I. Background

Title VII of the Consolidated Natural Resources Act of 2008 (CNRA) extends U.S. immigration law to the CNMI and provides CNMI-specific provisions affecting foreign workers. See Public Law 110-229, 122 Stat. 754, 853 (2008). The CNRA included provisions for a “transition period” to phase-out the CNMI's nonresident contract worker program and phase-in the U.S. federal immigration system in a manner that minimizes the adverse economic and fiscal effects and maximizes the CNMI's potential for future economic and business growth. See sec. 701(b) of the CNRA, 48 U.S.C. 1806 note. The CNRA authorized DHS to create a nonimmigrant classification that would ensure adequate employment in the CNMI during the transition period, which ends December 31, 2014. 1 See id.; 48 U.S.C. 1806(d)(2). The CNRA also mandated an annual reduction in the allocation of the number of permits issued per year and the total elimination of the CW nonimmigrant classification by the end of the transition period. 48 U.S.C. 1806(d)(2).

Consistent with this mandate under the CNRA, DHS published a final rule on September 7, 2011 amending the regulations at 8 CFR 214.2(w) to implement a temporary, CNMI-only transitional worker nonimmigrant classification (CW classification, which includes CW-1 for principal workers and CW-2 for spouses and minor children). See 76 FR 55502 (Sept. 7, 2011). DHS established the CW-1 numerical limitation for fiscal year 2011 at 22,417 and for fiscal year 2012 at 22,416. See 8 CFR 214.2(w)(1)(viii)(A) and (B). In the final rule, DHS did not provide a numerical limit reduction plan for the remainder of the transition period. DHS instead delayed development of a numerical limit reduction plan due to the uncertainty of the CNMI's future workforce needs and economic conditions. See 76 FR at 55510. As such, DHS opted to publish any future annual numerical limitation in a Federal Register notice. See 8 CFR 214.2(w)(1)(viii)(C). This method maximizes the CNMI's potential for future economic growth by providing flexibility for the continued use of workers during this phase-in of Federal immigration law. See 76 FR at 55510.

The numerical limitations set forth in the final rule for the first two years of the CW classification provided a baseline for the maximum number of transitional workers in the CNMI. 2 This initial approach to the allocation system ensured that employers had an adequate supply of workers for the projected CW nonimmigrant visas needed to transition umbrella permit holders to CW-1 status. This approach also provided DHS with the flexibility to adjust to the future needs of the CNMI economy and to assess the total alien workforce needs based on the number of requests for transitional worker nonimmigrant classification received following implementation of the final rule. Based on these factors, DHS determined that it would assess the CNMI's workforce needs on a yearly basis. See 8 CFR 214.2(w)(1)(viii)(C).

The maximum number of CW-1 workers announced in this document (15,000) is appropriate based on the actual demonstrated need for foreign workers within the CNMI. In the final rule, DHS provided for an accurate assessment of the actual labor needs within the CNMI by setting a limit in the final rule that ensured an adequate supply of CW visas to test the labor market. Although DHS set the numerical limitation for fiscal year 2012 at 22,416, employers in the CNMI have filed only 5,985 Petitions for CNMI-Only Nonimmigrant Transitional Workers (Form I-129 CW), requesting a total of 12,247 transitional workers. 3 Therefore, DHS believes the numerical limitation provided for fiscal year 2012 greatly outweighed the demand for labor and the number of requests received for CW classification in fiscal year 2012 to date provides a more appropriate baseline for the maximum number of transitional workers in the CNMI.

All requests received to date were submitted during fiscal year 2012, as the final rule took effect shortly after the beginning of that fiscal year. USCIS has not completed adjudication of these requests but anticipates doing so before the end of the current calendar year. These requests, to the extent they are granted, will be counted under the fiscal year 2012 cap of 22,416. The vast majority of CW petitions were filed by CNMI employers in November 2011, shortly before the expiration of “grandfathered” CNMI work authorization on November 27, 2011. See 48 U.S.C. 1806(e)(2). For these reasons, DHS believes that the number of requested CW-1 workers to date in fiscal year 2012 is an accurate baseline to use in determining the likely demand in fiscal year 2013.

The CNRA requires an annual reduction in the number of transitional workers (and complete elimination of the CW nonimmigrant classification by the end of the transition period) but does not mandate a specific reduction. See 48 U.S.C. 1806(d)(2). In addition, 8 CFR 214.2(w)(1)(viii)(C) provides that the numerical limitation for any fiscal year will be less than the number for the previous fiscal year, and it will be reasonably calculated to reduce the number of CW-1 nonimmigrant workers to zero by the end of the transition period.

To comply with these requirements, meet the CNMI's labor market's needs, and provide opportunity for growth, DHS has set the numerical limitation for fiscal year 2013 at 15,000. DHS calculated this figure by first taking the number of CW-1 nonimmigrant workers needed based on fiscal year 2012 filings to date of 12,247 (or 11,927, taking into account 320 denials to date), which rounded to the nearest thousand is 12,000. DHS then added an additional 25 percent to the 12,000 to accommodate possible economic growth that might lead to a need for additional CW workers, for a total of 15,000. Accordingly, DHS reduces the number of transitional workers from the current fiscal year numerical limitation of 22,416, and establishes the maximum number of CW-1 visas available for fiscal year 2013 at 15,000.

This number of CW-1 workers will be available beginning on October 1, 2012. DHS may adjust the numerical limitation for a fiscal year or other period, in its discretion, at any time via notice in the Federal Register . See 8 CFR 214.2(w)(1)(viii)(D). Consistent with the rules applicable to other nonimmigrant worker visa classifications, if the numerical limitation for the fiscal year is not reached, the unused numbers do not carry over to the next fiscal year. See 8 CFR 214.2(w)(1)(viii)(E).

Petitions requesting a validity start date within fiscal year 2013 will be counted against the 15,000 limit. As such, each CW-1 worker who is listed on a Form I-129CW is counted against the numerical limitation at the time USCIS receives the petition. Counting the petitions in this manner will help ensure that USCIS does not approve requests for more than 15,000 CW-1 workers. If the number of CW-1 workers approaches the 15,000 limit, USCIS will hold any subsequently-filed petition until a final determination is made on the petitions that are already included in the numerical count. Subsequently-filed petitions will be forwarded for adjudication in the order in which they were received until USCIS has approved petitions for the maximum number of CW workers; any remaining petitions that were held or that are newly received will be rejected.

This document does not affect the status of aliens who hold CW-1 nonimmigrant status. Aliens currently holding such status, however, will be affected by this document when they apply for an extension of their CW-1 classification, or a change of status from another nonimmigrant status to CW-1 status.

This document does not affect the status of any alien currently holding CW-2 status as the spouse or minor child of a CW-1 nonimmigrant. This document also does not directly affect the ability of any alien to extend or otherwise obtain CW-2 status, as the numerical limitation applies to CW-1 principals only. Aliens seeking CW-2 status may be affected indirectly by the applicability of the cap to the CW-1 principals from whom their status is derived.

In a notice published in the Federal Register of December 22, 1999 (64 FR 71792), FDA announced that a food additive petition (FAP 9M4695) had been filed by the USDA/FSIS, 300 12th St. SW., rm. 112, Washington, DC 20250 (currently, Food Safety and Inspection Service, Stop Code 3782, Patriots Plaza III, Cubicle 8-163A, 1400 Independence Ave. SW., Washington, DC 20250-3700). The petition proposed that the food additive regulations in part 179, Irradiation in the Production, Processing and Handling of Food (21 CFR part 179), be amended to provide for the safe use of a 4.5 kGy maximum dose of ionizing radiation to treat unrefrigerated (as well as refrigerated  1 ) uncooked meat, meat byproducts, 2 and certain meat food products to reduce levels of foodborne pathogens and extend shelf-life.

FDA's current regulation under § 179.26(b)(8) permits the irradiation of refrigerated or frozen, uncooked products that are meat within the meaning of 9 CFR 301.2(rr), meat byproducts within the meaning of 9 CFR 301.2(tt), or meat food products within the meaning of 9 CFR 301.2(uu), with or without nonfluid seasoning, that are otherwise composed solely of intact or ground meat, meat byproducts, or both meat and meat byproducts. The foods covered under § 179.26(b)(8) are subject to the Federal Meat Inspection Act (21 U.S.C. 601, et seq. ), and, as described previously in this document, are defined by the USDA/FSIS in Title 9 of the Code of Federal Regulations. In this document, the term “meat” will be used to refer collectively to meat, meat byproducts, and certain meat food products applicable to this notice.

FDA has previously reviewed the irradiation of meat and meat byproducts (62 FR 64107, December 3, 1997), and concluded that the irradiation of refrigerated meat and meat byproducts is safe. The current rulemaking concerns the irradiation of meat at temperatures that are above refrigerated temperature. FDA has previously reviewed and evaluated the safety of irradiated food products in a variety of applications. Discussions of these applications have been presented in various Federal Register documents (see, e.g., 62 FR 64107 and 70 FR 48057, August 16, 2005). FDA has also updated its review of the safety of irradiation of food with a thorough survey of the literature to the present time and found no new studies on the irradiation of meat (Ref. 1).

Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(s)), a source of radiation used to treat food is a food additive. The additive is not added to food literally, but is rather a source of radiation used to process or treat food such that, analogous to other food processing technologies, its use can affect the characteristics of the food. Under section 409(c)(3)(A) of the FD&C Act (21 U.S.C. 348(c)(3)(A)), a food additive cannot be approved for a particular use unless a fair evaluation of the evidence establishes that the additive is safe under the conditions of that use. Importantly, the statute does not prescribe the safety tests to be performed but leaves that determination to the discretion and scientific expertise of FDA. Not all food additives require the same amount or type of testing to establish safety. The testing and data required to establish the safety of an additive will vary depending on the particular additive and its intended use.

In evaluating the safety of a source of radiation to treat food intended for human consumption, the Agency must identify the various effects that may result from irradiating the food and assess whether any of these effects pose a public health concern. In doing so, the following three general areas need to be addressed: (1) Potential toxicity, (2) nutritional adequacy, and (3) effects on the microbiological profile of the treated food. Each of these areas is discussed in this document.

The term “radiation chemistry” refers to the chemical reactions that occur as a result of the absorption of ionizing radiation. Because an understanding of radiation chemistry is fundamental in addressing these three areas, key aspects of radiation chemistry are also discussed.

FDA has fully considered the data and studies submitted in the subject petition as well as other data and information relevant to safety. The safety data that have been obtained from irradiating various foods under various conditions support conclusions about the safety of many irradiated foods, including unrefrigerated meat (Refs. 2 through 6).

The conditions under which foods are irradiated are important in considering the radiation chemistry of a given food. These conditions include: The radiation dose, the physical state of the food ( e.g., frozen or dried), and the atmosphere in the package.

The radiolysis products generated in any food are directly proportional to the absorbed radiation dose (Ref. 2). Radiation-induced chemical changes may cause changes in the organoleptic properties of the food. The radiation chemistry of food is strongly influenced by the physical state of the food. If all other conditions, including radiation dose and ambient atmosphere, are the same, the extent of chemical change that occurs in a particular food in the frozen state is less than the change that occurs in the non-frozen state. This is because of the reduced mobility, in the frozen state, of the initial radiolysis products, which will tend to recombine rather than diffuse and react with other food components. For similar reasons, if all other conditions are the same, the extent of chemical change that occurs in the dehydrated state is less than the change that occurs in the fully hydrated state (62 FR 64107 at 64110 and references cited therein).

The major components of meat are proteins and lipids and the ratios vary. Ground beef is a food defined by USDA and ranges from 5 percent to 30 percent lipids. The ratio of protein to lipid in whole cuts of beef varies depending on many factors. 3 FDA has extensively reviewed the radiation chemistry of flesh foods  4 in its rulemakings on the use of ionizing radiation to treat meat (62 FR 64107) and molluscan shellfish (70 FR 48057). In the meat rule (62 FR 64107 at 64111), FDA concluded: “In summary, the results obtained from chemical analyses of irradiated flesh foods establish that there would be very small amounts of individual radiolytic products generated by radiation doses comparable to those proposed in the petition. In addition, most of these radiolytic products are either the same as, or structurally very similar to, compounds found in foods that have not been irradiated. Because of their structural similarities to compounds found in foods that have not been irradiated, these radiolytic products would be expected to be toxicologically similar to such compounds as well. Thus, the available information regarding the radiation chemistry of the major components of flesh foods supports the proposition that there is no reason to suspect a toxicological hazard due to consumption of an irradiated flesh food.”

During its review of this food additive petition (FAP 9M4695), the Agency evaluated the changes that may occur from the irradiation of meat at temperatures greater than those previously approved. These evaluations are discussed in the following sections of this section II.A.1.

a. Proteins. As noted previously in this document, FDA has previously provided detailed discussions of the radiation chemistry of proteins in its rulemakings on the use of ionizing radiation to treat meat (62 FR 64107 at 64110) and molluscan shellfish (70 FR 48057 at 48059-48060). Those prior discussions support the findings in this rule. Studies conducted with high-protein foods ( e.g., meat, poultry, and seafood), have established that most of the radiolysis products derived from food proteins have the same amino acid composition as the original protein and are altered only in their secondary and tertiary structures ( i.e., they are denatured, Ref. 2). These changes are similar to those that occur as a result of heating, but in the case of irradiation, even at doses up to 50 kGy and when food is irradiated at temperatures ranging from −168 °C to 60 °C in various studies, such changes are far less pronounced than heating and the amounts of reaction products generated are far lower (62 FR 64107 at 64110). Based on these studies and on the analysis set forth in the prior rulemakings referenced previously in this document, FDA concludes that there will be no significant change in the amino acid composition of meat that is irradiated at doses up to 4.5 kGy at temperatures higher than refrigeration temperature.

b. Lipid. FDA has also previously provided detailed discussions of the radiation chemistry of lipids in the meat rule (62 FR 64107 at 64110-64111) and molluscan shellfish rule (70 FR 48057 at 48060). Those discussions also support this rule.

To summarize the previous discussions, a variety of radiolysis products derived from lipids have been identified. These include the following: Fatty acids, esters, aldehydes, ketones, alkanes, alkenes, and other hydrocarbons (Ref. 2). Identical or analogous products are found in foods that have not been irradiated. In particular, heating food produces generally the same types of products, but in amounts far greater than the trace amounts produced by irradiating food (62 FR 64107 at 64111 and references cited therein).

A class of radiolysis products that is derived from lipids, 2-alkylcyclobutanones (2-ACBs), has been reported to form in small quantities when fats are exposed to ionizing radiation. Any 2-ACB formed will depend on the fatty acid composition of the food, e.g., 2-dodecylcyclobutanone (2-DCB) is a radiation byproduct of palmitic acid (Refs. 7 and 8). In the molluscan shellfish rule, the Agency noted the reported creation of 2-DCB in irradiated chicken and ground beef, which contain triglycerides with esterified palmitic acid. FDA did not find that the presence of low levels of 2-DCB raised a safety issue (70 FR 48057 at 48060).

During the course of reviewing the chemical effects of irradiation, FDA became aware of a report that suggested that the irradiation of apple juice might produce furan (Ref. 9). Because furan has been shown to cause tumors in laboratory animals, FDA has extensively researched the occurrence of furan in irradiated foods over the last 10 years. FDA has confirmed that certain foods form furan in low quantities when irradiated (Ref. 10). Studies conducted by FDA scientists and other researchers show that some foods form furan when heated and still other foods form furan during storage at refrigeration temperatures (Refs. 10 and 12). Testing of irradiated non-refrigerated meat found no furan at the limit of detection in the tests and detected no furan above the background levels of natural furan formation during storage (Refs. 10, 11, and 12). Therefore, the Agency concludes that the irradiation of meat at the requested maximum absorbed dose will not increase the amount of furan in the diet and does not present a toxicological hazard under the conditions proposed in the USDA/FSIS petition.

As discussed previously in this document, the available information from chemical analyses of irradiated foods suggests that there is no reason to suspect a toxicological hazard due to consumption of an irradiated food (Ref. 4.) The Agency notes that the large body of data from studies where irradiated foods were fed to laboratory animals provides an independent way to assess toxicological safety. These studies include those relied on by the Agency in previous evaluations of the safety of irradiated foods (see 51 FR 13376, April 18, 1986; 55 FR 18538, May 2, 1990; 62 FR 64107; 65 FR 45280, July 21, 2000; and 70 FR 48057, August 16, 2005). The Agency is also relying on additional data and information in FDA files (Ref. 13). The Agency reviewed the data from chemical analysis of beef irradiated at 45 kGy (Ref. 19) and concluded that, although there will be an increase in the yields of some of the radiolysis products produced by irradiating meat at 30-40 °C versus 5 °C, the increase is no greater than an order of magnitude (Ref. 14), and is insignificant with respect to toxicity (Ref. 15).

In summary, FDA has reviewed data relevant to the assessment of potential toxicity of irradiated meat. While all of the studies are not of equal quality or rigor, the Agency has concluded that the quantity and breadth of testing and the number and significance of endpoints assessed would have identified any meaningful risk. Based on the totality of the evidence, FDA concludes that irradiation of meat under the conditions proposed in this petition does not present a toxicological hazard.

It has been established that the nutrient values of the macronutrients in the diet (protein, fats, and carbohydrates) are not significantly altered by irradiation at the petitioned doses (62 FR 64107 at 64114 and Refs. 16 and 17). Minerals ( e.g., calcium and iron) are also unaffected by irradiation (62 FR 64107 at 64114 and Ref. 17). Levels of certain vitamins may be reduced as a result of irradiation. The extent to which this reduction occurs depends on the specific vitamin, the type of food, and the conditions of irradiation. Not all vitamin loss is nutritionally significant; the extent to which the reduction in a specific vitamin level is significant depends on the relative contribution of the food in question to the total dietary intake of the vitamin (62 FR 64107 at 64114).

FDA has extensively reviewed the nutritional losses that occur when meat is irradiated (62 FR 64107 at 64114). During this review, FDA noted that the majority of meat would be irradiated at refrigerated temperatures or frozen, and possibly in a reduced oxygen environment, which would reduce the loss of vitamins. Although this rule covers irradiation of meat under unrefrigerated conditions, FDA concludes that this difference in temperature will not result in significant vitamin loss. Thiamine is known to be more sensitive to irradiation than other vitamins; FDA considered a worst-case scenario ( e.g., thiamine levels in all these foods would be reduced by 50 percent) and the Agency concluded that, if all flesh foods ( i.e., meat, poultry, and fish) were irradiated under such conditions, there would be no deleterious effect on the total dietary intake of thiamine as a result of irradiating flesh foods, including meat (62 FR 64107 at 64115).

In summary, based on the available data and information, FDA concludes that amending the regulations, as set forth in this document, to allow for the use of ionizing radiation to treat unrefrigerated meat up to a maximum dose of 4.5 kGy will not have an adverse impact on the nutritional adequacy of the overall diet.

FDA previously examined the effects of radiation-induced changes in the microbiological profile of meat and on the growth patterns of any surviving microorganisms, including Clostridium botulinum, to determine whether the microbiological safety of meat will be adversely affected by irradiation (62 FR 64107 at 64115). The Agency determined that irradiation of frozen and refrigerated meat and meat byproducts at a dose up to 4.5 kGy will not result in any additional health hazard from C. botulinum. Likewise, FDA also determined that irradiation will not result in any additional hazard from common pathogens other than C. botulinum (Ref. 18).

The Agency has determined that, although the use would be modestly different in the current petitioned request, the microbial hazards that carcasses would be subjected to would be equivalent to the microbial hazards from meat that has been further processed, i.e., meat from a completely broken-down carcass that has been refrigerated. Moreover, the same doses of irradiation would be expected to be equally effective in lowering levels of pathogenic and spoilage microorganisms. 5 Therefore, the Agency concludes, based on all the evidence before it, that irradiation of meat under the conditions set forth in the regulation presented in this document will not result in a microbiological hazard (Ref. 18).

In summary, based on the available data and information, FDA concludes that irradiation of meat conducted in accordance with good manufacturing practices will reduce or eliminate bacterial populations with no increased microbial risk from pathogens that may survive the irradiation process (Ref. 18).

The meat products covered by this rule are defined under the Federal Meat Inspection Act (21 U.S.C. 601, et seq. ). Therefore, the labeling of these products irradiated under the conditions set forth in the regulation must comply with any requirements imposed by USDA/FSIS under its authority to approve the labeling of such products.

FDA has received numerous comments, primarily form letters, from individuals that state their opinions regarding the potential dangers and unacceptability of irradiating food. FDA has also received several comments from individuals or organizations that state their opinions regarding the potential benefits of irradiating food and urging FDA to approve the petition. Additionally, FDA received several comments from Public Citizen (PC) and the Center for Food Safety (CFS) requesting the denial of this and other food irradiation petitions.

Overall, the comments were of a general nature and not necessarily specific to the requests in the individual petitions, and did not contain any substantive information that could be used in a safety evaluation of irradiated meat. Many of these comments from PC and CFS were also submitted to the docket for this Agency rulemaking on irradiation of molluscan shellfish (Docket No. 1999F-4372, FAP 9M4682). The topics raised in these comments included the following: Studies reviewed in the 1999 Food and Agriculture Organization of the United Nations/International Atomic Energy Agency/World Health Organization (FAO/IAEA/WHO) report on high-dose irradiation; a review article that analyzed studies of irradiated foods performed in the 1950s and 1960s; the findings of a 1971 study in which rats were fed irradiated strawberries; the findings regarding reproductive performance in a 1954 study in which mice were fed a special irradiated diet; issues regarding mutagenicity studies; certain international opinions; issues related to 2-ACBs, including purported promotion of colon cancer; the findings of certain studies conducted by the Indian Institute of Nutrition in the 1970s; general issues regarding toxicity data; FDA's purported failure to meet certain statutory requirements; data from a 2002 study purportedly showing an irradiation-induced increase in trans fatty acids in ground beef; studies regarding purported elevated hemoglobin levels and their significance; and an affidavit describing the opinions of a scientist regarding the dangers of irradiation and advocating the use of alternative methods for reducing the risk of foodborne disease. These comments have all been addressed by FDA in a previous rulemaking. For a detailed discussion of the Agency's response to each of the previous general comments, the reader is referred to the molluscan shellfish rule (70 FR 48057 at 48062 through 48071). Because these comments do not raise issues specific to irradiated meat and meat byproducts, and the previous responses are sufficient to address these issues as they pertain to the rule to permit the irradiation of meat as described in this document, the Agency will not address these comments further here.

Based on the data and studies submitted in the petition and other information in the Agency's files, FDA concludes that the proposed use of irradiation to provide for the safe use of a 4.5 kGy maximum dose of ionizing radiation to treat unrefrigerated (as well as refrigerated) uncooked meat, meat byproducts, and certain meat food products to reduce levels of foodborne pathogens and extend shelf-life is safe, and therefore the regulations in § 179.26 should be amended as set forth in this document.

In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the use of irradiation of unrefrigerated meat in response to the petition will be made available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT ). As provided in § 171.1(h), the Agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

This final rule does not provide for the collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

The Agency has carefully considered the potential environmental effects of this action. The Agency has determined under 21 CFR 25.32(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see ADDRESSES ) either electronic or written objections. Each objection must be separately numbered, and each numbered objection must specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested must specifically so state. Failure to request a hearing for any particular objection constitutes a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested must include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection constitutes a waiver of the right to a hearing on the objection. It is only necessary to send one set of documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

FDA's review of this petition was limited to section 409 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, the Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amended the FD&C Act to, among other things, add section 301(ll) (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exceptions in section 301(ll)(1) to (ll)(4) of the FD&C Act applies. In our review of this petition, FDA did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to the ionizing radiation source. Accordingly, this final rule should not be construed to be a statement that ionizing radiation used to treat meat, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all food additive final rules and therefore, should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

The following sources are referred to in this document. References marked with an asterisk (*) have been placed on display at the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. References without asterisks are not on display; they are available as published articles and books.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 179 is amended as follows:

Table of Contents I. Background II. Safety Evaluation A. Radiation Chemistry B. Toxicological Considerations C. Nutritional Considerations D. Microbiological Considerations III. Labeling IV. Comments V. Conclusions VI. Paperwork Reduction Act of 1995 VII. Environmental Impact VIII. Objections IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act X. References I. Background

In a notice published in the Federal Register of December 21, 1999 (64 FR 71461), FDA announced that a food additive petition (FAP 9M4696) had been filed by the USDA/FSIS, 300 12th St. SW., rm. 112, Washington, DC 20250 (currently, Food Safety and Inspection Service, Stop Code 3782, Patriots Plaza III, Cubicle 8-163A, 1400 Independence Ave. SW., Washington, DC 20250-3700). The petition proposed to amend the food additive regulation, Ionizing radiation for the treatment of food (§ 179.26 (21 CFR 179.26)) in item 6 of the table in paragraph (b) to: (1) Increase the maximum dose of ionizing radiation permitted in the treatment of poultry products; (2) include specific language intended to clarify the poultry products covered by the regulations; and (3) remove the limitation that any packaging used during irradiation of poultry shall not exclude oxygen.

FDA's current regulation under § 179.26(b)(6) permits the irradiation of fresh or frozen, uncooked poultry products that are: (1) Whole carcasses or disjointed portions of such carcasses that are “ready-to-cook poultry” within the meaning of 9 CFR 381.1(b)(44) or (2) mechanically separated poultry product (a finely comminuted ingredient produced by the mechanical deboning of poultry carcasses or parts of carcasses) up to a maximum absorbed dose of 3.0 kiloGray (kGy) with the restriction that any packaging used shall not exclude oxygen.

The amended regulation clarifies the range of poultry products that may be irradiated, increases the maximum dose of ionizing radiation permitted in the treatment of covered poultry products, and will remove the requirement that the packaging for covered poultry products must not exclude oxygen. The amended regulation clarifies that the regulation covers fresh (refrigerated or unrefrigerated) or frozen, uncooked poultry products that are: (1) Whole carcasses or disjointed portions (or other parts) of such carcasses that are “ready-to-cook poultry” within the meaning of 9 CFR 381.1(b) (with or without nonfluid seasoning; includes, e.g., ground poultry) or (2) mechanically separated poultry product (a finely comminuted ingredient produced by the mechanical deboning of poultry carcasses or parts of carcasses). In this document, the term “poultry” will be used to refer collectively to all of these products.

This amendment will bring the poultry regulation into conformity with the current regulation permitting the irradiation of refrigerated or frozen, uncooked products that are meat, meat byproducts, or meat food products; i.e., it permits a maximum absorbed dose of 4.5 kGy for non-frozen products and 7.0 kGy for frozen products (§ 179.26(b)(8)), and provides no limitation that the packaging shall not exclude oxygen, which would allow the use of packaging including modified atmosphere packaging and vacuum packaging.

FDA has previously evaluated the safety of irradiated protein food products in a variety of applications. Discussions of these applications have been presented in various Federal Register documents (see 51 FR 13376, April 18, 1986; 55 FR 18538, May 2, 1990; 62 FR 64107, December 3, 1997; 65 FR 45280, July 21, 2000; and 70 FR 48057, August 16, 2005). FDA specifically reviewed the irradiation of flesh foods and concluded that the irradiation of refrigerated flesh foods is safe at the absorbed doses that were reviewed (see 62 FR 64107 at 64111). FDA has also updated its review of the safety of irradiation of food with a thorough review of the literature to the present time and found no new studies on the irradiation of poultry (Ref. 1).

Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(s)), a source of radiation used to treat food is a food additive. The additive is not added to food literally but is rather a source of radiation used to process or treat food such that, analogous to other food processing technologies, its use can affect the characteristics of the food. Under section 409(c)(3)(A) of the FD&C Act (21 U.S.C. 348(c)(3)(A)), a food additive cannot be approved for a particular use unless a fair evaluation of the evidence establishes that the additive is safe under the conditions of that use. Importantly, the statute does not prescribe the safety tests to be performed but leaves that determination to the discretion and scientific expertise of FDA. Not all food additives require the same amount or type of testing to establish safety. The testing and data required to establish the safety of an additive will vary depending on the particular additive and its intended use.

In evaluating the safety of a source of radiation to treat food intended for human consumption, the Agency must identify the various effects that may result from irradiating the food and assess whether any of these effects pose a public health concern. In doing so, the following three general areas need to be addressed: (1) Potential toxicity, (2) nutritional adequacy, and (3) effects on the microbiological profile of the treated food. Each of these areas is discussed in this document.

The term “radiation chemistry” refers to the chemical reactions that occur as a result of the absorption of ionizing radiation. Because an understanding of radiation chemistry is fundamental in addressing the three areas noted in this document, key aspects of radiation chemistry are also discussed.

FDA has fully considered the data and studies submitted in the subject petition as well as other relevant data and information. The safety data that have been obtained from irradiating various foods under various conditions support conclusions about the safety of irradiating the poultry products covered in this rule (Refs. 2 and 4 through 7).

The conditions under which foods are irradiated are important in considering the radiation chemistry of a given food. These conditions include: The radiation dose, the physical state of the food (e.g., frozen or dried), and the atmosphere in the package.

The radiolysis products generated in any food are directly proportional to the absorbed radiation dose (Ref. 2). Radiation-induced chemical changes may cause changes in the organoleptic properties of the food, and the radiation chemistry of food is strongly influenced by the physical state of the food. If all other conditions, including radiation dose and ambient atmosphere, are the same, the extent of chemical change that occurs in a particular food in the frozen state is less than the change that occurs in the non-frozen state. This is because of the reduced mobility, in the frozen state, of the initial radiolysis products, which will tend to recombine rather than diffuse and react with other food components. For similar reasons, if all other conditions are the same, the extent of chemical change that occurs in the dehydrated state is less than the change that occurs in the fully hydrated state (62 FR 64107 at 64110 and references cited therein).

FDA has previously determined that flesh foods, including poultry, can be considered a single group for the purposes of evaluating the safety of irradiation because they are similar in composition (62 FR 64107 at 64111). Specifically, the approximate composition of beef and lamb is 17 percent to 20 percent protein, 15 percent to 25 percent fat, and 56 percent to 65 percent water. Chicken (depending on cut and whether or not skin is included) is about 18 percent to 25 percent protein, 5 percent to 19 percent fat, and 57 percent to 75 percent water (Ref. 3). Fatty acids in the triglycerides from all flesh foods are comprised of the same predominant species: Oleic, palmitic, linoleic, and stearic acid.

Because of the commonality in the chemistry of the components of flesh foods and the predictability of the types and amounts of radiolytic products produced when food is irradiated, the Agency determined in the 1997 rule permitting the irradiation of meat, meat byproducts, and certain meat food products, that the conclusions regarding the irradiation of specific flesh foods can be used to draw conclusions about the irradiation of flesh foods as a class (62 FR 64107 at 64111). The effects of irradiation on non-frozen poultry irradiated at levels up to 4.5 kGy and in frozen poultry irradiated at levels up to 7.0 kGy are similar to the effects that occur in irradiated meat and have been shown to be safe.

a. Protein. As noted previously in this document, FDA has previously provided detailed discussions of the radiation chemistry of proteins in its rulemakings on the use of ionizing radiation to treat meat, meat byproducts, and certain meat food products (62 FR 64107 at 64110) and molluscan shellfish (70 FR 48057 at 48059-48060). Studies conducted with high-protein foods (e.g., meat, poultry, and seafood) have established that most of the radiolysis products derived from food proteins have the same amino acid composition as the original protein and are altered only in their secondary and tertiary structures (i.e., they are denatured, Ref. 2). These changes are similar to those that occur as a result of heating, but in the case of irradiation, even at doses up to 50 kGy and when food is irradiated at temperatures ranging from −168 °C to 60 °C in various studies, such changes are far less pronounced than heating and the amounts of reaction products generated are far lower (62 FR 64107 at 64110). Based on these studies, FDA concludes that there will be no significant change in the amino acid composition of poultry that is irradiated at absorbed doses not to exceed 4.5 kGy for non-frozen products and not to exceed 7.0 kGy for frozen products.

b. Lipid. FDA has also previously provided a detailed discussion of the radiation chemistry of lipids in the rules to permit the irradiation of meat, meat byproducts, and certain meat food products (62 FR 64107 at 64110-64111) and molluscan shellfish (70 FR 48057 at 48060). Those discussions also support this rule.

To summarize the previous discussions, a variety of radiolysis products derived from lipids have been identified. These include the following: Fatty acids, esters, aldehydes, ketones, alkanes, alkenes, and other hydrocarbons (Ref. 2). Identical or analogous products are also found in foods that have not been irradiated. In particular, heating food produces generally the same types of products, but in amounts far greater than the trace amounts produced by irradiating food (62 FR 64107 at 64111 and references cited therein).

A class of radiolysis products that is derived from lipids, 2-alkylcyclobutanones (2-ACBs), has been reported to form in small quantities when fats are exposed to ionizing radiation. Any 2-ACB formed will depend on the fatty acid composition of the food, e.g., 2-dodecylcyclobutanone (2-DCB) is a radiation byproduct of palmitic acid. (Refs. 8 and 9). In the molluscan shellfish rule, the Agency noted the reported creation of 2-DCB in irradiated chicken and ground beef, which contain triglycerides with esterified palmitic acid. FDA did not find that the presence of low levels of 2-DCB raised a safety issue (70 FR 48057 at 48060).

During the course of reviewing the chemical effects of irradiation, FDA became aware of a report that suggested that the irradiation of apple juice may produce furan (Ref. 10). Because furan has been shown to cause tumors in laboratory animals, FDA has extensively researched the occurrence of furan in irradiated foods over the last 10 years.

FDA has confirmed that certain foods form furan in low quantities when irradiated (Ref. 11). Studies conducted by FDA scientists and other researchers show that some foods form furan when heated and still other foods form furan during storage at refrigeration temperatures (Refs. 11 and 13). Testing of irradiated poultry found no furan at the limit of detection in the tests and detected no furan above the background levels of natural furan formation during storage (Refs. 11, 12, and 13). Therefore, the Agency concludes that the irradiation of poultry at the requested maximum absorbed dose will not increase the amount of furan in the diet and does not present a toxicological hazard under the conditions proposed in the USDA/FSIS petition.

As discussed previously in this document, the available information from chemical analyses of irradiated foods suggests that there is no reason to suspect a toxicological hazard due to consumption of an irradiated food (Ref. 5). The Agency notes that the large body of data from studies where irradiated foods were fed to laboratory animals provides an independent way to assess toxicological safety. These studies include those relied on by the Agency in previous evaluations of the safety of irradiated foods (see 51 FR 13376, April 18, 1986; 55 FR 18538, May 2, 1990; 62 FR 64107; 65 FR 45280, July 21, 2000 and 70 FR 48057, August 16, 2005). Additionally, FDA has looked at data and information in FDA files summarized by the Bureau of Foods Irradiated Food Committee (Refs. 14 and 15).

In summary, FDA has reviewed data relevant to the assessment of potential toxicity of irradiated poultry. While all of the studies are not of equal quality or rigor, the Agency has concluded that the quantity and breadth of testing and the number and significance of endpoints assessed would have identified any meaningful risk. Based on the totality of the evidence, FDA concludes that irradiation of poultry under the conditions proposed in the petition does not present a toxicological hazard.

It has been established that the nutrient values of the macronutrients in the diet (protein, fats, and carbohydrates) are not significantly altered by irradiation at the petitioned doses (62 FR 64107 at 64114 and Refs. 16 and 17). Minerals (e.g., calcium and iron) are also unaffected by irradiation (62 FR 64107 at 64114 and Ref. 17). Levels of certain vitamins may be reduced as a result of irradiation. The extent to which this reduction occurs depends on the specific vitamin, the type of food, and the conditions of irradiation. Not all vitamin loss is nutritionally significant; the extent to which the reduction in a specific vitamin level is significant depends on the relative contribution of the food in question to the total dietary intake of the vitamin (62 FR 64107 at 64114).

FDA has made the following finding with respect to the nutritional impact of consuming non-frozen flesh foods irradiated at levels up to 4.5 kGy and frozen flesh foods irradiated at levels up to 7.0 kGy: The effects of irradiation on the nutritional adequacy of irradiated flesh foods, which includes poultry, at or above the petitioned doses have been considered previously. Although the meat final rule (62 FR 64107, December 3, 1997), codified only the irradiation of red meat at up to the petitioned doses, the safety evaluation took into account the effects on the diet of irradiating all flesh foods. The Agency concluded that permitting the irradiation of poultry at the petitioned levels will not affect the nutritional status of poultry consumers (Ref. 3).

In summary, based on the available data and information, FDA concludes that amending the regulations, as set forth in this document, to allow for the use of ionizing radiation to treat poultry up to a maximum absorbed dose of 4.5 kGy for non-frozen products and not to exceed 7.0 kGy for frozen products will not have an adverse impact on the nutritional adequacy of the overall diet.

In the 1990 final rule for irradiation of poultry (55 FR 18538), FDA determined that while irradiation at a dose of 3 kGy reduces the number of many pathogenic and spoilage bacteria, it does not eliminate the relatively radiation-resistant spore-forming bacteria such as Clostridium botulinum (55 FR 18541). FDA also determined in the final rule that C. botulinum, if present, would not render fresh poultry irradiated at 3 kGy toxic before normal signs of spoilage became apparent (55 FR 18542). 1 As an extra margin of safety, however, the final rule established the limitation that packaging shall not exclude oxygen with respect to poultry, because C. botulinum does not grow in oxygenated environments (Ref. 18).

Since the final rule permitting the irradiation of poultry was published in 1990, the Agency notes that poultry production practices have changed, making C. botulinum contamination and growth less of a concern. 2 As part of the 1990 rulemaking, the Agency considered the fact that C. botulinum type E could potentially contaminate fish meal, which was typically used in chicken feed. Currently, however, fish meal has almost been completely replaced with high protein soybean and corn meal. Additionally, C. botulinum does not produce toxin when held at 10 °C (Ref. 19), and current USDA/FSIS regulations generally require that poultry plants maintain poultry at temperatures below 10 °C during processing (9 CFR 381.66(b)(1)). Finally, controlling microbiological contamination, including contamination from C. botulinum, is now required under mandatory USDA/FSIS poultry processing Hazard Analysis Critical Control Point plans (9 CFR part 417).

In addition to the changes in poultry production practices after the issuance of the 1990 final rule, a study published after the issuance of the 1990 poultry regulation demonstrates that lactic acid producing bacteria predominate on irradiated raw chilled meat at doses up to 5 kGy (Ref. 20) and flourish in an anaerobic environment that could potentially allow C. botulinum to grow. The growth of C. botulinum and other pathogens is inhibited by these non-pathogenic lactic acid producing bacteria (such as Lactobacillus species).

All of the previously mentioned factors would render it unlikely that C. botulinum could either grow or produce toxin in poultry under the conditions of irradiation specified in the regulation as amended by this final rule, including removal of the restriction on packaging that excludes oxygen (Ref. 18). Further, the presence of spoilage bacteria will warn consumers of spoilage before any C. botulinum present would produce toxin.

In summary, based on the available data and information, FDA concludes that irradiation of poultry under the conditions in this amended regulation will reduce or eliminate bacterial populations with no increased microbial risk from pathogens that may survive the irradiation process in either an aerobic or anaerobic atmosphere (Ref. 18).

Poultry products are subject to the Poultry Products Inspection Act (21 U.S.C. 451, et seq. ). Therefore, the labeling of these products irradiated under the conditions set forth in the regulation must comply with any requirements imposed by USDA/FSIS under its authority to approve the labeling of such products.

FDA has received numerous comments, primarily form letters, from individuals that state their opinions regarding the potential dangers and unacceptability of irradiating food. FDA has also received several comments from individuals or organizations that state their opinions regarding the potential benefits of irradiating food and urging FDA to approve the petition. Additionally, FDA received several comments from Public Citizen (PC) and the Center for Food Safety (CFS) requesting the denial of this and other food irradiation petitions.

Overall, the comments were of a general nature and not necessarily specific to the requests in the individual petitions, and did not contain any substantive information that could be used in a safety evaluation of irradiated poultry. Many of the comments from PC and CFS were also submitted to the docket for the Agency rulemaking on irradiation of molluscan shellfish (Docket No. 1999F-4372, FAP 9M4682). The topics raised in these comments included the following: Studies reviewed in the 1999 Food and Agriculture Organization of the United Nations/International Atomic Energy Agency/World Health Organization (FAO/IAEA/WHO) report on high-dose irradiation; a review article that analyzed studies of irradiated foods performed in the 1950s and 1960s; the findings of a 1971 study in which rats were fed irradiated strawberries; the findings regarding reproductive performance in a 1954 study in which mice were fed a special irradiated diet; issues regarding mutagenicity studies; certain international opinions; issues related to 2-ACBs, including purported promotion of colon cancer; the findings of certain studies conducted by the Indian Institute of Nutrition in the 1970s; general issues regarding toxicity data; FDA's purported failure to meet certain statutory requirements; data from a 2002 study purportedly showing an irradiation-induced increase in trans fatty acids in ground beef; studies regarding purported elevated hemoglobin levels and their significance; and an affidavit describing the opinions of a scientist regarding the dangers of irradiation and advocating the use of alternative methods for reducing the risk of foodborne disease. These comments have all been addressed by FDA in a previous rulemaking. For a detailed discussion of the Agency's response to each of the previously mentioned general comments, the reader is referred to the molluscan shellfish rule (70 FR 48057 at 48062 through 48071). Because these comments do not raise issues specific to irradiated poultry, and the previous responses are sufficient to address these issues as they pertain to the rule to permit the irradiation of poultry as described in this document, the Agency will not address these comments further here.

Based on the data and studies submitted in the petition and other information in the Agency's files, FDA concludes that the proposed use of irradiation to treat fresh (refrigerated and unrefrigerated) poultry food products  3 with absorbed doses that will not exceed 4.5 kGy and frozen poultry products not to exceed 7.0 kGy is safe with no need for a requirement that the packaging shall not exclude oxygen, and therefore, § 179.26 should be amended as set forth in this document.

In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the use of irradiation of poultry in response to the petition will be made available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT ). As provided in § 171.1(h), the Agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

This final rule does not provide for collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

The Agency has carefully considered the potential environmental effects of this action. The Agency has determined under 21 CFR 25.32(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see ADDRESSES ) either electronic or written objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. It is only necessary to send one set of documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

FDA's review of this petition was limited to section 409 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, the Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amended the FD&C Act to, among other things, add section 301(ll) (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exceptions in section 301(ll)(1) to (ll)(4) of the FD&C Act applies. In our review of this petition, FDA did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to the ionizing radiation source. Accordingly, this final rule should not be construed to be a statement that ionizing radiation used to treat poultry products, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all food additive final rules and therefore, should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

The following sources are referred to in this document. References marked with an asterisk (*) have been placed on display at the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. References without asterisks are not on display; they are available as published articles and books.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 179 is amended as follows:

The Pension Benefit Guaranty Corporation (PBGC) administers the pension plan termination insurance program under Title IV of the Employee Retirement Income Security Act of 1974 (ERISA). PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) sets forth (in subpart B) the methods for valuing plan benefits of terminating single-employer plans covered under Title IV. Guaranteed benefits and benefit liabilities under a plan that is undergoing a distress termination must be valued in accordance with subpart B of part 4044. In addition, when PBGC terminates an underfunded plan involuntarily pursuant to ERISA section 4042(a), it uses the subpart B valuation rules to determine the amount of the plan's underfunding.

Under § 4044.51(b) of the asset allocation regulation, early retirement benefits are valued based on the annuity starting date, if a retirement date has been selected, or the expected retirement age, if the annuity starting date is not known on the valuation date. Sections 4044.55 through 4044.57 set forth rules for determining the expected retirement ages for plan participants entitled to early retirement benefits. Appendix D of part 4044 contains tables to be used in determining the expected early retirement ages.

Table I in appendix D (Selection of Retirement Rate Category) is used to determine whether a participant has a low, medium, or high probability of retiring early. The determination is based on the year a participant would reach “unreduced retirement age” ( i.e., the earlier of the normal retirement age or the age at which an unreduced benefit is first payable) and the participant's monthly benefit at unreduced retirement age. The table applies only to plans with valuation dates in the current year and is updated annually by the PBGC to reflect changes in the cost of living, etc.

Tables II-A, II-B, and II-C (Expected Retirement Ages for Individuals in the Low, Medium, and High Categories respectively) are used to determine the expected retirement age after the probability of early retirement has been determined using Table I. These tables establish, by probability category, the expected retirement age based on both the earliest age a participant could retire under the plan and the unreduced retirement age. This expected retirement age is used to compute the value of the early retirement benefit and, thus, the total value of benefits under the plan.

This document amends appendix D to replace Table I-12 with Table I-13 in order to provide an updated correlation, appropriate for calendar year 2013, between the amount of a participant's benefit and the probability that the participant will elect early retirement. Table I-13 will be used to value benefits in plans with valuation dates during calendar year 2013.

PBGC has determined that notice of and public comment on this rule are impracticable and contrary to the public interest. Plan administrators need to be able to estimate accurately the value of plan benefits as early as possible before initiating the termination process. For that purpose, if a plan has a valuation date in 2013, the plan administrator needs the updated table being promulgated in this rule. Accordingly, the public interest is best served by issuing this table expeditiously, without an opportunity for notice and comment, to allow as much time as possible to estimate the value of plan benefits with the proper table for plans with valuation dates in early 2013.

PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this regulation, the Regulatory Flexibility Act of 1980 does not apply (5 U.S.C. 601(2)).

In consideration of the foregoing, 29 CFR part 4044 is amended as follows:

I. Authorization of State-Initiated Changes A. Why are revisions to State programs necessary?

States which have received Final authorization from the EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal hazardous waste program. As the Federal program changes, the States must change their programs and ask the EPA to authorize the changes. Changes to State hazardous waste programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to the EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 268, 270, 273 and 279. States can also initiate their own changes to their hazardous waste program and these changes must then be authorized.

We conclude that Texas' revisions to its authorized program meet all of the statutory and regulatory requirements established by RCRA. We found that the State-initiated changes make Texas' rules more clear or conform more closely to the Federal equivalents and are of such nature that a formal application is unnecessary. Therefore, we grant Texas final authorization to operate its hazardous waste program with the changes described in the table at Section G below. Texas has responsibility for permitting Treatment, Storage, and Disposal Facilities (TSDFs) within its borders (except in Indian Country) and for carrying out all authorized aspects of the RCRA program, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, the EPA will implement those requirements and prohibitions in Texas, including issuing permits, until the State is granted authorization to do so.

The effect of this decision is that a facility in Texas subject to RCRA will now have to comply with the authorized State requirements instead of the equivalent Federal requirements in order to comply with RCRA. Texas has enforcement responsibilities under its State hazardous waste program for violations of such program, but the EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to:

• Do inspections, and require monitoring, tests, analyses, or reports;

• Enforce RCRA requirements and suspend or revoke permits; and

• Take enforcement actions regardless of whether the State has taken its own actions.

This action does not impose additional requirements on the regulated community because the statutes and regulations for which Texas is being authorized by this direct action are already effective and are not changed by this action.

The EPA did not publish a proposal before this rule because we view this as a routine program change and do not expect comments that oppose this approval. We are providing an opportunity for public comment now. In addition to this rule, in the Proposed Rules section of this Federal Register , we are publishing a separate document that proposes to authorize the State program changes.

If the EPA receives comments that oppose this authorization or the incorporation-by-reference of the State program, we will withdraw this rule by publishing a timely document in the Federal Register before the rule becomes effective. The EPA will base any further decision on the authorization of the State program changes, or the incorporation-by-reference, on the proposal mentioned in the previous paragraph. We will then address all public comments in a later final rule. If you want to comment on this authorization and incorporation-by-reference, you must do so at this time. If we receive comments that oppose only the authorization of a particular change to the State hazardous waste program or the incorporation-by-reference of the State program, we may withdraw only that part of this rule, but the authorization of the program changes or the incorporation-by-reference of the State program that the comments do not oppose will become effective on the date specified above. The Federal Register withdrawal document will specify which part of the authorization or incorporation-by-reference of the State program will become effective and which part is being withdrawn.

The State of Texas initially received final authorization on December 26, 1984 (49 FR 48300), to implement its Base Hazardous Waste Management Program. This authorization was clarified in a notice published March 26, 1985 (50 FR 11858). Texas received authorization for revisions to its program, effective October 4, 1985 (51 FR 3952), February 17, 1987 (51 FR 45320), March 15, 1990 (55 FR 7318), July 23, 1990 (55 FR 21383), October 21, 1991 (56 FR 41626), December 4, 1992 (57 FR 45719), June 27, 1994 (59 FR 16987), June 27, 1994 (59 FR 17273), November 26, 1997 (62 FR 47947), December 3, 1997 (62 FR 49163), October 18, 1999 (64 FR 44836), November 15, 1999 (64 FR 49673), September 11, 2000 (65 FR 43246), June 14, 2005 (70 FR 34371), December 29, 2008, (73 FR 64252), July 13, 2009 (74 FR 22469), May 6, 2011 (76 FR 12283), and May 7, 2012 (77 FR 13200).

The State has made amendments to the provisions listed in the table which follows. These amendments clarify the State's regulations and make the State's regulations more internally consistent. The State's laws and regulations, as amended by these provisions, provide authority which remains equivalent to, no less stringent than, and not broader in scope than the Federal laws and regulations. These State-initiated changes satisfy the requirements of 40 CFR 271.21(a). We are granting Texas final authorization to carry out the following provisions of the State's program in lieu of the Federal program. These provisions are analogous to the indicated RCRA statutory provisions or RCRA regulations found at 40 CFR as of July 1, 2008. The Texas provisions are from the Texas Administrative Code (TAC), Title 30, effective December 31, 2009.

This authorization does not affect the status of State permits and those permits issued by the EPA because no new substantive requirements are a part of these revisions.

Texas is not authorized to carry out its Hazardous Waste Program in Indian Country within the State. This authority remains with EPA. Therefore, this action has no effect in Indian Country.

Codification is the process of placing a State's statutes and regulations that comprise the State's authorized hazardous waste management program into the Code of Federal Regulations (CFR). Section 3006(b) of RCRA, as amended, allows the Environmental Protection Agency (EPA) to authorize State hazardous waste management programs to operate in lieu of the Federal hazardous waste management regulatory program. The EPA codifies its authorization of State programs in 40 CFR part 272 and incorporates by reference State statutes and regulations that the EPA will enforce under sections 3007 and 3008 of RCRA and any other applicable statutory provisions.

The incorporation by reference of State authorized programs in the CFR should substantially enhance the public's ability to discern the current status of the authorized State program and State requirements that can be Federally enforced. This effort provides clear notice to the public of the scope of the authorized program in each State.

The EPA incorporated by reference Texas' then authorized hazardous waste program effective December 3, 1997 (62 FR 49163), November 15, 1999 (64 FR 49673), December 29, 2008 (73 FR 64252), and May 6, 2011 (76 FR 12283). In this action, EPA is revising Subpart SS of 40 CFR part 272 to include the recent authorization revision actions effective May 7, 2012 (77 FR 13200).

The purpose of this Federal Register document is to codify Texas' base hazardous waste management program and its revisions to that program. The EPA provided notices and opportunity for comments on the Agency's decisions to authorize the Texas program, and the EPA is not now reopening the decisions, nor requesting comments, on the Texas authorizations as published in the Federal Register notices specified in Section F of this document.

This document incorporates by reference Texas' hazardous waste statutes and regulations and clarifies which of these provisions are included in the authorized and Federally enforceable program. By codifying Texas' authorized program and by amending the Code of Federal Regulations, the public will be more easily able to discern the status of Federally approved requirements of the Texas hazardous waste management program.

The EPA is incorporating by reference the Texas authorized hazardous waste program in subpart SS of 40 CFR part 272. Section 272.2201 incorporates by reference Texas' authorized hazardous waste statutes and regulations. Section 272.2201 also references the statutory provisions (including procedural and enforcement provisions) which provide the legal basis for the State's implementation of the hazardous waste management program, the Memorandum of Agreement, the Attorney General's Statements and the Program Description, which are approved as part of the hazardous waste management program under Subtitle C of RCRA.

The EPA retains its authority under statutory provisions, including but not limited to, RCRA sections 3007, 3008, 3013, and 7003, and other applicable statutory and regulatory provisions to undertake inspections and enforcement actions and to issue orders in authorized States. With respect to these actions, the EPA will rely on Federal sanctions, Federal inspection authorities, and Federal procedures rather than any authorized State analogues to these provisions. Therefore, the EPA is not incorporating by reference such particular, approved Texas procedural and enforcement authorities. Section 272.2201(c)(2) of 40 CFR lists the statutory and regulatory provisions which provide the legal basis for the State's implementation of the hazardous waste management program, as well as those procedural and enforcement authorities that are part of the State's approved program, but these are not incorporated by reference.

The public needs to be aware that some provisions of Texas' hazardous waste management program are not part of the Federally authorized State program. These non-authorized provisions include:

(1) Provisions that are not part of the RCRA subtitle C program because they are “broader in scope” than RCRA subtitle C (see 40 CFR 271.1(i));

(2) Federal rules for which Texas is not authorized, but which have been incorporated into the State regulations because of the way the State adopted Federal regulations by reference;

(3) Unauthorized amendments to authorized State provisions; and

(4) New unauthorized State requirements.

State provisions that are “broader in scope” than the Federal program are not part of the RCRA authorized program and the EPA will not enforce them. Therefore, they are not incorporated by reference in 40 CFR part 272. For reference and clarity, 40 CFR 272.2201(c)(3) lists the Texas regulatory provisions which are “broader in scope” than the Federal program and which are not part of the authorized program being incorporated by reference. “Broader in scope” provisions cannot be enforced by the EPA; the State, however, may enforce such provisions under State law.

Texas has adopted but is not authorized for the following Federal rules published in the Federal Register on April 12, 1996 (61 FR 16290); December 5, 1997 (62 FR 64504); June 8, 2000 (65 FR 36365); March 4, 2005 (70 FR 10776), as amended June 16, 2005 (70 FR 35034). Therefore, these Federal amendments included in Texas' adoption by reference at 30 Texas Administrative Code (TAC) sections 335.112(a)(1) and (a)(4), 335.152(a)(1) and (a)(4), and 335.431(c)(1) and (c)(3), are not part of the State's authorized program and are not part of the incorporation by reference addressed by this Federal Register document.

Additionally, Texas' hazardous waste regulations include amendments which have not been authorized by the EPA. Since the EPA cannot enforce a State's requirements which have not been reviewed and authorized in accordance with RCRA section 3006 and 40 CFR part 271, it is important to be precise in delineating the scope of a State's authorized hazardous waste program. Regulatory provisions that have not been authorized by the EPA include amendments to previously authorized State regulations as well as new State requirements.

In those instances where Texas has made unauthorized amendments to previously authorized sections of State code, the EPA is identifying in 40 CFR 272.2201(c)(4) any regulations which, while adopted by the State and incorporated by reference, include language not authorized by the EPA. Those unauthorized portions of the State regulations are not Federally enforceable. Thus, notwithstanding the language in Texas hazardous waste regulations incorporated by reference at 40 CFR 272.2201(c)(1), the EPA will only enforce those portions of the State regulations that are actually authorized by the EPA. For the convenience of the regulated community, the actual State regulatory text authorized by the EPA for the citations listed at 40 CFR 272.2201(c)(4) (i.e., without the unauthorized amendments) is compiled as a separate document, Addendum to the EPA Approved Texas Regulatory Requirements Applicable to the Hazardous Waste Management Program, July 2009. This document is available from EPA Region 6, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733, Phone number: (214) 665-8533.

State regulations that are not incorporated by reference in this rule at 40 CFR 272.2201(c)(1), or that are not listed in 40 CFR 272.2201(c)(3) (“broader in scope”) or 40 CFR 272.2201(c)(4) (“unauthorized amendments to authorized State provisions”), are considered new unauthorized State requirements. These requirements are not Federally enforceable.

With respect to any requirement pursuant to the Hazardous and Solid Waste Amendments of 1984 (HSWA) for which the State has not yet been authorized, the EPA will continue to enforce the Federal HSWA standards until the State is authorized for these provisions.

The EPA is not amending 40 CFR part 272 to include HSWA requirements and prohibitions that are implemented by EPA. Section 3006(g) of RCRA provides that any HSWA requirement or prohibition (including implementing regulations) takes effect in authorized and not authorized States at the same time. A HSWA requirement or prohibition supersedes any less stringent or inconsistent State provision which may have been previously authorized by the EPA (50 FR 28702, July 15, 1985). The EPA has the authority to implement HSWA requirements in all States, including authorized States, until the States become authorized for such requirement or prohibition. Authorized States are required to revise their programs to adopt the HSWA requirements and prohibitions, and then to seek authorization for those revisions pursuant to 40 CFR part 271.

Instead of amending the 40 CFR part 272 every time a new HSWA provision takes effect under the authority of RCRA section 3006(g), the EPA will wait until the State receives authorization for its analog to the new HSWA provision before amending the State's 40 CFR part 272 incorporation by reference. Until then, persons wanting to know whether a HSWA requirement or prohibition is in effect should refer to 40 CFR 271.1(j), as amended, which lists each such provision.

Some existing State requirements may be similar to the HSWA requirement implemented by the EPA. However, until the EPA authorizes those State requirements, the EPA can only enforce the HSWA requirements and not the State analogs. The EPA will not codify those State requirements until the State receives authorization for those requirements.

The Office of Management and Budget has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore, this action is not subject to review by OMB. This rule incorporated by reference Texas' authorized hazardous waste management regulations, and imposes no additional requirements beyond those imposed by State law. This final rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Incorporation by reference will not impose any new burdens on small entities. Accordingly, I certify that this action 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. ). Because this rule merely incorporates by reference certain existing State hazardous waste management program requirements which the EPA already approves under 40 CFR part 271, and does not impose any additional enforceable duty beyond that required by State law, it 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).

This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely incorporates by reference existing State hazardous waste management program requirements without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also does not have Tribal implications within the meaning of Executive Order 13175 (65 FR 67249, November 6, 2000).

This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This action is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply Distribution or Use” (66 FR 28344, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

Under RCRA 3006(b), the EPA grants a State's application for incorporation by reference as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a State incorporation by reference application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply. The final rule does not include environmental justice issues that require consideration under Executive Order 12898 (59 FR 7629, February 16, 1994). The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.

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 prior to publication in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective January 29, 2013.

For the reasons set forth in the preamble, under the authority at 42 U.S.C. 6912(a), 6926, and 6974(b), the EPA is granting final authorization under part 271 to the State of Texas for revisions to its hazardous waste program under the Resource Conservation and Recovery Act and is amending 40 CFR part 272 as follows:

This document makes the following corrections to the final rule published October 26, 2012, at 77 FR 65320:

1. On page 65320, column 2, revise the DATES section to read as follows:

This document makes the following correction to the final rule published May 24, 2012, at 77 FR 30915:

A “rail equipment accident/incident” is a collision, derailment, fire, explosion, act of God, or other event involving the operation of railroad on-track equipment (standing or moving) that results in damages to railroad on-track equipment, signals, tracks, track structures, or roadbed, including labor costs and the costs for acquiring new equipment and material, greater than the reporting threshold for the year in which the event occurs. 49 CFR 225.19(c). Each rail equipment accident/incident must be reported to FRA using the Rail Equipment Accident/Incident Report (Form FRA F 6180.54). 49 CFR 225.19(b) and (c). As revised, effective in 1997, paragraphs (c) and (e) of 49 CFR 225.19 provide that the dollar figure that constitutes the reporting threshold for rail equipment accidents/incidents will be adjusted, if necessary, every year in accordance with the procedures outlined in appendix B to part 225 to reflect any cost increases or decreases.

Approximately one year has passed since the rail equipment accident/incident reporting threshold was revised. 76 FR 72850 (November 28, 2011). Consequently, FRA has recalculated the threshold, as required by § 225.19(c), based on increased costs for labor and increased costs for equipment. FRA has determined that the current reporting threshold of $9,500, which applies to rail equipment accidents/incidents that occur during calendar year 2012, should increase by $400 to $9,900 for equipment accidents/incidents occurring during calendar year 2013, effective January 1, 2013. The specific inputs to the equation set forth in appendix B ( i.e., Tnew = Tprior * [1 + 0.4( Wnew − Wprior )/ Wprior + 0.6( Enew − Eprior )/100]) to part 225 are:

In this rule, FRA has recalculated the monetary reporting threshold based on the formula discussed in detail and adopted, after notice and comment, in the final rule published December 20, 2005, 70 FR 75414. FRA has found that both the current cost data inserted into this pre-existing formula and the original cost data that they replace were obtained from reliable Federal government sources. FRA has found that this rule imposes no additional burden on any person, but rather provides a benefit by permitting the valid comparison of accident data over time. Accordingly, finding that notice and comment procedures are either impracticable, unnecessary, or contrary to the public interest, FRA is proceeding directly to the final rule.

This rule has been evaluated in accordance with existing policies and procedures, and determined to be non-significant under both Executive Order 12866 and 13563 in addition to DOT policies and procedures (44 FR 11034 (Feb. 26, 1979)).

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) requires a review of proposed and final rules to assess their impact on small entities, unless the Secretary certifies that the rule will not have a significant economic impact on a substantial number of small entities. Pursuant to Section 312 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), FRA has issued a final policy that formally establishes “small entities” as including railroads that meet the line-haulage revenue requirements of a Class III railroad. 49 CFR part 209, app. C. For other entities, the same dollar limit in revenues governs whether a railroad, contractor, or other respondent is a small entity. Id. About 719 of the approximately 764 railroads in the United States are considered small entities by FRA. FRA certifies that this final rule will have no significant economic impact on a substantial number of small entities. To the extent that this rule has any impact on small entities, the impact will be neutral or insignificant.

The frequency of rail equipment accidents/incidents, and therefore also the frequency of required reporting, is generally proportional to the size of the railroad. A railroad that employs thousands of employees and operates trains millions of miles is exposed to greater risks than one whose operation is substantially smaller. Small railroads may go for months at a time without having a reportable occurrence of any type, and even longer without having a rail equipment accident/incident. For example, current FRA data indicate that 2,693 rail equipment accidents/incidents were reported in 2007, with small railroads reporting 364 of them. Data for 2008 show that 2,481 rail equipment accidents/incidents were reported, with small railroads reporting 294 of them. In 2009, 1,910 rail equipment accidents/incidents were reported, and small railroads reported 271 of them. In 2010, 1,902 rail equipment accidents/incidents were reported, with small railroads reporting 258 of them. In 2011, 2010 rail equipment accidents/incidents were reported, with small railroads reporting 267 of them. On average for those five calendar years, small railroads reported about 13% (ranging from 12% to 14%) of the total number of rail equipment accidents/incidents. FRA notes that these data are based on accidents/incidents reported by railroads with less than 400,000 employee hours per year. FRA's accident reporting regulations require railroads to report employee hours; thus for purposes of 49 CFR part 225, FRA has historically categorized and displayed the data in this manner. Of the approximately 764 railroads in the United States, 731 fit into the category of less than 400,000 employee hours per year and the characteristics of such railroads are substantively similar to railroads otherwise considered small entities in accordance with FRA's policy. Accordingly, because the number and characteristics of these railroads are consistent with those otherwise considered small entities FRA believes that this approach is appropriate. FRA notes, however, that these data are accurate as of the date of issuance of this final rule, and are subject to minor changes due to additional reporting. Absent this rulemaking ( i.e., any increase in the monetary reporting threshold), the number of reportable accidents/incidents would increase, as keeping the 2012 threshold in place would not allow it to keep pace with the increasing dollar amounts of wages and rail equipment repair costs. Therefore, this rule will be neutral in effect. Increasing the reporting threshold will slightly decrease the recordkeeping burden for railroads over time. Any recordkeeping burden will not be significant and will affect the large railroads more than the small entities, due to the higher proportion of reportable rail equipment accidents/incidents experienced by large entities.

There are no new information collection requirements associated with this final rule. Therefore, no estimate of a public reporting burden is required.

Executive Order 13132, entitled, “Federalism,” signed on August 4, 1999, requires that each agency “in a separately identified portion of the preamble to the regulation as it is to be issued in the Federal Register , provide[] to the Director of the Office of Management and Budget a federalism summary impact statement, which consists of a description of the extent of the agency's prior consultation with State and local officials, a summary of the nature of their concerns and the agency's position supporting the need to issue the regulation, and a statement of the extent to which the concerns of the State and local officials have been met * * *” This rulemaking action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132. This rule will not have a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and the responsibilities among the various levels of government, as specified in the Executive Order 13132. Accordingly, FRA has determined that this rule will not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism assessment. Accordingly, a federalism assessment has not been prepared.

FRA has evaluated this regulation in accordance with its “Procedures for Considering Environmental Impacts” (FRA's Procedures) (64 FR 28545 (May 26, 1999)) as required by the National Environmental Policy Act (42 U.S.C. 4321 et seq. ), other environmental statutes, Executive Orders, and related regulatory requirements. FRA has determined that this regulation is not a major FRA action (requiring the preparation of an environmental impact statement or environmental assessment) because it is categorically excluded from detailed environmental review pursuant to section 4(c)(20) of FRA's Procedures. 64 FR 28545, 28547 (May 26, 1999). In accordance with section 4(c) and (e) of FRA's Procedures, the agency has further concluded that no extraordinary circumstances exist with respect to this regulation that might trigger the need for a more detailed environmental review. As a result, FRA finds that this regulation is not a major Federal action significantly affecting the quality of the human environment.

Pursuant to Section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency “shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector (other than to the extent that such regulations incorporate requirements specifically set forth in law).” Section 202 of the Act (2 U.S.C. 1532) further requires that “before promulgating any general notice of proposed rulemaking that is likely to result in the promulgation of any rule that includes any Federal mandate that may result in expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) [currently $143,100,000] in any one year, and before promulgating any final rule for which a general notice of proposed rulemaking was published, the agency shall prepare a written statement” detailing the effect on State, local, and tribal governments and the private sector. The final rule will not result in the expenditure, in the aggregate, of $143,100,000 or more in any one year, and thus preparation of such a statement is not required.

Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.” 66 FR 28355 (May 22, 2001). Under the Executive Order, a “significant energy action” is defined as any action by an agency (normally published in the Federal Register ) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking: That (1)(i) is a significant regulatory action under Executive Order 12866 or any successor order, and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (2) that is designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. FRA has evaluated this final rule in accordance with Executive Order 13211. FRA has determined that this final rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Consequently, FRA has determined that this regulatory action is not a “significant energy action” within the meaning of Executive Order 13211.

Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). See http://www.regulations.gov/#!privacyNotice for the privacy notice of regulations.gov or interested parties may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477).

In consideration of the foregoing, FRA amends part 225 of chapter II, subtitle B of title 49, Code of Federal Regulations, as follows: