FSIS carries out programs designed to ensure that meat, poultry, and egg products are wholesome, not adulterated, and properly marked, labeled, and packaged. FSIS is implementing the “Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems” final rule published July 25, 1996 (61 FR 38806), to reduce the risk of foodborne illness associated with the consumption of meat and poultry products to the maximum extent possible. The Pathogen Reduction (PR)/HACCP final rule requires establishments to take appropriate and feasible measures to prevent or reduce the likelihood of physical, chemical, and microbiological hazards in the production of meat and poultry products. Specifically, the PR/HACCP final rule: (1) Requires each official meat and poultry establishment to develop and implement written sanitation standard operating procedures (Sanitation SOP's); (2) requires regular microbial testing (for generic Escherichia coli ) by slaughter establishments to verify the adequacy of the establishment's process controls for the prevention and removal of fecal contamination and associated bacteria; (3) establishes pathogen reduction performance standards for Salmonella that slaughter establishments producing raw ground products must meet; and (4) requires that all meat and poultry establishments develop and implement a system of preventive controls designed to improve the safety of their products, known as HACCP.

HACCP is a conceptually simple, science-based process control system by which food processors identify and evaluate hazards to the production of safe products, institute controls necessary to reduce or eliminate those hazards, monitor the performance of these controls, and maintain records of this monitoring.

FSIS is reviewing its regulations to determine how they can be revised to conform with the PR/HACCP regulations and the regulatory approach they embody. This approach favors performance-based standards over prescriptive, command-and-control regulations. In its December 29, 1995, advance notice of proposed rulemaking (ANPR) “FSIS Agenda for Change: Regulatory Review” (60 FR 67469), FSIS said that by eliminating unnecessary regulations and replacing command-and-control prescriptions with performance standards, inspected establishments would have greater flexibility to adopt innovations that can yield food safety benefits. Identified as candidates for modification or elimination were those regulations that delimit processing and treatment methods intended to address specific food safety hazards and requirements that establish quality control programs.

Under FSIS regulations, a company may choose to place all of the processes and products in a plant under a comprehensive, or total, quality control (TQC) system, or the company may choose to place only individual products or processes under quality control. A quality control program for only one process or product in a plant is known as a partial quality control, or PQC, program. This final rule addresses PQC programs.

Some PQC programs control potential health and safety problems; others focus on economic or quality factors. PQC programs controlling for safety factors include those for thermally processed products, which are intended primarily to prevent toxin formation in the processed product. The programs for cooked beef products are intended to ensure that the processing of the products meets the regulatory requirements for handling, processing (time, temperature, and relative humidity), and storage to prevent pathogen formation in the products. PQC programs that control for product safety have been superseded by required HACCP plans.

PQC programs that control for economic or non-food safety factors include those used to control the fat and water content of hotdogs; the number of meatballs in or pepperoni slices on, a product; and the moisture or protein-fat-free (PFF) content of a product labeled “ham, water added.” The quality control program for mechanically separated (species) (MS(S)) is intended to control bone particle size, calcium content, fat and protein content, and protein efficiency ratio (9 CFR 319.5). The programs for pressed ham and spiced ham products are intended to ensure that the products meet the PFF regulatory requirements of § 319.104.

PQC programs to control products for economic factors are intended to prevent the marketing of products that are misbranded or that lack the quality or value that consumers expect. A plant operating under a PQC program for net weight keeps records of its checks and corrective actions to avoid lot inspection. Under PQC programs for fat and water in frankfurters, plants keep ingredient records by lot and results of laboratory tests for verification by FSIS inspectors. A plant operating a PQC program for boneless meat inspection does its own on-line inspection and keeps records. The FSIS inspector randomly selects samples of product that the plant has already inspected to ensure that the records are accurate.

FSIS regulations have required establishments to have PQC programs for certain products or processes, such as the one for MS(S), just mentioned. A PQC program for on-line carcass quality control has been required for an establishment operating under either the NELS or the NTIS poultry inspection system (9 CFR 381.76(c)).

In 1997, the Agency published a final rule that, among other things, removed the requirement for FSIS prior approval of most PQC programs (62 FR 45016; August 25, 1997). FSIS now thinks it appropriate to take the further step of eliminating the remaining PQC requirements so that establishments will have the flexibility they need to be innovative, consistent with HACCP and the Agency's regulatory policy.

On May 18, 1999, FSIS proposed to amend the meat and poultry products inspection regulations by removing requirements pertaining to PQC programs, except programs for poultry product irradiation plants (64 FR 26892). The December 23, 1999, final rule “Irradiation of Meat Food Products” removed requirements for quality control programs in such irradiation plants (64 FR 72165).

FSIS received six letters in response to the May 18, 1999, proposal. All were from the regulated industry and all supported the proposal. Some commenters wanted clarification of matters addressed in the preamble of the proposal, and one requested the removal of additional regulatory restrictions. The substantive comments and the Agency's responses are summarized below.

Comment: An organization representing the food processing industry supported the proposed removal from the thermal processing regulations of requirements for FSIS prior approval of systems and devices not specified in the regulations and of all requirements concerning PQC programs. This commenter also recommended the removal from these regulations of additional command-and-control provisions. The commenter asked that, in the regulations on the handling of containers after closure (9 CFR 318.301(f)(2) and 381.301(f)(2)), approval by a processing authority replace the need to obtain the FSIS Administrator's permission for a time lapse between container closing and initiation of thermal processing of greater than two hours.

Response: FSIS set the regulatory maximum 2-hour time period between container closure and initiation of the thermal process in its 1984 canning regulation amendments. The Agency did so to prevent adulteration from the holding of unprocessed products for an extended period, and because it was aware of several documented incidents of illness from staphylococcal enterotoxin in such products. The commenter's suggested change would place the judgment whether to alter the specified time interval between closure and the initiation of thermal processing with the process authority rather than the FSIS Administrator.

A processing authority is an individual or organization with expert knowledge of thermal processing requirements for foods in hermetically sealed containers, having access to facilities for making such determinations, and designated by the establishment to perform certain functions required by the regulations. FSIS already requires the processing authority to perform the vital function of developing and determining the process schedule and specifying the critical factors in the process.

The change suggested by the commenter is consistent with the Agency's stated aim of making the meat and poultry canning regulations more consistent with the Agency's new, non-command-and-control regulatory approach by eliminating some prior approval requirements. With respect to the canning regulations, however, this rulemaking addresses only PQC programs and prior approval requirements other than the one addressed by the commenter. FSIS therefore considers the commenter's request to be outside the scope of this rulemaking.

Comment: The same commenter requested the addition to the regulations on pH measurement in canning plants (9 CFR 318.304(e) and 381.304(e)) of a provision allowing use of colorimetric or other methods in addition to potentiometric methods, provided that the methods are sufficiently accurate to ensure product safety and stability. The commenter also asked for the removal of the requirement for approval by the FSIS Administrator of methods other than the potentiometric. In addition, the commenter requested the removal of the requirement at 9 CFR 318.305(h)(2) and 381.305(h)(2) for approval by the FSIS Administrator for the use in cooling canal water of chemicals other than chlorine that have a bactericidal effect equivalent to that of chlorine.

Response: As stated in the previous response, FSIS proposed to make the thermal processing regulations more consistent with its new regulatory approach by eliminating provisions concerning PQC programs and certain prior approval requirements. FSIS did not propose changes in its requirements for pH measuring devices or chemicals used in cooling canal water. These suggested changes are outside the scope of this rulemaking, and, accordingly, FSIS is not making them in this final rule.

Regarding the regulation on chemicals in cooling canal water, FSIS announced in early 1998 that it was ending its prior approval system for all non-food compounds and proprietary substances (63 FR 7319; February 13, 1998). These classes of substances include water treatment compounds. The program was ended because the Agency considered it to be redundant with those of other Federal agencies and because of the program's inconsistency with the PR/HACCP regulations.

Since establishments are responsible for developing and implementing HACCP plans incorporating the controls necessary and appropriate to produce safe meat and poultry products, FSIS is not responsible for determining whether the nonfood compounds and proprietary substances they use are safe and effective. Therefore, establishments need not obtain the approval of the Administrator to use chemicals other than chlorine in cooling canal water.

Nevertheless, FSIS retains the discretionary authority to prevent the use of such substances in official establishments if the Agency finds, through its normal inspection activities, that the substances directly or indirectly contaminate edible product. FSIS expects establishments to use only compounds that are safe and that have the intended technical effect when used appropriately in a food preparation environment. The Agency expects establishments to keep on file any information provided by chemical manufacturers (written approvals from other agencies, letters of guaranty, etc.) as part of their sanitation SOP, HACCP, or other records.

Comment: The same commenter requested the removal of two other prior-approval requirements in the canning regulations: first, the requirement (in 9 CFR 318.305(a)(2)(ii) and 381.305(a)(2)(ii))for FSIS Administrator approval of recording devices other than temperature/time recording devices; and second, the requirement at 9 CFR 318.305(d)(5) and 381.305(d)(5) that the FSIS Administrator be notified of the use of any batch retorts with steam/air circulation systems.

Response: FSIS proposed the elimination of the requirement for prior-approval of thermometric measuring devices other than mercury-in-glass thermometers (proposed §§ 318.305(a)(1)(ii) and 381.305(a)(1)(ii)). The Agency also proposed the elimination of prior approval requirements for automated process monitoring and recordkeeping systems not specified in the canning processing regulations (proposed §§ 318.307(b) and 381.307(b)). The commenter's suggestion to remove the requirement in §§ 318.305(a)(2)(ii) and 381.305(a)(2)(ii) for prior approval of time/temperature recording devices other than chart-type devices is consistent with the Agency's proposals regarding temperature measurement and automatic process monitoring devices. Accordingly, FSIS is making the requested change to the regulations in this final rule.

Regarding the prior approval of batch retorts with steam-air cooling, FSIS finds the commenter's request to be consistent with the Agency's proposal to eliminate the requirement for prior approval of thermal processing systems other than those delineated in §§ 318.305 and 381.305 of the canning regulations (proposed §§ 318.305(f) and 381.305(f)). FSIS is therefore adopting the requested change in this final rule.

Comment: The same commenter—the organization representing the food processing industry—questioned the intent of the Agency's statement in the preamble of the proposal regarding alternative documented procedures for handling process deviations or finished product inspections. FSIS stated, at 64 FR 26894, that such procedures “would have to ensure that only safe, stable product is shipped in commerce.” The procedures would have to ensure that the product is free of microorganisms of public health significance and is not adulterated by other types of bacteria, such as “flat-sour” bacteria or other spoilage organisms.

The commenter thought that the Agency's statement could be misinterpreted to mean that a product might be adulterated if spoilage organisms were merely present in a product not likely to be subject to conditions that would lead to the growth of the organisms and deterioration of the product. Citing the regulatory definition of shelf stability (at 9 CFR 318.300 and 381.300), the commenter pointed out that the presence in low numbers of flat-sour bacteria or other spoilage organisms that would not grow under intended conditions of distribution and storage would not render the product adulterated. However, the growth of spoilage organisms to high numbers that affected product characteristics before or after processing would adulterate the finished product. The product then would not be cleared by a processing authority or released into commerce.

Response: The commenter has accurately explained the intended meaning of the phrase “adulterated by * * * spoilage organisms” in the preamble of the proposal (at 64 FR 26894). In stating the conditions for use of procedures alternative to the existing prescriptive requirements (9 CFR 318.308(d) and 381.308(d); 9 CFR 318.309(d) and 381.309(d)), FSIS assumed the current regulatory definitions of “shelf stability.”

Comment: The same commenter questioned whether the Agency's example of an establishment's incorporation of a PQC program for raw materials in the establishment's HACCP plan (at 64 FR 26896) might imply that non-food safety regulatory concerns might become part of HACCP systems, which only address food safety issues.

Response: FSIS agrees with the commenter that HACCP systems are only intended to control food safety hazards. The Agency recognizes the potential for misunderstanding that can arise when PQC programs and HACCP systems are discussed because PQC programs may address either safety or quality issues or both. The context of the statements to which the commenter refers was the analysis of benefits of the rule. One benefit to establishments is a possible efficiency gain through integration of some facets of quality control with HACCP. FSIS meant to suggest by its example that a food safety-related PQC program or other food safety process control could be used in the context of an establishment's HACCP plan. The HACCP plan would include a critical control point for raw materials only if the hazard analysis identified a food safety hazard associated with raw materials. Raw material control is identified as a CCP in many HACCP plans and is not so identified in others. A PQC program for raw materials or any other step in processing a product would be relevant to HACCP and be subject to being subsumed in or superseded by a HACCP plan only if it were food safety-related.

Comment: The food-processing industry organization also read proposed § 318.308(b)(2) and § 381.308(b)(2) as inadvertently depriving very small establishments of the option of using the alternative procedures for handling process deviations (§ 318.308(d) and § 381.308(d)).

Response: The proposal language did not exclude any canning establishment without a HACCP plan that addresses microbial hazards from using the procedures in paragraph (d) of § 318.308 or § 381.308. Further, under the final rule, these procedures will continue to be available to establishments whose HACCP plans do not address microbial hazards.

Comment: Three of the commenters—the food-processing industry organization, an organization representing the Nation's turkey industry, and a producer of processed meat and poultry products—wanted FSIS to continue to recognize the value of PQC programs, and particularly of those programs that the Agency has previously approved. The food-processing industry organization expressed concern that such programs might automatically become invalid when the final rule goes into effect. The organization wanted the Agency to address this matter in implementing notices or directives to the FSIS field force lest previously approved procedures have to be re-documented.

Response: FSIS has not changed its policy of encouraging establishments to adopt statistically sound quality control systems. FSIS recognizes, however, that product formulations, processing operations, and technology may change over time, and that establishments should have the ability to change the variables and parameters of their control programs without seeking Agency revalidation of those programs. The Agency is therefore removing the prescriptive, command-and-control regulatory requirements that may inhibit innovation—especially innovation that may yield food safety benefits. The Agency's approval process for PQC programs was part of that old command-and-control system.

Obviously, a PQC program that the Agency approved in the past may still be regarded as useful if no significant changes have been made in the process or product controlled. However, the proof of the program's effectiveness must be found primarily in the data collected under the program or other studies of the product or process controlled and not in an old approval letter. This is particularly the case with respect to food safety-related PQC programs. Where food safety is concerned, FSIS will be relying primarily on its verification of HACCP systems to determine whether official establishments are taking sound control measures.

Regarding the enforcement of this final rule, FSIS will issue appropriate instructions to its field force. Many of the changes necessary to carry out this final rule have already been instituted with the revision of the Agency's automated system for directing inspection program activities.

Comment: An organization representing the meat and poultry canning industry supported the proposal but thought the preamble should have expanded on how and why the elimination of PQC programs would not diminish consumer confidence. The commenter thought that FSIS should have furnished a more comprehensive explanation of PR/HACCP for readers unfamiliar with it, and of why and how PR/HACCP systems make PQC programs redundant. The commenter also thought the explanation for the elimination of specific PQC requirements was insufficient to allay consumer skepticism or fears about eliminating such requirements. In particular, a more substantial justification should have been given for removing FSIS case-by-case approval of thermal processing systems not specifically delineated in the regulations. In this context, the commenter thought that FSIS should have discussed the fact that scientific evaluation of all new processes by competent experts is a long-established practice of the canned food industry.

Response: FSIS made an editorial decision to limit the explanation of the PR/HACCP final rule and its underlying principles because they had been fully discussed in previous Agency publications and at the many public meetings and media events conducted since 1995. The PR/HACCP final rule and the other documents referred to in the preamble of the proposal were made available for public viewing in the FSIS Docket Room at the address given in the proposal. Nevertheless, in response to the commenter's suggestion, FSIS has added, near the beginning of this preamble, a summary of the main features of the PR/HACCP final rule.

While FSIS may not have provided a discussion of PR/HACCP sufficient to satisfy the commenter, the Agency did state in the proposal that requirements for PQC programs that control for product safety have been superseded by required HACCP plans (64 FR 26893, col. 1). The Agency also stated that requirements pertaining to PQC programs that control food safety factors are inconsistent with PR/HACCP (64 FR 26894, col. 3). The Agency further stated or implied in a number of places (64 FR 26892, col. 3; 26893, col. 3; 26894, col. 1, col. 3; 26895, col. 2, col. 3; and 26896, col. 2) that regulatory requirements for PQC programs tend to restrict innovation and perpetuate the command-and-control approach to food inspection and regulation. Such regulatory requirements are not in keeping with the Agency's new approach of defining industry compliance with performance-related objectives.

On the matter of consumer protection, the Agency stated that the proposed rule was intended to provide inspected establishments with flexibility and to encourage them to adopt new technologies and methods that will improve food safety and other consumer protections (64 FR 26892, 26895 col. 2). The Agency also stated, with respect to PQC programs required to ensure compliance with regulatory limits on certain restricted ingredients (64 FR 28693, col. 3) and with product standards, that the limits and standards themselves, as well as product labeling requirements, would continue to protect consumers (64 FR 26894, col. 3; 26895, col. 1).

FSIS stated that PQC programs were not necessary to ensure food safety protection where HACCP plans were in operation (64 FR 26894, col.2). It may be that FSIS could have said more about its regulatory provisions for continued consumer protection, but in the Agency's judgment, what it said was sufficient for the purposes of the rulemaking.

On the elimination of case-by-case approval of new types of thermal processing systems in 9 CFR 318.305(f) and 381.305(f), new systems must still meet the applicable requirements governing equipment and heat processing procedures and be capable of producing shelf-stable products consistently and uniformly. FSIS stated in the preamble of the proposal (at 64 FR 26894) that these requirements reflect the basic purposes of the canning regulations.

The canning regulations continue to address such matters as: container integrity before and after fill; container closure; thermal processing schedules; critical factors; operations in the thermal processing area; processing and production records; deviations in processing; finished product standards; recalls; and the role of the processing authority. FSIS has recognized that the thermal processing regulations are HACCP-consistent with respect to the control of microbial hazards and has supplemented them with a requirement for HACCP plans that address physical and chemical hazards. The Agency also realizes, however, that many of these regulations are excessively prescriptive and in its December 29, 1995, ANPR, cited above, listed them among candidates for revision or removal in conjunction with HACCP implementation.

The commenter's statement about the canning industry's practice of having all new processes evaluated scientifically by competent experts is a point well taken. Both the FDA and the FSIS regulations governing thermally processed, low-acid foods in hermetically sealed containers require thermal process schedules to be established by qualified persons—processing authorities—who have expert knowledge of thermal processing requirements for such foods and access to the facilities to make the necessary determinations (21 CFR 113.83; 9 CFR 318.302, 381.302). These requirements remain in effect for canned products. Also, FSIS has thought well enough of the process-authority concept to make use of it in the final rule “Performance Standards for the Production of Certain Meat and Poultry Products” (64 FR 732; January 6, 1999). Under that final rule, affected products not produced under a HACCP plan must be produced according to a process schedule approved in writing by a process authority for safety and efficacy in meeting the performance standards applicable to the product.

Regarding the interest commenters have shown in the few changes in the canning regulations to be made in this final rule, FSIS notes that in the December 29, 1995, ANPR cited above, FSIS listed the requirements for canning and canned products as candidates for reform. Possible actions to be taken were the conversion of these requirements to performance standards and clarifying the role of inspection program employees. A future rulemaking to reform the canning regulations remains under consideration.

FSIS is eliminating the requirement in 9 CFR 317.21(b) that establishments have, as an alternative to State or local certification of scales, PQC programs or total quality control system provisions for checking the accuracy of scales. The Agency will simply require that there be a certification of accuracy from State or local authorities or from a State-registered or -licensed scale repair firm or person. Establishments can, of course, continue to maintain scale-checking provisions in their QC programs and systems.

The Agency is removing from the meat and poultry inspection regulations the design requirements for partial quality control programs (9 CFR § 318.4(d), § 381.145(d)).

FSIS also is removing quality control requirements governing the use of nitrites in bacon curing and the use of certain organic acids singly or in combination to delay the discoloration of fresh meat cuts (9 CFR 424.21-.22). Such requirements are incompatible with the Agency's regulatory objectives because they specify a manner of compliance rather than simply a performance standard. Both the nitrite and the organic acid regulations clearly state the maximum limits of use of the substances they concern. Also, the consumer is informed by product labeling of the presence of the substances in products. The regulations provide clear limits and adequate consumer protections without the quality control requirements. In addition, the Agency is improving the accuracy of the regulation by using the term “production of botulinum toxin” rather than “growth of botulinum toxin” (see 9 CFR 424.22(b)(1)(ii)(B)).

FSIS is eliminating a number of prior-approval requirements from the meat and poultry canning regulations. The Agency is replacing the requirement that the Agency approve temperature-indicating devices other than mercury-in-glass thermometers (at §§ 318.305(a)(1)(ii) and 381.305(a)(1)(ii)) before they could be used. The devices must meet known standards of accuracy for such devices, but the Agency is not prescribing the frequency of testing for accuracy.

The Agency is removing the requirement for FSIS prior-approval of the use of time/temperature recording devices other than chart-type devices. The alternative devices must meet known standards of accuracy (9 CFR 318.305(a)(1)(ii) and (a)(2)(ii); 9 CFR 381.305(a)(1)(ii) and (a)(2)(ii)).

In response to comments, the Agency is removing the requirement at 9 CFR 318.305(d)(5) and 381.305(d)(5) that the FSIS Administrator be notified of the use of any batch retorts with steam/air circulation systems. As explained previously in this document, FSIS regards this action as consistent with the proposed rule.

As proposed, the Agency is removing the requirement for FSIS case-by-case evaluation and prior approval of systems for thermally processing canned product other than those systems specifically delineated in the regulations. Such alternative systems must still be adequate for producing shelf-stable product consistently and uniformly. (9 CFR 318.305(f), 381.305(f).)

FSIS is removing from the thermal processing regulations (9 CFR 318.307(b) and 381.307(b)) requirements for FSIS approval of automated process monitoring and recordkeeping systems.

The Agency also is removing from the thermal processing regulations the requirements in §§ 318.308 and 309 and §§ 381.308 and 309 concerning partial quality control programs to control process deviations and establishment finished product inspection procedures. The Agency finds that these requirements are unnecessary. The remaining provisions in these sections, which are based on HACCP principles, remain as acceptable protections against potential microbial contamination.

The proposal would have provided additional options for establishments, such as handling the deviations under an approved total quality control system or using alternative documented procedures until the PR/HACCP rule became applicable to the establishment. The alternative documented procedures could have included partial quality control programs or other documented corrective action, monitoring, or recordkeeping procedures developed by or for the establishment, but not subject to FSIS approval. Such food safety-related PQC programs were to be integrated in or superseded by the establishment's HACCP plan. Because the effective date of the final rule is after January 25, 2000, however, the PR/HACCP regulations will be applicable to all establishments that are subject to the final rule. Thus, there is no need to provide options for establishments that are not yet subject to the PR/HACCP requirements. Deviations in processing will need to be handled according to a HACCP plan that addresses hazards associated with microbial contamination or by the alternative procedures for handling deviations during processing or through record review (§§ 318.308(d) and 381.308(d)).

A thermal processing establishment will have available at least three alternatives for handling finished product inspections. The finished product inspections could be handled under: (1) The existing regulations (§§ 318.309(d) and 381.309(d)); (2) a HACCP plan; or (3) alternative documented procedures for handling finished product inspections. The alternative documented procedures can be PQC programs or the HACCP plan provisions.

In any case, any alternative procedures for handling process deviations or finished product inspections will have to ensure that only safe, stable product is shipped in commerce. The procedures will have to ensure that the product is free of microorganisms of public health significance, and that it does not contain other types of microorganisms, such as “flat-sour” bacteria or other viable spoilage organisms, that could cause adulteration under intended conditions of distribution and storage of the product. This requirement is consistent with the aims of HACCP and with the statutory prohibitions against the distribution of adulterated and misbranded meat and poultry products in commerce.

These amendments and revisions will make the thermal processing regulations more consistent with the PR/HACCP final rule by explicitly providing a HACCP-plan alternative (consistent with §§ 417.2(b)(3)) to the prescriptive procedures in §§ 318.309(d) and 381.309(d). The amended and revised regulations also include, as an option for handling process deviations or final product inspections, alternative documented procedures that ensure that only safe and stable products are shipped in commerce. This option will provide the establishment with the flexibility to use PQC programs or other procedures that meet a regulatory public health standard.

It should be noted that, under the HACCP regulations, an establishment's HACCP plan does not have to address potential microbial hazards in thermally processed/commercially sterile product if the establishment is following the current regulatory requirements for such product. However, the HACCP plan must address physical and chemical hazards to which the product may be subject.

Besides removing the requirements pertaining to PQC programs that control food safety factors, which are inconsistent with PR/HACCP, FSIS is removing the requirements affecting economic or quality-related PQC programs. FSIS considers both the food safety-related and the economic PQC requirements to be too prescriptive. They tend to perpetuate the command-and-control approach to food inspection and regulation. They are not in keeping with the Agency's new regulatory approach, which is oriented more toward monitoring industry compliance with performance-related objectives.

FSIS is removing the QC system requirements from the regulations and requirements governing the identity and composition of MS(S) product and label approval of the product (9 CFR 319.5). The MS(S) regulations specify the maximum calcium content, the minimum protein content, the protein efficiency ratio, the maximum fat content, and the maximum bone particle size for the product. The regulations also specify the elements that the QC system must contain, including a written description of the methods used by the establishment to maintain uniformity of raw materials used in manufacturing product and to control handling and processing of the raw materials and finished product. The regulations also specify the sample size and sampling frequency for food-chemistry analysis of product to determine compliance with the standards. FSIS regards these provisions as overly prescriptive and believes that, to achieve the purposes of the MS(S) regulations, it is sufficient to set the product standards for fat, protein, calcium content, and bone particle size.

The Agency also is updating the provision for finished product samples to be analyzed according to methods of the Association of Official Analytical Chemists (AOAC) or methods listed in the FSIS “Chemistry Laboratory Guidebook” to reflect use of the most recent edition of the AOAC compendium. In addition, establishments will have the latitude to use validated scientific methods equivalent to, but not listed in, the AOAC and FSIS references. They will have the flexibility to choose the most appropriate means of ensuring that MS(S) meets the compositional and labeling identity requirements of the regulations. The Agency cautions, however that, if the establishment is to adequately protect its interests, it should ensure that the method that it uses will produce results comparable to the relevant AOAC or FSIS method.

Second, FSIS is eliminating the quality control program requirements from the protein-fat-free (PFF) percentage regulations (§§ 319.104 and 319.105) for various “finely divided” cured ham products, such as patties, chopped or pressed ham, and spiced ham. Establishments, however, must continue to comply with the PFF percentage limits for these products.

Finally, FSIS is removing the requirement that poultry slaughtering establishments operating under the NELS and NTIS inspection systems have PQC programs for carcass defects. The establishments will now have the flexibility to adopt quality control programs or other measures for ensuring the quality of their products. Removing the prior-approval aspect of these requirements contributes to clarifying the respective roles of the inspection service and the regulated industry—a necessary task in making the requirements consistent with HACCP.

FSIS inspectors will continue to check poultry in NELS and NTIS plants for visible contamination and carcass trimming defects.

This final rule has been determined to be significant, though not economically significant, and was reviewed by the Office of Management and Budget under Executive Order 12866.

FSIS is eliminating the regulatory requirements pertaining to establishment-operated PQC programs. This action removes regulatory obstacles to innovation and command-and-control requirements, which are inconsistent with the Agency's new regulatory approach and the objectives of the PR/HACCP regulations. In the Agency's August 25, 1997, final rule “Elimination of Prior Approval Requirements for Establishment Drawings and Specifications, Equipment, and Certain Partial Quality Control Programs” (62 FR 45016), the requirements for FSIS prior approval of most PQC programs were eliminated. This action was taken to facilitate the transition to HACCP in official establishments producing the greatest portion of meat and poultry products consumed in the United States. FSIS is now taking the additional step of eliminating the remaining requirements for establishments to have PQC programs for specific products or processes, as well as design requirements affecting PQC programs.

The alternatives to this rulemaking that FSIS considered were, in addition to the alternative of no rulemaking, those of mandating additional in-plant controls and mandating general requirements and standards for PQC programs.

The alternative of no rulemaking would impose no additional regulatory burdens on establishments, which would continue to have the assurance that their PQC programs meet basic design criteria. However, the Agency rejected this alternative. The failure to change the regulations would leave in place a prescriptive regulatory regime for process controls and PQC programs that also conflicts in a material way with the objectives of the PR/HACCP final rule. Under HACCP, establishments assume responsibility for building science-based, preventive process controls into the food production system to reduce or eliminate food safety hazards. This responsibility includes ensuring that processes conform with sound food safety performance standards. Establishments need to be able to implement better and more innovative food safety and other consumer-protection strategies, including having flexibility to design a PQC program and determine its content and implementation date.

The alternative of mandating additional in-plant controls, whether in addition to or in lieu of PQC requirements, would add regulatory assurances that processes are under control and that products are safe, wholesome, and not misbranded. However, this alternative would add prescriptive, command-and-control requirements and restrict the scope for establishment food safety initiatives, contradicting the Agency's new regulatory approach. The additional requirements also would likely not result in food safety improvement.

The alternative of mandating new general requirements or standards for PQC programs would differ little in its effects from the current requirements for PQC programs to have certain features and for process control under the programs to be based on generally accepted statistical principles (9 CFR 318.4(d); 381.145(d)). Even if the current requirements were condensed, they would still be inconsistent with the PR/HACCP regulations and with the Agency's new regulatory approach, establishments would continue to incur a substantial recordkeeping burden, and the Agency would have nearly the same burden as it now does of verifying establishment compliance with the requirements.

FSIS chose the option of eliminating regulatory requirements for all PQC programs except QC programs for the irradiation of poultry products. (As mentioned previously, the final rule “Irradiation of Meat Food Products” removed requirements for poultry irradiation QC programs.) This option provides establishments with the most flexibility in implementing process control programs in a HACCP environment.

This final rule will affect, overall, as many as 72 poultry slaughtering establishments and about 3,550 establishments that process meat and poultry products beyond slaughtering, dressing, and cut-up. The most far-reaching effect of the rule will be to increase the flexibility establishments have in controlling their processes. This benefit arises from eliminating the required PQC program elements in §§ 318.4(d) and 381.145(d).

With or without this final rule, establishment HACCP plans will supersede or incorporate the few PQC programs that control food safety factors. Under the final rule, most establishments that have PQC programs that control for non-food safety factors will continue to use the programs. In all likelihood, in developing new PQC programs, they will continue to include the information now required by FSIS. They will also be free to adopt other methods of process control and different techniques of observation, measurement, documentation, recordkeeping, and evaluation than are prescribed in the current regulations. They are likely to change their PQC-controlled operations to coordinate their food quality process control more effectively with their HACCP system operations to improve overall efficiency. Thus, raw material control, which has been a required element in PQC programs, could be handled under a HACCP plan with a CCP for raw materials, and other process controls for food safety could be handled in the same manner. Similarly, the records requirements for PQC programs could be superseded by more efficient and appropriate establishment-developed systems. Establishments would thus be able to achieve unquantifiable gains in efficiency that would yield food safety and other consumer-protection benefits.

FSIS-inspected establishments develop about 1,900 PQC programs a year according to regulatory design specifications. Assuming that a PQC program is developed by a QC manager earning about $26 an hour, and that it takes about 20 hours, on average, to develop a PQC program, the cost to an establishment of developing such a program is about $520. FSIS estimates that the cost to the regulated industry of developing such programs is about $1,000,000 per year.

This cost of developing PQC programs according to FSIS requirements, plus $13 million in annual operating costs for about 1,852 mandatory (required by regulation) PQC programs ($26/hr. × 260 hrs./yr./program × 1,852 programs), add up to about $14 million in costs to the regulated industry.

For most establishments, the final rule will not yield immediate, direct savings from removal of burdens associated with developing PQC programs because most PQC programs are voluntarily adopted by establishments. Establishments likely will continue the use of QC methods in their operations, so the removal of the regulatory requirement for establishments to follow the regulatory design specifications will not immediately yield a savings to establishments. Further, a substantial proportion of the costs of complying with this regulation was removed with the publication of the final rule eliminating prior approvals for facilities, equipment, and PQC programs (62 FR 45016; August 25, 1997).

However, FSIS currently requires that if establishments adopt PQC programs, the programs must meet certain design specifications and must contain certain specified information. Some establishments that are required to have PQC programs for certain products and processes would benefit from the removal of burdens associated with developing PQC programs. These establishments, including those involved in producing MS(S), meat cuts treated with organic acids, and other processing, may benefit from shifting some portion of their PQC program development and operation costs into HACCP-related or other activities.

Also, under the final rule, establishments would have greater freedom to innovate. An indeterminate proportion of the annual burden of developing PQC programs according to FSIS specifications could eventually be channeled into more efficient and effective use of industry resources, especially where PQC programs have been operated.

Thus, although there will not be a direct savings from the removal of the regulatory requirements governing PQC programs, the industry potentially will be able to make more efficient and effective use of the $1 million or so in annual costs of developing the programs.

Finally, the final rule will permit FSIS to reallocate field inspection and headquarters resources now used in oversight of establishment-operated PQC programs to higher priority food safety-related activities.

The Administrator of FSIS has determined that this final rule will not have a significant effect on a substantial number of small entities. The final rule will affect about 72 poultry slaughtering establishments, most of which are large business enterprises. It also will affect as many as 3,550 official meat and poultry processing establishments, of which a substantial majority, 3,330, are considered small entities under Small Business Administration criteria (500 or fewer employees per establishment). However, the rule will not have a significant effect on these establishments. It will impose no new regulatory requirements necessitating investments or other resource commitments by establishments but would, by removing a number of existing regulatory requirements, permit more efficient resource utilization, especially to support establishment HACCP systems.

The final rule will remove the remaining requirements for establishments to have PQC programs for certain products or processes and the general requirement concerning the design of such programs. The final rule will give inspected establishments greater flexibility to innovate and to introduce new processes or products that meet HACCP or other consumer protection objectives. As a result, the final rule will theoretically provide several thousand dollars of regulatory relief annually per establishment.

The final rule will enable establishments to avoid the costs associated with developing and implementing PQC programs that address regulatory requirements for the use of certain substances in preparation of meat and poultry products, such as the use of organic acids to delay discoloration of fresh meat cuts. Thermal processing establishments (of which there are about 130) will avoid the costs associated with developing PQC programs according to Agency specifications and the costs associated with obtaining Agency prior approvals.

As many as 3,330 small establishments will no longer be required to operate PQC programs for certain processes (such as PQC programs for processing cooked beef) and products (such as mechanically separated, or “deboned,” product). Small and large establishments will save about $520 per PQC program in development costs for 310 mandatory PQC programs, or $161,720 total. Out of this total, small establishments will save about $151,320.

Operating costs of PQC programs vary widely. A simple PQC program to verify the accuracy of scales, for example, may require that tests be performed only several times a year, at little cost in operator time. A PQC program for a complex process, on the other hand, may require daily tests and data collection and recordkeeping tasks lasting up to 4 hours. For the purposes of this document, PQC programs are each assumed to require up to 1 hour's worth of daily attention by the establishment QC specialist. The removal of the PQC requirements will relieve small establishments of these burdens.

Assuming, for example, that small establishments incur annual costs of about $12,000,000 in operating mandatory PQC programs (solely in operating the QC evaluation process of such programs, and not including laboratory analysis or special facilities that may be required to determine whether products are in compliance with the regulations), each establishment will save about $3,600 in PQC program operations.

In addition, small establishments will benefit from savings (at the rate of $300 per establishment) that accrue from the removal of regulatory design requirements for both mandatory and voluntary PQC programs. They will have flexibility to develop and implement HACCP-consistent or other process control systems, beyond the flexibility that was provided by the FSIS final rule that removed prior approval requirements for blueprints, equipment, and certain PQC programs (62 FR 45016; August 25, 1997).

Thus, at least $3,900 in recurring savings is available to each small meat and poultry establishment. However, because many, if not most, affected establishments will be likely to continue to operate PQC programs that help in producing products with consistent and uniform characteristics, establishments may not choose to reap the savings that could result from adopting alternatives to their PQC programs. The effect of the final rule on the substantial number of affected small establishments is therefore not likely to be significant.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. States and local jurisdictions are preempted by the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) from imposing any marking or packaging requirements on federally inspected meat and meat products or poultry products that are in addition to, or different than, those imposed under the FMIA and PPIA. States and local jurisdictions may, however, exercise concurrent jurisdiction over meat and poultry products that are outside official establishments for the purpose of preventing the distribution of meat or poultry products that are misbranded or adulterated under the FMIA or PPIA, or, in the case of imported articles, which are not at such an establishment, after their entry into the United States.

This final rule is not intended to have retroactive effect.

There are no applicable administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this final rule. However, the administrative procedures specified in 9 CFR 381.35 must be exhausted prior to any judicial challenge of the application of the provisions of this final rule, if the challenge involves any decision of an FSIS employee relating to inspection services provided under the FMIA or PPIA.

Pursuant to Executive Order 12898 (59 FR 7629; February 16, 1994), “Federal Actions to Address Environmental Justice in Minority and Low-Income Populations,” FSIS has considered potential impacts of this final rule on environmental and health conditions in low-income and minority communities.

This final rule will remove the requirements pertaining to PQC programs in federally inspected meat and poultry establishments. It will also remove from the canning regulations all requirements concerning PQC programs, the requirements for case-by-case FSIS approval of systems and devices not specified in the regulations, and several other prior-approval requirements.

As explained in the economic impact analysis, the regulations should generally benefit firms that process meat, meat food products, and poultry products. The regulations will not require or compel meat or poultry establishments to relocate or alter their operations in ways that could adversely affect the public health or environment in low-income and minority communities. Further, this final rule will not exclude any persons or populations from participation in FSIS programs, deny any persons or populations the benefits of FSIS programs, or subject any persons or populations to discrimination because of their race, color, or national origin. The benefits of this final rule from ensuring that products are not adulterated or misbranded will accrue to the members of all classes of the public, including minorities, women, and persons with disabilities.

About 4 percent of official meat and poultry establishments are under female or minority ownership. FSIS does not believe that the effects of this rulemaking, whether beneficial or adverse, on such establishments will be disproportionate. however, the Agency welcomes any data or information that would contribute to an understanding of the effects of this rule on minorities, women, or persons with disabilities.

Public awareness of all stages of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this final rule, FSIS will announce it and provide copies of this Federal Register publication in the weekly FSIS Constituent Update. FSIS communicates the Constituent Update by fax to over 300 organizations and individuals. In addition, the update is available on line through the FSIS web page located at “http://www.fsis.usda.gov”. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and other information that could affect or would be of interest to the Agency's constituents/stakeholders. The constituent fax list consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. Through these various channels, FSIS is able to provide information to a much broader, more diverse audience. For more information and to be added to the constituent fax list, readers of this document may fax their requests to the Congressional and Public Affairs Office, at (202) 720-5704.

Title: Processing Procedures and Quality Control Systems.

Type of Collection: Revision.

Abstract: FSIS has reviewed the paperwork and recordkeeping requirements in this final rule in accordance with the Paperwork Reduction Act. This final rule will substantially reduce reporting requirements for official establishments. The final rule will remove the design requirements affecting most PQC programs that establishments have and most requirements for establishments to have PQC programs for certain products or processes. Currently, there are 624,465 burden hours associated with the PQC program requirements. FSIS will request OMB to eliminate all these burden hours from the information collection request 0583-0089.

The Board is instituting a feedback program for its managers and officers. Under this Multi-rater Feedback program, Board employees who work for or with a particular manager or officer are asked to complete a voluntary, confidential questionnaire regarding the performance of that manager/officer and send it directly to a consultant hired by the Board for this program. The consultant analyzes the completed questionnaires and compiles a report for the manager/officer that summarizes the comments from the questionnaires. This report does not identify individual comments or those who completed the questionnaires. The report is given only to the manager/officer being evaluated; no other Board employee or officer receives a copy of the report. The consultant maintains all of the data connected with this program, identified only by the name of the manager/officer being evaluated.

Although information from the completed questionnaires is stored in the system of records without identifying the individual who completed the questionnaire, it is possible that the individual could be identified by careful study of the answers provided. To protect the confidentiality of these participants, which is expressly promised when the questionnaires are distributed, this data will not be available to the manager/officer that is the subject of the questionnaires. Accordingly, access to certain data in this system of records is restricted pursuant to the exemption provided in subsection (k)(5) of the Privacy Act, 5 U.S.C. 552a(k)(5). The Board's Rules Regarding Access to Personal Information under the Privacy Act must be amended to include this system of records in the list of “exempt” systems of records. In addition, the Board is taking this opportunity to remove from that list a system of records that was amended in 1998 and no longer contains information that is exempt from the access provisions of the Privacy Act.

In accordance with 5 U.S.C. 605, the Board certifies that this rule will not have a significant economic impact on a substantial number of small entities, because it applies only to internal personnel matters of the agency.

This rule is exempt from the rulemaking provisions of the Administrative Procedure Act, 5 U.S.C. 553, and the Congressional Review Act, pursuant to 5 U.S.C. 804(3)(B) and (C), because it is a rule relating to agency management or personnel and a rule of agency procedure that does not substantially affect the rights or obligations of non-agency parties.

On March 22, 2000, the FAA proposed to amend 14 CFR part 71 by modifying the Class E airspace area at Willis, CA (65 FR 15282). Additional controlled airspace extending upward from 700 feet above the surface is needed to contain aircraft executing the RNAV RWY 16 and RWY 34 SIAP at Ells Field-Willis Municipal Airport. This action will provide adequate controlled airspace for aircraft executing the RNAV RWY 16 and RWY 34 SIAP at Ells Field-Willits Municipal Airport, Willits, CA.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments to the proposal were received. Class E airspace designation for airspace extending from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9G dated September 1, 1999, and effective September 16, 1999, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This amendment to 14 CFR part 71 modifies the Class E airspace area at Willits, CA. The development of a RNAV RWY 16 and RWY 34 SIAP has made this action necessary. The effect of this action will provide adequate airspace for aircraft executing the RNAV RWY 16 and RWY 34 SIAP at Ells Field-Willits Municipal Airport, Willits, CA.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Subchapter III of the Federal Employees' Retirement System Act of 1986 (FERSA), Pub. L. No. 99-335, 100 Stat. 514, codified largely at 5 U.S.C. 8351 and 8401-8479, created a retirement savings plan for Federal employees known as the Thrift Savings Plan (TSP). As provided at 5 U.S.C. 8437, the TSP is funded by the Thrift Savings Fund (Fund).

Pursuant to 5 U.S.C. 8474(b)(5) and (c)(1), the Executive Director of the Board is granted authority to prescribe such regulations as may be necessary for the administration of the Fund. However, these statutory provisions expressly prohibit the Executive Director from prescribing any regulations relating to fiduciary responsibilities with respect to the Fund. Instead, at 5 U.S.C. 8477(e)(1)(E), the Secretary of Labor is directed to prescribe, in regulations, procedures by which fiduciary responsibilities may be allocated among fiduciaries, including investment managers. The Secretary of Labor published regulations setting forth such procedures in final form in the Federal Register on December 29, 1988 (53 FR 52664). These regulations comprise 29 CFR part 2584.

Pursuant to 29 CFR 2584.8477(e)-2(b), the Executive Director may allocate certain fiduciary responsibilities in connection with the management and investment of the Fixed Income Investment Fund (F Fund) to a qualified professional asset manager(s). Section 2584.8477(e)-2(c) of title 29, Code of Federal Regulations, provides that the Executive Director may also allocate certain fiduciary responsibilities in connection with the management and investment of the Government Securities Investment Fund (G Fund) and the Common Stock Index Investment Fund (C Fund) to an investment manager(s). Section 2584.8477(e)-6 of title 29, Code of Federal Regulations, provides definitions for these investment funds.

The Thrift Savings Investment Funds Act of 1996, Pub. L. 104-208, 110 Stat. 3009-372, authorized the creation of two new investment funds. The new funds are the Small Capitalization Stock Index Investment Fund (S Fund) and the International Stock Index Investment Fund (I Fund).

This document provides in § 2584.8477(e)-2 that, in addition to the G, C, and F Funds, the Executive Director may allocate certain fiduciary responsibilities in connection with the management and investment of the two new funds (S and I Funds) to an investment manager(s). The rule also provides definitions for these two new funds in § 2584.8477(e)-6, which conform to the definitions in sections of the Thrift Savings Investment Funds Act of 1996.

Because part 2584 originally adopted the definition of investment manager provided in the Employee Retirement Income Security Act of 1974 (ERISA), Pub. L. 93-406, 88 Stat. 829, 29 U.S.C. 1002, which was later amended by Act of November 10, 1997, § 1(a), Pub. L. 105-72, 111 Stat. 1457, this document replaces the old definition of investment manager in 29 CFR 2584.8477(e)-6 with the amended definition as currently provided in ERISA.

Furthermore, this rule adds the word “Fund” to § 2584.8477(e)-2(c), which was inadvertently omitted from “Common Stock Index Investment Fund” in the final rule, and updates the United States Code citation for FERSA in § 2584.8477(e)-6(a).

The Department has determined that this rule shall be effective as a final rule 45 days after publication in the Federal Register . As explained more fully above, the purpose of this rulemaking is to conform the existing regulation with the creation of two new investment funds authorized by the Thrift Savings Investment Funds Act of 1996, and to make certain other minor changes and corrections.

As a result, the Department anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. The amendment will enhance the ability of federal employees to diversify their account balances in the Thrift Investment Fund. In accordance with 5 U.S.C. 553(b), the Department for good cause finds that notice and public procedure on this rule are unnecessary.

Unless a written adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. If the Department does receive, within the comment period, an adverse or negative comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

The regulation set forth in this document is not classified as a “significant regulatory action” under Executive Order 12866 because it is not likely to result in: (1) An annual effect on the economy of $100 million or more; (2) a major increase in costs or prices for consumers, individual industries, Federal, state, or local government agencies, or geographic regions; or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic or export markets. As a result this rule is not subject to review by the Office of Management and Budget.

Because this rule is being promulgated without a notice of proposed rulemaking it is not covered by the Regulatory Flexibility Act. Nevertheless, the Department has determined that it will not have a significant economic impact on a substantial number of small entities. The rule merely makes changes necessary to permit the operation of two new investment funds authorized under the Thrift Savings Investment Funds Act of 1996 in the same manner as the existing investment funds.

The rule being issued here is not subject to the requirements of the Paperwork Reduction Act of 1996 (44 U.S.C. 3501 et seq. ) because it does not contain an information collection request as defined in 44 U.S.C. 3502(3).

This rule affects only the authority of the Executive Director of the Thrift Investment Board and has no federalism implications.

Pursuant to the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4, § 201, 109 Stat. 48, 64, the effects of this regulation on state, local, and tribal governments and the private sector have been assessed. This regulation will not compel the expenditure in any one year of $100 million or more by state, local, and tribal governments, in the aggregate, or by the private sector. Therefore, a statement under § 202, 109 Stat. 48, 64-65, is not required.

The rule being issued here is subject to the provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ) and has been transmitted to Congress and the Comptroller General for review. The rule is not a “major rule” as that term is defined in 5 U.S.C. 804, because it is not likely to result in (1) an annual effect on the economy of $100 million or more: (2) a major increase in costs or prices for consumers, individual industries, or federal, State or local government agencies, or geographic regions; or (3) significant adverse effects on competition, employment, investment, productivity, innovations, or on the ability of the United States-based enterprises to compete with foreign-based enterprises in domestic or export markets.

The regulation set forth herein is issued pursuant to 5 U.S.C. 8477(e)(1)(E) and under Secretary of Labor's Order No. 1-87.

Throughout this document wherever “we,” “us,” or “our” is used we mean EPA.

The purpose of transportation conformity is to assure that transportation plans, programs and projects, approved by the United States Department of Transportation conform to the purpose of the SIP to attain and maintain the public health based air quality standards. Conformity provisions first appeared in the Clean Air Act (CAA) amendments of 1977 (Public Law 95-95). Although these provisions did not define the term conformity, they provided that no Federal department could engage in, support in any way or provide financial assistance for, license or permit, or approve any activity which did not conform to a SIP that has been approved or promulgated for the nonattainment or maintenance areas.

The CAA Amendments of 1990 expanded the scope and content of the conformity provisions by defining conformity to an implementation plan. Conformity is defined in section 176(c) of the CAA as conformity to the SIP's purpose of eliminating or reducing the severity and number of violations of the National Ambient Air Quality Standards and achieving expeditious attainment of such standards, and that affected activities will not: (1) Cause or contribute to any new violation of any standard in any area, (2) increase the frequency or severity of any existing violation of any standard in any area, or (3) delay timely attainment of any standard or any required interim emission reductions or other milestones in any area.

The CAA requires EPA to promulgate criteria and procedures for determining conformity of all Federal actions in the nonattainment or maintenance areas to the SIP. Actions under title 23 United States Code (U.S.C.) or the Federal Transit Act are covered under the transportation conformity rules codified at 40 CFR part 51, subpart T and part 93, subpart A—Conformity to State or Federal Implementation Plans of Transportation Plans, Programs, and Projects Developed, Funded or Approved Under Title 23 U.S.C. or the Federal Transit Act. The criteria and procedures developed for all other federal actions are called “general conformity” rules.

The original 1993 conformity rule required the States and local agencies to adopt and submit a transportation conformity SIP revision to the EPA not later than November 24, 1994 (40 CFR 51.396). Ohio submitted its SIP revision for state transportation conformity rules on August 17, 1995.

The federal transportation conformity rule however, was amended on August 8, 1995, and again on November 14, 1995. The November 14, 1995, amendments allow 12 months, or until November 14, 1996, for States to submit a transportation conformity SIP revision consistent with these amendments. Ohio had submitted state conformity rules consistent with the original November 24, 1994, conformity rules on August 17, 1995, and these rules were conditionally approved by EPA on May 16, 1996 (61 FR 24702). The condition of the approval was that Ohio update the State transportation conformity rules to be consistent with the federal amendments. Ohio updated its State rules and met the condition of the conditional approval within the allotted time.

The federal conformity rule was again amended on August 15, 1997 (40 CFR parts 51 and 93 Transportation Conformity Rule Amendments: Flexibility and Streamlining). States were again given a 12 month time frame to submit State rules consistent with the amendment. Ohio proceeded to update the state transportation conformity rules and submitted the rules on October 6, 1999 (this submittal is the subject of this rulemaking action). However, on March 2, 1999, the United States Court of Appeals for District of Columbia Circuit issued its opinion in Environmental Defense Fund v. Environmental Protection Agency , No. 97-1637. The Court granted the environmental group's petition for review and ruled that several provisions in the federal transportation conformity rules were unlawful. The rules approved in this rulemaking are consistent with the August 15, 1997, federal conformity amendments that remained unchanged by the Court decision. However, Ohio will need to submit another transportation conformity SIP revision consistent with future amendments to the transportation conformity rule.

The approval of these State transportation conformity rules will update the federally approved State rules to be more consistent with the federal conformity rules, thereby improving the conformity process and providing consistency with other States rules and the federal rule.

Pursuant to the requirements under section 176(c)(4)(C) of the Clean Air Act, the Ohio Environmental Protection Agency (OEPA) submitted a SIP revision to the EPA on October 6, 1999. In its submittal, the State adopted State rules to meet the requirements of 40 CFR part 51, subpart T, and part 93 subpart A, as published on August 15, 1997. Transportation conformity is required for all nonattainment or maintenance areas for any transportation related criteria pollutants (40 CFR 51.394 (b)).

The State of Ohio currently has 28 counties which are ozone nonattainment or ozone maintenance areas and thus require Ohio to prepare transportation conformity analyses. These areas are: Toledo area (Lucas and Wood Counties), Cleveland/Akron area (Lorain, Cuyahoga, Medina, Summit, Portage, Geauga, Lake, and Ashtabula Counties), Youngstown area (Trumbull and Mahoning Counties), Canton (Stark County), Columbus (Franklin, Delaware and Licking Counties), Cincinnati (Hamilton, Butler, Clermont, and Warren Counties), Dayton (Preble, Montgomery, and Greene Counties), Springfield (Miami and Clark Counties), Clinton County, Columbiana County, and Jefferson County. In addition to the ozone nonattainment and maintenance areas, Cuyahoga County is also a maintenance area for carbon monoxide.

Section 51.390 of the transportation conformity rule requires that the majority of the Federal rules be incorporated verbatim, with only a few exceptions. In addition, the rule states that State rules can not be more stringent than the Federal rules unless the conformity provisions “apply equally to non-federal as well as Federal entities” (40 CFR 51.396(a)). The OEPA held a public hearing on the transportation conformity submittal on December 10, 1998.

The currently approved Ohio conformity rules comply with the 1994 federal conformity regulations. These federal regulations have been amended significantly, as discussed in the previous section. The Ohio submittal revises the State conformity regulations consistent with the 1997 Transportation Conformity Rule Amendments: Flexibility and Streamlining, which is the most current federal transportation conformity regulation.

Section 51.390 of the federal transportation conformity rule states that to be approved by the EPA, the submitted SIP revision must “address all requirements of this subpart in a manner which gives them full legal effect.” In particular, the revision shall incorporate the provisions of the following sections verbatim, except insofar as needed to give effect to a stated intent in the revision to establish criteria and procedure more stringent than the requirements stated in these sections: 93.101, 93.102, 93.103, 93.104, 93.106, 93.109, 93.110, 93.111, 93.112, 93.113, 93.114, 93.115, 93.116, 93.117, 93.118, 93.119, 93.120, 93.121, 93.126, and 93.127. The State of Ohio submittal incorporated all of the above sections verbatim following the August 15, 1997 version of the federal rules, with only clarifying changes. The criteria and procedures for consultation between State and local agencies, metropolitan planning organizations and federal agencies were changed from the previous State consultation rules. These changes are not being approved, as discussed further in the next section.

We are approving certain sections of the Ohio transportation conformity rule amendments which were adopted on January 26, 1999, and became effective on February 16, 1999.

The following is a summary of the Ohio Administrative Code and the sections that are being approved and why, and the sections that are not being approved and why:

OAC 3745-101-02 Definitions. These definitions are consistent with the federal rule and the Court decisions. This rule is being approved.

OAC 3745-101-03 (A), (B), (C), (D), (G), (H), (I), (J), (K), (L) Applicability, priority, and frequency of conformity determinations. The sections listed are being approved as consistent with the federal rule and the Court decisions. However, sections (E) and (F) are not being approved. Section E allows projects to proceed to completion after completing the National Environmental Policy Act (NEPA) requirements. This provision was struck down by the court in case No. 97-1637. Section F allows a grace period of 12 months for new nonattainment areas. This was disallowed by the United States Court of Appeals for the District of Columbia Circuit in case No. 96-1007.

OAC 3745-101-04 Consultation. This section is not being approved. The State is required to promulgate procedures and rules for consultation between State and local agencies, metropolitan planning organizations and federal agencies. Although this section has not been affected by the Court decisions, the submitted version does not have the detail of the previously approved consultation rule. Therefore, rule OAC 3745-101-04 will remain the same as previously approved.

OAC 3745-101-05 Content of transportation plans. This section is being approved. It is consistent with the federal rule and the Court decisions.

OAC 3745-101-06 Relationship with NEPA and fiscal constraints. This section is being approved. It is consistent with the federal rule and the Court decisions.

OAC 3745-101-07 Criteria and procedures for conformity determination, assumptions, emissions model, and consultation. Sections A, B, C, D, E, F, G, H, I, and J are being approved except for the parts of the sections which require a submitted budget to be used 45 days after submittal to EPA. These sections are contrary to the March 2, 1999, Court decisions. The parts of sections that are not being approved are as follows: OAC 3745-101-07 (C)(1)(a), (C)(2)(a),

OAC 3745-101-08 Criteria and procedures for implementation of TCMs, current conformity, and projects from a plan and TIP. This section is being approved. It is consistent with the federal rule and the Court decisions.

OAC 3745-101-09 Localized CO and PM10 violations and compliance with PM10 control measures. This section is being approved. It is consistent with the federal rule and the Court decisions.

OAC 3745-101-10 Motor Vehicle Emissions Budgets. Sections A, B, C and D are being approved because these sections are consistent with the federal rule and the Court decisions. Section E is not being approved because it is not consistent with the March 2, 1999 Court decisions.

OAC 3745-101-11 Criteria and Procedures: Emission Reductions in Areas Without Motor Vehicle Emissions Budgets. This section is being approved. It is consistent with the federal rule and the Court decisions.

OAC 3745-101-12 Consequences of Control Strategy Implementation Plan Failures. This section is being approved because it is consistent with the federal rule and the Court decisions, except for section (A)(2) which allows 120 days after a control strategy SIP disapproval before a conformity lapse takes effect. The Court ruled that a conformity lapse must take effect on the same day as the effective date of a control strategy disapproval.

OAC 3745-101-13 Requirements for Adoption or Approval of Projects by Other Recipients of Funds Designated Under Title 23 U.S.C. or the Federal Transit Laws. This section is being approved because it is consistent with the federal rule and the Court decisions, except for section (A)(1) which allows a regionally significant project in the first 3 years of the Transportation Improvement Program to proceed during a conformity lapse. This provision was rescinded by the Court.

OAC 3745-101-14 Procedures for Determining Regional Transportation-Related Emissions. This section is being approved. It is consistent with the federal rule and the Court decisions.

OAC 3745-101-15 Procedures for Determining Localized CO and PM10 Concentrations (Hot-Spot Analysis). This section is being approved. It is consistent with the federal rule and the Court decisions.

OAC 3745-101-17 Enforceability of design concept and scope and project-level mitigation and control measures. This section is being approved. It is consistent with the federal rule and the Court decisions.

OAC 3745-101-18 Exempt projects. This section is being approved. It is consistent with the federal rule and the Court decisions.

OAC 3745-101-19 Traffic Signal Synchronization Projects. This section is being approved. It is consistent with the federal rule and the Court decisions.

EPA is approving portions of the Ohio Transportation Conformity SIP revision submitted on October 6, 1999. EPA is only approving the sections detailed in the above listing. The rules being approved are consistent with the federal transportation conformity rule and the subsequent Court decisions. EPA is publishing this action without prior proposal because EPA views this as a noncontroversial revision and anticipates no adverse comments. However, in a separate document in this Federal Register publication, EPA is proposing to approve the SIP revision should adverse written comments be filed. This action will be effective without further notice unless EPA receives significant and relevant adverse written comments by June 29, 2000. Should the Agency receive such comments, it will publish a final rule informing the public that this action will not take effect. Any parties interested in commenting on this action should do so at this time. If no such comments are received, the public is advised that this action will be effective on July 31, 2000.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

Under Executive Order 12875, EPA may not issue a regulation that is not required by statute and that creates a mandate upon a state, local, or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments. If the mandate is unfunded, EPA must provide to the Office of Management and Budget a description of the extent of EPA's prior consultation with representatives of affected state, local, and tribal governments, the nature of their concerns, copies of written communications from the governments, and a statement supporting the need to issue the regulation.

In addition, Executive Order 12875 requires EPA to develop an effective process permitting elected officials and other representatives of state, local, and tribal governments “to provide meaningful and timely input in the development of regulatory proposals containing significant unfunded mandates.” Today's rule does not create a mandate on state, local or tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 1(a) of Executive Order 12875 do not apply to this rule.

On August 4, 1999, President Clinton issued a new executive order on federalism, Executive Order 13132, (64 FR 43255 (August 10, 1999),) which will take effect on November 2, 1999. In the interim, the current Executive Order 12612, (52 FR 41685 (October 30, 1987),) on federalism still applies. This rule will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 12612. The rule affects only one State, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act.

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.

This rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation.

In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.” Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This final rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co. , v. U.S. EPA , 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated annual costs to State, local, or tribal governments in the aggregate; or to private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated annual costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 31, 2000.

Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Throughout this document, wherever “we,” “us,” or “our” are used, we mean the Environmental Protection Agency (EPA).

We are approving the Governor's submittal of September 22, 1997, that requests a redesignation for the Canon City nonattainment area to attainment for the 1987 PM 10 standards. We are also approving the maintenance plan for the Canon City PM 10 nonattainment area, which was submitted with the State's September 22, 1997 redesignation request. We are approving this request and maintenance plan because Colorado has adequately addressed all of the requirements of the Act for redesignation to attainment applicable to the Canon City PM 10 nonattainment area. Upon the effective date of this action, the Canon City area's designation status under 40 CFR part 81 will be revised to attainment.

We are publishing this rule without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the “Proposed Rules” section of today's Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective July 31, 2000, without further notice unless the Agency receives adverse comments by June 29, 2000.

If we receive such comments, then we will publish a timely withdrawal of the direct final rule informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this rule. Any parties interested in commenting on this rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on July 31, 2000, and no further action will be taken on the proposed rule.

In order for a nonattainment area to be redesignated to attainment, the following conditions in section 107(d)(3)(E) of the Act must be met:

(i) We must determine that the area has attained the NAAQS;

(ii) The applicable implementation plan for the area must be fully approved under section 110(k) of the Act;

(iii) We must determine that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable implementation plan and applicable Federal air pollutant control regulations and other permanent and enforceable reductions;

(iv) We must fully approve a maintenance plan for the area as meeting the requirements of CAA section 175A; and,

(v) The State containing such area must meet all requirements applicable to the area under section 110 and part D of the CAA.

Our September 4, 1992 guidance entitled “Procedures for Processing Requests to Redesignate Areas to Attainment” outlines how to assess the adequacy of redesignation requests against the conditions listed above.

On September 22, 1997, the Governor of Colorado submitted a revision to the SIP for the Canon City area and a request that we redesignate the area to attainment for PM 10 . The following is a brief discussion of how Colorado's redesignation request and maintenance plan meets the requirements of the Act for redesignation of the Canon City area to attainment for PM 10 .

A State must demonstrate that an area has attained the PM 10 NAAQS through submittal of ambient air quality data from an ambient air monitoring network representing maximum PM 10 concentrations. The data, which must be quality assured and recorded in the Aerometric Information Retrieval System (AIRS), must show that the average annual number of expected exceedances for the area is less than or equal to 1.0, pursuant to 40 CFR 50.6. In making this showing, three consecutive years of complete air quality data must be used.

The State operates one PM 10 monitoring site in the Canon City PM 10 nonattainment area. Colorado submitted ambient air quality data from the monitoring site which demonstrates that the area has attained the PM 10 NAAQS. This air quality data was quality-assured and placed in AIRS. Only one exceedance of the 24-hour PM 10 NAAQS was measured which occurred in 1988. Since that time, no exceedances of the 24-hour or the annual PM 10 NAAQS have been measured. Officially, the State relied on the years 1993—1995 to show that the Canon City area had attained the PM 10 NAAQS. The area has continued to attain the PM 10 NAAQS since 1995. We believe that Colorado has adequately demonstrated, through ambient air quality data, that the PM 10 NAAQS has been attained in the Canon City area.

Those States containing initial moderate PM 10 nonattainment areas were required to submit a SIP by November 15, 1991 which demonstrated attainment of the PM 10 NAAQS by December 31, 1994. To approve a redesignation request, the SIP for the area must be fully approved under section 110(k) and must satisfy all requirements that apply to that area. We approved the PM 10 SIP for Canon City on December 23, 1993 (58 FR 68036) as meeting those moderate PM 10 nonattainment plan requirements that were due to EPA on November 15, 1991.

The State must be able to reasonably attribute the improvement in air quality to emission reductions which are permanent and enforceable. However, Canon City is a unique case in which no area-specific PM 10 control measures were needed to bring the area into attainment (or to ensure continued attainment), even when growth in emissions through 1997 was considered, because the monitored ambient PM 10 concentrations were (and still are) so far below the NAAQS. Colorado's September 22, 1997 submittal did cite several State-wide regulations, including SIP-approved regulations for particulates (Regulation No. 1), new source review permitting (Regulation No. 3), and residential wood burning (Regulation No. 4), as being responsible for the improvement in air quality in Canon City. Thus, we believe the Canon City area satisfies this requirement.

Section 107(d)(3)(E) of the Act requires that, for a nonattainment area to be redesignated to attainment, we must fully approve a maintenance plan which meets the requirements of section 175A of the Act. The plan must demonstrate continued attainment of the relevant NAAQS in the area for at least 10 years after our approval of the redesignation. Eight years after our approval of a redesignation, the State must submit a revised maintenance plan demonstrating attainment for the 10 years following the initial 10 year period. The maintenance plan must also contain a contingency plan to ensure prompt correction of any violation of the NAAQS. (See sections 175A(b) and (d).) Our September 4, 1992 guidance outlines 5 core elements that are necessary to ensure maintenance of the relevant NAAQS in an area seeking redesignation from nonattainment to attainment. Those elements, as well as guidelines for subsequent maintenance plan revisions, are as follows:

a. Attainment Inventory. The maintenance plan should include an attainment emission inventory to identify the level of emissions in the area which is sufficient to attain the NAAQS. An emissions inventory was developed and submitted with the moderate PM 10 nonattainment plan for the Canon City area on April 9, 1992. As detailed in the TSD for EPA's December 23, 1993 approval of the moderate PM 10 nonattainment plan for Canon City, the plan contained a comprehensive emissions inventory for mobile source emissions (including re-entrained road dust), residential wood and coal combustion emissions, and stationary source emissions for wintertime emissions in the base year of 1990. The Canon City area was in attainment of the PM 10 NAAQS in 1990, based on three complete years of data. Thus, we believe Colorado has prepared an adequate attainment inventory for the area.

b. Maintenance Demonstration. A State may generally demonstrate maintenance of the NAAQS by either showing that future emissions of a pollutant or its precursors will not exceed the level of the attainment inventory, or by modeling to show that the future mix of sources and emission rates will not cause a violation of the NAAQS. Colorado chose the modeling approach. The maintenance demonstration for the Canon City area uses emissions rollback, which was the same level of modeling used in the original attainment demonstration for the moderate PM 10 SIP for Canon City. The State's rollback approach takes the design day PM 10 value for 1989/1990 of 93 μg/m 3 , subtracts the background concentration, and divides the remainder by the total design day actual emissions for 1989/1990. This ratio is then applied to 2015 projected emissions to calculate the projected concentration without background. The background value is then added back in to give the total 2015 projected concentration of 141 μ/m 3 . Since this is below the 24-hour PM 10 NAAQS of 150 μ/m 3 , the maintenance plan demonstrates maintenance. Although EPA would normally insist on some interim year projections between 2000 and 2015, EPA has no reason to believe that total emissions will be greater than the 2015 projections in any of the interim years. The State applied simple, environmentally conservative, growth rates to all source categories other than stationary sources, and stationary sources were projected at allowable emissions. Thus, total emissions in all years before 2015 should be less than 2015 total emissions.

Since no violations of the annual PM 10 NAAQS have ever occurred in Canon City and since the maintenance demonstration clearly shows maintenance of the 24-hour PM 10 NAAQS in Canon City through the year 2015, it is reasonable and adequate to assume that protection of the 24-hour standard will be sufficient to protect the annual standard as well. Thus, EPA believes the State has adequately demonstrated that the Canon City area will maintain the PM 10 NAAQS for at least the next ten years.

c. Monitoring Network. Once a nonattainment area has been redesignated to attainment, the State must continue to operate an appropriate air quality monitoring network, in accordance with 40 CFR part 58, to verify the attainment status of the area. The maintenance plan should contain provisions for continued operation of air quality monitors that will provide such verification. Colorado operates one PM 10 monitoring site in the Canon City area. We approve this site annually, and any future change would require discussion with us. In its September 22, 1997 submittal, Colorado committed to continue to operate the PM 10 monitoring station in Canon City, in accordance with 40 CFR part 58.

d. Verification of Continued Attainment. The State's maintenance plan submittal should indicate how the State will track the progress of the maintenance plan. This is necessary due to the fact that the emissions projections made for the maintenance demonstration depend on assumptions of point and area source growth. Colorado has committed in the Canon City maintenance plan to analyze the three most recent consecutive years of ambient air quality data on an annual basis to verify continued attainment of the PM 10 NAAQS in Canon City. In addition, they committed to conduct periodic emission inventory reviews every three years to determine if any adjustments to the assumptions used in the maintenance demonstration need to be made. The first such report will be submitted to us in October 2001 for the year 2000.

e. Contingency Plan. Section 175A(d) of the Act requires that a maintenance plan also include contingency provisions, as necessary, to promptly correct any violation of the NAAQS that occurs after redesignation of the area. For the purposes of section 175A, a State is not required to have fully adopted contingency measures that will take effect without further action by the State in order for the maintenance plan to be approved. However, the contingency plan is an enforceable part of the SIP and should ensure that contingency measures are adopted expeditiously once they are triggered. The plan should discuss the measures to be adopted and a schedule and procedure for adoption and implementation. The State should also identify the specific indicators, or triggers, which will be used to determine when the contingency plan will be implemented.

The Canon City contingency plan will be triggered upon our determination that a PM 10 NAAQS violation has occurred in Canon City. The Canon City contingency plan provides that, within one month of our determination that a violation has occurred, Colorado and the Canon City and Fremont County governments and other interested parties will convene a contingency plan subcommittee. The subcommittee will identify the cause(s) of the violation within one month of convening. The subcommittee will then select one of the following potential contingency measures for the area to bring to the Colorado Air Quality Control Commission (AQCC) for adoption: street sweeping requirements, road paving requirements, street sand specifications, woodburning curtailment, use of liquid de-icers, re-establishing nonattainment new source review requirements, or other measures as deemed appropriate. The Canon City contingency plan provides that the contingency measures should become effective within 10 months of our determination that a violation has occurred in the Canon City area. In a letter dated April 24, 2000, from Margie Perkins, Director, Colorado Air Pollution Control Division, to Richard Long, Director, EPA Region VIII Air and Radiation Program, Colorado commits to adopt and implement contingency measures for the Canon City area within one year of a violation of either the 24-hour or annual PM 10 standard. EPA relies on this commitment in approving the Canon City contingency plan.

f. Subsequent Maintenance Plan Revisions. In accordance with section 175A(b) of the Act, the State of Colorado is required to submit a revision to the maintenance plan eight years after the redesignation of the Canon City area to attainment for PM 10 . This revision is to provide for maintenance of the NAAQS for an additional ten years following the first ten year period. The State committed in the Canon City redesignation request to submit a revised maintenance plan in 2006. EPA notes that the State chose 2006 based on an assumption that EPA would approve the redesignation request in 1998. Because EPA is approving the redesignation request in 2000, the State must submit the revised maintenance plan in 2008. See section 175A(b) of the Act.

In order for an area to be redesignated to attainment, section 107(d)(3)(E) requires that it must have met all applicable requirements of section 110 and part D of the Act. We interpret this to mean that, for a redesignation request to be approved, the State must have met all requirements that applied to the subject area prior to, or at the time of, submitting a complete redesignation request. In our evaluation of a redesignation request, we don't need to consider other requirements of the CAA that became due after the date of the submission of a complete redesignation request.

a. Section 110 Requirements. Section 110(a)(2) contains general requirements for nonattainment plans. For purposes of redesignation, the Colorado SIP was reviewed to ensure that all applicable requirements under the amended Act were satisfied. These requirements were met with the Colorado's April 9, 1992 submittal for the Canon City PM 10 nonattainment area. We approved this submittal on December 23, 1993 (58 FR 68036).

b. Part D Requirements. Before a PM 10 nonattainment area may be redesignated to attainment, the State must have fulfilled the applicable requirements of part D. Subpart 1 of part D establishes the general requirements applicable to all nonattainment areas, subpart 4 of part D establishes specific requirements applicable to PM 10 nonattainment areas.

The requirements of sections 172(c) and 189(a) regarding attainment of the PM 10 NAAQS, and the requirements of section 172(c) regarding reasonable further progress, imposition of RACM, the adoption of contingency measures, and the submission of an emission inventory, have been satisfied through our December 23, 1993 approval of the Canon City PM 10 SIP (58 FR 68036), our December 14, 1994 approval of PM 10 contingency measures for the area (59 FR 64332), and the demonstration that the area is now attaining the NAAQS.

Although EPA's regulations (see 40 CFR 51.396) require that states adopt transportation conformity provisions in their SIPs for areas designated nonattainment or subject to an EPA-approved maintenance plan, we have decided that a transportation conformity SIP is not an applicable requirement for purposes of evaluating a redesignation request under section 107(d) of the CAA. This decision is reflected in EPA's 1996 approval of the Boston carbon monoxide redesignation. (See 61 FR 2918, January 30, 1996.)

We approved the requirements of the part D new source review permit program for the Canon City area on August 18, 1994 (59 FR 42506). Once the Canon City area is redesignated to attainment, the prevention of significant deterioration (PSD) requirements of part C of the Act will apply. We must ensure that the State has made any needed modifications to its PSD regulations so that Colorado's PSD regulations will apply in the Canon City area after redesignation. Colorado's PSD regulations, which we approved as meeting all applicable Federal requirements, apply to any area designated as unclassifiable or attainment and, thus, will become fully effective in the Canon City area upon redesignation of the area to attainment.

Under our transportation conformity regulations, States are to define the mobile vehicle emissions budget to which Federal transportation plans must demonstrate conformity. The emissions budget is defined as the level of mobile source emissions relied upon in the attainment or maintenance demonstration to maintain compliance with the NAAQS.

Colorado had previously adopted mobile source emissions budgets for the years 1994 and 1997 of 4981 lb/day and 5130 lb/day, respectively. In the Canon City maintenance plan, Colorado indicated that it would adopt a new mobile source emissions budget of 7439 lb/day for the year 1997 and beyond. This value is equivalent to the year 2015 projected emissions for mobile sources. EPA believes use of this value as a budget for years before 2015 is acceptable because the available safety margin in years before 2015 is adequate to support such a budget. This is because pre-2015 projected emissions for source categories other than mobile sources are lower than 2015 projected emissions for these other source categories. EPA's approval of 7439 lb/day as the budget means that this value must be used for conformity determinations for all years after 1997, including 2015 (the end of the maintenance period) and beyond. After promulgation of approval of this redesignation request, the State indicated that it would revise its regulation entitled “Ambient Air Standards for the State of Colorado” to include this emissions budget for the years 1997 through 2015.

On March 2, 1999, the United States Court of Appeals for the District of Columbia Circuit issued a decision in Environmental Defense Fund v. the Environmental Protection Agency, No. 97-1637, that we must make an affirmative determination that the submitted motor vehicle emission budgets contained in SIPs are adequate before they are used to determine the conformity of Transportation Improvement Programs or Long Range Transportation Plans. In response to the court decision, we are making most submitted SIP revisions containing a control strategy plan available for public comment and responding to these comments before announcing our adequacy determination. (We do not perform adequacy determinations for SIP revisions that only create new emission budgets for years in which an EPA-approved SIP already establishes a budget, because these new budgets cannot be used for conformity until they are approved by EPA.) We make SIP revisions available for comment by posting notification of their availability on our web site (currently, these notifications are posted at www.epa.gov/oms/transp/conform/adequacy.htm). The adequacy process is discussed in greater detail in a May 14, 1999 memorandum from Gay MacGregor entitled “Conformity Guidance on Implementation of March 2, 1999 Conformity Court Decision,” also available on our web site (www.epa.gov/oms/transp/traqconf.htm).

As noted above, the Canon City maintenance plan was submitted to EPA on September 22, 1997. After the court decision, EPA conducted an adequacy review of all SIP submissions that had been received prior to the decision but not yet acted on. However, EPA did not conduct an adequacy review of the Canon City maintenance plan, because the Colorado AQCC voted on April 15, 1999 to request that the Governor withdraw this plan. The AQCC later rescinded its request that the plan be withdrawn, and EPA reviewed the emission budget in this plan for adequacy using the criteria located at 40 CFR 93.118(e).

This notice also serves as our determination that the emission budget in the maintenance plan of 7439 pounds per day of PM 10 is adequate for conformity purposes. As a result of this adequacy finding, the Colorado Department of Transportation and the Federal Highway Administration are required to use this budget in future conformity analyses, even if EPA withdraws this direct final rule. This adequacy determination will be in effect as of the publication date of this direct final rule, and will remain in effect unless and until EPA disapproves the maintenance plan. EPA will not be publishing a separate notice in the Federal Register documenting this adequacy determination.

Notice of the availability of this SIP was posted on our adequacy web site on January 26, 2000, and a 30-day comment period for adequacy was provided following the procedures described in the May 14, 1999 Gay MacGregor memorandum referenced above. No comments were received. Interested parties can still comment on the Canon City mobile source emissions budget in response to the Notice of Proposed Rulemaking that accompanies this Federal Register document. If EPA receives adverse comments with respect to the adequacy of the Canon City emissions budget or any other aspect of our approval of this SIP by the time the comment period closes on the proposed rule, we will publish a timely withdrawal of the direct final rule informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this rule. Any parties interested in commenting on this rule should do so at this time.

The Act requires States to observe certain procedural requirements in developing implementation plans and plan revisions for submission. Section 110(a)(2) of the Act provides that each implementation plan submitted by a State must be adopted after reasonable notice and public hearing. Section 110(l) of the Act similarly provides that each revision to an implementation plan submitted by a State under the Act must be adopted by such State after reasonable notice and public hearing.

We also must determine whether a submittal is complete and therefore warrants further review and action (see section 110(k)(1) and 57 FR 13565, April 16, 1992). Our completeness criteria for SIP submittals are set out at 40 CFR part 51, appendix V. We attempt to make completeness determinations within 60 days of receiving a submission. However, a submittal is deemed complete by operation of law under section 110(k)(1)(B) if a completeness determination is not made within six months after receipt of the submission.

Copies of the proposed changes were made available to the public and the AQCC held a public hearing on October 17, 1996 to entertain public comment on the redesignation request and maintenance plan for the Canon City PM 10 nonattainment area, after providing for more than 30 days of public notice. Colorado did not receive any adverse comments and therefore, the redesignation request and maintenance plan were subsequently adopted by the AQCC on October 17, 1996. The request was formally submitted to us for approval on September 22, 1997. We did not issue a completeness or an incompleteness finding for the September 22, 1997 submittal. Thus, pursuant to section 110(k)(1)(B), the submittal was deemed administratively and technically complete by operation of law on March 22, 1997 (six months after the date of receipt). We have evaluated the Governor's submittal and have determined that the State met the requirements for reasonable notice and public hearing under section 110(a)(2) of the CAA.

To implement our 1987 revisions to the particulate matter NAAQS, on August 7, 1987 (52 FR 29383), we categorized areas of the nation into three groups based on the likelihood that protection of the PM 10 NAAQS would require revisions of the existing SIP. We identified Canon City as a PM 10 “Group I” area of concern, i.e., an area with a strong likelihood of violating the PM 10 NAAQS and requiring a substantial SIP revision. The Canon City area was among several Group I PM 10 areas, all of which were designated and classified as moderate PM 10 nonattainment areas by operation of law upon enactment of the Clean Air Act Amendments of 1990 (November 15, 1990). See 56 FR 56694 at 56705-56706 (November 6, 1991).

By November 15, 1991, States containing initial moderate PM 10 nonattainment areas were required to submit most elements of their PM 10 SIPs. (See sections 172(c), 188, and 189 of the Act.) Some provisions, such as PM 10 contingency measures required by section 172(c)(9) of the Act and nonattainment new source review (NSR) provisions, were due at later dates. In order for a nonattainment area to be redesignated to attainment, the above mentioned conditions in section 107(d)(3)(E) of the Act must be met. We approved Colorado's SIP for the Canon City PM 10 nonattainment area on December 23, 1993 (58 FR 68036) and PM 10 contingency measures for the area on December 14, 1994 (59 FR 64332).

On September 22, 1997, the Governor of Colorado submitted a request to redesignate the Canon City moderate PM 10 nonattainment area to attainment for the 1987 PM 10 NAAQS along with a maintenance plan for the area. Colorado's submittal was not approved at that time because we promulgated new standards for PM 10 on September 18, 1997 and at the time of this redesignation request, we were transitioning from the 1987 PM 10 standard to the new PM 10 standard. Areas were to be designated under the new PM 10 standard by July 2000 and for that reason we were encouraging areas to withdraw any redesignation requests for the pre-existing standard. The AQCC had voted to withdraw the Canon City redesignation request and maintenance plan due to the fact that Canon City would have been designated attainment by July 2000 under the 1997 PM 10 standard. (Colorado's request for withdrawal had not yet been officially sent to us by the Governor and so we are able to process the original redesignation request and maintenance plan now.) On May 18, 1999, the United States Court of Appeals for the D.C. Circuit in American Trucking Associations, Inc. et al., v. United States Environmental Protection Agency vacated the 1997 PM 10 standard. Because of the Court ruling, we are continuing to implement the pre-existing PM 10 standard, and are therefore approving redesignations to qualified PM 10 nonattainment areas.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves 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 (Public Law 104-4). For the same reason, this rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This rule 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 approves 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 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 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 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. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective July 31, 2000 unless EPA receives adverse written comments by June 29, 2000.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 31, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

In December, 1998 EPA promulgated National Primary Drinking Water Regulations (NPDWRs) for disinfectants and disinfection byproducts (D/DBPs) that included a Maximum Contaminant Level Goal (MCLG) of zero for chloroform, a disinfectant byproduct. The MCLG was challenged by the Chlorine Chemistry Council and Chemical Manufacturers Association, and the U.S. Court of Appeals for the District of Columbia Circuit found that EPA had not used the best available, peer-reviewed science to set the MCLG as required by the Safe Drinking Water Act. In Chlorine Chemistry Council and Chemical Manufacturers Association v. EPA, (No. 98-1627) filed on March 31, 2000, the Court issued an order vacating the zero MCLG. Today EPA is removing the MCLG for chloroform from its NPDWRs to ensure that the regulations conform to the Court's order. No other provision of the D/DBP regulations is affected.

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because today's action is ministerial, to ensure the Code of Federal Regulations conforms to the Court's order. Thus, notice and public comment are unnecessary. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B). For this same reason, EPA has also determined that it has “good cause” under 5 U.S.C. 553(d) to make the rule effective upon publication.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget. Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute (see section B), it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. This rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10 1998). This rule 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). This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

This rule does not impose technical standards; 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. The rule also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). 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. ). EPA's compliance with these statutes and Executive Orders for the underlying rule is discussed in 63 FR 69390 (Dec. 16, 1998).

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. 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 May 30, 2000. 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 FCC published a document in the Federal Register of May 10, 2000 (65 FR 29985), establishing a Class A television service. In rule FR Doc. 00-11481, published on May 10, 2000, 65 FR 29985, correct the effective date, §§ 11.11, 73.1690, 73.2080, 73.3580, and the table of contents to subpart J of part 73.

In rule FR Doc. 00-11481, published May 10, 2000 (65 FR 29985), make the following corrections:

1. On page 29985, in the second column, the effective date is corrected to read as follows:

Section 11.11(a) is amended by revising the second entry in the first column of the table “Timetable Broadcast Stations” to read as follows:

4. On page 30005, in the third column, § 73.1690 is corrected by adding paragraph (c)(3) immediately preceding paragraph (c)(4) to read as follows:

This is a summary of a Commission's Order in CC Docket Nos. 96-45 and 97-21 released on May 22, 2000. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 Twelfth Street, SW., Washington, DC, 20554.

1. On March 1, 2000, the Commission released the Bureau Extension Order, 65 FR 12135 (March 8, 2000), that amended a rule to make clear that the Common Carrier Bureau (Bureau) may extend, for up to ninety days, the time period for taking action on a request for review of the Schools and Libraries Division of the Universal Service Administrative Company's (USAC or Administrator) decision that is pending before the Bureau or the Commission pursuant to § 54.724 of the Commission's rules. The Bureau Extension Order clarified that the Commission may extend the time period for taking action on a pending request for review of an Administrator's decision that is before either the Bureau or the Commission, but the Commission is not limited to a maximum 90-day extension period. In this Order, we amend a procedural rule which sets out the time period by which the Bureau or the Commission must take action on a request for review of a decision issued by the Administrator). We amend § 54.724 of the Commission's rules to make clear that a decision of the Administrator will not be deemed approved upon the running of the 90-day deadline for taking action on requests for review that are pending before the Bureau.

2. Section 54.724(a) of the Commission's rules establishes procedures for a request for review of an Administrator decision that is properly before the Bureau. Matters that are properly before the Bureau are appeals of Administrator decisions that do not involve novel issues of fact, law or policy. If the Bureau does not take action within 90 days regarding a request for review not involving novel issues, the decision issued by the Administrator is deemed approved. The rule also specifies that either the Commission or the Bureau may extend the time period for taking action on a matter before the Bureau.

3. In contrast, § 54.724(b) of the Commission's rules directs the Commission to issue, within 90 days, a written decision resolving a request for review of an Administrator decision that involves novel questions of fact, law or policy. The rules provide that the Commission or Bureau may extend the time period for taking action. Unlike appeals pending before the Bureau, if the Commission does not issue a decision within 90 days or does not extend the time period for taking action on the request for review, the Commission's rules do not provide that the Administrator's decision will be automatically approved.

4. The procedural distinction between matters pending before the Commission and those pending before the Bureau may pose problems for schools and libraries that request reviews of Administrator decisions. The appellants will not be certain whether or not their requests for review raise novel questions of fact, law or policy. As a consequence, appellants are not in a position to determine whether their appeals are pending before the Bureau or the Commission. Without knowledge of whether an appeal is being considered by the Bureau or Commission, a school or library cannot determine whether its appeal remains pending before the Commission or was subject to automatic denial where the 90-day time period for taking action ran without a decision or extension of time having been issued by the Bureau. Because of this lack of certainty, appellants cannot know when a denial is final and when the time period for pursuing further review has begun.

5. We believe that this uncertainty puts appellants in an untenable position. A party adversely affected by a Bureau decision has the right to seek reconsideration or Commission review of the decision. In order to exercise their right to seek review of an adverse decision, however, appellants must file either a petition for reconsideration or an application for review within thirty days from the date of public notice of the final action or release of the decision. The rules fail, however, to set forth a mechanism for public notice of Administrator decisions that are deemed approved upon the passage of 90 days in the absence of action by the Bureau.

6. The requirement in § 54.724(a) that Administrator decisions will be deemed approved in the absence of Bureau action on matters not involving new or novel issues was adopted to promote the prompt and efficient resolution of pending requests for review. We did not anticipate, however, that this means of streamlining our review process would add uncertainty to the appeals process or interfere with the ability of appellants to seek further review. Because we conclude that the different procedural processes found in §§ 54.724(a) and (b) generate uncertainty as to the status of certain requests for review, we find that it is in the public interest to eliminate the provision in § 54.724(a) specifying that a decision by the Administrator will be deemed approved where the Bureau has not acted within the 90-day review period. Accordingly, we find that it is appropriate to amend § 54.724(a) in this respect to conform to the rule that applies to Commission-level appeals. At the same time, we recognize the need of applicants under the schools and libraries program to have certainty over the status of their funding requests, and we remain committed to timely resolution of all appeals before us.

7. We believe this procedural amendment will clarify our administrative processes and prevent confusion regarding the procedural status of requests for review of Administrator decisions that are pending before the Bureau. Accordingly, as set forth, we amend § 54.724(a) of the Commission's rules to clarify that a decision of the Administrator will not be deemed approved upon the running of the 90-day time period for taking action on requests for review that are pending before the Bureau.

8. The authority contained in sections 1-4, 201-205, 218-220, 254, 303(r), 403, and 405 of the Communications Act of 1934, as amended, and § 1.108 of the Commission's rules, is adopted.

9. Part 54 of the Commission's Rules 47 CFR part 54, is revised as set forth.

10. This action is exempt from the notice and comment requirements of the Administrative Procedure Act, 5 U.S.C. 553, because it affects only rules of agency procedure or practice.

11. Because this action involves an internal procedural matter, it is further ordered that the rule change set forth is May 30, 2000.

The DPCIA, 16 U.S.C. 1385, as amended by the IDCPA, requires the Secretary of Commerce to develop an official mark that can be used to label tuna products as “dolphin-safe.” The IDCPA and the official mark provisions of the DPCIA became effective on March 3, 1999, when the Secretary of State certified to Congress that the Agreement on the International Dolphin Conservation Program had been adopted and was in force.

As discussed in the proposed rule to implement the IDCPA (December 22, 1999; 64 FR 71722), the Secretary of Commerce considered the designation of a commonly used “dolphin-safe” logo as the official mark, but instead decided to develop a unique logo as the official mark.

The DPCIA establishes “dolphin-safe” standards applicable to tuna products labeled with either the official mark or an alternative mark (16 U.S.C. 1385(d)). The DPCIA does not mandate the use of the official mark nor does it prohibit the use of alternative marks. However, as set forth under paragraph (d)(3)(B) of the DPCIA, whenever a tuna product bears the official mark, it may not bear any other mark or label that refers to dolphins, porpoises, or marine mammals. The dolphin-safe labeling standards, which are not a part of this rule-making, appear at 50 CFR 216.91 through 216.94. The standards are the subject of ongoing litigation. This final rule codifies the official mark at 50 CFR 216.96.

On December 22, 1999, NMFS published proposed regulations to designate an official mark that can be used to label tuna products as being dolphin-safe (64 FR 71722). Public comments on the proposed rule were accepted through January 5, 2000. In addition to publishing the proposed rule in the Federal Register , NMFS sent via fax and mail the notice to industry representatives, environmental groups, the Department of State, the Inter-American Tropical Tuna Commission (IATTC), the U.S. Commissioners to the IATTC, the Secretary of the Treasury, the U.S. Customs Service, the Marine Mammal Commission, and the Federal Trade Commission. NMFS also issued a press release summarizing the major issues contained in the proposed rule. Information in the press release was sent to several national newspapers and published on e-mail discussion groups and NMFS websites.

NMFS received 43 letters of comment in response to the proposed rule. Comments were received from environmental organizations and members of the public.

Numerous comments received were beyond the scope of the proposed rule to designate an official mark. These comments included concerns about subjects other than the official mark itself, such as: the dolphin-safe labeling standards, the initial finding required by the IDCPA on whether chase and encirclement of dolphins by the tuna purse seine fishery is having an adverse impact on depleted dolphin stocks in the eastern tropical Pacific Ocean (ETP) (notice published at 64 FR 24590), World Trade Organization influence and decisions related to U.S. embargoes against tuna harvested by purse seine in the ETP, enforcement of the Tuna Tracking and Verification Program, observer safety and objectivity, foreign trade interests and influence on the United States legislative process, the effects of purse seine fishing methods on dolphin stocks, mixed well storage of caught tuna onboard purse seine vessels, and decisions and procedures of the IATTC. The scope of the proposed rule is limited to the design elements of an official mark such as the graphics, color, appearance, and shape. The following is a summary of the comments NMFS received and NMFS responses.

Comment 1: Several commenters indicated that the short 14-day comment period and the publishing of the rule near the holidays did not provide adequate time for public comment.

Response: NMFS disagrees. The short comment period was adequate given the limited scope of the proposed rule.

Comment 2: Several commenters indicated that by designating an official mark NMFS would be intentionally defrauding the public about the effects of chase and encirclement on dolphins and unnecessarily confusing consumers with regard to the dolphin-safe status of labeled tuna.

Response: NMFS disagrees. The commenters appear to disagree with the standards for designating tuna products as being dolphin-safe. The standards are not the subject of this rule-making. The subject of this rule-making is an appropriate mark that can be used to show that a product is in compliance with the standards.

Comment 3: To avoid fraudulent representations, one commenter indicated “dolphin-safe” should not be used on the official mark without additional clarifying language such as “Dolphin Safe as Defined by Congressional Committee.”

Response: NMFS disagrees. The official mark may only be used to label tuna products that meet the “dolphin-safe” standards set forth in the DCPIA and its implementing regulations. The words “Dolphin Safe” are defined in the DCPIA (16 U.S.C. 1385(d)). A reference to Congressional committees is inappropriate since the law was enacted by the entire Congress and signed by the President.

Comment 4: One commenter indicated that use of the official mark would be damaging to alternative tracking and certification programs.

Response: NMFS disagrees. Use of the official mark is discretionary and not mandated (16 U.S.C. 1385 (d)(3)(2)). Tuna products labeled as being dolphin-safe by any mark must meet the dolphin-safe labeling standards (16 U.S.C. 1385(d)) and the standards of the Tuna Tracking and Verification Program (16 U.S.C. 1385 (d)(3)(c)(ii)), this does not preclude the use of alternative marks or alternative tracking and certification programs.

Comment 5: One environmental organization asserted that the proposed official mark would detract, or undermine, their trademarked “Flipper Seal of Approval” by misleading the consumer about the “true” definition of dolphin-safe tuna.

Response: NMFS disagrees. The commenter appears to disagree with the standards for designating tuna products as being dolphin-safe. The standards are not the subject of this rule-making. The subject of this rule-making is an appropriate mark that can be used to show that a product is in compliance with the standards.

The design and layout of the official mark and the Flipper Seal of Approval are very different and do not resemble each other. The official mark contains the words “U.S. Department of Commerce” in red letters, along with a blue-colored dolphin profile facing the upper left, and a tricolor (light blue, blue, and a dark blue) banner along the bottom of the mark that overlaps the dolphin's fluke. In contrast, the Flipper Seal of Approval depicts a partly submerged dolphin that is smiling and waving, with the word “Flipper” written across the top in bright yellow letters and the words “Seal of Approval” along the bottom of the mark. The unique official mark is easily distinguishable and could not mislead consumers into believing that it was the Flipper Seal of Approval.

Comment 6: Several commenters felt that the development and designation of the official mark is a waste of taxpayer money and contrary to the will of United States consumers.

Response: The DPCIA (16 U.S.C. 1385) requires the Secretary of Commerce to develop an official mark that may be used to label tuna products as “dolphin-safe.” The Secretary is obligated to implement this mandate.

Comment 7: One commenter expressed concern that the designation of an official mark would limit the right of tuna companies to use an alternative dolphin-safe marks.

Response: The DPCIA does not mandate the use of the official mark nor does it prohibit the use of alternative marks. However, as set forth under paragraph (d)(3)(B) of the DPCIA, whenever a tuna product bears the official mark, it may not bear any other mark or label that refers to dolphins, porpoises, or marine mammals.

After considering the comments received, there are no changes to the regulatory text from the proposed rule.

This final rule has been determined to not be significant for purposes of E.O. 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this final rule would not have a significant economic impact on a substantial number of small entities. NMFS received one comment regarding this certification. The commenter indicated that a Regulatory Flexibility Analysis should be completed before designating the official mark because of potential impacts and costs to small businesses to educate the consumer about the official mark. Because the IDCPA does not mandate the use of the official mark, and use of the official mark is discretionary, there are no compliance costs associated with use of the official mark. This comment did not cause NMFS to change its determination regarding the certification. As a result, no regulatory flexibility analysis was prepared.

(b) Location and size of the official mark. The official mark on labels must allow the consumer to identify the official mark and be similar in design and scale to figure 1. A full color version of the official mark is available at http://swr.ucsd.edu/dsl.htm.