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

Under the authority of the OFPA, the National List can be amended by the Secretary based on substance recommendations developed by the NOSB. This final rule amends the National List to enact recommendations submitted to the Secretary by the NOSB from November 15, 2000, through March 3, 2005.

The following provides an overview of the amendments to designated sections of the National List regulations:

This final rule amends § 205.2 of the NOP regulations by adding the following terms:

AMDUCA. The Animal Medicinal Drug Use Clarification Act of 1994 (Pub. L. 103-396).

Excipients. Any ingredients that are intentionally added to livestock medications but do not exert therapeutic or diagnostic effects at the intended dosage, although they may act to improve product delivery (e.g., enhancing absorption or controlling release of the drug substance). Examples of such ingredients include fillers, extenders, diluents, wetting agents, solvents, emulsifiers, preservatives, flavors, absorption enhancers, sustained-release matrices, and coloring agents.

This final rule amends paragraph (a) of § 205.603 of the National List regulations by adding the following substances:

Atropine (CAS #-51-55-8)—federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires: (1) Use by or on the lawful written order of a licensed veterinarian, in full compliance with the AMDUCA; and (2) a meat withdrawal period of at least 56 days after administering to livestock intended for slaughter; and a milk discard period of at least 12 days after administering to dairy animals.

Butorphanol (CAS #-42408-82-2)—federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires: (1) Use by or on the lawful written order of a licensed veterinarian, in full compliance with the AMDUCA; and (2) a meat withdrawal period of at least 42 days after administering to livestock intended for slaughter; and a milk discard period of at least 8 days after administering to dairy animals.

Flunixin (CAS #-38677-85-9)—in accordance with approved labeling; except that for use under 7 CFR part 205, the NOP requires a withdrawal period of at least two-times that required by the FDA.

Furosemide (CAS #-54-31-9)—in accordance with approved labeling; except that for use under 7 CFR part 205, the NOP requires a withdrawal period of at least two-times that required by the FDA.

Magnesium hydroxide (CAS #-1309-42-8)—federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires use by or on the lawful written order of a licensed veterinarian, in full compliance with the AMDUCA.

Peroxyacetic/Peracetic acid (CAS #-79-21-0)—for sanitizing facility and processing equipment.

Poloxalene (CAS #-9003-11-6)—for use under 7 CFR part 205, the NOP requires that poloxalene only be used for the emergency treatment of bloat.

Tolazoline (CAS #-59-98-3)—federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires: (1) Use by or on the lawful written order of a licensed veterinarian, in full compliance with the AMDUCA; (2) use only to reverse the effects of sedation and analgesia caused by Xylazine; and (3) a meat withdrawal period of at least 8 days after administering to livestock intended for slaughter; and a milk discard period of at least 4 days after administering to dairy animals.

Xylazine (CAS #-7361-61-7)—federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires: (1) Use by or on the lawful written order of a licensed veterinarian, in full compliance with the AMDUCA; (2) the existence of an emergency; and (3) a meat withdrawal period of at least 8 days after administering to livestock intended for slaughter; and a milk discard period of at least 4 days after administering to dairy animals.

This final rule amends § 205.603 of the National List regulations by adding a new paragraph (f) to read as follows:

Excipients, only for use in the manufacture of drugs used to treat organic livestock when the excipient is: Identified by the FDA as Generally Recognized As Safe; Approved by the FDA as a food additive; or Included in the FDA review and approval of a New Animal Drug Application or New Drug Application.

This final rule also makes a technical correction to § 205.603 paragraph (e) by removing the word “a” from between “or” and “synthetic”.

Six notices were published regarding the meetings of the NOSB and its deliberations on recommendations and substances petitioned for amending the National List. Substances and recommendations included in this final rule were announced for NOSB deliberation in the following Federal Register Notices: (1) 65 FR 64657, October 30, 2000, (Calcium borogluconate); (2) 66 FR 10873, February 20, 2001, (Poloxalene); (3) 67 FR 54784, August 26, 2002, (Activated charcoal, Bismuth subsalicylate, Butorphanol, Epinephrine, Kaolin pectin, Magnesium hydroxide, Potassium sorbate, Propylene glycol, Tolazoline, and Xylazine); (4) 67 FR 62949, October 9, 2002, (Excipients and Flunixin); (5) 68 FR 23277, May 1, 2003, (Atropine, Calcium propionate, Furosemide, and Mineral oil); and (6) 69 FR 18036, April 6, 2004, (Moxidectin). The proposed rule for this final rule was published on July 17, 2006 (71 FR 40624).

The OFPA, as amended (7 U.S.C. 6501 et seq. ), authorizes the Secretary to make amendments to the National List based on substance recommendations developed by the NOSB. Sections 6518(k)(2) and 6518(n) of OFPA authorize the NOSB to develop substance recommendations to the National List for submission to the Secretary and establish a petition process by which persons may petition the NOSB for the purpose of having substances evaluated for inclusion on or deletion from the National List. The National List petition process is implemented under § 205.607 of the NOP regulations. The current petition process (72 FR 2167) can be accessed through the NOP Web site at http://www.ams.usda.gov/nop.

This action has been determined not significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget.

Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. This final rule is not intended to have a retroactive effect.

States and local jurisdictions are preempted under the OFPA from creating programs of accreditation for private persons or State officials who want to become certifying agents of organic farms or handling operations. A governing State official would have to apply to USDA to be accredited as a certifying agent, as described in § 2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under §§ 2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507) from creating certification programs to certify organic farms or handling operations unless the State programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA.

Pursuant to § 2108(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a State organic certification program may contain additional requirements for the production and handling of organically produced agricultural products that are produced in the State and for the certification of organic farm and handling operations located within the State under certain circumstances. Such additional requirements must: (a) Further the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) not be discriminatory toward agricultural commodities organically produced in other States, and (d) not be effective until approved by the Secretary.

Pursuant to § 2120(f) of the OFPA (7 U.S.C. 6519(f)), this final rule would not alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601 et seq. ), the Poultry Products Inspections Act (21 U.S.C. 451 et seq. ), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq. ), concerning meat, poultry, and egg products, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq. ), nor the authority of the Administrator of the Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq. ).

Section 2121 of the OFPA (7 U.S.C. 6520) provides for the Secretary to establish an expedited administrative appeals procedure under which persons may appeal an action of the Secretary, the applicable governing State official, or a certifying agent under this title that adversely affects such person or is inconsistent with the organic certification program established under this title. The OFPA also provides that the U.S. District Court for the district in which a person is located has jurisdiction to review the Secretary's decision.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose is to fit regulatory actions to the scale of businesses subject to the action. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

Pursuant to the requirements set forth in the RFA, the Agricultural Marketing Service (AMS) performed an economic impact analysis on small entities in the final rule published in the Federal Register on December 21, 2000 (65 FR 80548). The AMS has also considered the economic impact of this action on small entities. The impact on entities affected by this final rule would not be significant. The effect of this final rule would be to allow the use of additional substances in agricultural production and handling. This action would modify the regulations to provide small entities with more tools to use in day-to-day operations. The AMS concludes that the economic impact of this addition of allowed substances, if any, would be minimal and entirely beneficial to small agricultural service firms. Accordingly, USDA certifies that this rule will not have a significant economic impact on a substantial number of small entities.

Small agricultural service firms, which include producers, handlers, and accredited certifying agents, have been defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $6,500,000 and small agricultural producers are defined as those having annual receipts of less than $750,000. This final rule would have an impact on a substantial number of small entities.

The U.S. organic industry at the end of 2001 included nearly 6,949 certified organic crop and livestock operations. Data on the numbers of certified organic handling operations (any operation that transforms raw product into processed products using organic ingredients) were not available at the time of survey in 2001; but they were estimated to be in the thousands. By the end of 2006, the number of certified organic crop, livestock, and handling operations totaled over 14,800 operations based on reports by certifying agents to the NOP as part of their annual reporting requirements. AMS believes that most of these entities would be considered small entities under the criteria established by SBA.

U.S. sales of organic food and beverages have grown from $1 billion in 1990 to nearly $17 billion in 2006. Organic food sales are projected to reach $23.8 billion for 2010. The organic industry is viewed as the fastest growing sector of agriculture, currently representing nearly 3 percent of overall food and beverage sales. Since 1990, organic retail sales have historically demonstrated a growth rate between 20 to 24 percent each year including a 22 percent increase in 2006.

In addition, 95 certifying agents are currently accredited by USDA to provide certification services to producers and handlers under the NOP. A complete list of names and addresses of accredited certifying agents may be found on the NOP web site, at http://www.ams.usda.gov/nop. AMS believes that most of these entities would be considered small entities under the criteria established by the SBA.

Under the OFPA, no additional collection or recordkeeping requirements are imposed on the public by this final rule. Accordingly, OMB clearance is not required by section 350(h) of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq. , or OMB's implementing regulation at 5 CFR part 1320.

AMS is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.

AMS received 79 comments on proposed rule TM-03-04. Comments were received from organic livestock producers, veterinarians, accredited certifying agents, consumers, retailers, trade associations, manufacturers of animal medications, and public interest groups. A number of comments expressed total opposition to all amendments proposed in TM-03-04 and asserted that such amendments weakened the NOP regulations. A few comments supported the addition of all the proposed amendments without changes. Many comments indicated conditional support for some of the proposed amendments; however, they suggested modifications be made to their inclusion on the National List. Such comments conveyed that the proposed amendments altered the original intent for how the NOSB recommended the substance be used in organic livestock production. Some of those comments proposed that if the substance was not to be listed as recommended by the NOSB, then the proposed amendment should not be added to the National List.

Additional comments raised concern regarding USDA's decision not to include certain substances on the National List. These substances include activated charcoal, calcium borogluconate, calcium propionate, kaolin pectin, mineral oil, propylene glycol, and epinephrine. Comments also indicated that a few of the proposed amendments required further clarification or correction to avoid misinterpretation of the regulations and misapplication of the substance.

The following changes are made based upon comments received.

Calcium propionate as a mold inhibitor in dry formulated herbal products. Some comments expressed opposition to the proposed amendment to add Calcium propionate as a mold inhibitor in dry herbal products to § 205.603(d). At their May 2003 meeting, the NOSB recommended adding Calcium propionate as a mold inhibitor in dry formulated herbal “remedies.” Comments on Calcium propionate concluded that the NOSB did not recommend Calcium propionate to be added onto the National List as a livestock feed additive under § 205.603(d); rather, these comments argued that the NOSB recommended Calcium propionate be included as a “medical treatment” and listed under § 205.603(a). Comments further suggested that if calcium propionate could not be listed under § 205.603(a) that it should not be included on the National List because the authorization for the substance could be misinterpreted to allow its use for organic livestock feed, which was not the intent of the proposal or the NOSB recommendation.

We agree with these comments that the proposed amendment for Calcium propionate did not correspond with the NOSB recommendation. Based on the consultation between USDA and FDA, we were informed that “dry formulated herbal remedies” are not recognized as a “medical treatment” for animal illness and could not be authorized as such in the Federal Register and under § 205.603(a) of the National List without having been approved by FDA through a New Animal Drug Application (NADA).

As a result, USDA researched the most appropriate way to include the substance on the National List to reflect the NOSB's recommendation. To that effect, we recognized that Calcium propionate did not have any approved uses as a medical treatment under the FDA regulations. However, under 21 CFR 582.3221 (Animal Drugs, Feeds, and Related Products), it is approved as a chemical preservative that is Generally Recognized as Safe. Therefore, since “dry formulated herbal remedies” are not recognized as medical treatments under the FDA's regulations and could not be prescribed as such in the National List, the USDA believed that it could implement the recommendation and intent of the NOSB by permitting the use of Calcium propionate as a mold inhibitor in dry formulated “products” (instead of “remedies”) by authorizing it as a feed. We concluded that herbs (agricultural products) would be fed to an animal and would therefore be considered part of the feed provisions of the National List.

In addition to the general public comments received on Calcium propionate, we received comments from the FDA concerning the proposed language to authorize the use of Calcium propionate as a “mold inhibitor.” The FDA shared that Calcium propionate is not authorized for use as a “mold inhibitor,” but a “chemical preservative.” Therefore, it must only be recognized for use within the parameters for which it has been authorized. The FDA also commented that the AMDUCA does not apply to Calcium propionate and cannot be used to attempt broader uses than authorized by the FDA.

As a result, based on comments received on Calcium propionate's proposed addition to § 205.603(d) of the National List and information shared by the FDA, we have decided not to add Calcium propionate to the National List. Instead, we are referring this substance back to the NOSB for the purpose of reconsidering its placement on the National List ( i.e. § 205.603(d)), as it relates to the regulatory provisions of the FDA).

Incorrect CAS number for Butorphanol. One commenter observed that the proposed rule included an incorrect CAS number for Butorphanol. The proposed rule listed Butorphanol's CAS number as 14887-18-9. This comment indicated that the proper CAS number is 42408-82-2. NOP research confirmed the CAS number provided within the comment is accurate. Therefore, we agree with this comment and have inserted the proper CAS number into the final rule.

Extended Withdrawal Periods. Many commenters disagreed with USDA's decision to omit the NOSB's recommendations to extend the withdrawal periods for a number of proposed livestock medications ( e.g. Atropine, Butorphanol, Flunixin, Furosemide, Tolazoline, and Xylazine). Commenters argued that the NOP has the authority to require stricter standards for animal drug use than those specified by the FDA. According to the commenters, all drugs permitted for use in organic farming are subject to stricter standards than those used by nonorganic farmers, because they are subject to certifiers' review and approval in an Organic System Plan (OSP). Commenters also noted that there are currently several livestock medications (Ivermectin, Lidocaine, and Procaine) on the National List whose withdrawal periods already extend beyond that required by FDA.

Commenters expressed that USDA should either accept the NOSB's recommendation to extend the withdrawal period of the proposed livestock medications or not amend the National List at all. Without the extended withdrawal period, according to these commenters, the NOSB's recommendations would be weakened and the synthetic substances would be allowed to be used in ways that the NOSB did not intend.

As a proposed compromise to satisfy the intent of the NOSB, many commenters suggested that USDA should consider amending the annotations of Atropine, Butorphanol, Flunixin, Furosemide, Tolazoline, and Xylazine by establishing extended withdrawal periods, calculated using withdrawal times from the Food Animal Residue Avoidance Databank (FARAD). The FARAD is a National Food Safety Project administered through the USDA Cooperative State Research, Education, and Extension Service. It is a system designed to provide livestock producers, extension specialists, and veterinarians with practical information on how to avoid drug, pesticide and environmental contaminant residue problems. FARAD is a repository of comprehensive residue avoidance information. It is also sanctioned to provide “withholding period” (also known as withdrawal period) estimates to the U.S. Pharmacopeia-Drug Information (USP-DI) Veterinary Medicine Advisory Committee. Commenters suggested that USDA account for an extra margin of at least double the withdrawal times of FARAD to safely capture the intent of the NOSB.

USDA agrees with the position stated in the comments. Since many of the aforementioned livestock medications are being authorized for use under AMDUCA and do not have formal FDA approved labels for the use recommended by the NOSB, veterinarians who are authorized to administer the medical treatment to organic livestock would be responsible for establishing a substantially extended withdrawal period prior to the marketing of milk, meat, eggs, or other edible products. The FDA requires that these withdrawal periods be supported by appropriate scientific information, if applicable. The FDA also requires that the veterinarian take appropriate measures to assure the assigned timeframes for withdrawal are met and that no illegal drug residues occur in any food-producing animal subjected to extra-label treatment (21 CFR 530.20(a)(2)(ii); (iv)). Therefore, in an effort to ensure uniformity and consistency regarding the application of withdrawal periods, USDA has amended the annotations of Atropine, Butorphanol, Tolazine, and Xylazine to reflect minimum withdrawal periods that are double the FARAD withdrawal period suggested for the administration of the referenced livestock medication.

With respect to the withdrawal periods for Flunixin and Furosemide, however, these drugs do have FDA approved labels for the use recommended by the NOSB and were not proposed for use in organic livestock production under AMDUCA but rather existing FDA approved animal drug use and labeling, 21 CFR part 520. As a result, the withdrawal period associated with the use of these substances under the NOP would be based upon the withdrawal period established by the FDA, as opposed to a FARAD withdrawal period.

Based on public comment, USDA consulted further with the FDA, concerning the ability to extend the withdrawal period on these approved drugs. Based on our consultations, USDA agreed to clarify the rationale for extending the FDA established withdrawal period. Secondly, USDA agreed to clarify the language used to authorize the use of the substances by indicating the extended withdrawal periods (at least two-times that required by the FDA) were only relevant for use of the substances under the NOP regulations.

Therefore, to clarify our rationale for extending the withdrawal periods established by the FDA, we acknowledge that this determination was not based on scientific research or risk assessments. The decision to extend the FDA withdrawal periods (or any other withdrawal period) for the use of Flunixin and Furosemide (and other substances) was based on consumer preference and the recommendations of the NOSB. FDA exercises full responsibility for determining and enforcing the withdrawal intervals for animal drugs. No food safety arguments are used or implied to support the use of extended withdrawal periods authorized under the NOP regulations. Rather, we determined that extended withdrawal periods are more compatible with consumer expectations of organically raised animals.

Verification of lawful order of a licensed veterinarian. Federal law restricts Atropine, Butorphanol, Magnesium hydroxide, Tolazine, and Xylazine to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. For use under 7 CFR part 205, the NOP is requiring use by or on the lawful written order of a licensed veterinarian. Further, under the NOP, a written order is necessary for the livestock producer to prove compliance with paragraph (b) of § 205.238 Livestock health care practice standard. Written orders will also facilitate compliance with the recordkeeping provisions of § 205.103.

Other use restrictions for Tolazine and Xylazine. In addition to the use restrictions noted above, in response to comments, the NOP has added the following use restrictions. For Tolazine, the NOP has added the requirement that Tolazine only be used to reverse the effects of sedation and analgesia caused by Xylazine as originally recommended by the NOSB at its September 17-19, 2002, meeting in Washington, DC. For Xylazine, the NOP has added the requirement for the existence of an emergency as originally recommended by the NOSB at its September 17-19, 2002, meeting in Washington, DC.

Excipients. Commenters suggested that the proposed amendment to include excipients onto the National List was too broad or needed further clarification to reduce possible confusion for producers, certifying agents, and consumers. Commenters asserted that the proposed language could lead readers to believe that excipients are permitted for use in livestock feed or feed supplements.

We do not agree that the proposed language is so misleading to readers. However, we do believe that a definition of excipients would help clarify its meaning. Therefore, we have amended the regulations to include the following definition for excipients: “any ingredients intentionally added to livestock medications but that do not exert therapeutic or diagnostic effects at the intended dosage, although they may act to improve product delivery (e.g., enhancing absorption or controlling release of the drug substance). Examples include fillers, extenders, diluents, wetting agents, solvents, emulsifiers, preservatives, flavors, absorption enhancers, sustained-release matrices, and coloring agents.”

Poloxalene annotation. A number of comments objected to USDA omitting the NOSB's recommendation to authorize the use of Poloxalene with the annotation “only be used for emergency treatment of bloat.” With regard to Poloxalene and the proposed language in TM-03-04, commenters expressed concern that the proposed language would allow routine use of Poloxalene. As a result, commenters believed the proposed language for Poloxalene represents the use of a substance that was not approved by the NOSB.

We agree that the proposed language in TM-03-04, authorizing the use of Poloxalene, did not restrict its use for only the “emergency treatment of bloat,” as the NOSB had recommended. Based on our initial consultations with the FDA, we originally proposed the use of the substance as follows “in accordance with approved labeling.” However, after reviewing the comments and further consultation with the FDA, we have modified the authorizing language to (1) reflect the intent of the NOSB and (2) clarify the language used to authorize the use of the substance by indicating that the restricted use of Poloxalene (only for the emergency treatment of bloat) is only relevant for use of the substance under the NOP.

Exclusion of Moxidectin. A number of commenters requested that USDA include Moxidectin on the National List, as the NOSB had recommended (to control internal parasites). We did not propose to add Moxidectin to the National List because the substance is a macrolide antibiotic and does not comply with the April 22, 2005, NOP policy statement on antibiotic use in livestock production. The statement provides that the use of antibiotics and other prohibited substances is not allowed for organically produced livestock or their edible products once a producer is certified organic. Commenters stated that USDA's rationale for not adding Moxidectin to the National List was arbitrary and without scientific or regulatory basis. Commenters argued that Moxidectin should not be considered an antibiotic, but a parasiticide, and therefore should be allowed for use as medication to treat organic livestock. One commenter presented information that attempted to delineate the difference between an antibiotic and a parasiticide. The comment argued that the defining feature of an antibiotic is its ability to inhibit the growth of microorganisms or kill them outright. It included that Moxidectin does not have this capacity. Instead, Moxidectin targets parasites, rather than bacterial infections.

We have verified the information shared through public comment and agree that Moxidectin, even though an animal drug that is a macrolide antibiotic, does not function as an antibiotic (targeting bacterial infections), but as a parasiticide (targeting parasites/helminthes, e.g., roundworms, lungworms, hookworms, flatworms, etc.). As a result, we will initiate proposed rulemaking to authorize Moxidectin as a livestock medication to control internal parasites.

Removal of Bismuth subsalicylate (CAS #-14887-18-9). Bismuth subsalicylate was proposed for inclusion on the National List. It was proposed for use as a drug restricted to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the FDA regulations. In the proposed rule, the NOP shared that consultations with the FDA revealed that Bismuth subsalicylate is approved as a drug for use in humans (FDA, “Approved Drug Products with Therapeutic Equivalence Evaluations, 2005”) and that New Animal Drug Application (NADA) approvals for Bismuth subsalicylate were not identified. The NOP further stated that despite the absence of a NADA approval for Bismuth subsalicylate, the substance could be permitted for use in livestock production if used in full compliance with the AMDUCA and 21 CFR part 530 of the FDA regulations, “Provision permitting extra-label use of animal drugs.” This action was based on the rationale that Bismuth subsalicylate was an approved human drug and qualified for use under the provisions of AMDUCA.

However, in response to the proposed rule, the FDA informed the NOP that Bismuth subsalicylate could not be authorized for use in livestock production under the AMDUCA and 21 CFR part 530 of the FDA regulations, because Bismuth subsalicylate is not approved as an independent, active ingredient for use as a human drug, but only in combination with Metronidazole and Tetracycline hydrochloride. The FDA further commented that over-the-counter medications do not qualify for use under the provisions of AMDUCA and 21 CFR part 530. As a result, they advised the NOP to remove Bismuth subsalicylate from the proposed amendments to the National List; Bismuth subsalicylate has been removed from inclusion.

Several of the new substance listings contain the term “AMDUCA.” For the convenience of persons using the NOP regulations we have added a definition of AMDUCA to § 205.2. That definition reads: “AMDUCA. The Animal Medicinal Drug Use Clarification Act of 1994 (Pub. L. 103-396).”

While preparing this final rule, we noted a technical error in the wording of § 205.603(e). Accordingly, this final rule also makes a technical correction to § 205.603 paragraph (e) by removing the word “a” from between “or” and “synthetic”. Section 205.603(e) now reads: “As synthetic inert ingredients as classified by the Environmental Protection Agency (EPA), for use with nonsynthetic substances or synthetic substances listed in this section and used as an active pesticide ingredient in accordance with any limitations on the use of such substances.”

A number of commenters opposed the addition of any of the proposed amendments to the National List. The majority of these comments did not provide any evidence under the OFPA and NOP regulations that would support the position stated. Instead, these commenters stated the addition of any of the proposed amendments weakened the NOP regulations and compromised the integrity of organic foods. We considered these comments but have determined that the record supports the need for livestock medications in the interest of humane treatment of livestock. We believe commenters' concerns have been addressed by including double withdrawal periods and other use restrictions.

Six non-accepted substances . Several comments, including a number from organic dairy farmers, supported adding Activated charcoal, Calcium borogluconate, Calcium propionate (as a medical treatment for milk fever), Kaolin pectin, Mineral oil, and Propylene glycol onto § 205.603(a) as substances that should be allowed for use as medical treatments in organic livestock production. These substances were not included as amendments to the National List in the proposed rule. The NOSB recommended that the Secretary include these substances onto the National List, in § 205.603, as veterinary treatments in organic livestock production. Comments in support of including these substances onto the National List argued that these substances were essential tools for dairy farmers, effective in restoring animal health, and widely available and commonly used by livestock producers and veterinarians, with no significant environmental impacts. Additionally, a few of these commenters argued that FDA considers these drugs to be a low regulatory priority or “allowed by regulatory discretion.”

As stated in the proposed rule, consultation with the FDA revealed that Activated charcoal, Calcium borogluconate, Calcium propionate, Kaolin pectin, Mineral oil, and Propylene glycol have not received approval through the FDA drug approval process to be authorized as medical treatments for livestock. Consultation also revealed that the proposed substances could not qualify for extra-label use by a licensed veterinarian under AMDUCA. As a result, the synthetic forms of these substances remain prohibited for use in organic livestock production.

One commenter asserted that USDA should have not stated that the six substances could not be used in organic livestock production, because some of the substances could be sourced and used in nonsynthetic form. USDA agrees that nonsynthetic forms of the medication would not be prohibited from use in organic livestock production. The proposed rule did not address the nonsynthetic forms of the medications because the NOSB's recommendations only addressed the synthetic forms. As a result, we reiterate that the prohibited use of the six substances was made in the context of the synthetic form of the substances, not the nonsynthetic form.

Epinephrine as a prohibited nonsynthetic substance . A few comments were received concerning USDA's decision not to include Epinephrine as a prohibited nonsynthetic substance on the National List. Some comments were in favor of the proposed action on Epinephrine, while a few did not favor USDA's decision to exclude the substance from the National List. We also received one comment that recommended USDA, with respect to the FDA restriction on the use of Epinephrine, consult with the NOSB to see if there is still a need to identify the substance as a prohibited nonsynthetic on the National List.

The proposed rule acknowledged that Epinephrine is a nonsynthetic substance; and it emphasized that nonsynthetic substances are allowed in organic production, unless prohibited. For instance, under the NOP regulations, a livestock producer may not administer animal drugs in violation of the Federal Food, Drug and Cosmetic Act. The proposed rule also noted that the FDA regulations currently restrict the use of the medication to the emergency treatment of anaphylactic shock in cattle, horses, sheep, and swine, which is what the NOSB had recommended. As a result, we did not see a clear need to include the substance on the National List. USDA will consult with the NOSB to see if there is still a need to identify Epinephrine as a prohibited nonsynthetic on the National List.

This final rule reflects recommendations submitted to the Secretary by the NOSB. The substances being added to the National List were based on petitions from the industry and evaluated by the NOSB using criteria in the Act and the regulations. Because these substances are crucial to organic livestock production operations, producers should be able to use them in their operations as soon as possible. Accordingly, AMS finds that good cause exists under 5 U.S.C. 553(d)(3) for not postponing the effective date of this rule until 30 days after publication in the Federal Register .

The National Securities Markets Improvement Act of 1996 (NSMIA). (Pub. L. 104-290, 110 Stat. 3416) amended section 7 of the Securities Exchange of 1934 (15 U.S.C. 78g) to limit the Board's authority to impose restrictions on credit extended, maintained, or arranged to or for a member of a national securities exchange or a registered broker or dealer, a substantial portion of whose business consists of transactions with persons other than brokers or dealers, or to finance its activities as a market maker or an underwriter. Restrictions on these types of credit were found at that time in Regulations G, T and U (12 CFR Parts 207, 220, and 221, respectively).

NSMIA gave the Board the authority to maintain or adopt restrictions on these types of credit if it determines that such action is necessary or appropriate in the public interest or for the protection of investors. In November 1996, the Board adopted an interpretation of its margin regulations (1996 interpretation), indicating that the Board had not made such a finding (61 FR 60166, November 26, 1996). The 1996 interpretation stated the Board's belief that the restrictions on these types of credit found in the Regulations G, T and U had been superseded by NSMIA.

NSMIA also repealed section 8(a) of the Securities Exchange Act of 1934, dealing with extensions of credit to brokers and dealers collateralized with exchange-traded securities. The Board's 1996 interpretation indicated that the provisions in Regulations G, T and U adopted to implement section 8(a) of the Securities Exchange Act of 1934 were without effect in light of NSMIA.

The text of the 1996 interpretation was published as part of Regulation G, and Regulations T and U were amended with interpretations that referred to the text of the 1996 interpretation appearing in Regulation G.

In 1998, the Board adopted regulatory amendments to remove the restrictions that conflicted with NSMIA (63 FR 2806, January 16, 1998). As part of this process, the Board amended the 1996 interpretation to delete references to the conflict between the regulations and NSMIA. The remaining provisions of Regulation G, including the amended 1996 interpretation, were incorporated into Regulation U. However, the reference in Regulation T to the text of the 1996 interpretation was inadvertently not changed to reflect the elimination of Regulation G. Today's action will correct this cross-reference by amending Regulation T to reflect the fact that the text of the amended 1996 interpretation now appears in Regulation U.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, the FAA is charged with promoting safe flight of civil aircraft in air commerce by prescribing minimum standards required in the interest of safety for the design and performance of aircraft; regulations and minimum standards in the interest of safety for inspecting, servicing, and overhauling aircraft; and regulations for other practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it prescribes—

• New safety standards for the design of transport category airplanes, and

• New requirements necessary for safety for the design, production, operation, and maintenance of those airplanes, and for other practices, methods, and procedures relating to those airplanes.

Fatigue cracking has been a major aviation safety concern for many years. Unless detected and repaired, fatigue cracks can grow to the point of catastrophic failure. Since 1978 the FAA has required new types of airplanes to meet damage tolerance  1 (DT) requirements to ensure their continued airworthiness. Industry has also used this method successfully to develop inspection programs for older airplanes. Since the 1980s, the FAA has mandated that operators of most large transport airplanes carry out these programs.

While these programs have been largely effective, industry has not carried out DT methods comprehensively. In particular, while these programs apply to the airplane “baseline” structure (the airplane structure as originally manufactured), they often do not apply to repairs and alterations. 2 This omission is important because airplanes are subject to many repairs and alterations throughout their operational lives. If fatigue cracking occurs in a repaired or altered area, the results can be just as catastrophic as if it had occurred in the baseline structure.

The FAA adopted the Aging Airplane Safety final rule (AASFR)  3 in early 2005. Among other things, the AASFR requires airline operators of certain large transport category airplanes  4 to implement DT-based inspection programs for airplane structure; that is, structure susceptible to fatigue cracking that could contribute to a catastrophic failure. In this final rule, we refer to this structure as “fatigue critical structure.” Most importantly for this rule, the AASFR requires these inspection programs to “take into account the adverse effects repairs, alterations, and modifications may have on fatigue cracking and the inspection of this airplane structure.”

With the AASFR, we now have in place the regulatory means to provide for comprehensive implementation of DT methods on all large transport airplanes used by air carriers. To carry out these requirements fully, however, it is necessary to place corresponding requirements on the holders of FAA design approvals for these airplanes. Otherwise, the operators may not be able to obtain the data and documents they need to comply with the AASFR. As the owners of the data for these airplanes, the design approval holders  5 (DAHs) are in the best position to identify the fatigue critical structure and the methods and frequency of inspections that may be needed. Therefore, this final rule requires DAHs to develop and make available to operators the data and documents they need to support compliance with the DT requirements of the AASFR.

Specifically, this final rule requires DAHs to develop and make available the following four types of documents to operators:

(1) Lists of fatigue critical structure (to aid operators in identifying repairs and alterations that need to be addressed for DT).

(2) Damage tolerance inspections to provide operators with the necessary inspection times and methods for the following:

• Repair data published by type certificate (TC) holders. 6

• TC holder's future repair data not published for general use. 7

• Repair data developed by supplemental type certificate (STC) holders.

• Alteration data developed by TC and STC holders.

(3) Damage tolerance evaluation guidelines for all other repairs (to enable operators to obtain the necessary damage tolerance inspections).

(4) Implementation schedules (to define the necessary timing for performing damage tolerance evaluations and developing damage tolerance inspections and for incorporating the DT data into the operator's maintenance program).

This final rule transfers the responsibility for developing DT-based data from operators to DAHs and, therefore, has minimal to no societal costs. The aviation industry as a whole would also benefit because DAHs could amortize their development costs for DT data over a larger fleet.

On April 21, 2006, the FAA published in the Federal Register the Notice of proposed rulemaking (NPRM) entitled, Damage Tolerance Data for Repairs and Alterations (DAH DT Data NPRM), 8 which is the basis of this final rule.

In the DAH DT Data NPRM, the FAA proposed to require DAHs to develop and make available to operators certain damage tolerance (DT) data that address the adverse effects repairs, alterations, and modifications may have on fatigue critical structure. These data are necessary to support operator compliance with the Aging Airplane Safety Final Rule (AASFR). 9 Specifically, we proposed to require DAHs to develop and make available to operators the following: (1) Lists of fatigue critical structure for baseline and alteration structure; (2) Damage tolerance inspections (DTIs) for existing published repair and alteration data; (3) DTIs for future repair and alteration data; (4) Repair evaluation guidelines (REGs) that include a process for conducting airplane surveys, a process for establishing DT Data, and implementation schedules for the above actions. In addition, we proposed to require DAHs to develop a compliance plan for meeting these four requirements and to obtain FAA approval of the plan.

The NPRM contains the background and rationale for this rulemaking and, except where we have made revisions in this final rule, you should refer to it for that information.

In July 2004, we published the Fuel Tank Safety Compliance Extension (Final Rule) and Aging Airplane Program Update (Request for Comments), 10 where we informed the public of our intent to propose DAH airworthiness requirements to support certain operational rules. We requested comments on our proposal.

In December 2002, we published the Aging Airplane Safety Interim final rule; request for comments. 11 In February 2005, we adopted the AASFR in which we responded to the comments from the interim rule and made some changes to that rule. The February 2005 AASFR requires affected operators to include certain damage tolerance inspections and procedures in their maintenance programs by December 20, 2010. Today's final rule is directly related to the AASFR in that it provides a means for operators to get the data and documents they need to comply with the AASFR.

In July 2005, we published a disposition of comments document, 12 in which we responded to comments to the July 2004 action. Also in July 2005, we published a policy statement, Safety—A Shared Responsibility—New Direction for Addressing Airworthiness Issues for Transport Airplanes, 13 that explains our criteria for adopting DAH requirements like those described in this final rule.

On April 21, 2006, 14 along with the NPRM for this rulemaking, we published a Notice of Availability (NOA) and request for comments on draft AC 120-XX  15 (Damage Tolerance Inspections for Repairs). This AC included guidance related to repairs, which the Aviation Rulemaking Advisory Committee's (ARAC) Airworthiness Assurance Working Group (AAWG)  16 developed.

On July 7, 2006, we published a notice  17 that granted industry a 90-day extension to comment on the NPRM; and on February 27, 2007, we published a NOA  18 and request for comments on revised AC 120-XX, 19 which includes guidance from the AAWG on both repairs and alterations.

In the NPRM (and other Aging Airplane Program rules), we placed the DAH airworthiness requirements in part 25, subpart I. As we explained in the recently adopted Enhanced Airworthiness Program for Airplane Systems/Fuel Tank Safety final rule (EAPAS/FTS), 20 we have placed these requirements in new part 26, and we have moved the enabling regulations into part 21. 21 We determined that this was the best course of action because it keeps part 25 as strictly airworthiness standards for transport category airplanes, thus maintaining harmonization and compatibility among the United States, Canada, and the European Union regulatory systems. Providing references to part 26 in part 21 clarifies how the part 26 requirements will address existing and future design approvals.

In creating new part 26, we renumbered the proposed sections of part 25, subpart I and we incorporated the changes discussed in this preamble. A table of this renumbering is shown below.

We discussed in the preamble to the proposed rule that we would establish new subparts for airworthiness-related operational rules. Since there were several other aging airplane proposals (e.g., EAPAS) published around the same time, each proposal contained language that established the new subparts and redesignated certain sections of those rules. We said when any one of those proposals became a final rule, we would remove the duplicative provisions that established the new subparts and redesignated sections from the other aging airplane rules. In the DAH DT Data proposal, we included regulatory text to add subparts AA and B (Continued Airworthiness and Safety Improvements) to include the airworthiness requirements from parts 121 and 129, respectively. We also included regulatory language to redesignate the section numbers in parts 121 and 129 that were moved to the new subparts. However, since the EAPAS final rule was the first to be codified, that final rule adopted subparts AA and B and redesignated appropriate sections of parts 121 and 129. Therefore, we have removed the duplicative regulatory text from this final rule.

To aid understanding of our discussion about the DAH DT Data rule as it relates to the AASFR, we have indicated below the prior and redesignated sections of parts 121 and 129 of the AASFR that include DT-related requirements.

During the rulemaking process for the DAH DT Data rule, the FAA determined that minor changes to the AASFR were needed to ensure clarity of the two rules. The original wording in §§ 121.370a and 129.16 (redesignated as §§ 121.1109 and 129.109, respectively) required that changes to the certificate holder's maintenance program (i.e., inclusion of DT-based inspections and procedures and any revisions to them) be approved by the Aircraft Certification Office (ACO)  24 or office of the Transport Airplane Directorate with oversight responsibility for the relevant type certificate or supplemental type certificate, as determined by the Administrator.

Although the ACO will approve the documentation that the DAH DT Data final rule requires DAHs to submit to the FAA, the DT inspections and procedures resulting from this documentation, which certificate holders must incorporate into their maintenance programs, should be approved by their Principal Maintenance Inspector (PMI). Therefore, we revised §§ 121.1109 and 129.109 to state that it is the PMI's responsibility to review and approve changes to a certificate holder's maintenance program.

Also, we believe the requirements in current §§ 121.1109(c)(1) and 129.109(b)(1) that address DT relative to baseline structure and repairs, alterations, and modifications would be clearer if they were in separate paragraphs. Therefore, we revised §§ 121.1109 and 129.109 to include requirements related to baseline structure in § 121.1109(c)(1) and § 129.109(b)(1) and those related to repairs, alterations, and modifications in § 121.1109(c)(2) and § 129.109(b)(2). We also made minor wording changes for clarity and consistency with the new part 26 requirements and Advisory Circular (AC) 120-XX, 25 which describes an acceptable means of compliance with the DAH DT Data final rule.

Based on comments to the proposed rule, we have revised the final rule as summarized below and discussed in more detail under the Discussion of the Final Rule heading.

We extended the compliance times for DAHs to develop the required lists of fatigue critical structure. For TC holders, we extended the compliance date for them to submit their lists of fatigue critical baseline structure to the FAA Oversight Office for review and approval from 90 to 180 days after the effective date of the final rule. We also added a provision that makes it clear to future TC holders that the lists of fatigue critical baseline structure must be submitted as part of the type certification process.

In the NPRM, we proposed TC holders submit their lists of fatigue critical alteration structure to the FAA Oversight Office for review and approval 90 days after the effective date of the final rule. We proposed 270 days for STC holders. In the final rule, we extended the compliance date to 360 days after the effective date of the final rule for both TC holders and STC holders to submit these lists.

The NPRM included a requirement for TC and STC holders to develop a process to enable operators to “establish” damage tolerance inspections (DTIs) for repairs and alterations to fatigue critical baseline structure (FCBS). This final rule replaces the term “establish” with “obtain.” We made this change because the term “obtain” better reflects the intent of the rule and is meant to be all inclusive. That is, the operator may “obtain” a DTI by establishing it themselves, or by receiving the DTI directly from a TC holder, STC holder, or a third party.

Section 25.1823(f)(1)(iii) (adopted as § 26.43(e)(1)(iii)) proposed an implementation schedule for repairs covered by the repair evaluation guidelines (REGs). To clarify this proposed requirement, we revised it in the final rule to specify that the implementation schedule must identify the times when actions must be taken as specific numbers of flight cycles, flight hours, or both.

We revised proposed § 25.1823(f)(3) (adopted as § 26.43(e)(3)) to remove the reference to § 25.1827. That reference would have required TC holders to make their REGs available to STC holders. We made this change because TC holders do not need to provide REGs to STC holders. However, they must provide their lists of fatigue critical structure (FCS) to STC holders.

As discussed in more detail later in this preamble, based on comments submitted to other DAH airworthiness rules, we removed some provisions of the compliance plan in proposed § 25.1829 (adopted as § 26.49). Specifically, we removed the proposed requirements in § 25.1829(a)(3) for DAHs to identify the intended means of compliance that differ from those described in FAA advisory materials. Similarly, we removed the requirement in proposed § 25.1829(c) that would have authorized the FAA Oversight Office to identify deficiencies in a compliance plan or the DAH's implementation of the plan and to require specified corrective actions to remedy those deficiencies. We do not believe removal of these requirements will adversely affect our ability to facilitate DAH compliance.

In § 25.1829(5), we proposed a requirement for including in the compliance plan a process for continuous assessment of service information related to structural fatigue damage. As discussed later in this preamble, we have determined that existing regulations should enable us to determine whether the objectives of this DAH DT Data final rule are being met. Therefore, we have removed this provision from this final rule.

In addition to the changes discussed above, we made minor changes to clarify the definitions of damage tolerance inspections and published repair data in proposed § 25.1823 (the definitions are now in § 26.41). We also made other minor changes to clarify the requirements in proposed §§ 25.1823 (adopted as § 26.43), 25.1825 (adopted as § 26.45), 25.1827 (adopted as § 26.47), and 25.1829 (adopted as § 26.49).

The FAA received multiple comments from 17 commenters, including the Air Transport Association (ATA) and a collective group of certain industry representatives who are members of the AAWG. 26 In the following discussion of the comments received to the proposed rule, we will refer to the comments received from those industry representatives of the AAWG as the “AAWG industry representatives.” Also, several of the AAWG and the ATA member organizations sent separate comments on behalf of their organizations, with some specifically expressing support for the comments submitted by the AAWG industry representatives and the ATA. The comments to the proposed rule covered an array of topics and contained a range of responses, which we discuss more fully below under the Discussion of the Final Rule heading. In general, commenters supported the intent of the rule and the guidance material. They also requested some changes and clarifications.

Many of the comments to the proposed rule concerned issues specific to the Widespread Fatigue Damage (WFD)  27 proposal. The FAA intends to address the WFD-related comments in a separate action, so we will not address them here.

We also received several comments about the DAH airworthiness requirements. We addressed many of the same or similar comments and issues in the July 2005 disposition of comments document to the Fuel Tank Safety Compliance Extension (Final Rule) and Aging Airplane Program Update (Request for Comments). In addition, we explained in detail the need for these requirements in our July 2005 policy statement. As a result, we will not revisit those comments and issues here.

Fatigue cracking has been a major aviation safety concern for many years. Unless detected and repaired, fatigue cracks can grow to the point of catastrophic failure. Since the adoption of Amendment 25-45  28 in 1978, the FAA has required new types of airplanes to meet damage tolerance (DT) requirements to ensure their continued airworthiness. Industry has also used this method successfully to develop inspection programs for older airplanes, such as Supplemental Structural Inspection Programs (SSIP). Since the 1980s, the FAA has mandated that operators of most large transport airplanes carry out these programs.

Although these programs have been effective for baseline structure (the airplane structure as originally manufactured), industry has not comprehensively implemented DT methods for repairs and alterations. For airplanes certified to Amendment 25-45 and later, repairs and alterations were not always evaluated for damage tolerance. This omission is important because airplanes are subject to many repairs and alterations throughout their operational lives. If fatigue cracking occurs in a repaired or altered area, the results can be just as catastrophic as if it had occurred in the baseline structure.

The AASFR requires airline operators of certain large transport category airplanes  29 to implement DT-based inspection programs for airplane structure; that is, structure susceptible to fatigue cracking that could contribute to a catastrophic failure. In today's DAH DT Data final rule, we refer to this structure as “fatigue critical structure.” Most importantly for today's DAH DT Data final rule, the AASFR requires the maintenance program for the airplane include a means to address the adverse effects repairs and alterations may have on airplane structure.

With the AASFR, we now have in place the regulatory means to provide for comprehensive implementation of DT methods on all large transport category airplanes used by air carriers operating under 14 CFR parts 121 and 129. To carry out these requirements fully, however, we must place corresponding requirements on the holders of FAA design approvals for these airplanes. Otherwise, the operators may not be able to obtain the data and documents they need to comply with the AASFR. As the owner of the design data for these airplanes, the DAH is in the best position to identify the fatigue critical structure and the methods and frequency of inspections that may be needed.

As indicated in our July 2005 policy statement about the shared responsibility for addressing airworthiness issues, in cases where operators must rely on data or documents from DAHs to comply with operational rules, we will require DAHs to develop that information by a specified date. This final rule includes such requirements.

Specifically, 14 CFR 26.43, 26.45, and 26.47 require that the TC holders and STC holders develop certain information that will provide a means for operators to address the adverse effects of repairs and alterations. The information required by this final rule includes the following:

• List of Fatigue Critical Structure (baseline and alteration).

• Damage tolerance inspections (DTIs) for existing published repair data and all future repair data.

• DTIs for all existing and future alteration data.

• Repair evaluation guidelines (REGs), which include—

The FAA has issued Advisory Circular (AC) 120-93, Damage Tolerance of Repairs and Alterations, concurrently with this rule. The AC provides TC and STC holders with an acceptable method of compliance with this final rule. The AC, which was developed through a collaborative effort between the FAA and the Aviation Rulemaking Advisory Committee (ARAC), supports operator compliance with the AASFR with respect to repairs and alterations.

As amended by this final rule, § 121.1109(c)(2) of the AASFR requires operators to incorporate into their maintenance program a “means” for addressing the adverse effects that repairs and alterations may have on fatigue critical structure. This AC provides guidance that TC holders, STC holders, and operators can use in developing a means for addressing repairs and alterations.

To facilitate operators' timely compliance with the AASFR for repairs, the guidance material in this AC includes implementation schedules that specify acceptable time frames for when operators can incorporate required DT data into their maintenance programs. The implementation schedules allow for a phased-in program where existing repairs on the older and higher utilization airplanes are assessed first, and the newer airplanes assessed as they approach their Design Service Goal (DSG). This approach ensures that DTIs will be available when needed for both older and newer airplanes.

This rule applies to transport category, turbine powered airplane models with an original TC issued after January 1, 1958. With certain exceptions, this rule applies to those airplanes that, as a result of the original certification or later increase in capacity, have a maximum type certificated passenger seating capacity of 30 or more or a maximum payload capacity of 7,500 pounds or more. The final rule differs from the proposal in that we revised the list of excepted airplanes to include the Lockheed L-300, deHavilland DHC-7, and Boeing 707/720 airplanes. We included these airplanes on the excepted list because they are not currently being operated in commercial service in the U.S., and we do not expect they will be in the future.

Airbus and United Parcel Service (UPS) expressed concern that the requirements of this rule duplicate certain requirements of current regulations.

Airbus said because newer airplanes like the A330/A340 and A380 have a state-of-the-art damage tolerance assessment for all activities related to baseline structure, repairs, and alterations, the TC holder's activities under proposed §§ 25.1823(d) and (e) and 25.1825(c) and (d) would be “senseless.” It said applying the proposed requirements to its newer model airplanes would offer no additional safety benefit because they are already inherent in the consistent application of the damage tolerance requirements in § 25.571. It also said the proposed activities for these airplane models would create an unnecessary administrative burden and would require re-approval of already DT-justified modifications and repairs. Airbus asked the FAA to reconsider applying proposed §§ 25.1823 and 25.1825 to TC holders as they relate to airplane models A330/A340/A380 and future Airbus models. It suggested addressing this issue under proposed § 25.1829 in the model-specific compliance plans.

UPS said if the proposed rule is adopted, it would force operators to survey every airplane in their fleet to find repairs and then evaluate them based on guidelines produced by TC holders. UPS believes airplanes certified to comply with Amendment 25-54 or later already have DT data developed for fatigue critical structure, which includes certain baseline structure, as well as all repairs and alterations. UPS suggested the FAA make the proposed surveys applicable only to airplanes certified prior to Amendment 25-54. To accomplish this, it said, the FAA should revise proposed § 25.1823(a) to limit the applicability to airplanes type certified to pre-Amendment 25-54 requirements.

As discussed in the NPRM, the FAA has identified several airplane models certified to Amendment 25-45 or later (including airplane models certified to Amendment 25-54) for which published repair data have not been evaluated for DT. Therefore, unless accomplished previously, a damage tolerance evaluation (DTE) needs to be accomplished for all airplanes, regardless of the certification level. For those airplanes certified to Amendment 25-45 or later that have had a DTE completed for all published repair and alteration data, the compliance plan required by § 26.49 (proposed as § 25.1829) should contain a statement to that effect, and the TC holder will need to substantiate this statement with previously approved data from their certification effort to show compliance with this rule. TC holders who have already substantiated compliance with DT requirements should not find compliance with this rule burdensome.

Regarding UPS's comment, if the TC holder can substantiate compliance for its repairs and alterations, it is still likely that operators have installed repairs and alterations that were not designed by the TC holder on many airplanes. It is also likely that many of these repairs and alterations were not assessed for damage tolerance. Therefore, a survey will still be necessary to identify those repairs and alterations and to determine if DT data are available to support operator compliance with the AASFR.

Bombardier noted that the proposed rule would apply only to DAHs for airplanes currently operated under parts 121 or 129. It said this would not change the requirement to maintain damage tolerance for all airplanes originally certified as damage tolerant under § 25.571 (Amendment 45 or later). It said it presumes these airplanes will continue to be regulated under § 25.1529, using AC 25.1529-1 as guidance (and under Canadian Air Regulations & Airworthiness Manual 511.34 for Canadian DAHs). Bombardier asserted that the four DAH deliverables required by proposed § 25.1823 (lists of fatigue critical baseline structure, damage tolerance inspections, damage tolerance evaluation guidelines, and implementation schedules) are already required under § 25.1529 (with guidance provided in AC 25.1529-1) and could constitute compliance with the proposed rule.

We agree that TC holders and others designing repairs and alterations for airplanes certificated to Amendment 25-45 or later amendments will continue to be required to comply with § 25.1529, regardless of the types of operations conducted. For airplanes subject to this DAH DT Data rule, DAHs and operators should use the guidance in AC 120-93 instead of AC 25.1529-1 for repairs. Because this rule is entirely consistent with §§ 25.571 and 25.1529, DTIs that comply with this rule will also comply with those sections. To the extent such data have been developed previously, their compliance will be simplified.

Transport Canada and Mr. Thomas A. Knott expressed concern that the proposed rule only applies to airplanes operated under parts 121 and 129. Mr. Knott also stated that it leaves out airplanes operated under parts 91, 125, and 135. Transport Canada expressed concern that the DAH DT Data proposal and the AASFR do not apply to airplanes operated under part 125 and would allow airplanes such as the B727 and B747 to operate as passenger-carrying airplanes under part 125 without having to meet DT or the aging airplane safety requirements.

As we discussed earlier in this preamble, the purpose of this rule is to support parts 121 and 129 operators' compliance with the AASFR. For the reasons discussed in the preamble to the AASFR, we limited applicability of the DT requirements (supplemental inspections) in that rule to certain large transport airplanes that are typically operated under parts 121 or 129. For the affected airplanes that are operated under parts 91, 125, or 135, their utilization is much lower and the risks associated with fatigue damage that the AASFR is intended to address is, therefore, also much lower. Because of this, we determined it would not be cost-effective to impose the AASFR's supplemental inspection requirements on parts 91, 125, or 135 operators.

Viking Air Limited said it owns seven de Havilland heritage aircraft, including the DHC-5 Buffalo and DHC-7. Viking Air Limited said there are about 23 DHC-5s in confirmed operation, and the DHC-7 has about 66 in confirmed operation. Many of those in confirmed operation are used in military operations and are not subject to part 121 or 129. According to the FAA Registry, no DHC-5 aircraft are presently registered in the U.S. Therefore, Viking proposed that the DHC-5 be added as an exception under proposed § 25.1823(h). Viking Air Limited also said that for the DHC-7, there presently are the following safety measures in place: Canadian Airworthiness Directive CF-94-19R1 that mandates a Supplemental Inspection Program; CF-2005-36 that imposes a Structural Life Limit; and CF-98-03 that mandates the Corrosion Prevention and Control Program. With these actions, the DHC-7, the commenter stated, has already met the intentions of aging aircraft initiative for structures.

The FAA researched its data bases and found that the DHC-5 does not have a type certificate issued by the U.S. Therefore, there is no need for an exception for the DHC-5 Buffalo. Furthermore, we have determined that there are no DHC-7 airplanes currently operated under part 121 or U.S.-registered DHC-7 airplanes operated under part 129. For the reasons discussed earlier in this preamble, we added the DHC-7, as well as the Lockheed L-300 and the Boeing 707/720, to the list of excepted airplanes in § 26.43(g) of this final rule.

This final rule requires TC and STC holders to evaluate their designs for baseline and alteration structure to identify FCS. They must also develop lists of FCS and make the lists available to operators.

This final rule defines fatigue critical structure as airplane structure that is susceptible to fatigue cracking that could contribute to a catastrophic failure, as determined under § 25.571. This is structure that may need special maintenance actions to manage the threat of fatigue. This would be the case for structure that has the potential to develop fatigue cracks that, without intervention, could lead to a catastrophic failure. The fatigue evaluations are performed to determine if special actions are needed and if so, to provide the data needed to define the maintenance action requirements. Fatigue critical structure may be part of the baseline structure or part of an alteration to the baseline structure. As explained in the NPRM, 30 by referencing § 25.571 in the sentence noted below, we intended to rely on the many precedents established in finding compliance with this section.

To clarify how the criteria of § 25.571 apply within the context of this rule, we revised the definition of “fatigue critical structure” by adding the following language: “Fatigue critical structure includes structure, which, if repaired or altered, could be susceptible to fatigue cracking and contribute to a catastrophic failure.”

Airbus, the ATA, and UPS, asked for a more detailed definition of fatigue critical structure. They expressed concern that, as proposed, the definition is open to varying interpretations, so it may not be applied consistently across industry or across different airplane models. UPS added that some STC holders do not have experience in complying with § 25.571. It asserted, the definition must be clear so that it can be interpreted and applied in the same manner across the industry.

The ATA and UPS said the methodology for identifying fatigue critical structure should include quantitative criteria for assessing the criticality of structural elements, based on a comparison of their operational loads to their design limit loads or ultimate loads; and it should account for load type and single- and multiple-load paths. Also, the ATA said, the methodology should define what “could contribute” means as stated in the definition of fatigue critical structure. It recommended possibly using criteria similar to that in § 25.1309 to clarify the definition.

The term “fatigue critical structure,” as explained in the proposed rule, is intended to identify the same kind of structure for which applicants must perform fatigue evaluations to comply with § 25.571. 31 These evaluations have been required for new type certificates since the adoption of Amendment 25-45 in 1978. Furthermore, AC 25-571-1C, published in 1998, provides many examples of the types of structural elements that should be evaluated. Therefore, we believe there is little, if any, room for differing interpretations of this term.

We believe many of the commenters' concerns result from differences in the way industry has used the term “principal structural elements” (PSEs). This term, as used in § 25.571 and AC 25.571, is synonymous with the term “fatigue critical structure.” That is, a PSE is structure that needs to be evaluated to determine if special maintenance actions are needed to manage fatigue. And if such actions are needed, they must be defined. The meaning of PSE in § 25.571 contrasts significantly with its usage in certain industry practices that have evolved over the years.

For some TC and STC holders, a PSE is considered to be a specific, localized area within fatigue critical structure where special, directed inspections are required by an Airworthiness Directive (AD) or airworthiness limitations. For example, all longitudinal skin splices in a pressurized fuselage should be considered fatigue critical structure if they are not immune to fatigue cracking which could lead to a catastrophic failure. However, it may be reasonable to manage fatigue in these splices by only performing a special directed inspection on the most highly stressed area, which may only constitute a small percentage of the at-risk structure.

Some TC and STC holders have identified the PSE as being limited to this localized area. While this narrow usage of the term might be acceptable within the context of specific supplemental inspection documents (SID) or Airworthiness Limitations Sections (ALS), it could and has led to confusion and inappropriate actions when taken out of context. For this reason, we have chosen not to use the term “principal structural element” in this rule.

The purpose of requiring identification and listing of fatigue critical structure under this rule is to provide operators with a tool that will help in the evaluation of existing and future repairs and alterations. In this context, fatigue critical structure (FCS) is any structure that, if repaired or altered, could be susceptible to fatigue cracking and contribute to a catastrophic failure.

In the case of the longitudinal skin splices discussed above, we would expect that the FCS listed by the TC holder would include much more structure than just, for example, the localized area that is being inspected to gauge the fatigue state of all the splices. A hypothetical repair applied to even the lowest stress area of the splices could potentially make it more critical than the highest stressed area without a repair by increasing and redistributing structural loads. The result would be a repair needing its own special directed inspection to prevent potentially catastrophic failure. The only way to cover this contingency would be to perform a DTE.

As discussed above, we revised the proposed definition of FCS to clarify how the criteria of § 25.571 apply in the context of this rule. As we stated in the NPRM, 32 we intend for this rule to apply to future type certificate holders, as well as current holders. Because the list of FCS required by this rule may be more extensive than the structure identified as airworthiness limitations items currently developed by TC applicants, we added provisions to § 26.43 paragraphs (a) and (e) to make it clear that the list of FCS must be submitted as part of the type certification process. This requirement will help ensure that, new TC holders are properly addressing DT requirements in developing structural repair manuals (SRMs) and other service documents for use by operators. It will also assist operators in ensuring that a DTE is performed for all repairs and alterations to structure identified as FCS, as required by the AASFR, from the beginning of an airplane's operational life.

Regarding the concern that STC holders may not have experience in complying with § 25.571, current and earlier versions of AC 25.571-1C provide guidance on identifying PSEs that is also applicable to identification of FCS under this rule. Also, one reason this rule requires a compliance plan is to ensure that TC holders, STC holders, and the FAA have a common understanding of the rule's requirements, including acceptable compliance methods.

Regarding suggestions to use quantitative methods or methodologies used to comply with § 25.1309, our intent is to use the same method to identify FCS that is required by § 25.571. Paragraph (a) of § 25.571 states that an evaluation must be conducted for “each part of structure that could contribute to a catastrophic failure.” Therefore, the applicant must determine which parts of structure could contribute to a catastrophic failure when damaged as a result of fatigue cracking. Applying a probabilistic approach to determine if and when a part will contribute to a catastrophic failure has not been industry practice in complying with § 25.571. TC holders are required under § 25.571 to perform a damage tolerance evaluation on structure to determine when fatigue cracking may occur. At that point an inspection is performed to determine if cracking has occurred. A probabilistic approach would raise many implementation questions because fatigue cracking in metallic structure is a certainty and detection is imperative in order to prevent catastrophic failure of airplane structure. Probabilistic approaches would not be consistent with our objective of facilitating timely compliance.

This rule requires TC holders and STC holders to review their repair and alteration data and determine if a DTE is needed. Unless previously accomplished, a DTE must be performed on all repairs and alterations that affect fatigue critical structure. A DTE is a process that leads to a determination of maintenance actions necessary to detect or preclude fatigue cracking that could contribute to a catastrophic failure. As applied to repairs and alterations, a DTE includes the evaluation of the repair or alteration and the fatigue critical baseline structure affected by the repair or alteration. Acceptable methods for performing DTEs are described in AC 25.571-1C.

The maintenance actions developed as a result of a DTE may include inspections, time limits for removal and replacement of repairs, modification of the repair, alteration to improve its fatigue characteristics, or in some cases modification of the affected FCS. The type of maintenance action that is appropriate depends upon the type of structure affected and the type of fatigue anticipated. For example, for fatigue cracks that grow at a predictable rate and that can be detected by inspections, a repetitive inspection program would be acceptable. For cracks in locations that cannot be inspected and for cracking that may grow too rapidly to be detected reliably, replacement or modification may be necessary.

Section 26.43(c) requires TC holders to perform a DTE of those repairs specified in their published repair data that affect fatigue critical structure. Similarly, §§ 26.45(c) and 26.47(c) require TC and STC holders to perform a DTE on their FAA-approved alteration data. In addition to the published repair and alteration data, this final rule requires that all future repair and alteration data receive a DTE to determine if inspections or other actions are necessary to ensure the airworthiness of the repair or alteration. This rule also requires TC holders to develop Repair Evaluation Guidelines (REGs) that will enable operators to survey their airplanes to identify repairs that affect fatigue critical baseline structure (FCBS) and to obtain any necessary damage tolerance inspections (DTI) for those repairs. If the REG directs the operator to obtain assistance from the TC holder for developing the DTI, the TC holder must make such assistance available.

As discussed below, based on comments to the NPRM, we revised the proposed requirements in §§ 25.1825(c) and 25.1827(c) (adopted as §§ 26.45(c)(1) and 26.47(c)(1), respectively)) to clarify that a DTE must be performed and the DTI developed for the alteration and the FCBS that is affected by the alteration.

Boeing and AAWG industry representatives asked that the regulatory text in proposed §§ 25.1825 and 25.1827 be revised to clarify that both alteration and baseline structure need to be assessed. They state that the description of the work proposed in these sections of the NPRM may be interpreted to mean that DTIs only need to be developed for the alteration that happens to affect FCBS. However, AAWG industry representatives do not believe this is the interpretation the FAA intends. AAWG industry representatives recommended that the language in both §§ 25.1825 and 25.1827 be changed to clearly say that the following three components must be addressed for alterations:

The commenters are correct in that we did not intend for the development of DTIs to be limited to the alteration structure. When a DTE is performed for an alteration, the DTE must be applied to both the alteration and the FCBS that is affected by the alteration. Therefore, the DTI developed (as determined by the DTE) for an alteration would apply to the alteration structure and to the FCBS that is affected by the alteration. As stated above, we revised §§ 25.1825(c) and 25.1827(c) (adopted as §§ 26.45(c)(1) and 26.47(c)(1), respectively) to clarify that for the alteration and the FCBS that is affected by the alteration a DTE must be performed and the DTI developed.

The FAA does not believe that §§ 25.1825(c) and 25.1827(c) (adopted as §§ 26.45(c) and 26.47(c), respectively) need to be revised to clarify that alterations that affect FCBS need to be assessed, or to provide clarification on which structural design details of an alteration would require a DTE. Sections 25.1825(c)(1) (adopted as § 26.45(c)(1)) and 25.1827(c)(1) (adopted as § 26.47(c)(1)) already specify that a DTE must be performed for alterations that affect FCBS. In addition, the structure of the alteration that requires development of a DTI will be identified as part of a DTE performed on the alteration. The DTI may need to be developed for fatigue critical alteration structure or for other alteration structure that may affect the FCBS. We expect that this identification would be part of the DTE of the alteration.

Regarding the commenters' position that the proposed rule needs to be revised to clarify the design details of the affected FCBS that will need a re-evaluation of their DTE, the DTE of an alteration will include an evaluation of the FCS that is affected by the alteration. Therefore, in performing the evaluation of the affected FCBS, it must be determined if new or revised DTIs need to be developed for this structure. Such a determination is made as part of a DTE.

Mr. Thomas A. Knott, P.E., said the proposed rule “is fine,” except it does not address repairs and modifications done under part 43. He said there are many alterations and repairs that were not approved under an STC or developed by TC holders.

The FAA acknowledges that there are existing repairs and alterations that were developed and installed under 14 CFR part 43 without involvement by DAHs. This final rule takes into account these types of repairs. The guidelines the DAHs are required to develop will describe procedures for operators to follow in developing DTIs for repairs. For alterations affecting FCS for which no DAH is responsible, the AASFR requires operators either to develop the DT data themselves or contract for their development. Because there is no DAH for these alterations, they may be especially problematic if the installers failed to consider the fatigue characteristics of the alterations or their effects on the baseline structure. Both repairs and alterations will be identified and assessed as part of surveys conducted to support compliance with the AASFR.

A DTI is defined in this final rule as inspections developed as a result of a DTE. The DTI includes the location of the airplane structure to be inspected, the inspection method, inspection procedures that include acceptance and rejection criteria, and the thresholds and intervals associated with those inspections. The DTI may also specify a time limit when the repair or alteration needs to be replaced. As discussed below, this definition reflects minor changes from the one in the proposed rule.

Boeing asked that the FAA revise the definition of DTI. It said the phrase “and corrective maintenance actions” could be confused with a requirement to provide repair instructions or other corrective measures for a condition found during an inspection. It said, historically, the only instructions provided are how to accomplish the inspection contained in the DTI and what action should be taken if the inspection could not be accomplished. Therefore, Boeing requested that the phrase “and corrective maintenance actions” be removed from the definition and replaced with the phrase, “or a time limit when the repair needs to be replaced, or both.”

We agree and have revised the definition in the final rule as requested. The purpose of this rule is to support operators' implementation of damage tolerance inspection programs, as required by the AASFR. Operators already have access to information on corrective actions in the form of SRMs and other documents that may be necessary if the inspections reveal fatigue cracks. Therefore, it is not necessary to include the phrase “and corrective maintenance actions” in the definition of DTI.

Bombardier asked, with respect to inspections of repairs, that we clarify the phrase “the location of the airplane structure to be inspected” used in the DTI definition. Bombardier said it understands this phrase to mean that the DTI should clearly define which regions of the repair and underlying structure should be inspected and the NDT (non-destructive testing) method to be used in carrying out the inspection. It said the DTI should be clearly linked to the repair data, which will of itself define the repair location.

The FAA agrees that the DTI should clearly define the areas of the repair and underlying structure that should be inspected and the inspection method to be applied. The DTI will be applicable to specific repair data that will define the repair location. This approach is the same as that currently used by TC holders in developing SRMs to comply with § 25.571, Amendment 25-45 and later.

This final rule requires TC holders to review their published repair data and determine if DT data exist for the repairs or if the DT data need to be developed. This final rule defines published repair data as instructions for accomplishing repairs, which are published for general use in SRMs and service bulletins (or equivalent types of documents). As discussed below, we made minor revisions to the proposed definition.

Boeing requested that we revise the definition of “published repair data” to make it clearer. It recommended the following revised version of the proposed definition:

The FAA agrees with the recommended revision to the definition of “published repair data,” and we have revised the definition, accordingly, with a minor change in wording.

Bombardier said a list of Structural Significant Items (primary structure) is provided in the SRMs for Bombardier Regional Aircraft. It urged the FAA to consider rulemaking to require the SRM to be an approved document. The SRM, Bombardier commented, can then incorporate all of the instructions for continuing airworthiness required by the NPRM and described previously in AC 25.1529. It said this approach has been used by Bombardier and Transport Canada for SRMs and component maintenance manuals (CMMs) applicable to aircraft and components certified as damage tolerant to § 25.571 (Amendment 25-45) and later.

As explained in the NPRM, SRMs, while not required documents, are FAA approved. Their purpose is to provide operators with readily available sources of approved repair data. Because the operational rules require that major repairs be accomplished according to FAA-approved data, an SRM that has not been FAA approved would not serve operators' needs. The SRM, if assessed for damage tolerance under § 25.571 (Amendment 25-45 or later Amendment), should include the necessary instructions to ensure a particular repair meets the criteria in AC 25.1529.

Mr. Glenn Davis commented that DT data should address the effects of multiple repairs in close proximity on older aircraft, and future inspections should be based on a “worst case scenario of the ‘combination effect’ of the multiple repairs.” He said the FAA might consider requiring a time limit for individual or multiple repairs when the repaired structure would have to be replaced, unless the applicant or operator can confirm through a rational fatigue analysis, using an acceptable fatigue model, that the repaired structure does not need to be replaced. Mr. Davis said such a requirement could be applied to high stress areas in older aircraft such as pressure bulkheads, door apertures, attach fitting support structure for wings, and stabilizers.

The FAA agrees with Mr. Davis's comment that the DT data, specifically the DTE, should take into account the close proximity of repairs. AC 25.571-1C provides guidance on determining the effects of multiple repairs that are in close proximity. In addition, the repair assessment guideline (RAG) documents developed in support of § 121.370 (redesignated as § 121.1107) 33 address the effects of these types of repairs on the pressure vessel. The FAA believes that existing guidance in AC 25-571-1C, along with guidance developed in AC 120-93, as part of this final rule, adequately addresses this issue.

This final rule requires TC holders to develop REGs that include processes operators could use to support compliance with §§ 121.1109 and 129.109 for repairs that affect FCBS. The guidelines must include—

• A process for conducting surveys of affected airplanes to identify and document all existing repairs that affect FCBS;

• A process that will enable operators to obtain DTIs for repairs that affect FCBS and for the FCBS affected by the repairs; and

• An implementation schedule that provides the timing for conducting airplane surveys and for developing and incorporating DTIs into the operator's maintenance program.

TC holders must submit the REGs to the FAA Oversight Office for review and approval and then make them available to affected operators.

As discussed below, we made several minor revisions to the proposed REG requirements.

In § 25.1823(f)(1)(iii) and (f)(4) (adopted as § 26.43(e)(1)(iii) and (e)(4)), we removed the term “DT data” from the phrase “DT data implementation schedule.” We made this change because the term “DT data implementation schedule” may be misunderstood to mean the actual timing of DT inspections (thresholds and inspection intervals). It was only intended to refer to the timing of major process related events (i.e., survey, development of DTIs, and incorporation of the DTI into the maintenance program).

We revised proposed § 25.1823(f)(1)(iii) (adopted as § 26.43(e)(1)(iii)) to make it clear that the implementation schedule must identify the times when actions must be taken as specific numbers of flight cycles, flight hours, or both. In developing its recommendation regarding implementation schedules, the AAWG proposed an approach that would have referenced the design service goal (DSG) for determining the timing of various actions and would have allowed for variability in DSGs for different airplanes of the same model, depending upon actual flight lengths and other factors.

We agree with the AAWG that it is appropriate to allow reference to DSGs in the implementation schedule to allow for industry resources to be allocated for compliance when they are needed. For example, the AAWG recommended that certain actions be taken when an airplane reaches 3/4 DSG, before which fatigue cracking is less likely to have occurred. However, allowing variability in DSG for different airplanes of the same model would introduce a level of complexity and uncertainty to the requirements of the operational rules that would jeopardize their enforceability. Therefore, this rule requires that DSGs be stated as “hard numbers.”

We revised § 25.1823(f)(3) (adopted as § 26.43(e)(3)) to remove the requirement that TC holders must make REGs available to STC holders. As adopted, this paragraph only requires the TC holder to make the REGs available to specified operators. We made this change because if STC holders have access to the TC holder's list of FCS, they will not need their REGs.

We also revised § 25.1823(f)(4) (adopted as § 26.43(e)(4)). The proposed paragraph reads as follows: “If the guidelines direct the operator to obtain assistance from the holder of a type certificate, provide such assistance in accordance with * * *” We revised this paragraph in the final rule to replace the words “provide such assistance” with the words “make such assistance available.” This change makes it clear that, as with other requirements for TC holders to support operators, this rule is not intended to require TC holders to provide this support without compensation.

Boeing said proposed § 25.1823(f)(3) specifies that the TC holder will make available the guideline documents to various entities. Boeing believes this proposed requirement is in error and the reference to proposed § 25.1827 should be removed from § 25.1823. Section 25.1827 is applicable to holders of and applicants for an STC. In reading § 25.1827 and draft AC 120-XX, 34 Boeing said there is no need for third parties to have access to the guidelines developed as part of § 25.1823. According to § 25.1827 and AC 120-XX, the only data required by an STC holder is the list of fatigue critical structure, as stipulated in § 25.1823(c)(2). In light of this, Boeing said, the reference to § 25.1827 should be deleted from proposed § 25.1823.

We agree that STC holders do not need the guidelines to comply with this final rule as long as they have access to the TC holder's list of FCS. We have revised the final rule as discussed above.

Boeing commented that proposed § 25.1823(f)(4) appears to be using incorrect terminology. It said the wording in § 25.1823(f)(4) could circumvent the current business practices and established relationships between the TC holder and the operator. Boeing requested that paragraph (f)(4) be changed as follows:

It was not our intent to require TC holders to provide assistance to operators without compensation. As indicated above, we have revised the final rule as the commenter requested.

UPS expressed concern about the effectiveness of the proposed REGs. The proposed rule, it said, assumes that practical, cost effective REGs are achievable. However, the proposed procedure will be significantly more complex than the current Repair Assessment Guideline (RAG) documents, which only survey fuselage skin. UPS said the current repair assessment of pressurized fuselage skin results in removal and replacement of some repairs due to the inability to accurately determine the exact repair details. Fuselage skin repairs are relatively easy to assess because almost all damage is cut out and one side of the repair is accessible for detailed measurements. For other structure (e.g., stringers, ribs, spars, frames, shear clips, bathtub fitting) the ability to determine hidden repair details may not be possible without removing the repair. Consequently, the proposed survey method of documenting and establishing DTIs on existing repairs could result in a higher than necessary repair replacement frequency. To minimize the impact of the DTE of repairs, UPS believes it is vital that the FCS be properly identified.

In response to UPS's concerns about the effectiveness of the proposed REGs, the airplane repair survey process was patterned after existing RAG documents to minimize the impact of the DTE of repairs. AC 120-93 provides guidance for performing surveys to identify repairs that may affect FCS.

Regarding UPS's comment that certain structure may be difficult to inspect without having to remove the repair, operators should work with the TC holder in the Structural Task Group (STG) meetings to ensure an efficient process is developed for assessing repairs to minimize the unnecessary removal of repairs. The DTE will determine what actions are necessary to ensure the continued airworthiness of the affected FCBS. Performing DTIs on these airplanes should be no more difficult than performing them on airplanes for which repair data already have DTIs for compliance with the airplane's certification basis. We agree that it is vital that FCS be properly identified. As discussed previously, this final rule requires TC holders to apply the same analytical methods to create this list that they have applied for many years in complying with § 25.571.

This final rule requires TC holders to perform DTEs, and develop DTI, if necessary, for their alterations that affect FCBS. For existing alterations, TC holders must submit the DT data for FAA approval by June 30, 2009. For future alterations, the DT data are required before we approve the alteration data.

Similarly, STC holders must perform DTEs and develop DTIs for their alterations that affect FCBS. In addition to alterations, some STC holders must perform DTEs and develop DTIs, if necessary, for repairs developed by them that affect any FCS. For existing alterations, STC holders must submit the DT data for FAA approval by June 30, 2009. For future alterations, the DT data are required before we approve the alteration data.

The sections of the proposal that relate to alterations, (§§ 25.1825 and 25.1827 (adopted as §§ 25.45 and 25.47, respectively)) were revised as discussed below to make them clearer. As proposed, these sections may be misinterpreted to mean that the TC and STC holders need to perform a DTE of their alterations as installed on individual airplanes, addressing variations in the configurations of these airplanes. Our intent, however, is that they perform a DTE only of their alteration design data.

These sections may also be misinterpreted to mean that DTIs only need to be developed for the FCS of the alteration. In addition, as stated in the definition of damage tolerance evaluation in proposed § 25.1823(b), we intended that the DTE would also apply to the FCBS that is affected by the alteration and that the resulting DTI would also address the affected baseline structure. To clarify these requirements, the final rule specifies that TC and STC holders must, for each alteration affecting FCBS, identify and develop DTIs for both the FCBS that is affected by the alteration and the fatigue critical alteration structure. Other than some additional minor wording changes, there are no other changes to the sections of the final rule pertaining to alterations.

The ATA commented that the FAA should limit the number of DTEs necessary for alterations. Proposed § 25.1825(c) and § 25.1827(c) require TC holders to perform a DTE of each existing and future alteration and submit DT data for the existing alterations to the FAA. These provisions would apply to an impracticable number of alterations, according to the commenter. The ATA recommended, therefore, that the FAA clarify §§ 25.1825(c) and 25.1827(c) to stipulate that “each alteration” applies to each certificate or approval of an alteration rather than each installation.

The FAA agrees that it would be impracticable for TC or STC holders to perform a DTE for alterations as installed on individual airplanes, which may contain alterations and repairs that would affect the DTE of which the TC or STC holder is unaware. It was not the FAA's intent to require TC and STC holders to develop DT data for the actual installation of their developed design changes (alterations), but rather to require them to perform a DTE of the design changes affecting FCBS that are specified in their FAA-approved alteration data. This DTE must, however, address the range of airplane configurations on which the TC or STC holder showed the alteration is eligible for installation. We revised §§ 25.1825(c) and 25.1827(c) (adopted as §§ 26.45(c) and 26.47(c), respectively) to clarify that the DAHs are only responsible for performing DTE of their alteration data, and not of the alterations as actually installed.

The ATA said the FAA should define the documents required of DAHs as specifically as possible, and the product should be delivered to the FAA for certification or approval in a form ready for direct installation or incorporation as required by the associated operating rule. The ATA said adherence to this recommendation should be facilitated by the participation of Structural Task Groups (STG) in the development of the DTI and REG. The ATA recommended that the FAA use consistent terminology in the final rule and in AC 120-XX, 35 so they clearly describe the documentation and data DAHs must make available to operators. It said draft AC 120-XX states that DAHs would provide operators with a model-specific “compliance document.” The NPRM, however, does not discuss the “compliance document” referenced in the draft AC. Similar to the ATA comment, Horizon Air asked that the rule define the specific type of required data that DAHs must make available to operators.

We agree with the ATA that this final rule should clearly identify the required data and documents. This final rule requires DAHs to develop and make available to operators lists of fatigue critical structure, damage tolerance inspections for their alterations and repair data (supported by DTE documentation submitted to the FAA), repair evaluation guidelines, and implementation schedules.

Based on the Aviation Rulemaking Advisory Committee's (ARAC) recommendations, the FAA developed AC 120-93 to facilitate DAH compliance with this rule and operator compliance with the AASFR. This AC describes a compliance document that would either contain or reference these required documents. Because the compliance dates for these documents differ, the DAH would not make the compliance document, as a whole, available until the last of these documents is approved.

As described in the AC, this compliance document would support an operator's development of an Operator's Implementation Plan (OIP). The OIP would provide the means for addressing the adverse effects of repairs and alterations. Once this OIP is approved by the operator's principal maintenance inspector (PMI), the operator would comply with the AASFR by incorporating the OIP into its maintenance program and implementing the OIP by performing surveys of its airplanes, obtaining necessary damage tolerance inspections and procedures, and performing those inspections and procedures, all in accordance with the approved implementation schedule contained in the OIP.

STGs, working under the auspices of the ARAC's Airworthiness Assurance Working Group (AAWG), may be convened to assist TC holders in developing airplane model-specific DT data. This rule and AC 120-93 reflect consistent terminology. The DT data to be developed and made available are described in §§ 26.43, 26.45, and 26.47 of this final rule, as well as in AC 120-93.

The ATA said the FAA should work with DAHs to establish a narrow and clear definition of proprietary data. DAHs have expressed concerns that the proposed requirements could lead to the disclosure of proprietary data (e.g., DT documentation). Conversely, operators are concerned that restrictive disclosure policies could result in REGs and DTIs that are too general to be used without costly and time-consuming consultation with the DAH. The ATA recommended that the FAA coordinate with DAHs to support a goal for documents that must be “made available” under the proposal that would allow operators to comply autonomously with the DT requirements without consulting with the DAH more than absolutely necessary. ATA said the FAA can support this recommendation further by providing guidelines to DAHs and STGs to ensure that claims of proprietary data are not overstated.

For many years, the FAA has required DAHs to disclose to affected persons information they might otherwise consider proprietary. For example, since 1981, DAHs have been required to provide Instructions for Continued Airworthiness, including DT data, which DAHs may have considered proprietary. However, because we have determined that this information is essential to maintaining the airplanes in an airworthy condition, we have required DAHs to make it available as a condition for obtaining and retaining their certificates. Regarding the usefulness of the documents developed by the DAHs, because we expect these documents will be developed by DAHs in collaboration with the affected operators, we anticipate that the operators will ensure they are useful for their intended purposes. FAA technical specialists will also be monitoring development of these documents for this purpose.

This final rule includes requirements for a compliance plan to ensure that affected TC and STC holders produce DT data in a timely manner that are acceptable in content and format. Integral to the compliance plan are procedures to allow the FAA to monitor progress toward compliance. The affected TC and STC holders must submit to the FAA Oversight Office on the compliance dates specified in the rule a compliance plan that addresses—

• The project schedule for meeting the compliance dates, including all major milestones;

• A proposed means of compliance with the requirements to develop and make available DT data; and

• A plan to submit to the FAA Oversight Office, not less than 60 days before the stated compliance dates, a draft of the required compliance items.

Based on comments submitted to other DAH airworthiness rules, the FAA has determined that we can remove some provisions of proposed § 25.1829 (adopted as § 26.49) without adversely affecting our ability to facilitate DAH compliance. Specifically, in § 25.1829(a)(3), we proposed a requirement for DAHs to identify the intended means of compliance that differ from those described in FAA advisory materials. While this is still a desirable element of any compliance plan, we have concluded that an explicit requirement is unnecessary. As with normal type certification planning, we expect that DAHs will identify these differences and fully discuss them with the FAA Oversight Office early in the compliance period to ensure that these differences will ultimately not jeopardize full and timely compliance.

Similarly, § 25.1829(c) contains provisions that would have authorized the FAA Oversight Office to identify deficiencies in a compliance plan or the DAH's implementation of the plan and to require specified corrective actions to remedy those deficiencies. While we anticipate that this process will still occur in the event of potential non-compliance, we have concluded that it is unnecessary to adopt explicit requirements to correct deficiencies.

Ultimately, DAHs are responsible for submitting compliant documents by the dates specified in §§ 26.43, 26.45, and 26.47 of this final rule. Section 26.49 retains the requirements to submit a compliance plan and to implement the approved plan. If the FAA Oversight Office determines that the DAH is at risk of not submitting compliant documents by the compliance dates because of deficiencies in either the compliance plan or the DAH's implementation of the plan, the FAA Oversight Office will document the deficiencies and request DAH corrective action. Failure to implement proper corrective action under these circumstances, while not constituting a separate violation, will be considered in determining appropriate enforcement action if the DAH ultimately fails to meet the requirements of this section.

We also added an exception for future TC applicants in § 26.49(a) to make it clear that these applicants are not required to submit a separate compliance plan for the applicable requirements of this final rule. These compliance issues should be addressed as part of the normal certification plan submitted for any type certificate project.

Section 25.1829(5) included a proposed requirement to include in the compliance plan a process for continually assessing service information related to structural fatigue damage. We have reconsidered this proposed requirement and concluded that existing regulations  36 that require both DAHs and operators to report structural defects should be adequate to enable us to determine whether the objectives of this final rule are being met. Therefore, we removed this provision from the final rule.

Bombardier, in its comment on the compliance plan, referred to the proposed requirement that the compliance plan must address a process for continuous assessment of service information. Bombardier said feedback from operators on the effectiveness and findings resulting from DT-based inspections of baseline structure, as well as repairs and alterations, may not be adequate to enable them to meet this requirement.

As discussed above, we have removed this provision from this final rule since existing regulations will enable us to determine if the objectives of this final rule are being met.

Airbus expressed concern that the FAA may not have sufficient resources to handle approval of compliance plans in a timely manner. Therefore, it recommends a thorough review of FAA resources needed for this activity before committing to the proposed compliance date.

FedEx said it understands that the compliance documents must be approved by the FAA Aircraft Certification Office (ACO) before they are made available to operators, but the proposed rule does not state when the documents would be made available to operators. FedEx said the rule should include a date by which the FAA would approve the DT data that TC and STC holders provide, as well as a date by which the approved data will be made available to operators.

The ATA said the FAA should commit to a schedule for approving the DT data from DAHs and implementation plans from operators. It requested that the FAA give an estimate of when industry can expect the FAA to approve the DT documents and implementation plans, taking into account the volume of the submissions.

We are not including time frames in the regulation for our review and approval of the compliance plans and compliance documents. Expectations for FAA personnel have been defined in FAA Order 8110.26, which directs the Aircraft Certification Service and Flight Standards Service in their roles and responsibilities for implementing these initiatives. The Order includes expected times for reviewing and approving DAH compliance plans, plans to correct deficiencies, and draft and final compliance data and documents. To facilitate implementation, we will also train affected personnel in their roles and responsibilities and provide familiarization with requirements of the regulations and associated guidance. However, our ability to approve documents, and the timing of our approvals, ultimately depends on the quality of the documents submitted by the DAHs and their responsiveness if we identify deficiencies.

The AAWG industry representatives, ATA, Boeing, Embraer, and Horizon Air commented that the FAA should harmonize the DT Data rule with EASA and other national airworthiness authorities. If the rule is not harmonized, the AAWG industry representatives expressed concern that the FAA's retention of authority to make all necessary compliance determinations for foreign DAHs will establish “a substantial precedent that could create a significant challenge to all future certification programs.” The AAWG industry representatives said the stated requirements advocate “a procedure that could permit unilateral and potentially arbitrary certification activities at the whim of any regulatory authority.”

Boeing and the ATA said the lack of harmonization will cause unnecessary conflicts and complexities between the FAA's and foreign authorities' requirements. Boeing said while it is aware that EASA is pursuing a similar proposal, EASA may not adopt the same requirements as the FAA. Also, Boeing said, having to comply with different requirements in the same time frame would cause added complications and difficulties with meeting aggressive schedules, and it would result in unnecessary, additional work for the FAA.

Both Boeing and the ATA believe harmonization is a standard of excellence that has been achieved over many years of hard work and this rule should not interfere with that achievement.

We agree with the commenters that harmonization of this rule with other national authorities is an important objective. We fully expect to coordinate with EASA and other authorities on findings of compliance. EASA and Transport Canada Civil Aviation (TCCA) have participated in the AAWG's development of the AC that will support compliance with this final rule. As a follow-on to this activity, EASA has proposed the formation of a European Aging Aircraft Working Group and has requested participation by the FAA. The FAA plans to support this activity with representatives from both the Aircraft Certification Service and the Flight Standards Service. There is general agreement among the authorities on the need to address DT for repairs and alterations and on the approach adopted in this rule.

The AAWG industry representatives commented that there is the potential for creating substantial negative impact in the industry with respect to airplane certification sales and transfers between U.S. and foreign entities because the proposal has not been harmonized with EASA. According to the AAWG industry representatives, the economics of this impact has not been accounted for in the regulatory evaluation; therefore, the FAA should assure that the final rule is harmonized to the extent possible with EASA because of the potential economic issue for all parties. The AAWG industry representatives also said it appears that the long-term intention of EASA is to harmonize with the U.S. requirements by 2008 or 2009. And it said that the implementation time scales are different between the two authorities' approaches.

This rule will not have the negative effects suggested by the commenter. In fact, by requiring DAHs to develop and make available the data necessary to comply with the AASFR, this rule will facilitate compliance for all airplanes, which is a prerequisite for transferability. All authorities recognize that harmonization of this rule is important in that common requirements will allow expeditious transfer of airplanes across borders, and we are working towards that objective.

Airbus commented that the NPRM preamble indicates that the FAA cannot accept foreign authority approval for documents under Bilateral Agreements because these foreign authorities have not yet adopted a similar rule. It said the Joint Aviation Authorities (JAA) issued and applied Notice of Proposed Amendment (NPA 20-10) (the European Aviation Safety Agency (EASA) updated NPA 20-10 to NPA 05/2006), which addresses the same airworthiness issues and incorporates similar technical guidance. Moreover, evaluation of repairs, alterations, and modifications to DT requirements is state-of-the-art and is approved under the EASA regulatory system on a daily basis.

Airbus also said it will be at a disadvantage by having to deal unilaterally with the FAA without the support and involvement of EASA. Also, it said it would have to coordinate with the FAA's international branch along with several other non-U.S. TC holders. However, U.S. TC holders will have a dedicated FAA certification office to work with and may be able to use their authorized designees to perform compliance related activities.

According to Airbus, obtaining support from the FAA is especially important for proposed §§ 25.1823(d) and 25.1825(c) and (d) for alteration and repair approvals. Therefore, Airbus requested that the FAA include EASA in the approval process, such that in the near future the FAA could accept the majority of the activities performed by EASA under the Bilateral Agreement. In addition, Airbus requested that the FAA give non-U.S. TC and STC holders the same level of priority and the same allocation of FAA resources as U.S. TC and STC holders. This, Airbus said, would help mitigate delays in reaction and approval time.

Horizon Air said the proposed rule states that data will be submitted to the FAA Oversight Office or its properly authorized designees. In defining “authorized designees,” reference is made only to Designated Engineering Representatives (DERs) specifically authorized by their supervising ACO.

Horizon Air also said that currently because of the Bilateral Agreement between Transport Canada and the FAA, it is able to incorporate DTE and DTI documentation for Bombardier and deHavilland airplanes directly into its maintenance program. Under the new rule, it appears it would be required to submit the developed repair data to the ACO before being able to implement it. Therefore, Horizon Air requested that Foreign Authorities, specifically Transport Canada, or their designees be included under Bilateral Agreements.

We recognize the important role other national authorities are likely to play in implementation of this rule. In addition to the on-going efforts to harmonize these requirements, we have been working closely with the other national authorities to define appropriate roles, responsibilities, and relationships among all affected authorities. As discussed in the NPRM, the compliance planning provisions are equally important for foreign TC holders, and we expect to have mutually agreeable arrangements with their authorities on how compliance planning will be overseen. We expect these other authorities to play a major role in reviewing their TC holders' compliance plans and other required documents, which will enable us to provide timely approvals for all affected TC and STC holders, assuming the submitted documents comply with the applicable requirements.

Bombardier and UPS expressed concerns about enforcement. Bombardier asked what mechanism the FAA would use to impose civil penalties on non-U.S. DAHs. UPS said the proposed rule does not state how the FAA would handle a DAH that does not complete the damage tolerance assessment tasks on time. It is also concerned whether the FAA can effectively enforce the intent of these types of provisions.

The compliance planning provisions of this rule are intended to facilitate timely compliance and avoid the need of enforcement for non-compliance. However, under 49 U.S.C. 46301, the FAA has authority to take civil penalty action without regard to nationality of the respondent. The FAA's general enforcement policies, which are set forth in 14 CFR part 13 and Order 2150.3, will apply to the DAH requirements. These general policies provide wide discretion for us to impose administrative action, civil penalties (up to $25,000 per violation per day) or action against a TC or STC holder's certificate (including suspension or revocation).

If a TC or STC holder is found to be non-compliant, we will consider the circumstances of non-compliance before determining an appropriate course of action. For example, deliberate violations will be treated more severely than inadvertent non-compliance. Any enforcement action the FAA may choose to take will be in consideration of the circumstances of the violation and defined on a case-by-case basis.

UPS commented that DT analysis depends on complex methodology and data. Because of this, there are very few DERs in the industry that have FAA DTE approval authority. UPS suggested it is highly unlikely that this methodology and relevant data can be streamlined into an approach that is useful and effective. It suggested the FAA establish an initiative to authorize additional structures DERs with DTE approval authority.

ABX expressed concern that both industry and the FAA have a shortage of specialists in areas related to the rule. It said FAA ACOs don't have enough resources to provide the needed support to industry in a timely manner. It also said the present delegation requirements in the area of DT are unachievable for non-OEM DERs. Therefore, ABX said the FAA, with support of the industry, should take the following steps:

• Create different levels of delegation for DTE. If necessary, keep the requirements the same for full authority but allow DERs with less than required experience to obtain delegation to show compliance in specific areas, using previously FAA-approved methodology.

• Provide training to DERs and/or call for specific college courses that can substitute the experience to facilitate the delegation.

• Develop methodologies for DT analysis in the areas that are frequently needed by operators and STC holders.

• Postpone any rulemakings until the industry has the required tools to comply with the rule in the mandated time frame.

Recognizing the limited industry and FAA resources available to perform and approve DTEs, ARAC has developed guidance material in AC 120-93 that describes a means of compliance with this rule and the AASFR that allows the available resources to focus on the highest priority DTEs for repairs. This AC describes an implementation schedule with a phased-in approach under which existing repairs on the older and higher-utilization airplanes are assessed first (highest risk repairs), with newer airplanes being assessed when they approach their design service goal (DSG). This approach is similar to that established for certain RAGs developed for compliance with § 121.370 37 (redesignated as § 121.1107)). Therefore, we find the implementation schedule approach described in AC 120-93 to be a rational one. We believe this approach will help ensure that adequate industry and FAA resources will be available to support timely compliance with this final rule and with the AASFR.

The FAA agrees that there is a need for an increased number of designees having authorization for DT. To address this potential problem, the FAA is continuing to hold DER seminars to encourage participation by DERs in these programs. DERs can work with their FAA Oversight Office to develop a plan that would support expanding their authorized delegation to include DT. Due to the complexities associated with DT, particularly those related to performing DTEs on repairs and alterations, it is necessary to ensure DER candidates have adequate experience in performing DT and in analyzing repairs and alterations. The current process for obtaining DT-delegated functions requires DER applicants to have at least 1 year of experience in performing DTEs. This experience is necessary for the FAA to gain a level of confidence that the DER, once authorized to perform DT on repairs and alterations, will submit DT data that are appropriate and not subject to a need for extensive review by the FAA Oversight Office.

For compliance with the AASFR, it is of particular importance that the DERs have a working knowledge of what is required for showing compliance with § 25.571 for repairs and alterations. The FAA does not agree with the commenter's recommendation to allow DER candidates with less than the required experience to obtain a delegation for DT, or to substitute the requirement for experience with college courses to facilitate delegation. Experience is a key element in ensuring the success of the FAA's delegation program.

Regarding the recommendation that the FAA develop methodologies for DT analysis in the areas that are frequently needed by operators and STC holders, we believe the methodologies employed today, which have been used for several years throughout the aviation industry, are adequate. Damage-tolerance-based programs such as RAGs developed by TC holders to support operator compliance with § 121.370 (redesignated as § 121.1107), provide a streamlined approach operators can use for assessing repairs common to the airplane pressure boundary. Expansion of these guidelines to address additional structural areas (e.g., frequently repaired areas), or development of new RAGs, may support operator compliance with the AASFR. However, these types of DT-based programs are model specific and typically require TC holder involvement. Operators should coordinate with TC holders during STG meetings to determine the need for such programs and how they should be structured.

We disagree with the recommendation to postpone this rulemaking because we do not believe industry needs additional time to comply. As we have discussed, this final rule is needed to support operator compliance with the AASFR. That rule was adopted in February 2005. Delaying adoption of the DAH requirements in this rule would adversely affect operators' ability to meet the compliance time frame in the AASFR. In addition, methodologies for performing a DTE have been applied for several years and are readily available. Also, to reduce the resource burden, we describe in AC 120-93 an implementation schedule that may provide more time for operators to obtain DTEs for alterations for which there are no TC or STC holders. This implementation schedule may provide, in part, a means for addressing the potential adverse effects of alterations.

UPS said some STC holders may not have the resources (either financially, technically, or both) to comply with the proposal. Further, it said, the proposal does not address the situation where an STC holder has gone out of business or has surrendered its STC to the FAA.

The FAA recognizes that there may be some occasions where the DAH is unwilling or unable to comply with the regulations. There may also be cases where the DAH no longer exists. As stated in the policy statement, Safety—A Shared Responsibility—New Direction for Addressing Airworthiness Issues for Transport Category Airplanes, under these circumstances, the operator is still obligated to comply with the operational rules. However, the FAA recognizes that such occasions may significantly complicate the operator's effort to show compliance with the operational rules. The FAA recommends the affected operators contact their DAHs early in the compliance process to ensure their intent to comply. These operators are also encouraged to collaborate with other operators who may also be impacted by lack of support on a means for compliance.

As noted before, today's final rule supports the AASFR, which requires operators to incorporate a means to address the adverse effects of repairs and alterations into their maintenance program by December 20, 2010. This DAH DT Data final rule includes compliance dates that require DAHs to make the required DT documents available to operators in enough time for them to comply with their approved means for addressing repairs and alterations. The approved means will include implementation schedules that provide timing for when airplane repair surveys are to be performed and when DTI or other maintenance actions for repairs and alterations need to be incorporated into the maintenance program. Certain of the compliance dates in the DAH DT Data final rule have changed from those in the proposed rule.

Specifically, in proposed § 25.1823(g)(1), TC holders would have 90 days after the effective date of the rule to submit their lists of fatigue critical baseline structure. In proposed § 25.1825(e)(1), they would have 90 days to submit their lists of fatigue critical alteration structure. In proposed § 25.1827(e)(1), STC holders would have 270 days to submit their lists of fatigue critical alteration structure.

In the final rule (§ 26.43(f)(1)), TC holders have 180 days from the effective date to submit their lists of fatigue critical baseline structure. TC and STC holders (§§ 26.45(e)(1) and 26.47(e)(1), respectively) have 360 days from the effective date of the rule to submit their lists of fatigue critical alteration structure.

The AAWG industry representatives, Boeing, FedEx, and Embraer asked for an extension of the compliance date in the AASFR and a commensurate extension of the DAH DT Data rule's compliance date. While several of the commenters acknowledged the FAA's prior 3-year extension (from 2007 to 2010) to the compliance time for the AASFR, they said if the FAA had published the DAH DT Data NPRM at the time of that extension, industry would have had more time to comply with the DAH DT Data final rule.

The AAWG industry representatives asked us to extend the AASFR compliance date of December 20, 2010 to December 20, 2013. FedEx asked the FAA to give operators a minimum of 12 months after receiving the FAA-approved documents to develop their implementation plan to send to their FAA Flight Standards District Office. Boeing asked us to extend the AASFR compliance date to August 18, 2013. It said the FAA should impose incremental compliance times from the effective date of final rules, rather than impose a fixed date. For the DAH DT Data final rule, Boeing believes the FAA should allow DAHs 4 years from the effective date of the rule to submit their documents to the FAA because of the addition of the DAH requirements and related compliance plan in this final rule.

Except as discussed previously regarding lists of fatigue critical structure (FCS), we do not believe an extension of the compliance dates in either rule is appropriate. As several of the commenters acknowledged, we previously extended the compliance date for the AASFR by 3 years to allow ARAC time to develop guidance material operators could use to support compliance with DT requirements related to repairs and alterations.

Based on requests from industry, in May 2004, we tasked  38 ARAC to develop guidance to support operator compliance with the AASFR. Included in the tasking notice was a task for ARAC to do the following:

In addition, the tasking states that the data developed by the TC holders via STG meetings, using the guidance material developed by ARAC, should be completed by December 18, 2009. ARAC accepted this tasking, which it assigned to the AAWG, and agreed to complete it by the specified date of December 18, 2009.

In the February 2005 AASFR, we extended the December 5, 2007 compliance date adopted in the Aging Airplane Safety Interim final rule  39 to December 20, 2010. This extension was meant to give ARAC time to complete the tasking and allow operators a full year to implement the resulting program changes. The AAWG developed a schedule for completion of the tasking by the agreed-upon date. The compliance dates specified in this DAH DT Data final rule are fully consistent with these commitments, and none of the commenters have identified reasons why we should not expect these commitments to be fulfilled.

Regarding Boeing's comment that this rule imposes additional requirements for which they need more time, assuming ARAC and the STGs fulfill their commitments, we anticipate that the products of the tasking will enable Boeing and other participating TC holders to meet the requirements of this rule with little additional effort. Specifically, regarding compliance planning, this type of planning is normal business practice, regardless of the requirements of this rule, as evidenced by the AAWG's schedule development discussed earlier.

The ATA, Boeing, UPS, FedEx, and AAWG industry representatives asked that DAHs be given 180 days from the effective date of the final rule to submit their lists of fatigue critical baseline structure to the FAA. The ATA and UPS asked that the FAA allow 360 days from the effective date of the final rule for STC holders to submit their lists of fatigue critical alteration structure. Airbus requested an extension of 1 year from the effective date of the final rule to submit its lists of fatigue critical baseline structure. The commenters believe it is important to allow DAHs enough time to develop the lists to ensure they are accurate.

Boeing and AAWG industry representatives indicated that the FAA should allow additional time to develop the lists because of their importance to industry and to other rules like the proposed Widespread Fatigue Damage (WFD) rule. Boeing said more time would enable it to consult with the STGs on the format and content of the lists. It also said more time is needed because of the large numbers of airplanes and alterations involved and the need for internal coordination to ensure consistency. It estimates that for its airplane models, it would have to produce more than 40 lists.

The ATA, FedEx, and UPS said if DAHs do not have sufficient time to develop accurate lists, they may produce overly conservative lists that include all primary structure. The ATA and FedEx add that such lists would be of little value to operators and would add costs and complexities to operator compliance with the AASFR. Also, the ATA said DAHs may opt to recommend replacement of structural elements rather than inspections and repairs if they do not have enough time to compile the lists. Airbus commented that it does not have the resources to complete the necessary assessments and compile the lists in the proposed time frames. Airbus said the consequence of not having enough time to develop accurate lists could be either incomplete lists or extremely long lists.

The FAA believes additional time to establish the lists of fatigue critical baseline and alteration structures is appropriate, and has revised the rule as discussed above. The revised time frames, which give TC holders 180 days to submit their lists of FCBS and TC and STC holders 360 days to submit their lists of fatigue critical alteration structure, should allow sufficient time to develop the lists. This is particularly true since the TC holders have been required to identify fatigue critical structure to comply with the damage tolerance requirements of § 25.571 since 1978. For pre-amendment 25-45 airplanes, the TC holder analysis that led to the development of the SID documents provide a useful starting point for developing these lists. As discussed previously, these activities should already be well underway.

The AAWG industry representatives and Boeing commented on our statement in the NPRM that the costs of the proposed rule were accounted for in the AASFR. The AAWG industry representatives believe that the economics on which the proposed rule is based are questionable and their basis cannot be determined. Boeing said the FAA assumed that much of the work required for compliance with the proposed rule was already completed by the TC holders on other programs, such as the SID and RAG initiatives. The commenters added that the costs ascribed to the TC holder in the proposed rule, in fact, did not exist at the time the original rule was published for comment, nor do they exist today.

The AAWG industry representatives and Boeing requested that the FAA revise the basis of the economic evaluation of the proposed rule, and include accurate estimates of the cost of the development of compliance data by the TC holders, based on the means of compliance suggested in AC 120-93.

The ATA said the FAA should disclose DAH estimates for the cost of damage tolerance data and documents. The ATA indicated that it does not concur with the FAA's assertion that the proposed rule has minimal to no costs. The ATA recommended that the FAA include DAH estimates for the cost of these documents in its disposition of comments to the proposal.

UPS said the costs of the proposed rule changes are understated. Although the regulatory flexibility analysis in the rulemaking states that this rule would relieve small-entity part 121 operators of what could be a significant cost, there is nothing in this proposal that prevents DAHs from passing all their costs on to the operators. Although this compensation could be reasonable, it will also likely be significant. UPS suggested that an accurate cost-benefit analysis be accomplished and evaluated prior to adopting this rulemaking.

The requirements to develop damage tolerance (DT) based data for repairs and alterations were originally established in the Aging Airplane Safety Interim final rule (AASIFR). These responsibilities were initially placed on the operators of part 121 and U.S.-registered part 129 transport category airplanes. The costs and benefits were computed in the regulatory evaluation for that rulemaking. The regulatory evaluation for the AASIFR, as well as the regulatory evaluation for the AASFR, which clarified these requirements, recognized that to comply with the rule's requirements, operators would have to develop and implement DT-based inspections and procedures for the affected airplane structure. This DAH DT Data final rule is a counterpart to the AASFR; it transfers the responsibility of developing DT-based data from operators to design approval holders (DAHs). Therefore, it has minimal to no societal costs.

We anticipate that by the compliance date for the AASFR, DT inspection programs for baseline structure, required by this DAH DT Data final rule, will already be mandated by AD or certification or operational regulations for all airplanes affected by this final rule. A significant number of operators subject to the AASFR are small entities. If each of the small-entity operators individually took the responsibility for developing DT-based data, the cost for the data would be significant. By transferring the responsibility from part 121 operators to DAHs, this rule will relieve those operators of what could be a significant cost.

While UPS is correct that operators may have to compensate TC holders for the data they make available, we expect these costs to be substantially less than if the operators had been required to individually develop their own data.

The DAHs, with their greater expertise and access to design data, are in the best position to identify fatigue critical structure and methods and frequency of inspections operators need to comply with the AASFR. DAHs can develop these data with greater efficiency than individual operators and these costs would be amortized over a larger fleet. With STG participation, we expect that the resulting compliance documents will minimize costs for operators and facilitate their compliance with the AASFR. This final rule will ensure that the required data are developed in a timely manner to minimize the possibility for disruption of airline operations when the AASFR compliance deadline is reached. AC 120-93 is largely a product of ARAC and reflects industry's view of the most cost effective means for developing the data operators must implement under the AASFR.

Under the Paperwork Reduction Act of 1995, (5 CFR 1320.8(b)(2)(vi)), 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. Information collection requirements in the AASFR previously have been approved by the Office of Management and Budget (OMB) under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) and have been assigned OMB Control Numbers: 2120-0020 and 2120-0008. Part 129 record requirements can be found in International Civil Aviation Organization Annexes.

The FAA reviewed data associated with compliance to the AASFR and data associated with this rule. We have determined that this rule is a transfer of responsibility only, and there is no additional paperwork burden on the public. The paperwork burden for compliance with the AASFR will be reduced as a result of this rule due to a reduction in the numbers of repairs and alterations that will need an individual damage tolerance assessment. This is because this rule will require design approval holders to develop a streamlined approach for assessing repairs.

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to comply with International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to these regulations.

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 directs that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule.

Department of Transportation Order DOT 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits that a statement to that effect and the basis for it be included in the preamble if a full regulatory evaluation of the cost and benefits is not prepared. Such a determination has been made for this final rule. The reasoning for this determination follows.

We begin with a discussion of the AASFR. Then we discuss the existing certification and operational rules that already require operators to develop and implement the DT inspections and procedures this final rule will require.

This rule transfers the responsibility of developing AASFR DT data and documents from operators to DAHs. A transfer of responsibility from one entity to another does not increase societal costs; therefore, this rule has minimal to no costs. Additionally, the DAH requirements do not preclude DAHs from recouping their costs by seeking reasonable compensation from the operators for the required DT data and documents. The recently published AASFR  40 requires airline operators of certain large transport category airplanes to implement DT-based inspections and procedures for airplane structure susceptible to fatigue cracking that could contribute to catastrophic failure. Damage tolerance data are essential for operators to implement and conduct DT-based inspections and procedures.

This final rule is a counterpart to the AASFR to ensure that operators have the necessary data and documents to support timely compliance with the requirements of §§ 121.1109 and 129.109. Timely operator compliance improves the safety of the fleet.

This final rule will require DAHs to develop DT inspections and procedures for repairs and alterations. Existing operational rules already require DT inspections and procedures for repairs and alterations to baseline structure. TC Holders of airplanes certified to Amendment 25-45 (or later), which are affected by this proposal, are required by § 25.571 to perform a damage tolerance evaluation and establish, as necessary, damage tolerance inspections or other procedures. On pre-Amendment 25-45 airplanes, DT inspection and procedures for the baseline structure are required by airworthiness directive (AD). Damage tolerance inspections for repairs and alterations to affected Boeing 727 and 737-100/200 airplanes are also required by AD. Damage tolerance inspections for repairs to the pressurized fuselage  41 for certain pre-Amendment 25-45 airplanes  42 are required by § 121.370 (redesignated as § 121.1107). By December 2010, damage tolerance inspections for the baseline structure and repairs and alterations will be required by §§ 121.1109 and 129.109 for airplanes certificated after January 1, 1958 that have a passenger seating capacity of 30 or more or a maximum payload capacity of 7500 pounds or more. Despite these requirements, in many cases, DT data and documents have not yet been developed for many repairs and alterations made to the affected airplanes.

The following table summarizes the regulatory requirements for DT inspection programs. The shaded areas in the table represent regulatory gaps filled by the AASFR (§ 121.1109) requirements to develop DT inspections and procedures for fatigue critical airplane structural areas.

In summation, this final rule will transfer the responsibility from the existing requirements for developing DT based inspections and procedures from part 121 operators to DAHs. The DAHs, with their greater expertise and access to design data, are in the best position to identify fatigue critical structure and methods and frequency of inspections operators need to comply with the AASFR. DAHs can develop these data with greater efficiency than individual operators and these costs will be amortized over a larger fleet. This final rule will ensure that the required data are developed in a timely manner to minimize the possibility for disruption of airline operations when the AASFR compliance deadline is reached.

The FAA has, therefore, determined this rulemaking action is not a “significant regulatory action” as defined in section 3(f) of Executive Order 12866, and is not “significant” as defined in DOT's Regulatory Policies and Procedures. In addition, the FAA has determined that this final rulemaking action: (1) Will not have a significant economic impact on a substantial number of small entities; (2) will not affect international trade; and (3) will not impose an unfunded mandate on State, local, or tribal governments, or on the private sector.

The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA.

However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

We did not receive comments from U.S. small entities in the responses to the proposed rule.

The FAA recently adopted the Aging Airplane Safety Final Rule (AASFR), 44 which, among other things, requires airline operators of certain large transport category airplanes  45 to implement damage tolerance (DT) based inspections and procedures for airplane structure.

This final rule is a counterpart to the AASFR. By the effective date of this rule, DT inspection programs will already be required by AD, certification or operational regulations for all part 121 airplanes affected by this proposal. The final rule will transfer the requirement to develop AASFR DT based data for inspections and procedures from part 121 operators to design approval holders (DAH). A significant number of part 121 operators are small entities. By transferring the responsibility from part 121 operators to DAH, this final rule may relieve small-entity part 121 operators of what could be a significant cost.

DAHs include manufacturers of part 25 airplanes and supplemental type certificate (STC) holders for repairs and alterations made to these airplanes.

The current United States part 25 airplane manufacturers include: Boeing, Cessna Aircraft, Gulfstream Aerospace, Learjet (owned by Bombardier), Lockheed Martin, and Raytheon Aircraft. These manufacturers will incur Type Certificate (TC) and Amended TC costs. Because all U.S. transport-aircraft category manufacturers have more than 1,500 employees, none are considered small entities.

STC holders include manufacturers and operators of part 25 airplanes, some of which are small-entities. Since the DAH requirements do not preclude them from seeking reasonable compensation from the operators for the proposal's required DT data and documents, small-entities STC holders, with less than 1,500 employees, should be able to recoup their costs.

Therefore, as the Acting FAA Administrator, I certify that this rule will not have a significant economic impact on a substantial number of small entities.

The Trade Agreements Act of 1979 (Pub. L. 96-39) prohibits Federal agencies from establishing any standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this final rule and determined that it will impose the same costs on domestic and international entities and thus has a neutral trade impact.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (adjusted annually for inflation with the base year 1995) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $128.1 million in lieu of $100 million.

This final rule does not contain such a mandate. The requirements of Title II do not apply.

The FAA has analyzed this rule under the principles and criteria of Executive Order 13132, Federalism. We determined that this action 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, and, therefore, will not have federalism implications.

FAA Order 1050.1E identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 312f and involves no extraordinary circumstances.

The FAA has analyzed this final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). We have determined that it is not a “significant energy action” under Executive Order 12866, and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

You can get an electronic copy of rulemaking documents using the Internet by—

1. Searching the Federal eRulemaking Portal ( http://www.regulations.gov );

2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/; or

3. Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.

You can also get a copy by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue, SW., Washington, DC 20591, or by calling (202) 267-9680. Make sure to identify the amendment number or docket number of this rulemaking.

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://DocketsInfo.dot.gov.

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. If you are a small entity and you have a question regarding this document, you may contact your local FAA official, or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. You can find out more about SBREFA on the Internet at http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

Under part 740 of the EAR, License Exception Temporary Imports, Exports, and Reexports (TMP) (§ 740.9) and License Exception Baggage (BAG) (§ 740.14) both contain tools of trade provisions (§ 740.9(a)(2)(i) and § 740.14(b)(4), respectively) which authorize certain temporary exports and reexports for usual and reasonable kinds and quantities of tools of trade for use in a lawful enterprise or undertaking of the exporter. Previously, License Exceptions TMP and BAG did not authorize temporary exports or reexports of technology because the scope of these license exceptions was limited to commodities and software.

This rule expands the availability of License Exceptions TMP and BAG to allow for certain temporary exports and reexports of technology by U.S. persons to U.S. persons or their employees traveling or temporarily assigned abroad. This rule does not authorize any new release of technology. Technology exported under License Exceptions TMP or BAG may only be released to persons who may receive that same technology pursuant to other provisions of the EAR. Exporters and reexporters who wish to use the tools of trade provisions of the two relevant license exceptions for the temporary export or reexport of technology subject to the EAR may do so, subject to certain restrictions specifically applicable to technology exports and reexports. These restrictions provide safeguards against the unauthorized risk of access to technology.

This rule makes the following revisions to the Export Administration Regulations (EAR) to reflect changes to License Exceptions TMP and BAG:

In part 740 (License Exceptions):

(1) This rule makes changes in § 740.9 (Temporary Imports, Exports, and Reexports (TMP)), to amend the “tools of trade” provisions in paragraph (a)(2)(i) to authorize the export or reexport by U.S. persons of certain technology to U.S. persons or their employees traveling or temporarily assigned abroad. This rule adds a new paragraph (a)(2)(i)(C) to add a specific definition of U.S. person applicable to paragraph (a)(2)(i).

In § 740.9, this rule also adds a new paragraph (a)(3)(iv), establishing restrictions to prevent unauthorized export or reexport of technology. These restrictions include a restriction added to paragraph (a)(3)(iv)(A) for exports or reexports to employees who are not U.S. persons, as defined in (a)(2)(i)(C), to ensure that this license exception will not be used to circumvent other license requirements under the EAR such as the “deemed export” license requirements set forth in § 734.2(b)(2)(ii). Specifically, TMP may be available to employees who are not U.S. persons, as defined in paragraph (a)(2)(i)(C), for exports or reexports of technology under the tools of trade provisions set forth in paragraph (a)(2)(i)(A) only to the extent that such employees are authorized to receive the same technology in accordance with the EAR (e.g., a license or license exception), or, alternatively, do not require such authorization on account of the technology's NLR status. As an additional safeguard, under paragraph (a)(3)(iv)(A)(2), the U.S. person employer must demonstrate and document for recordkeeping purposes the reason that the technology to be authorized for export or reexport under the tools of trade provisions of paragraph (a)(2)(i)(A) is needed by such employees in their temporary business activities abroad on behalf of their U.S. person employer.

This rule adds a new paragraph (a)(1)(i) to provide an additional requirement and guidance for the return or disposal of technology authorized under License Exception TMP. This paragraph (a)(1)(i) clarifies that technology shipped or transmitted as temporary exports or reexports under the provisions of paragraph (a)(2)(i)(A) that exists in a format that could facilitate a subsequent release of the technology must be returned or disposed of in accordance with paragraph (a)(4) of License Exception TMP. This paragraph also provides an illustrative list of examples of technology that exists in a format that could facilitate a subsequent release of technology.

(2) This rule also revises § 740.14 (Baggage (BAG)) to amend the tools of trade provisions in paragraph (b)(4) (Tools of Trade) to authorize the export or reexport of certain technology to U.S. persons for use in the trade, occupation, employment, vocation, or hobby of the traveler or members of the U.S. person's household, provided they are also U.S. persons, who are traveling or moving. This rule adds a new paragraph (b)(4)(i) to add a specific definition of U.S. person applicable to paragraph (b)(4) of this section. In addition, this rule adds a new paragraph (h) prohibiting the unauthorized export or reexport of technology.

(3) In § 772.1 (Definitions of Terms as Used in the Export Administration Regulations), this rule revises paragraph (b) of the definition of U.S. person to clarify that exporters should see § 740.14 (License Exception BAG) for a definition of U.S. person that is specific to that section.

(4) In § 740.9, the reference to Note 2 in Category 5—Part 2 “Information Security” of the Commerce Control List (CCL) (Supplement No. 1 to Part 774 of the EAR) is removed. Note 2 in Category 5, Part 2 refers persons to License Exceptions TMP and BAG. Prior to the publication of this rule, the last sentence of paragraph (a)(2)(i) of License Exception TMP referred persons back to Note 2 in Category 5, Part 2. License Exception BAG does not contain a reference to Note 2 of Category 5, Part 2. To provide clarity, the reference to Note 2 in § 740.9 is eliminated with the publication of this rule.

In order to provide clearer guidance to the public regarding which encryption items are authorized under License Exceptions TMP and BAG, this rule also specifies certain restrictions applicable to the use of both License Exceptions TMP and BAG for exports and reexports of certain types of encryption technology. First, encryption technology controlled under ECCN 5E002 is not authorized for export or reexport under the amended “tools of trade” provisions of License Exception TMP. Second, in License Exception BAG § 740.14, the new U.S. person “tools of trade” provisions do not authorize the export or reexport of ECCN 5E002 encryption technology to any destination listed in Country Group E:1 of Supplement No. 1 to part 740. For the export or reexport of 5E002 technology by companies, their subsidiaries and employees, see License Exception Encryption Commodities and Software (ENC) set forth in § 740.17.

In License Exception TMP § 740.9 paragraph (a)(2)(i), this rule also removes the second to last sentence that stated, prior to the publication of this rule, that items controlled under ECCN 5D992 are permitted pursuant to this section, as this sentence is not needed to clarify the scope of items available under License Exception TMP.

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as extended by the Notice of August 15, 2007, 72 FR 46137 (August 16, 2007), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act.

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

2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid Office of Management and Budget Control Number. This rule contains a collection of information subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This collection has been approved by the Office of Management and Budget under control number 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 58 minutes for a manual or electronic submission.

3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (5 U.S.C. 553(a)(1)). Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Therefore, this regulation is issued in final form.

On May 24, 2007, we published a notice of proposed rulemaking (NPRM) entitled “Anchorage Regulations; Edgecomb Maine, Sheepscot River” in the Federal Register (72 FR 29092). We received no comments on the proposed rule. No public hearing was requested, and none was held.

This rule is intended to reduce the risk of vessel collisions by creating a general anchorage area in Edgecomb, Maine adjacent to the current town mooring fields. This rule is designed to reserve approximately 15 anchorages for transient vessels visiting the area from May through October each year. The anchorage would accommodate both sail and power vessels with a 3-to-12-foot draft.

The Coast Guard is designating the general anchorage area in accordance with 33 U.S.C. 471. The Coast Guard has defined the anchorage area contained herein with the advice and consent of the Army Corps of Engineers, Northeast, located at 696 Virginia Rd., Concord, MA 01742.

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

The anchorage area does not impede the passage of recreational or commercial vessels as it is not located in the primary channel of the Sheepscot River, and will therefore have a minimal economic impact.

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

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

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

If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance; please contact John J. Mauro, at the address listed in ADDRESSES above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph 34(f), of the Instruction from further environmental documentation. Paragraph (34)(f) applies to this rule because it establishes an anchorage area. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket for inspection or copying where indicated under ADDRESSES .

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Public comment is not necessary since the event requiring the closure has modified its schedule and the bridge closure no longer conforms to the dates and times of the event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective in less than 30 days after publication in the Federal Register . There is no need to delay the implementation of this rule because the portion of the regulation being removed was date specific to the last weekend in October of each year.

On October 11, 2001, a Final Rule was published in the Federal Register [65 FR 60360] to change the operating schedule of the SR 23 vertical lift bridge across the Gulf Intracoastal Waterway (Algiers Alternate Route), mile 3.8, in Belle Chasse, Louisiana. The change allowed the drawbridge to not open for the passage of vessels from 4 p.m. to 7 p.m. on Saturday and Sunday of the last weekend in October. This regulation was in addition to the existing regulation that required the draw to open on signal; except that, from 6 a.m. to 8:30 a.m. and from 3:30 p.m. to 5:30 p.m. Monday through Friday, except Federal holidays, the draw need not be opened from the passage of vessels. The change was to facilitate the movement of vehicular traffic from the New Orleans Open House Air Show held annually at the Naval Air Station, Joint Reserve Base at Belle Chasse, Louisiana.

Subsequent to the modification of the rule, the Air Show was cancelled in 2005, moved to a different weekend in 2006, and the time of the closure request was modified in 2007. The rule change for 2006 required a Temporary Rule to be published and the rule change for 2007 required a Temporary Deviation to be published. Additionally, the Air Show will not be held in 2008 in Belle Chasse making the regulation unnecessary. Therefore, it has been determined that the regulation be modified to remove the requirements of § 117.451(b)(2). Any future closure requirements, associated with any future Air Shows in Belle Chase, will be publicized as required by 33 CFR part 117, subpart A.

The Coast Guard is changing 33 CFR 117.451 without publishing an NPRM. This final rule changes the regulation governing the bridge to eliminate the section of the regulation that does not require the draw to open for the passage of vessels from 4 p.m. to 7 p.m. on Saturday and Sunday of the last weekend in October. This change improves the ability of vessels to transit on the waterway during this time period. As explained above, it is not necessary to publish an NPRM.

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

The Coast Guard does not consider this rule to be “significant” under that Order because it does not adversely affect the owners and operators of vessels operating on the waterway.

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

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

This rule will have no impact on any small entities because it will not adversely affect the owners and operators of vessels needing to transit the waterway.

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

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.lD which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (32)(e) of the Instruction, from further environmental documentation. Under figure 2-1, paragraph (32)(e), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule.

The Spuyten Duyvil Bridge, across the Harlem River, mile 7.9, at New York City, New York, has a vertical clearance in the closed position of 5 feet at mean high water and 9 feet at mean low water. The existing drawbridge operation regulations are listed at 33 CFR 117.789(f).

The owner of the bridge, National Railroad Passenger Corporation (Amtrak), requested a temporary deviation to facilitate scheduled bridge maintenance, the replacement of the bridge protective fender system at the west end.

Under this temporary deviation in effect from January 10, 2008 through April 14, 2008, the Spuyten Duyvil Bridge need not open for the passage of vessel traffic from 6 a.m. to 1:30 p.m. and from 3 p.m. to 9 p.m. The draw shall open on signal one time each day to accommodate vessel traffic between 1:30 p.m. and 3 p.m., after at least a one-hour notice is given by calling the number posted at the bridge. Vessels that can pass under the bridge without a bridge opening may do so at all times.

In accordance with 33 CFR 117.35(e), the bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Should the bridge maintenance authorized by this temporary deviation be completed before the end of the effective period published in this notice, the Coast Guard will rescind the remainder of this temporary deviation, and the bridge shall be returned to its normal operation schedule.

Notice of the above action shall be provided to the public in the Local Notice to Mariners and the Federal Register , where practicable.

This section is organized as follows:

Citizens concerned with water quality in Puerto Rico may be interested in this rulemaking which establishes federal antidegradation implementation methods by regulation for waters in the Commonwealth of Puerto Rico (hereafter, “the Commonwealth” or “Puerto Rico”). Entities discharging pollutants to the surface waters of Puerto Rico could be indirectly affected by this rulemaking since water quality standards are used in determining National Pollutant Discharge Elimination System (NPDES) permit limits, CWA section 404 dredge and fill permits, and other activities requiring CWA section 401 certification. Categories and entities that may ultimately be affected include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding NPDES-regulated entities likely to be affected by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your facility may be affected by this action, you should carefully examine today's proposed rule. If you have questions regarding the applicability of this action to the particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

1. Docket. EPA has established an official public docket for this action under Docket Id. No. [EPA-HQ-OW-2007-0259]. The official public docket consists of the document specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Water Quality Standards for Puerto Rico docket located at both U.S. EPA Region 2, 290 Broadway, New York, New York 10007, and the OW Docket, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC 20004. These Docket Facilities are open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The Docket telephone numbers are 212-637-3807 and 202-566-1744, respectively. A reasonable fee will be charged for copies.

2. Electronic Access. You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.regulations.gov to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through one of the Docket Facilities identified in Section I.B.1.

Section 303 (33 U.S.C. 1313) of the Clean Water Act (CWA or “the Act”) directs States, Territories, and authorized Tribes (hereafter referred to as “States”), with oversight by EPA, to adopt water quality standards to protect the public health and welfare, enhance the quality of water and serve the purposes of the CWA. Under section 303, States are required to develop water quality standards for navigable waters of the United States within the State. Section 303(c) and EPA's implementing regulations at 40 CFR part 131 require State and Tribal water quality standards to include the designated use or uses to be made of the water, the water quality criteria necessary to protect those uses and an antidegradation policy. States are required to review their water quality standards at least once every three years and, if appropriate, revise or adopt new standards. The results of this triennial review must be submitted to EPA, and EPA must approve or disapprove any new or revised standards.

Section 303(c) of the CWA authorizes the EPA Administrator to promulgate water quality standards to supersede State standards that EPA has disapproved or in any case where the Administrator determines that a new or revised standard is needed to meet the CWA's requirements. In a February 14, 2007, Opinion and Order from the United States District Court for the District of Puerto Rico in the case of CORALations and the American Littoral Society v. United States Environmental Protection Agency, et al. (No. 02-1266 (JP) (D. Puerto Rico)), the Court ordered EPA to “prepare and publish new or revised water quality standards identifying antidegradation methods for Puerto Rico within 60 days” (April 17, 2007). The Court granted EPA's motion for an additional 30 days. EPA proposed Federal water quality standards for these waters in Puerto Rico on May 17, 2007.

As one of the minimum elements that must be included in a State's water quality standards, antidegradation is an important tool for States and authorized Tribes to use in meeting the CWA's requirement that water quality standards protect public health or welfare, enhance the quality of water and meet the objective of the CWA to restore and maintain the chemical, physical and biological integrity of the nation's waters. Antidegradation requirements help ensure that any degradation in water quality is subject to review and approval by the State even in cases where the existing water quality far exceeds the water quality criteria and designated use applicable to individual waters.

EPA's regulation at 40 CFR 131.12 requires that States and authorized Tribes adopt antidegradation policies and identify implementation methods to provide three levels or tiers of water quality protection. The first level of protection at 40 CFR 131.12(a)(1), also known as Tier 1 of antidegradation, requires the maintenance and protection of existing instream water uses and the level of water quality necessary to protect those existing uses. Protection of existing uses is the floor of water quality protection afforded to all waters of the United States. Existing uses are “* * * those uses actually attained in the water body on or after November 28, 1975, whether or not they are included in the water quality standards” (40 CFR 131.3(e)).

The second level of protection, or Tier 2 of antidegradation, is for high quality waters. High quality waters are defined in 40 CFR 131.12(a)(2) as waters where the quality of the waters is better than the levels necessary to support propagation of fish, shellfish, and wildlife and recreation in and on the water. This water quality is to be maintained and protected unless the State or authorized Tribe finds, after public participation and intergovernmental review, that allowing lower water quality is necessary to accommodate important economic or social development in the area in which the waters are located. In allowing lower water quality, the State or authorized Tribe must assure water quality adequate to protect existing uses. Further, the State or authorized Tribe must ensure that all applicable statutory and regulatory requirements are achieved for all new and existing point sources and all cost-effective and reasonable best management practices are achieved for nonpoint source control.

Finally, the third and highest level of antidegradation protection, or Tier 3, is for outstanding national resource waters (ONRWs). If a State or authorized Tribe determines that the characteristics of a water body constitute an outstanding national resource, such as waters of National and State parks and wildlife refuges and waters of exceptional recreational or ecological significance, and designates a water body as such, then that water quality must be maintained and protected (see 40 CFR 131.12(a)(3)).

In addition to requiring States and authorized Tribes to adopt an antidegradation policy, 40 CFR 131.12 requires States to identify methods for implementing such a policy. Such methods are not required to be contained in the State's regulation, but because they inform EPA's judgment regarding whether the State's antidegradation policy is consistent with the Federal regulations at 40 CFR 131.12, they are subject to EPA review. Where the State chooses to make such methods part of its water quality standards regulations, section 303(c)(3) of the CWA and EPA's implementing regulations require them to be submitted to EPA for review and approval. When a State or authorized Tribe chooses to develop such methods as guidance or outside of regulation, EPA reviews the methods in the context of determining whether the State's antidegradation policy as interpreted and implemented through the methods, is consistent with 40 CFR 131.12.

EPA's regulations at 40 CFR 131.12 provide a great deal of discretion to States regarding the amount of specificity required in a State's antidegradation implementation methods. The regulations do not specify minimum elements for such methods, but do require that such methods not undermine the intent of the antidegradation policy. See Advanced Notice of Proposed Rulemaking, 63 FR 36742, 36781, July 7, 1998.

Puerto Rico has an existing EPA-approved antidegradation policy, which was adopted on October 27, 1990, and approved by EPA on March 28, 2002. This antidegradation policy mirrors that of the federal regulation. The policy states the following:

The Environmental Quality Board of the Commonwealth of Puerto Rico (EQB or Board) first adopted an antidegradation policy in its water quality standards regulation in June 1973. EQB is responsible, in part, for developing and recommending to the Governor public policy to encourage and promote the improvement of environmental quality so as to meet the conservation, social, economic, health and other requirements and goals of the Commonwealth. One of the specific functions of EQB is to develop and adopt water quality standards, which are intended to “enhance, maintain and preserve the quality of the waters of Puerto Rico compatible with the social and economic needs of Puerto Rico.” This antidegradation policy was approved by EPA on November 15, 1973. Puerto Rico's antidegradation policy statement remained unchanged until 1990. In August 1990, the Commonwealth of Puerto Rico adopted revisions to the Puerto Rico Water Quality Standards Regulation (PRWQSR). These were sent to EPA Region 2 on September 21, 1990, with the caveat from the Chairman of the EQB that the transmittal may not be the final submittal, since EQB was going to hold additional public hearings on November 1, 1990, regarding certain aspects of the revisions. Because of this caveat, and because the requisite certification from the Commonwealth's Secretary of Justice was not submitted with the revisions as required by 40 CFR 131.6(e), EPA did not act on these revisions immediately.

From 1991 to 1993, EPA Region 2 worked with EQB on a series of subsequent draft revisions to the PRWQSR. These drafts were never adopted by Puerto Rico.

The requisite certification from the Commonwealth's Secretary of Justice was ultimately submitted to EPA on February 25, 2002. Upon receipt of this certification EPA took final action on all new and revised provisions of the 1990 PRWQSR on March 28, 2002. These revisions included the above-referenced revisions to the Puerto Rico antidegradation policy.

Prior to October 2001, Puerto Rico had antidegradation implementation methods set forth in a document known as its Continuing Planning Process (CPP). In the fall of 2001, EPA commenced work with the Puerto Rico EQB to enhance their antidegradation implementation methods. EQB submitted its first reasonably complete draft of its consolidation of antidegradation implementation methods on September 3, 2003.

On February 20, 2002, CORALations, American Littoral Society, and the American Canoe Association filed a complaint in the U.S. District Court for the District of Puerto Rico. In this action, the plaintiffs alleged, among other things, that a September 4, 1992 letter from a EPA Region 2 Division Director to the EQB had triggered a mandatory duty under section 303(c)(4) of the CWA for EPA to prepare and propose regulations for Puerto Rico setting forth a revised water quality standard for antidegradation implementation methods.

In October and December 2003, EQB submitted two revised drafts of its consolidation of antidegradation implementation methods. The December 2003 draft was submitted under cover of a letter dated December 16, 2003, from Ruben Gonzalez Delgado, Director of EQB's Water Quality Area, to Walter Mugdan, Director of the EPA Region 2's Division of Environmental Planning and Protection. This letter stated that it was EQB's intent to promulgate this consolidation as part of the PRWQSR in order to consolidate EQB's existing antidegradation implementation methods “either explicitly or by reference, into one document so that it is readily accessible to the public and the regulated community.”

On June 17, 2004, EQB submitted to EPA its final revised consolidation document. This consolidation document, however, was not adopted as a regulation. In a letter dated July 9, 2004, from Mr. Mugdan to EQB's President, Esteban Mujica Cotto, EPA stated that these methods meet the requirements of the Clean Water Act and 40 CFR 131.12(a).

On February 14, 2007, the U.S. District Court of Puerto Rico issued an opinion ruling that EPA had failed to execute a mandatory duty to propose antidegradation implementation methods for Puerto Rico and ordered EPA to prepare and publish new or revised water quality standards identifying antidegradation implementation methods for Puerto Rico within 60 days. The court granted a 30-day extension and EPA proposed federal water quality standards identifying methods for implementing Puerto Rico's antidegradation policy on May 17, 2007.

EPA is promulgating federal water quality standards identifying methods for implementing Puerto Rico's antidegradation policy. If Puerto Rico adopts antidegradation implementation methods and EPA approves Puerto Rico's action, EPA will initiate withdrawal of its corresponding federal water quality standards.

The federal antidegradation implementation methods are the same as the implementation methods Puerto Rico provided to EPA in 2004. EPA reviewed those and on July 9, 2004, sent a letter from Walter Mugdan, Director of EPA Region 2's Division of Environmental Planning and Protection Division to Esteban Mujica Cotto, President of Puerto Rico's Environmental Quality Board stating that these methods meet the requirements of 40 CFR 131.12(a). (It should be noted that subsequent to the issuance of EPA's July 9, 2004 letter, EQB incorporated some non-substantive updates to its consolidation of implementation methods. The purpose of these updates is to reflect the fact that the Puerto Rico Environmental Public Policy Act (12 LPRA 8001 et. seq.), which is one of the referenced documents in the consolidation document, was amended and re-issued on September 22, 2004. The June 17, 2004 version of the consolidation document had referenced the previously applicable version of the Puerto Rico Environmental Public Policy Act. The methods EPA is promulgating reflect this update).

Consistent with Puerto Rico's antidegradation implementation methods, the federal methods provide that all point sources would be subject to antidegradation review. The CWA and EPA's regulations leave to the States and authorized Tribes the decision whether to regulate nonpoint sources by requiring that they undergo antidegradation review (American Wildlands v. Browner, 260 F.3d 1192, 1198 (10th Cir. 2001)). To date, Puerto Rico has not chosen to subject nonpoint sources to antidegradation review. As a result, EPA is not applying Puerto Rico's methods to sources other than point sources.

In addition, as envisioned by Puerto Rico, the federal methods provide that the antidegradation review would occur as part of Puerto Rico's CWA section 401 certification process. EPA issues all of the National Pollutant Discharge Elimination System (NPDES) permits under CWA section 402 for the Commonwealth of Puerto Rico. As part of this process, Puerto Rico must certify under CWA section 401 that those permits comply with Puerto Rico's water quality requirements. Conducting the antidegradation review process during this certification is a logical time for this review to occur, since this is the time when EQB conducts its formal analysis to determine, in part, if a proposed action will comply with all aspects of the Puerto Rico Water Quality Standards Regulation (PRWQSR).

To implement Tier 1, it is important to explain what is meant by the term “existing in-stream water use” (40 CFR 131.12 (a)(1)) and explain how the level of water quality will be identified that is required to allow an existing use to continue to occur. Section 131.3 of the federal regulations defines existing uses as “those uses actually attained in the water body on or after November 28, 1975* * *”. The proposed methods provide that where there are concentrations or levels of a particular pollutant that have caused a waterbody to be listed as impaired under section 303(d) of the CWA, no additional degradation may occur in the waterbody. Puerto Rico's methods provide that this would be assured through water quality-based effluent limits meeting water quality criteria “end-of-pipe”. EPA believes this approach will protect the quality of water in the waterbody from further degradation, which will lead to the protection of the existing uses.

EPA has articulated that states may take one of two approaches in identifying their high quality waters, also known as Tier 2 of antidegradation: a parameter-by-parameter approach or a waterbody-by-waterbody approach. Under the parameter-by-parameter approach, States and authorized Tribes determine whether water quality is better than the applicable criteria for a specific parameter or pollutant that would be affected by a new discharge or an increase in an existing discharge of the pollutant. The water body-by-water body approach weighs the chemical, physical, biological, or other factors to judge a water body's overall quality. In EPA's Advanced Notice of Proposed Rulemaking (ANPRM), EPA discussed the advantages and disadvantages to both approaches to designating high quality waters. 63 FR 36782, 36783, July 7, 1998. EPA also discussed these issues in the preamble to its proposed rule regarding antidegradation implementation methods for Kentucky. 67 FR 68971, 67798-99, November 14, 2002. EPA interprets its regulation to authorize either approach. Consistent with the implementation methods identified by Puerto Rico, EPA is today requiring that antidegradation reviews for high quality waters in Puerto Rico occur on a parameter-by-parameter basis.

Under the federal methods, Puerto Rico must implement protection of waters it identifies as ONRWs, also known as Tier 3 of antidegradation, through a requirement that prohibits point source discharges in ONRWs. As described earlier in this section, the federal methods mirror those methods already identified by Puerto Rico for implementing its antidegradation implementation policy. EPA believes this approach is more than sufficient to meet the federal requirements at 40 CFR 131.12(a)(3) to maintain and protect the water quality of waters identified as ONRWs and is consistent with Puerto Rico's preferred approach.

Consistent with the antidegradation methods identified by Puerto Rico, this final rule includes methods for implementing Puerto Rico's antidegradation policy for permits issued under section 404 of the CWA or permits issued under section 10 of the River and Harbors Act. The federal methods require that the discharge of dredged or fill material not have an unacceptable adverse impact either individually or in combination with other activities affecting the wetland before they can be allowed to discharge. Further, the federal methods provide that any proposed discharge will not be allowed if there is a practicable alternative that would have less adverse impact. With regard to how the permits for these types of activities will be implemented in waters identified by Puerto Rico as ONRWs, the federal methods provide that any proposed permitted activity under these sections of the statutes be treated the same as NPDES-permitted dischargers, that is, that these types of activities will be prohibited. This approach, also contained in Puerto Rico's methods, will assure that the water quality in waters identified as ONRWs be maintained and protected.

Puerto Rico will implement the federal antidegradation implementation methods through its ongoing CWA section 401 certification process. As described earlier in Section III.A., EPA Region 2 issues the NPDES permits for the Commonwealth of Puerto Rico. The permit issuance and preparation of the water quality certification occurs sequentially as described below.

Section 6.11 of the PRWQSR describes how the EQB will issue CWA section 401 Water Quality Certifications (WQC) for federally-issued permits, such as NPDES permits. This provision provides, in part, that when requesting a WQC, an applicant must submit, as part of the application, all relevant information to demonstrate to the satisfaction of the Board that the proposed action will not cause a violation of any applicable water quality standards in the receiving water body.

Puerto Rico's requirements for conducting CWA section 401 certifications, which include antidegradation reviews, are found in Resolution R-89-2-2 of the Governing Board of EQB—February 2, 1989, and are summarized as follows.

1. EPA Region 2 (the Region) receives an application from a discharger for a NPDES permit, or for the renewal or modification of an existing NPDES permit. The applicant also submits a copy of the application to the EQB.

2. The Region reviews the application, and, if necessary, obtains additional information from the applicant. After all information is submitted, and EPA completes its review, EPA solicits certification from EQB in accordance with 40 CFR Part 124.

3. EQB evaluates the application/draft permit and issues or denies a 401 certification, or waives the right to review the permit. (EQB will not waive the right when an initial environmental assessment indicates that the discharge for which a permit is sought will have a significant impact on the environment, triggering the need for an antidegradation review.) In summary, if EQB plans to certify the discharge, an intent to issue a WQC will be prepared. If EQB plans to deny the certification, an intent to deny a WQC will be prepared, including the basis of the determination that the discharge will not comply with applicable water quality standards. A copy of the intent to issue or deny a WQC, whichever the case, will be sent to EPA and the petitioner. A public notice and comment period follows. EQB then decides to issue the WQC or denial. Petitioners have the ability to seek reconsideration before the WQC decision becomes final.

4. In conducting an antidegradation review as part of the CWA section 401 certification process, EQB first determines which level of antidegradation applies based upon a review of existing water quality data, and other required information, to be provided by the applicant. Based upon this review, EQB then determines if additional information is necessary in order to make a determination. In the case of Tier I waters, a determination is made as to whether a discharge would lower water quality such that it would no longer be sufficient to protect and maintain the existing and designated uses of that water body. When the assimilative capacity of a water body is determined to be insufficient to protect existing and designated uses with an additional load to the water body, EQB does not allow a discharge increase by requiring that the applicable water quality standards be met at the end of the pipe. In order to allow the lowering of water quality in Tier 2 waters, EQB evaluates the existing and protected quality of the receiving water on a parameter-by-parameter basis. In those cases where a potential increase in loading from a discharge may result in the lowering of water quality, the applicant must show and justify the necessity for such lowering of water quality. As part of the Tier 2 antidegradation review process, EQB provides a public comment period of at least 30 days. In the case of Tier 3 waters, no point source discharge will be allowed.

5. If EQB issues a 401 certification, then EPA Region 2 incorporates the WQC into the draft permit and issues public notice of its intention to issue a final permit pursuant to 40 CFR Part 122.

Puerto Rico's existing antidegradation implementation methods are the same as the antidegradation methods set forth in this final rule. Thus, while not in regulation, these implementation methods are already in place in Puerto Rico and as such, EPA's federal antidegradation methods are not expected to result in any additional monetary costs. Nonetheless, EPA prepared an analysis to evaluate potential impacts to the Commonwealth of Puerto Rico associated with future implementation of EPA's federal standards. This analysis is documented in the “Economics Analysis of Antidegradation Implementation Methods for the Commonwealth of Puerto Rico,” which can be found in the record for this rulemaking and concludes that the total annualized costs of EPA's final rule for both the Commonwealth and the point source dischargers could range from $14,500 to $32,900.

Any NPDES-permitted facility that discharges to water bodies affected by this final rule could potentially incur costs to comply with the rule's provisions. The types of affected facilities may include industrial facilities and publicly owned treatment works (POTWs). EPA did not consider the potential costs for nonpoint sources, such as agricultural and forestry-related nonpoint sources, because EPA's final rule would only require that antidegradation be applied to point sources. In addition, EPA did not address the potential monetary benefits of this final rule for Puerto Rico.

EPA identified approximately 265 point source facilities that may be affected by the rule. Of these potentially affected facilities, 76 are classified as major dischargers, and 189 are minor dischargers.

Exhibit 1 provides a summary of facilities that are currently permitted to discharge to Puerto Rico surface waters, as identified in EPA's Permit Compliance System (PCS). There are a total of 265 facilities, 71 percent of which are minor dischargers.

In the case of Tier 1 waters, EQB would make a determination as to whether a discharge would lower water quality such that it would no longer be sufficient to protect and maintain the existing and designated uses of that water body. For Tier 2 waters, EQB would evaluate the existing and protected quality of the receiving water on a parameter-by-parameter basis. Under this approach, EQB would determine whether water quality is better than the applicable criteria for a specific parameter or pollutant that would be affected by a new discharge or an increase in an existing discharge of the pollutant. In addition, no point source discharges would be allowed to Tier 3 waters.

EPA Region 2 indicates that is has received five antidegradation review requests within the last five years, or approximately one request per year. This includes antidegradation reviews for both existing and new facilities. EPA assumed that each type of facility ( e.g. , major municipal, minor municipal, major industrial, and minor industrial) is equally likely to request an antidegradation review.

Costs for the final antidegradation implementation methods include costs to facilities for preparing the review material and necessary data, and costs associated with the Commonwealth's review of the facility information and certification process. The cost incurred by facilities represents the cost of a preliminary engineering analysis and the subsequent financial analysis for which EPA provides guidance and a workbook. This analysis could cost between one percent and three percent of the installed cost of additional pollution controls.

The cost potentially incurred by Puerto Rico's Environmental Quality Board (EQB) represents the cost of reviewing the engineering cost analysis and financial impact analysis, validating source data and checking calculations, evaluating the engineering design and the conclusions regarding potential financial and community impacts, evaluating the information provided regarding the importance of the proposed development to the economic and social conditions of the affected community, and reviewing and responding to comments from the public. EPA estimated the total time requirement to process each request to be 140 hours.

Based on the potential number of antidegradation requests, EPA estimated that point source dischargers may incur total annual costs from $9,200 to $27,600 per year. EPA also estimated that Puerto Rico's EQB may incur annual costs to review the requests of approximately $5,300. Thus, total annual costs of the final rule could be $14,500 to $32,900.

EPA solicited written public comment on the federal antidegradation methods proposed in the Federal Register on May 17, 2007 and held a public hearing on Monday, June 4, 2007 in Puerto Rico. No public comments were received.

This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the EO.

Puerto Rico is already implementing the antidegradation methods set forth in this final rule. Therefore, these EPA methods are not expected to result in any additional monetary costs. However, EPA has prepared an analysis of the costs of the Puerto Rico antidegradation policy and methods. This analysis is contained in the “Economic Analysis of Antidegradation Implementation Methods for the Commonwealth of Puerto Rico.” A copy of the analysis is available in the docket for this action and is briefly summarized in Section III.C of today's notice.

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995. It does not include any information collection, reporting or recordkeeping requirements.

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

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

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

After considering these economic impacts of today's final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. Puerto Rico's existing antidegradation implementation methods are the same as the antidegradation implementation methods set forth in this final rule. Thus, while not in regulation, the implementation methods are already in place in Puerto Rico and, as a result, this regulation is not expected to result in any additional monetary costs. Nonetheless, EPA prepared an analysis to evaluate potential impacts to the Commonwealth of Puerto Rico associated with future implementation of EPA's federal standards. This analysis is documented in the “Economic Analysis of Antidegradation Implementation Methods for the Commonwealth of Puerto Rico,” which can be found in the record for this rulemaking.

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

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. Therefore, this rule is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act.

EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, this rule is not subject to the requirements of section 203 of the Unfunded Mandates Reform Act.

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

This final rule does not affect the nature of the relationship between EPA and States generally, for the rule only applies to waters within Puerto Rico's jurisdiction. Further the final rule does not substantially affect the relationship of EPA and the Commonwealth of Puerto Rico, or the distribution of power or responsibilities between EPA and the various levels of government. Because Puerto Rico is already implementing these antidegradation methods, this final rule does not change the Commonwealth's ability to implement these methods. Further, this final rule does not preclude Puerto Rico from adopting its own antidegradation methods that meet the requirements of the CWA into its own regulations. Thus, Executive Order 13132 does not apply to this rule.

Although section 6 of Executive Order 13132 does not apply to this final rule, EPA did consult with the Commonwealth of Puerto Rico in developing this rule.

In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicited comment on the proposed rule from State and local officials.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175, because no Indian Tribal Governments exist in Puerto Rico. Thus, Executive Order 13175 does not apply to this rule.

Executive Order 13045: “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 final rule is not subject to the Executive Order because it is not economically significant and EPA does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.

This final 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.

As noted in the proposed rule, Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (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 final rulemaking does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA has determined that this final rule does not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. The antidegradation implementation methods set forth in this final rule are the same as the implementation methods Puerto Rico provided to EPA in 2004, which Puerto Rico is already implementing.

EPA transmitted the proposed rule to the Fish and Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS) for review and comment concurrent with its publication in the Federal Register on May 17, 2007. That transmittal constituted EPA's initiation of informal consultation with the Services on this rulemaking, pursuant to section 7 of the Endangered Species Act and its implementing regulations. EPA received concurrence from the FWS on June 18, 2007, that the rule is not likely to adversely affect federally-listed species in the Commonwealth of Puerto Rico. EPA also received a similar concurrence from the NMFS on September 18, 2007.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. § 804(2). This rule will be effective January 11, 2008.