In Title 7 of the Code of Federal Regulations, parts 1000 to 1199, revised as of January 1, 2001, in § 1007.7, paragraph (c) is revised to read as follows:

Section 236 of the Immigration and Nationality Act (the Act), 8 U.S.C. 1226, authorizes the Attorney General to determine whether to hold an alien in custody while proceedings are pending to determine whether an alien is to be removed from the United States. As a general principle, whether to detain an alien or to release the alien on bond or other appropriate conditions is a matter entrusted to the Attorney General's discretion. Under section 236(c) of the Act, however, certain aliens are subject to mandatory detention during the course of proceedings to determine their removal. These generally include individuals who are inadmissible or deportable due to the commission of specified crimes or due to having engaged in terrorist activity.

More than a century ago, the Supreme Court upheld detention as a necessary aspect of the exclusion or expulsion of aliens. Wong Wing v. United States , 163 U.S. 228, 235 (1896); see also Carlson v. Landon , 342 U.S. 524, 538 (1952) (“Detention is necessarily a part of this deportation procedure. Otherwise aliens arrested for deportation would have opportunities to hurt the United States during the pendency of deportation proceedings.”). An alien's interest in being at liberty during the course of immigration proceedings is “narrow” and “circumscribed by considerations of the national interest.” Doherty v. Thornburgh , 943 F.2d 204, 208, 208, 209 (2d Cir. 1991). “An alien's freedom from detention is only a variation on the alien's claim of an interest in entering the country.” Clark v. Smith , 967 F.2d 1329, 1332 (9th Cir. 1992).

Section 236 of the Act confers discretion upon the Attorney General to determine the custody of aliens who are in proceedings as long as they are not subject to the mandatory detention provisions of section 236(c) of the Act. The detention of aliens during the pendency of the immigration proceedings serves two essential purposes: ensuring removal by preventing the alien from fleeing, and protecting the public from potential harm.

Under the regulations, the Immigration and Naturalization Service (Service) makes the initial custody decision in each case—that is, whether to keep the alien in detention pending completion of the removal proceedings, or whether to release the alien on bond or other appropriate conditions. The alien, however, may ask an immigration judge to review the custody decision, subject to specified exceptions in § 3.19(h). The immigration judge may then reduce the required bond amount, release the alien on his or her own recognizance, or make such other custody decision as the immigration judge finds warranted. The Board then has jurisdiction to hear an appeal (whether by the alien or by the Service) from the immigration judge's decision.

This rule revises the existing provisions in § 3.19(i). That rule currently provides for an automatic stay in certain cases where the Service has denied release of an alien during the pendency of removal proceedings or has set a bond in excess of $10,000, an immigration judge orders an alien released, and the Service promptly files a Form EOIR-43, Notice of Intent to Appeal Custody Redetermination, with the Immigration Court. If the Service then files a timely appeal, the stay will continue pending the disposition of the appeal by the Board. See Matter of Joseph , Int. Dec. 3387 (1999).

Under the existing rule, since the expiration of the Transition Period Custody Rules, this automatic stay applies only to cases involving aliens subject to mandatory detention. This interim rule extends the existing scope of the automatic stay provisions in § 3.19(i) to authorize the Service, in its discretion, to invoke the automatic stay in other cases in which the Service has denied release of an alien during the pendency of the removal proceedings or has set a bond of $10,000 or more.

This change will allow the Service to maintain the status quo while it seeks review by the Board, and thereby avoid the necessity for a case-by-case determination of whether a stay should be granted in particular cases in which the Service had previously determined that the alien should be kept in detention and no conditions of release would be appropriate. This stay is a limited measure and is limited in time—it only applies where the Service determines that it is necessary to invoke the special stay procedure pending appeal, and the stay only remains in place until the Board has had the opportunity to consider the matter.

However, in order to ensure that any custody appeal proceedings are conducted on an expeditious basis, this rule also amends § 3.19(i) to add a new limitation that the automatic stay will continue, pending the decision by the Board on appeal, only if the Service files its appeal within ten business days of the immigration judge's order. Under the current rules, once the Service has invoked the automatic stay provision, it has the usual 30 days to file an appeal to the Board. As a matter of practice, the Service does not take that long and makes a prompt decision on whether or not to appeal a custody decision that is subject to an automatic stay. This change in the rule will better reflect the need for an expedited decision in the case of a custody appeal that is subject to an automatic stay.

In addition to the existing provisions for an automatic stay of an immigration judge's custody decision in § 3.19(i), pending an appeal to the Board, this rule also provides an automatic five-day stay of the Board's decision, where the Board dismisses the Service's appeal of an immigration judge's custody decision. This provision will allow the Commissioner a meaningful opportunity to review the Board's decision and to decide whether to certify the case to the Attorney General pursuant to § 3.1(h). Where the Commissioner certifies a custody decision of the Board to the Attorney General within that five-day period, the automatic stay will continue pending the Attorney General's review of the custody issues.

This change in § 3.19 makes explicit, in the context of bond appeals, the general principle that a “decision of the Board is not final while pending review before the Attorney General on certification.” Matter of Farias , 21 I&N Dec. 269, 282 (BIA 1996; A.G. 1997). This provision for an automatic stay will avoid the necessity of having to decide whether to order a stay on extremely short notice with only the most summary presentation of the issues.

The rule also makes a slight modification to the existing rule by providing that the Form EOIR-43 must be filed within one business day of the decision of the immigration judge. This is intended to afford the Service an opportunity to file the Form EOIR-43 in those cases where the immigration judge's custody decision is issued after normal business hours.

The Department's immediate implementation of this interim rule, with provision for post-promulgation public comment, is based upon findings of good cause pursuant to 5 U.S.C. 553(b)(3)(B) and (d).

The immediate implementation of this interim rule without prior public comment is necessary to prevent the release of aliens who may pose a threat to national security and to provide a clear set of procedural rules of administrative procedure with respect to determining the custody conditions and bond status for aliens during the pendency of removal proceedings. The existing rules permit the Service to appeal a decision ordering the release of an alien, but in many cases the rules do not provide for a stay of the release decision during the time that the Service would be pursuing an appeal. Thus, an alien who has received a custody redetermination by an immigration judge is eligible for release under the terms of that order unless and until a stay of that order is granted by the Board.

The time that elapses from the custody redetermination to the granting of a stay by the Board may be significant. The time it takes to draft a notice of appeal and motion for emergency stay and file these documents with the Board is often up to twenty-four hours, as the Service attorney handling the case may have to complete his or her duties in court that day before securing the necessary supervisory approval to file the motion for stay. The Service attorney then must draft the filings and transmit them to the Board in Falls Church, Virginia. The Board then must review the record and adjudicate the motion. The Board does not have a complete record upon which to base a ruling, because that record remains with the immigration court. As a matter of practice, the Board will not grant a stay without communicating with the alien or opposing counsel, so as to ascertain the alien's position regarding the necessity of the stay. Thus, under current procedures, there is a significant window of time wherein the alien may be released while the Service prepares its filings to the Board and while the Board adjudicates the motion. Also, the crucial determination by the Board is made without the benefit of a full record of proceedings and the Board instead relies upon the submissions of the parties.

Another significant problem that is remedied by this provision concerns custody determinations that arise on the west coast. Due to the time difference between the east and west coast, an alien may be ordered released after the Board has closed for the day. When this occurs, the Service is effectively barred from filing a stay request and this significantly increases the period during which the alien may be released.

During this window of time, the Service may be required to release an alien that it believes is a threat to national security or the public safety without even having the opportunity to present its case to the Board. The automatic stay provision allows the Service attorney to maintain the alien's custody status via immediate filing of the Form EOIR-43. This rule extends the scope of the existing automatic stay provision to cover all cases in which the Service has denied release of an alien pending the completion of removal proceedings or has set a bond of $10,000 or more, and in which the Service specifically invokes the automatic stay in order to seek an expedited appeal. The purpose of the automatic stay is to allow the Service to maintain the status quo during such time as is necessary for the Service to take a prompt appeal to the Board, and the stay only remains in place until the Board has had an opportunity to consider the matter. This rule similarly provides a five-day period after a decision by the Board to allow sufficient time for the Commissioner to determine whether to certify a decision of the Board to the Attorney General for review. These provisions for a temporary automatic stay will avoid the necessity of the Service having to seek stays on a case by case basis and the Board or the Attorney General having to decide whether to order a stay on extremely short notice with only the most summary presentation of the issues.

Finally, the current investigation in connection with recent terrorist activities has resulted in the detention of a large number of individuals. This may overwhelm the capacity of the Service to take the steps necessary to secure stays of custody redeterminations in timely fashion. The automatic stay provision will address this problem and prevent the Service and the Board from being overwhelmed with stay requests.

For these reasons, the Attorney General has determined that there is good cause to publish this interim rule and to make it effective upon filing for public inspection at the Office of the Federal Register, because the delays inherent in the regular notice-and-comment process would be “impracticable, unnecessary and contrary to the public interest.”

The Attorney General, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities. This rule extends the scope of the existing automatic stay provision to cover cases in which the Service has denied release of an alien pending the completion of removal proceedings or has set a bond of $10,000 or more, in order to allow the Service to maintain the status quo while it pursues an expedited appeal of an order to release the alien from custody. This rule does not affect small entities as that term is defined in 5 U.S.C. 601(6).

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Act of 1996, 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

This rule is considered by the Department of Justice to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, this rule has been submitted to the Office of Management and Budget (OMB) for review.

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. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform.

Under the Paperwork Reduction Act of 1995, Public Law 104-13, all Departments are required to submit to OMB, for review and approval, any reporting or recordkeeping requirements inherent in a final rule. This rule does not impose any new reporting or recordkeeping requirements under the Paperwork Reduction Act.

On May 5, 1999, Hogan and Hartson, L.L.P. filed a petition with FSIS on behalf of its client, Ajinomoto, USA, Inc. (Ajinomoto), requesting that the Agency amend its regulations to allow the use of TG enzyme, at usage levels of up to 65 ppm of product formulation, to improve texture and cooking yields in various standardized meat and poultry products. Ajinomoto also requested that FSIS permit TG enzyme to be used as a protein cross-linking agent, at usage levels of up to 65 ppm, to fabricate or reform cuts of meat. When TG enzyme is used to fabricate or reform cuts of meat, Ajinomoto requested that the resulting product be distinguished from its non-fabricated counterpart through terms such as “formed” or “reformed” as part of the product name ( e.g. “formed beef tenderloin”), as opposed to a statement that declares the presence of the enzyme as part of the product name ( e.g. “beef tenderloin formed with water and transglutaminase enzyme”).

TG enzyme is derived from a non-toxigenic and non-pathogenic strain of Streptoverticillium mobaraense and functions by catalyzing the formation of a covalent bond between the glutamine and lysine side residues of proteins. There are no current allowances in the FSIS regulations or those of the Food and Drug Administration (FDA) for the use of TG enzyme as a binder or protein cross-linking agent in standardized meat or poultry products.

In a previous petition submitted in June 1997, Ajinomoto requested that FSIS permit the use of TG enzyme in both standardized and non-standardized meat and poultry products. In support of the petition, Ajinomoto submitted data to support the generally recognized as safe (GRAS) status of TG enzyme for use as a cross-linking agent in meat and poultry products at levels of up to 65 ppm. As part of its review of the petition, FSIS asked FDA to evaluate the data submitted by Ajinomoto on the safety of TG enzyme for this proposed use. In January 1998, FDA sent a letter to FSIS that said that, although it has not made a determination regarding the GRAS status of any use of this enzyme, FDA would not challenge, at this time, Ajinomoto's conclusion that TG enzyme is safe under the proposed conditions of use.

Based on the findings of FDA's evaluation, described above, and the technical data provided by Ajinomoto, FSIS concluded that TG enzyme was suitable for use in non-standardized meat and poultry products, and in meat and poultry products that have been formulated to reduce sodium or fat content. Thus, the Agency permits the use of TG enzyme, at levels of up to 65 ppm, in such products, provided that the products are identified by a truthful descriptive designation, such as “low fat pork sausage, water and TG enzyme product.”

Although FSIS determined that TG enzyme was suitable for use in non-standardized meat and poultry products, and in meat and poultry products that have been formulated to reduce sodium or fat content, in its review of the 1997 petition, the Agency also found that Ajinomoto submitted insufficient data on the suitability of the use of TG enzyme in standardized meat and poultry products. FSIS informed Ajinomoto that in order to permit the use of TG enzyme in standardized products, the Agency must pursue rulemaking to amend the regulatory standards of identity. FSIS suggested that Ajinomoto submit a petition to request that the Agency amend the individual meat and poultry product standards to provide for the use of TG enzyme. The Agency also informed Ajinomoto that such a petition must include technical data to establish the suitability of TG enzyme for use in standardized meat and poultry products. In response, Ajinomoto submitted the May 5, 1999, petition, to which this rulemaking responds.

In support of its most recent petition, Ajinomoto submitted numerous published studies on the efficacy of TG enzyme in cross-linking muscle proteins. FSIS determined that the data demonstrate that TG enzyme is effective in improving texture by increasing elasticity and improving cooking yields in standardized meat sausage products, standardized restructured meat products, standardized “roast beef parboiled and steam roasted” meat products, and standardized poultry rolls. The Agency also determined that TG enzyme is effective in binding pieces of whole muscle meat to fabricate or reform cuts of meat. FSIS concluded that the data demonstrate efficacy at 65 ppm. However, FSIS found that the petition contained insufficient data to support the use of TG enzyme in standardized poultry products other than poultry rolls.

In support of its request that cuts of meat fabricated or reformed using TG enzyme be identified as “formed” or “reformed” in conjunction with the product name, Ajinomoto claimed that TG enzyme does not change the essential character of a meat product. According to the data presented by Ajinomoto, TG enzyme functions to fuse together muscle tissue, and that whole muscle tissues fused together with the TG enzyme have the same taste, aroma, nutritional profile, and other properties as untreated whole muscle tissue. Thus, Ajinomoto argued, the primary difference between a cut of meat formed with TG enzyme and an untreated cut will be the shape or size of the final product.

Because muscle fibers treated with TG enzyme will not be aligned as they would be naturally, the Agency does not agree that TG enzyme does not affect the essential character of a product. However, the Agency does agree that, because the primary difference between a cut of meat formed with TG enzyme and an untreated cut is the shape of the product, special labeling to alert the consumer to the presence of the TG enzyme in the product, such as “beef tenderloin formed with water and transglutaminase enzyme,” is not necessary. Therefore, in this direct final rule, the Agency is requiring that products that are fabricated using TG enzyme bear the term “formed” or “reformed” in conjunction with product name. The words “formed” and “reformed” are appropriate terms to identify these products because these terms reveal the material fact that multiple pieces of meat have been formed to look like a solid piece of meat. Otherwise, consumers could be misled. The product must also declare the presence of TG enzyme in the list of ingredients on the product's label, as required by 9 CFR 317.2(f)(1) and 381.118(a)(1).

On September 27, 1999, AMPC, Inc., petitioned FSIS to amend its regulations to allow the use of pork collagen, a connective tissue protein, as a binder in sausage as provided in 9 CFR Part 319, at usage levels of up to 3.5% of product formulation. In addition to sausage as provided in 9 CFR Part 319, AMPC requested that FSIS allow the use of pork collagen as a binder in other standardized meat and poultry products, such as cured pork products, luncheon meat, meat food entrée products, pies, turnovers, meat snacks, hors d'oeuvres, pizza and specialty items, meat salads, meat spreads, barbecued meats, poultry breakfast sausages, and canned, frozen, or dehydrated meat food products. There are no current allowances in the FSIS regulations for the use of pork collagen as a binder in standardized meat or poultry products.

Before petitioning FSIS, AMPC submitted a GRAS Notification to FDA concerning the use of pork collagen as a binder in meat products. After consulting with FSIS, FDA sent a letter to AMPC on July 29, 1999, that said that FDA “has no questions at this time regarding the conclusion of AMPC that pork collagen is GRAS for use as a binder and purge reducing additive in meat and meat type products at a level of 1-3.5% “ (GRAS Notice No. GRN 000021). FDA instructed AMPC to consult with FSIS regarding the suitability of the use of pork collagen in meat and poultry products, and the acceptability of use within the context of the Federal meat and poultry products inspection regulations.

AMPC has conducted research to support the efficacy of pork collagen as a binder in sausages and submitted data with the petition. After evaluating the data submitted by AMPC, FSIS determined that the data demonstrate that pork collagen is effective at reducing purge and improving cooking yields in those meat sausages whose standards permit binders, in certain standardized cured pork products, and in non-standardized meat and poultry products. FSIS also determined that the data demonstrate efficacy at 3.5% of the product formulation. Thus, the Agency permits the use of pork collagen, at the specified levels, in non-standardized meat and poultry products, provided that these products are identified by a truthful descriptive designation, such as “low fat pork sausage, water and pork collagen.”

However, to permit the use of pork collagen in standardized meat and poultry products, the Agency must conduct rulemaking to amend the individual product standards. Therefore, in response to AMPC's petition, FSIS is publishing this direct final rule to amend the standards of identity for certain meat sausages and certain standardized cured pork products. The Agency is not amending other product standards in this rulemaking because it found that the petition contained insufficient data to support the suitability of pork collagen for use in standardized poultry products.

In order to permit the use of a food ingredient in the production of meat or poultry products, FDA, in consultation with FSIS, assesses the safety of the ingredient's proposed use, while FSIS evaluates its efficacy and suitability for use in meat and poultry products. At the time that AMPC and Ajinomoto submitted their petitions, substances permitted for use in the production of meat products were listed in the chart of approved substances contained in former 9 CFR 318.7(c)(4), and substances permitted to be used in the production of poultry products were listed in the chart of approved substances contained in former 9 CFR 381.147(f)(4). Therefore, in its petition, Ajinomoto requested that FSIS amend the chart of substances in former §§ 318.7(c)(4) and 381.147(f)(4) to include the acceptable use of TG enzyme as a binder and cross-linking agent for sausage and other standardized meat and poultry products. Likewise, in its petition, AMPC requested that FSIS amend the chart of substances in former §§ 318.7(c)(4) and 381.147(f)(4) to include the acceptable use of pork collagen as a binder for sausage and other standardized meat and poultry products.

On December 23, 1999, FSIS published a final rule, “Food Ingredients and Sources of Radiation Listed or Approved for Use in Meat and Poultry Products,” designed to improve the efficiency of the procedures used by FSIS and FDA to review and approve the use of food ingredients and sources of radiation in the production of meat and poultry products (64 FR 72168). Under the new regulations, rather than listing substances approved for use in the production of meat and poultry products in the chart of substances contained in former 9 CFR 318.7(c)(4) and former 9 CFR 381.147(f)(4), FDA now lists food ingredients and sources of radiation that are safe for specific use in the production of meat and poultry products in its regulations in title 21 of the CFR. 9 CFR parts 310, 318, 319, and 381 of the FSIS regulations were amended to include appropriate cross-references to title 21 listings of substances and sources of radiation approved for use in meat and poultry products. In the final rule, FSIS also created one list of food ingredients approved for use in the production of meat and poultry products by combining the listing contained in former section 318.7(c)(4) with the listing contained in former section 381.147(f)(4) and moving the combined listing to section 424.21(c). The final rule became effective on January 24, 2000.

Because FDA now lists food ingredients and sources of radiation approved for use in the production of meat and poultry products in its regulations, FSIS has stated that it will limit substance-specific rulemakings to those necessary to establish specific prohibitions or limitations on the use of food ingredients in the production of meat or poultry products. Such rulemakings are necessary when a standard of identity or composition prohibits or limits the use of an ingredient. In these instances, the standard of identity must be amended to include the permitted use of the ingredient. FSIS does not intend to add any new substances to the chart contained in 9 CFR 424.21(c).

As previously mentioned, FSIS currently permits TG enzyme and pork collagen to be used in non-standardized meat and poultry products, such as meat links or patties, and modified versions of traditional products, such as “low fat pork sausage, water, and pork collagen product,” and “reduced fat breakfast sausage with transglutaminase enzyme,” provided that these products are identified by a truthful descriptive designation (9 CFR 317.2(c)(1), 317.2(e) and 381.117(a)). However, according to the petitioners, these descriptive designations may confuse some consumers or may cause some consumers to believe that the product identified by the descriptive designation is inferior to the traditional standardized version. Thus, the petitioners requested that, when TG enzyme or pork collagen is used as a binder in certain standardized products, these products be permitted to be identified by a standardized term, such as “hotdogs” or “breakfast sausage.”

FSIS is amending its meat inspection regulations and poultry products inspection regulations to permit the use of TG enzyme as a binder at up to 65 ppm of product formulation in sausages as provided in 9 CFR part 319, in fabricated steaks under 9 CFR 319.15(d), in “roast beef parboiled and steam roasted” under 9 CFR 319.81, and in poultry rolls under 9 CFR 319.81. FSIS is also amending its meat inspection regulations to permit the use of pork collagen as a binder at up to 3.5% of product formulation in sausages whose standards currently permit binders as provided in 9 CFR part 319 and cured pork products as provided in 9 CFR 319.104. Under § 319.104, binders are only permitted in certain cured pork products, such as “Ham Water Added,” “Ham and Water Product-X% of Weight is Added Ingredients,” and “Ham with Natural Juices.” Under this direct final rule, the use of pork collagen is also limited to those particular cured pork products.

Because it no longer adds new substances to the list of approved substances codified at 9 CFR 424.21(c), the Agency is amending the standards of identity for sausage at 9 CFR 319.140, fabricated steaks at 9 CFR 319.15(d), “roast beef parboiled and steam roasted” at 9 CFR 319.81, certain cured pork products at 9 CFR 319.104, and poultry rolls at 9 CFR 381.159 to permit the use of either TG enzyme, pork collagen, or both of these substances at the specified levels. The Agency is revising the standards of identity for the sausages that currently permit the use of binders, such as “breakfast sausage” (9 CFR 319.143), “frankfurter,” “frank,” “furter,” “hotdog,” “weiner,” “vienna,” “bologna,” “garlic bologna,” “knockwurst,” and similar products (9 CFR 319.180), and “cheesefurters” and similar products (9 CFR 319.181), to cross reference 319.140 for the purpose of determining which binders are permitted for use in these products and at what levels. The standards of identity for “braunschweiger” (9 CFR 319.182(a)) and “liver sausage” or “liverwurst” (9 CFR 319.182(b)) permit the addition of binders and contain a cross reference to § 319.140 for purposes of determining the permissible use of these substances in these products. Therefore, there is no need to change these product standards.

The Agency is also amending 9 CFR 317.8(b) of the meat inspection regulations to require that, when transglutaminase enzyme is used to fabricate or reform a cut of meat, the resulting product's labeling include a statement to indicate that the product has been “formed” or “reformed” as part of the product name. The Agency has determined that such labeling is necessary because TG enzyme alters the essential character of a product by making multiple cuts of meat or pieces of muscle tissue appear to be one intact cut or piece of meat, which could mislead consumers about the nature of this type of product. The Agency has determined that the terms “formed” and “reformed” are appropriate descriptive terms. Although it must be revealed in the ingredients statement, the presence of TG enzyme need not be disclosed as part of the product name. The labeling of these products must still comply with the requirement that a product that has been prepared by salting, smoking, drying, cooking, chopping, or otherwise must be so described on the label, unless the name of the product implies, or the manner of packaging shows that the product was subject to such preparation (9 CFR 317.2(e)).

The following examples are intended to provide further clarification on the application of the labeling requirements for products that have been fabricated or reformed using TG enzyme. When the surface of two whole beef tenderloins are fused together to create a product with a uniform thickness or portion size, an appropriate name for the product would be “Formed Beef Tenderloin.” However, if TG enzyme is used to fuse non-intact pieces of beef tenderloin to form a roll that resembles a tenderloin, an appropriate name would be “Reformed Beef Tenderloin Pieces.” When a beefsteak is formed by treating chopped pieces of meat trim with TG enzyme to fuse the pieces together, an appropriate name for this product would be “Formed Beefsteak, Chopped and Shaped.” When seam fat is removed from a cut of meat and the cut is then reassembled using TG enzyme, an appropriate name for the product would be “reformed” in conjunction with the name of the product, for example, “Reformed Ribeye Steak.”

The petition did not request that FSIS adopt these labeling requirements for fabricated or reformed poultry products. However, because FSIS has determined that TG enzyme is suitable for use in non-standardized poultry products and modified versions of traditional poultry products, and because it is interested in harmonizing the meat and poultry inspection regulations, the Agency is amending 9 CFR 381.129 to require that the labels of poultry products fabricated or reformed using TG enzyme state that the product has been “formed” or “reformed” as part of the product name.

Establishments that choose to use TG enzyme or pork collagen in their products will be required to list these substances, in descending order of predominance, in the product's ingredients statement (9 CFR 317.2(f)(1) and 381.118(a)(1)). This will require modification of the product's label and the printing of new product labels.

Because the use of these substances at the level that are being provided for by FSIS is not controversial, and because these substances are permitted in non-standardized products, FSIS expects no adverse comment to result from the changes that it is making in this direct final rule. Therefore, unless the Agency receives written adverse comments within the scope of this rulemaking, or a written notice of intent to submit adverse comments within the scope of this rulemaking, within 30 days, this action will become final 60 days after publication in the Federal Register . If written adverse comments within the scope of the rulemaking are received, the final rulemaking notice will be withdrawn, and the Agency will publish a proposed rulemaking notice that includes a comment period.

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

This direct final rule will permit the use of TG enzyme and pork collagen in certain standardized meat food products. It also prescribes labeling requirements for meat and poultry products fabricated or reformed using TG enzyme.

The use of these ingredients is voluntary and therefore, the impact of this direct final rule on small establishments is likely to be minimal. FSIS does not believe that any costs associated with changes to labels will be significant. The decision by individual establishments to use these ingredients will be based on their conclusions that the benefits of providing new product to meet consumers' needs outweigh the implementation costs.

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

Abstract: FSIS has submitted an emergency information collection request for the paperwork and record keeping requirements in this direct final rule in accordance with the Paperwork Reduction Act. Establishments that choose to use any of the substances permitted by this final rule will have to make changes to their product labels.

Estimate of Burden: Establishments must develop product labels in accordance with the regulations. To receive approval of the labels, establishments must complete FSIS Form 7234-1. FSIS program employees review FSIS Form 7234-1 to ensure that the information on the labels complies with the regulations. FSIS estimates that it will take 60 minutes to design and develop modified product labels in accordance with this direct final rule and 15 minutes to prepare FSIS Form 7234-1 and submit it, along with the sketch label, to FSIS.

Establishments will only need to make the label change once.

Respondents: Meat and poultry product establishments.

Estimated Number of Respondents: 992

Estimated number of Responses per Respondents: FSIS estimates that each establishment will modify one product label.

Estimated Total Annual Burden on Respondents: 1,240 hours.

Copies of this information collection assessment can be obtained from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection Service, USDA, Room 109 Cotton Annex., Washington, DC 20250-3700.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the method and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to Lee Puricelli, see the address above, and to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) Washington, DC 20253.

Public awareness of all segments 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 direct final rule and are informed about the mechanism for providing their comments, FSIS will announce it and provide copies of this Federal Register publication in the FSIS Constituent Update. FSIS provides a weekly FSIS Constituent Update, which is communicated via 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 any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent fax list consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that 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, fax your request to the Congressional and Public Affairs Office, at (202) 720-5704.

“Transglutaminase enzyme at levels of up to 65 ppm may be used as a binder in such product.”

“In addition to the binders and extenders referred to in the preceding sentence, the following two substances may also be used as binders in those sausages in which the use of such class of substances is permitted: pork collagen at up to 3.5% of the product formulation and transglutaminase enzyme at up to 65 ppm of the product formulation.”

On December 21, 1999, the Finance Board published an interim final rule implementing the specific limits on annual compensation for the Chairperson, Vice Chairperson, and other members of a Bank's board of directors imposed by section 7(i) of the Federal Home Loan Bank Act, as amended by the Gramm-Leach-Bliley Act (GLB Act) (section 606(b)), Pub. L. No. 106-102, 113 Stat. 1338 (November 12, 1999). See 64 FR 71275 (December 21, 1999). The interim final rule required each Bank's board of directors, notwithstanding the compensation limits, to continue to maintain its level of oversight of the management of the Bank (maintenance of effort standard). Consistent with this maintenance of effort standard, the interim final rule required that each Bank's board of directors hold no fewer in-person meetings in any year than it held on average over the immediately preceding three years (three-year averaging requirement).

The Finance Board finalized the interim final rule on March 14, 2000. See 65 FR 13663 (March 14, 2000). The final rule revised the minimum meetings requirement in § 918.7(a) to the lesser of: (1) Nine; or (2) the three-year averaging requirement. See id. This change was made in order to avoid the vagaries of timing of the pure averaging requirement and reflect the operational reality at the Banks regarding the average number of meetings held over the preceding three years. In addition, § 918.7(b) of the final rule clarified that a Bank could apply to the Finance Board for a waiver of the minimum meetings requirement pursuant to the procedures of 12 CFR part 907. See id.

Based on subsequent experience with the minimum meetings requirement, on May 14, 2001, the Finance Board published a second interim final rule that further amended the maintenance of effort provision to eliminate the three-year averaging requirement and to reduce the required minimum number of in-person board of directors meetings that a Bank must hold annually to six meetings. See 66 FR 24263 (May 14, 2001). The May 2001 interim final rule also removed the waiver provision of § 918.7(b), because the ability to request a waiver of Finance Board regulatory provisions is already provided for in 12 CFR part 907. See id.

As discussed in the SUPPLEMENTARY INFORMATION section of the May 2001 interim final rule, these changes were made based on arguments by the Banks that they would be able to conduct their business more efficiently and effectively by holding only six annual in-person board meetings. The Banks indicated that they would be able to continue to maintain their level of oversight over the management of the Banks by conducting more business at fewer, but longer, board meetings, and/or placing greater reliance on board committees for the conduct of certain board business. The Banks noted that the three-year averaging requirement created a standard that varied among the Banks, with, for example, one Bank, based on the standard, already holding only six in-person board meetings annually.

The Finance Board also determined, based on a survey of the number of board of directors meetings held in 1999 by a number of financial institution holding companies and housing Government-Sponsored Enterprises (GSEs), that requiring at least six in-person Bank board of directors meetings in any year is within the range of the number of annual board meetings held by such holding companies and GSEs. Further, providing the boards of the Banks with greater discretion in determining the number of board meetings to hold annually is consistent with the GLB Act's emphasis on devolving governance issues to the Banks.

The May 2001 interim final rule provided for a 30-day comment period, which closed on June 13, 2001. The Finance Board received comment letters from two Banks, which are discussed below.

The final rule adopts § 918.7 of the May 2001 interim final rule without change. Section 918.7 states:

One commenter interpreted the changes to the maintenance of effort requirement as a conclusion by the Finance Board that six in-person board meetings each year will fully enable the directors of a Bank to fulfill their fiduciary duties to the Bank's members. This comment misinterprets the maintenance of effort requirement. Section 918.7 requires that, in maintaining its level of oversight of the management of the Bank, the Bank shall hold at least six in-person board meetings in any year. As the SUPPLEMENTARY INFORMATION section of the May 2001 interim final rule explains, if a Bank's board intends to hold fewer annual in-person board meetings than it has held in past years, it would be in the board's best interest to document how it will continue to meet the maintenance of effort standard and its fiduciary duties regarding the Bank's safety and soundness. If the Bank cannot continue to maintain its level of oversight over Bank management with six board meetings in a given year, then it would need to hold more board meetings per year. See 66 FR at 24264.

The other commenter contended that the Finance Board should only be concerned that a Bank's board of directors has established sound governing processes, and should not pre-determine what governance practices are absolutely required for all Banks in all circumstances. As discussed in the SUPPLEMENTARY INFORMATION section of the March 2000 final rule, the minimum meetings requirement was adopted for safety and soundness reasons. While the Finance Board acknowledges that decisions on the number of Bank board meetings generally should be within the purview of the corporate governance responsibilities of the Banks' boards, the Finance Board believes that its safety and soundness concerns with respect to the Bank boards' level of oversight of Bank management warrant a regulatory response. Accordingly, the Finance Board is retaining the minimum meetings requirement in the final rule.

Because no notice of proposed rulemaking is required for this final rule, the provisions of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. , do not apply. Moreover, the final rule applies only to the Banks, which do not come within the meaning of “small entities” as defined in the Regulatory Flexibility Act. See id. section 601(6).

This final rule does not contain any collections of information pursuant to the Paperwork Reduction Act of 1995. See 44 U.S.C. 3501 et seq. Therefore, the Finance Board has not submitted any information to the Office of Management and Budget for review.

Accordingly, the interim final rule amending 12 CFR part 918, published at 66 FR 24263 (May 14, 2001), is adopted by the Federal Housing Finance Board as final without change.

On October 12, 2001, the FAA issued emergency AD 2001-21-51, which is applicable to certain Boeing Model 737-600, -700, and -800 series airplanes.

The FAA recently received a report indicating that an operator found damage to the web of the aft pressure bulkhead at body station (BS) 1016 on a Boeing Model 737-700 series airplane. One section of the web had two large dents that crossed a radial tearstrap and a crease common to one edge. During replacement of the damaged web sections of the bulkhead, additional damage to the vertical shear beam web and to the skin adjacent to the attachment fittings of the vertical fin at BS 1016 was found. The vertical shear beam webs are integral to the attachment fittings that attach the vertical fin to the fuselage. A shimmy event of the main landing gear (MLG) on that airplane also was reported, and was so severe that it damaged the MLG and resulted in replacement of the right MLG.

Subsequent to the first report, three other operators reported similar damage to the aft pressure bulkhead on other Boeing Model 737-700 series airplanes, following severe shimmy events which resulted in damage to the MLG. A 0.65-inch crack in the aft pressure bulkhead also was found on one of the damaged airplanes. Shimmy events are a possible cause of the aft pressure bulkhead damage; however, the actual cause is undetermined. Hard landings and tail strikes are other possible causes. Such damage, if not fixed, could result in structural failure of the aft pressure bulkhead and consequent uncontrolled decompression, or loss of structural integrity of the forward support of the vertical fin, loss of the vertical fin, and consequent loss of control of the airplane.

Boeing Model 737-600 and -800 series airplanes have identical structure in the subject area and may also be subject to the same unsafe condition described above.

The FAA has reviewed and approved Boeing Telegraphic Alert Service Bulletin, 737-53A1238, dated October 11, 2001, which describes procedures for a detailed visual inspection for damage of the aft pressure bulkhead at body station (BS) 1016 and the forward attachment of the vertical fin at body section 48. For airplanes on which damage is found, the service bulletin describes procedures for doing an additional detailed visual inspection of the vertical beam web installation. The service bulletin also specifies contacting Boeing for repair of any damage found, and reporting inspection results to Boeing.

Since the unsafe condition described is likely to exist or develop on other airplanes of the same type design, the FAA issued emergency AD 2001-21-51 to find and fix damage of the aft pressure bulkhead at BS 1016 and the forward attachment of the vertical fin at body section 48, which could result in structural failure of the aft pressure bulkhead and consequent uncontrolled decompression, or loss of structural integrity of the forward support of the vertical fin, loss of the vertical fin, and consequent loss of control of the airplane. The AD requires a detailed visual inspection for damage of the aft pressure bulkhead at body station 1016 and the forward attachment of the vertical fin at body section 48, and corrective action, if necessary. The actions are required to be accomplished in accordance with the service bulletin previously described, except as discussed below.

Although the service bulletin specifies that the manufacturer may be contacted for disposition of certain repair conditions, this AD requires the repair of those conditions to be accomplished per a method approved by the FAA, or per data meeting the type certification basis of the airplane approved by a Boeing Company Designated Engineering Representative who has been authorized by the Manager, Seattle Aircraft Certification Office, to make such findings.

The service bulletin also specifies doing a detailed visual inspection of the aft pressure bulkhead at body station 1016 and the forward attachment of the vertical fin at body section 48 for damage, within a compliance time that ranges between 5 and 30 days, depending upon airplane grouping. However, this AD also requires doing the detailed visual inspection before further flight if a severe shimmy event that damaged the main landing gear, a hard landing, or a tail strike occurs after the effective date of this AD.

This is considered to be interim action. The inspection reports that are required by this AD will enable the FAA to complete its evaluation of the need for final action. Once final action is developed, approved, and made available, the FAA may consider further rulemaking.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment thereon were impracticable and contrary to the public interest, and good cause existed to make the AD effective immediately by individual notices issued on October 12, 2001, to all known U.S. owners and operators of Boeing Model 737-600, -700, and -800 series airplanes; line numbers 1 through 405 inclusive, and line numbers 466, 585, 590, and 793. These conditions still exist, and the AD is hereby published in the Federal Register as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption “ ADDRESSES. ” All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2001-NM-310-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

The FAA has received reports of cracks and corrosion in the outer hinge pins that attach the horizontal stabilizer to the vertical fin on several Boeing Model 727 series airplanes. The cracks in the outer hinge pins, which are made of 4330 steel, have been attributed to stress corrosion. These cracks often initiate in corroded areas of the hinge pin not protected by chrome plating. Corrosion has also been found on inner fail-safe hinge pins. Corrosion or cracking in the outer hinge pins of the horizontal stabilizer could lead to structural degradation of the stabilizer hinge joint and consequent loss of the horizontal stabilizer, which would result in loss of controllability of the airplane.

The FAA has reviewed and approved Boeing Alert Service Bulletin 727-55A0090, Revision 1, dated September 20, 2001, which describes procedures for repetitive detailed visual inspections for migration or corrosion of the outer hinge pins of the horizontal stabilizer, and various follow-on actions, if necessary. The follow-on actions include:

• A torque test (referred to in the service bulletin as a “torque check”) of the nut on the outer hinge pins, and reduction of the torque values for the nut on the outer hinge pins, if necessary.

• Repetitive detailed visual and magnetic particle inspections for corrosion or cracking of the outer and inner hinge pins (which also involves removal of outer and inner hinge pins, as necessary, and application of corrosion preventative compound or grease on the hinge pins).

• Replacement of migrated, cracked, or broken hinge pins with new or serviceable hinge pins.

Accomplishment of the repetitive detailed visual and magnetic particle inspections for corrosion or cracking of the outer and inner hinge pins, as necessary, including all associated actions, eliminates the need for the repetitive detailed visual inspections for migration or corrosion of the hinge pins.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design, this AD is being issued to find and fix corrosion or cracking in the outer hinge pins of the horizontal stabilizer, which could lead to structural degradation of the hinge of the horizontal stabilizer and result in loss of the horizontal stabilizer and consequent loss of controllability of the airplane. This AD requires accomplishment of the actions specified in the service bulletin described previously, except as discussed below.

This AD differs from the referenced service bulletin in the following ways:

• The service bulletin specifies that the manufacturer may be contacted for disposition of repair conditions. However, this AD requires the repair of those conditions to be accomplished per a method approved by the FAA, or per data meeting the type certification basis of the airplane approved by a Boeing Company Designated Engineering Representative who has been authorized by the Manager, Seattle Aircraft Certification Office, to make such findings.

• The referenced service bulletin recommends accomplishment of the repetitive detailed visual and magnetic particle inspections for corrosion or cracking of the outer and inner hinge pins; and provides initial and repetitive compliance times for these inspections. However, for airplanes on which no migrated, cracked, broken, or corroded hinge pins are found, this AD provides for accomplishment of the repetitive detailed visual and magnetic particle inspections as an option which terminates the requirement for repetitive inspections for pin migration or corrosion.

This is considered to be interim action. The FAA is currently considering requiring, for all airplanes, accomplishment of the inspections in Part 3 and Part 4 of the service bulletin, which—as described above—are specified in this AD as optional for airplanes on which no migrated, cracked, broken, or corroded hinge pins are found. However, the planned compliance time for such inspections is sufficiently long so that notice and opportunity for prior public comment will be practicable.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES . All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification ( e.g. , reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2001-NM-281-AD.” The postcard will be date-stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

Section 15(b) of the Consumer Product Safety Act (CPSA), 15 U.S.C. 2064(b) requires manufacturers, distributors, and retailers of consumer products to report possible “substantial product hazards” to the Commission. In 1978, the Commission published in the Federal Register “Substantial Product Hazard Reports”, 16 CFR 1115, an interpretative rule that set forth the Commission's understanding of this requirement and established procedures for filing such reports and proffering remedial action to the Commission. That rule addresses the types of information a firm should evaluate in considering whether to report. It does not, however, specifically address information about experience with products manufactured or sold outside of the United States. The Commission has always expected that firms would report when they obtained reportable information, no matter where that information comes from. Neither the statute, nor the rule itself, suggests otherwise.

Over the past several years, the Commission has received reports under section 15(b) that included information on experience with products abroad and technical data concerning such products. When appropriate, the Commission has initiated recalls based in whole or in part on that experience. In addition, the Bridgestone/Firestone tire recall of 2000 focused public attention on the possible relevance of information generated abroad to safety issues in the United States. Accordingly, to assure that firms who obtain information generated abroad are aware that they should consider such information in deciding whether to report under section 15(b), on January 3, 2001, the Commission solicited comments in the Federal Register on a proposed policy statement. The statement set forth the Commission's position that firms should evaluate and, if appropriate, report to the Commission information concerning products manufactured or sold outside of the United States that may be relevant to defects and hazards associated with products distributed within the United States

On June 7, 2001, after considering the comments, the Commission published in the Federal Register a final policy statement memorializing this position. Simultaneously, the Commission proposed for comment an amendment to codify this policy guidance as part of the Substantial Product Hazard Reports interpretative rule, 16 CFR 1115. The proposed amendment notes in substance that information about product experience, performance, design or manufacture outside the United States may be relevant to products sold or distributed in the United States. It further notes that firms should study and evaluate such information under section 15(b).

Discussion: The Commission received four comments in response to the proposed amendment. One of these commentors, the CPSC Coalition of the National Association of Manufacturers (“NAM”), resubmitted comments that it had presented in response to the Commission's January proposed policy statement. NAM's resubmission contended that the Commission's response to its comments to that proposal did not take the Coalition's concerns into account. However, NAM did not point to any specific inadequacy in the Commission's response, nor did it otherwise elaborate on its contention. The Commission, on the other hand, believes that its response to the NAM comments in the June 7 Federal Register notice was more than adequate. The NAM comments largely voiced the same hypothetical concerns that commentors on the original 1977 proposed interpretative rule on reporting raised. As the June 7 Federal Register notice points out, the Commission addressed the substance of those comments in the preamble to and text of the final rule in 1978. 43 FR 34988. The Commission believes, therefore, that the NAM comments require no further response.

a. Imputing Knowledge: The three commentors other than NAM expressed concern that the proposed amendment treated information generated abroad in the same manner that the Commission views domestically obtained data. In the commentors' view, the amendment should have, but did not, take into account differences in data-gathering capabilities abroad from those within the United States, as well as perceptions of the significance of data that becomes available. The commentors requested that the final rule or its preamble recognize these differences. These commentors also noted that U.S. subsidiaries of foreign companies are often not in a position to require corporate parents to collect and/or forward safety-related information to those subsidiaries. They further indicated that U.S. subsidiaries will not necessarily be aware of, or be able to obtain, information that other independent subsidiaries of a common foreign parent acquire. Again, the commentors suggested that the Commission recognize in the final rule or its preamble these possible impediments to the acquisition of information.

The issue of obtaining and evaluating information from abroad is pertinent to two aspects of reporting—timely reporting and corrective action. With respect to the first aspect—failing to report in a timely manner or not at all, the Commission believes that the commentors may have misconstrued the intent and scope of the proposed amendment. The Commission recognizes that a number of factors may affect the ability of a firm located in the United States to obtain information from abroad, including limitations on the availability of and access to information. The Commission also appreciates that the nature of corporate business relationships and affiliations may impact the ability of a firm to obtain such information. The Commission further understands that training, experience, and corporate position, and differences in product design, use and operating environment from standard practices in the United States may affect the ability of recipients abroad to appreciate the significance of information that may relate to products to be sold in the United States.

As commentors acknowledged in their written comments and in discussions with the Commission staff, the evaluation of compliance with the reporting obligations requires a case-by-case assessment of relevant facts, including those relating to the considerations identified above. The Consumer Product Safety Act provides the standard for this evaluation. In the context of reporting, section 20, 15 U.S.C. 2069, only permits the assessment of civil penalties against a party who “knowingly” commits a prohibited act by failing to furnish information required by section 15(b). Section 20(d) of the act defines “knowingly” as “* * *” (2) the presumed having of knowledge deemed to be possessed by a reasonable man who acts in the circumstances, including knowledge obtainable upon the exercise of due care to ascertain the truth of representations.”

The existing interpretative rule also provides guidance, consistent with section 20, on how the Commission will analyze the facts of each case. In its discussion of the imputation of knowledge to a firm, 16 CFR 1115.11 notes that “the Commission will deem a subject firm to know what a reasonable person acting in the circumstances in which the firm finds itself would know.” The section goes on to explain that this imputation extends to knowledge that a firm could have obtained, had it exercised due care to ascertain the truth of complaints or other representations or conducted a reasonably expeditious investigation to evaluate the reportability of a death, grievous bodily injury, or other information.

Under section 115.11, the “reasonable person” standard applies to a firm's accountability for failure to obtain information that exists abroad. Considerations, such as those described above that may have affected the firm's ability to obtain or appreciate the significance of such information are certainly relevant to whether a firm acted reasonably in the circumstances. In view of the strictures in the statute and the existing interpretative regulation, the Commission believes that the commentors' fears that the Commission would not take such factors into account when assessing a firm's compliance with the reporting obligations are unfounded.

With respect to the second aspect of reporting—corrective action, as the June 7, 2001 final policy statement points out, information from abroad may be relevant to the core issue of whether some form of remedial action is necessary to protect American consumers from defective products that present a substantial risk of death or injury. The Commission hopes that all of the commentors to the proposed amendment accept that, in evaluating potential hazards, firms should attempt to obtain all reasonably available information, including that from abroad, in a timely manner to assure that they can reach reasoned decisions. Indeed, one of the three commentors expressly stated its agreement with this proposition. The Commission believes that this perspective is appropriate, since the welfare of their domestic customers should be of paramount concern to U.S. companies.

b. Two commentors believed that the proposed amendment differed materially from the final policy statement because, unlike the policy statement, the amendment did not expressly note that firms had to have first obtained information from abroad for the obligation to evaluate the information to arise. The commentors feared that the omission signaled a possibility that, in evaluating a firm's compliance with the reporting requirements, the Commission might hold a firm responsible for not exercising due diligence to search for and obtain information that was available abroad, but that had not come to the firm's attention. The commentors therefore requested that the final amendment expressly state that a firm only needs to review information that it obtains.

The Commission believes that the amendment as proposed implicitly recognized that, in order to have an obligation to study and evaluate information, a firm must first obtain the information, or be reasonably expected to have obtained it because, for example, of the firm's relationship with or access to a firm or individual who possesses it. To alleviate the apparent confusion, however, the Commission has included in the final amendment an express statement that the information that should be evaluated includes information that a firm “has obtained, or reasonably should have obtained in accordance with section 1115.11” relating to product experience, etc. The Commission has not, however, limited this revision to cover only information that a firm has “actually” obtained, as one commentor requested. As is discussed infra, both the CPSA and the interpretative rule recognize that a firm need not have actually obtained information for obligations under section 15(b) to arise, if a reasonable person acting in the circumstances in which the firm finds itself would have obtained the information. Accordingly, the Commission believes that these provisions that address the imputation of knowledge to a firm dictate against further limiting the revision to the amendment. Adopting the restriction suggested by the commentor, on the other hand, could encourage firms to avoid seeking reasonably available information that could ultimately support the need for those firms to take corrective action.

c. Recipients of Information: One commentor stated that the rule should reflect that a firm “obtains” information only when an employee of the firm capable of appreciating the significance of the information actually receives it. Section 1115.11 of the interpretative rule already states that “ the Commission will deem a firm to have obtained reportable information when the information has been received by an official or employee who may reasonably be expected to be capable of appreciating the significance of the information.” Because this provision already addresses the commentor's request, no additional revision to the final amendment is necessary.

d. Products Imported into the United States: Section 3(a)(4) of the CPSA, 15 U.S.C. 2051(a)(4) classifies importers as “manufacturers” under the act, while section 15(b) itself imposes reporting obligations on manufacturers, distributors, and retailers of consumer products. The Commission notes that foreign manufacturers export many products into the United States directly to importers, distributors, and retailers. In these circumstances, the Commission reminds importers, distributors, and retailers that they also have obligations under section 15 to conduct reasonable and diligent investigations, and to evaluate and report information about possible safety defects based on information they obtain or should reasonably obtain, including information from outside the United States. Retailers and distributors should refer to section 1115.13(b) of the interpretative rule for procedures for reporting.

Effective Date: This revision becomes effective 30 days after the date of publication of the revised final interpretative rule in the Federal Register .

The proposed rules were previously published on August 17, 2001, at 66 FR 43138. No comments were received; therefore, the National Reconnaissance Office is adopting the rules as final.

The Director of Administration and Management, Office of the Secretary of Defense, hereby determines that Privacy Act rules for the Department of Defense are not significant rules. The rules do not (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order.

The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that Privacy Act rules for the Department of Defense do not have significant economic impact on a substantial number of small entities because they are concerned only with the administration of Privacy Act systems of records within the Department of Defense.

The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that Privacy Act rules for the Department of Defense impose no information requirements beyond the Department of Defense and that the information collected within the Department of Defense is necessary and consistent with 5 U.S.C. 552a, known as the Privacy Act of 1974.

The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that the Privacy Act rulemaking for the Department of Defense does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that such rulemaking will not significantly or uniquely affect small governments.

The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that the Privacy Act rules for the Department of Defense do not have federalism implications. The rules do 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.

The proposed rule was published on August 17, 2001, at 66 FR 43141. No comments were received therefore the Navy is adopting the rules as final.

The Director of Administration and Management, Office of the Secretary of Defense, hereby determines that Privacy Act rules for the Department of Defense are not significant rules. The rules do not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in this Executive order.

The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that Privacy Act rules for the Department of Defense do not have significant economic impact on a substantial number of small entities because they are concerned only with the administration of Privacy Act systems of records within the Department of Defense.

The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that Privacy Act rules for the Department of Defense impose no information requirements beyond the Department of Defense and that the information collected within the Department of Defense is necessary and consistent with 5 U.S.C. 552a, known as the Privacy Act of 1974. Section 202, Public Law 104-4, “Unfunded Mandates Reform Act”. The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that the Privacy Act rulemaking for the Department of Defense does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that such rulemaking will not significantly or uniquely affect small governments.

The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that the Privacy Act rules for the Department of Defense do not have federalism implications. The rules do 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.

The proposed rules were published on August 21, 2001, at 66 FR 43820. No comments were received therefore the Department of the Air Force is adopting the rules as final.

The Director of Administration and Management, Office of the Secretary of Defense, hereby determines that Privacy Act rules for the Department of Defense are not significant rules. The rules do not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order.

The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that Privacy Act rules for the Department of Defense do not have significant economic impact on a substantial number of small entities because they are concerned only with the administration of Privacy Act systems of records within the Department of Defense.

The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that Privacy Act rules for the Department of Defense impose no information requirements beyond the Department of Defense and that the information collected within the Department of Defense is necessary and consistent with 5 U.S.C. 552a, known as the Privacy Act of 1974.

The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that the Privacy Act rulemaking for the Department of Defense does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that such rulemaking will not significantly or uniquely affect small governments.

The Director of Administration and Management, Office of the Secretary of Defense, hereby certifies that the Privacy Act rules for the Department of Defense do not have federalism implications. The rules do 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.

The SR 84 Bridge across the South Fork of the New River at Ft. Lauderdale, Broward County, Florida is a single leaf bridge with a vertical clearance of 21.0 feet above mean high water (MHW) measured at the fenders in the closed position with a horizontal clearance of 40 feet. On October 2, 2001, the Florida Department of Transportation, the drawbridge owner, requested a deviation from the current operating regulation in 33 CFR 117.315(b) which requires the draw of the SR 84 Bridge, mile 4.4 at Fort Lauderdale, to open on signal if at least 24 hours notice is given. Public vessels of the Unites States, regularly scheduled cruise vessels, tugs with tows, and vessels in distress shall be passed through the draw as soon as possible. This temporary deviation was requested to allow necessary repairs to the drawbridge in a critical time sensitive manner.

The District Commander has granted a temporary deviation from the operating requirements listed in 33 CFR 117.315(b) to complete repairs to the drawbridge. Under this deviation, the SR 84 Bridge need not open from October 29, 2001 through November 3, 2001, except in the event of an emergency with 24 hours advance notification.

Title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3111-3126) requires that the Secretary of the Interior and the Secretary of Agriculture (Secretaries) implement a joint program to grant a preference for subsistence uses of fish and wildlife resources on public lands in Alaska, unless the State of Alaska enacts and implements laws of general applicability that are consistent with ANILCA and that provide for the subsistence definition, preference, and participation specified in Sections 803, 804, and 805 of ANILCA. In December 1989, the Alaska Supreme Court ruled that the rural preference in the State subsistence statute violated the Alaska Constitution and, therefore, negated State compliance with ANILCA.

The Department of the Interior and the Department of Agriculture (Departments) assumed, on July 1, 1990, responsibility for implementation of Title VIII of ANILCA on public lands. The Departments administer Title VIII through regulations at Title 50, Part 100 and Title 36, Part 242 of the Code of Federal Regulations (CFR). Consistent with Subparts A, B, and C of these regulations, as revised January 8, 1999, (64 FR 1276), the Departments established a Federal Subsistence Board to administer the Federal Subsistence Management Program. The Board's composition includes a Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture; the Alaska Regional Director, U.S. Fish and Wildlife Service; the Alaska Regional Director, National Park Service; the Alaska State Director, Bureau of Land Management; the Alaska Regional Director, Bureau of Indian Affairs; and the Alaska Regional Forester, USDA Forest Service. Through the Board, these agencies participate in the development of regulations for Subparts A, B, and C, which establish the program structure and determine which Alaska residents are eligible to take specific species for subsistence uses, and the annual Subpart D regulations, which establish seasons, harvest limits, and methods and means for subsistence take of species in specific areas. Subpart D regulations for the 2001 fishing seasons, harvest limits, and methods and means were published on February 13, 2001, (66 FR 10142). Because this rule relates to public lands managed by an agency or agencies in both the Departments of Agriculture and the Interior, identical closures and adjustments would apply to 36 CFR part 242 and 50 CFR part 100.

The Alaska Department of Fish and Game (ADF&G), under the direction of the Alaska Board of Fisheries (BOF), manages sport, commercial, personal use, and State subsistence harvest on all lands and waters throughout Alaska. However, on Federal lands and waters, the Federal Subsistence Board implements a subsistence priority for rural residents as provided by Title VIII of ANILCA. In providing this priority, the Board may, when necessary, preempt State harvest regulations for fish or wildlife on Federal lands and waters.

These emergency closures (restricted subsistence fishing schedules) and adjustments were necessary because of predictions of extremely weak returns of chinook and chum salmon in the Kuskokwim River drainage. These emergency actions are authorized and in accordance with 50 CFR 100.19(d) and 36 CFR 242.19(d).

The Federal Subsistence Board, ADF&G, and subsistence users were very concerned that not enough chinook and chum salmon would be returning to the Kuskokwim River and its tributaries in 2001 to meet both spawning escapement objectives and subsistence needs. Adequate spawning escapement is necessary to assure sustaining the population. Last year, subsistence salmon harvests in the Kuskokwim River were among the lowest in the past 12 years. Returns of chinook and chum salmon have been extremely poor over the last 3 years. The expected low runs and poor spawning escapements in 2001 could jeopardize the viability of future returns. Federal and State biologists anticipated that the 2001 salmon returns would be critically low, and subsistence needs in some areas may not be met.

The BOF met in January 2001 to review the status of salmon returns on the Kuskokwim River and identified Kuskokwim River chinook and chum salmon as stocks of concern. The BOF then took action to establish a salmon rebuilding plan for the Kuskokwim River. In addition, ADF&G indicated that no commercial fishing periods were being considered for June and July for the Kuskokwim River, that they intended to limit the sport fishery to one salmon per person per day, and that they would close the sport fishery for salmon in the entire Kuskokwim River drainage if the runs were weaker than expected. The ADF&G and U.S. Fish & Wildlife Service personnel conducted public meetings, produced information posters, and published news articles to let the local users know about concerns regarding the expected low salmon returns and advise them regarding the restrictions and closures to protect spawning escapement.

On May 10, 2001, in public forum and after hearing testimony, the Federal Subsistence Board adopted the first emergency action closing the chinook and chum salmon fishery on Federal waters in the Kuskokwim River drainage to all users except Federally-qualified subsistence users. That closure was for 60 days (the maximum amount of time allowed under 50 CFR 100.19(d) and 36 CFR 242.19(d)) from June 1, 2001, to July 30, 2001 (66 FR 32750, June 18, 2001). This is the period of the majority of chinook and chum salmon run passage through the river. The effect of that action was to close the sport take for chinook and chum salmon in the Kuskokwim River drainage within the boundaries of the Yukon Delta National Wildlife Refuge, within or adjacent to Denali National Park and Preserve, and within or adjacent to Lake Clark National Park and Preserve and to close subsistence harvest on those same waters by any residents living outside the Kuskokwim Fishery Management Area. Additionally, any chinook or summer chum salmon taken incidentally in another fishery must be released immediately. In other words, if you catch a chinook or chum salmon in Federal waters while fishing for sheefish or pike, you must immediately release it. Although commercial fisheries were closed and ADF&G indicated that an opening in June or July was highly unlikely, this action would prevent any such opening from occurring on Federal waters. Should the runs have come in stronger than expected with spawning escapements and subsistence needs being met, the delegated field manager, as authorized by the Federal Subsistence Board, could have removed this restriction.

On June 1, 2001, the Federal Subsistence Board, acting through the delegated field official and in concert with ADF&G managers and the Kuskokwim River Salmon Management Working Group (KRSMWG), initiated a second closure on Federal waters for the period from June 3, 2001, through June 5, 2001, in the Kuskokwim Area District 1 for the subsistence gillnet and fishwheel fisheries (66 FR 33642, June 25, 2001). This reduced the subsistence salmon fishing schedule to four days that week. In Kuskokwim Area District 1, fishing for whitefish, suckers and other non-salmon species during closed salmon fishing periods continued to be allowed seven days per week with gillnets of 4 inches or less stretch mesh that are 60 feet or less in length. Salmon caught incidentally in those nets could be kept for subsistence uses.

On June 8, 2001, the Federal Subsistence Board, acting through the delegated field official and in concert with ADF&G managers and the KRSMWG initiated a third closure on Federal waters for the period from June 10, 2001, through June 12, 2001, in the Kuskokwim Area Districts 1 and 2 for the subsistence gillnet and fishwheel fisheries (66 FR 33642, June 25, 2001). In Kuskokwim Area District 1 and 2, fishing for whitefish, suckers and other non-salmon species during closed salmon fishing periods continued to be allowed seven days per week with gillnets of 4 inches or less stretch mesh that are 60 feet or less in length. Salmon caught incidentally in those nets could be kept for subsistence uses.

On June 14, 2001, the Federal Subsistence Board, acting through the delegated field official and in concert with ADF&G managers and the KRSMWG initiated a fourth closure on Federal waters for the period from June 17, 2001, through June 19, 2001, in the Kuskokwim Aera Districts 1and 2 for the subsistence gillnet and fishwheel fisheries. In Kuskokwim Area District 1 and 2, fishing for whitefish, suckers and other non-salmon species during closed salmon fishing periods continued to be allowed seven days per week with gillnets of 4 inches or less stretch mesh that are 60 feet or less in length. Salmon caught incidentally in those nets could be kept for subsistence uses.

On June 22, 2001, the Federal Subsistence Board, acting through the delegated field official and in concert with ADF&G managers and the KRSMWG initiated a fifth closure on Federal waters for the period from June 24, 2001, through June 26, 2001, in the Kuskokwim Area Districts 1and 2 for the subsistence gillnet and fishwheel fisheries. This action was necessary due to continued low returns. In Kuskokwim Area District 1 and 2, fishing for whitefish, suckers and other non-salmon species during closed salmon fishing periods continued to be allowed seven days per week with gillnets of 4 inches or less stretch mesh that are 60 feet or less in length. Salmon caught incidentally in those nets could be kept for subsistence uses.

On June 28, 2001, the Federal Subsistence Board, acting through the delegated field official and in concert with ADF&G managers and the KRSMWG initiated a sixth closure (Sunday through Tuesday of each week) on Federal waters for the period from July 1, 2001, through July 10, 2001, in the Kuskokwim Area Districts 1 and 2 for the subsistence gillnet and fishwheel fisheries. This action was necessary due to continued low returns. In Kuskokwim Area District 1 and 2, fishing for whitefish, suckers and other non-salmon species during closed salmon fishing periods continued to be allowed seven days per week with gillnets of 4 inches or less stretch mesh that are 60 feet or less in length. Salmon caught incidentally in those nets could be kept for subsistence uses.

On July 10, 2001, the Federal Subsistence Board, acting through the delegated field official and in concert with ADF&G managers and the KRSMWG initiated a seventh closure (Friday through Tuesday of each week) on Federal waters for the period from July 11, 2001, through July 10, 2001, in the Kuskokwim Area Districts 1and 2 for the subsistence gillnet and fishwheel fisheries. This action was necessary due to continued low returns. In Kuskokwim Area District 1 and 2, fishing for whitefish, suckers and other non-salmon species during closed salmon fishing periods continued to be allowed seven days per week with gillnets of 4 inches or less stretch mesh that are 60 feet or less in length. Salmon caught incidentally in those nets could be kept for subsistence uses.

On July 25, 2001, the Federal Subsistence Board, acting through the delegated field official and in concert with ADF&G managers and the KRSMWG initiated an eighth action (establishing four days of each week) on Federal waters for the period from July 27, 2001, through July 31, 2001, in the Kuskokwim Area Districts 1and 2 for the subsistence gillnet and fishwheel fisheries. In Kuskokwim Area District 1 and 2, fishing for whitefish, suckers and other non-salmon species during closed salmon fishing periods continued to be allowed seven days per week with gillnets of 4 inches or less stretch mesh that are 60 feet or less in length. Salmon caught incidentally in those nets could be kept for subsistence uses.

These regulatory actions were necessary to assure the continued viability of the chinook and chum salmon runs and provide a long-term subsistence priority during a period of limited harvest opportunity. These closures and adjustments brought the Federal subsistence fishing regulations in line with the similar ADF&G action for unified management and minimized confusion under the dual management system.

The Board finds that additional public notice and comment requirements under the Administrative Procedure Act (APA) for these emergency closures are impracticable, unnecessary, and contrary to the public interest. Lack of appropriate and immediate conservation measures could seriously affect the continued viability of fish populations, adversely impact future subsistence opportunities for rural Alaskans, and would generally fail to serve the overall public interest. Therefore, the Board finds good cause pursuant to 5 U.S.C. 553(b)(3)(B) to waive additional public notice and comment procedures prior to implementation of these actions and pursuant to 5 U.S.C. 553(d) to make this rule effective as indicated in the DATES section.

A Final Environmental Impact Statement (FEIS) was published on February 28, 1992, and a Record of Decision on Subsistence Management for Federal Public Lands in Alaska (ROD) signed April 6, 1992. The final rule for Subsistence Management Regulations for Public Lands in Alaska, Subparts A, B, and C (57 FR 22940-22964, published May 29, 1992) implemented the Federal Subsistence Management Program and included a framework for an annual cycle for subsistence hunting and fishing regulations. A final rule that redefined the jurisdiction of the Federal Subsistence Management Program to include waters subject to the subsistence priority was published on January 8, 1999, (64 FR 1276.)

The intent of all Federal subsistence regulations is to accord subsistence uses of fish and wildlife on public lands a priority over the taking of fish and wildlife on such lands for other purposes, unless restriction is necessary to conserve healthy fish and wildlife populations. A Section 810 analysis was completed as part of the FEIS process. The final Section 810 analysis determination appeared in the April 6, 1992, ROD which concluded that the Federal Subsistence Management Program, under Alternative IV with an annual process for setting hunting and fishing regulations, may have some local impacts on subsistence uses, but the program is not likely to significantly restrict subsistence uses.

The adjustment and emergency closures do not contain information collection requirements subject to Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1995.

The adjustment and emergency closures have been exempted from OMB review under Executive Order 12866.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires preparation of flexibility analyses for rules that will have a significant effect on a substantial number of small entities, which include small businesses, organizations, or governmental jurisdictions. The exact number of businesses and the amount of trade that will result from this Federal land-related activity is unknown. The aggregate effect is an insignificant economic effect (both positive and negative) on a small number of small entities supporting subsistence activities, such as guides and boat, fishing tackle, and gasoline dealers. The number of small entities affected is unknown; but, the effects will be seasonally and geographically-limited in nature and will likely not be significant. The Departments certify that the adjustment and emergency closures will not have a significant economic effect on a substantial number of small entities within the meaning of the Regulatory Flexibility Act.

Title VIII of ANILCA requires the Secretaries to administer a subsistence preference on public lands. The scope of this program is limited by definition to certain public lands. Likewise, the adjustment and emergency closures have no potential takings of private property implications as defined by Executive Order 12630.

The Service has determined and certifies pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that the adjustment and emergency closures will not impose a cost of $100 million or more in any given year on local or State governments or private entities. The implementation is by Federal agencies, and no cost is involved to any State or local entities or Tribal governments.

The Service has determined that the adjustment and emergency closures meet the applicable standards provided in Sections 3(a) and 3(b)(2) of Executive Order 12988, regarding civil justice reform.

In accordance with Executive Order 13132, the adjustment and emergency closures do not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. Title VIII of ANILCA precludes the State from exercising management authority over fish and wildlife resources on Federal lands. Cooperative salmon run assessment efforts with ADF&G will continue.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and 512 DM 2, we have evaluated possible effects on Federally recognized Indian tribes and have determined that there are no effects. The Bureau of Indian Affairs is a participating agency in this rulemaking.

On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, or use. This Executive Order requires agencies to prepare Statements of Energy Effects when undertaking certain actions. As these actions are not expected to significantly affect energy supply, distribution, or use, they are not significant energy actions and no Statement of Energy Effects is required.

William Knauer drafted this document under the guidance of Thomas H. Boyd, of the Office of Subsistence Management, Alaska Regional Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Taylor Brelsford, Alaska State Office, Bureau of Land Management; Rod Simmons, Alaska Regional Office, U.S. Fish and Wildlife Service; Bob Gerhard, Alaska Regional Office, National Park Service; Ida Hildebrand, Alaska Regional Office, Bureau of Indian Affairs; and Ken Thompson, USDA-Forest Service, provided additional guidance.

Title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3111-3126) requires that the Secretary of the Interior and the Secretary of Agriculture (Secretaries) implement a joint program to grant a preference for subsistence uses of fish and wildlife resources on public lands in Alaska, unless the State of Alaska enacts and implements laws of general applicability that are consistent with ANILCA and that provide for the subsistence definition, preference, and participation specified in Sections 803, 804, and 805 of ANILCA. In December 1989, the Alaska Supreme Court ruled that the rural preference in the State subsistence statute violated the Alaska Constitution and, therefore, negated State compliance with ANILCA.

The Department of the Interior and the Department of Agriculture (Departments) assumed, on July 1, 1990, responsibility for implementation of Title VIII of ANILCA on public lands. The Departments administer Title VIII through regulations at Title 50, part 100 and Title 36, part 242 of the Code of Federal Regulations (CFR). Consistent with Subparts A, B, and C of these regulations, as revised January 8, 1999, (64 FR 1276), the Departments established a Federal Subsistence Board to administer the Federal Subsistence Management Program. The Board's composition includes a Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture; the Alaska Regional Director, U.S. Fish and Wildlife Service; the Alaska Regional Director, National Park Service; the Alaska State Director, Bureau of Land Management; the Alaska Regional Director, Bureau of Indian Affairs; and the Alaska Regional Forester, USDA Forest Service. Through the Board, these agencies participate in the development of regulations for Subparts A, B, and C, which establish the program structure and determine which Alaska residents are eligible to take specific species for subsistence uses, and the annual Subpart D regulations, which establish seasons, harvest limits, and methods and means for subsistence take of species in specific areas. Subpart D regulations for the 2001 fishing seasons, harvest limits, and methods and means were published on February 13, 2001, (66 FR 10142). Because this rule relates to public lands managed by an agency or agencies in both the Departments of Agriculture and the Interior, identical closures and adjustments would apply to 36 CFR part 242 and 50 CFR part 100.

The Alaska Department of Fish and Game (ADF&G), under the direction of the Alaska Board of Fisheries (BOF), manages sport, commercial, personal use, and State subsistence harvest on all lands and waters throughout Alaska. However, on Federal lands and waters, the Federal Subsistence Board implements a subsistence priority for rural residents as provided by Title VIII of ANILCA. In providing this priority, the Board may, when necessary, preempt State harvest regulations for fish or wildlife on Federal lands and waters.

These emergency closures were necessary because of predictions of extremely weak returns of sockeye salmon in the Redoubt and Salmon Lakes drainages. These emergency actions are authorized and in accordance with 50 CFR 100.19(d) and 36 CFR 242.19(d).

Since the projected escapement was well below desirable levels for Redoubt Lake, the system was closed to provide for spawning escapement needs. The total return to July 11, 2001, was 1,089 sockeye. Usually 16% of the run returned to the lake by that time. The projected escapement is 7,571 fish for the 2001 season. This projection represents 21% of the average escapement of 36,000 sockeye during the period 1989-1999

Salmon Lake was closed since returns were low, and to avoid excessive harvest effort for this relatively small sockeye population. Closure of the nearby Redoubt Lake system could displace harvest effort in the Sitka Sound area to Salmon Lake. The total escapement to July 11, 2001, was 320 at Salmon Lake. Past subsistence harvest for Salmon Lake has ranged from zero to 353 sockeye salmon since monitoring began in 1985.

On July 11, 2001, the Federal Subsistence Board, acting through the delegated field official and in concert with ADF&G managers initiated a sockeye salmon closure in the Redoubt and Salmon Lakes drainages for the period from July 13, 2001, through August 31, 2001. This action was necessary due to low sockeye returns.

This regulatory action was necessary to assure the continued viability of the sockeye salmon runs and provide a long-term subsistence priority during a period of limited harvest opportunity. This closure brought the Federal subsistence fishing regulations in line with the similar ADF&G action for unified management and minimized confusion under the dual management system.

The Board finds that additional public notice and comment requirements under the Administrative Procedure Act (APA) for this emergency closure is impracticable, unnecessary, and contrary to the public interest. Lack of appropriate and immediate conservation measures could seriously affect the continued viability of fish populations, adversely impact future subsistence opportunities for rural Alaskans, and would generally fail to serve the overall public interest. Therefore, the Board finds good cause pursuant to 5 U.S.C. 553(b)(3)(B) to waive additional public notice and comment procedures prior to implementation of this action and pursuant to 5 U.S.C. 553(d) to make this effective as indicated in the DATES section.

A Final Environmental Impact Statement (FEIS) was published on February 28, 1992, and a Record of Decision on Subsistence Management for Federal Public Lands in Alaska (ROD) signed April 6, 1992. The final rule for Subsistence Management Regulations for Public Lands in Alaska, Subparts A, B, and C (57 FR 22940-22964, published May 29, 1992) implemented the Federal Subsistence Management Program and included a framework for an annual cycle for subsistence hunting and fishing regulations. A final rule that redefined the jurisdiction of the Federal Subsistence Management Program to include waters subject to the subsistence priority was published on January 8, 1999, (64 FR 1276).

The intent of all Federal subsistence regulations is to accord subsistence uses of fish and wildlife on public lands a priority over the taking of fish and wildlife on such lands for other purposes, unless restriction is necessary to conserve healthy fish and wildlife populations. A Section 810 analysis was completed as part of the FEIS process. The final Section 810 analysis determination appeared in the April 6, 1992, ROD which concluded that the Federal Subsistence Management Program, under Alternative IV with an annual process for setting hunting and fishing regulations, may have some local impacts on subsistence uses, but the program is not likely to significantly restrict subsistence uses.

The emergency closure does not contain information collection requirements subject to Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1995.

The emergency closure has been exempted from OMB review under Executive Order 12866.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires preparation of flexibility analyses for rules that will have a significant effect on a substantial number of small entities, which include small businesses, organizations, or governmental jurisdictions. The exact number of businesses and the amount of trade that will result from this Federal land-related activity is unknown. The aggregate effect is an insignificant economic effect (both positive and negative) on a small number of small entities supporting subsistence activities, such as boat, fishing tackle, and gasoline dealers. The number of small entities affected is unknown; but, the effects will be seasonally and geographically-limited in nature and will likely not be significant. The Departments certify that the emergency closure will not have a significant economic effect on a substantial number of small entities within the meaning of the Regulatory Flexibility Act.

Title VIII of ANILCA requires the Secretaries to administer a subsistence preference on public lands. The scope of this program is limited by definition to certain public lands. Likewise, the emergency closure has no potential takings of private property implications as defined by Executive Order 12630.

The Service has determined and certifies pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq. , that the emergency closure will not impose a cost of $100 million or more in any given year on local or State governments or private entities. The implementation is by Federal agencies, and no cost is involved to any State or local entities or Tribal governments.

The Service has determined that the emergency closure meets the applicable standards provided in Sections 3(a) and 3(b)(2) of Executive Order 12988, regarding civil justice reform.

In accordance with Executive Order 13132, the emergency closure does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. Title VIII of ANILCA precludes the State from exercising management authority over fish and wildlife resources on Federal lands. Cooperative salmon run assessment efforts with ADF&G will continue.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and 512 DM 2, we have evaluated possible effects on Federally recognized Indian tribes and have determined that there are no effects. The Bureau of Indian Affairs is a participating agency in this rulemaking.

On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, or use. This Executive Order requires agencies to prepare Statements of Energy Effects when undertaking certain actions. As this action is not expected to significantly affect energy supply, distribution, or use, it is not a significant energy action and no Statement of Energy Effects is required.

William Knauer drafted this document under the guidance of Thomas H. Boyd, of the Office of Subsistence Management, Alaska Regional Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Taylor Brelsford, Alaska State Office, Bureau of Land Management; Rod Simmons, Alaska Regional Office, U.S. Fish and Wildlife Service; Bob Gerhard, Alaska Regional Office, National Park Service; Ida Hildebrand, Alaska Regional Office, Bureau of Indian Affairs; and Ken Thompson, USDA-Forest Service, provided additional guidance.

On September 20, 1995, April 16, 1996, May 2, 1996, July 2, 1997, July 24, 1998, December 7, 1998, April 9, 1999, and April 20, 1999, PADEP submitted revisions to the Pennsylvania SIP which establish and impose RACT for several sources of VOC and/or NO X . This rulemaking pertains to eighteen of those sources. The remaining sources are or have been the subject of separate rulemakings. The Commonwealth's submittals consist of plan approvals and operating permits which impose VOC and/or NO X RACT requirements for each source. These sources are all located in the Philadelphia area and include: Amerada Hess Corp.; Amoco Oil Company; Cartex Corporation; Exxon Company, USA; GATX Terminals Corporation; Hatfield Quality Meats, Incorporated; J. L. Clark, Incorporated; Johnson Matthey, Incorporated; Kurz Hastings, Incorporated; Lawrence McFadden Company; Philadelphia Baking Company; Philadelphia Gas Works; PPG Industries, Incorporated; SmithKline Beecham Pharmaceuticals; Teva Pharmaceuticals, USA; The Philadelphian Condominium Building; Warner Company; and Webcraft Technologies, Incorporated.

On August 20, 2001, EPA published a direct final rule (66 FR 43502) and a companion notice of proposed rulemaking (66 FR 43551) to approve these SIP revisions. On September 7, 2001, we received adverse comments on our direct final rule from the Citizens for Pennsylvania's Future (PennFuture). On September 26, 2001, (66 FR 49107), we published a timely withdrawal in the Federal Register informing the public that the direct final rule did not take effect. We indicated in our August 20, 2001 direct final rulemaking that if we received adverse comments, EPA would address all public comments in a subsequent final rule based on the proposed rule (66 FR 43551). This is that subsequent final rule. A description of the RACT determination(s) made for each source was provided in the August 20, 2001 direct final rule and will not be restated here. A summary of the comments submitted by PennFuture germane to this final rulemaking and EPA's responses are provided in Section II of this document.

The Citizens for Pennsylvania's Future (PennFuture) submitted adverse comments on the proposed rule published by EPA in the Federal Register on August 20, 2001 to approve case-by-case RACT SIP submissions from the Commonwealth for NO X and or VOC sources located in the Philadelphia area. A summary of those comments and EPA's responses are provided below.

A. Comment: PennFuture comments that EPA has conducted no independent technical review, and has prepared no technical support document to survey potential control technologies, determine the capital and operating costs of different options, and rank these options in total and marginal cost per ton of NO X and VOC controlled. In citing the definition of the term “RACT,” and the Strelow Memorandum [Roger Strelow, Assistant Administrator for Air and Waste Management, EPA, December 9, 1976, cited in Michigan v. Thomas, 805 F.2d 176, 180 (6th Cir. 1986) and at 62 FR 43134, 43136 (1997)], PennFuture appears to comment that in every situation, RACT must include an emission rate. PennFuture asserts that EPA should conduct its own RACT evaluation for each source, or at a minimum document a step-by-step review demonstrating the adequacy of state evaluations, to ensure that appropriate control technology is applied. The commenter also believes that EPA's failure to conduct its own independent review of control technologies has resulted in our proposing to approve some RACT determinations that fail to meet the terms of EPA's own RACT standard.

Response: On March 23, 1998 (63 FR 13789), EPA granted conditional limited approval of Pennsylvania's generic RACT regulations, 25 PA Code Chapters 121 and 129, thereby approving the definitions, provisions and procedures contained within those regulations under which the Commonwealth would require and impose RACT. Subsection 129.91, Control of major sources of NO X and VOCs, requires subject facilities to submit a RACT plan proposal to both the Pennsylvania Department of Environmental Protection (DEP) and to EPA Region III by July 15, 1994 in accordance with subsection 129.92, entitled, RACT proposal requirements. Under subsection 129.92, that proposal is to include, among other information: (1) A list of each subject source at the facility; (2) The size or capacity of each affected source, and the types of fuel combusted, and the types and amounts of materials processed or produced at each source; (3) A physical description of each source and its operating characteristics; (4) Estimates of potential and actual emissions from each affected source with supporting documentation; (5) A RACT analysis which meets the requirements of subsection 129.92 (b), including technical and economic support documentation for each affected source; (6) A schedule for implementation as expeditiously as practicable but not later than May 15, 1995; (7) The testing, monitoring, recordkeeping and reporting procedures proposed to demonstrate compliance with RACT; and (8) any additional information requested by the DEP necessary to evaluate the RACT proposal. Under subsection 129.91, the DEP will approve, deny or modify each RACT proposal, and submit each RACT determination to EPA for approval as a SIP revision.

The conditional nature of EPA's March 23, 1998 conditional limited approval did not impose any conditions pertaining to the regulation's procedures for the submittal of RACT plans and analyses by subject sources and approval of case-by-case RACT determinations by the DEP. Rather, EPA stated that “* * * RACT rules may not merely be procedural rules (emphasis added) that require the source and the State to later agree to the appropriate level of control; rather the rules must identify the appropriate level of control for source categories or individual sources.”

On May 3, 2001 (66 FR 22123), EPA published a rulemaking determining that Pennsylvania had satisfied the conditions imposed in its conditional limited approval. In that rulemaking, EPA removed the conditional status of its approval of the Commonwealth's generic VOC and NO X RACT regulations on a statewide basis. EPA received no public comments on its action and that final rule removing the conditional status of Pennsylvania's VOC and NO X RACT regulations became effective on June 18, 2001. As of that time, Pennsylvania's generic VOC and NO X RACT regulations retained a limited approval status. On September 6, 2001 (66 FR 46571), EPA proposed to remove the limited nature of its approval of Pennsylvania's generic RACT regulation in the Philadelphia area. EPA received no comments on that proposal. Final action converting the limited approval to full approval shall occur once EPA has completed rulemaking to approve either (1) the case-by-case RACT proposals for all sources subject to the RACT requirements currently known in the Philadelphia area or (2) for a sufficient number of sources such that the emissions from any remaining subject sources represent a de minimis level of emissions as defined in the March 23, 1998 rulemaking (63 FR 13789).

EPA agrees that it has an obligation to review the case-by-case RACT plan approvals and/or permits submitted as individual SIP revisions by Commonwealth to verify and determine if they are consistent with the RACT requirements of the Act and any relevant EPA guidance. EPA does not agree, however, that this obligation to review the case-by-case RACT determinations submitted by Pennsylvania necessarily extends to our performing our own RACT analyses, independent of the sources' RACT plans/analyses (included as part of the case-by-case RACT SIP revisions) or the Commonwealth's analyses. EPA first reviews this submission to ensure that the source and the Commonwealth followed the SIP-approved generic rule when applying for and imposing RACT for a specific source. Then EPA performs a thorough review of the technical and economic analyses conducted by the source and the state. If EPA believes additional information may further support or would undercut the RACT analyses submitted by the state, then EPA may add additional EPA-generated analyses to the record.

While RACT, as defined for an individual source or source category, often does specify an emission rate, such is not always the case. EPA has issued Control Technique Guidelines (CTGs) which states are to use as guidance in development of their RACT determinations/rules for certain sources or source categories. Not every CTG issued by EPA includes an emission rate. There are several examples of CTGs issued by EPA wherein equipment standards and/or work practice standards alone are provided as RACT guidance for all or part of the processes covered. Such examples include the CTGs issued for Bulk gasoline plants, Gasoline service stations—Stage I, Petroleum Storage in Fixed-roof tanks, Petroleum refinery processes, Solvent metal cleaning, Pharmaceutical products, External Floating roof tanks and Synthetic Organic Chemical Manufacturing (SOCMI)/polymer manufacturing. (The publication numbers for these CTG documents may be found at http://www.epa.gov/ttn/catc/dir1/ctg.txt ).

EPA disagrees with PennFuture's general comment that our failure to conduct our own independent review of control technologies for every case-by-case RACT determination conducted by the Commonwealth has resulted in our proposing to approve some RACT determinations that fail to meet the terms of our own RACT standard. PennFuture submitted comments specific to the case-by-case RACT determinations for two located in the Philadelphia area, namely for Kurz-Hastings and GATX Terminals Corporation. EPA summarizes those comments and provides responses in the final rule pertaining to those sources.

B. Comment: PennFuture comments that when EPA reviewed Pennsylvania's RACT program, it noted that Pennsylvania coal-fired boilers with a rated heat input of equal to or greater than 100 million Btu per hour “are some of the largest NO X emitting sources in the Commonwealth and in the Northeast United States” [63 FR 13789, 13791 (1998)] and as such should have numeric emission limitations imposed as RACT whether or not they install presumptive RACT (under 25 Pa.Code 129.93) to guarantee that sources would achieve quantifiable emissions reductions under the RACT program. PennFuture goes on to comment that because EPA has not conducted and documented a technical review of Pennsylvania case-by-case RACT submissions, EPA has not demonstrated that these large boilers are subject to “numeric emission limitations” under RACT. EPA must conduct a thorough RACT evaluation or review for each such source, and must document the application of numeric emission limits and quantifiable reductions for each coal-fired boiler with a rated heat input of over 100 million Btu per hour.

Response: Circumstances may exist wherein a state could justify otherwise, however, in general, EPA agrees with PennFuture that coal-fired boilers with a rated heat input of equal to or greater than 100 million Btu per hour should have numeric emission limitations imposed as RACT whether or not they install presumptive RACT (under 25 Pa.Code 129.93).

As provided in the response found in II. A, EPA does not agree that it must conduct its own technical analysis of each of the case-by-case RACT determinations submitted for each RACT source in order to document that its RACT requirements include numeric emission limitations. That determination can be made by EPA when it reviews the plan approval, consent order, or permit issued to such a source as submitted by the Commonwealth as SIP revision. PennFuture's comment did not point to a specific instance where a RACT plan approval, consent order or permit imposing RACT on a coal-fired boiler with a rated heat input of equal to or greater than 100 million Btu per hour did, in fact, lack a numerical emission limitation(s). Nonetheless, pursuant to PennFuture's comment, EPA has re-examined all of the case-by-case RACT SIP submissions made by the Commonwealth for such sources located in the Philadelphia area. That re- examination, combined with information provided by the Commonwealth, indicates that each case-by-case RACT plan approval, consent order and/or permit for each coal-fired boiler with a rated heat input of equal to or greater than 100 million Btu per hour includes a numeric emission limitation. A listing of each source, its plan approval, consent order and/or permit number and its numerical emission limitation has been placed in the Administrative Records for the case-by-case RACT rulemakings for the Philadelphia area.

C. Comment: PennFuture asserts that the Commonwealth has not adopted and submitted category RACT rules for all VOC source categories for which federal control technique guidelines (CTGs) have been issued. The commenter refers to Appendix 1 of the Technical Support Document (dated May 14, 2001), prepared by EPA in support of its proposed rule to redesignate the Pittsburgh-Beaver Valley Ozone Nonattainment Area (66 FR 29270), to assert that EPA has failed to require the Commonwealth to submit VOC RACT rules for certain categories of sources. PennFuture specifically names source categories such as equipment leaks from natural gas/gas processing plants, coke oven batteries, iron and steel foundries, and publically owned treatment works and asserts that the Commonwealth has neglected a statutory requirement to adopt category RACT regulations for these and 14 other unnamed VOC source categories.

Response: EPA has not issued CTGs for coke oven batteries, iron and steel foundries and publically owned treatment works. The Appendix 1, referred to by the commenter, lists CTG covered categories as well as source categories taken from two STAPPA/ALAPCO documents entitled, “Meeting the 15-Percent Rate-of-Progress Requirement Under the Clean Air Act—A Menu of Options” (September 1993) and “Controlling Nitrogen Oxides Under the Clean Air Act—A Menu of Options” (July 1994). The categories referenced by PennFuture are not VOC categories for which EPA has issued CTGs, but were included in Appendix A as examples of some of the types of sources that could be subject to Pennsylvania's generic RACT regulations. The Commonwealth is under no statutory obligation to adopt RACT rules for source categories for which EPA has not issued a CTG. In fact, CTGs do not exist for all but one of the categories to which the commenter explicitly refers.

The Act requires that states adopt regulations to impose RACT for “major sources of VOC,” located within those areas of a state where RACT applies under Part D of the Act [182(b)(2)(C)]. This is referred to as the non-CTG VOC RACT requirement. Moreover, EPA disagrees that there is a statutory mandate that a state adopt a source category RACT regulation even for a source category where EPA has issued a CTG. There are two statutory provisions that address RACT for sources covered by a CTG. One provides that states must adopt RACT for “any category of VOC sources” covered by a CTG issued prior to November 15, 1990 [182(b)(2)(A)]. The other provides that states must adopt VOC RACT for all “VOC sources” covered by a CTG issued after November 15, 1990 [182(b)(2)(B)]. EPA has long interpreted the statutory RACT requirement to be met either by adoption of category-specific rules or by source-specific rules for each source within a category. When initially established, RACT was clearly defined as a case-by-case determination, but EPA provided CTG's to simplify the process for states such that they would not be required to adopt hundreds or thousands of individual rules. See Strelow Memorandum dated December 9, 1976 and 44 FR 53761, September 17, 1979. EPA does not believe that Congress' use of “source category” in one provision of section 182(b)(2) was intended to preclude the adoption of source-specific rules.

Thus, where CTG-subject sources are located within those areas of a state where RACT applies under Part D of the Act, the state is obligated to impose RACT for the same universe of sources covered by the CTG. However, that obligation is not required to be met by the adoption and submittal of a source category RACT rule. A state may, instead, opt to impose RACT for such sources in permits, plan approvals, consent orders or in any other state enforceable document and submit those documents to EPA for approval as source-specific SIP revisions. This option has been exercised by many states, and happens most commonly when only a few CTG-subject sources are located in the state. The source-specific approach is generally employed to avoid what can be a lengthy and resource-intensive state rule adoption process for only a few sources that may have different needs and considerations that must be taken into account.

As stated earlier, there is one source category explicitly included in PennFuture's comment for which EPA has issued a CTG, namely natural gas/gas processing plants. The Commonwealth made a negative declaration to EPA on April 13, 1993, stating that as of that date there were no applicable sources in this category. Therefore, the Commonwealth did not adopt a category RACT regulation for natural gas/gas processing plants.

D. Comment: PennFuture cites EPA correspondence [letter from Marcia Spink, EPA, to James Salvaggio, DEP, December 15, 1993] to the Commonwealth which states that establishing any dollar figure in RACT guidance will not provide for the “automatic” selection or rejection of a control technology or emission limitation as RACT for a source or source category. With regard to the Pennsylvania DEP's intent to finalize a NO X RACT Guidance Document for implementation of its NO X RACT regulation, EPA's 1993 letter stated that the document could improperly be used to establish “bright line” or “cook-book” approaches, particularly for a regulation applicable to many source categories and suggested that if the guidance document must include dollar figures/ton, it provide approximate ranges by source category. PennFuture comments that DEP issued its “Guidance Document on Reasonably Available Control Technology for Sources of NO X Emissions,” March 11, 1994, and on pp. 8-9 states that the acceptable threshold is $1500 per ton, and that this figure applies to “all source categories.” PennFuture notes that EPA later objected to the $1500 per ton methodology as “not generically acceptable to EPA” [letter from Thomas Maslany, EPA, to James Salvaggio, DEP, June 24, 1997] and further stated in a Federal Register notice that a “dollar per ton threshold” is “inconsistent with the definition of RACT” [62 FR 43134, 37-38 (1997)].

PennFuture comments that EPA is proposing to approve RACT determinations based on a cost per ton method that EPA had previously rejected, and according to its own clearly expressed standard, EPA must not approve RACT determinations by Pennsylvania DEP that apply this $1500 per ton threshold. PennFuture asserts EPA must reject all Pennsylvania RACT determinations applying the standard of $1500 per ton, or any other “bright line” approach, as failing to follow EPA procedures established for Pennsylvania RACT.

Response: EPA still takes the position that a single cost per ton dollar figure may not, in and of itself, form the basis for rejecting a control technology, equipment standard, or work practice standard as RACT. The Technical Support Document prepared by EPA in support of its March 23, 1998 rulemaking [63 FR 13789] clearly indicates that the Commonwealth's document, “Guidance Document on Reasonably Available Control Technology for Sources of NO X Emissions.” March 11, 1994, had not been included as part of the SIP submission of the Commonwealth's generic regulation and, therefore, had not been approved by EPA. EPA further notes that the Administrative Record of the March 23, 1998 rulemaking [63 FR 13789], in addition to the correspondence cited by PennFuture, also includes correspondence from DEP to EPA [letter from James Salvaggio, DEP to David Arnold, EPA, September 10, 1997] stating that DEP's RACT guidance document does not establish a maximum dollar per ton for determining the cost effectiveness for RACT determinations and notes that the DEP's $1500 per ton cost effectiveness is a target value and not an absolute maximum. For example, in its analyses of the cost effectiveness of RACT control options submitted by DEP as part of the case-by-case SIP revision for Peoples Natural Gas (PNG) Valley Compressor Station's turbo charged lean burn IC engine (see the Administrative Record for 66 FR 43492), the Commonwealth included DEP interoffice memoranda (Thomas Joseph to Krishnan Ramamurthy, July 14, 1994 and Krishnan Ramamurthy to Thomas McGinley, Babu Patel, Ronald Davis, Richard Maxwell, and Devendra Verma, July 15, 1994) which spoke directly to the $1500/ton dollar figure as being a guideline and not an upper limit. These memoranda explain that although PNG initially proposed intermediate original equipment manufacturer (OEM) combustion controls which would have reduced NO X emissions from 254.7 tons per year to 115 tons per year (by 55 %) at a cost of $1355 per ton reduced, DEP required the installation of an OEM lean combustion modification that reduced NO X emissions from 254.7 tons per year to 76 tons per year (by 69%) at a cost of $1684 per ton reduced. The DEP's July 15, 1994 interoffice memorandum says of the PNG RACT determination which exceeded the cost effectiveness screening level of $1500 per ton “Tom's (Joseph) insistence for the next more stringent level of control than the company's chosen level in the case of PNG was consistent with EPA Region III's sentiment that establishing any dollar figure in RACT guidance will not provide for an “automatic” rejection of a control technology as RACT for a source.”

In no instance, has EPA proposed to approve a RACT determination submitted by the Commonwealth which was based solely on a conclusion that controls that cost more than $1500/ton were not required as RACT. As explained in the response provided in section II. A. of this document, EPA conducts its review of the entire case-by-case RACT SIP submittal including the source's proposed RACT plan and analyses, Pennsylvania's analyses and the RACT plan approval, consent order or permit itself to insure that the requirements of the SIP-approved generic RACT have been followed. These analyses not only evaluate and consider the costs of potential control options, but also evaluate their technological feasibility.

E. Comment: PennFuture comments that any emission reduction credits (ERCs) earned by sources subject to RACT must be surplus to all applicable state and federal requirements. Under Pennsylvania law, ERCs must be surplus, permanent, quantified, and Federally enforceable. 25 Pa.Code 127.207(1). As to the requirement that ERCs be surplus, the Pennsylvania Code states: ERCs shall be included in the current emission inventory, and may not be required by or be used to meet past or current SIP, attainment demonstration, RFP, emission limitation or compliance plans. Emission reductions necessary to meet NSPS, LAER, RACT, Best Available Technology, BACT and permit or plan approval emissions limitations or another emissions limitation required by the Clean Air Act or the [Air Pollution Control Act] may not be used to generate ERCs. 25 Pa.Code 127.207(1)(i). To be creditable, ERCs must surpass not only RACT requirements but a host of other possible sources of emission limits. PennFuture comments that some of the RACT evaluations at issue in the current EPA notices purport to establish RACT as a baseline for future ERCs. PennFuture does acknowledge that EPA notes in its boilerplate for the notices, that Pennsylvania and EPA have established a series of NO X -reducing rules, including the recent Chapter 145 rule, to reduce NO X at large utility and industrial sources. See, for example, 66 FR 42415, 16-17 (August 13, 2001). Because any ERCs must be surplus to the most stringent limitation applicable under state or federal law as described in the Pennsylvania Code provision set forth above, DEP and EPA must not approve ERCs unless they surpass all such limitations in addition to any limits set by RACT.

Response: EPA agrees with this comment by PennFuture. The approval of a case-by-case RACT determination, in and of itself, does not establish the baseline from which further emission reductions may be calculated and assumed creditable under the Commonwealth's SIP-approved NSR and ERC program. Moreover, EPA's review of the Pennsylvania DEP's implementation of its approved SIP-approved NSR and ERC program indicates that the Commonwealth calculates and credits ERCs in accordance with the SIP-approved criteria for doing so as outlined in PennFuture's comment. No source for which EPA is approving a case-by-case RACT determination should assume that its RACT approval alone automatically establishes the baseline against which it may calculate creditable ERCs.

F. Comment: PennFuture comments that as in the case with Pennsylvania Power—Newcastle, EPA should compare RACT proposals to applicable acid rain program emission limits and control strategies. PennFuture contends that EPA previously disapproved a RACT proposal for the Pennsylvania Power—Newcastle plant [62 FR 43959 (1997); 63 FR 23668 (1998)] and that EPA did so on the basis that the acid rain program requires more stringent emission limits. PennFuture asserts that while EPA had originally proposed to approve this proposal, an analysis of comparable boilers and, especially, a comparison to Phase II emission limits under the acid rain program led EPA to conclude that the RACT proposal emission limits were too lenient. [62 FR at 43961]. Therefore, PennFuture contends that for sources subject to the acid rain program, EPA should consider emissions and control strategies for compliance with acid rain emission limits when evaluating proposals for compliance with RACT.

Response: Title IV of the Act, addressing the acid rain program, contains NO X emission requirements for utilities which must be met in addition to any RACT requirements (see NO X Supplement to the General Preamble at 57 FR 55625, November 25, 1992). The Act provides for a number of control programs that may affect similar sources. For example, new sources may be subject to new source performance standards (NSPS), best available control technology (BACT), and lowest achievable emission rate (LAER). Other controls, under such programs as the acid rain program or the hazardous air pollutant program may also apply to sources. However, the applicability of these other requirements, which are often more stringent than RACT, do not establish what requirements must apply under the RACT program. While these programs may provide information as to the technical and economic feasibility of reduction programs for RACT, there is no presumption that acid rain controls should be mandated as RACT.

EPA stated in the final disapproval of the NO X RACT determination for PPNC [63 FR at 23669], that the discussion concerning average emission rates for boilers with respect to the acid rain program requirements were included in order to provide a context for EPA's proposed disapproval. EPA made clear in its August 18, 1997 proposed disapproval of Pennsylvania Powers'—Newcastle (PPNC) RACT determination, that the basis for disapproval was a comparison between PPNC's boilers and other similar combustion units, not acid rain limits. In fact, EPA stated in the August 18, 1997 proposed disapproval that “Without additional knowledge or information, it would be erroneous and premature to conclude that the limits in the acid rain permit are RACT.” [62 FR at 43961]. EPA clearly stated in the final disapproval for PPNC that it did not use acid rain permit limits, or Pennsylvania's participation in any other NO X control program, to determine PPNC RACT approvability [63 FR at 23670]. Nor has EPA intended to use participation in NO X control programs including acid rain, in determining RACT for PPNC or any other subject sources. EPA also stated that the April 30, 1998, PPNC disapproval was based on the absence of pertinent information regarding a computerized combustion optimization system through an enforceable permit, not comparison of acid rain permit limits.

G. Comment: PennFuture submitted comments specific to the case-by-case RACT determinations for two sources located in the Philadelphia area, namely for Kurz-Hastings, and GATX Terminals Corporation.

(1) Kurz-Hastings—PennFuture comments that the Kurz-Hastings plant is the second-highest VOC emitter in Philadelphia with the potential to emit 3400 tons per year of VOCs. PennFuture's comment recognizes that Kurz-Hastings' VOC-emitting processes (several printing machines) are subject to SIP-approved category RACT regulations and do not require a case-by-case RACT evaluation. PennFuture asserts, however, that Kurz-Hastings' own data show that annual emissions from these units are still one-third or more of its potential to emit, suggesting that VOC controls on these units are only modestly effective. PennFuture also comments that the case-by-case RACT evaluation of Kurz-Hastings' mixing room operations, rejects control technologies that are up to 99% effective in favor of minimal work-practice efforts. Therefore, PennFuture comments that the RACT determination for Kurz-Hastings merits close review by EPA to determine whether RACT requires a more effective control strategy for VOCs, and as at other plants, EPA must not approve this RACT proposal without conducting a thorough evaluation of available control technology.

Response: EPA disagrees with PennFuture's comments. The comment regarding the RACT requirements applicable to the printing machines at Kurz-Hastings are outside the scope of this rulemaking. Those printing machines are subject to a SIP-approved source category VOC RACT regulation adopted by the Commonwealth pursuant to the Graphic Arts CTG. The fact that compliance with that applicable regulation achieves an approximate 66 percent annual reduction in VOCs from Kurz-Hastings' printing machines does not require that a different or more stringent RACT be explored and imposed on this facility. With regard to fugitive emissions from the mixing room and clean-up operations, the work practice standards imposed on Kurz-Hastings for its mixing room and clean-up operations are consistent with RACT determinations routinely made and approved for such fugitive emission sources at graphic arts facilities. EPA's review of the SIP revision submitted for Kurz-Hastings indicates that the applicable SIP-approved definitions, provisions and procedures have been followed in imposing RACT for this facility.

(2) GATX Terminals Corporation—Citing Philadelphia Air Management Service (AMS) documents, PennFuture notes that GATX has the potential to emit 12,867 tons per year of VOC as a Bulk Terminal facility, and that its marine vessel loading unit has a potential to emit 3,520 tons of VOC per year. PennFuture then comments that the Philadelphia AMS's RACT review memorandum notes that a permit restriction limits emissions from this marine vessel loading operation to 59 tons per year in place of an add-on VOC control device. PennFuture goes on to note that, EPA promulgated a National Emission Standard for Marine Tank Vessel Loading Operations in 1995, which specifically established RACT for such sources at 40 CFR Part 63, Subpart Y. PennFuture notes that the RACT evaluation submitted by GATX to AMS in 1994 noted the pendency of this rule, which requires capture of VOCs and routing for combustion or recovery at an efficiency of up to 98 percent (RACT Proposal for a Marine Tank Vessel Loading Terminal Facility, prepared for GATX Terminals Corporation by Versar, Inc., July 14, 1994, p. 12). PennFuture comments that AMS either overlooked this reference or chose not to require as RACT a highly effective control technology that, according to the GATX consultant, was “technically viable” at this plant. PennFuture, therefore, asserts that since EPA has promulgated a regulation specifically designating RACT for sources such as the GATX marine vessel loading operation, EPA must not approve a RACT proposal for this operation unless it includes the application of technology required by EPA in its regulation at 40 CFR, Part 63, Subpart Y.

Response: EPA disagrees with PennFuture's comments regarding the marine vessel loading operation at GATX. The federal regulations cited by PennFuture were promulgated at 40 CFR, Part 63, Subpart Y on September 19, 1995 (61 FR 48399) more than 3 months after the compliance date imposed in Act for major sources of VOC subject to non-CTG RACT. Moreover, the compliance date promulgated for the RACT standards of Subpart Y for sources such as GATX was two years beyond after the regulation's effective date. Most relevantly, the 59 ton per year annual limit imposed by AMS (and submitted by DEP on its behalf as a SIP revision) on GATX's marine vessel loading operation represents a 98.3 percent reduction in VOC emissions from the operation's 3,520 tons per year potential to emit which is at least as stringent as the requirements of 40 CFR Part 63, Subpart Y. Moreover, GATX's RACT plan approval (PA-51-5003) requires the compliance with the 59 ton per year annual limit by the date imposed in Act for major sources of VOC subject to non-CTG RACT. Environmentally, there is no additional benefit that would result in disapproving the case-by-case RACT SIP submittal for GATX's marine vessel loading operation. Approval of the case-by-case RACT SIP revision for GATX in no way relieves the source from any otherwise applicable Maximum Available Control Technology (MACT) requirements of 40 CFR Part 63, Subpart Y.

EPA is approving the SIP revisions to the Pennsylvania SIP submitted by PADEP to establish and require VOC and/or NO X RACT for 18 major sources located in the Philadelphia area. EPA is approving Pennsylvania's RACT SIP submittals because the AMS and PADEP established and imposed these RACT requirements in accordance with the criteria set forth in the SIP-approved RACT regulations applicable to these sources. The AMS and PADEP have also imposed record-keeping, monitoring, and testing requirements on these sources sufficient to determine compliance with the applicable RACT determinations.

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. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely 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). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does 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 action 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 “Protection of Children from Environmental Health Risks and Safety Risks” (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. 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. Section 804 exempts from section 801 the following types of rules: (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability establishing source-specific requirements for eighteen (18) named sources.

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 December 31, 2001. 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 approving VOC and/or NO X RACT for eighteen sources located in the Philadelphia area may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

On December 8, 1995, March 21, 1996, January 21, 1997, July 24, 1998, April 20, 1999, March 23, 2001 (two separate submissions), and July 5, 2001; PADEP submitted revisions to the Pennsylvania SIP to establish and impose RACT for several major sources of VOC and/or NO X . This rulemaking pertains to fourteen of those sources. The remaining sources are or have been the subject of separate rulemakings. These sources are all located in the Philadelphia area and include: Perkasie Industries; Quaker Chemical Corporation; Rohm and Haas—Bucks County Plant; Rohm and Haas—Philadelphia Plant; SBF Communications Graphics; Schlosser Steel, Inc.; SEPTA's Berridge/Courtland Maintenance Shop; Smith-Edwards-Dunlap Company; Southwest Water Pollution Control Plant/Biosolids Recycling Center; Stroehman Bakeries, Inc.; Sunoco, Inc. (R&M) Refinery; Tasty Baking Company; Transcontinental Gas Pipeline Corp.—Compressor Station #200; and Worthington Steel Company.

On September 6, 2001 (66 FR 46525), EPA published a direct final rule and a companion notice of proposed rulemaking (66 FR 46573) to approve these SIP revisions. On October 9, 2001, we received adverse comments on our direct final rule from the Citizens for Pennsylvania's Future (PennFuture). On October 10, 2001, EPA signed a withdrawal notice for timely publication in the Federal Register informing the public that the direct final rule did not take effect. We indicated in our September 6, 2001 direct final rulemaking that if we received adverse comments, EPA would address all public comments in a subsequent final rule based on the proposed rule (66 FR 46573). This is that subsequent final rule. A description of the RACT determination(s) made for each source was provided in the September 6, 2001 direct final rule and will not be restated here. A summary of the comments submitted by PennFuture germane to this final rulemaking and EPA's responses are provided in Section II of this document.

On October 9, 2001, the Citizens for Pennsylvania's Future (PennFuture) submitted adverse comments on the proposed rule published by EPA in the Federal Register on September 6, 2001 to approve case-by-case RACT SIP submissions from the Commonwealth for NO X and or VOC sources located in the Philadelphia area. A summary of those comments and EPA's responses are provided below.

A. Comment: PennFuture comments that EPA has conducted no independent technical review, and has prepared no technical support document to survey potential control technologies, determine the capital and operating costs of different options, and rank these options in total and marginal cost per ton of NO X and VOC controlled. In citing the definition of the term “RACT,” and the Strelow Memorandum [Roger Strelow, Assistant Administrator for Air and Waste Management, EPA, December 9, 1976, cited in Michigan v. Thomas, 805 F.2d 176, 180 (6th Cir. 1986) and at 62 FR 43134, 43136 (1997)], PennFuture appears to comment that in every situation, RACT must include an emission rate. PennFuture asserts that EPA should conduct its own RACT evaluation for each source, or at a minimum document a step-by-step review demonstrating the adequacy of state evaluations, to ensure that appropriate control technology is applied. The commenter also believes that EPA's failure to conduct its own independent review of control technologies has resulted in our proposing to approve some RACT determinations that fail to meet the terms of EPA's own RACT standard.

Response: On March 23, 1998 (63 FR 13789), EPA granted conditional limited approval of Pennsylvania's generic RACT regulations, 25 PA Code Chapters 121 and 129, thereby approving the definitions, provisions and procedures contained within those regulations under which the Commonwealth would require and impose RACT. Subsection 129.91, Control of major sources of NO X and VOCs, requires subject facilities to submit a RACT plan proposal to both the Pennsylvania Department of Environmental Protection (DEP) and to EPA Region III by July 15, 1994 in accordance with subsection 129.92, entitled, RACT proposal requirements. Under subsection 129.92, that proposal is to include, among other information: (1) A list each of subject source at the facility; (2) The size or capacity of each affected source, and the types of fuel combusted, and the types and amounts of materials processed or produced at each source; (3) A physical description of each source and its operating characteristics; (4) Estimates of potential and actual emissions from each affected source with supporting documentation; (5) A RACT analysis which meets the requirements of subsection 129.92 (b), including technical and economic support documentation for each affected source; (6) A schedule for implementation as expeditiously as practicable but not later than May 15, 1995; (7) The testing, monitoring, recordkeeping and reporting procedures proposed to demonstrate compliance with RACT; and (8) any additional information requested by the DEP necessary to evaluate the RACT proposal. Under subsection 129.91, the DEP will approve, deny or modify each RACT proposal, and submit each RACT determination to EPA for approval as a SIP revision.

The conditional nature of EPA's March 23, 1998 conditional limited approval did not impose any conditions pertaining to the regulation's procedures for the submittal of RACT plans and analyses by subject sources and approval of case-by case RACT determinations by the DEP. Rather, EPA stated that “* * * RACT rules may not merely be procedural rules (emphasis added) that require the source and the State to later agree to the appropriate level of control; rather the rules must identify the appropriate level of control for source categories or individual sources.”

On May 3, 2001 (66 FR 22123), EPA published a rulemaking determining that Pennsylvania had satisfied the conditions imposed in its conditional limited approval. In that rulemaking, EPA removed the conditional status of its approval of the Commonwealth's generic VOC and NO X RACT regulations on a statewide basis. EPA received no public comments on its action and that final rule removing the conditional status of Pennsylvania's VOC and NO X RACT regulations became effective on June 18, 2001. As of that time, Pennsylvania's generic VOC and NO X RACT regulations retained a limited approval status. On September 6, 2001 (66 FR 46571), EPA proposed to remove the limited nature of its approval of Pennsylvania's generic RACT regulation in the Philadelphia area. EPA received no public comments on that proposal. Final action converting the limited approval to full approval shall occur once EPA has completed rulemaking to approve either: (1) The case-by-case RACT proposals for all sources subject to the RACT requirements currently known in the Philadelphia area or (2) for a sufficient number of sources such that the emissions from any remaining subject sources represent a de minimis level of emissions as defined in the March 23, 1998 rulemaking (63 FR 13789).

EPA agrees that it has an obligation to review the case-by-case RACT plan approvals and/or permits submitted as individual SIP revisions by Commonwealth to verify and determine if they are consistent with the RACT requirements of the Act and any relevant EPA guidance. EPA does not agree, however, that this obligation to review the case-by-case RACT determinations submitted by Pennsylvania necessarily extends to our performing our own RACT analyses, independent of the sources' RACT plans/analyses (included as part of the case-by case RACT SIP revisions) or the Commonwealth's analyses. EPA first reviews this submission to ensure that the source and the Commonwealth followed the SIP-approved generic rule when applying for and imposing RACT for a specific source. Then EPA performs a thorough review of the technical and economic analyses conducted by the source and the state. If EPA believes additional information may further support or would undercut the RACT analyses submitted by the state, then EPA may add additional EPA-generated analyses to the record.

While RACT, as defined for an individual source or source category, often does specify an emission rate, such is not always the case. EPA has issued Control Technique Guidelines (CTGs) which states are to use as guidance in development of their RACT determinations/rules for certain sources or source categories. Not every CTG issued by EPA includes an emission rate. There are several examples of CTGs issued by EPA wherein equipment standards and/or work practice standards alone are provided as RACT guidance for all or part of the processes covered. Such examples include the CTGs issued for Bulk gasoline plants, Gasoline service stations—Stage I, Petroleum Storage in Fixed-roof tanks, Petroleum refinery processes, Solvent metal cleaning, Pharmaceutical products, External Floating roof tanks and Synthetic Organic Chemical Manufacturing (SOCMI)/polymer manufacturing. (The publication numbers for these CTG documents may be found at http://www.epa.gov/ttn/catc/dir1/ctg.txt ).

EPA disagrees with PennFuture's general comment that our failure to conduct our own independent review of control technologies for every case-by-case RACT determination conducted by the Commonwealth has resulted in our proposing to approve some RACT determinations that fail to meet the terms of our own RACT standard. PennFuture submitted comments specific to the case-by-case RACT determinations for two located in the Philadelphia area, namely for Kurz-Hastings and GATX Terminals Corporation. EPA summarizes those comments and provides responses in the final rule pertaining to those sources.

B. Comment: PennFuture comments that when EPA reviewed Pennsylvania's RACT program, it noted that Pennsylvania coal-fired boilers with a rated heat input of equal to or greater than 100 million Btu per hour “are some of the largest NO X emitting sources in the Commonwealth and in the Northeast United States” [63 FR 13789, 13791 (1998)] and as such should have numeric emission limitations imposed as RACT whether or not they install presumptive RACT (under 25 Pa.Code 129.93) to guarantee that sources would achieve quantifiable emissions reductions under the RACT program. PennFuture goes on to comment that because EPA has not conducted and documented a technical review of Pennsylvania case-by case RACT submissions, EPA has not demonstrated that these large boilers are subject to “numeric emission limitations” under RACT. EPA must conduct a thorough RACT evaluation or review for each such source, and must document the application of numeric emission limits and quantifiable reductions for each coal-fired boiler with a rated heat input of over 100 million Btu per hour.

Response: Circumstances may exist wherein a state could justify otherwise, however, in general, EPA agrees with PennFuture that coal-fired boilers with a rated heat input of equal to or greater than 100 million Btu per hour should have numeric emission limitations imposed as RACT whether or not they install presumptive RACT (under 25 Pa.Code 129.93).

As provided in the response found in II. A, EPA does not agree that it must conduct its own technical analysis of each of the case-by-case RACT determinations submitted for each RACT source in order to document that its RACT requirements include numeric emission limitations. That determination can be made by EPA when it reviews the plan approval, consent order, or permit issued to such a source as submitted by the Commonwealth as SIP revision. PennFuture's comment did not point to a specific instance where a RACT plan approval, consent order or permit imposing RACT on a coal-fired boiler with a rated heat input of equal to or greater than 100 million Btu per hour did, in fact, lack a numerical emission limitation(s). Nonetheless, pursuant to PennFuture's comment, EPA has re-examined all of the case-by-case RACT SIP submissions made by the Commonwealth for such sources located in the Philadelphia area. That re-examination, combined with information provided by the Commonwealth, indicates that each case-by-case RACT plan approval, consent order and/or permit for each coal-fired boiler with a rated heat input of equal to or greater than 100 million Btu per hour includes a numeric emission limitation. A listing of each source, its plan approval, consent order and/or permit number and its numerical emission limitation has been placed in the Administrative Records for the case-by-case RACT rulemakings for the Philadelphia area.

C. Comment: PennFuture asserts that the Commonwealth has not adopted and submitted category RACT rules for all VOC source categories for which federal control technique guidelines (CTGs) have been issued. The commenter refers to Appendix 1 of the Technical Support Document (dated May 14, 2001), prepared by EPA in support of its proposed rule to redesignate the Pittsburgh-Beaver Valley Ozone Nonattainment Area (66 FR 29270), to assert that EPA has failed to require the Commonwealth to submit VOC RACT rules for certain categories of sources. PennFuture specifically names source categories such as equipment leaks from natural gas/gas processing plants, coke oven batteries, iron and steel foundries, and publically owned treatment works and asserts that the Commonwealth has neglected a statutory requirement to adopt category RACT regulations for these and 14 other unnamed VOC source categories. PennFuture contends that the case-by-case approach for establishing and approving RACT is unacceptable under a statutory scheme that specifically requires category-wide RACT regulations for sources covered by CTGs. PennFuture's comment cites to Wall v. EPA, 2001 FED App. 0318P (6th Cir.)(Cincinnati ozone redesignation and RACT). EPA should reject any proposed case-by-case VOC RACT for a source in a category for which there is a CTG but no Pennsylvania RACT regulation.

Response: EPA has not issued CTGs for coke oven batteries, iron and steel foundries and publically owned treatment works. The Appendix 1, referred to by the commenter, lists CTG covered categories as well as source categories taken from two STAPPA/ALAPCO documents entitled, “Meeting the 15-Percent Rate-of-Progress Requirement Under the Clean Air Act—A Menu of Options'' (September 1993) and “Controlling Nitrogen Oxides Under the Clean Air Act—A Menu of Options” (July 1994). The categories referenced by PennFuture are not VOC categories for which EPA has issued CTGs, but were included in Appendix A as examples of some of the types of sources that could be subject to Pennsylvania's generic RACT regulations. The Commonwealth is under no statutory obligation to adopt RACT rules for source categories for which EPA has not issued a CTG. In fact, CTGs do not exist for all but one of the categories to which the commenter explicitly refers.

The Act requires that states adopt regulations to impose RACT for “major sources of VOC,” located within those areas of a state where RACT applies under Part D of the Act [182(b)(2)(C)]. This is referred to as the non-CTG VOC RACT requirement. Moreover, EPA disagrees that there is a statutory mandate that a state adopt a source category RACT regulation even for a source category where EPA has issued a CTG. There are two statutory provisions that address RACT for sources covered by a CTG. One provides that states must adopt RACT for “any category of VOC sources” covered by a CTG issued prior to November 15, 1990 [182(b)(2)(A)]. The other provides that states must adopt VOC RACT for all “VOC sources” covered by a CTG issued after November 15, 1990 [182(b)(2)(B)]. EPA has long interpreted the statutory RACT requirement to be met either by adoption of category-specific rules or by source-specific rules for each source within a category. When initially established, RACT was clearly defined as a case-by-case determination, but EPA provided CTG's to simplify the process for states such that they would not be required to adopt hundreds or thousands of individual rules. See Strelow Memorandum dated December 9, 1976 and 44 FR 53761, September 17, 1979. EPA does not believe that Congress' use of “source category” in one provision of section 182(b)(2) was intended to preclude the adoption of source-specific rules.

Thus, where CTG-subject sources are located within those areas of a state where RACT applies under Part D of the Act, the state is obligated to impose RACT for the same universe of sources covered by the CTG. However, that obligation is not required to be met by the adoption and submittal of a source category RACT rule. A state may, instead, opt to impose RACT for such sources in permits, plan approvals, consent orders or in any other state enforceable document and submit those documents to EPA for approval as source-specific SIP revisions. This option has been exercised by many states, and happens most commonly when only a few CTG-subject sources are located in the state. The source-specific approach is generally employed to avoid what can be a lengthy and resource-intensive state rule adoption process for only a few sources that may have different needs and considerations that must be taken into account. EPA disagrees with the commenter's citing to Wall v. EPA, 2001 FED App. 0318P (6th Cir. Sept. 11, 2001) (Cincinnati ozone redesignation and RACT) as indicative of his contentions regarding states' obligations to adopt category-wide RACT regulations for sources covered by CTGs. The opinion rendered in the cited case neither requires states to adopt category-wide RACT regulations for sources covered by CTGs, nor does it preclude states from exercising their option to impose RACT for CTG-subject sources, on a case-by-case basis. Rather, it speaks only to the Act's requirement that states must implement RACT for CTG-subject sources in ozone nonattainment areas; and not to any specific regulatory construct by which they must do so. Pennsylvania has implemented RACT for all CTG-subject sources in the Philadelphia area, and, EPA has approved all such RACT determinations as revisions to the Pennsylvania SIP. As stated earlier, there is one source category explicitly included in PennFuture's comment for which EPA has issued a CTG, namely natural gas/gas processing plants. The Commonwealth made a negative declaration to EPA on April 13, 1993, stating that as of that date there were no applicable sources in this category. Therefore, the Commonwealth did not adopt a category RACT regulation for natural gas/gas processing plants.

D. Comment: PennFuture cites EPA correspondence [letter from Marcia Spink, EPA, to James Salvaggio, DEP, December 15, 1993] to the Commonwealth which states that establishing any dollar figure in RACT guidance will not provide for the “automatic” selection or rejection of a control technology or emission limitation as RACT for a source or source category. With regard to the Pennsylvania DEP's intent to finalize a NO X RACT Guidance Document for implementation of its NO X RACT regulation, EPA's 1993 letter stated that the document could improperly be used to establish “bright line” or “cook-book” approaches, particularly for a regulation applicable to many source categories and suggested that if the guidance document must include dollar figures/ton, it provide approximate ranges by source category. PennFuture comments that DEP issued its “Guidance Document on Reasonably Available Control Technology for Sources of NO X Emissions,” March 11, 1994, and on pp. 8-9 states that the acceptable threshold is $1500 per ton, and that this figure applies to “all source categories.” PennFuture notes that EPA later objected to the $1500 per ton methodology as “not generically acceptable to EPA” [letter from Thomas Maslany, EPA, to James Salvaggio, DEP, June 24, 1997] and further stated in a Federal Register notice that a “dollar per ton threshold” is “inconsistent with the definition of RACT” [62 FR 43134, 37-38 (1997)].

PennFuture comments that EPA is proposing to approve RACT determinations based on a cost per ton method that EPA had previously rejected, and according to its own clearly expressed standard, EPA must not approve RACT determinations by Pennsylvania DEP that apply this $1500 per ton threshold. PennFuture asserts EPA must reject all Pennsylvania RACT determinations applying the standard of $1500 per ton, or any other “bright line” approach, as failing to follow EPA procedures established for Pennsylvania RACT.

Response: EPA still takes the position that a single cost per ton dollar figure may not, in and of itself, form the basis for rejecting a control technology, equipment standard, or work practice standard as RACT. The Technical Support Document prepared by EPA in support of its March 23, 1998 rulemaking [63 FR 13789] clearly indicates that the Commonwealth's document, “Guidance Document on Reasonably Available Control Technology for Sources of NO X Emissions.” March 11, 1994, had not been included as part of the SIP submission of the Commonwealth's generic regulation and, therefore, had not been approved by EPA. EPA further notes that the Administrative Record of the March 23, 1998 rulemaking [63 FR 13789], in addition to the correspondence cited by PennFuture, also includes correspondence from DEP to EPA [letter from James Salvaggio, DEP to David Arnold, EPA, September 10, 1997] stating that DEP's RACT guidance document does not establish a maximum dollar per ton for determining the cost effectiveness for RACT determinations and notes that the DEP's $1500 per ton cost effectiveness is a target value and not an absolute maximum. For example, in its analyses of the cost effectiveness of RACT control options submitted by DEP as part of the case-by-case SIP revision for Peoples Natural Gas (PNG) Valley Compressor Station's turbo charged lean burn IC engine (see the Administrative Record for 66 FR 43492), the Commonwealth included DEP interoffice memoranda (Thomas Joseph to Krishnan Ramamurthy, July 14, 1994 and Krishnan Ramamurthy to Thomas McGinley, Babu Patel, Ronald Davis, Richard Maxwell, and Devendra Verma, July 15, 1994) which spoke directly to the $1500/ton dollar figure as being a guideline and not an upper limit. These memoranda explain that although PNG initially proposed intermediate original equipment manufacturer (OEM) combustion controls which would have reduced NO X emissions from 254.7 tons per year to 115 tons per year (by 55%) at a cost of $1355 per ton reduced, DEP required the installation of an OEM lean combustion modification that reduced NO X emissions from 254.7 tons per year to 76 tons per year (by 69%) at a cost of $1684 per ton reduced. The DEP's July 15, 1994 interoffice memorandum says of the PNG RACT determination which exceeded the cost effectiveness screening level of $1500 per ton “Tom's (Joseph) insistence for the next more stringent level of control than the company's chosen level in the case of PNG was consistent with EPA Region III's sentiment that establishing any dollar figure in RACT guidance will not provide for an “automatic” rejection of a control technology as RACT for a source.”

In no instance, has EPA proposed to approve a RACT determination submitted by the Commonwealth which was based solely on a conclusion that controls that cost more than $1500/ton were not required as RACT. As explained in the response provided in section II. A. of this document, EPA conducts its review of the entire case-by-case RACT SIP submittal including the source's proposed RACT plan and analyses, Pennsylvania's analyses and the RACT plan approval, consent order or permit itself to insure that the requirements of the SIP-approved generic RACT have been followed. These analyses not only evaluate and consider the costs of potential control options, but also evaluate their technological feasibility.

E. Comment: PennFuture comments that any emission reduction credits (ERCs) earned by sources subject to RACT must be surplus to all applicable state and federal requirements. Under Pennsylvania law, ERCs must be surplus, permanent, quantified, and Federally enforceable. 25 Pa.Code 127.207(1). As to the requirement that ERCs be surplus, the Pennsylvania Code states: ERCs shall be included in the current emission inventory, and may not be required by or be used to meet past or current SIP, attainment demonstration, RFP, emission limitation or compliance plans. Emission reductions necessary to meet NSPS, LAER, RACT, Best Available Technology, BACT and permit or plan approval emissions limitations or another emissions limitation required by the Clean Air Act or the [Air Pollution Control Act] may not be used to generate ERCs. 25 Pa.Code 127.207(1)(i). To be creditable, ERCs must surpass not only RACT requirements but a host of other possible sources of emission limits. PennFuture comments that some of the RACT evaluations at issue in the current EPA notices purport to establish RACT as a baseline for future ERCs. PennFuture does acknowledge that EPA notes in its boilerplate for the notices, that Pennsylvania and EPA have established a series of NO X -reducing rules, including the recent Chapter 145 rule, to reduce NO X at large utility and industrial sources. See, for example, 66 FR 42415, 16-17 (August 13, 2001). Because any ERCs must be surplus to the most stringent limitation applicable under state or federal law as described in the Pennsylvania Code provision set forth above, DEP and EPA must not approve ERCs unless they surpass all such limitations in addition to any limits set by RACT.

Response: EPA agrees with this comment by PennFuture. The approval of a case-by-case RACT determination, in and of itself, does not establish the baseline from which further emission reductions may be calculated and assumed creditable under the Commonwealth's SIP-approved NSR and ERC program. Moreover, EPA's review of the Pennsylvania DEP's implementation of its approved SIP-approved NSR and ERC program indicates that the Commonwealth calculates and credits ERCs in accordance with the SIP-approved criteria for doing so as outlined in PennFuture's comment. No source for which EPA is approving a case-by-case RACT determination should assume that its RACT approval alone automatically establishes the baseline against which it may calculate creditable ERCs.

F. Comment: PennFuture comments that as in the case with Pennsylvania Power—Newcastle, EPA should compare RACT proposals to applicable acid rain program emission limits and control strategies. PennFuture contends that EPA previously disapproved a RACT proposal for the Pennsylvania Power—Newcastle plant [62 FR 43959 (1997); 63 FR 23668 (1998)] and that EPA did so on the basis that the acid rain program requires more stringent emission limits. PennFuture asserts that while EPA had originally proposed to approve this proposal, an analysis of comparable boilers and, especially, a comparison to Phase II emission limits under the acid rain program led EPA to conclude that the RACT proposal emission limits were too lenient. [62 FR at 43961]. Therefore, PennFuture contends that for sources subject to the acid rain program, EPA should consider emissions and control strategies for compliance with acid rain emission limits when evaluating proposals for compliance with RACT.

Response: Title IV of the Act, addressing the acid rain program, contains NO X emission requirements for utilities which must be met in addition to any RACT requirements (see NO X Supplement to the General Preamble at 57 FR 55625, November 25, 1992). The Act provides for a number of control programs that may affect similar sources. For example, new sources may be subject to new source performance standards (NSPS), best available control technology (BACT), and lowest achievable emission rate (LAER). Other controls, under such programs as the acid rain program or the hazardous air pollutant program may also apply to sources. However, the applicability of these other requirements, which are often more stringent than RACT, do not establish what requirements must apply under the RACT program. While these programs may provide information as to the technical and economic feasibility of reduction programs for RACT, there is no presumption that acid rain controls should be mandated as RACT.

EPA stated in the final disapproval of the NO X RACT determination for PPNC [63 FR at 23669], that the discussion concerning average emission rates for boilers with respect to the acid rain program requirements were included in order to provide a context for EPA's proposed disapproval. EPA made clear in its August 18, 1997 proposed disapproval of Pennsylvania Powers'—Newcastle (PPNC) RACT determination, that the basis for disapproval was a comparison between PPNC's boilers and other similar combustion units, not acid rain limits. In fact, EPA stated in the August 18, 1997 proposed disapproval that “Without additional knowledge or information, it would be erroneous and premature to conclude that the limits in the acid rain permit are RACT.” [62 FR at 43961]. EPA clearly stated in the final disapproval for PPNC that it did not use acid rain permit limits, or Pennsylvania's participation in any other NO X control program, to determine PPNC RACT approvability [63 FR at 23670]. Nor has EPA intended to use participation in NO X control programs including acid rain, in determining RACT for PPNC or any other subject sources. EPA also stated that the April 30, 1998, PPNC disapproval was based on the absence of pertinent information regarding a computerized combustion optimization system through an enforceable permit, not comparison of acid rain permit limits.

EPA is approving the SIP revisions to the Pennsylvania SIP submitted by PADEP to establish and require VOC and/or NO X RACT for fourteen major of sources located in the Philadelphia area. EPA is approving these SIP submittals because the Philadelphia AMS and PADEP established and imposed these RACT requirements in accordance with the criteria set forth in the SIP-approved RACT regulations applicable to these sources. The AMS and PADEP have also imposed record keeping, monitoring, and/or testing requirements sufficient to determine compliance with the applicable RACT determinations.

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. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely 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). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does 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 action 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 “Protection of Children from Environmental Health Risks and Safety Risks” (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. 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. Section 804 exempts from section 801 the following types of rules: (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability establishing source-specific requirements for fourteen named sources.

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 December 31, 2001. 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 approving VOC and NO X RACT for fourteen major sources located in the Philadelphia area may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

On April 16, 1996, June 10, 1996, November 4, 1997, December 31, 1997, March 24, 1998, March 23, 2001, and August 8, 2001, PADEP submitted revisions to the Pennsylvania SIP which establish and impose RACT for several sources of VOC and/or NO X . This rulemaking pertains to the 9 of those sources. The remaining sources are or have been the subject of separate rulemakings. The Commonwealth's submittals consist of plan approvals and operating permits which impose VOC and/or NO X RACT requirements for each source. These sources are all located in the Philadelphia area and include: Jefferson Smurfit Corporation and Container Corporation of America; Maritank Philadelphia, Inc.; Moyer Packing Company; PECO Energy Company; Exelon Generation Company—Schuylkill Generating Station; Exelon Generation Company—Delaware Generating Station; Philadelphia Gas Works, Richmond Plant; SPS Technologies; and Tullytown Resource Recovery Facility (Waste Management of PA, Inc.).

On August 31, 2001, EPA published a direct final rule (66 FR 45928) and a companion notice of proposed rulemaking (66 FR 45953) to approve these SIP revisions. On October 1, 2001, we received adverse comments on our direct final rule from the Citizens for Pennsylvania's Future (PennFuture). On October 11, 2001, we published a timely withdrawal in the Federal Register informing the public that the direct final rule did not take effect. We indicated in our August 31, 2001 direct final rulemaking that if we received adverse comments, EPA would address all public comments in a subsequent final rule based on the proposed rule (66 FR 45953). This is that subsequent final rule. A description of the RACT determination(s) made for each source was provided in the August 31, 2001 direct final rule and will not be restated here. A summary of the comments submitted by PennFuture germane to this final rulemaking and EPA's responses are provided in Section II of this document.

On October 1, 2001, the Citizens for Pennsylvania's Future (PennFuture) submitted adverse comments on the proposed rule published by EPA in the Federal Register on August 31, 2001 to approve case-by-case RACT SIP submissions from the Commonwealth for NO X and or VOC sources located in the Philadelphia area. A summary of those comments and EPA's responses are provided below.

A. Comment: PennFuture comments that EPA has conducted no independent technical review, and has prepared no technical support document to survey potential control technologies, determine the capital and operating costs of different options, and rank these options in total and marginal cost per ton of NO X and VOC controlled. In citing the definition of the term “RACT,” and the Strelow Memorandum [Roger Strelow, Assistant Administrator for Air and Waste Management, EPA, December 9, 1976, cited in Michigan v. Thomas, 805 F.2d 176, 180 (6th Cir. 1986) and at 62 FR 43134, 43136 (1997)], PennFuture appears to comment that in every situation, RACT must include an emission rate. PennFuture asserts that EPA should conduct its own RACT evaluation for each source, or at a minimum document a step-by-step review demonstrating the adequacy of state evaluations, to ensure that appropriate control technology is applied. The commenter also believes that EPA's failure to conduct its own independent review of control technologies has resulted in our proposing to approve some RACT determinations that fail to meet the terms of EPA's own RACT standard.

Response: On March 23, 1998 (63 FR 13789), EPA granted conditional limited approval of Pennsylvania's generic RACT regulations, 25 PA Code Chapters 121 and 129, thereby approving the definitions, provisions and procedures contained within those regulations under which the Commonwealth would require and impose RACT. Subsection 129.91, Control of major sources of NO X and VOCs , requires subject facilities to submit a RACT plan proposal to both the Pennsylvania Department of Environmental Protection (DEP) and to EPA Region III by July 15, 1994 in accordance with subsection 129.92, entitled, RACT proposal requirements. Under subsection 129.92, that proposal is to include, among other information: (1) A list each of subject source at the facility; (2) The size or capacity of each affected source, and the types of fuel combusted, and the types and amounts of materials processed or produced at each source; (3) A physical description of each source and its operating characteristics; (4) Estimates of potential and actual emissions from each affected source with supporting documentation; (5) A RACT analysis which meets the requirements of subsection 129.92 (b), including technical and economic support documentation for each affected source; (6) A schedule for implementation as expeditiously as practicable but not later than May 15, 1995; (7) The testing, monitoring, recordkeeping and reporting procedures proposed to demonstrate compliance with RACT; and (8) any additional information requested by the DEP necessary to evaluate the RACT proposal. Under subsection 129.91, the DEP will approve, deny or modify each RACT proposal, and submit each RACT determination to EPA for approval as a SIP revision.

The conditional nature of EPA's March 23, 1998 conditional limited approval did not impose any conditions pertaining to the regulation's procedures for the submittal of RACT plans and analyses by subject sources and approval of case-by case RACT determinations by the DEP. Rather, EPA stated that “* * * RACT rules may not merely be procedural rules (emphasis added) that require the source and the State to later agree to the appropriate level of control; rather the rules must identify the appropriate level of control for source categories or individual sources.”

On May 3, 2001 (66 FR 22123), EPA published a rulemaking determining that Pennsylvania had satisfied the conditions imposed in its conditional limited approval. In that rulemaking, EPA removed the conditional status of its approval of the Commonwealth's generic VOC and NO X RACT regulations on a statewide basis. EPA received no public comments on its action and that final rule removing the conditional status of Pennsylvania's VOC and NO X RACT regulations became effective on June 18, 2001. As of that time, Pennsylvania's generic VOC and NO X RACT regulations retained a limited approval status. On September 6, 2001 (66 FR 46571), EPA proposed to remove the limited nature of its approval of Pennsylvania's generic RACT regulation in the Philadelphia area. EPA received no public comments on that proposal. Final action converting the limited approval to full approval shall occur once EPA has completed rulemaking to approve either (1) the case-by-case RACT proposals for all sources subject to the RACT requirements currently known in the Philadelphia area or (2) for a sufficient number of sources such that the emissions from any remaining subject sources represent a de minimis level of emissions as defined in the March 23, 1998 rulemaking (63 FR 13789).

EPA agrees that it has an obligation to review the case-by-case RACT plan approvals and/or permits submitted as individual SIP revisions by the Commonwealth to verify and determine if they are consistent with the RACT requirements of the Act and any relevant EPA guidance. EPA does not agree, however, that this obligation to review the case-by-case RACT determinations submitted by Pennsylvania necessarily extends to our performing our own RACT analyses, independent of the sources' RACT plans/analyses (included as part of the case-by case RACT SIP revisions) or the Commonwealth's analyses. EPA first reviews this submission to ensure that the source and the Commonwealth followed the SIP-approved generic rule when applying for and imposing RACT for a specific source. Then EPA performs a thorough review of the technical and economic analyses conducted by the source and the state. If EPA believes additional information may further support or would undercut the RACT analyses submitted by the state, then EPA may add additional EPA-generated analyses to the record.

While RACT, as defined for an individual source or source category, often does specify an emission rate, such is not always the case. EPA has issued Control Technique Guidelines (CTGs) which states are to use as guidance in development of their RACT determinations/rules for certain sources or source categories. Not every CTG issued by EPA includes an emission rate. There are several examples of CTGs issued by EPA wherein equipment standards and/or work practice standards alone are provided as RACT guidance for all or part of the processes covered. Such examples include the CTGs issued for Bulk gasoline plants, Gasoline service stations—Stage I, Petroleum Storage in Fixed-roof tanks, Petroleum refinery processes, Solvent metal cleaning, Pharmaceutical products, External Floating roof tanks and Synthetic Organic Chemical Manufacturing (SOCMI)/polymer manufacturing. (The publication numbers for these CTG documents may be found at http://www.epa.gov/ttn/catc/dir1/ctg.txt ).

EPA disagrees with PennFuture's general comment that our failure to conduct our own independent review of control technologies for every case-by-case RACT determination conducted by the Commonwealth has resulted in our proposing to approve some RACT determinations that fail to meet the terms of our own RACT standard. PennFuture submitted comments specific to the case-by-case RACT determinations for two located in the Philadelphia area, namely for Kurz-Hastings and GATX Terminals Corporation. EPA summarizes those comments and provides responses in the final rule pertaining to those sources.

B. Comment: PennFuture comments that when EPA reviewed Pennsylvania's RACT program, it noted that Pennsylvania coal-fired boilers with a rated heat input of equal to or greater than 100 million Btu per hour “are some of the largest NO X emitting sources in the Commonwealth and in the Northeast United States” [63 FR 13789, 13791 (1998)] and as such should have numeric emission limitations imposed as RACT whether or not they install presumptive RACT (under 25 Pa.Code 129.93) to guarantee that sources would achieve quantifiable emissions reductions under the RACT program. PennFuture goes on to comment that because EPA has not conducted and documented a technical review of Pennsylvania case-by case RACT submissions, EPA has not demonstrated that these large boilers are subject to “numeric emission limitations” under RACT. EPA must conduct a thorough RACT evaluation or review for each such source, and must document the application of numeric emission limits and quantifiable reductions for each coal-fired boiler with a rated heat input of over 100 million Btu per hour.

Response: Circumstances may exist wherein a state could justify otherwise, however, in general, EPA agrees with PennFuture that coal-fired boilers with a rated heat input of equal to or greater than 100 million Btu per hour should have numeric emission limitations imposed as RACT whether or not they install presumptive RACT (under 25 Pa.Code 129.93).

As provided in the response found in II. A, EPA does not agree that it must conduct its own technical analysis of each of the case-by-case RACT determinations submitted for each RACT source in order to document that its RACT requirements include numeric emission limitations. That determination can be made by EPA when it reviews the plan approval, consent order, or permit issued to such a source as submitted by the Commonwealth as SIP revision. PennFuture's comment did not point to a specific instance where a RACT plan approval, consent order or permit imposing RACT on a coal-fired boiler with a rated heat input of equal to or greater than 100 million Btu per hour did, in fact, lack a numerical emission limitation(s). Nonetheless, pursuant to PennFuture's comment, EPA has re-examined all of the case-by-case RACT SIP submissions made by the Commonwealth for such sources located in the Philadelphia area. That re-examination, combined with information provided by the Commonwealth, indicates that each case-by-case RACT plan approval, consent order and/or permit for each coal-fired boiler with a rated heat input of equal to or greater than 100 million Btu per hour includes a numeric emission limitation. A listing of each source, its plan approval, consent order and/or permit number and its numerical emission limitation has been placed in the Administrative Records for the case-by-case RACT rulemakings for the Philadelphia area.

C. Comment: PennFuture asserts that the Commonwealth has not adopted and submitted category RACT rules for all VOC source categories for which federal control technique guidelines (CTGs) have been issued. The commenter refers to Appendix 1 of the Technical Support Document (dated May 14, 2001), prepared by EPA in support of its proposed rule to redesignate the Pittsburgh-Beaver Valley Ozone Nonattainment Area (66 FR 29270), to assert that EPA has failed to require the Commonwealth to submit VOC RACT rules for certain categories of sources. PennFuture specifically names source categories such as equipment leaks from natural gas/gas processing plants, coke oven batteries, iron and steel foundries, and publically owned treatment works and asserts that the Commonwealth has neglected a statutory requirement to adopt category RACT regulations for these and 14 other unnamed VOC source categories. PennFuture's comment cites to Wall v. EPA , 2001 FED App. 0318P (6th Cir.)(Cincinnati ozone redesignation and RACT). EPA should reject any proposed case-by-case VOC RACT for a source in a category for which there is a CTG but no Pennsylvania RACT regulation.

Response: EPA has not issued CTGs for coke oven batteries, iron and steel foundries and publically owned treatment works. The Appendix 1, referred to by the commenter, lists CTG covered categories as well as source categories taken from two STAPPA/ALAPCO documents entitled, “Meeting the 15-Percent Rate-of-Progress Requirement Under the Clean Air Act—A Menu of Options” (September 1993) and “Controlling Nitrogen Oxides Under the Clean Air Act—A Menu of Options” (July 1994). The categories referenced by PennFuture are not VOC categories for which EPA has issued CTGs, but were included in Appendix A as examples of some of the types of sources that could be subject to Pennsylvania's generic RACT regulations. The Commonwealth is under no statutory obligation to adopt RACT rules for source categories for which EPA has not issued a CTG. In fact, CTGs do not exist for all but one of the categories to which the commenter explicitly refers.

The Act requires that states adopt regulations to impose RACT for “major sources of VOC,” located within those areas of a state where RACT applies under Part D of the Act [182(b)(2)(C)]. This is referred to as the non-CTG VOC RACT requirement. Moreover, EPA disagrees that there is a statutory mandate that a state adopt a source category RACT regulation even for a source category where EPA has issued a CTG. There are two statutory provisions that address RACT for sources covered by a CTG. One provides that states must adopt RACT for “any category of VOC sources” covered by a CTG issued prior to November 15, 1990 [182(b)(2)(A)]. The other provides that states must adopt VOC RACT for all “VOC sources” covered by a CTG issued after November 15, 1990 [182(b)(2)(B)]. EPA has long interpreted the statutory RACT requirement to be met either by adoption of category-specific rules or by source-specific rules for each source within a category. When initially established, RACT was clearly defined as a case-by-case determination, but EPA provided CTG's to simplify the process for states such that they would not be required to adopt hundreds or thousands of individual rules. See Strelow Memorandum dated December 9, 1976 and 44 FR 53761, September 17, 1979. EPA does not believe that Congress' use of “source category” in one provision of section 182(b)(2) was intended to preclude the adoption of source-specific rules.

Thus, where CTG-subject sources are located within those areas of a state where RACT applies under Part D of the Act, the state is obligated to impose RACT for the same universe of sources covered by the CTG. However, that obligation is not required to be met by the adoption and submittal of a source category RACT rule. A state may, instead, opt to impose RACT for such sources in permits, plan approvals, consent orders or in any other state enforceable document and submit those documents to EPA for approval as source-specific SIP revisions. This option has been exercised by many states, and happens most commonly when only a few CTG-subject sources are located in the state. The source-specific approach is generally employed to avoid what can be a lengthy and resource-intensive state rule adoption process for only a few sources that may have different needs and considerations that must be taken into account. EPA disagrees with the commenter's citing to Wall v. EPA , 2001 FED App. 0318P (6th Cir. Sept. 11, 2001) (Cincinnati ozone redesignation and RACT) as indicative of his contentions regarding states' obligations to adopt category-wide RACT regulations for sources covered by CTGs. The opinion rendered in the cited case neither requires states to adopt category-wide RACT regulations for sources covered by CTGs, nor does it preclude states from exercising their option to impose RACT for CTG-subject sources, on July 2, 1997, November 4, 1997, July 24 1998, October 2, 1998, March 3, 1999, April 9, 1999, and April 20, 1999, on a case-by-case basis. Rather, it speaks only to the Act's requirement that states must implement RACT for CTG-subject sources in ozone nonattainment areas; and not to any specific regulatory construct by which they must do so. Pennsylvania has implemented RACT for all CTG-subject sources in the Philadelphia area, and, EPA has approved all such RACT determinations as revisions to the Pennsylvania SIP. As stated earlier, there is one source category explicitly included in PennFuture's comment for which EPA has issued a CTG, namely natural gas/gas processing plants. The Commonwealth made a negative declaration to EPA on April 13, 1993, stating that as of that date there were no applicable sources in this category. Therefore, the Commonwealth did not adopt a category RACT regulation for natural gas/gas processing plants.

D. Comment: PennFuture cites EPA correspondence [letter from Marcia Spink, EPA, to James Salvaggio, DEP, December 15, 1993] to the Commonwealth which states that establishing any dollar figure in RACT guidance will not provide for the “automatic” selection or rejection of a control technology or emission limitation as RACT for a source or source category. With regard to the Pennsylvania DEP's intent to finalize a NO X RACT Guidance Document for implementation of its NO X RACT regulation, EPA's 1993 letter stated that the document could improperly be used to establish “bright line” or “cook-book” approaches, particularly for a regulation applicable to many source categories and suggested that if the guidance document must include dollar figures/ton, it provide approximate ranges by source category. PennFuture comments that DEP issued its “Guidance Document on Reasonably Available Control Technology for Sources of NO X Emissions,” March 11, 1994, and on pp. 8-9 states that the acceptable threshold is $1500 per ton, and that this figure applies to “all source categories.” PennFuture notes that EPA later objected to the $1500 per ton methodology as “not generically acceptable to EPA” [letter from Thomas Maslany, EPA, to James Salvaggio, DEP, June 24, 1997] and further stated in a Federal Register notice that a “dollar per ton threshold” is “inconsistent with the definition of RACT” [62 FR 43134, 37-38 (1997)].

PennFuture comments that EPA is proposing to approve RACT determinations based on a cost per ton method that EPA had previously rejected, and according to its own clearly expressed standard, EPA must not approve RACT determinations by Pennsylvania DEP that apply this $1500 per ton threshold. PennFuture asserts EPA must reject all Pennsylvania RACT determinations applying the standard of $1500 per ton, or any other “bright line” approach, as failing to follow EPA procedures established for Pennsylvania RACT.

Response: EPA still takes the position that a single cost per ton dollar figure may not, in and of itself, form the basis for rejecting a control technology, equipment standard, or work practice standard as RACT. The Technical Support Document prepared by EPA in support of its March 23, 1998 rulemaking [63 FR 13789] clearly indicates that the Commonwealth's document, “Guidance Document on Reasonably Available Control Technology for Sources of NO X Emissions.” March 11, 1994, had not been included as part of the SIP submission of the Commonwealth's generic regulation and, therefore, had not been approved by EPA. EPA further notes that the Administrative Record of the March 23, 1998 rulemaking [63 FR 13789], in addition to the correspondence cited by PennFuture, also includes correspondence from DEP to EPA [letter from James Salvaggio, DEP to David Arnold, EPA, September 10, 1997] stating that DEP's RACT guidance document does not establish a maximum dollar per ton for determining the cost effectiveness for RACT determinations and notes that the DEP's $1500 per ton cost effectiveness is a target value and not an absolute maximum. For example, in its analyses of the cost effectiveness of RACT control options submitted by DEP as part of the case-by-case SIP revision for Peoples Natural Gas (PNG) Valley Compressor Station's turbo charged lean burn IC engine (see the Administrative Record for 66 FR 43492), the Commonwealth included DEP interoffice memoranda (Thomas Joseph to Krishnan Ramamurthy, July 14, 1994 and Krishnan Ramamurthy to Thomas McGinley, Babu Patel, Ronald Davis, Richard Maxwell, and Devendra Verma, July 15, 1994) which spoke directly to the $1500/ton dollar figure as being a guideline and not an upper limit. These memoranda explain that although PNG initially proposed intermediate original equipment manufacturer (OEM) combustion controls which would have reduced NO X emissions from 254.7 tons per year to 115 tons per year (by 55%) at a cost of $1355 per ton reduced, DEP required the installation of an OEM lean combustion modification that reduced NO X emissions from 254.7 tons per year to 76 tons per year (by 69%) at a cost of $1684 per ton reduced. The DEP's July 15, 1994 interoffice memorandum says of the PNG RACT determination which exceeded the cost effectiveness screening level of $1500 per ton “Tom's (Joseph) insistence for the next more stringent level of control than the company's chosen level in the case of PNG was consistent with EPA Region III's sentiment that establishing any dollar figure in RACT guidance will not provide for an ‘automatic’ rejection of a control technology as RACT for a source.”

In no instance, has EPA proposed to approve a RACT determination submitted by the Commonwealth which was based solely on a conclusion that controls that cost more than $1500/ton were not required as RACT. As explained in the response provided in section II. A. of this document, EPA conducts its review of the entire case-by-case RACT SIP submittal including the source's proposed RACT plan and analyses, Pennsylvania's analyses and the RACT plan approval, consent order or permit itself to insure that the requirements of the SIP-approved generic RACT have been followed. These analyses not only evaluate and consider the costs of potential control options, but also evaluate their technological feasibility.

E. Comment: PennFuture comments that any emission reduction credits (ERCs) earned by sources subject to RACT must be surplus to all applicable state and federal requirements. Under Pennsylvania law, ERCs must be surplus, permanent, quantified, and Federally enforceable. 25 Pa.Code 127.207(1). As to the requirement that ERCs be surplus, the Pennsylvania Code states: ERCs shall be included in the current emission inventory, and may not be required by or be used to meet past or current SIP, attainment demonstration, RFP, emission limitation or compliance plans. Emission reductions necessary to meet NSPS, LAER, RACT, Best Available Technology, BACT and permit or plan approval emissions limitations or another emissions limitation required by the Clean Air Act or the [Air Pollution Control Act] may not be used to generate ERCs. 25 Pa.Code 127.207(1)(i). To be creditable, ERCs must surpass not only RACT requirements but a host of other possible sources of emission limits. PennFuture comments that some of the RACT evaluations at issue in the current EPA notices purport to establish RACT as a baseline for future ERCs. PennFuture does acknowledge that EPA notes in its boilerplate for the notices, that Pennsylvania and EPA have established a series of NO X -reducing rules, including the recent Chapter 145 rule, to reduce NO X at large utility and industrial sources. See, for example, 66 FR 42415, 16-17 (August 13, 2001). Because any ERCs must be surplus to the most stringent limitation applicable under state or federal law as described in the Pennsylvania Code provision set forth above, DEP and EPA must not approve ERCs unless they surpass all such limitations in addition to any limits set by RACT.

Response: EPA agrees with this comment by PennFuture. The approval of a case-by-case RACT determination, in and of itself, does not establish the baseline from which further emission reductions may be calculated and assumed creditable under the Commonwealth's SIP-approved NSR and ERC program. Moreover, EPA's review of the Pennsylvania DEP's implementation of its approved SIP-approved NSR and ERC program indicates that the Commonwealth calculates and credits ERCs in accordance with the SIP-approved criteria for doing so as outlined in PennFuture's comment. No source for which EPA is approving a case-by-case RACT determination should assume that its RACT approval alone automatically establishes the baseline against which it may calculate creditable ERCs.

F. Comment: PennFuture comments that as in the case with Pennsylvania Power—Newcastle, EPA should compare RACT proposals to applicable acid rain program emission limits and control strategies. PennFuture contends that EPA previously disapproved a RACT proposal for the Pennsylvania Power—Newcastle plant [62 FR 43959 (1997); 63 FR 23668 (1998)] and that EPA did so on the basis that the acid rain program requires more stringent emission limits. PennFuture asserts that while EPA had originally proposed to approve this proposal, an analysis of comparable boilers and, especially, a comparison to Phase II emission limits under the acid rain program led EPA to conclude that the RACT proposal emission limits were too lenient. [62 FR at 43961]. Therefore, PennFuture contends that for sources subject to the acid rain program, EPA should consider emissions and control strategies for compliance with acid rain emission limits when evaluating proposals for compliance with RACT.

Response: Title IV of the Act, addressing the acid rain program, contains NO X emission requirements for utilities which must be met in addition to any RACT requirements (see NO X Supplement to the General Preamble at 57 FR 55625, November 25, 1992). The Act provides for a number of control programs that may affect similar sources. For example, new sources may be subject to new source performance standards (NSPS), best available control technology (BACT), and lowest achievable emission rate (LAER). Other controls, under such programs as the acid rain program or the hazardous air pollutant program may also apply to sources. However, the applicability of these other requirements, which are often more stringent than RACT, do not establish what requirements must apply under the RACT program. While these programs may provide information as to the technical and economic feasibility of reduction programs for RACT, there is no presumption that acid rain controls should be mandated as RACT.

EPA stated in the final disapproval of the NO X RACT determination for PPNC [63 FR at 23669], that the discussion concerning average emission rates for boilers with respect to the acid rain program requirements were included in order to provide a context for EPA's proposed disapproval. EPA made clear in its August 18, 1997 proposed disapproval of Pennsylvania Powers'—Newcastle (PPNC) RACT determination, that the basis for disapproval was a comparison between PPNC's boilers and other similar combustion units, not acid rain limits. In fact, EPA stated in the August 18, 1997 proposed disapproval that “Without additional knowledge or information, it would be erroneous and premature to conclude that the limits in the acid rain permit are RACT.” [62 FR at 43961]. EPA clearly stated in the final disapproval for PPNC that it did not use acid rain permit limits, or Pennsylvania's participation in any other NO X control program, to determine PPNC RACT approvability [63 FR at 23670]. Nor has EPA intended to use participation in NO X control programs including acid rain, in determining RACT for PPNC or any other subject sources. EPA also stated that the April 30, 1998, PPNC disapproval was based on the absence of pertinent information regarding a computerized combustion optimization system through an enforceable permit, not comparison of acid rain permit limits.

EPA is approving the SIP revisions to the Pennsylvania SIP submitted by PADEP to establish and require VOC and/or NO X RACT for nine major of sources located in the Philadelphia area. EPA is approving these RACT SIP submittals because the Philadelphia Air Management Services (AMS) and PADEP established and imposed these RACT requirements in accordance with the criteria set forth in the SIP-approved RACT regulations applicable to these sources. The AMS and PADEP have also imposed record-keeping, monitoring, and testing requirements on these sources sufficient to determine compliance with the applicable RACT determinations.

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. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely 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). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does 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 action 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 “Protection of Children from Environmental Health Risks and Safety Risks” (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. 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. Section 804 exempts from section 801 the following types of rules: (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability establishing source-specific requirements for nine named sources.

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 December 31, 2001. 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 approving VOC and/or NO X RACT for nine sources located in the Philadelphia area may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

This section provides additional information by addressing the following questions:

Title V of the CAA Amendments of 1990 required all state and local permitting authorities to develop operating permit programs that met certain federal criteria. In implementing the title V operating permit programs, the permitting authorities require certain sources of air pollution to obtain permits that contain all applicable requirements under the CAA. The focus of the operating permit program is to improve enforcement by issuing each source a permit that consolidates all of the applicable CAA requirements into a federally enforceable document. By consolidating all of the applicable requirements for a facility, the source, the public, and the permitting authorities can more easily determine what CAA requirements apply and how compliance with those requirements is determined.

Sources required to obtain an operating permit under the title V program include: “major” sources of air pollution and certain other sources specified in the CAA or in EPA's implementing regulations. For example, all sources regulated under the acid rain program, regardless of size, must obtain operating permits. Examples of major sources include those that have the potential to emit 100 tons per year or more of volatile organic compounds (VOCs), carbon monoxide, lead, sulfur dioxide, nitrogen oxides (NO X ), or particulate matter (PM 10 ); those that emit 10 tons per year of any single hazardous air pollutant (specifically listed under the CAA); or those that emit 25 tons per year or more of a combination of hazardous air pollutants (HAPs). In areas that are not meeting the National Ambient Air Quality Standards for ozone, carbon monoxide, or particulate matter, major sources are defined by the gravity of the nonattainment classification. For example, in ozone nonattainment areas classified as “serious,” major sources include those with the potential of emitting 50 tons per year or more of VOCs or NO X .

Where a title V operating permit program substantially, but not fully, met the criteria outlined in the implementing regulations codified at 40 Code of Federal Regulations (CFR) part 70, EPA granted interim approval contingent on the state revising its program to correct the deficiencies. Because the Kentucky program substantially, but not fully, met the requirements of part 70, EPA granted interim approval to this program in a rulemaking (60 FR 57186) published on November 14, 1995. The interim approval notice described the conditions that had to be met in order for the Kentucky program to receive full approval. Interim approval of this program expires on December 1, 2001.

The Kentucky Department of Environmental Protection has fulfilled the conditions of the interim approval granted on November 14, 1995. On September 12, 2001, EPA published a notice in the Federal Register (see 66 FR 47428) proposing full approval of the Kentucky title V operating permit program, and proposing approval of other program revisions. Since EPA did not receive any comments on the proposal, this action promulgates final full approval of the Kentucky program and final approval of the other program changes described in the proposal.

Copies of the Kentucky submittal and other supporting documentation used in developing the final full approval are contained in docket files maintained at the EPA Region 4 office. The docket is an organized and complete file of all the information submitted to, or otherwise considered by, EPA in the development of this proposed full approval. The primary purposes of the docket are: (1) To allow interested parties a means to identify and locate documents so that they can effectively participate in the approval process, and (2) to serve as the record in case of judicial review. The docket files are available for public inspection at the location listed under the ADDRESSES section of this document.

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

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 is not an economically significant regulatory action as defined in Executive Order 12866, and it does not involve decisions intended to mitigate environmental health or safety risks.

This rule does not have Federalism implications because it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, “Federalism” (64 FR 43255, August 10, 1999). This rule merely approves existing requirements under state law, and does not alter the relationship or the distribution of power and responsibilities between the state and the federal government established in the CAA.

This rule does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified by Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000).

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because it is not a significantly regulatory action under Executive Order 12866.

The Regulatory Flexibility Act 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 rule will not have a significant impact on a substantial number of small entities because operating permit program approvals under section 502 of the CAA do not create any new requirements but simply approve requirements that the state is already imposing. Therefore, because this 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.

Under sections 202 of the Unfunded Mandates Reform Act of 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 costs to state, local, or tribal governments in the aggregate, or to the 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 proposed does not include a federal mandate that may result in estimated 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.

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.

In reviewing operating permit programs, EPA's role is to approve state choices, provided that they meet the criteria of the CAA and EPA's regulations codified at 40 CFR part 70. In this context, in the absence of a prior existing requirement for the state to use VCS, EPA has no authority to disapprove an operating permit program for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews an operating permit program, to use VCS in place of an operating permit program that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of NTTAA do not apply.

This action will not impose any collection of information subject to the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , other than those previously approved and assigned OMB control number 2060-0243. For additional information concerning these requirements, see 40 CFR part 70. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The 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).

Entities potentially affected by this rule are manufacturers of motorcycles. Regulated categories include:

To determine whether you are affected by this rule, you should carefully examine the requirements in § 80.24(b) of title 40 of the Code of Federal Regulations (CFR). If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Prior to 1996, 40 CFR 80.24(b) contained size specifications for the gasoline tank filler inlet of motor vehicles equipped with an emission control device that would be significantly impaired by the use of leaded gasoline. The purpose of the tank filler inlet restriction was to allow the insertion of an unleaded gasoline pump nozzle, but not a leaded gasoline pump nozzle. Specifically, § 80.24(b) required that a manufacturer of motor vehicles “equipped with an emission control device which the Administrator has determined will be significantly impaired by the use of leaded gasoline” shall “[m]anufacture such vehicle with each gasoline tank filler inlet having a restriction which prevents the insertion of a nozzle with a spout as described in § 80.22(f)(1) and allows the insertion of a nozzle with a spout as described in § 80.22(f)(2).” Section 80.22(f)(1) specified that “[e]ach pump from which leaded gasoline is introduced into motor vehicles shall be equipped with a nozzle spout having a terminal end with an outside diameter of not less than 0.930 inch (2.363 centimeters).” Section 80.22(f)(2) specified that “[e]ach pump from which unleaded gasoline is introduced into motor vehicles shall be equipped with a nozzle spout which meets the following specifications: (i) The outside diameter of the terminal end shall not be greater than 0.840 inch (2.134 centimeters); (ii) * * *”

Section 80.24(b) contained additional specifications to prevent misfueling of motor vehicles with leaded gasoline. Section 80.24(b)(1) required that the filler inlet restrictor “pool” gasoline at the restrictor's opening, if fueling is attempted when the spout of a pump nozzle is not inserted into the restrictor opening. Historically, this had been accomplished by a spring-loaded door on the inside of the restrictor opening, which would be pushed open by inserting the spout of an unleaded gasoline nozzle. Since leaded gasoline nozzle spouts were larger than the inlet restrictor opening, they did not fit into the restrictor opening or push open the spring loaded door. Fueling with leaded gasoline would require the nozzle spout to be positioned in front of the restrictor opening and spring-loaded door. If fueling were attempted in this manner, the gasoline would pool at the restrictor opening and cause the nozzle's automatic shut-off device to activate. The related § 80.24(b)(2) exempted motorcycle manufacturers from meeting the “pooling” requirements of § 80.24(b)(1).

Section 211(n) of the Clean Air Act, 42 U.S.C. 7545(n), prohibits the introduction of gasoline containing lead or lead additives into commerce for use as a motor vehicle fuel after December 31, 1995. For consistency with this Clean Air Act prohibition, we published in the Federal Register on February 2, 1996 a direct final rule and associated notice of proposed rulemaking revising our regulations (61 FR 3832 and 61 FR 3894, respectively). The direct final rule became effective on March 4, 1996 except for language associated with § 80.24(b). We withdrew language for that paragraph from the direct final rule on March 4, 1996 (61 FR 8221) due to adverse comment, and subsequently published revised language in the Federal Register on June 6, 1996 (61 FR 28763).

In the February 2, 1996 direct final rule and associated notice of proposed rulemaking, we removed various portions of § 80.24, including the introductory text, and modified § 80.24(b) to make the size requirements of the tank filler inlet applicable to all new motor vehicles, and not just to those equipped with an emission control device that would be significantly impaired by the use of leaded gasoline. We reasoned that retaining the requirement for the tank filler inlet restrictor would conform with the statutory ban prohibiting the use of gasoline containing lead or lead additives as a motor vehicle fuel. The restrictor requirements for motor vehicles would match the nozzle size requirement for dispensing unleaded gasoline, which we had retained in § 80.22(f)(2). Further, General Motors and several gasoline pump nozzle manufacturers had requested that the specification for the tank filler inlet size be retained so that automobile equipment would continue to be compatible with Stage II vapor recovery pump nozzles. We simplified the applicability language of § 80.24(b) to refer to all motor vehicles, instead of motor vehicles equipped with an emission control device that would be significantly impaired by the use of leaded gasoline, because we thought that all motor vehicles were manufactured with tank filler inlet restrictors at that time. We did not intend to broaden the applicability of § 80.24(b).

In the February 2, 1996 direct final rule and associated notice of proposed rulemaking, we also removed §§ 80.24(b)(1) and 80.24(b)(2). We believed misfueling would be unlikely, making the § 80.24(b)(1) “pooling” safeguard against misfueling unnecessary. Once we removed § 80.24(b)(1), it was appropriate for us to remove § 80.24(b)(2) as well, since § 80.24(b)(2) exempted motorcycle manufacturers from the requirements of § 80.24(b)(1).

We received an adverse comment from Harley Davidson, Inc. (Harley) on the revised language of 40 CFR 80.24(b) in the February 2, 1996 direct final rule and proposed rule. 1 In its comment, Harley stated that motorcycles generally do not use emission control devices that would be significantly impaired by the use of leaded gasoline (e.g., catalytic converters) and are therefore not manufactured with tank filler inlet restrictors matching the requirements of the existing § 80.24(b). The February 2, 1996 direct final rule and associated notice of proposed rulemaking would have required these motorcycles to meet the fuel inlet size requirements of 40 CFR § 80.24(b), thereby causing additional economic burden and manufacturing complexity for Harley. We did not intend or foresee that we would be expanding the applicability of § 80.24(b) by the revised applicability language. Because of this adverse comment, we withdrew paragraph 40 CFR 80.24(b) from the direct final rule, and published it in the June 6, 1996 final rule with its previous applicability.

There are few, if any, offsetting environmental benefits to support the continued use of gasoline tank filler inlet restrictors in motorcycles equipped with emission control devices that would be significantly impaired by the use of leaded gasoline. Today there is relatively little risk of misfueling a motorcycle. Gasoline tank filler inlet restrictors were originally required to prevent motor vehicles with an emission control device, such as a catalytic converter, from using leaded gasoline. Leaded gasoline can damage catalytic converters and certain other emission control devices. Significantly, leaded gasoline has now been banned from use in all motor vehicles for over five years and is generally no longer available for sale at gasoline filling stations. Also, it is unlikely that a gasoline tank filler inlet restrictor on a motorcycle helps to control gasoline vapors when the motorcycle is refueled. Although a vapor recovery gasoline nozzle, in conjunction with the gasoline tank filler inlet restrictor, helps to control gasoline vapors and emissions when used to refuel most motor vehicles, they are relatively ineffective when used to refuel motorcycles.

During refueling of a car or truck, the fuel nozzle spout is inserted into the fill tube and through the filler neck restrictor plate. The fuel nozzle automatically stops the flow of gasoline when it senses a sufficiently high level of gasoline vapors below the restrictor plate, which indicates the fuel tank is full. We understand that, beginning with the introduction of Stage I vapor recovery fueling systems in the early 1990s and continuing with current Stage II vapor recovery systems, the fuel tank inlet restrictor of a car or truck has been used as a guide, a seat and a pressure contact point for some vapor recovery gasoline nozzle spouts.

For some vapor recovery fueling systems, the restrictor plate lines up the nozzle and helps concentrate the fugitive emissions for collection. Without the restrictor plate, more fugitive emissions would be released. The “balance” type of vapor recovery system uses a boot to seal around the outside of the tank filler inlet tube. While this system does not require the restrictor plate to help capture fugitive emissions, it requires the restrictor plate to push against in order to activate an interlock. An “emission” or “efficiency” control vapor recovery device does not need the restrictor plate to control fugitive emissions. This device consists of a cup, which has an outside diameter the same as the inside diameter of the fill hole, that is clipped to the spout. A similar type of vapor recovery system, the Marconi system, does not need the restrictor plate or the plastic cup. 2

Most on-board vapor recovery systems, which are required for light-duty vehicles and light-duty trucks but not for motorcycles, are also designed around the restrictor plate. A seal is needed between the pump nozzle and the tank filler inlet tube to prevent fugitive emissions from escaping. This seal is normally located below the restrictor plate, and uses the restrictor plate to line-up the nozzle with the seal. Fugitive emissions below the seal are then diverted to a canister in the vehicle. 3

We understand that gasoline tank filler inlet restrictors do not work well with most motorcycle fuel tanks, especially the saddle type of tank, because of their shallow depth. The use of gasoline tank inlet restrictors in motorcycles may in fact contribute to unnecessary releases of gasoline vapors and emissions. Unlike a car or truck, motorcycles are typically fueled while the operator observes the tank fuel level, similar to filling a small gasoline container typically used to refuel lawnmowers and other small gasoline powered equipment. However, the restrictor plate obstructs the view of the fuel level, and could contribute to inadvertent fuel overfill and spillage. If fueling with the “balance” type of vapor recovery nozzle, motorcycle operators generally pull back and hold the rubber boot to activate the interlock and allow for better visibility, but that defeats the vapor recovery system. 4 Further, the filler inlet restrictor may cause the nozzle spout to be inserted deeper into the motorcycle tank than otherwise would be necessary, potentially causing increased splash back from the shallow tank. Besides causing excess gasoline vapors and spitback through the restrictor plate openings, this splashback could cause the pump nozzle to prematurely stop the flow of gasoline. The operator may have to reactivate the pump nozzle, possible several times, before the tank is full.

These problems were not much of an issue in the 1995 and earlier time frame, because only relatively few motorcycles were equipped with catalytic converters, and thus, only relatively few required tank inlet restrictors. However, a significant number of 2001 model year motorcycles have been equipped with catalytic converters.

Today's direct final rule revises 40 CFR 80.24(b) to exempt motorcycles equipped with an emission control device that will be affected by the use of leaded gasoline, such as a catalytic converter, from having to be equipped with a fuel tank inlet restrictor.

EPA is publishing this rule without prior proposal because we view this as a noncontroversial action and anticipate no adverse comment. This rulemaking is very narrow in scope and exempts motorcycles from a requirement that, when applied to motorcycles, generally has no air quality benefits and that, in fact, could cause increased evaporative emissions from motorcycles during refueling. In the “Proposed Rules” section of today's Federal Register , however, we are publishing a separate document that will serve as the proposal to exempt motorcycles from having to be equipped with a tank filler inlet restrictor if adverse comments are filed. This direct final rule will be effective on December 31, 2001 without further notice unless we receive adverse comment by November 30, 2001. If EPA receives adverse comment, we will publish a timely withdrawal of this direct final rule in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on today's proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

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

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

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

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

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

It has been determined that this rule is not a “significant regulatory action” under the terms of EO 12866 and is therefore not subject to OMB review.

This action does not impose any new information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , and therefore is not subject to these requirements.

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

EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. Today's rule exempts motorcycles from a current provision that requires them, under certain circumstances, to be equipped with fuel inlet restrictors, and thus avoids the costs imposed by the existing Federal regulations. Today's rule, therefore, is not subject to the requirements of sections 202 and 205 of the UMRA.

EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. As discussed above, the rule is a deregulatory action and affects only motorcycle manufacturers.

Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, Apr. 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 the Executive Order because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. EPA reduced the content of lead in leaded gasoline, because EPA found that lead particle emissions from motor vehicles presented a significant risk of harm to the health of urban populations, especially children (38 FR 33734, Dec. 6, 1973). Congress ultimately banned the use of leaded gasoline in motor vehicles after 1995. 42 U.S.C. 7545(n). Gasoline tank filler inlet restrictors were related to the phase-out of leaded gasoline to prevent a motor vehicle with an emission control device, such as a catalytic converter, from using leaded gasoline. Leaded gasoline can damage such emission control devices. Today there is relatively little risk of misfueling a motorcycle with an emission control device that could be damaged by the use of leaded gasoline, because leaded gasoline has now been banned from use in all motor vehicles for over five years and is generally no longer available for sale at gasoline filling stations.

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

This rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States or on the distribution of power and responsibilities among the various levels of government as specified in Executive Order 13132. Today's rule eliminates the existing requirement that manufacturers of motorcycles must equip certain motorcycles with fuel tank filler inlet restrictors. Thus, Executive Order 13132 does not apply to this rule.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Pub L. No. 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

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

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(a).

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

Today's rule is a deregulatory action and affects all motorcycle manufacturers. It eliminates the existing requirement that manufacturers of motorcycles must equip certain motorcycles with fuel tank filler inlet restrictors. We have therefore concluded that today's rule will relieve regulatory burden for any small entity.

On January 1, 2001, Executive Order 13084 was superseded by Executive Order 13175. However, this rule was developed during the period when Executive Order 13084 was still in force, and so tribal considerations were addressed under Executive Order 13084. Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, Nov. 6, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.”

Today's rule does not have tribal implications. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. The rule affects the applicability of the fuel tank filler inlet restrictor to motorcycles. It therefore affects only manufacturers of motorcycles. Thus, Executive Order 13175 does not apply to this rule.

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

A copy of this action is available on the Internet at http://www.epa.gov/otaq under the title: “Direct Final Rule—Prohibition on Gasoline Containing Lead or Lead Additives for Highway Use: Fuel Inlet Restrictor Exemption for Motorcycles.”

Authority for this action is in sections 211, and 301(a) of the Clean Air Act, 42 U.S.C. 7545, 7601(a).