On December 21, 2000, the Secretary established within the NOP (7 CFR part 205) the National List regulations sections 205.600 through 205.607. The National List identifies the synthetic substances that may be used and the nonsynthetic (natural) substances that may not be used in organic production. The National List also identifies nonagricultural synthetic, nonsynthetic nonagricultural and nonorganic agricultural substances that may be used in organic handling. The Organic Foods Production Act of 1990 (OFPA), as amended, (7 U.S.C. 6501-6522), and NOP regulations, in section 205.105, specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is on the National List. Section 205.105 also requires that any nonorganic agricultural and any nonsynthetic nonagricultural substance used in organic handling must also appear on the National List.

Under the authority of the OFPA, the National List can be amended by the Secretary based on recommendations developed by the National Organic Standards Board (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 13504); August 3, 2011 (76 FR 46595); February 14, 2012 (77 FR 8089); May 15, 2012 (77 FR 28472); June 6, 2012 (77 FR 33290); and August 2, 2012 (77 FR 45903). Additionally, a proposed amendment to the National List was published on January 12, 2012 (77 FR 1980).

This final rule amends the National List to enact a recommendation submitted to the Secretary by the NOSB on April 29, 2010.

The following provides an overview of the amendment made to the designated section of the National List regulations:

This final rule amends the listing for synthetic methionine at section 205.603(d)(1) of the National List regulations by removing the expiration date “October 1, 2012”, revising the maximum levels of synthetic methionine allowed per ton of feed for organic poultry, and correcting the Chemical Abstracts Service (CAS) numbers in the annotation as follows:

(d)(1) DL-Methionine, DL-Methionine-hydroxy analog, and DL-Methionine-hydroxy analog calcium (CAS #'s 59-51-8, 583-91-5, 4857-44-7, and 922-50-9)—for use only in organic poultry production at the following maximum levels of synthetic methionine per ton of feed: laying and broiler chickens—2 pounds; turkeys and all other poultry—3 pounds.

Methionine is classified as an essential amino acid for poultry because it is needed to maintain viability and must be acquired through the diet. Methionine is required for proper cell development and feathering in poultry. Natural feed sources with a high percentage of methionine include blood meal, fish meal, crab meal, corn gluten meal, alfalfa meal, and sunflower seed meal. Synthetic methionine is also used in poultry feed. This substance is a colorless or white crystalline powder that is soluble in water. It is regulated as an animal feed nutritional supplement by the Food and Drug Administration (21 CFR 582.5475).

In 2001, the NOSB evaluated a technical advisory panel analysis of methionine against the criteria provided in the OFPA, and determined that the use of synthetic methionine in organic poultry feed is compatible with a system of organic poultry production. Based on multiple NOSB recommendations, AMS has amended section 205.603 of the National List to allow methionine as a synthetic substance for use in organic poultry production four times (68 FR 61987, 70 FR 61217, 73 FR 54057, and 75 FR 51919). AMS published a complete account of the past NOSB recommendations and rulemaking pertaining to methionine in the interim rule published in the Federal Register on August 24, 2010 (75 FR 51919) (finalized on March 14, 2011 (76 FR 13501)).

On July 31, 2009, the Methionine Task Force (MTF), which is comprised of organic poultry producers, submitted a new petition requesting to extend the allowance for synthetic methionine for five years until October 2014. In addition, the MTF proposed that the total amount of synthetic methionine in the diet remain below the following levels, calculated as the average pounds per ton of 100% synthetic methionine over the life of the bird: laying chickens—4 pounds; broiler chickens—5 pounds; and, turkey and all other poultry—6 pounds. In consideration of the July 2009 petition and public comments, the NOSB issued two recommendations on April 29, 2010. These recommendations acknowledged a need for the continued allowance of synthetic methionine, and conveyed the intent to decrease the amount of synthetic methionine allowed in organic poultry production and encourage development of natural alternatives. One recommendation proposed to allow synthetic methionine in organic poultry production until October 1, 2012, at the following maximum levels per ton of feed: laying chickens—4 pounds; broiler chickens—5 pounds; and turkey and all other poultry—6 pounds. The first recommendation was implemented through a final rule published on March 14, 2011 (76 FR 13501).

This final rule addresses the second NOSB recommendation on synthetic methionine from April 2010. 1 This recommendation was based upon their evaluation of a petition submitted by the Methionine Task Force, a group of organic poultry producers, a third party technical review, and public comments received as part of their April 2010 public meeting. 2 In their deliberations, the NOSB conveyed that the intent of this recommendation was to balance various interests including: (i) Providing for the basic maintenance requirements of organic poultry; (ii) satisfying consumer preference to reduce the use of synthetic methionine in organic poultry production; and (iii) motivating the organic poultry industry to continue the pursuit of commercially sufficient sources of allowable natural sources of methionine. A detailed discussion of the NOSB recommendation is available in the proposed rule which was published in the Federal Register on February 6, 2012 (77 FR 5717). 3

This NOSB recommendation from April 2010 recommended that AMS delete the expiration date from the substance's current restrictive annotation to provide for use of synthetic methionine in organic production after its current expiration date, October 1, 2012. 4 In response to the NOSB recommendation and public comment, this final rule removes the October 1, 2012 expiration date from the listing for synthetic methionine on the National List. In effect, removal of the expiration date from the current restrictive annotation provides for the use of synthetic methionine until it is reviewed again by the NOSB as part of either the substance's next sunset review or through the petition process. 5

The NOSB also recommended a reduction in the maximum levels of synthetic methionine allowed in organic poultry feed as part of their April 2010 recommendation. In response to this recommendation, this final rule amends the listing for synthetic methionine by reducing the maximum levels of the substance allowed per ton of feed for organic poultry from “laying chickens—4 pounds; broiler chickens—5 pounds; turkeys and all other poultry—6 pounds” to “laying and broiler chickens—2 pounds; turkeys and all other poultry—3 pounds”.

Through this final rule, AMS is also correcting the CAS numbers for the forms of synthetic methionine specified on the National List. CAS numbers are numeric identifiers which are used to uniquely identify substances. As discussed in the proposed rule, two of the three CAS numbers in the current listing for synthetic methionine are not appropriately specified in the regulation (77 FR 5719). An overview of the changes is provided in Table 1.

A notice was published in the Federal Register announcing a meeting of the NOSB and its planned deliberations to address a petition pertaining to the use of methionine in organic poultry production on March 17, 2010 (75 FR 12723).

The current listing for methionine was codified through publication of an interim rule with request for comments in the Federal Register on August 24, 2010 (75 FR 51919), and reaffirmed by a final rule published on March 14, 2011 (76 FR 13501).

The proposal to allow the use of methionine as specified in this final rule was published as a proposed rule on February 6, 2012 (77 FR 5717).

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 the 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 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/nop.

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 (OMB).

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 section 6514(b) of the OFPA. States are also preempted under section 6503 through 6507 of the OFPA 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 section 6507(b)(2) of the OFPA, 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 section 6519(f) of the OFPA, 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 the Environmental Protection Agency under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136-136(y)).

Section 6520 of the OFPA 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 final 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 is to fit regulatory actions to the scale of businesses subject to the action. 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 action on small entities. The impact on entities affected by this final rule would not be significant. The effect of this final rule is to continue the allowance of synthetic methionine in poultry production, which would otherwise expire in October 2012. While the rule will reduce the rates of synthetic methionine allowed in organic poultry feed, this action amends the regulations such that small entities will continue to have access to a substance for use in organic poultry production. AMS concludes that the economic impact of extending the allowance for synthetic methionine in organic poultry production, if any, will be minimal to small agricultural service firms. Accordingly, AMS certifies that this rule will not have a significant economic impact on a substantial number of small entities.

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. Based on USDA data from the Economic Research Service (ERS) in 2008, these operations contained more than 4.8 million certified acres consisting of 2,665,382 acres of cropland and 2,160,577 acres of pasture and rangeland. 6 The total acreage under organic management represents a twelve percent increase from 2007. Organic poultry production has steadily contributed to the overall growth in the organic food market. ERS estimated that there were 5,538,011 laying chickens and 9,015,984 broiler chickens raised under organic management in 2008. 7 ERS estimated the number of certified organic turkeys raised in the United States in 2008 at 398,531. Based on the USDA data reported by the National Agricultural Statistical Service (NASS), the US market value for organic eggs, and laying and broiler chickens was calculated at $352,831,850 in 2008. 8 In addition to being sold as whole products, organic eggs and poultry by-products are used in the production of organic processed products including soups, broths, prepared meals, ice cream, and egg nog. U.S. sales of organic food and beverages have grown from $1 billion in 1990 to $26.7 billion in 2010. Sales in 2010 represented 7.7 percent growth over 2009 sales. 9

In addition, USDA has 93 accredited certifying agents who provide certification services to producers and handlers under the NOP. 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 38 comments on the proposed rule. Comments were received from organic livestock producers, consumers, accredited certifying agents, trade associations, non-profit organizations, advocacy groups, and a methionine manufacturer. The majority of comments supported a continued allowance for synthetic methionine in organic poultry production after its current expiration date, October 1, 2012. Nine comments specifically supported the amendment as proposed. Seven of these nine comments further stated their support for the proposed action because it will meet the intent of the NOSB to phase out the use of synthetic methionine in organic poultry production over time. Three commenters opposed the proposed rule as they wanted no synthetic methionine to be included in organic poultry diets.

Many commenters stated that the proposed reduction in the maximum levels of synthetic methionine allowed per ton of feed could pose issues for some organic producers. These commenters described their concerns with the proposed reduction, including the lack of commercially available natural sources of methionine, and considerations pertaining to animal health and welfare and the environment.

Commenters stated that natural alternatives to compensate for the reduction in synthetic methionine are not commercially available at quantities that would meet the nutritional requirements of the birds. Commenters acknowledged that research was ongoing to identify high methionine feeds, but noted that these alternatives are not produced in sufficient quantities to meet the demand of the organic poultry market. Some commenters stated that, in the absence of natural alternatives, synthetic methionine continues to be important for overall production output, increased flock uniformity and reduced feed costs. Some commenters noted that poultry diets are corn and soybean based and suggested that producers may need to meet the nutritional requirement for methionine by overfeeding protein with extra soybean meal. A commenter questioned if a sufficient quantity of organic soybeans were available for this strategy of overfeeding soybean meal to compensate for reduced synthetic methionine levels. One commenter also suggested that feed costs could rise by 20% if producers opt to overfeed protein sources in response to the reduced levels.

Some commenters cited scientific literature and National Research Council (NRC)  10 recommendations on the quantity of methionine needed in a poultry diet to optimize animal health. The commenters stated that the nutritional requirements for birds change over time with greater methionine demand early in life and early in the laying period, and that the proposed reduction in synthetic methionine would not align with the nutritional demands of the birds during certain life stages. Commenters also referenced the benefits to animal welfare when the nutritional requirement for methionine is met. Commenters noted that diets with inadequate amounts of methionine could lead to increased feather pecking and cannibalism.

Some commenters also raised concerns about the environmental impacts of poultry diets with lower levels of synthetic methionine. These commenters stated that studies show that inclusion of synthetic methionine in poultry diets reduced greenhouse gas production, reduced nitrogen waste and required less land be cultivated to produce the same amount of poultry products as those without methionine supplementation. Other commenters noted that producers may choose to meet the methionine needs of the birds by overfeeding protein. These commenters stated that increased protein in the diet has been shown to lead to more nitrogen excretion and an increase in ammonia levels in poultry houses.

To address these concerns, commenters recommended alternatives to the proposed reduction in the levels of synthetic methionine. Some commenters suggested that the annotation on synthetic methionine should align with the methionine recommendation from the National Research Council. Some commenters stated that the maximum levels of methionine per ton of feed should remain at the levels currently codified (i.e. for laying chickens—4 pounds; for broiler chickens—5 pounds; and turkey and all other poultry—6 pounds). Other commenters suggested that, if the proposed reduction in synthetic methionine levels is finalized at 2 pounds for laying and broiler chickens and at 3 pounds for turkeys and all other poultry, then the annotation should specify that these levels be based upon an average amount of synthetic methionine per ton of feed fed over the life of the birds. These commenters noted that this latter approach would be consistent with the request of the 2011 petition submitted by the Methionine Task Force.

Consistent with the NOSB recommendation, AMS is maintaining the proposed amendment to allow synthetic methionine in organic poultry production after October 1, 2012, at reduced levels. The NOSB received numerous public comments at their April 2010 public meeting regarding the use of synthetic methionine in organic poultry production. During their deliberations, the NOSB also reviewed technical information on synthetic methionine 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). As part of their decision making, the NOSB is mandated by OFPA to evaluate whether alternative practices make the use of a substance such as synthetic methionine unnecessary. The NOSB recommended an allowance for lower levels of synthetic methionine based on their perspective that implementing management strategies and different housing practices should lessen or eliminate the need for synthetic methionine in organic production. The NOSB also believed that a reduction in the levels allowed after October 1, 2012, will stimulate further market development of natural alternatives and drive management changes in the organic poultry industry. Amending the listing for this substance on the National List to allow higher levels of the substance than recommended by the NOSB would not meet the intent of the NOSB to phase out the use of this synthetic methionine in organic poultry production over time. Therefore, consistent with the NOSB recommendation, AMS is codifying the amendment to synthetic methionine through this final rule as proposed.

One commenter suggested that poultry diets without synthetic methionine may not be in compliance with the Association of American Feed Control Officials' Model Feed Bill and Regulations which have been adopted in 18 states. This rule allows for synthetic methionine in organic poultry feed in accordance with its restrictive annotation on the National List. This action is not requiring the formulation of organic poultry feed without synthetic methionine.

Some commenters questioned the process through which the NOSB made its April 2010 recommendation to the NOP. Commenters reiterated that methionine requirements for poultry and the commercial availability of natural sources of methionine have not changed since the NOSB began its deliberations on the allowance for synthetic methionine in organic production. Therefore, commenters questioned, with the same information, the NOSB decision to further restrict the use of synthetic methionine in their April 2010 recommendation. One commenter also stated that the NOSB should have accepted additional public comment at the April 2010 meeting on the reduced levels of the substance in their recommendation prior to voting. One commenter disputed the information provided to the NOSB Livestock Committee by anonymous feed mills and scientific experts about the feed requirements for poultry.

On March 17, 2010, a notice was published in the Federal Register announcing a meeting of the NOSB and its planned deliberations to address a petition pertaining to the use of methionine in organic poultry production (75 FR 12723). In response to this notice, the NOSB accepted both written and oral public comment on this issue in advance of making their recommendation. All comments were considered alongside the technical information as part of the NOSB's recommendation on synthetic methionine to the Secretary.

Two commenters suggested that, if organic poultry were produced using synthetic substances, then the organic poultry products from these poultry should be labeled as produced through use of a synthetic. The NOP regulations authorize the use of synthetic substances that have been recommended by the NOSB and included on the National List by the Secretary. Requiring labeling for the use of synthetic inputs as suggested by the commenters is outside the scope of this rulemaking.

Several commenters provided comments in reference to the petition submitted in 2011 by the Methionine Task Force. 11 A few comments regarding the 2011 petition addressed the potential for increased audit times based on upon the petitioner's request and the need for NOSB to consider use of a natural omnivorous diet as an alternative to the petitioner's request. Other comments supported the 2011 petition and urged the NOSB to review it as soon as possible. These comments are outside the scope of this rulemaking. The NOSB is currently reviewing this petition and would accept comments on any NOSB proposal to address this petition as part of a future NOSB meeting.

AMS specifically requested comments on proposed corrections to the CAS numbers for the allowed forms of methionine. One comment was received from a trade association on this issue. The commenter stated that correcting the CAS numbers (348-67-4 for D-Methionine and 63-68-3 for L-Methionine) would not impact any poultry feeds currently on the market, but noted that the correction would prevent the addition of D-methionine or L-methionine in future feed formulations. AMS is retaining the corrections as proposed to ensure that the appropriate CAS numbers are reflected in the annotation for synthetic methionine on the National List. Forms of synthetic methionine which are not indicated by their CAS number on the National List at section 205.603 would need to be petitioned for review by the NOSB.

This final rule reflects a recommendation submitted to the Secretary by the NOSB for extending the use of synthetic methionine in organic poultry production. The NOSB evaluated this substance using criteria in the OFPA in response to a petition. The NOSB has determined that while wholly natural substitute products exist, they are not presently available in sufficient supplies to meet poultry producer needs. Therefore, some allowance for synthetic methionine is a necessary component of a nutritionally adequate diet for organic poultry. Pursuant to 5 U.S.C. 553, it is found and determined upon good cause that it is impracticable and contrary to the public interest to give preliminary notice prior to putting this rule into effect in order to ensure the continued use of synthetic methionine after October 1, 2012, and avoid any disruption to the organic poultry market.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 99-08-23, Amendment 39-11132 (64 FR 19879, April 23, 1999). That AD applies to the specified products. The NPRM published in the Federal Register on June 28, 2012 (77 FR 38547). That NPRM proposed to continue to require repetitive inspections to detect cracking in the web of the aft pressure bulkhead at body station 1016 at the aft fastener row attachment to the “Y” chord, and corrective actions if necessary. That NPRM also proposed to require adding various inspections for discrepancies at the aft pressure bulkhead, and related investigative and corrective actions if necessary.

We gave the public the opportunity to participate in developing this AD. We have considered the comments received. Boeing supports the NPRM (77 FR 38547, June 28, 2012). Aviation Partners Boeing stated that it has reviewed the NPRM and has determined that the installation of winglets per supplemental type certificate ST01219SE does not affect the NPRM.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD as proposed.

We estimate that this AD affects 566 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary on-condition inspections that would be required based on the results of the initial inspection. We have no way of determining the number of aircraft that might need these inspections:

We have received no definitive data that would enable us to provide cost estimates for the crack repairs specified in this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

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

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

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

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

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

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in the Federal Register on June 25, 2012 (77 FR 37827). That NPRM proposed to require replacing the auxiliary power unit (APU) generator control unit (GCU).

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (77 FR 37827, June 25, 2012) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed.

We estimate that this AD affects 58 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

According to the manufacturer, all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

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

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

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

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

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

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

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

Discussion

On December 28, 2011, at 76 FR 81430, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 to include an AD that would apply to Eurocopter Model SA330F, SA330G, SA330J, AS332C, AS332L, AS332L1, and AS332L2 helicopters. That NPRM proposed to require within 50 hours time-in-service (TIS) cleaning, inspecting and lubricating each gearbox, and adjusting, as necessary, the fuel shut-off control travel.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Emergency AD No. 2007-0082-E, dated March 27, 2007, to correct an unsafe condition for the Eurocopter Model SA330F, SA330G, SA330J, AS332C, AS332C1, AS332L, AS332L1, and AS332L2 helicopters. EASA advises that the emergency AD was issued following two reports of jamming of one of the fuel shut-off control levers discovered during maintenance. In both cases, this jamming originates from solidified grease in the gearboxes. EASA also found corrosion in a gearbox. Jamming of a fuel shut-off control lever constitutes an unsafe condition because it prevents the shut off of engine fuel and prevents the parallel-mounted electrical micro switches, normally activated by shutting off both of the fuel shut-off control levers, from switching off the electrical power system during an emergency shut down.

We gave the public the opportunity to participate in developing this AD, but we did not receive any comments on the NPRM.

We have reviewed the relevant information and determined that an unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs and that air safety and the public interest require adopting the AD requirements as proposed except we are replacing the word “travel” in the required actions paragraph with the more accurate word “lever,” and other minor editorial changes. These changes are consistent with the intent of the proposals in the NPRM and will not increase the economic burden on any operator nor increase the scope of the AD.

• We use the word “inspect” to describe the actions required by a mechanic rather than the word “check.”

• We refer to the compliance time as “hours TIS” rather than “flying hours.”

• We use a different compliance time for inspecting and lubricating the gearboxes.

• We are not including the military model helicopters or Model AS332C1 in the applicability because they are not type certificated in the United States.

• We are not requiring measuring the operating loads of the fuel shut-off controls per paragraph 1.1 of the EASA AD (paragraph 2.B.1 of the Eurocopter Alert Service Bulletin).

Eurocopter has issued an Alert Service Bulletin (ASB), Revision 1, dated March 22, 2007, with three numbers (Nos. 76.00.04, 76.00.03, and 76.03). ASB No. 76.03 applies to the U.S. type-certificated Model SA330F, SA330G, and SA330J and also applies to the non-type-certificated military Model 330 helicopters. ASB No. 76.00.04 applies the U.S. type-certificated Model AS332C, AS332L, AS332L1, and AS332L2 helicopters and also applies to the non-type-certificated AS332C1 and military Model 332 helicopters. ASB No. 76.00.03 applies to the non-type-certificated military Model 532 helicopters. EASA classified this service information as mandatory and issued Emergency AD No. 2007-0082-E, dated March 27, 2007, to correct the same unsafe condition as identified in the service information.

We estimate that this proposed AD will affect 29 helicopters of U.S. registry. We also estimate that the cost to comply with this AD is $255 per helicopter, $7,395 for the fleet, assuming three work-hours at $85 per hour to lubricate each gearbox.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

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

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

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

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

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

We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on March 20, 2012 (77 FR 16193). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2011-13-05, Amendment 39-16728 (76 FR 40222, July 8, 2011). That AD applies to Turbomeca S.A. Arriel 2B and 2B1 turboshaft engines. The NPRM published in the Federal Register on June 1, 2012 (77 FR 32437). That NPRM proposed to continue to require accomplishment of the TU166 modification on Turbomeca S.A. Arriel 2B and 2B1 turboshaft engines. That NPRM also proposed to require adding the Arriel 2S2 engine to the applicability of engines requiring the TU166 modification with a different compliance time.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal and the FAA's response to each comment.

Turbomeca S.A. requested that we add the Arriel 2C2 engine model to the proposed AD applicability. The commenter referenced European Aviation Safety Agency (EASA) AD 2012-0124, dated July 9, 2012, issued to include the Arriel 2C2 engine model requiring the TU166 modification.

We agree. We added the Arriel 2C2 engine model to the AD applicability.

Sikorsky requested that we reduce the proposed AD compliance time for Arriel 2S2 engine models to within 100-cycles-in-service (CIS), instead of 500 CIS, and, add a calendar time limitation of “but not later than September 30, 2012,” based on the EASA AD having a compliance date of November 16, 2012. The commenter believes that the frequency of occurrence of the blade ruptures, when the risk is analyzed per the FAA Advisory Circular 39-8, targeting a reasonable risk, argues for an earlier TU166 modification.

We do not agree. The risk analyzed by Sikorsky had inputs that were too conservative. We did not change the AD.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously.

Based on the service information, we estimate that this AD will affect about 551 products of U.S. registry. We also estimate that it will take about 60 work-hours per product to comply with this AD. The average labor rate is $85 per work-hour. Required parts will cost about $3,900 per product. Based on these figures, we estimate the cost of the AD on U.S. operators to be $4,959,000.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

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

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

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

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

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

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

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

We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 to supersede AD 2006-20-09, amendment 39-14778 (71 FR 57407, September 29, 2006). That AD applies to the specified products. The SNPRM published in the Federal Register on April 6, 2012 (77 FR 20743). The original NPRM (76 FR 50152, August 12, 2011) proposed to retain the requirements of AD 2006-20-09 to replace certain crankshafts and to correct the start date of MSB No. 569A from March 1, 1997 to January 1, 1997, which is the start date in Supplement No. 1 to Lycoming MSB No. 569A, dated May 27, 2009. The SNPRM proposed to add IO-390, AEIO-390, and AEIO-580 series engine models that have the affected crankshafts to the applicability of the AD. The SNPRM also proposed to change Service Instruction No. 1009AS, dated May 25, 2006, to Service Instruction No. 1009AU, dated November 18, 2009, because Lycoming updated this service instruction. The changes to Service Instruction 1009AS do not affect the engine overhaul time.

We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the proposal and the FAA's response to that comment.

A commenter asked if the AD applies to the Lycoming Engine IO-360-A3B6D. We reply that this engine is listed in Lycoming MSB No. 569A, so if the crankshaft serial number of that engine is also listed in Table 5 of MSB No. 569A, then the AD applies.

We reviewed our previous credit paragraph in the SNPRM (77 FR 20743, April 6, 2012) and found that not all the ADs and service bulletins (SBs) listed in paragraphs (f)(1) and (f)(2) of the SNPRM resolved the unsafe conditions. Accordingly, we changed the Credit for Previous Actions paragraphs, paragraphs (g)(1) and (g)(2) of this AD, retaining only Lycoming MSB No. 569A and AD 2006-20-09 (71 FR 57407, September 29, 2006) in the AD to resolve the unsafe condition and deleting all other ADs and SBs referenced in the SNPRM. Paragraphs (g)(1) and (g)(2) now read: “(1) If you previously complied with AD 2006-20-09 (71 FR 57407, September 29, 2006), no further action is required. (2) If you previously accomplished Lycoming MSB No. 569A, no further action is required.”

We reviewed the cost estimate made in AD 2006-20-09 (71 FR 57407, September 29, 2006) when we added the new affected engine models to the SNPRM (77 FR 20743, April 6, 2012). We found that the cost estimate in AD 2006-20-09 included the number of affected engines worldwide rather than those installed only on aircraft of U.S. registry. We also found that the cost estimate in AD 2006-20-09 already included the engine models that we have now added to the applicability of this AD. Accordingly, we changed the number of affected engine models from 3,774 to 2,831 and the overall cost estimate from $60,384,000 to $45,288,000.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD as proposed.

We estimate that this AD affects 2,831 engines installed on airplanes of U.S. registry. Because the AD compliance interval coincides with engine overhaul or other engine maintenance, we estimate no additional labor hours will be needed to comply with this AD. Required parts will cost about $16,000 per engine. Based on these figures, we estimate the total cost of the AD to be $45,288,000. Our estimate is independent of any possible warranty coverage.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

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

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

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

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

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

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

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

The Entity List (Supplement No. 4 to Part 744) provides notice to the public that certain exports, reexports, and transfers (in-country) to entities identified on the Entity List require a license from BIS and that the availability of license exceptions in such transactions is limited. Entities are placed on the Entity List on the basis of certain sections of part 744 (Control Policy: End-User and End-Use Based) of the EAR.

The ERC, composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, when appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List. The ERC makes all decisions to add an entry to the Entity List by majority vote and all decisions to remove or modify an entry by unanimous vote.

This rule implements the decision of the ERC to add six persons under eight entries to the Entity List on the basis of Section 744.11 (license requirements that apply to entities acting contrary to the national security or foreign policy interests of the United States) of the EAR. The eight entries, two of which are alternate addresses of two of the persons being added to the Entity List, consist of two entries in Iran and six entries in the U.A.E.

The ERC reviewed Section 744.11(b) (Criteria for revising the Entity List) in making the determination to add these persons to the Entity List. Under that paragraph, persons for which there is reasonable cause to believe, based on specific and articulable facts, that the persons have been involved, are involved, or pose a significant risk of being or becoming involved in activities that are contrary to the national security or foreign policy interests of the United States and those acting on behalf of such persons may be added to the Entity List pursuant to Section 744.11. Paragraphs (b)(1)-(b)(5) of Section 744.11 include an illustrative list of activities that could be contrary to the national security or foreign policy interests of the United States.

The six persons being added to the Entity List under this rule have been determined by the ERC to be involved in activities that are contrary to the national security or foreign policy interests of the United States. Two of the persons being added to the Entity List under this rule, Seyed Mahdi Mousavi (“Mousavi”) and his company, Seyed Mousavi Trading, are located in the U.A.E. and in Iran. BIS's investigation of Mousavi and his company, Seyed Mousavi Trading, indicates that he, individually, and by and through his company, knowingly acquired U.S.-origin items for transshipment to Iran through the U.A.E. and Hong Kong. Further, the investigation indicates that the shipments to Iran included shipments to a person on the Denied Persons List (see section 764.3(a)(2) of the EAR). Therefore, pursuant to Section 744.11(b)(5) of the EAR, the ERC determined that Mousavi and Seyed Mousavi Trading are knowingly and willfully engaging in the transshipment of U.S.-origin equipment subject to the EAR, without the required Department of Commerce or Department of the Treasury, Office of Foreign Assets Control (OFAC) export licenses, for use in Iran in violation of the embargo against Iran as specified in the Iranian Transactions Regulations (31 CFR Part 560). Iran has been designated by the Secretary of State as a country that has repeatedly provided support for acts of international terrorism. In addition, pursuant to paragraph (b) of Supplement No. 1 to Part 764 of the EAR, no person may, directly or indirectly, export or reexport any item subject to the EAR to or on behalf of a denied person.

The other four persons being added to the Entity List under this rule, Fajr Almadeena Electronics (FAE) and its owners, Alex Nouri Zadeh, Mohammad Nayeb, and Jamal Hasan are all located in the U.A.E. BIS's investigation indicates that FAE was listed as a recipient of hundreds of U.S.-origin items. Although FAE claims that the items it receives remain in the U.A.E. and that it is the end-user of record, FAE principals have not been able to provide information on the items' current location or end-use. Moreover, BIS's investigation indicates that FAE's office space is inappropriate for end-use in situ of the items shipped. Therefore, pursuant to Section 744.11(b)(4) and (b)(5) of the EAR, the ERC determined that FAE, Alex Nouri Zadeh, Mohammad Nayeb, and Jamal Hasan are unreliable recipients of U.S.-origin items and may be diverting such items through the U.A.E. to Iran, without the required Department of Commerce or OFAC export licenses, for use in Iran in violation of the embargo against Iran as specified in the Iranian Transactions Regulations (31 CFR Part 560). As noted above, Iran has been designated by the Secretary of State as a country that has repeatedly provided support for acts of international terrorism.

For all eight entries for the six persons being added to the Entity List, the ERC specified a license requirement for all items subject to the EAR and established a license application review policy of a presumption of denial. The license requirement applies to any transaction in which items are to be exported, reexported, or transferred (in-country) to such persons or in which such persons act as purchaser, intermediate consignee, ultimate consignee, or end-user. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to those persons being added to the Entity List.

This final rule adds the following six persons under eight entries to the Entity List:

(1) Seyed Mahdi Mousavi, BLK 6, No. 12 Beside Gilan Street, Rodstar Street, Under Hafez Bridge, Tehran, Iran; and No. 10-6th Floor Iranian Trade Center, Valiasr Square, Tehran, Iran (See alternate addresses under U.A.E.); and

(2) Seyed Mousavi Trading, a.k.a., the following two aliases:

(1) Alex Nouri Zadeh, a.k.a. the following three aliases:

(2) Fajr Almadeena Electronics, No. 102 and 106, 1st Floor, K5 Entrance, Alshami Rest. Bldg., Al Muraqqabat Rd., Deira, Dubai, 184609 U.A.E.; and P.O. Box 184607, Dubai, U.A.E.

(3) Jamal Hasan, a.k.a. the following alias:

(4) Mohammad Nayeb, No. 102 and 106, 1st Floor, K5 Entrance, Alshami Rest. Bldg., Al Muraqqabat Rd., Deira, Dubai, 184609 U.A.E.; and P.O. Box 184607, Dubai, U.A.E.

(5) Seyed Mahdi Mousavi, P.O. Box 49465, Dubai, U.A.E.; and, P.O. Box 7941, Dubai, U.A.E. (See alternate addresses under Iran); and

(6) Seyed Mousavi Trading, a.k.a., the following two aliases:

This rule implements a decision of the ERC to remove one person, Raaziq International (Pvt.) Ltd., located in Pakistan, from the Entity List as a result of the person's request for removal from the Entity List. Based upon the review of the information provided in the removal request in accordance with section 744.16 (Procedure for requesting removal or modification of an Entity List entity), and after review by the ERC's member agencies, the ERC determined that this person should be removed from the Entity List.

The ERC decision to remove this person took into account this person's cooperation with the U.S. Government, as well as this person's assurances of future compliance with the EAR. In accordance with section 744.16(c), the Deputy Assistant Secretary for Export Administration has sent written notification to this person, informing this entity of the ERC's decision to remove it from the Entity List. This final rule implements the decision to remove the following person located in Pakistan from the Entity List:

(1) Raaziq International (Pvt.) Ltd., House Number 32, F-2, Khusal Khan Khattak Road, University Town, Peshawar, Pakistan.

This rule also amends the Entity List on the basis of the annual review of the Entity List conducted by the ERC, in accordance with the procedures outlined in Supplement No. 5 to part 744 (Procedures for End-User Review Committee Entity List Decisions). The changes from the annual review of the Entity List that are approved by the ERC are implemented in stages as the ERC completes its review of entities listed under different destinations on the Entity List. This rule implements the results of the annual review for entities located in Belarus, China, Egypt, Hong Kong, Kuwait, Malaysia, Pakistan, Singapore and South Africa. The entities located in Canada, Germany, Ireland, Israel, Lebanon, Taiwan, and the United Kingdom were also reviewed by the ERC, but no additional changes are being made to those entries as a result of the annual review of the Entity List.

This rule removes fourteen entries from the Entity List on the basis of the annual review of the Entity List. The persons removed were determined to no longer meet the criteria for inclusion on the Entity List. Specifically, this rule implements the decision of the ERC to remove one person located in China, three persons located in Egypt, eight persons located in Hong Kong, and two persons located in Kuwait, as follows:

(1) Tracy Little, Room 1104, North Tower Yueziu City Plaza, No. 445 Dong Feng Zhong Rd., Guangzhou, China.

(1) H Logic, Behind 14 Mahmoud Sedky St., El Ekbal, Alexandria, Egypt; and 11 Abd El-Hamid Shoman St., Nasser City, Cairo;

(2) Hesham Yehia, Behind 14 Mahmoud Sedky St., El Ekbal, Alexandria, Egypt; and

(3) Najeeb Al Awadhi, 14 Mahmoud Sedky St., El Ekbal, Alexandria, Egypt.

(1) Amy So, Room 1701, New Commerce Centre, 19 On Sum St., Siu Lek Yuen, Shatin, N.T., Hong Kong;

(2) Frank Lam, 1206-7, 12/F New Victory House, Hong Kong;

(3) Gary Chan, 4/F, Chinabest International Centre, 8 Kwai On Rd., Kwai Chung, N.T., Hong Kong;

(4) Green Channel Electronics Company, Unit 902, Ricky Center, 36 Chong Yip St., Kwun Tong, Kowloon, Hong Kong;

(5) Techlink Electronics, Unit 5, 18/F, Laurels Industrial Centre, 32 Tai Yau St., San Po Kong, Kowloon, Hong Kong;

(6) TLG Electronics, Room 1701, New Commerce Centre, 19 On Sum St., Siu Lek Yuen, Shatin, N.T., Hong Kong;

(7) Unite Chance Technology Company, Workshop A14, 5/F, Block A Sheung Shui Plaza, 3 Ka Fu Close Sheung Shui, N.T., Hong Kong; and

(8) Wing Shing Computer Components Company (H.K.) Ltd., Unit E, 9/F, Lladro Centre, 72 Hoi Yuen Rd., Kwon Tong, Kin, Hong Kong.

(1) Advanced Technology General Trading Company, Hawalli, Bin Khaldoun St., Fadhalah Complex, Mizzanin, Office #4, P.O. Box 22682, Safat, 13087, Kuwait. (See alternate address under U.A.E.); and

(2) Abubakr Abuelazm, Hawalli, Bin Khaldoun St., Fadhalah Complex, Mizzanin, Office #4, P.O. Box 22682, Safat, 13087, Kuwait (See alternate address under U.A.E.).

The two entities removed from Kuwait are also listed in the U.A.E.; BIS is not removing the two U.A.E. listings from the Entity List at this time. The ERC will evaluate those entries as part of the annual review of the entities located in the U.A.E. The removal of the above-referenced fourteen entities on the basis of annual review of the Entity List, and the removal of the one entity referenced above on the basis of a Section 744.16 removal request that was approved by the ERC, eliminates the existing license requirements in Supplement No. 4 to part 744 for exports, reexports and transfers (in-country) to these fifteen entities. However, the removal of these fifteen entities from the Entity List does not relieve persons of other obligations under part 744 of the EAR or under other parts of the EAR. Neither the removal of an entity from the Entity List nor the removal of Entity List-based license requirements relieves persons of their obligations under General Prohibition 5 in section 736.2(b)(5) of the EAR which provides that, “you may not, without a license, knowingly export or reexport any item subject to the EAR to an end-user or end-use that is prohibited by part 744 of the EAR.” Additionally these removals do not relieve persons of their obligation to apply for export, reexport or in-country transfer licenses required by other provisions of the EAR. BIS strongly urges the use of Supplement No. 3 to part 732 of the EAR, “BIS's `Know Your Customer' Guidance and Red Flags,” when persons are involved in transactions that are subject to the EAR.

On the basis of decisions made by the ERC during the annual review, in addition to the removals described above, this rule amends thirty-six entries currently on the Entity List. The amended entries consist of three entries under Belarus, twelve entries under China, three entries under Malaysia, twelve entries under Pakistan, one entry under Singapore, and five entries under South Africa. The amendments clarify the relationship between listed persons and/or provide alternate addresses, alternate spellings and acronyms and/or aliases for the names of the listed persons, as follows:

(1) Belmicrosystems Research and Design Center, Office 313, 12 Korzhenevsky Street, 20108 Minsk, Republic of Belarus; and Korjenevsky Str., 12, Minsk, 220108, Republic of Belarus; and 12, Korzhenevskogo Str., Minsk, 220108, Republic of Belarus;

(2) SOE Semiconductor Devices Factory, Office 313, 12 Korzhenevsky Street, 20108 Minsk, Republic of Belarus; and Korjenevsky Str., 12, Minsk, 220108, Republic of Belarus; and 12, Korzhenevskogo Str., Minsk, 220108, Republic of Belarus; and

(3) Vasili Kuntsevich, Office 313, 12 Korzhenevsky Street, 20108 Minsk, Republic of Belarus; and Korjenevsky Str., 12, Minsk, 220108, Republic of Belarus; and 12, Korzhenevskogo Str., Minsk, 220108, Republic of Belarus.

(1) 33 Institute, a.k.a., the following three aliases:

(2) 35 Institute, a.k.a., the following four aliases:

(3) 54th Research Institute of China, a.k.a., the following three aliases:

(4) Beijing Aerospace Automatic Control Institute (BICD), a.k.a., the following four aliases:

(5) Chinese Academy of Engineering Physics, a.k.a., the following seventeen aliases:

(6) First Department, Chinese Academy of Launch Vehicle Technology (CALT), a.k.a., the following three aliases:

Background

Pursuant to the provisions of the 1970 UNESCO Convention, codified into U.S. law as the Convention on Cultural Property Implementation Act (hereafter, the “Cultural Property Implementation Act” or the “Act”) (Pub. L. 97-446, 19 U.S.C. 2601 et seq. ), signatory nations (State Parties) may enter into bilateral or multilateral agreements to impose import restrictions on eligible archaeological and ethnological materials under procedures and requirements prescribed by the Act. Under the Act and applicable CBP regulations (19 CFR 12.104g), the restrictions are effective for no more than five years beginning on the date on which the agreement enters into force with respect to the United States (19 U.S.C. 2602(b)). This period may be extended for additional periods, each such period not to exceed five years, where it is determined that the factors justifying the initial agreement still pertain and no cause for suspension of the agreement exists (19 U.S.C. 2602(e); 19 CFR 12.104g(a)).

In certain limited circumstances, the Cultural Property Implementation Act authorizes the imposition of restrictions on an emergency basis (19 U.S.C. 2603(c)(1)). Under the Act and applicable CBP regulations (19 CFR 12.104g(b)), emergency restrictions are effective for no more than five years from the date of the State Party's request and may be extended for three years where it is determined that the emergency condition continues to apply with respect to the covered materials (19 U.S.C. 2603(c)(3)).

On September 23, 1993, under the authority of the Cultural Property Implementation Act, the former U.S. Customs Service published Treasury Decision (T.D.) 93-74 in the Federal Register (58 FR 49428) imposing emergency import restrictions on archaeological objects from the region of the Niger River Valley of Mali and the Bandiagara Escarpment (Cliff), Mali and accordingly amending 19 CFR 12.104g(b).

On September 19, 1997, the United States entered into a bilateral agreement with Mali that continued without interruption the import restrictions previously placed on the same archaeological material. On September 23, 1997, the former United States Customs Service published T.D. 97-80 in the Federal Register (62 FR 49594), which amended 19 CFR 12.104g(a) to reflect the imposition of these restrictions, and included a list designating the types of archaeological material covered by the restrictions.

Import restrictions listed in 19 CFR 12.104g(a) are “effective for no more than five years beginning on the date on which the agreement enters into force with respect to the United States. This period can be extended for additional periods not to exceed five years if it is determined that the factors which justified the initial agreement still pertain and no cause for suspension of the agreement exists” (19 CFR 12.104g(a)).

On September 20, 2002, the former United States Customs Service published T.D. 02-55 in the Federal Register (67 FR 59159), which amended 19 CFR 12.104g(a) to reflect the extension of these import restrictions for an additional period of five years until September 19, 2007.

On September 19, 2007, CBP published CBP Dec. 07-77 in the Federal Register (72 FR 53414), which amended 19 CFR 12.104g(a) to reflect the extension of the import restrictions on this cultural property and the addition of new subcategories of objects representing a broader time frame in the amended Designated List for an additional period of five years until September 19, 2012. Accordingly, the title of the bilateral agreement was amended at this time to read: “Agreement between the Government of the United States of America and the Government of the Republic of Mali Concerning the Imposition of Import Restrictions on Archaeological Material from Mali from the Paleolithic Era (Stone Age) to Approximately the Mid-Eighteenth Century.”

On March 12, 2012, the Department of State proposed in the Federal Register (77 FR 14583) to extend the Agreement. Upon review of the findings and recommendations of the Cultural Property Advisory Committee, the Assistant Secretary for Educational and Cultural Affairs, Department of State, made the necessary determinations on July 20, 2012 for extending the Agreement with Mali to continue the imposition of import restrictions on the aforementioned categories of archaeological material for an additional five-year period. An exchange of diplomatic notes reflects the extension of those restrictions. Accordingly, CBP is amending 19 CFR 12.104g(a) to reflect the extension of the import restrictions.

The Designated List of Archaeological Material from Mali covered by these import restrictions is set forth in CBP Dec. 07-77, see 72 FR 53414 dated September 19, 2007. More information on import restrictions can be obtained from the Mali country section of the International Cultural Property Protection Web site ( http://exchanges.state.gov/heritage/culprop/mlfact.html ).

The restrictions on the importation of these archaeological materials from Mali are to continue in effect through September 19, 2017. Importation of such materials continues to be restricted unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met.

This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure (5 U.S.C. 553(a)(1)). For the same reasons, pursuant to 5 U.S.C. 553(d)(3), a delayed effective date is not required.

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply.

Because this rule involves a foreign affairs function of the United States, it is not subject to Executive Order 12866.

This regulation is being issued in accordance with 19 CFR 0.1(a)(1).

For the reasons set forth above, part 12 of Title 19 of the Code of Federal Regulations (19 CFR part 12), is amended as set forth below:

FDA has noticed that the animal drug regulations for certain monensin free-choice Type C medicated feeds for growing cattle on pasture or in dry lot (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers) reflect a warning statement regarding the overdosing risk posed by uneaten free-choice feeds (refusals) that is unnecessary and not required on product labeling.

Refusals of free-choice cattle feeds, including compressed blocks, granules, and liquids, are unlikely in practice to be fed to another group of cattle. These products are used almost exclusively in pasture-based systems where the product is placed in the pasture with the animals and is left until consumed. In addition, it is extremely unlikely that these free-choice cattle feeds would be fed to another production class because these products generally are not appropriate for the nutritional needs of another production class.

For these reasons, FDA is revising the regulations to exclude monensin free-choice Type C medicated feeds for growing cattle on pasture or in dry lot from the requirement to include a warning statement. This action is being taken to improve the accuracy of the regulations.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and 558 are amended as follows:

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Montana program on April 1, 1980. You can find background information on the Montana program, including the Secretary's findings, the disposition of comments, and conditions of approval in the April 1, 1980, Federal Register (45 FR 21560). You can also find later actions concerning Montana's program and program amendments at 30 CFR 926.15 and 926.30.

By letter dated August 19, 2011, Montana sent us an amendment to its program (Administrative Record No. MT-31-01) under SMCRA (30 U.S.C. 1201 et seq. ). Montana submitted the amendment at its own initiative.

We announced receipt of the proposed amendment in the December 6, 2011, Federal Register (76 FR 76111; Administrative Record No. MT-31-10). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the amendment's adequacy. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on January 5, 2012. We received comments from two Federal agencies, one State agency, and one industry group.

Following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment.

Montana proposed recodification changes to its statutory definitions. MCA § 82-4-203(27) through (56) have been recodified as MCA § 82-4-203(28) through (58). The addition of two new definitions (discussed below) necessitated these changes. These non-substantive changes do not alter the definitions' meaning or effectiveness.

Because these changes are minor, we find the provisions remain no less stringent than SMCRA.

Montana proposed revisions to its statutory definition of Approximate Original Contour (AOC). The existing definition contained language similar to the Federal definition of AOC as well as additional stipulations. Montana proposed to reference its definition of “hydrologic balance” within its existing AOC definition. The Federal counterpart definition does not employ the term hydrologic balance.

The proposed addition has no effect beyond referring the reader to the definition of an existing term. This addition does not alter the definition's meaning or effectiveness. This definition remains no less stringent than SMCRA.

Montana proposed two new definitions which do not have Federal counterparts under SMCRA: “in situ coal gasification” and “recovery fluid.”

Montana proposed to define “in situ coal gasification” whereas SMCRA defines “in situ processing.” The Federal definition lists in situ gasification as one type of in situ processing. Montana is proposing to define a subset of what the Federal Program defines. Montana's proposed language directly mirrors Wyoming's existing definition of “in situ mining.” Wyoming's definition was approved on March 31, 1980 (45 FR 20930), under the partial approval of its original program. That approval set precedent for the definition Montana recently proposed.

Montana's proposed definition excludes “the storage of carbon dioxide in a geologic storage reservoir” from inclusion under in situ coal gasification. This phrase precludes in situ gasification projects from including carbon capture and sequestration (CCS) under the Montana coal regulatory program.

Montana Senate Bill 498 (SB498) designated the Board of Oil and Gas Conservation as the regulatory authority for CCS activities within the State. SB498 generally established that land surface owners own the pore space below the surface unless it is otherwise documented. As such, the Board would regulate any proposed CCS activities appropriately. CCS operations have potential environmental impacts such as groundwater contamination which, by exclusion from regulation under in situ coal gasification, would be avoided under Montana's coal regulatory program (CCS would invoke a separate regulatory scheme). For this reason, excluding CCS from in situ coal gasification is more stringent than the Federal Program because the Federal Program does not address this issue at all.

Montana's new definition provides a technically accurate description of in situ coal gasification. Because there is precedent for Montana's proposed definition, the proposed language exceeds what is defined or restricted under the Federal program, and the definition is technically accurate, this addition is no less stringent than SMCRA.

Montana proposed to define “recovery fluid.” The Federal Program does not define this term; however, the Wyoming program approved by OSM on March 31, 1980 (45 FR 20930) defines this term. That approval set precedent for the definition Montana recently proposed. Montana's new definition provides a technically accurate description of recovery fluid. Because there is precedent for Montana's proposed definition, the proposed language is technically accurate, and Montana exceeds what is defined under the Federal program, this addition is no less stringent than SMCRA.

We are approving all of Montana's August 19, 2011 proposed amendments.

We asked for public comments on the amendment (Administrative Record ID No. MT-31-10), but did not receive any.

Under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Montana program (Administrative Record ID No. MT-31-3).

By letter dated November 1, 2011, the Mine Safety and Health Administration (MSHA) responded to our request (Administrative Record ID No. MT-31-08). MSHA concurs with the proposed revisions. We agree with MSHA that the proposed revisions are acceptable.

By letter dated November 1, 2011, the Bureau of Land Management (BLM) Montana State Office responded to our request (Administrative Record ID No. MT-31-09). The BLM stated that the proposed changes appear to be substantially in agreement with the corresponding Federal regulations and are therefore no less stringent than SMCRA. The BLM has no objection to the proposed amendments. We agree with BLM's assessment.

Under 30 CFR 732.17(h)(11)(ii), we are required to obtain concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Montana proposed to make in this amendment pertains to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment.

Under 30 CFR 732.17(h)(11)(i), OSM requested comments on the amendment from EPA (Administrative Record Document ID No. MT-31-3) by letter dated September 28, 2011. EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On September 28, 2011, we requested comments on Montana's amendment (Administrative Record ID Nos. MT-31-4 and MT-31-5). By letter dated September 26, 2011, the SHPO responded to our request (Administrative Record ID No. MT-31-07). The SHPO believes the proposed changes do not appear to degrade consideration of cultural resources in any less effective fashion than required in Federal regulations. We agree with the SHPO's assessment.

Based on the above findings, we approve Montana's August 19, 2011 amendment. To implement this decision, we are amending the Federal regulations at 30 CFR Part 926, which codify decisions concerning the Montana program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrates that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this regulation effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866 (Regulatory Planning and Review).

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally recognized Indian Tribes and have determined that the rule does not have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal government and Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes. The rule does not involve or affect Indian Tribes in any way.

On May 18, 2001, the President issued Executive Order 13211, which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C) et seq. ).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), of the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million.

b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the federal regulation did not impose an unfunded mandate.

For the reasons set out in the preamble, 30 CFR part 926 is amended as set forth below:

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Texas program effective February 16, 1980. You can find background information on the Texas program, including the Secretary's findings, the disposition of comments, and the conditions of approval, in the February 27, 1980, Federal Register (45 FR 12998). You can find later actions on the Texas program at 30 CFR 943.10, 943.15, and 943.16.

By letter dated February 9, 2012 (Administrative Record No. TX-700), Texas sent us an amendment to its program under SMCRA (30 U.S.C. 1201 et seq.). Texas sent the amendment on its own initiative.

We announced receipt of the proposed amendment in the March 28, 2012, Federal Register (77 FR 18738). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on April 27, 2012. We did not receive any public comments.

The following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment as described below.

Texas proposed to revise its regulations at 16 TAC sections 12.108(b)(1)-(3), adjusting the annual coal mining permit fees for calendar year 2011 and 2012. Fees for mining activity during calendar year 2011 must be paid by coal mine operations by March 15, 2012, which is in Texas' 2012 fiscal year. Similarly, fees for mining activity during calendar year 2012 are due by March 15, 2013, which is in Texas' 2013 fiscal year.

By this amendment, Texas is:

(1) Increasing the current $130.00 per acre fee to $154.00 per acre, the amount in paragraph (b)(1) for each acre of land within the permit area on which coal or lignite was actually removed during the calendar year;

(2) Increasing the current $5.50 per acre fee to $10.40 per acre, the amount in paragraph (b)(2) for each acre of land within a permit area covered by a reclamation bond on December 31st of the year; and

(3) Increasing the current $4,250.00 fee to $6,900.00, the amount in paragraph (b)(3) for each permit in effect on December 31st of the year.

The Federal regulations at 30 CFR 777.17, concerning permit fees, provide that applications for surface coal mining permits must be accompanied by a fee determined by the regulatory authority. The Federal regulations also provide that the fees may be less than, but not more than, the actual or anticipated cost of reviewing, administering, and enforcing the permit.

Texas' amendment describes how Texas funds its coal mining regulatory program. Texas operates on a biennial budget which appropriates general revenue funds for permitting and inspecting coal mining facilities within the state. This appropriation is contingent on the Railroad Commission of Texas (Commission) assessing fees sufficient to generate revenue to recover the general revenue appropriation. When calculating anticipated costs to the Commission for regulating coal mining activity, Texas anticipates OSM providing grant funding for regulatory program costs based on section 705(a) of SMCRA. Historically, Texas has estimated that OSM would fund 50% of the regulatory program costs. However, OSM does not agree that this is a reasonable expectation in light of the Administration's proposed fiscal year 2013 budget which reduces overall funding to states, and may result in them receiving less than fifty percent of their anticipated regulatory program costs, consistent with Section 705 of SMCRA.

Texas adjusts its fees biennially to recover the amounts expended from state appropriations in accordance with a formula and schedule agreed to in 2005 by the coal mining industry and the Commission. This amendment represents the fourth adjustment to surface mining fees based upon that agreement. Adjustments are expected to continue for a ten year period that began in 2005.

We find that Texas' fee changes are consistent with the discretionary authority provided by the Federal regulation at 30 CFR 777.17. Therefore, OSM approves Texas' proposed permit fees, recognizing that Texas has a process to adjust its fees to cover the cost of its regulatory program not covered by the Federal grant.

We asked for public comments on the amendment, but did not receive any.

On February 28, 2012, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Texas program (Administrative Record No. TX-700.1). We did not receive any comments.

Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Texas proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment. However, on February 28, 2012, under 30 CFR 732.17(h)(11)(i), we requested comments from the EPA on the amendment (Administrative Record No. TX-700.1). The EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On February 28, 2012, we requested comments on Texas' amendment (Administrative Record No. TX-700.1), but neither the SHPO nor ACHP responded to our request.

Based on the above findings, we approve the amendment Texas sent us on February 9, 2012 (Administrative Record No. TX-700).

To implement this decision, we are amending the Federal regulations at 30 CFR Part 943 that codify decisions concerning the Texas program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this rule effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally-recognized Indian tribes and have determined that the rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. The basis for this determination is that our decision is on a State regulatory program and does not involve Federal regulations involving Indian lands.

On May 18, 2001, the President issued Executive Order 13211, which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). The State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.

For the reasons set out in the preamble, 30 CFR part 943 is amended as set forth below:

EPA is taking final action to approve portions of Florida's March 15, 2012, SIP revision to adopt federal NSR permitting requirements. Florida's March 15, 2012, SIP revision includes changes to the Florida Administrative Code (F.A.C.) Chapter 62-210, Stationary Sources—General Requirements, Section 200—Definitions (rule 62-210.200), and Chapter 62-212, F.A.C., Stationary Sources—Preconstruction Review, Section 300—General Preconstruction Review Requirements (rule 62-212.300) and Section 400—Prevention of Significant Deterioration (rule 62-212.400). These changes adopt federal PSD permitting regulations promulgated in the final rulemakings entitled “Implementation of the New Source Review (NSR) Program for Particulate Matter Less than 2.5 Micrometers (PM 2.5 ),” 73 FR 28321 (May 16, 2008), hereafter referred to as the “NSR PM 2.5 Rule” and “Prevention of Significant Deterioration (PSD) for Particulate Matter Less Than 2.5 Micrometers (PM 2.5 )—Increments, Significant Impact Levels (SILs) and Significant Monitoring Concentration (SMC),” 75 FR 64864 (October 20, 2010), hereafter referred to as the “PM 2.5 PSD Increment-SILs-SMC Rule.” EPA is not approving in this action Florida's incorporation into its SIP of the SIL thresholds and provisions promulgated in EPA's PM 2.5 PSD Increment-SILs-SMC Rule.

On July 27, 2012, EPA published a proposed rulemaking to approve the aforementioned changes to Florida's NSR PSD program. See 77 FR 44198. Comments on the proposed rulemaking were due on or before August 27, 2012. No comments, adverse or otherwise, were received on EPA's July 27, 2012 proposed rulemaking. Pursuant to section 110 of the CAA, EPA is now taking final action to approve the changes to Florida's NSR PSD program as provided in EPA's July 27, 2012, proposed rulemaking. A summary of the background for today's final action is provided below. EPA's July 27, 2012, proposed rulemaking contains more detailed information regarding the Florida SIP revision being approved today and the rationale for today's final action. Detailed information regarding the PM 2.5 NAAQS and NSR Program can also be found in EPA's July 27, 2012, proposed rulemaking as well as the abovementioned final rulemakings.

EPA finalized the NSR PM 2.5 Rule on May 16, 2008, which revised the NSR program requirements to establish the framework for implementing preconstruction permit review for the PM 2.5 NAAQS in both attainment areas and nonattainment areas (NAA) that: (1) Require NSR permits to address directly emitted PM 2.5 and precursor pollutants; (2) establish significant emission rates for direct PM 2.5 and precursor pollutants (including sulfur dioxide (SO 2 ) and nitrogen oxides (NO X )); (3) establish PM 2.5 emission offsets; (4) provide exceptions to the grandfathering policy for permits being reviewed under the PM 10 surrogate program; and (5) require states to account for gases that condense to form particles (condensables) in PM 2.5 and PM 10 emission limits in PSD or nonattainment NSR (NNSR) permits. Additionally, the NSR PM 2.5 Rule authorized states to adopt provisions in their NNSR rules that would allow interpollutant offset trading. See 73 FR 28321. States were required to provide SIP submissions to address the requirements for the NSR PM 2.5 Rule by May 16, 2011. Florida's March 15, 2012, SIP revision addresses only the PSD requirements related to EPA's May 16, 2008, NSR PM 2.5 Rule. 1

In the NSR PM 2.5 Rule, EPA required that major stationary sources seeking permits must begin directly satisfying the PM 2.5 requirements, as of the effective date of the rule, rather than relying on PM 10 as a surrogate, with two exceptions. 2 The first exception is a “grandfathering” provision in the federal PSD program at 40 CFR 52.21(i)(1)(xi). This grandfathering provision applied to sources that had applied for, but had not yet received, a final and effective PSD permit before the July 15, 2008, effective date of the May 2008 final rule. The second exception was that states with SIP-approved PSD programs could continue to implement the Seitz Memo's PM 10 Surrogate Policy for up to three years (until May 2011) or until the individual revised state PSD programs for PM 2.5 are approved by EPA, whichever comes first. On May 18, 2011 (76 FR 28646), EPA took final action to repeal the grandfathering provision at 40 CFR 52.21(i)(1)(xi). This final action ended the use of the 1997 PM 10 Surrogate Policy for PSD permits under the federal PSD program at 40 CFR 52.21. In effect, any PSD permit applicant previously covered by the grandfathering provision (for sources that completed and submitted a permit application before July 15, 2008)  3 that did not have a final and effective PSD permit before the effective date of the repeal will not be able to rely on the 1997 PM 10 Surrogate Policy to satisfy the PSD requirements for PM 2.5 unless the application includes a valid surrogacy demonstration. 4 See 76 FR 28646. In its March 15, 2012, SIP revision, Florida did not adopt the grandfathering provision at 40 CFR 52.21(i)(1)(xi) into its PSD regulations. Therefore, Florida's SIP is consistent with current federal regulations regarding the repeal of the grandfathering provision.

In the NSR PM 2.5 Rule, EPA revised the definition of “ regulated NSR pollutant ” for PSD to add a paragraph providing that “particulate matter (PM) emissions, PM 2.5 emissions and PM 10 emissions” shall include gaseous emissions from a source or activity which condense to form particulate matter at ambient temperatures and that on or after January 1, 2011, such condensable particulate matter shall be accounted for in applicability determinations and in establishing emissions limitations for PM, PM 2.5 and PM 10 in permits issued. See 40 CFR 51.166(b)(49)(vi), 52.21(b)(50)(vi) and “Emissions Offset Interpretative Ruling” (40 CFR part 51, appendix S). On March 16, 2012, EPA proposed a rulemaking to amend the definition of “ regulated NSR pollutant” promulgated in the NSR PM 2.5 Rule regarding the PM condensable provision at 40 CFR 51.166(b)(49)(vi), 52.21(b)(50)(i) and EPA's Emissions Offset Interpretative Ruling. See 77 FR 15656. The rulemaking proposes to remove the inadvertent requirement in the NSR PM 2.5 Rule that the measurement of condensable “particulate matter emissions” be included as part of the measurement and regulation of “particulate matter emissions.”  5

The PM 2.5 PSD Increment-SILs-SMC Rule provided additional regulatory requirements under the PSD program regarding the implementation of the PM 2.5 NAAQS for NSR including: (1) PM 2.5 increments pursuant to section 166(a) of the CAA to prevent significant deterioration of air quality in areas meeting the NAAQS; (2) SILs used as a screening tool (by a major source subject to PSD) to evaluate the impact a proposed major source or modification may have on the NAAQS or PSD increment; and (3) a SMC, (also a screening tool) used by a major source subject to PSD to determine the subsequent level of PM 2.5 data gathering required for a PSD permit application. The SILs and SMC are numerical values that represent thresholds of insignificant, i.e., de minimis, 6 modeled source impacts or monitored (ambient) concentrations, respectively. EPA established such values to be used as screening tools by a major source subject to PSD to determine the subsequent level of analysis and data gathering required for a PSD permit application for emissions of PM 2.5 . EPA's authority to implement the SILs and SMC for PSD purposes has been challenged by the Sierra Club. Sierra Club v. EPA, Case No. 10-1413 (DC Circuit Court). 7

PSD increments prevent air quality in clean areas from deteriorating to the level set by the NAAQS. Therefore, an increment is the mechanism used to estimate “significant deterioration”  8 of air quality for a pollutant in an area. Under section 165(a)(3) of the CAA, a PSD permit applicant must demonstrate that emissions from the proposed construction and operation of a facility “will not cause, or contribute to, air pollution in excess of any maximum allowable increase or allowable concentration for any pollutant.” When a source applies for a permit to emit a regulated pollutant in an area that meets the NAAQS, the state and EPA must determine if emissions of the regulated pollutant from the source will cause significant deterioration in air quality. As described in the PM 2.5 PSD Increment-SILs-SMC Rule, pursuant to the authority under section 166(a) of the CAA, EPA promulgated numerical PSD increments for PM 2.5 as a new pollutant  9 for which NAAQS were established after August 7, 1977, 10 and derived 24-hour and annual PM 2.5 increments for the three area classifications (Class I, II and III) using the “contingent safe harbor” approach. See 75 FR 64869 and the ambient air increment tables at 40 CFR 51.166(c)(1) and 52.21(c). In addition to PSD increments for the PM 2.5 NAAQS, the PM 2.5 PSD Increment-SILs-SMC Rule amended the definition at 40 CFR 51.166 and 52.21 for “ major source baseline date ” and “ minor source baseline date ” (including trigger date) to establish the PM 2.5 NAAQS specific dates associated with the implementation of PM 2.5 PSD increments. See 75 FR 64864.

As mentioned above, the SMC numerical value represents a threshold of insignificant (i.e., de minimis ) monitored ambient impacts on pollutant concentrations. In the PM 2.5 PSD Increment-SILs-SMC Rule, EPA established a PM 2.5 SMC of 4 µg/m 3 to be used as a screening tool by a major source subject to PSD to determine the subsequent level of PM 2.5 data gathering required for a PSD permit application. Using the SMC as a screening tool, sources may be able to demonstrate that the modeled air quality impact of emissions from the new source or modification, or the existing air quality level in the area where the source would construct, is less than the SMC (i.e., de minimis ), and as such, may be allowed to forego the preconstruction monitoring requirement for a particular pollutant at the discretion of the reviewing authority.

Recently, the Sierra Club filed suit challenging EPA's authority to implement the PM 2.5 SILs  11 as well as the SMC for PSD purposes as promulgated in the October 20, 2012, rule. Sierra Club v. EPA, Case No 10-1413, DC Circuit Court. Specifically, regarding the SMC, Sierra Club claims that the use of SMCs to exempt a source from submitting a year's worth of monitoring data is inconsistent with the CAA. EPA responded to Sierra Club's claims in a Brief dated April 6, 2012, which describes the Agency's authority to develop and promulgate SMC. 12 A copy of EPA's April 6, 2010, Brief can be found in the docket for today's final rulemaking at www.regulations.gov using docket ID: EPA-R04-OAR-2012-0555.

EPA is taking final action to approve into the Florida SIP portions of the State's March 15, 2012, SIP revision to adopt the PSD permitting regulations to implement the PM 2.5 NAAQS including the NSR PM 2.5 and PM 2.5 Increment-SILs-SMC Rules. FDEP's PSD program definitions and preconstruction permitting rules are found at rule 62-210.200, F.A.C., and rules 62-212.300 through 62-212.400, F.A.C., respectively and apply to major stationary sources or modifications constructed in areas designated attainment or unclassifiable/attainment as required under part C of title I of the CAA with respect to the NAAQS. These changes to Florida's rules became state effective on March 28, 2012. FDEP's SIP revision adopts the NSR PM 2.5 Rule PSD provisions including: (1) The requirement for NSR permits to address directly emitted PM 2.5 and precursor pollutants; (2) the amendment establishing significant emission rates for direct PM 2.5 and precursor pollutants (SO 2 and NO X ) and recognizing PM 2.5 precursors for the definition of “ significant emission rates ” (at rule 62-21.200(282)) (as amended at 40 CFR 51.166(b)(23)(i)); and (3) the PSD requirement for states to address condensable PM in establishing enforceable emission limits for PM 10 and PM 2.5 (at 62-212.300(1)(f)) as promulgated at 40 CFR 51.166(b)(49). Additionally, Florida's March 15, 2012, SIP revision did not adopt the grandfathering provision at 40 CFR 52.21(i)(1)(xi) in accordance with the repeal of the PM 2.5 grandfathering provision.

Regarding the condensable provision and EPA's intent to amend the definition of “regulated NSR pollutant” as discussed in the March 16, 2012, correction rulemaking, Florida's March 15, 2012, SIP revision did not adopt the term “particulate matter emissions” regarding the requirement to consider condensables as promulgated in the NSR PM 2.5 Rule. See 77 FR 15656. As mentioned above, EPA is taking final action to approve into the Florida SIP the remaining condensable requirement at 40 CFR 51.166(b)(49)(vi), which requires that condensable emissions be accounted for in applicability determinations and in establishing emissions limitations for PM 2.5 and PM 10. Florida's March 15, 2012, SIP revision added definitions for “ condensable PM 10 ” at 62-210.200(94), “ condensable PM 2.5 ” at 62-210-200(95) and “ condensable PM” at 62-210.200(93), for clarification purposes. EPA is taking final action to approve the aforementioned changes into the Florida SIP.

With respect to the PM 2.5 PSD Increment-SILs SMC Rule, EPA is taking final action to also approve into the Florida SIP the PSD increments for PM 2.5 annual and 24-hour NAAQS pursuant to section 166(a) of the CAA and SMC of 4 µg/m 3 for PM 2.5 NAAQS. The March 15, 2012, SIP revision: (1) Revises the definition for “ maximum allowable increase” to incorporate by reference (IBR) the PM 2.5 PSD increments numerical values (established in the ambient air increment tables at 40 CFR 51.166(c)(1) and 52.21(c) at 62-204.800, F.A.C. 13 ); (2) amends the definitions for “ major source baseline date” and “ minor source baseline date” to establish relevant dates for PM 2.5 increment consumption and establish trigger dates (as established at 40 CFR 51.166(b)(14)(i)(c) and 51.166(b)(14)(ii)(c) respectively) and; (3) revises the definition for “ baseline area” as promulgated at 40 CFR 51.166(b)(15)(i) and (ii) and adds definitions for “baseline concentration.” The March 15, 2012, SIP submission also adds definitions for “ Class I Area” and “ Class II Area” at Chapter 62-210.200(77) and (78), F.A.C., respectively. The definition for Class I Area IBR 40 CFR part 81, Subpart D (the federal Class I Area list) at rule 62-204.800, F.A.C.

Regarding the SILs and SMC, EPA's authority to implement the PM 2.5 SILs and SMC is currently the subject of litigation by the Sierra Club. In a brief filed in the DC Circuit on April 6, 2012, EPA described the Agency's authority under the CAA to promulgate and implement the SMCs and SILs de minimis thresholds. Sierra Club v. EPA, Case No 10-1413 DC Circuit. However, EPA is finalizing approval of the promulgated SMC thresholds into the Florida SIP (at rule 62-212.400(3)(e)1, F.A.C.) because the Agency believes the SMC is a valid exercise of the Agency's de minimis authority as well as the fact they are consistent with EPA's promulgated levels in the PM 2.5 PSD Increment-SILs-SMC Rule. The ongoing litigation may result in the court decision that may require subsequent rule revisions and SIP revisions from Florida.

In response to the litigation, EPA requested that the court remand and vacate the new regulatory text at 40 CFR 51.166(k)(2) and 52.21(k)(2) concerning the implementation of SILs for PM 2.5 so that EPA can make necessary rulemaking revisions to that text. 14 In light of EPA's request for remand and vacatur and our acknowledgement of the need to revise the regulatory text presently contained at paragraph (k)(2) of sections 51.166 and 52.21, the Agency has determined at this time not to approve the SILs portion of FDEP's March 15, 2012, SIP revision that contains the affected regulatory text in Florida's PSD regulations at rule, 62-212.400(5), F.A.C., and 62-210.200(283)(c), F.A.C. EPA will take action on the SILs portion of Florida's March 15, 2012, SIP revision in a separate rulemaking once the issue regarding the court case has been resolved. 15

EPA is taking final action to approve portions of Florida's March 15, 2012, SIP revision (with the exception of the SILs threshold and provisions), that adopt federal permitting regulations amended in the NSR PM 2.5 and the PM 2.5 PSD Increment-SILs-SMC Rules to implement the PM 2.5 NAAQS for the NSR program because they are consistent with section 110 of the CAA and its regulations regarding NSR permitting.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 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).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 19, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

Throughout this document, “we,” “us,” and “our” means EPA.

The background for today's action is discussed in detail in our April 13, 2012 proposal (76 FR 22249). In that notice we proposed to approve submittals from Albuquerque/Bernalillo County that address the infrastructure elements specified in the CAA section 110(a)(2), necessary to implement, maintain, and enforce the 1997 and 2008 ozone and the 1997 and 2006 PM 2.5 standards. Those submittals are dated May 24, 2006 and August 16, 2010. We proposed to find that the following section 110(a)(2) elements are contained in the current Albuquerque/Bernalillo County SIP and provide the infrastructure for implementing the 1997 and 2008 ozone and the 1997 and 2006 PM 2.5 standards: emission limits and other control measures (section 110(a)(2)(A)); ambient air quality monitoring/data system (section 110(a)(2)(B)); the program for enforcement of control measures (section 110(a)(2)(C)); international and interstate pollution abatement (section 110(a)(2)(D)(ii)); adequate resources (section 110(a)(2)(E)); stationary source monitoring system (section 110(a)(2)(F)); emergency power (section 110(a)(2)(G)); future SIP revisions (section 110(a)(2)(H)); consultation with government officials (section 110(a)(2)(J)); public notification (section 110(a)(2)(J)); PSD and visibility protection (section 110(a)(2)(J)); air quality modeling/data (section 110(a)(2)(K)); permitting fees (section 110(a)(2)(L)); and consultation/participation by affected local entities (section 110(a)(2)(M)).

In addition, we proposed to find that Albuquerque/Bernalillo County has adequately addressed one of the four required elements (or prongs) of CAA section 110(a)(2)(D)(i), the element which requires that the SIP prohibit air emissions from sources within a state from interfering with measures required to prevent significant deterioration of air quality in any other state. We are determining that emissions from sources in Albuquerque/Bernalillo County do not interfere with measures to prevent significant deterioration of air quality in any other state for the 1997 and 2008 ozone and the 1997 and 2006 PM 2.5 NAAQS (CAA section 110(a)(2)(D)(i)(II)).

In conjunction with our proposed finding that the Albuquerque/Bernalillo County SIP meets the section 110(a)(1) and (2) infrastructure and interstate transport SIP elements previously listed for the four NAAQS, we proposed to approve portions of two SIP revisions submitted by the Governor of New Mexico to EPA on May 24, 2006 and August 16, 2010 to the Albuquerque PSD Permitting Program at 20.11.61 NMAC. These revisions identify NO X as a precursor to ozone, identify the precursors for PM 2.5 and the applicable significant emission rates for PM 2.5 PSD permitting, and make other necessary updates to maintain consistency with the federal PSD permitting requirements at 40 CFR 51.166 and 40 CFR Part 51, Appendix W. EPA believes that these PSD revisions, taken together with the PSD SIP and the interstate transport SIP, satisfies the PSD-related requirements of 110(a)(2)(C), 110(a)(2)(J), and the element of section 110(a)(2)(D)(i) which requires that the SIP prohibit air emissions from sources within a state from interfering with measures required to prevent significant deterioration of air quality in any other state.

EPA also proposed to approve a portion of a SIP revision submitted on November 6, 2009 revising the Albuquerque/Bernalillo County SIP for Ambient Air Quality Standards, codified at 20.11.8 NMAC (Part 8). The substantive revisions submitted to Part 8 revise the local ambient air quality standards to make them consistent with the current NAAQS.

Our April 13, 2012 proposal provides a detailed description of all relevant submittals and the rationale for EPA's proposed actions, together with a discussion of the opportunity to comment. The public comment period for these actions closed on May 14, 2012, and we did not receive any adverse comments.

We are approving the submittals provided to demonstrate that the Albuquerque/Bernalillo County SIP meets the infrastructure elements for the 1997 and 2008 ozone and 1997 and 2006 PM 2.5 NAAQS listed below:

We are approving the portion of the Albuquerque/Bernalillo County SIP revision submittal that addresses the requirement of section 110(a)(2)(D)(i)(II) of the Act that emissions from sources in Albuquerque/Bernalillo County do not interfere with measures required in the SIP of any other state under part C of the Act regarding PSD for the 1997 and 2008 8-hour ozone and 1997 and 2006 PM 2.5 NAAQS.

We are approving Albuquerque/Bernalillo County PSD SIP provisions to 20.11.61 NMAC submitted May 24, 2006 and August 16, 2010. These SIP revisions address NO X as a precursor for ozone, consistent with EPA's November 29, 2005 Phase 2 rule for the 1997 ozone NAAQS (70 FR 71612). These revisions also identify the precursors for PM 2.5 and significant emission rates necessary for PM 2.5 PSD permitting, consistent with EPA's 2008 PM 2.5 NSR rule for the 1997 and 2006 PM 2.5 NAAQS (73 FR 28321, May 16, 2008). Additionally, the May 24, 2006 and August 16, 2010 submittals make numerous other changes necessary to maintain consistency with the federal PSD permitting requirements. Specifically, we are approving revisions to 20.11.61.7, 20.11.61.28, and 20.11.61.29 NMAC submitted on May 24, 2006. We are also approving revisions to 20.11.61.1, 20.11.61.2, 20.11.61.7, 20.11.61.11, 20.11.61.12, 20.11.61.14, 20.11.61.15, 20.11.61.16, 20.11.61.17, 20.11.61.18, 20.11.61.19, 20.11.61.20, 20.11.61.21, 20.11.61.23, 20.11.61.24, 20.11.61.25, 20.11.61.26, 20.11.61.27, 20.11.61.28, 20.11.61.29, 20.11.61.30, and 20.11.61.31 NMAC submitted on August 16, 2010.

We are also approving SIP revisions from November 6, 2009 pertaining to updating Part 8 Ambient Air Quality Standards (20.11.8 NMAC). EPA is approving these revisions pursuant to section 110 of the CAA. These revisions improve the Albuquerque/Bernalillo County SIP and update 20.11.8 NMAC to add new standards and revise existing NAAQS in 20.11.8 NMAC to be consistent with 40 CFR Part 50—National Primary and Secondary Ambient Air Quality Standards.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 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).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 19, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

EPA is publishing this rule without a prior proposed rule because we view this as a non-controversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of today's Federal Register, we are publishing a separate document that will serve as the proposed rule if adverse comments are received or a public hearing is requested on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document. If EPA receives adverse comment or a request for a public hearing, we will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. If a public hearing is requested, EPA will provide notice in the Federal Register as to the location, date, and time. We would address all public comments in a subsequent final rule based on the proposed rule.

The regulations implementing the Significant New Alternatives Policy (SNAP) program are codified at 40 CFR part 82, subpart G. The appendices to subpart G list substitutes for ozone-depleting substances (ODSs) for specific end uses as unacceptable or acceptable with certain restrictions imposed on their use. In addition, a list of acceptable substitutes without restrictions is available at http://www.epa.gov/ozone/snap/lists/index.html. The action in this direct final rule will add a total of three fire suppression agents to the SNAP list of acceptable substitutes in the appendices to subpart G: two fire suppression agents are added to the list of substitutes for halon 1301 that are acceptable subject to use conditions and one fire suppression agent is added to the list of substitutes for halon 1211 that are acceptable subject to narrowed use limits. This action does not place any significant burden on the regulated community but lists as acceptable, subject to use restrictions, three new halon substitutes. The restrictions will ensure that these substitutes will not pose a greater risk to human health or the environment than other potentially available substitutes in the fire suppression end use.

This direct final rule regulates the use of Powdered Aerosol F (KSA®) and Powdered Aerosol G (Dry Sprinkler Powdered Aerosol (DSPA) Fixed Generators) by finding them acceptable subject to use conditions as substitutes for halon 1301 for use in total flooding fire suppression systems in normally unoccupied spaces. This action also finds C7 Fluoroketone acceptable subject to narrowed use limits as a substitute for halon 1211 for use as a streaming agent in portable fire extinguishers in nonresidential applications. Halons are chemicals that were once widely used in the fire protection sector but have been banned from production in the U.S. since 1994 because their emissions into the atmosphere are highly destructive to the stratospheric ozone layer. This action will provide users that need specialized fire protection applications with more alternatives to the use of halons. Businesses that may be regulated, either through manufacturing, distribution, installation and servicing, or use of the fire suppression equipment containing the substitutes are listed in the table below:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0569 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 19, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0569, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-9), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1E7882) by IR-4, 500 College Road East, Suite 201W., Princeton, NJ 08540. The petition requested that 40 CFR 180.431 be amended by establishing tolerances for residues of the herbicide clopyralid, (3,6-dichloro-2-pyridinecarboxylic acid), in or on apple at 0.05 parts per million (ppm); brassica, leafy greens, subgroup 5B at 5.0 ppm; rapeseed subgroup 20A, except gold of pleasure, seed at 3.0 ppm; rapeseed subgroup 20A, except gold of pleasure, meal at 6.0 ppm; and rapeseed subgroup 20A, except gold of pleasure, forage at 3.0 ppm. That notice referenced a summary of the petition prepared on behalf of IR-4 by Dow AgroSciences, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Additionally, in the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-6), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2E8013) by IR-4. The petition requested that 40 CFR 180.431 be amended by establishing tolerances for residues of the herbicide clopyralid, (3,6-dichloro-2-pyridinecarboxylic acid), in or on teff, forage at 9.0 ppm; teff, grain at 3.0 ppm; teff, straw at 9.0 ppm; and teff, hay at 9.0 ppm. That notice referenced a summary of the petition prepared on behalf of IR-4 by Dow AgroSciences, the registrant, which is available in docket ID number EPA-HQ-OPP-2012-0309, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has determined that the proposed tolerance on rapeseed subgroup 20A, except gold of pleasure, forage is not necessary. Additionally, EPA has determined that several established tolerances should be removed. Finally, the Agency determined that the proposed tolerance on rapeseed subgroup 20A, except gold of pleasure, meal should be established as a tolerance on rapeseed, meal. The reasons for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for clopyralid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with clopyralid follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Clopyralid has low acute toxicity via the oral, dermal, and inhalation routes of exposure. It is not a dermal irritant or sensitizer, but it is a severe eye irritant in its acid form. No consistent mammalian target organ was identified in the clopyralid toxicological studies submitted to the Agency. Effects were noted in various organs and systems in different species, including increases in liver weight, changes in clinical chemistry and blood cell parameters, skin lesions, and decreases in body weight gain.

In subchronic mouse studies, decreased body weights were observed in males and females. Following chronic exposure, effects in dogs included reductions in red blood cell parameters, increased liver weight (males), and vacuolated adrenal cortical cells (females). Additionally, skin lesions and clinical chemistry changes (decreased serum glucose, protein, and albumin) were observed at the highest dose tested. In the rat, epithelial hyperplasia, thickening of the limiting ridge of the stomach, and decreased body weight were observed following chronic exposure. There were no clinical indications of neurotoxicity or immunotoxicity in the subchronic or chronic toxicity studies.

No developmental toxicity was observed in the rat at doses that caused maternal mortality and decreased body weight gains. In the rabbit developmental toxicity study, decreased fetal body weights and hydrocephalus were observed at a dose that caused severe maternal toxicity including a high rate of mortality, clinical signs of toxicity, decreased body weight gains, and gastric mucosal lesions. Reproductive toxicity was not observed in the rat, but mean pup weight reductions and relative liver weight increases were observed at doses that caused parental toxicity (decreased body weight/weight gain and food consumption and gastric lesions).

There was no evidence of carcinogenic potential in the rat and mouse 2-year carcinogenicity studies. Further, there were no positive findings for mutagenicity or clastogenicity observed in a battery of mutagenicity studies (including bacterial reverse gene mutation, in vitro and in vivo host-mediated assays in Salmonella and Saccharomyces, in vivo chromosomal aberrations, unscheduled DNA synthesis, and dominant lethal activity studies). Based on the results of these studies, EPA has determined that clopyralid is “not likely to be carcinogenic to humans.”

Specific information on the studies received and the nature of the adverse effects caused by clopyralid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, “Clopyralid. Human Health Risk Assessment for New Uses on Apples, Teff, Brassica Leafy Greens, and Rapeseed” at pages 32-35 in docket ID number EPA-HQ-OPP-2011-0569.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm .

A summary of the toxicological endpoints for clopyralid used for human risk assessment is shown in Table 1 of this unit. EPA notes that in the last final rule for clopyralid, published in the Federal Register of March 24, 2010 (75 FR 14086) (FRL-8814-2), the Agency identified an acute dietary toxicological POD based on decreased maternal body weight in the rat developmental toxicity study. However, upon reevaluation of the toxicological database for clopyralid, EPA determined that the effect is not the result of a single dose, and is not appropriate for an acute dietary endpoint. Additionally, while the last final rule included endpoints and points of departure for intermediate-term residential scenarios, including postapplication incidental oral exposure for children, the Agency has reevaluated this scenario and has determined that for clopyralid, residential exposure to children on turf is not likely to occur over an intermediate-term duration (i.e., 1 month to 6 months). Further, intermediate-term exposures are not expected for residential handlers, based on the use pattern.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to clopyralid, EPA considered exposure under the petitioned-for tolerances as well as all existing clopyralid tolerances in 40 CFR 180.431. EPA assessed dietary exposures from clopyralid in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for clopyralid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As to residue levels in food, EPA assumed tolerance-level residues, 100 percent crop treated (PCT) estimates, and DEEM TM ver. 7.81 default processing factors.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that clopyralid does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for clopyralid. Tolerance level residues or 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for clopyralid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of clopyralid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

Based on the First Index Reservoir Screening Tool (FIRST) model, the estimated drinking water concentration (EDWC) of clopyralid for chronic exposures is estimated to be 11.9 parts per billion (ppb) for surface water. The Agency also considered available monitoring data from the United States Geological Survey (USGS) National Water Quality Assessment Data Warehouse ( http://water.usgs.gov/nawqa/ ) for clopyralid. For ground water monitoring data, the peak observed value for detectable levels of clopyralid was 0.5288 ppb (Oregon) with a nationwide mean value of 0.065 ppb. Therefore, the EDWC of clopyralid for chronic exposures is estimated to be 0.5288 ppb for ground water.

For chronic dietary risk assessment, the water concentration of value 11.9 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Clopyralid is currently registered for use on lawns, turf, and ornamentals in residential and public areas, which could result in residential exposures. EPA assessed residential exposure using the following assumptions: Short-term inhalation exposure for adult residential handlers and short-term postapplication exposure for children from incidental oral contact with treated turf (hand-to-mouth, object-to-mouth and soil ingestion). Although dermal exposure is anticipated from residential use of clopyralid, risks via the dermal route of exposure are not of concern for clopyralid; therefore, dermal risks were not quantitatively assessed for residential exposure. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found clopyralid to share a common mechanism of toxicity with any other substances, and clopyralid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that clopyralid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There was no evidence of increased prenatal and/or postnatal qualitative or quantitative susceptibility in the available studies in the toxicology database, including the rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats. In the developmental rat study, no developmental effects were seen at doses that caused maternal toxicity. In the rabbit developmental study, hydrocephalus and decreased mean fetal weight were observed at a dose that caused severe maternal toxicity, including mortality. In the 2-generation reproduction study, decreased pup weights and increased relative liver weights were observed at the same level that resulted in parental toxicity (decreased body weights, body weight gains and food consumption and slight focal hyperkeratotic changes in the gastric squamous mucosa).

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for clopyralid is complete. EPA has waived the requirement of a 28-day inhalation toxicity study in rats (OCSPP Guideline 870.3465) based on the low volatility and low acute inhalation toxicity for clopyralid, as well as the selection of conservative and adequately protective points of departure from oral studies for clopyralid. As the 28-day inhalation toxicity study was not required, oral studies were considered for use with route-to-route extrapolation for the short-term adult handler inhalation exposure assessment. For short-term inhalation exposure, the maternal toxicity NOAEL of 75 mg/kg/day from the rat developmental toxicity study was selected based on mortality, decreased maternal body weight gain, and decreased food consumption at the LOAEL of 250 mg/kg/day. This study was chosen because it was of the appropriate duration and route, and it provided the most sensitive NOAEL. This endpoint is protective of potential pre- and postnatal toxicity because developmental toxicity in the rabbit was only seen in the presence of significant maternal toxicity (maternal/developmental NOAEL = 250 mg/kg/day), and developmental toxicity in the rat was not observed up to a maternally toxic dose. As such, it is considered to be a conservative endpoint for this exposure scenario.

ii. In the rabbit developmental toxicity study, neuropathology (hydrocephalus) was observed at the highest dose tested. However, the concern for this effect is considered low because it occurred at a dose that caused severe maternal toxicity, including a high rate of mortality and decreased body weight gain and food consumption. Further, there was no evidence of neurotoxicity in the rat developmental or reproduction studies or in the available subchronic or chronic studies; therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that clopyralid results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessment was performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to clopyralid in drinking water. EPA used similarly conservative assumptions to assess postapplication incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by clopyralid.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, clopyralid is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to clopyralid from food and water will utilize 25% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of clopyralid is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Clopyralid is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to clopyralid.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 5,300 for the general population and 1,700 for children 1-2 years old. Because EPA's level of concern for clopyralid is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, clopyralid is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for clopyralid.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, clopyralid is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to clopyralid residues.

The following adequate enforcement methodology is available in The Pesticide Analytical Manual Vol. II to enforce the tolerance expression for plant commodities: a gas chromatography/electron-capture detection (GC/ECD) method.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for clopyralid in or on the commodities associated with these petitions.

Based on the data supporting the petitions, EPA has determined that the proposed tolerance on rapeseed subgroup 20A, except gold of pleasure, forage at 3.0 ppm is not necessary because the commodity is not a significant livestock feed item. Additionally, the Agency has determined that the established tolerances in or on crambe, seed; flax, seed; mustard, seed; and rapeseed, seed should be removed because they are superseded by inclusion in rapeseed, subgroup 20A, except gold of pleasure at 3.0 ppm. EPA is also removing the established tolerance on mustard greens, as it is superseded by inclusion in brassica, leafy greens, subgroup 5B. Finally, the Agency determined that the proposed tolerance on rapeseed subgroup 20A, except gold of pleasure, meal at 6.0 ppm should be established on rapeseed, meal at 6.0 ppm. The EPA may establish an individual tolerance on a processed commodity that is a member of rapeseed subgroup 20A. However, the Agency will not establish a subgroup tolerance for processed foods prepared from crops covered by a group tolerance, as outlined in 40 CFR 180.40, paragraph (f). Therefore, a separate tolerance for the processed commodity is appropriate.

Therefore, tolerances are established for residues of clopyralid, (3,6-dichloro- 2-pyridinecarboxylic acid), in or on apple at 0.05 ppm; brassica, leafy greens, subgroup 5B at 5.0 ppm; rapeseed, subgroup 20A, except gold of pleasure at 3.0 ppm; rapeseed, meal at 6.0 ppm; teff, forage at 9.0 ppm; teff, grain at 3.0 ppm; teff, hay at 9.0 ppm; and teff, straw at 9.0 ppm. This regulation additionally removes established tolerances in or on crambe, seed; flax, seed; mustard greens; mustard, seed; and rapeseed, seed.

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the 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 this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

Regulations governing the bluefish fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is apportioned on a percentage basis among the coastal states from Florida through Maine. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.162.

The initial total commercial quota for bluefish for the 2012 fishing year is 10,317,362 lb (4,679,878 kg) (77 FR 25100, April 27, 2012). The percent allocated to vessels landing bluefish in Massachusetts is 6.7167 percent, resulting in a commercial quota of 692,986 lb (314,333 kg) after deduction of research set-aside.

The Administrator, Northeast Region, NMFS (Regional Administrator), monitors the state commercial quotas and determines when a state's commercial quota has been harvested. NMFS is required to publish notification in the Federal Register advising and notifying commercial vessels and dealer permit holders that, effective upon a specific date, the state's commercial quota has been harvested and no commercial quota is available for landing bluefish in that state. The Regional Administrator has determined, based upon dealer reports and other available information, that Massachusetts has harvested its quota for 2012.

Section 648.4(b) provides that Federal permit holders agree, as a condition of the permit, not to land bluefish in any state that the Regional Administrator has determined no longer has commercial quota available. Therefore, effective 0001 hours, September 19, 2012, landings of bluefish in Massachusetts by vessels holding Federal commercial bluefish permits are prohibited for the remainder of the 2012 calendar year, unless additional quota becomes available through a transfer and is announced in the Federal Register . Effective 0001 hours, September 19, 2012, federally permitted dealers are also notified that they may not purchase bluefish from federally permitted vessels that land in Massachusetts for the remainder of the calendar year, or until additional quota becomes available through a transfer from another state.

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.