petroleum refineries and chemical plants are subject to numerous and duplicative recordkeeping and reporting requirements under various 40 CFR parts 60, 61 and 63 subparts, as well as under the title V program. We have estimated a total recordkeeping and reporting burden for a typical refinery subject to current rules of about $106,000, with a burden of approximately $52,800 for the required reporting. For an example chemical plant, we have estimated a total recordkeeping and reporting burden of approximately $66,900 for the current rules, with a burden of about $16,000 for the current required reporting. In order to reduce burden to industry, while retaining the reporting requirements needed to monitor compliance, we are proposing annual periodic reporting for some reporting elements and we are proposing to accept semiannual reporting data elements electronically, as discussed in sections II.F and VI.B.7 of this preamble. We anticipate that the proposed reporting requirements will reduce the burden of reporting for a typical refinery by 59 percent. This would represent a burden reduction of about $31,400 for reporting burden, and a total burden reduction of 30 percent for a typical refinery. For a typical chemical plant, we anticipate that the proposed requirements will reduce the burden of reporting by 42 percent. This would represent a burden reduction of $6,780 per year for reporting, and would represent a total burden reduction of 10 percent for a typical chemical plant. However, there will be some burden for a source to initially set up their facility in the electronic reporting system. We estimated set up costs for the example refinery and chemical plant as $5,300 and $2,700, respectively. See technical memorandum,
This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is, therefore, not subject to review under Executive Order 12866 and Executive Order 13563 (76 FR 3821, January 21, 2011).
Executive Order 13563 (76 FR 15859, March 22, 2011) directs each federal agency to “periodically review its existing significant regulations to determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.” Through this proposal, the EPA is responding to Executive Order 13563 by presenting steps to increase the ease and efficiency of data submittal and improve data accessibility.
Specifically, the EPA is proposing that owners and operators of facilities affected by this proposal electronically submit certain specified compliance reports to the EPA. Electronic data reporting informs a number of our programs and offers several advantages over traditional paper reporting. First, electronic reporting provides the agency easy and routine access to the data needed to review and evaluate our regulations. This results in fewer future ICR, thereby saving both industry and the agency time and resources. In addition, electronic reporting of emissions data will allow the agency to develop and update emissions factors on a timelier basis. Finally, electronic reporting informs our compliance program and allows easier identification of compliance issues.
Executive Order 13563 requires the EPA to evaluate current regulatory decisions to help generate a more transparent review process. We believe that, through this proposal, electronic reporting and data collection will provide a more effective and less burdensome approach to recordkeeping
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501,
The Regulatory Flexibility Act generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations and small governmental jurisdictions.
For purposes of assessing the impacts of this proposed action on small entities, small entity is defined as: (1) A small business, as defined by the Small Business Administration regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise that is independently owned and operated and is not dominant in its field.
After considering the economic impacts of this proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This proposed rule will not directly impose any requirements on any entities, including small entities. There are no entities subject to this proposed rule unless and until the Uniform Standards are referenced in future rulemakings for particular source categories. We continue to be interested in the potential impacts of the proposed rule on small entities and welcome comments on issues related to such impacts.
This action contains no federal mandates under the provisions of title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for state, local or tribal governments or the private sector. This rule does not contain a federal mandate that may result in expenditures of $100 million or more for state, local and tribal governments, in the aggregate, or the private sector in any one year. The Uniform Standards will not apply to any source category until future rulemakings under 40 CFR part 60, 61 or 63 reference their use. Thus, this rule is not subject to the requirements of sections 202 or 205 of UMRA.
This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. Upon proposal of a rule that references the Uniform Standards, consideration will be made whether that rule exceeds $100 million or more for state, local and tribal governments or presents a significant impact on small government entities.
This proposed rule does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The Uniform Standards will not apply to any source category until a future rulemaking under 40 CFR part 60, 61 or 63 references their use; therefore, the proposed Uniform Standards do not impose substantial direct compliance costs on state or local governments. Thus, Executive Order 13132 does not apply to this proposed rule. Upon proposal of a rule that references the Uniform Standards, consideration will be made whether that rule has federalism implications. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between the EPA and state and local governments, the EPA specifically solicits comment on this proposed rule from state and local officials.
This proposed rule does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian tribes or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified in Executive Order 13175. The proposed Uniform Standards do not directly impose requirements on owners and operators of specified sources or tribal governments, but will be referred to in future rulemakings, as discussed in section II of this preamble. If any industries that are owned or operated by tribal governments may be referenced to the Uniform Standards by another subpart in the future, the effect of this proposed rule on communities of tribal governments would not be unique or disproportionate to the effect on other communities. Thus, Executive Order 13175 does not apply to this proposed rule. The EPA specifically solicits additional comment on this proposed rule from tribal officials.
The EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to EO 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.
The proposed rule is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. The proposed Uniform Standards provide testing, monitoring, recordkeeping and reporting requirements only and do not specify applicability thresholds or emissions reduction performance requirements
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) Public Law 104-113, (15 U.S.C. 272 note) directs the EPA to use voluntary consensus standards (VCS) in its regulatory activities, unless to do so would be inconsistent with applicable law or otherwise impractical. VCS are technical standards (e.g., materials specifications, test methods, sampling procedures and business practices) that are developed or adopted by VCS bodies. NTTAA directs the EPA to provide Congress, through the Office of Management and Budget, explanations when the agency decides not to use available and applicable VCS. This proposed rulemaking involves technical standards. The EPA cites the following standards: Methods 1, 1A, 2, 2A, 2C, 2D, 2F, 2G, 3, 3A, 3B, 4, 5, 18, 21, 22, 23, 25A, 26, 26A, 27, 29, 201A, 202, 301 and 320 of 40 CFR part 60, appendix A. Consistent with the NTTAA, the EPA conducted searches to identify VCS in addition to these EPA methods. No applicable VCS were identified for EPA Methods 1A, 2A, 2D, 2F, 2G, 21, 22, 27, 201A or 202. The search and review results are in the docket for this rule. The search identified six VCS as acceptable alternatives to EPA test methods for the purpose of this rule. The method, ASME PTC 19.10-1981,
The VCS, ASTM D6735-01,
The search for emissions measurement procedures identified 23 other VCS that were potentially applicable for the Uniform Standards in lieu of EPA reference methods. The EPA determined that these 23 standards identified for measuring emissions of the regulated pollutants or their surrogates subject to emission standards in this proposed rule were impractical due to lack of equivalency, documentation, validation data and other important technical and policy considerations. Therefore, the EPA does not intend to adopt these standards for this purpose. The reasons for the determinations for the 23 methods are in the docket for this proposed rule. For the methods required or referenced by the proposed rules, a source may apply to the EPA for permission to use alternative test methods or alternative monitoring requirements in place of any required testing methods, performance specifications or procedures, as specified in proposed 40 CFR part 65, subpart H.
Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies and activities on minority populations and low-income populations in the United States.
The EPA has concluded that it is not practicable to determine whether there would be disproportionately high and adverse human health or environmental effects on minority and/or low income populations from this proposed rule. The proposed Uniform Standards only provide thresholds, emissions reduction requirements and operational, testing, monitoring, recordkeeping and reporting requirements, and are not applicable until referenced by a future rulemaking for a particular source category. The impact of the proposed rule on minority and/or low-income populations would be determined during proposal in future rulemakings that reference the Uniform Standards.
Air pollution control, Environmental protection, Incorporation by reference, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, title 40, chapter I, of the Code of Federal Regulations is proposed to be amended as follows:
1. The authority citation for part 65 continues to read as follows:
42 U.S.C. 7401
2. Replace subpart H to read as follows:
The purpose of this subpart is to provide general provisions for the Uniform Standards of this part. These general provisions apply to you if a subpart of part 60, 61 or 63 of this chapter references the use of this subpart. The general provisions applicable to the referencing subpart (subpart A of part 60, 61 or 63) apply to this subpart, as specified in § 65.210. Section 65.295 contains definitions of “uniform standards” and “referencing subpart,” as well as other terms used in these Uniform Standards. The General Provisions for the Consolidated Federal Air Rule (subpart A of this part) do not apply to the Uniform Standards.
You are subject to this subpart if you are an owner or operator who is subject to a referencing subpart and you have been expressly directed to comply with the uniform standards by a referencing subpart.
You must comply with this subpart by the date specified in the referencing subpart that directed you to comply with this subpart.
You must comply with the provisions of 40 CFR part 60, subpart A; 40 CFR part 61, subpart A; and 40 CFR part 63, subpart A, as applicable, that are specified in Table 1 to this subpart. Table 1 to this subpart specifies the provisions in 40 CFR part 60, subpart A; 40 CFR part 61, subpart A; and 40 CFR part 63, subpart A that continue to apply to owners or operators of regulated sources expressly referenced to the Uniform Standards. You must comply with the provisions in Table 1 to this subpart that correspond to the referencing part. All provisions of 40 CFR part 60, subpart A; 40 CFR part 61, subpart A; and 40 CFR part 63, subpart A that are not expressly referenced in Table 1 to this subpart do not apply, and the provisions of the Uniform Standards apply instead, except that provisions that were required to be met prior to implementation of the Uniform Standards still apply.
(a)
(1) At all times, you must operate and maintain any regulated source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions.
(2) The emission standards and established parameter ranges of the referencing subpart and of the Uniform Standards apply at all times, except during periods of non-operation of the regulated source (or specific portion thereof), as specified in paragraphs (a)(2)(i) and (ii) of this section. However, if a period of non-operation of one portion of a regulated source does not affect the ability of a particular emission point to comply with the specific provisions to which it is subject, then that emission point must comply with the applicable provisions of the Uniform Standards during the period of non-operation. For example, the degassing of a storage vessel would not affect the ability of a process vent to meet the requirements of subpart M of this part.
(i) For all Uniform Standards except subpart J of this part, periods of non-operation of the regulated source (or specific portion thereof) are those periods resulting in cessation of the emissions to which the Uniform Standards apply.
(ii) For subpart J of this part, periods of non-operation of the regulated source (or specific portion thereof) are those periods in which the lines are drained and depressurized, resulting in cessation of the emissions to which subpart J of this part applies.
(3) Operation and maintenance requirements are enforceable independent of emissions limitations or other requirements in relevant standards.
(b)
(1)
(2)
(3)
(i)
(ii)
(4)
(i) Review of records, inspection of the regulated source and other procedures specified in the Uniform Standards.
(ii) Evaluation of your conformance with operation and maintenance requirements, as specified in paragraph (a) of this section and in the Uniform Standards.
(c)
(a)
(b)
(a)
(1) A Notification of Compliance Status described in paragraph (c) of this section.
(2) Semiannual periodic reports, as described in paragraph (d) of this section.
(3) Annual periodic reports, as described in paragraph (e) of this section.
(4) Other notifications and reports, as described in paragraph (f) of this section.
(b)
(c)
(1)
(2)
(d)
(1)
(2)
(i) The first report must be submitted no later than the last day of the month that includes the date 8 months after the date the source became subject to this part or 6 months after the date since the last part 60, 61 or 63 periodic report was submitted for the applicable requirement, whichever is earlier.
(ii) For sources complying with the Uniform Standards at initial startup, the first report must cover the 6 months after the Notification of Compliance Status is due. The first report must be submitted no later than the last day of the month that includes the date 8 months after the Notification of Compliance Status is due.
(e)
(1)
(2)
(i) The first report must be submitted no later than the last day of the month that includes the date 14 months after the date the source became subject to this part or 12 months after the date since the last part 60, 61 or 63 periodic report was submitted for the applicable requirement, whichever is earlier.
(ii) For sources complying with the Uniform Standards at initial startup, the first report must cover the 12 months after the Notification of Compliance Status is due. The first report must be submitted no later than the last day of the month that includes the date 14 months after the Notification of Compliance Status is due.
(f)
(1)
(i) Any request for a waiver for recordkeeping or reporting requirements, as specified in § 65.235.
(ii) Any request for an alternative or change in monitoring or an alternative recordkeeping method, as specified in § 65.240.
(iii) Any request for a waiver for a performance testing requirement, as specified in § 65.245.
(iv) Any request to use a different method than one specified in the Uniform Standards, as specified in § 65.250.
(2)
(i) Notification of inspection (§ 65.388(a)).
(ii) Requests for alternate devices (§ 65.388(b)).
(3)
(i) Notification of performance test (§ 65.884(a)).
(ii) Performance test reports (§ 65.884(b)) submitted, as specified in paragraph (k) of this section.
(iii) Notification of CEMS performance evaluation (§ 65.884(c)).
(iv) CEMS performance evaluation and monitoring plan (§ 65.884(c)).
(v) CEMS performance evaluations (§ 65.884(d)) submitted, as specified in paragraph (k) of this section.
(vi) Continuous parameter monitoring system (CPMS) monitoring plan (§ 65.884(e)).
(vii) Application to substitute a prior performance test (§ 65.884(f)).
(viii) A batch precompliance report (§ 65.884(g)).
(ix) Request for approval of an alternative monitoring parameter or use of a control device other than those listed in subpart M of this part (§ 65.884(h)).
(x) Changes in continuous monitoring system, processes or controls (§ 65.884(i)).
(xi) New operating scenarios for batch operations (§ 65.884(j)).
(g)
(1) Company name, address and telephone number (fax number may also be provided).
(2) The name, address and telephone number of the person to whom inquiries should be addressed, if different than the owner or operator.
(3) The address (physical location) of the reporting facility.
(4) Identification of each regulated source covered in the submission.
(5) Identification of which referencing subpart is applicable to each regulated source.
(6) Identification of which Uniform Standards are applicable to that regulated source.
(7) Summaries and groupings of the information specified in paragraphs (g)(4) through (6) of this section are permitted.
(8) The date of the report.
(h)
(i)
(1) Notifications and reports not required to be submitted electronically under this part must be sent to the Administrator at the appropriate EPA Regional Office, and to the delegated State authority; except if you request permission to use an alternative means of emission limitation, as provided for in § 65.260, you must submit the request to the Director of the Office of Air Quality Planning and Standards (C404-04), U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711. The EPA Regional Office may waive the requirement to receive a copy of any notification or report at its discretion.
(2) If any State requires a notice that contains all the information required in a notification or report listed in this part, you may send the appropriate EPA Regional Office a copy of the notification or report that you sent to the state to satisfy the requirements of this part for that notification or report.
(3) Wherever this subpart specifies “postmark” dates, submittals may be sent by methods other than the U.S. Mail (for example, by email, fax or courier) upon mutual agreement with the Administrator. Submittals must be sent on or before the specified date.
(4) If acceptable to both the Administrator and you, notifications and reports may be submitted on electronic media.
(j)
(1)
(2)
(3)
(4)
(k)
(1) Within 60 days after the date of completing each performance test required by Uniform Standards, you must submit performance test data electronically to EPA's Central Data Exchange (CDX) by using the ERT (see
(2) If you claim that some of the information being submitted for performance tests is confidential business information (CBI), you must omit such CBI data from the electronic submissions and submit a complete ERT file, including information claimed to be CBI, on a compact disk or other commonly used electronic storage media (including, but not limited to, flash drives) to EPA by the due date specified in paragraph (j)(1) of this section. The electronic media must be clearly marked as CBI, with the company name, facility location, contact name and phone number, and mailed to U.S. EPA/OAQPS/CORE CBI Office, Attention: WebFIRE Administrator, MD C404-02, 4930 Old Page Rd., Durham, NC 27703.
(3) Within 60 days after the date of completing each CEMS performance evaluation test required by § 65.711(c), you must submit the relative accuracy test audit data electronically into EPA's CDX by using the ERT, as described in paragraph (k)(1) of this section.
(4) The Administrator or the delegated authority may request a report in any form suitable for the specific information, (e.g., by commonly used electronic media, such as spreadsheet, on CD or hard copy). The Administrator retains the right to require submittal of reports in paper format.
You may request a waiver from recordkeeping or reporting according to the procedures in paragraphs (a) and (b) of this section. The Administrator will process the waiver according to the procedures in paragraphs (c) through (e) of this section. You remain subject to the reporting and recordkeeping requirements of the Uniform Standards until a waiver has been granted by the Administrator.
(a)
(b)
(c)
(1) Approves or denies an extension of compliance under § 63.6(i) of this chapter or a waiver of compliance under § 61.10(b) of this chapter.
(2) Makes a determination of compliance following the submission of a required semiannual periodic report.
(3) Makes a determination of suitable progress toward compliance following the submission of a compliance progress report, whichever is applicable.
(d)
(e)
You may submit a request for approval to use alternatives (major, intermediate or minor changes to monitoring methods) to the monitoring provisions of the Uniform Standards, as specified in paragraphs (a) through (d) of this section.
(a)
(1) Information justifying your request for an alternative monitoring method, such as the technical or economic infeasibility, or the impracticality of the regulated source using the required method.
(2) A description of the proposed alternative monitoring system that addresses the four elements contained in the definition of monitoring in § 65.295.
(3) A CEMS performance evaluation and monitoring plan, as specified in § 65.711(c) or a CPMS monitoring plan, as specified in § 65.712(c), as applicable.
(b)
(1) You may submit the application at any time, provided that it is submitted with enough time prior to the compliance date specified in the referencing subpart to ensure a timely review by the Administrator in order to conduct the alternative monitoring method after the compliance date.
(2) If the alternative monitoring procedure will serve as the performance test method that is to be used to demonstrate compliance with a referencing subpart, the application must be submitted at least 60 days before the performance test is scheduled to begin and must meet the requirements for an alternative test method under § 65.250.
(3) For a request to make a minor change to monitoring, you must submit your request with your CEMS performance evaluation and monitoring plan required in § 65.711(c) or your CPMS monitoring plan required in § 65.712(c), as applicable. Approval of the plan will constitute approval of the minor change.
(c)
(1) Notice of the information, and findings on which the intended disapproval is based.
(2) Notice of opportunity for you to present additional information to the Administrator before final action on the request. At the time the Administrator notifies you of the intention to disapprove the request, the Administrator will specify how much time you will have after being notified of the intended disapproval to submit the additional information.
(d)
(1) You are subject to the monitoring requirements of the Uniform Standards, unless permission to use an alternative monitoring method has been granted by the Administrator. Once an alternative is approved, you must use the alternative for the emission points or regulated sources cited in the approval, and must meet the monitoring requirements of the Uniform Standards for all other emission points or regulated sources.
(2) If the Administrator approves the use of an alternative monitoring method for a regulated source, you must continue to use the alternative monitoring or method unless you receive approval from the Administrator to use another method.
(3) If the Administrator finds reasonable grounds to dispute the results obtained by an alternative monitoring method, requirement or procedure, the Administrator may require the use of a method, requirement or procedure specified in the Uniform Standards. If the results of the specified and alternative methods, requirements or procedures do not agree, the results obtained by the method, requirement or procedure specified in the Uniform Standards will prevail.
You may request a waiver from the requirements to conduct a performance test by following the procedures specified in paragraphs (a) through (e) of this section. Unless and until a waiver of a performance testing requirement has been granted by the Administrator under this paragraph, you remain subject to the performance testing requirements in §§ 65.820 through 65.829.
(a)
(1) You are meeting the Uniform Standards on a continuous basis.
(2) You are operating under an extension of compliance, as specified in § 63.6(i) of this chapter.
(3) You have requested an extension of compliance, as specified in § 61.11 and the Administrator is still considering that request.
(b)
(c)
(1) If you request an extension of compliance under § 63.6(i) of this chapter, the application for a waiver of an initial performance test must accompany the information required for the request for an extension of compliance, and must be submitted on the schedule in § 63.6(i) of this chapter.
(2) If you have not requested an extension of compliance or if you have requested an extension of compliance and the Administrator is still considering that request, the application for a waiver of a performance test must be submitted at least 60 days before performance testing would be required. The application may accompany a Notification of Compliance Status Report or semiannual periodic report, as specified in § 65.225(c) or (d).
(d)
(1) Approves or denies an extension of compliance under § 63.6(i)(8) or under § 63.11.
(2) Approves or disapproves a performance test plan under § 65.820(c).
(3) Makes a determination of compliance following the submission of a required compliance status report or periodic report.
(4) Makes a determination of suitable progress towards compliance following the submission of a compliance progress report.
(e)
You may submit a request for approval to use an alternative test method (i.e., major, intermediate or minor change to a test method, or an EPA test method other than one in the Uniform Standards), as described in paragraphs (a) through (d) of this section.
(a)
(1) A justification for using the proposed alternative method instead of using the method specified in the Uniform Standards.
(2) Results of applying Method 301 at 40 CFR part 63, appendix A of this part to validate the alternative test method. This may include the use of only specific procedures of EPA Method 301, if use of such procedures are sufficient to validate the alternative test method.
(3) For minor changes to a test method and for EPA test methods other than those specified in the Uniform Standards, Method 301 at 40 CFR part 63, appendix A of this part is not required to validate the test method.
(b)
(c)
(d)
(1) If you have not received notification of approval/disapproval within 45 days after submission of the request to use an alternative method and the request satisfies the requirements in paragraphs (a) and (b) of this section, you may conduct the performance test using the alternative method.
(2) If you use an alternative test method for a regulated source during a required performance test, you must continue to use the alternative test method for subsequent performance tests at that regulated source until you receive approval from the Administrator to use another test method, as allowed under this section.
(3) If the Administrator finds reasonable grounds to dispute the results obtained by an alternative test method for the purposes of demonstrating compliance with a relevant standard, the Administrator may require the use of a test method specified in the Uniform Standards.
(4) Neither the validation and approval process nor the failure to validate an alternative test method abrogates your responsibility to comply with the requirements of the Uniform Standards.
(a)
(1) The notice may provide permission on the condition that the alternative means of emission limitation must include requirements to assure the proper operation and maintenance of equipment and practices that would be required for compliance with the alternative emission standard, including appropriate quality assurance and quality control requirements that are deemed necessary.
(2) Any such notice will be published only after public notice and an opportunity for a hearing.
(3) A manufacturer of control devices or monitoring equipment may request an alternative means of emission limitation approval for their product.
(b)
(1) In order to obtain approval, any person seeking permission to use an alternative means of emission limitation under this section must collect, verify and submit to the Administrator information showing that the alternative means achieves equivalent emission reductions. If you seek permission to use an alternative means of emission limitation and you have not previously performed testing, you must also submit the proposed performance test plan required in § 65.820(b). If you seek permission to use an alternative means of emission limitation, based on previously performed testing, you must submit the results of that testing, a description of the procedures followed in testing or monitoring and a description of pertinent conditions during testing or monitoring.
(2) If you request an alternative means of emission limitation, you must submit a description of the proposed testing, monitoring, recordkeeping and reporting that you will use and the proposed basis for demonstrating compliance.
(3) Any testing or monitoring conducted to request permission to use an alternative emission standard must be appropriately quality assured and quality controlled, as specified in § 65.820(b), as applicable.
(4) If you request the use of an alternate device for a fitting on a floating roof, as described in § 65.315(e), you must submit an application, including emissions test results and an analysis demonstrating that the alternate device has an emission factor that is less than or equal to the emission factor for the device specified in § 65.315(a). The test results must include all documentation required by the applicable test methods and documentation of monitoring during the performance test of any operating parameters on which you establish limits. The tests must be conducted using full-size or scale-model storage vessels that accurately collect and measure all regulated material emissions using a given control technique, and that accurately simulate wind and account for other emission variables, such as temperature and barometric pressure, or an engineering analysis that the Administrator determines is an accurate method of determining equivalence.
(c)
The materials listed in this section are incorporated by reference in the corresponding sections of the Uniform Standards. These incorporations by reference were approved by the Director of the
(a) The following materials are available for purchase from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, (703) 605-6000 or (800) 553-6847; or for purchase from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, (202) 512-1800.
(1) Office of Air Quality Planning and Standards (OAQPS), Fabric Filter Bag Leak Detection Guidance, EPA-454/R-98-015, September 1997 (EPA-454/R-98-015).
(2) Emissions Inventory Improvement Program, Volume II: Chapter 16, Methods for Estimating Air Emissions from Chemical Manufacturing Facilities, August 2007, Final, (EPA EIIP Volume II: Chapter 16)
(3) Test Method for Vapor Pressure of Reactive Organic Compounds in Heavy Crude Oil Using Gas Chromatography,
(b) The following materials are available for purchase from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, Pennsylvania 19428-2959, (610) 832-9585,
(1) ASTM D6420-99(2010), Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry.
(2) ASTM D1946-90(2006), Standard Practice for Analysis of Reformed Gas by Gas Chromatography.
(3) ASTM D4809-09a, Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter (Precision Method).
(4) ASTM D2879-95(2011), Standard Test Method for Hydrocarbon Types in Low Olefinic Gasoline by Mass Spectrometry.
(c) The following materials are available for purchase from ASME, Information Central Orders/Inquiries, P.O. Box 2300, Fairfield, New Jersey 07007-2300, (800) 843-2763,
(1) ANSI/ASME PTC 19.10-1981, Flue and Exhaust Gas Analyses [Part 10, Instruments and Apparatus].
(2) ASME B31.3-2010, Process Piping.
(d) The following materials are available for purchase from the National Technical Information Service (NTIS), Alexandria, Virginia 22312, (800) 553-6847,
(1) Flammability Characteristics of Combustible Gases and Vapors, Zabetakis, M.G., U.S. Bureau of Mines, Bulletin 627, 1965.
(2) [Reserved].
(e) The following materials are available for purchase from the American Petroleum Institute (API), 1220 L Street NW., Washington, DC 20005-4070, (202) 682-8000,
(1) Evaporative Loss From External Floating Roof Tanks, API MPMS Chapter 19.2, September 1, 2003.
(2) [Reserved].
If you are subject to a uniform standard that includes requirements for regulated sources “in regulated material service,” you must determine if regulated sources or equipment are in regulated material service using either paragraph (a) or (b) of this section, as applicable.
(a) If the referencing subpart includes a procedure or definition of “in regulated material service,” you must use the procedure or definition of “in regulated material service” in the referencing subpart.
(b) If the referencing subpart does not include a procedure or definition of “in regulated material service,” you must use the procedures specified in paragraphs (b)(1) through (3) of this section.
(1) Regulated sources or equipment that can reasonably be expected to be in regulated material service are presumed to be in regulated material service unless you demonstrate that the regulated sources or equipment are not in regulated material service.
(2) Except as provided in paragraph (b)(1) and (3) of this section, you must use Method 18 of 40 CFR part 60, appendix A-6 and either of the methods specified in paragraphs (b)(2)(i) or (ii) of this section to demonstrate that regulated sources or equipment are not in regulated material service.
(i) Determine the weight percent regulated material content of the process fluid that is contained in or contacts the regulated source as the arithmetic sum of the weight percent concentration of each compound defined as regulated material. Demonstrate that the regulated material concentration is less than 5 weight percent on an annual average basis.
(ii) Demonstrate that the non-regulated material content exceeds 95 percent by weight on an annual average basis.
(3) You may use good engineering judgment rather than the procedures in paragraph (b)(1) or (2) of this section to determine if regulated sources or equipment are not in regulated material service. However, when you and the Administrator do not agree on whether the regulated sources or equipment are in regulated material service, you must use the procedures in paragraph (b)(2) of this section to resolve the disagreement.
In delegating implementation and enforcement authority to a state under sections 111(c) and 112(l) of the Clean Air Act, the following authorities are retained by the Administrator and not transferred to a state:
(a) In § 65.235, request for recordkeeping and reporting waiver.
(b) In § 65.240, major changes to monitoring methods.
(c) In § 65.250, major changes to test methods or a different EPA method than one specified in the Uniform Standards.
(d) In 65.260, alternative means of emissions limitation.
Except as specified in paragraph (c) of this section, if you are subject to a requirement in the Uniform Standards to complete a particular task on a periodic basis, you must comply, as described in paragraphs (a) and (b) of this section.
(a)
(b)
(1) Tasks that you are required to complete weekly must be separated by at least 3 calendar days.
(2) Tasks that you are required to complete monthly must be separated by at least 14 calendar days.
(3) Tasks that you are required to complete bimonthly (
(4) Tasks that you are required to complete quarterly must be separated by at least 30 calendar days.
(5) Tasks that you are required to complete three times per year must be separated by at least 40 calendar days.
(6) Tasks that you are required to complete semiannually (
(7) Tasks that you are required to complete annually must be separated by at least 120 calendar days.
(8) Tasks that you are required to complete biennially (
(c)
(2) If the paragraph in the Uniform Standards that imposes a periodic requirement specifies a different schedule for complying with that requirement, you must follow that
(3) Time periods may be changed by mutual agreement between you and the Administrator, as specified in § 65.225(j). For example, a period could begin on the compliance date or another date, rather than on the first day of the standard calendar period. For each time period that is changed by agreement, the revised period applies until it is changed. A new request is not necessary for each recurring period.
(4) Nothing in paragraphs (a) and (b) of this section shall be construed as prohibiting you from conducting a periodic task at a more frequent interval than required.
All terms used in the Uniform Standards have the meaning given them in the Clean Air Act, the referencing subpart and in this section. The definition in the referencing subpart takes precedence.
(1) Use of a CEMS in lieu of a parameter monitoring approach;
(2) Decreased frequency for non-continuous parameter monitoring or physical inspections;
(3) Changes to quality control requirements for parameter monitoring; and
(4) Use of an electronic data reduction system in lieu of manual data reduction.
(1) Modifications to a test method's sampling procedure, including substitution of sampling equipment that has been demonstrated for a particular sample matrix and use of a different impinger absorbing solution;
(2) Changes in sample recovery procedures and analytical techniques, such as changes to sample holding times and use of a different analytical finish with proven capability for the analyte of interest; and
(3) “Combining” a federally required method with another proven method for application to processes emitting multiple pollutants.
(1) Use of a new monitoring approach developed to apply to a control technology not contemplated in the applicable regulation;
(2) Use of a predictive emission monitoring system (PEMS) in place of a required CEMS;
(3) Use of alternative calibration procedures that do not involve calibration gases or test cells;
(4) Use of an analytical technology that differs from that specified by a performance specification;
(5) Decreased monitoring frequency for a CEMS, continuous opacity monitoring system, PEMS or CPMS;
(6) Decreased monitoring frequency for a leak detection and repair program; and
(7) Use of alternative averaging times for reporting purposes.
(1) Use of an unproven analytical finish;
(2) Use of a method developed to fill a test method gap;
(3) Use of a new test method developed to apply to a control technology not contemplated in the applicable regulation; and
(4) Combining two or more sampling/analytical methods (at least one
(1) A modification to federally required monitoring that:
(i) Does not decrease the stringency of the compliance and enforcement measures for the relevant standard;
(ii) Has no national significance (
(iii) Is site-specific, made to reflect or accommodate the operational characteristics, physical constraints or safety concerns of a regulated source.
(2) Examples of minor changes to monitoring include, but are not limited to:
(i) Modifications to a sampling procedure, such as use of an improved sample conditioning system to reduce maintenance requirements;
(ii) Increased monitoring frequency; and
(iii) Modification of the environmental shelter to moderate temperature fluctuation and, thus, protect the analytical instrumentation.
(1) A modification to a federally enforceable test method that:
(i) Does not decrease the stringency of the emission limitation or standard;
(ii) Has no national significance (
(iii) Is site-specific, made to reflect or accommodate the operational characteristics, physical constraints or safety concerns of a regulated source.
(2) Examples of minor changes to a test method include, but are not limited to:
(i) Field adjustments in a test method's sampling procedure, such as a modified sampling traverse, or location to avoid interference from an obstruction in the stack, increasing the sampling time or volume, use of additional impingers for a high moisture situation, accepting particulate emission results for a test run that was conducted with a lower-than-specified temperature, substitution of a material in the sampling train that has been demonstrated to be more inert for the sample matrix; and
(ii) Changes in recovery and analytical techniques, such as a change in quality control/quality assurance requirements needed to adjust for analysis of a certain sample matrix.
(1) Indicator(s) of performance—the parameter or parameters you measure or observe for demonstrating proper operation of the pollution control measures or compliance with the applicable emissions limitation or standard. Indicators of performance may include direct or predicted emissions measurements (including opacity), operational parametric values that correspond to process or control device (and capture system) efficiencies or emissions rates and recorded findings of inspection of work practice activities, materials tracking or design characteristics. Indicators may be expressed as a single maximum or minimum value, a function of process variables (for example, within a range of pressure drops), a particular operational or work practice status (for example, a damper position, completion of a waste recovery task, materials tracking) or an interdependency between two or among more than two variables.
(2) Measurement techniques—the means by which you gather and record information of or about the indicators of performance. The components of the measurement technique include the detector type, location and installation specifications, inspection procedures, and quality assurance and quality control measures. Examples of measurement techniques include CEMS, continuous opacity monitoring systems, CPMS, and manual inspections that include making records of process conditions or work practices.
(3) Monitoring frequency—the number of times you obtain and record monitoring data over a specified time interval. Examples of monitoring frequencies include at least four points equally paced for each hour for continuous emissions or parametric monitoring systems, at least every 10 seconds for continuous opacity monitoring systems and at least once per operating day (or week, month, etc.) for work practice or design inspections.
(4) Averaging time—the period over which you average and use data to verify proper operation of the pollution control approach or compliance with the emissions limitation or standard. Examples of averaging time include a 3-hour average in units of the emissions limitation, a 30-day rolling average emissions value, a daily average of a control device operational parametric range and an instantaneous alarm.
(1) To remove water vapor that would cause icing in a downstream condenser.
(2) To remove water vapor that would negatively affect the adsorption capacity of carbon in a downstream carbon adsorber.
(3) To remove high molecular weight organic compounds or other organic compounds that would be difficult to remove during regeneration of a downstream carbon adsorber.
(1) An unscheduled work practice or operations procedure that stops production from a process unit, or part of a process unit, for less than 24 hours.
(2) An unscheduled work practice or operations procedure that would stop production from a process unit, or part of a process unit, for a shorter period of time than would be required to clear the process unit, or part of the process unit of materials and start up the unit, and would result in greater emissions than delay of repair of leaking components, until the next scheduled process unit shutdown.
(3) The use of spare equipment and technically feasible bypassing of equipment without stopping production.
(1) If indications of a potential leak or liquids dripping are observed during sensory monitoring or a visual inspection, then the equipment, seal, fitting or other emissions source is adjusted, or otherwise altered, to eliminate the indications of a potential leak or liquids dripping.
(2) If a leak is detected by instrument monitoring, then the equipment, seal, fitting or other emissions source is adjusted or otherwise altered to eliminate a leak, as defined in the applicable sections of subparts I through M of this part and the emissions source is monitored, as specified in § 65.431(a) and (b) to verify that emissions are below the applicable instrument reading that defines a leak.
(3) If a leak is detected by a sensor or by failure of one or more design or inspection criteria, then the equipment, seal, fitting or other emissions source is adjusted, or otherwise altered, to return the emissions source to conditions such that the sensor no longer indicates a leak or that the emissions source is meeting the design or inspection criteria, as applicable.
(4) If a leak is detected by optical gas imaging, then the equipment, seal, fitting or other emissions source is adjusted, or otherwise altered, to eliminate the leak and the emissions source is monitored, as specified in § 65.450(b)(2) to verify that the leak can no longer be imaged by the optical gas imaging instrument.
(5) Repair does not mean repairs to CEMS or CPMS.
(1) Vessels permanently attached to motor vehicle, such as trucks, railcars, barges or ships;
(2) Vessels storing liquid that contains regulated material only as an impurity;
(3) Wastewater tanks; and
(4) Process tanks.
3. Add subpart I to read as follows:
This subpart specifies requirements to meet the emission standards of a referencing subpart for storage vessels and transfer operations.
You are subject to this subpart if you are an owner or operator who is subject to a referencing subpart and you have been expressly directed to comply with the Uniform Standards of this subpart by a referencing subpart.
This subpart applies to storage vessels and transfer operations that contain or contact regulated material and are subject to a referencing subpart.
The General Provisions of 40 CFR parts 60, 61 and 63 apply to this subpart, as specified in subpart H of this part.
The provisions of this subpart apply to storage vessels and transfer operations that contain or contact regulated material, as specified in paragraphs (a) through (e) of this section.
(a) For each atmospheric storage vessel that meets the requirements in item 1 of Table 1 to this subpart, you must comply with § 65.310. Alternatively, you may elect to comply with either paragraph (a)(1) or (a)(2) of this section.
(1) Comply with § 65.310 if you install an internal floating roof, vapor balance or connect the storage vessel to a closed vent system and control device, but you are not required to comply with § 65.315, § 65.320 or § 65.325.
(2) Comply with any of the options in paragraphs (b)(1) through (4) of this section.
(b) For each atmospheric storage vessel that meets the size and maximum true vapor pressure (MTVP) thresholds in item 2 or item 3 of Table 1 to this subpart, you must comply with either paragraph (b)(1), (2), (3) or (4) of this section.
(1) Use an external floating roof or a fixed roof with an internal floating roof, in accordance with § 65.315. This option may be used only if the MTVP of the stored liquid is less than 76.6 kilopascals (kPa).
(2) Vapor balance in accordance with § 65.320.
(3) Maintain a fixed roof and route emissions through a closed vent system to a control device, in accordance with § 65.325.
(4) Route emissions to a fuel gas system in accordance with § 65.330. This option may not be used when the displaced vapors from the storage vessel include halogenated compounds.
(c) For each pressure vessel, you must comply with § 65.340.
(d) For transfer operations that involve loading of transport vehicles, you must comply with § 65.360.
(e) For transfer operations that involve loading of containers, you must comply with § 65.370.
(a) Determine the MTVP at the times specified in paragraphs (b) through (d) of this section and keep records, as specified in paragraph (e) of this section. For a single-component stock, use any one of the methods specified in paragraphs (a)(1), (2), (3) or (5) of this section. For a mixture of compounds (such as petroleum liquids), use any one of the methods specified in paragraphs (a)(2) through (5) of this section.
(1) As obtained from standard reference texts.
(2) In accordance with methods described in chapter 19.2 of the API Manual of Petroleum Measurement Standards, “Evaporative Loss from Floating Roof Tanks” (incorporated by reference, see § 65.265). If you need the total vapor pressure of a petroleum liquid mixture (e.g., crude oil or gasoline), you must test for Reid vapor pressure and distillation slope, as applicable, to determine the constants A and B for the vapor pressure equation. If only part of a mixture is regulated material, you must test to determine the composition of the stored liquid. Testing is not required if you determine, based on engineering judgment, that the mixture contains less than 1-percent regulated material by weight.
(3) As determined by the “American Society for Testing and Materials Method D2879-83” (incorporated by reference, see § 65.265).
(4) As determined using “Test Method for Vapor Pressure of Reactive Organic Compounds in Heavy Crude Oil Using Gas Chromatography” (incorporated by reference, see § 65.265).
(5) Any other method approved by the Administrator in accordance with § 65.250.
(b) Determine the MTVP for each storage vessel that contains a regulated material either prior to the required submittal date of your Notification of Compliance Status or prior to the initial fill with regulated material, whichever is later.
(c) Determine the MTVP each time the storage vessel is filled with a different type of material.
(d) Determine the MTVP at least annually if the storage vessel stores a mixture and it was determined to be subject to § 65.305(a) the last time the MTVP was determined.
(e) Keep records of each MTVP determination, as specified in § 65.380(b)(2).
You must equip the storage vessel with a fixed roof and operate in accordance with paragraphs (a) through (d) of this section.
(a)
(b)
(2) You may open closure devices or remove the fixed roof under the conditions specified in paragraphs (b)(2)(i) and (ii) of this section.
(i) A closure device may be opened or the roof may be removed when needed to provide access for manual operations such as maintenance, inspection, sampling and cleaning.
(ii) Opening of a spring-loaded conservation vent or similar type of device that vents to the atmosphere (or allows air to enter the storage vessel) is allowed to maintain the tank internal operating pressure within tank design specifications when loading operations or diurnal ambient temperature fluctuations cause the pressure inside the storage vessel to migrate beyond the operating pressure range for the storage vessel.
(c)
(i) Monitor using Method 21 of 40 CFR part 60, appendix A-7, in accordance with § 65.431(a) and (b). A leak is detected if you obtain an instrument reading greater than 500 parts per million by volume. Conduct monitoring within 90 days after the initial fill and at least annually.
(ii) Monitor in accordance with the protocol for optical gas imaging, as specified in 40 CFR part 60, appendix K. You may use this monitoring option only if at least one compound in the emissions can be detected by the optical gas imaging instrument. A leak is detected if you observe an image of emissions when using the optical gas imaging instrument. Conduct monitoring within 90 days after the initial fill and at least semiannually.
(2) If you determine parts of the roof are unsafe to monitor using Method 21 of part 60, appendix A-7, because operating personnel would be exposed to an imminent or potential danger as a consequence of complying with such monitoring, then the inspection requirements specified in paragraph (c)(1)(i) of this section do not apply and you must comply with the requirements specified in paragraphs (c)(2)(i) through (iii) of this section.
(i) You must prepare and maintain at the plant site written documentation that identifies all parts of the fixed roof and any closure devices that are unsafe to monitor and explains why such parts are unsafe to monitor.
(ii) You must develop and implement a written plan and schedule to conduct inspections during times when it is safe to do so. The required inspections must be performed as frequently as practicable, but do not need to be performed more than annually. Keep a copy of the written plan and schedule at the plant site, as specified in § 65.380(c)(4).
(iii) As an alternative to paragraphs (c)(2)(i) and (ii) of this section, you may monitor the parts of the roof identified in paragraph (c)(2)(i) of this section by using optical gas imaging, as specified in paragraph (c)(1)(ii) of this section, if the criteria in paragraph (c)(1)(ii) of this section and 40 CFR part 60, appendix K, are met.
(3) No monitoring is required during a calendar year when either of the conditions in paragraph (c)(3)(i) or (ii) of this section are met.
(i) The storage vessel stores no regulated material at any time during the calendar year.
(ii) The storage vessel is emptied less than 120 days since the last inspection and no regulated material is stored in the storage vessel for the remainder of the year.
(4) Keep records of the date of each inspection, as specified in § 65.380(c)(1), and keep records of each leak, as specified in § 65.380(c)(2). Provide notification of each inspection, as specified in § 65.388(a)(1).
(d)
You must comply with the requirements in paragraphs (a) through (g) of this section.
(a)
(i) A liquid-mounted seal.
(ii) A mechanical shoe seal.
(iii) Two seals mounted one above the other. The lower seal may be vapor-mounted.
(2)
(i) A liquid-mounted seal and a secondary seal.
(ii) A mechanical shoe seal and a secondary seal. The upper end of the shoe(s) must extend a minimum of 24 inches above the stored liquid surface.
(3)
(i) Each opening, except those for automatic bleeder vents (vacuum breaker vents) and rim space vents, must have its lower edge below the surface of the stored liquid.
(ii) Each opening, except those for automatic bleeder vents (vacuum breaker vents), rim space vents, leg sleeves and deck drains, must be equipped with a deck cover. The deck cover must be equipped with a gasket between the cover and the deck.
(iii) Each automatic bleeder vent (vacuum breaker vent) and rim space vent must be equipped with a gasketed lid, pallet, flapper or other closure device.
(iv) Each opening for a fixed roof support column may be equipped with a flexible fabric sleeve seal instead of a deck cover.
(v) Each opening in an internal floating roof for a sample well may be equipped with a slit fabric seal or similar device that covers at least 90 percent of the opening instead of a deck cover.
(vi) Each opening for a deck drain that empties into the stored liquid must be equipped with a slit fabric seal or similar device that covers at least 90 percent of the opening.
(vii) Each cover on access hatches and gauge float wells must be designed to be bolted or fastened when closed.
(viii) Each opening for an unslotted guidepole must be equipped with a pole wiper, and each unslotted guidepole must be equipped with either a gasketed or welded cap on the top of the guidepole.
(ix) Each opening for a slotted guidepole must be equipped with one of the control device configurations specified in paragraph (a)(3)(ix)(A), (B), (C) or (D) of this section.
(A) A pole wiper and a pole float. The wiper or seal of the pole float must be at or above the height of the pole wiper.
(B) A pole wiper and a pole sleeve.
(C) A flexible enclosure device and either a gasketed or welded cap on the top of the guidepole.
(D) An internal guidepole sleeve, a pole wiper and either a gasketed or welded cap on the top of the guidepole.
(x) Each opening for a ladder that has at least one slotted leg must be equipped with one of the control device configurations specified in paragraph (a)(3)(x)(A), (B) or (C) of this section.
(A) A pole float in the slotted leg and pole wipers for both legs. The wiper or seal of the pole float must be at or above the height of the pole wiper.
(B) A ladder sleeve and pole wipers for both legs of the ladder.
(C) A flexible enclosure device and either a gasketed or welded cap on the top of the slotted leg.
(b)
(i) During the initial fill.
(ii) When necessary for maintenance or inspection, including refill, provided you also comply with either paragraph (b)(1)(ii)(A) or (B) of this section.
(A) If the storage vessel does not need to be completely empty in order to perform the maintenance or inspection, then refill must begin no later than 24 hours after the roof is landed. Refill must be performed in accordance with paragraph (b)(2) of this section.
(B) If the storage vessel must be completely empty in order to perform the maintenance or inspection, then actions to completely empty the storage vessel must begin no later than 24 hours after the roof is landed. Refill may occur at any time after the storage vessel is completely empty.
(iii) When necessary to support a change in service to an incompatible liquid, including refill. Actions to completely empty the storage vessel must begin no later than 24 hours after the roof is landed. Refill may occur at any time after the storage vessel is completely empty.
(iv) When necessary to take the storage vessel out of service. Actions to completely empty the storage vessel must begin no later than 24 hours after the roof is landed.
(v) When the vapors are routed through a closed vent system to a non-flare control device that reduces regulated material emissions by at least 90 percent by weight from the time the floating roof is landed until the floating roof is within 10 percent by volume of being refloated. You must comply with the requirements in subpart M of this part for the closed vent system and the applicable non-flare control device(s). To demonstrate initial compliance with the 90-percent reduction requirement, you must conduct either a design evaluation, as specified in § 65.850, or a performance test, as specified in §§ 65.820 through 65.829.
(vi) When non-halogenated vapors are routed through a closed vent system to a flare that reduces regulated material emissions from the time the floating roof is landed until the floating roof is within 10 percent by volume of being refloated. You must comply with the requirements in subpart M of this part for the closed vent system and the requirements of § 63.11(b) of this chapter for the flare.
(2) Once you start filling or refilling a storage vessel that has a landed floating roof, you may not suspend filling or refilling until the roof is floating (except when the quantity of liquid produced in one batch is insufficient to float the roof, and the output from additional batches will be added before any material is withdrawn from the storage vessel), and you may not withdraw liquid from the storage vessel while simultaneously filling or refilling.
(3) Each cover over an opening in the floating roof, except for automatic bleeder vents (vacuum breaker vents) and rim space vents, must be closed at all times, except when the cover must be open for access.
(4) Each automatic bleeder vent (vacuum breaker vent) and rim space vent must be closed at all times, except when required to be open to relieve excess pressure or vacuum, in accordance with the manufacturer's design, and during periods when the floating roof is allowed to be supported by its legs or other support devices.
(5) Each guidepole cap and slotted ladder leg cap must be closed at all times except when gauging the liquid level or taking liquid samples.
(c)
(1) Visually inspect for any of the conditions specified in paragraphs (c)(1)(i) through (iv) of this section at the frequency specified in Table 2 to this subpart or Table 3 to this subpart, as applicable. Observing any of these conditions constitutes an inspection failure. These inspections may be performed entirely from the top side of the floating roof, as long as there is visual access to all deck fittings and the top rim seal specified in paragraph (a) of this section.
(i) Stored liquid on the floating roof.
(ii) Holes or tears in the primary or secondary seal (if one is present).
(iii) Floating roof deck, deck fittings or rim seals that are not functioning as designed (as specified in paragraph (a) of this section).
(iv) Failure to comply with the operational requirements of paragraph (b) of this section.
(2) If you comply with Option 1 or Option 3 in Table 2 to this subpart or Option 1 in Table 3 to this subpart, inspect each deck fitting in accordance with paragraph (c)(2)(i) of this section. If you comply with Option 2 in Table 2 to this subpart or Option 3 in Table 3 to this subpart, monitor each deck fitting in accordance with paragraph (c)(2)(iii) of this section. If you comply with Option 2 in Table 3 to this subpart, monitor each deck fitting in accordance with paragraph (c)(2)(ii) of this section.
(i) Measure the gap between each deck fitting gasket or wiper (required by paragraph (a) of this section) and any surface that it is intended to seal. The inspector must attempt to slide a
(ii) Use Method 21 of 40 CFR part 60, appendix A-7, in accordance with § 65.431(a) and (b) to monitor all sources of potential vapor leakage around each fitting. Conduct monitoring only when the roof is floating on the stored liquid. An instrument reading greater than 500 ppmv constitutes an inspection failure. This option may be used only for an EFR.
(iii) Monitor the deck fittings using an optical gas imaging instrument in accordance with the protocol for optical gas imaging, as specified in 40 CFR part 60, appendix K. You may use this monitoring option only if at least one compound in the emissions can be detected by the optical gas imaging instrument. Conduct monitoring only when the roof is floating on the stored liquid. Any imaged emissions constitutes an inspection failure.
(3) If you comply with Option 1 in Table 3 to this subpart, conduct seal gap inspections for an EFR by determining the presence and size of gaps between the rim seals and the wall of the storage vessel in accordance with the procedures specified in paragraph (c)(3)(i) through (iv) of this section. Any exceedance of the gap requirements specified in paragraphs (c)(3)(ii) and (iii) of this section constitutes inspection failure.
(i) Rim seals must be measured for gaps at one or more levels while the EFR is floating, as specified in paragraphs (c)(3)(i)(A) through (F) of this section.
(A) The inspector must hold a
(B) Determine the length of each gap by inserting the probe into the gap (vertically) and sliding the probe along the vessel wall in each direction as far as it will travel freely without binding between the seal and the vessel wall. The circumferential length along which the probe can move freely is the gap length.
(C) Determine the maximum width of each gap by inserting probes of various diameters between the seal and the vessel wall. The smallest probe diameter should be
(D) Determine the average width of each gap by averaging the minimum gap width (
(E) The area of a gap is the product of the gap length and average gap width.
(F) Determine the ratio of accumulated area of rim seal gaps to storage vessel diameter by adding the area of each gap, and dividing the sum by the nominal diameter of the storage vessel. Determine this ratio separately for primary and secondary rim seals.
(ii) The ratio of seal gap area to vessel diameter for the primary seal must not exceed 10 square inches per foot of vessel diameter, and the maximum gap width must not exceed 1.5 inches.
(iii) The ratio of seal gap area to vessel diameter for the secondary seal must not exceed 1 square inch per foot, and the maximum gap width must not exceed 0.5 inches, except when you must pull back or remove the secondary seal to inspect the primary seal.
(iv) If you determine that it is unsafe to perform an EFR inspection as specified in paragraph (c)(3)(i) of this section, comply with the requirements of paragraph (c)(3)(iv)(A) or (B) of this section.
(A) Perform the inspection no later than 30 days after the determination that the floating roof is unsafe.
(B) Completely empty the storage vessel no later than 45 days after determining the floating roof is unsafe. If the vessel cannot be completely emptied within 45 days, you may utilize up to two extensions of up to 30 additional days each. Keep records documenting each decision to use an extension, as specified in § 65.380(d)(3).
(4) If you comply with Option 3 in Table 3 to this subpart, monitor the circumference of the floating roof when the roof is floating on stored liquid using an optical gas imaging instrument in accordance with the procedures specified in the protocol for optical gas imaging in 40 CFR part 60, appendix K. This monitoring option may be used only if at least one compound emitted from the storage vessel can be detected by the optical gas imaging instrument. Any imaged emissions constitutes an inspection failure.
(5) If you comply with Option 2 in Table 3 to this subpart, monitor the interface between the rim seal and the tank shell and any gaps in the secondary seal using Method 21 of 40 CFR part 60, appendix A-7, in accordance with § 65.431(a) and (b). Conduct monitoring when the roof is floating on stored liquid. An instrument reading greater than 500 ppmv constitutes an inspection failure.
(6) If you comply with Option 2 in Table 2 to this subpart, monitor the circumference of the IFR using an optical gas imaging instrument in accordance with the protocol for optical gas imaging, as specified in 40 CFR part 60, appendix K. You may use this monitoring option only if at least one compound in the emissions can be detected by the optical gas imaging instrument. Conduct monitoring when the roof is floating on stored liquid. Any imaged emissions constitutes an inspection failure.
(d)
(1) If the inspection is performed while the storage vessel is completely empty, you must complete repairs before refilling the storage vessel with regulated material.
(2) If the inspection is performed while the storage vessel is not completely empty, you must complete repairs or completely empty the storage vessel within 45 days. If a repair cannot be completed or the vessel cannot be completely emptied within 45 days, you may use up to two extensions of up to 30 additional days each. Keep records documenting each decision to use an extension, as specified in § 65.380(d)(3). Not repairing or emptying the storage vessel within the time frame specified in this paragraph (d) is a deviation and must be reported in your semiannual periodic report, as specified in § 65.384(a).
(e)
(2) Tests to determine emission factors for an alternate device must accurately simulate representative conditions under which the device and storage vessel will operate, such as wind speed, ambient and liquid temperatures, pressure or vacuum, and filling and withdrawal rates, but without creating an unsafe condition. You must include a copy of the proposed testing protocol in your request.
(f)
(2) Each time a floating roof is landed, even if the alarm did not activate, estimate the amount of regulated material emitted to the atmosphere during the time the floating roof is landed. Keep records of this emissions estimate, as specified in § 65.380(d)(1). Report the estimated emissions in your annual periodic report, as specified in § 65.386(b).
(g)
(2) Each time the storage vessel is overfilled, estimate the amount of regulated material spilled and the amount emitted to the atmosphere. Keep records of this emissions estimate, as specified in § 65.380(i). Report the estimated emissions in your annual periodic report, as specified in § 65.386(c).
If you elect to use vapor balancing to control emissions from a fixed roof storage vessel, you must comply with the requirements in paragraphs (a) through (d) of this section.
(a)
(b)
(ii) All vapor connections and lines on the storage vessel must be equipped with closures that seal upon disconnect.
(2)
(ii) Barges must have been pressure tested for vapor tightness within the 365-day period prior to being used in a vapor balancing system to comply with the control requirements in this section. Pressure testing must be conducted in accordance with paragraphs (b)(2)(ii)(A) through (F) of this section, and you must maintain copies of documentation showing the required testing was conducted, as specified in § 65.380(e)(3). You must either conduct the test at your facility or obtain documentation of the test from the barge owner or operator.
(A) Each barge must be pressurized with dry air or inert gas to no more than the pressure of the lowest-pressure relief valve setting.
(B) Once the pressure is obtained, the dry air or inert gas source must be shut off.
(C) At the end of
(D) The change in pressure, P, must be compared to the pressure drop calculated using Equation 2 of this section.
(E) If P is less than or equal to PM, the vessel is vapor tight.
(F) If P is greater than PM, the vessel is not vapor tight and the source of the leak must be identified and repaired before retesting.
(3) Monitoring requirements. For pieces of equipment in the vapor balancing system, comply with § 65.325(b) and (d), except as specified in paragraphs (b)(3)(i) through (iii) of this section. Keep records, as specified in § 65.380(e)(5).
(i) When § 65.325(b) refers to a “closed vent system,” it means a “vapor balancing system” for the purposes of this section.
(ii) When subpart M of this part, which is referenced from § 65.325(b), refers to “bypass lines that divert a vent stream away from a control device and to the atmosphere,” it means “bypass lines that divert displaced storage vessel emissions to the atmosphere and away from the transport vehicle or barge from which the storage vessel is being filled” for the purposes of this section.
(iii) As an alternative to the otherwise applicable monitoring requirements specified in subpart J of this part, you may elect to comply with the alternative monitoring frequencies in § 65.440 for equipment in a vapor balancing system that convey emissions from a storage vessel for the purposes of this subpart.
(c)
(2) Each pressure relief device on the storage vessel or on the transport vehicle or barge must remain closed while the storage vessel is being filled.
(3) Pressure relief devices on storage vessels must be set to no less than 2.5 pounds per square inch gauge (psig) at all times to prevent breathing losses, unless you provide rationale in the Notification of Compliance Status specified in § 65.382(c) explaining why a lower value is sufficient to prevent breathing losses at all times or control breathing losses by another method. Keep records of the vent settings, as specified in § 65.380(e)(4).
(d)
If you elect to control emissions from a fixed roof atmospheric storage vessel by routing emissions through a closed vent system to a control device, you must comply with the requirements in paragraphs (a) through (e) of this section.
(a)
(b)
(1) Equipment in the closed vent system is in regulated material service when it conveys emissions from the storage vessel. For such equipment, comply with § 65.410(a) or (c) and applicable sections referenced therein, except that § 65.410(a)(2)(ii) does not apply for the purposes of this subpart. When § 65.410(c) refers to “your referencing subpart,” it means “the subpart that references subpart I.” You must conduct the monitoring while the equipment is in regulated material service.
(2) Comply with § 65.430 for each potential source of emissions in the closed vent system that is not defined as
(3) Keep records, as specified in § 65.380(f)(2).
(c)
(1) A non-flare control device must meet the requirements for the applicable control device in subpart M of this part; and reduce organic regulated material emissions by at least 95 percent by weight or to an outlet concentration of regulated material less than 20 ppmv. If the regulated material is a subset of organic compounds (
(2) A flare must meet the requirements of § 63.11(b) of this chapter. You must not use a flare to control halogenated vent streams, as defined in § 65.295.
(3) To demonstrate initial compliance with the emission limit(s) specified in paragraph (c)(1) of this section, you must conduct either a design evaluation, as specified in § 65.850, or a performance test, as specified in §§ 65.820 through 65.829.
(4) During periods of planned routine maintenance of a control device, operate the storage vessel in accordance with paragraphs (c)(4)(i) and (ii) of this section. Keep records, as specified in § 65.380(f)(4).
(i) Do not add material to the storage vessel during periods of planned routine maintenance.
(ii) Limit periods of planned routine maintenance for each control device to no more than 360 hours per year (hr/yr).
(d)
(e)
If you elect to control emissions from a fixed roof storage vessel by routing emissions to a fuel gas system, you must comply with paragraphs (a) through (d) of this section.
(a)
(b)
(1) Comply with the requirements for fuel gas systems as specified in § 65.732(a), (c), and (d).
(2) Comply with the requirements for equipment leaks, as specified in subpart J of this part and paragraphs (b)(2)(i) and (ii) of this section.
(i) Equipment in the fuel gas system is in regulated material service when it conveys emissions from the storage vessel. For such equipment, comply with § 65.410(a) or (c) and applicable sections referenced therein, except that § 65.410(a)(2)(ii) does not apply for the purposes of this subpart. When § 65.410(c) refers to “your referencing subpart,” it means “the subpart that references subpart I.” You must conduct the monitoring while the equipment is in regulated material service.
(ii) Comply with § 65.430 for each potential source of emissions from the fuel gas system that is not defined as a piece of equipment (
(3) Keep records of the fuel gas system, as specified in § 65.380(g)(2).
(c)
(d)
If you have a pressure vessel that contains any regulated material, you must operate and maintain the pressure vessel, as specified in paragraphs (a) through (d) of this section.
(a) The pressure vessel must be designed to operate with no detectable emissions at all times.
(b) All openings in the pressure vessel must be equipped with closure devices.
(c) Conduct initial and annual performance tests by monitoring in accordance with either paragraph (c)(1) or (2) of this section to demonstrate compliance with paragraph (a) of this section.
(1) Monitor each point on the pressure vessel through which regulated material could potentially be emitted using Method 21 of 40 CFR part 60, appendix A-7, in accordance with the procedures specified in § 65.431(a) and (b) and paragraphs (c)(1)(i) through (iii) of this section.
(i) When § 65.431(a)(5) refers to “monitoring when the equipment in regulated material service or in use with any other detectable material,” it means “monitoring when the pressure vessel contains a regulated material with a concentration representative of the range of concentrations for the materials expected to be stored in the pressure vessel” for the purposes of this section.
(ii) Section 65.431(a)(6) does not apply for the purposes of this section.
(iii) Each instrument reading greater than 500 ppmv is a deviation. Comply with paragraphs (c)(1)(iii)(A) through (C) of this section each time you obtain an instrument reading greater than 500 ppmv.
(A) Estimate the flow rate and total regulated material emissions from the defect. Assume the pressure vessel has been emitting for half of the time since the last performance test, unless other information supports a different assumption.
(B) Keep records of the performance test and emission estimates, as specified in § 65.380(h)(1).
(C) Submit information in your semiannual periodic report, as specified in § 65.384(c).
(2) Monitor each point on the pressure vessel through which regulated material potentially could be emitted using an optical gas imaging instrument, as specified in paragraphs (c)(2)(i) and (ii) of this section.
(i) Operate and maintain the optical gas imaging instrument in accordance with the protocol for optical gas imaging
(ii) Each image of emissions is a deviation. Comply with paragraphs (c)(2)(ii)(A) and (B) of this section each time you detect an image when using an optical gas imaging instrument.
(A) Estimate emissions, as specified in paragraph (c)(1)(iii)(A) of this section.
(B) Keep records and report information, as specified in paragraphs (c)(1)(iii)(B) and (C) of this section.
(d) Whenever material regulated by a referencing subpart is in the pressure vessel, operate the pressure vessel as a closed system that does not vent to the atmosphere except at those times when purging of inerts or noncondensables from the pressure vessel is required and the purge stream is routed through a closed vent system to a control device in accordance with paragraphs (d)(1) through (3) of this section, as applicable. Keep records, as specified in § 65.380(h)(2), and report deviations in your semiannual periodic report, as specified in § 65.384(c).
(1) For the closed vent system, comply with § 65.325(b).
(2) For a non-flare control device, comply with requirements for the applicable control device in subpart M of this part, and comply with paragraphs (d)(2)(i) and (ii) of this section.
(i) A non-flare control device must reduce organic regulated material emissions by at least 98 percent by weight or to an outlet concentration of total regulated material less than 20 ppmv. If the regulated material is a subset of organic compounds (
(ii) To demonstrate initial compliance with the emission limit(s) specified in paragraph (d)(2)(i) of this section, you must conduct either a design evaluation, as specified in § 65.850, or a performance test, as specified in §§ 65.820 through 65.829.
(3) For a flare, comply with the requirements of § 63.11(b) of this chapter. You must not use a flare to control halogenated vent streams, as defined in § 65.295.
For each transfer rack that is used to load transport vehicles with regulated material, you must comply with paragraphs (a) and (b) of this section. You must also comply with paragraph (c) of this section for transport vehicles that are loaded with regulated material.
(a)
(b)
(1) Route displaced emissions from the transport vehicle through a closed vent system to a control device and comply with paragraphs (b)(1)(i) through (iii) of this section. Keep records, as specified in § 65.380(j)(2).
(i) For the closed vent system, comply with the requirements specified in § 65.720(b) through (d) and paragraphs (b)(1)(i)(A) through (C) of this section.
(A) Determine if a piece of equipment in the closed vent system is in regulated material service, based on the MTVP of each transferred material that generates vapor that contacts the equipment. If any such vapor meets the definition of “in regulated material service,” comply with § 65.410(a) or (c) and applicable sections referenced therein, except that § 65.410(a)(2)(ii) does not apply for the purposes of this subpart. When § 65.410(c) refers to “your referencing subpart” it means “the subpart that references subpart I.” If equipment in the closed vent system contacts regulated material from transfers, but is not in regulated material service, comply with requirements in § 65.430, unless you are required to comply with § 65.429 for other emissions conveyed by the closed vent system.
(B) If equipment in the closed vent system is determined to be in regulated material service, conduct monitoring and inspections when the closed vent system is conveying vapor that causes the equipment in the closed vent system to be in regulated material service (
(C) Comply with § 65.430 for each potential source of vapor leakage in the closed vent system that is not defined as a piece of equipment. Keep identification records, as specified in § 65.380(j)(3).
(ii) For a non-flare control device, comply with the applicable requirements in subpart M of this part, and comply with paragraphs (b)(1)(ii)(A) and (B) of this section.
(A) A non-flare control device must reduce organic regulated material emissions by at least 95 percent by weight or to an outlet concentration of total organic regulated material less than 20 ppmv. If the regulated material is a subset of organic compounds (
(B) To demonstrate initial compliance with the emission limit specified in paragraph (b)(1)(ii)(A) of this section, you must conduct either a design evaluation, as specified in § 65.850, or a performance test, as specified in §§ 65.820 through 65.829.
(iii) For flares, comply with the requirements of § 63.11(b) of this chapter. You must not use a flare to control halogenated vent streams, as defined in § 65.295.
(2) Route displaced emissions from the transport vehicle to a fuel gas system and comply with the requirements specified in paragraphs (b)(2)(i) through (iii) of this section.
(i) Comply with the requirements for fuel gas systems, as specified in § 65.732(a), (c) and (d).
(ii) For equipment in the fuel gas system, comply with the requirements for equipment leaks, as specified in subpart J of this part, and paragraphs (b)(2)(ii)(A) through (C) of this section.
(A) Determine if a piece of equipment in the fuel gas system is in regulated
(B) For equipment in the fuel gas system that is determined to be in regulated material service, conduct monitoring and inspections, while transferring any material that generates vapor that causes the equipment in the fuel gas system to be in regulated material service. Alternatively, you may conduct monitoring and inspections when the fuel gas system is conveying vapors from other emission points that cause the equipment to be in regulated material service. If equipment in the fuel gas system contacts regulated material, but is not in regulated material service, conduct inspections when regulated material vapors are flowing through the fuel gas system (
(C) Comply with § 65.430 for each potential source of emissions in the fuel gas system that is not defined as a piece of equipment. Keep identification records, as specified in § 65.380(j)(3).
(iii) Keep records, as specified in § 65.380(j)(7).
(3) Design and operate a vapor balancing system, as specified in paragraphs (b)(3)(i) through (v) of this section. This option may not be used if the applicable storage vessel is controlled using a floating roof. Keep records, as specified in § 65.380(j)(5).
(i) The vapor balancing system must be designed to route vapors displaced from the loading of regulated liquids into transport vehicles back to the storage vessel from which the liquid being loaded originated or to another storage vessel connected to a common header.
(ii) The vapor balancing system must be designed to prevent any regulated material vapors collected at one transfer rack from passing to another transfer rack.
(iii) All vapor connections and lines in the vapor collection equipment and vapor balancing system must be equipped with closures that seal upon disconnect.
(iv) Each pressure relief device on the transport vehicle and storage vessel must remain closed while the transport vehicle is being filled with regulated material.
(v) For pieces of equipment in the vapor balancing system, comply with paragraph (b)(1)(i) of this section, except that when paragraph (b)(1)(i) of this section refers to a “closed vent system,” it means a “vapor balancing system” for the purposes of this section.
(c) Transport vehicles. (1) Except when loading transport vehicles that meet the requirements in paragraph (c)(2) of this section, you must ensure that regulated material liquids are loaded only into transport vehicles that have a current certification in accordance with the DOT pressure test requirements in 49 CFR part 180 for cargo tanks or 49 CFR 173.31 for tank cars. Keep records of these certifications, as specified in § 65.380(j)(6).
(2) Each transport vehicle that is loaded with regulated material that has a MTVP greater than 4 psia at a transfer rack that is subject to this section must pass an annual vapor tightness test conducted using Method 27 of 40 CFR part 60, appendix A-8. Either you or the owner of the transport vehicle may conduct the test. Conduct the test using a time period (t) for the pressure and vacuum tests of 5 minutes. The initial pressure (P
(3) You must act to assure that your vapor balancing system, closed vent system or fuel gas system is connected to the transport vehicle's vapor collection equipment during each loading of a transport vehicle at the regulated source. Examples of actions to accomplish this include training drivers in the hookup procedures and posting visible reminder signs at the transfer racks that load regulated material.
For each transfer rack that is used to load containers, you must comply with paragraphs (a) through (c) of this section, as applicable.
(a) Except as specified in paragraph (c) of this section, you must transfer regulated material into containers using either submerged fill or a fitted opening in the top of the container through which the regulated material is filled, with subsequent purging of the transfer line before removing it from the container opening.
(b) Whenever a container that is subject to this paragraph contains a regulated material, you must install all covers and closure devices for the container, and secure and maintain each closure device in the closed position, except when access to the container is necessary, such as for adding or removing material, sampling or cleaning. If the container is 55 gallons (gal) or larger, the transferred liquid has a MTVP greater than 4 psia, and the container is used for onsite storage, comply with either paragraph (b)(1) or (2) of this section.
(1) Demonstrate initially and at least annually that the container is vapor tight by testing in accordance with Method 27 of 40 CFR part 60, appendix A-8. Conduct the test using a time period (t) for the pressure and vacuum tests of 5 minutes. The initial pressure (P
(2) Monitor annually each potential leak interface on the container using Method 21 of 40 CFR part 60, appendix A-7, in accordance with § 65.431(a) and (b), and paragraphs (b)(2)(i) through (iv) of this section.
(i) Section 65.431(a)(6) does not apply for the purposes of this section.
(ii) When § 65.431(a) and (b) refers to “equipment,” it means “each potential leak interface on the container” for the purposes of this section.
(iii) A leak is identified when you obtain an instrument reading greater than 500 ppmv.
(iv) For each leak, either repair the leak or empty the container within 15 days after detecting the leak.
(c) As an alternative to complying with paragraph (a) of this section, you may elect to control displaced vapors generated when filling the container in accordance with paragraph (c)(1), (2) or (3) of this section, as applicable.
(1) Design and operate a vapor balancing system to route vapors displaced from the loading of regulated material into containers directly (
(2) Vent displaced emissions directly through a closed vent system to a control device in accordance with paragraph (c)(2)(i) through (iii) of this section.
(i) Comply with § 65.360(b)(1)(i) for the closed vent system, except that when § 65.360(b)(1)(i) refers to a “transport vehicle,” it means a “container” for the purposes of this section.
(ii) Comply with § 65.360(b)(1)(ii) or (iii) for the applicable control device.
(iii) Keep records, as specified in § 65.380(j)(2).
(3) When filling, locate the containers in an enclosure that is exhausted through a closed vent system to a control device, as specified in paragraphs (c)(3)(i) and (ii) of this section.
(i) Design and operate the enclosure in accordance with the criteria for a permanent total enclosure, as specified in “Procedure T—Criteria for and Verification of a Permanent or Temporary Total Enclosure” under 40 CFR 52.741, appendix B. The enclosure may have permanent or temporary openings to allow worker access; passage of containers through the enclosure by conveyor or other mechanical means; entry of permanent mechanical or electrical devices; or to direct airflow into the enclosure. Perform the verification procedure for the enclosure, as specified in Section 5.0 to “Procedure T—Criteria for and Verification of a Permanent or Temporary Total Enclosure” initially when the enclosure is first installed and, thereafter, annually. Keep records of these verifications, as specified in § 65.380(j)(4).
(ii) Comply with § 65.360(b)(1)(i) for the closed vent system and comply with § 65.360(b)(1)(ii) or (iii) for the applicable control device.
(a)
(b)
(2) Keep a record of each MTVP determination and the supporting information used in the determination.
(c)
(2) For each leak detected during monitoring required by § 65.310(c), record the location of the leak, a description of the leak, the date of detection, a description of actions taken to repair the defect and the date repair was completed. When using Method 21 of 40 CFR part 60, appendix A-7, keep a record of the instrument reading. When using optical gas imaging, keep a record of the video image.
(3) If you elect to use an extension in accordance with § 65.310(d), keep records, as specified in paragraphs (c)(3)(i) through (iii) of this section.
(i) Records for a first extension must include a description of the defect, documentation that alternative storage capacity was unavailable in the 45-day period after the inspection and a schedule of actions that you took in an effort to either repair or completely empty the storage vessel during the extension period.
(ii) For a second extension, if needed, you must maintain records documenting that alternative storage capacity was unavailable during the first extension period and a schedule of the actions you took to ensure that the control device was repaired or the vessel was completely emptied by the end of the second extension period.
(iii) Record the date on which the storage vessel was completely emptied, if applicable.
(4) If applicable, maintain a copy of the written plan required by § 65.310(c)(2)(ii) for parts of fixed roofs that are unsafe to monitor.
(d)
(i) The date when a floating roof is set on its legs or other support devices.
(ii) The date when the roof was refloated.
(iii) Whether the process of refloating was continuous (
(iv) Estimated emissions from the landing event.
(2)
(i) If the floating roof passes inspection, keep a record that includes the information specified in paragraphs (d)(2)(i)(A) and (B) of this section. If the floating roof fails inspection, keep a record that includes the information specified in paragraphs (d)(2)(i)(A) through (E) of this section.
(A) Identification of the storage vessel that was inspected.
(B) The date of the inspection.
(C) A description of all inspection failures.
(D) A description of all repairs and the dates they were made.
(E) The date the storage vessel was completely emptied, if applicable.
(ii) Keep records of the data specified in paragraphs (d)(2)(ii)(A) through (C) of this section, as applicable for EFR inspections and monitoring.
(A) EFR seal gap measurements, including the raw data obtained and any calculations performed, as required by § 65.315(c)(3).
(B) Instrument readings when monitoring is conducted using Method 21 of 40 CFR part 60, appendix A-7.
(C) A record of the video image when monitoring is conducted using optical gas imaging.
(3)
(i) Records for a first extension must include an explanation of why it was unsafe to perform the inspection, documentation that alternative storage capacity was unavailable during the 45-day period after determining the floating roof is unsafe to inspect and a schedule of actions that you took in an effort to completely empty the storage vessel during the extension period.
(ii) For a second extension, if needed, you must maintain records documenting that alternative storage capacity was unavailable during the first extension period and a schedule of actions that you took to ensure that the vessel was completely emptied by the end of the second extension period.
(iii) Record the date on which the storage vessel was completely emptied, if applicable.
(e)
(2) For transport vehicles, keep records of DOT certification(s) required by § 65.320(b)(2)(i).
(3) For barges, keep records of vapor tightness pressure test documentation
(i) Test title: Barge Pressure Test.
(ii) Barge owner and address.
(iii) Barge identification number.
(iv) Testing location.
(v) Test date.
(vi) Tester name and signature.
(vii) Witnessing inspector, if any: Name, signature and affiliation.
(viii) Initial and final test pressures and the time at the beginning and end of the test.
(ix) Test results: Actual pressure change in 30 minutes, mm of water.
(4) Keep records of the pressure relief vent setting that prevents breathing losses from the storage vessel required by § 65.320(c)(3).
(5) For equipment in the vapor balancing system, keep records, as required by subpart J of this part.
(f)
(2) For the closed vent system, keep records, as specified in subpart J of this part and subpart M of this part.
(3) For a non-flare control device, keep the applicable records specified in subpart M of this part. For flares, keep records of all visual emissions observed, periods when a pilot flame is out, and any periods that the pilot flames are not monitored.
(4) Record the day and time at which planned routine maintenance periods begin and end, and the type of maintenance performed on the control device. If you need more than 240 hr/yr, keep a record that explains why additional time up to 360 hr/yr was needed and describes how you minimized the amount of additional time needed.
(5) Keep a record identifying each potential source of vapor leakage in the closed vent system that is not defined as a piece of equipment, as required by § 65.325(b)(2).
(g)
(2) For the fuel gas system, keep records, as specified in subpart J of this part and subpart M of this part.
(3) Keep a record identifying each potential source of vapor leakage in the fuel gas system that is not defined as a piece of equipment, as required by § 65.330(b)(2).
(h)
(i) The date of the test.
(ii) The instrument reading (and background level, if you adjust for background, as described in § 65.431(a)(7)), if you test using Method 21 of 40 CFR part 60, appendix A-7.
(iii) The video image, if you test using optical gas imaging.
(2) Keep records of the information in paragraphs (h)(2)(i) through (iv) of this section when the performance test required by § 65.340(c) detects a defect.
(i) Date each defect was detected.
(ii) Date of the next performance test that shows either the instrument reading is less than 500 ppmv when using Method 21 of 40 CFR part 60, appendix A-7, or no image is detected when using an optical gas imaging instrument.
(iii) Start and end dates of each period after the date in paragraph (h)(2)(i) of this section when the pressure vessel was completely empty.
(iv) Estimated emissions from each defect.
(3) When complying with § 65.340(d), keep records for the closed vent system, as specified in subpart J of this part and subpart M of this part, and for a non-flare control device, keep the applicable records specified in subpart M of this part. For flares, keep records of all visual emissions observed, periods when a pilot flame is out, and any periods that the pilot flames are not monitored.
(i)
(j)
(i) Test title: Transport Vehicle or Container Pressure Test—EPA Reference Method 27.
(ii) Transport vehicle or container owner and address.
(iii) Transport vehicle or container identification number.
(iv) Testing location.
(v) Date of test.
(vi) Tester name and signature.
(vii) Witnessing inspector, if any: Name, signature and affiliation.
(viii) Initial and final test pressures, initial and final test vacuums and the time at the beginning and end of the test.
(ix) Test results: Actual pressure and vacuum changes in 5 minutes, mm of water (average for 2 runs, as required by Method 27 of 40 CFR part 60, appendix A-8).
(2) If you use a closed vent system and control device, as specified in § 65.360(b)(1) or § 65.370(c)(2)(ii), keep records for the closed vent system, as specified in subpart J of this part and subpart M of this part, and for a non-flare control device, keep the applicable records specified in subpart M of this part. For flares, keep records of all visual emissions observed, periods when a pilot flame is out, and any periods that the pilot flames are not monitored.
(3) Keep a record identifying each potential source of vapor leakage in the closed vent system or fuel gas system that is not defined as a piece of equipment, as required by § 65.360(b)(1)(i)(C) or (2)(ii)(C).
(4) For containers filled inside an enclosure, as specified in § 65.370(c)(3)(i), keep records of the most recent set of calculations and measurements performed to verify that the enclosure meets the criteria of a permanent total enclosure, as specified in “Procedure T—Criteria for and Verification of a Permanent or Temporary Total Enclosure” under 40 CFR 52.741, appendix B.
(5) If you use a vapor balancing system, as specified in § 65.360(b)(3) or § 65.370(c)(1), keep records of the date of each sensory inspection or instrument monitoring, the number of potential leaks to the atmosphere that you identified and the records required by subpart J of this part for monitoring conducted in accordance with § 65.430(b)(2) and the requirements referenced therein.
(6) For transport vehicles, keep records of DOT certification(s) required by § 65.360(c)(1).
(7) If you route emissions from transport vehicles to a fuel gas system, as specified in § 65.360(b)(2), keep records as specified in subpart M of this part.
(k)
You must include the information listed in paragraphs (a) through (c) of this section, as applicable, in the Notification of Compliance Status that you submit according to the procedures in § 65.225.
(a) The identification of each storage vessel in the regulated source under the referencing subpart, its storage capacity and the liquid stored in the storage vessel.
(b) The identification of each transfer rack in the regulated source under the referencing subpart.
(c) If applicable, you must include rationale, pursuant to § 65.320(c)(3), explaining why pressure lower than 2.5 psig is sufficient to prevent breathing losses from pressure relief devices on storage vessels.
Submit the information specified in paragraphs (a) through (f) of this section, as applicable, in semiannual periodic reports that you submit, as specified in § 65.225.
(a) If you do not empty or repair leaks before the end of the second extension period, as required by § 65.310(d) or § 65.315(d)(2), report the date when the storage vessel was emptied or repaired.
(b) Report the storage vessel identification and the start and end dates of each floating roof landing that does not meet the criteria specified in § 65.315(b)(1).
(c) If you obtain an instrument reading greater than 500 ppmv or an image of a leak when monitoring a pressure vessel in accordance with § 65.340(c)(1) or (2), submit a copy of the records specified in § 65.380(h)(2).
(d) If you use a closed vent system and non-flare control device, as specified in § 65.325, § 65.360(b)(1) or § 65.370(c)(2), submit information in semiannual reports, as specified in subparts J and M of this part. For flares, report any instances when visual emissions occur longer than 5 minutes during any 2 consecutive hours, a pilot flame is out, or the pilot flames are not monitored.
(e) If you use a vapor balancing system, as specified in § 65.320, § 65.360(b)(3) or § 65.370(c)(1), submit information in semiannual reports, as specified in subparts J and M of this part.
(f) If you use a fuel gas system, as specified in § 65.330 or § 65.360(b)(2), submit information in semiannual reports, as specified in subparts J and M of this part.
You must report the information specified in paragraphs (a) through (c) of this section, as applicable, in annual periodic reports that you submit, as specified in § 65.225.
(a)
(b)
(c)
(a)
(2) Except as specified in paragraph (a)(3) of this section, if an inspection is unplanned and you could not have known about the inspection 30 days in advance, then you must notify the Administrator at least 7 days before the inspection. Notification must be made by telephone immediately, followed by written documentation demonstrating why the inspection was unplanned. Alternatively, the notification, including the written documentation, may be made in writing and sent so that it is received by the Administrator at least 7 days before the inspection.
(3) A delegated state or local agency may waive the requirement for notification of storage vessel inspections.
(b)
All terms used in this subpart have the same meaning given in the Clean Air Act and subpart H of this part, unless otherwise specified in the referencing subpart.
4. Add subpart J to read as follows:
This subpart specifies requirements to meet the emission standards of a referencing subpart for equipment leaks.
You are subject to this subpart if you are an owner or operator who is subject to a referencing subpart and you have been expressly directed to comply with this subpart by a referencing subpart.
This subpart applies to equipment in process units, closed vent systems and fuel gas systems that contains or contacts regulated material and is subject to a referencing subpart. This subpart applies to valves, pumps, connectors, agitators, pressure relief devices, compressors, sampling connection systems, open-ended valves and lines, instrumentation systems and any other equipment, as defined in the referencing subpart. This subpart also applies to closed-purge and closed-loop systems used to meet the requirements of this subpart.
The General Provisions of 40 CFR parts 60, 61 and 63 apply to this subpart, as specified in subpart H of this part.
(a) Except as specified in paragraphs (b) and (c) of this section, for each regulated source that is subject to control requirements for equipment leaks in a referencing subpart, you must comply with paragraphs (a)(1) through (3) of this section.
(1) Identify subject equipment in accordance with §§ 65.415 and 65.416.
(2) Comply with the requirements in paragraph (a)(2)(i) of this section or, as applicable, comply with the alternative specified in paragraph (a)(2)(ii) of this section.
(i) As applicable, comply with the equipment-specific standards in §§ 65.420 through 65.429 and the related requirements in §§ 65.430 through 65.432.
(ii) As an alternative to paragraph (a)(2)(i) of this section, if you have equipment in a batch operation, you may elect to comply with the alternative monitoring frequency requirements in § 65.440.
(3) Comply with the applicable notification, reporting and recordkeeping requirements in §§ 65.470 and 65.475.
(b) You are not required to comply with the requirements of §§ 65.420 through 65.440 for equipment in vacuum service, provided that you comply with paragraphs (b)(1) through (3) of this section.
(1) Identify the equipment, as specified in § 65.415(f).
(2) Continuously demonstrate that the equipment remains in vacuum service, as described in § 65.416(e).
(3) Comply with the applicable recordkeeping requirements in § 65.475(b)(6).
(c) If your referencing subpart specifies that you may comply with the optical gas imaging requirements in § 65.450 as an alternative to complying with paragraph (a) of this section, you must comply with paragraphs (c)(1) through (3) of this section if you elect to comply with the optical gas imaging alternative.
(1) Identify subject equipment in accordance with § 65.415.
(2) Comply with § 65.450 for leak detection and repair.
(3) Comply with the applicable notification, reporting and recordkeeping requirements in §§ 65.470 and 65.475(e).
A closed vent system and non-flare control device or a fuel gas system used to meet applicable requirements in §§ 65.420 through 65.427 must meet the applicable requirements of subpart M of this part. A flare used to meet applicable requirements in §§ 65.420 through 65.427 must meet the applicable requirements in § 63.11(b) of this chapter. You must not use a flare to control halogenated vent streams, as defined in § 65.295. The non-flare control device must also meet the requirements of paragraphs (a) and (b) of this section.
(a) A non-flare control device must reduce regulated material emissions by at least 95 percent by weight or to an outlet concentration less than 20 ppmv.
(b) To demonstrate initial compliance with the emission limit specified in paragraph (a) of this section, you must conduct either a design evaluation or a performance test in accordance with subpart M of this part.
You must identify equipment subject to this subpart, as described in paragraphs (a) through (g) of this section. Identification of the equipment does not require physical tagging of the equipment. For example, the equipment may be identified on a plant site plan, in log entries, by designation of process unit boundaries, by some form of weatherproof identification or by other appropriate methods.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(a)
(i) Valves complying with § 65.420 or § 65.440.
(ii) Pumps complying with § 65.421 or § 65.440.
(iii) Connectors complying with § 65.422 or § 65.440.
(iv) Agitators complying with § 65.423 or § 65.440.
(2)
(i) Valves complying with § 65.420 or § 65.440. In a new source, the number of valves you designate as difficult-to-monitor must be less than 3 percent of the total number of valves in that new source, unless all of the difficult-to-monitor valves in that source are low leak technology, as described in § 65.432(e)(3).
(ii) Pumps complying with § 65.421 or § 65.440.
(iii) Connectors complying with § 65.422 or § 65.440.
(iv) Agitators complying with § 65.423 or § 65.440.
(3)
(4)
(i) For equipment designated as unsafe-to-monitor according to the provisions of paragraph (a)(1) of this section, you must have a written plan that requires monitoring of the equipment as frequently as practical during safe-to-monitor times, but not more frequently than the periodic monitoring schedule otherwise applicable, and repair of the equipment according to the procedures in § 65.432 if a leak is detected. If applicable, your written plan must also address how you will address any indications of liquids dripping observed during a weekly visual inspection.
(ii) For equipment designated as difficult-to-monitor according to the provisions of paragraph (a)(2) of this section, you must have a written plan that requires monitoring of the equipment at least once per calendar year and repair of the equipment according to the procedures in § 65.432 if a leak is detected. If applicable, your written plan must also address how you will address any indications of liquids dripping observed during a weekly visual inspection.
(b)
(1) The connector is buried.
(2) The connector is insulated in a manner that prevents access to the connector by a monitor probe.
(3) The connector is obstructed by equipment or piping that prevents access to the connector by a monitor probe.
(c)
(d)
(e)
(1)
(2)
(3) In vacuum service alarm records. You must maintain records, as specified in § 65.475(b)(6).
Except as provided in paragraph (d) of this section, you must comply with the requirements specified in paragraphs (a) through (c) of this section for valves in gas and vapor service and valves in light liquid service.
(a)
(1)
(2)
(i) At process units with at least 2-percent leaking valves, calculated according to paragraph (b) of this section, you must monitor each valve according to either paragraph (a)(2)(i)(A) or (B) of this section.
(A) Monitor each valve monthly.
(B) If the summed number of valves found to be leaking (
(ii) At process units with less than 2-percent leaking valves, calculated as specified in paragraph (b) of this section, you must monitor each valve quarterly, except as provided in paragraphs (a)(2)(iii) through (v) of this section.
(iii) At process units with less than 1-percent leaking valves, you may elect to monitor each valve semiannually.
(iv) At process units with less than 0.5-percent leaking valves, you may elect to monitor each valve annually.
(v) At process units with less than 0.25 percent leaking valves, you may elect to monitor each valve biennially.
(vi) Monitoring data generated before the regulated source became subject to the referencing subpart and meeting the criteria of either § 65.431(a)(1) through (5), or § 65.431(a)(6), may be used to qualify initially for less frequent monitoring under paragraphs (a)(2)(ii) through (v) of this section.
(3)
(i) The overall performance of total valves in the applicable process unit or group of process units to be subdivided must be less than 2-percent leaking valves, as detected according to paragraphs (a)(1) and (2) of this section and, as calculated according to paragraphs (b)(1)(ii) and (b)(2) of this section.
(ii) The initial assignment or subsequent reassignment of valves to subgroups shall be governed by the provisions of paragraphs (a)(3)(ii)(A) through (C) of this section.
(A) You must determine which valves are assigned to each subgroup. Valves with less than 1 year of monitoring data or valves not monitored within the last 12 months must be placed initially into the most frequently monitored subgroup until at least 1 year of monitoring data have been obtained.
(B) Any valve or group of valves can be reassigned from a less frequently monitored subgroup to a more frequently monitored subgroup provided that you monitored the valves to be reassigned during the most recent monitoring period for the less frequently monitored subgroup. The monitoring results must be included with that less frequently monitored subgroup's associated percent leaking valves calculation for that monitoring event.
(C) Any valve or group of valves can be reassigned from a more frequently monitored subgroup to a less frequently monitored subgroup provided that the valves to be reassigned have not leaked for the period of the less frequently monitored subgroup (
(iii) Every 6 months, you must determine if the overall performance of total valves in the applicable process unit or group of process units is less than 2-percent leaking valves and so indicate the performance in the next periodic report. You must calculate the overall performance of total valves in the applicable process unit or group of process units as a weighted average of the percent leaking valves of each subgroup according to Equation 1 of this section:
(iv) If the overall performance of total valves in the applicable process unit or group of process units, determined according to paragraph (a)(3)(iii) of this section, is 2-percent leaking valves or greater, you may no longer subgroup and must revert to the program required in paragraphs (a)(1) and (2) of this section for that applicable process unit or group of process units. You can again elect to comply with the valve subgrouping procedures of paragraph (a)(3) of this section if future overall performance of total valves in the process unit or group of process units is again less than 2 percent.
(v) You must maintain the records specified in § 65.475(c)(1)(ii).
(vi) To determine the monitoring frequency for each subgroup, use the
(vii) Except for the overall performance calculations required by paragraphs (a)(3)(i) and (iii) of this section, each subgroup must be treated as if it were a process unit for the purposes of applying the provisions of this section.
(b)
(1)
(ii) Calculate the percent leaking valves for each monitoring period for each process unit or valve subgroup, as provided in paragraph (a)(3) of this section, using Equation 2 of this section:
(2)
(3)
(i) You must include a non-repairable valve in the calculation of percent leaking valves the first time the valve is identified as leaking and non-repairable.
(ii) You may exclude a number of non-repairable valves (identified and included in the percent leaking valves calculation in a previous period, as required in paragraph (b)(3)(i)) up to a maximum of 1 percent of the total number of valves in regulated material service at a process unit. If the number of non-repairable valves exceeds 1 percent of the total number of valves in regulated material service at a process unit, you must include the number of non-repairable valves exceeding 1 percent of the total number of valves in regulated material service in the calculation of percent leaking valves.
(c)
(2) After a leak has been repaired, you must monitor the valve at least once within the first 3 months after its repair. The monitoring required by this paragraph is in addition to the monitoring required to satisfy the definitions of repair and first attempt at repair.
(i) You must conduct monitoring, as specified in § 65.431(a) and determine whether the valve has resumed leaking, as specified in § 65.431(b).
(ii) If the timing of the monitoring required by paragraph (a) of this section coincides with the timing of the monitoring specified in this paragraph, you may use the monitoring required by paragraph (a) of this section to satisfy the requirements of this paragraph. Alternatively, you may perform other monitoring to satisfy the requirements of this paragraph, regardless of whether the timing of the monitoring period for periodic monitoring coincides with the time specified in this paragraph.
(iii) If a leak is detected by monitoring that is conducted, pursuant to paragraph (c)(2) of this section, you must follow the provisions of paragraphs (c)(2)(iii)(A) and (B) of this section to determine whether that valve must be counted as a leaking valve for purposes of paragraph (b)(1)(ii) of this section.
(A) If you elected to use periodic monitoring required by paragraph (a) of this section to satisfy the requirements of paragraph (c)(2) of this section, then you must count the valve as a leaking valve.
(B) If you elected to use other monitoring, prior to the periodic monitoring required by paragraph (a) of this section, to satisfy the requirements of paragraph (c)(2) of this section, then you must count the valve as a leaking valve unless it is repaired and shown by periodic monitoring not to be leaking.
(d)
(2)
(3)
(4)
Except as specified in paragraph (d) of this section, you must comply with the requirements specified in paragraphs (a) through (c) of this section for pumps in light liquid service.
(a)
(1)
(i) 5,000 ppm or greater for pumps handling polymerizing monomers.
(ii) 2,000 ppm or greater for all other pumps.
(2)
(b)
(c)
(2) If there are indications of liquids dripping from the pump seal at the time of the weekly inspection, you must follow the procedure specified in either paragraph (c)(2)(i) or (ii) (if applicable) of this section prior to the next required inspection, except as specified in paragraph (c)(2)(iii) of this section.
(i) Before the next weekly inspection, you must repair the pump seal, as defined in § 65.295 for indications of liquids dripping.
(ii) You must monitor the pump, as specified in § 65.431(a).
(A) If the instrument reading indicates a leak, as specified in § 65.431(b) and paragraph (a)(1) of this section, a leak is detected, and you must repair it using the procedures in § 65.432.
(B) If the instrument reading does not indicate a leak, as specified in § 65.431(b) and paragraph (a)(1) of this section, then a leak is not detected and no repair is required.
(iii) If you observed liquids dripping during the last weekly inspection and the characteristics of the liquids dripping have not changed since that last weekly inspection (
(3) You must document each inspection, as specified in § 65.475(c)(2)(i). If you comply with paragraph (c)(2)(iii) of this section, the record must include a description of the characteristics of the liquids dripping.
(d)
(1)
(i) Each dual mechanical seal system meets the requirements specified in paragraph (d)(1)(i)(A), (B) or (C) of this section.
(A) The seal system is operated with the barrier fluid at a pressure that is at all times greater than the pump stuffing box pressure.
(B) The seal system is equipped with a barrier fluid degassing reservoir that is connected by a closed vent system to a control device or is routed to a fuel gas system. The closed vent system and control device or the fuel gas system must meet § 65.413.
(C) The seal system is equipped with a closed-loop system that purges the barrier fluid into a process stream.
(ii) The barrier fluid is not in light liquid service.
(iii) Each barrier fluid system is equipped with a sensor that will detect failure of the seal system, the barrier fluid system or both.
(iv) Unless the pump is located within the boundary of an unmanned plant site, each sensor described in paragraph (d)(1)(iii) of this section is observed daily or is equipped with an alarm.
(v) Each pump is checked by visual inspection each calendar week for indications of liquids dripping from the pump seal. You must document each inspection, as specified in § 65.475(c)(2)(ii). If there are indications of liquids dripping from the pump seal at the time of the weekly inspection, you must follow the procedure specified in paragraph (d)(1)(v)(A) or (B) of this section prior to the next required inspection.
(A) Before the next weekly inspection, you must repair the pump seal, as defined in § 65.295 for indications of liquids dripping.
(B) You must monitor the pump, as specified in § 65.431(a) and determine if there is a leak of regulated material in the barrier fluid, as specified in § 65.431(b). If an instrument reading of 2,000 ppm or greater is measured, a leak is detected.
(vi) You must determine, based on design considerations and operating experience, criteria applicable to the presence and frequency of drips and to the sensor that indicate failure of the seal system, the barrier fluid system or both. You must keep records of the design criteria, as specified in § 65.475(c)(2)(iii).
(vii) If indications of liquids dripping from the pump seal exceed the criteria established in paragraph (d)(1)(vi) of this section, or if, based on the criteria established in paragraph (d)(1)(vi) of this section, the sensor indicates failure of the seal system, the barrier fluid system or both, a leak is detected.
(viii) When you detect a leak, pursuant to paragraph (d)(1)(v)(B) or (d)(1)(vii) of this section, you must repair it, as specified in § 65.432.
(2)
(3)
(4)
(5)
If required by your referencing subpart, you must comply with the requirements specified in paragraphs (a) through (c) of this section for connectors in gas and vapor service and connectors in light liquid service except as provided in paragraph (d) of this section.
(a)
(1)
(2)
(3)
(i) If the percent leaking connectors in the process unit was greater than or equal to 0.5 percent, then you must monitor annually.
(ii) If the percent leaking connectors in the process unit was greater than or equal to 0.25 percent, but less than 0.5 percent, then monitor within 4 years. You are not required to monitor all connectors at the same time in the 4-year period, but you must separate monitoring of an individual connector by at least 2 years.
(iii) If the percent leaking connectors in the process unit was less than 0.25 percent, then monitor, as provided in paragraph (a)(3)(iii)(A) of this section and either paragraph (a)(3)(iii)(B) or (C) of this section, as appropriate.
(A) You must monitor at least 50 percent of the connectors within 4 years of the start of the monitoring period.
(B) If the percent-leaking-connectors calculated from the monitoring results in paragraph (a)(3)(iii)(A) of this section is greater than or equal to 0.35 percent of the monitored connectors, you must monitor all connectors that have not yet been monitored during that monitoring period as soon as practical, but within the next 6 months. At the conclusion of monitoring, a new monitoring period shall be started, pursuant to paragraph (a)(3) of this section, based on the percent leaking connectors of the total monitored connectors.
(C) If the percent leaking connectors calculated from the monitoring results in paragraph (a)(3)(iii)(A) of this section is less than 0.35 percent of the monitored connectors, you must monitor all connectors that have not yet been monitored within 8 years of the start of the monitoring period.
(b)
(c)
(2) After a leak has been repaired, you must monitor the connector, as specified in § 65.431(a), once within the first 90 days after its repair to confirm that it is not leaking. The monitoring required by this paragraph is in addition to the monitoring required to satisfy the definitions of repair and first attempt at repair.
(d)
(2)
(3)
(A) Any connector you designate, in accordance with § 65.416(b), as an inaccessible connector.
(B) Any connector that is ceramic or ceramic-lined (
(ii) If you observe indications of a potential leak from any connector identified in paragraph (d)(2)(i) of this section by visual, audible, olfactory or other means, you must eliminate the visual, audible, olfactory or other indications of a potential leak to the atmosphere as soon as practical, but no later than the end of the next process unit shutdown or 5 years after detection, whichever is sooner.
Except as provided in paragraph (d) of this section, you must comply with the requirements specified in paragraphs (a) through (c) of this section for agitators in gas and vapor service and agitators in light liquid service.
(a)
(1)
(2)
(b)
(c)
(1) Before the next weekly inspection, you must repair the agitator seal, as defined in § 65.295 for indications of liquids dripping.
(2) You must monitor the agitator seal, as specified in § 65.431(a). If an instrument reading of 10,000 ppm or greater is measured, as specified in § 65.431(b), a leak is detected, and you must repair it according to paragraph (b) of this section.
(d)
(i) Each dual mechanical seal system meets the requirements specified in paragraph (d)(1)(i)(A), (B) or (C) of this section.
(A) The seal system is operated with the barrier fluid at a pressure that is, at all times greater than the agitator stuffing box pressure.
(B) The seal system is equipped with a barrier fluid degassing reservoir that is connected by a closed vent system to a control device or is routed to a fuel gas system. The closed vent system and control device or the fuel gas system must meet § 65.413.
(C) The seal system is equipped with a closed-loop system that purges the barrier fluid into a process stream.
(ii) The barrier fluid is not in light liquid service.
(iii) Each barrier fluid system is equipped with a sensor that will detect failure of the seal system, the barrier fluid system or both.
(iv) Unless the agitator seal is located within the boundary of an unmanned plant site, each sensor described in paragraph (d)(1)(iii) of this section is observed daily or is equipped with an alarm.
(v) Each agitator seal is checked by visual inspection each calendar week for indications of liquids dripping from the agitator seal. You must document each inspection, as specified in § 65.475(c)(4)(ii). If there are indications of liquids dripping from the agitator seal at the time of the weekly inspection, you must follow the procedure specified in paragraph (d)(1)(v)(A) or (B) of this section prior to the next required inspection.
(A) Before the next weekly inspection, you must repair the agitator seal, as defined in § 65.295 for indications of liquids dripping.
(B) You must monitor the agitator seal, as specified in § 65.431(a) and determine if there is a leak of regulated material in the barrier fluid, as specified in § 65.431(b). If an instrument reading of 10,000 ppm or greater is measured, a leak is detected.
(vi) You must determine, based on design considerations and operating experience, criteria applicable to the presence and frequency of drips and to the sensor that indicate failure of the seal system, the barrier fluid system or both. You must keep records of the design criteria, as specified in § 65.475(c)(4)(iii).
(vii) If indications of liquids dripping from the agitator seal exceed the criteria established in paragraph (d)(1)(vi) of this section, or if, based on the criteria established in paragraph (d)(1)(vi) of this section, the sensor indicates failure of the seal system, the barrier fluid system or both, a leak is detected.
(viii) When you detect a leak, pursuant to paragraph (d)(1)(v)(B) or (d)(1)(vii) of this section, you must repair it, as specified in § 65.432.
(2)
(3)
(4)
(5)
(6)
Except as specified in paragraph (d), you must comply with the requirements specified in paragraphs (a) and (b) of this section for PRD in gas and vapor service. If your referencing subpart specifies that releases to the atmosphere from PRD in regulated material service are not allowed, you must comply with the requirements specified in paragraph (c) or (d) of this section for all PRD in regulated material service.
(a) Operating requirements. Operate each PRD in gas or vapor service with an instrument reading of less than 500 ppm above background.
(b) Release requirements. If a PRD in gas or vapor service vents or releases to atmosphere, you must comply with either paragraph (b)(1) or (2) of this section following the release.
(1) If the PRD does not consist of or include a rupture disk, conduct instrument monitoring, as specified in § 65.431 no later than 5 calendar days after the PRD returns to regulated material service following a pressure release to verify that the PRD is operating with an instrument reading of less than 500 ppm. An instrument reading of 500 ppm or greater is a deviation.
(2) If the PRD consists of or includes a rupture disk, install a replacement disk as soon as practicable after a pressure release, but no later than 5 calendar days after the pressure release. You must also conduct instrument monitoring, as specified in § 65.431 no later than 5 calendar days after the PRD returns to regulated material service following a pressure release to verify that the PRD is operating with an instrument reading of less than 500 ppm. An instrument reading of 500 ppm or greater is a deviation.
(c)
(1) You must equip each PRD in regulated material service with a device(s) that is capable of identifying and recording the time and duration of each pressure release and of notifying operators that a pressure release has occurred. If this instrument is capable of measuring the concentration of leaks through the PRD, then you may use this instrument to meet the requirements of paragraph (b) of this section.
(2) If any PRD in regulated material service vents or releases to atmosphere, you must calculate the quantity of regulated material released during each pressure relief event. Calculations may be based on data from the PRD monitoring alone or in combination with process parameter monitoring data and process knowledge.
(d)
You must comply with either the requirements specified in paragraph (a) or (b) of this section for compressors in regulated material service.
(a)
(1)
(i) The seal system is operated with the barrier fluid at a pressure that is at all times greater than the compressor stuffing box pressure.
(ii) The seal system is equipped with a barrier fluid degassing reservoir that is connected by a closed vent system to a control device or is routed to a fuel gas system. The closed vent system and control device or the fuel gas system must meet § 65.413.
(iii) The seal system is equipped with a closed-loop system that purges the barrier fluid directly into a process stream.
(2)
(3)
(ii) You must keep records of the design criteria, as specified in § 65.475(c)(6)(i).
(4) You must comply with § 65.430 for all potential points of vapor leakage on the compressor other than the seal system.
(b)
(2) You must conduct instrument monitoring of all potential points of vapor leakage initially upon designation, annually and at other times requested by the Administrator to demonstrate that the compressor operates with an instrument reading of less than 500 ppm above background.
(3) You must keep records of the compliance tests, as specified in § 65.475(c)(6)(ii).
Except as provided in paragraph (b) of this section, you must comply with the requirements specified in paragraph (a) of this section for sampling connection systems in regulated material service. For the purposes of the definition of “sampling connection system” in § 65.295, a continuous emission monitoring system is not an analyzer vent.
(a)
(1) Gases displaced during filling of a sample container are not required to be collected or captured.
(2) Containers that are part of a closed-purge system must be covered or closed when not being filled or emptied.
(3) Gases remaining in the tubing or piping between the closed-purge system valve(s) and sample container valves(s) after the valves are closed and a sample container is disconnected are not required to be collected or captured.
(4) Each closed-purge, closed-loop or closed vent system must be designed and operated to meet requirements in either paragraph (a)(4)(i), (ii), (iii) or (iv) of this section.
(i) Return the purged process fluid directly to the process line.
(ii) Collect and recycle the purged process fluid to a process or to a fuel gas system that meets the requirements of subpart M of this part.
(iii) Capture and transport all the purged process fluid to a control device that meets § 65.413.
(iv) Collect, store and transport the purged process fluid to a system or facility identified in paragraph (a)(4)(iv)(A), (B), (C), (D) or (E) of this section.
(A) A waste management unit, as defined in 40 CFR 63.111, if the waste management unit is subject to and operated in compliance with the provisions of 40 CFR part 63, subpart G, applicable to group 1 wastewater streams.
(B) A treatment, storage or disposal facility subject to regulation under 40 CFR parts 262, 264, 265 or 266.
(C) A facility permitted, licensed or registered by a state to manage municipal or industrial solid waste, if the process fluids are not hazardous waste, as defined in 40 CFR part 261.
(D) A waste management unit subject to and operated in compliance with the treatment requirements of § 61.348(a), provided all waste management units that collect, store or transport the purged process fluid to the treatment unit are subject to and operated in compliance with the management requirements of §§ 61.343 through 61.347.
(E) A device used to burn-off specification used oil for energy recovery in accordance with 40 CFR part 279, subpart G, provided the purged process fluid is not hazardous waste, as defined in 40 CFR part 261.
(b)
Except as provided in paragraph (c) of this section, you must comply with the requirements specified in paragraphs (a) and (b) of this section for all open-ended valves and lines in regulated material service.
(a)
(b)
(c)
(2)
You must conduct sensory monitoring, as described in § 65.430 for the equipment specified in paragraphs (a) through (i) of this section.
(a) All equipment at a plant site with less than 1,500 total pieces of equipment.
(b) Any equipment that contains or contacts regulated material, but is not in regulated material service.
(c) Equipment in regulated material service less than 300 hours per calendar year.
(d) Valves, pumps, connectors and agitators in heavy liquid service.
(e) Connectors in gas and vapor service and connectors in light liquid service not required by your referencing subpart to comply with the provisions of § 65.422.
(f) Instrumentation systems.
(g) Pressure relief devices in liquid service.
(h) Any equipment for which sensory monitoring is required specifically by a provision in §§ 65.420 through 65.427.
(i) Other equipment, as required by your referencing subpart.
You must meet the requirements of this section for equipment in any closed vent system or fuel gas system required to comply with subpart M of this part. You are not required to comply with §§ 65.420 through 65.428 for equipment complying with this section.
(a) You must conduct instrument monitoring, as specified in § 65.431 of all potential points of vapor leakage on any equipment in a closed vent system or fuel gas system initially upon installation, annually and at other times requested by the Administrator to demonstrate that the equipment operates with an instrument reading of less than 500 ppm above background. Any instrument reading of 500 ppm above background or greater is a deviation.
(b) You must keep records of the compliance tests, as specified in § 65.475(c)(9).
(a) You must conduct sensory monitoring, as defined in § 65.295 for equipment identified in § 65.428. You must also comply with paragraph (b) through (d) of this section, as applicable.
(b) If indications of a potential leak to the atmosphere are found by sensory monitoring methods, you must comply with either paragraph (b)(1) or (2) of this section.
(1) Within 5 calendar days of detection, you must comply with either paragraph (b)(1)(i) or (ii) of this section.
(i) Repair the equipment, as defined in § 65.295 for indications of a potential leak to the atmosphere detected during sensory monitoring.
(ii) Determine that no bubbles are observed at potential leak sites during a leak check, using a soap solution.
(2) Conduct instrument monitoring, as described in § 65.431 within 5 calendar days of detection and repair the equipment in accordance with § 65.432 if the instrument reading is equal to or greater than the applicable level in Table 1 to this subpart.
(c) Except as provided in paragraph (c)(4) of this section, you must comply with the requirements of either paragraph (c)(1) or (2) of this section for equipment in heavy liquid service. Paragraph (c)(3) of this section describes how to determine or demonstrate that a piece of equipment is in heavy liquid service.
(1) Retain information, data and analyses used to determine that a piece of equipment is in heavy liquid service.
(2) When requested by the Administrator, demonstrate that the piece of equipment or process is in heavy liquid service.
(3) A determination or demonstration that a piece of equipment or process is in heavy liquid service shall include an analysis or demonstration that the process fluids do not meet the definition of “in light liquid service.” Examples of information that could document this include, but are not limited to, records of chemicals purchased for the process, analyses of process stream composition, engineering calculations or process knowledge.
(4) You are not required to comply with paragraphs (c)(1) through (3) of this section if all the equipment of a certain type (
(d) You must comply with the recordkeeping requirements of § 65.475(b)(5) for equipment in regulated material service less than 300 hours per calendar year.
(a)
(1)
(2)
(ii) If there is no instrument commercially available that will meet the performance criteria specified in paragraph (a)(2)(i) of this section, the instrument readings may be adjusted by multiplying by the representative response factor of the process fluid, calculated on an inert-free basis, as described in paragraph (a)(2)(i) of this section.
(3)
(ii) Perform a calibration drift assessment, at a minimum, at the end of each monitoring day, as specified in paragraphs (a)(3)(ii)(A) through (D) of this section.
(A) Check the instrument using the same calibration gas(es) that were used to calibrate the instrument before use. Follow the procedures specified in Method 21 of 40 CFR part 60, appendix A-7, section 10.1, except do not adjust the meter readout to correspond to the calibration gas value.
(B) Record the instrument reading for each scale used, as specified in paragraph (b) of this section. Divide these readings by the initial calibration values for each scale and multiply by 100 to express the calibration drift as a percentage.
(C) If any calibration drift assessment shows a negative drift of more than 10 percent from the initial calibration value, then you must re-monitor all equipment monitored since the last calibration with instrument readings below the applicable leak definition and above the applicable leak definition adjusted for negative drift. Determine the leak definition adjusted for negative drift according to Equation 4 of this section:
(D) If any calibration drift assessment shows a positive drift of more than 10 percent from the initial calibration value, then, at your discretion, you may re-monitor all equipment monitored since the last calibration with instrument readings above the applicable leak definition and below the applicable leak definition adjusted for positive drift. Determine the leak definition adjusted for positive drift according to Equation 5 of this section:
(4)
(i) Mixtures of methane in air at a concentration no more than 2,000 ppm greater than the leak definition concentration of the equipment monitored. If the monitoring instrument's design allows for multiple calibration scales, then calibrate the lower scale with a calibration gas that is no higher than 2,000 ppm above the concentration specified as a leak and calibrate the highest scale with a calibration gas that is approximately equal to 10,000 ppm. If only one scale on an instrument will be used during monitoring, you need not calibrate the scales that will not be used during that day's monitoring.
(ii) A calibration gas other than methane in air may be used if the instrument does not respond to methane or if the instrument does not meet the performance criteria specified in paragraph (a)(2)(i) of this section. In such cases, the calibration gas may be a mixture of one or more of the compounds to be measured in air.
(5)
(6)
(7)
(b)
(i) Monitor the equipment according to the procedures specified in paragraphs (a)(1) through (5) of this section.
(ii) Compare all instrument readings directly to the applicable leak definition or performance level for the monitored equipment to determine whether there is a leak or to determine compliance with § 65.424(a) (pressure relief devices), § 65.425(b) (alternative compressor standard) or § 65.427(b) (open-ended lines and valves).
(2) If you elect to adjust instrument readings for background, as described in paragraph (a)(7) of this section, you must comply with paragraphs (b)(2)(i) through (iv) of this section.
(i) Monitor the equipment according to the procedures specified in paragraphs (a)(1) through (5) of this section.
(ii) Determine the background level, as described in paragraph (a)(7) of this section.
(iii) Compute the arithmetic difference between the maximum concentration indicated by the instrument and the background level determined.
(iv) Compare this arithmetic difference to the applicable leak definition or performance level for the monitored equipment to determine whether there is a leak or to determine compliance with § 65.424(a) (pressure relief devices), § 65.425(b) (alternative compressor standard) or § 65.427(b) (open-ended lines and valves).
(a)
(1) When each leak is detected, pursuant to §§ 65.420 through 65.428, § 65.440 or § 65.450, attach a weatherproof and readily visible identification to the leaking equipment.
(2) When each leak is detected, record and keep the information specified in § 65.475(b)(8)(i).
(b)
(2) Except as provided in paragraphs (b)(4), (d) and (e) of this section, if the first attempt at repair required by paragraph (b)(1) of this section was not successful, you must repair each leak detected as soon as practical, but not later than 15 calendar days after it is detected. If required by the applicable definition of “repair” in § 65.295, you must conduct monitoring following the repair, but no later than 15 calendar days after the leak is detected to determine whether the repair was successful.
(3) You must keep records, as specified in § 65.475(b)(8)(ii) through (iv).
(4) You may designate equipment as unsafe-to-repair, if you determine that repair personnel would be exposed to an immediate danger as a consequence of complying with the repair requirements of this subpart. You are not required to comply with paragraphs (b)(1) and (2) for equipment that you have designated unsafe-to-repair, but you must keep records, as specified in § 65.475(b)(8)(v). You must also comply with paragraph (d) of this section.
(c)
(1)
(2)
(3)
(d)
(1) Delay of repair of equipment for which leaks have been detected is allowed if repair within 15 days after a leak is detected is technically infeasible without a process unit shutdown, provided you comply with paragraphs (d)(1)(i) through (iii) of this section.
(i) You must repair this equipment as soon as practical, but no later than the end of the next process unit shutdown or 5 years after detection, whichever is sooner. For the purposes of this section, a process unit shutdown is any shutdown that lasts more than 24 hours, regardless of whether it was planned or unplanned.
(ii) Except as specified in paragraph (d)(1)(iii) of this section, you must repair all equipment for which you have delayed repair during the process unit shutdown.
(iii) If you detect a leak less than 15 days before the process unit shutdown, you are not required to repair that leak during the process unit shutdown.
(2) Delay of repair of equipment for which leaks have been detected is allowed if the equipment is designated as unsafe to repair according to paragraph (b)(4) of this section. You must repair this equipment as soon as practical, but no later than the end of the next process unit shutdown or 5 years after detection, whichever is sooner.
(3) Delay of repair of equipment for which leaks have been detected is allowed for equipment that you isolate from the process such that it does not contact or contain regulated material.
(4) Delay of repair for valves, connectors and agitators is also allowed if you meet the provisions of paragraphs (d)(4)(i) and (ii) of this section.
(i) You document the planned repair date and demonstrate that emissions of purged material resulting from immediate repair would be greater than the fugitive emissions likely to result from delay of repair.
(ii) When you do repair the equipment, the purged material is collected and destroyed, collected and routed to a fuel gas system or routed through a closed vent system to a control device. The fuel gas system or the closed vent system and the control device must meet § 65.413.
(5) Delay of repair for pumps is also allowed if you meet the provisions of paragraphs (d)(5)(i) and (ii) of this section.
(i) Repair will consist of any of the design changes specified in paragraph (d)(5)(i)(A), (B), (C) or (D) of this section.
(A) Replacing the existing seal design with a new system that you have determined will provide better performance. You must document the demonstration that the new system will provide better performance than the existing seal.
(B) Installing a dual mechanical seal system that meets the requirements of § 65.421(d)(1).
(C) Installing a pump that meets the requirements of § 65.421(d)(2).
(D) Installing a system that routes emissions through a closed vent system to a control device or to a fuel gas system. The closed vent system and control device or the fuel gas system must meet § 65.413.
(ii) You complete repair as soon as practical, but not later than 6 months after the leak was detected.
(e)
(2) If you delay repair for a pump or agitator according to the provisions of paragraph (d)(1), (2), (3), (4) or (5) of this section, you may suspend the weekly visual inspection required by § 65.421(c) for pumps or § 65.423(c) for agitators.
(3) Unless it is technically infeasible to do so, when you repair a valve or connector for which you have delayed repair according to the provisions of paragraph (d)(1), (2), (3) or (4) of this section, you must replace the leaking equipment with low leak technology, as described in paragraphs (e)(3)(i) through (iv) of this section. You must develop a written plan that addresses the demonstration of whether a device or repair technique qualifies as low leak technology, criteria for selecting the low leak technology to be used for a repair and installation procedures for the selected technology.
(i) Low leak technology for valves includes, but is not limited to, the options in paragraphs (e)(3)(i)(A) through (D) of this section.
(A) Repacking the valve or replacing the existing valve packing with low emissions packing.
(B) Replacing the leaking valve with a valve designed to accommodate low emissions packing.
(C) Replacing the existing valve with a bellow seal valve.
(D) Other repair or replacement that has been tested rigorously and did not leak above 500 ppm during the entirety of the test.
(ii) Low leak technology for connectors includes, but is not limited to, the options in paragraphs (e)(3)(ii)(A) through (C) of this section.
(A) Replacing the flange gasket.
(B) Replacing the entire connector.
(C) Other repair or replacement that has been tested rigorously and did not leak above 500 ppm during the entirety of the test.
(iii) If you cannot replace the leaking equipment with low leak technology, then you would be required to explain why that replacement is technically infeasible in your annual periodic report, pursuant to § 65.470(c)(3).
(iv) If that equipment leaks again in the future and you delay the repair beyond 15 days, you must conduct a new analysis of the technical feasibility of using low leak technology.
For equipment in a batch operation that operates in regulated material service during the calendar year, you may comply with the equipment monitoring requirements specified in paragraphs (a) through (c) of this section as an alternative to complying with the requirements of §§ 65.420 through 65.427.
(a) You must comply with the requirements of §§ 65.420 through 65.427, as modified by paragraph (b) of this section.
(b) Monitor the equipment to detect leaks by the method specified in § 65.431 and as specified in paragraphs (b)(1) through (3) of this section.
(1) Each time the process components and transport piping are reconfigured for the production of a different product, monitor the equipment in the reconfigured process unit for leaks within 30 days of startup of the process. Do not include this initial monitoring of reconfigured equipment in determining percent leaking equipment in the process unit.
(2) You may elect to monitor pumps, valves and agitators at the frequencies specified in Table 2 to this subpart. Determine the operating time as the proportion of the year the batch operation that is subject to the provisions of this subpart is operating.
(3) The monitoring frequencies specified in paragraph (b)(2) of this section are not requirements for monitoring at specific intervals and can be adjusted to accommodate process operations. You may monitor anytime during the specified monitoring period (
(c) You must keep the records for equipment in batch operations, as specified in § 65.475(d).
(a)
(b)
(1) Your referencing subpart must directly reference this section and specify that the use of an optical gas imaging instrument is allowed to screen for leaking equipment.
(2) The optical gas imaging instrument must be able to meet all of the criteria and requirements specified in 40 CFR part 60, appendix K for optical gas imaging instruments, and you must conduct monitoring, as specified in 40 CFR part 60, appendix K.
(3) You may only use the optical gas imaging instrument as an alternative to provisions that would otherwise require you to conduct monitoring, as described in §§ 65.430 and 65.431. You must continue to comply with all other requirements in §§ 65.420 through 65.427 (
(c)
(1) Pursuant to § 65.415, you must identify the equipment and process units for which the optical gas imaging instrument will be used to identify leaks.
(2) Unless your referencing subpart specifies otherwise, the leak detection level for all equipment is 60 grams per hour.
(3) Unless your referencing subpart specifies otherwise, you must monitor all equipment identified in paragraph (c)(1) of this section bimonthly.
(4) For equipment identified in paragraph (c)(1) of this section, you may not use the provisions for less frequent monitoring, based on the percent of equipment leaking in §§ 65.420(a)(2) and 65.422(a)(3).
(5) When following the leak survey procedure in 40 CFR part 60, appendix K, a leak is detected if you see any emissions using the optical gas imaging instrument. The leaking equipment must be identified for repair, as required in § 65.432(a).
(6) You must repair the leaking equipment as required in § 65.432(b) through (e).
(7) Monitoring to confirm repair of leaking equipment must be conducted using the procedures referenced in paragraph (b)(2) of this section.
(d)
(a)
(1) The notification must provide the information listed in paragraphs (a)(1)(i) through (iii) of this section for each regulated source subject to the requirements of this subpart.
(i) Process unit, closed vent system or fuel gas system identification.
(ii) Number of each equipment type (
(iii) Method of compliance with the standard (
(2) For valves subject to § 65.420 and connectors subject to § 65.422, provide the historical monitoring data you are using to qualify for less frequent monitoring in lieu of having to do initial monitoring, if applicable.
(3) If you are required to comply with § 65.424(c), provide the information in paragraphs (a)(3)(i) and (ii) of this section.
(i) Description of the monitoring system to be implemented, including the PRD and process parameters to be monitored.
(ii) A description of the alarms or other methods by which operators will be notified of a release.
(4) For closed vent systems, non-flare control devices and fuel gas systems, pursuant to § 65.413, provide the applicable information specified in § 65.880.
(b) Semiannual periodic report. You must report the information specified in paragraphs (b)(1) through (5) of this section, as applicable, in the semiannual periodic report that you submit, as specified in § 65.225.
(1) For compressors, pursuant to § 65.425(b), that are to be operated with an instrument reading of less than 500 ppm, report the date of any instrument reading 500 ppm or greater and the date of the next instrument reading of less than 500 ppm.
(2) For PRD in gas or vapor service, pursuant to § 65.424(b), any instrument reading of 500 ppm or greater, more than 5 days after the PRD returns to service after a release.
(3) For open-ended valves and lines, pursuant to § 65.427(b), report the date of any instrument reading 500 ppm or greater and the date of the next instrument reading of less than 500 ppm.
(4) If your referencing subpart specifies that releases are not allowed from PRD in regulated material service to the atmosphere, report each release, including duration of the release and estimate of quantity of substances released.
(5) For open-ended lines in an emergency shutdown system that are designed to open automatically in the event of a process upset (and are not required to install a cap/plug), report each release if your referencing subpart states that releases from these types of open-ended lines are not allowed.
(6) For equipment in closed vent systems and fuel gas systems, pursuant to § 65.429, report the date of any instrument reading 500 ppm or greater and the date of the next instrument reading of less than 500 ppm.
(7) For closed vent systems, non-flare control devices and fuel gas systems, pursuant to § 65.413, provide the applicable information specified in § 65.882. For flares, report any instances when visual emissions occur longer than 5 minutes during any 2 consecutive hours, a pilot flame is out, or the pilot flames are not monitored.
(c)
(1) Provide a summary table that includes the information specified in paragraphs (c)(1)(i) through (iv) of this section for each process unit.
(i) For the equipment specified in paragraphs (c)(1)(i)(A) through (E) of this section, report the number of each type of equipment for which leaks were detected.
(A) Valves, pursuant to § 65.420(a).
(B) Pumps, pursuant to § 65.421(a), (d)(1)(v)(B) and (d)(1)(vii).
(C) Connectors, pursuant to § 65.422(a).
(D) Agitators, pursuant to § 65.423(a), (d)(1)(v)(B) and (d)(1)(vii).
(E) Compressors, pursuant to § 65.425(a).
(ii) Report the total number of valves and connectors monitored and the percent leaking, pursuant to §§ 65.420(b) (valves) and 65.422(b) (connectors).
(iii) For each type of equipment specified in paragraphs (c)(1)(i)(A) through (E) of this section, report the number of leaks that were not repaired, as required by § 65.432.
(iv) Identify the number of valves that are determined by § 65.420(b)(3) to be non-repairable.
(2) Where you delay any repair, pursuant to § 65.432(d), report that delay of repair has occurred and explain why delay of repair is necessary.
(3) If you delayed repair for a valve or connector and you demonstrated that it is technically infeasible to repair the equipment using low leak technology, pursuant to § 65.432(e)(3), include documentation of that demonstration.
(4) For PRD subject to § 65.424(b), report confirmation that you conducted all monitoring to show compliance conducted within the reporting period.
(5) For compressors, pursuant to § 65.425(b), that are to be operated with an instrument reading of less than 500 ppm, report confirmation that you conducted all monitoring to show compliance conducted within the reporting period.
(6) For open-ended lines and valves, pursuant to § 65.427(b), report confirmation that you conducted all monitoring to show compliance conducted within the reporting period.
(7) For equipment in closed vent systems and fuel gas systems, pursuant to § 65.429, report confirmation that you conducted all monitoring to show compliance conducted within the reporting period.
(8) Report the information listed in § 65.470(a)(1) through (3) for the Notification of Compliance Status for regulated sources with later compliance dates. Report any revisions to items reported in an earlier Notification of Compliance Status if the method of compliance has changed since the last report.
(a)
(b)
(2) If you designate equipment as either unsafe- or difficult-to-monitor, you must keep the records specified in paragraph (b)(2)(i) through (iii) of this section onsite as long as the equipment is designated as either unsafe- or difficult-to-monitor.
(i) You must maintain the identity of unsafe- and difficult-to-monitor equipment, as specified in § 65.416(a).
(ii) You must keep records of the planned schedule for monitoring unsafe- or difficult-to-monitor equipment and an explanation why the equipment is unsafe- or difficult-to-monitor, as specified in § 65.416(a)(3).
(iii) You must keep a written plan for monitoring unsafe- or difficult-to-monitor equipment, as required by § 65.416(a)(4). Your plan must include procedures for repairing any leaks found when monitoring is conducted.
(3) You must maintain the identity of compressors operating with an instrument reading of less than 500 ppm, as specified in § 65.416(c).
(4) You must keep records associated with the determination that equipment is in heavy liquid service, as specified in § 65.430(c), if applicable.
(5) You must keep records associated with the determination that equipment is in regulated material service less than 300 hours per calendar year, as specified in § 65.430(d), if applicable.
(6) For equipment in vacuum service, you must keep records of any pressure alarms triggered, including the date and time the alarm was triggered, as well as the duration the equipment was not in vacuum service.
(7) You must maintain records of the information specified in paragraphs (b)(7)(i) through (vi) of this section for monitoring instrument calibrations conducted according to sections 8.1.2 and 10 of Method 21 of 40 CFR part 60, appendix A-7, and § 65.431(a)(3) and (4).
(i) Date of calibration and initials of operator performing the calibration.
(ii) Calibration gas cylinder identification, certification date and certified concentration.
(iii) Instrument scale(s) used.
(iv) A description of any corrective action taken if the meter readout could not be adjusted to correspond to the calibration gas value in accordance with section 10.1 of Method 21 of 40 CFR part 60, appendix A-7.
(v) Results of each calibration drift assessment required by § 65.431(a)(3)(ii) (
(vi) If you make your own calibration gas, a description of the procedure used.
(8) You must keep the records specified in paragraphs (b)(8)(i) through (viii) of this section for leaking equipment detected according to § 65.431 and repaired according to § 65.432. You must keep the information for connectors complying with the 8-year monitoring period allowed under § 65.422(a)(3)(iii) for 5 years beyond the date of its last use.
(i) The date the leak was detected and the maximum instrument reading measured by Method 21 of 40 CFR part 60, appendix A-7, including the background concentration if you elect to adjust instrument readings for background, as described in § 65.431(a)(7).
(ii) The date of first attempt to repair the leak.
(iii) The date of successful repair of the leak.
(iv) Maximum instrument reading measured by Method 21 of 40 CFR part 60, appendix A-7, at the time the leak is successfully repaired or determined to be non-repairable.
(v) A record of the identity and an explanation, as specified in § 65.432(b)(4) for any equipment designated as unsafe-to-repair.
(vi) “Repair delayed,” the reason for the delay if a leak is not repaired within 15 calendar days after discovery of the leak and, where appropriate, why the repair was technically infeasible without a process unit shutdown, pursuant to § 65.432(d)(1), or the calculation showing that emissions of purged material resulting from immediate repair would be greater than the fugitive emissions likely to result from delay of repair, pursuant to § 65.432(d)(4)(i). As an alternative to listing the reason for delay of repair for each leak, you may elect to develop written guidelines that identify the conditions that justify a delay of repair. If you elect to develop written guidelines, you may document the reason for delay of repair for each leak in your records by citing the relevant sections of the written guidelines. You must maintain the written guidelines at the plant site.
(vii) Dates of process unit shutdowns that occur while the equipment is unrepaired.
(viii) Instrument readings measured by Method 21 of 40 CFR part 60, appendix A-7, while repair is delayed.
(9) You must keep the applicable records specified in § 65.860 for closed vent systems, control devices and fuel gas systems used to comply with this subpart.
(c)
(1) For valves, you must maintain the records specified in paragraphs (c)(1)(i) through (iii) of this section.
(i) The start and end dates of each monitoring period for each process unit, as specified in § 65.420(a)(2).
(ii) If you decided to subgroup valves, pursuant to § 65.420(a)(3), the valve subgrouping records specified in paragraphs (c)(1)(ii)(A) through (D) of this section.
(A) Which valves are assigned to each subgroup.
(B) Monitoring results and calculations made for each subgroup for each monitoring period.
(C) Which valves are reassigned, the last monitoring result prior to reassignment and when they were reassigned.
(D) The results of the semiannual overall performance calculation required in § 65.420(a)(3)(iii).
(iii) The inputs and results for the calculation to determine percent leaking valves in § 65.420(b)(1).
(2) For pumps, you must maintain the records specified in paragraphs (c)(2)(i) through (iii) of this section.
(i) Pursuant to § 65.421(c), documentation that pump visual inspections occurred, the date of each inspection and the results of each inspection, including a description of the characteristics of the liquids dripping, if observed.
(ii) Pursuant to § 65.421(d)(1)(v), documentation that dual mechanical seal pump visual inspections occurred, the date of each inspection and the results of each inspection.
(iii) Pursuant to § 65.421(d)(1)(vi), documentation of the criteria that indicate failure of the seal system, the barrier fluid system or both. Record the design criteria selected, explanations of how those criteria were selected and any changes to the criteria and the reason for the changes.
(3) For connectors, you must maintain the records specified in paragraphs (c)(3)(i) and (ii) of this section.
(i) The start date and end date of each monitoring period for each process unit, pursuant to § 65.422(a)(3).
(ii) The inputs and results for the calculation to determine percent leaking connectors in § 65.422(b).
(4) For agitators, you must maintain the records specified in paragraphs (c)(4)(i) through (iii) of this section.
(i) Pursuant to § 65.423(c), documentation that agitator seal visual inspections occurred, the date of each inspection and the results of each inspection.
(ii) Pursuant to § 65.423(d)(1)(v), documentation that dual mechanical seal agitator visual inspections occurred, the date of each inspection and the results of each inspection.
(iii) Pursuant to § 65.423(d)(1)(vi), documentation of the criteria that indicate failure of the seal system, the barrier fluid system or both. Record the design criteria selected, explanations of how those criteria were selected, and any changes to the criteria and the reason for the changes. This record must be available for review by an inspector.
(5) For pressure relief devices, you must maintain records of the information specified in paragraphs (c)(5)(i) through (iii) of this section.
(i) Pursuant to § 65.424(b), the dates of pressure releases and the dates and results of monitoring following a pressure release, including the background level measured and the maximum instrument reading measured during the monitoring (or the concentration measured by the monitor required by § 65.424(c), if applicable).
(ii) Pursuant to § 65.424(b)(2), the date the rupture disk was replaced.
(iii) Pursuant to § 65.424(c)(2), the quantity of regulated material released during each pressure relief event.
(6) For compressors, you must maintain the records specified in paragraphs (c)(6)(i) and (ii) of this section.
(i) Pursuant to § 65.425(a)(3), documentation of the criteria that indicate failure of the seal system, the barrier fluid system or both. Record the design criteria selected, explanations of how those criteria were selected, and any changes to the criteria and the reason for the changes.
(ii) Pursuant to § 65.425(b), for compressors operating under the alternative compressor standard, records of the dates and results of each compliance test, including the background level measured and the maximum instrument reading measured during each compliance test.
(7) For sampling connection systems complying with § 65.426, you must maintain the records specified in paragraphs (c)(7)(i) and (ii) of this section.
(i) Records of the date of each purge.
(ii) An estimate of the amount of material purged.
(8) Pursuant to § 65.427(b), for open-ended valves and lines, records of the dates and results of each compliance test, including the background level measured and the maximum instrument reading measured during each compliance test.
(9) Pursuant to § 65.413, for equipment in closed vent systems and fuel gas systems, records of the dates and results of each compliance test, including the background level measured and the maximum instrument reading measured during each compliance test.
(d)
(1) Prepare a list of equipment added to the batch operation since the last monitoring period required in § 65.440.
(2) Record and keep, pursuant to the referencing subpart and this subpart, the date and results of the monitoring required in § 65.440 for equipment added to a batch operation since the last monitoring period. If no leaking equipment is found during this monitoring, you must record that the inspection was performed, but records of the actual monitoring results are not required.
(3) Maintain records demonstrating the proportion of the time during the calendar year the equipment is in use in a batch operation that is subject to the provisions of this subpart. Examples of suitable documentation are records of time in use for individual pieces of equipment or average time in use for the process unit. These records are not required if you do not adjust monitoring frequency by the time in use, as provided in § 65.440(b)(2) and (3).
(4) Document that the equipment was in service at the time you conducted instrument monitoring, pursuant to § 65.440.
(e)
(1) The equipment and process units for which you choose to use the optical gas imaging instrument.
(2) All records required by 40 CFR part 60, appendix K.
(3) A video record to document the leak survey results. The video record must include a time and date stamp for each monitoring event.
(4) Identification of the equipment screened and the time and date of the screening.
(5) Documentation of repairs attempted and repairs delayed, as specified in paragraph (b)(8)(ii) through (viii) of this section. If you confirm repair of a leak using the optical gas imaging instrument, then instead of the maximum instrument reading measured by Method 21 of 40 CFR part 60, appendix A-7 required by paragraph (b)(8)(iv) of this section, you must keep a video record following repair to confirm the equipment is repaired. You must keep the information for connectors complying with the 8-year monitoring period allowed under § 65.422(a)(3)(iii) for 5 years beyond the date of its last use.
(f)
All terms used in this subpart have the same meaning given in the Clean Air Act and subpart H of this part, unless otherwise specified in the referencing subpart.
5. Add subpart M to read as follows:
This subpart specifies requirements to meet the emission standards of a referencing subpart for closed vent systems, control devices and routing of air emissions to a fuel gas system.
You are subject to this subpart if you are an owner or operator who is subject to a referencing subpart and you have been expressly directed to comply with this subpart by a referencing subpart.
(a) You must comply with the following:
(1) The applicable provisions of subpart H of this part.
(2) The General Provisions that are applicable to the referencing subpart (
(3) The section(s) of this subpart corresponding to the control measure(s) being used.
(4) § 65.720 for closed vent systems.
(5) All applicable requirements referenced in the provisions listed in paragraphs (a)(1) through (4) of this section.
(b)
(c)
(1) Process knowledge that no halogen, hydrogen halides or organic halides are present in the process.
(2) Applicable engineering assessment, as discussed in § 65.830.
(3) Concentration of compounds containing halogen and hydrogen halides measured by Method 26 or 26A at 40 CFR part 60, appendix A-8, and organic halides measured by Method 18 of 40 CFR part 60, appendix A-6.
(4) Concentration of compounds containing hydrogen halides may be measured by Method 320 at 40 CFR part 63, appendix A.
(5) Any other method or data that has been validated according to the applicable procedures in Method 301 at 40 CFR part 63, appendix A.
(d)
(e)
(1) A control device for which the referencing subpart allows a design evaluation as an alternative to the performance test.
(2) You use a continuous emission monitoring system (CEMS) meeting the requirements in § 65.711 to monitor the performance of the control device that would otherwise require performance testing.
(3) Control measures for which you have received an approved performance test waiver, according to § 65.245 of this chapter.
(4) If a prior performance test was conducted using the same procedures specified in § 65.724(b) for boilers and process heaters, § 65.726(b) for thermal oxidizers, § 65.728(b) for catalytic oxidizers, § 65.740(b) for absorbers, § 65.742(f) for adsorbers regenerated on site, § 65.744(b) for non-regenerative adsorbers, § 65.746(b) for condensers, § 65.748(b) for biofilters, § 65.760(b) for sorbent injection, § 65.762(b) for fabric filters and § 65.800(b) for other control devices, as applicable, and, either no process changes have been made since the test or you can demonstrate that the results of the performance test, with or without adjustments, reliably demonstrate compliance despite process changes, you may only use a prior performance test that is less than 5 years old in lieu of a performance test. You must request permission to substitute a prior performance test by application to the Administrator that includes the information specified in § 65.884(f). You must be able to establish appropriate operating limits using the information collected during the prior performance test. If a performance test is waived, you are still subject to any subsequent or periodic performance test requirements.
(5) If you use a condenser and comply with § 65.746.
(f)
(g)
(h)
(i)
This subpart applies to control devices that receive regulated material and that are used to comply with a referencing subpart. This subpart also applies to closed vent systems that route
The General Provisions of 40 CFR parts 60, 61 and 63 apply to this subpart, as specified in subpart H of this part.
All terms used in this subpart have the same meaning given in the Clean Air Act and subpart H of this part, unless otherwise specified in the referencing subpart.
(a) You must meet the general monitoring requirements of this section for all control devices used to comply with the referencing subpart.
(b) If you choose to use a CEMS to meet the requirements as specified in Table 1 to this subpart, you must comply with the provisions specified in § 65.711. If you choose to use a continuous parameter monitoring system (CPMS) to meet the requirements, as specified in Table 2 to this subpart, you must comply with the provisions specified in § 65.712.
(c) You are not required to operate CEMS or CPMS during periods of no flow, or no flow of regulated material to the control device; however, if flow could be intermittent, you must install a flow indicator to identify periods of flow/no flow at the inlet or outlet of the control device. You must keep records of periods of flow/no flow, or no flow of regulated material to the control device, as specified in § 65.860(i). Flow indicators used only to identify periods of flow and no flow are not subject to the requirements of § 65.712. However, you must perform a flow meter verification check annually. You must perform the annual verification check for at least two points, one at the instrument's zero and the other at the instrument's span.
(d) All monitoring equipment must be capable of providing a continuous record.
(e) A deviation means any of the cases listed in paragraphs (e)(1) through (5) of this section. Monitoring data are not required to be collected during periods of non-operation of the process unit or portion thereof (resulting in cessation of the emissions to which monitoring applies).
(1) Periods of excess emissions, which are those periods when the daily or block average value from a CEMS, reduced to the units of the emissions standards, as specified in § 65.711(j), exceeds an emission limit specified in the referencing subpart.
(2) Operating parameter exceedances, which are those periods when the daily or block average value of one or more monitored operating parameters is outside the operating limit established under this rule.
(3) Any discharges to the atmosphere through a bypass line.
(4) Any period when you route regulated materials to a monitored emission point that you do not collect data using your CEMS, CPMS or other required non-continuous monitoring, as applicable. This does not include periods of normally scheduled quality assurance activities in your CEMS performance evaluation and monitoring plan or CPMS monitoring plan that require the instrument to be offline (
(5) Any period when you route regulated emissions to a monitored emission point when the continuous monitoring system (CMS) is not operating properly or is out of control, as specified in § 65.711(i) or § 65.712(d).
(a)
(b)
(1) Install each CEMS according to the procedures contained in the applicable performance specification(s) listed in paragraph (h) of this section. Locate the sampling probe or other interface at a measurement location relative to each regulated process unit such that you obtain representative measurements of emissions from the regulated source (
(2) When you combine the regulated emissions from two or more regulated emission units before release to the atmosphere, you may install an applicable CEMS for each emissions unit or for the combined emissions stream, provided the monitoring is sufficient to demonstrate compliance with the emission limit for each emissions unit.
(3) If the relevant emission limit is a mass emission standard and the regulated emissions from a regulated emissions unit are released to the atmosphere through more than one emission point, you must install an applicable CEMS at each emission point.
(4) You must ensure the readout (that portion of the CEMS that provides a visual display or record), or other indication of emissions, from any CEMS required for compliance with an emission standard is readily accessible onsite for operational control or inspection by the operator of the source.
(5) You must conduct a CEMS performance evaluation, pursuant to the schedule specified in the referencing subpart, and periodically, as specified in your CEMS performance evaluation and monitoring plan described in paragraph (c) of this section.
(6) All CEMS must complete a minimum of one cycle of operation (sampling, analyzing and data recording) for each successive 15-minute period.
(7) Except for maintenance periods, instrument adjustments or checks to maintain precision and accuracy, calibration checks, and zero and span adjustments, you must operate all CEMS and collect data continuously when you route regulated emissions to the monitored emission point.
(8) Upon submittal of the CEMS performance evaluation and monitoring plan to the Administrator for approval, you must operate and maintain each CEMS according to the CEMS performance evaluation and monitoring plan specified in paragraph (c) of this section.
(9) You must modify the CEMS performance evaluation and monitoring plan to incorporate the Administrator's comments and resubmit the plan for approval to the Administrator within 30 days of receiving the Administrator's comments. Upon re-submittal to the Administrator for approval, you must operate and maintain each CEMS in conformance with the revised CEMS performance evaluation and monitoring plan.
(10) For each CEMS, you must comply with the procedures for out-of-control periods described in paragraph (i) of this section.
(11) You must reduce data from each CEMS, as specified in paragraph (j) of this section.
(c)
(1) Routine quality control and assurance procedures that address the requirements of paragraph (d) of this section.
(2) CEMS evaluation procedures that meet the requirements of paragraph (e) of this section.
(3) Additional information, as listed in paragraph (f) of this section.
(d)
(1) Initial and subsequent calibration of the CEMS and acceptance criteria.
(2) Determination and adjustment of the calibration drift of the CEMS.
(3) Preventive maintenance of the CEMS, including spare parts inventory.
(4) Data recording, calculations and reporting;
(5) Accuracy audit procedures, including sampling and analysis methods.
(6) Program of corrective action for a CEMS that is not operating properly or is out-of-control.
(e)
(1) A description of the applicable CEMS evaluation procedure specified in paragraph (h) of this section and the site-specific details and procedures necessary to describe the applicable procedure for your specific operation.
(2) The evaluation program objectives.
(3) Acceptance criteria.
(4) An evaluation program summary.
(5) Data quality objectives. (The pre-evaluation expectations of precision, accuracy and completeness of data.)
(6) Conditions that would trigger a CEMS evaluation, which must include, at a minimum, a newly installed CEMS; an existing CEMS that is newly used to demonstrate compliance with a referencing subpart and has not previously had a CEMS evaluation; a process change that is expected to affect the performance of the CEMS; and the Administrator's request for a performance evaluation under section 114 of the Clean Air Act. A CEMS that is newly used to demonstrate compliance with a referencing subpart that has previously had a CEMS evaluation, as specified in this paragraph (e) of this section, and has followed routine quality assurance procedures, as specified in paragraph (d) of this section, since the previous CEMS evaluation, does not trigger an additional CEMS evaluation unless a change is also made that is expected to affect the performance of the CEMS.
(f)
(1) Identification of the pollutant being monitored by the CEMS and the expected concentrations, including worst case concentrations at normal operation and during possible process upsets.
(2) Description of the monitoring equipment, including the information specified in paragraphs (f)(2)(i) through (vii) of this section.
(i) Manufacturer and model number for all monitoring equipment components.
(ii) Performance specifications, as provided by the manufacturer and any differences expected for your installation and operation.
(iii) Location of the CMS sampling probe or other interface and a justification of how the location meets the requirements of paragraph (b)(1) of this section.
(iv) Placement of the CEMS readout, or other indication of emissions, indicating how the location meets the requirements of paragraph (b)(2) of this section.
(v) Span of the analyzer.
(vi) Justification of the selection for the specific monitoring equipment with respect to the pollutant and pollutant concentrations expected.
(vii) Identification of the cycle time for the CEMS, indicating that it meets the requirement of (b)(3) of this section.
(3) Description of the data collection and reduction systems, including the information specified in paragraphs (f)(3)(i) through (iv) of this section.
(i) A copy of the data acquisition system algorithm used to reduce the measured data into the reportable form of the standard and calculate the applicable averages.
(ii) Identification of whether the algorithm excludes data collected during CEMS breakdowns, out-of-control periods, repairs, maintenance periods, instrument adjustments or checks to maintain precision and accuracy, calibration checks, and zero (low-level), mid-level (if applicable) and high-level adjustments.
(iii) If the data acquisition algorithm does not exclude data collected during CEMS breakdowns, out-of-control periods, repairs, maintenance periods, instrument adjustments or checks to maintain precision and accuracy, calibration checks, and zero (low-level), mid-level (if applicable) and high-level adjustments, then include a description of your procedure for excluding this data when the averages calculated, as specified in § 65.855, are determined.
(iv) If the measured data are converted to the reportable form of the standard and/or averages calculated manually, documentation of the calculation procedure.
(4) Identification of the applicable EPA performance specification(s) for the CEMS.
(g)
(1) Except as provided in paragraphs (g)(2) through (4) of this section, you must comply with procedure 1 at 40 CFR part 60, appendix F. If you operate a CEMS, based on Fourier transform infrared spectroscopy, you must replace the Relative Accuracy Test Audit requirements of procedure 1 with the validation requirements and criteria of sections 11.1.1 and 12.0 of Performance Specification 15 of part 60, appendix B.
(2) If you operate a particulate matter CEMS, you must comply with procedure 2 at 40 CFR part 60, appendix F, instead of procedure 1 at 40 CFR part 60, appendix F.
(3) If you operate a mercury CEMS, you must comply with procedure 5 at 40 CFR part 60, appendix F, instead of procedure 1 at 40 CFR part 60, appendix F.
(4) If you operate a CEMS, meeting Performance Specification 9 or 15 requirements, you must determine the target analyte(s) for calibration using either process knowledge of the vent stream or the presurvey screening procedures in section 16 of Method 18 at 40 CFR part 60, appendix A-6 on the control device outlet stream.
(h)
(1) For particulate matter, Performance Specification 11.
(2) For hydrogen halides, Performance Specification 15.
(3) For mercury, Performance Specification 12A or 12B.
(4) For sulfur dioxide, Performance Specification 2.
(5) For total hydrocarbons, Performance Specification 8A.
(6) For speciated organic compounds using a gas chromatograph, Performance Specification 9.
(7) For speciated organic compounds using Fourier transform infrared spectroscopy, Performance Specification 15.
(8) For oxygen or carbon dioxide, Performance Specification 3.
(9) For carbon monoxide, Performance Specification 4, if your emission limit is above 200 ppmv, or Performance Specification 4A if your emission limit is equal to or less than 200 ppmv.
(10) If you operate a CEMS meeting Performance Specification 9 or 15, you must determine the target analyte(s) for calibration using either process knowledge of the vent stream or the pre-survey screening procedures in section 16 of Method 18 at 40 CFR part 60, appendix A-6 on the control device outlet stream.
(11) You may only use Performance Specification 15 to measure hydrogen halides if you are not required to include halogens in your measurement or you can demonstrate that there are no halogens in the vent stream.
(12) If you wish to use a CEMS with no applicable Performance Specification, you must submit a request for approval to use an alternate monitoring method according to § 65.240. Your alternative monitoring method request must include the procedures for a CEMS evaluation and other information typically contained in a Performance Specification. This information must also be included in the CEMS performance evaluation and monitoring plan specified on paragraph (d) of this section.
(i)
(1) If the conditions in paragraph (i)(1)(i) or (ii) of this section occur, the CEMS is out-of-control.
(i) If the zero (low-level), mid-level (if applicable) or high-level calibration drift exceeds two times the applicable calibration drift specification in the applicable performance specification.
(ii) A CEMS is out of control if the CEMS fails a performance test audit (
(2) When the CEMS is out of control, you must take the necessary corrective action and repeat all necessary tests that indicate the system is out of control. You must take corrective action and conduct retesting until the performance requirements are below the applicable limits. The beginning of the out-of-control period is the hour you conduct a performance check (
(j)
(1) Convert all CEMS emission data into units of the emission limit of the referencing subpart for reporting purposes using the conversion procedures specified in that subpart. After conversion into units of the emission limit, you may round the data to the same number of significant digits as used in that emission limit.
(2) If a referencing subpart specifies an emission standard in a specific percent oxygen, you must correct the concentrations, as measured by the CEMS in accordance with § 65.826(b).
(3) Calculate averages, as specified in § 65.855.
(4) Record the CEMS data, as specified in § 65.860.
(k) The CEMS performance evaluation and monitoring plan must be submitted for approval to the Administrator 60 days before the CEMS evaluation is to be conducted.
(l) If you are not proposing any alternative monitoring methods and are intending to demonstrate compliance using the monitoring method(s) specified in this section, you do not have to wait for approval of your CEMS performance evaluation and monitoring plan before conducting the CEMS evaluation or before following the other procedures of the CEMS performance evaluation and monitoring plan.
(m) If you are proposing an alternative monitoring method, follow the procedures in § 65.240.
(a)
(b)
(1) Install and locate each CPMS sampling probe or other interface at a measurement location relative to each regulated process unit or control device being monitored such that you obtain representative measurements of the operating parameter from the regulated source or control device (
(2) You must ensure the readout (that portion of the CPMS that provides a visual display or record), or other indication of the monitored operating parameter from any CPMS required for compliance is readily accessible onsite for operational control or inspection by the operator of the source.
(3) All CPMS must complete a minimum of one cycle of operation (sampling, analyzing and data recording) for each successive 15-minute period.
(4) Except for maintenance periods, instrument adjustments or checks to maintain precision and accuracy, calibration checks, and zero and span adjustments, you must operate all CPMS and collect data continuously when you route regulated emissions to the monitored emission point.
(5) Upon submittal of the CPMS monitoring plan to the Administrator for approval, you must operate and maintain each CPMS according to the
(6) You must modify the CPMS monitoring plan to incorporate the Administrator's comments and resubmit the plan for approval to the Administrator within 30 days of receiving the Administrator's comments. Upon re-submittal to the Administrator for approval, you must operate and maintain each CPMS in conformance with the revised CPMS monitoring plan.
(7) For each CPMS, you must comply with the out-of-control procedures described in paragraphs (d) of this section.
(8) You must reduce data from a CPMS, as specified in paragraphs (e) of this section.
(9) All monitoring equipment must meet the minimum accuracy, calibration and quality control requirements specified in Table 4 to this subpart.
(10) Your CPMS must be capable of measuring the appropriate parameter over a range that extends from a value that is at least 20 percent less than the lowest value that you expect your CPMS to measure, to a value that is at least 20 percent greater than the highest value that you expect your CPMS to measure. The data recording system associated with each CPMS must have a resolution that is equal to or better than one-half of the required system accuracy.
(11) All CPMS must be installed, operational and calibrated, as specified in paragraph (b) of this section, within 24 hours before conducting the performance test or, if a performance test is not required, prior to the compliance date. Subsequent calibrations must be conducted, as specified in the CPMS monitoring plan, as specified in paragraph (c) of this section.
(c)
(1) The information specified in § 65.225(g).
(2) Identification of the parameter to be monitored by the CPMS and the expected parameter range, including worst case and normal operation.
(3) Description of the monitoring equipment, including the information specified in (c)(3)(i) through (viii) of this section.
(i) Manufacturer and model number for all monitoring equipment components.
(ii) Performance specifications, as provided by the manufacturer, and any differences expected for your installation and operation.
(iii) The location of the CMS sampling probe or other interface and a justification of how the location meets the requirements of paragraph (b)(1) of this section.
(iv) Placement of the CPMS readout, or other indication of parameter values, indicating how the location meets the requirements of paragraph (b)(2) of this section.
(v) Span of the analyzer.
(vi) Identify the parameter detected by the parametric signal analyzer and the algorithm used to convert these values into the operating parameter monitored to demonstrate compliance, if the parameter detected is different from the operating parameter monitored.
(vii) Justification for the selection of the specific monitoring equipment with respect to the parameter and expected parameter values.
(viii) Identify the cycle time for the CPMS.
(4) Description of the data collection and reduction systems, including the information specified in paragraphs (c)(4)(i) through (iv) of this section.
(i) A copy of the data acquisition system algorithm used to reduce the measured data into the reportable form of the standard and calculate the applicable averages.
(ii) Identification of whether the algorithm excludes data collected during CPMS breakdowns, out-of-control periods, repairs, maintenance periods, instrument adjustments or checks to maintain precision and accuracy, calibration checks, and zero (low-level), mid-level (if applicable) and high-level adjustments.
(iii) If the data acquisition algorithm does not exclude data collected during CEMS breakdowns, out-of-control periods, repairs, maintenance periods, instrument adjustments or checks to maintain precision and accuracy, calibration checks, and zero (low-level), mid-level (if applicable) and high-level adjustments, then include a description of your procedure for excluding this data when the averages calculated, as specified in § 65.855 are determined.
(iv) If the measured data are converted to the reportable form of the standard and/or averages calculated manually, documentation of the calculation procedure.
(5) Routine quality control and assurance procedures, including descriptions of the procedures listed in paragraphs (c)(5)(i) through (vi) of this section and a schedule for conducting these procedures. The routine procedures must provide an assessment of CPMS performance.
(i) Initial and subsequent calibration of the CPMS and acceptance criteria.
(ii) Determination and adjustment of the calibration drift of the CPMS.
(iii) Daily checks for indications that the system is responding. If the CPMS system includes an internal system check, you may use the results to verify the system is responding, as long as you check the internal system results daily for proper operation and the results are recorded.
(iv) Preventive maintenance of the CPMS, including spare parts inventory.
(v) Data recording, calculations and reporting.
(vi) Program of corrective action for a CPMS that is not operating properly.
(d)
(1) A CPMS is out-of-control if the zero (low-level), mid-level (if applicable) or high-level calibration drift exceeds two times the accuracy requirement of Table 4 of this subpart.
(2) When the CPMS is out of control, you must take the necessary corrective action and repeat all necessary tests that indicate the system is out of control. You must take corrective action and conduct retesting until the performance requirements are below the applicable limits. The beginning of the out-of-control period is the hour you conduct a performance check (
(e)
(1) You may round the data to the same number of significant digits, as used in that emission limit.
(2) Periods of non-operation of the process unit (or portion thereof), resulting in cessation of the emissions to which the monitoring applies must not be included in daily averages.
(3) Calculate averages, as specified in § 65.855.
(4) The data from a CPMS must be recorded, as specified in § 65.860.
(f)
(g)
(h)
You must establish operating limits for operating parameters required to be monitored by this subpart by following the requirements in this section or you may request approval of monitoring alternatives, as specified in § 65.884(h).
(a) You must establish the operating limit for each operating parameter for each control device, based on the operating parameter values recorded during the performance test, and may be supplemented by engineering assessments and/or manufacturer's recommendations. Performance testing is not required to be conducted over the entire range of allowed operating parameter values.
(b) The established operating limit must represent the conditions for which the control device is meeting the specified emission limit of the referencing subpart.
(c) You must establish your operating limit as an operating parameter range, minimum operating parameter level or maximum operating parameter level, as specified in Table 3 to this subpart, as applicable. Where this subpart does not specify which format to use for your operating limit (
(d) The operating limit may be based on ranges or limits previously established under a referencing subpart. If a performance test is not required for a control device and, except as specified in § 65.748(b) for biofilters, the operating limit may be based on engineering assessments and/or manufacturer's recommendations included in the required design evaluation.
(e) For batch processes, you may establish operating limits for individual emission episodes, including each distinct episode of vent stream emissions, if applicable. If you elect to establish separate operating limits for different emission episodes within a batch process, then you must comply with the provisions in paragraphs (e)(1) and (2) of this section.
(1) Maintain a daily schedule or log of operating scenarios for batch processes according to § 65.860(f)(1).
(2) Provide rationale for each operating limit for each emission episode in a batch pre-compliance report, as specified in § 65.884(g). You must also report the rationale according to § 65.884(j).
(a)
(b)
(c)
(1)
(i) Install a CPMS for flow at the entrance to any bypass line. The CPMS must record the volume of the gas stream that bypassed the control device.
(ii) Equip the CPMS for flow with an alarm system that will alert an operator immediately and automatically when flow is detected in the bypass line. Locate the alarm such that an operator can easily detect and recognize the alert.
(2)
(d)
(1) You must maintain records of any alarms triggered because flow was detected in the bypass line, including the date and time the alarm was triggered and the duration of the flow in the bypass line. You must also maintain records of all periods when the vent stream is diverted from the control device or air intrudes into the control device. You must include an estimate of the volume of gas, the concentration of regulated material in the gas and the resulting emissions of regulated material that bypassed the control device.
(2) Where a seal mechanism is used to comply with paragraph (c)(2) of this section, hourly records of flow are not required. In such cases, you must record the date that you complete the monthly visual inspection of the seals or closure mechanisms. You must also record the occurrence of all periods when the seal or closure mechanism is broken, the bypass line valve position has changed or the key for a lock-and-key type lock has been checked out. You must include an estimate of the volume of gas, the concentration of regulated material in the gas and the resulting emissions of regulated material that bypassed the control device.
(a)
(b)
(1) When demonstrating compliance with a percent reduction emission limit in a referencing subpart, you must determine the weight-percent reduction of organic regulated material or total organic compounds (minus methane and ethane) across the device by comparing the total organic compounds (minus methane and ethane) or organic regulated material in all combusted vent
(2) When determining the weight-percent reduction, you must locate the sampling sites for the measurement of total organic regulated material or total organic compound (minus methane and ethane) concentrations, as applicable, at the inlet of the small boiler or process heater such that all vent streams and primary and secondary fuels introduced into the boiler or process heater are included.
(c)
(d)
(e)
(1) Record the fire box temperature measured during the performance test at least every 15 minutes and average the temperature over each run of the performance test.
(2) Record a location description of the vent stream junction into the boiler or process heater.
(f)
(1) Continuous records of the control device operating parameters or emissions specified to be monitored under paragraph (a) of this section, as applicable.
(2) Records of the daily average value, or for batch operations, operating block average value, of each continuously monitored operating parameter or records of continuous emissions according to the procedures specified in § 65.860(a).
(a)
(b)
(c)
(d)
(e)
(1) Continuous records of the control device operating parameters or emissions specified to be monitored under paragraph (a) of this section, as applicable.
(2) Records of the daily average value, or for batch operations, operating block average value, of each continuously monitored operating parameter or records of continuous emissions according to the procedures specified in § 65.860(a).
(a)
(1) You must conduct sampling and analysis of the catalyst and meet the requirements of paragraphs (a)(1)(i) through (iv) of this section.
(i) You must determine a schedule for conducting sampling and analysis of the catalyst, based upon the expected degradation rate of the catalyst, and following the manufacturer's or catalyst supplier's recommended procedures for sampling and analysis.
(ii) The catalyst sampling and analysis schedule must be included in the performance test plan specified in § 65.820(b) and approved by the Administrator.
(iii) If results from the catalyst sampling and analysis indicate that your catalyst will become inactive in 18 months or less, you must replace the catalyst bed or take other corrective action consistent with the manufacturer's recommendations within 3 months before the catalyst is anticipated to become inactive or within half the time available between receiving the catalyst activity report and when the catalyst is expected to become inactive, whichever is less. Additionally, you must determine if a more frequent catalyst replacement schedule is necessary.
(iv) If you replace the catalyst bed with a catalyst different from the
(2) You must conduct annual internal inspections of the catalyst bed to check for fouling, plugging, mechanical breakdown, channeling, abrasion and settling, and follow the procedures specified in paragraph (a)(2)(i) through (iii) of this section.
(i) If indications of fouling, plugging, mechanical breakdown, channeling, abrasion or settling are found during the internal inspection of the catalyst, you must replace the catalyst bed or take other corrective action consistent with the manufacturer's recommendations.
(ii) If you find any of these issues during the annual inspection, then you must increase your inspection frequency to semi-annual. You must increase the inspection frequency from semi-annual to quarterly, and quarterly to monthly, if you find any issues requiring corrective action during the semi-annual or quarterly inspection. You may return the inspection frequency to the next less stringent frequency level when no issues are found during an inspection.
(iii) If you replace the catalyst bed with a catalyst different from the catalyst used during the performance test, you must conduct a new performance test according to paragraph (b) of this section.
(b)
(c)
(d)
(e)
(1) Continuous records of the control device operating parameters or emissions specified to be monitored under paragraph (a) of this section, as applicable.
(2) Records of the daily average value, or for batch operations, operating block average value, of each continuously monitored operating parameter or records of continuous emissions according to the procedures specified in § 65.860(a).
(f)
(a) You must submit a statement that the emission stream is connected to the fuel gas system in the Notification of Compliance Status Report, as required, pursuant to § 65.880(b).
(b) You must meet the requirements of subpart J of this part for all components of a fuel gas system.
(c) If you have small boilers or process heaters that are part of a fuel gas system, you must also comply with the provisions of § 65.724 for the small boilers or process heaters.
(d) You must not route halogenated vent streams to a fuel gas system unless the requirements of § 65.702(d) are met.
(a)
(b)
(c)
(1) For an absorber, the design evaluation must consider the vent stream composition, constituent concentrations, liquid-to-gas ratio, absorber liquid flow rate and concentration, temperature, pressure drop and the reaction kinetics or absorption characteristics of the constituents with the scrubbing liquid. The design evaluation must establish the design exhaust vent stream organic compound concentration level.
(2) For tray and packed column absorbers, the design evaluation must consider the characteristics specified in paragraph (c)(1) of this section, in addition to type and total number of theoretical and actual trays, type and total surface area of packing for the entire column and type and total surface area for individual packed sections if the column contains more than one packed section.
(d)
(1) The absorber influent liquid flow rate or liquid-to-gas ratio measured during the performance test. Record the influent liquid flow rate or liquid-to-gas ratio at least every 15 minutes and average the flow rate or liquid-to-gas ratio over each run of the performance test.
(2) If applicable, the pressure drop through the absorber, the pH of the absorber liquid effluent, exit gas temperature, inlet gas temperature, specific gravity, liquid feed pressure, oxidation chemical flow rate and/or the oxidation chemical strength of the absorber liquid influent measured during the performance test. Record the pressure drop through the absorber, the pH of the absorber liquid effluent, exit gas temperature, inlet gas temperature, specific gravity, liquid feed pressure, oxidation chemical flow rate and/or the
(e)
(1) Continuous records of the control device operating parameters or emissions specified to be monitored under paragraph (a) of this section, as applicable.
(2) Records of the daily average value, or for batch operations, operating block average value, of each continuously monitored operating parameter or records of continuous emissions according to the procedures specified in paragraph § 65.860(a).
(a)
(b)
(c)
(d)
(1) You must measure the concentration using the method that you used to establish the maximum normal concentration, and the method must be one of the methods specified in paragraphs (d)(1)(i) through (iii) of this section. You must use Method 1 or 1A at 40 CFR part 60, appendix A-1 to select the sampling location, which should be at the centrally located 10-percent area of the stack or sample port cross-section.
(i) Use chromatographic analysis by using Method 18 at 40 CFR part 60, appendix A. Calibrate the instrument following the procedures described in EPA Method 18 using a calibration gas or gas mixture containing the compounds present in the adsorber vent gas that can be measured by the method.
(ii) Use a portable analyzer, in accordance with Method 21 at 40 CFR part 60, appendix A-7, for open-ended lines. Where EPA Method 21 uses the term “leak definition,” you must substitute the term “maximum normal concentration.” Calibrate the instrument following the procedures described in EPA Method 21 using one of the calibration gases specified in paragraphs (d)(1)(ii)(A) through (D) of this section.
(A) A calibration gas or gas mixture representative of the normal compound(s) present in the adsorber vent gas.
(B) Propane.
(C) Methane.
(D) Isobutylene.
(iii) Use a flame ionization analyzer by using Method 25A at 40 CFR part 60, appendix A-7. Calibrate the instrument following the procedures described in EPA Method 25A using propane.
(2) You must establish a maximum normal concentration for each adsorber bed vent gas, as specified in paragraphs (d)(2)(i) through (iv) of this section.
(i) For each adsorber bed, measure the outlet volatile organic compound or regulated material concentration weekly, as specified in paragraph (d) of this section, during the last 5 minutes of the adsorption cycle for at least 8 weeks. These measurements must be taken within a 90-day time period.
(ii) Calculate the average outlet concentration for each adsorber bed as the average of the outlet concentrations measured, as required in paragraph (d)(2)(i) of this section.
(iii) Determine maximum normal concentration for each adsorber bed as the 99th percentile confidence level using the one-sided z-statistic test described in Equation 1 of this section.
(iv) You must reestablish your maximum normal concentration for an adsorber bed according to paragraphs (d)(2)(i) through (iii) of this section each time you replace the adsorbent in an adsorber bed.
(e)
(1) Analyze the adsorber inlet vent to determine if inlet concentrations are in the expected range.
(2) Obtain samples at other locations in the system to determine if conditions are normal.
(3) Verify the system temperatures, regeneration stream mass and other operational parameters are within normal ranges.
(4) Test the operation of valves in the system, verify the valves are working as intended and not allowing gas to pass through when closed.
(5) Obtain a sample of the carbon to check for bed poisoning or deterioration of the carbon.
(6) Replace the adsorbent in the adsorber bed with fresh adsorbent.
(f)
(g)
(h)
(1) For non-vacuum regenerative adsorbers, you must record the total regeneration stream mass flow during each adsorber bed regeneration cycle during the period of the performance test, and temperature of the adsorber bed after each regeneration during the period of the performance test (and within 15 minutes of completion of any cooling cycle or cycles).
(2) For non-vacuum regeneration adsorbers, you must record the adsorber bed temperature during regeneration, except for any temperature regulating (cooling or warming to bring bed temperature closer to vent gas temperature) portion of the regeneration cycle.
(3) For vacuum regenerative adsorbers, you must record the vacuum profile over time during each regeneration cycle, and the period of time the vacuum level is below the minimum target level during the period of the performance test.
(4) You must record regeneration frequency and duration during the period of the performance test.
(5) You must record the observations of the verification of the adsorber operation during the period of the performance test.
(i)
(1) Continuous records of the control device operating parameters and emissions required to be monitored under paragraph (b) of this section, as applicable.
(2) Records of the daily average value, or for batch operations, operating block average value, of each continuously monitored operating parameter or records of continuous emissions according to the procedures specified in § 65.860(a).
(j)
(1) The corrective action plan required in paragraph (e) of this section.
(2) For the adsorber verification required in paragraph (c) of this section, you must maintain daily records of the verification inspections, including the visual observations and/or any activation of an automated alarm or shutdown system with a written entry into a log book or other permanent form of record.
(3) For the monitoring required in paragraph (d) of this section, you must record the weekly volatile organic compound or regulated material outlet concentration observed over the last 5 minutes of the adsorption cycle for each adsorber bed.
(4) If the measured concentration obtained during the monitoring required in paragraph (d) of this section is greater than the maximum normal concentration for 3 consecutive weekly measurements, you must keep a record of these periods, including the date of the third measurement and the date and time when the concentration becomes less than the maximum normal concentration, or when the adsorbent is replaced.
(5) You must keep records of the measurements used to determine the maximum normal concentrations established for each adsorber bed.
(6) You must keep records of the date and time the adsorbent is replaced and which adsorbent bed was replaced.
(a)
(1) The first adsorber in series must be replaced immediately when breakthrough, as defined in § 65.295, is detected between the first and second adsorber. The original second adsorber (or a fresh canister) will become the new first adsorber and a fresh adsorber will become the second adsorber. For purposes of this paragraph, “immediately” means within 8 hours of the detection of a breakthrough for adsorbers of 55 gallons or less, and within 24 hours of the detection of a breakthrough for adsorbers greater than 55 gallons.
(2) In lieu of the daily monitoring, as specified in Table 3 to this subpart, you may reduce your monitoring frequency by establishing the average adsorber bed life. To establish the average adsorber bed life, you must conduct daily monitoring of the outlet volatile organic compound or regulated material concentration of the first adsorber bed in series until breakthrough, as defined in § 65.295, occurs for the first three adsorber bed change-outs. You must re-establish an average adsorber bed life if you change the adsorbent brand or type,
(i) You may conduct monthly monitoring if the adsorbent has more than 2 months of life remaining, based on the average adsorber bed life, as established in paragraph (a)(2) of this section, and the date the adsorbent was last replaced.
(ii) You may conduct weekly monitoring if the adsorbent has more than 2 weeks of life remaining, based on the average adsorber bed life, established in paragraph (a)(2) of this section, and the date the adsorbent was last replaced.
(b)
(c)
(d)
(e)
(1) Continuous records of the control device operating parameters or emissions specified to be monitored under paragraph (a) of this section, as applicable.
(2) Records of the daily average value, or for batch operations, operating block average value, of each continuously monitored operating parameter or records of continuous emissions according to the procedures specified in § 65.860(a).
(f)
(1) Records of the date and time you replace the adsorbent.
(2) If you conduct monitoring less frequently than daily, as specified in Table 2 to this subpart, you must record the average life of the bed.
(a)
(b)
(c)
(1) The design evaluation must consider the vent stream flow rate, relative humidity, temperature and conditions under which entrainment of the condensing liquid could occur, and must establish the design outlet organic regulated material compound concentration level, design average temperature of the condenser exhaust vent stream and the design average temperatures of the coolant fluid at the condenser inlet and outlet.
(2) You must establish your operating limit for temperature of the condensate receiver and calculate the resulting regulated material concentration using the methodologies in § 65.835(d) to demonstrate compliance with the emissions standard of the referencing subpart.
(d)
(1) Continuous records of the control device operating parameters or emissions specified to be monitored under paragraph (a) of this section, as applicable.
(2) Records of the daily average value, or for batch operations, operating block average value, of each continuously monitored operating parameter or records of continuous emissions according to the procedures specified in § 65.860(a).
(e)
(a)
(b)
(1) The operating temperature limit must be based on only the temperatures measured during the performance test; these data may not be supplemented by engineering assessments or manufacturer's recommendations, as otherwise allowed in § 65.713(a).
(2) You may expand the biofilter bed temperature operating limit by conducting a repeat performance test that demonstrates compliance with the percent reduction requirement or outlet concentration limit, as applicable.
(3) You must conduct a repeat performance test using the applicable methods specified in § 65.825 within 2 years following the previous
(c)
(d)
(e)
(f)
(1) Continuous records of the control device operating parameters or emissions specified to be monitored under paragraph (a) of this section, as applicable.
(2) Records of the daily average value, or for batch operations, operating block average value, of each continuously monitored operating parameter or records of continuous emissions according to the procedures specified in § 65.860(a).
(a)
(b)
(c)
(1) You must conduct the performance test at the outlet of the fabric filter used for sorbent collection.
(2) If the sorbent is replaced with a different brand and type of sorbent that was used during the performance test, you must conduct a new performance test.
(d)
(1) For a sorbent injection system, the design evaluation must consider the vent stream flow rate and temperature, levels of regulated materials to be adsorbed in the vent stream, sorbent type and brand, sorbent mass injection rate, sorbent injection carrier gas system, design of the injection system, location of sorbent injection site, downstream collection device (fabric filter or other device to capture the sorbent), residence time of the gas-sorbent mixture and contact characteristics of the gas-sorbent mixture.
(2) For a sorbent injection system that is controlling dioxins, furans, total hazardous air pollutants (HAP) or total organic HAP, as specified in Table 2 to this subpart, you must consider the temperature in the combustion device and in any particulate control devices upstream of injection system.
(e)
(1) Record the brand and type of sorbent used during the performance test.
(2) If you have chosen to monitor operating parameters in Table 2 to this subpart, you must record the parameters, as specified in paragraphs (e)(2)(i) through (iii) of this section, as applicable.
(i) Record the rate of sorbent injection measured during the performance test at least every 15 minutes and average the injection rate over each run of the performance test.
(ii) Record the carrier gas flow rate measured during the performance test at least every 15 minutes and average the flow rate over each run of the performance test.
(iii) Record the temperature downstream of the combustion device and/or downstream of any particulate control devices, as applicable, measured during the performance test. Record the temperature(s) at least every 15 minutes and average the temperature(s) over each run of the performance test.
(f)
(1) Continuous records of the control device operating parameters or emissions specified to be monitored under paragraph (b) of this section, as applicable.
(2) Records of the daily average value, or for batch operations, operating block average value, of each continuously monitored operating parameter or records of continuous emissions according to the procedures specified in § 65.860(a).
(g)
(a) Fabric filter monitoring. You must equip fabric filters with a bag leak detection system that is installed, calibrated, maintained and continuously operated according to the requirements in paragraphs (a)(1) through (10) of this section. Monitoring systems associated with bag leak detection are also subject to the requirements of § 65.710.
(1) Install a bag leak detection sensor(s) in a position(s) that will be representative of the relative or absolute particulate matter loadings for each exhaust stack, roof vent or compartment (
(2) Use a bag leak detection system certified by the manufacturer to be capable of detecting particulate matter emissions at concentrations of 1 milligram per actual cubic meter (0.00044 grains per actual cubic foot) or less.
(3) Conduct a performance evaluation of the bag leak detection system in accordance with paragraph (b) of this section and consistent with the guidance provided in EPA-454/R-98-015 (incorporated by reference, see § 65.265).
(4) Use a bag leak detection system equipped with a device to continuously record the output signal from the sensor.
(5) Use a bag leak detection system equipped with a system that will sound an alarm when an increase in relative particulate material emissions over a preset level is detected. The alarm must be located such that the alert is observed readily by plan operating personnel.
(6) Install a bag leak detection system in each compartment or cell for positive pressure fabric filter systems that do not duct all compartments or cells to a common stack. Install a bag leak detector downstream of the fabric filter if a negative pressure or induced air filter is used. If multiple bag leak detectors are required, the system's instrumentation and alarm may be shared among detectors.
(7) Calibration of the bag leak detection system must, at a minimum, consist of establishing the baseline output level by adjusting the range and the averaging period of the device and establishing the alarm set points and the alarm delay time.
(8) Following initial adjustment, you must not adjust the sensitivity or range, averaging period, alarm set points or alarm delay time, except as established in a CPMS monitoring plan required in § 65.712 and paragraph (e)(1) of this section. In no event may the sensitivity be increased more than 100 percent or decreased by more than 50 percent over a 365-day period unless such adjustment follows a complete baghouse inspection that demonstrates the baghouse is in good operating condition.
(9) Each bag leak detection system must be operated and maintained such that the alarm does not sound more than 5 percent of the operating time during a 6-month period. If the alarm sounds more than 5 percent of the operating time during a 6-month period, it is considered an operating parameter exceedance and, therefore, a deviation, as specified in § 65.710(e)(2). You must calculate the alarm time, as specified in paragraphs (a)(9)(i) through (iv) of this section.
(i) If inspection of the fabric filter demonstrates that no corrective action is required, no alarm time is counted.
(ii) If corrective action is required, each alarm time is counted as a minimum of 1 hour.
(iii) If you take longer than 1 hour to initiate corrective action, each alarm time (
(iv) Your maximum alarm time is equal to 5 percent of the operating time during a 6-month period.
(10) If the alarm on a bag leak detection system is triggered, you must, within 1 hour of an alarm, initiate procedures to identify the cause of the alarm and take corrective action, as specified in the corrective action plan required in paragraph (e)(2) of this section.
(b)
(c)
(d)
(e)
(1) A CPMS monitoring plan, as specified in § 65.712. You must also include performance evaluation procedures and acceptance criteria (
(2) A corrective action plan describing corrective actions to be taken and the timing of those actions when the bag leak detection alarm sounds. You must initiate corrective action no later than 48 hours after a bag leak detection system alarm. Failure to take action within the prescribed time period is considered a deviation. Corrective actions may include, but are not limited to, the actions listed in paragraphs (e)(2)(i) through (vi) of this section.
(i) Inspecting the fabric filter for air leaks, torn or broken bags or filter media, or any other conditions that may cause an increase in regulated material emissions.
(ii) Sealing off defective bags or filter media.
(iii) Replacing defective bags or filter media or otherwise fixing the control device.
(iv) Sealing off a defective fabric filter compartment.
(v) Cleaning the bag leak detection system probe or otherwise fixing the bag leak detection system.
(vi) Shutting down the process producing the regulated material emissions.
(3) Records of any bag leak detection system alarm, including the date, time, duration and the percent of the total operating time during each 6-month period that the alarm sounds, with a brief explanation of the cause of the alarm, the corrective action taken and the schedule and duration of the corrective action.
(f) You must submit analyses and supporting documentation demonstrating conformance with EPA-454/R-98-015 (incorporated by reference, see § 65.265) and specifications for bag leak detection systems as part of the Notification of Compliance Status Report, as required, pursuant to § 65.880(f).
(a)
(1) You must submit to the Administrator for approval the planned operating parameters to be monitored, and the recordkeeping and reporting procedures, as specified in § 65.884(h). You must also include a rationale for the proposed monitoring in your submittal. The Administrator will approve, deny or modify the proposed monitoring, reporting and recordkeeping requirements as part of the review of the plan or through the review of the permit application or by other appropriate means.
(2) If you receive approval from the Administrator for the information required in paragraph (a)(1) of this section, you must then establish an operating limit for the operating parameters that indicates proper operation of the control device. The information required in § 65.880(d) must be submitted in the Notification of Compliance Status Report. The operating limit may be based upon a prior performance test meeting the specifications of § 65.702(e)(4).
(b)
(c)
(d)
(1) You must keep records of the operating parameter(s) monitored, pursuant to the approved plan established in paragraph (a) of this section.
(2) Records of flow/no flow, as provided in § 65.860(i).
For each control device for which a performance test is required, you must conduct a performance test according to the schedule specified by the referencing subpart and the procedures in this section §§ 65.820 through 65.829, as applicable, unless any of the general control measures specified in § 65.702(e) are used. For all performance tests, a notification of the performance test and a performance test plan are also required, as specified in paragraphs (a) through (c) of this section. You must also provide the performance testing facilities, as specified in paragraph (d) of this section.
(a)
(b)
(1) The internal quality assurance program must include, at a minimum, the activities planned by routine operators and analysts to provide an assessment of test data bias and precision; an example of internal quality assurance to measure precision is the sampling and analysis of replicate samples.
(2) You must perform a test method performance audit during the performance test, as specified in § 60.8(g), § 61.13(e), or § 63.7(c)(2)(iii) of this chapter.
(3) You must submit the performance test plan to the Administrator at least 60 calendar days before the performance test is scheduled to take place, that is, simultaneously with the notification of intention to conduct a performance test required under paragraph (a) of this section, or on a mutually agreed upon date.
(4) The Administrator may request additional relevant information after the submittal of a performance test plan.
(5) If you would like to use an alternative test method or a change to a test method, you must follow the requirements of § 65.250, except for minor test method changes. You may propose minor test method changes in your performance test plan. Approval of the test plan is approval of any minor test method changes included in the test plan.
(c)
(1) The Administrator will notify you of approval or intention to deny approval of the performance test plan within 30 calendar days after receipt of the original plan and within 30 calendar days after receipt of any supplementary information that is submitted under paragraph (c)(1)(ii) of this section. An intention to disapprove the plan will include the information provided in (c)(1)(i) and (ii) of this section and will be provided to you before the Administrator disapproves a performance test plan.
(i) Notice of the information and findings on which the intended disapproval is based.
(ii) Notice of opportunity for you to present, within 30 calendar days after you have been notified of the intended disapproval, additional information to the Administrator before final action on the plan.
(2) If the Administrator does not approve or disapprove the performance test plan within the time period specified in paragraph (c)(1) of this section, then you must conduct the performance test within the time specified in this subpart using the specified method(s) and any minor changes to the test methods proposed in the test plan.
(d)
(1) Sampling ports adequate for the applicable test methods, including meeting the provisions of paragraphs (d)(1)(i) and (ii) of this section, as applicable.
(i) Constructing the air pollution control system such that volumetric flow rates and pollutant emission rates can be accurately determined by applicable test methods and procedures; and
(ii) Providing a stack or duct free of cyclonic flow during performance tests, as demonstrated by applicable test methods and procedures.
(2) Safe sampling platform(s).
(3) Safe access to sampling platform(s).
(4) Utilities for sampling and testing equipment.
(5) Any other facilities that the Administrator deems necessary for safe and adequate testing of a source.
You must conduct performance tests under the conditions specified in paragraphs (a) through (d) of this section, as applicable, unless the Administrator specifies or approves alternate operating conditions. Upon request, you must make available to the Administrator such records as may be
(a)
(b)
(c)
(d) You must not conduct a performance test during startup, shutdown, periods when the control device is bypassed or periods when the process, monitoring equipment or control device is not operating properly.
If you choose to conduct testing at absolute worst-case conditions for batch process operations, you must characterize the conditions by the criteria presented in paragraph (a) of this section. If you choose to conduct testing at hypothetical worst-case conditions for batch process operations, you must characterize the conditions by the criteria presented in paragraph (b) of this section. In all cases, a performance test plan must be submitted to the Administrator for approval prior to testing in accordance with § 65.820(a) through (d). The performance test plan must include the emission profile described in paragraph (c) of this section.
(a)
(1) The period in which the inlet to the control device will contain the maximum projected regulated material load and will always contain at least 50 percent of the maximum regulated material load (in pounds) capable of being vented to the control device over any 8-hour period. An emission profile, as described in paragraph (c)(1) of this section, must be used to identify the 8-hour period that includes the maximum projected regulated material load.
(2) A 1-hour period of time in which the inlet to the control device will contain the highest regulated material mass loading rate, in lb/hr, capable of being vented to the control device. An emission profile, as described in paragraph (c)(1) of this section, must be used to identify the 1-hour period of maximum regulated material loading.
(3) The period of time when the regulated material loading or stream composition (including non-regulated material) is most challenging for the control device. These conditions include, but are not limited to, paragraphs (a)(3)(i) through (iii) of this section.
(i) Periods when the stream contains the highest combined regulated material load, in lb/hr, described by the emission profiles in paragraph (c) of this section.
(ii) Periods when the stream contains regulated material constituents that approach limits of solubility for scrubbing media.
(iii) Periods when the stream contains regulated material constituents that approach limits of adsorptivity for adsorption systems.
(b)
(c)
(1)
(2)
(3)
You must conduct the applicable sampling, as specified in paragraphs (a) through (d) of this section.
(a) You must use Method 1 or 1A at 40 CFR part 60, appendix A-1, as appropriate, to select the sampling sites.
(1) For determination of compliance with a percent reduction requirement of regulated material or total organic compounds, sampling sites must be located at the outlet of the control device, and with the exception noted in § 65.724(b)(2), the control device inlet sampling site must be located at the exit from the unit operation before any control device.
(2) For determining compliance with a ppmv total regulated material or total organic compounds emissions limit in a referencing subpart, the sampling site
(3) For determining compliance with an emission limit requirement of a vent stream halogen atom mass emission rate prior to a combustion device, or to demonstrate that a vent stream is not halogenated, pursuant to § 65.702(c), collect samples prior to the combustion device.
(b) For determining compliance with percent reduction emission limits, you must collect samples simultaneously at the inlet and outlet of the control device during the performance test.
(c) For correcting concentrations to specified percent oxygen, the sampling site for the measurement of oxygen concentration must be the same as that of the regulated material samples, and the samples must be taken concurrently.
(d) For each test run, you must take either real-time measurements, an integrated sample or a minimum of four grab samples per hour. If grab sampling is used, then the samples must be taken at approximately equal intervals in time, such as 15-minute intervals during the run.
(a) Except as provided in paragraph (c) of this section, for continuous process operations, a performance test must consist of three runs of at least 1 hour in length; and must be conducted under the conditions specified in § 65.821(a).
(b) Except as provided in paragraph (c) of this section, for batch process operations, a performance test must consist of three runs; and must be conducted under the conditions specified in § 65.821(b). Each run must occur over the same absolute or hypothetical worst-case conditions, as defined in § 65.822, and be tested over the length of the episode, at a minimum of 1 hour and not to exceed 8 hours.
(c) For control devices used to control emissions from transfer racks (except low throughput transfer racks that are capable of continuous vapor processing, but do not handle continuous emissions or multiple loading arms of a transfer rack that load simultaneously), each run must represent at least one complete tank truck or tank car loading period, during which regulated materials are loaded.
You must conduct the performance test using the applicable test methods and procedures specified in Table 5 to this subpart and paragraphs (a) through (e) of this section, as applicable, unless you request an alternative test method or a change to a test method, as specified in § 65.250.
(a) If you use ASTM D6420-99(2010), “Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry” (incorporated by reference, see § 65.265) in lieu of Method 18 at 40 CFR part 60, appendix A-6 or Method 320 at 40 CFR part 63, appendix A to measure specific organic regulated material compound concentration, as applicable, at the inlet and/or outlet of a control device, then you must meet the conditions specified in paragraphs (a)(1) through (3) of this section.
(1) The target compound(s) must be listed in Section 1.1 of ASTM D6420-99 (2010), “Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry” (incorporated by reference, see § 65.265), and the target concentration is between 150 parts per billion by volume and 100 ppmv.
(2) If one (or more) target compound(s) is not listed in Section 1.1 of ASTM D6420-99 (2010), “Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry” (incorporated by reference, see § 65.265), but is potentially detected by mass spectrometry, an additional system continuing calibration check after each run, as detailed in Section 10.5.3 of ASTM D6420-99, must be followed, met, documented and submitted with the performance test report, even if a moisture condenser is not used or the compound is not considered soluble.
(3) A minimum of one sample/analysis cycle must completed at least every 15 minutes.
(b) If using Method 25A at 40 CFR part 60, appendix A-7 to determine compliance with a total organic compounds outlet concentration or percent reduction limit specified in a referencing subpart, you must follow the procedures in paragraphs (b)(1) through (3) of this section.
(1) Calibrate the instrument on propane.
(2) When demonstrating compliance with an outlet concentration emission limit specified in the referencing subpart, you must use a span value of the analyzer between 1.5 and 2.5 times the applicable emission limit in the referencing subpart. When demonstrating compliance with a percent reduction by making measurements at the inlet and outlet of the control device, you must use a span value of the analyzer of between 1.5 and 2.5 times the highest expected total organic compounds concentration at each location.
(3) Report the results as carbon, calculated according to Equation 25A-1 of Method 25A at 40 CFR part 60, appendix A-7.
(c) If you are using Method 320 at 40 CFR part 63, appendix A, pursuant to Table 5 to this subpart, you must follow the validation procedure of section 13.0 of EPA Method 320 unless the validation procedure was conducted at another source and it can be shown that the exhaust gas characteristics are similar at both sources. When demonstrating compliance with an emission limit for hydrogen halides and halogens, EPA Method 320 may only be used if you can show that there are no diatomic halogen molecules present in the vent stream being tested.
(d) If the uncontrolled or inlet gas stream to the control device contains formaldehyde, you must conduct emissions testing according to paragraph (d)(1) or (2) of this section.
(1) If you elect to comply with a percent reduction requirement and formaldehyde is the principal regulated material compound (
(2) If you elect to comply with an outlet total organic regulated material concentration or total organic compounds concentration limit, and the uncontrolled or inlet gas stream to the control device contains greater than 10 percent (by volume) formaldehyde, you must use Method 320 at 40 CFR part 63, appendix A, to determine the formaldehyde concentration, unless the vent stream being tested has entrained water droplets. If the vent stream contains entrained water droplets, you must use EPA Method 316 instead of EPA Method 320 to measure formaldehyde concentration. Calculate the total organic regulated material concentration or total organic compounds concentration by totaling the formaldehyde emissions measured using EPA Method 316 or EPA Method 320 and the other regulated material
(e) If the uncontrolled or inlet gas stream to the control device contains carbon disulfide, you must conduct emissions testing according to paragraph (e)(1) or (2) of this section.
(1) If you elect to comply with a percent reduction requirement and carbon disulfide is the principal regulated material compound (i.e., the highest concentration for any regulated compound in the stream by volume), you must use Method 18 at 40 CFR part 60, appendix A-6 or Method 15 at 40 CFR part 60, appendix A-5, to measure carbon disulfide at the inlet and outlet of the control device. Use the percent reduction in carbon disulfide as a surrogate for the percent reduction in total regulated material emissions.
(2) If you elect to comply with an outlet total organic regulated material concentration or total organic compounds concentration limit, and the uncontrolled or inlet gas stream to the control device contains greater than 10 percent (by volume) carbon disulfide, you must use Method 18 at 40 CFR part 60, appendix A-6 or Method 15 at 40 CFR part 60, appendix A-5, to determine the carbon disulfide concentration. Calculate the total organic regulated material concentration or total organic compounds concentration by totaling the carbon disulfide emissions measured using Method 15 at 40 CFR part 60, appendix A-5 or Method 18 at 40 CFR part 60, appendix A-6 and the other regulated material compound emissions measured using Method 18 at 40 CFR part 60, appendix A-6, or Method 25A at 40 CFR part 60, appendix A-7, Method 320 at 40 CFR part 63, appendix A or ASTM D6420-99(2010), “Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry” (incorporated by reference, see § 65.265), as applicable.
(f) You must not use Method 26 at 40 CFR part 60, appendix A-8, to test gas streams with entrained water droplets.
Use the procedures specified in paragraph (a) of this section to calculate ppmv concentration. The calculated concentration must be corrected to a standard percent oxygen, if required by the referencing subpart, using the procedures specified in paragraph (b) of this section.
(a)
(1) The total organic compounds concentration (CTOC) is the sum of the concentrations of the individual components and must be computed for each run using Equation 2 of this section.
(2) You must compute the total organic regulated material (CREG) according to Equation 2 of this section except that you need only sum the regulated species.
(b)
(1) Determine the concentration corrected to a standard percent oxygen (Cc) specified by the referencing subpart, using Equation 3 of this section.
(2) For batch process operations, correct the measured concentration for any supplemental gases using Equation 4 of this section.
(a) To demonstrate compliance with a percent reduction requirement for a control device specified in a referencing subpart, you must comply with § 65.828.
(b) To meet a process aggregated percent reduction emission requirement specified in a referencing subpart for a batch process, you must follow the provisions, as specified in § 65.835.
(c) For combined streams of continuous and batch process operations subject to a process aggregated percent reduction emission requirement in a referencing subpart, you must demonstrate that the control device meets the percent reduction requirements for both batch and continuous process operations by following the provisions specified in §§ 65.828 and 65.835.
To determine a percent reduction for a control device, you must use the procedures specified in paragraphs (a) and (b) of this section. For small boilers and process heaters, you must follow the provisions of § 65.724(b)(1) and (2).
(a)
(b)
You must conduct a performance test, pursuant to § 65.820, and follow the procedures in paragraphs (a) through (d) of this section, as applicable, when determining compliance with a hydrogen halide and halogen emission limit specified in a referencing subpart.
(a) To determine compliance with a halogen atom mass emission rate emission limit requirement, you must use Equation 8 of this section to calculate the mass emission rate of halogen atoms:
(b) Calculate the mass emissions rate of each hydrogen halide and halogen compound as the summation of the measured concentrations and the gas stream flow rate, as shown in Equations 9 and 10 of this section. To determine compliance with an outlet mass emission rate limit specified in a referencing subpart, only Equation 10 is required.
(c) Calculate the percent reduction of hydrogen halide and halogen compounds using the inlet and outlet mass emission rates calculated in paragraph (b) of this section and Equation 7 of this section.
(d) To demonstrate compliance with a mass rate (
(a) You may conduct an engineering assessment if you perform any of the actions described in paragraphs (a)(1) through (6) of this section.
(1) Determine whether a vent stream is halogenated, as specified in § 65.702(c)(2).
(2) Supplement your performance test, as specified in § 65.713(a).
(3) Establish your operating limit on ranges or limits previously established under a referencing subpart, as specified in § 65.713(d).
(4) Determine flow rate of a gas stream, as specified in Equation 8 of § 65.829(a).
(5) Calculate regulated material emissions for each emission episode that is not described in Section 3 of EPA EIIP Volume II: Chapter 16 (incorporated by reference, see § 65.265), as specified in § 65.835(b)(2) or § 65.835(d)(3).
(6) Calculate regulated material emissions for each emission episode that you can demonstrate to the Administrator that the emission estimation techniques in Section 3 of EPA EIIP Volume II: Chapter 16 (incorporated by reference, see § 65.265) are not appropriate, as specified in § 65.835(e).
(b) An engineering assessment includes, but is not limited to, the information specified in paragraphs (b)(1) through (4) of this section.
(1) Previous test results, provided the tests are representative of current operating practices at the process unit.
(2) Bench-scale or pilot-scale test data representative of the process under representative operating conditions.
(3) Maximum flow rate, regulated material emission rate, concentration or other relevant parameter specified or implied within a permit limit applicable to the vent stream.
(4) Design analysis, based on accepted chemical engineering principles, measurable process parameters or physical or chemical laws or properties. Examples of analytical methods include, but are not limited to, the methods specified in paragraphs (b)(4)(i) through (iii) of this section.
(i) Use of material balances, based on process stoichiometry to estimate maximum organic regulated material concentrations.
(ii) Estimation of maximum flow rate, based on physical process equipment design such as pump or blower capacities.
(iii) Estimation of regulated material concentrations, based on saturation conditions.
(a)
(b)
(1) Except as provided in paragraph (e) of this section, you must determine uncontrolled emissions of regulated material using measurements and/or calculations for each batch emission episode within each unit operation using the emission estimation techniques described in Section 3 of EPA EIIP Volume II: Chapter 16 (incorporated by reference, see § 65.265). Chemical property data can be obtained from standard reference texts.
(2) You must conduct an engineering assessment according to § 65.830 in order to calculate uncontrolled regulated material emissions for each emission episode that is not described in Section 3 of EPA EIIP Volume II: Chapter 16 (incorporated by reference, see § 65.265). You may also conduct an engineering assessment according to § 65.830 if you meet the requirements of paragraphs (d)(3) or (e) of this section. Data or other information supporting a finding that the emissions estimation equations are inappropriate are subject to preapproval by the Administrator and must be reported in the batch pre-compliance report.
(c)
(d)
(1) Except as provided in paragraph (d)(2) of this section, you must determine controlled emissions from the condenser using calculations for each batch emission episode within each unit operation according to the emission estimation techniques described in Section 3 of EPA EIIP Volume II: Chapter 16 (incorporated by reference, see § 65.265). You must use the temperature and regulated material partial pressures that are determined at the exit temperature and exit pressure conditions of the condenser. Chemical property data can be obtained from standard reference texts.
(2) For heating and depressurization episodes, you must determine controlled emissions from the condenser using the procedures, as specified in paragraphs (d)(2)(i) through (iii) of this section.
(i) You must determine the average molecular weight of regulated material in vapor exiting the receiver using Equation 14 of this section.
(ii) You must determine the number of moles of non-condensable gas displaced from the vessel using Equation 15 of this section for heating episodes; and Equation 16 of this section for depressurization episodes, as applicable.
(iii) You must determine the mass of regulated material emitted from the receiver due to the vessel being heated or depressurized using Equation 17 of this section.
(3) You must conduct an engineering assessment, as specified in paragraph (b)(2) of this section, for each emission episode that is not described in Section 3 of EPA EIIP Volume II: Chapter 16 (incorporated by reference, see § 65.265).
(4) You may elect to conduct an engineering assessment, as specified in paragraph (e) of this section, if you demonstrate to the Administrator that the methods described in paragraphs (d)(1) or (2) of this section are not appropriate.
(e)
(a) For each non-flare control device for which a design evaluation, as allowed by the referencing subpart, is used as an alternative to a performance test, as specified in § 65.702(e)(1), you must conduct the design evaluation according to the procedures in paragraphs (b) through (e) of this section.
(b) You must prepare a design evaluation, as specified in paragraph (c) of this section. Also, unless you are using a CEMS to monitor the emissions to demonstrate compliance with the emission standard of the referencing subpart, you must prepare a monitoring description, as specified in paragraph (d) of this section. The design
(c) The design evaluation must include documentation demonstrating that the control device being used achieves the required emission limit of a referencing subpart. You must identify in the design evaluation, each emission point routed to the control device and the applicable emission limit. The design evaluation must also address the composition of the vent stream entering the control device, including flow and regulated material concentration, and the information specified in paragraphs (c)(1) through (4) of this section and § 65.724(d) for boilers and process heaters, § 65.726(c) for thermal oxidizers, § 65.728(c) for catalytic oxidizers, § 65.740(c) for absorbers, § 65.742(d) for adsorbers regenerated onsite, § 65.744(c) for non-regenerative adsorbers, § 65.746(c) for condensers, § 65.748(d) for biofilters, § 65.760(d) for sorbent injection and § 65.762(c) for fabric filters, as applicable.
(1) For storage vessels, the design evaluation must include documentation demonstrating that the control device being used achieves the required control efficiency during reasonably expected maximum filling rate.
(2) For transfer racks, the design evaluation must demonstrate that the control device achieves the required control efficiency during the reasonably expected maximum transfer loading rate.
(3) For a non-flare control device used to control emissions from batch process operations, establish emission profiles and conduct the evaluation under worst-case conditions, as determined, pursuant to § 65.822.
(4) If the vent stream is not the only inlet to the control device, the efficiency demonstration also must consider all other vapors, gases and liquids other than fuels received by the control device.
(d) The monitoring description must include the information specified in paragraphs (d)(1) and (2) of this section to identify the operating parameters that you will monitor to assure proper operation of the control device such that the control device is meeting the specified emission limit of the referencing subpart.
(1) A description of the operating parameter or parameters to be monitored, an explanation of the criteria used for selection of that parameter (or parameters) and when the monitoring will be performed (
(2) The operating limit, monitoring frequency (
(e) You must operate and maintain the non-flare control device so that the monitored operating parameters, as determined in paragraph (d) of this section, remain within the operating limits specified in the Notification of Compliance Status whenever emissions of regulated material are routed to the control device.
(a)
(1) Except as specified in paragraphs (a)(2) through (4) of this section, daily average values of continuously monitored emissions and operating parameters must be calculated for each operating day using all continuously monitored data, except the data specified in paragraph (b) of this section must be excluded from the average. The operating day must be the period defined in the operating permit or in the Notification of Compliance Status.
(2) For batch process operations and as an alternative to the requirement for daily averages in paragraph (a)(1) of this section, you may determine averages for operating blocks while excluding the data specified in paragraph (b) of this section.
(3) If all values of a monitored operating parameter, during an operating day or operating block, are below the operating limit established, pursuant to § 65.713, you do not have to calculate the daily average for the operating parameter. In such cases, you may not discard the recorded values, as allowed in § 65.860(a)(2).
(4) If all values of monitored continuous emissions, during an operating day or operating block, reduced, as specified in § 65.711(j), are below the emission limit specified in the referencing subpart, you do not have to calculate the daily or block average of the emissions. In such cases, you may not discard the recorded values, as allowed in § 65.860(a)(2).
(b)
(1) Periods of non-operation of the process unit (or portion thereof), resulting in cessation of the emissions to which the monitoring applies.
(2) Periods of no flow to a control device, as recorded, pursuant to paragraph § 65.860(i).
(3) Any monitoring data recorded during CEMS or CPMS system breakdowns, out-of-control periods, repairs, maintenance periods, instrument adjustments or checks to maintain precision and accuracy, calibration checks, and zero (low-level), mid-level (if applicable) and high-level adjustments.
(c)
(a)
(1) Except as provided in paragraph (a)(2) of this section, you must maintain a record of each measured value measured at least once every 15 minutes.
(2) Except as provided in paragraph (a)(3) of this section, or in § 65.855(a)(4) through (6), you may calculate and record block hourly average values calculated, as specified in § 65.855(c) and discard all but the most recent 3 hours of continuous (15-minute or shorter) records that do not include deviations that are specified in § 65.710(e). If you select this method for retaining monitoring data, you must also meet the provisions of paragraphs (a)(2)(i) through (iii) of this section.
(i) You must retain a file that contains a hard copy of the data acquisition
(ii) The 1-hour averages may include measurements taken during periods of CEMS or CPMS system breakdowns, out-of-control periods, repairs, maintenance periods, instrument adjustments or checks to maintain precision and accuracy, calibration checks, and zero (low-level), mid-level (if applicable) and high-level adjustments. However, you must not include these periods for any average computed to determine compliance, as specified in § 65.855(a).
(iii) A record must be maintained stating whether the calculated 1-hour averages include, or do not include, measurements taken during periods of CEMS or CPMS breakdowns, out-of-control periods, repairs, maintenance periods, instrument adjustments or checks to maintain precision and accuracy, calibration checks, and zero (low-level), mid-level (if applicable) and high-level adjustments.
(3) The Administrator, upon notification to you, may require you to maintain all measurements, as required by paragraph (a)(1) of this section, if the Administrator determines these records are required to more accurately assess the compliance status of the regulated source.
(4) You must keep records of all applicable daily and operating block averages, as calculated, pursuant to § 65.855(a).
(5) You must keep records of periods of operation during which the daily average of monitored operating parameters, calculated as specified in § 65.855(a), is outside the operating limits established, pursuant to § 65.713.
(6) You must keep records of periods of operation during which the daily average of continuous emissions, calculated as specified in § 65.855(a), is above the emission standard specified in the referencing subpart.
(b)
(c)
(1) The records specified in § 65.724(e) for boilers and process heaters, § 65.726(d) for thermal oxidizers, § 65.728(d) for catalytic oxidizers, § 65.740(d) for absorbers, § 65.742(h) for adsorbers regenerated onsite, § 65.744(d) for non-regenerative adsorbers, § 65.746(e) for condensers, § 65.748(e) for biofilters, § 65.760(e) for sorbent injection, § 65.762(d) for fabric filters and § 65.800(c) for other control devices.
(2) The concentration of regulated material or total organic compounds (ppmv, by compound), as applicable, at the outlet of the control device, as specified in § 65.826; or the percent reduction of regulated material or total organic compounds, as applicable, achieved by the control device, as specified in § 65.828.
(3) You must retain copies of the performance test reports during the period that the performance tests are applicable to the operating limits being complied with and 5 years after the time they become obsolete. A complete test report must include the items listed in paragraphs (c)(3)(i) through (xvii) of this section. A performance test is “completed” when field sample collection is terminated.
(i) The purpose of the test.
(ii) A brief process description.
(iii) A complete unit description, including a description of feed streams and control devices.
(iv) Sampling site description.
(v) Pollutants measured.
(vi) Description of sampling and analysis procedures and any modifications to standard procedures.
(vii) Quality assurance procedures.
(viii) Record of operating conditions during the test, including the records required by paragraph (c)(1) of this section.
(ix) Record of preparation of standards.
(x) Record of calibrations.
(xi) Raw data sheets for field sampling.
(xii) Raw data sheets for field and laboratory analyses.
(xiii) Chain-of-custody documentation.
(xiv) Explanation of laboratory data qualifiers.
(xv) Example calculations of all applicable stack gas parameters, emission rates, percent reduction rates and analytical results, as applicable.
(xvi) Any other information required by the test method or the Administrator.
(xvii) Any additional information necessary to determine the conditions of performance tests.
(d)
(1) The CEMS performance evaluation and monitoring plan and the CPMS monitoring plan, as applicable, developed and implemented, as specified in §§ 65.711 and 65.712, respectively.
(2) Results of all CEMS evaluations, as specified in the CEMS performance evaluation and monitoring plan and, as specified in § 65.711, including the information listed in paragraphs (d)(2)(i) through (v) of this section.
(i) Raw CEMS evaluation measurements.
(ii) All measurements necessary to determine the conditions of the CEMS evaluation.
(iii) Raw performance testing measurements associated with relative accuracy tests and audits.
(iv) Cylinder gas certifications.
(v) Information specified to be recorded in the applicable performance specification.
(3) Records of all calibrations, certifications, audits, adjustments and other quality control procedures required in the CEMS performance evaluation and monitoring plan or CPMS monitoring plan.
(4) If you use more than one CEMS to measure the regulated materials from one emissions unit (
(e)
(1) A description of the process and the type of process equipment used, including a description of storage vessels, wastewater, transfer operations or heat exchangers that are subject to this subpart.
(2) An identification of related vent streams, including, for batch operations, their associated emissions episodes.
(3) The applicable control requirements of this subpart, including the level of required control for each emission point.
(4) The control device(s) and/or methods used on each regulated emission point to meet the emission standard, including a description of the operating conditions of the control device.
(5) Combined emissions that are routed to the same control device.
(6) The applicable monitoring requirements of this subpart and the operating limit(s) that apply for each emission point routed to the control device.
(7) Calculations and engineering analyses required to demonstrate compliance.
(8) Actual total monthly process operating time.
(f)
(1) You must keep a schedule or log of operating scenarios, updated each time you put a different operating scenario into effect. You must maintain records in your daily schedule or log of processes indicating each point at which an emission episode with a different operating limit begins and ends, even if the duration of the emission episode and the monitoring for an operating limit is less than 15 minutes.
(2) For each operating scenario, you must record a justification demonstrating that the operating limit selected for the operating scenario (or operating limits selected for the individual emission episodes of the operating scenario) will not result in emissions in excess of the emissions standards. All calculations and engineering analyses performed to develop the operating limits must be included in the records. For the purposes of this paragraph, a revised operating scenario for an existing process is considered a different operating scenario when one or more of the data elements listed in paragraphs (e)(1) through (7) of this section have changed.
(3) You must keep records of all emission profiles you develop according to § 65.822(c). You must include descriptions and documentation of worst-case operating and/or testing conditions for control devices.
(4) Calculations used to demonstrate compliance according to §§ 65.820 through 65.829 and, if applicable, § 65.835. You must include data and rationale used to support an engineering assessment to calculate uncontrolled emissions in accordance with § 65.835(b)(2), if applicable.
(5) You must keep records of the information specified in paragraphs (f)(5)(i) and (ii) of this section for the collection of all batch vent streams at the regulated source in compliance with an aggregated percent reduction emission limit specified in the referencing subpart if some of the vents are controlled to less than the percent reduction requirement.
(i) Records of each batch operated and whether it was considered a standard or nonstandard batch.
(ii) The estimated uncontrolled and controlled emissions for each nonstandard batch.
(g)
(h)
(1) All times when flow was detected in the bypass line, the vent stream was diverted from the control device or the flow indicator was not operating, as specified in § 65.720(d)(1).
(2) All occurrences of periods when a bypass of the system was indicated (the seal mechanism is broken, the bypass line valve position has changed, or the key for a lock-and-key type lock has been checked out and records of any car-seal that has been broken), as specified in § 65.720(d)(2).
(i)
(j)
(1) Periods of excess emissions.
(2) Periods when the daily average of an operating parameter is outside the established operating limit.
(3) Periods when CEMS or CPMS are out-of-control.
(4) Periods when a CEMS or CPMS is not operating properly or is inoperative, except for zero (low-level), mid-level (if applicable) and high-level checks.
(5) Periods when the process is not operating properly.
(6) Periods when a control device is not working properly.
(k)
(l)
(m)
(n)
(o)
You must include the information listed in paragraphs (a) through (g) of this section, as applicable, in the Notification of Compliance Status that you submit according to the procedures in § 65.225.
(a)
(b)
(c)
(1) The design evaluation and monitoring description specified in § 65.850(c) and (d), respectively.
(2) Any data and calculations used to select the operating parameters and establish the operating limits specified in 65.850(d).
(3) The information specified in paragraphs (d)(3) and (4) of this section, as applicable.
(d)
(1) The operating limit and averaging time for each operating parameter identified for each control device, as determined, pursuant to § 65.713 or § 65.884(h), and the emission point(s) routed to each control device.
(2) The rationale for the established operating limit for each operating parameter for each emission point, including any data and calculations used to develop the operating limit and a description of why the operating limit indicates proper operation of the control device.
(3) A definition of the source's operating day for purposes of determining daily average values of monitored operating parameters. The definition must specify the times at which an operating day begins and ends. The operating day must cover a 24-hour period if operation is continuous. It may be from midnight to midnight or another daily period. For batch process operations, you may define the operating blocks, as specified in § 65.295, instead of an operating day.
(e)
(f)
(g)
You must include the information listed in paragraphs (a) through (e) of this section, as applicable, in the semiannual periodic report that you submit, according to the procedures in § 65.225.
(a) The beginning and ending dates of the reporting period and the total operating time of the regulated source during the reporting period.
(b) For any information reported in a semiannual periodic report, provide the identification of the process unit and/or emission unit the information, using the same terminology and identification numbers used in the Notification of Compliance Status or subsequent periodic report.
(c) For CEMS and CPMS, include the information specified in paragraphs (c)(1) through (6) of this section, as applicable.
(1) For each period when a CEMS or CPMS is out of control, inoperative or not operating properly, include the date, the start time and the stop time of the period.
(2) For each period when your CEMS or CPMS data does not meet the data availability requirements defined in § 65.710(e)(4) and (5), include the date, the start time and the stop time of the period.
(3) The daily average emission value, as calculated in § 65.855, for each day when the calculated daily average emission value indicated excess emissions, include the date, the start time and the stop time of the period.
(4) The block average emission value, as calculated in § 65.855, for each block when the calculated block average value indicated excess emissions, include the date, the start time and the stop time of the period.
(5) The daily average value of each monitored operating parameter, as calculated in § 65.855, that is outside the operating limit established according to § 65.713 and documented in your Notification of Compliance Status or subsequent periodic report, include the date, the start time and the stop time of the period.
(6) The block average value of each monitored operating parameter, as calculated in § 65.855, that is outside the operating limit established according to § 65.713 and documented in your Notification of Compliance Status or subsequent periodic report, include the date, the start time and the stop time of the period.
(d) For closed vent systems, include the records of periods when vent steam flow was detected in the bypass line or diverted from the control device, a flow indicator was not operating or a bypass of the system was indicated, as specified in § 65.860(h).
(e) All records of daily and operating block averages, required in § 65.860(a)(4).
You must submit the reports specified in paragraphs (a) through (j) of this section, as applicable, according to the procedures in § 65.225. You must provide the identification of the process unit and/or emission unit information, using the same terminology and identification numbers used in the Notification of Compliance Status or subsequent report.
(a)
(b)
(c)
(1) If you are conducting a performance test, you must submit the notification and plan simultaneously with the notification of the performance test date required in paragraph (a) of this section.
(2) If you are not conducting a performance test, you must submit the notification and plan at least 60
(3) If you are unable to conduct the CEMS performance evaluation on the date specified in the notification specified in paragraph (c)(1) or (2) of this section, due to unforeseeable circumstances beyond your control, you must notify the Administrator as soon as practicable and without delay prior to the scheduled CEMS performance evaluation date and specify the date when the evaluation is rescheduled.
(d)
(e)
(1) If no performance test is required, submit your CPMS monitoring plan 60 days prior to your compliance date.
(2) If you submit an application specified in § 65.884(f) to use a prior performance test, submit your CPMS monitoring plan with the application to use the prior performance test.
(3) If you are making a change to a previously submitted monitoring plan, submit the revised monitoring plan 60 days before you intend to implement the revised plan.
(f)
(g)
(1) You must submit the report for approval at least 6 months prior to the compliance date of the referencing subpart, or with the permit application for modification, construction or reconstruction.
(2) We will either approve or disapprove the report within 90 days after we receive it. If we disapprove the report, you must still be in compliance with the emission limitations and work practice standards of the referencing subpart by the compliance date of the referencing subpart.
(3) To change any of the information submitted in the report, you must submit a revised report 60 days before the planned change is to be implemented in order to allow time for review and approval by the administrator before the change is implemented.
(h)
(1) A description of the operating parameter(s) to be monitored to ensure the control technology or pollution prevention measure is operated in conformance with its design and achieves the emission limit, as specified in the referencing subpart. Specify the applicable averaging time(s) for the operating parameter(s) and an explanation of the criteria used to select the operating parameter(s) and averaging times.
(2) A description of the methods and procedures that will be used to demonstrate that the operating parameter indicates proper operation of the control device and the schedule for this demonstration.
(3) For parameter monitoring that does not generate continuous data, include the monitoring results that demonstrate that the device is outside the established limit.
(4) The frequency and content of monitoring, recording and reporting.
(5) If continuous records are specified, indicate whether the provisions of §§ 65.712 and 65.713 apply.
(6) The rationale for the proposed monitoring, recordkeeping and reporting system.
(7) If your request includes a proposal to use a control device other than those listed in this subpart, your request must include a description of the proposed control device and your proposed operating parameters.
(8) A statement that you will establish an operating limit for the monitored operating parameter(s) as part of the Notification of Compliance Status or a semiannual periodic report.
(9) You must submit the request for this approval according to the procedures specified for alternative monitoring in § 65.240.
(i)
(1) A description of the change.
(2) Revisions to any of the information reported in the Notification of Compliance Status Report specified in § 65.880, or subsequent report.
(j)
Environmental Protection Agency.
Proposed rule.
EPA is proposing to approve a State implementation plan (SIP) revision submitted by the State of Colorado on May 25, 2011 that addresses regional haze (RH). EPA is proposing to determine that the plan submitted by Colorado satisfies the requirements of the Clean Air Act (CAA or “the Act”) and our rules that require states to prevent any future and remedy any existing man-made impairment of visibility in mandatory Class I areas caused by emissions of air pollutants from numerous sources located over a wide geographic area (also referred to as the “regional haze program”). States are required to assure reasonable progress toward the national goal of achieving natural visibility conditions in Class I areas. EPA is taking this action pursuant to section 110 of the CAA.
Written comments must be received at the address below on or before May 25, 2012.
Submit your comments, identified by Docket ID No. EPA-R08-OAR-2011-0770, by one of the following methods:
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Laurel Dygowski, Air Program, U.S. Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129, (303) 312-6144,
For the purpose of this document, we are giving meaning to certain words or initials as follows:
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a. Identify the rulemaking by docket number and other identifying information (subject heading,
b. Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
c. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
d. Describe any assumptions and provide any technical information and/or data that you used.
e. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
f. Provide specific examples to illustrate your concerns, and suggest alternatives.
g. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
h. Make sure to submit your comments by the comment period deadline identified.
EPA is proposing to approve a SIP revision submitted by the State of Colorado on May 25, 2011 that addresses RH. In so doing, EPA is proposing to determine that the plan submitted by Colorado satisfies the requirements of 40 CFR 51.308.
RH is visibility impairment that is produced by a multitude of sources and
Data from the existing visibility monitoring network, the “Interagency Monitoring of Protected Visual Environments” (IMPROVE) monitoring network, show that visibility impairment caused by air pollution occurs virtually all the time at most national park and wilderness areas. The average visual range
In section 169A of the 1977 Amendments to the CAA, Congress created a program for protecting visibility in the nation's national parks and wilderness areas. This section of the CAA establishes as a national goal the “prevention of any future, and the remedying of any existing, impairment of visibility in mandatory Class I Federal areas
Congress added section 169B to the CAA in 1990 to address RH issues. EPA promulgated a rule to address RH on July 1, 1999. 64 FR 35714 (July 1, 1999), codified at 40 CFR part 51, subpart P. The RHR revised the existing visibility regulations to integrate into the regulation provisions addressing RH impairment and established a comprehensive visibility protection program for Class I areas. The requirements for RH, found at 40 CFR 51.308 and 51.309, are included in EPA's visibility protection regulations at 40 CFR 51.300-309. Some of the main elements of the RH requirements are summarized in section III of this preamble. The requirement to submit a RH SIP applies to all 50 states, the District of Columbia and the Virgin Islands. 40 CFR 51.308(b) requires states to submit the first implementation plan addressing RH visibility impairment no later than December 17, 2007.
Few states submitted a RH SIP prior to the December 17, 2007 deadline, and on January 15, 2009, EPA found that 37 states (including Colorado), the District of Columbia, and the Virgin Islands, had failed to submit SIPs addressing the RH requirements. 74 FR 2392. Once EPA has found that a state has failed to make a required submission, EPA is required to promulgate a FIP within two years unless the state submits a SIP and the Agency approves it within the two-year period. CAA § 110(c)(1).
Successful implementation of the RH program will require long-term regional coordination among states, tribal governments and various federal agencies. As noted above, pollution affecting the air quality in Class I areas can be transported over long distances, even hundreds of kilometers. Therefore, to effectively address the problem of visibility impairment in Class I areas, states need to develop strategies in coordination with one another, taking into account the effect of emissions from one jurisdiction on the air quality in another.
Because the pollutants that lead to RH can originate from sources located across broad geographic areas, EPA has encouraged the states and tribes across the United States to address visibility impairment from a regional perspective. Five regional planning organizations (RPOs) were developed to address RH and related issues. The RPOs first evaluated technical information to better understand how their states and tribes impact Class I areas across the country, and then pursued the development of regional strategies to reduce emissions of particulate matter (PM) and other pollutants leading to RH.
The Western Regional Air Partnership (WRAP) RPO is a collaborative effort of state governments, tribal governments, and various federal agencies established to initiate and coordinate activities associated with the management of RH, visibility and other air quality issues in the western United States. WRAP member State governments include: Alaska, Arizona, California, Colorado, Idaho, Montana, New Mexico, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming. Tribal members include Campo Band of Kumeyaay Indians, Confederated Salish and Kootenai Tribes, Cortina Indian Rancheria, Hopi Tribe, Hualapai Nation of the Grand Canyon, Native Village of Shungnak, Nez Perce Tribe, Northern Cheyenne Tribe, Pueblo of Acoma, Pueblo of San Felipe, and Shoshone-Bannock Tribes of Fort Hall.
The following is a summary of the requirements of the RHR. See 40 CFR 51.308 for further detail regarding the requirements of the rule.
RH SIPs must assure reasonable progress (RP) towards the national goal of achieving natural visibility conditions in Class I areas. Section 169A of the CAA and EPA's implementing regulations require states to establish long-term strategies for making RP toward meeting this goal. Implementation plans must also give
The RHR establishes the deciview (dv) as the principal metric or unit for expressing visibility. See 70 FR 39104, 39118. This visibility metric expresses uniform changes in the degree of haze in terms of common increments across the entire range of visibility conditions, from pristine to extremely hazy conditions. Visibility expressed in dvs is determined by using air quality measurements to estimate light extinction and then transforming the value of light extinction using a logarithm function. The dv is a more useful measure for tracking progress in improving visibility than light extinction itself because each dv change is an equal incremental change in visibility perceived by the human eye. Most people can detect a change in visibility at one dv.
The dv is used in expressing Reasonable Progress Goals (RPGs) (which are interim visibility goals towards meeting the national visibility goal), defining baseline, current, and natural conditions, and tracking changes in visibility. The RH SIPs must contain measures that ensure “reasonable progress” toward the national goal of preventing and remedying visibility impairment in Class I areas caused by anthropogenic air pollution by reducing anthropogenic emissions that cause RH. The national goal is a return to natural conditions, i.e., anthropogenic sources of air pollution would no longer impair visibility in Class I areas.
To track changes in visibility over time at each of the 156 Class I areas covered by the visibility program (40 CFR 81.401-437), and as part of the process for determining RP, states must calculate the degree of existing visibility impairment at each Class I area at the time of each RH SIP submittal and periodically review progress every five years midway through each 10-year implementation period. To do this, the RHR requires states to determine the degree of impairment (in dvs) for the average of the 20 percent least impaired (“best”) and 20 percent most impaired (“worst”) visibility days over a specified time period at each of their Class I areas. In addition, states must also develop an estimate of natural visibility conditions for the purpose of comparing progress toward the national goal. Natural visibility is determined by estimating the natural concentrations of pollutants that cause visibility impairment and then calculating total light extinction based on those estimates. We have provided guidance to states regarding how to calculate baseline, natural and current visibility conditions.
For the first RH SIPs that were due by December 17, 2007, “baseline visibility conditions” were the starting points for assessing “current” visibility impairment. Baseline visibility conditions represent the degree of visibility impairment for the 20 percent least impaired days and 20 percent most impaired days for each calendar year from 2000 to 2004. Using monitoring data for 2000 through 2004, states are required to calculate the average degree of visibility impairment for each Class I area, based on the average of annual values over the five-year period. The comparison of initial baseline visibility conditions to natural visibility conditions indicates the amount of improvement necessary to attain natural visibility, while the future comparison of baseline conditions to the then current conditions will indicate the amount of progress made. In general, the 2000-2004 baseline period is considered the time from which improvement in visibility is measured.
The vehicle for ensuring continuing progress towards achieving the natural visibility goal is the submission of a series of RH SIPs from the states that establish two RPGs (i.e., two distinct goals, one for the “best” and one for the “worst” days) for every Class I area for each (approximately) 10-year implementation period. See 40 CFR 51.308(d), (f). The RHR does not mandate specific milestones or rates of progress, but instead calls for states to establish goals that provide for “reasonable progress” toward achieving natural visibility conditions. In setting RPGs, states must provide for an improvement in visibility for the most impaired days over the (approximately) 10-year period of the SIP, and ensure no degradation in visibility for the least impaired days over the same period.
In establishing RPGs, states are required to consider the following factors established in section 169A of the CAA and in our RHR at 40 CFR 51.308(d)(1)(i)(A): (1) The costs of compliance; (2) the time necessary for compliance; (3) the energy and non-air quality environmental impacts of compliance; and (4) the remaining useful life of any potentially affected sources. States must demonstrate in their SIPs how these factors are considered when selecting the RPGs for the best and worst days for each applicable Class I area. In setting the RPGs, states must also consider the rate of progress needed to reach natural visibility conditions by 2064 (referred to as the “uniform rate of progress” (URP) or the “glidepath”) and the emission reduction measures needed to achieve that rate of progress over the 10-year period of the SIP. Uniform progress towards achievement of natural conditions by the year 2064 represents a rate of progress, which states are to use for analytical comparison to the amount of progress they expect to achieve. In setting RPGs, each state with one or more Class I areas (“Class I state”) must also consult with potentially “contributing states,” i.e., other nearby states with emission sources that may be affecting visibility impairment at the state's Class I areas. 40 CFR 51.308(d)(1)(iv). In determining whether a state's goals for visibility improvement provide for RP toward natural visibility conditions, EPA is required to evaluate the demonstrations developed by the state pursuant to paragraphs 40 CFR 51.308(d)(1)(i) and (d)(1)(ii). 40 CFR 51.308(d)(1)(iii).
Section 169A of the CAA directs states to evaluate the use of retrofit controls at certain larger, often uncontrolled, older stationary sources in order to address visibility impacts from these sources. Specifically, section 169A(b)(2)(A) of the CAA requires states to revise their SIPs to contain such measures as may be necessary to make RP towards the natural visibility goal, including a requirement that certain categories of existing major stationary
On July 6, 2005, EPA published the
The process of establishing BART emission limitations can be logically broken down into three steps: first, states identify those sources which meet the definition of “BART-eligible source” set forth in 40 CFR 51.301;
States must address all visibility-impairing pollutants emitted by a source in the BART determination process. The most significant visibility impairing pollutants are SO
Under the BART Guidelines, states may select an exemption threshold value for their BART modeling, below which a BART-eligible source would not be expected to cause or contribute to visibility impairment in any Class I area. The state must document this exemption threshold value in the SIP and must state the basis for its selection of that value. Any source with emissions that model above the threshold value would be subject to a BART determination review. The BART Guidelines acknowledge varying circumstances affecting different Class I areas. States should consider the number of emission sources affecting the Class I areas at issue and the magnitude of the individual sources' impacts. Any exemption threshold set by the state should not be higher than 0.5 dv. 40 CFR part 51, appendix Y, section III.A.1.
In their SIPs, states must identify the sources that are subject to BART and document their BART control determination analyses for such sources. In making their BART determinations, section 169A(g)(2) of the CAA requires that states consider the following factors when evaluating potential control technologies: (1) The costs of compliance; (2) the energy and non-air quality environmental impacts of compliance; (3) any existing pollution control technology in use at the source; (4) the remaining useful life of the source; and (5) the degree of improvement in visibility which may reasonably be anticipated to result from the use of such technology.
A RH SIP must include source-specific BART emission limits and compliance schedules for each source subject to BART. Once a state has made its BART determination, the BART controls must be installed and in operation as expeditiously as practicable, but no later than five years after the date of EPA approval of the RH SIP. CAA section 169(g)(4) and 40 CFR 51.308(e)(1)(iv). In addition to what is required by the RHR, general SIP requirements mandate that the SIP must also include all regulatory requirements related to monitoring, recordkeeping, and reporting for the BART controls on the source. See CAA section 110(a). As noted above, the RHR allows states to implement an alternative program in lieu of BART so long as the alternative program can be demonstrated to achieve greater RP toward the national visibility goal than would BART.
Consistent with the requirement in section 169A(b) of the CAA that states include in their RH SIP a 10 to 15 year strategy for making RP, section 51.308(d)(3) of the RHR requires that states include a LTS in their RH SIPs. The LTS is the compilation of all control measures a state will use during the implementation period of the specific SIP submittal to meet applicable RPGs. The LTS must include “enforceable emissions limitations, compliance schedules, and other measures as necessary to achieve the reasonable progress goals” for all Class I areas within, or affected by emissions from, the state. 40 CFR 51.308(d)(3).
When a state's emissions are reasonably anticipated to cause or contribute to visibility impairment in a Class I area located in another state, the RHR requires the impacted state to coordinate with the contributing states in order to develop coordinated emissions management strategies. 40 CFR 51.308(d)(3)(i). In such cases, the contributing state must demonstrate that it has included, in its SIP, all measures necessary to obtain its share of the emission reductions needed to meet the RPGs for the Class I area.
States should consider all types of anthropogenic sources of visibility impairment in developing their LTS, including stationary, minor, mobile, and area sources. At a minimum, states must describe how each of the following seven factors listed below are taken into account in developing their LTS: (1) Emission reductions due to ongoing air pollution control programs, including measures to address RAVI; (2) measures to mitigate the impacts of construction activities; (3) emissions limitations and schedules for compliance to achieve the RPG; (4) source retirement and replacement schedules; (5) smoke management techniques for agricultural and forestry management purposes including plans as currently exist within the state for these purposes; (6) enforceability of emissions limitations and control measures; and (7) the anticipated net effect on visibility due to projected changes in point, area, and mobile source emissions over the period
As part of the RHR, EPA revised 40 CFR 51.306(c) regarding the LTS for RAVI to require that the RAVI plan must provide for a periodic review and SIP revision not less frequently than every three years until the date of submission of the state's first plan addressing RH visibility impairment, which was due December 17, 2007, in accordance with 40 CFR 51.308(b) and (c). On or before this date, the state must revise its plan to provide for review and revision of a coordinated LTS for addressing RAVI and RH, and the state must submit the first such coordinated LTS with its first RH SIP. Future coordinated LTS's, and periodic progress reports evaluating progress towards RPGs, must be submitted consistent with the schedule for SIP submission and periodic progress reports set forth in 40 CFR 51.308(f) and 51.308(g), respectively. The periodic review of a state's LTS must report on both RH and RAVI impairment and must be submitted to EPA as a SIP revision.
Section 51.308(d)(4) of the RHR includes the requirement for a monitoring strategy for measuring, characterizing, and reporting of RH visibility impairment that is representative of all mandatory Class I Federal areas within the state. The strategy must be coordinated with the monitoring strategy required in section 51.305 for RAVI. Compliance with this requirement may be met through “participation” in the IMPROVE network, i.e., review and use of monitoring data from the network. The monitoring strategy is due with the first RH SIP, and it must be reviewed every five years. The monitoring strategy must also provide for additional monitoring sites if the IMPROVE network is not sufficient to determine whether RPGs will be met.
The SIP must also provide for the following:
• Procedures for using monitoring data and other information in a state with mandatory Class I areas to determine the contribution of emissions from within the state to RH visibility impairment at Class I areas both within and outside the state;
• Procedures for using monitoring data and other information in a state with no mandatory Class I areas to determine the contribution of emissions from within the state to RH visibility impairment at Class I areas in other states;
• Reporting of all visibility monitoring data to the Administrator at least annually for each Class I area in the state, and where possible, in electronic format;
• Developing a statewide inventory of emissions of pollutants that are reasonably anticipated to cause or contribute to visibility impairment in any Class I area. The inventory must include emissions for a baseline year, emissions for the most recent year for which data are available, and estimates of future projected emissions. A state must also make a commitment to update the inventory periodically; and
• Other elements, including reporting, recordkeeping, and other measures necessary to assess and report on visibility.
The RHR requires control strategies to cover an initial implementation period extending to the year 2018, with a comprehensive reassessment and revision of those strategies, as appropriate, every 10 years thereafter. Periodic SIP revisions must meet the core requirements of section 51.308(d) with the exception of BART. The requirement to evaluate sources for BART applies only to the first RH SIP. Facilities subject to BART must continue to comply with the BART provisions of section 51.308(e), as noted above. Periodic SIP revisions will assure that the statutory requirement of RP will continue to be met.
The RHR requires that states consult with FLMs before adopting and submitting their SIPs. 40 CFR 51.308(i). States must provide FLMs an opportunity for consultation, in person and at least 60 days prior to holding any public hearing on the SIP. This consultation must include the opportunity for the FLMs to discuss their assessment of impairment of visibility in any Class I area and to offer recommendations on the development of the RPGs and on the development and implementation of strategies to address visibility impairment. Further, a state must include in its SIP a description of how it addressed any comments provided by the FLMs. Finally, a SIP must provide procedures for continuing consultation between the state and FLMs regarding the state's visibility protection program, including development and review of SIP revisions, five-year progress reports, and the implementation of other programs having the potential to contribute to impairment of visibility in Class I areas.
The State of Colorado submitted a revision to its SIP to address the requirements for RH on May 25, 2011. The following is a discussion of our evaluation of the revision.
Pursuant to 40 CFR 51.308(d), the State identified 12 mandatory Class I areas in Colorado: Black Canyon of the Gunnison National Park, Eagles Nest Wilderness Area, Flat Tops Wilderness Area, Great Sand Dunes National Park, La Garita Wilderness Area, Maroon Bells-Snowmass Wilderness Area, Mesa Verde National Park, Mount Zirkel Wilderness Area, Rawah Wilderness Area, Rocky Mountain National Park, Weminuche Wilderness Area, and West Elk Wilderness Area. The State developed and submitted as part of its RH SIP technical support documents (TSDs) for each of the Class I areas. The Class I area TSDs include a detailed description of each area, along with photographs, summaries of monitoring data, an overview of current visibility conditions, and sources of pollution.
The State also identified in the TSD areas outside of the State that modeling shows may be impacted from emissions from Colorado.
As required by 40 CFR 51.308(d)(2), Colorado determined baseline visibility, natural visibility, and the URP for each Class I area in the State. Natural background visibility, as defined in our 2003 Natural Visibility Guidance, is estimated by calculating the expected light extinction using default estimates of natural concentrations of fine particle components adjusted by site-specific estimates of humidity. This calculation uses the IMPROVE equation, which is a
One alternative approach is to develop and justify the use of alternative estimates of natural concentrations of fine particle components. Another alternative is to use the “new IMPROVE equation” that was adopted for use by the IMPROVE Steering Committee in December 2005.
Colorado used the new IMPROVE equation to calculate natural conditions and baseline visibility. The natural condition for each Class I area represents the visibility goal expressed in dvs for the 20% worst days and the 20% best days that would exist if there were only naturally occurring visibility impairment. In accordance with 40 CFR 51.308(d)(2)(iii), the State calculated natural visibility conditions based on available monitoring information and appropriate data analysis techniques and in accordance with our 2003 Natural Visibility Guidance. The State also calculated the number of dvs by which baseline conditions exceed natural conditions at each of its Class I areas to meet the requirements of 40 CFR 51.308(d)(2)(iv)(A).
Colorado has established baseline visibility for the best and worst visibility days for each Class I area based on data from the IMPROVE monitoring sites. Each IMPROVE monitor collects particulate concentration data which are converted into reconstructed light extinction through a complex calculation using the IMPROVE equation (see Class I area TSDs for more information on reconstructed light extinction and the IMPROVE equation). Per 40 CFR 51.308(d)(2)(i), the State calculated baseline visibility using a five-year average (2000 to 2004) of IMROVE data for both the 20% best and 20% worst days. The State's baseline calculations were made in accordance with our 2003 Tracking Progress Guidance.
Pursuant to 40 CFR 51.308(d)(1)(i)(B), the State calculated the URP for each of its Class I areas. For the 20% worst days, the URP is the calculation of the dv reduction needed to achieve natural conditions by 2064. For the 20% worst days, the State calculated the URP in dvs per year using the following formula: URP = [Baseline Condition − Natural Condition]/60 years. In order to determine the uniform progress needed by 2018 to be on the path to achieving natural visibility conditions by 2064, the State multiplied the URP by the 14 years in the first planning period (2004-2018).
Table 1 shows the baseline visibility, natural conditions, and URP for each of the Class I areas.
We have reviewed Colorado's calculations of baseline visibility, natural conditions, and URP. We find they have been calculated correctly and are proposing to approve them.
BART is an element of Colorado's LTS for the first implementation period. As discussed in more detail in section IV.D of this notice, the BART evaluation process consists of three components: (1) An identification of all the BART-eligible sources; (2) an assessment of whether those BART-eligible sources are in fact subject to BART; and (3) a determination of any BART controls. Colorado addressed these steps as follows:
The first step of a BART evaluation is to identify all the BART-eligible sources within the State's boundaries. Colorado identified the BART-eligible sources in Colorado by utilizing the approach set out in the BART Guidelines (70 FR 39158). This approach provides three criteria for identifying BART-eligible sources: (1) One or more emission units at the facility fit within one of the 26 categories listed in the BART Guidelines; (2) the emission unit or units began operation on or after August 6, 1962, and were in existence on August 6, 1977; and (3) combined potential emissions of any visibility-impairing pollutant from the units that meet the criteria in (1) and (2) are 250
The State analyzed the emissions from VOC and NH
Table 2 lists the 12 sources that Colorado determined were BART-eligible.
The second step of the BART evaluation is to identify those BART-eligible sources that may reasonably be anticipated to cause or contribute to any visibility impairment at any Class I area, i.e., those sources that are subject to BART. The BART Guidelines allow states to consider exempting some BART-eligible sources from further BART review because they may not reasonably be anticipated to cause or contribute to any visibility impairment in a Class I area. Consistent with the BART Guidelines, Colorado performed dispersion modeling on the BART-eligible sources to assess the extent of their contribution to visibility impairment at surrounding Class I areas.
The BART Guidelines provide that states may use the CALPUFF
The BART Guidelines also recommend that states develop a modeling protocol for making individual source attributions, and suggest that states may want to consult with EPA and their RPO to address any issues prior to modeling. Colorado used the CALPUFF model for Colorado BART sources in accordance with a protocol it developed titled
To determine if each BART-eligible source has a significant impact on visibility, Colorado used the CALPUFF model to estimate daily visibility impacts above estimated natural conditions at each Class I area within 300 km of any BART-eligible facility, based on maximum actual 24-hour emissions over a three year period (2000-2002).
For states using modeling to determine the applicability of BART to single sources, the BART Guidelines note that the first step is to set a contribution threshold to assess whether the impact of a single source is sufficient to cause or contribute to visibility impairment at a Class I area. The BART Guidelines state that, “[a] single source that is responsible for a 1.0 deciview change or more should be considered to `cause' visibility impairment.” (70 FR 39104, 39161). The BART Guidelines also state that “the appropriate threshold for determining whether a source contributes to visibility impairment may reasonably differ across states,” but, “[a]s a general matter, any threshold that you use for determining whether a source ‘contributes’ to visibility impairment should not be higher than 0.5 deciviews.” Id. Further, in setting a contribution threshold, states should “consider the number of emissions sources affecting the Class I areas at issue and the magnitude of the individual sources' impacts.” The Guidelines affirm that states are free to use a lower threshold if they conclude that the location of a large number of BART-eligible sources in proximity to a Class I area justifies this approach.
Colorado used a contribution threshold of 0.5 dvs for determining which sources are subject to BART. The State's decision was based on the following factors: 0.5 dvs equates to the 5% extinction threshold for new sources under the Prevention of Significant Deterioration (PSD) New Source Review rules, and 0.5 dvs represents the limit of perceptible change. Although we do not agree with Colorado that these factors are always the appropriate ones to consider in determining which BART-eligible sources should be subject to BART in Colorado, we propose to approve the State's threshold of 0.5 dvs based on our own evaluation, discussed below. As shown in Table 2 below, Colorado exempted three of the 12 BART-eligible sources in the State from further review under the BART requirements. These three sources are Lamar Light and Power, Suncor Denver Refinery, and Ray D. Nixon Unit 1. According to Colorado's modeling, each of these sources had a visibility impact less than 0.5 dvs. As shown in Table 2, the visibility impact attributable to each of these sources is 0.06, 0.48, and 0.24 dvs, respectively. Given the relatively limited combined impact on visibility from these three sources, we propose to agree with Colorado that 0.5 dvs is a reasonable threshold for determining
Because our recommended modeling approach already incorporates choices that tend to lower peak daily visibility impact values,
Table 2 shows the sources that the State identified as BART-eligible and the results of the State's CALPUFF modeling. Colorado determined that the BART-eligible facilities with modeled impacts at all Class I areas less than 0.5 dvs were not subject to BART and those with impacts greater than 0.5 dvs were subject to BART (see Chapter 6.3 of the SIP).
The third step of a BART evaluation is to perform the BART analysis. The BART Guidelines (70 FR 39164) describe the BART analysis as consisting of the following five steps:
• Step 1: Identify All Available Retrofit Control Technologies;
• Step 2: Eliminate Technically Infeasible Options;
• Step 3: Evaluate Control Effectiveness of Remaining Control Technologies;
• Step 4: Evaluate Impacts and Document the Results; and
• Step 5: Evaluate Visibility Impacts.
In determining BART, the State must consider the five statutory factors in section 169A of the CAA: (1) The costs of compliance; (2) the energy and non-air quality environmental impacts of compliance; (3) any existing pollution control technology in use at the source; (4) the remaining useful life of the source; and (5) the degree of improvement in visibility which may reasonably be anticipated to result from the use of such technology. See also 40 CFR 51.308(e)(1)(ii)(A). The five-factor analysis occurs during steps 4 and 5 of the BART analysis.
Colorado performed BART determinations for all of the sources subject to BART for NO
For NO
EPA does not necessarily agree that the State's criteria for selecting NO
While we do not necessarily agree that the criteria used by the State would always be appropriate to select NO
Scrubbing is one of the most common ways to control emissions of SO
Generally, wet FGD controls can achieve a slightly higher level of SO
The BART Guidelines provide that states may use the CALPUFF modeling system or another appropriate model to determine the visibility improvement expected at a Class I area from potential BART control technologies applied to the source. Colorado performed CALPUFF modeling to determine the degree of visibility improvement expected at a Class I area based on the controls evaluated for BART for the subject-to-BART sources, with the exception of Cemex. For Cemex, the State relied on modeling submitted by the source based on a modeling protocol approved by the State.
The BART Guidelines also recommend that states develop a modeling protocol for modeling visibility improvement, and suggest that states may want to consult with EPA and their RPO to address any issues prior to modeling. Colorado used the CALPUFF model for Colorado BART sources in accordance with a protocol it developed titled Supplemental BART Analysis
In lieu of individual BART determinations, the State submitted a BART alternative as allowed for by 40 CFR 51.308(e)(2) for three of the subject-to-BART sources: Cherokee Station Unit 4, Pawnee Station Unit 1, and Valmont Station Unit 5. We provide a summary of the BART alternative in section IV.C.3.b.vii of this notice. We are proposing to approve the BART alternative. For the rest of the subject-to-BART sources, the State provided analyses that took into consideration the five factors as required by section 169A(g)(2) of the CAA. The State's five factor analyses, as well as additional technical information and materials, are included in Appendix C of the SIP. Chapter 6 of the SIP provides a summary of the five factor analyses. EPA is proposing to approve the BART determinations submitted by the State for Cemex Lyons Kiln and Dryer, CENC Unit 4 and Unit 5, Comanche Unit 1 and Unit 2, Craig Unit 2, Hayden Unit 1 and Unit 2, and Martin Drake Unit 5, Unit 6, and Unit 7. A summary of the BART determination for each source is provided below.
The Cemex facility manufactures Portland cement and is located in Lyons, Colorado, approximately 20 miles from Rocky Mountain National Park. There are two BART-eligible units at the facility: The dryer and the kiln. The Lyons plant was originally constructed with a long dry kiln. In 1980, the kiln was cut to one-half its original length, and a flash vessel was added with a single-stage preheater. The permitted kiln feed rate is 120 tons per hour of raw material (kiln feed), and on average yields approximately 62 tons of clinker per hour. The kiln is the main source of SO
The State has emissions data for the dryer from 1999, 2003, 2008, and 2009. The 1999 emissions are based on emission factors, whereas the 2003, 2008 and 2009 emissions are based on a stack test. The State has determined that the 2008 emissions best represent baseline emissions for the dryer since the State considers stack test data more reliable than emission factors. Furthermore, the 2008 clinker production is representative of typical operations because it falls within the normal range of the historical average. The 2008 baseline emissions for the dryer are: 10.41 tpy for NO
The State has determined that the 2002 emissions best represent baseline emissions for the kiln because they correspond to the high range for SO
CALPUFF modeling provided by the source, using a maximum SO
EPA is proposing to approve the State's SO
The kiln has no current SO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, and there are no remaining-useful-life issues for this source. A summary of the State's SO
Based upon its consideration and weighing of the five factors, the State has determined that no additional SO
We are proposing to approve the State's SO
The kiln is currently uncontrolled for NO
Although we disagree with the State's conclusion on the commercial availability of SCR for cement kilns, we accept the State's decision, for purposes of RH, not to analyze this control technology further. We note that EPA has acknowledged, in the context of establishing the New Source Performance Standards (NSPS) for Portland Cement Plants, substantial uncertainty regarding the cost effectiveness associated with the use of SCR at such plants. See 75 FR 54995. We expect the State to reevaluate this technology in subsequent RP planning periods.
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, and there are no remaining-useful-life issues for this facility. A summary of the State's NO
As the table shows, SNCR with LNB could potentially achieve the greatest emission reductions for the control technologies evaluated. The Cemex-Lyons facility is a unique kiln system most accurately described as a modified long dry kiln. The characteristics of a modified long dry kiln system are not similar to either a long wet kiln or a multi-stage preheater/precalciner kiln. The temperature profile in a long dry kiln system (>1500°F) is significantly higher at the exit than a more typical preheater/precalciner kiln (650 °F). This limits the location and residence time available for an effective NO
We agree with the State's conclusion, and we are proposing to approve the State's NO
PM emissions from the kiln and dryer are currently controlled by fabric filter baghouses and wet dust suppression techniques. Current PM emission limits are in compliance with the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Source Categories; Portland Cement Manufacturing Industry, 40 CFR part 63, subpart LLL. The existing NESHAP regulatory emission limits for the kiln are 0.275 lb/ton of dry feed and 20% opacity. For the dryer, the emission limit is 22.8 tpy and 10% opacity. For sources already regulated by a NESHAP standard, EPA stated the following in the BART guidelines: “We believe that, in many cases, it will be unlikely that States will identify emission controls more stringent than the MACT standards without identifying control options that would cost many thousands of dollars per ton. Unless there are new technologies subsequent to the MACT standards which would lead to cost effective increases in the level of control, you may rely on the MACT standards for purposes of BART.” (70 FR 39163) (MACT means Maximum Achievable Control Technology).
The State determined that no new PM control methodologies could be identified that would improve upon the PM controls required in the NESHAP. The State determined that the current emission limit and control technology represent the most stringent level of control and are BART for PM for the Cemex-Lyons kiln and dryer. Per the BART Guidelines, if the BART source has the most stringent control technology and limit in place, a full five-factor analysis is not required (70 FR 39165). The State determined that PM BART emission limits for the kiln are 0.275 lb/ton of dry feed and 20% opacity and the emission limits for the dryer are 22.8 tpy (12-month rolling average) and 10% opacity. The State assumes the limits can be achieved with the operation of the current fabric filter baghouses.
We are proposing to approve the State's PM BART determinations for the Cemex-Lyons kiln and dryer. We agree with the State that the existing controls and emission limits represent the most stringent level of PM control for this type of facility.
This CENC facility is located adjacent, and supplies steam and electrical power, to the Coors Brewery in Golden, Colorado. The facility consists of five boilers and the associated equipment for coal and ash handling. Boilers 4 and 5 are the only units that are subject to BART. Boiler 4 mainly fires coal, but can also fire natural gas. Fuel oil may be used as a backup fuel, but has not been used in recent years. Boiler 5 fires coal, but uses oil as a backup fuel. Either boiler may also fire ethanol or sludge from the Coors Brewery. Boiler 4 is rated at 360 MMBtu/hr and Boiler 5 at 650 MMBtu/hr. Both boilers are pulverized-coal dry-bottom tangentially-fired boilers. The BART determination for CENC Boilers 4 and 5 can be found in Chapter 6.4.3.2 and Appendix C of the SIP.
Boilers 4 and 5 are currently uncontrolled for SO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for the source. A summary of the State's SO
Based on its consideration of the five factors, the State determined that SO
We agree with the State's conclusions, and we are proposing to approve its SO
Boilers 4 and 5 are currently uncontrolled for NO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. A summary of the State's NO
Based
Per the BART Guidelines, states may consider allowing sources to average emissions across any set of BART eligible emissions units within a fenceline, so long as the emission reductions from each pollutant being controlled for BART would be equal to those reductions that would be obtained by simply controlling each of the BART-eligible sources (70 FR 39172). Pursuant to this, the State also established a combined NO
We agree with the State's conclusions, and we are proposing to approve the State's NO
CENC Boilers 4 and 5 are each equipped with fabric filter baghouses to control PM emissions with a current emission limit of 0.07 lb/MMBtu. Fabric filter baghouses are the most stringent control technology for controlling PM emissions, and stack tests show that the fabric filter baghouses are achieving a 98% reduction in PM. The State determined that PM BART for Boiler 4 and Boiler 5 is an emission limit of 0.07 lb/MMBtu. The State assumes the BART emission limit can be met with the operation of the current fabric filter baghouses.
While we do not agree with all of the State's assumptions and conclusions in arriving at a PM BART limit of 0.07 lb/MMBtu, we are proposing to approve the State's PM BART determinations for CENC Boiler 4 and Boiler 5. Based on our review/analysis, CENC is capable of achieving a lower emission limit than 0.07 lb/MMBtu with existing equipment. However, we anticipate that the visibility improvement that would result from lowering the limit from 0.07 lb/MMBtu to 0.03 lb/MMBtu would be insignificant. Under these circumstances, we propose to find that the State's BART determination was reasonable.
Comanche Station is located in Pueblo, Colorado. It consists of three coal-fired EGUs, Units 1, 2, and 3. Unit 1 is rated at 325 megawatts (MW) and Unit 2 is rated at 335 MW. Unit 1 and Unit 2 are the only subject-to-BART units at Comanche Station. The boilers burn sub-bituminous coal as fuel and use natural gas for startup, shutdown, and flame stabilization. Both units are dry-bottom pulverized coal-fired boilers. Unit 1 is tangentially fired and Unit 2 is wall-fired.
In August of 2004, PSCO proposed to construct and operate Unit 3 at Comanche Station. As part of the project, PSCO proposed to install NO
The State determined that the LSD on Unit 1 is achieving 76.1% control and the LSD on Unit 2 is achieving 81.9% control. Baseline SO
The State also assessed emissions limit tightening based on current operations. The State reviewed available SO
Based on this information, the State determined that the limited emissions data from 2009 and 2010 may not accurately represent future plant emissions. In addition, since the LSDs only came on line recently, the State recognized that PSCO has limited operating experience with these units. Although PSCO has other units that are equipped with LSDs, Comanche Station Units 1 and 2 are the first such units in PSCO's system that are firing Powder River Basin coal. After startup of the LSDs in 2009, both units have had a number of days indicating zero emissions, presumably due to a unit shutdown. In many cases, emissions data shows that for one or more days following these events, the daily SO
Based on the information discussed above, the State concluded that a tighter 30-day rolling average and annual average SO
We agree with the State's conclusions and are proposing to approve its SO
Comanche Station Units 1 and 2 currently have a NO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. Baseline NO
Based on its consideration of the five factors, the State has determined that the NO
The State assumes that the BART emission limits can be achieved through the operation of existing LNBs. Although the other alternatives achieve better emissions reductions, the State determined that the added expense of achieving lower limits through different controls was not reasonable based on the high cost effectiveness coupled with the low visibility improvement (under 0.2 dv) afforded.
We agree with the State's conclusions, and we are proposing to approve the State's NO
Comanche Station Units 1 and 2 are each equipped with fabric filter baghouses to control PM emissions with an emission limit of 0.03 lb/MMBtu. Stack tests show that the fabric filter baghouses are achieving a 99% reduction in PM. Fabric filter baghouses are the most stringent control technology for controlling PM emissions. The State also evaluated what would constitute the most stringent level of control for PM by looking at recent Best Available Control Technology (BACT) determinations. Based on this evaluation, the State determined that an emission limit of 0.03 lb/MMBtu represents the most stringent level of control for this type of source. Consistent with the BART Guidelines, the State did not provide a full five-factor analysis because the State determined BART to be the most stringent control technology and limit. The State determined that the PM BART limit for Comanche Station Units 1 and 2 is 0.03 lb/MMBtu (30-day rolling average). The State assumes the BART limit can be met with the operation of the existing fabric filter baghouses.
We agree with the State's conclusions, and we are proposing to approve its PM BART determinations for Comanche Station Unit 1 and Unit 2.
The Tri-State Generation & Transmission Association, Inc. (Tri-State) Craig Station is located in Moffat County approximately 2.5 miles southwest of the town of Craig,
Craig Unit 1 and Unit 2 are currently controlled with wet FGD. The units have a current SO
The State evaluated the following wet FGD upgrades: (1) Elimination of bypass reheat; (2) installation of liquid distribution rings; (3) installation of perforated trays; (4) use of organic acid additives; (5) improve or upgrade scrubber auxiliary equipment; and (6) redesign spray header or nozzle configuration. Tri-State performed numerous upgrades at Units 1 and 2 during 2003-2004. The State determined that Tri-State had installed all of the above upgrades with the exception of liquid distribution rings and use of organic additives. The State determined that the installation of perforated trays achieved the same objective as these upgrades.
The State evaluated emission limit tightening based on current operations. The State analyzed the baseline period (2006-2008) emission data from EPA's CAMD to determine the maximum and average 30-day rolling emission rates. The emissions data shows that the maximum 30-day rolling average was 0.08 lb/MMBtu for Unit 1 and 0.09 lb/MMBtu for Unit 2. The average 30-day rolling emission rate was 0.05 lb/MMBtu for Unit 1 and 0.08 for Unit 2. The daily maximum over the three-year period was 0.17 lb/MMBtu for Unit 1 and 0.16 lb/MMBtu for Unit 2. Table 11 shows the visibility improvement modeled by the State for possible lower SO
The State determined that an emission limit of 0.11 lb/MMBtu would be achievable without additional capital investment. The State determined that an emission limit lower than 0.11 lb/MMBtu would likely require additional capital expenditure and determined it was not reasonable for the incremental visibility improvement of 0.02. The State has determined that the SO
We agree with the State's conclusions, and we are proposing to approve its SO
Craig Units 1 and 2 are currently controlled with ultra low NO
The State determined that SNCR was reasonable for BART for both Unit 1 and Unit 2 based on the cost effectiveness and visibility improvement associated with this level of control. The State determined SCR was not reasonable because of the high cost effectiveness value. Based upon its consideration of the five factors, the State determined that the NO
Although the State determined that 0.27 lb/MMBtu was NO
Craig Units 1 and 2 are each equipped with fabric filter baghouses to control PM emissions with an emission limit of 0.03 lb/MMBtu. Stack tests show that the fabric filter baghouses are achieving a 99% reduction in PM. Fabric filter baghouses are the most stringent control technology for controlling PM emissions. The State also evaluated what would constitute the most stringent level of control for PM by looking at recent BACT determinations. Based on this evaluation, the State determined that an emission limit of 0.03 lb/MMBtu represents the most stringent level of control for this type of source. Consistent with the BART Guidelines, the State did not provide a full five-factor analysis because the State determined BART to be the most stringent control technology and limit. The State determined that the PM BART emission limit is 0.03 lb/MMBtu (30-day rolling average) at Craig Unit 1 and Craig Unit 2. The State assumes the BART emission limits can be met through the operation of the current fabric filter baghouses.
We agree with the State's conclusions, and we are proposing to approve its PM BART determinations for Craig Unit 1 and Unit 2.
The Hayden facility is located four miles east of Hayden, Colorado in Routt County. This facility consists of two steam driven turbine/generator units, Units 1 and 2, and the associated equipment needed for generating electricity. Unit 1 is a pulverized-coal front-fired dry-bottom boiler, firing coal, with natural gas and No. 2 fuel oil used for startup, shutdown, and/or flame stabilization. Unit 2 is a pulverized-coal tangentially-fired dry-bottom boiler, firing coal, with No. 2 fuel oil used for startup, shutdown, and/or flame stabilization. Units 1 and 2 are the only subject-to-BART units at the facility. The State's BART determination for Hayden Units 1 and 2 can be found in Chapter 6.4.3.5 and Appendix C of the SIP.
PSCO Hayden Units 1 and 2 are currently controlled with LSDs. Both units have a current SO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. Baseline SO
The State determined that the cost of an additional scrubber vessel was not reasonable for BART controls. The State determined that additional equipment and maintenance was reasonable for SO
We agree with the State's conclusions, and we are proposing to approve its SO
Hayden Units 1 and 2 are currently controlled with LNBs plus OFA, achieving emission reductions of 54 percent and 33 percent, respectively. The State determined that upgrades to the existing LNBs, SNCR, and SCR were technically feasible. The State determined that ECO, RRI, ROFA, and coal reburn plus SNCR were not technically feasible. The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. Baseline NO
Based on its consideration of the five factors, the State has determined that the NO
We agree with the State's conclusions, and we are proposing to approve its NO
Hayden Units 1 and 2 are each equipped with fabric filter baghouses to control PM emissions with an emission limit of 0.03 lb/MMBtu. Stack tests show that the fabric filter baghouses are achieving a 99% reduction in PM. Fabric filter baghouses are the most stringent control technology for controlling PM emissions. The State also evaluated what would constitute the most stringent level of control for PM by looking at recent BACT determinations. Based on this evaluation, the State determined that an emission limit of 0.03 lb/MMBtu represents the most stringent level of control for this type of source. Consistent with the BART Guidelines, the State did not provide a full five-factor analysis because the State determined BART to be the most stringent control technology and limit. The State has determined that the PM BART emission limit is 0.03 lb/MMBtu (30-day rolling average) for Hayden Unit 1 and Unit 2. The State assumes the BART emission limit can be met through the operation of the current fabric filter baghouses.
We agree with the State's conclusions, and we are proposing to approve its PM BART determinations for Hayden Unit 1 and Unit 2.
The CSU's Martin Drake facility is located in Colorado Springs, Colorado. This facility consists of three steam driven turbine/generator units, Units 5, 6, and 7, and the associated equipment needed for generating electricity. Units 5, 6, and 7 are the only BART-eligible units at the facility. These units fire coal as the primary fuel and use natural gas for backup and startup. All three boilers are pulverized-coal, dry-bottom, front-fired boilers. The State's BART determination for CSU Martin Drake can be found in Chapter 6.4.3.6 and Appendix C of the SIP.
Martin Drake Units 5, 6, and 7 are currently uncontrolled for SO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. Baseline SO
The State also examined emission limits tightening based on current operations for Unit 5. (The State did not evaluate emissions limit tightening on Units 6 and 7 because the State determined BART to be the most stringent control technology). In order to evaluate emissions limit tightening, the State analyzed actual emission data for Unit 5 from the baseline period of 2006-2008. The State found that the maximum 30-day rolling emission rate for Unit 5 was 0.83 lb/MMBtu. The State applied a 5 percent buffer to the maximum 30-day rolling emission rate because the Drake facility has limited coal storage capacity and blends four different types of coals. These factors can lead to a greater fluctuation in emissions. Assuming no new control technology for Unit 5 and a 5 percent buffer, the State determined that an appropriate SO
Based upon its consideration of the five factors, the State determined that the following are the SO
We agree with the State's conclusions, and we are proposing to approve its SO
Martin Drake Units 5, 6, and 7 are currently controlled with LNBs achieving 54.7%, 52.8%, and 57.7% control, respectively. The State's BART analysis shows that OFA, ULNBs, ULNBs plus OFA, SNCR, SNCR plus ULNBs, and SCR are technically feasible for reducing NO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. Baseline NO
The State determined that ULNBs plus OFA constitute BART based on the low dollars-per-ton control costs and the visibility improvement afforded by this control technology. The State did not choose SNCR as that technology provides a similar level of NO
Based upon its consideration of the five factors, the State determined that the following are the NO
We agree with the State's conclusions, and we are proposing to approve the State's NO
Martin Drake Units 5, 6, and 7 are each equipped with fabric filter baghouses to control PM emissions with an emission limit of 0.03 lb/MMBtu. Stack tests show that the fabric filter baghouses are achieving a 95% reduction in PM. Fabric filter baghouses are the most stringent control technology for controlling PM emissions. The State also evaluated what would constitute the most stringent level of control for PM by looking at recent BACT determinations. Based on this evaluation, the State determined that an emission limit of 0.03 lb/MMBtu represents the most stringent level of control for this type of source. Consistent with the BART Guidelines, the State did not provide a full five-factor analysis because the State determined BART to be the most stringent control technology and limit.
The State has determined that 0.03 lb/MMBtu (30-day rolling average) is the PM BART limit for Martin Drake Units 5, 6, and 7. The State assumes the limits can be met with the operation of the current fabric filter baghouses.
We agree with the State's conclusions, and we are proposing to approve its PM BART determinations for Martin Drake Units 5, 6, and 7.
Table 24 provides a summary of the State's BART determinations that we are proposing to approve.
Colorado has adopted the PSCO BART Alternative Program (BART alternative) to meet the requirements for BART for PSCO Cherokee Unit 4, Valmont Unit 5, and Pawnee Station Unit 1 and RP for PSCO Arapahoe Units 3 and 4 and Cherokee Units 1, 2, and 3. Under 40 CFR 51.308(e)(2), states may choose to meet the BART requirements with a BART alternative. Section 51.308(e)(2) specifies the requirements that a state must meet to show that the alternative measure or alternative program achieves greater RP than would be achieved through the installation and operation of BART. Section 51.308(e)(3) contains additional requirements that states must address pertaining to their alternative program. Table 25 provides a summary of the units covered under the BART alternative, as well as the required control or shutdown date for the facility.
A summary of Colorado's BART alternative and the requirements under 40 CFR 51.308(e)(2) and (e)(3) are discussed below. The State's analysis of the PSCO BART alternative can be found in Chapter 6.4.3.7 of the SIP.
Pursuant to 40 CFR 51.308(e)(2)(i)(A), the State included a list of all BART-eligible sources in the State in Chapter 6, Table 6-3 of the SIP. A list of BART-eligible sources can also be found in Table 2 of this notice.
Pursuant to 40 CFR 51.308(e)(2)(i)(B), the State included in the SIP a list of the BART-eligible sources that are included in the BART alternative, as well as the RP sources covered under the program.
As required by 40 CFR 51.308(e)(2)(i)(C), the State determined the best system of continuous emission control for sources that are subject to BART and that are covered by the BART alternative program. Because the State's BART alternative program was designed to meet requirements other than BART,
Pursuant to 40 CFR 51.308(e)(2)(i)(D), the State provided a calculation of the emission reductions expected from the BART alternative compared to emissions reductions that would be achieved by the application of the presumptive limits to sources covered under the alternative. Tables 26 and 27 show the relative emissions.
Tables 26 and 27 demonstrate that the State's BART Alternative achieves greater RP than would be achieved through the installation of BART. By applying presumptive limits to the sources, the resulting emissions would be 8,614 tpy for SO
Pursuant to 40 CFR 51.308(e)(2)(ii), Table 25 shows that all controls under the BART alternative will occur by December 17, 2017, within the first planning period, which ends in December 2018.
As required by 40 CFR 51.308(e)(2)(iv), the State has concluded that emission controls associated with the BART alternative have not been used for other SIP purposes and are only a requirement under the RH SIP. The State has thus determined they are surplus. EPA agrees with the State's assessment.
The State has determined that the distribution of emissions under the BART alternative is not substantially different than under source-by-source BART or RP. The BART alternative includes only sources that are BART or RP sources and does not include any sources that would not have been included in the RH SIP. All of the units in the BART alternative are located within or adjacent to the 8-hour ozone non-attainment area in the Front Range of Colorado. Pursuant to 40 CFR 51.308(e)(3), since the State has determined that the geographic distribution of emissions is not substantially different under the alternative program, the State is not required to perform visibility modeling. We agree that the BART alternative will not result in a significant shift in the distribution of emissions.
EPA is proposing to approve the State's BART alternative as it meets the requirements for alternative programs under 40 CFR 51.308(e)(2) and (e)(3).
In order to establish RPGs for its Class I areas, and to determine the controls needed for the long-term strategy, Colorado followed the process established in the RHR. First, Colorado identified the anticipated visibility improvement in 2018 in all its Class I areas using the WRAP Community Multi-Scale Air Quality (CMAQ) modeling results. This modeling identified the extent of visibility improvement from the baseline by pollutant for each Class I area. The modeling relied on projected source emission inventories, which included enforceable Federal and State regulations already in place and anticipated BART controls.
Colorado then identified sources and source categories (other than BART sources) in Colorado that are major contributors to visibility impairment and considered whether these sources should be controlled based on a consideration of the factors identified in the CAA and EPA's regulations.
The SIP includes Colorado's analysis and conclusion that reasonable progress will be made by 2018, including an analysis of pollutant trends, emission reductions, and improvements expected. The RP discussion and analyses are included in Chapter 8 and Appendix D of the SIP. We are proposing to approve Colorado's submitted RP goals as described more fully below.
In order to determine the significant sources contributing to haze in Colorado's Class I areas, Colorado relied upon two source apportionment analysis techniques developed by the WRAP. The first technique was regional modeling using the Comprehensive Air Quality Model (CAMx) and the PM Source Apportionment Technology (PSAT) tool, used for the attribution of sulfate and nitrate sources only. The second technique was the Weighted Emissions Potential (WEP) tool, used for attribution of sources of OC, EC, PM
PSAT uses the CAMx air quality model to show nitrate-sulfate-ammonia chemistry and apply this chemistry to a system of tracers or “tags” to track the chemical transformations, transport, and removal of NO
WEP is a screening tool that helps to identify source regions that have the potential to contribute to haze formation at specific Class I areas. Unlike PSAT, this method does not account for chemistry or deposition. The WEP combines emissions inventories, wind patterns, and residence times of air
Table 29 shows influences from sources both inside and outside of Colorado per the PSAT modeling for 2018. As indicated, boundary conditions or outside domain are the highest contributor to sulfate at all Colorado Class I areas. The boundary conditions represent the background concentrations of pollutants that enter the edge of the modeling domain. Depending on meteorology and the type of pollutant (particularly sulfate), these emissions can be transported great distances that can include regions such as Canada, Mexico, and the Pacific Ocean.
Colorado appears to be a major contributor of particulate sulfate at those Class I areas near significant sources of SO
The State conducted a detailed evaluation of six visibility impairing pollutants: nitrates, sulfates, OC, EC, fine soil and coarse mass (CM) (fine soil and CM are collectively known as PM) contributing to visibility impairment at Colorado's Class I areas.
Based on its analysis, the State determined that the sources of OC, EC, and area source PM are not well documented because of emission inventory limitations associated with natural sources (predominantly wildfires), uncertainty of windblown emissions, and poor model performance for these constituents. The State determined it would defer on addressing these pollutants until science and emission inventories are improved for consideration in future RH SIPs. The State determined that RP controls would be evaluated for SO
The State's analysis evaluated the projected sources of SO
Colorado's analysis shows that point sources comprise 36% of total NO
The State has determined that large point sources are the dominant source of NO
The State used a RP screening methodology called “Q/d” to determine which stationary (point) sources would be candidates for controls under RP. The methodology Q/d is a calculated ratio that evaluates stationary source emissions (mathematical sum of actual SO
The evaluation of potential RP sources involved all Colorado stationary sources with actual SO
Table 30 shows the subject-to-RP sources identified by the State.
We agree with the State's analysis on appropriate source categories and stationary sources to be evaluated under RP.
In determining the measures necessary to make RP, states must take into account the following four factors and demonstrate how they were taken into consideration in selecting RP goals for a Class I area:
• Costs of Compliance;
• Time Necessary for Compliance;
• Energy and Non-air Quality Environmental Impacts of Compliance; and
• Remaining Useful Life of any Potentially Affected Sources. CAA § 169A(g)(1) and 40 CFR 308(d)(1)(i)(A).
The State performed a four factor analysis for each of the RP sources pursuant to 40 CFR 51.308(d)(1)(i)(A).
For potential NO
As it did in the BART context, the State eliminated wet FGD from consideration as a potential RP control for the same reasons—because of negative non-air quality environmental impact on water usage. EPA is proposing that the State has provided adequate justification to eliminate wet FGD as a potential SO
Colorado concluded that it is also appropriate to consider a fifth factor for evaluating potential RP control options—the degree of visibility improvement that may reasonably be anticipated from the use of the RP controls. Our RP guidance contemplates that states may be able to consider other relevant factors for RP sources (see EPA's
For the RP modeling, the State followed the BART Guidelines. The BART Guidelines provide that states may use the CALPUFF modeling system or another appropriate model to determine the visibility improvement expected at a Class I area from the potential BART control technology applied to the source. Colorado performed CALPUFF modeling to determine the degree of visibility improvement expected at a Class I area based on the controls evaluated for RP for the subject-to-RP sources.
The BART Guidelines also recommend that states develop a modeling protocol for making individual source attributions, and suggest that states may want to consult with EPA and their RPO to address any issues prior to modeling. Colorado used the CALPUFF model for Colorado RP sources in accordance with a protocol it developed titled “Supplemental BART Analysis CALPUFF Protocol for Class I Federal Area Visibility Improvement Modeling Analysis, revised August 19, 2010,” which was approved by EPA and is included in the Supplemental Information section of the docket. The Colorado protocol follows recommendations for long range transport described in appendix W to 40 CFR part 51, “Guideline on Air Quality Models,” and in EPA's “Interagency Workgroup on Air Quality Modeling (IWAQM) Phase 2 Summary Report and Recommendations for Modeling Long Range Transport Impacts,” as recommended by the BART Guidelines. (40 CFR part 51, appendix Y, section III.D.5).
For the subject-to-RP sources, the State provided analyses that took into consideration the four factors as required by section 169A(g)(1) of the CAA. The State also included visibility improvement as a fifth factor in its RP analyses for most sources. The State elected to consider EPA's BART Guidelines as relevant to its RP evaluations, in addition to EPA's Reasonable Progress Guidance. A summary of the RP analysis for each source is included in Chapter 8 of the SIP. The State's complete RP analyses, as well as additional technical information and materials, are included in Appendix D of the SIP. EPA is
The PRPA Rawhide Energy Station is located in Larimer County approximately 10 miles north of the town of Wellington, Colorado. Rawhide Unit 101 is a coal-fired steam-driven EGU with a rated electric generating capacity of 305 MW (gross). The Rawhide Station also has five natural-gas-fired combustion turbines. The primary use of these units is to meet PRPA's energy reliability and peak load requirements. The turbines operate on limited, intermittent, and unpredictable schedules as peak loading units. Additionally, the facility includes a number of fugitive dust sources. The State did not do a RP analysis for the turbines or fugitive dust sources since these units fall below the de minimis threshold established by the State.
Rawhide Unit 101 is currently controlled with a dry FGD achieving over 72 percent SO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source.
Baseline SO
The State determined it would take PRPA approximately 2-3 years to switch from coal to natural gas. The State determined fuel switching was not reasonable based on the high cost effectiveness value.
The State also assessed emissions limit tightening based on current operations. Rawhide Unit 101's average 30-day rolling emission rate during the baseline period (2006-2008) was 0.09 lb/MMBtu. The maximum 30-day rolling emission rate during this period was 0.11 lb/MMBtu. The State evaluated both these levels as potential emissions limits. The State also evaluated an emission limit of 0.07 lb/MMBtu. Emissions limit tightening to emissions levels currently achieved is a no-cost control option. The State modeled visibility improvement for SO
The State has determined that the SO
We agree with the State's conclusions, and we are proposing to approve its SO
Rawhide Unit 101 is currently controlled with LNB+ close coupled over fire air + SOFA achieving a 49.6% control. The State determined that enhanced combustion controls (ECC), SNCR, fuel switching from coal to natural gas, and SCR were technically feasible NO
The State did not identify any energy or non-air quality environmental
The State estimates that the time necessary for compliance after SIP approval would be approximately 2-3 years for SNCR and 3-4 years for SCR. ECC could be functional within 6 months of SIP approval.
The State eliminated switching to natural gas and SCR from consideration due to the high cost effectiveness values and associated degree of visibility improvement. The State determined that ECC was reasonable for RP control. The State made this determination based on the cost effectiveness and visibility improvement associated with ECC. SNCR would achieve similar emissions reductions to ECC and would afford a minimal additional visibility benefit (0.01 delta dv), but it would do so at a significantly higher dollar-per-ton control cost compared to the selected ECC. Thus, the State determined that SNCR was not reasonable. Based upon its consideration of the five factors that it used for RP, the State determined that the NO
We agree with the State's conclusions, and we are proposing to approve its NO
Rawhide Unit 101 is equipped with fabric filter baghouses to control PM emissions with an emission limit of 0.03 lb/MMBtu. Stack tests show that the fabric filter baghouses are achieving a 99% reduction in PM. Fabric filter baghouses are the most stringent control technology for controlling PM emissions. The State also evaluated what would constitute the most stringent level of control for PM by looking at recent BACT determinations. Based on this evaluation, the State determined that an emission limit of 0.03 lb/MMBtu represents the most stringent level of control for this type of source. The State did not provide a full four-factor analysis plus visibility improvement modeling because the State determined RP to be the most stringent control technology and limit.
The State has determined that the PM RP emission limit for Rawhide Unit 101 is 0.03 lb/MMBtu (30-day rolling average). The State assumes that the emission limit can be achieved through the operation of the existing fabric filter baghouses.
We agree with the State's conclusions, and we are proposing to approve its PM RP determination for PRPA Rawhide Unit 101.
The CENC facility includes five coal-fired boilers (Boilers 1-5) that supply steam and electrical power to Coors Brewery. Of these five Boilers, Boilers 4 and 5 are subject to BART and Boiler 3 is subject to RP. Boiler 3 is a 225 MMBtu/hr boiler. The State did not evaluate Boiler 1, Boiler 2, or fugitive dust sources at the facility for RP controls since emissions from these units were below the State's de minimis levels. The State's RP determination for CENC Boiler 3 can be found in Chapter 8.5.2.2 and Appendix D of the SIP.
CENC Boiler 3 is currently uncontrolled for SO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. The baseline SO
The State determined it would take CENC five years after SIP approval to install any controls.
The State used modeling results from CENC Boiler 4 to determine the projected visibility improvement for Boiler 3 because the units are similar and located at the same facility. CALPUFF modeling indicates a 0.08 dv improvement for DSI applied to Boiler 4. DSI controls for Boiler 4 would reduce SO
The State determined that fuel switching and DSI were not reasonable to select as RP controls due to the high cost effectiveness values and low visibility improvement associated with these controls. Based on a fuel analysis, the State determined that the maximum SO
We agree with the State's conclusions, and we are proposing to approve its SO
The State determined that flue gas recirculation (FGR), SNCR, ROFA, fuel switching to natural gas, and three options for SCR (regenerative SCR (RSCR), high temperature SCR (HTSCR), and low temperature SCR (LTSCR)) were technically feasible for reducing NO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. A summary of the State's NO
The State estimates that the source would need at least five years after SIP approval to install the control equipment.
The State used modeling results from CENC Boiler 4 to determine the projected visibility improvement for Boiler 3 since the units are similar and located at the same facility. CALPUFF modeling indicates a 0.12 dv improvement for LNB + SOFA + SNCR applied to Boiler 4. LNB + SOFA + SNCR controls for Boiler 4 would reduce NO
Based on a review of historical load characteristics of this boiler, the State determined that RP for Boiler 3 is an annual NO
We agree with the State's conclusions, and we are proposing to approve its NO
CENC Boiler 3 is equipped with a fabric filter baghouse to control PM emissions with a current emission limit of 0.07 lb/MMBtu. Fabric filter baghouses are the most stringent control technology for controlling PM emissions, and stack tests show that the fabric filter baghouses are achieving a 98% reduction in PM. The State determined that PM RP for Boiler 3 is an emission limit of 0.07 lb/MMBtu.
While we do not agree with all of the State's assumptions and conclusions in arriving at a PM RP limit of 0.07 lb/MMBtu, we are proposing to approve the State's PM RP determination for CENC Boiler 3. Based on our review/analysis, it appears CENC is capable of achieving a lower emission limit than 0.07 lb/MMBtu with existing equipment. However, we anticipate that the visibility improvement that would result from lowering the limit to a value below 0.07 lb/MMBtu would be insignificant. Under these circumstances, we are proposing to find that the State's RP determination was reasonable.
We find that an emission limit of 0.07 lb/MMBtu is reasonable, as a lower emission limit would not result in significant visibility improvement. Thus, we are proposing to approve the State's PM RP determination for CENC Boiler 3.
The Nixon facility is located in Fountain, Colorado. This facility consists of one coal fired boiler (Unit 1), an auxiliary boiler, the associated equipment needed for generating electricity, and two natural-gas-fired simple cycle combustion turbines driving electricity generators. The facility also includes the various processes necessary to handle the coal, flyash and bottom ash. The State determined that Unit 1 and the two combustion turbines were subject to RP. The State determined the rest of the units at this facility had emissions below the de minimis thresholds set by the State. The boiler is a 227 MW unit with a pulverized-coal, dry-bottom, front-fired boiler that fires low sulfur western coal as the primary fuel. It can currently use No. 2 distillate oil or natural gas for an ignition fuel. The State's RP determination can be found in Chapter 8.5.2.3 and Appendix D of the SIP. The analysis for the combustion turbines can be found in section V.D.2.b.x of this notice.
Nixon Unit 1 is currently uncontrolled for SO
The State estimates it would take 3-5 years after SIP approval for the source to install controls on Nixon Unit 1.
The State determined that dry FGD was reasonable for RP control for Nixon Unit 1. Based upon its consideration of the five factors that it used for RP, the State determined that the SO
We agree with the State's conclusions, and we are proposing to approve its SO
Nixon Unit 1 is currently controlled for NO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. A summary of the State's NO
The State estimates it would take CSU 2-3 years to install SNCR and 3-4 years to install SCR after SIP approval.
The State determined NO
We agree with the State's conclusions, and we are proposing to approve the State's NO
Nixon Unit 1 is equipped with fabric filter baghouses to control PM emissions with an emission limit of 0.03 lb/MMBtu. Stack tests show that the fabric filter baghouses are achieving greater than a 95% reduction in PM. The State determined that fabric filter baghouses are the most stringent control technology for controlling PM emissions. The State also evaluated what would constitute the most stringent level of control for PM by looking at recent BACT determinations. Based on this evaluation, the State determined that an emission limit of 0.03 lb/MMBtu represents the most stringent level of control for this type of source. The State did not provide a full four-factor analysis plus visibility improvement modeling because the State determined RP to be the most stringent control technology and limit.
The State has determined that the PM RP emission limit for CSU Nixon Unit 1 is 0.03 lb/MMBtu (30-day rolling average). The State assumes that the emission limit can be achieved through the operation of the existing fabric filter baghouses.
We agree with the State's conclusions, and we are proposing to approve its PM RP determination for CSU Nixon Unit 1.
Black Hills/Colorado Electric Utility Company informed the State that the Clark Units 1 and 2 will be shut down by December 31, 2013. The shutdown will result in SO
The Holcim Florence Cement Plant is a Portland cement plant located in Florence, Colorado. In May 2002, a newly constructed cement kiln commenced operation at the plant. This more energy-efficient 5-stage preheater/precalciner kiln replaced three older wet process kilns. The Florence Plant includes a quarry where major raw materials used to produce Portland cement, such as limestone, translime and sandstone, are mined, crushed and then conveyed to the plant site. Emissions from the kiln system, raw mill, coal mill, alkali bypass and clinker cooler are all routed through a common main stack for discharge to the atmosphere. The kiln system is rated at 950 MMBtu per hour of fuel input with a nominal clinker production rate of 5,950 tons per day. It is permitted to burn the following fuel types: Coal, tire derived fuel, petroleum coke, natural gas, dried cellulose, and oil, including non-hazardous used oil. The State determined that the kiln system, quarry, and finish mill were subject to RP and that all other units at this facility fall below the State's de minimis threshold. The quarry and finish mill only have PM emissions. The State RP determination for the Holcim Florence Cement Plant can be found in Chapter 8.5.2.5 and Appendix D of the SIP.
The kiln system is currently controlled with a wet FGD with a current SO
On August 9, 2010, EPA finalized changes to the NSPS for Portland Cement Plants. The NSPS requires new, modified, or reconstructed cement kilns to meet an emission standard of 0.4 pound of SO
The State did evaluate emissions limit tightening based on current operations. As a part of its submittals to the State, Holcim analyzed continuous hourly emission data for SO
We agree with the State's conclusions, and we are proposing to approve its SO
NO
Although we disagree with the State's conclusion on the commercial availability of SCR for cement kilns, we accept the State's decision, for purposes of RH, not to analyze this control technology further. We note that EPA has acknowledged, in the context of establishing NSPS for Portland Cement Plants, substantial uncertainty regarding the cost effectiveness associated with the use of SCR at such plants. See 75 FR 54995. We expect the State to reevaluate this technology in subsequent RP planning periods.
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. A summary of the State's NO
The State has determined that Holcim will need five years from SIP approval to install SNCR controls.
The State determined that NO
The State calculated the 30-day rolling average short-term limit by adjusting upward by 10% (to account for the use of tire-derived fuel) the short-term baseline emission rate of 4.47 pounds of NO
We agree with the State's conclusions, and we are proposing to approve its NO
The kiln system is currently controlled with fabric filter baghouses with an emission limit of 246.3 tpy. The units are exceeding a PM control efficiency of 95%. The State has determined that the existing fabric filter baghouses installed on the kiln system represent the most stringent control technology.
The 246.3 tpy limit equates to an annual average of 0.26 pound of PM per ton of clinker. The State evaluated the impact on visibility of a lower emission rate. The State modeled possible visibility improvements associated with two emission rates: an emission rate of 0.08 pound of PM per ton of clinker (19.83 lbs/hour) and a rate of 0.04 pound of PM per ton of clinker (9.92 lbs/hour). This analysis assumed the emissions were all attributable to the kiln (i.e., no contribution from the clinker cooler) to assess the impact of a possible reduction of the kiln emission limit. The 98th percentile impact for all pollutants is 0.435 dv. The modeling showed no change to this value when the State modeled the lower emission limits. The State's modeling demonstrates that PM is an insignificant contributor to visibility impairment.
Given the very limited impact of PM emissions from the kiln system on visibility impairment, the State determined that no additional PM emissions control is warranted. The State has determined that the PM RP emission limit for the Holcim Florence Cement Kiln is 246.3 tpy of PM (12-month rolling total) from the kiln system main stack (including emissions from the clinker cooler). The State assumes that the emission limit can be achieved through the operation of the existing fabric filter baghouses.
We agree with the State's conclusions, and we are proposing to approve its PM RP determination for the Holcim Florence Cement Kiln.
The quarry has a current PM emission limit of 47.9 tpy. The State has determined that the existing fugitive dust control plan and associated control measures represent the most stringent controls for the quarry emission sources. The control measures include: watering and the use of chemical stabilizers, compaction and re-vegetation of stockpiles, vehicle speed limitations, reclamation and sequential extraction of materials, paving, graveling and cleaning of haul roads, sequential blasting, wet drilling, and the suspension of activities during high wind events. The State also determined that additional controls would result in no additional visibility benefit based on the low permitted emissions.
The State has determined that the PM RP emission limit for the Holcim Florence Cement Quarry is 47.9 tpy fugitive PM (12-month rolling total).
We agree with the State's conclusions, and we are proposing to approve its PM RP determination for the Holcim Florence Cement Quarry.
The finish mill is currently controlled with fabric filter baghouses with an emission limit of 34.3 tpy of PM (12-month rolling total). The units are exceeding a PM control efficiency of 95%. The State determined that the current control technology and limit represent the most stringent level of control for the finish mill. Accordingly, the State did not provide a four-factor analysis plus visibility improvement modeling for the finish mill.
The State has determined that the PM RP emission limit for the Holcim Florence Cement Finish Mill is 34.3 tpy (12-month rolling total). The State assumes that the emission limit can be achieved through the operation of the existing fabric filter baghouses.
We agree with the State's conclusions, and we are proposing to approve its PM RP determination for the Holcim Florence Cement Finish Mill.
The Tri-State Nucla facility is located in Montrose County approximately 3 miles southeast of the town of Nucla, Colorado. The Nucla facility consists of one coal-fired steam-driven electric generating unit, Unit 4, with a rated electric generating capacity of 110 MW (gross). The Nucla facility is an atmospheric circulating fluidized bed (CFB) unit. Additionally, the facility includes a number of fugitive dust sources. Unit 4 is the only unit subject to RP as the fugitive dust sources fall below the de minimis levels set by the State. The State's RP determination for the Nucla facility can be found in Chapter 8.5.2.6 and Appendix D of the SIP.
Unit 4 is currently controlled for SO
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. A summary of the State's SO
The State's analysis assumes that the LII will not require any construction or capital improvements and compliance time will be minimal. The State anticipates that the time necessary for installing dry FGD or dry FGD plus LII would be 3-5 years after SIP approval.
The State eliminated dry FGD and dry FGD plus limestone injection improvements from consideration due to the high cost effectiveness values. The State originally asserted in the Nucla RP analysis that limestone injection improvements are technically feasible. However, Tri-State provided additional information on November 29, 2011 in the Colorado Air Quality Control Commission hearing that introduced significant uncertainty regarding the technical feasibility of LII for Unit 4 at Nucla Station. The State determined upon further evaluation that LII beyond current operations were not feasible in all operating conditions.
Based upon its consideration of the four factors, the State has determined that the SO
We agree with the State's conclusions, and we are proposing to approve the State's SO
In 2006, Tri-State installed a small-scale SNCR system on Unit 4 that injects anhydrous ammonia to achieve NO
The State determined full-scale SNCR and SCR were technically feasible for reducing NO
The State determined that the costs for SCR would likely be excessive, and the State did not further evaluate this control option. The State estimated that the incremental cost of using SCR versus SNCR on a CFB Boiler as $25,315 per ton per the Spiritwood BACT analysis and $40,297 per ton per the Bonanza BACT analysis. The State expects a SCR system at the Nucla Station to have even higher costs due to the retrofit factor and small size of Unit 4.
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of the remaining control evaluated, nor are there any remaining-useful-life issues for this source. A summary of the State's NO
The State anticipates that the time necessary to install and operate SNCR would be approximately 3-5 years after SIP approval.
Based on its consideration of the four factors, the State has determined that NO
We agree with the State's conclusions, and we are proposing to approve its NO
Nucla Unit 4 is equipped with fabric filter baghouses to control PM emissions with an emission limit of 0.03 lb/MMBtu. Stack tests show that the fabric filter baghouses are achieving a 99.9% reduction in PM. The State determined that fabric filter baghouses are the most stringent control technology for controlling PM emissions. The State also evaluated what would constitute the most stringent level of control for PM by looking at recent BACT determinations. Based on this evaluation, the State determined that an emission limit of 0.03 lb/MMBtu represents the most stringent level of control for this type of source. The State did not provide a full four-factor analysis because the State determined RP to be the most stringent control technology and limit.
The State has determined that the PM RP emission limit for Tri-State Nucla Unit 4 is 0.03 lb/MMBtu (30-day rolling average). The State assumes that the emission limit can be achieved through the operation of the existing fabric filter baghouses.
We agree with the State's conclusions, and we are proposing to approve its PM RP determination for Tri-State Nucla Unit 4.
The Tri-State Craig Station is located in Moffat County about 2.5 miles southwest of the town of Craig, Colorado. This facility is a three unit coal-fired power plant with a total net electric generating capacity of 1264 MW. Craig Units 1 and 2 are subject to BART. The State determined Craig Unit 3 was subject to RP. Craig Unit 3 is a dry-bottom pulverized coal-fired boiler. The Craig facility also includes two cooling towers, coal handling systems, ash handling systems, limestone handling system, and the staging/landfill area. In addition to Craig Unit 3, the State determined that the ash handling system and the limestone hauling system were subject to RP (they only emit PM emissions, not SO
Craig Unit 3 is currently controlled with a dry FGD currently achieving over 80 percent SO
The State analyzed emission limit tightening based on current operations. Tri-State made upgrades to the dry FGD between 2007 and 2009. The maximum 30-day rolling emission rate post-upgrade (June 2009-June 2010) was 0.14 lbs/MMBtu and the average 30-day rolling average was 0.11 lbs/MMBtu. The State modeled the visibility improvement that would result from a 0.15 lbs/MMBtu emission limit and 0.07 lbs/MMBtu emission limit. The visibility improvement was 0.26 dv and 0.38 dv, respectively.
Based on its analysis, the State determined that a more stringent 30-day rolling SO
The State has determined that a SO
We agree with the State's conclusions, and we are proposing to approve its SO
Craig Unit 3 is currently controlled with LNBs and OFA that were installed in 2009. The State determined that combustion control refinements, neural network system (NNS) combustion controls, SNCR, and SCR were technically feasible. The State determined that ROFA, ECO, RRI, and coal reburn plus SNCR were not technically feasible.
The State did not identify any energy or non-air quality environmental impacts that would preclude the selection of any of the controls evaluated, nor are there any remaining-useful-life issues for this source. A summary of the State's NO
The State eliminated SCR from consideration due to the high cost effectiveness value and the visibility improvement associated with this control. The State determined SNCR was reasonable for RP control. Based upon its consideration of the five factors that it used for RP, the State has determined that the NO
We agree with the State's conclusions, and we are proposing to approve its NO
Craig Unit 3 is equipped with fabric filter baghouses to control PM emissions with an emission limit of 0.013 lb/MMBtu for PM filterable and 0.012 lb/MMBtu for PM
The State has determined that the PM RP emission limits for Tri-State Craig Unit 3 are 0.013 lb/MMBtu for filterable PM (30-day rolling average) and 0.012 lb/MMBtu for PM
We agree with the State's conclusions, and we are proposing to approve its PM RP determination for Tri-State Craig Unit 3.
PSCO informed the State that the Cameo Station east of Grand Junction, Colorado would be shut down by December 31, 2011, resulting in SO
Because the area source oil and gas category is made up of numerous smaller sources, the State determined it is only practical to evaluate the category for RP control as a whole. When reviewing oil and gas area sources, the State identified heater-treaters and RICE as the largest NO
A heater-treater is a device used to remove contaminants from the natural gas or oil at or near the wellhead before the gas is sent down the production line to a natural gas processing plant or the oil is collected in storage tanks. The latest 2018 emissions inventory for the State assumes approximately 23,000 tons of NO
The State's research shows that emission controls and control applications for this source category are not well developed and have focused primarily on methane reductions. Though the State identified some technically feasible control options, the State determined that the costs of compliance and the control effectiveness could not be confidently determined. Because of the uncertainty of controls, the State has determined that additional controls under RP are not reasonable in this initial planning period.
Power generated by large RICE is generally used to compress natural gas or to generate electricity in remote locations. The designation large RICE refers to engines have a rating of at least 100 horsepower (hp) for the purpose of this RP analysis. Large RICE produce power by combustion of fuel and are operated at various air-to-fuel ratios. RICE are operated with either fuel-rich ratios, which are called rich-burn (RB) engines, or air-rich ratios, which are called lean-burn (LB) engines. The State's 2018 emission inventory shows that large RICE represent 16% of the Statewide point source NO
The State determined the following were technically feasible for controlling NO
A summary of the State's RP analysis for RICE engines is provided in Table 42 below. Because control effectiveness and cost effectiveness is dependent on a number of engine-specific factors, the State has provided a range for these factors. Due to a lack of available information, the State did not provide the cost effectiveness for SNCR.
For RICE NO
In addition, for new and modified RICE of 100 hp or greater, the State is relying on emissions controls that are required by EPA's NSPS subpart JJJJ, 40 CFR part 60, and EPA's NESHAP subpart ZZZZ, 40 CFR part 63. The State determined that these federal control requirements satisfy RP for these sources in this planning period.
Colorado adopted regulations to control NO
In December 2008, Colorado adopted section XVII.E.3.a into Regulation No. 7. Section XVII.E.3.a applies to all existing RB RICE over 500 hp throughout the State. The revisions to Regulation No. 7 required that by July 1, 2010 all existing RB RICE over 500 hp in Colorado had to install NSCR with an ATF controller. Sources subject to emission controls under a MACT, BACT, or NSPS are not subject to the requirements of section XVII.E.3.a. In addition, sources that fall below State permitting thresholds are not subject to the requirements of section XVII.E.3.a. An exemption from control for RB RICE can be obtained upon demonstration that the cost of emission control would exceed $5,000 per ton. The State has included Regulation No. 7, section XVII.E.3.a, as part of the RH SIP to become federally enforceable upon EPA approval.
We are proposing to approve the State's RP determination for RICE engines. We are also proposing to approve Regulation No. 7, section XVII.E.3.a, as part of the SIP.
Combustion turbines fueled by natural gas are either co-located with coal-fired electric generating units or are stand-alone facilities. These units are primarily used to supplement power supply during peak demand periods when electricity use is highest. Typical emissions for this source type may be significant for NO
The State evaluated combustion turbines that are co-located at subject-to-BART or subject-to-RP sources. The State determined there are five BART and RP facilities with combustion turbines: PSCO Valmont Generating Station, PSCO Arapahoe Generating Station, CSU—Nixon Power Plant, PRPA Rawhide Energy Station, and PSCO Pawnee Generating Station. Of these, only two turbines located at the Nixon Front Range Power Plant (Turbine #1 and Turbine #2) emit levels of pollutants above the State de minimis levels for NO
The combustion turbines at the Nixon Front Range Power Plant were installed with advanced dry-low-NO
The State analyzed SCR for RP control. The State determined that applying SCR at a 90% control efficiency to both turbines would result in about 275 tons of NO
We agree with the State's analysis and are proposing to approve its RP determination for combustion turbines and for the CSU—Nixon Power Plant Turbine #1 and Turbine #2.
40 CFR 51.308(d)(1) requires states to “establish goals (in dvs) that provide for RP towards achieving natural visibility conditions” for each Class I area of the State. These RP goals are interim goals that must provide for incremental visibility improvement for the most impaired visibility days, and ensure no degradation for the least impaired visibility days. The RP goals for the first planning period are goals for the year 2018. The State's discussion of RP and RPGs can be found in Chapter 8 and section 9.5 of the SIP.
Colorado is relying on the WRAP's CMAQ regional modeling performed in 2009 to establish its RP goals for 2018. As part of the 2009 CMAQ modeling, WRAP included all western states' reasonably foreseeable control measures in the projections of 2018 visibility levels.
The Regional Modeling Center at the University of California Riverside, under the oversight of the WRAP Modeling Forum, performed modeling used for the RH long-term strategy for the WRAP member states, including Colorado. The modeling analysis is a complex technical evaluation that began with selection of the modeling system. The Regional Modeling Center primarily used the CMAQ photochemical grid model to estimate 2018 visibility conditions in Colorado and all western Class I areas, based on application of the RH strategies in the various state plans, including assumed controls on BART sources.
The Regional Modeling Center developed air quality modeling inputs, including annual meteorology and emissions inventories for: (1) A 2002 actual emissions base case; (2) a planning case to represent the 2000-2004 RH baseline period using averages for key emissions categories; and (3) a 2018 base case of projected emissions determined using factors known at the end of 2005. Each of these inventories underwent a number of revisions throughout the development process to arrive at the final versions used in CMAQ modeling. The WRAP states' modeling was developed in accordance with our guidance.
The photochemical modeling of RH for the WRAP states for 2002 and 2018 was conducted on the 36-km resolution national regional planning organization domain that covered the continental United States, portions of Canada and Mexico, and portions of the Atlantic and Pacific Oceans along the east and west coasts. The Regional Modeling Center examined the model performance of the regional modeling for the areas of interest before determining whether the CMAQ model results were suitable for use in the RH assessment of the long-term strategy and for use in the modeling assessment. The 2002 modeling efforts were used to evaluate air quality/visibility modeling for a historical episode, in this case, for calendar year 2002, to demonstrate the suitability of the modeling systems for subsequent planning, sensitivity, and emissions control strategy modeling. Model performance evaluation compares output from model simulations with ambient air quality data for the same time period to determine whether model performance is sufficiently accurate to justify using the model to simulate future conditions.
Once the Regional Modeling Center determined that model performance was acceptable, it used the model to determine the 2018 RP goals using the current and future year air quality modeling predictions, and compared the RP goals to the uniform rate of progress.
The State determined that the WRAP 2018 projections represent significant visibility improvement and RP toward natural visibility based upon the State's consideration of the factors required for BART and RP. The State is adopting the WRAPs 2018 projections as its RPG for each Class I area in Colorado. Table 43 shows the URP and the 2018 RPG adopted by the State for such areas.
Table 43 shows that the State's RH SIP will provide for improvement in visibility for the most-impaired days over the period ending in 2018 and will allow for no degradation in visibility for the least-impaired days.
Table 43 also shows that Colorado is not meeting the URP to meet natural visibility conditions by 2064 because the projected 2018 RPG is greater than the 2018 URP. The State finds that the RPGs established in this SIP are reasonable for this planning period and that achieving the URP in this planning period is not reasonable. Pursuant to 40 CFR 51.308(d)(1)(ii), the State has determined and presented detailed analyses to show why certain controls for specified RP sources are reasonable, and why additional controls during this planning period are not reasonable based upon its consideration of the required factors for RP (40 CFR 51.308(d)(1)(i)(A)). The State has determined and presented detailed analyses to show why certain controls for specified BART sources are reasonable based upon its consideration of the five-factors (40 CFR 51.308(e)(1)(A)). In addition, sources outside of the modeling domain are the single largest contributor to sulfate or nitrate at many Class I areas (see Table 29 in section V.D.1 of this notice). These sources are not under the control of Colorado or the surrounding States, and
Since the State is not meeting the URP, the State is required by 40 CFR 51.308(d)(1)(ii) to assess the number of years it would take to reach natural conditions if visibility improvement continues at the current rate of progress. The State has calculated the year and the length of time to reach natural visibility as follows: Great Sand Dunes: 2152 (148 years); Mesa Verde: 2168 (164 years); Zirkel and Rawah: 2106 (102 years); Rocky Mountain: 2098 (94 years); Black Canyon, Weminuche, and La Garita: 2119 (115 years); and Eagles Nest, Flat Tops, Maroon Bells and West Elk: 2083 (79 years).
We note that the WRAP 2018 reasonable progress projections did not reflect the additional RH controls that Colorado adopted in 2010. These controls included additional BART requirements, the PSCO BART alternative, and RP limits as described above. These additional controls will produce about 44,500 tpy of NO
EPA has evaluated Colorado's demonstrations concerning the RPGs and finds that they provide for reasonable progress towards natural visibility conditions for the first planning period. Based on the RP factors, Colorado has demonstrated that it is not reasonable to attain the URPs for Colorado's Class I areas in the first planning period, and that Colorado's RPGs (as augmented by the additional measures that Colorado adopted in 2010) are reasonable. Colorado has adopted BART, BART alternative, and RP controls that will achieve substantial reductions of NO
40 CFR 51.308(d)(3)(iii) requires that Colorado document the technical basis, including modeling, monitoring, and emissions information, on which it relied to determine its apportionment of emission reduction obligations necessary for achieving RP in each mandatory Class I Federal area it affects. Colorado must identify the baseline emissions inventory on which its strategies are based. 40 CFR 51.308(d)(3)(iv) requires that Colorado identify all anthropogenic (human-caused) sources of visibility impairment it considered in developing its long-term strategy. This includes major and minor stationary sources, mobile sources, and area sources.
In order to meet these requirements, Colorado relied on the emission inventory developed by the WRAP. The pollutants inventoried by the WRAP that Colorado used for this SIP include SO
There are a number of emission inventory source categories identified in the Colorado SIP: point, area, on-road mobile, off-road mobile, anthropogenic fire, natural fire, road dust, fugitive dust, area source oil and gas, and biogenic emissions. The State provided the 2002 baseline, the 2018 projected emissions, and the net change of emissions between 2002 and 2018 for SO
Sulfur dioxide emissions come primarily from coal combustion at EGUs but smaller amounts come from natural gas combustion, mobile sources and wood combustion.
Overall, SO
NO
Overall, NO
VOCs come from such sources as automobiles, industrial and commercial facilities, solvent use, and refueling automobiles. Substantial natural emissions of VOCs come from vegetation.
Overall, VOC emissions are projected to decrease by 3% statewide, with a 37% increase in area source emissions and a 60% increase in oil and gas emissions. Area source emission increases are a result of increased population growth, and increases in oil and gas emissions are attributable to increased oil and gas development.
OC are emitted directly from the combustion of organic material. A wide variety of sources contribute emissions to this pollutant, including diesel emissions and combustion byproducts from wood and agricultural burning.
Overall, OC emissions decrease by 1% in 2018. The main source category expected to increase by 2018 is road dust. The increase in road dust is associated with increases in population and more vehicle miles traveled.
Elemental carbon, also known as soot, is a byproduct of incomplete combustion. Emissions and reductions in this category are dominated by mobile sources. Expected new federal emission standards for mobile sources, especially for diesel engines, along with fleet replacement, are the reasons for the reductions.
Overall, this category is expected to decline by 23%, with on-road and off-road mobile sources expected to decline by 72% and 58%, respectively. The main source category expected to increase by 2018 is road dust. The increase in road dust is associated with increases in population and more vehicle miles traveled.
Fine soil emissions are largely related to agricultural and mining activities, windblown dust from construction areas and emissions from unpaved and paved roads.
Overall, PM
PM
Overall, PM
40 CFR 51.308(d)(3)(i) requires that Colorado consult with another state if its emissions are reasonably anticipated to contribute to visibility impairment at that state's Class I area(s), and that Colorado consult with other states if those other states' emissions are reasonably anticipated to contribute to visibility impairment at its Class I areas. Colorado consulted with other states during ongoing participation in the WRAP while developing its SIP. Through the WRAP consultation process, Colorado has reviewed and analyzed contributions from other states that reasonably may cause or contribute to visibility impairment in Colorado's Class I areas and Colorado's impact on other states' Class I areas. The State held specific discussions with states that have a primary impact on Colorado Class I areas. These include California, Utah, Nebraska, Wyoming, New Mexico, and Arizona.
40 CFR 51.308(d)(3)(ii) requires that if Colorado emissions cause or contribute to impairment in another state's Class I area, Colorado must demonstrate that it has included in its RH SIP all measures necessary to obtain its share of the emission reductions needed to meet the progress goal for that Class I area. Section 51.308(d)(3)(ii) also requires that, since Colorado participated in a regional planning process, it must ensure it has included all measures needed to achieve its apportionment of emission reduction obligations agreed upon through that process. As we state in the RHR, Colorado's commitments to participate in WRAP bind it to secure emission reductions agreed to as a result of that process.
Colorado analyzed the WRAP PSAT modeling and determined that emissions from the State do not significantly impact other states' Class I areas. Colorado's largest visibility impacts are at Canyonlands National Park in Utah and Bandelier National Monument in New Mexico. Colorado's total nitrate and sulfate contributions represent 1.0% and 0.5%, respectively, of total haze at these Class I areas. The State determined this is not a meaningful level of contribution. Colorado accepted and incorporated the WRAP-developed visibility modeling into its RH SIP, and the State's RH SIP includes the controls assumed in the modeling. Colorado satisfied the RHR's requirements for consultation and included controls in the SIP sufficient to address the relevant requirements of the RHR related to impacts on Class I areas in other states.
We are proposing to find that the State has met the requirements for consultation under 40 CFR 51.308(d)(3)(ii) and 40 CFR 51.308(d)(3)(iii).
40 CFR 51.308(d)(3)(v) requires that Colorado, at a minimum, consider certain factors in developing its long-term strategy (the long-term strategy factors). These are: (a) Emission reductions due to ongoing air pollution control programs, including measures to address reasonably attributable visibility impairment (RAVI); (b) measures to mitigate the impacts of construction activities; (c) emissions limitations and schedules for compliance to achieve the RPGs; (d) source retirement and replacement schedules; (e) smoke management techniques for agricultural and forestry management purposes including plans that currently exist within the state for these purposes; (f) enforceability of emissions limitations and control measures; and (g) the anticipated net effect on visibility due to projected changes in point, area, and mobile source emissions over the period addressed by the long-term strategy.
In addition to its BART and RP determinations, the State's long-term strategy contains other reductions due to ongoing air pollution programs. The State's long-term strategy contains both state only and federally enforceable programs. Some examples of these programs that are federally enforceable and the emission reductions they achieve include: (1) Oil and gas condensate tank control regulations for the Front Range region that have achieved approximately 52,000 tpy of VOC emission reductions by 2007 with additional projected reductions of 18,000 tpy by 2010 (Regulation No. 7); (2) existing industrial engine control regulations for the Front Range region that have achieved NO
Regulation No.1
Colorado addresses the requirements for smoke management in Regulation No. 9
The regulation requires all prescribed fire permitees to submit an application to the State. The State only grants a permit if the State's assessment demonstrates that under the prescribed meteorological conditions for the burn there will be no unacceptable air pollution, including visibility impacts. The regulation provides for the State to impose permit conditions necessary to ensure that the burn will be conducted to minimize the impacts of the fire on visibility and on public health and welfare. Permitted sources are also required to report actual activity to the State. Depending on the size and type of fire, reporting may be a daily requirement. At a minimum, permitted sources must report yearly to the State with information indicating whether or not there was any activity in the area covered by the permit and, if so, how many acres were burned.
Colorado inputs fire data into the WRAP Fire Emissions Tracking System (FETS). The FETS gives the State more precise information for future inventories and studies. The State commits in this SIP to continue administration of Regulation 9 as part of this LTS, and to input data into the FETS as long as it is operational.
The State has included the emission limitations and compliance schedules for those sources specifically identified for control in this RH SIP in Chapters 6 and 8, Regulation No. 3, Part F and Regulation No.7, Section XVII.E.3.a. For the BART sources, Regulation No. 3, section VI.A contains the emission limitations for each of the sources and provides that sources must comply as expeditiously as possible, but no later than five years from EPA approval of the SIP. For RP sources, Regulation No. 3, section VI.B, contains the emission limitations for each of the sources and provides that sources must comply no later than December 31, 2017. For the PSCO BART alternative, Regulation No. 3, section VI.C, contains the emission limitations and the compliance deadlines for sources covered by the PSCO BART alternative. Regulation No. 7, Section XVII.E.3.a contains the compliance schedule for RB RICE over 500 hp.
We are proposing to approve the emission limits and compliance schedules contained in Regulation No. 3, sections VI.A, VI.B, and VI.C.
The State has included specific information on source retirement for those sources specifically identified for shutdown in its RH SIP. The State has identified the sources in the PSCO BART alternative that will shut down. Specifically, under the PSCO BART alternative, the following units will be retired: Arapahoe Unit 3 by December 31, 2013; Cherokee Unit 1 by July 1, 2012, Cherokee Unit 2 by December 31, 2011, Cherokee Unit 3 by December 31, 2016, and Valmont by December 31, 2017. The shutdown of the sources under the BART alternative is required by the RH SIP (see Chapter 6.4.3.7 of the SIP and Regulation No. 3, Part F, SectionVI.C). Under RP, PSCO Cameo Station and Black Hills Clark Facility Units 1 and 2 will be, or have already, shut down. The shutdown of these RP sources is required by the RH SIP (see Chapter 8.5.2 of the SIP and Regulation No. 3, Part F, Section VI.B). The State is assuming that all other stationary sources evaluated in the SIP will remain in operation through the end of this planning period.
The State is also assuming mobile source fleet turnover. For mobile sources, the turnover of the fleet from older, higher-emitting vehicles to newer, lower-emitting vehicles is captured in the emission inventory presented in section V.E.1 of this notice. The State developed the fleet turnover rate utilizing EPA-approved methodologies.
Section 51.308(d)(3)(v)(f) of the RHR requires States to ensure that emission limitations and control measures used to meet RPGs are enforceable. In addition to what is required by the RHR, general SIP requirements mandate that the SIP must also include adequate monitoring, recordkeeping, and reporting requirements for the RH emission limits and requirements. (see CAA section 110(a)). As noted above, Chapters 6 and 8 of the SIP and Regulation No. 3, Part F, Sections VI.A, VI.B, and VI.C, specify BART, RP, and BART alternative emission limits and compliance schedules. The State is submitting Regulation No. 3, Part F, Section VI, as part of the RH SIP.
Regulation No. 3, Part F, Section VII, specifies monitoring, recordkeeping, and reporting requirements for BART, RP, and BART alternative units. The State is submitting Regulation No. 3, Part F, Section VII, as part of its RH SIP. Colorado worked closely with EPA in developing these requirements. For SO
The anticipated net effect on visibility due to projected changes in point, area, and mobile source emissions during this planning period is addressed in section V.D.3 of this notice.
Based on our analysis, we have determined the State is meeting the long-term strategy requirements under 40 CFR 51.308(d)(3)(v). EPA is proposing to approve the State's long-term strategy found in Chapter 9 of the SIP. In addition, EPA is proposing to approve Regulation No. 3, Part F, Section VI and Section VII.
Our visibility regulations direct states to coordinate their RAVI long-term strategy and monitoring provisions with those for RH, as explained in section IV.F above. Under our RAVI regulations, the RAVI portion of a state SIP must address any integral vistas identified by the FLMs pursuant to 40 CFR 51.304 (see 40 CFR 51.302). An integral vista is defined in 40 CFR 51.301 as a view perceived from within the mandatory Class I Federal area of a specific landmark or panorama located outside the boundary of the mandatory Class I Federal area. Visibility in any mandatory Class I Federal area includes any integral vista associated with that area. The long-term strategy must have the capability of addressing current and future existing impairment situations as they face the state.
Regulation No. 3, Part D, Section XIV provides FLMs the opportunity to certify whether an existing stationary source(s) is reasonably attributable to existing visibility impairment and potentially subject to BART and provides the State's review schedule for the RAVI long-term strategy. The EPA previously approved the State's 2004 RAVI long-term strategy as meeting the requirements of 40 CFR 51.306 (see 71 FR 64465). In order to coordinate the RH long-term strategy and the RAVI long-term strategy, the State submitted revisions to Regulation No. 3, Part D, Section XIV. The State amended Regulation No. 3, Part D, Section XIV.F as part of this SIP action to change the current three-year RAVI long-term strategy review cycle to a five-year cycle (as required by the RH Rule) to coordinate the RAVI and RH elements together as intended by the RH rule.
We propose to find that the RH SIP appropriately supplements and augments Colorado's RAVI provisions by updating the monitoring and long-term strategy provisions to address RH. We discuss the relevant monitoring provisions further below. We are also proposing to approve the revision to Regulation No. 3, Part D, Section XIV.F, to change the review period from three years to five years to coordinate with the five-year periodic review required by the RH Rule.
40 CFR 51.308(d)(4) requires that the SIP contain a monitoring strategy for measuring, characterizing, and reporting RH visibility impairment that is representative of all mandatory Class I Federal areas within the state. This monitoring strategy must be coordinated with the monitoring strategy required in 40 CFR 51.305 for RAVI. As 40 CFR 51.308(d)(4) notes, compliance with this requirement may be met through participation in the IMPROVE network. 40 CFR 51.308(d)(4)(i) further requires the establishment of any additional monitoring sites or equipment needed to assess whether RPGs to address RH for all mandatory Class I Federal areas within the state are being achieved.
Consistent with EPA's monitoring regulations for RAVI and RH, Colorado indicates in Chapter 3 of the RH SIP that it will rely on the IMPROVE network for compliance purposes, in addition to any additional visibility impairment monitoring that may be needed in the future. The IMPROVE monitors at the Colorado Class I Areas are described in section IV.B of this notice.
Section 51.308(d)(4)(ii) requires that Colorado establish procedures by which monitoring data and other information are used in determining the contribution of emissions from within Colorado to RH visibility impairment at mandatory Class I Federal areas both within and outside the state. The IMPROVE monitoring program is national in scope, and other states have similar monitoring and data reporting procedures, ensuring a consistent and robust monitoring data collection system. As 40 CFR 51.308(d)(4) indicates, Colorado's participation in the IMPROVE program constitutes compliance with this requirement.
Section 51.308(d)(4)(iv) requires that the SIP provide for the reporting of all visibility monitoring data to the Administrator at least annually for each mandatory Class I Federal area in the state. To the extent possible, Colorado should report visibility monitoring data electronically. Section 51.308(d)(4)(vi) also requires that the SIP provide for other elements, including reporting, recordkeeping, and other measures, necessary to assess and report on visibility. We propose that Colorado's participation in the IMPROVE network ensures that the monitoring data is reported at least annually and is easily accessible; therefore, such participation complies with this requirement. IMPROVE data are centrally compiled and made available to EPA, states and the public via various electronic formats and Web sites including IMPROVE (
Section 51.308(d)(4)(v) requires that Colorado maintain a statewide inventory of emissions of pollutants that are reasonably anticipated to cause or contribute to visibility impairment in any mandatory Class I Federal area. The inventory must include emissions for a baseline year, emissions for the most recent year for which data are available, and estimates of future projected emissions. The state must also include a commitment to update the inventory periodically. The State's emission inventory is discussed in section V.E.1 above. Chapter 3 of the SIP states that Colorado will update its portion of the regional inventory on the tri-annual cycle as dictated by the Air Emissions Reporting Rule in order to track emission change commitments and trends as well as for input to regional modeling exercises.
Section 51.308(d)(4)(vi) requires that states provide for any additional reporting, recordkeeping, and measures necessary to evaluate and report on visibility. The State has committed to provide any additional reporting, recordkeeping and measures necessary to evaluate and report on visibility but has concluded that it cannot identify a need for any specific commitment at this time. We agree with the State's conclusion that no specific additional measures are necessary at this time.
We propose to find that Colorado has satisfied the requirements in 40 CFR 51.308(d)(4).
Class I areas in Colorado are managed by either the U.S. Forest Service (FS) or the U.S. National Park Service (NPS). Although the FLMs are very active in participating in the regional planning organizations, the RHR grants the FLMs a special role in the review of the RH SIPs, summarized in section IV.H, above. The FLMs and the state environmental agencies are our partners in the RH process. Under 40 CFR 51.308(i)(2), Colorado was obligated to provide the FS and the NPS with an opportunity for consultation, in person and at least 60 days prior to holding a public hearing on the RH SIP. In development of its 2010 RH SIP submittal, Colorado met with the FS and NPS for consultation on June 2, 2010, August 12, 2010, and October 5, 2010.
Section CFR 51.308(i)(3) requires that Colorado provide in its RH SIP a description of how it addressed any comments provided by the FLMs. The FLMs formally commented on the 2010 proposed SIP in November and December of 2010. The NPS and FS provided support for the modeling approach used by the State in the BART determinations and complimented the State on thorough BART and RP analyses and area source evaluations. The FLMs also presented recommendations that the State reevaluate costs and emission limits for some of the BART and RP sources. Chapter 2.1 of the State's SIP provides more detailed information on the State's response to FLM comments.
Lastly, 40 CFR 51.308(i)(4) specifies the RH SIP must provide procedures for continuing consultation between the state and FLMs on the implementation of the visibility protection program required by 40 CFR 51.308. This includes development and review of implementation plan revisions and five-year progress reports and the implementation of other programs having the potential to contribute to impairment of visibility in mandatory Class I Federal areas. In Chapter 10 of the SIP, the State has included a commitment that it will provide the FLMs an opportunity to review and comment on SIP revisions, the five-year progress reports, and other developing programs that may contribute to Class I visibility impairment. Colorado will afford the FLMs with an opportunity for consultation in person and at least 60 days prior to holding any public hearing on a SIP revision. The FLM consultation must include the opportunity to discuss the FLMs' assessment of visibility impairment in each federal Class I area and to provide recommendations on the development and implementation of the visibility control strategies.
In accordance with the requirements listed in 40 CFR 51.308(g), Colorado commits in Chapter 10 of its SIP to submit a report on RP to EPA every five years following the initial submittal of the SIP. That report will be in the form of an implementation plan revision. The State's report will evaluate the progress made towards the RPGs for each mandatory Class I area located within Colorado and in each mandatory Class I area located outside Colorado, which have been identified as being affected by emissions from Colorado. The State will also evaluate the monitoring strategy adequacy in assessing RPGs.
Based on the findings of the five-year progress report, 40 CFR 51.308(h) requires a state to make a determination of adequacy of the current implementation plan. The State must take one or more of the actions listed in 40 CFR 51. 308(h)(1) through (4) that are applicable at the same time as the state submits a five-year progress report. Colorado commits in Chapter 10 of the SIP to determine the adequacy of the current SIP at the same time a five-year progress report is due.
Section CFR 51.308(f) requires a state to revise and submit its RH SIP to EPA by July 31, 2018, and every ten years thereafter. The State commits in Chapter 10 of the SIP to provide this revision and to evaluate and reassess elements required under 40 CFR 51.308(d), taking into account improvements in monitoring data collection and analysis, and control technologies.
EPA is proposing to approve a SIP revision submitted by the State of Colorado on May 25, 2011 that addresses RH. EPA is proposing to determine that the plan submitted by Colorado satisfies requirements of the CAA and our rules under 40 CFR 51.308 that require states to prevent any future and remedy any existing man-made impairment of visibility in mandatory Class I areas. We are proposing to approve the State's RH SIP, including revisions submitted as part of the RH SIP to:
• Regulation No. 3, Part F, Section VI and Section VII.
• Regulation No. 3, Part D, Section XIV.F.
• Regulation No. 7, Section XVII.E.3.a.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations (42 USC 7410(k), 40 CFR 52.02(a)). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this proposed action merely approves state law as meeting Federal requirements; this proposed action does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 USC 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 USC 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 USC 272 note) because application of those requirements would be inconsistent with the CAA; and,
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on Tribal governments or preempt Tribal law.
Environmental protection, Air pollution control, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.