This final rule has been determined to be not significant for purposes of Executive Order 12866; and, therefore has not been reviewed by the Office of Management and Budget (OMB).

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this rule.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this action on small entities and has determined that its implementation will not have a significant economic impact on a substantial number of small businesses.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. There are an estimated 25,000 cotton growers in the U.S. who voluntarily use the AMS cotton classing services annually, and the majority of these cotton growers are small businesses under the criteria established by the Small Business Administration (13 CFR 121.201). Continuing the user fee at the 2011 crop level as stated will not significantly affect small businesses as defined in the RFA because:

(1) The fee represents a very small portion of the cost-per-unit currently borne by those entities utilizing the services. (According to USDA's Economic Research Service, the U.S. average total cost of production in 2010 was $483 per bale. The user fee for classification services of $2.20 per bale represents less the one half percent of this average U.S. per-bale cost of production.);

(2) The fee for services will not affect competition in the marketplace;

(3) The use of classification services is voluntary. For the 2011 crop, approximately 15.1 million bales were produced; and, almost all of these bales were voluntarily submitted by growers for the classification service; and

(4) Based on the average price paid to growers for cotton from the 2010 crop of 0.8212 cents per pound, 500 pound bales of cotton are worth an average of $410 each. The user fee for classification services, $2.20 per bale, is less than one percent of the value of an average bale of cotton.

In compliance with Office of Management and Budget (OMB) regulations (5 CFR part 1320), which implement the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3520), the information collection requirements contained in the regulation to be amended is currently approved under OMB control number 0581-0008, Cotton Classing, Testing and Standards.

This final rule establishes the 2012 user fee charged to producers for cotton classification at $2.20 per bale—the same as the 2011 user fee. The 2012 user fee was set in accordance to section 14201 of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-234) (2008 Farm Bill). Section 14201 of the 2008 Farm Bill provides that: (1) The Secretary shall make available cotton classification services to producers of cotton, and provide for the collection of classification fees from participating producers or agents that voluntarily agree to collect and remit the fees on behalf of the producers; (2) classification fees collected and the proceeds from the sales of samples submitted for classification shall, to the extent practicable, be used to pay the cost of the services provided, including administrative and supervisory costs; (3) the Secretary shall announce a uniform classification fee and any applicable surcharge for classification services not later than June 1 of the year in which the fee applies; and (4) in establishing the amount of fees under this section, the Secretary shall consult with representatives of the United States cotton industry. At pages 313-314, the Joint Explanatory Statement of the committee of conference for section 14201 stated the expectation that the cotton classification fee would be established in the same manner as was applied during the 1992 through 2007 fiscal years. Specifically, it states that the classification fee should continue to be a basic, uniform fee per bale fee as determined necessary to maintain cost-effective cotton classification service. Further, in consulting with the cotton industry, the Secretary should demonstrate the level of fees necessary to maintain effective cotton classification services and provide the Department of Agriculture with an adequate operating reserve, while also working to limit adjustments in the year-to-year fee.

Under the provisions of section 14201, a user fee (dollar amount per bale classed) is established for the 2012 cotton crop that, when combined with other sources of revenue, will result in projected revenues sufficient to reasonably cover budgeted costs—adjusted for inflation—and allow for adequate operating reserves to be maintained. Costs considered in this method include salaries, costs of equipment and supplies, and other overhead costs, such as facility costs and costs for administration and supervision. In addition to covering expected costs, the user fee is set such that projected revenues will generate an operating reserve adequate to effectively manage uncertainties related to crop size and cash-flow timing while meeting minimum reserve requirements set by the Agricultural Marketing Service, which require maintenance of a reserve fund amount equal to at least four months of projected operating costs.

The user fee charged to cotton producers for cotton classification in 2012 is $2.20 per bale, which is the same fee charged for the 2011 crop. This fee is based on the preseason projection that 14,475,000 bales will be classed by the United States Department of Agriculture during the 2012 crop year.

Accordingly, § 28.909, paragraph (b) reflects the continuation of the cotton classification fee at $2.20 per bale.

As provided for in the 1987 Act, a 5 cent per bale discount will continue to be applied to voluntary centralized billing and collecting agents as specified in § 28.909(c).

Growers or their designated agents receiving classification data will continue to incur no additional fees if classification data is requested only once. The fee for each additional retrieval of classification data in § 28.910 will remain at 5 cents per bale. The fee in § 28.910(b) for an owner receiving classification data from the National Database will remain at 5 cents per bale, and the minimum charge of $5.00 for services provided per monthly billing period will remain the same. The provisions of § 28.910(c) concerning the fee for new classification memoranda issued from the National Database for the business convenience of an owner without reclassification of the cotton will remain the same at 15 cents per bale or a minimum of $5.00 per sheet.

The fee for review classification in § 28.911 is maintained at $2.20 per bale.

The fee for returning samples after classification in § 28.911 will remain at 50 cents per sample.

A proposed rule was published in the Federal Register on April 11, 2012, with a comment period of April 11, 2012 through April 26, 2012 (77 FR 21684). AMS received two comments: One from a national trade organization that represents approximately 80 percent of the U.S. cotton industry, including cotton producers, ginners, warehousemen, merchants, cooperatives, cottonseed processors, and textile manufacturers from Virginia to California; and one from a national trade organization comprised of eight state and regional membership organizations that represent approximately 680 individual cotton ginning operations in 17 cotton-producing states. Comments from the national trade organizations expressed support for the decision to maintain the fee at the level established for the 2011 crop. Comments may be viewed at www.regulations.gov .

Pursuant to 5 U.S.C. 533, good cause exists for not postponing the effective date of this final rule until 30 days after publication in the Federal Register because this rule maintains uniform user fees for 2012 crop cotton classification services as mandated by the Cotton Statistics and Estimates Act, at the same level as 2011.

For the reasons set forth in the preamble, 7 CFR part 28 is amended to read as follows:

I. Background

The Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501-6522) authorizes the establishment of the National List of Allowed and Prohibited Substances (National List). The National List identifies synthetic substances that may be used in organic production and nonsynthetic (natural) substances that are prohibited in organic crop and livestock production. The National List also identifies nonagricultural nonsynthetic, nonagricultural synthetic and nonorganic agricultural substances that may be used in organic handling.

The exemptions and prohibitions granted under the OFPA are required to be reviewed every 5 years by the National Organic Standards Board (NOSB). The Secretary of Agriculture has authority under the OFPA to renew such exemptions and prohibitions. If the substances are not reviewed by the NOSB within 5 years of their inclusion on the National List and addressed by the Secretary, then their authorized use or prohibition expires under OFPA's sunset provision.

In response to the sunset provisions in the OFPA, this final rule addresses multiple recommendations submitted to the Secretary by the NOSB pertaining to substances due to expire from the National List in 2012. AMS published an Advanced Notice of Proposed Rulemaking (ANPR) in the Federal Register on March 26, 2010 (75 FR 14500), announcing the NOSB's review of exempted and prohibited substances codified at the National List of the National Organic Program (NOP) regulations and set to expire in 2012. AMS provided the comments received in response to the ANPR to the NOSB in advance of their review of these substances. Based upon the NOSB's recommendations, AMS published a proposed rule in the Federal Register on January 12, 2012, (77 FR 1996) to address the continued use of these substances on the National List in organic production and handling.

Consistent with the recommendations from the NOSB, this final rule renews, without change, multiple exemptions (uses) and prohibitions on the National List (along with any restrictive annotations) for 5 years. This final rule also amends the exemptions for 7 substances and removes the exemptions for 3 substances on the National List. A list of these substances is provided in the Appendix to this final rule. As referenced in the proposed rule for this 2012 Sunset Review, AMS notes that the listings for nutrient vitamins and minerals at section 205.605(b) and sodium nitrate at section 205.602 will be dealt with in separate actions.

Under the authority of the OFPA, the National List can be amended by the Secretary based on recommendations developed by the NOSB. Since established, the NOP has published multiple amendments to the National List: October 31, 2003 (68 FR 61987); November 3, 2003 (68 FR 62215); October 21, 2005 (70 FR 61217); June 7, 2006 (71 FR 32803); September 11, 2006 (71 FR 53299); June 27, 2007 (72 FR 35137); October 16, 2007 (72 FR 58469); December 10, 2007 (72 FR 69569); December 12, 2007 (72 FR 70479); September 18, 2008 (73 FR 54057); October 9, 2008 (73 FR 59479); July 6, 2010 (75 FR 38693); August 24, 2010 (75 FR 51919), December 13, 2010 (75 FR 77521); March 14, 2011 (76 FR 13501); August 3, 2011 (76 FR 46595); and February 14, 2012 (77 FR 8089). Additionally, proposed amendments to the National List were published on May 5, 2011 (76 FR 25612); November 8, 2011 (76 FR 69141); January 12, 2012 (77 FR 1980); and February 6, 2012 (77 FR 5717).

A complete overview of final actions for designated sections of the National List regulations is presented in the Appendix. 1 In the proposed rule, AMS indicated that proposed actions for each listing would be effective on the sunset date in 2012 for that listing (e.g. a listing due to sunset on October 21, 2012 would be renewed effective October 21, 2012). However, AMS determined that the effective dates for this sunset review should be streamlined to the extent possible through this final rule. Therefore, the actions pertaining to all listings, with the exception of the amendment to yeast at section 205.605(a) and the removal of sulfur dioxide at section 205.601, will be effective on one date, June 27, 2012. The effective date for each listing is specified in the Appendix. In accordance with the sunset provisions in the OFPA, the new sunset date for all listings is five years from the effective date of their renewal or amendment.

Consistent with the NOSB recommendations and in consideration of the public comments received on the proposed rule (77 FR 1996), AMS is renewing multiple listings pertaining to the National List through this final rule.

This final rule continues the exemptions at section 205.601, along with any restrictive annotations, for the synthetic substances allowed for use in organic crop production as shown in the Appendix.

This final rule continues the prohibitions at section 205.602, along with any restrictive annotations, for the nonsynthetic substances prohibited for use in organic crop production as shown in the Appendix. It should be noted that the nonsynthetic, prohibited substance “Ash from manure burning” was listed incorrectly in Table 1 of the proposed rule as “Ash for manure burning” (emphasis added). The correct listing is included in the Appendix of this final rule.

This final rule continues the exemptions at section 205.603, along with any restrictive annotations, for the synthetic substances allowed for use in organic livestock production as shown in the Appendix.

This final rule continues the prohibition at section 205.604, for the nonsynthetic substance prohibited for use in organic livestock production as shown in the Appendix.

This final rule continues the exemptions at section 205.605(a), along with any restrictive annotations, for the nonsynthetic, nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s))” as shown in the Appendix.

This final rule continues the exemptions at section 205.605(b), along with any restrictive annotations, for the synthetic, nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s))” as shown in the Appendix.

This final rule continues the exemptions at section 205.606, along with any restrictive annotations, for the nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic” as shown in the Appendix.

This final rule amends the National List by removing the exemptions as shown in the Appendix for the following 3 substances in organic production and handling:

This final rule amends section 205.601 of the National List regulations by removing the exemption for sulfur dioxide at paragraph (g)(1) and redesignating current paragraph (g)(2) as (g) to read: (g) As rodenticides. Vitamin D 3 . This amendment is effective on the sunset date for sulfur dioxide, October 21, 2012.

This final rule amends section 205.605(b) of the National List regulations by removing the exemption for pectin (low-methoxy), and the exemption, along with its restrictive annotation, for potassium iodide. These amendments are effective on June 27, 2012.

This final rule amends the National List regulations by amending the exemptions as shown in the Appendix for the following 7 substances in organic production and handling:

This final rule amends the listing for chlorine materials at section 205.601(a)(2) to read as follows: Chlorine materials—For pre-harvest use, residual chlorine levels in the water in direct crop contact or as water from cleaning irrigation systems applied to soil must not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act, except that chlorine products may be used in edible sprout production according to EPA label directions. (i) Calcium hypochlorite. (ii) Chlorine dioxide. (iii) Sodium hypochlorite. This amendment is effective on June 27, 2012.

This final rule amends section 205.601(i)(11) to add an expiration date to the listing for streptomycin to read as follows: Streptomycin, for fire blight control in apples and pears only until October 21, 2014. This amendment is effective on June 27, 2012.

This final rule amends the listing for lignin sulfonate at section 205.601(j)(4) to remove the words “floatation agent.” The new listing will read: Lignin sulfonate—chelating agent, dust suppressant. This amendment is effective on June 27, 2012. It should be noted that the amendatory language for lignin sulfonate was incorrectly listed in the proposed rule as “Lignin sulfate —chelating agent, dust suppressant” (emphasis added). This error is corrected in this final rule.

This final rule amends the listing for yeast section 205.605(a) to read as follows: Yeast—When used as food or a fermentation agent in products labeled as “organic,” yeast must be organic if its end use is for human consumption; nonorganic yeast may be used when organic yeast is not commercially available. Growth on petrochemical substrate and sulfite waste liquor is prohibited. For smoked yeast, nonsynthetic smoke flavoring process must be documented. This amendment is effective on the sunset date for yeast, October 21, 2012.

This final rule adds a restrictive annotation to the listing for colors at section 205.606(d) to read as follows: Colors derived from agricultural products—Must not be produced using synthetic solvents and carrier systems or any artificial preservative. This amendment is effective on the sunset date for colors derived from agricultural products, June 27, 2012.

This final rule adds an expiration date to the listing for hops at section 205.606(l) to read as follows: Hops ( Humulus lupulus ) until January 1, 2013. This amendment is effective on the sunset date for hops, June 27, 2012.

This final rule amends the listing for pectin at section 205.606(t) to read as follows: Pectin (non-amidated forms only). This amendment is effective on June 27, 2012.

An Advance Notice of Proposed Rulemaking with request for comments was published in the Federal Register on March 26, 2010 (75 FR 14500), to make the public aware that the exemptions and prohibitions for over 200 listings of synthetic and nonsynthetic substances in organic production and handling would expire, if not reviewed by the NOSB and addressed by the Secretary. Substances and recommendations addressed through this final rule were announced for NOSB deliberation in the following Federal Register notices: (1) March 17, 2010 (75 FR 12723); September 20, 2010 (75 FR 57194); and (2) March 4, 2011 (76 FR 12013). The proposal to address the substances in this final rule was published as a proposed rule in the Federal Register on January 12, 2012 (77 FR 1996).

The OFPA authorizes the Secretary to make amendments to the National List based on proposed amendments developed by the NOSB. Sections 6518(k)(2) and 6518(n) of OFPA authorize the NOSB to develop proposed amendments to the National List for submission to the Secretary and establish a petition process by which persons may petition the NOSB for the purpose of having substances evaluated for inclusion on or deletion from the National List. The National List petition process is implemented under section 205.607 of the NOP regulations. The current petition process (72 FR 2167, January 18, 2007) can be accessed through the NOP Web site at http://www.ams.usda.gov.

This action has been determined not significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget.

Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. This final rule is not intended to have a retroactive effect.

States and local jurisdictions are preempted under the OFPA from creating programs of accreditation for private persons or State officials who want to become certifying agents of organic farms or handling operations. A governing State official would have to apply to USDA to be accredited as a certifying agent, as described in the OFPA (7 U.S.C. 6514(b)). States are also preempted by the OFPA (7 U.S.C. 6503 through 6507) from creating certification programs to certify organic farms or handling operations unless the State programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA.

Pursuant to the OFPA (7 U.S.C. 6507(b)(2)), a State organic certification program may contain additional requirements for the production and handling of organically produced agricultural products that are produced in the State and for the certification of organic farm and handling operations located within the State under certain circumstances. Such additional requirements must: (a) Further the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) not be discriminatory toward agricultural commodities organically produced in other States, and (d) not be effective until approved by the Secretary.

Pursuant to the OFPA (7 U.S.C. 6519(f)), this final rule would not alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056), concerning meat, poultry, and egg products, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-399), nor the authority of the Administrator of EPA under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136-136(y)).

The OFPA (7 U.S.C. 6520) provides for the Secretary to establish an expedited administrative appeals procedure under which persons may appeal an action of the Secretary, the applicable governing State official, or a certifying agent under this title that adversely affects such person or is inconsistent with the organic certification program established under this title. The OFPA also provides that the U.S. District Court for the district in which a person is located has jurisdiction to review the Secretary's decision.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small business will not be unduly or disproportionately burdened. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

Pursuant to the requirements set forth in the RFA, AMS performed an economic impact analysis on small entities in the final rule published in the Federal Register on December 21, 2000 (65 FR 80548). AMS has also considered the economic impact of this final rule on small entities and has determined that this rule would not have a significant economic impact on a substantial number of small entities. The effect of this final rule would be to allow the continued use of multiple substances in agricultural production and handling. AMS concludes that the economic impact of the renewals and renewals with amendment of allowed substances, if any, would be minimal and beneficial to small agricultural service firms. For the substances removed or further restricted through this final action, AMS determined that their use is either not prevalent or that alternatives to their use are available to organic producers and handlers.

Small agricultural service firms, which include producers, handlers, and accredited certifying agents, have been defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $7,000,000 and small agricultural producers are defined as those having annual receipts of less than $750,000.

According to NOP's Accreditation and International Activities Division, the number of certified U.S. organic crop and livestock operations totaled over 17,000 in 2010. According to USDA, Economic Research Service (ERS) data based on information from USDA-accredited certifying agents, certified organic acreage exceeded 4.8 million acres in 2008. 2 In 2009, U.S. certified organic apple acreage exceeded 21,000 acres, primarily concentrated in Washington and California. 3 ERS, based upon the list of certified operations maintained by the NOP, estimated the number of certified handling operations was 3,225 in 2007. 4 AMS believes that most of these entities would be considered small entities under the criteria established by the SBA.

The U.S. sales of organic food and beverages have grown from $3.6 billion in 1997 to nearly $21.1 billion in 2008. 5 The organic industry is viewed as the fastest growing sector of agriculture, representing over 3 percent of overall food sales in 2009. Between 1990 and 2008, organic food sales historically demonstrated a growth rate between 15 to 24 percent each year. In 2010, organic food sales grew 7.7%. 6

In addition, USDA has 93 accredited certifying agents who provide certification services to producers and handlers. A complete list of names and addresses of accredited certifying agents may be found on the AMS NOP Web site, at http://www.ams.usda.gov/nop. AMS believes that most of these accredited certifying agents would be considered small entities under the criteria established by the SBA.

No additional collection or recordkeeping requirements are imposed on the public by this final rule. Accordingly, OMB clearance is not required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35.

This final rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.

AMS received approximately 40 comments on the proposed rule. AMS received comments from consumers, organic producers and handlers, trade representatives, certifying agents, ingredient manufacturers, consultants, and an environmental organization. Most comments specifically addressed proposed amendments for individual substances. A few comments were received in support of multiple or all of the substances under this sunset review. A few comments presented concerns that were not within the scope of the sunset review action.

All comments on the proposed amendments for hops and lignin sulfonate and the proposed removal of potassium iodide were supportive of the actions as proposed. Therefore, AMS is finalizing the amendments and removals as proposed through this final rule.

Some comments suggested changes to the proposal rule for specific substances. These comments are described below in conjunction with AMS' response, including any amendments that will be addressed through this final rule.

AMS received six comments regarding the amendment for chlorine materials allowed in crop production at section 205.601(a)(2). Comments were received from trade associations, an environmental organization and a sprout producer. Four comments supported the proposed amendment for chlorine materials, while two comments raised issues associated with the use of chlorine in sprouts.

AMS requested comments in the proposed rule on the use of chlorine in treatment of seeds for organic sprout production. Consistent with the NOSB recommendation, the proposed rule included an annotation change which, in part, intended to clarify the use of chlorine in edible sprout production. AMS specifically asked commenters to provide information on whether using the Environmental Protection Agency (EPA) labeled rate of chlorine for sprouts (20,000 ppm), followed by a rinse of potable water, is appropriate for organic production. AMS also sought input from commenters on whether there are other Food and Drug Administration (FDA) and EPA approved materials or methods suitable for sprout treatment.

One commenter responded that methods to ensure sprout safety are complex and stated that no single practice will completely eliminate pathogens. This commenter supported the clarification on chlorine as proposed and urged further development of criteria and procedures for assessing alternatives that would be both acceptable to FDA and in organic products.

One commenter stated that there are other equally effective alternatives that would be more consistent with organic principles. This commenter, however, noted that the 20,000 ppm soak in calcium hypochlorite, a chlorine material currently allowed under the NOP regulations, is the only treatment for sprouts addressed by FDA in their guidance document. 7 This commenter recommended that FDA clarify other treatment options that are permitted and effective for sprout treatment. AMS believes that this comment is pertinent to FDA's guidance, rather than AMS' proposed amendment for chlorine. In the absence of comments demonstrating acceptable alternatives for treatment of seed for sprouting, AMS concludes that the annotation change on chlorine specifying its allowance in spout production is appropriate and will codify this change through this final rule.

One commenter opposed all uses of chlorine in organic production, other than unavoidable residues of chlorine from its use in treated drinking water. This commenter stated that chlorine is a reactive chemical that can combine with organic matter to form persistent organochlorines and other disinfection byproducts. For this reason, the commenter felt that added chlorine should not be used in organic crop production. The commenter requested that AMS amend the annotation for chlorine to restrict all chlorine used in direct contact with crops, in irrigation systems, and in disinfection of equipment or tools to levels no greater than the maximum residual disinfectant limit under the Safe Drinking Water Act.

AMS disagrees with the commenter on this issue. The NOSB reviewed and recommended chlorine for inclusion on the National List in 1995, 2003, 2006 and 2011, according to the OFPA evaluation criteria in 7 U.S.C. 6517 and 6518. In these reviews, the NOSB assessed the impact of using chlorine on the environment and human health, but concluded that the need for this substance in some instances is necessary to ensure prevention of food borne pathogens. Consistent with the April 2011 NOSB recommendation, AMS proposed an annotation to chlorine, which would limit its direct use on crops and in soil contact to levels no higher than those found in municipal drinking water. The NOSB has not recommended any limitation on the use of chlorine for disinfecting tools and equipment when necessary to prevent spread of plant diseases. Therefore, AMS is codifying the annotation change to chlorine as proposed through this final rule.

AMS received one comment about the continued allowance for pheromones for insect management at section 205.601(f). The commenter objected to the categorical relisting of pheromones and indicated that the NOSB acted without sufficient information. The commenter indicated that although pheromone products are valuable to organic producers, there are many types of pheromones, and that the different types of pheromones were not reviewed by the NOSB. The commenter also indicated that the NOSB should address the use of additional ingredients in pheromone product formulations. The commenter suggested that the annotation be changed to list pheromones for insect management on section 205.601, provided that they are exempt from regulation under FIFRA (7 U.S.C. 136-136(y)) by 40 CFR 152.25(b).

AMS disagrees with the commenter on this issue. The NOSB is responsible for reviewing generic materials, not specific product formulations. The NOSB has previously reviewed and recommended pheromones for inclusion on the National List according to the OFPA criteria. The NOP regulations currently allow the use of inert ingredients in pesticide formulations under a separate listing at section 205.601(m). During their sunset deliberations, the NOSB reviewed pheromones against the evaluation criteria in 7 U.S.C. 6517 and 6518 of the OFPA and concluded that they remain essential to organic production since no organic alternatives exist. The NOSB recommended that the exemption for pheromones continue as previously allowed. AMS concurs with the NOSB's evaluation and recommendation of this substance, and therefore, does not find that sufficient information was provided by the commenter to justify the addition of an annotation to the listing for pheromones on the National List. Consistent with the NOSB recommendation, AMS is renewing the listing for pheromones through this final rule as proposed.

AMS received one comment that objected to the removal of sulfur dioxide from section 205.601(g) based upon its use for rodent control on organic farms. However, AMS did not receive any comments from organic producers that this substance is commonly used. Furthermore, as explained in the proposed rule, the NOSB determined that the EPA does not register any products for use as a rodenticide that contain sulfur dioxide as an active ingredient. Therefore, consistent with the NOSB recommendation, AMS is removing the listing for sulfur dioxide as a rodenticide from the National List through this final rule.

AMS received one comment about the continued allowance for synthetic inert ingredients under the listing at section 205.601(m)(1) for “EPA List 4—Inerts of Minimal Concern.” The commenter opposes the inclusion of EPA List 4 as a category on the National List and indicated that all substances included on EPA List 4 should be individually considered by the NOSB. The commenter also objected to the use of the term “inert” in describing other ingredients in pesticide products. The commenter noted that “inert” ingredients may be biologically active or have toxicological affects. AMS disagrees with the commenter on this issue of redefining the term “inert ingredient” at this time. The term “inert ingredient,” is defined under the NOP regulations for consistency with EPA regulations under FIFRA. AMS does not conclude that sufficient information was provided by the commenter to justify the removal of this listing from the National List. Therefore, AMS is renewing the listing for EPA List 4 through this final rule as proposed.

The commenter also suggested that the NOSB adopt a policy to transition to the individual review of inert ingredients. This comment is outside the scope of this rulemaking; however, AMS notes that a working group is currently in place to address the allowance of inerts that were previously classified as EPA List 4, since the EPA is no longer maintaining this list.

AMS received eight comments on the proposed rule to relist streptomycin at section 205.601(i)(11) with an expiration date of October 21, 2014. Comments were received from a university-affiliated researcher, an agricultural pest and disease management specialist, an apple producer, a trade association, certifying agents, a streptomycin product manufacturer and an environmental organization.

One comment supported the proposal to set October 21, 2014, as the expiration date for the use of streptomycin as recommended by the NOSB. 8 This comment cited the following factors in support of phasing out streptomycin in organic apple and pear production: (i) Potential for the substance's continued use to result in antibiotic resistance in human pathogens; (ii) inconsistency with the prohibition on antibiotic use in organic livestock production; and, (iii) incompatibility with organic and sustainable agriculture. The commenter further clarified the third point by stating that streptomycin use discourages cultural and biological controls, such as disease-resistant varieties and rootstock, site selection, careful fertilization, adequate tree spacing, proper pruning, as well as newer biological control products.

Seven comments supported the proposal to relist streptomycin, but opposed the addition of the October 21, 2014 expiration date. These commenters stated that a longer allowance time is needed and provided the following reasons for this opinion: (i) In practice, applications of streptomycin are coupled with management strategies to reduce susceptibility to fire blight and are generally limited to situations when computer models warn that an infection is likely to occur; (ii) there is a lack of viable, commercially available alternatives to streptomycin for fire blight control in apple and pear production; (iii) the research community is engaged in an ongoing effort to develop alternatives to antibiotics for controlling fire blight; (iv) streptomycin is particularly effective in humid areas where fire blight has not developed resistance; and, (v) without the availability of streptomycin to treat fire blight, some U.S. organic apple and pear producers may exit organic production and imported products could compensate for any decrease in U.S. production.

These commenters further stated that there is no assurance that current research efforts will yield any commercially viable alternative(s) to streptomycin in time for the October 21, 2014, expiration date. A number of commenters specifically cited a USDA-Organic Agriculture Research and Extension Initiative grant for the development of non-antibiotic programs for fire blight control in organic apple and pear production. Commenters explained that the findings of this project, which started in September 2011, will not be available until 2016, and would enable the NOSB to assess the strategies for controlling fire blight without antibiotics after that time.

Comments also addressed the efficacy of several of alternatives to streptomycin, including resistant rootstocks and varieties, and biological controls, all of which the NOSB cited in its justification for recommending an expiration date. Several commenters explained that resistant rootstocks are still in development and that resistance would not convey to the upper part of the tree where the fire blight infection takes hold. Some commenters stated that apple and pear varieties have varying degrees of susceptibility to fire blight, but none are immune. One commenter reported that consumers demand newer apple and pear varieties, which are susceptible to fire blight, and stated that there is no market for other varieties. One commenter noted the slow progress in developing new varieties that exhibit favorable eating and storage qualities, as well as fire blight resistance. Some comments described biological controls as a component of an overall fire blight management strategy, which are most effective when supplemented with antibiotics. Comments also contended that years of research have not yielded any biological control product that matches the effectiveness of streptomycin.

Commenters specifically requested that the proposed expiration date for streptomycin be deleted. In effect, such an action would renew the current listing for streptomycin on the National List for five years, until 2017, when it would be subject to sunset review.

Consistent with the NOSB recommendation, AMS is maintaining the proposed amendment to allow streptomycin for fire blight control in organic apple and pear production until October 21, 2014. During deliberations, the NOSB reviewed technical information on streptomycin in accordance with the criteria in OFPA (7 U.S.C. 6517-6518) and the NOP regulations for synthetic substances on the National List (§ 205.600). The Technical Report considered by the NOSB addressed the same issues raised by the commenters to the proposed rule concerning the efficacy of alternatives to streptomycin. 9 These alternatives include biological controls, allowed synthetic substances, the selection of varieties with low susceptibility to fire blight, and agronomic practices including careful and timely pruning, maintaining well-drained soil, limiting or excluding the use of manure and blossom removal. The NOSB is mandated by OFPA to evaluate whether alternative practices make the use of a substance such as streptomycin unnecessary. In this case, the NOSB found widespread fire blight resistance to streptomycin in apple production and continued use of apple and pear varieties that are highly susceptible to fire blight. Ultimately, the NOSB recommendation conveyed the expectation that preparation for the removal of streptomycin would augment the development and use of resistant rootstocks and cultivars, preventive management methods and the use of allowed biological and chemical controls.

The NOSB also considered additional factors in its decision, including antibiotic resistance in humans and the high susceptibility of leading varieties of organic apple and pears, in terms of acreage, to fire blight. Consistent with the OFPA, the NOSB evaluated the effects of the use of streptomycin upon human health. The NOSB considered information from the Technical Report that streptomycin sprays can leave detectable residues in apple cores and skins. Based on this information, the NOSB was concerned that the continued use of streptomycin could contribute to antibiotic resistance which would be inconsistent with the principles of organic production and the OFPA criteria. The NOSB also stated that consumers expect that organic products are not produced with antibiotics.

At the April 2011 meeting, the NOSB Crops Committee put forth a proposal to extend the exemption for streptomycin until October 21, 2014. This proposal was intended to phase out use of this substance while providing a sufficient timeframe for industry members to prepare for the removal of streptomycin from the National List. At the April 2011 NOSB meeting, the NOSB took two votes on the proposal for streptomycin: one vote on their recommendation to list streptomycin with the October 21, 2014, expiration date, and one “back up vote” to relist streptomycin without restriction. The NOSB conducted these votes in accordance with their sunset review process. 10 The April 2011 NOSB recommendation for streptomycin specified their intent to phase out use of the substance over time through addition of the October 21, 2014, expiration date. 11 Therefore, consistent with the recommendation of the NOSB, AMS published a rule proposing the October 21, 2014, expiration date for streptomycin.

While some commenters submitted comments advocating for relisting streptomycin without restriction, AMS did not receive any new information from commenters on this issue that the NOSB had not considered during their April 2011 deliberations on streptomycin. Furthermore, AMS believes that relisting streptomycin without an expiration date would not meet the intent of the NOSB to phase out the use of this substance in organic apple and pear production over time. Therefore, consistent with the NOSB recommendation, AMS is codifying the addition of an expiration date to the listing for streptomycin through this final rule. Finally, AMS notes that extending the allowance for the use of streptomycin after the October 21, 2014, expiration date would require a petition to the NOSB. This process can be initiated in accordance with the Notice of Guidelines on Procedures for Submitting National List Petitions (72 FR 2167).

AMS received one comment from a trade association that specifically addressed the proposed relisting of flavors, nonsynthetic sources only, on section 205.605(a). The commenter supported the continued listing of nonsynthetic flavors with the existing restriction, “must not be produced using synthetic solvents and carrier system or any artificial preservatives.” AMS is renewing the listing for flavors as proposed through this final rule.

The commenter, however, further requested that the NOP issue a guidance document to request that certifying agents use a standardized industry questionnaire to verify compliance of the use of nonsynthetic flavors in organic handling. AMS concludes this request is beyond the scope of this final rule.

AMS received over twenty comments in response to the proposed amendment for yeast. The majority of comments were supportive of the amendment in the proposed rule.

One commenter noted that the proposed amendment for yeast would require producers of products labeled “made with organic (specified ingredients or food group(s))” to be subject to commercial availability before using a nonorganic ingredient, which is not required for products in this labeling category. Under section 205.301(c) of the NOP regulations, products sold, labeled, or represented as “made with organic (specified ingredients or food group(s))” are not subject to the requirement that the product must not be produced using nonorganic ingredients when organic ingredients are available. AMS concludes that a modification to the proposed amendment for yeast is necessary to ensure consistency with the NOP regulations. Therefore, AMS has amended the yeast annotation through this final rule to clarify that the requirement that yeast be organic when commercially available is only applicable to products labeled “organic.”

One commenter noted that the use of the term “equivalent organic yeast” in the proposed amendment was unclear since “equivalent” was not defined. The commenter noted that organic yeast may have lower leavening activity than conventional yeast, or may only be available in a specific form (e.g. dry and not fresh), and therefore would not be considered “equivalent.” AMS notes that the amendment allows the use of conventional yeast when organic yeast is not commercially available. Under the NOP regulations, “commercially available” is defined as the ability to obtain a production input in an appropriate form, quality, or quantity to fulfill an essential function in a system of organic production or handling, as determined by the certifying agent in the course of reviewing the organic plan. Thus, organic yeast is not required to be used if it is not available in the appropriate form or quality, as noted in the commenter's examples. To reduce confusion over the use of the term “equivalent,” AMS has removed this term from the amendment in the final rule as we believe the inclusion is redundant with the existing criteria for commercial availability.

One commenter requested that AMS develop guidelines specifically for changes to the National List for which label revisions will be necessary. The commenter specifically noted that an operator presently using nonorganic yeast that successfully sources organic yeast will need to update the ingredient statement in their product labels to indicate the yeast is organic. The commenter suggested these guidelines allow at least one year for label revisions.

AMS notes that the effective date of this amendment requires that product formulations be compliant by October 21, 2012. The publication of this final rule provides almost four months of notice to the industry about this change. Sections 205.304-205.306 of the NOP regulations require that each organic ingredient in the ingredient statement be identified with the word, “organic,” or with an asterisk or other reference mark which is defined below the ingredient statement to indicate the ingredient is organically produced. Therefore, if product formulations must be compliant by October 21, 2012, then the labels for these products should also be compliant with the regulations at sections 205.304-205.306 by the effective date for this amendment. Products entering the stream of commerce prior to the effective date do not have to be relabeled. AMS further notes that development of broad guidelines on label use up for any National List change is beyond the scope of this rulemaking.

Two commenters requested that yeast be moved from section 205.605 of the National List to section 205.606, as an agricultural product. One commenter noted that listing yeast on section 205.605 would allow products labeled “made with organic (specified ingredients or food group(s))” to use non-organic yeast without the requirements for documenting commercial availability. The NOP has addressed the concerns for products labeled “made with organic (specified ingredients or food group(s))” by clarifying that the annotation which requires organic yeast is applicable only to products labeled “organic.” One commenter noted that yeast is an organism grown for food and that it should be considered an agricultural product for listing on section 205.606, rather than section 205.605. Based on review of the record, the NOSB considered this perspective during its deliberations before issuing its formal recommendation to the NOP; therefore, AMS has chosen to retain the listing on section 205.605, as recommended by the NOSB, rather than moving the listing to section 205.606.

One commenter was opposed to the proposed amendment for yeast and supported the existing listing. The commenter noted that organic yeast is only available in dry form, not fresh. In addition, the commenter claimed that leavening activity in organic yeast is much lower than conventional yeast and that organic yeast is costly, and, therefore, is not equivalent in performance and cost. AMS notes that the current annotation permits the use of nonorganic yeast when organic yeast is not commercially available. Under the NOP regulations, section 205.2, commercially available is defined as the ability to obtain a production input in an appropriate form, quality, or quantity to fulfill an essential function in a system of organic production or handling, as determined by the certifying agent in the course of reviewing the organic plan. The commenter's concern about sourcing an appropriate form (e.g. fresh, rather than dry) or quality (e.g. better leavening activity) could be considered by the certifying agent to determine whether nonorganic yeast would be allowed under the regulations in specific applications. The higher cost of organic yeast is not one of the permitted criteria for determining commercial availability under the NOP regulations. The NOSB considered the issues raised by the commenters, and AMS concludes that the inclusion of a commercial availability clause addresses the commenter's concern about the allowance for conventional yeast when organic yeast is not available in an appropriate form, quality, or quantity.

The NOP received one comment stating that the listing for silicon dioxide at section 205.605(b) should be amended to reflect a December 2011 NOSB recommendation on this substance. In their December 2011 recommendation, the NOSB recommended the addition of a restrictive annotation to specify that silicon dioxide, a synthetic used in processed products, could only be used if a nonsynthetic alternative for certain uses is not commercially available. However, the December 2011 NOSB recommendation was not available when drafting the proposed rule for this 2012 Sunset Review. Therefore, consistent with the October 2010 NOSB recommendation pertaining to the 2012 Sunset Review for this substance, AMS published a proposed rule on January 12, 2012, to renew silicon dioxide at section 205.605(b) as currently listed (i.e. without annotation). Because the proposal to amend the annotation for silicon dioxide was not included in the proposed rule and AMS did not receive public comment on such a change, AMS is not amending the annotation in this final rule. AMS is, therefore, renewing the existing listing for silicon dioxide through this final rule as proposed. AMS intends to address the December 2011 NOSB recommendation for this substance through a separate rulemaking action for National List amendments.

AMS received one comment from a trade association in support of relisting xanthan gum; however, this commenter also suggested reclassifying the substance as nonsynthetic and relisting it at section 205.605(a) of the National List. This commenter describes xanthan gum as a natural extracellular polysaccharide. The NOSB reviewed xanthan gum in April 2010 and did not propose any change in classification at that time. Therefore, AMS is renewing the listing for xanthan gum as codified.

In accordance with the October 2010 NOSB recommendation, the NOP proposed to remove the listing of synthetic pectin (low methoxy) at section 205.605(b), and to amend the listing for pectin (high-methoxy) at section 205.606(t) to “Pectin (non-amidated forms only).” The NOP received five comments in support of these proposed changes from trade associations, a beverage and dairy products manufacturer, and a consulting firm. The commenters agreed generally that non-amidated forms of pectin are adequate for use in organic products.

One commenter opposed the proposed changes for technical reasons. This commenter disagreed with the October 2010 NOSB recommendation that considered both low-methoxy and high-methoxy pectin to be derived from a similar non-synthetic extraction process, with the difference in the final substance resulting from a longer extraction period. The commenter pointed out that the low-methoxy pectin is produced as a result of esterification (by removal of methyl groups, or demethylation) of high-methoxy pectin which is initially derived from citrus peel or apple pomace. 12 This commenter agreed that amidated forms of pectin (forms treated with ammonia) are not necessary for use in organic production, but noted that only low-methoxy pectin is available in amidated form. This commenter suggested that the listing at section 205.605(b) be amended to: “Low-methoxy pectin, non-amidated forms only” and that the existing listing for high-methoxy pectin be retained at section 205.606.

While AMS believes that the commenter has merit regarding technical classification of the substance, the intent of the NOSB was to require that all forms of pectin used in organic products be subject to the requirement that organic sources be used when commercially available. Therefore, consistent with the intent of the NOSB, we have retained the proposed amendments for pectin in this final rule.

AMS received four comments in support of the proposed amendment to the listing for colors at section 205.606(d). The proposed listing was “Colors derived from agricultural products—Must not be produced using synthetic solvents and carrier systems or any artificial preservative.” These commenters, however, requested that AMS clarify whether synthetic substances allowed under section 205.605(b) for solvent extraction, or as carriers, preservatives or stabilizers, and which are currently allowed for use in organic colors, would also be allowed for use in nonorganic colors at section 205.606. Commenters specifically referenced ascorbic acid, carbon dioxide, glycerin, silicon dioxide and tocopherols, as examples of substances listed at section 205.605(b), which are currently allowed to produce organic colors. These substances were previously recommended by the NOSB and are currently codified as allowed synthetics at section 205.605(b) of the National List. The commenters requested clarification as to whether such substances at section 205.605(b) would still be allowed in the production of nonorganic colors under the proposed amendment.

At their October 2010 meeting, the NOSB discussed the need for an annotation to clarify the allowance of synthetic solvents in the preparation of the colors listed on section 205.606. 13 The NOSB recommended an amendment to restrict the use of synthetic solvents, carrier systems and artificial preservatives in the production of colors. However, in their recommendation, the NOSB did not address whether this restriction would apply to synthetics already listed at section 205.605(b).

The NOSB has already reviewed and recommended the synthetics listed at section 205.605(b) of the National List. Therefore, the synthetics listed at section 205.605(b) of the National List are already allowed in organic processed products, including in the formulation of colors. AMS believes the intent of the NOSB recommendation for colors is to prevent the use of synthetic substances that are not on the National List in the formulation of colors. Substances at section 205.605(b) of the National List will still be allowed in the production of nonorganic colors under the amendment.

One commenter stated that unrestricted use of synthetic solvents or carriers permitted by FDA should be acceptable in colors used for organic production. AMS disagrees with this comment. While certain synthetic solvents or carriers may be permitted by FDA, these synthetics would need to be petitioned and reviewed by the NOSB for inclusion on the National List under the NOP regulations.

Some commenters requested that AMS provide a one year compliance date from the effective date of the amendment to colors. Commenters stated that, while they believe that colors that comply with the amendment are available, manufacturers will need time to reformulate products that contained colors produced with synthetic solvents or carrier systems no longer allowed under the amendment. Based on the comments received, AMS understands that some product reformulation may be necessary. The effective date for this amendment is June 27, 2012, the sunset date for the current listing for colors. While this amendment is effective on June 27, 2012, AMS considers a one year period from that date as reasonable and appropriate for the industry to reformulate products in order to ensure that the amendment is effectively and rationally implemented. AMS will be conducting outreach to the industry and training for certifying agents as appropriate.

AMS received one comment opposed to the continued listing of cornstarch (native) at section 205.606(w)(1) of the National List. This commenter cited several sources for organic cornstarch that include a number of types for different applications, and suggested that nonorganic cornstarch should no longer be given an exemption for organic use. The commenter also believes that nonorganic cornstarch should not be included on the National List since most nonorganic sources could be derived from genetically engineered corn.

During the October 2010 NOSB deliberations on the 2012 Sunset Review for cornstarch, the NOSB did not receive public comments objecting to relisting of cornstarch, and received several in support of relisting on section 205.606. In their review, the NOSB did not identify risks to the environment, human or animal health resulting from the use or manufacture of the substance. Based upon the NOSB's recommendation, AMS is relisting cornstarch as codified at section 205.606. AMS notes that all nonorganic ingredients, including cornstarch, used in products labeled “organic” or “made with organic (specified ingredients or food group(s)” must not be produced using excluded methods, and that organic cornstarch should be used if commercially available.

This final rule reflects recommendations submitted to the Secretary by the NOSB for the purpose of fulfilling the requirements of 7 U.S.C. 6517(e) of the OFPA. Section 7 U.S.C. 6517(e) requires the NOSB to review each substance on the National List within 5 years of its publication. The substances being renewed or reauthorized with amended annotations on the National List were most recently reauthorized for use in organic agriculture on June 27, 2007, October 21, 2007, December 11, 2007, and December 13, 2007. In the case of substances reauthorized for use on June 27, 2007 and due to expire on June 27, 2012, the substances being renewed and amended are critical to organic production and handling operations.

Accordingly, pursuant to 5 U.S.C. 553, it is found and determined that good cause exists for not postponing the effective date for amendments and renewals contained in this rule that are due to expire on June 27, 2012, until 30 days after publication in the Federal Register . The effective dates for all substances are indicated in the Appendix.

For the reasons set forth in the preamble, 7 CFR part 205 is amended as follows:

Note: The following Appendix will not appear in the Code of Federal Regulations.

Prior documents in this proceeding: Notice of Hearing issued on March 4, 2011, and published in the March 14, 2011, issue of the Federal Register (76 FR 13528). The Recommended Decision was issued on November 3, 2011, and published in the November 9, 2011, issue of the Federal Register (76 FR 69673), and a Secretary's Decision and Referendum Order issued on February 28, 2012, and published in the March 5, 2012 issue of the Federal Register (77 FR 13015).

This action is governed by the provisions of sections 556 and 557 of title 5 of the United States Code and is therefore excluded from the requirements of Executive Order 12866.

This final rule was formulated on the record of a public hearing held April 20 and 21, 2011, in Grand Rapids, Michigan, and a second public hearing held April 26, 2011, in Provo, Utah. The hearing was held pursuant to the provisions of the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act”, and the applicable rules of practice and procedure governing the formulation of marketing agreements and orders (7 CFR Part 900). Notice of this hearing was published in the Federal Register on March 14, 2011 (76 FR 13528). The notice of hearing contained the proposal submitted by CIAB and one proposal by the Agricultural Marketing Service (AMS).

Upon the basis of evidence introduced at the hearings and the record thereof, the Administrator of AMS issued a Recommended Decision published in the Federal Register on November 9, 2011 (76 FR 69673). An opportunity to file written exceptions was provided through November 25, 2011. Two comments were received during that period in support of these amendments.

A Secretary's Decision and Referendum Order was issued on February 28, 2012, and published in the March 5, 2012, issue of the Federal Register (77 FR 13015). This document directed that a referendum among tart cherry growers and processors be conducted during the period March 19, 2012, through March 30, 2012, to determine whether they favor the proposed amendments to the order. To become effective, the amendments had to be approved by at least two-thirds of the growers voting in the referendum or two thirds of the production represented by such growers. In addition, processors who had frozen or canned at least fifty percent of the volume of tart cherries had to vote in favor of the amendments for them to become effective. All of the proposed amendments were approved by growers and processors. The amendments included in this final order will:

1. Amendment 1 revises the term “handle” within the order. This amendment revises existing section 930.10, Handle, to exclude handler acquisition of grower diversion certificates from the definition of handle.

2. Amendment 2 revises the “marketing policy” provisions in section 930.50 of the order so that grower-diverted cherries are not counted as production in the volume control formula.

3. Amendment 3 revises the existing section 930.58, so grower-diverted cherries are not treated as actual harvested cherries.

In addition to the proposed amendments to the order, AMS proposed to make any additional changes to the order as may be necessary to conform to any amendment that may result from the hearings.

A marketing agreement was subsequently mailed to all tart cherry handlers in the production area for their approval. The marketing agreement was approved by handlers representing more than 50 percent of the volume of tart cherries handled by all handlers during the representative period of July 1, 2010, to June 30, 2011.

Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA), AMS has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions so that small businesses will not be unduly or disproportionately burdened. Marketing orders and amendments thereto are unique in that they are normally brought about through group action of essentially small entities for their own benefit.

There are approximately 40 handlers of tart cherries subject to regulation under the order and approximately 600 producers of tart cherries in the regulated area. Small agricultural service firms, which include handlers, have been defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $7,000,000, and small agricultural producers are defined as those having annual receipts of less than $750,000. A majority of the tart cherry producers and handlers are considered small entities under the SBA standards.

The geographic region regulated by the order includes the states of Michigan, New York, Oregon, Pennsylvania, Utah, Washington, and Wisconsin. Acreage devoted to tart cherry production in the regulated area has declined in recent years. According to data presented at the hearings, bearing acreage in 1987-88 totaled 50,050 acres; by 2010-11 it had declined to 35,650 acres. Michigan accounts for 73 percent of total U.S. bearing acreage with 26,200 bearing acres. Utah is second, with a reported 3,300 acres, or approximately nine percent of the total. The remaining states' acreage ranges from 600 to 1,800 acres. The order includes authority for (1) volume regulation, (2) promotion and research, and (3) grade and quality standards. Volume regulation is used under the order to augment supplies during low supply years, with product placed in reserves during large supply years.

Production of tart cherries can fluctuate widely from year to year. The magnitude of these fluctuations is one of the most pronounced for any agricultural commodity in the United States, and is due in large part to weather related conditions during the bloom and growing seasons. This fluctuation in supply presents a marketing challenge for the tart cherry industry because demand for the product is relatively inelastic, meaning a change in supply has a proportionately larger change in price.

According to data presented at the hearing, production has ranged from a low of 62.5 million pounds in 2002-03 to a high of 395.6 million pounds in 1995-96. For 2010-11, Michigan accounted for 71 percent of total U.S. production with 135 million pounds. Utah is second, with a reported 23 million pounds, or approximately twelve percent of the total. The remaining states produce between 15.4 and 1.2 million pounds.

During the hearings, multiple witnesses testified that they did not believe that these amendments will have any adverse impacts on small agricultural service firms or small agricultural producers as defined by the SBA. According to the record, these amendments will help agricultural businesses and growers by encouraging growers to divert some of their tart cherries in the orchard during years of extremely large supply and result in higher grower returns during years of extremely large supply. Furthermore, the growers who divert their crop do not incur harvest and transportation costs. These amendments will result in a lower possibility of market saturation. Overall the supply of tart cherries in extremely large supply years results in higher returns for growers.

These amendments provide additional flexibility in administering the volume control provisions of the order, and improve its operation and administration. Record evidence indicates that these amendments benefit all producers and handlers under the order, regardless of size.

The amendments in this final order are: Amendment 1 revises Section 930.10 of the order to change the definition of “handle,” so that handler acquisition of grower diversion certificates is not considered handling. Amendment 2 revises the “marketing policy” provisions in Section 930.50 of the order so that grower-diverted cherries are not counted as production in the OSF. Amendment 3 revises section 930.58 of the order so that grower-diverted cherries are not treated as actual harvested cherries. These amendments modify how grower diversions are accounted for under the order.

Evidence presented when the order was promulgated indicated that a grower diversion program benefits the industry by managing fluctuating supply. Witnesses indicated that the order has been successful in this regard. However, the record indicated that the order should be more flexible in addressing how grower diversions are utilized under the order.

The most efficient method to deal with a surplus is at the lowest level of the production and processing chain. The industry wastes the least amount of resources if it diverts cherries in the orchard. Once they are harvested, chilled, washed, de-stemmed, sorted, pitted, and packed, significantly higher costs are incurred and there is a greater risk of waste. Diverting surplus cherries in the orchard is the most cost effective method of dealing with a surplus situation and provides the largest benefit to growers through lower costs.

The order establishes an opportunity for growers to undertake in-orchard diversions of cherries (section 930.58). These diversions are done during harvest in accordance with procedures defined under the order and are overseen by the CIAB. The CIAB issues grower diversion certificates to the growers that represent the pounds of cherries that were left in the orchard.

Growers redeem the diversion certificates with handlers, who use them as one of their compliance alternatives to meet their reserve or restricted obligation. However, under the previous order definition of “handle,” handlers must include the pounds of cherries represented by the certificates as part of the total cherries that have been delivered and processed.

Consequently, grower in-orchard diversions effectively increased the supply of restricted cherries even though none of those cherries were delivered for processing. Grower diversion certificates are considered to be part of the total quantity of cherries that a handler receives and processes, and contribute to the total supply of restricted cherries in the OSF. This creates confusion in accounting for the cherries in years when cherries are restricted for both the growers and processors.

The OSF is the mechanism specified in the order and used by CIAB to determine the relationship between the demand and supply of tart cherries in a given year. When the supply of tart cherries exceeds the average demand, volume regulation is implemented.

In an effort to stabilize supply and prices, the tart cherry industry uses volume regulation, which allows the industry to set free and restricted percentages. Free percentage cherries can be marketed by handlers to any outlet, while restricted percentage cherries are placed in a reserve inventory. The primary purpose of setting restricted percentages and placing cherries in a reserve inventory is to attempt to balance supply with demand.

A related component of the OSF under the order involves growers diverting cherries by leaving them un-harvested in the orchard. Handlers can coordinate with their growers in large crop years by encouraging them to divert cherries from production. Handlers can then acquire the diversion certificates issued to growers and use them as credit toward their restriction or reserve obligations.

Prior to implementation of these amendments, the interaction of sections 930.10 and 930.50 of the order established that grower in-orchard diversion is subject to the restriction percentage calculated for the year. Because of this, grower diversion certificates had less value when growers redeemed them with handlers. Therefore, when a handler utilized the grower diversion certificates received from growers, the certificates had a reduced value as a compliance tool in meeting the restricted obligation. Because the certificates have a reduced value, growers delivered most of their crop to handlers instead of diverting cherries in the orchard in large crop years.

The implementation of these amendments will remove the grower disincentive for in-orchard diversion. Because the way grower diversions are accounted for will change, the grower diversion program helps mitigate the negative effects of oversupply by increasing the amount of cherries diverted from production.

This action will have a positive impact on growers. The value of the grower diversion certificates will increase. As the value of the certificates increases, grower diversion of cherries in large crop years will increase. Increased grower diversion activity will help reduce excess supplies, which in turn will have a positive impact on grower returns. In addition, grower costs associated with harvesting and transporting cherries to handlers will be reduced as more cherries are diverted.

This action will also have a positive impact on handlers. As more fruit is diverted in the orchard, handlers will avoid the processing and storage costs that they would otherwise incur if growers harvested and delivered the fruit. Reducing the available supply of cherries will mitigate the price depressing effects that oversupply typically has on the market, resulting in a positive effect for both growers and handlers.

Testimony at the hearing suggested that the amendments, which encourage grower diversions, will not have a negative impact on small growers or handlers. The hearing record suggests that these amendments will benefit small growers by providing better opportunities to divert cherries in the orchard in large crop years. Small handlers are not always able to ship to export markets or have as much new product activity as larger handlers. Small handlers will benefit from these amendments by providing diversion credits as a way to meet their restrictions.

In accordance with the Paperwork Reduction Act of 1995, (44 U.S.C. chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0177, (Tart cherries Grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington and Wisconsin). No changes in those requirements is necessary a result of this action. Should any change become necessary, it would be submitted to OMB for approval.

As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. All of these amendments are designed to enhance the administration and functioning of the marketing order to the benefit of the industry.

The implementation of these requirements will not impose any additional costs on handlers. In fact, these amendments will reduce costs for both growers and handlers.

AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

The amendments to Marketing Order 930 stated herein have been reviewed under Executive Order 12988, Civil Justice Reform. They are not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order, is not in accordance with the law, and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United Sates in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed no later than 20 days after the date of the entry of the ruling.

The findings and determinations hereinafter set forth are supplementary to the findings and determinations that were previously made in connection with the issuance of the marketing agreement and order; and all said previous findings and determinations are hereby ratified and affirmed, except insofar as such findings and determinations may be in conflict with the findings and determinations set forth herein.

(a) Findings and Determinations Upon the Basis of the Hearing Record.

Pursuant to the provisions of the Agricultural Marketing Agreement Act of 1937, as amended, (7 U.S.C. 601-612), and the applicable rules of practice and procedure effective thereunder (7 CFR part 900), a public hearing was held upon proposed further amendment of Marketing Agreement and Order No. 930, regulating the handling of tart cherries grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin. Upon the basis of the evidence introduced at such hearing and the record thereof, it is found that:

1. The marketing agreement and order, as amended, and as hereby further amended, and all of the terms and conditions thereof, will tend to effectuate the declared policy of the Act;

2. The marketing agreement and order, as amended, and as hereby further amended, regulate the handling of tart cherries grown in the production area in the same manner as, and are applicable only to, persons in the respective classes of commercial and industrial activity specified in the marketing agreement and order upon which a hearing has been held;

3. The marketing agreement and order, as amended, and as hereby further amended, are limited in their application to the smallest regional production area which is practicable, consistent with carrying out the declared policy of the Act, and the issuance of several orders applicable to subdivisions of the production area would not effectively carry out the declared policy of the Act;

4. The marketing agreement and order, as amended, and as hereby further amended, prescribe, insofar as practicable, such different terms applicable to different parts of the production area as are necessary to give due recognition to the differences in the production and marketing of tart cherries grown in the production area; and

5. All handling of tart cherries grown in the production area as defined in the marketing agreement and order, is in the current of interstate or foreign commerce or directly burdens, obstructs, or affects such commerce.

(b) Additional Findings.

It is necessary and in the public interest to make these amendments effective not later than one day after publication in the Federal Register . A later effective date would unnecessarily delay implementation of the amendments. These amendments should be in place as soon as possible, as the new production year begins on July 1.

In view of the foregoing, it is hereby found and determined that good cause exists for making these amendments effective one day after publication in the Federal Register , and that it would be contrary to the public interest to delay the effective date for 30 days after publication in the Federal Register (Sec. 553(d), Administrative Procedure Act; 5 U.S.C. 551-559).

(c) Determinations. It is hereby determined that:

1. Handlers (excluding cooperative associations of producers who are not engaged in processing, distributing, or shipping tart cherries covered by the order as hereby amended) who, during the period July 1, 2010, through June 30, 2011, handled 50 percent or more of the volume of such cherries covered by said order, as hereby amended, have signed a marketing agreement, and

2. The issuance of this amendatory order, further amending the aforesaid order, is favored or approved by at least two-thirds of the producers who participated in a referendum on the question of approval and who, during the period of July 1, 2010, through June 30, 2011 (which has been determined to be a representative period), have been engaged within the production area in the production of such cherries, such producers having also produced for market at least two-thirds of the volume of such commodity represented in the referendum.

3. The issuance of this amendatory order is favored or approved by processors who, during the period of July 1, 2010, through June 30, 2011 (which has been determined to be a representative period), have engaged in canning or freezing cherries for market and have frozen or canned more than 50 percent of the total volume of cherries regulated which were canned or frozen within the production area.

It is therefore ordered, That on and after the effective date hereof, all handling of tart cherries grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin shall be in conformity to, and in compliance with the terms and conditions of the said order as hereby amended as follows:

The provisions of the proposed marketing order amending the order contained in the Secretary's Decision issued on February 28, 2012 and published in the Federal Register on March 5, 2012 (77 FR 13015) shall be and are the terms and provisions of this order amending the order and are set forth in full below.

For the reasons stated in the preamble, the Agricultural Marketing Service amends 7 CFR part 930 as follows:

The Coast Guard will enforce the regulations found in 33 CFR 100.1303 restricting regular navigation and anchoring activities on the Columbia River near Kennewick, Washington during the periods specified in the DATES section.

Under the provisions of 33 CFR 100.1303, no person or vessel may enter or remain in the regulated area without permission of the Captain of the Port, Columbia River or his designated on-scene Patrol Commander. Persons or vessels wishing to enter the area may request permission to do so from the on-scene Patrol Commander via VHF Channel 16 or 13. The Coast Guard may be assisted by other Federal, State, or local enforcement agencies in enforcing this regulation.

This notice is issued under authority of 5 U.S.C. 552(a).

In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with notification of these enforcement periods via Local Notice to Mariners.

The Washington State Department of Transportation (WSDOT) has requested that the Montlake Bridge temporarily remain in the down or closed position to facilitate maintenance of the King County Metro Trolley system. The scheduled maintenance will take place on two separate nights in June 2012. The first maintenance period will be the night of June 16, 2012 starting at 10 p.m. lasting until 8 a.m. June 17, 2012. The second maintenance period will be June 23, 2012 starting at 10 p.m. lasting until 8 a.m. June 24, 2012. During these maintenance periods WSDOT has requested that the Montlake Bridge remain in the closed position. King County Metro Transit will be replacing the electrical cables and installing new electrical switches for the Metro Trolley system. King County will have electrical equipment and associated maintenance vehicles staged on the Montlake Bridge during these maintenance periods. The Montlake Bridge crosses the Lake Washington Ship Canal at mile 5.2 and while in the closed position provides 30 feet of vertical clearance throughout the navigation channel and 46 feet of vertical clearance throughout the center 60-feet of the bridge; vertical clearance referenced to the Mean Water Level of Lake Washington. Vessels which do not require a bridge opening may continue to transit beneath the bridge during these closure periods. Under normal conditions this bridge operates in accordance with 33 CFR 117.1051(e) which requires the bridge to open on signal, except that the bridge need not open for vessels less than 1,000 gross tons between 7 a.m. and 9 a.m. and 3:30 p.m. and 6:30 p.m. Monday through Friday. This deviation period is from 10 p.m. June 16, 2012 through 8 a.m. June 24, 2012. This deviation allows the bascule span of the Montlake Bridge to remain in the closed position and need not open for maritime traffic from 10 p.m. on June 16, 2012 until 8 a.m. on June 17, 2012, and also from 10 p.m. on June 23, 2012 until 8 a.m. June 24, 2012. The bridge shall operate in accordance to 33 CFR 117.1051(e) at all other times. Waterway usage on the Lake Washington Ship Canal ranges from commercial tug and barge to small pleasure craft. Mariners will be notified and kept informed of the bridge's operational status via the Coast Guard Notice to Mariners publication and Broadcast Notice to Mariners as appropriate. The draw span will be required to open, if needed, for vessels engaged in emergency response operations during the closure periods.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Coast Guard will enforce the safety zones established for Annual Fireworks Displays within the Captain of the Port, Puget Sound Area of Responsibility in 33 CFR 165.1332 during the dates and times noted below.

The following safety zone will be enforced from 5:00 p.m. on June 30, 2012 through 1:00 a.m. on July 1, 2012:

The following safety zones will be enforced from 5:00 p.m. on July 3, 2012 through 1:00 a.m. on July 4, 2012:

The following safety zones will be enforced from 5:00 p.m. on July 4, 2012 through 1:00 a.m. on July 5, 2012.

A. Regulatory Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with a power boat race, which are discussed further below.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . For the same reasons discussed in the preceding paragraph, waiting for 30 day notice period run would also be impracticable and contrary to the public interest.

The legal basis for the rule is the Coast Guard's authority to establish regulated navigation areas and other limited access areas: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Public Law 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.

The purpose of the rule is to protect the public and vessels from the hazards associated with power boat races. Between 9:00 a.m. and 6:00 p.m. on June 15-17, 2012 a series of hydroplane and powerboat races will take place on Onondaga Lake near Syracuse, NY. The Captain of the Port Buffalo has determined that hydroplane and powerboat races create a significant risk of collisions between participants and the boating public.

With the aforementioned risks in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of participants and the boating public during the Race on the Lake.

The safety zone will be effective and enforced from 8:30 a.m. until 6:30 p.m. on June 15-17, 2012.

The safety zone will encompass all waters of Onondaga Lake, Syracuse, NY starting from position 43°6′49.63″ N and 76°14′8.82″ W then South East to 43°6′9.79″ N and 76°13′5.07″ W then West to 43°5′57.22″ N and 76°13′33.64″ W then North to 43°6′44.01″ N and 76°14′28.24″ W then returning to the point of origin to form a square (NAD 83).

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on scene patrol personnel. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule will have a significant economic impact on a substantial number of small entities. 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 rule will not have a significant economic impact on a substantial number of small entities.

This temporary final rule may affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Onondaga Lake, Syracuse, NY between 8:30 a.m. and 6:30 p.m. on June 15-17, 2012.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: this rule will be in effect for approximately ten hours each day in an area with low commercial vessel traffic. Also, in the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of the Port Buffalo to transit through the safety zone. Additionally, the Coast Guard will give advanced notice to the public via a local Broadcast Notice to Mariners that the regulation is in effect. Moreover, the COTP will suspend enforcement of the safety zone if the event for which the zone is established ends earlier than the expected time.

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 offer to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness.

If this rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact LT Christopher Mercurio, Chief of Waterway Management, U.S. Coast Guard Sector Buffalo; email SectorBuffaloMarineSafety@uscg.mil ; telephone 716-843-9343. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for no 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 State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it will 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34) (g), of the Instruction. Because it involves the establishment of a safety zone, a final environmental analysis checklist and a preliminary categorical exclusion determination are 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 rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

Regulatory Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with aerial insertions and aircraft maneuvering, which are discussed further below.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . For the same reasons discussed in the preceding paragraph, waiting for 30 day notice period run would also be impracticable and contrary to the public interest.

Beginning at 10 a.m. on June 15, 2012, through 3:30 p.m. on June 17, 2012, there will be Marine Air Ground Task Force movement on and over Burke Lakefront to include Recon Insertions (parachuting), and various maneuvers by USMC aircraft and personnel on the Burke Lakefront Airport grounds. A heavy amount of recreational boat traffic is expected for this event. The Captain of the Port Buffalo has determined that the Marines' maneuvers combined with a high concentration of recreational vessels will create significant risks for the boating public.

With the aforementioned risks in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of participants and the boating public during the Marine Event. This temporary safety zone will be effective from 10 a.m. on June 15, 2012 until 3:30 p.m. on June 17, 2012. It will be enforced from 10 a.m. to 11:30 a.m. and 3 p.m. to 4:30 p.m. on June 15, 2012, 2 p.m. to 3:30 p.m. on June 16, 2012, and 2 p.m. to 3:30 p.m. on June 17, 2012.

The safety zone will encompass a portion of Lake Erie and Cleveland Harbor near Burke Lakefront Airport from position 41°30′20″ N and 081°42′20″ W, to 41°30′50″ N and 081°42′49″ W, to 41°32′09″ N and 081°39′49″ W, to 41°31′53″ N and 081°39′24″ W, then return to the original position. (NAD 83).

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on scene Patrol Commander (PATCOM). Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. Only state, federal, and local vessels will be allowed in the safety zone. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Executive Order 12866, or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule will have a significant economic impact on a substantial number of small entities. 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 rule will not have a significant economic impact on a substantial number of small entities.

This temporary final rule may affect the following entities, some of which might be small entities: The owners of operators of vessels intending to transit or anchor in a portion of Lake Erie and Cleveland Harbor from 10 a.m. to 11:30 a.m. and 3 p.m. to 4:30 p.m. on June 15, 2012, 2 p.m. to 3:30 p.m. on June 16, 2012, and 2 p.m. to 3:30 p.m. on June 17, 2012.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be enforced for approximately three hours each day in an area with low commercial vessel traffic. Also, in the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of the Port Buffalo to transit through the safety zone. Additionally, the Coast Guard will give advanced notice to the public via a local Broadcast Notice to Mariners that the regulation is in effect. Moreover, the COTP will suspend enforcement of the safety zone if the event for which the zone is established ends earlier than the expected time.

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 offer to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness.

If this rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact LT Christopher Mercurio, Chief of Waterway Management, U.S. Coast Guard Sector Buffalo; email SectorBuffaloMarineSafety@uscg.mil ; telephone 716-843-9343. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for no 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 State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it will 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34) (g), of the Instruction because it involves the establishment of a safety zone. A final environmental analysis checklist and a categorical exclusion determination are 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 rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

Background

On May 3, 2012, the Postal Service published a final rule in the Federal Register (77 FR 26185-26191) to discontinue price eligibility for POSTNET barcodes for all types of mail. This revision adds DMM revisions (regarding Periodicals automation letters and flats) that were inadvertently omitted in the original final rule, but does not change any of the DMM revisions previously published in that rule.

Effective January 28, 2013, the Postal Service will discontinue price eligibility for the use of POSTNET barcodes and allow only Intelligent Mail barcodes (IMbs) for automation price eligibility purposes, including Qualified Business Reply Mail (QBRM) prices. The Postal Service understands that some mailers currently use POSTNET barcodes and we are committed to providing information to and working with individual mailers and software providers to ensure that the use of an Intelligent Mail barcode is achievable for all mailing customers.

For the past several years, both USPS and the mailing industry have used the IMb to gain information about letters and flats as they move from induction to delivery. As of January 28, 2013, the use of the IMb will be required for all automation letters, including Business Reply Mail® letters that qualify for Qualified Business Reply Mail prices, Permit Reply Mail letters, and automation flats.

The Postal Service adopts the following additional changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), which is incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

Accordingly, 39 CFR Part 111 is further amended as follows:

We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.

This final action provides motor vehicle manufacturers and their suppliers with a refrigerant option subject to use conditions for motor vehicle air conditioning systems for use in new vehicles. The refrigerant discussed in this action, carbon dioxide (R-744, CO 2 ) is non-ozone-depleting and has a global warming potential (GWP)  1 of 1.

This final rule lists carbon dioxide (CO 2 ) 2 , also known as R-744, as an acceptable substitute subject to use conditions for use as a refrigerant in new motor vehicle air conditioning (MVAC) systems designed specifically for the use of CO 2 refrigerant in motor vehicles 3 . Businesses in this end-use that may want to use CO 2 in MVAC systems include:

• Motor vehicle manufacturers

• Motor vehicle air conditioning service and repair shops

Regulated entities may include:

This table is not intended to be exhaustive, but rather a guide regarding entities likely to be regulated by this action. If you have any questions about whether this action applies to a particular entity, consult the person listed in the preceding section, FOR FURTHER INFORMATION CONTACT .

Section 612 of the Clean Air Act (CAA) requires U.S. Environmental Protection Agency (EPA) to develop a program for evaluating alternatives to ozone-depleting substances (ODS). EPA refers to this program as the Significant New Alternatives Policy (SNAP) program. The major provisions of section 612 are:

Section 612(c) requires EPA to promulgate rules making it unlawful to replace any class I (i.e., chlorofluorocarbon, halon, carbon tetrachloride, methyl chloroform, methyl bromide, and hydrobromofluorocarbon) or class II (i.e., hydrochlorofluorocarbon) substance with any substitute that the Administrator determines may present adverse effects to human health or the environment where the Administrator has identified an alternative that (1) reduces the overall risk to human health and the environment, and (2) is currently or potentially available.

Section 612(c) requires EPA to publish a list of the substitutes unacceptable for specific uses and to publish a corresponding list of acceptable alternatives for specific uses. The list of acceptable substitutes is found at http://www.epa.gov/ozone/snap/lists/index.html and the lists of “unacceptable,” “acceptable subject to use conditions,” and “acceptable subject to narrowed use limits” substitutes are found in the appendices to 40 CFR part 82 subpart G.

Section 612(d) grants the right to any person to petition EPA to add a substance, add or delete use restrictions, or delete a substance from the lists published in accordance with section 612(c). The Agency has 90 days to grant or deny a petition. Where the Agency grants the petition, EPA must publish the revised lists within an additional six months.

Section 612(e) directs EPA to require any person who produces a chemical substitute for a class I substance to notify the Agency not less than 90 days before new or existing chemicals are introduced into interstate commerce for significant new uses as substitutes for a class I substance. The producer must also provide the Agency with the producer's unpublished health and safety studies on such substitutes.

Section 612(b)(1) states that the Administrator shall seek to maximize the use of federal research facilities and resources to assist users of class I and II substances in identifying and developing alternatives to the use of such substances in key commercial applications.

Section 612(b)(4) requires the Agency to set up a public clearinghouse of alternative chemicals, product substitutes, and alternative manufacturing processes that are available for products and manufacturing processes which use class I and II substances.

On March 18, 1994, EPA published the original rulemaking (59 FR 13044) which established the process for administering the SNAP program and issued EPA's first lists identifying acceptable and unacceptable substitutes in the major industrial use sectors (40 CFR part 82, subpart G). These sectors include: refrigeration and air conditioning; foam blowing; solvents cleaning; fire suppression and explosion protection; sterilants; aerosols; adhesives, coatings and inks; and tobacco expansion. These sectors comprise the principal industrial sectors that historically consumed the largest volumes of ODS.

Section 612 of the CAA requires EPA to list as acceptable those substitutes that do not present a significantly greater risk to human health and the environment as compared with other substitutes that are currently or potentially available.

Under the SNAP regulations, anyone who produces a substitute to replace a class I or II ODS in one of the eight major industrial use sectors must provide notice to the Agency, including health and safety information on the substitute at least 90 days before introducing it into interstate commerce for significant new use as an alternative. 40 CFR 82.176(a). This requirement applies to the person planning to introduce the substitute into interstate commerce, 4 typically chemical manufacturers, but may also include importers, formulators, equipment manufacturers, or end-users 5 when they are responsible for introducing a substitute into commerce. The 90-day SNAP review process begins once EPA receives the submission and determines that the submission includes complete and adequate data. 40 CFR 82.180(a). The CAA and the SNAP regulations, 40 CFR 82.174(a), prohibit use of a substitute earlier than 90 days after notice has been provided to the Agency.

The Agency has identified four possible decision categories for substitutes: acceptable; acceptable subject to use conditions; acceptable subject to narrowed use limits; and unacceptable. 6 40 CFR 82.180(b).Use conditions and narrowed use limits are both considered “use restrictions” and are explained below. Substitutes that are deemed acceptable with no use restrictions (no use conditions or narrowed use limits) can be used for all applications within the relevant end-uses within the sector. Substitutes that are acceptable subject to use restrictions may be used only in accordance with those restrictions.

After reviewing a substitute, the Agency may determine that a substitute is acceptable only if certain conditions in the way that the substitute is used are met to minimize risks to human health and the environment. EPA describes such substitutes as “acceptable subject to use conditions.” Entities that use these substitutes without meeting the associated use conditions are in violation of section 612 of the Clean Air Act and EPA's SNAP regulations. 40 CF 82.174(c).

For some substitutes, the Agency may permit a narrow range of use within an end-use or sector. For example, the Agency may limit the use of a substitute to certain end-uses or specific applications within an industry sector. The Agency requires a user of a narrowed use substitute to demonstrate that no other acceptable substitutes are available for their specific application by conducting comprehensive studies. EPA describes these substitutes as “acceptable subject to narrowed use limits.” A person using a substitute that is acceptable subject to narrowed use limits in applications and end-uses that are not consistent with the narrowed use limit is using these substitutes in an unacceptable manner and is in violation of section 612 of the CAA and EPA's SNAP regulations. 40 CFR 82.174(c).

The Agency publishes its SNAP program decisions in the Federal Register (FR). EPA publishes decisions concerning substitutes that are deemed acceptable subject to use restrictions (use conditions and/or narrowed use limits), or for substitutes deemed unacceptable, as proposed rulemakings to allow the public opportunity to comment, before publishing final decisions.

In contrast, EPA publishes substitutes that are deemed acceptable with no restrictions in “notices of acceptability,” rather than as proposed and final rules. As described in the preamble to the rule initially implementing the SNAP program (59 FR 13044; March 18, 1994), EPA does not believe that rulemaking procedures are necessary to list alternatives that are acceptable without restrictions because such listings neither impose any sanction nor prevent anyone from using a substitute.

Many SNAP listings include “comments” or “further information” to provide additional information on substitutes. Since this additional information is not part of the regulatory decision, these statements are not binding for use of the substitute under the SNAP program. However, regulatory requirements so listed are binding under other regulatory programs. The “further information” classification does not necessarily include all other legal obligations pertaining to the use of the substitute. While the items listed are not legally binding under the SNAP program, EPA encourages users of substitutes to apply all statements in the “further information” column in their use of these substitutes. In many instances, the information simply refers to sound operating practices that have already been identified in existing industry and/or building-codes or standards. Thus, many of the statements, if adopted, would not require the affected user to make significant changes in existing operating practices.

For copies of the comprehensive SNAP lists of substitutes or additional information on SNAP, refer to EPA's Ozone Depletion Web site at www.epa.gov/ozone/snap/index.html. For more information on the Agency's process for administering the SNAP program or criteria for evaluation of substitutes, refer to the SNAP final rulemaking published March 18, 1994 (59 FR 13044), codified at 40 CFR part 82, subpart G. A complete chronology of SNAP decisions and the appropriate citations are found at http://www.epa.gov/ozone/snap/chron.html.

In this final rule, EPA is modifying its previous determination that listed CO 2 as an acceptable substitute for CFC-12 in new MVAC systems (59 FR 13044; March 18, 1994) and is listing CO 2 acceptable, subject to use conditions, as a substitute for CFC-12 in new MVAC systems. This final action does not apply to the use of CO 2 as a conversion or retrofit for existing MVAC systems. In addition, it does not apply to the use of CO 2 in the air conditioning or refrigeration systems of buses, trains, rail or subway cars, or appliances such as refrigerated transport. This refrigerant may be used only in equipment designed specifically and clearly identified for this refrigerant (i.e., it may not be used as a conversion or “retrofit” refrigerant for existing equipment). EPA is not mandating the use of CO 2 or any other alternative to ODS in MVAC systems. Vehicle manufacturers have the option of using any refrigerant listed as acceptable for this end-use, so long as they meet the applicable use conditions. This action removes CO 2 from the list of acceptable substitutes for MVAC systems and instead lists it as acceptable subject to the following use conditions:

1. Engineering strategies and/or mitigation devices shall be incorporated such that in the event of refrigerant leaks the resulting CO 2 concentrations do not exceed:

• The short term exposure level (STEL) of 3% or 30,000 ppm averaged over 15 minutes in the passenger free space; and

• The ceiling limit of 4% or 40,000 ppm in the passenger breathing zone.

2. Vehicle manufacturers (i.e., original equipment manufacturers [OEMs]) must keep records of the tests performed for a minimum period of three years demonstrating that CO 2 refrigerant levels do not exceed the STEL of 3% averaged over 15 minutes in the passenger free space, and the ceiling limit of 4% in the breathing zone.

3. The use of CO 2 in MVAC systems must adhere to the standard conditions identified in SAE 7 Standard J639 (2011 version) including:

• Installation of a high pressure system warning label;

• Installation of a compressor cut-off switch;  8 and

• Use of unique fittings with:

i. Outside diameter of 16.6 +0/−0.2 mm (0.6535 +0/−0.0078 inches) for the MVAC low-side service port;

ii. Outside diameter of 18.1 +0/−0.2 mm (0.7126 +0/−0.0078 inches) for the MVAC high-side service port; and

iii. Outside diameter of 20.955 +0/−0.127 mm (0.825 +0/−0.005 inches) and right-hand thread direction for CO 2 refrigerant service containers. 9

To help ensure that the first use condition is met, we are including several recommendations in the listing decision. First, OEMs should conduct and keep on file Failure Mode and Effect Analysis (FMEA) on the MVAC as stated in SAE J1739 (Potential Failure Mode and Effects Analysis in Design [Design FMEA], Potential Failure Mode and Effect Analysis in Manufacturing and Assembly Process [Process FMEA]), or equivalent. Second, OEMs should factor in background CO 2 concentrations that come about from normal respiration by the maximum number of vehicle occupants. 10 Third, EPA recommends the use of the following industry standards as additional references when locating the driver's and passengers' breathing zone consistent with the head and seating position, measuring refrigerant concentrations at different locations inside the passenger compartment including the breathing zone, and addressing risks associated with MVAC use:

• SAE J1052 —Motor Vehicle Driver and Passenger Head Position;

• SAE J2772 —Measurement of Passenger Compartment Refrigerant Concentrations under System Refrigerant Leakage Conditions; and

• SAE J2773 —Standard for Refrigerant Risk Analysis for Mobile Air Conditioning Systems.

Fourth, EPA recommends additional training for MVAC service technicians that will service MVAC systems using CO 2 as the refrigerant.

In the initial SNAP rulemaking issued on March 18, 1994 (59 FR 13044), EPA found CO 2 acceptable as a substitute for CFC-12 in new MVAC systems. In that final rule, EPA also found other substitutes (i.e., HFC-134a and R-401C, evaporative cooling and stirring cycle) acceptable for use in new MVAC systems. On June 13, 1995 (60 FR 31092) and October 16, 1996 (61 FR 54040) EPA took two separate actions requiring the use of unique fittings for several refrigerants then currently listed as acceptable for use in new MVAC systems (60 FR 31092) and for refrigerants subsequently found acceptable for use in MVAC (61 FR 54040). The use conditions requiring unique fittings were codified at 40 CFR Part 82, Subpart G, Appendix D. None of these actions applied to CO 2 . However, in the preamble to the October 16, 1996 SNAP rule, EPA stated that for any decision made under SNAP, the Agency may, on its own, determine that additional conditions or restrictions should be added or removed through future rulemaking (61 FR 54032). Also, EPA stated in the October 16, 1996 SNAP rule that due concerns about potential cross-contamination as a result of the large number of MVAC refrigerants, the Agency may choose to list a substitute as acceptable subject to use the conditions listed (in that rule, i.e., use of unique fittings) while proceeding with notice-and-comment rulemaking to impose other restrictions (61 FR 54034).

Although the initial SNAP rulemaking listed CO 2 as acceptable for use in new MVAC systems, at that time, EPA was not aware of any interest in using CO 2 in MVAC systems and did not receive any submission for unique fittings to be used on CO 2 MVAC systems or any information specified in 40 CFR Part 82, Subpart G, Appendix D. EPA was subsequently made aware through risk screens of concerns regarding health risks to exposure of CO 2 from refrigerant leaks into the passenger compartment (EPA-HQ-OAR-2004-0488-0025.2). EPA was also made aware of potential interest in using CO 2 as a refrigerant for MVAC systems and of technology being developed (71 FR 55141; September 21, 2006). On September 21, 2006, we issued a Notice of Proposed Rulemaking (referred to hereinafter as “the proposal” or NPRM) proposing to find CO 2 acceptable as a substitute for CFC-12 in new MVAC systems, subject to the use conditions specified at 40 CFR part 82, subpart G, appendix D (71 FR 55140). In addition, due to concerns regarding the possibility of driver performance decrement and adverse effects on passengers if exposed to concentrations of CO 2 above 3% during a short period of time (e.g., 15 minutes), we proposed use conditions restricting CO 2 refrigerant concentrations to a STEL of 3% averaged over 15 minutes in the passenger free space caused by leaks from the MVAC. 11 Subsequently, on September 17, 2009 (74 FR 47774), EPA issued a notice of data availability (NODA) making available to the public additional information received supporting a ceiling limit of 4% CO 2 as a level that should not be exceeded for any period of time due to possible adverse health effects. We also requested public comment on whether EPA should include in a final rule, listing CO 2 as acceptable subject to use conditions for new MVAC systems, a ceiling limit of 4% CO 2 in addition to the proposed STEL of 3% averaged over 15 minutes inside the passenger compartment, and whether the proposed use conditions should apply when the ignition is off.

EPA proposed three use conditions in the NPRM. One use condition required that systems be designed to avoid occupant exposure to CO 2 concentrations above a STEL of 3% CO 2 averaged over 15 minutes in the passenger free space, during the event of a leak. The passenger free space is the space inside the passenger compartment excluding the space enclosed by the ducting in the HVAC module (71 FR 55149). The proposal also stated that a breathing zone ceiling limit may provide additional assurance regarding vehicle driver alertness and requested comment on whether a maximum limit should be applied in the driver and passenger breathing zone, in addition to the 3% CO 2 free space limit averaged over 15 minutes. In the NODA, we defined the breathing zone as the space where people breathe (74 FR 47775), and data received during the public comment period defined this zone as the area inside the passenger compartment where the driver's and passengers' heads are located during a normal sitting position. 12

The other proposed use conditions required OEMs to: (1) Keep records of the test performed to ensure that MVAC systems are safe and designed with sufficient safety mitigation devices so that occupants are not exposed to levels above the CO 2 STEL; and (2) adhere to all the safety requirements listed in the SAE Standard J639, in addition to the use conditions already established under Appendix D to Subpart G of 40 CFR part 82, for MVAC substitutes: unique fittings, 13 label, and a compressor cut-off switch.

We received a number of public comments on the proposed use conditions and subsequent data announced in the NODA regarding the 4% CO 2 ceiling limit. Some commenters claimed that the proposed STEL of 3% CO 2 averaged over 15 minutes was enough to protect passengers and ensure driver alertness (EPA-HQ-OAR-2004-0448-0025.1, -0032, -0044). Other commenters stated that there are sufficient arguments for choosing percent concentration limits higher than the proposed STEL of 3% CO 2 averaged over 15 minutes (EPA-HQ-OAR-2004-0448-0043, -0049). Alternatively, some commenters requested a maximum CO 2 ceiling limit in the passenger breathing zone (EPA-HQ-OAR-2004-0448-0030, -0035, -0047.1) and one commenter considered appropriate the 4% CO 2 ceiling limit as an additional use condition (EPA-HQ-OAR-2004-0448-0047.1).

After considering the information in the docket at the time of proposal, comments received on the proposed rule, and additional information we have received in response to the NODA, we have decided to finalize the use conditions as proposed in the September 21, 2006, NPRM, and to add a ceiling limit of 4% CO 2 , which would apply in addition to the 3% averaged over 15-minute CO 2 STEL. We believe that requiring a CO 2 ceiling limit is necessary because it is possible for a time-weighted average concentration, such as the STEL, to be under 3%, while peak concentrations could reach higher limits resulting in possible hearing and vision effects that could distract and endanger a driver, or cause other, potentially more severe adverse health effects (EPA-HQ-OAR-2004-0488-0041). Thus, the proposed use condition requiring mitigation strategies for MVAC systems, to prevent leaks of CO 2 refrigerant reaching concentrations above 3% averaged over 15 minutes inside the passenger compartment free space, may not be sufficient on its own to protect drivers and passengers. This further protective limit is necessary to ensure that overall risks to human health and the environment from CO 2 will be similar to or less than those of other available refrigerants that EPA has already listed as acceptable for MVAC.

In the final rule, we also revised the proposed use condition on recordkeeping to refer to the 4% ceiling limit. The September 21, 2006 NPRM proposed requiring OEMs to keep records demonstrating they have met the use condition requiring safety mitigation devices to avoid occupant exposure above the 3% CO 2 STEL in the passenger compartment. The final use condition addressing recordkeeping requires OEMs to keep records of the tests performed for a minimum period of three years demonstrating that MVAC systems are designed incorporating engineering devices or mitigation strategies so that in the event of refrigerant leak, the resulting concentrations of CO 2 in the passenger free space do not exceed the STEL of 3% averaged over 15 minutes and do not exceed the ceiling limit of 4% in the passenger breathing zone. Keeping records of tests performed evaluating system safety is a customary practice for OEMs while vehicles are in production and for several years afterward (EPA-HQ-OAR-2004-0488-0057).

For purposes of the final rule, we are referencing to the 2011 version of SAE J639 instead of the 2005 version referenced in the proposed rule. The SAE J639 2011 version added new provisions designed specifically to address use of another refrigerant, HFO-1234yf (EPA-HQ-OAR-2004-0488-0059). The provisions under the 2011 version of SAE J639 for high pressure system warning label, compressor cut-off switch, and unique fittings, remain unchanged. Consistent with the proposed rule, the criteria for uniqueness of fittings under Appendix H to Subpart G of 40 CFR Part 82, and the provisions of Appendix D to Subpart G of 40 CFR Part 82 and SAE J639 (2011 version), in this final rule we specify that the CO 2 refrigerant fittings must have: (1) An outside diameter of 16.6 +0/−0.2 mm (0.6535 +0/−0.0078 inches) for the MVAC low-side, (2) an outside diameter of 18.1 +0/−0.2 mm (0.7126 +0/−0.0078 inches) for the MVAC high-side, and (3) an outside diameter of 20.955 +0/−0.127 mm (0.825 +0/−0.005 inches) and right-hand thread direction for refrigerant service containers. 14

EPA is listing CO 2 acceptable subject to use conditions because the use conditions are necessary to ensure that use of CO 2 will not present greater risk to human health and the environment than other available substitutes acceptable for use in new MVAC systems. Examples of other substitutes that EPA has already found acceptable subject to use conditions for use in new MVAC systems include HFC-152a and HFO-1234yf. 15 A list of acceptable substitutes subject to use conditions for use in new MVAC systems can be found at Appendix B to Subpart G of 40 CFR, Part 82 and http://www.epa.gov/ozone/snap/refrigerants/lists/mvacs.html.

EPA is requiring the use of unique fittings for CO 2 refrigerant consistent with Appendix D to Subpart G of 40 CFR part 82 (61 FR 54040; October 16, 1996). All acceptable substitutes for use in MVAC systems are subject to those use conditions (and thus are identified as acceptable subject to use conditions). For CO 2 , the unique fittings that must be used for MVAC systems are those identified in the industry standard SAE J639 (2011 version).

In addition to the use conditions regarding unique fittings, EPA is requiring OEMs to adhere to all the safety requirements of SAE J639 (2011 version) for the safe design of new MVAC systems using CO 2 . We are establishing this as a use condition to ensure that new MVAC systems that use CO 2 are specifically designed to minimize release of the refrigerant into the passenger cabin. Adherence to the standard will minimize the risks that CO 2 refrigerant levels in the passenger compartment and breathing zone would exceed the CO 2 limits of 3% averaged over 15 minutes in the passenger cabin free space and the 4% ceiling limit in the passenger breathing zone.

EPA finds that CO 2 does not pose greater risk to the environment than other substitutes that are currently available in the end-use being evaluated in this rulemaking. In at least one aspect, CO 2 is significantly better for the environment than most alternatives currently listed as acceptable subject to use conditions in the MVAC end-use. CO 2 has a hundred-year time horizon (100-yr) global warming potential (GWP) of one, compared with a GWP of four for HFO-1234yf, 124 for HFC-152a, and 1,430 for HFC-134a. Further, CO 2 has an ozone depletion potential (ODP) of zero, comparable to HFO-1234yf, HFC-152a, and HFC-134a. Other SNAP-approved refrigerant blends containing HCFCs have ODPs ranging from 0.065 to 0.022. Additionally, CO 2 is excluded from the definition of volatile organic compound (VOC) under CAA regulations ( see 40 CFR 51.100(s)).

Carbon dioxide is not flammable, similar to HFC-134a and most other acceptable alternatives for MVACs. Therefore, it does not add risks of fire in a vehicle when used. For the MVAC end-use, the EPA has listed two flammable alternatives (HFC-152a and HFO-1234yf) acceptable, subject to use conditions to mitigate flammability risks.

CO 2 is an asphyxiant that obstructs the oxygen flow into the body (OSHA, 1996; as cited in EPA-HQ-OAR-2004-0488-0041). However, it is not the only gas that may cause asphyxia. Releasing almost any gas  16 into an unventilated or poorly ventilated space can lower the oxygen concentration to a level that poses significant health risks (EPA-HQ-OAR-2004-0488-0041). Health risks could occur to drivers or vehicle occupants during release of CO 2 refrigerant into the passenger compartment. Additionally, occupational risks could occur during the manufacture of the refrigerant, initial installation of the refrigerant into the MVAC system at the vehicle assembly plant, servicing of the MVAC system, or final disposition of the MVAC system (i.e., recycling or disposal).

We evaluated potential human health and safety impacts, including the short- and long-term toxicity of CO 2 and risk of injury to service personnel from high-pressure CO 2 MVAC systems, and considered detailed risk assessments with fault-tree analysis (FTA), (EPA-HQ-OAR-2004-0488-0017, -0022, and -0025.2), scientific data provided in public comments (EPA-HQ-OAR-2004-0488-0037.1) and other information obtained during the notice of data availability (EPA-HQ-OAR-2004-0488-0041). We also reviewed a risk assessment with fault-tree analysis from the SAE Corporate Research Program (CRP) for HFO-1234yf and CO 2 , submitted during the public comment period for another SNAP rulemaking  17 (EPA-HQ-OAR-2004-0488-0051, EPA-HQ-OAR-2008-0664-0008, and -0056). We also evaluated and provided additional information on the health effects and risks to CO 2 exposure through a contractor-authored report “Review of Health Impacts from Short-Term Carbon Dioxide Inhalation Exposures” (EPA-HQ-OAR-2004-0488-0041). This report revealed that exposures over 4% (40,000 ppm) CO 2 are likely to cause discomfort and signs of intoxication that could impair the driver's response to road and driving conditions, and could create safety and health risks to the passengers. In addition to this report, a revised risk analysis performed by the U.S. Army Research, Development and Engineering Command (herein referred as U.S. Army risk analysis), 18 submitted during the public comment period, indicated that limiting passenger exposure to 4% CO 2 is sufficiently protective to avoid serious or irreversible health effects in potentially sensitive subpopulations (EPA-HQ-OAR-2004-0488-0025.2). Also, the U.S. Army risk analysis selected the 4% CO 2 level based on the lowest level at which performance decrements were observed in studies by Wong, 1992 (EPA-HQ-OAR-2004-0488-0025.2).

EPA's review of vehicle driver and passenger risks from CO 2 refrigerant exposure indicated that a potential refrigerant leak into the vehicle passenger compartment is not expected to present an unreasonable exposure risk if engineering strategies or mitigation strategies are applied (EPA-HQ-OAR-2004-0488-0025, -0037.1). The U.S. Army risk assessment indicated a possible strategy to limit refrigerant leakage into the passenger compartment by installing a device referred as a “3-second squib valve” to discharge refrigerant to a location outside the passenger compartment three seconds after a major leak is detected. 19 The assessment showed that for CO 2 MVAC systems, using a squib valve to evacuate the charge in three seconds after a leak is detected kept passenger exposure to below levels of concern (i.e., 3% over 15 minutes in the passenger compartment, as a whole, and 4% in the breathing zone).We listed in the proposal additional possible mitigation strategies that may reduce the likelihood of exceeding refrigerant levels of concern inside the passenger compartment, including within the breathing zone. We also received information from commenters on additional engineering strategies and mitigation strategies (EPA-HQ-OAR-2004-0488-0037.1, -0025.2, -0030, -0050). In this final rule, we are not establishing a use condition requiring a specific mitigation strategy, but instead leaving to vehicle manufacturers the choice of which mitigation strategy to use in order to ensure that in the event of refrigerant leak, the resulting concentrations of CO 2 in the passenger free space above 3% or 30,000 ppm averaged over 15 minutes are avoided and the resulting concentrations of CO 2 in the passenger breathing zone do not exceed the ceiling limit of 4% or 40,000 ppm at any time.

EPA evaluated risks of injury and refrigerant exposure to workers by examining risk screens, published research information and data made available during the public comment period (EPA-HQ-OAR-2004-0017, -0025.2, -0041, -0022, -0015, -0051). We compared long-term occupational exposures to CO 2 to a workplace exposure limit of 5,000 ppm (or 0.5%) time weighted average CO 2 concentration over a period of eight hours, consistent with the Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit-Time Weighted Average (PEL-TWA), 20 the Centers for Disease Control and Prevention's (CDC's) National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Limit-Time Weighted Average (REL-TWA), 21 and the American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value-Time Weighted Average (TLV-TWA). 22 23 Additionally, we compared short-term occupational worker exposures to CO 2 to a workplace short-term exposure limit of 30,000 ppm (or 3%) time weighted average CO 2 concentration over a 15-minute period during a workday, consistent with NIOSH's Recommended Exposure Limit-Short term Exposure Limit (REL-STEL)  24 and ACGIH's Threshold Limit Value-Short Term Exposure Limit (TLV-STEL). 25 26

The U.S. Army risk assessment (EPA-HQ-OAR-2004-0488-0025.2) evaluated occupational risks for the MVAC service sector using FTA. The FTA found probabilities of refrigerant exposure while servicing CO 2 MVAC systems of approximately 10 −5 cases per year (i.e., approximately 5 annual cases per 100,000 technicians) (EPA-HQ-OAR-2004-0488-0025). This figure is significantly lower when compared to the general injury and illness rate for auto repair technicians, which is approximately 4 annual cases per 100 full time technicians (BLS, 2003; EPA-HQ-OAR-2004-0488-0025); thus risks from CO 2 exposures in the MVAC service field are expected to be significantly less than the risks of injury already present in shops (EPA-HQ-OAR-2004-0488-0025). The U.S. Army risk assessment additionally found that the chances of refrigerant exposure for persons servicing an MVAC system do not vary considerably by the type of refrigerant used and found similar results for end-of-life (i.e., recycling or disposal) activities (EPA-HQ-OAR-2004-0488-0025).

EPA notes that occupational risks could occur during the manufacture of the refrigerant and initial installation of the refrigerant into the MVAC system at the vehicle assembly plant. Although we did not analyze the risk of exposure during refrigerant manufacture and initial installation of CO 2 refrigerant into the MVAC system at the vehicle assembly plant, we expect risks at the vehicle assembly plant, and at other workplaces were CO 2 refrigerant handling will occur (e.g., service shops, and recycling or disposal facilities), to be similar to or lower than the risks from other refrigerants used for these purposes due to occupational safety practices (e.g., proper ventilation, use of personal protective equipment) established for these type of facilities and subject to occupational safety and health standards under 29 CFR Part 1910, which are intended to address risk to such workers.

EPA finds that the overall environmental and human health risks posed by the use of CO 2 in new MVAC systems, subject to the use conditions being adopted in this final rule, is lower than or comparable to the risks posed by other substitutes found acceptable subject to use conditions in the same end-use.

This final SNAP rule addresses the conditions for safe use of CO 2 in new MVAC systems. Thus, the requirements in this rule apply primarily to OEMs, except for specific requirements for unique fittings required under Appendix D to Subpart G of 40 CFR part 82 which also applies for servicing of the MVAC. Section 609 of the CAA establishes standards and requirements regarding servicing of MVAC systems. These requirements include training and certification of any person that services MVAC systems for consideration, 27 as well as standards for certification of equipment for refrigerant recovery and recycling. EPA has issued regulations implementing these statutory requirements and those regulations are codified at subpart B of 40 CFR part 82. MVAC end-of-life disposal and recycling specifications are covered under section 608 of the CAA and our regulations are codified at subpart F of 40 CFR part 82. The statutory and regulatory provisions regarding MVAC servicing, refrigerant recovery, and refrigerant venting prohibition apply to any refrigerant alternative and are not limited to refrigerants that are also ODS. CO 2 is exempted from the refrigerant venting prohibition provisions promulgated under CAA 608 (40 CFR 82.154 and 70 FR 19278; April 13, 2005).

This section summarizes EPA's response to significant comments received during the public comment periods for the NPRM and the NODA. EPA's response to all comments received can also be found in a response to comments document in docket EPA-HQ-OAR-2004-0488.

Comment: Some commenters claimed that the proposed STEL of 3% CO 2 averaged over 15 minutes in the cabin free space is enough to protect passengers and ensure driver alertness. One commenter suggested to consider a 3% CO 2 concentration limit averaged over 15 minutes in the breath level (i.e., breathing zone) instead of 3% in the cabin free space. The commenter considered the breathing zone to be a relevant point for measurement and claimed that high refrigerant concentrations lower in the vehicle would not impair vehicle operation. Other commenters supported higher CO 2 concentration limits but over a shorter period of time (e.g., 5.5% CO 2 for 5 minutes and 9% CO 2 as a ceiling limit). Other commenters requested that EPA include a CO 2 ceiling limit in the passenger breathing zone and one commenter considered appropriate a 4% CO 2 ceiling limit (i.e., a limit not to be exceeded at any time) as an additional use condition. Another commenter stated that use conditions requiring mitigation strategies are not necessary for low probability events (i.e., exceeding 4% CO 2 for any duration) and that requiring such conditions would prevent the use of this refrigerant.

Response: After evaluating the comments and risk screens (EPA-HQ-OAR-2004-0488-0025.2, -0041, 0051), EPA is revising the proposed use conditions to add a ceiling limit of 4% CO 2, in addition to the CO 2 STEL of 3% averaged over 15 minutes. We believe that the original proposed use condition requiring mitigation strategies for MVAC systems, to prevent leaks of CO 2 refrigerant reaching concentrations above 3% averaged over 15 minutes inside the passenger compartment free space, may not be sufficient on its own to protect drivers and passengers. We also believe that requiring a CO 2 ceiling limit of 4% is necessary because it is possible for a time-weighted average concentration, such as the STEL, to be under 3%, while peak concentrations could reach higher limits for a few minutes. As shown in published data, CO 2 concentration peaks above 4% could result in effects on hearing and vision that could distract and endanger a driver, or other, potentially more severe adverse health effects (EPA-HQ-OAR-2004-0488-0041).

CFD modeling showed that during unmitigated refrigerant leak scenarios, CO 2 refrigerant concentrations in the passenger breathing zone can reach up to 10.2% in 50 seconds (0.83 minutes) and 8.0% in 200 seconds (3.33 minutes) (EPA-HQ-OAR-2004-0488-0025.2). The U.S. Army risk analysis's FTA showed that unmitigated leak scenario occurrences for CO 2 systems (reaching concentrations above 4% CO 2 ) could reach 4,300 per year for the vehicle fleet (EPA-HQ-OAR-2004-0488-0025.2). These occurrences are about 10,000 higher than the expected occurrences associated with leaks of a fluorinated refrigerant (e.g., HFC-134a, HFC-152a, or HFO-1234yf) breakdown product (i.e., hydrogen fluoride) exposure above health based limits. 28 Several studies reported that exposure ranging from 7% to 10% CO 2 for few minutes (e.g., 2-3 minutes) resulted in loss of consciousness (EPA-HQ-OAR-2004-0488-0441). 29

EPA disagrees with the commenter stating that use conditions requiring mitigation strategies are not necessary for low probability events and that requiring such conditions would prevent the use of this refrigerant. Consistent with the information above, we believe that unmitigated exposure occurrences are not rare. We believe the use conditions required in this final rule are necessary to ensure that overall risks to human health and the environment from CO 2 will be similar to or less than those of other available refrigerants that EPA has already listed as acceptable for MVAC. We also believe that requiring the use conditions listed in this final rule would not make the refrigerant use less practicable. Use conditions imposed on other acceptable alternatives for MVACs (e.g., adherence to all safety requirements under SAE standard J639, use of unique fittings and labels, use of pressure relief devices) has not prevented use of such alternatives. 30

Comment: Several commenters indicated that concentration measurements of CO 2 inside the passenger compartment should consider passenger respiration in addition to a refrigerant leak from the A/C system. Another commenter indicated that the MVAC recirculation mode operates with at least 1% of fresh air. One commenter suggested changing the text of the proposed use condition indicating the STEL for CO 2 refrigerant inside the passenger compartment to state that the STEL is “3% v/v fully-occupied-volume, time averaged over 15 minutes” and to clarify that the calculation of such value is based on a double average consisting of the average CO 2 concentration over the air volume of a fully occupied car and a time-average of volume-average over 15 minutes. 31 Another commenter suggested alternative language for the use condition specifying a ceiling limit of 4% CO 2 applicable in any part of the free space inside the passenger compartment for a time period of 60 seconds when the car ignition is on. The suggested language reads:

“Engineering strategies and/or devices shall be incorporated into the system such that foreseeable leaks into the passenger compartment do not result in R744 concentrations of 4.0% v/v or above in any part of the free space inside the passenger compartment for more than 60 seconds when the car ignition is on.”

Response: EPA notes that the U.S. Army risk analysis assumed that a maximum number of passengers were in the vehicle before the release of refrigerant into the passenger compartment, allowing for some build-up of respiratory CO 2 (EPA-HQ-OAR-2004-0488-0025.2). Thus, that analysis recognized that CO 2 concentrations can occur from human respiration in a space with limited exchange of outside air and may consequently build up in the passenger cabin. For that reason, in the proposal, we indicated that OEMs should account for background CO 2 concentrations in the passenger compartment that can result from human respiration when designing their systems and mitigation devices (71 FR 55140; September 21, 2006). However, we did not specify whether the vehicle should be fully occupied to account for CO 2 background concentrations. We believe that CO 2 refrigerant concentrations may reach levels of concern (i.e., above 4% CO 2 ) during an unmitigated event of refrigerant leak either when the vehicle is fully occupied or when not fully occupied (e.g., the vehicle is occupied by the driver only). Thus we do not agree with the commenter's suggestion to state that the STEL is “3% v/v fully-occupied-volume, time averaged over 15 minutes”. In this final rule, we recommend but do not require, consistent with the NPRM, to account for background CO 2 concentrations from human respiration, in addition to refrigerant leaks when designing the MVAC.

EPA notes that the proposal (79 FR 55140; September 21, 2006) specifies the CO 2 STEL as a concentration limit averaged over 15 minutes, in the event of a refrigerant leak. The STEL is determined from the sum of concentration and exposure time products (e.g., concentration 1 times exposure time 1 plus concentration 2 times exposure time 2), divided by the total exposure time which shall not exceed 15 minutes (EPA-HQ-OAR-2004-0448-0041). Thus the STEL is a time-weighted average concentration and not necessarily a time-average of a volume-average as indicated by the commenter since STEL refers to a total exposure time (i.e., 15 minutes) and not an average time. For this reason, we do not agree with the commenter's suggestion to clarify that the calculation of the 3% STEL is based on a double average consisting of the average CO 2 concentration over the air volume of a fully occupied car and a time-average of volume-average over 15 minutes since the approach does not provide further clarity of the use condition. In this final rule, the CO 2 STEL of 3% averaged over 15 minutes considers the average CO 2 concentration in a passenger cabin over a total time period of 15 minutes during the event of refrigerant leak; and the ceiling limit of 4% CO 2 considers the total CO 2 in the passenger breathing zone at any one moment in a passenger compartment during the event of a leak.

Regarding the alternative language suggested by the other commenter specifying a ceiling limit of 4% CO 2 applicable in any part of the free space inside the passenger compartment for a time period of 60 seconds when the car ignition is on, we note that the commenter did not provided information supporting his suggestion that the ceiling limit apply in areas other than the passenger breathing zone for the specified 60-second time period.

Comment: Two commenters indicated the need for clarity on whether the use conditions apply when the ignition is off as well as when the ignition is on. Other commenters suggested considering the results of a risk assessment performed by SAE's CRP indicating a significantly low probability for a leak when the ignition is off, and several other commenters stated that the use conditions should only apply when the ignition is on.

Response: The NODA provided data and requested additional comment on whether the use conditions should apply when the engine is off. In December, 2009, after the public comment period closed on the NODA, SAE issued a report, “Risk Assessment for HFO-1234yf and R-744 (CO 2 ) Phase III” (referred herein after as SAE CRP report), that evaluated toxicity effects and quantitative risks of CO 2, similarly to the U.S. Army risk analysis. This report was submitted to EPA during the public comment period for another SNAP rulemaking. 32 The report evaluates CO 2 exposure estimations due to leaks into the passenger compartment during different modeled scenarios such as different MVAC operation mode, system failure, and during a collision (EPA-HQ-OAR-2008-0664-0056.2, EPA-HQ-OAR-2004-0488-0025.2, -0051). The SAE CRP report also evaluated refrigerant release into the passenger compartment during a scenario where the engine is expected to be off (EPA-HQ-OAR-2004-0488-0051, EPA-HQ-OAR-2008-0664-0056.2). For this scenario, which involves passengers sleeping inside a vehicle with the windows closed while refrigerant leaks occur, the SAE CRP report showed a probability for occurrences of CO 2 refrigerant exposure above 6% (a threshold limit used by the CRP for this scenario) to be in the order of 10 −12 per vehicle/hour/occupant (EPA-HQ-OAR-2004-0488-0051, EPA-HQ-OAR-2008-0664-0056.2). We believe that exposures of concern inside the passenger compartment are more likely to result from a large, sudden release of refrigerant inside the passenger compartment and that such a situation is most likely during a collision while the ignition is on, as described on the U.S. Army risk analysis (EPA-HQ-OAR-2004-0488-0025.2) and consistent with the SAE CRP report (EPA-HQ-OAR-2004-0488-0051, EPA-HQ-OAR-2008-0664-0056.2). In addition, even if a rupture on the evaporator line is large, the overall leak rate is limited to the maximum flow rate of refrigerant through the fixed orifice tube opening of the MVAC (EPA-HQ-OAR-2004-0488-0025.2). The maximum flow rate is determined by the differential compressor discharge pressure, which is only available when the vehicle ignition is on and MVAC system is running. Therefore, EPA finds that the overall risks to human health and the environment from CO 2 will be similar to or less than those of other available refrigerants that EPA has already listed as acceptable for MVAC when the ignition is off. Thus, consistent with a SNAP rule issued in June 12, 2008 (73 FR 33304) listing HFC-152a  33 as acceptable subject to use conditions for use in new MVAC systems, the use conditions in this final rule apply only when the ignition is on.

Comment: One commenter suggested that the regulation should precisely define the area in the vehicle being regulated and indicated that SAE is working on a standard to establish standards for passenger compartment refrigerant concentration measurement. Another commenter indicated that a CO 2 concentration limit should focus on the driver breathing zone rather than the cabin free space.

Response: EPA has clarified the regulatory text of the use condition to define the passenger free space as the space inside the passenger compartment, excluding the space enclosed by the ducting in the HVAC module. The passenger breathing zone, where the ceiling limit of 4% must be met, is defined as the area inside the passenger compartment where the driver's and passengers' heads are located during normal sitting position (i.e., space where people breathe, as defined in the NODA (71 FR 47775; September 17, 2009)). Additionally, we note that the passenger breathing zone is defined in SAE J2772 and the driver's head position in SAE J1052. Since the automotive industry often relies on standards for designs and assessments, we recommend the use of the SAE J1052 and SAE J2772 standards as references for further specifications regarding the driver's and passengers' head and seating position and to establish the passenger breathing zone consistent with our explanation provided in Section V of the preamble (i.e., the area inside the passenger compartment where the driver's and passengers' heads are located during a normal sitting position).

EPA disagrees with the comment indicating that a CO 2 concentration limit should only focus on the driver breathing zone rather than the passenger cabin free space. Based on the risk analyses and available data, we include in this final rule a 4% ceiling limit that must not be surpassed at any time in the passenger (and driver) breathing zone (EPA-HQ-OAR-2004-0488-0044-0025.2). We also include, as proposed, a 3% CO 2 STEL averaged over 15 minutes in the passenger cabin free space as an additional protective measure for passenger exposure to CO 2 . As indicated by the U.S. Army risk assessment, sensitive subpopulations (e.g., elderly and children) may be affected from exposures to high concentrations of CO 2 (EPA-HQ-OAR-2004-0488-0025.2), thus we believe it is necessary to set a limit that would address risk to all people in the passenger compartment and not solely the driver. We also take into consideration that passengers may not be in a normal sitting position all the time (e.g., passenger may rest in a reclined position) and note CO 2 is heavier than air, thus higher concentrations may be found at lower points of the passenger cabin (EPA-HQ-OAR-2004-0488-0025.2, -0041, -0051). As indicated previously, the STEL is the concentration limit that people can be exposed continuously for a short period of time (i.e., 15 minutes) without suffering adverse health risks. For these reasons we include both limits (i.e., 4% CO 2 ceiling limit in the passenger breathing zone and 3% CO 2 averaged over 15 minutes in the passenger cabin free space) in this final rule.

Comment: Several commenters suggested that a CO 2 ceiling limit should rely on exposure time since potential effects of CO 2 vary with both concentration and duration of the exposure. One commenter stated that if the ceiling limit is exceeded, it is likely due to collision events.

Response: EPA agrees the health effects of CO 2 are functions of exposures over time. The commenter appears to misunderstand what a ceiling limit is. A ceiling limit is a limit that shall not be exceeded for any period of time, thus it is not consistent with the concept of a ceiling limit to also include a period of time during which it cannot be exceeded. As explained previously, we believe that both a ceiling limit and a STEL are necessary to ensure that risks posed from CO 2 MVAC systems are not greater than risks posed by other available MVAC systems.

While EPA agrees with the commenter that collision events are the most likely cause of a refrigerant leak that could cause CO 2 levels to the exceed the ceiling limit established in the use conditions, there may be other system failures that could cause the ceiling limit to be exceeded. OEMs should consider risks from all possible events in designing MVACs for use with CO 2 .

Comment: Several commenters suggested considering ceiling limits of CO 2 above 4% (e.g., 6%, 9%) based on studies showing that visual disturbances occur at concentrations of 6% CO 2. They stated that the SAE CRP report's rationale suggested a 9% CO 2 concentration ceiling limit, based on studies showing central nervous system (CNS) effects at CO 2 exposure concentrations of 10% (100,000 ppm).

Response: Studies report that human exposures to 6% CO 2 for periods as short as 2 minutes can lead to hearing and visual disturbances, and that exposures to 7.5% for 5 minutes lead to significant reasoning and performance decrements (Gellhorn, 1936; Sayers, 1987 as cited in EPA-HQ-OAR-2004-0488-0041). To provide a margin of safety, EPA considers it necessary to require a ceiling limit of 4% CO 2 in the passenger breathing zone as indicated in the NODA and suggested by some commenters, to avoid driver performance decrement and other adverse health effects on passengers.

Comment: Several commenters said that the ceiling limit should rely on NIOSH's Immediately Dangerous to Life and Health (IDLH) value of 4% CO 2 based on a 30-minute exposure.

Response: EPA disagrees with the commenters to the extent they are suggesting that the 4% limit be based on a 30-minute exposure. The NIOSH IDLH value is a worker's exposure limit based on the effects that might occur as a consequence of a 30-minute exposure (NIOSH 2005; EPA-HQ-OAR-2004-0488-0041). The OSHA regulation (1910.134(b)) defines the term as “an atmosphere that poses an immediate threat to life, would cause irreversible adverse health effects, or would impair an individual's ability to escape from a dangerous atmosphere.” We believe NIOSH's IDLH is inappropriate as a ceiling limit for the use of CO 2 as a refrigerant in MVACs because, as indicated above, a ceiling limit is a limit that shall not be exceeded for any period of time. Also, a 4% limit over 30-minutes would not protect drivers and passengers from the effects of CO 2 exposure at concentrations equal or higher than 4%. CO 2 is an asphyxiant that obstructs the oxygen flow into the body and we believe that 30-minute duration, in particular, where the person affected by such a concentration may be operating a vehicle and thus posing risk to others, creates a significant risk. Risk Mitigation Strategies

Comment: The U.S. Army noted a CFD parameter error in their 2005 risk analysis which used an incorrect refrigerant leak angle in their 2005 risk analysis (EPA-HQ-OAR-2004-0488-0017). The U.S. Army corrected this error for purposes of their 2006 risk analysis by using a perpendicular leak angle to the rupture cross-sectional area (EPA-HQ-OAR-2004-0488-0025.1). The 2006 analysis finds that an unmitigated discharge of CO 2, in full recirculation mode, results in CO 2 concentration above 3% for more than 60 minutes. The U.S. Army also indicated that a 3-second, rather than a 10-second squib valve, as originally determined, would be needed to ensure that CO 2 concentrations remain below the 3% on a 15-minute average inside the passenger compartment.

Response: EPA notes that the U.S. Army is commenting on its own risk assessment performed in collaboration with EPA and several stakeholders, and referenced in the NPRM (71 FR 55140). We also note that the 2005 U.S. Army risk analysis referred in the NRPM (71 FR 55140) contained technical errors (EPA-HQ-OAR-2004-0488-0017). This final rule relies on the results of the revised (2006) U.S. Army risk analysis submitted during the public comment period.

Based on the U.S. Army revised assessment, we understand that, in order for a squib valve to be an effective mitigation device, the activation time of such device should be 3 seconds rather than the 10 seconds indicated in the original risk assessment. Since we are not specifying in this final rule what mitigation strategies must be used, we believe the 2006 revised risk analysis does not affect the use conditions addressed in this final rule, but may affect the potential risk mitigation strategies OEMs might apply for use with CO 2 refrigerant.

Comment: One commenter stated that secondary loop technology is not a viable risk mitigation strategy for CO 2 because of reduced system performance and reduced fuel efficiency.

Response: This final rule does not specify design options. EPA does not intend to limit engineering innovation by requiring any specific risk mitigation strategy; however, EPA notes that secondary loop technology could potentially reduce the risks of exceeding the ceiling limit of CO 2 in the passenger compartment because the refrigerant charge stays separate from the passenger compartment. OEMs may choose to investigate secondary loops as a risk mitigation strategy, and would have to weigh the pros and cons, including any potential effect on fuel efficiency. However, even if secondary loop technology were not an attractive option, other feasible mitigation technologies could be applied to meet the use conditions of this final rule, such as a squib valve with a 3-second response time.

Comment: One commenter indicated that squib valves with activation time of less than 10 seconds (e.g., few milliseconds) are available and such devices have been tested. Another commenter stated that a 10-second squib valve is not technically feasible given CO 2 sensor performance. Additionally, the commenter stated that during sharp increases in CO 2 concentration in the passenger compartment, a short activation time for a squib-valve would increase the possibility of purging the refrigerant from the air conditioning system to outside the vehicle when no leak in fact exists.

Response: EPA agrees with the first commenter regarding the availability of squib valves and disagrees with the second commenter's statement regarding feasibility of a squib valve. The 2006 U.S. Army risk analysis indicated that a squib valve is one effective strategy and viable engineering option to reduce the amount of charge that could potentially leak into the passenger compartment (EPA-HQ-OAR-2004-0488-0025.2). EPA notes that in the proposal, we intended for the squib valve activation time to include: 1) the time the sensor takes to detect a significant leak that would cause CO 2 refrigerant to enter into the passenger compartment, and 2) the time it takes for the squib valve to open (71 FR 55140; September 21, 2006). The 2006 U.S. Army risk assessment evaluated different activation times (i.e., 30, 10 and 3 seconds) of squib valve during modeled scenarios of CO 2 refrigerant leak. The results showed higher effectiveness of the valve preventing high refrigerant concentration reaching the passenger compartment during the shorter activation time.

EPA believes that sharp increases in CO 2 concentration in the passenger compartment will likely occur only when a significant amount of CO 2 refrigerant leaks into the passenger compartment. Risk assessments showed that CO 2 buildup due to passenger respiration occurs slowly (e.g., 60 minutes) to levels up to 2.4% in a fully-occupied 100 cubic feet sealed passenger compartment of a vehicle with no introduction of outside air (EPA-HQ-OAR-2004-0488-0025.2, -0041). EPA notes that a passenger compartment in a vehicle is not confined space and infiltration/exfiltration rates of air changes within the passenger compartment and outside air are at least 0.3 air changes per hour (NREL, 2003 as cited in EPA-HQ-OAR-2004-0488-0025.2). Therefore, we do not agree that refrigerant purging from the air conditioning system to outside the vehicle will occur when no leak in fact exists.

Comment: A commenter stated that odorants that alert drivers to a leak should be another option for compliance with the rule.

Response: EPA did not propose the use of odorants, and this final action neither requires nor prohibits the use of odorants in new CO 2 MVAC systems. Odorized CO 2 may be an effective means to alert the driver and passengers to a refrigerant leak into the passenger compartment. However, EPA does not believe odorants used alone provide sufficient risk mitigation as it may take vehicle occupants a period of time to recognize what the odor signifies. Documentation has not been provided to show how long and how much odorized CO 2 drivers must be exposed to before they recognize that the smell indicates a health and safety risk.

Comment: One commenter suggested that EPA consider use of sensors to allow continuous monitoring of refrigerant concentration inside the passenger cabin as a mitigation strategy. Another commenter mentioned that an alarm system or other technical solutions should allow for air renewal and lowering concentration levels below the limits indicated in the use conditions within a reasonable time period

Response: As noted previously, EPA is not specifying the risk mitigation strategies that must be used to ensure CO 2 levels do not exceed the levels established in the use conditions. We do not believe that a sensor alone would be sufficient to provide effective protection to the passengers and to ensure that concentrations inside the passenger compartment and passenger breathing zone do not exceed the established CO 2 concentration limits of this final rule. In response to the commenter stating that an alarm system or other technical solutions should allow for air renewal, EPA believes the use of such tool might be effective but that such strategy would need to rely on an automatic supply of air, rather than a driver's response, to ensure CO 2 concentrations do not exceed the exposure limits established in the use conditions. Thus, an additional mitigation device would need to be used in addition to any alarm system.

Comment: One commenter said that evaporator isolation valves are not realistic as mitigation devices because of cost. The commenter stated that close-coupled and hermetically sealed systems are technically feasible and noted that an automatic increase in air exchange is a possible strategy that is technically feasible. Another commenter suggested that switching the MVAC blower to operate on outside air mode on high, rapidly after CO 2 refrigerant is released, could reduce the overall refrigerant concentration in the compartment to a peak lower than 4%.

Response: EPA believes the mitigation strategies mentioned by the commenters may all be technically feasible means to meet concentration levels specified in the use conditions. We note that in the proposed rule we suggested using evaporator isolation valves, close coupled or hermetically closed systems that would reduce refrigerant charge size, and increasing air exchange (with outside air) in the passenger compartment upon detection of leaks as some of several potential risk mitigation strategies (71 FR 55140; September 21, 2006). In this final rule we are not requiring a specific mitigation strategy or engineering device. We are allowing OEMs to choose a mitigation strategy that is consistent with the use conditions and that they will employ to protect the driver and passengers in a vehicle from CO 2 exposure above the limits specified in this rule.

Comment: One commenter stated that a vehicle crash could be so severe that the MVAC system evaporator could be damaged and possibly reduce a risk mitigation system's effectiveness. The commenter proposed the inclusion of an evaporator crush resistance standard in this action.

Response: EPA agrees that a vehicle crash could reduce the effectiveness of the risk mitigation strategy. However we believe that in such a case, the damage to the car would be so severe as to result in an inflow of ambient air that would negate the risks associated with potentially elevated CO 2 concentrations. A crush-resistant evaporator could be selected as a possible mitigation strategy but, as stated previously, in this final rule we do not specify which engineering device or strategies must be incorporated into the MVAC system and leave this choice to the OEMs.

Comment: Several commenters indicated that SAE is developing standards for safety and servicing of CO 2 MVAC systems and that it is customary for OEMs to follow those standards. Other commenter claimed that every OEM is responsible for its own safety concept and has to show compliance with already existing and future safety standards.

Response: EPA notes and agrees with the important role industry standards play particularly for the MVAC sector. In addition, we note that the regulatory text references the relevant SAE technical standards to promote consistency with established industry practices. Specifically, use conditions in this final rule reference SAE J639 (2011 version). Other standards such as SAE J1739, which addresses design, safety, and recordkeeping requirements, are recommended to help ensure that the use conditions are met.

We disagree with the comment stating that every OEM is responsible for its own safety concept because we believe that in addition to customary business standards and industry practices outside the scope of this rule, OEMs will comply with all the use conditions specified in this rule.

Comment: Commenters noted that SAE is developing SAE J2772 standard, “Measurement of Passenger Compartment Refrigerant Concentrations Under System Refrigerant Leakage Conditions” (EPA-HQ-OAR-2004-0448-0054) and SAE J2773 standard, “Standard for Safety and Risk Analysis for Use in Mobile Air Conditioning Systems” (EPA-HQ-OAR-2004-0448-00553), formerly known as Refrigerant Guidelines for Safety and Risk Analysis for Use in Mobile Air Conditioning Systems.

Response: We note that standards J2772 and J2773 were recently published and are readily available. In the comments column of our listing decision, we recommend the use of J2772 and J2773 standards as well as other available standards such as SAE J1052, Motor Vehicle Driver and Passenger Head Position (EPA-HQ-OAR-2004-0448-0055).

Comment: One commenter indicated CAA Section 609-certified, independent MVAC service technicians should be consulted before the rule is issued.

Response: EPA took comments on a range of topics during the 60-day public comment period. In addition, EPA contacted the National Institute for Automotive Service Excellence (ASE), which represents a significant number of MVAC service technicians. A summary is in the docket for this final rule. ASE stated they did not see any servicing concerns in the proposal that would impact the service technicians they represent, but would be interested in any follow-on rulemaking that will address MVAC servicing for consideration under CAA Section 609 and codified at 40 CFR part 82 subpart B (EPA-HQ-OAR-2004-0488-0031).

Comment: One commenter said risks associated with MVAC service should be considered.

Response: EPA agrees with the commenter and notes that risk associated with service were evaluated in the published risk analyses (EPA-HQ-OAR-2004-0488-0017, -0025.2, -0041, -0051) and discussed in the preamble to the proposed rulemaking (71 FR 55144 September 21, 2006). Additional details regarding our evaluation of risk associated with MVAC service can be found in Section VI of this final rule preamble (Why is EPA listing CO 2 acceptable subject to use conditions?). As explained in more detail in Section VI above, we do not believe it is necessary to establish any use conditions regarding servicing because the overall environmental and human health risks posed by the use of CO 2 in new MVAC systems, subject to the use conditions being adopted in this final rule, is lower than or comparable to the risks posed by other substitutes found acceptable subject to use conditions in the same end-use. Comment: One commenter requested more information on why CO 2 systems are not found acceptable as a substitute in retrofitted systems.

Response: In the original SNAP rulemaking (59 FR 13854; March 18, 1994), EPA listed CO 2 as an acceptable substitute for CFC-12 only for new MVAC systems. We have never received a SNAP submission requesting consideration of CO 2 in retrofitted MVAC systems. EPA understands that the higher working pressure of CO 2 compared to CFC-12 and other SNAP-acceptable refrigerants could raise significant issues with retrofitting such systems to CO 2. Because we have not received a request to use CO 2 in retrofitted systems, which would include the technical and other analyses necessary to determine whether such use would present more risk than other available substitutes, this final rule only applies to the use of CO 2 as a refrigerant in new MVAC systems, consistent with the NPRM (71 FR 55140; September 21, 2006). When and if the Agency receives a submission for retrofitting to CO 2, we will consider CO 2 for use as a refrigerant to retrofit existing MVAC systems.

Under Executive Order (EO) 12866, (58 FR 51735; October 4, 1993) this action is a “significant regulatory action.” It raises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011) and any changes made in response to OMB recommendations have been documented in the docket for this action.

This action does not impose any new information collection burden under the Paperwork Reduction Act (44 U.S.C. 3501 et seq). This action is an Agency determination. It contains no new requirements for reporting. The only new recordkeeping requirement involves customary business practice. This rule requires minimal recordkeeping of studies done for three years to ensure that MVAC systems using CO 2 meet the requirements set forth in this rule. Because it is customary business practice that OEMs conduct and keep on file records of the tests they perform, consistent with a widely recognized industry standard, SAE J1739 (Potential Failure Mode and Effect Analysis in Design [Design FMEA], Potential Failure Mode and Effect Analysis in Manufacturing and Assembly Processes [Process FMEA]), on any potentially hazardous part or system from the beginning of production of a vehicle model until three years or more after production of the model ends, we believe this requirement will not impose an additional paperwork burden. However, the Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations in subpart G of 40 CFR part 82 under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control numbers 2060-0226. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9.

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business, as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201;” (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of this final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This final rule modifies the current listing of CO 2 as an acceptable alternative refrigerant subject to use conditions necessary for the safe use of CO 2 in MVAC in new motor vehicles. The use conditions will need to be met by large entities (i.e., OEMs) that manufacturer motor vehicles if these choose to use CO 2 as a refrigerant in new MVACs. This final rule does not mandate the use of CO 2 as a refrigerant in new MVAC systems, thus will not impose significant requirements on small entities such as MVAC service shops. This final rule effectively ensures consistency with current practices in MVAC service shops regarding the use of unique fittings. It is not clear that there would be any cost differential between the unique fittings required for the use of CO 2 and those used with the current automotive refrigerant, HFC-134a, or other fittings that the industry could adopt instead, for other refrigerants. It is possible that the fittings required in the revised use condition will be equally or less expensive than those required for other acceptable alternative refrigerants because they are a standard shape and size and can be easily produced in a metal-working shop. Thus, cost impacts of this final rule on small entities are expected to be small.

Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this rule on small entities. EPA has worked together with SAE International and with groups representing professional service technicians such as the Mobile Air Conditioning Society Worldwide, which conducts regular outreach with technicians and owners of small businesses such as retail refrigerant suppliers and automobile repair shops.

This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for State, local, or tribal governments or the private sector. This action does not affect State, local, or tribal governments. The enforceable requirements of this action related to integrating risk mitigation devices and documenting the safety of alternative MVAC systems affect only a small number of OEMs. The impact of this action on the private sector will be less than $100 million per year. Thus, this action is not subject to the requirements of sections 202 and 205 of the UMRA. This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This action applies directly to facilities that use these substances and not to governmental entities.

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, as specified in EO 13132 (64 FR 43255, August 10, 1999). This regulation applies directly to facilities that use these substances and not to governmental entities. Thus, EO 13132 does not apply to this rule.

This final rule does not have tribal implications, as specified in EO 13175 (65 FR 67249, November 6, 2000). It does not significantly or uniquely affect the communities of Indian tribal governments, because this regulation applies directly to facilities that use these substances and not to governmental entities. Thus, EO 13175 does not apply to this rule.

This final rule is not subject to the EO 13045 (62 FR 19885, April 23, 1997) because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action's health and risk assessments are discussed in sections VI and VIII of the preamble and in documents EPA-HQ-OAR-2004-0488-0025.2, EPA-HQ-OAR-2004-0488-0041 and EPA-HQ-OAR-2004-0488-0051 in the docket for this rulemaking.

This rule is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355; May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This action would impact manufacturers of CO 2 MVAC systems for new vehicles. Preliminary information indicates that these new systems are equally or more energy efficient than currently available systems in some climates. Therefore, we conclude that this rule is not likely to have any adverse effects on energy supply, distribution or use.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995, Public Law 104-113, Section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This rulemaking involves technical standards. EPA has incorporate by reference, the 2011 version of SAE standard J639 which is a voluntary consensus standard. This standard can be obtained from http://www.sae.org/technical/standards/. This standard addresses safety and reliability issues of CO 2 MVAC systems.

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.

EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it increases the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. The refrigerant CO 2 is a non ozone-depleting substance with a GWP of 1.0. Based on the toxicological and atmospheric data described earlier, the use of CO 2 subject to the use conditions specified in this final rule will not have any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. This final rule requires specific use conditions for MVAC systems, if motor vehicle manufacturers choose to market MVAC systems using this refrigerant alternative.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A Major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective August 6, 2012.

The documents below are referenced in the preamble. All documents are located in the Air Docket at the address listed in section titled ADDRESSES at the beginning of this document. Unless specified otherwise, all documents are available in Docket ID No. EPA-HQ-OAR-2004-0488 at http://www.regulations.gov.

For the reasons set out in the preamble, 40 CFR Part 82 is amended as follows:

Legal Basis

The Motor Carrier Act of 1935 provides that “The Secretary of Transportation may prescribe requirements for (1) qualifications and maximum hours of service of employees of, and safety of operation and equipment of, a motor carrier; and (2) qualifications and maximum hours of service of employees of, and standards for equipment of, a motor private carrier, when needed to promote safety of operation” [49 U.S.C. 31502(b)].

The Motor Carrier Safety Act of 1984 (MCSA) confers on the Secretary the authority to regulate drivers, motor carriers, and vehicle equipment. It requires the Secretary to prescribe safety standards for commercial motor vehicles (CMVs). At a minimum, the regulations must ensure that (1) CMVs are maintained, equipped, loaded, and operated safely; (2) the responsibilities imposed on operators of CMVs do not impair their ability to operate the vehicles safely; (3) the physical condition of operators of CMVs is adequate to enable them to operate the vehicles safely; and (4) the operation of CMVs does not have a deleterious effect on the physical condition of the operator [49 U.S.C. 31136(a)]. The Act also grants the Secretary broad power to “prescribe recordkeeping and reporting requirements” and to “perform other acts the Secretary considers appropriate” [49 U.S.C. 31133(a)(8) and (10)].

The Administrator of FMCSA has been delegated authority to carry out the functions vested in the Secretary by the Motor Carrier Act of 1935 [49 CFR 1.73(l)], and the MCSA [§ 1.73(g)]. The provisions affected by this Notice of Regulatory Guidance are based on these statutes.

This document adds regulatory guidance on the applicability of the hours-of-service (HOS) regulations for property-carrying drivers in 49 CFR 395.3 to drivers of vehicles designed or used to transport passengers, while operating the vehicle on a “driveaway-towaway” trip as defined 49 CFR 390.5. These drivers often work for motor carriers that specialize in delivery of commercial motor vehicles (CMVs), and they do not operate CMVs to transport passengers on a regular basis.

The § 390.5 definition of “driveaway-towaway” is “* * * an operation in which an empty or unladen motor vehicle with one or more sets of wheels on the surface of the roadway is being transported: (1) Between vehicle manufacturer's facilities; (2) between a vehicle manufacturer and a dealership or purchaser; (3) between a dealership, or other entity selling or leasing the vehicle, and a purchaser or lessee; (4) to a motor carrier's terminal or repair facility for the repair of disabling damage (as defined in § 390.5) following a crash; (5) to a motor carrier's terminal or repair facility for repairs associated with the failure of a vehicle component or system; or (6) by means of a saddle-mount or tow-bar.”

Section 395.3 prescribes the primary HOS regulations applicable to property-carrying drivers, and § 395.5 prescribes the comparable regulations for passenger-carrying drivers. Neither the term “property-carrying” nor “passenger-carrying” is defined in these regulations. The FMCSA has received inquiries from motor carriers as to whether the property-carrying or passenger-carrying HOS rules would apply in driveaway situations usually involving the delivery of a bus, motorcoach, or similar CMV from the manufacturer or distributor to the dealer, or similar scenario. The Agency agrees that regulatory guidance is needed to clarify applicability of the HOS regulations. For the reasons explained above, FMCSA issues Regulatory Guidance Question 1 to § 395.5 of the FMCSRs.