On February 9, 2004, OPM published proposed regulations in the Federal Register (69 FR 5935-5936) on changes in health benefits enrollment for annuitants or survivor annuitants when a carrier terminates participation in the FEHB Program. Effective August 18, 1997, OPM amended 5 CFR 890.306(l)(4) to authorize OPM to enroll an annuitant in the standard option of the Service Benefit Plan when the annuitants' health plan terminates participation in whole or in part in the FEHB Program and the annuitant fails to elect to change to another participating health plan. At that time, the BC/BS Service Benefit Plan offered the high option and the standard option. The standard option was the lower level of benefits with a lower premium cost. Beginning with the January 1, 2002, contract year, the BC/BS Service Benefit Plan merged the high option coverage into the standard option coverage and added a basic option. The standard option is now the highest level of coverage offered with the more costly premium rate.

In the existing regulation, an annuitant who does not elect to change health plans is deemed to have enrolled in the standard option, or if the plan he or she was enrolled in had two options, he or she is deemed to have enrolled in the same option previously enrolled in (either high or low), if the annuity is sufficient to pay the high option premium. The annuitant may not change to another health plan until the next open season.

The more costly premium rate may not be affordable for many annuitants. Amending this regulation will allow OPM the flexibility to consider the premium rate and the benefits that the annuitant was receiving under his or her terminated health plan, and enroll the annuitant in the option of the BC/BS Service Benefit Plan that most closely approximates the terminated plan. In addition, this amendment will give the annuitant the opportunity to change the option or to change to another health plan of his or her choice retroactively within 90 days of the date OPM sent notification that he or she has been deemed enrolled in a particular option of the BC/BS Service Benefit Plan.

On February 9, 2004, OPM issued proposed regulations at 69 FR 5935-5936 and requested comments by April 9, 2004. OPM received comments from NARFE. NARFE contends that the benefit structure of the BC/BS Service Benefit Plan basic option is not suitable for annuitants who have Medicare because the basic option does not have a mail service prescription drug benefit and co-payments are based on a supply of up to 34-days as opposed to a 90-day supply under the standard option. In addition, NARFE contends that the basic option does not have a skilled nursing facility benefit in conjunction with Medicare, as does the standard option. OPM's response to these contentions is that annuitants who are deemed enrolled in the BC/BS Service Benefit Plan basic option will have been previously enrolled in a health plan that is similar to the basic option. NARFE also requests that annuitants be allowed up to 90-days to elect to enroll in a new health plan. OPM has agreed to amend the regulation to allow all annuitants up to 90-days to elect to enroll in a new plan to accommodate the annuitants who do not realize that there has been a change in the amount of their health insurance premiums until they receive their February annuity check.

OPM has determined that this regulation will not have a significant economic impact on a substantial number of small entities because the regulation will only affect health benefits of certain Federal retirees.

This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866.

We have examined this rule in accordance with Executive Order 13132, Federalism, and have determined that this rule will not have any negative impact on the rights, roles, and responsibilities of State, local, or tribal governments.

This rule sets out regulations governing the use of “designated marketing associations” (DMA's) by peanut producers in connection with the Farm Security and Rural Investment Act of 2002, Public Law 107-171, (“2002 Act”), in the making of marketing assistance loans (MAL's) and loan deficiency payments (LDP's) in lieu of MAL's. Section 1307(a)(4) of the 2002 Act provided for peanuts that such loans and LDP's could be obtained through a DMA or a marketing cooperative of producers approved by the Secretary, or the Farm Service Agency of the Department. Regulations governing such loans and LDP's are codified in 7 CFR Part 1421 and include DMA provisions. Rules relating to the use of cooperative marketing associations (CMA's) are found at 7 CFR Part 1425. This rule adds greater specificity to part 1421's DMA provisions consistent with current procedures and reorganizes part 1421 by designating a separate subpart for the DMA provisions. Also, the rule specifies when storage credit may begin for DMA-handled loans. Also, § 1421.115 is renumbered as 1421.114 to reflect that the latter number was not being used. Further, the authority citation for Part 1421 is updated.

Section 1601(c) of the Farm Security and Rural Investment Act of 2002 (2002 Act) provides that the administration of Title I of the 2002 Act shall be made without regard to the notice and comment provisions of 5 U.S.C. 553 or the Statement of Policy of the Secretary of Agriculture effective July 24, 1971, (36 FR 13804) relating to notices of proposed rulemaking and public participation in rulemaking. Likewise, Section 1601 of the 2002 Act provides that in carrying out the provisions exempting the administration of the program from notice and comment, the Secretary shall use the authority provided under 5 U.S.C. section 808 of Title 5, United States Code. Under the latter provisions, certain rules are exempted from possible Congressional review before implementation where it is determined that going without notice and public procedures are in the public interest. Such is the case here, in light of the explicit provisions of Section 1601. In addition, this rule simply sets out procedures for voluntary participation by non-producers related to an ongoing program and the new regulations reflect current policy. For those reasons as well, delay in implementation would be contrary to the public interest. Accordingly, this rule is made effective on publication.

This rule has been designated as “Not Significant” under Executive Order 12866, and has not been reviewed by the Office of Management and Budget.

The title and number of the Federal assistance program in the Catalog of Federal Domestic Assistance to which this final rule applies is 10.051—Commodity Loans and Loan Deficiency Payments.

The Regulatory Flexibility Act is not applicable to this rule because the Office of the Secretary, FSA and CCC are not required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking for the subject matter of this rule.

The environmental impacts of this rule have been considered consistent with the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321 et seq. , the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and regulations of the Farm Service Agency (FSA) of the Department of Agriculture (USDA) regarding compliance with NEPA, 7 CFR part 799. An environmental evaluation was completed and the action has been determined not to have the potential to significantly impact the quality of the human environment and no environmental assessment or environmental impact statement is necessary. A copy of the environmental evaluation is available for inspection and review upon request.

The final rule has been reviewed under Executive Order 12778. This rule preempts State laws that are inconsistent with its provisions. This rule is not retroactive. Before any judicial action may be brought regarding this rule, all administrative remedies must be exhausted.

This program is not subject to Executive Order 12372, which requires consultation with State and local officials. See the notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115 (June 24, 1983).

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) does not apply to this rule because the Office of the Secretary, FSA and CCC are not required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking about the subject matter of this rule. Further, this rule imposes no unfunded mandates, as defined in UMRA, on any local, State, or tribal government or the private sector.

Section 1601(c) of the 2002 Act provides that the promulgation of regulations and the administration of Title I of the 2002 Act shall be made without regard to chapter 5 of title 44 of the United States Code (the Paperwork Reduction Act). Accordingly, these regulations and the forms, and other information collection activities needed to administer the program authorized by these regulations, are not subject to review by the Office of Management and Budget under the Paperwork Reduction Act.

FSA is committed to compliance with the Government Paperwork Elimination Act (GPEA) and the Freedom to E-File Act, which require Government agencies in general, and FSA in particular, to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. The forms and other information collection activities required for participation in the program are not yet fully implemented for the public to conduct business with FSA electronically. Currently, however, loan application forms are available electronically through the USDA eForms Web site for downloading. Applications from producers may be submitted to current DMA, by mail or by FAX if appropriate FAX authorization forms are on file. At this time, electronic submission of forms is also available and producers, or DMA's acting on their behalf, may also file for e-LDP's on line.

Highly pathogenic avian influenza (HPAI) is an extremely infectious and fatal disease of poultry and a wide variety of other birds. HPAI can strike poultry quickly without any infection warning signs and, once established, the disease can spread rapidly from flock to flock. In some instances, strains of HPAI viruses can be infectious to people. Human infections with AI viruses under natural conditions have been documented in recent years. Particularly alarming is the HPAI strain of most of these outbreaks, H5N1, which has crossed the species barrier and caused severe disease, with high mortality, in humans. Recent outbreaks of HPAI in Southeast Asia have caused significant concern among health authorities worldwide because of the potential for the human and avian flu viruses to swap genes, creating a new virus to which humans would have little or no immunity.

The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA or the Department) regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases. The regulations in 9 CFR parts 93, 94, and 95 (referred to below as the regulations) govern the importation of certain animals, birds, poultry, meat, other animal products and byproducts, hay, and straw into the United States in order to prevent the introduction of various animal diseases, including HPAI subtype H5N1.

In an interim rule effective August 7, 2004, and published in the Federal Register on February 1, 2005 (70 FR 5043-5044, Docket No. 04-091-1), we amended the regulations in part 94 by adding Malaysia to the list of regions in § 94.6(d) where HPAI subtype H5N1 exists.

Comments on the interim rule were required to be received on or before April 4, 2005. We received one comment by that date, from a private citizen. The commenter supported the interim rule.

Therefore, for the reasons given in the interim rule and in this document, we are adopting the interim rule as a final rule without change.

This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Order 12988, and the Paperwork Reduction Act.

Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

On December 29, 1995, FSIS published a proposed rule in the Federal Register to amend the Federal meat and poultry products inspection regulations to establish a general definition and standard of identity (the “general standard”) for standardized meat and poultry products that have been modified to qualify for use of an expressed nutrient content claim in their product names (60 FR 67474). Under the proposed general standard, meat and poultry products with a regulatory standard of identity or composition in 9 CFR Parts 319 and 381, subpart P, would be permitted to be formulated and processed with ingredients otherwise not provided for, or in amounts greater than, that allowed by the standard in order to qualify for certain expressed nutrient content claims permitted in 9 CFR 317 subpart B and 381, subpart Y, such as “fat free,” “low fat,” and “light.” Instead of being identified as “substitute” standardized meat and poultry products, as required by the current regulations (9 CFR 317.313(d) and 381.413(d)), standardized meat and poultry products formulated or processed in accordance with the proposed general standard could be identified by an expressed nutrient content claim in conjunction with the standardized term.

To allow modified versions of standardized meat and poultry products that have been formulated to reduce their fat content to be marketed without having to be labeled as “substitutes,” FSIS issued Policy Memo 123, “Modified Breakfast Sausage, Cooked Sausage, and Fermented Sausage Products Identified by a Nutrient Content Claim and a Standardized or Traditional Name,” and Policy Memo 121B “Labeling of Low Fat Ground Beef and Low Fat Hamburger Containing Added Ingredients,” in January of 1995. These policy memoranda stated, among other things, that these products are permitted to be identified by a nutrient content claim that reflects the reduction in fat content in the product in conjunction with the appropriate standardized product name, e.g. , “Fat Free Bologna,” “Low Fat Pepperoni,” or “Low Fat Hamburger, Water, and Carrageenan Product.” Both Policy Memo 121B and Policy Memo 123 were issued as interim measures until such time that rulemaking could be completed. Both of these policy memoranda will be rescinded by this final rule.

In this final rule, FSIS is establishing a general definition and standard of identity for modified versions of meat and poultry products that substitute for meat and poultry products defined by a regulatory standard of identity or composition in 9 CFR Part 319 and 381, subpart P, i.e. , “substitute standardized products.” This rule is needed to facilitate the development and availability of substitute standardized meat and poultry products that have reductions in constituents that are of health concern to some people, e.g. , fat, cholesterol, and sodium. The rule allows FSIS to rely more on labeling requirements and less on restrictive recipe-type standards to carry out its mandate to ensure that the labels of meat and poultry products are truthful and not misleading to consumers.

FSIS received 56 comments in response to the proposed rule from members of the meat and poultry processing industry, industry trade associations, members of the flavoring and ingredients industry, members of the soybean industry, academia, health professionals, governmental entities, consumer advocacy groups, and individual consultants. In general, the comments submitted in response to the proposed rule were favorable. Most commenters agreed that FSIS should establish a regulatory general standard for substitute standardized products that are lower in fat, cholesterol, or sodium.

One commenter opposed the rule because the commenter believed it did not go far enough in providing flexibility to industry. This commenter stated that, rather than converting FSIS Policy Memo 123 into regulation, FSIS should create a new standard for substitute standardized meat and poultry products to allow the use of non-traditional ingredients in all products, not just versions of products that are identified by a nutrient content claim and a standardized product name.

Response: FSIS recognizes the need to explore this and other issues concerning reform of the meat and poultry product standards. However, expanding the use of non-traditional ingredients for all standardized products is an issue that is outside the scope of this rulemaking. The Agency is, however, exploring this and other related issues in a separate rulemaking to modernize meat and poultry product standards. This rulemaking is discussed in greater detail later in this document.

Comment: A few commenters felt that FSIS Policy Memo 121B and Policy Memo 123 should remain in effect once this final rule becomes effective so that products produced under these policies can continue to be manufactured. Other commenters stated that the general standard defined in the proposed rule should apply to food products whose standards are documented in the FSIS Food Standards and Labeling Policy Book (the Policy Book), as well as those products whose standards of identity and composition are codified in Parts 319 and 381, subpart P. The commenters noted that the wording in proposed 9 CFR 319.10(a) and 381.172(a) does not specifically include the standards described in the Policy Book, while FSIS Policy Memo 123 does. They were concerned that once the rule is in place, and Policy Memo 123 is rescinded, certain products, such as “Low Fat Pepperoni,” would no longer be permitted because pepperoni does not have a standard of identity codified in the regulations.

Response: The policy embodied in the proposed general standard will also apply to the informal standards for products, such as pepperoni, that are described in the Policy Book. Thus, Policy Memo 121B and Policy Memo 123 will not remain in effect once the proposed rule becomes final. FSIS issued both Policy Memo 121B and Policy 123 as interim measures to accommodate certain lower fat substitute meat and poultry products until such time that rulemaking was completed. This final rule incorporates, expands, and codifies the intent of these policy memoranda. Thus, rescinding Policy Memo 121B and Policy Memo 123 will not preclude the production of products that have been made under those policies. The Agency intends to clarify this point in a policy bulletin, which is a more appropriate document for addressing the informal standards described in the Policy Book.

Comment: Some commenters disagreed with the Agency's proposal to permit only expressed nutrient content claims that relate to reductions in constituents such as fat, cholesterol, or sodium, in conjunction with the standardized name of the substitute product. These commenters felt that nutrient content claims, such as “high in” and “good source of,” that emphasize the presence of an ingredient, should also be permitted to be used as part of the substitute standardized product's name, provided that the product qualifies for these claims under 9 CFR part 317 subpart B or 9 CFR 381 subpart Y.

Response: Under the current regulations, meat and poultry products that satisfy the criteria for use of nutrient content claims defined in 9 CFR part 317 subpart B and 9 CFR 381 subpart Y are permitted to make claims, such as “high in” or “good source of,” that emphasize the presence of a nutrient. The ability to make these kinds of nutrient content claims is not affected by this rulemaking.

In the preamble to the proposed rule, FSIS noted that the meat and poultry product standards did not appear to preclude the making and marketing of standardized products that qualify for the use of claims such as “high in” and “good source of.” Therefore, in the proposed regulation, the Agency did not expressly provide for these types of nutrient content claims in the general standard. However, in the proposal, FSIS did solicit comments on whether current regulatory standards prevent the distribution of products with nutrient content claims other than those that reflect a reduction in the level of a nutrient.

None of the comments received suggested that the existing meat and poultry product standards preclude the making and marketing of standardized products that qualify for the use of claims such as “high in” or “good source of.” Furthermore, because of the FSIS policy that precludes direct nutrient fortification of meat and poultry products, standardized meat and poultry products are not permitted to be modified to qualify to use a nutrient content claim by adding nutrients to the product. Therefore, FSIS has decided not to modify the scope of coverage in this final rule to permit nutrient content claims other than those that reflect a reduction of constituents that are of health concern to some people, e.g. , fat, cholesterol, and sodium, to be used as part of the product name. Products that qualify for “high in” and “good source of” nutrient content claims may continue to highlight these claims as provided in 9 CFR 317.354 and 9 CFR 381.454.

Comment: Four commenters suggested that FSIS reexamine its policy precluding direct nutrient fortification of meat and poultry products. Two of these commenters suggested that FSIS allow selective nutrient fortification in meat and poultry products to permit standardized products to be modified so that they qualify to use nutrient content claims, such as “high in Vitamin A,” as part of the product name. One of these commenters requested that FSIS modify the language in proposed 9 CFR 319.10(a) to delete the following italicized words “ * * * because of a compositional deviation that results from reduction of a constituent that is described by an expressed nutrient content claim * * *”

Another commenter suggested that FSIS permit selective protein fortification in substitute standardize products so that they may use claims such as “High in Protein” and “Good Source of Protein” as part of the product name. This commenter recommended that FSIS continue to require substitute standardized products to meet the same basic minimum meat and poultry content requirements contained in the existing meat and poultry product standards, but that the overall protein level in these products should be allowed to be fortified using ingredients such as soy protein. Another commenter that expressed support for permitting direct nutrient fortification of meat and poultry products felt that, because the over-consumption of protein in the American diet, that protein fortification should not be permitted.

Two other commenters requested that FSIS allow fortification to replace vitamins and minerals that may be lost due to formulation adjustments to produce nutrient-modified foods. These commenters also requested that FSIS exempt substitute standardized products subject to the general standard from the minimum meat and poultry content requirements imposed by the existing meat and poultry product standards. Both commenters suggested that for these substitute products, FSIS should focus on nutritional equivalency to the traditional standardized product rather than meat content equivalency, and permit reductions in the meat and poultry content for purposes of reducing the product's fat content. The commenters stated that if FSIS were to permit such reductions in the meat and poultry content, fortification might be necessary to replace lost nutrients.

One commenter suggested that, while existing FDA regulations state that the FDA does not consider it appropriate to fortify meat and poultry products (21 CFR 104.20(a)), the FDA regulations appear to make an exception for fortification of foods that replace traditional foods when fortification is necessary to avoid nutritional inferiority.

Response: The comments requesting that FSIS reexamine its policy on nutrient fortification raise some interesting points, particularly with respect to the issues concerning nutritional equivalency versus meat content equivalency. However, the decision to allow fortification of meat and poultry products involves several complex issues, many of which are outside the scope of this rulemaking.

FSIS” fortification policy is derived from FDA's policy statement on nutrient fortification codified at 21 CFR part 104, subpart B, which states, in part, that the FDA “* * * does not consider it appropriate to fortify fresh produce; meat, poultry, or fish products * * * (21 CFR 104.20(a)). The fundamental objective of FDA's fortification policy is “* * * to establish a uniform set of principles that will serve as a model for the rational addition of nutrients to food'(21 CFR 104.20(a)). As stated in its policy, FDA determined that, “* * * random fortification of foods could result in over-or under-fortification in consumer diets and create nutrient imbalances in the food supply” (21 CFR 104.20(a)).

FSIS has a long history of prohibiting direct fortification of meat and poultry products, which is supported by the codified FDA fortification policy. Thus, when determining whether to revise its nutrient fortification policy for meat and poultry products, FSIS must consider the issues in relationship to the codified FDA policy statement on fortification. Furthermore, in order to maintain consistent policies regarding nutrient fortification between the two agencies, any effort by FSIS to revise its prohibition on direct nutrient fortification of meat and poultry products should include FDA participation and involve the scientific community ( e.g. , the National Academy of Sciences, Institute of Medicine). FSIS, FDA, and the scientific community need to first consider the guiding scientific principles that form the basis for establishing a public health need for fortifying meat and poultry with nutrients. Only after these principles are applied could there be consideration of revising the current fortification policy. 1 Obviously, this type of effort is outside the intended purpose and scope of this rulemaking. It would be more appropriate to consider this matter in a separate rulemaking where the Agency can receive the benefit of an open and thorough review of all issues related to the fortification of meat and poultry products.

Furthermore, FSIS believes that the formulation adjustments needed to produce substitute standardized products with reductions in constituents such as fat, cholesterol, and sodium, will not result in a product that is nutritionally inferior to the product for which it is a substitute. Important nutrients, such as iron, zinc, B vitamins, and protein, are associated with the lean muscle portion of meat and poultry tissue, not the fat. Because the minimum meat and poultry requirement for substitute standardized products is not changed by this rule, reductions in the fat content should not affect the levels of nutrients associated with the lean muscle portion of these products. Therefore, nutrient fortification is not necessary to prevent the products subject to the general standard defined by this rule from being nutritionally inferior to the standardized products for which they are a substitute.

Comment: The proposed regulation stated that a substitute standardized product with performance characteristics, e.g. , cooking quality, freezing quality, spreadability of product, and shelf-life, that materially limit the use of the product must include a disclaimer on the product's label adjacent to the product name informing the consumer of such differences.

Most commenters agreed that limitations in a product's performance characteristics should be disclosed on the product label, and be conspicuous and readable. A number of commenters stated that the disclaimer should be adjacent to the most prominent claim on the label. One commenter, although in agreement with the disclaimer requirement, felt that disclosure on the label, not necessarily adjacent to the product name as provided in the proposed rule, was sufficient to inform the consumer of performance differences. This same commenter recommended that FSIS harmonize the requirement for labeling of performance differences with a similar FDA rule, which requires a disclaimer adjacent to the most prominent claim on the label (21 CFR, 101.13(d)). Another commenter stated that the disclaimer should be adjacent to the most prominent claim and should most likely appear on the principal display panel.

Response: In the preamble to the proposed rule, FSIS stated that “if there is a difference in performance characteristics that materially limits the use of the product, the product may still be considered a substitute if the label includes a disclaimer adjacent to the most prominent claim in accordance with 9 CFR 317.313(d)(1) and (2) and 9 CFR 381.413(d)(1) and (2), informing the consumer of such difference” (60 FR 67480). However, in the text of the proposed rule, FSIS stated that the label must include, “adjacent to the product name,” a statement in accordance with 9 CFR 317.313(d)(1) and (2) and 9 CFR 381.413(d)(1) and (2) informing the consumer of differences in performance characteristics (60 FR 67486, 67487). Thus, the preamble and the text of the proposed rule differed in that the preamble did not mention that the disclaimer must be “adjacent to the product name.” The regulations referenced by both the preamble and the text of the proposed rule, 9 CFR 317.313(d)(1) and 9 CFR 381.413(d)(1), require that differences in performance characteristics that materially limit the performance of a substitute product be disclosed adjacent to the most prominent claim on the product label.

FSIS is resolving the discrepancy regarding placement of the disclaimer. FSIS agrees with the comment that disclosure on the label, not necessarily adjacent to the product name, is sufficient to inform the consumer of performance differences. Therefore, in this final rule, FSIS is not requiring that the disclaimer be placed adjacent to the product name. As in FDA regulations 21 CFR 130.10 and 101.13(d), a disclaimer for differences in performance characteristics shall be placed adjacent to the most prominent claim on the label. To reflect this decision, FSIS is removing the phrase “adjacent to the product name” from proposed §§ 319.10(b)and 381.172(b).

Comment: Two commenters disagreed with the need for the proposed disclaimer requirement and suggested that disclosure of any limitations in the performance characteristics of a substitute standardized product be voluntary. One of these commenters stated that disclaimers on a product's labeling informing consumers of performance characteristics that materially limit the use of the product need not be required by regulations because a substitute standardized product produced under the general standard will succeed or fail in the market place based on consumer expectations associated with the product's performance. This commenter stated that businesses would voluntarily place disclaimers on a product's label in the absence of a regulation requiring that they do so because it would be good business to inform consumers that a product they are purchasing can not be used in a traditional application.

The other commenter agreed that, in practice, poorly formulated products would fail in the marketplace long before any regulatory system could determine that they did not meet the specific performance characteristics they would be expected to have. However, this commenter acknowledged that requiring a disclaimer informing consumers of limitations in a product's performance characteristics, when they exist, will require manufacturers of substitute standardized products to monitor performance characteristics during product development and may help ensure that new low- and reduced-fat standardized products are formulated well from the beginning. The commenter went on to state that consumers are also more likely to accept this category of substitute products if they are well formulated from the beginning.

Response: FSIS disagrees with the commenters' suggestion that disclosure of performance characteristics that materially limit the use of a substitute standardized product compared to the use of the traditional standardized product should be voluntary. The FMIA and the PPIA require that the labeling of a meat or poultry product must be truthful and not misleading, and that such labeling accurately disclose to consumers what they are buying when they purchase any meat or poultry product. Information disclosing differences in performance characteristics that affect the use of a substitute standardized product ( e.g. , cooking quality, freezing quality, spreadability of product, and shelf life) is a material fact that must be disclosed on the labeling of these products. Without such labeling, consumers would be misled about significant characteristics and uses the product has compared to the standardized product for which it substitutes. Accordingly, this information must be communicated to consumers on the product's label, or the label will be misleading and the product will be misbranded under the FMIA or PPIA.

Moreover, FSIS agrees with the commenter who suggested that processors are more likely to monitor the performance characteristics of substitute standardized products during product development when limitations in the product's performance characteristics are required to be disclosed on the product's labeling. FSIS also agrees that if substitute standardized products are well formulated from the beginning, it will promote consumer acceptance of this category of meat and poultry products.

Comment: One commenter pointed out that it may be possible for performance characteristics to be introduced into a substitute standardized product that improve upon the performance characteristics of the traditional standardized product. The commenter suggested that the Agency consider substituting the term “not inferior” for “ similar” in proposed 9 CFR 319.10(b).

Response: FSIS did not intend to prohibit improvements in the performance characteristics of substitute products when it proposed that substitute standardized products subject to the general standard perform similarly to the traditional standardized products for which they substitute. However, FSIS disagrees that it should require that substitute standardized products have performance characteristics that are “not inferior to” rather than “similar to” the traditional standardized products as suggested by the commenter. As proposed, §§ 319.10(b) and 381.172(b) permit products subject to the general standard to have limitations in performance characteristics provided that such limitations are properly disclosed on the product's labeling. The Agency believes that requiring disclosure of any performance limitations on the labeling of products subject to the general standard provides sufficient incentive for manufacturers of these products to market products that are not inferior to the traditional standardized products. Furthermore, proposed 9 CFR 319.10(b) and 9 CFR 381.172(b) require a disclaimer for performance characteristics that “materially limit” the use of a substitute standardized product, not for characteristics that improve the performance of the product. Thus, the disclaimer requirement contained in proposed 9 CFR 319.10(b) and 9 CFR 381.172(b) will not discourage manufacturers from making improvements to the performance characteristics of substitute products when it is possible to do so.

Comment: Two commenters questioned FSIS's ability to enforce and ensure uniform compliance with the performance characteristics requirements proposed in 9 CFR 319.10(b) and 381.172(b). One commenter asked how FSIS intends to determine differences in performance characteristics. The commenter went on to state that the proposed performance characteristics requirements seem to be “command and control” regulations that are not related to product safety. The other commenter stated that, in practice, poorly formulated products would fail in the marketplace long before any regulatory system could determine that they did not meet the specific performance characteristics discussed in the proposal.

Response: FSIS expects that substitute standardized products that are produced under the general standard will conform to the performance characteristics requirements set forth in proposed 9 CFR 319.10(b) and 381.172(b). To ensure that there is compliance, FSIS will examine the performance characteristics and product quality of substitute products as it would other types of products, through scientific review and experimental investigations. In addition, FSIS will use traditional methods available to the Agency, such as sample analysis, inspections, surveys, and follow-up investigations of consumer and trade complaints to identify products that do not comply with the new regulations in order to enforce this regulation as the need arises.

Furthermore, FSIS disagrees with the comment that the proposed performance characteristics requirements are “command and control” regulations. Under §§ 319.10(b) and 381.172(b), FSIS is not establishing specific criteria for determining similarities in performance characteristics. FSIS believes that judgments about similarity are best left to product developers, who have the incentive to market a product that resembles the traditional standardized product as closely as possible and to disclose product performance limitations to ensure that there is consumer satisfaction with the substitute standardized product.

Comment: There was general agreement among the commenters that the ingredients used in a substitute standardized product produced under the general standard should be those ingredients provided by the traditional standard, with the exception of “safe and suitable ingredients,” as defined in (former) 9 CFR 318.7 and 381.147, at the minimum level necessary to improve texture and prevent syneresis. However, several commenters requested clarification and expansion of the ingredients permitted under this provision.

Three commenters stated that allowances for ingredients should be broadened to include any safe and suitable ingredients to replace functional characteristics. These commenters all noted that the FSIS proposal limits ingredient usage to achieve textural improvement and to prevent syneresis. They felt that FSIS should build additional flexibility into the final rule to allow for a wider use of safe and suitable ingredients to replace functional characteristics that may be lost when a formulation is adjusted to meet a claim requirement. These commenters mentioned that the comparable FDA regulation allows the use of safe and suitable ingredients “* * * to add flavor, extend shelf life, improve appearance, or add sweetness” (21 CFR 130.10(d)). One commenter suggested that any ingredient that is generally recognized as safe (GRAS) or that is an approved additive should be permitted to be used as desired by the manufacturer. Another commenter stated that limiting the use of safe and suitable ingredients to the minimum level necessary to improve texture and to prevent syneresis severely limits the ability to produce a consumer-acceptable meat or poultry product. One commenter specifically requested that FSIS clarify the acceptability of flavorings, especially meat flavorings, as safe and suitable ingredients in substitute standardized products.

Response: For purposes of clarification, since it published the general standard proposal, FSIS issued the final rule “Food Ingredients and Sources of Radiation Listed or Approved for Use in Meat and Poultry Products” (64 FR 72168, December 23, 1999). The rule is intended to improve the efficiency of the procedures used by FSIS and FDA to review and approve the use of food ingredients and sources of radiation in the production of meat and poultry products. Under the new regulations, rather than listing substances approved for use in the production of meat and poultry products in the chart of substances contained in former 9 CFR 318.7(c)(4) and former 9 CFR 381.147(f)(4), FDA now lists food ingredients and sources of radiation that are safe for specific use in the production of meat and poultry products in its regulations in title 21 of the CFR. In the final rule, FSIS also created a list of food ingredients approved for use in the production of meat and poultry products by combining the listing contained in former section 318.7(c)(4) with the listing contained in former section 381.147(f)(4) and moving the combined listing to section 424.21(c). The final rule became effective on January 24, 2000.

FSIS did not include ingredients that would affect flavor, shelf life, or sweetness because these kinds of ingredients do not affect the ability of a manufacturer to modify a meat or poultry product to reduce fat, cholesterol, or sodium, which was the focus of this rulemaking. Thus, §§ 319.10 and 381.172 provide only for increased amounts of safe and suitable ingredients that are needed to achieve the effect of replacing fat, i.e. , binders, texturizers, and emulsifiers.

As for the acceptability of flavorings in substitute standardized products, manufacturers will not be limited by §§ 319.10 or 381.172 in their ability to use ingredients that impart flavor. This final rule does not limit a manufacturer's ability to use safe and suitable meat and poultry flavorings.

Comment: In the preamble to the proposed rule, FSIS provided a list of “fat replacing” binders to assist meat and poultry processors to understand the types of ingredients that are permitted to be used to achieve the effects of fat in making substitute standardized products under the general standard. However, the list was not intended to be all-inclusive. One commenter supported the use of ingredients not identified in the preamble as part of a fat replacement system and requested that FSIS clarify whether other fat replacers, such as milk protein concentrates, would be permitted in substitute standardized products, given this substance's similarities to the listed substances. The commenter also requested that the preamble to the final rule specifically note that milk protein concentrates and egg whites are acceptable substances in fat replacement systems.

Three commenters agreed that the ingredients listed in the preamble are appropriate for use in a substitute version of a standardized product but felt that the list should be broadened to include other safe and suitable ingredients that have a demonstrated ability to function as a fat replacement system. One of these commenters requested that if the list provided within the context of the preamble is not meant to be all-inclusive, FSIS should state that fact. The commenters also encouraged FSIS to include a list of criteria for evaluating fat replacing binders not on the list to determine whether they qualify as acceptable binders.

Response: The list of “fat-replacing binders” presented in the preamble to the proposed rule represents examples of ingredients or additives historically classified as binders by food scientists and ingredient technologists. This list is not intended to be all encompassing, and other safe and suitable ingredients historically recognized as binders are permitted to be used in “fat replacement” systems for substitute standardized products produced under the general standard.

In general, a safe and suitable ingredient qualifies for use as a fat replacing binder under this final rule if it is only used for its functional properties and does not impart other characterizing qualities, such as taste and nutritional value, to the standardized product when used in the product formulation. FSIS will evaluate whether safe and suitable ingredients that were not listed in the preamble to the proposal qualify as fat replacing ingredients on a case-by-case basis.

As a point of clarification, milk protein concentrates have historically been used by meat and poultry product manufacturers as binding ingredients in meat and poultry products and therefore, under the general standard, FSIS will permit milk protein concentrates to be used as binders in fat replacement systems for substitute standardized products.

Regarding the use of egg whites as a fat replacing binder, egg whites are considered an egg product and as such function as an individual food product that is consumed for its own taste and nutritional value. Thus, FSIS considers the use of egg whites in the formulation of a meat or poultry product to be sufficiently characterizing so as to result in a product that is not a substitute standardized product, but one that is a non-standardized product, e.g. , identified with a true product name, such as “Low Fat Pork Sausage made with Egg Whites.”

Although FSIS is not providing an all inclusive list of suitable fat replacing binders in this final rule, the Agency did provide an extensive listing of binders in the preamble to the proposed rule to convey the intent of the rule (see 60 FR 67481). Persons interested in determining whether an ingredient is an appropriate fat replacing binder may refer to this original listing.Furthermore, safe and suitable ingredients that meet the general criteria outlined above, i.e. , have historically been classified as binders, are only used for their functional properties, and do not impart other characterizing qualities when used in the formulation of substitute products, will also qualify as acceptable fat replacing binders under this final rule.

Comment: In the preamble to the proposed rule, FSIS stated that the Agency views TVP as a “meat or poultry replacer,” and that the use of TVP as a fat replacing ingredient in a substitute standardized product subject to the general standard would be inappropriate. At the time that the proposal was published, FSIS had determined that the use of TVP in a substitute standardized product would change the nature of the product to such an extent that it would no longer be a substitute product within the parameters of the proposed rule. This view, in part, was based on the belief that TVP was used as a “meat replacing” ingredient in foods considered “meat replacing products,” such as “veggie-burgers,” which are primarily TVP with water, flavorings, and seasonings.

FSIS received numerous comments expressing strong disagreement with FSIS's historic views. Forty-three commenters submitted statements in support of allowing TVP as a fat replacer in substitute standardized meat and poultry products subject to the general standard so that these products may be identified by a nutrient content claim. Many of these commenters provided supporting studies on the health and nutritional benefits of soy protein, along with data on consumer awareness and acceptance of products containing TVP. Many commenters felt that not permitting TVP as a fat replacing ingredient would greatly limit the ability of the industry to develop substitute standardized meat and poultry products that are lower in fat. These commenters stated that the use of TVP as a fat replacer is important in expanding the flexibility of the meat and poultry industry to create and market an increased variety of healthful substitute meat and poultry products. Some commenters specifically mentioned that prohibiting TVP would limit product development in areas of coarse ground cooked and fermented sausage.

Several commenters stated that TVP should be permitted as a fat replacer so long as its use conforms to the requirements of the general standard. These commenters stated that TVP should be permitted as part of a “fat replacement system” in substitute standardized meat and poultry products so long as: (1) Its use does not substantially change the nature of the finished product; (2) it is not used to replace the meat or poultry content required by the traditional standard; and (3) it is used only at the minimum level necessary in a fat replacement system to qualify for use of the nutrient content claim.

A number of commenters stated that TVP should be regulated on the basis of its functional properties rather than on its physical form. Many of these commenters pointed out that, while in the past TVP was used as a “filler” or “substitute” for meat components in food, advancements in TVP technology have made TVP a highly functional ingredient that could now be used as part of a fat replacement system to improve the textural character and quality of a substitute standardized meat or poultry product. Many commenters noted that TVP, when used in combination with other water binders, provides improved product texture, visual appearance, performance, and storage characteristics. Data supporting this view were presented to the Agency.

Some commenters felt that TVP should be allowed as a fat replacer in all meat items where non-textured vegetable proteins are allowed. One commenter stated that texture is a matter of degree, and that forms of vegetable proteins range from fine powders, to small granules, to small flakes, to larger granules and flakes. This commenter stated that it is arbitrary to require that TVP be excluded as a “fat replacer” but not the powdered forms. One commenter questioned the logic of permitting soy flour, soy protein concentrate, and isolated soy protein in products because they replace fat, but prohibiting the use of TVP because it is inappropriately thought to replace meat. The commenter pointed out that the proposed rule does not permit a reduction in the meat or poultry content, and therefore, TVP could not be used as a meat replacer. Another commenter mentioned that other binders, such as carrageenan, can be texturized, and therefore, TVP is being singled out unfairly.

A number of commenters stated that, because the presence of TVP can be disclosed in product labeling, consumers should be allowed to decide for themselves whether to purchase a lower fat standardized product that contains TVP. Some commenters pointed out that the presence of TVP in a meat food product could be communicated to consumers in the same manner as any other ingredient, in the ingredient statement. The commenters asserted that appropriate product labeling required by the general standard would ensure that consumers would not be misled about the presence of TVP in substitute standardized products produced.

Some commenters stated that if TVP is permitted as a fat replacer in substitute standardized products, the substitute product should provide the same amount of animal protein as the traditional standardized product. One commenter stated that this approach would provide manufacturers with optimum flexibility, yet guarantees that the consumer receives a product that is at least as valuable as the unmodified product. Another commenter mentioned that consumers are interested in over-all nutrition, not in specific ingredients.

Some commenters expressed the view that TVP should not be considered as a “food,” because it is not consumed by itself as a food. These commenters stated that TVP is a functional food ingredient that can be used as part of a fat replacement system.

Response: FSIS has been persuaded by the comments, information, and other data submitted by commenters to permit the use of TVP as a part of a fat replacing system in substitute standardize products produced under the general standard. Accordingly, in this final rule, proposed §§ 319.10(c) and 381.172(c) have been modified to provide for the use of TVP, alone or in combination with other binders and water, as part of a fat replacement system.

The Agency will permit the use of TVP as a functional food ingredient that is used to replace fat. Like the other fat replacing ingredients permitted to be used under this final rule, the use of TVP as an ingredient in a substitute standardized product will be permitted only at the lowest level necessary to achieve the intended effect of replacing fat. When TVP is used to replace fat, the ingredients statement on the product label must alert the consumer to the fact that TVP is not permitted in the traditional standardized product or is used in excess of amounts permitted in the traditional standardized product. The labeling requirements will ensure that consumers will not be misled when TVP is used to replace fat in substitute standardized meat and poultry products subject to the general standard.

Under this final rule, TVP may not be used to replace the meat or poultry content of a product when a product standard specifies a minimum meat or poultry content requirement. However, if the formulation of a substitute product produced under the general standard contains the same amount of meat or poultry prescribed by the traditional standard, the fat component of the meat or poultry in the substitute product may be removed during processing and replaced with TVP, or any other safe and suitable binder, alone or in combination with water as part of a fat replacement system.

For example, the product standard for “chili con carne” provides that the product shall contain not less than 40% meat computed on the weight of the fresh meat (9 CFR 319.300). The product formulation for a substitute version of chili con carne produced under the general standard must contain 40% meat, but the fat content of the meat component may be replaced with TVP during processing.

According to information presented to the Agency, TVP is particularly useful in developing lower fat versions of cooked sausages and other comminuted meat and poultry products. Although the standards for these kinds of products generally do not prescribe a minimum meat or poultry content, most of these standards limit the amount of fat that is permitted in the product. For example, the standard for cooked sausages defined in 9 CFR 319.180 limits the fat content of these products to no more than 30% of the finished product, and the standard for ground beef defined in 9 CFR 319.15 limits the fat content in this product to no more than 30%. Thus, under this final rule, the amount of TVP permitted in such products will be limited by both the requirement that fat replacing ingredients may be used only at the lowest level necessary to replace fat and by the minimum fat content requirement established by the product standard.

For example, a substitute cooked sausage produced under the general standard is permitted to contain up to 30% TVP, provided that the sole function of the TVP is to replace the fat. For purposes of this rule, FSIS does not consider replacing the fat component of a single ingredient standardized product, such as ground beef, as reducing the product's meat content, provided that the product complies with the manufacturing and labeling requirements prescribed in this final rule.

To eliminate the possibility of confusion, the phrases “textured vegetable protein shall not replace meat” and “textured vegetable protein shall not replace poultry,” which were used as examples in the regulatory text of proposed 9 CFR 319.10(c)(2) and 381.172(c)(2), will be removed in the final rule. These phrases are unnecessary because the regulation already prohibits reductions in the meat or poultry content required by a regulatory standard regardless of whether TVP is used in the product.

Nine commenters indicated that in the final rule, FSIS should permit foods, such as bread, rice, potatoes, fruits, and vegetables to be used in substitute standardized meat and poultry products to reduce their fat content. Some of these commenters stated that these ingredients could serve the same role as the water and binder systems permitted as fat replacers in the proposed rule, but that food ingredients are more beneficial because they may contain some nutritional constituents, such as vitamins and minerals, that many binders do not. One commenter stated that food ingredients, when used at proper levels, help to provide consumers with substitute standardized products that perform similarly to traditional standardized products. Another commenter stated that the nutrition label would enable consumers to make informed purchase decisions based on the entire nutritional profile of the product. This commenter pointed out that many consumers would prefer the nutritional profile of substitute standardized products that use starchy vegetables and complex carbohydrates, such as rice and potatoes, rather than a combination of water and ingredients such as highly refined vegetable gums to lower the percentage of calories from fat. One commenter stated that it makes sense to allow other foods as fat replacers if the goal is to make more healthful products available to consumers. Another commenter suggested that consumers might be more interested in overall nutritional quality, taste, convenience, and performance of the product than in the specific ingredients present in the product.

Response: FSIS concedes that because foods such as bread, rice, potatoes, fruits, and vegetables, have little or no fat, their use as ingredients in standardized meat and poultry product could have the effect of reducing the fat content of such products. However, when foods are used as ingredients in a standardized product, the composition of the product may be altered to such an extent that the resulting product is not a substitute version of the traditional standardized product but a new and different product with a separate identity that reflects the combination of the individual foods. For example, because diced apples and rice are not specified as ingredients in the standardized product “Pork Sausage,” when they are added to “Pork Sausage,” the result is a new product, which, provided that it does not have a standard of identity or composition prescribed by 9 CFR part 319 or other established common or usual name, is required to bear a descriptive name, such as “Pork Sausage with Diced Apples and Rice,” that clearly identifies the product (see 9 CFR 317.2(c)(1) and (e) and 9 CFR 381.117(a)). Because the product “Pork Sausage with Diced Apples and Rice” is a new product and not a substitute version of the standardized product “Pork Sausage,” it is not the type of product that the general standard established by this final rule is intended to address.

As a point of clarification, this final rule does not prevent non-standardized meat and poultry products that use food ingredients to reduce their fat content from using a traditional nutrient content claim permitted under 9 CFR 317 subpart B and 381 subpart Y, provided they meet the requirements of the claim. For example, the product “Pork Sausage with Diced Apples and Rice” is permitted to bear the claim “low fat” on its label if it complies with § 317.362, and therefore, may be referred to as “Low Fat Pork Sausage with Diced Apples and Rice.” Consumers who prefer the nutritional profile of meat and poultry products that use other foods, rather than binders and water, or other functional food additives, to reduce their fat content will be able to identify these products by their descriptive product name and the traditional nutrient content claim on the product labeling. Furthermore, any benefits in the nutritional profile of products that use foods as ingredients to reduce their fat content will be reflected in the nutrition facts panel, as well, if appropriate, in other nutrient content claims.

Comment: One commenter expressed agreement with the provision in proposed 9 CFR 319.10(c)(3) and 381.172(c)(3) that states that ingredients specifically prohibited for use in standardized meat and poultry products should also be prohibited for use in substitute standardized products subject to the general standard. However, the commenter felt that ingredients prohibited from use in all meat and poultry products should be based on safety considerations rather than quality considerations.

Response: The general standard allows for the use of any safe and suitable fat replacement ingredient, e.g. , binders and water. Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq. ), FDA is responsible for determining the safety of food ingredients for use in food in general. Under the authority of the FMIA and PPIA, FSIS acquiesces to FDA's safety judgments, but FSIS determines the suitability of ingredients determined to be safe by FDA for use in meat and poultry products. These responsibilities are fully described in the final rule “Food Ingredient and Sources of Radiation Listed or Approved for Use in the Production of Meat and Poultry Products,” which was published in the December 23, 1999, Federal Register (64 FR 72168).

Thus, although it is the responsibility of the FDA to evaluate the safety of a substance for use in meat or poultry products, under the authority of the FMIA and PPIA, FSIS may preclude the use of a substance in meat or poultry products for reasons other than safety. There are instances in which the use of a substance, even if safe, may promote deception when used in a meat and poultry product, and, accordingly, such use would be prohibited by FSIS. For example, paprika is considered GRAS by FDA and is also listed for use as a color additive, but the FSIS regulations prohibit its use on fresh, uncooked meat products because such use adds color that may make the meat appear fresher than it actually is (9 CFR 424.23(a)(1)). Therefore, it is incumbent upon FSIS to consider suitability, as well as the safety, of ingredients for use in the production of meat and poultry products in order to prevent these products from being adulterated or misbranded.

Comment: One commenter stated that the provision in proposed §§ 319.10 and 381.172 that requires that the meat portion of a substitute standardized product undergo the same basic processing procedures as the traditional standardized product for which it is a substitute has the potential to limit the use of new technologies without producing any stated goal that would justify the limitation. The commenter stated, that as long as the substitute standardized product has performance characteristics that are similar to the traditional standardized product, and is produced only from authorized ingredients, additional restrictions on processing procedures are unnecessary and undesirable.

Another commenter stated that the general standard should permit substitute standardized products to contain different meat species and different kinds of poultry than those prescribed by the traditional standard, and that it should permit meat or poultry from different anatomical locations than the locations prescribed by the traditional standard, provided that the difference in species or anatomical location is stated in the product name. This commenter felt that a literal reading of the proposed regulation could be interpreted to mean that products such as “Beef Bacon” or “Pork Shoulder Bacon” would no longer be permitted to include the term “Bacon” in their product names if coupled with a nutrient content claim. The commenter went on to say that these kinds of products should continue to be permitted to be marketed under the same familiar names that have been used in the past, and that use of a nutrient content claim next to the product name should not change this.

Response: The intent of the general standard for substitute standardized products is to enable the meat and poultry industries to produce modified versions of standardized products that have reductions of certain constituents that are of health concern to some consumers, such as fat, cholesterol, and sodium, and to increase flexibility and support product innovation. Under this rule, deviations from the existing standards are not expected to result in a product that no longer resembles the original standardized product. Thus, the use of a different meat species or kind of poultry, or the use of meat or poultry from different anatomic locations from those specified in the standard, that results in a product that is so physically dissimilar from the traditional standardized product that it does not meet the definition of “substitute” set forth in 9 CFR 317.313(d) and 381.413(d) would be inconsistent with the intent of this rule. For these kinds of products to represent themselves as substitute standardized products would be false and misleading under the FMIA and PPIA.

As an illustration, the regulatory standard for “Bacon” under 9 CFR 319.107 requires that this product be prepared from cured, sliced pork bellies. Curing and slicing a cut of meat from a different livestock species or from a different anatomical location, or preparing sliced pork bellies using a method other than curing, would result in a product with physical characteristics so different from the standardized product “Bacon” that the resulting product could not be considered a “substitute” for bacon under 9 CFR 317.313(d) and 381.413(d). Thus, instead of being identified as a substitute product, the product would be identified by a descriptive term such as “Beef Bacon” or “Pork Shoulder Bacon.”

However, FSIS will consider the types of changes requested by the commenters, such as amending a standard to permit the use of alternative processing methods, on a case-by-case basis. FSIS agrees that certain technologies used to prepare standardized foods may yield a product with the same physical, nutritional, and sensory characteristics as the food made in accordance with the traditional standards. To reflect this fact, instead of specifying that substitute standardized products must contain all ingredients specifically required by a standard of identity or composition, and that the meat or poultry portion of substitute products come from the same anatomical location, be of the same kind and amount, and undergo the same basic processing procedures as the standardized product as was proposed, FSIS is revising §§ 319.10(c)(4) and 381.172(c)(4) to require only that substitute standardized products comply with all other applicable standards of identity or composition.

Regarding the comment expressing concern that under the general standard, products such as “Beef Bacon” or “Pork Shoulder Bacon” would no longer be permitted to include “Bacon” in their product names if coupled with a nutrient content claim, as previously mentioned, FSIS intends to apply the principles embodied in the general standard established by this final rule to other products as appropriate. The Agency will clarify this fact in a policy bulletin after this final rule is published.

Thus, this final regulation will not prohibit the “bacon-like” products described in the Policy Book, such as “Turkey Bacon-Cured Turkey Breast Meat-Chopped and Formed,” from being modified to qualify to use a nutrient content claim as part of the product name. The modified version of this “bacon-like” product would be permitted to be identified as “Low Fat Turkey Bacon-Cured Turkey Breast Meat-Chopped and Formed.” FSIS reiterates that the intent of this rule is to provide a wider array of nutritionally improved substitute products that would provide consumers with more meat and poultry products from which to choose. The intent is not to diminish or interfere with markets providing innovative as well as traditional kinds of products to consumers.

Comment: Several commenters submitted statements both for and against the proposed requirement that a substitute standardized product subject to the general standard rule maintain the same minimum meat or poultry requirement as the standardized product for which it is a substitute. Seven commenters agreed that substitute standardized products should be required to maintain the minimum meat and poultry requirement established by the traditional standard, while ten commenters expressed disagreement with this requirement.

Several commenters stated that the meat or poultry content of a standardized product often contains the highest concentration of fat, and, while it may be theoretically possible for manufacturers to use leaner meat to reduce fat, it is not economical. One of these commenters stated that fat-reduced products that meet the existing minimum meat or poultry content requirement would be prohibitively expensive. Another commenter stated that relying exclusively on leaner meat to reduce fat might also make products tougher in texture and less palatable. Another commenter stated that, without reducing the “meat block” (meat or poultry content), the proposed general standard can not deliver on its promise to encourage innovation and the production of nutritionally improved meat and poultry products.

Some commenters stated that minimum meat and poultry content requirements for substitute products are not necessary so long as the labeling of the substitute standardized products provides sufficient information to distinguish these products from the traditional standardized products for which they substitute. One commenter submitted data showing that consumers do not mind if part of the meat block in a substitute product is replaced with another ingredient, so long as the labeling of the substitute standardized product discloses the presence of the replacing ingredient. Another commenter stated that trends in consumer behavior, which include reducing the amount of meat consumed in order to reduce fat intake, strongly support the argument that consumers will not be misled by nutrient-modified food products that contain less meat and poultry than is required by the traditional standardized form of the food. One commenter suggested that a substitute standardized product with reductions in its meat or poultry content should state on its label that, “in order to reduce fat, this product contains less meat than the traditional standardized product.” Some commenters stated that nutritional equivalency, rather than meat-content equivalency, should serve as the basis for defining requirements for the use of nutrient content claims. These commenters felt that FSIS should allow for necessary reductions in meat or poultry content to meet the requirements of the claim, with the reduction accomplished in such a manner that nutritional equivalency to the traditional standardized product is maintained. One commenter stated that meat replacers may be more desirable than some of the fat replacers, which hold water but contribute little in taste or nutritional value.

One commenter stated that it is widely recognized that the requirements for minimum meat content are based on the notion that meat and poultry represented the most valuable constituent of a meat or poultry product. This commenter claimed that meat and poultry are simply no longer the indisputable “highest value” components of food products. Another commenter mentioned that FDA regulations provide for marketing of products, such as reduced-fat peanut butter, which allows for reduction of the peanut content of the product below that required for the standardized product.

Those commenters that agreed with the requirement that substitute standardized products subject to the general standard maintain the same minimum meat and poultry requirement as the standardized product for which they are a substitute maintained that consumers have come to expect a certain amount of meat or poultry in products that bear a standardized term, and that the meat and poultry content of the product is still the most valued constituent.

Response: Because many consumers have come to expect a certain amount of meat or poultry in products that bear a standardized term, deviations in the prescribed meat or poultry content will not be permitted in this final rule. Moreover, while FSIS appreciates these comments, the Agency does not view this rulemaking as the appropriate vehicle for changing the specific meat and poultry content requirements of meat and poultry product standards. These issues will be considered in a separate rulemaking that will examine FSIS's overall regulatory approach to standardized meat and poultry products that was described in the ANPR “Meat and Poultry Standards of Identity and Composition” published in the September 9, 1996, edition of the Federal Register (61 FR 47453).

In response to that ANPR, FSIS and FDA are jointly working on a more comprehensive approach to modernizing food standards whose goal is to establish “general principles” that interested parties could follow in requesting changes to food standards. One change that interested parties may be able to pursue, if these principles are adopted, would be reductions in the meat or poultry content requirements of standardized products. FSIS and FDA expect to soon publish the joint proposed rule in the Federal Register .

Comment: Of those who commented, all agreed that the name of a substitute standardized product subject to the general standard should be an expressed nutrient content claim in conjunction with ( i.e. , next to) the appropriate standardized term, as provided in the proposal. However, several commenters did not agree with the provision in proposed 9 CFR 319.10(d) and 9 CFR 381.172(d) that states that the nutrient content claim and standardized term should be presented “in the same style, color, and size of type on the product label.”

One commenter stated that it was unaware of any evidence that consumers are confused or misled by the labels currently in the marketplace on similar FDA-regulated products, which are not subject to a style, color, and size of type requirement. The commenter stated that the 3:1 type size requirement that generally applies to names on FSIS-regulated products should apply to foods that are marketed under the general standard rule.

Another commenter stated that some flexibility should be allowed for the type size of the nutrient content claim. The commenter stated that some product names are fairly lengthy, and therefore, FSIS's Policy Memo 87A , Word Size in Labeling of Product Names and Fanciful Names , states that the Agency will not object to a 1/3 type size flexibility between the largest letter and the smallest letter in a product name. The commenter also noted that the existing FSIS regulations for nutrient content claims allow a 1/2 type size flexibility to assure that nutrient claims are not disproportionately larger than the product's statement of identity.

Two commenters stated that the FDA regulation establishing a general standard for FDA-regulated substitute standardized products (21 CFR 130.10(e)) does not contain the same restrictions on the style, color, and size of type of the nutrient content claim that FSIS's proposed rule does. One of these commenters requested that FSIS consider modifying the proposed nomenclature for products subject to its general standard to make it similar in format to that prescribed by the FDA regulation. A similar comment suggested that FSIS delete the last clause from the nomenclature section, i.e. , “ * * * which shall be in the same style, color, and size of type,” because it is unwarranted and unnecessary to inform consumers of the nature of the substitute product.

Response: FSIS agrees with the commenters' arguments and in this final rule has deleted the last clause from the nomenclature section (“ * * * which shall be in the same style, color, and size of type”). FSIS has been persuaded by the arguments against requiring the nutrient content claim portion of the substitute standardized product's name to be presented in the same style, color, and size of type, as the standardized product term and agrees that this requirement is unnecessary for consumers to distinguish the substitute product from other products that bear nutrient content claims but that are not substitute products that meet the requirements of this final rule. Therefore, to harmonize, to the extent possible, its labeling requirements with the labeling requirements of FDA's corresponding regulations found in 21 CFR 130.10, FSIS will not require that the expressed nutrient content claim that is part of the product identity appear in “the same style, color, and size of type” as the standardized term. The product name on the principal display panel of the substitute product, as well as its ingredients statement, are the pertinent labeling features that identify the differences between the traditional standardized product and the modified version bearing the standardized name.

Comment: Twenty commenters expressed agreement with the provision in proposed 9 CFR 319.10(e) and 381.172(e) that all safe and suitable ingredients not provided for by the traditional standard, as well as permitted ingredients added at a level in excess of those allowed by the traditional standard, must be appropriately identified as such with an asterisk in the ingredients statement. Three commenters disagreed.

Two commenters stated that because a nutrient content claim calls the consumer's attention to the fact that the product has been modified from the traditional standardized product, there is no need for asterisks to be included in the labeling information. These commenters believed that the product name with the appropriate nutrient content claim, along with the ingredients statement, is all that is necessary to adequately inform the consumer that the product has been modified from the traditional standard. One commenter stated that, in addition to adding to label clutter, the requirement to highlight ingredients present in amounts greater than in the standardized product could result in the “ludicrous” situation where a label indicates that the substitute product contains more meat than the traditional standardized product. The commenter felt that requiring an asterisks for particular ingredients will provide a disincentive for meat and poultry processors to make products using the new technologies in fat replacement products because they must market products with labels that are cluttered with additional statements.

One commenter expressed support for using an asterisk to identify ingredients not provided for, or used in excess of those levels provided for, by the traditional standard in so far as it provides parity with FDA's regulation but questioned the real value of this labeling feature to the consumer. The commenter suggested that this labeling requirement be applicable on a short-term basis, with provisions for its phase-out in no more than three years as consumer become more familiarly with nutritionally-modified foods.

Two commenters felt that FSIS should require more than just the identification of the substitute ingredients in the ingredients listing, as proposed by the Agency. These commenters suggested that FSIS also require that whenever ingredients are present in the substitute product that are not permitted by the traditional product standard, an appropriate disclosure ( e.g. “made with non-standard ingredients—see back panel for ingredient lists”) appear on the principal display panel. One of these commenters stated that such a disclosure would alert consumers to the fact that a substitute product is different from the standardized product and would direct them to specific information about the differences.

Several commenters requested that FSIS clarify whether the ingredient “water” or the added moisture not normally in or in excess of that permitted in a standardized product should be indicated with an asterisk.

Response: FSIS disagrees with the comment that ingredients not provided for by the traditional standard, as well as permitted ingredients added at a level in excess of those allowed by the traditional standard, need not be identified as such with an asterisk in the ingredients statement. Differences between the ingredients in a standardized product and a substitute standardized product identified in part by a nutrient content claim must be highlighted so that consumers will be able to differentiate between the traditional standardized product and the substitute version. Highlighting these ingredient differences also ensures that the labeling of the substitute product will not be misleading. Furthermore, as a point of clarification, when water or added moisture not found in or used in excess of that permitted in a traditional standardized product is added to a substitute standardized product, this fact must be highlighted with an asterisk as is required for all other safe and suitable ingredients not found in, or used in excess of, the amount permitted by the traditional standard.

FSIS disagrees with the comment that requiring an asterisks to highlight specific ingredients present in a substitute standardized product will provide a disincentive for meat and poultry processors to make and manufacture standardized products with reductions in their fat content. Similar labeling has been required on FDA-regulated products for several years and does not appear to have been a disincentive for industry to develop these kinds of products. FSIS also disagrees that labeling features in addition to those provided in the proposed rule are necessary to inform consumers of ingredient differences between a traditional standardized product and its nutritionally modified substitute. Highlighting ingredient differences with an asterisk in the ingredients statement, along with the product name on the principal display panel, are the pertinent labeling features that identify the differences between the traditional standardized product and the substitute version. Furthermore, to some consumers, statements such as “made with non-standard ingredients” may imply that the ingredients used in a substitute product are inferior or harmful to the ingredients used in the traditional standardized product. Such statements could be misleading because only ingredients that have been found to be safe and suitable for use in meat and poultry products are permitted to be used in formulating substitute standardized products.

Consumers who have purchased substitute standardized products manufactured pursuant to FDA's general standard codified at 21 CFR 130.10 are familiar with the labeling of such products through the use of asterisks and the statement referenced by the asterisks, which appear adjacent to the ingredient list. Thus, many consumers already look to the ingredient statement to determine differences in formulation between traditional standardized products and nutritionally modified versions of these products. Harmonizing labeling to the extent possible with that of the FDA benefits consumers by providing a more consistent food labeling system across all foods.

FSIS finds no merit in the comment that asterisks are unnecessary because they could lead to the “ludicrous” situation where an ingredients statement asterisk would indicate that more meat or poultry than required by the food standard has been used in the product. Because food standards for meat and poultry products generally require minimum amounts of meat and poultry and maximum amounts of fat and water, it has always been possible for manufacturers to include more meat or poultry than the minimum established by the food standard in the product formulation. This rule does not change that fact and there is no need to require an asterisk to highlight the fact that a manufacture chose to include more meat or poultry in a substitute product than the minimum required by the traditional standard.

Regarding the comment that the asterisk provision should be phased out at some point in the future, FSIS does not agree with this view because the ingredient statement is the primary feature where the differences between the standardized product and the substitute version can be made known to the consumer in labeling. As described earlier, during the joint FSIS and FDA standards modernization activities, if appropriate, the agencies may revisit the issue of phasing out the asterisk requirement and consider it within the context of a more comprehensive approach to food standards modernization.

In this final rule, FSIS is establishing a general definition and standard of identity for standardized meat and poultry products that have been modified to qualify for use of an expressed nutrient content claim in their product names in conjunction with a standardized term. FSIS is adding new §§ 319.10 and 381.172 to the meat and poultry products regulations in title 9 of the CFR. As was proposed, §§ 319.10(a) and 381.172(a) describe the type of meat and poultry products that are defined by the general standard. These are products that substitute, in accordance with 9 CFR 317.313(d) or 381.413(d), for a standardized product, but that do not comply with the established standard because of a compositional deviation that results from reductions of a constituent that is described by an express nutrient content claim, such as “low fat” or “fat free.”

As was proposed, §§ 319.10(b) and 381.172(b) require that a substitute standardized product subject to the general standard have similar performance characteristics to the traditional standardized product for which it is a substitute. However, if a substitute product has performance characteristics that materially limit the uses of the product compared to the uses of the traditional standardized product, §§ 319.10(b) and 381.172(b) require that a product's label include a disclaimer informing consumers of such differences, such as “not suitable for grilling.” In response to some of the comments and to be consistent with the existing definition of substitute products found in 9 CFR 317.313 and 381.413, FSIS is removing the provision in proposed §§ 319.10(b) and 381.172(b) that would have required the performance characteristics disclaimer to appear “adjacent to the product name.” Deleting this provision is also intended to provide consistency with 21 CFR 130.10 of the FDA regulations, which is the codified general standard of identity for substitute standardized products under FDA jurisdiction. As was proposed, §§ 319.10(b) and 381.172(b) will require that deviations in the ingredients in a substitute standardized product be the minimum necessary to qualify for the nutrient content claim.

Sections 319.10(c) and 381.172(c) prescribe the ingredients that must be used in, and the ingredients that are permitted to be used in, substitute standardized products under the general standard. As was proposed, §§ 319.10(c)(1) and 381.172(c)(1) require that the ingredients used in a substitute standardized product be those ingredients provided for by the traditional standard, except that in addition, safe and suitable ingredients may be used in the substitute product at the minimum level necessary to improve texture or prevent synereses. The final rule replaces references to former §§ 318.7 and 381.147 with the phrase “as provided in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B,” to reflect the issuance of the final rule “Food Ingredients and Sources of Radiation Listed or Approved for Use in Meat and Poultry Products” (64 FR 72168).

As was proposed, §§ 319.10(c)(2) and 381.172(c)(2) forbid substitute standardized products to replace or exchange ingredients required by the traditional standard with functionally similar ingredients from other sources not provided for in the traditional standard. In the final rule, FSIS is removing the phrases “textured vegetable protein shall not replace meat” and “textured vegetable protein shall not replace poultry” from proposed §§ 319.10 (c)(2) and 381.172(c)(2). These phrases are unnecessary and could potentially cause confusion since the final rule permits TVP to be used in limited amounts as a fat replacer, although it may not be used to replace meat. Reductions in the meat or poultry content required by the traditional standard are already prohibited by the final rule regardless of whether TVP is used in the product.

As was proposed, §§ 319.10(c)(3) and 381.172(c)(3) prohibit substitute standardized products from containing ingredients that are prohibited for use in traditional standardized products. Proposed §§ 319.10(c)(2) and(3), and 381.172(c)(2) and (3) use the phrase “[a]n ingredient or component of an ingredient” when describing the ingredients permitted and prohibited in substitute standardized products. In this final rule, FSIS is deleting the words “or component of an ingredient” because they are unnecessary and may cause confusion.

Proposed, §§ 319.10(c)(4) and 381.172(c)(4) required substitute standardized products to conform to certain aspects of the traditional standard, such as the meat or poultry content specified in the standard, the anatomic location and kind of meat or poultry specified in the standard, and the processing procedures specified in the standard. As previously mentioned, deviations from these types of requirements may result in a product that is so physically dissimilar from the traditional standardized product that it does not come within the established definition of a substitute product.

However, because certain technologies used to prepare standardized foods may yield a product with the same physical, nutritional, and sensory characteristics as the food made in accordance with the traditional standards, FSIS intends to consider certain deviations from product standards, such as alternative processing methods, on a case-by-case basis. As stated above, FSIS and FDA are jointly working on a more comprehensive approach to modernizing food standards to establish “general principles” that interested parties would follow in requesting changes to or creating new food standards. Therefore, FSIS is revising proposed §§ 319.10(c)(4) and 381.172(c)(4) to require that substitute standardized products comply with all other applicable standards of identity or composition unless otherwise specified in part 319 or part 381. The Agency is making this revision to accommodate changes to food standards that may result from the joint FSIS/FDA food standards modernization approach.

As was proposed, §§ 319.10(c)(5) and 381.172(c)(5) permit water and fat-replacing binders to be used to reduce the fat content in a substitute standardized product subject to the general standard. Based on the comments and data submitted in response to the proposal in support of using TVP as a “fat replacer,” FSIS will permit the use of TVP as a functional fat replacing ingredient in substitute standardized products defined by the general standard. FSIS is adding new language to the final rule that permits the use of TVP as part of a fat replacement system at the lowest level necessary to achieve the technical effect of replacing the characteristics of fat in the substitute product. This language is found in new §§ 319.10(c)(6) and 381.172(c)(6). Because §§ 319.10(c)(2) and 381.172(c)(2) of the final rule forbid reductions in the meat or poultry content of a substitute product where one is established by a standard, under the final rule, TVP may only be used to replace fat component and not to replace the lean meat or poultry content of the substitute standardized product.

Sections 319.10(d) and 381.172(d) prescribe the nomenclature for the substitute meat and poultry products that comply with the general standard. As was proposed, these products may be identified by the appropriate expressed nutrient content claim and the applicable standardized term ( e.g. , “Fat Free Bologna”). If a product meets the requirements of the general standard, it is itself a standardized product, and therefore, its name will not be required to contain the term “substitute” despite the fact that it does not meet all of the requirements of the traditional product standard.

This final rule removes the provisions in proposed §§ 319.10(d) and 381.172(d) that would have required that the expressed nutrient content claim part of the substitute standardized product's name appear in the “same style, color and size type” as the standardized term. This change is in response to public comments and to harmonize, to the extent possible, with similar FDA regulations.

As was proposed, §§ 319.10(e) and 381.172(e) require each of the ingredients used in the substitute product to be declared on the product label as required by the applicable FSIS regulations. 9 CFR parts 317 and 381, subpart N, require that all ingredients be listed by common or usual name in descending order of predominance by weight. As was proposed, §§ 319.10(e) and 381.172(e) also require that all safe and suitable ingredients not provided for by the traditional standard, as well as those used in excess of those permitted by the traditional standard, be identified as such with and asterisks in the ingredients statement.

This rule has been determined to be significant and therefore has been reviewed by OMB under EO 12866.

FSIS is issuing this rule to facilitate the development and availability of substitute standardized products that have reductions in certain constituents that are of health concern to some consumers, such as fat, cholesterol, and sodium. This rule allows FSIS to rely more on labeling requirements and less on restrictive recipe-like standards in endeavoring to ensure that the labels of meat and poultry products are truthful and not misleading as well as to improve the public health. The names of products covered by the General Standard will be composed of an express nutrient content claim that reflects the modifications made in formulating and processing the product (so that it qualifies to bear the claim) and an established standardized term. FDA has already promulgated a corresponding General Standard for the products that it regulates (21 CFR 130.10). By harmonizing an FSIS labeling requirement with that of FDA, this final rule represents a significant step towards providing consumers with an informative and consistent food standard and labeling system. This final rule also promotes product innovation by encouraging the production of meat and poultry products that are low in constituents that are of health concern to some people.

FSIS regulations contain approximately 80 standards of identity or composition for meat and poultry products. Most of these standards are for processed products, including sliced, injected, smoked, fermented, heat-treated, and raw products. According to the Agency's Performance Based Inspection System Database, in the second quarter of 2003, there were approximately 6,600 Federal and State Establishments  2 that potentially will be affected by the final rule if they develop and make available substitute products for standardized products. Some of these establishments, however, are already producing sausage and other comminuted meat and poultry products under FSIS Policy Memo 121B and Policy Memo 123 which provide for the type of substitute products defined under this final rule. Thus, this rule is likely to have little or no impact on the processing establishments that are producing products in accordance with the policy memos.

Ingredient manufacturers who produce binders and textured (source) protein products ( e.g. , textured soy or wheat protein) will be affected by the final rule because the rule will permit the increased use of these ingredients as fat replacing ingredients in some modified standardized products.

The decision to produce products subject to the General Standard established by this rule is voluntary. Therefore, only those manufacturers that choose to produce and market these products will incur the direct costs imposed by this rule. These costs include research and development, production and marketing, and labeling production. However, because the rule is voluntary, companies that choose to produce products covered by the General Standard will do so only if they determine that the benefits of producing and selling these products outweigh the costs of complying with the final rule. Furthermore, companies that are already producing and marketing products under Policy Memo 121B and Policy Memo 123 ( i.e. , comminuted meat and poultry products) are likely to incur minimal or no costs as a result of this final rule.

Under most circumstances, companies are likely to charge a premium for substitute standardized product produced in compliance with this final rule because many consumers will be willing to pay a premium for products with improved nutritional profiles. They view these products as “value added” products. 3 Therefore, based on the experience of food companies that are operating under FDA's 21 CFR 130.10 regulations, e.g. , the manufacturers of fat-free ice cream and reduced fat cream cheese, any costs associated with producing and marketing substitute products most likely will be passed on to the consumer in the form of higher retail prices.

However, once this rule becomes effective, some companies that are not producing substitute meat and poultry products under Policy Memo 121B or Policy Memo 123 may begin to manufacture and market substitute standardized products in accordance with the General Standard because of the market value of using traditional product names. Their decision to do so could have the effect of increasing the supply of these types of products in the short run, which could translate into lower prices for consumers.

This rule will assist consumers in making dietary choices by providing for modified versions of standardized meat and poultry products that have reductions of certain constituents that are of health concern to some consumers, such as fat, cholesterol, and sodium. Therefore, there will be a greater opportunity for consumers to maintain or to initiate healthy dietary practices. In the United States, diets high in fat, cholesterol, and sodium are associated with chronic diseases such as coronary heart disease, cancer, stroke, and diabetes. In 2002, according to the Centers for Disease Control National Center for Chronic Disease Prevention and Health Promotion, 7 out of every 10 U.S. deaths and more than 60% of medical care expenditures are attributed to chronic diseases. In addition, the prolonged illness and disability associated with many chronic diseases decrease the quality of life for millions of consumers.

According to the 2002 Heart and Stroke Statistical Update published by the American Heart Association and the American Stroke Association, the total cost of cardiovascular diseases and strokes in the United States was estimated at $279.8 billion and $49.4 billion, respectively, as reflected in the above table and figure 1 below. Direct costs ($168.7 billion and $30.8 billion, respectively) consist of the cost of physicians and other health professionals, hospital and nursing home services, medication, home health care, and other medical durables. Indirect costs ($111.1 billion and 18.6 billion, respectively) consist of lost productivity resulting from morbidity and mortality.

The total cost in 2002 associated with diabetes was $132 billion of which $92 billion were direct costs and $40 billion were indirect costs. 4 The estimated total costs for all cancers in 2002 were $172 billion ($61 billion in direct costs and $110 billion in indirect costs)  5 .

Most chronic diseases are preventable, or their onset can be delayed, through increased physical activity and healthy eating. There is research to support that practicing good nutrition lowers the risk of chronic diseases for many consumers. 6 The total estimated cost of chronic diseases to the consumer is $633.2 billion. The extent to which these costs might be reduced by an improved diet cannot be calculated precisely, but some researchers estimate that a balanced and healthful diet might forestall at least 20 percent of the annual deaths from heart disease, stroke, cancer, and diabetes. 7

It is reasonably expected that the final rule could contribute to the reduction of these costs, but this contribution, too, cannot be calculated precisely. In the “Economic Benefits of Nutrition Labeling: A Case Study for Fresh Meat and Poultry Products,” the Agency estimated the potential benefits of reducing the incidence of coronary heart disease and three types of cancers at $61.8 million, (7 percent discount rate); and $125 million (3 percent discount rate). 8

The results of the 2002 “Trends” survey” conducted by the Food Marketing Institute ( Trends in the United States, Consumer Attitudes and the Supermarket ) stated that 80 percent of consumers surveyed indicated that they had sought out and purchased products based on “low-fat” claims; 60 percent had purchased products because of “low cholesterol” claims; 59 percent purchased products because of “natural” claims; and 52 percent purchased products because of “low salt” claims. If this trend continues, and the final rule is promulgated, it is more than likely that the final rule will assist in the reduced incidence of chronic diseases by expanding the availability of meat and poultry products with lower levels of constituents such as fat, cholesterol, and sodium.

In conclusion, this final rule will assist consumers who want to reduce their dietary intake of fat, cholesterol, and sodium by encouraging the production of modified versions of traditional meat and poultry products that are formulated with fat, cholesterol, and sodium-replacing ingredient systems that reduce these constituents. The final rule will provide parity with FDA's regulations and will promote a unified approach to food standards and labeling. Most importantly, the final rule supports national efforts to reduce the expenditures for health care and the cost of morbidity and lost productivity by permitting the introduction of modified, substitute foods.

In terms of administrative benefits, the General Standard established by this final rule will permit industry to introduce modified, substitute versions of traditional standardized meat and poultry products without having to petition FSIS to establish new standards for products on a case-by-case basis. This will generate efficiency within the food standards system by saving time and resources that would have been expended by both the industry and FSIS to establish new or modified product standards. It will also permit companies to introduce standardized meat and poultry products with improved nutritional profiles into the marketplace in a timely manner, making such products more readily available to consumers.

The FSIS Administrator has made a final determination that this rule will not have a significant economic impact on a substantial number of small entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).

This final rule will not impose any new requirements on small entities. The decision to produce versions of standardized products that have been modified to qualify for use of an expressed nutrient content claim in conjunction with a traditional product name is voluntary. Therefore, the requirements of this final rule will only apply to those small manufacturers who choose to produce these types of products. Those small entities that choose to produce these products will be required to design new labels or to revise current labels to comply with this new rule, and thereby incur some costs. However, small entities who will be marketing these substitute products will most likely have anticipated that the revenues generated from the sale of these products will outweigh the costs of complying with the new regulation.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This final rule: (1) Preempts State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. However, the administrative procedures specified in 9 CFR 306.5, 381.35, and 590.320 through 590.370 must be exhausted before any judicial challenge of the application of the provisions of this rule, if the challenge involves any decision of an FSIS employee relating to inspection services provided under the FMIA or PPIA.

In accordance with section 3507(j) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), FSIS will submit the information collection and recordkeeping requirements in this final rule to the Office of Management and Budget (OMB) for approval.

Title: Food Standards: Requirements for Substitute Standardized Meat and Poultry Products Named by Use of an Expressed Nutrient Content Claim and a Standardized Term.

Type of collection: New.

Abstract: Under this final rule, FSIS is requiring that establishments that produce meat and poultry products in accordance with the definition and general standard of identity for substitute standardized products design new product labels and submit sketches of the new labeling to FSIS for approval. To receive approval of the labels, establishments must complete FSIS form 7234-1. FSIS employees review FSIS form 7234-1 to ensure that information on the labels complies with the regulations.

Estimate of burden: FSIS estimates that it will take 60 minutes to design and develop modified product labels in accordance with the final regulations and 15 minutes to prepare FSIS form 7234-1 and submit it, along with the label, to FSIS.

Respondents: Establishments that produce substitute standardized meat or poultry products in accordance with this final rule.

Estimated Number of Respondents: 100.

Estimated Number of Responses per Respondent: 5.

Estimated Total Annual Burden on Respondents: 625 hours.

Copies of this information collection assessment can be obtained from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety and Inspection Service, USDA, 112 Annex, 300 12th Street, SW., Washington, DC 20250. Comments are invited on (a) Whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected, ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both John O'Connell, Paperwork Reduction Act Coordinator, at the address provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20253. To be most effective, comments should be sent to OMB within 30 days of publication.

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that the public and in particular minorities, women, and persons with disabilities, are aware of this final rule, FSIS will announce it on-line through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/2005_Interim_&_Final_Rules_Index/index.asp. The Regulations.gov Web site is the central online rulemaking portal of the United States government. It is being offered as a public service to increase participation in the Federal government's regulatory activities. FSIS participates in Regulations.gov and will accept comments on documents published on the site. The site allows visitors to search by keyword or Department or Agency for rulemakings that allow for public comment. Each entry provides a quick link to a comment form so that visitors can type in their comments and submit them to FSIS. The Web site is located at http://www.regulations.gov/.

FSIS also will make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and other types of information that could affect or would be of interest to our constituents and stakeholders. The update is communicated via Listserv, a free e-mail subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The update also is available on the FSIS Web page. Through Listserv and the Web page, FSIS is able to provide information to a much broader, more diverse audience.

In addition, FSIS offers an email subscription service which provides an automatic and customized notification when popular pages are updated, including Federal Register publications and related documents. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/ and allows FSIS customers to sign up for subscription options across eight categories. Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves and have the option to password protect their account.

1. On page 30531, in the first column, under Response, in the fourteenth line, the word “commenters?” is corrected to read “commenters.”

2. On page 30535, in the second column, under 4. Charging Fees for Unlicensed Sites in Decommissioning , in the eleventh line, the word “licensees?” is corrected to read “licensees.”

3. On page 30537, in TABLE III.—REBASELINED ANNUAL FEES FOR FY 2005, the first number under the FY 2005 Annual Fee column “$3,115,000” is corrected to read “$3,155,000.”

4. On page 30540, in the second column, in the fourth line of the continued paragraph under Table VIII, the number “$2,966,000” is corrected to read “$2,996,000.” Also, in the tenth line in the same paragraph, the number “$3,115,000” is corrected to read “$3,155,000.”

Has FAA taken any action to this point? A report of loss of control on a Revo, Incorporated (REVO) Lake LA-4 series airplane during flight caused us to issue AD 98-10-12, Amendment 39-10524 (63 FR 26964, May 15, 1998). AD 98-10-12 currently requires the following on all REVO (Type Certificate 1A13 formerly held by Colonial Aircraft Company, Lake Aircraft Corporation, Consolidated Aeronautics, Inc., and Global Amphibians LLC) Models Colonial C-2, Lake LA-4, Lake LA-4A, Lake LA-4P, and Lake LA-4-200 airplanes:

• Measuring for a clearance of 5/32 of an inch between the attachment fitting and the horizontal stabilizer rear beam.

• If this minimum measurement is not met, removing the affected horizontal tail half from the airplane and inspecting the attachment fitting for any evidence of fretting, cracking, or corrosion.

• If cracks, fretting, or corrosion are/is present, replacing the attachment fitting with a new fitting, ensuring a clearance of 1/16 of an inch exists between the attachment fitting, and, if needed, trimming the stabilizer skin to provide a positive clearance for the fitting.

What has happened since AD 98-10-12 to initiate this AD action? The FAA has received more reports of fatigue cracks found in the horizontal stabilizer attachment fitting (part number (P/N) 2-2200-21) of REVO Model LA-4-200 airplanes. These airplanes were in compliance with AD 98-10-12. This includes one report of a REVO Model LA-4-200 airplane accident with a fatality attributed to a fatigue crack in the horizontal stabilizer attachment fitting.

The cracks occurred with as little as 942 hours time-in-service (TIS) on the horizontal stabilizer attachment fitting.

What is the potential impact if FAA took no action? Failure of the horizontal stabilizer attachment fitting (P/N 2-2200-21) could result in loss of control of the airplane.

Is there service information that applies to this subject? REVO has issued Service Bulletin B-78, dated April 3, 1998.

What are the provisions of this service information? The service bulletin includes procedures for:

What has FAA decided? We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other products of this same type design.

Since the unsafe condition described previously is likely to exist or develop on other REVO (Type Certificate 1A13 formerly held by Colonial Aircraft Company, Lake Aircraft Corporation, Consolidated Aeronautics, Inc., and Global Amphibians LLC) Models Colonial C-2, Lake LA-4, Lake LA-4A, Lake LA-4P, and Lake LA-4-200 airplanes of the same type design, we are issuing this AD to detect, correct, and prevent future cracks in the horizontal stabilizer attachment fitting (P/N 2-2200-21), which could result in failure of the horizontal stabilizer attachment fitting. This failure could result in loss of control of the airplane.

What does this AD require? This AD supersedes AD 98-10-12 by requiring the following:

• Dye penetrant inspection of the horizontal stabilizer attachment fitting for any evidence of fretting, cracking, or corrosion (with necessary replacement and modification) for those airplanes with less than 825 hours TIS on the fitting;

• Replacement of the fittings for those airplanes with 825 or more hours TIS on the fittings;

• Repetitive replacement of the fitting every 850 hours time-in-service (TIS);

• Repetitive visual inspections of the fitting every 50 hours TIS (or at the next annual inspection) between the fitting replacements; and

• Submittal of a report to FAA on the findings of the initial inspection and report of any cracks found for the repetitive inspections.

In preparing this rule, we contacted type clubs and aircraft operators to get technical information and information on operational and economic impacts. As a result of this contact, we received a report of an additional airplane with a crack in the fitting. This airplane had 942 hours total TIS. Consequently, we adjusted the compliance times in the AD based on this information.

How does the revision to 14 CFR part 39 affect this AD? On July 10, 2002, we published a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs FAA's AD system. This regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. This material previously was included in each individual AD. Since this material is included in 14 CFR part 39, we will not include it in future AD actions.

Will I have the opportunity to comment before you issue the rule? This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any written relevant data, views, or arguments regarding this AD. Send your comments to an address listed under ADDRESSES. Include “Docket No. FAA-2005-21092; Directorate Identifier 2005-CE-20-AD” in the subject line of your comments. If you want us to acknowledge receipt of your mailed comments, send us a self-addressed, stamped postcard with the docket number written on it; we will date-stamp your postcard and mail it back to you. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify it. If a person contacts us through a nonwritten communication, and that contact relates to a substantive part of this AD, we will summarize the contact and place the summary in the docket. We will consider all comments received by the closing date and may amend the AD in light of those comments.

What authority does FAA have for issuing this rulemaking action? Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

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

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

Will this AD involve a significant rule or regulatory action? For the reasons discussed above, I certify that this AD:

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

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

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

We prepared a summary of the costs to comply with this AD (and other information as included in the Regulatory Evaluation) and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under ADDRESSES. Include “AD Docket FAA-2005-21092; Directorate Identifier 2005-CE-20-AD” in your request.

The Department of Commerce (“Commerce”) is withdrawing its final rule published on May 12, 2005 at 70 FR 24941. That rule finalized tariff rate quotas (TRQ) for a limited quantity of worsted wool fabrics pursuant to Title V of the Trade and Development Act of 2000 (“the Act”) as amended by the Trade Act of 2002. The rule is being withdrawn because the effective date of the rule is incorrect. The effective date for the final rule was incorrectly established for June 13, 2005.

Commerce currently has open for comment a related interim final rule that implements amendments made by the Miscellaneous Trade Act of 2004 (70 FR 25774). Comments may be submitted until 5:00 p.m. on July 15, 2005. Please see the interim final rule for background information and instructions for submitting comments.

Classification: It has been determined that this notice is not significant for purposes of E.O. 12866.

The Department finds good cause to waive prior notice and an opportunity for public comment required by the Administrative Procedure Act because it is unnecessary and contrary to the public interest. Prior notice and opportunity for public comment is unnecessary because this rule will not have a substantive impact on the affected industry. The provisions implemented by the May 12, 2005 rule are not currently in effect and have not impacted the regulated industry. The withdrawal of the May 12, 2005 rule will, therefore, not substantively change the requirements currently imposed on the regulated industry. It would be contrary to the public interest to allow for prior notice and an opportunity for public comment because the published effective date of the May 12, 2005 rule conflicts with an interim final rule that implemented recently enacted statutory amendments. Consequently, if the May 12, 2005 rule is allowed to go into effect, it would create confusion in the industry. Therefore, it is unnecessary and contrary to the public interest to provide prior notice and an opportunity for public comment.

The Department finds that the 30-day in effectiveness is inapplicable because this rule is not a substantive rule. The provisions implemented by the May 12, 2005 rule are not currently in effect and its withdrawal will not substantively change the requirements currently imposed on the regulated industry.

Because notice and opportunity for comment are not required pursuant to 5 USC 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 USC 601 et seq.) are inapplicable. Therefore, a regulatory flexibility analysis is not required and has not been prepared.

1. The Federal Energy Regulatory Commission (Commission) has reviewed its hydropower procedural regulations to determine whether they contain any outdated requirements or impose any unnecessary burdens on persons subject to the Commission's jurisdiction. This review was begun by the FERC Information Assessment Team (FIAT), which was directed by the Chairman to assess the Commission's information needs. Goal 2 of the tasks identified by the team to meet this mission included identifying all of the Commission's current information collections, through forms and filing requirements, and evaluating their original purposes and current uses, and proposing ways to reduce the reporting burden on industry through elimination, reduction, streamlining or reformatting of current collections.

2. In this final rule, the Commission is amending its regulations to eliminate 18 CFR 4.81(d) (3), in order to remove the requirement that the applicant for a preliminary permit must identify a market for the power that it proposes to generate and provide related power system information at the preliminary permit stage of a hydropower license application. At the preliminary permit stage, the applicant is not required to develop a proposed project in detail, so this information is unnecessary.

3. The Commission expects these regulations will reduce the amount of information the Commission requires applicants to file, and that these modifications will not have a significant impact on preliminary permit proceedings. Because these changes relate only to the Commission's procedures and relieve unnecessary regulatory burdens, notice and comment on the changes is not required, and the changes are effective July 11, 2005.

4. The Commission's regulations provide a range of alternatives for development of a hydropower project. A prospective developer may, inter alia , apply to the Commission for a preliminary permit under Section 4(f) of the Federal Power Act. 1 These permits allow a specified term, no more than three years, for the prospective developer to perform investigations and studies to support a license application and to determine the economic, engineering and environmental feasibility of developing a hydropower project at a specific site. The permit preserves the exclusive right to file, during the specified term, an application for either a license or an exemption from licensing for the proposed project. Thus, the permittee may conduct needed studies to determine the feasibility of the project without fear of someone else filing a development application for the site. A preliminary permit is not required to develop a project; a developer may choose to file directly for either a license or an exemption from licensing. Preliminary permits are not transferable.

5. The Commission regulates non-Federal hydropower development under Part I of the Federal Power Act  2 (FPA). The Commission issues licenses for terms up to 50 years for “projects best adapted to a comprehensive plan” for improving a waterway for beneficial public purposes. Pursuant to Section 4(f) of the FPA, the Commission is authorized to issue preliminary permits, for the purpose of enabling prospective license applicants to secure the information necessary to support an application for license. Preliminary permits, issued for three years, reserve the right to file a development application at a specific site, 3 but do not authorize construction of any hydropower facilities or other land-disturbing activities. 4

6. The purpose of obtaining a preliminary permit, as noted above, is to maintain a priority status for an application for a license while the prospective applicant conducts site examinations and surveys to prepare maps, plans, specifications and estimates. This period of time also provides the applicant with the opportunity to conduct engineering, economic and environmental feasibility studies, and to make financial arrangements for the construction of any project. During the term of the permit, the Commission will accept no other application for a preliminary permit or application for license or exemption submitted by another person for the same site.

7. The Commission is eliminating 18 CFR 4.81(d) (3), thus eliminating the need for preliminary permit applicants to identify the market for the power that they propose to generate and to provide certain related power system information. At the time of a preliminary permit application, the project proposal is necessarily incomplete and this information is not needed to understand the project at this stage. The Commission is also incorporating 18 CFR 4.81(d) (1) and (2), concerning study costs and financing sources, into 18 CFR 4.81(c), which requires the applicant to describe studies conducted or to be conducted in connection with the preparation of a development application for the proposed project. These rules benefit applicants for preliminary permits by simplifying and expediting the preliminary permit process.

8. Office of Management and Budget (OMB) regulations require OMB to approve certain information collection requirements imposed by agency rule. 5 Comments are solicited on the Commission's need for this information, whether it will have practical utility, the accuracy of burden estimates, ways to enhance the quality, utility and clarity of the information to be collected, and any suggested methods for minimizing respondents' burden, including the use of automated information techniques.

9. The current reporting burden for this information collection is as follows:

The Commission estimates that preliminary permit applications filed pursuant to the new rule would require approximately 15 percent less time to prepare. Using an assumed cost of $52 per hour, the total savings would be $572 per application or $28,000 saved for a year in which 50 applications are prepared and filed.

Title: Application for Preliminary Permit (FERC-512).

Action: Change to an Existing Collection.

OMB Control No.: 1902-0073.

Respondents: Businesses or other for-profit and not-for-profit institutions.

Frequency of Responses: On occasion.

Necessity of Information: The proposed regulations will revise the reporting requirements for a preliminary permit application to streamline the requirements and reduce the burden on the applicant. The information filed with the Commission preserves a priority to file by a prospective developer of a hydropower project. These permits allow a specified time for the developer to conduct investigations necessary to support a license application and to determine the economic, engineering and environmental feasibility of developing a hydropower project at a certain site. The preliminary permit is not required to develop a project. Therefore, the developer may file directly for either a license or an exemption from licensing. The Commission offers preliminary permits as part of its efforts to simplify and expedite the hydropower licensing process. This final rule will take those efforts one step further.

Internal Review: The Commission has reviewed the proposed amendments to its regulations to remove the requirement that an applicant for a preliminary permit must identify a market for the power that it proposes to generate and provide related power system information at the preliminary permit stage of a hydropower license application. At the preliminary permit application stage, it is not necessary for the applicant to provide information regarding a market for the project's power and related matters. This amendment to the Commission's regulations conforms to the Commission's plan for efficient information collection, communication, and management within the hydropower industry. The Commission has assured itself, by means of internal review, that the new rule will reduce the burden estimates associated with preliminary permit applications.

10. Interested persons may obtain information on the information requirements by contacting the following: The Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426 [Attention: Michael Miller, Office of the Executive Director, Phone (202) 502-8415, fax: (202) 273-0873, e-mail: michael.miller@ferc.gov. ]

11. Please send your comments concerning the collection of information(s) and the associated burden estimate(s) to the contact listed above and to the Office of Management and Budget, Office of Information and Regulatory Affairs, Washington, DC 20503, [Attention: Desk Officer for the Federal Energy Regulatory Commission, phone: (202) 395-4650, fax: (202) 395-7285].

12. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment. 6 The Commission has categorically excluded certain actions from these requirements as not having a significant effect on the human environment. 7 The action taken here falls within the categorical exclusions in the Commission's regulations for rules that involve information gathering, analysis, and dissemination. 8 This proposed rule, if finalized, is procedural in nature and therefore falls under this exception. Therefore, an environmental assessment is unnecessary and one has not been prepared for this rulemaking.

13. The Regulatory Flexibility Act of 1980 (RFA)  9 requires a description and analysis of final rules that will have significant economic impact on a substantial number of small entities. 10 The Commission is not required to make such analyses if a rule would not have such an effect.

14. The Commission has concluded that the amendments to its regulations would not have such an impact on small entities. These regulations are intended to benefit all entities regardless of size by reducing the burden of information collection while preparing an application for a preliminary permit. The adoption of these amendments to the regulations will reduce the amount of information that must be filed with the Commission and will be of greater benefit to small entities who have limited resources for conducting investigations and preparing a licensing application if they so choose. Therefore, the Commission certifies that this rule will not have a significant economic impact on a substantial number of small entities.

15. In addition to publishing the full text of this document in the Federal Register , the Commission provides all interested persons an opportunity to view and print the contents of this document via the Internet through FERC's Home Page (http://www.ferc.gov) and in FERC's Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426.

16. From FERC's Home Page on the Internet, this information is available in the Commission's document management system, eLibrary, using the eLibrary link. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing and downloading. To access this document in eLibrary, type the docket number of this document, excluding the last three digits, in the docket number field.

17. User assistance is available for eLibrary and the FERC's Web site during normal business hours. For assistance, please contact FERC Online Support at FERCOnlineSupport@ferc.gov or calling toll-free at (866) 208-3676. For TTY, contact (202) 502-8659, or the Public Reference Room at (202) 502-8371, TTY (202) 502-8659, (e-mail at public.referenceroom@ferc.gov ).

18. This Final Rule will take effect July 11, 2005. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), that this rule is not a major rule within the meaning of Section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996. 11 The Commission will submit the Final Rule to both houses of Congress and to the General Accountability Office. 12

19. The Administrative Procedure Act (APA)  13 requires rulemakings to be published in the Federal Register . It also requires that an opportunity for comment be provided when the agency promulgates regulations. However, notice and comment are not required by the APA when the agency for good cause finds that notice and public comments thereon are impracticable, unnecessary, or contrary to the public interest. 14 The Commission finds that notice and comment are unnecessary to this rulemaking. As explained above, we are merely clarifying the scope of our regulations concerning applications for preliminary permits. This action should benefit the public by reducing the need to provide more information than is necessary for the Commission to evaluate preliminary permit applications. This clarification will result in a reduction of the filing requirements and will decrease the reporting burden on persons planning to develop hydroelectric power projects. Accordingly, this rule is effective July 11, 2005.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Publishing an NPRM would be impracticable and contrary to public interest. The event will take place on July 2, 3, and 4, 2005. Immediate action is needed to protect the safety of life at sea from the danger posed by high-speed powerboats.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, spectator craft and other vessels transiting the event area. However advance notifications will be made to affected waterway users via marine information broadcasts and area newspapers.

On July 2, 3 and 4, 2005, the Carolina Virginia Racing Association will sponsor the “Bo Bowman Memorial—Sharptown Regatta”, on the waters of the Nanticoke River at Sharptown, Maryland. The event will consist of approximately 100 hydroplanes and runabout conducting high-speed competitive races on the waters of the Nanticoke River between the Maryland S.R. 313 Highway Bridge and Nanticoke River Light 43 (LLN 24175). A fleet of spectator vessels normally gathers nearby to view the competition. Due to the need for vessel control before, during and after the event, vessel traffic will be temporarily restricted to provide for the safety of participants, spectators and transiting vessels.

The Coast Guard is establishing temporary special local regulations on specified waters of the Nanticoke River near Sharptown, Maryland. The regulated area includes the waters of the Nanticoke River between the Maryland S.R. 313 Highway Bridge and Nanticoke River Light 43 (LLN 24175). The temporary special local regulations will be enforced from 9:30 a.m. to 6:30 p.m. on July 2, 3, and 4, 2005, and will restrict general navigation in the regulated area during the power boat race. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area during the enforcement period. The Patrol Commander may allow non-participating vessels to transit the regulated area between races, when it is safe to do so. This regulated area is needed to control vessel traffic before, during and after the event to enhance the safety of participants, spectators and transiting vessels.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. Although this regulation will prevent traffic from transiting a portion of the Nanticoke River during the event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly. Additionally, the regulated area has been narrowly tailored to impose the least impact on general navigation yet provide the level of safety deemed necessary. Vessel traffic may transit the regulated area between heats, when the Coast Guard Patrol Commander deems it is safe to do so.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the Nanticoke River during the event.

This rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This rule would be in effect for only a limited period. Vessel traffic may transit the regulated area between heats, when the Coast Guard Patrol Commander deems it is safe to do so. Before the enforcement period, we will issue maritime advisories so mariners can adjust their plans accordingly.

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under ADDRESSES. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

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

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

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction, from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine parade permit are specifically excluded from further analysis and documentation under that section.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Publishing an NPRM would be impracticable and contrary to public interest. The event will take place on June 18, 2005. Immediate action is needed to protect the safety of life at sea from the danger posed by transiting vessels.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, support craft and other vessels transiting the event area. However, advance notifications will be made to affected waterway users via marine information broadcasts and area newspapers.

On June 18, 2005, the Maryland Swim for Life Association will sponsor the “Maryland Swim for Life”, an open water swimming competition held on the waters of the Chester River, near Chestertown, Maryland. Approximately 100 swimmers start from Rolph's Wharf and swim upriver 2.5 miles then swim down river returning back to Rolph's Wharf. A fleet of approximately 20 support vessels accompanies the swimmers. To provide for the safety of participants and support vessels, the Coast Guard will temporarily restrict vessel traffic in the event area during the swim.

The Coast Guard is establishing temporary special local regulations on specified waters of the Chester River, near Chestertown, Maryland. The regulated area includes all waters of the Chester River between Rolph's Wharf and the Maryland S.R. 213 Highway Bridge. The temporary special local regulations will be enforced from 6:30 a.m. to 1:30 p.m. on June 18, 2005, and will restrict general navigation in the regulated area during the swimming event. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area during the effective period. The regulated area is needed to control vessel traffic during the event to enhance the safety of participants and transiting vessels.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. Although this regulation will prevent traffic from transiting a portion of the Chester River during the event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the Chester River during the event.

This rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This rule would be in effect for only a limited period. Before the enforcement period, we will issue maritime advisories so mariners can adjust their plans accordingly.

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under ADDRESSES. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

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

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

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction, from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine parade permit are specifically excluded from further analysis and documentation under that section.

On April 19, 2005, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations, Housatonic River, Connecticut, in the Federal Register (70 FR 20322). We received no comments in response to the notice of proposed rulemaking. No public hearing was requested and none was held.

Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

The Coast Guard believes making this final rule effective less than 30 days after publication is reasonable because the bridge rehabilitation construction is necessary vital work that needs to be performed as soon as possible.

Any delay in making this final rule effective would not be in the best interest of public or safety because performing this work during the non-winter months June 18, 2005 through December 30, 2005, is the best time period during which construction personnel may work in a more safe and productive manner to help restore the bridge to a safe and reliable operational status.

The US 1 Bridge has a vertical clearance in the closed position of 32 feet at mean high water and 37 feet at mean low water. The existing drawbridge operation regulations are listed at 33 CFR § 117.207(a).

The owner of the bridge, the Connecticut Department of Transportation, requested a temporary change to the drawbridge operation regulations to facilitate rehabilitation maintenance at the bridge.

Under this temporary rule only one of the two-bascule leafs at the US 1 Bridge would open for the passage of vessel traffic from June 18, 2005 through December 30, 2005.

The Monday through Friday closures to facilitate vehicular commuter traffic in the existing operation regulations, 7 a.m. to 9 a.m. and 4 p.m. to 5:45 p.m., will continue to be in effect during this temporary rule.

Two-leaf openings will be provided on the following holidays: the Fourth of July, Friday, July 1 through Monday, July 4; Labor Day, Friday, September 2 through Monday, September 5; Thanksgiving, Thursday, November 24 through Sunday, November 27; and Christmas, Saturday, December 24 through Monday, December 26, 2005.

In addition, full two leaf bridge opening will be provided at any time, except during the closed periods for vehicular commuter traffic, after at least a three-day advance notice is given by calling the number posted at the bridge.

The Coast Guard received no comments in response to the notice of proposed rulemaking. As a result of the above, no changes were made to this temporary final rule.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3), of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

This conclusion is based on the fact that the bridge will fully open at any time after a three-day notice is given.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b), that this rule will not have a significant economic impact on a substantial number of small entities.

This conclusion is based on the fact that the bridge will fully open at any time after a three-day notice is given.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

No small entities requested Coast Guard assistance and none was given.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

This final rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

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

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

We have analyzed this final rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction, from further environmental documentation. It has been determined that this final rule does not significantly impact the environment.

On April 20, 2005, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations, Kennebec River, Maine, in the Federal Register (70 FR 20490). We received no comments in response to the notice of proposed rulemaking. No public hearing was requested and none was held.

The Carlton Bridge has a vertical clearance of 10 feet at mean high water and 16 feet at mean low water in the closed position. The existing drawbridge operation regulations are listed at 33 CFR 117.525.

The owner of the bridge, Maine Department of Transportation (MDOT), requested a temporary change to the drawbridge operation regulations to allow the bridge to open on signal every three hours at 6 a.m., 9 a.m., 12 p.m., 3 p.m., and 6 p.m., only, Monday through Saturday, from July 5 through December 17, 2005, and again from April 1 through June 30, 2006, to facilitate rehabilitation construction at the bridge.

From 6 p.m. through 6 a.m. the draw shall open on signal after at least a two-hour notice is given by calling the number posted at the bridge.

The bridge shall open on signal for Labor Day weekend, Friday, September 2, 2005 through Monday, September 5, 2005, from 8 a.m. to 5 p.m., and from 5 p.m. through 8 a.m., the draw shall open after a two-hour notice is given by calling the number posted at the bridge.

From December 18, 2005 through March 31, 2006, the bridge shall operate in accordance with its normal winter schedule.

In addition, this temporary final rule allows five three-day bridge closures as follows: September 7 through September 9; September 20 through September 22; October 4 through October 6; October 18 through October 20; and November 1 through November 3, 2005.

The Coast Guard received no comments in response to the notice of proposed rulemaking. We have changed the start date of the rule, from July 5, 2005, to July 11, 2005, to ensure that a full 30 days notice is provided to the public after publication of this rule.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3), of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not ?significant? under the regulatory policies and procedures of the Department of Homeland Security (DHS).

This conclusion is based on the fact that the bridge will continue to open on signal for all vessels at three-hour intervals from 6 a.m. to 6 p.m.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b), that this rule will not have a significant economic impact on a substantial number of small entities.

This conclusion is based on the fact that the bridge will continue to open on signal for all vessel traffic at three-hour intervals from 6 a.m. to 6 p.m.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

No small entities requested Coast Guard assistance and none was given.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency?s responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

This final rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

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

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

We have analyzed this final rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction, from further environmental documentation. It has been determined that this final rule does not significantly impact the environment.

Today, customers can submit a temporary forwarding request for their First-Class Mail and Periodicals mail. Customers also can have their mail held at the Post Office for short periods of time. Premium Forwarding Service (PFS) is a two-year, nationwide experiment that reships all of a customer's mail on a weekly basis.

PFS is a personalized service designed for sending mail from a customer's primary residential address to a temporary address using Priority Mail. With PFS, the Postal Service boxes and ships mail to customers who are away for at least two weeks and up to one year.

Express Mail and Priority Mail packages that are too large to fit inside the weekly PFS package are immediately and separately rerouted at no additional charge. Package Services parcels that are too large to fit inside the PFS package are forwarded with postage due. All mail requiring a delivery scan or a signature also is separately rerouted. Examples include Certified Mail, Registered Mail, and mail with Delivery Confirmation.

PFS generally provides a shipment of a customer's mail every Wednesday from their primary address to their temporary address by Priority Mail. There is an initial enrollment fee of $10, plus a weekly per-shipment charge of $10.

Customers who wish to participate must submit an application to the Post Office responsible for delivery to their primary address and pay the enrollment fee and shipment charges for the full duration they will be away. The minimum enrollment is two weeks, and the maximum is one year.

Customers who wish to cancel PFS early may request a refund for any unused weekly shipment charges from the Post Office serving their primary address. Additionally, customers can contact that Post Office prior to the termination date to extend PFS service (up to one year total) as needed.

The Board of Governors of the United States Postal Service approved the PFS experiment on May 10, 2005. The standards, which will be incorporated into Mailing Standards of the United States Postal Service , Domestic Mail Manual (DMM®) are included in the Opinion and Recommended Decision of the Postal Rate Commission Approving Stipulation and Agreement for Experimental Premium Forwarding Service, Docket No. MC2005-1.

The mailing standards for the two-year Premium Forwarding Service experiment are provided below.

The Postal Service is making the following amendments to Mailing Standards of the United States Postal Service , Domestic Mail Manual (DMM), which is incorporated by reference in the Code of Federal Regulations ( see 39 CFR 111).

Entities potentially affected by the subject rule for today's action include sources in all industry groups. The majority of sources potentially affected are expected to be in the following groups.

Entities potentially affected by the subject rule for today's action also include State, local, and tribal governments.

The information presented in this preamble is organized as follows:

On October 27, 2003, we published the Equipment Replacement Provision (“ERP”) amendments to our regulations implementing the major NSR requirements of the CAA. 1 The ERP amended the exclusion from major NSR for “routine maintenance, repair, and replacement” (“RMRR”) activities at existing major sources. Several parties sought judicial review of the ERP in the U.S. Court of Appeals for the District of Columbia Circuit. See State of New York v. EPA , No. 03-1380 and consolidated cases (DC Cir.). As a result of a court order, the ERP is “stayed” ( i.e. , not in effect) until the court decides this case.

On December 24, 2003, EPA published a rule amending the Prevention of Significant Deterioration (PSD) provisions of state programs that did not have approved state rules for PSD. 68 FR 74483. In each of these states, EPA previously had made the area subject to the PSD rules in 40 CFR 52.21, the Federal Implementation Plan (“FIP”) for PSD. Please see 68 FR 74483 (December 24, 2003), for additional background on this rule. Parties have also sought judicial review of this rule, and their petitions for review have been consolidated with the challenges to the ERP.

Also on December 24, 2003, a group of environmental organizations  2 petitioned EPA, pursuant to section 307(d)(7)(B) of the CAA, to reconsider three aspects of the Equipment Replacement Provision that we published on October 27, 2003. Specifically, the petitioners  3 asserted that our legal basis for the ERP is flawed, the basis for the 20 percent ERP cost threshold is arbitrary and capricious, and EPA has retroactively applied the ERP.

On January 16, 2004, a subset of the environmental petitioners on the ERP rule filed a petition for reconsideration of the December 24, 2003 rule that incorporated the ERP into the FIP portion of a State plan where the State does not have an approved PSD State Implementation Plan (SIP). This petition reiterated the issues raised in the December 24, 2003 petition concerning the ERP. On February 23, 2004, a group of states and the District of Columbia  4 filed a petition for reconsideration of the December 24, 2003 rule. This petition raised two issues. First, it asked for reconsideration on whether EPA needed to make a finding of deficiency for the PSD portions of each SIP before it amended the incorporation of the PSD FIP into the state plans. Second, it challenged whether EPA needed to provide an opportunity for comment on the revised format for incorporating the PSD FIP into state plans, which would automatically update the state plans whenever EPA amends the PSD FIP.

On July 1, 2004 (69 FR 40278), we granted reconsideration and requested comment on three issues raised by petitioners—specifically, the contentions that our legal basis is flawed, that our selection of 20 percent for the cost limit is arbitrary and capricious and lacks sufficient record, and that we should provide an opportunity for comment on the revised format for incorporating the PSD FIP into state plans. We decided to grant reconsideration on these issues because of the importance EPA attaches to ensuring that all have ample opportunity to comment. At that time, we did not act on the remaining two issues in those petitions.

On August 2, 2004, we held a public hearing on the issues for which we granted reconsideration. Five individuals gave oral presentations at the hearing. The transcript of their comments is located in Docket OAR-2002-0068 (Legacy Number A-2002-04), which can be accessed on the Internet at http://www.epa.gov/edocket.

The public comment period on the reconsideration issues ended on August 30, 2004, and we allowed until September 1, 2004 to receive public comments for issues arising out of the August 2nd public hearing. More than 350 written public comments on the reconsideration issues were received. The individual comment letters can be found in Docket OAR-2002-0068 (Legacy Number A-2002-04).

At this time, we are announcing our final action on reconsideration of the three issues for which we asked for comment in our July 1, 2004 notice. We are also announcing our final decision on the remaining two issues that were raised by the petitioners. We are making available a document entitled, “Technical Support Document for the Equipment Replacement Provision of the Routine Maintenance, Repair and Replacement Exclusion: Reconsideration,” EPA 456/R-05-003. This document contains (1) a summary of comments received on the issues for which we granted reconsideration and our responses to these comments, and (2) a summary of petition issues for which we are not granting reconsideration, and our rationale for denying reconsideration. This document is available on our Web site at http://www.epa.gov/nsr/ ; and, through the National Technical Information Services, 5285 Port Royal Road, Springfield, VA 22161; telephone (800) 553-6846, e-mail http://www.ntis.gov ; and, from the U.S. EPA, Library Services, MD C267-01, Research Triangle Park, NC 27711, telephone (919) 541-2777, e-mail library.rtp@epa.gov .

Our July 1, 2004 notice noted that underlying our legal rationale for the ERP is a basic tenet of administrative law stated in Chevron, U.S.A., Inc. v. NRDC , 467 U.S. 837 (1984). The Chevron Court held that expert agencies have the discretion to reasonably interpret ambiguous statutory terms and that such interpretations are due deference. Id. at 842-845. In the October 27, 2003 final rule and in the July 1, 2004 notice, we explained that the statutory definition of ‘modification,’ CAA 111(a)(4), and, in particular, the word “change” in the phrase “any physical change or change in the method of operation,” is ambiguous. The word itself is ambiguous, and the use of “any” as a modifier, in the context of the statute, simply requires EPA to include an indeterminate number of changes as potential modifications  5 once EPA defines the ambiguous term “change.” The ERP, which establishes criteria for determining what equipment replacement activities do not constitute physical changes, is a rational interpretation of “physical change” in the definition of “modification.” See 68 FR 61268-61274 for our more detailed legal support for the ERP.

In granting reconsideration, we invited comments on several legal arguments suggested by commenters on the meaning of the statutory definition of “modification.” In particular, we noted that commenters had suggested that the plain meaning of the “modification” definition required that functionally equivalent equipment replacements not be deemed to be changes and, therefore, be deemed RMRR. We also noted that other commenters took the opposite view about the plain meaning of the statute. Both sides of this argument cited the principle from Chevron that where the statute's meaning is clear, the agency must give its meaning effect (the first step in statutory analysis under Chevron , or Chevron 1 ). Some commenters had argued that only de minimis exceptions could be allowed under the statute. Others had pointed out that a recognized principle of administrative law allows an agency to establish “bright line” criteria to reduce regulatory burden and provide certainty. We invited comment on these arguments and any other possible legal arguments when we granted reconsideration on the issue of whether our legal basis in the ERP was flawed.

We received a number of comments supporting and opposing the legal basis for our rule. Commenters renewed and expanded prior arguments that the definition of “modification” was clear and either prohibited or compelled treating like-kind replacements as physical changes when replacement resulted in a potential emissions increase. Some comments, summarized below, addressed Congressional intent as construed by courts, provided specific textual analysis of the modification definition, and offered policy objections to the ERP. We discuss significant comments below and refer you to the TSD for this action for additional discussion of comments and responses.

a. Congressional Intent. Commenters assert that the ERP is contrary to Congressional intent and the decision in Alabama Power v. Costle , 636 F.2d 323 (D.C. Cir. 1979). They characterize the opinion as holding that Congressional intent behind the modification provision was to include any physical change that increases emissions, even though it would undoubtedly prove inconvenient and costly to affected industries. They cite a portion of the opinion that declared, “the term ‘modification’ is nowhere limited to physical changes that exceed a certain magnitude.” Additionally, they claim the Court found EPA's authority to exempt activity from “modification” was limited to de minimis activity. Id . at 400.

We disagree with the commenters' reading of Alabama Power. Alabama Power does not directly address whether like-kind replacements must be deemed to be physical changes. The Alabama Power Court addressed an exemption for physical changes that resulted in an emissions increase of less than 100 tons. It is in this context, where the replacement activity has been conceded to be a physical change, that the court states that the modification definition “is nowhere limited to physical changes that exceed a certain magnitude.” Alabama Power , 636 F.2d at 400. In context, the “magnitude” language only addresses the size of the emission tonnage increase resulting from a “change,” once the activity meets the definition of a “change.” The Court did not have before it the question of whether the phrase “any physical change” is ambiguous. Contrary to the commenter's assertions, the cited portion of the Alabama Power opinion discusses a de minimis exemption only in the context of emission increases and not in terms of what constitutes a physical change (“EPA does have the discretion * * * to exempt from PSD review some emission increases on grounds of de minimis or administrative necessity”). Id .

Moreover, the Alabama Power Court also expresses the expectation that “bubbling” (or netting) in calculating emission increases and an allowance for physical changes that result in de minimis increases in emissions “will allow for improvement of plants, technological changes, and replacement of depreciated capital stock , without imposing a completely disabling administrative and regulatory burden.” Alabama Power , 636 F.2d at 400. (emphasis added). Our subsequent experience has shown that, even with netting, a definition of “physical change” as encompassing as that supported by these commenters is inadequate to allow for appropriate replacement of depreciated capital stock. See “New Source Review: Report to the President”, June 2002 (Docket No. OAR-2002-0068, Document No. 0004). It simply is not the case that the Alabama Power opinion analyzes and requires the commenters' encompassing construction of “any physical change.” Equally important, a narrow interpretation of ERP as advocated by commenters would create hurdles for ensuring that a process operates reliably, safely, and efficiently, thereby increasing the likelihood that net emissions would be higher.

The commenters point to several enforcement filings and other EPA pronouncements prior to promulgation of the ERP in which we said the definition of modification was unambiguous and had broad application. Furthermore, they note that we repeatedly recognized that the structure of the Act demonstrates that Congress intended grandfathering to be of limited duration.

We recognize that, prior to promulgation of the ERP, we had not specifically asserted that our interpretation of “change” and the exclusions from NSR are based on an exercise of Chevron discretion. In some instances, such as in a decision of the Environmental Appeals Board (EAB), In re: Tennessee Valley Authority , 9 E.A.D. 357 (EAB 2000), and in briefs in various enforcement-related cases, we had interpreted “change” such that virtually all changes, even trivial ones, were encompassed by the Act. Thus, we generally had interpreted the exclusion as being limited to de minimis circumstances. However, in the ERP we asserted that EPA does have the authority to interpret these key terms through rulemaking. Upon further consideration of the history of our actions, the statute, and its legislative history, we said that we believe a different view is permissible, and, for policy reasons discussed in the ERP final rule, more appropriate. Therefore, we adopted our Chevron -based interpretation of the statute prospectively in the ERP final rule. 6

Subsequent to promulgating the ERP, we filed court papers noting that, as of the date of the final ERP rule, we adopted a new interpretation of the statute. Our position is most clearly spelled out in a filing we made in United States v. Illinois Power Co., et al. , Civil Action No. 99-833 (S.D. Ill.) (“Illinois Power”). As we stated to the Illinois Power Court, “the United States does not rely on any prior statements * * * that a very narrow construction of the “routine maintenance” exemption is required by the Clean Air Act itself. Instead, the United States will continue to rely on EPA's narrow interpretation of its prior “routine maintenance” exception, which remains applicable to this action.” Illinois Power , Plaintiff's Reply to Defendants' Proposed Findings of Fact and Conclusions of Law (Liability Phase) at 5. We no longer interpret the language or structure of the NSR provisions of the Act as an expression of Congress's intent to limit “grandfathering” through the indirect means of the “modification” provision rather than through other provisions that clearly can reach all existing sources. See, e.g. , CAA section 110 (SIP provisions); CAA section 112 (hazardous air pollutant provisions); CAA sections 401-416 (acid rain provisions).

Finally, one group of commenters argues that Congress's decision in 1977 to cross-reference the preexisting definition of “modification” in CAA section 111(a)(4) when it adopted the modification provision for NSR should have no impact on assessing whether the terms of the definition are ambiguous. They cite EPA's arguments in our August 2004 brief in State of New York v. EPA , D.C. Cir. Case No. 02-1387, which refuted arguments that EPA is compelled to interpret both the NSPS and the NSR modification provisions the same way. They construe the “legal basis” discussion in our October 27, 2003, ERP final rule as arguing that Congress ratified our ERP interpretation when it enacted the 1977 amendments.

We disagree with the characterization of our argument in the October 27, 2003 preamble to the final ERP rule. Nowhere in that notice do we argue that Congress mandated adoption of the 1977 NSPS regulatory interpretation of what is a “modification” when it cross-referenced the definition in CAA 111(a)(4) into the NSR program. As we discussed in the cited passages of our briefs, we do not believe Congress intended to ratify the then-existing interpretation or “congeal” our NSR regulations as they stood under the NSPS program in 1977. Our discussion of the history of our interpretation of CAA 111(a)(4) simply points out the obvious: that words of CAA 111(a)(4) historically have been taken to have quite different meanings in the NSR and NSPS programs. From this, we argue that any words that can be given such divergent meanings for decades cannot have but one clear meaning on their face. To argue that the definition of “modification” in CAA 111(a)(4) is unambiguous, as the commenters have, one must advance an unusual position: that the same words, with no further definitions or legislative history, facially and unambiguously mean different things.

b. Textual analysis of the modification definition. It is axiomatic that the most clear expression of what Congress intended by the “modification” definition is in the words it chose to use. Many significant comments we received analyzed the structure of the definition and particular words and phrases in it.

One commenter argued that the statutory term “modification” itself is not ambiguous, so the definition of modification should not be read to create ambiguity in the term. The commenter, who argued that the ERP is too generous in excluding equipment replacements from NSR, observed that the plain meaning of modification connotes moderate, as opposed to fundamental, change.

We disagree with the assertion that the ERP allows for “fundamental” change in an emission source. In focusing on the 20 percent criterion of the ERP, the commenter ignores other important criteria under the ERP that would, in any ordinary sense of the term, prohibit the possibility of fundamental change as a result of activities that meet the ERP exclusion. A source that maintains its basic design parameters is not fundamentally changed, nor is a source that replaces one piece of equipment with another that is functionally equivalent. Thus, the ERP does not allow for fundamental change of the type the commenter suggests that the term “modification” should prohibit. In fact, to clarify this, the ERP explicitly precludes activities that would change the basic design parameters from qualifying for a RMRR exclusion.

Moreover, we disagree with the commenter's assertion that the term “modification” itself is unambiguous and in no need of further clarification. In fact, we note that over the years permitting authorities have had to respond to numerous queries regarding whether certain activities constitute a “modification,” a testament that there is considerable ambiguity surrounding this term. Apparently, Congress agrees with our view, because it supplied further definition in CAA 111(a)(4).

Many of the comments focused on the significance of the modifier “any” in “any physical change or change in the method of operation.” In our October 27, 2003 final rule, we said that the word “any” did not compel EPA to define what constitutes a “physical change” to include all activities that could conceivably be defined as a physical change. In our view, we had discretion to define what activities were physical changes, and once we defined physical change, “any” simply meant that any activity that met our definition of physical change could be a modification if it also increased net emissions.

In our July 1, 2004 notice, we invited comment on a recent Supreme Court case that construed a prohibition on states and localities enacting legislation to bar “any entity” from offering interstate telecommunications services to not apply to legislation that restrained political subdivisions of states from entering the field. Nixon v. Missouri Municipal League , 541 U.S. 125, 124 S. Ct. 1555, 1559-60 (2004). The Nixon Court observed that Congress's understanding of “any” can differ depending upon the statutory setting. Id. at 1561. This opinion reversed a case litigants had relied upon in seeking a stay of the ERP on the proposition for which it was cited. 7

In discussing the significance of the modifier “any” in the statute and in discussing the Nixon case, commenters opposed to the ERP argued that numerous cases besides Nixon have held that terms modified by the word “any” must be given the most inclusive meaning possible, that such terms must be interpreted expansively, and that “any” has a broad meaning. 8 These commenters distinguished Nixon on the grounds that this case raised peculiar federalism concerns ( i.e. , the ability of a state to regulate its own political subdivisions) not present in CAA 111(a)(4) or the ERP.

Several other precedents establish that the principle on which Nixon relies, that the understanding of “any” can depend on the statutory context, is not limited to situations with federalism implications. E.g., O'Connor v. U.S. , 479 U.S. 27, 31 (1986) (statutory context shows “any taxes” limited to taxes of the Republic of Panama); Mastro Plastics Corp. v. NLRB , 350 U.S. 270-85 (1956) (“any strike” does not include strike in response to unfair labor practices); Bell Atlantic Tel. Cos. v. FCC , 131 F.3d 1044, 1047 (D.C. Cir. 1997) (FCC regulation narrowing “any * * * facilities or services” that a Bell operating company could offer affirmed when Court notes “textual analysis is a language game played on a field known as ‘context”'). Therefore, we believe the “broader frame of reference” adopted by the Nixon Court is not an isolated and unsupported view of the law limited to cases raising federalism concerns.

None of the cases cited by the commenters stand for the proposition that a term modified by the word “any” invariably must be given its broadest meaning. In Harrison and in other cases, the Court found “no indication whatever” that Congress intended a narrower or limited construction of statutory term. These cases discuss a different statutory context than the adoption of the definition of “modification” in the NSR provisions of the CAA. These cases do not involve a situation in which Congress incorporated into a section of a statute a term that had been used in another section of the statute and which had been given a different meaning under that prior section. While there is no evidence that Congress compelled EPA to replicate its NSPS interpretation of “any physical change” in the NSR program, the fact that the words at issue were given a different construction in the NSPS is an indication that the words do not have a unique and, therefore, unambiguous meaning.

The cases cited by the petitioners and the Nixon line of cases are not, in fact, opposing and contradictory. Both support looking for indications in the statute that suggest a more limited meaning of the modified term is possible or intended. We believe such indications exist in the NSR context because the modification definition inserted into the NSR provisions by a 1977 technical amendment to the 1977 CAA Amendments cross-referenced the pre-existing term under CAA 111(a)(4).

Implicitly, at least one of the commenters critical of the ERP recognized that a broader frame of reference can apply by arguing that while in Nixon , a broad construction of “any” would have led to absurd, futile, and farfetched results, the same would not be true for the NSR modification definition. For NSR, according to the commenters, Congress placed a clear limit on what changes must be considered modifications—those that increase emissions.

In the definition of “modification,” we believe a view that “any” compels a broad construction of the modified terms also has farfetched implications. The same word “any” that modifies “physical change in” also modifies “change in the method of operation of.” The commenters' argument proves too much. The argument would say that exemptions from the definition of modification on any basis other than de minimis increases would not be necessary or appropriate, even long accepted ones that limit the scope of “change in the method of operation.” As the preamble to the final rule notes, many of these exemptions can result in non- de minimis increases in emissions. 68 FR at 61272. To accept the commenter's argument would mean that one word (“change”) that modifies two clauses in a definition compels a broad construction of one modified clause while allowing discretion when it modifies the other clause.

Another commenter picks up on Nixon 's reliance on the doctrine of avoiding absurd or futile results and echoes the view that this doctrine would not apply in the context of the modification definition. In this commenter's view, EPA cannot claim that a broad construction of “any physical change” would lead to absurd or futile results when we adopted such a broad construction of “any physical change” in the past and continue to seek deference for such an interpretation in ongoing enforcement litigation.

We do not claim our prior interpretation is absurd or futile. The Agency claims that the use of the word “any” in the statute does not compel only our prior interpretation.

We note that under the NSPS program, we interpreted CAA 111(a)(4) to allow us to exempt “[m]aintenance, repair, and replacement which the Administrator determines to be routine for a source category.” 40 CFR 60.14(e)(1). In contrast, under the NSR program, historically we have interpreted the RMRR provision on a case-by-case basis, and we have not followed suit with the NSPS program in determining that the same activities are categorically exempt from RMRR. Thus, a modification that is categorically exempt under the NSPS could be potentially subject to NSR under our historical RMRR interpretation. It would be incongruous to argue that the identical statutory text incorporated into both the NSPS and the NSR provisions “clearly” could support only one meaning in the NSR context while it supports a different meaning in the NSPS context. Rather than saying CAA 111(a)(4) is clear but has two distinct meanings, common sense suggests the wording is ambiguous and allows for an expert agency to adopt reasonable interpretations in the context of the programs.

Commenters incorrectly claim that we have recognized all equipment replacements, including “like-kind” replacements, to be “physical changes” within the ordinary meaning of the word. While our October 27, 2003, final rule recognized that “change” is susceptible to multiple meanings, and outlined many common uses of the word, we did so to illustrate that there is no one, unambiguous, common meaning for the word. That is the essence of ambiguity.

Several commenters agreed with our view that “any” should be interpreted within the “broader frame of reference” of its statutory context. One commenter argued that Nixon undermined much of the logic in Wisconsin Electric Power Co. v. Reilly , 893 F.2d 901 (7th Cir. 1990) ( WEPCO ). That case contains sweeping language that repeatedly stressed that “any” compelled a broad interpretation of “any physical change.”

As we noted in our October 27, 2003 final rule, we believe that the WEPCO Court was correct to determine that the statute does not unambiguously allow all like-kind replacements to avoid NSR, which was the position advanced by WEPCO in that litigation and which is the position advanced in this reconsideration by certain commenters. The Court's conclusion that the statute does not compel the outcome favored by WEPCO leads to a result that is completely consistent with our current view. Additionally, we continue to believe that the activities at issue in WEPCO were not RMRR under the rules at issue in that case. Furthermore, we continue to believe that, under the ERP, the equipment replacements at issue in that case would not automatically qualify as being excluded from major NSR. However, we agree with the commenter that Nixon calls into question the additional discussion in WEPCO that construes “any” to compel a broad view of what is a “physical change.” In our view, “any physical change” is an ambiguous term that can be defined by the Agency through rulemaking.

Focusing on a different portion of the definition of “modification,” commenters argue that Congress provided the only acceptable limitation on what physical changes are not subject to NSR as a modification, which is the requirement that the physical change result in an increase in emissions of any pollutant or the emission of any pollutant not previously emitted. 9 Commenters argue that an agency cannot imply an exemption to, or otherwise insert limiting language into, a categorical statutory provision, especially where Congress was specific in how it would allow the language to be limited.

We disagree with the commenters on three grounds. First, the commenters seem to assume the answer to the threshold question—that equipment replacements that meet the ERP criteria are “physical changes”—in order to say that we are creating an exemption for activity that is presumptively subject to NSR. We believe that there is no such presumption prior to the agency defining the ambiguous term. Second, we believe that the implication of the commenters' argument would mean that several long-accepted exemptions from NSR would no longer be valid were their position adopted. These exemptions from “any * * * change in the method of operations” were discussed in our final rule legal basis. Finally, we believe that the commenters' argument would not give meaning to all the words of the definition of modification. The commenters' position reads the “any physical change or change in the method of operation” to be so inclusive that essentially the test for a modification becomes whether emissions increase at a source because there always will be some “change” to which the increase can be linked. In contrast, the ERP, as part of our overall approach to the definition of modification, gives meaning to both the “change” portion as well as the “emissions increase” portion of the definition.

To summarize: With respect to existing sources, the purpose of the NSR provisions is simply to require the installation of controls at the appropriate and opportune time. The kind of replacements that automatically fall within the equipment replacement provision established today do not represent such an appropriate and opportune time. Accordingly, and given that it is consistent with the meaning of “change” to treat this kind of replacement as not being a “change,” we believe excluding them on that basis from the definition of “modification” as used in the NSR program is well calculated to serve all of the policies of the NSR provisions of the CAA, and is therefore a legitimate exercise of our discretion under Chevron, U.S.A. Inc. v. NRDC , 467 U.S. 837 (1984), to construe an ambiguous term. Likewise, we believe this approach is consistent with the holding in the WEPCO case, and with some though not all of that case's reasoning.

Finally, one comment argued that EPA's position on the meaning of “change” is internally inconsistent. If equipment replacement is not a change, then the comment suggests EPA lacks authority to regulate changes that exceed 20 percent of the replacement cost. If equipment replacement is a change, then the comment suggests that an exemption can only be justified by de minimis authority.

We note that establishing bright line criteria in a manner that reduces regulatory cost and provide certainty is a well-recognized and accepted approach to clarifying ambiguous terms in statutes. See Time Warner Entertainment Co. LP v. FCC , 240 F.3d 1126, 1141 (D.C. Cir. 2001). The ERP simply establishes bright lines for when an equipment replacement activity is automatically excluded from major NSR.

As we explained in our final ERP rule preamble, this approach is consistent with our approach towards “reconstruction” in the NSPS context. Under the NSPS rules, we treat a 50 percent threshold as a trigger for scrutiny as to whether the source must meet the NSPS. 40 CFR 60.15(b)(1). We then assess the technological and economic feasibility of meeting the NSPS standard. 40 CFR 60.15(b)(2).

In the ERP, we do not take the position that all like-kind or functionally-equivalent replacements automatically are or are not changes. Instead, we simply draw criteria for when such activities are excluded from NSR and when the multi-factor RMRR approach applies.

c. Policy objections. Several comments disputed the manner in which we exercised our discretion in defining which equipment replacement activities are not changes. As noted below, these comments tended to infer that we were defeating Congressional intent through the practical effects of the ERP.

Some commenters criticize the ERP as allowing for perpetual immunity from emissions control requirements. These commenters claim that the ERP reflects EPA's disagreement with Congress's determination that the time to install controls is when a unit is modified. In the commenters' opinion, EPA's belief that it is not plausible that replacements would proceed if emissions controls needed to be installed lacks a factual basis and is contrary to the statutory scheme.

Our disagreement over what constitutes a modification is with the commenter and not Congress. Major source NSR permitting is required unless the source can meet the criteria of the ERP, is not otherwise exempt under the RMRR provision or another NSR exemption or exclusion, and the source does not accept enforceable emissions limit below the significant emissions increase levels. When a replacement is a modification under our clearer, more focused definition, NSR permitting will apply, consistent with the Act.

We do not believe, however, the modification provisions of the CAA should be interpreted to ensure that all major facilities either must eventually trigger NSR or must degrade in performance, safety, and reliability. In fact, such an interpretation cannot be squared with the plain language of the CAA. An existing source triggers NSR only if it makes a physical or operational change that results in an emissions increase. Thus, a facility can conceivably continue to operate indefinitely without triggering NSR—making as many physical or operational changes as it desires—as long as the changes do not result in emissions increases. This outcome is an unavoidable consequence of the plain statutory language and is at odds with the notion that Congress intended that every major source would eventually trigger NSR or otherwise fall into disrepair. Moreover, there is nothing in the legislative history of the 1977 Amendments, which created the NSR program, to suggest that Congress intended to force all then-existing sources to go through NSR. To the extent that some members of Congress expressed that view during the debate over the 1990 amendments, such statements are not probative of what Congress meant in 1977. Central Bank of Denver, N.A. v. First Interstate Bank of Denver, N.A. , 511 U.S. 164, 185—86 (1994), and cases cited.

To the extent that our preamble to the ERP final rule suggested that no replacements ever would take place if controls were required, we recognize that such a generalization is not established by the record, nor was it our intent to make such a sweeping statement. Nevertheless, the substantial body of testimony and studies in the record demonstrates that the vagueness of the RMRR provision operated as a substantial restraint on replacement activity even when such activity would result in safer, more efficient, more reliable processes that had the potential to lower emissions in the overall economy by displacing higher polluting production. See “New Source Review: Report to the President”, June 2002 (Docket No. OAR-2002-0068, Document No. 0004). Based on the record, we believe that an owner or operator of a source often has the financial incentive to repair existing equipment or artificially constrain production, rather than install emission controls. Therefore, as a general matter, the replacement of that equipment is not, in fact, an opportune time for the installation of such controls. It follows that a policy treating such replacements as an NSR trigger generally will not lead to the installation of controls. Rather, it will merely create incentives to make a plant less productive than its design capacity would allow it to be.

These commenters also claim that Congress intended to strike a different balance between the nation's economic and environmental interests than that which the ERP strikes. They believe requiring emission controls on modified sources would facilitate economic growth and preserve air quality. They point out that the 1977 House Committee report noted, when the emissions impact of each new or modified plant is minimized, “then more and bigger plants will be able to locate in the same area without serious air quality degradation.”

We agree that we strike the balance between productive capacity of the nation and the protection of the environment differently than these commenters would. We disagree with the assertion that the balance we struck inappropriately weights either consideration. To the extent that Congress left discretion to anyone in striking such a balance, it is afforded to the Administrator and not to litigants. The record demonstrates that our approach, in concert with other CAA programs, is consistent with preserving clean air resources and improving air quality in areas that are not attaining the NAAQS as well as Congress's intentions written explicitly in Sec. 101(b)(1) to preserve the productive capacity of the nation's population and in Sec. 160(3) to balance economic and environmental concerns.

When balancing the economic and environmental interests of the nation, we have also considered that there are many other systematic air programs that will not merely prevent emission increases from existing sources but even reduce emissions at sources we expect to use the ERP. In fact, the entire state implementation plan (SIP) program under Sec. 110(a) establishes a framework for systematic reduction of emissions from existing sources when such reductions are deemed necessary to meet or maintain the NAAQS. The CAA places primary responsibility on the States to achieve the emissions reductions needed to attain and maintain the NAAQS. Over the years, States have in fact achieved significant emissions reductions in furtherance of this obligation.

To assist States, we have developed model market-based programs patterned after the successful Acid Rain provision in Title IV of the CAA. For example, EPA's recently issued “Clean Air Interstate Rule (CAIR),” will ensure, through States adopting a “cap and trade” or other program approach, that overall emissions from electric utilities throughout much of the Eastern part of the country will meet overall emission limits that are sharply below that which they emit today. CAIR ensures that, by 2015, SO 2 and NO X emissions will be permanently reduced by 5.4 million tons and 2.0 million tons, respectively, over 2003 levels. Additional emission reductions will occur after 2015 when CAIR is fully implemented.

There are other CAA programs, as well, that are specifically tailored to require emission reductions from existing utility and nonutility sources. These programs include the Maximum Achievable Control Technology (MACT) standards that apply to new and existing sources of air toxics and Control Technique Guidelines that provide guidance to states in determining Reasonably Available Control Technology (RACT) for sources in ozone nonattainment areas. All of these CAA measures will apply systematically to existing sources, and are unaffected by the applicability or non-applicability of any NSR exclusion, such as the RMRR exclusion and its further definition as set forth in the ERP. And, in appropriate circumstances, a State may seek to use CAA Section 126 to petition for additional controls on out-of-state sources.

Even in the absence of these other CAA programs, we note that the substitution effect of replacing deteriorating emission sources with well-maintained emission sources will generally reduce emissions per unit of output. The ERP itself should not materially affect demand in markets. Thus, to the extent individual sources will increase output (and emissions) following maintenance allowed by the ERP, output (and emissions) at other plants will decrease. Thus, we conclude that the ERP will not lead to an overall emission increase.

In contrast to the CAA programs discussed above that systematically and efficiently obtain emission reductions, the NSR program for existing sources, as that program existed before the ERP, was applied in a scattershot manner, only triggered by “modifications” however defined on a case-by-case manner. Under NSR, emissions reductions can only be obtained in a “catch-as-catch-can” manner, and there never has been and never can be a date certain by which all existing sources in an area of the country must comply with an emission cap or a NAAQS. Moreover, as fully explained in our recent brief filed in defense of the NSR Improvements Rule of December 31, 2002, the NSR program is not an emission reduction program. It is a program to limit emission increases resulting from physical and operational changes. Brief for Respondent at 73-75, State of New York v. U.S. EPA, No. 02-1387 & consolidated cases (D.C. Cir.) (“If Congress had intended to compel decreases in emissions, it would be irrational for the requirement to be triggered only when a facility, in fact, increases its emissions”). In light of the programs under the Act that systematically and efficiently allow for both reductions in emissions and firm caps on emissions, and the scattershot applicability and limited goals of NSR program with respect to existing sources, it was appropriate for us to strike the balance of economic and environmental interests in accordance with the CAA, as we did when we changed our method for implementing the modification definition in the NSR program.

Commenters suggest that EPA's decision in promulgating the ERP is not entitled to deference because, in their view, it appears that Congress would not have sanctioned an interpretation that allows sources to conduct multi-million dollar refurbishment activities that increase emissions without triggering NSR. However, the record establishes that adoption of the ERP will not cause overall emissions to increase, while, at the same time, safety, efficiency, and reliability of plants will improve. Furthermore, improvements in safety, efficiency, and reliability improve environmental performance by minimizing the frequency of startup, shutdowns, and malfunctions. While the record contains some conflicting data and studies, Congress left the weighing of this information and the forming of policies based on this information to EPA as an expert agency. We considered the quality and validity of the submitted data and studies in developing our conclusions. Our decisions in this matter are entitled to deference under Chevron.

In the December 31, 2002 proposed rule, EPA solicited comments on the ERP approach. At that time, we sought input on a range of possible percentages of cost that could serve as one of the criteria that must be met to qualify for the RMRR exclusion from NSR. We asked for comment on percentages ranging up to 50 percent, the threshold for reconstruction under the New Source Performance Standards (NSPS) program. 67 FR at 80301.

Under the ERP, a project must meet four separate requirements before it is automatically excluded from NSR pursuant to the ERP. The 20 percent replacement cost threshold is but one of the four requirements. Thus, projects that meet the 20 percent threshold are not exempt from major NSR under the ERP if they do not meet the other necessary criteria in the final rule. These other criteria require that the replaced component: (1) Be identical or functionally equivalent; (2) does not alter the basic design parameters of the process unit; and (3) does not cause the process unit to exceed any emission limitation or operational limitation (that has the effect of constraining emissions) that applies to any component of the process unit and that is legally enforceable.

Some commenters have asserted that an equipment replacement project would be excluded from NSR if it costs 20 percent or less of the replacement cost of a process unit. However, a replacement project must meet all four of the ERP criteria for the ERP to apply. Thus, only if the replaced component is (1) identical or functionally equivalent, (2) does not alter the basic design parameters of the process unit, and (3) does not cause the unit to exceed any emission or operational limit, will the 20 percent criterion be relevant. Of all of these qualifiers, including the 20 percent cost threshold, the key qualifier is that the equipment replacement is “like-kind” ( i.e. , identical or functionally equivalent). This criterion provides strong support for our determination and conclusion that where the ERP applies, the process unit has undergone “no change” as a result of the activity at issue. Thus, the 20 percent cost threshold serves primarily as an administrative threshold, by which activities that fall beneath threshold and which also meet the other rule criteria safeguards qualify automatically as RMRR, while those activities that meet the other criteria but are over the 20 percent cost threshold may still be RMRR, but only by applying the multi-factor RMRR approach.

In the final ERP, we presented policy arguments and data analyses supporting 20 percent of replacement costs of a process unit as the threshold cost that would entitle an equipment replacement activity (or aggregation of activities) to qualify automatically as RMRR, if the other three criteria were met. See 68 FR 61255-61258. In short, we received a substantial amount of industry data—both from electric utilities and from other industry sectors—that supported a decision to set the threshold at 20 percent. These data show that many like-kind replacements occurring at facilities typically cost less than 20 percent of the process unit's value and do not increase emissions. We also conducted case studies on a number of industries, analyzed the costs involved in the Wisconsin Electric Power Company v. Reilly (“WEPCO”) case (See 893 F.2d 901 (7th Cir. 1990)) and other relevant information, and provided a legal basis as to why 20 percent is a reasonable ERP cost threshold for equipment replacements across all industries. We also stipulated other rule criteria which must be met to qualify for the ERP. The ERP allows sources to know, with certainty, that RMRR can be conducted without delay in situations where the 20 percent replacement cost criterion and other specified criteria are met.

Petitioners asked EPA to reconsider the 20 percent cost threshold, and claimed that none of EPA's arguments supporting the threshold had appeared in the proposed rule. We granted reconsideration on this issue and solicited additional comment on the data, our analyses, and the policy considerations supporting the 20 percent threshold. We also invited comment on whether it is appropriate to consider approaches used by local governments in determining construction building code applicability when establishing criteria for RMRR determinations.

Thus, our goal in selecting the cost threshold is not to create a bright line below which any activity is excluded solely based on its cost. Rather, the threshold is intended to operate in combination with the three other ERP criteria as a screen for determining when the multi-factor RMRR approach is applicable and when it is appropriate to automatically exclude an activity as RMRR based on satisfying the three non-cost ERP criteria. As discussed below, we continue to believe that 20 percent is an appropriate threshold for this purpose. The available data indicate that the 20 percent threshold will effectively identify those more significant projects for which applying the multi-factor RMRR approach is prudent.

Another important factor of the ERP is that related activities must be aggregated in the same way as they would have to be aggregated for other NSR applicability purposes. Under our current policy of aggregation, two or more replacement activities that occur at different times are not automatically considered separate activities solely because they happen at different times. In the case of replacing an entire facility, it is not feasible that an owner or operator could successfully argue that multiple projects occurring one after the other are not related to one another and should not be aggregated for applicability purposes. These other rule criteria play an important part in determining what replacements can qualify for the ERP.

Much of the comment on the 20 percent replacement value threshold focused on our use of six non-utility case studies that we believe support our selection of a 20 percent replacement value threshold. Though equipment replacement activities vary widely across industry sectors, the six industry sector studies (pulp and paper mills, automobile manufacturing, natural gas transmission, carbon black manufacturing, pharmaceutical manufacturing, and petroleum refining) indicated that equipment replacement activities of the type allowed under the ERP generally do not cause increases in actual emissions. Additionally, though the six studies address specific case examples from only a part of regulated industry, the data indicated that most typical replacement activities fall within the 20 percent threshold, and that some major replacement activities will cross the 20 percent threshold and be subject to the multi-factor RMRR approach.

We received a number of comments through the reconsideration process that were supportive of the calculations performed in the case studies of the six industries. Many of these comments came from the trade groups representing industries that were analyzed in the case studies. These organizations—including the American Forest & Paper Association, Alliance of Automobile Manufacturers, National Petrochemical & Refiners Association, and Interstate Natural Gas Association of America—supported the analyses conducted and conclusions reached in the case studies for each of their industries. In some cases, these trade groups provided further amplification of their cost ranges for projects, which provided additional depth and support to the conclusions of the report. Other commenters stated that the case studies failed to provide sufficient data to support the 20 percent cost threshold.

We never claimed that the case studies encompassed all equipment replacement activities at these industries. Further, we recognize that the case studies do not justify exempting all “routine” equipment replacement activity in any one of the case study industries. As discussed elsewhere in this notice, activities falling below the 20 percent replacement value threshold are not exempt under the ERP if they do not meet the other three criteria of the rule. It is important to note that the case studies were performed prior to decisions on the exact form and content of the final rule. If the studies had chosen a different set of assumptions ( e.g. , for costing of projects, or in defining the process unit), they may have identified additional equipment replacement projects exceeding 20 percent in cost. Furthermore, these studies showed industry-wide results, not plant-specific determinations. Under the ERP, if a plant-specific replacement activity does not satisfy all four of the criteria that must be met to qualify for the RMRR exclusion, then the activity is subject to the multi-factor RMRR approach. The studies indicate that larger, less frequent maintenance activities could exceed the ERP cost threshold and, consequently, would be subject to the multi-factor RMRR approach. 10 Thus, we do not believe there is a basis, nor did the petitioners provide one, that all equipment replacements in these industries would be exempt under a 20 percent cost threshold.

We continue to believe that this information on other industrial sectors beyond electric utilities supports our 20 percent bright line test. In short, the case studies support our view that it is reasonable to assume that equipment replacement activities in the utility industry are similar enough to replacement practices in other industry, such that the 20 percent value determined for utilities is appropriate for industry as a whole.

While most industry commenters agreed that the 20 percent threshold was adequate and reasonable and was well supported by available data, several industry commenters provided additional data as further support that the 20 percent threshold is appropriate. For example, Solar Turbines estimates for their products (turbines of 1 to 14 megawatts in capacity), a periodic refurbishing of the gas producer unit—normally performed every 4 years—would cost 6 to 14 percent of the replacement cost, depending on the extent of deterioration. The Gas Turbine Association noted that the restoration cost as a percentage of total equipment replacement cost varies significantly with turbine unit size. According to the Gas Turbine Association, one supplier estimated a range from 9 percent for a combined cycle system to over 20 percent for a simple cycle system. Other commenters—including the National Petrochemical & Refiners Association and the American Forest & Paper Association—further supported the 20 percent equipment replacement cost threshold providing lists of their plant maintenance activities, many of which were beneath 20 percent in cost, and explained why they felt that their listed projects are routine. We have evaluated the projects described by commenters and, assuming that they would meet all other criteria of the ERP, these projects would not be the types of activities that would be subject to the multi-factor RMRR approach.

We should note, however, that by referring to these lists provided by industry, we are not categorically determining that these activities are RMRR. As we have explained above, the 20 percent threshold is only one part of the ERP. Therefore, each activity must be evaluated against not only the 20 percent cost threshold but also the other three rule criteria before making a determination that these activities are RMRR under the ERP.

Comments filed by the State and Territorial Air Pollution Program Administrators (STAPPA) and the Association of Local Air Pollution Control Officials (ALAPCO) suggested that we reject the percent threshold approach and replace it with a list of RMRR activities, along with a list of projects that are not RMRR, for each major industrial sector. Prior to promulgating the ERP, we evaluated developing a list of activities that are considered RMRR as a component of an overall RMRR program. Although it was decided that we could develop a list for industry sectors for which we had ample amounts of information, we believe that there are too many activities in too many industries, and an excessive number of facility-specific particulars, to effectively improve major NSR implementation by creating such lists. We also were concerned that such lists would need to be updated often.

We believe the ERP provides more clarity than does the multi-factor approach that permitting authorities employed in making past RMRR determinations. With the multi-factor RMRR approach, no “bright lines” were ever established, either through rule or guidance, to evaluate the factors ( e.g. , nature/extent, purpose, frequency and cost), which contributed to regulatory uncertainty. Conversely, to the greatest extent possible, the ERP provides “bright lines” by specifying criteria that must be met to qualify as RMRR. Of course, even with the ERP, there will be times when a permitting authority must make judgment calls, such as over whether the process unit's basic design parameters will change as a result of the equipment replacement. However, we believe that the ERP will enable these sorts of decisions to be more limited to engineering judgments and, therefore, less contentious (and more uniform from jurisdiction-to-jurisdiction) than the decisions required under the multi-factor test.

The EPA continues to believe that our basis for selection of the 20 percent replacement cost of the process unit is not arbitrary and capricious, and that there is support in both the rulemaking record and preamble for the 20 percent replacement cost threshold. Considering all of this information, together with the additional supporting data provided by commenters in response to the reconsideration issues, we believe our decision to establish the cost threshold at 20 percent is strongly supported and persuades us that we have established the correct cost threshold for the ERP.

As discussed above, the December 24, 2003 final rule revised the PSD provision in each state plan that lacked an approved state regulation concerning PSD. In lieu of an approved PSD SIP, each of these state plans contained a reference incorporating the relevant provisions of 40 CFR 52.21, the PSD FIP, that applied within the state. Prior to the December 24th rule, we incorporated the relevant paragraphs of 40 CFR 52.21 by referring to the range of paragraphs from the first paragraph incorporated to the last paragraph. This format required updates every time we added paragraphs to section 52.21. The December 24th rule adopted a different cross-referencing format—“40 CFR 52.21 except paragraph (a)(1).” Under the new format, the cross-references would automatically update whenever new sections were added to the PSD FIP.

We granted reconsideration and solicited comment on the issue of the new format and its ability to automatically update affected state plans whenever EPA modifies the PSD FIP. We did not receive comments in opposition of this new format and thus will not change it. We believe the automatic update function will eliminate paperwork delays and typographical errors associated with future updates to federal PSD requirements. It will reduce the potential for confusion when the PSD rules are updated and will ensure that the relevant federal provisions are included in updated PSD FIPs in a consistent and efficient manner.

We denied two issues contained in petitioners' requests for reconsideration because they failed to meet the standard for reconsideration under section 307(d)(7)(B) of the CAA. Specifically, on these issues, the petitioners have failed to show: That it was impracticable to raise their objections during the comment period, or that the grounds for their objections arose after the close of the comment period; and/or that their concern is of central relevance to the outcome of the rule. We discuss our reasons for denying reconsideration in the Technical Support Document, which is available on our Web site at http://www.epa.gov/nsr. We have concluded that no clarifications to the underlying rules are warranted for these two remaining issues, as described below.

Petitioners' claimed that EPA retroactively applied the ERP, citing an EPA official's announcement in November 2003 that the Agency would no longer pursue past RMRR violations if the cases had not been filed. In response, we are, and have been, pursuing all filed cases and will continue to file new cases as appropriate. Our decisions on which cases to file is guided by a myriad of factors, including available resources and environmental protection. We acknowledge that the ERP is stayed and not currently effective in any jurisdiction. We continue to request information and put violators on notice when they violate our rules and policies. We note that none of the ERP rule revisions apply to any changes that are the subject of existing enforcement actions that the Agency has brought and none constitute a defense thereto.

As discussed in the final ERP preamble (68 FR 61263), according to the U.S. Supreme Court, an agency may not promulgate retroactive rules absent express congressional authority. See Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208, 102 L. Ed. 2d 493, 109 S. Ct. 468 (1988). The CAA contains no such expressed grant of authority, and we do not intend by our actions today to create retroactive applicability to the ERP. The promulgated ERP applies only to conduct that occurs after the rule is effective.

Petitioners' opposed the provisions in our FIP rule published on December 24, 2003, stating that EPA doesn't have the authority to issue a FIP without a finding of deficiency or notice of such deficiency as required under section 110(k)(5), 42 U.S.C. 7410(k)(5). They noted that, in order to require a State to revise its SIP, the EPA must find that a SIP is “inadequate to attain or maintain the relevant national ambient air quality standard, to mitigate adequately the interstate pollution described in section 7506a of this title or section 7511c of this title, or to otherwise comply with any requirement of this chapter.” They further noted that EPA can only require a SIP revision upon the finding that a particular SIP is deficient.

We are not issuing a new FIP. Rather, we are modifying an existing FIP. As such, the original findings of inadequacy of the plans for states subject to the PSD FIP continue to apply because these states never submitted an approvable PSD program in the first place, or have not submitted a revised program since EPA's disapproval of their earlier submission. Our longstanding procedure has been to incorporate § 52.21 into the applicable implementation plan for a state where there is no approved, SIP-based, permitting program. In every PSD rulemaking since the program's inception, we have incorporated all provisions of the promulgated rules into the applicable implementation plan for a state where there is no approved, SIP-based, permitting program. (See 68 FR 11317-11318.) We again are taking these actions in the case of the December 24, 2003 rules.

As a result, we fail to see how the petitioning states were not clearly on notice about our intentions for these portions of the rule. Thus, EPA believes states subject to the PSD FIP had adequate notice and opportunity for comment that EPA planned to amend the FIP citations to § 52.21 to reflect any changes EPA made to § 52.21 in the final NSR rule. Therefore, the petitioners have failed to meet the procedural requirement for reconsideration. Moreover, EPA does not believe it makes sense for states subject to the PSD FIP to have the option to pick what portions of the FIP should apply—these states are free to submit PSD programs for approval as SIP revisions if they wish to apply something other than § 52.21 in its entirety (although we are making no conclusion about the approvability of a program that does not include all the elements of § 52.21 at this time). Therefore, even if the petitioners had been correct that a procedural error had occurred in this instance, the outcome would not have been of central relevance to the outcome of the rule.

It is inherent in the regulatory nature of a FIP that we retain the authority to make appropriate changes to the Federal Program and that these changes will automatically apply in any jurisdiction in which the Federal FIP applies whether or not we delegate authority to a State to implement the PSD FIP. We believe that the ERP improves the ability of a State to “attain or maintain the relevant NAAQS, or to mitigate adequately the interstate pollution transport.” As noted in the preamble to the final ERP (68 FR 61255), nothing in the promulgated ERP would prevent a State or local program from imposing additional requirements necessary to meet Federal, State or local air quality goals.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of Executive Order 12866, EPA determined that this rule is a “significant regulatory action” within the meaning of the Executive Order. As such, EPA has submitted this action to OMB for review. Changes made in response to OMB suggestions or recommendations will be documented in the public record.

The information collection requirements (ICR) for this rule have been prepared under the Paperwork Reduction Act , 44 U.S.C. 3501 et seq. The EPA has deferred submission of the ICR to Office of Management and Budget (OMB) pending judicial review of the ERP. An ICR document has been prepared by EPA (ICR No. 1230.14), and a copy may be obtained from Susan Auby, U.S. Environmental Protection Agency, Office of Environmental Information, Collection Strategies Division (2822T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001, by e-mail at auby.susan@epa.gov , or by calling (202) 566-1672. A copy may also be downloaded off the Internet at http://www.epa.gov/icr. The information requirements included in ICR No. 1230.14 are not enforceable until OMB approves them.

The information that ICR No. 1230.14 covers is required for the submittal of a complete permit application for the construction or modification of all major new stationary sources of pollutants in attainment and nonattainment areas, as well as for applicable minor stationary sources of pollutants. This information collection is necessary for the proper performance of EPA's functions, has practical utility, and is not unnecessarily duplicative of information we otherwise can reasonably access. We have reduced, to the extent practicable and appropriate, the burden on persons providing the information to or for EPA. In fact, we feel that this rule will result in less burden on industry and reviewing authorities since it streamlines the process of determining whether a replacement activity is RMRR.

However, according to ICR No. 1230.14, we do anticipate an initial increase in burden for reviewing authorities as a result of the rule changes, to account for revising state implementation plans to incorporate these rule changes. As discussed above, we expect those one-time expenditures to be limited to $580,000 for the estimated 112 affected reviewing authorities. For the number of respondent reviewing authorities, the analysis uses the 112 reviewing authorities count used by other permitting ICR's for the one-time tasks (for example, SIP revisions).

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purpose of responding to the information collection; adjust existing ways to comply with any previously applicable instructions and requirements; train personnel to respond to a collection of information; search existing data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is approved by OMB, the Agency will publish a technical amendment to 40 CFR part 9 in the Federal Register to display the OMB control number for the approved information collection requirements contained in this final rule.

The EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with this final rule.

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

After considering the economic impacts of today's final rule on small entities, EPA has concluded that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the proposed rule on small entities.” 5 U.S.C. 603 and 604. Thus, an agency may conclude that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule.

We believe this final rule will reduce the regulatory burden associated with the major NSR program for all sources, including all small businesses, by improving the operational flexibility of owners and operators, improving the clarity of requirements, and providing alternatives that sources may take advantage of to further improve their operational flexibility. We have therefore concluded that today's final rule will relieve regulatory burden for all affected small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation as to why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan.

The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

We have determined that today's rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. The change in this rule is expected to result in a small decrease in the burden imposed upon reviewing authorities in order for them to be included in the State's SIP, as well as other small increases in burden discussed under “Paperwork Reduction Act.” In addition, we believe this final rule will actually reduce the regulatory burden associated with the major NSR program by improving the operational flexibility of owners and operators, and improving the clarity of requirements. Thus, today's action is not subject to the requirements of sections 202 and 205 of the UMRA.

For the same reasons stated above, we have determined that today's action contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, today's action is not subject to the requirements of section 203 of the UMRA.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

This final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to this rule. Nonetheless, EPA did consult with representatives of state and local governments in developing this rule, through face-to-face consultations and through soliciting comment from State and local officials in our July 1, 2004 Federal Register notice.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” Today's final action does not have tribal implications as specified in Executive Order 13175. This action will benefit permitting authorities and the regulated community, including any major source owned by a tribal government or located in or near tribal land, by providing increased certainty as to making RMRR determinations within the NSR program. Thus, Executive Order 13175 does not apply to this action.

Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), applies to any rule that: (1) is determined to be “economically significant” as defined under Executive Order 12866; and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

Today's action is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. We believe that today's action as a whole will result in equal or better environmental protection than provided by earlier regulations, and do so in a more streamlined and effective manner. As a result, today's final rule is not expected to present a disproportionate environmental health or safety risk for children.

Today's action is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

Today's rule improves the ability of sources to maintain the reliability of production facilities, and effectively utilize and improve existing capacity.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Pub. L. No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical.

Voluntary consensus standards are technical standards (for example, materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

Today's action does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

The Congressional Review Act (CRA), 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. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA has made such a good cause finding, including the reasons therefor, and established an effective date of June 10, 2005. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

The statutory authority for this action is provided by sections 101, 111, 114, 116, 301, and 307 of the CAA as amended (42 U.S.C. 7401, 7407, 7411, 7414, 7416, and 7601).

Under section 307(b)(1) of the Act, the opportunity to file a petition for judicial review of the October 27, 2003 final rule or the December 24, 2003 final rule has passed. Judicial review of today's final action is available only by the filing of a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit by August 9, 2005. Any such judicial review is limited to only those objections that are raised with reasonable specificity in timely comments. Under section 307(b)(2) of the Act, the requirements that are the subject of the October 27, 2003 and December 24, 2003 final rules and today's final action may not be challenged later in civil or criminal proceedings brought by us to enforce these requirements.

On January 27, 2005, PADEP submitted revisions to the Pennsylvania SIP. These SIP revisions consist of source-specific operating permits and/or plan approvals issued by PADEP to establish and require RACT for 18 sources pursuant to Pennsylvania's SIP-approved generic RACT regulations. This proposed rulemaking covers the Commonwealth's source-specific RACT determinations for seven of those sources The remaining RACT determinations submitted by PADEP on January 27, 2005 are or will be the subject of separate rulemakings.

Pursuant to sections 182(b)(2) and 182(f) of the CAA, Pennsylvania is required to establish and implement RACT for all major VOC and NO X sources. The major source size is determined by its location, the classification of that area and whether it is located in the ozone transport region (OTR). Under section 184 of the CAA, RACT as specified in sections 182(b)(2) and 182(f) applies throughout the OTR. The entire Commonwealth is located within the OTR. Therefore, RACT is applicable statewide in Pennsylvania.

State implementation plan revisions imposing RACT for three classes of VOC sources are required under section 182(b)(2). The categories are:

(1) All sources covered by a Control Technique Guideline (CTG) document issued between November 15, 1990 and the date of attainment;

(2) All sources covered by a CTG issued prior to November 15, 1990; and

(3) All major non-CTG sources.

The Pennsylvania SIP already has approved RACT regulations and requirements for all sources and source categories covered by the CTGs. The Pennsylvania SIP also has approved regulations to require major sources of NO X and additional major sources of VOC emissions (not covered by a CTG) to implement RACT. These regulations are commonly termed the “generic RACT regulations”. A generic RACT regulation is one that does not, itself, specifically define RACT for a source or source categories but instead establishes procedures for imposing case-by-case RACT determinations. The Commonwealth's SIP-approved generic RACT regulations consist of the procedures PADEP uses to establish and impose RACT for subject sources of VOC and NO X . Pursuant to the SIP-approved generic RACT rules, PADEP imposes RACT on each subject source in an enforceable document, usually a Plan Approval (PA) or Operating Permit (OP). The Commonwealth then submits these PAs and OPs to EPA for approval as source-specific SIP revisions. EPA reviews these SIP revisions to ensure that the Pennsylvania DEP has determined and imposed RACT in accordance with the provisions of the SIP-approved generic RACT rules.

It must be noted that the Commonwealth has adopted and is implementing additional “post RACT requirements” to reduce seasonal NO X emissions in the form of a NO X cap and trade regulation, 25 Pa Code Chapters 121 and 123, based upon a model rule developed by the States in the OTR. That regulation was approved as SIP revision on June 6, 2000 (65 FR 35842). Pennsylvania has also adopted 25 Pa Code Chapter 145 to satisfy Phase I of the NO X SIP call. That regulation was approved as a SIP revision on August 21, 2001 (66 FR 43795). Federal approval of a source-specific RACT determination for a major source of NO X in no way relieves that source from any applicable requirements found in 25 PA Code Chapters 121, 123 and 145.

The following table identifies the sources and the individual plan approvals (PAs) and operating permits (OPs) which are the subject of this rulemaking.

Interested parties are advised that copies of Pennsylvania's SIP submittals for these sources, including the actual PAs and OPs imposing RACT, PADEP's evaluation memoranda and the sources' RACT proposals (referenced in PADEP's evaluation memoranda) are included and may be viewed in their entirety in both the electronic and hard copy versions of the docket for this final rule. As previously stated, all documents in the electronic docket are listed in the RME index at http://www.docket.epa.gov/rmepub/ . Publicly available docket materials are available either electronically in RME or in hard copy during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the Pennsylvania Department of Environmental Protection, Bureau of Air Quality, P.O. Box 8468, 400 Market Street, Harrisburg, Pennsylvania 17105.

EPA is approving these RACT SIP submittals because PADEP established and imposed these RACT requirements in accordance with the criteria set forth in its SIP-approved generic RACT regulations applicable to these sources. In accordance with its SIP-approved generic RACT rule, the Commonwealth has also imposed record-keeping, monitoring, and testing requirements on these sources sufficient to determine compliance with the applicable RACT determinations.

EPA is approving the revisions to the Pennsylvania SIP submitted by PADEP on January 27, 2005 to establish and require VOC and NO X RACT for seven sources pursuant to the Commonwealth's SIP-approved generic RACT regulations. EPA is soliciting public comments on this proposed rule to approve these source-specific RACT determinations established and imposed by PADEP in accordance with the criteria set forth in its SIP-approved generic RACT regulations applicable to these sources. These comments will be considered before taking final action.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)). This action merely proposes to approve state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule proposes to approve pre-existing requirements under state law 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 proposed rule also does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it 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 proposes to approve a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This proposed rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this proposed rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. 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.

This proposed rule to approve source-specific RACT determinations established and imposed by the Commonwealth of Pennsylvania pursuant to its SIP-approved generic RACT regulations does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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 program. As the Federal program changes, States must change their programs and ask the EPA to authorize the changes. Changes to State 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 266, 268, 270, 273, and 279.

We conclude that Louisiana's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we grant Louisiana final authorization to operate its hazardous waste program with the changes described in the authorization application. Louisiana has responsibility for permitting treatment, storage, and disposal facilities within its borders (except in Indian Country) and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that the 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 Louisiana including issuing permits, until the State is granted authorization to do so.

The effect of this decision is that a facility in Louisiana 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. Louisiana 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 regulations for which Louisiana is being authorized by today's action are already effective under State law, and are not changed by today's action.

The EPA did not publish a proposal before today's 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 today's 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, we will withdraw this rule by publishing a 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 on the proposal mentioned in the previous paragraph. We will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, 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, we will withdraw only that part of this rule, but the authorization of the program changes 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 will become effective, and which part is being withdrawn.

The State of Louisiana initially received final authorization on February 7, 1985, (50 FR 3348), to implement its base Hazardous Waste Management Program. We granted authorization for changes to their program on November 28, 1989 (54 FR 48889) effective January 29, 1990; August 26, 1991 (56 FR 41958) effective August 26, 1991; November 7, 1994 (59 FR 55368) effective January 23, 1995; December 23, 1994 (59 FR 66200) effective March 8, 1995; there were technical corrections made on January 23, 1995 (60 FR 4380), effective January 23, 1995; and another technical correction was made on April 11, 1995 (60 FR 18360) effective April 11, 1995; October 17, 1995 (60 FR 53704) effective January 2, 1996; March 28, 1996 (61 FR 13777) effective June 11, 1996; December 29, 1997 (62 FR 67572) effective March 16, 1998; October 23, 1998 (63 FR 56830) effective December 22, 1998; August 25, 1999 (64 FR 46302) effective October 25, 1999; September 2, 1999 (64 FR 48099) effective November 1, 1999; February 28, 2000 (65 FR 10411) effective April 28, 2000; January 2, 2001 (66 FR 23 ) effective March 5, 2001 and December 9, 2003 (68 FR 68526) effective February 9, 2004. On November 4, 2004, Louisiana applied for approval of its program revisions for RCRA Cluster XIII including Conditionally Exempt Small Quantity Generator's (CSQGs), Small Quantity Generators (SQGs) and Manifest Requirements. In this application, Louisiana is seeking approval of RCRA Cluster XIII also including Conditionally Exempt Small Quantity Generator's (CSQGs), Small Quantity Generators (SQGs) and Manifest Requirements that was repealed in accordance with 40 CFR 271.21(b)(3).

Since 1979, the State of Louisiana, through the Louisiana Department of Natural Resources, has conducted a program designed to regulate those who generate, transport, treat, store, dispose of or recycle hazardous waste. During the 1983 Regular Session of the Louisiana Legislature, Act 97, the Environmental Affairs Act, was adopted. This Act amended and reenacted Louisiana Revised Statutes (LRS) 30:1051 et seq. and also created the Louisiana Department of Environmental Quality (LDEQ). During the 1999 Regular Session of Louisiana Legislature, Act 303 revised the LRS 30:2011 et seq. , allowing LDEQ to re-engineer itself to perform more efficiently and to meet its strategic goals.

Act 97, which amended and reenacted Louisiana Revised Statutes 30:1051 et seq; transferred the duties and previously delegated responsibilities of the Department of Natural Resources, Office of Environmental Affairs, to LDEQ. The LDEQ and the Department of Natural Resources, Office of Conservation, has a memorandum of understanding that outlines the protocol for activities associated with the exploration, development, or production of oil, gas, or geothermal resources. The LDEQ has lead agency jurisdictional authority for administering the RCRA Subtitle C program in Louisiana. The LDEQ is designated to facilitate communication between the EPA and the State.

The State law governing the generation, transportation, treatment, storage and disposal of hazardous waste can be found in LRS 30:2171-2205. This part may be cited as the “Louisiana Hazardous Waste Control Law.” The laws governing hazardous waste should be viewed as part of a larger framework of environmental laws specified in Title 30, Subtitle II Louisiana Revised Statutes. The State of Louisiana adopted the Federal regulations for Cluster XIII promulgated from July 1, 2003 through June 30, 2004, including CSQGs, SQGs, and Manifest requirements dated November 1, 1981, through September 23, 1987 and the State's regulations which became effective January 20, 2001, May 20, 2001 and September 20, 2004.

The State has made amendments to the provisions listed in the table which follows. These amendments correct typographical and/or printing errors, clarify 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 and no less stringent than the Federal laws and regulations. These State initiated changes are submitted under the requirements of 40 CFR 271.21(a).

On November 4, 2004, Louisiana submitted a final complete program revision application, seeking authorization of their changes in accordance with 40 CFR 271.21. We now make an immediate final decision, subject to receipt of written comments that oppose this action, that Louisiana's hazardous waste program revision satisfies all of the requirements necessary to qualify for Final authorization. Therefore, we grant the State of Louisiana Final authorization for the following changes: The State of Louisiana's program revisions consist of regulations which specifically govern RCRA Cluster XIII including amendment to CSEQ's SQG's and Manifest requirements as documented below:

We consider the following State requirements to be more stringent than the Federal requirements: At the State of Louisiana regulations LHWR Sections 105.D.5.a, 108.A-J, 108.G.3.g.4 and 5, are more stringent because the State assess fees based on notifications including mandatory fees for Conditionally exempt small quantity generators. The Federal rule regulation at 40 CFR 261 does not assess any generator's fees. There are no broader in scope provisions in this program revisions.

Louisiana will issue permits for all the provisions for which it is authorized and will administer the permits it issues. The EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization. We will not issue any more new permits or new portions of permits for the provisions listed in the Table in this document after the effective date of this authorization. The EPA will continue to implement and issue permits for HSWA requirements for which Louisiana is not yet authorized.

Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the CFR. We do this by referencing the authorized State rules in 40 CFR part 272. We reserve the amendment of 40 CFR part 272, subpart T for this authorization of Louisiana's program changes until a later date. In this authorization application the EPA is not codifying the rules documented in this Federal Register notice.

The Office of Management and Budget (OMB) 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 action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. 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 action authorizes preexisting requirements under State law 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). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). 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 authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. 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 rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (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 authorization 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 authorization 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 note) do not apply. 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 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. This 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. ).

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. The EPA will submit a report containing this document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication 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 August 9, 2005.