The FAA invites you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2019-0566; Product Identifier 2018-CE-035-AD” at the beginning of your comments. The FAA specifically invites comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. The FAA will consider all comments received by the closing date and may amend this proposed AD because of those comments.

The FAA will post all comments the FAA receives, without change, to http://regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about this proposed AD.

The Civil Aviation Authority (CAA), which is the aviation authority for New Zealand, has issued AD DCA/750XL/31, dated July 5, 2018 (referred to after this as “the MCAI”), to correct an unsafe condition for Pacific Aerospace Limited Model 750XL airplanes. The MCAI states:

The CAA advised the design is non-compliant with regard to the fireproof requirements for firewalls. Ineffective sealant may fail to prevent fire propagation through the firewall, which could result in smoke or fire in the cockpit. The CAA issued the MCAI to correct this unsafe condition. You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-0566.

Pacific Aerospace Limited has issued Pacific Aerospace Service Bulletin PACSB/XL/101, Issue 1, dated May 9, 2018. The service information provides instructions for installing improved firewall sealing for wiring penetration looms and correcting any damaged or chafed looms. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI and service information referenced above. The FAA is proposing this AD because the FAA evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

The FAA estimates that this proposed AD will affect 22 products of U.S. registry. The FAA also estimates that it would take about 8 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $385 per product.

Based on these figures, the FAA estimates the cost of the proposed AD on U.S. operators to be $23,430, or $1,065 per product.

According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all costs in our cost estimate.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. 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.

The FAA is issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, balloons, airships, domestic business jet transport airplanes, and associated appliances to the Director of the Policy and Innovation Division.

The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect 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.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

Background

The proposed regulations that are the subject of this correction are under sections 199A and 1388 of the Internal Revenue Code.

As published, the notice of proposed rulemaking; withdrawal of notice of proposed rulemaking (REG-118425-18) contains errors which may prove to be misleading and need to be clarified.

Accordingly, the notice of proposed rulemaking; withdrawal of notice proposed rulemaking (REG-118425-18) that was the subject of FR Doc. 2019-11501, published at 84 FR 28668 (June 19, 2019), is corrected to read as follows:

1. On page 28668, in the preamble, second column, under caption ADDRESSES , third line from the bottom of the paragraph, the language “1118425-18” is corrected to read “118425-18”.

2. On page 28670, in the preamble, first column, the sixth line from the bottom of the last paragraph, the language “defined under section” is corrected to read “defined under”.

3. On page 28670, in the preamble, second column, the third line from the bottom of the last partial paragraph, the language “deduction and” is corrected to read “deduction, and “.

4. On page 28671, in the preamble, first column, the twelfth line from the bottom of the page, the language “deduction and” is corrected to read “deduction, and”.

5. On page 28671, in the preamble, second column, under the paragraph heading “ D. Determination of W-2 Wages and UBIA of Qualified Property”, the first line of the paragraph, the language “Section § ” is corrected to read “Section”.

6. On page 28676, in the preamble, second column, under the paragraph V. Proposed § 1.199A-11, Wage Limitation, the sixth line of the paragraph, the language “2019-16” is corrected to read “2019-31”.

On May 20, 2019, Race World Offshore notified the Coast Guard that it will be conducting a high speed boat race from 9:30 a.m. to 4:30 p.m. on November 6, 8, and 10, 2019. Approximately 50 participants and 200 spectator craft will attend the event, which will take place in the Atlantic Ocean, off the tip of Key West, Florida, on the waters of the Key West Main Ship Channel, Key West Turning Basin, and Key West Harbor Entrance in Key West, FL. The Captain of the Port Key West has determined the potential hazards associated with the high speed boat race would be a safety concern for the participants, participant vessels, and the general public.

The purpose of this rulemaking is to protect event participants, spectators, and vessels on the navigable waters of the Key West Main Ship Channel, Key West Turning Basin, and Key West Harbor Entrance before, during, and after the scheduled event. The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70041.

The COTP Key West proposes to establish a temporary special local regulation from 9:30 a.m. through 4:30 p.m. on November 6, 8, and 10, 2019. The proposed special local regulation would consist of two regulated areas: (1) A race and safety buffer area and (2) a spectator area. These areas would prohibit persons and vessels from entering, transiting through, anchoring in, or remaining within the race area or buffer zone and prohibits vessels from transiting at speeds that cause wake within the spectator area, unless authorized by the Captain of the Port Key West or a designated representative The special local regulation would cover all navigable waters In the Atlantic Ocean, off the tip of Key West, Florida, on the waters of the Key West Main Ship Channel, Key West Turning Basin, and Key West Harbor Entrance. The regulatory text we are proposing appears at the end of this document.

We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the location, duration, and time-of-day of the regulated area. Although persons and vessels may not enter, transit through, anchor in, or remain within the area without authorization from the COTP or a designated representative, they will be able to safely transit around the area. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the area, and the rule would allow vessels to seek permission to enter the area between race heats.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the regulated area may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132 (Federalism), if it has a substantial direct effect 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. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect 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. If you believe this proposed rule has implications for federalism or Indian tribes, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this proposed rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a temporary special local regulation for a 7 hour duration on 3 days that would prohibit entry into the race area or buffer zone, and prohibit vessels from transiting at speeds that cause wake within the spectator area. Normally such actions are categorically excluded from further review under paragraph L61 in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, call or email the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to https://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit https://www.regulations.gov/privacyNotice.

Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 100 as follows:

This proposed rule is organized as follows:

This proposed action is proposing to withdraw certain federal human health criteria that are no longer needed due to the EPA's approval of corresponding state human health criteria on May 10, 2019. Entities discharging in Washington waters, citizens, as well as the state of Washington may be interested in this rulemaking, as after the completion of this rulemaking Washington's EPA-approved human health criteria, rather than the federal human health criteria, will be the applicable water quality standards in Washington waters for CWA purposes. If you have questions regarding the applicability of this action to a particular entity, consult the person identified in the preceding FOR FURTHER INFORMATION CONTACT section.

Consistent with the CWA, the EPA's water quality standards (WQS) program assigns to states and authorized tribes the primary authority for adopting WQS. 1 After states adopt WQS, they must be submitted to the EPA for review and action in accordance with the CWA. The Act authorizes the EPA to promulgate federal WQS following the EPA's disapproval of state WQS or an Administrator's determination that new or revised WQS are “necessary to meet the requirements of the Act.”  2

On September 14, 2015, the EPA proposed a federal rule to establish updated human health criteria in Washington based on an Administrator's determination that new or revised WQS were necessary to meet the requirements of the Act. Specifically, in its 2015 proposed rulemaking, the EPA considered data representing regional and local fish consumption that reflected consumption levels much higher than the National Toxics Rule (NTR) fish consumption rate of 6.5 grams/day, and accordingly “determined that the federal human health criteria in the NTR as applied to Washington no longer protect the relevant designated uses of Washington's waters.”  3 To address the Administrator's determination pursuant to its section 303(c) authority, the EPA's proposed rulemaking established human health criteria using a fish consumption rate of 175 grams/day. 4 As explained in the EPA's May 10, 2019, letter, the EPA also used all of the inputs from the EPA's recently updated 2015 CWA section 304(a) recommendations to calculate the proposed federal criteria. 5

Following the EPA's 2015 proposed rulemaking, on August 1, 2016, Washington submitted human health criteria for the EPA's review. 6 Washington's criteria were based on a fish consumption rate of 175 grams/day and incorporated most of the components of the EPA's updated 2015 CWA section 304(a) recommendations. 7 By using a fish consumption rate of 175 grams/day which is consistent with the EPA's proposed rulemaking, Washington's human health criteria addressed the basis for the EPA's 2015 Administrator's determination—that it is necessary to adopt new or revised human health criteria based on a higher fish consumption rate.

For the reasons explained in the EPA's 2016 disapproval letter and final federal rule, the EPA partially disapproved certain human health criteria that Washington submitted to the EPA. 8 The EPA's final federal rule was issued concurrent with its partial disapproval letter. 9 In explaining the rationale underlying the partial disapproval of Washington's August 1, 2016, submittal, the EPA “agree[d] with Washington's decision to derive the human health criteria using a FCR of 175 g/day,” noting that that value was consistent with the EPA's final federal rule, 10 however the EPA disagreed with the risk management decisions the State made during the development of its human health criteria and its decision not to incorporate all components of the updated 2015 CWA section 304(a) recommendations. 11

Although the EPA promulgated human health criteria for Washington in the NTR, and subsequently in November 2016, the EPA prefers that states maintain primary responsibility and establish their own WQS. In response to a February 21, 2017, petition from several entities asking the EPA to reconsider the partial disapproval of Washington's August 2016 human health criteria, 12 the EPA issued a letter on August 3, 2018 stating its intent to reconsider its partial disapproval of Washington's human health criteria and its subsequent promulgation of federal criteria. 13 After a thorough review of the State's 2016 submittal and applicable provisions of the CWA, implementing regulations and longstanding EPA guidance, on May 10, 2019, the EPA reconsidered its partial disapproval of Washington's human health criteria and approved all but two of the criteria that the EPA previously disapproved. 14

As provided in 40 CFR 131.21(c), federally promulgated WQS that are more stringent than EPA-approved state WQS remain applicable for purposes of the CWA until the EPA withdraws the federal standards. Accordingly, the EPA is proposing to amend the federal regulations to withdraw those federally promulgated human health criteria for which the EPA has approved Washington's criteria and is providing an opportunity for public comment on this proposed action.

The EPA's proposal to withdraw federal criteria following approval of state criteria is consistent with the federal and state roles contemplated by the CWA. Consistent with the cooperative federalism structure of the CWA, once the EPA approves state WQS addressing the same pollutants for which the EPA has promulgated federal WQS, it is incumbent on the EPA to withdraw the federal WQS to enable the EPA-approved state WQS to become the applicable WQS for CWA purposes. That is what the EPA is proposing to do in this proposed rulemaking. This proposal is consistent with the EPA's withdrawal of other federally promulgated WQS following the EPA's approval of state-adopted WQS. 15 Further, although the state of Washington opposes the EPA withdrawing the 2016 federal human health criteria, the State remains free to promulgate the federal standards into state law if it so chooses. 16

Shortly before taking its action to approve Washington's human health criteria, the EPA received several letters expressing concerns about the EPA revising or repealing the federal criteria and the EPA's authority under the CWA to “propose new standards” for a state. 17 As described herein, the EPA reconsidered the human health criteria that Washington submitted to the EPA in 2016 and approved the majority of those criteria. In light of that approval, the EPA proposes to amend federal regulations to withdraw the federal criteria the EPA previously promulgated for Washington. Thus, in this proposed rulemaking, the EPA is not proposing to promulgate any new or revised federal criteria for Washington. The EPA's authority to promulgate new or revised federal criteria is not at issue in this proposal to withdraw the federal criteria.

This action proposes to amend federal regulations to withdraw all federal human health criteria promulgated for Washington in November 2016 at 40 CFR 131.45, 18 with the exception of criteria for arsenic, methylmercury, and bis(2-chloro-1-methylethyl) ether. For arsenic, on May 10, 2019, the EPA reaffirmed its November 2016 disapproval of the two criteria Washington submitted for arsenic (water + organism and organism only), and therefore the federal arsenic criteria for Washington at 40 CFR 131.45 will remain in place. 19 For methylmercury and bis(2-chloro-1-methylethyl) ether, Washington did not submit criteria for those pollutants and therefore the federally promulgated criteria are the only criteria in effect for those pollutants in the State. Although the EPA is proposing to maintain the federally promulgated criteria for these pollutants, the EPA is also soliciting comment on whether to withdraw the federally promulgated criteria for methylmercury and bis(2-chloro-1-methylethyl) ether.

On May 10, 2019, the EPA revised its disapproval of 141 of Washington's human health criteria and approved those criteria. In addition, the EPA approved four criteria for two pollutants (thallium and 2,3,7,8-TCDD [dioxin]) that the EPA previously deferred action on in November 2016. 20

Because Washington now has 145 additional human health criteria approved by the EPA for CWA purposes, the EPA has determined that the 141 corresponding federally promulgated human health criteria are no longer needed in Washington. As noted in the EPA's May 10, 2019, action, the EPA determined upon reconsideration that Washington's 2016 human health criteria are scientifically sound and protective of the applicable designated uses in the state. 21 More information on the EPA's action to approve Washington's human health criteria upon reconsideration, including the EPA's approval letter and associated Technical Support Document, can be accessed at https://www.epa.gov/wqs-tech/water-quality-standards-regulations-washington and in the docket for this proposed rulemaking.

As explained above, the EPA seeks public comment before withdrawing the federally promulgated criteria. Although the EPA has determined that these state criteria are scientifically sound and protective of the applicable designated uses for waters in the state and otherwise meet the requirements of the CWA and EPA's implementing regulations at 40 CFR 131, the EPA recognizes that many of Washington's human health criteria are less stringent than the EPA's federally promulgated criteria which are based on the EPA's CWA section 304(a) criteria (see Table 1). However, as explained in the EPA's May 10, 2019, approval and Technical Support Document, the EPA's CWA section 304(a) criteria are national recommendations and states retain discretion to adopt different criteria, that may be less stringent, if the state's criteria are based on sound science and protect the designated use. In issuing the May 10, 2019, approval, the EPA determined that Washington's human health criteria meet the requirements of the CWA and the EPA's regulations because the State's inputs are based on sound science and the resulting criteria protect the designated uses.

Washington did not submit human health criteria for methylmercury or bis(2-chloro-1-methylethyl) ether in August 2016. For methylmercury, Washington explained in its August 2016 submittal documents that it “decided to defer state adoption of [human health criteria] for methylmercury at this time, and plans to schedule adoption of methylmercury criteria and develop a comprehensive implementation plan after the current rulemaking is completed and has received EPA Clean Water Act approval.”  22 To date, the EPA is not aware of any efforts Washington has undertaken since 2016 to adopt methylmercury criteria or develop associated implementation materials, likely because the EPA promulgated a federal criterion. For bis(2-chloro-1-methylethyl) ether (which was previously named `bis(2-chloroisopropyl) ether' in the NTR), Washington explained its position that “bis(2-chloroisopropyl) ether does not have a [CWA section] 304(a) national recommended criteria associated with it, thus the proposed criteria for this chemical were deleted from the [state's] final rule. Ecology has determined that the older NTR criteria for bis(2-chloroisopropyl) ether were incorrect, and were not developed for that particular priority pollutant. Ecology is adopting criteria only for the priority pollutants for which EPA has published 304(a) criteria documents.”  23

CWA section 303(c)(2)(B) requires states to adopt numeric criteria for all toxic pollutants listed pursuant to CWA section 307(a)(1) for which the EPA has published 304(a) criteria, as necessary to protect the states' designated uses. In 1992, the EPA promulgated the NTR at 40 CFR 131.36, establishing chemical-specific numeric criteria for 85 priority toxic pollutants for 14 states and territories (states), including Washington, that were not in compliance with the requirements of CWA section 303(c)(2)(B). In the proposed NTR, the EPA provided states three options for demonstrating compliance with section 303(c)(2)(B). 24

• Option 1: Adopt statewide numeric criteria in state WQS for all section 307(a) toxic pollutants for which the EPA has developed criteria guidance, regardless of whether the pollutants are known to be present.

• Option 2: Adopt chemical-specific numeric criteria for priority toxic pollutants that are the subject of the EPA's section 304(a) criteria guidance, where the state determines based on available information that the pollutants are present or discharged and can reasonably be expected to interfere with designated uses.

• Option 3: Adopt a procedure to be applied to a narrative WQS provision prohibiting toxicity in receiving waters. Such procedures would be used by the state in calculating derived numeric criteria which must be used for all purposes under section 303(c) of the CWA. At a minimum, such criteria need to be developed for section 307(a) toxic pollutants, as necessary to support designated uses, where these pollutants are discharged or present in the affected waters and could reasonably be expected to interfere with designated uses.

For the NTR in Washington, the EPA applied Option 1, explaining that Washington “has not adopted numeric criteria for any human health based criteria for priority pollutants, and EPA has reason to believe that at least some additional criteria are necessary to comply with section 303(c)(2)(B).”  25 The EPA further explained that it did not attempt “to determine the specific priority pollutants and water bodies that require criteria. However, EPA has determined that at least some Federal criteria are necessary to protect designated uses. This determination is supported by information in the record which demonstrates that priority toxic pollutants are discharged or present in surface waters at levels that can reasonably be expected to interfere with State designated uses. For some priority toxic pollutants, available data clearly demonstrate use impairment and the need for toxics criteria. For most priority toxic pollutants, however, available data on the discharge and presence of priority toxic pollutants are spatially and temporally limited. Nevertheless, EPA believes that the data for many of these pollutants are sufficient to satisfy the `reasonable expectation' test established in section 303(c)(2](B).”  26

In 2016, Washington explained in its submittal that it was following Option 1 outlined in the NTR by adopting human health criteria for all CWA section 307(a) priority toxic pollutants (except mercury/methylmercury) for which the EPA has developed national recommended CWA section 304(a) criteria, regardless of whether the pollutants are known to be present in the state. 27 The EPA followed this same approach in 2016 when promulgating federal human health criteria for Washington. 28 However, while Washington concluded in 2016 that it wanted to retain the 1992 federally promulgated NTR criteria for mercury and adopt methylmercury criteria in the future, the EPA determined that revised criteria for all priority pollutants were necessary in Washington and therefore promulgated a fish tissue methylmercury criterion (replacing the NTR water column mercury criteria) for Washington in 2016. Also, as explained in a memo to the file in the docket for the 2016 rulemaking, 29 the EPA disagreed with Washington's conclusion that bis(2-chloro-1-methylethyl) ether was not a CWA section 307(a) priority pollutant with associated CWA section 304(a) criteria, and therefore the EPA promulgated criteria for bis(2-chloro-1-methylethyl) ether at 40 CFR 131.45. Because the EPA followed the same Option 1 approach in 2016 as it used in the NTR and as Washington used for its submittal in 2016, the EPA did not specifically conduct a search for available information indicating that any of the priority pollutants, including methylmercury and bis(2-chloro-1-methylethyl) ether, are present or discharged in Washington and can reasonably be expected to interfere with Washington's designated uses.

However, as Washington noted in its 2016 submittal, mercury contamination is widespread across all 50 states, and Washington has listed waters as impaired and issued fish advisories due to mercury. 30 Additionally, Washington's 2016 cost-benefit analysis for its human health criteria rulemaking identified mercury as one of the five most detected chemicals in three discharger categories (wastewater treatment plants, pulp and paper mills, and resource extraction). 31 For its final rulemaking in 2016, the EPA identified reasonable potential for certain industrial dischargers in the state to cause or contribute to exceedances of the federally promulgated methylmercury criterion. 32 Therefore, the available evidence indicates that mercury is present and discharged in Washington and can reasonably be expected to interfere with Washington's designated uses.

The available data on bis(2-chloro-1-methylethyl) ether are more limited. The EPA did not identify reasonable potential for any dischargers in Washington to cause or contribute to exceedances of the federally promulgated criteria for bis(2-chloro-1-methylethyl) ether. Washington did not evaluate bis(2-chloro-1-methylethyl) ether in its cost-benefit analysis because it did not include this pollutant in the state rulemaking. Therefore, the EPA is not aware of evidence on whether bis(2-chloro-1-methylethyl) ether is present or discharged in Washington and can reasonably be expected to interfere with Washington's designated uses.

Given the information outlined above, the EPA proposes to retain ( i.e., not withdraw) the methylmercury and bis(2-chloro-1-methylethyl) ether human health criteria promulgated for Washington at 40 CFR 131.45 (81 FR 85417, November 28, 2016). This is consistent with the Option 1 approach and will ensure that Washington has CWA-effective human health criteria for these two pollutants that may be present in Washington's waters. The EPA specifically solicits any additional information on whether mercury/methylmercury and/or bis(2-chloro-1-methylethyl) ether are present or discharged in Washington and can reasonably be expected to interfere with Washington's designated uses. Based on the public comments received, the EPA may consider withdrawing the federally promulgated criteria for one or both of these pollutants. If the EPA withdraws the federal criteria for methylmercury and/or bis(2-chloro-1-methylethyl) ether, there would be no applicable numeric criteria for CWA purposes. Washington may, at any time adopt and submit to the EPA human health criteria for either pollutant, consistent with CWA section 303(c) and the EPA's implementing regulations at 40 CFR part 131.

It has been determined that this proposed rule 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 Orders 12866 and 13563 (76 FR 3821, January 21, 2011). The proposed rule does not establish any requirements directly applicable to regulated entities or other sources of toxic pollutants.

This action is expected to be an Executive Order 13771 deregulatory action.

This action does not impose any new information-collection burden under the Paperwork Reduction Act (PRA) because it is administratively withdrawing federal requirements that are no longer needed in Washington. It does not include any information collection, reporting, or recordkeeping requirements. The Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations 40 CFR part 131 and has assigned OMB control number 2040-0286.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (RFA). This action will not impose any requirements on small entities. Small entities, such as small businesses or small governmental jurisdictions, are not directly regulated by this rule.

This action contains no unfunded federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. As this action proposes to withdraw certain federally promulgated criteria, the action imposes no enforceable duty on any state, local, or tribal governments, or the private sector.

This action 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. This rule imposes no regulatory requirements or costs on any state or local governments. Thus, Executive Order 13132 does not apply to this action.

This action may have tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. In the state of Washington, there are 29 federally recognized Indian tribes.

The EPA initiated consultation with federally recognized tribal officials under the EPA's Policy on Consultation and Coordination with Indian tribes early in the process of developing this proposed rule to allow meaningful and timely input into its development. The EPA initially offered tribal consultation on this rule making on May 21, 2019. EPA staff then offered two informational calls for tribal staff on June 4 and 5, 2019, to assist tribes with the consultation process, including the tribes' decisions on whether to accept the offer to consult. Many tribes have expressed dissatisfaction that EPA did not offer consultation prior to its May 10, 2019, decision and have questioned how meaningful the EPA's offer for consultation is on this rule making as a result. To the extent tribes have been interested in consulting on this rulemaking, they have emphasized the importance of consultation occurring prior to publication of a proposed rule. A number of tribes expressed the need for more time prior to the proposed rule publication to conduct consultation, for more information provided in advance to prepare for and engage in consultation and for the actual EPA decision-maker to be present.

Input received from tribes during consultation, meetings and through letters received thus far, indicates tribes are opposed to this proposed action. Tribes have raised health, economic and implementation concerns, as well as the EPA's trust responsibility, treaty obligations and consultation practices. While the EPA acknowledges it may not satisfy the tribal consultation expectations of each tribe, the EPA will continue to offer the opportunity to consult up to the point of finalizing this rule and will evaluate the input received before making a final decision.

This rule is not subject to Executive Order 13045, because it is not economically significant as defined in Executive Order 12866, and because the environmental health or safety risks addressed by this action do not present a disproportionate risk to children.

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

This proposed rulemaking does not involve technical standards.

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 concludes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The EPA has previously determined that Washington's adopted and EPA-approved criteria are protective of human health.

For the reasons set forth in the preamble, the EPA proposes to amend 40 CFR part 131 as follows:

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. 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 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to final SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after September 5, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

EPA is proposing these SNURs under TSCA section 5(a)(2) for chemical substances that were the subject of PMNs and an MCAN. These proposed SNURs would require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity proposed as a significant new use. Receipt of such notices would allow EPA to assess risks and, if appropriate, to regulate the significant new use before it may occur. Additional background regarding SNURs is more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376). Consult that preamble for further general information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

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 four bulleted TSCA section 5(a)(2) factors listed in Unit III. 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)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)).

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the proposed rule, recordkeeping requirements, and exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to § 721.1(c), persons subject to SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A) (15 U.S.C. 2604(a)(1)(A)). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

TSCA section 5(a)(2) 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:

• 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.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining significant new use for the 31 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances and potential human exposures and environmental releases that may be associated with the conditions of use for the substances, in addition to the factors in TSCA section 5(a)(2). Note that when the Agency issues an order under TSCA section 5(e), TSCA section 5(f)(4) requires that the Agency consider whether to promulgate a SNUR for any use not conforming to the restrictions of the order or publish a statement describing the reasons for not initiating the rulemaking.

EPA is proposing significant new use and recordkeeping requirements for 31 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

• Basis for the SNUR or basis for the TSCA 5(e) Order.

• Information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR. This information may include testing required in a TSCA section 5(e) Order to be conducted by the PMN submitter, as well as testing not required to be conducted but which would also help characterize the potential health and/or environmental effects of the PMN substance. Any recommendation for information identified by EPA was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. See Unit VII. for more information.

• CFR citation assigned in the regulatory text section of the proposed rule. The regulatory text section of each proposed rule specifies the activities that would be designated as significant new uses. Certain new uses, including exceedance of production volume limits ( i.e., limits on manufacture volume) and other uses designated in this proposed rule, may be claimed as CBI.

These proposed rules include 7 PMN substances that are subject to Orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) Orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the 40 CFR 721.63 respirator requirements may request to do so under 40 CFR 721.30. EPA expects that persons whose 40 CFR 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) Order for the same chemical substance.

These proposed rules also include 24 PMN substances that received “not likely to present an unreasonable risk” determination in TSCA section 5(a)(3)(c). However, during the course of these reviews, EPA identified concerns for certain health and/or environmental risks if the chemicals were not used following the limitations identified by the submitters in the notices but the TSCA section 5(a)(3)(C) determinations did not deem those uses as reasonably foreseen. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to those same protection measures.

The chemicals subject to these proposed SNURs are as follows:

Chemical Name: Alkanes, C11-16-branched and linear.

CAS Number: 1809170-78-2.

Basis for action: The PMN states that the use of the PMN substance will be as a chemical intermediate, in cured coatings, cleaning fluids, metalworking fluids/rolling oils, and in agrochemicals. Based on the estimated physical chemical properties of the PMN substance and analogy to structurally similar substances, EPA has identified concerns for lung effects and dermal irritation if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No manufacture, processing, or use of the PMN substance other than for the uses stated in the PMN; and

2. No manufacture, processing, or use of the PMN substance for consumer use.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the human health effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of irritation and pulmonary effects testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11300.

Chemical Name: Alkyl alkenoic acid, alkoxyalkyl ester, polymer with alkyl alkenoate, alkyl alkyl alkenoate and tris alkyl silyl alkyl alkenoate (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a component of industrial coatings. Based on the estimated physical chemical properties of the PMN substance and test data on the PMN substance, EPA has identified concerns for lung effects and irritation to the eyes, skins, lung, and mucous membranes if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No domestic manufacture of the PMN substance; and

2. No manufacture, processing, or use of the PMN substance that results in inhalation exposures.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the human health effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11301.

Chemical Name: Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-, reaction products with propylene oxide (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a polyurethane catalyst. Based on the estimated physical chemical properties of the PMN substance and data on analogous compounds, EPA has identified concerns for skin, eye, and lung corrosion, neurotoxicity, and systemic effects if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No manufacture, processing, or use of the PMN substance that would generate a spray, mist, or aerosol.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the human health effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of skin irritation/corrosion and neurotoxicity testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11302.

Chemical Name: 2-Oxepanone, reaction products with alkylenediamine-alkyleneimine polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and tetrahydro-2H-pyran-2-one (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an additive, open, non-dispersive use. Based on the estimated physical chemical properties of the PMN substance, comparison with structurally analogous chemical substances, and Structure Analysis Relationships (SAR) analysis of test data on polycationic polymers, EPA has identified hazards for irritation to the eye, lung, and mucous membranes, lung effects, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No domestic manufacture of the PMN substance;

2. No manufacture or import of the PMN substance other than in liquid form; and

3. No manufacture, processing, or use of the PMN substance other than for the confidential use stated in the PMN.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the human health and environmental effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of aquatic toxicity and pulmonary effects testing would help characterize the potential health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11303.

Chemical Name: Dicarboxylic acids, polymers with alkanoic acid, alkanediol, substituted-alkylalkanoic acid, substituted alkyl carbomonocycle, alkanedioic acid, alkanolamine blocked compds with alkanolamine (P-17-387 and P-17-388) (generic).

CAS Numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as paint. Based on the estimated physical/chemical properties of the PMN substances and available PMN data, EPA has identified developmental and reproductive effects, lung toxicity, and nasal and ocular irritation if the chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMNs include the following protective measures:

1. No manufacture (including import) of the PMN substances that results in amine counter ions greater than 4% by weight;

2. No manufacture (including import) of the PMN substances that results in isocyanate residuals greater than 0.1% by weight;

3. No manufacture (including import) of the PMN substances that results in a proportion of the acid group greater than 20% by weight; and

4. No manufacture (including import) of the PMN substances that results in the average molecular weight smaller than the confidential molecular weight specified in the PMNs or proportion of the low molecular weight species greater than the confidential values specified in the PMNs for the 500 and 1000 dalton species.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the human health effects of the PMN substances may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of developmental/reproductive and pulmonary effects testing would help characterize the potential health effects of the PMN substances.

CFR Citation: 40 CFR 721.11304.

Chemical name: Unsaturated polycyclic hydrocarbon (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) Order: February 6, 2019.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a cyclic hydrocarbon building block. Based on physical/chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194; November 4, 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. EPA has also identified concern for skin irritation, reproductive and developmental toxicity based on analog data and concern for sensitization based on Safety Data Sheet (SDS) information. Based on SAR analysis of test data on analogous neutral organics, EPA has identified concern for aquatic toxicity. The Order was issued under 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the available information is insufficient to permit a reasoned evaluation of the human health and environmental effects of the PMN substance. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

1. Submit to EPA certain toxicity testing within 9 months from the effective date of the Order.

2. Submit to EPA certain toxicity testing for within 12 months from EPA's direction to proceed with that testing.

3. Refrain from manufacturing (including import) more than the confidential annual production volume limit specified in the Order.

4. Use of the PMN substance only for the confidential use allowed by the Order.

5. No release of the PMN substance to surface waters.

6. Use of personal protective equipment to its workers to prevent dermal exposure where there is potential for dermal exposure.

7. Use of a National Institute for Occupational Safety and Health (NIOSH) certified respirator with an Assigned Protection Factor (APF) of at least 50 where there is a potential for inhalation exposure.

8. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The SNUR designates as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed to perform certain acute aquatic toxicity testing within 9 months of the effect of the Order, and certain chronic aquatic toxicity testing within 12 months of EPA's direction to proceed. The Agency has determined that specific target organ toxicity, reproductive and developmental toxicity, sensitization, and fate information would help EPA determine the potential health effects of the PMN substance. Although the Order does not require this information, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11305.

Chemical Names: Glycerides, soya mono- and di-, epoxidized, acetates (P-18-7) and Glycerides, C16-18 and C18-unsatd. mono- and di-, epoxidized, acetates (P-18-8).

CAS Numbers: 2097734-14-8 (P-18-7) and 2097734-15-9 (P-18-8).

Basis for action: The PMNs state that the use of the substances will be as plasticizers/stabilizers for flexible polyvinyl chloride. Based the estimated physical/chemical properties of the PMN substances and comparison with structurally analogous chemical substances, EPA has identified skin irritation and kidney and liver hazards if the chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMNs include the following protective measures:

1. No manufacture, processing, or use that results in inhalation exposures; and

2. No release of a manufacturing, processing, or use stream associated with any use of the PMN substances into the waters of the United States exceeding a surface water concentration of 9,000 parts per billion (ppb).

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the human effects of the PMN substances may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of specific target organ toxicity and skin irritation testing would help characterize the potential health effects of the PMN substances.

CFR Citations: 40 CFR 721.11306 (P-18-7) and 40 CFR 721.11307 (P-18-8).

Chemical Name: Mixed metal oxide (generic).

CAS Number: Not Available.

Effective date of TSCA section 5(e) Order: April 2, 2019.

Basis for TSCA section 5(e) Order: The PMN states that the generic use of the PMN substance will be as a catalyst. EPA identified concerns for lung effects including cancer, and respiratory and dermal sensitization based on the estimated physical/chemical properties, available PMN data, and by comparison to structurally analogous chemical substances. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

1. Use of personal protective equipment where there is a potential for dermal exposure;

2. Use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure or compliance with a NCEL of 0.04 mg/m 3 as an 8-hour time-weighted average to prevent inhalation exposure;

3. Use of the PMN substance only for the confidential use allowed by the Order; and

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The SNUR designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has also determined that specific pulmonary toxicity and sensitization effects testing of the PMN substance would be useful in determining the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11308.

Chemical Name: Urea, reaction products with N-butylphosphorothioic triamide and formaldehyde.

CAS Number: 2093385-47-6.

Basis for action: The PMN states that the use of the PMN substance will be as an additive for urea-containing fertilizer. Based on physical-chemical properties, available test data, and test data on analogous chemical substances for the PMN substance, EPA has identified concerns for neurotoxicity, reproductive toxicity, kidney toxicity, irritation and sensitization if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No manufacture, processing, or use of the substance that results in inhalation exposure; and

2. No use of the substance in a consumer product.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of neurotoxicity, specific target organ toxicity, irritation, sensitization, and reproductive/developmental toxicity testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11309.

Chemical Name: Fatty acid reaction products with ethyleneamines and dialkyl ester (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be for industrial use in oilfields. Based on the estimated physical chemical properties of the PMN substance and comparison with structurally analogous chemical substances, EPA has identified irritation to the eyes, lungs, and skin, and lung effects if the chemical substance is not used following the limitation noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:

• No manufacture, processing, or use that results in inhalation exposures.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11310.

Chemical Name: Pentaerythritol, mixed esters with linear and branched fatty acids (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be for industrial use. Based on the estimated physical chemical properties of the PMN substance and comparison with structurally analogous chemical substances, EPA has identified concerns for developmental effects, blood and thyroid effects, and skin and eye irritation if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No manufacturing, processing, or use involving an application method that generates a vapor, mist, or aerosol.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of specific organ toxicity and reproductive/developmental testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11311.

Chemical Name: Alcohol capped polycarbodiimide from diethyldiisocyanatobenzene (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a hydrolysis stabilizer. Based on the physical chemical properties of the PMN substance and comparison with structurally analogous chemical substances, EPA has identified concerns for systemic toxicity and developmental toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No manufacture (including import) of the PMN substances that results in isocyanate residuals greater than 0.1% by weight.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of reproductive/development toxicity testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11312.

Chemical Names: Oxirane, 2-methyl-, polymer with methoxirane homopolymer, 1,1′-methylenebis[4-isocyanatobenzene], and glycerol-propylene oxide polymer (generic) (P-18-118) and Oxirane, 2-methyl-, polymer with methoxirane homopolymer, 1,1′-methylenebis[isocyanatobenzene], and glycerol-propylene oxide polymer (generic) (P-18-119).

CAS Numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as industrial adhesives. Based on the estimated physical chemical properties of the PMN substances and comparison with structurally analogous chemical substances. EPA has identified concerns for lung effects, irritation, and sensitization if the chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMNs include the following protective measures:

1. No manufacturing, processing, or use that results in inhalation exposures;

2. No manufacturing, processing, or use of the PMN substances with isocyanate residuals greater than 0.1%; and

3. Refrain from using the PMN substance for consumer use.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substances may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of skin sensitization testing would help characterize the potential health effects of the PMN substances.

CFR Citations: 40 CFR 721.11313 (P-18-118) and 40 CFR 721.11314 (P-18-119).

Chemical Name: Lithium nickel hydride oxide (P-18-123) and Lithium nickel potassium oxide (P-18-124).

CAS Numbers: 2081933-92-6 (P-18-123) and 210352-95-7 (P-18-124).

Effective date of TSCA section 5(e) Order: December 7, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substances will be as a chemical intermediate used in the production of battery electrodes (P-18-123) and a cathode material for standard and premium (P-18-124). Based on physical/chemical properties and on test data submitted with the PMN, EPA identified concerns for pulmonary effects, neurotoxicity, developmental toxicity, kidney toxicity, carcinogenicity, skin and respiratory sensitization, and irritation to the eye, skin, and respiratory tract. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(I)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substances may present an unreasonable risk of injury to human health and the environment. The Order was also issued under TSCA section 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substances are or will be produced in substantial quantities and that the substances either enter or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substances. To protect against these risks, the Order requires:

1. Use of personal protective equipment where there is a potential for dermal exposure.

2. Use a NIOSH-certified respirator with an APF of at least 50 where there is potential for inhalation exposure or compliance with a NCEL of 0.05 mg/m 3 as an 8-hour time-weighted average to prevent inhalation exposure.

3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

4. Submit to EPA certain environmental and health hazard testing within six months and four years of the first manufacture (including import), respectively on P-18-124.

5. No release of the PMN substances resulting in surface water concentrations that exceed 32 ppb.

The SNUR designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substances may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed to submit an algal toxicity test 6 months after the date of first manufacture and a specific organ toxicity test 4 years after the date of first manufacture on PMN substance P-18-124. EPA has also determined that information on specific target organ toxicity and reproductive/developmental toxicity would help characterize the potential health effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR Citations: 40 CFR 721.11315 (P-18-123) and 40 CFR 721.11316 (P-18-124).

Chemical Name: Hydrolyzed functionalized di-amino silanol polymer (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an intermediate. Based on the estimated physical chemical properties of the PMN substance, data on the PMN substance, comparison with structurally analogous chemical substances, and Structure Analysis Relationships (SAR) analysis of test data on analogous aliphatic amines, EPA has identified irritation and corrosion to all tissues, sensitization, lung toxicity, and aquatic toxicity at surface water concentrations exceeding 3 parts per billion (ppb) if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure; and

2. No release of a manufacturing, processing, or use stream associated with any use of the PMN substance exceeding a surface water concentration of 3 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of skin toxicity, sensitization, and aquatic toxicity testing of would help characterize the potential health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11317.

Chemical Name: Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with dimethyl carbonate, 1,6-hexanediol, diamine and 1,1′-methylenebis[4-isocyanatocyclohexane], pentaerythritol, triacrylate-blocked, compds. with triethylamine (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a protective coating. Based on estimated physical chemical properties of the PMN substance and comparison with structurally analogous acrylates/methacrylates, EPA has identified dermal and respiratory irritation and sensitization, developmental toxicity, and neurotoxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. Use of personal protective equipment including impervious gloves where there is a potential for dermal exposure;

2. Use of a NIOSH certified respirator with an APF of at least 1,000 for spray applications and 50 for non-spray applications; and

3. No manufacture (including import) of the PMN substance with triethylamine concentrations greater than the confidential concentration described in the PMN.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of composition of Low Molecular Weight (LMW) species and specific organ toxicity testing for the LMW species would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11318.

Chemical names: Waste plastics, poly(ethylene terephthalate), polymers with diethylene glycol, glycerol, polyerythritol, triethylene glycol, trimethylolalkane and polypropylene glycol (P-18-200) (generic) and Waste plastics, poly(ethylene terephthalate), polymers with diethylene glycol, glycerol, polyerythritol glycol, trimethylolalkane and polypropylene glycol (P-18-201) (generic).

CAS numbers: Not available.

Effective date of TSCA section 5(e) Order: January 20, 2019.

Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances will be as insulation components. Based on analogue data for low molecular weight components and metabolites of high molecular weight components, EPA identified concerns for bladder and kidney effects. . Based on SAR predictions for nonionic polymers EPA also identified concerns for aquatic toxicity at concentrations that exceed 280 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to human health and the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substances are or will be produced in substantial quantities and that the substances either enter or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substances. To protect against these risks, the Order requires:

1. Use of personal protective equipment involving impervious gloves where there is a potential for dermal exposure;

2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;

3. Use of a NIOSH-certified respirator with an APF of at least 10 where there is a potential for inhalation exposure;

4. Refrain from using the PMN substances for consumer use; and

5. No release of the PMN substances resulting in surface water concentrations that exceed 280 ppb.

The SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the human and environmental health effects of the PMN substances may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. A toxicokinetics test, a specific target organ toxicity test, and a chronic aquatic organism toxicity test would help EPA determine the potential health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citations: 40 CFR 721.11319 (P-18-200) and 40 CFR 721.11320 (P-18-201).

Chemical Name: Naphtha oils (generic).

CAS Number: Not Available.

Effective date of TSCA section 5(e) Order: April 10, 2019.

Basis for TSCA section 5(e) Order: The PMN states that the generic use of the PMN substance will be as a component in automotive gasoline and transportation fuel for consumer use. EPA identified concerns for neurological, liver, kidney, developmental, immunological, carcinogenic, mutagenic and irritation effects based on estimated physical/chemical properties and analysis of test data on structurally analogous chemical substances. In addition, based on SAR analysis of test data on analogous neutral organics, EPA predicts acute and chronic toxicity to aquatic organisms may occur at concentrations greater than 88 ppb and 3 ppb respectively. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substance. To protect against these risks, the Order requires:

1. No domestic manufacture of the PMN substance (import only).

2. Processing and use of the PMN substance only for the confidential use specified in the PMN.

The SNUR designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has also determined that specific product composition testing of the PMN substance would be useful in determining the health and environmental effects of the PMN substance. Although the Order does not require this test, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11321.

Chemical Name: Saccharide reaction products with acid anhydride, etherified (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a binder for wood panels. Based on the estimated physical chemical properties of the PMN substance, structural alerts, data on an analogue of a potential metabolites, and test data on analogous esters, EPA has identified skin and respiratory sensitization, germ cell mutagenicity, carcinogenicity, reproductive/developmental, liver, and kidney toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include this protective measure:

• No manufacturing, processing, or use that results in inhalation exposures.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of absorption, specific target organ toxicity, sensitization, genetic toxicology, and reproductive/developmental toxicity testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11322.

Chemical Name: Alkyl alkenoic acid, alkyl ester, telomer with alkyl alkenoate, substituted alkyl alkyl alkenoate, alkylthiol, substituted carbomonocycle, hydroxyalkyl alkyl alkenoate and alkyl alkyl alkenoate (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a binder resin in coatings. Based on the estimated and measured physical chemical properties of the PMN substance, data submitted on the new chemical substance, and comparison with structurally analogous chemical substances, EPA has identified concerns for systemic effects if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No manufacture (including import) of the PMN substance with more than 5% of the molecular weight content less than 1,000 Daltons.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of toxicokinetic and specific target organ toxicity testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11323.

Chemical Name: Formaldehyde, polymer with 2-phenoxyalkanol and .alpha.-phenyl-.omega. hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen phosphate 2-phenoxyalkyl hydrogen phosphate, alkaline salt (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a dispersing agent. Based on the estimated physical chemical properties of the PMN substance and hazard data on chemically analogous substances, EPA has identified concerns for lung effects, eye irritation, and systemic (blood/kidney) effects, if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No manufacturing, processing, or use that results in inhalation exposures; and

2. No manufacture of the PMN substance with greater than 20% (weight percent) components with molecular weight below 500 Daltons.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of composition of low molecular weight (LMW) species and specific organ toxicity testing for the LMW species would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11324.

Chemical Name: Substituted polyalkylenepolycarbomonocycle ester, polymer with dialkanolamine, [(hydroxyalkoxy)carbonyl] derivs., (alkoxyalkoxy) alkanol-blocked (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a component in coating resin products that are applied by cathodic electrodeposition and used as additives for corrosion protection. Based on the estimated physical chemical properties of the PMN substance and comparison with structurally analogous chemical substances, EPA has identified concerns for irritation, lung effects, immunotoxicity, and blood effects if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No manufacture (including import) or processing the PMN substance in the forms of a powder or solid; and

2. No use of the PMN substance involving application methods that generate inhalation exposures.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects and specific target organ toxicity testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11325.

Chemical Name: Carbonmonocycles, polymer with haloalkyl substituted heteromonocycle and hydro-hydroxypoly[oxy(alkyl-alkanediyl)], dialkyl-alkanediamineterminated, hydroxyalkylated, acetates (salts) (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a corrosion protection additive in resin for cathodic electrodeposition dip coating for metal substrates. Based on the estimated physical chemical properties of the PMN substance and comparison with structurally analogous chemical substances, EPA has identified concerns for lung effects and irritation if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No manufacturing (including import), processing, or use that results in inhalation exposures; and

2. No manufacture beyond an annual production volume of 85,000 kg.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects and skin irritation testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11326.

Chemical Name: Alkanoic acid, compds. with substituted carbomonocycle-dialkyl-alkanediamine-halosubstituted heteromonocycle-polyalkylene glycol polymerdialkanolamine reaction products (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a component in coating resin products that are applied by cathodic electrodeposition and as an additive for corrosion protection. Based on the estimated physical chemical properties of the PMN substance, comparison with structurally analogous chemical substances, and Structure Analysis Relationships (SAR) analysis of test data on cationic polymers, EPA has identified concerns for irritation, lung effects, and aquatic toxicity at concentrations greater than 15 ppb if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No manufacturing (including import), processing, or use that results in inhalation exposures to vapor, particulate, mist or aerosols; and

2. No release of a manufacturing, processing, or use stream associated with any use of the PMN substance exceeding a surface water concentration of 15 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the human health and environmental effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects, skin irritation, and aquatic toxicity testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11327.

Chemical Name: Substituted carbomoncycle, polymer with haloalkyl substituted heteromonocycle, dialkyl-alkanediamine and hydro-hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal oxide and dialkanolamine, acetates (salt) (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as an isolated intermediate incorporated as a component in coating resin products that are applied by cathodic electrodeposition and used as additives for corrosion protection. Based on the estimated physical chemical properties of the PMN substance, comparison with structurally analogous chemical substances, and Structure Analysis Relationships (SAR) analysis of test data on analogous cationic polymers, EPA has identified lung effects and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No manufacturing, processing, or use that results in inhalation exposures to vapor, particulate, mist or aerosols; and

2. No manufacture (including import) of an annual production volume of the PMN substance greater than 95,600 kg.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the human health and environmental effects of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11328.

Chemical Name: Non-metal tetrakis (hydroxyalkyl)-, halide, polymer with amide oxidized (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a component of a textile coating. Based on the estimated physical chemical properties of the PMN substance and comparison with structurally analogous chemical substances, EPA has identified effects concerns for irritation to the skin and eyes, skin sensitization, and reproductive and developmental toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No manufacturing, processing, or use that results in inhalation exposures;

2. No manufacturing that results in unbound formaldehyde residuals greater than 0.1%; and

3. No manufacturing, processing, or use other than the confidential use described in the PMN.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of skin and eye irritation, skin sensitization, and developmental toxicity testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11329.

During review of the PMNs submitted for the chemical substances that are subject to these proposed SNURs, EPA concluded that for 7 chemical substances regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN/MCAN submitters. The SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).

During review of the other 24 chemical substances that are the subject of these SNURs and as further discussed in Unit IV, EPA identified circumstances different from the intended conditions of use identified in the PMNs that raised potential risk concerns. EPA determined that deviations from the protective measures identified in the submissions could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances, and therefore warranted SNURs. The SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the protection measures in the submission.

EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with respect to the significant new uses that would be designated in this proposed rule:

• EPA would receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.

• EPA would be required to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

• EPA would be required to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for 7 of the 31 chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which would be designated as significant new uses. The identities of 25 of the 31 chemical substances subject to this proposed rule have been claimed as confidential (per §§ 720.85 and 725.85) for a chemical substance covered by this action. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.

Therefore, EPA designates August 6, 2019 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.

Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

EPA recognizes that TSCA section 5 does not require developing any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: Development of test data is required where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)).

In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50 and 725.155). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists potentially useful information identified by EPA that would help characterize the potential health and/or environmental effects of the PMN/SNUN substance for all of the listed SNURs. EPA recognizes that the 2016 Lautenberg Amendments have led to modifications in our approach to testing requirements, including an increased consideration of alternatives to vertebrate testing. Descriptions of tests/information needs are provided for informational purposes only and EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the potentially useful information. EPA encourages dialogue with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.

The potentially useful information listed in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN or MCAN, including submission of test data on health and environmental effects as described in 40 CFR 720.50 or 725.160. SNUNs must be submitted 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 721.25 (or 40 CFR 725.25 and § 725.27). E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2019-0359.

This proposed rule would establish SNURs for several new chemical substances that were the subject of PMNs and TSCA section 5(e) Orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “ Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

According to PRA (44 U.S.C. 3501 et seq. ), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

The information collection requirements related to this proposed rule have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). 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 between 30 and 170 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, including through the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (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 et seq. ), the Agency hereby certifies that promulgation of this proposed SNUR would not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use 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 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this proposed SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

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 reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).

This proposed rule would not 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 proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action.

This proposed rule 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 proposed rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this proposed rule is not expected to affect energy supply, distribution, or use and because this proposed rule is not a significant regulatory action under Executive Order 12866.

In addition, since this proposed rule would not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.

This proposed rule does 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).

Therefore, it is proposed that 40 CFR chapter I be amended as follows:

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347, as amended by Pub. L. 114-113), added Title XXXIII to the Public Health Service (PHS) Act, 1 establishing the WTC Health Program within the Department of Health and Human Services (HHS). The WTC Health Program provides medical monitoring and treatment benefits for health conditions on the List to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001, or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors).

All references to the Administrator of the WTC Health Program (Administrator) in this document mean the Director of the National Institute for Occupational Safety and Health (NIOSH) or his designee.

Pursuant to section 3312(a)(6)(B) of the PHS Act, interested parties may petition the Administrator to add a health condition to the List in 42 CFR 88.15. Within 90 days after receipt of a valid petition to add a condition to the List, the Administrator must take one of the following four actions described in section 3312(a)(6)(B) of the PHS Act and § 88.16(a)(2) of the Program regulations: (1) Request a recommendation of the STAC; (2) publish a proposed rule in the Federal Register to add such health condition; (3) publish in the Federal Register the Administrator's determination not to publish such a proposed rule and the basis for such determination; or (4) publish in the Federal Register a determination that insufficient evidence exists to take action under (1) through (3) above.

In addition to the regulatory provisions, the WTC Health Program has developed policies to guide the review of submissions and petitions, 2 as well as the analysis of evidence supporting the potential addition of a non-cancer health condition to the List. 3

A valid petition must include sufficient medical basis for the association between the September 11, 2001, terrorist attacks and the health condition to be added; in accordance with WTC Health Program policy, reference to a peer-reviewed, published, epidemiologic study about the health condition among 9/11-exposed populations or to clinical case reports of health conditions in WTC responders or survivors may demonstrate the required medical basis. 4 Studies linking 9/11 agents or hazards  5 to the petitioned health condition may also provide sufficient medical basis for a valid petition.

After the Program has determined that a petition is valid, the Administrator must direct the Program to conduct a review of the scientific literature to determine if the available scientific information has the potential to provide a basis for a decision on whether to add the health condition to the List. 6 The literature review is a keyword search of relevant scientific databases; peer-reviewed, published, epidemiologic studies (including direct observational studies in the case of health conditions such as injuries) about the health condition among 9/11-exposed populations are then identified from the initial search results. The Program evaluates the scientific quality of each peer-reviewed, published, epidemiologic study of the health condition identified in the literature search; the Program then compiles the scientific results of each study to assess whether a causal relationship between 9/11 exposures and the health condition is supported, and evaluates whether the results of the studies are representative of the 9/11-exposed population of responders and survivors. A health condition may be added to the List if peer-reviewed, published, epidemiologic studies provide support that the health condition is substantially likely  7 to be causally associated with 9/11 exposures. If the evaluation of evidence provided in peer-reviewed, published, epidemiologic studies of the health condition in 9/11 populations demonstrates a high, but not substantial, likelihood of a causal association between the 9/11 exposures and the health condition, then the Administrator may consider additional highly relevant scientific evidence regarding exposures to 9/11 agents from sources using non-9/11-exposed populations. If that additional assessment establishes that the health condition is substantially likely to be causally associated with 9/11 exposures among 9/11-exposed populations, the health condition may be added to the List.

On March 11, 2019, the Administrator received a petition (Petition 022) requesting the addition of “monoclonal gammopathy of undetermined significance (MGUS)” to the List. 8 The petition included a 2018 study by Landgren et al., 9 which provided sufficient medical basis for the petition to be considered valid because it is a peer-reviewed, published, epidemiologic study about the health condition among 9/11-exposed populations; Landgren et al. is a scientific source that demonstrates a potential link between exposure to a 9/11 hazard (in this case, the identified 9/11 agents polychlorinated biphenyl (PCB), dioxins, polycyclic aromatic hydrocarbons (PAHs), and asbestos)  10 and the requested health condition, MGUS.

The Program policy on the addition of non-cancer health conditions to the List directs the Program to conduct a literature review of the health condition(s) petitioned. 11 Petition 022 requested the addition of MGUS, an asymptomatic condition characterized by the presence of a monoclonal immunoglobulin (Ig), also called an M-protein, in the blood without any evidence of multiple myeloma or another lymphoproliferative disorder. MGUS is not a cancer, and the vast majority of people with MGUS never develop the types of cancer for which it is a precursor. Immunoglobulin subtypes involved may be IgM, non-IgM ( e.g., IgA and IgG), or light-chain. 12 All pose a slight risk of progression (1-2 percent per year) to a malignant disorder. Typically, IgG and IgA MGUS are the precursors of multiple myeloma, IgM MGUS is the precursor of Waldenstrom macroglobulinemia or other lymphoproliferative conditions, and light-chain MGUS is the precursor of light-chain multiple myeloma. 13

In response to Petition 022, the Program conducted a review of the scientific literature on MGUS to identify peer-reviewed, published, epidemiologic studies of the health condition in the 9/11-exposed population. 14 Only one study meeting the Program's criteria for further evaluation was identified in this literature review, Landgren et al. [2018], referenced above.

Landgren et al. [2018] reported on two analyses conducted on 9/11-exposed firefighters from the New York City Fire Department (FDNY). One was a case series (a descriptive report) of 16 multiple myeloma cases identified among white male WTC-exposed FDNY firefighters. Since this analysis does not provide dispositive evidence linking 9/11 exposures to MGUS, it is not relevant to this petition and will not be further described.

The second analysis was a prevalence screening study of 781 9/11-exposed FDNY white male firefighters aged 50 to 79 years. Patients with MGUS, light-chain MGUS, and overall MGUS ( i.e., MGUS and light-chain MGUS combined) were diagnosed using a serum immunoglobulin assay. 9/11 exposure was assessed based on initial arrival time at Ground Zero and five exposure groups were recognized ( i.e., arriving the morning of 9/11 [most highly exposed]; arriving the afternoon of September 11, 2001; arriving on September 12, 2001; arriving between September 13 and 24, 2001; and arriving between September 25, 2001 and July 24, 2002 [least exposed]). 9/11 exposure was also assessed by length of time worked at Ground Zero (months in which a participant worked at least 1 day at Ground Zero).

Findings in this study were compared to those of a population-based cohort of 7,612 white male residents of Olmsted County, Minnesota, aged 50 years and older, previously assembled to estimate MGUS prevalence. 15 Among FDNY firefighters, the age-standardized prevalence rate (ASR) of overall MGUS ( i.e., MGUS and light-chain MGUS combined) was 7.63 per 100 persons (95% CI, 5.45-9.81). The ASR of light-chain MGUS was 3.08 per 100 persons (95% CI, 1.66-4.50), and for MGUS was 4.55 per 100 persons (95% CI, 2.90-6.21). The relative rate of overall MGUS ( i.e., MGUS and light-chain MGUS combined) was 1.76 (95% CI, 1.34-2.29) when comparing FDNY firefighters with the Olmsted County reference population; the relative rate was 3.13 for light-chain MGUS (95% CI, 1.99-4.93) and 1.35 for MGUS (95% CI, 0.96-1.91). The researchers evaluated the risk of overall MGUS ( i.e., MGUS and light-chain MGUS combined) by 9/11 exposure; for each of the arrival times described above, the ASRs for the 9/11-exposed FDNY firefighters were greater than in the Olmsted County reference population, although the authors did not find an exposure gradient and did not provide risk estimates for these findings. Additionally, the authors reported that there were no statistically significant differences in ASRs when length of time worked at Ground Zero was included in the analyses (the authors did not report a risk estimate for this finding). In addition, the authors did not report the results of the association between 9/11 exposures, expressed by time of arrival or duration of work at Ground Zero, and light-chain MGUS, nor for MGUS overall.

Among the strengths of Landgren et al. [2018] is that this is the first study to present the age-specific prevalence of MGUS or light-chain MGUS in 9/11-exposed responders, and show an excess age-standardized prevalence when compared to an unexposed reference population. 16 Health outcomes were objectively assessed, since diagnosis was determined in all study participants by testing serum samples, collected between December 2013 and October 2015, in the laboratory.

However, Landgren et al. [2018] is subject to a number of limitations. The prevalence study design limits the interpretation and generalizability of findings. IgM MGUS and non-IgM MGUS were lumped together as “MGUS” and not reported separately. Risk estimates of the association between 9/11 exposure and MGUS were not reported. A temporal relationship between 9/11 exposure and the first occurrence of MGUS could also not be established; because MGUS is asymptomatic, it is possible that some FDNY members with MGUS had the condition prior to September 11, 2001 (no baseline samples were collected prior to September 11, 2001 to ascertain date of onset). Another limitation suggested by the authors is inadequate statistical power to detect a statistically significant exposure-response relationship. Landgren et al. [2018] addressed confounding by race, gender, and age by limiting the analysis to white men and standardizing the rates by age. However, family history of MGUS and other occupational exposures were not controlled for. A major limitation of this study is the use of the Olmsted County reference group, 17 which is a general population selected from a mixed rural-urban setting and not comparable to the FDNY population, a predominantly urban working population. The authors acknowledged that a comparison group composed of firefighters with no 9/11 exposure or a truly random sample of the U.S. (or the New York City) population would be desirable. Finally, the authors reported that they were unable to control for all of the potential confounders between the study and reference populations.

Landgren et al. [2018] was assessed to determine whether a causal relationship between 9/11 exposures and MGUS is supported. As described in the policy on the addition of non-cancer health conditions to the List, 18 the WTC Health Program uses the following Bradford Hill criteria to evaluate studies of 9/11-exposed populations: strength of association, precision of the risk estimate, consistency of association, biological gradient, and plausibility and coherence. 19

Strength of association:   20 Landgren et al. [2018] found a relatively strong association between being a 9/11-exposed FDNY member and an increased prevalence of MGUS, especially light-chain MGUS. However, Landgren et al. [2018] did not report risk estimates for the association between their measures of 9/11 exposure (initial arrival time and length of time worked at Ground Zero); the WTC Health Program would need such risk estimates in order to evaluate the strength of the association between 9/11 exposure and MGUS.

Precision of risk estimate:   21 Landgren et al. [2018] reported reasonably precise risk estimates when comparing FDNY members with the Olmsted County reference population. 22 Because Landgren et al. [2018] did not report risk estimates and their confidence intervals for the association between 9/11 exposure and MGUS, the WTC Health Program is unable to evaluate the precision of such risk estimates.

Consistency of association:   23 Multiple studies are not available to ascertain consistency. Only the Landgren et al. [2018] study is available.

Biological gradient:   24 The exposure-response (biological gradient) information provided in Landgren et al. [2018] does not demonstrate an exposure gradient between 9/11 exposure and MGUS. In other words, the study does not provide evidence that the risk of MGUS increases with increasing levels of exposure.

Plausibility and coherence:  25 The findings of Landgren et al. [2018] do not demonstrate a basis for a potential relationship between 9/11 exposure and MGUS. Some FDNY members with MGUS may have had the condition prior to September 11, 2001. This lack of temporal information severely limits an evaluation of the plausibility of an association between 9/11 exposure and MGUS.

Landgren et al. [2018] was reviewed to determine whether both the WTC responder cohort studied is representative of the entire 9/11-exposed population and whether the results can be extrapolated. MGUS screening study subjects were a subset of FDNY members who were exposed to 9/11 agents on or in the aftermath of September 11, 2001 until the Ground Zero site closed in July 2002. All study subjects were white males between the ages of 50 and 79 who had serum samples taken by the FDNY WTC Health Program from December 2013 through October 2015. The findings of this study represent only a subset of white male FDNY responders and may not be generalizable to other 9/11-exposed groups.

The study by Landgren et al. [2018] was evaluated to determine whether a causal relationship between 9/11 exposures and MGUS is supported. As described in the policy on the addition of non-cancer health conditions to the List, 26 the WTC Health Program uses the Bradford Hill criteria described above to evaluate whether a causal relationship between 9/11 exposures and a health condition is supported. Although Landgren et al. [2018] speculated that the study results demonstrate an association between 9/11 exposure and MGUS, the information available in the study is insufficient to support a claim for causation using the Bradford Hill criteria. The study reported a reasonably strong and precise association between being a 9/11-exposed FDNY firefighter and an increased prevalence of MGUS; however, an exposure-response gradient was not found. Furthermore, the temporality of the findings was not established because some FDNY members with MGUS may have had the condition prior to September 11, 2001. Finally, the consistency of an association could not be assessed as Landgren et al. [2018] was the only relevant study that was identified. Given the lack of an exposure-response gradient, the questionable plausibility, the lack of other relevant studies, and the other limitations discussed above, the WTC Health Program considers the Landgren et al. [2018] study to be preliminary and insufficient to add MGUS to the List.

Pursuant to PHS Act, sec. 3312(a)(6)(B)(iv) and 42 CFR 88.16(a)(2)(iv), the Administrator has determined that insufficient evidence is available to take further action at this time, including proposing the addition of MGUS to the List (pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 CFR 88.16(a)(2)(ii)) or publishing a determination not to publish a proposed rule in the Federal Register (pursuant to PHS Act, sec. 3312(a)(6)(B)(iii) and 42 CFR 88.16(a)(2)(iii)). The Administrator has also determined that requesting a recommendation from the STAC (pursuant to PHS Act, sec. 3312(a)(6)(B)(i) and 42 CFR 88.16(a)(2)(i)) is unwarranted.

For the reasons discussed above, the Petition 022 request to add MGUS to the List of WTC-Related Health Conditions is denied.

The Secretary, HHS, or his designee, the Director, Centers for Disease Control and Prevention (CDC) and Administrator, Agency for Toxic Substances and Disease Registry (ATSDR), authorized the undersigned, the Administrator of the WTC Health Program, to sign and submit the document to the Office of the Federal Register for publication as an official document of the WTC Health Program. Robert Redfield M.D., Director, CDC, and Administrator, ATSDR, approved this document for publication on July 29, 2019.

Table of Contents I. Background A. History B. Petition P-1696 C. Statement of Enforcement Discretion II. Overview III. Regulatory Analyses and Notices A. Statutory/Legal Authority for This Rulemaking B. Executive Order 12866 and DOT Regulatory Policies and Procedures C. Executive Order 13771 D. Executive Order 13132 E. Executive Order 13175 F. Regulatory Flexibility Act, Executive Order 13272, and DOT Policies and Procedures G. Paperwork Reduction Act H. Regulation Identifier Number (RIN) I. Unfunded Mandates Reform Act J. Environmental Assessment K. Privacy Act L. Executive Order 13609 and International Trade Analysis M. National Technology Transfer and Advancement Act N. Executive Order 13211 List of Subjects I. Background A. History

On January 30, 2015, PHMSA published a notice of proposed rulemaking (NPRM) titled “Hazardous Materials: Adoption of Special Permits (MAP-21) (RRR)” [Docket No. PHMSA-2013-0042 (HM-233F); 80 FR 5339]. The HM-233F NPRM proposed to adopt provisions contained in 98 widely-used or longstanding special permits with an established safety record. Following a 60-day comment period, PHMSA published a final rule on January 21, 2016, that adopted the provisions of 96 of these special permits [81 FR 3635]. The HM-233F final rule became effective on February 22, 2016.

The HM-233F final rule amended § 180.209(e), which details conditions for allowing the requalification period to be longer for DOT 4-series specification cylinders in certain hazardous material service. Prior to publication of the final rule, § 180.209(e) authorized DOT 4B, 4BW, 4BA, or 4E cylinders used exclusively for a specified list of hazardous materials (non-corrosive gases) to be requalified by volumetric expansion every 12 years, instead of every 5 years. Alternatively, these cylinders were authorized to be requalified by the proof pressure test method every 7 years after the first 12-year period. A proof pressure test is a pressurization test without the determination of a cylinder's expansion, and a volumetric expansion test determines the total and permanent expansion of a cylinder at a given pressure and is conducted by either water jacket or direct expansion test, both of which are conducted with water (see § 180.203).

In the HM-233F NPRM, PHMSA proposed to adopt the provisions of special permit 12084, which was issued to Honeywell International, Inc. 1 This special permit authorized the requalification of DOT 4B, 4BA, or 4BW cylinders in accordance with § 180.209(e) for 11 additional non-corrosive gases. PHMSA identified this special permit as suitable for adoption into the regulations. In the HM-233F NPRM, PHMSA proposed to revise § 180.209(e) by replacing the list of specific hazardous materials with broader applicability to non-corrosive gases commercially free from corroding components.

PHMSA also proposed to amend the requalification periods of authorized cylinders for both the volumetric expansion and proof pressure tests in § 180.209(e). Specifically, PHMSA proposed to standardize the requalification period to 10 years for both the volumetric expansion test (previously a 12-year period) and the proof pressure test (previously a 7-year period after an initial 12-year period). While this proposed change was not discussed in the preamble of the HM-233F NPRM, PHMSA did propose amended regulatory text. PHMSA received no adverse comments to any of the proposed changes to § 180.209(e)—the adoption of special permit 12084 and 10-year requalification period—and therefore adopted the language as proposed in the final rule. While the effective date of the final rule was February 22, 2016, PHMSA allowed for delayed compliance to begin on January 23, 2017.

On January 13, 2017, the National Propane Gas Association (NPGA) submitted a petition to PHMSA and the Office of the Secretary of Transportation (OST) titled “Petition for Rulemaking and Emergency Stay Cylinder Requalification Requirements” [PHMSA-2017-0019 (P-1696)  2 ]. NPGA requested that PHMSA revise the initial timeframe before requalification, revise the requalification period for both the volumetric expansion and proof pressure tests in § 180.209(e) to those authorized prior to the HM-233F final rule, and update the table in § 180.209(a) accordingly. NPGA also requested a Statement of Enforcement Discretion while the rulemaking action was pending.

In the petition, NPGA advised PHMSA and OST that the HM-233F rulemaking created potential impacts and unanticipated costs. Specifically, NPGA asserted that the regulatory change to the requalification period created confusion in the propane industry because it was unclear whether those cylinders manufactured or requalified by the volumetric expansion test within the last 10 to 12 years had to be immediately requalified, since prior to the final rule they would not have required requalification until the 12-year date. Furthermore, NPGA stated that the requirement to test cylinders following manufacture or volumetric expansion testing more frequently ( i.e., every 10 years instead of every 12 years) would increase qualification and training costs. NPGA explained that current industry practice  3 is to mark newly manufactured cylinders, eligible for requalification in accordance with § 180.209(e), with a 12-year requalification mark. Even though this marking is not required by the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180), industry would have to train employees to ignore those markings. Additional training would be required on the revised requalification periods for both volumetric expansion and proof pressure testing.

On March 2, 2017, PHMSA met with NPGA representatives to: (1) Better understand NPGA's concerns; (2) identify existing industry practice and request data to assess the impact of the revised cylinder requalification periods; and (3) evaluate the merits of a rulemaking and Statement of Enforcement Discretion. During this meeting, NPGA reiterated their petition, in that the change in requalification intervals would impose unanticipated industry costs. Furthermore, NPGA conveyed that a majority of their associate members requalify certain DOT 4-series specification cylinders by volumetric expansion testing. Following these discussions, PHMSA accepted NPGA's petition for rulemaking.

On March 17, 2017, PHMSA issued a Statement of Enforcement Discretion stating that it will not take enforcement action against a person who requalifies DOT 4-series specification cylinders using volumetric expansion testing pursuant to a 12-year requalification period while it reviews NPGA's petition for rulemaking. 4 This Statement of Enforcement Discretion specified that until further action, DOT 4-series specification cylinders requalified by volumetric expansion in accordance with § 180.209(e) may have a 10- or 12-year requalification period without any enforcement action taken.

PHMSA has reviewed NPGA's petition for rulemaking and agrees that it merits a rulemaking to consider revising the § 180.209(e) requalification period, as accepting the petition is expected to reduce regulatory burden and industry cost. PHMSA does not anticipate that this revision poses any increased safety risk, as historically these cylinders were authorized to be requalified on a 12-year cycle for volumetric expansion testing and on a 7-year cycle (after an initial 12-year period) for proof pressure testing with no known incidents attributable to the requalification timeframe. It should be noted that in accordance with § 180.205(c), even if a cylinder is due for requalification, it may be used until emptied, as long as it was filled prior to the requalification due date. Once emptied and placed into transportation, it must be requalified in accordance with the appropriate test method before being refilled.

In this NPRM, PHMSA is proposing to return the initial and subsequent requalification periods to 12 years for volumetric expansion tests, as proposed in the NPGA petition and authorized prior to HM-233F. PHMSA is proposing to also return the initial requalification period for proof pressure testing to 12 years, but maintain the 10-year period for subsequent proof pressure requalification testing as adopted in HM-233F final rule. The proof pressure test requalification period of 10 years was not proposed in NPGA's petition for rulemaking (proposed as 7 years). We acknowledge that the proposed 10-year requalification period will likely result in one-time industry training costs; however, the allowance to requalify a cylinder by proof pressure test every 10-years, instead of every 7 years, after the initial 12-year requalification period, may outweigh the costs of training because of less frequent cylinder requalification. Thus, PHMSA believes that this could allow for the greatest regulatory relief. PHMSA invites comments on the potential for costs or savings that may result from maintaining a 10-year requalification period following the initial 12-year requalification period for proof pressure testing instead of returning to the 7-year cycle, after the initial 12-year period (as proposed by the NPGA in its petition and reflective of the requalification period prior to publication of the HM-233F final rule).

Additionally, PHMSA is proposing to revise the title of § 180.209(e) to more appropriately reflect the regulatory provisions in this paragraph. PHMSA is also proposing to revise the table in § 180.209(a) to properly reflect the baseline requalification period and the alternate requalification period allowances for various DOT specification cylinders. The baseline for DOT 4B, 4BA, 4BW, and 4E cylinder requalification is 5-years, but in accordance with the proposed language of § 180.209(e), these cylinders may be requalified every 10 or 12 years, under the specified conditions and dependent on the type of pressure test performed. In addition, PHMSA proposes to add a “7” to the § 180.209(a) table for DOT 4B, 4BA, or 4BW cylinders, as they are authorized for requalification every 7 or 12 years, instead of 5 years, when used as a fire extinguisher in accordance with § 180.209(j). There is no substantive change in adding “7” to the table as this is a conforming amendment for consistency between the table in paragraph (a) and the provisions in paragraph (j), which was inadvertently deleted in the HM-233F final rule.

PHMSA is also proposing to amend the table in § 180.209(a) to remove any reference to paragraph (e) for DOT 3A, 3AA, 3AL, 3AX, 3AAX, 3B, 3BN, and 4AA480 cylinders. Section 180.209(e) does not authorize requalification of these cylinder types. Therefore, this NPRM adjusts for any requalification period that is not currently authorized.

Further, PHMSA is proposing to make editorial corrections to the table for consistency. We propose to: Delete “DOT” preceding 3, 3A, 3AA, 3AL, 3AX, 3AAX, and 4E cylinders because the other entries do not have a similar qualifier; specify “service pressure” in the “Minimum test pressure (psig)” column for DOT 4D, 4DA, and 4DS cylinders to match other entries; and remove a duplicative citation of § 180.209 for DOT 3AL cylinders to be consistent with the other requalification period references.

This rulemaking is published under the authority of Federal Hazardous Materials Transportation Law (Federal hazmat law; 49 U.S.C. 5101 et seq. ), which authorizes the Secretary of Transportation to “prescribe regulations for the safe transportation, including security, of hazardous materials in intrastate, interstate, and foreign commerce.” The Secretary's authority is delegated to PHMSA at 49 CFR 1.97. This rulemaking proposes to amend the requalification periods for certain DOT 4-series specification cylinders under relief provided in § 180.209(e) and to revise the requalification table in § 180.209(a) accordingly.

This rulemaking is considered a nonsignificant regulatory action under section 3(f) of Executive Order 12866 (“Regulatory Planning and Review”) and was not reviewed by the Office of Management and Budget (OMB). This rulemaking is also considered a nonsignificant rulemaking under the DOT's Policies and Procedures for Rulemakings [DOT Order 2100.6; December 20, 2018].

Executive Order 12866 (“Regulatory Planning and Review”)  5 requires 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.”

Additionally, Executive Order 12866 requires agencies to provide a meaningful opportunity for public participation, which also reinforces requirements for notice and comment under the Administrative Procedure Act (APA). 6 Therefore, PHMSA solicits comment on the revised requalification periods for DOT 4-series specification cylinders as proposed in § 180.209(e). PHMSA also seeks comment on the preliminary cost and cost savings analyses, including industry costs or cost savings due to the revised requalification periods for volumetric expansion and proof pressure testing.

Overall, this rulemaking maintains the continued safe transportation of hazardous materials while producing a net cost savings. PHMSA's findings are summarized here and described in further detail in the following 13 sections, which together comprise our preliminary analysis for this NPRM:

PHMSA's preliminary analysis finds that the proposed changes would result in total net cost savings of approximately $142.4 million over 10 years, or $20.3 million annualized, when discounted at 7 percent.

These cost savings are almost entirely based on two effects. The first effect is avoiding the immediate, accelerated requalification of approximately 5 million DOT 4-series specification cylinders that would otherwise be required if the proposed changes of this rulemaking are not adopted. The second effect is an anticipated reduction in the number of cylinders in need of requalification in any given year. The avoidance of accelerated requalification occurs in year one, and the “enduring” effect of reducing the number of cylinders in need of requalification occurs in subsequent years (years 2-10). Our primary analysis focuses on cost savings to entities that requalify cylinders by volumetric expansion testing. However, this NPRM also proposes to retain the 10-year requalification period for the proof pressure test adopted under the HM-233F final rule, so we assume cylinder marketers require some training to ensure knowledge of the revised requalification timeframes for proof pressure testing. This NPRM would also relieve cylinder manufacturers of training to ensure that voluntary stamping practices align with the initial requalification timeframe, resulting in training-related cost savings for cylinder manufacturers. On net, we estimate training cost savings at approximately $0.2 million. We add the two types of requalification cost savings to the net cost savings related to training to determine the total net cost savings. See Exhibit 1.

Exhibit 1 shows “year one,” monetized cost savings as well as “enduring” cost savings in years 2-10 based on a reduction in the number of cylinders in need of requalification. Please see the section, “Analysis of total net cost savings,” for additional tabulation of the total net cost savings of the rule, discounted over 10 years.

If one were to present these cost savings on an indefinite or perpetual time horizon, their net present value would be approximately $209.3 million at a 7% discount rate, and their annualized value would be $14.7 million, also at a 7% discount rate. 8 Please note, to arrive at this calculation, year-one impacts are undiscounted because these impacts are expected to begin occurring soon after the rulemaking is made effective, if it is made effective. On a perpetual horizon, the year-one savings is $86,338,066 and subsequently, all other years repeat a savings of $8,610,338.

NPGA petitioned  9 PHMSA to amend § 180.209(e) because the HM-233F final rule was expected to impose a substantial cost burden on industry. Specifically, NPGA reasoned that, due to confusion about the applicability of the HMR, the requirements in the HM-233F final rule would accelerate the requalification of certain DOT 4-series specification cylinders by 2 years, even though the HMR allows a cylinder filled before the end of the requalification period to remain in service until emptied, as long as it is requalified prior to being refilled and offered back into transportation (see § 180.205(c)). For example, a cylinder tested by volumetric expansion would need to be requalified every 10 years, rather than every 12 years. This 2-year acceleration would effectively force 3 years of cylinder vintages to be requalified in a single year, and thus would have a potential one-time impact on thousands of propane marketers and millions of cylinders. To avoid this substantial cost burden, PHMSA issued a Statement of Enforcement Discretion on March 17, 2017, and initiated this rulemaking, which proposes to allow affected cylinders to be initially and subsequently requalified over a 12-year period when tested by volumetric expansion.

NPGA also cited confusion stemming from the industry practice of stamping a propane cylinder at the time of manufacture with an indication that the cylinder must be requalified 12 years after the manufacture date. The HMR do not require this stamp. However, this practice means that under current requirements, retraining would be necessary to educate employees on the 10-year requalification period and to ignore the stamp marking.

Further, PHMSA proposes to retain the 10-year period for proof pressure testing requalification, after the initial requalification test at 12 years. Prior to publication of the HM-233F final rule, the HMR required a 7-year timeframe for subsequent requalification by proof pressure. In its petition, NPGA asked that PHMSA return the proof pressure test requalification periods of paragraph (e) to 7 years. However, PHMSA is proposing to maintain the 10-year requirement on the basis that it may add regulatory relief. PHMSA solicits comments regarding this proposal, especially as it differs from the NPGA petition (P-1696). To address possible cost-saving effects on proof pressure-tested cylinders, PHMSA offers a supplemental analysis in the last section of this analysis. Due to data uncertainties, this supplemental cost savings analysis is separate from and secondary to our primary analysis methods and estimates. PHMSA solicits comments to address these data uncertainties, specifically comments regarding the extent of proof pressure testing.

This rulemaking is expected to have a variety of effects or impacts, some of which result in cost savings, others in costs. We do not estimate benefits in this analysis because PHMSA anticipates that the proposed changes maintain an equivalent level of safety. This section describes the baseline and rulemaking scenarios, which are the basis for determining whether the proposed rule may result in costs or cost savings.

Absent rulemaking action, the existing Statement of Enforcement Discretion relieves cylinder marketers of the HM-233F requirement to requalify cylinders every 10 years. However, the Statement of Enforcement Discretion does not provide regulatory certainty. Therefore, PHMSA uses the HM-233F or current HMR standards as the baseline, and uses this rulemaking action (HM-219B) as the rulemaking scenario and basis for incremental change.

Thus, in the baseline, requalifications are accelerated by 2 years, resulting in costs; in the rulemaking scenario, these accelerated requalifications are avoided, resulting in cost savings. This effect would occur in year one of impacts. In addition, in subsequent years, the pool of cylinders requiring requalification would be larger in the baseline than in the rulemaking scenario. Thus, if this rulemaking becomes effective, PHMSA is also providing “enduring” cost savings due to fewer cylinders being in need of requalification in the rulemaking versus the baseline scenario. These cost saving effects are the main effects of this proposed rulemaking.

Please note that this analysis focuses on the cost and cost-savings impacts of the 2-year acceleration of requalification by volumetric expansion because there is substantial uncertainty regarding the proportion and number of cylinders that are requalified by proof pressure testing. However, in the last section of this cost-savings analysis, we attempt to address this uncertainty by providing a supplemental analysis illustrating possible cost-savings effects on proof pressure-tested cylinders. In the baseline, proof pressure-tested cylinders must be requalified every 7 years after the initial 12-year period; in the rulemaking scenario, these cylinders can be requalified every 10 years after the initial 12-year period. This may enhance regulatory flexibility, and is a possible mechanism for cost savings. To better address these uncertainties in future analyses, PHMSA solicits comment on the proportion and number of cylinders that are proof pressure-tested versus cylinders tested using other methods. Due to data uncertainties, we limit our discussion of these proof-pressure cost savings to the supplemental analysis—they do not factor into our primary estimates for cost savings.

PHMSA also anticipates another, relatively smaller effect: Cost savings that result from relieving manufacturers of the need to mark cylinders with a revised requalification timeframe. This marking is not an HMR requirement. However, in the baseline scenario, this marking would need to be revised to indicate a 10-year initial requalification timeframe, resulting in costs; in the rulemaking scenario, this marking could continue to indicate a 12-year initial requalification timeframe, resulting in avoided costs or cost savings.

In addition to cost savings, the HM-219B proposal to retain a revised timeframe for subsequent proof pressure requalifications may result in training costs to cylinder marketers. In the baseline, current HMR requirements would necessitate this training and imposition of costs on cylinder marketers. Additionally, the rulemaking scenario will still necessitate this training and imposition of costs, since proof pressure requirements differ from pre-HM-233F conditions.

In summation, this rulemaking may have a variety of cost and cost-savings effects, but the main effects are due to the baseline and rulemaking scenarios for cylinders requalified by volumetric expansion. In the baseline scenario, cylinders must be initially requalified every 10 years. This is the current HMR requirement, as codified in HM-233F. Conversely, in the rulemaking scenario, cylinders tested by volumetric expansion must be requalified every 12 years. This is the change proposed in this rulemaking (HM-219B), which effectively revises the requalification timeframe for volumetric expansion testing back to the standards in place before HM-233F was published. See Exhibit 2.

This analysis assumes that this rulemaking will result in a “one-time” impact occurring in the first year the rulemaking is effective due to accelerated requalifications. After this first year, the rulemaking will also result in a reduction in the number of cylinders requiring requalification in any one year.

With respect to year-one impacts, we can elaborate further with an example using the baseline and rulemaking scenarios. In the baseline scenario, cylinder marketers need to requalify three different vintages of cylinders in 2019, specifically those cylinders manufactured or requalified in 2007, 2008, and 2009. This is the direct result of the requirement that these cylinders be requalified on a 10-year timeframe instead of a 12-year timeframe. As such, the HM-233F final rule imposed an accelerated requalification for cylinders manufactured or requalified in 2008 and 2009, whereas the cylinders manufactured or requalified in 2007 would need to be requalified in 2019 under either the baseline or rulemaking scenario. In the baseline scenario, 3 years' worth of cylinders need to be requalified in a single year, with the 2008 and 2009 cylinders needing requalification earlier than anticipated. Conversely, in the rulemaking scenario, the 2008 and 2009 cylinders can be requalified in 2020 and 2021, respectively, and the requalification costs that the HM-233F final rule imposed are avoided. To the extent that cylinders are requalified using volumetric expansion, this NPRM proposes a requalification timeframe that would have occurred were the HM-233F final rule never published.

PHMSA's analysis sees this effect as a “one-time” or “year one” impact. In the baseline, it is a one-time cost imposition; in the rulemaking scenario, it is a one-time avoidance of these costs (cost savings). See Exhibit 3.

As evident in Exhibit 3, the baseline scenario (HM 233F; current HMR requirements) primarily affects cylinder requalification in the first year of the rule's effect. Before this first year, there is no difference between the baseline and rulemaking scenario. After this first year of effect ( e.g., 2019 onward), the requalification cycle returns to a “normal state,” where only one vintage of cylinders are requalified per year, although the number of cylinders in need of requalification in any given year would be smaller in the rulemaking than in the baseline scenario.

Note that we do not have data on the manufacturing and requalification dates for the affected cylinders—this affects how we chose to model the timing of requalification in Exhibit 3 and the impacts of the baseline and rulemaking scenarios. As evident in Exhibit 3, we assume that each cylinder has a specific manufacturing or requalification year and do not distinguish between the cylinders on a more granular level ( e.g., month-to-month). For instance, we do not distinguish between a cylinder from January 2007 and one from June 2007. All 2007 cylinders are assumed to be requalified in 2019, as well as all 2008 and 2009 cylinders in the baseline. We make no further distinction about the timing of the manufacture and requalification of affected cylinders. Further, our analysis does not have a discounting component for avoiding accelerated requalifications because it is assumed to occur in the first year of the rulemaking's implementation, without distinctions between an expenditure made in January 2019 and one in December 2019, for example. For these reasons, the costs of accelerated requalification (or the avoidance of these costs) are undiscounted, one-time or “year one” impacts.

In addition to “year one” impacts, there is potential for “enduring” effects occurring in subsequent years. In subsequent years, the pool of DOT 4-series specification cylinders that need requalification in a given year may be smaller in the rulemaking scenario than in the baseline scenario. In the baseline scenario, this requalification pool represents effectively 1/10th of cylinders in service since these cylinders would need requalification once every 10 years. In the rulemaking scenario, this requalification pool would represent 1/12th of cylinders in service since these cylinders would need requalification once every 12 years. This rulemaking scenario reduction in requalification may result in cost savings. We attempt to quantify and monetize this effect as a cost savings, which in tandem with the avoided accelerated requalification costs, may be substantial. PHMSA solicits comment on the “one-time” and “enduring” effects, and on this analysis in general. We also solicit comment on whether there are additional economic effects that were not foreseen that could be represented in a future, revised analysis.

According to information provided by NPGA in P-1696, the revisions made in the HM-233F final rule affect nearly 5 million DOT 4-series specification cylinders ( e.g., 4B, 4BA, 4BW, and 4E). Furthermore, NPGA estimates that 75 percent of cylinders are 20-lb. cylinders (used primarily for BBQ grills, patio heaters, construction heat, temporary heat, etc.), and the remaining 25 percent comprise a variety of sizes, e.g., 33.5 lb. (forklift cylinders), 100 lb. (exchange cylinders), and the largest size, 420 lb. propane cylinders (residential/commercial heat). Absent any other data describing the population of affected cylinders, PHMSA uses NPGA's assumptions for this analysis. 10 See Exhibit 4.

Exhibit 4 reiterates that, absent this rulemaking, approximately 5 million cylinders would need to be requalified on an accelerated basis. If this rulemaking is adopted, these 5 million cylinders can be requalified on a 12-year timeframe. As explained previously, this would revert volumetric expansion test requalification back to the timing in place before publication of the HM-233F final rule.

This estimate of the number of affected cylinders is also important to the estimation of “enduring” cost savings. After year one, the difference between the annual number of cylinders in need of requalification in the baseline and rulemaking scenarios is an input to our method for the enduring cost savings. Specifically, NPGA's estimate of 5 million represents 2 cylinder vintages that would undergo accelerated requalification. This means an estimated 2.5 million cylinders may need requalification in any one year. As such, over 12 years, 30 million cylinders would need requalification (2.5 * 12). If this same number of cylinders were to be requalified instead over 10 years, as the baseline holds, this would mean 3 million cylinders per year, or an increase of 500,000 cylinders per year. In other words, the baseline scenario would require that 20% more cylinders be requalified each year; in the rulemaking scenario, 20% fewer. This differential is an input to our cost savings method for “enduring” cost savings, which occur after year one.

Based on the accelerated requalifications in year one and the enduring effects thereafter, PHMSA chooses a time period of analysis of 10 years. A different time period of analysis may result in different findings and PHMSA may revise this analysis in the future to reflect different time periods of analysis.

Because PHMSA relies on NPGA assumptions and data, this cost savings analysis includes a supplemental analysis addressing the number of affected cylinders. This is provided in the section, “Supplemental analysis regarding the number of affected cylinders.”

This rulemaking affects various entities, specifically cylinder marketers and manufacturers. If this rulemaking is not adopted, cylinder marketers bear the costs of accelerated cylinder requalification; however, if this rulemaking is adopted, cylinder marketers achieve a cost savings because they are relieved of the need to requalify cylinders on an accelerated basis. Moreover, cylinder marketer employees would require training if this rulemaking is adopted as proposed, since proof pressure requirements would be different. Lastly, if adopted, the rulemaking would relieve cylinder manufacturers of changes to voluntary stamping/marking practices, resulting in cost savings (avoided training costs). These training costs and cost savings are detailed in the section, “Analysis of training costs and cost savings.”

To describe the type and number of affected cylinder marketers, PHMSA relies on the North American Industrial Classification System (NAICS), 12 specifically sector code 454310 Fuel Dealers . 13 This sector is comprised of fuel dealers primarily engaged in retailing heating oil, liquefied petroleum (LP) gas, and other fuels via direct selling to customers. For the purposes of this analysis, we call entities in this sector, “cylinder marketers” or “marketers,” which is used synonymously with “fuel dealers.” There are approximately 8,700 establishments in this sector. 14 The employment estimate for this NAICS sector is approximately 74,000, according to U.S. Census data. This estimate of the number of cylinder marketer employees is used as an input in our estimation of this rulemaking's training costs. We detail cost and cost- savings methods and calculations in the sections, “Analysis of requalification cost savings” and “Analysis of training costs and cost savings.”

In addition to cylinder marketers, the rulemaking is likely to have an impact on NAICS sector 332420 Metal Tank Manufacturing, 15 which is the sector primarily engaged in cutting, forming, and joining heavy gauge metal to manufacture tanks, vessels, and other containers. For the purposes of this analysis, we call entities in this sector, “cylinder manufacturers,” or “manufacturers” for short. During 2014, this sector included 739 establishments and 36,869 employees. 16 It is industry practice—albeit not required by the HMR—that DOT 4-series specification cylinder manufacturers currently place a stamp during manufacture indicating that the cylinder must be requalified 12 years after the manufacture date. 17 If this rulemaking is not adopted (baseline), cylinder manufacturers may need to adjust this stamp to reflect the 10-year requirement, and implement any necessary training or manufacturing process changes to do so. This estimate of the number of cylinder manufacturing employees is used as an input in our estimation of this rule's training-related cost savings.

See Exhibit 5 for the estimates of the number of establishments and employees on payroll for the NAICS sectors, 454310 Fuel Dealers and 332420 Metal Tank Manufacturing .

Assuming the rulemaking takes effect in 2019, adoption of this rulemaking would relieve cylinder marketers of the cost to accelerate the requalification of cylinders manufactured in 2008 and 2009. PHMSA believes it would also provide a reduction in the number of cylinders in need of requalification after year one, on an enduring, year-over-year basis. In this section, we estimate the value of these potentially avoided costs.

In the baseline or HM-233F scenario, changes to § 180.209(e) require cylinder marketers to requalify some cylinders on an accelerated basis. Based upon assumptions provided by NPGA, a typical safety inspector can requalify three residential cylinders per hour and two commercial cylinders per hour. 19 We estimate the avoided requalification cost by multiplying the number of residential and commercial cylinders requiring requalification, from Exhibit 4, by the amount of time needed to requalify a single cylinder, differentiated by type, and the mean hourly labor rate  20 for a safety inspector in the 454310 Fuel Dealers sector. 21 This approach results in estimated costs of $15.26-$23.12 to requalify each residential and commercial cylinder, respectively. Total potentially avoided requalification costs for these cylinders are estimated to be approximately $86 million dollars. See Exhibit 6-1.

PHMSA interprets this impact as a “one-time” cost savings that is assumed to occur over a one-year period during 2019. We do not distinguish these cost savings on a month-to-month basis because we do not have data relaying the specific manufacturing dates of the affected cylinders. Further, this may not be relevant if requalification dates are uniformly distributed across different months of the year.

There is also cost savings due to enduring, year-over-year effects in which the number of cylinders in need of requalification is expected to be fewer in the rulemaking scenario. With a longer requalification timeframe (12 years vs. 10 years), there are fewer cylinders in need of requalification in a given year. In a previous section regarding the affected number of cylinders, PHMSA estimated that 20% fewer cylinders would be in need of requalification in the rulemaking scenario. Combining this 20% estimate with the cost findings related to year one impacts, we can estimate enduring, year-over-year cost savings. This assumes that input values ( e.g., labor rates, time to requalify, breakdown of cylinder types) remain constant over the time period of analysis. For example, labor rates are assumed to be constant; if they were adjusted to reflect inflation, our cost savings estimate would be higher.

Thus, Exhibit 6-1 above provides that the accelerated requalification of 2 cylinder vintages would result in approximately $86 million. We divide that figure in half to represent annual requalification costs and then take 20% of the resulting figure to estimate enduring, year-over-year cost savings. 25 This gives approximately $8.6 million in undiscounted, yearly cost savings. Equivalently, if 500,000 extra cylinders need requalification on an on-going basis in the baseline, this amounts to 1/10th of the “glut” created by the accelerated requalification in year one and hence 10% of the estimated costs. 26 Exhibit 6-2 below presents these cost savings in years 2-10, as well as the year-one cost savings based on avoidance of accelerated requalification. We present undiscounted (0%) and 3% and 7% discount rates.

Therefore, if this proposed rule is adopted, cylinder marketers in the 454310 Fuel Dealers NAICS sector would be relieved of requalifying approximately 5 million cylinders in year one, which would save them approximately $86 million dollars in costs (undiscounted). Conversely, $86 million in requalification costs would be imposed in year one if this rulemaking is not adopted, which this analysis assumes would sustain HM-233F's requirement for a 10-year requalification timeframe. Moreover, if adopted, cylinder marketers would have 20% fewer cylinders to requalify in each year after year one. This results in cost savings of approximately $8.6 million in years 2-10 (undiscounted).

Combining these two cost savings effects together, cylinder marketers are expected to save $142.2 million over 10 years, discounted at 7%. On an annual basis, they are expected to save $20.2 million annualized at 7%. We use these figures to calculate total net cost savings later in the document, but first we must account for training-related cost savings, as well as some training-related costs, due to the rulemaking scenario.

This rulemaking may relieve approximately 18,000 cylinder manufacturing employees from needing training. In the baseline scenario, these cylinder manufacturing employees may need to change the way they voluntarily stamp newly-manufactured cylinders, necessitating training; conversely, in the rulemaking scenario, their stamping practices can remain unchanged, avoiding this training and associated costs. The net effect of these training-related impacts is quantified in the section, “Analysis of total net cost savings.”

However, this rulemaking is also likely to result in approximately 36,000 cylinder marketer employees to need training on the proposed changes to proof pressure requalification periods. Specifically, PHMSA is proposing to retain the 10-year requalification timeframe for cylinders that are initially requalified using proof pressure testing. This may provide cylinder marketers regulatory relief by reducing the requalification frequency for proof pressure, but it is also likely to necessitate training because this proposal diverges from the standards in place before the HM-233F final rule. PHMSA seeks comment on this proposal.

Regarding the training of cylinder marketers, their employees need to understand that a 12-year timeframe applies to cylinders initially and subsequently requalified by volumetric expansion testing, and that a 10-year timeframe applies to cylinders requalified by proof pressure testing after an initial 12-year period. In P-1696, NPGA suggests that this training would take two hours per employee and that approximately half of employees would require training. 27 PHMSA believes only the training portion related to proof pressure testing is a relevant change, so we assume this training takes just one hour per employee, and, as stated by NPGA, that half of employees would require training. Thus, we take the number of employees for the 454310 Fuel Dealers sector from Exhibit 5 (73,555) and divide it by 2 to get the number of these employees requiring training (73,555/2 = 36,778, with rounding). We use the hourly labor rate for these 454310 Fuel Dealers employees, as exhibited in Exhibit 6-1 ($46.23), and multiply by 1 training hour to estimate the cost to train each employee ($46.23 * 1 = $46.23). We then multiply $46.23 by the number of 454310 Fuel Dealers employees requiring training to estimate the training cost for these employees ($46.23 * 36,778 = $1,700,247, with rounding).

As NPGA explains in P-1696, millions of cylinders currently in service show a stamp placed during manufacture, indicating that the cylinder must be requalified 12 years after the manufacture date. Under the baseline scenario, cylinder manufacturers would need to adjust this stamp to indicate a 10-year period. From this vantage, this proposed rulemaking results in training cost savings for cylinder manufacturers, not training costs; in other words, the regulations proposed here ensure that cylinder manufacturers can continue the industry practice of stamping to reflect the 12-year timeframe for initial requalification.

To estimate training cost savings for cylinder manufacturers, PHMSA references NPGA's estimate that training would take two hours per employee and that approximately half of employees would require training. 28 Thus, we take the number of employees for the 332420 Metal Tank Manufacturing NAICS sector from Exhibit 5 (36,869) and divide it by 2 to get the number of these employees requiring training (36,869/2 = 18,435, with rounding). We use $52.48 as the hourly labor rate for 332420 Metal Tank Manufacturing employees and multiply by 2 training hours to estimate the cost to train each employee ($52.48 * 2 = $104.96). 29 We then multiply $104.96 by the number of 332420 Metal Tank Manufacturing employees requiring training to estimate the training cost savings for these employees ($104.96 * 18,435 = $1,934,938, with rounding).

Based on these assumptions, input values, and methods, PHMSA estimates net cost savings related to training, totaling approximately $0.2 million dollars (undiscounted). See Exhibit 7. These training costs and cost savings would occur in year one of implementation of the rulemaking and are not discounted. They are not modeled to repeat in subsequent years.

PHMSA outlined our assumptions, input values, and methods for estimating the expected costs and cost savings of this rulemaking. We now present the total net cost savings as the sum of net cost savings to both 454310 Fuel Dealers and 332420 Manufacturers. See Exhibit 8-1. As such, we estimate total net cost savings at approximately $163.8 million dollars, undiscounted.

We also discount these savings over the time period of analysis. See Exhibit 8-2. To year one, we add the net cost savings related to training ($234,691) to cost savings related to the avoidance of accelerated requalification ($86,103,375), yielding $86,338,066 in cost savings in year one. The year-one impacts related to both effects are not discounted; they are assumed to occur at present value. However, the “enduring” cost savings are discounted according to the discount rate and the appropriate year in which the savings occurs. As such, we estimate total net cost savings of $142.4 million over 10 years, discounted at 7%, and $20.3 million annualized at 7%. These total figures do not differ much from the results presented in Exhibit 6-2 because training impacts are very small relative to requalification impacts.

PHMSA has not estimated quantitatively all the possible cost and cost-savings impacts of this rulemaking. This is due to data availability and uncertainty surrounding the actual impacts of the rulemaking if it is made effective. Ultimately, the actual impacts of the rulemaking may vary from the representation in this analysis; this analysis merely represents our expectations based on the available data and our professional judgment. For these reasons, PHMSA solicits comment on this rulemaking and its analysis as expressed in this NPRM.

To address some of these uncertainties and data limitations, we have identified various non-quantified costs and cost savings that might result from adopting this rulemaking. Our discussion here of non-quantified and non-monetized impacts is not exhaustive. For example, PHMSA can identify the following potential impacts, which are not quantified or monetized in this analysis:

1. Changes in the number of cylinders taken out of service due to accelerated requalification requirements;

2. Changes in the demand for or supply of DOT 4-series cylinders and requalification services; and

3. Changes in the prices faced by propane consumers.

If this rulemaking is not adopted, PHMSA expects there may be changes in the number of cylinders that are taken out of service in the first year of the rule's effect due to failure of a requalification test. The HM-233F final rule accelerated initial requalification requirements, resulting in industry performing triple the number of requalification tests during year one. The increase in the number of requalification tests performed in year one means there could also be an increase in the number of cylinders that are taken out of service as a result of the requalification testing. To the degree that accelerated testing would result in cylinders being removed from service sooner, cylinder marketers would incur costs to acquire more replacement cylinders. PHMSA has not quantified the number of cylinders that might be “prematurely” taken from service and has not monetized the costs of replacing them. This represents a new category of potential costs under the baseline scenario and a new category of potential cost savings for cylinder marketers under the petition scenario. As such, the cost savings of adopting this rulemaking may be understated. Therefore, PHMSA seeks comments and any supporting data on this analysis, including comments and data regarding the potential effect of accelerated requalification on the number of cylinders removed from service and associated costs.

In addition, if this rulemaking is not adopted, PHMSA can anticipate changes in the supply of and demand for DOT 4-series specification cylinders, as well as cylinder requalification services. For instance, accelerated requalification requirements may be expected to result in higher costs for cylinder marketers, disincentivizing cylinder supply in the overall market. Similarly, a temporary increase in the demand for cylinder requalification services could affect the price of these services faced by cylinder marketers. As another example, accelerated requalification requirements may result in increased demand for newly manufactured cylinders to the extent that they are a substitute for requalified cylinders. A temporary increase in the demand for newly manufactured cylinders might result in a temporary increase in economic activity for that sector and could affect the prices for these cylinders and the revenues of cylinder manufacturing companies. PHMSA has not quantified these market dynamics because of their complexity and highly uncertain nature.

Lastly, there is uncertainty about the potential impact on consumers ( e.g., propane end-users), so PHMSA has not quantified downstream price impacts. This is also a question of market dynamics. Specifically, the baseline scenario may result in price increases for propane-related goods and services for end-use consumers to the degree that the cylinder manufacturers and marketers are able to pass additional costs onto consumers.

The discussion in the previous section characterizes non-quantified and non-monetized impacts of this rulemaking. Other impacts were quantified and/or monetized in this analysis, but PHMSA's estimates remain uncertain. As such, this section characterizes additional uncertainty in the quantitative impacts estimated in this analysis. Note that this discussion is not exhaustive. PHMSA solicits comments on our analysis, including commentary on where our estimates could be improved and findings made more accurate. We note uncertainty in these quantitative areas:

1. Estimate of the number of affected entities and employees;

2. Estimate of the training hours necessitated by the rulemaking;

3. Estimate of the labor hours needed to requalify affected cylinders;

4. Estimate of the number of affected cylinders;

5. Proportion of cylinders initially requalified by proof pressure testing (estimated only in the supplemental analysis); and

6. Number of cylinders initially requalified by proof pressure testing (estimated only in the supplemental analysis).

As outlined, there is uncertainty regarding the estimate of the number of affected entities and, thus, the number of affected employees, per Exhibit 5. This uncertainty arises from the fact that only some establishments in NAICS 454310 Fuel Dealers may sell fuels in DOT 4-series specification cylinders affected by § 180.209(e). There may also be propane marketing entities in other NAICS sectors, but current data do not support estimates of the portion of affected establishments in additional sectors. These uncertainties may result in training costs or cost savings being over or underestimated. Since the number of affected entities is not actually used as an input variable to determine training costs or cost savings, we do not explore this variable in a supplemental analysis.

As another example of uncertainty in this analysis, PHMSA is not able to corroborate the NPGA estimate regarding the amount of time required for training. NPGA estimated that each employee would need two hours to be appropriately trained on the revised requalification periods. Since training costs are proportionately small compared to estimated requalification cost savings, we do not explore this uncertainty in a supplemental analysis. To illustrate this point, consider a simple example. Doubling the amount of time for training cylinder marketing employees would double estimated training costs, from approximately $1.7 million to $3.4 million, yet training costs would remain a relatively small proportion of the estimated, year-one requalification cost savings ($3.4 million/$86.1 million = 3.9%). It is unlikely that variance in this input value would alter PHMSA's assessment that this rulemaking provides total net cost savings.

We are also unable to corroborate NPGA's estimate regarding the amount of time required to requalify affected cylinders. To the extent that it takes longer to requalify affected cylinders, requalification costs are understated in the baseline scenario and cost savings are understated in the rulemaking scenario. If less time is required to requalify affected cylinders, the reverse is true: Requalification costs are overstated in the baseline scenario and requalification cost savings are overstated in the rulemaking scenario. However, we believe that NPGA is uniquely positioned to estimate this variable due to the nature of its member representation. For this reason, we do not explore this variable with a supplemental analysis.

Furthermore, PHMSA is not able to corroborate the NPGA estimate for the number of affected cylinders. In this analysis, we rely on NPGA's estimate of approximately 5 million cylinders affected due to accelerated requalification. The number of cylinders affected is a critical input value for the estimation of cylinder requalification costs and cost savings in the baseline and rulemaking scenarios, respectively. Moreover, this specific variable presents uncertainty in that the NPGA estimate may be overestimated. This is because the HMR allow a cylinder, filled before the requalification becomes due, to remain in service until it is emptied. 33 As such, filled cylinders may remain in service, and cylinder marketers would not need to remove compliant cylinders from service to meet the 10-year requalification timeframe codified in the HM-233F final rule and presented in this analysis as the baseline scenario. To the extent that fewer cylinders need to be requalified to meet the 10-year timeframe in the baseline scenario, the requalification costs estimated in the baseline scenario and the requalification cost savings in the rulemaking scenario are both overstated. To explore this uncertainty further, we provide a supplemental analysis regarding the number of affected cylinders in the following section.

Lastly, PHMSA notes uncertainty regarding the proportion and number of affected cylinders that would be requalified using proof pressure testing versus other methods. Proof pressure testing is an alternative to volumetric expansion testing. Despite proposing to retain the 10-year timeframe for a cylinder initially requalified by proof pressure testing, PHMSA did not include proof pressure-related requalification cost savings in our primary estimates because of the uncertainty surrounding the extent to which proof pressure testing is used to requalify the affected cylinders. If it is costlier to requalify using proof pressure testing than volumetric expansion testing and requalifiers continue to use proof pressure methods, then costs may be understated in the baseline scenario and cost savings may be understated in the rulemaking scenario. To the extent that requalifiers use proof pressure testing and it is less costly to requalify by proof pressure testing, then costs may be overstated in the baseline scenario and cost savings may be overstated in the rulemaking scenario. There also may be little or no difference between the costs of requalifying by volumetric expansion and proof pressure testing. PHMSA solicits comment on the extent of proof pressure testing versus other requalification methods.

Furthermore, our requalification cost savings analysis characterizes the timing of initial requalification in relation to cylinder manufacture. Refer to Exhibit 3. For volumetric expansion testing, the distinction between initial and subsequent requalification tests is not relevant since they would both occur at 12-year intervals; however, for proof pressure testing, the question of whether the cylinder is being initially or subsequently requalified is relevant and would determine the regulatory timeframe that applies (12 or 10 years). Noting this distinction, it may be reasonable to conceive of the cost-savings impacts on proof pressure-tested cylinders as altogether separate and possibly affecting a different, older pool of cylinders. We do not know whether the estimate of affected cylinders that NPGA provided accommodates this distinction. Put another way, uncertainty surrounds the proportion and number of cylinders that would be initially requalified by proof pressure testing versus volumetric expansion testing, as well as the overall number of cylinders that are requalified using proof pressure testing during subsequent requalification tests. These uncertainties are substantial to the point that we refrain from including cost savings related to proof pressure-tested cylinders in our primary estimates.

Nevertheless, we provide a supplemental analysis for the possible cost savings effects on proof pressure-tested cylinders, specifically how this proposed rulemaking would affect different vintages of cylinders that would initially be requalified by proof pressure (at the 12-year mark) and subsequently requalified at the 10-year mark as opposed to the 7-year mark, amounting to a 3-year deferral of these requalification tests and associated costs. This supplemental analysis is found in the section, “Supplemental analysis regarding possible effects on proof pressure-tested cylinders.”

See Exhibit 9 for a distillation of the uncertainties discussed in this analysis.

The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires each regional fishery management council to submit any FMP or amendment to NMFS for review and approval, partial approval, or disapproval. The Magnuson-Stevens Act also requires that NMFS, upon receiving an FMP or amendment, publish an announcement in the Federal Register notifying the public that the FMP or amendment is available for review and comment.

The FMP being revised by Amendments 50A-F was prepared by the Council and implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Act.

The red snapper stock annual catch limit (ACL) is divided into commercial (51 percent) and recreational (49 percent) sector allocations. In 2015, through Amendment 40 to the FMP, the recreational sector was separated into a private angling component and a Federal charter vessel and headboat (for-hire) component until the end of 2022 (80 FR 22422, April 22, 2015). Within the recreational sector, the recreational ACL is allocated 57.7 percent to the private angling component and 42.3 percent to the for-hire component. Recreational harvest of red snapper in Gulf Federal waters is managed through a two-fish bag limit, a 16-inch (40.6 cm) total length (TL) minimum size limit, and fishing seasons for each component that begin on June 1 and close when the annual catch target (ACT) of the respective recreational component is projected to be reached. However for the 2018 and 2019 fishing years, NMFS issued exempted fishing permits to each of the five Gulf states to allow each state to set the fishing season for private anglers landing in that state. The for-hire component fishing season continues to be set by NMFS. The Gulf red snapper stock is not undergoing overfishing, and is not overfished but continues to be managed under a rebuilding plan that ends in 2032.

From 1996 through 2014, the recreational fishing season for red snapper in Gulf Federal waters became progressively shorter, and increased catch rates and inconsistent (longer) Gulf state water recreational fishing seasons contributed to recreational harvest overages. Recreational fishermen throughout the Gulf have requested more flexibility from the Council and NMFS in recreational red snapper management to provide greater socio-economic benefits to their local areas.

In 2017, the Council began developing Amendments 50A-50F to establish state management programs for the harvest of red snapper in the Gulf by the recreational sector. State management refers to allowing a state to set some regulations applicable to anglers landing red snapper in that state ( e.g., recreational bag limits and season length), or in some circumstances applicable to anglers fishing for red snapper in Federal waters off that state ( e.g., closed areas). Amendment 50A includes actions affecting all Gulf states and the overall Federal management of recreational red snapper, regardless of whether all Gulf states participate in a state management program. Amendments 50B-F are individual amendments for each Gulf state (Louisiana, Mississippi, Alabama, Florida, and Texas, respectively) and contain the Council's selection of preferred alternatives for each individual state management plan.

Management measures under a state's approved state management program would have to achieve the same conservation goals as the current Federal management measures ( e.g., constrain harvest to the state's allocated portion of the recreational ACL). Although under state management for measures controlling certain harvesting activities, red snapper would remain a federally managed species. The Council's Scientific and Statistical Committee would continue to recommend the acceptable biological catch for red snapper, while the Council would determine the total recreational sector, component, and state ACLs. Unless area closures off a state are established in Federal waters, enforcement would primarily be conducted in state waters and dockside.

Amendments 50A-F include measures: Identifying the recreational component to include in state management programs; establishing the state-specific allocation of the annual catch limit (ACL); delegating the authority to the states to establish the recreational fishing season, recreational bag limit, and size limits; establishing the post-season ACL adjustments; and establishing the procedure for states to request an area closure in Federal waters off their state.

Currently, the Council and NMFS establish all management measures for both the Federal private angling and for-hire components in Gulf Federal waters. Amendments 50A-F would delegate to each state the authority to establish specific management measures applicable to the private angling component only. The Council and NMFS would continue to specify all management measures applicable to the Federal for-hire component. The sunset provision ending sector separation after the 2022 fishing year would be removed, and separate component ACLs would continue to be set for each component indefinitely. The Council decided not to pursue state management of the for-hire component at this time in order to reduce the administrative burden and potential complication of enforcement in developing a program for that component. The Council wanted to have Amendments 50A-F implemented for the 2020 fishing year, and including the for-hire component may have affected this timeline.

Currently, each Gulf state decides when to open and close their respective state waters to fishing for reef fish. These state water recreational reef fish seasons may not be consistent with the fishing seasons in Federal waters. In state waters, the states establish other management measures, such as recreational bag limits and size limits, while the Council has the responsibility for reef fish management measures applicable in Federal waters. Amendments 50A-F would delegate some management authority to a Gulf state to regulate recreational harvest of red snapper in Federal waters by private anglers landing in that state. Each state would be required to establish the private angling season structure for harvest of its assigned portion of the ACL, monitor landings, and prohibit further landings of red snapper when the state-specific component ACL is reached or projected to be reached. Each state would also be required to specify a bag limit and a minimum size limit within the range of 14 to 18 inches (35.6 cm to 45.7 cm), TL. In combination, these measures must be expected to maintain harvest levels within the state's ACL. A state could also establish a maximum size limit.

If NMFS determines that a state's red snapper private angling regulations are inconsistent with the FMP and the state fails to correct the inconsistency after notice and an opportunity to do so, or a state does not specify the required management measures, then NMFS would suspend that state's delegation and publish a document in the Federal Register stating that the default management measures for the red snapper private angling component apply in Federal waters off that state. The default management measures are the current season (June 1 until the projected closure date), bag limit (2 fish per person per day), and minimum size limit (16 inches (40.6 cm), TL).

The areas of Federal waters off Florida and off Texas are currently defined in the regulations. Amendment 50A would specify the area of Federal waters off Alabama, Mississippi, and Louisiana so that each Gulf state would have a defined Federal water boundary off that state.

Currently, the red snapper private angling component ACL is managed as a single unit for all of the Gulf states. Amendment 50A would apportion the private angling component ACL to each state. The allocation would be based on the allocations requested by each state in its EFP application, which totaled 96.22 percent of the overall component ACL. The remaining 3.78 percent would be apportioned between Florida and Alabama, proportionally, based on their EFP allocation request. This results in the apportionment of the private angling ACL to each Gulf state as follows: Alabama 26.298 percent (1,122,662 lb (509,231 kg)), round weight, Florida 44.822 percent (1,913,451 lb (867,927 kg)), round weight, Louisiana 19.120 percent (816,233 lb (370,237 kg)), round weight, Mississippi 3.550 percent (151,550 lb (68,742 kg)), round weight, and Texas 6.210 percent (265,105 lb (120,250 kg)), round weight.

If NMFS suspends one or more state's delegation, NMFS would project the private angling season in Federal waters off the applicable states based on the remaining aggregate portion of the ACL reduced by the established 20 percent buffer that is used to determine the Federal annual catch target. Anglers who fish in Federal waters off a state without an active delegation of authority would fish under the default Federal regulations described previously.

Amendments 50B-F would establish post-season quota adjustments. An overage adjustment, or payback provision, is an accountability measure (AM) that reduces the following year's ACL by some specified amount, usually the amount the ACL was exceeded. The current recreational red snapper post-season AM applies when the stock is classified as overfished and an overage of the total recreational sector's ACL occurs. The AM requires NMFS to reduce the recreational sector ACL and ACT, and applicable component ACL and ACT, in the year following an overage of the total recreational ACL by the full amount of the overage, unless the best scientific information available determines that a greater, lesser, or no overage adjustment is necessary. Amendments 50B-F would establish post-season ACL overage adjustments for states with an active delegation, regardless of stock status. If the landings of a state exceed that state's ACL, then in the following fishing year that state's ACL would be reduced by the amount of the ACL overage in the prior fishing year, unless the best scientific information available determines that a greater, lesser, or no overage adjustment is necessary. The total recreational ACL and the private angling component ACL would also be reduced.

In Amendments 50B-F, the Council expressed its intent to allow for carryover of a state's unused portion of its ACL to the following fishing year if permitted under a separate amendment to the FMP that the Council was developing to add a carryover provision to the Acceptable Biological Catch Control Rule. In June 2019, the Council postponed work on that amendment. Therefore, NMFS is not proposing to implement this provision at this time.

Amendment 50A would allow a Gulf state, consistent with the terms of an active delegation, to request that NMFS close all, or an area of, Federal waters off that state to the harvest and possession of red snapper by private anglers. The state would request the closure by letter to NMFS, providing dates and geographic coordinates for the closure. If the request is within the scope of the analysis in Amendment 50A, NMFS would publish a document in the Federal Register implementing the closure in Federal waters off that state for the fishing year.

Based on the analysis in Amendment 50A, Texas would be able to request a closure of all Federal waters off the state to allow a year-round fishing season in state waters and a limited season in Federal waters. Florida would be able to request a closure of Federal waters off the state seaward of the 20-fathom (36.6-m) depth contour, or seaward of the 35-fathom (64.0-m) depth contour, for the duration of Florida's open private angling component season. Alabama would be able to request a closure of Federal waters off the state seaward of the 20-fathom (36.6-m) depth contour, or seaward of the 35-fathom (64.0-m) depth contour, for the duration of Alabama's open private angling component season. Florida and Alabama want the ability to close deeper waters to potentially extend their seasons by decreasing the average size of fish landed. These areas were chosen because an approximation for the 20-fathom depth contour is currently defined in 50 CFR 622.34(d) for the seasonal shallow-water grouper closure, and an approximation of the 35-fathom depth contour is partially defined in 50 CFR 622.35(b) for the seasonal eastern Gulf longline closure. The coordinates for any closure off Texas, Florida, or Alabama are provided in Appendix H of Amendment 50A and would be included in the Federal Register document implementing the closure. Neither Louisiana nor Mississippi provided any potential closures to analyze in Amendment 50A and these states would not be able to request Federal waters closures through this process without further action by the Council.

A proposed rule that would implement Amendments 50A-F has been drafted. In accordance with the Magnuson-Stevens Act, NMFS is evaluating the proposed rule to determine whether it is consistent with the FMP, the Magnuson-Stevens Act, and other applicable law. If that determination is affirmative, NMFS will publish the proposed rule in the Federal Register for public review and comment.

The Council has submitted Amendments 50A-F for Secretarial review, approval, and implementation. Comments on Amendments 50A-F must be received by October 7, 2019. Comments received during the respective comment periods, whether specifically directed to Amendments 50A-F or the proposed rule, will be considered by NMFS in its decision to approve, partially approve, or disapprove Amendments 50A-F and will be addressed in the final rule.

All comments received by NMFS on Amendments 50A-F or the proposed rule during their respective comment periods will be addressed in the final rule.