The regulations in 7 CFR 301.75-1 through 301.75-14 (referred to below as the regulations) prohibit or restrict the interstate movement of regulated articles from and through areas quarantined because of citrus canker and provide conditions under which regulated fruit may be moved into, through, and from quarantined areas for packing. These regulations are promulgated pursuant to the Plant Protection Act (7 U.S.C. 7701 et seq. ).

In an interim rule published in the Federal Register on August 1, 2006 (71 FR 43345-43352, Docket No. APHIS-2006-0114), we amended the regulations to list the entire State of Florida as a quarantined area for citrus canker and to amend the requirements for the movement of regulated articles from Florida now that the eradication of citrus canker in Florida is no longer being carried out as an objective. We also amended the regulations to allow regulated articles that would not otherwise be eligible for interstate movement to be moved to a port for immediate export.

Following publication of the interim rule, it came to our attention that one of the provisions in the rule did not make clear our intention. As established by the interim rule, § 301.75-7 spells out the requirements that must be met in order for regulated fruit to be moved from a quarantined area. Paragraph (a)(2) of that section provides that, no more than 30 days before the beginning of harvest, every tree must be inspected by an inspector and the grove must be found free of citrus canker. Further, in groves producing limes, every tree must be inspected by an inspector and the grove must be found free of citrus canker every 120 days or less thereafter for as long as harvest continued. Some regulated entities have interpreted these provisions as allowing for the interstate movement of fruit from groves with trees showing signs of citrus canker, provided that the affected trees are removed and the grove is then reinspected prior to harvest and found free of citrus canker. This interpretation is not consistent with the intent of these provisions. Rather, these provisions are intended to only allow the interstate movement of fruit from groves where citrus canker has not been found during the preharvest inspection and afterward. Therefore, in order to avoid confusion, we are revising § 301.75-7(a)(2) to explicitly state that, if citrus canker is found in a grove when the preharvest inspection is conducted, or at any other time beginning August 1 of the year in which the fruit is to be harvested and extending through the harvest season (including into the next calendar year), fruit from the grove will not be eligible for interstate movement for the remainder of the harvest season.

The National Poultry Improvement Plan (NPIP, also referred to below as “the Plan”) is a cooperative Federal-State-industry mechanism for controlling certain poultry diseases. The Plan consists of a variety of programs intended to prevent and control egg-transmitted, hatchery-disseminated poultry diseases. Participation in all Plan programs is voluntary, but flocks, hatcheries, and dealers must first qualify as “U.S. Pullorum-Typhoid Clean” as a condition for participating in the other Plan programs.

The Plan identifies States, flocks, hatcheries, and dealers that meet certain disease control standards specified in the Plan's various programs. As a result, customers can buy poultry that has tested clean of certain diseases or that has been produced under disease-prevention conditions.

The regulations in 9 CFR parts 145 and 147 (referred to below as the regulations) contain the provisions of the Plan. The Animal and Plant Health Inspection Service (APHIS, also referred to as “the Service”) of the U.S. Department of Agriculture (USDA, also referred to as “the Department”) amends these provisions from time to time to incorporate new scientific information and technologies within the Plan.

On June 19, 2006, we published in the Federal Register (71 FR 35203-35220, Docket No. APHIS-2006-0008) a proposal  1 to amend the Plan by providing new or modified sampling and testing procedures; adding a procedure for the approval of diagnostic test kits; reorganizing the egg-type and meat-type breeding chicken regulations to separate the regulations concerning primary breeding flocks from those concerning multiplier breeding flocks; and making other changes to update and clarify the regulations.

We solicited comments concerning our proposal for 60 days ending August 18, 2006. We received one comment by that date, from a private citizen. The commenter raised concerns about the welfare of poultry in an agricultural setting.

APHIS does not have statutory authority to promulgate regulations regarding the welfare of poultry in an agricultural setting. The NPIP is designed to control the incidence of disease in breeding and commercial poultry.

The commenter also stated that the Plan should have provisions for ensuring that Authorized Agents are not corrupt.

The Official State Agencies that work with APHIS to administer the provisions of the Plan designate Authorized Agents to perform sampling on flocks that participate in the Plan. Each Official State Agency has provisions for determining whether persons are qualified to serve as Authorized Agents and for ensuring the integrity of Authorized Agents that it designates to perform tasks in the administration of the Plan.

We are not making any changes in response to this commenter's comments.

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

This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

We are amending the Plan and its auxiliary provisions by providing new or modified sampling and testing procedures for Plan participants and participating flocks. The proposed changes were voted on and approved by the voting delegates at the Plan's 2004 National Plan Conference. These changes will keep the provisions of the Plan current with changes in the poultry industry and provide for the use of new sampling and testing procedures.

The poultry industry plays an important role in the U.S. economy, directly employing approximately 240,000 workers. 2 The poultry industry is primarily composed of two types of companies: Primary breeding companies and highly integrated companies that combine multiplier breeding, hatching, and growing functions. The primary breeder companies are responsible for the development of genetic lines of poultry for commercial companies that market the product to final consumers. They maintain and expand pure designated blood lines and supply breeding stock to commercial poultry companies all over the globe. Improved genetic poultry are multiplied through the hatchery system. The hatcheries, in turn, supply these more efficient birds to producers and growers in nearby States. Hatcheries incubate and hatch eggs and sell chicks to the commercial producer when they are 1 day old. The commercial producers grow the chicks either for meat production or as egg-laying varieties. The genetic lines of both egg-laying varieties and meat-producing poultry are carefully controlled by primary breeding companies.

Almost all birds are produced on a contractual basis between a highly integrated company and individual contract growers who raise the birds, i.e. , growers. In such arrangements, the grower normally supplies the poultry house, land, labor, litter, equipment, taxes, utilities, and insurance, while the company provides the chicks, feed, necessary medications, and supervision. Labor and equipment for catching and hauling the birds to market are also provided by the company. The company retains title to the birds, and in return growers are paid according to the amount produced (pounds of birds or dozens of eggs).

Currently, there are three major firms that produce primary breeding stock of egg-type chickens, three breeders of meat-type chickens, two breeders of turkey, and one firm producing both egg-type and meat-type chickens. All of these are large facilities headquartered in the United States, and all of them operate in domestic and international markets. Other multinational organizations headquartered in Europe, Israel, and Japan produce several varieties of breeding stock offered to commercial facilities around the globe.

U.S. broiler production totaled 8.5 billion birds in 2003. Ten States accounted for over 79 percent of broilers produced in the United States (table 1). U.S. turkey production in 2003 totaled 274 million birds. The top 10 turkey-producing States accounted for 82 percent of total production. A total of 87.2 billion eggs were produced in 2003. Ten States accounted for 62 percent of total egg production. Approximately 85 percent of egg production was for human consumption (the table-egg market), while the remainder of production was for the hatching market.

Cash receipts from sales of poultry and eggs (broilers, farm chickens, eggs, turkey, ducks, and other poultry) were about $23.9 billion in 2003. 3 Of this total, 64 percent was from broilers, 22 percent from eggs, 11 percent from turkeys, and 3 percent from other poultry. In terms of tonnage, poultry production and trade exceeds that of beef or pork. For instance, in 2003, the United States produced 38.4 billion pounds of poultry meat, compared with 26.2 billion pounds of beef and 19.9 billion pounds of pork. Poultry meat per capita consumption (98.9 pounds) exceeded that of both beef (64.9 pounds) and pork (51.8). Furthermore, the United States exported more poultry meat (5,404 million pounds) than beef and veal (2,518 million pounds) or pork (1,717 million pounds) during the same period. 4

The United States is a major exporter of poultry and poultry products. It exported poultry and poultry products valued at $2,287 million in 2003. 5 The major importers, accounting for $1,720 million worth of exports of U.S. poultry, are Russia ($384 million), Canada ($346 million), Mexico ($293 million), Hong Kong ($236 million), China ($117 million), Japan ($83 million), South Korea ($56 million), European Union ($126 million), Turkey ($42 million), and Taiwan ($37 million). U.S. imports of poultry and poultry products totaled $307 million. Of this total, $135 million was from Canada, $113 million from China, $19 million from Taiwan, and $16 million from France.

The Regulatory Flexibility Act requires that agencies consider the economic impact of their rules on small entities. The Small Business Administration has established guidelines for determining which types of firms are to be considered small under the Regulatory Flexibility Act. The main entities that will be affected by this rule are those engaged in production of poultry breeding stock. Currently there are three major firms that produce primary breeding stock of egg-type chickens, three breeders of meat-type chickens, two breeders of turkeys, and one firm producing both egg-type and meat-type chickens. All of these are large facilities headquartered in the United States and operating in domestic and international markets. Additionally, broiler operations (North American Industry Classification System [NAICS] 112320), turkey operations (NAICS 112330), hatcheries (NAICS 112340) and other poultry operations (NAICS 112390) will be positively, at least qualitatively, affected, as they will benefit from the supply of improved and healthy breeding stock. There were a total of 79,600 commercial growers with sales in 2002. 6 Nearly 100 percent of broiler operations, 70 percent of turkey operations, and about 43 percent of layer operations produce poultry through production contracts. All of these commercial grower farms are considered to be small if they have annual sales of $750,000 or less. About 93 percent of these farms are small, while the rest are large. Commercial egg producers (NAICS 112310) are considered small if they have annual sales of less than $10.5 million.

This rule will introduce a series of minor changes to the NPIP and will not involve significant changes in program operations. Most of the changes involve clarifications, rearrangements of procedures, and definitions of terms. These changes are in line with the industry's best practices and will likely involve no additional costs in order to meet these requirements. Additionally, the NPIP is a voluntary program established between the industry and State and Federal governments. Any person producing or dealing in products may participate in the NPIP when he or she has demonstrated that his or her facilities, personnel, and practices are adequate for carrying out the applicable provisions of the NPIP. Since most countries will not accept hatching eggs or live birds from a producer unless it can be shown to be a NPIP participant, being a member of the NPIP allows greater ease in exporting hatching eggs or live birds to other countries. The poultry industry plays a very important role in the U.S. economy, and the final rule will help to ensure the safety of the industry and benefit the economy.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are in conflict with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

This final rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The purpose of this final rule is to revise the NRC's export/import regulations in 10 CFR Part 110, “Export and Import of Nuclear Equipment and Material,” with regard to Libya in light of the June 30, 2006 rescission by the Secretary of State of Libya's designation as a State Sponsor of Terrorism. Libya was designated as a State Sponsor of Terrorism in 1979. The Executive Branch has recommended that, in light of the rescission of the designation, 10 CFR Part 110 should be amended by moving Libya from the embargoed destinations list to the restricted destinations list.

This rule moves Libya from the embargoed destinations list for exports in 10 CFR 110.28 to the restricted destinations list in 10 CFR 110.29. This means that exports to Libya of small quantities of certain nuclear materials and byproduct materials may qualify for the NRC general license specified in §§ 110.21 through 110.24.

The NRC staff has determined that moving Libya from the embargoed list to the restricted list is consistent with current U.S. law and policy, and will pose no unreasonable risk to the public health and safety or to the common defense and security of the United States.

Because this rule involves a foreign affairs function of the United States, the notice and comment provisions of the Administrative Procedure Act do not apply (5 U.S.C. 553(a)(1)). This rule will become effective immediately upon publication.

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal Agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless using such a standard is inconsistent with applicable law or otherwise impractical. This final rule does not constitute the establishment of a standard for which the use of a voluntary consensus standard would be applicable.

The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(1). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for the rule.

This final rule does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing requirements were approved by the Office of Management and Budget (OMB), approval number 3150-0036.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

The NRC currently controls exports to Libya as an embargoed destination in section 110.28. There is no alternative to amending the regulations for the export and import of nuclear equipment and materials. This final rule would not result in any increase or cost to the public.

As required by the Regulatory Flexibility Act of 1980, (5 U.S.C. 605(b)), the Commission certifies that this final rule will not have a significant economic impact on a substantial number of small entities. This rule affects only companies exporting nuclear equipment and materials to Libya which do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act (5 U.S.C. 601(3)), or the Size Standards established by the NRC (10 CFR 2.810).

The NRC has determined that a backfit analysis is not required for this rule because these amendments do not include any provisions that would impose backfits as defined in 10 CFR Chapter I.

Under the Congressional Review Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB.

On November 30, 2004, we issued AD 2004-25-05, amendment 39-13893 (69 FR 71349, December 9, 2004). That AD applies to certain Boeing Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747SR, and 747SP series airplanes. That AD requires repetitive inspections to detect cracks and fractures of the strut front spar chord assembly at each strut location, and repair if necessary. That AD resulted from a report of a fractured front spar chord assembly for strut No. 3, which resulted in the loss of the strut upper link load path. The actions specified in that AD are intended to prevent loss of the strut upper link load path and consequent fracture of the diagonal brace, which could result in in-flight separation of the strut and engine from the airplane.

Since we issued AD 2004-25-05, we have received a report that the front spar chord assembly for strut No. 3 was found fractured on a Boeing Model 747-200 series airplane equipped with General Electric (GE) CF6-50E series engines. The fracture was located forward of the inspection area required by AD 2004-25-05. The airplane had accumulated about 79,800 total flight hours and 15,100 total flight cycles. (Since strut modification, the airplane had accumulated about 9,800 flight cycles and 48,200 flight hours.) We have determined that the inspection area required by AD 2004-25-05 must be expanded to adequately detect and correct cracks and fracture of the nacelle strut front spar chord assembly. Fracture of the front spar chord assembly could lead to loss of the strut upper link load path and consequent fracture of the diagonal brace, which could result in in-flight separation of the strut and engine from the airplane.

We have reviewed Boeing Alert Service Bulletin 747-54A2224, Revision 1, dated November 16, 2006. The Accomplishment Instructions of the service bulletin are divided into two parts: Part 1—Aft Side Inspection and Part 2—Forward Side Inspection. Part 1 describes procedures for accomplishing detailed and high frequency eddy current (HFEC) inspections for any cracks or fracture of the front spar chord assembly for strut Nos. 1, 2, 3, and 4. For struts carrying Pratt & Whitney JT9D-3 or -7 (excluding -70) series engines and inboard struts carrying GE CF6-45 or -50 series engines, the inspection area is aft of the rear engine mount bulkhead. For outboard struts carrying GE CF6-45 or -50 series engines, the inspection area is aft of the strut station 270 bulkhead. (Part 1 contains the same procedures as those described in the original issue of the service bulletin, dated September 30, 2006, which we referred to as the appropriate source of service information for AD 2004-25-05.) Part 2 describes procedures for accomplishing detailed and HFEC inspections for any cracks or fracture of the front spar chord assembly for strut Nos. 1, 2, 3, and 4, forward of the rear engine mount bulkhead or strut station 270 bulkhead, as applicable. The Part 2 inspections include inspecting in areas adjacent to the frame, around certain fasteners, and on the front spar chord radius. If any crack or fracture is found, Part 1 and Part 2 specify to contact Boeing for additional instructions and repair.

The unsafe condition described previously is likely to exist or develop on other airplanes of the same type design. For this reason, we are issuing this AD to supersede AD 2004-25-05. This new AD retains the requirements of the existing AD. This AD also requires repetitive inspections for any cracks or fracture of the strut front spar chord assembly forward of the bulkhead at each strut location, and repair if necessary, except as discussed under “Difference Between the AD and Service Bulletin.”

The service bulletin specifies to contact the manufacturer for instructions on how to repair certain conditions, but this AD requires repairing those conditions in one of the following ways:

• Using a method that we approve; or

• Using data that meet the certification basis of the airplane, and that have been approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization whom we have authorized to make those findings.

This AD retains all requirements of AD 2004-25-05. Since AD 2004-25-05 was issued, the AD format has been revised, and certain paragraphs have been rearranged. As a result, the corresponding paragraph identifiers have changed in this AD, as listed in the following table:

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that supersedes AD 2004-20-09, amendment 39-13814 (69 FR 59790, October 6, 2004). The existing AD applies to certain Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. That NPRM was published in the Federal Register on July 12, 2006 (71 FR 39237). That NPRM proposed to continue to require repetitive inspections for cracks, sealant damage, and corrosion of the main fittings of the main landing gear (MLG), and corrective actions if necessary. That NPRM also proposed to reduce the compliance times for inspecting certain low-utilization airplanes, and to provide a terminating action for the repetitive inspections.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments that have been received on the NPRM.

The Modification and Replacement Parts Association (MARPA) states that, typically, airworthiness directives are based on service information originating with the type certificate holder or its suppliers. MARPA adds that manufacturer service documents are privately authored instruments generally having copyright protection against duplication and distribution. MARPA notes that when a service document is incorporated by reference into a public document, such as an airworthiness directive, it loses its private, protected status and becomes a public document. MARPA adds that if a service document is used as a mandatory element of compliance, it should not simply be referenced, but should be incorporated into the regulatory document; by definition, public laws must be public, which means they cannot rely upon private writings. MARPA is concerned that the failure to incorporate essential service information could result in a court decision invalidating the AD.

MARPA adds that incorporated by reference service documents should be made available to the public by publication in the Docket Management System (DMS), keyed to the action that incorporates them. MARPA notes that the stated purpose of the incorporation by reference method is brevity, to keep from expanding the Federal Register needlessly by publishing documents already in the hands of the affected individuals; traditionally, “affected individuals” means aircraft owners and operators, who are generally provided service information by the manufacturer. MARPA adds that a new class of affected individuals has emerged, since the majority of aircraft maintenance is now performed by specialty shops instead of aircraft owners and operators. MARPA notes that this new class includes maintenance and repair organizations, component servicing and repair shops, parts purveyors and distributors, and organizations manufacturing or servicing alternatively certified parts under section 21.303 (“Parts Manufacturer Approval”) of the Federal Aviation Regulations (14 CFR part 21). MARPA adds that the concept of brevity is now nearly archaic as documents exist more frequently in electronic format than on paper. Therefore, MARPA asks that the service documents deemed essential to the accomplishment of the NPRM be incorporated by reference into the regulatory instrument, and published in the DMS.

We understand MARPA's comment concerning incorporation by reference. The Office of the Federal Register (OFR) requires that documents that are necessary to accomplish the requirements of the AD be incorporated by reference during the final rule phase of rulemaking. This final rule incorporates by reference the documents necessary for the accomplishment of the requirements mandated by this AD. Further, we point out that while documents that are incorporated by reference do become public information, they do not lose their copyright protection. For that reason, we advise the public to contact the manufacturer to obtain copies of the referenced service information.

Additionally, we do not publish service documents in DMS. We are currently reviewing our practice of publishing proprietary service information. Once we have thoroughly examined all aspects of this issue, and have made a final determination, we will consider whether our current practice needs to be revised. However, we consider that to delay this AD action for that reason would be inappropriate, since we have determined that an unsafe condition exists and that the requirements in this AD must be accomplished to ensure continued safety. Therefore, we have not changed the AD in this regard.

MARPA also states that type certificate holders in their service documents typically ignore the possible existence of PMA parts. MARPA states that this is particularly true with foreign manufacturers where the concept may not exist or be implemented in the country of origin. MARPA points out that the service document upon which an airworthiness directive is based frequently will require removing a certain part-numbered part and installing a different part-numbered part as a corrective action. According to MARPA, this runs afoul of section 21.303, which permits the development, certification, and installation of alternatively certified parts.

MARPA further states that installing a certain part-numbered part to the exclusion of all other parts is not a favored general practice. MARPA states that such an action has the dual effect of preventing, in some cases, the installation of a perfectly good part; while at the same time prohibiting the development of new parts permitted under section 21.303. According to MARPA, such a prohibition runs the risk of taking the AD out of the realm of safety and into the world of economics, since prohibiting the development, sale, and use of a perfectly airworthy part has nothing to do with safety. MARPA states that courts could easily construe such actions as being outside the statutory basis of the AD (safety) and, as such, unenforceable. MARPA adds that courts are reluctant to find portions of a rule unenforceable since they lack the knowledge and authority to re-write requirements, and are thus generally inclined to simply void the entire rule.

In response to the commenter's statement regarding running afoul of section 21.303, under which the FAA issues PMAs, this statement appears to reflect a misunderstanding of the relationship between ADs and the certification procedural regulations of 14 CFR part 21. Those regulations, including section 21.303, are intended to ensure that aeronautical products comply with the applicable airworthiness standards. But ADs are issued when, notwithstanding those procedures, we become aware of unsafe conditions in these products or parts. Therefore, an AD takes precedence over design approvals when we identify an unsafe condition, and mandating installation of a certain part number in an AD is not at variance with section 21.303.

The AD provides a means of compliance for operators to ensure that the identified unsafe condition is addressed appropriately. For an unsafe condition attributable to a part, the AD normally identifies the replacement parts necessary to obtain that compliance. As stated in section 39.7 of the Federal Aviation Regulations (14 CFR 39.7), “Anyone who operates a product that does not meet the requirements of an applicable airworthiness directive is in violation of this section.” Unless an operator obtains approval for an alternative method of compliance (AMOC), replacing a part with one not specified by the AD would make the operator subject to an enforcement action and result in a civil penalty. No change to the AD is necessary in this regard.

MARPA also believes that the practice of requiring an AMOC to install a PMA part should be stopped. MARPA states that this is somehow tantamount to stating, illogically, that all PMA parts are inherently defective and require an additional layer of approval when the original equipment manufacturer (OEM) part is determined to be defective. MARPA suspects that the FAA personnel who labored diligently to certify the PMA part might disagree with such a narrow, OEM-slanted view. MARPA states that if the PMA part is defective, then it must be deemed so in the AD, and not simply implied by a catch-all AMOC requirement. MARPA states that this is why it has repeatedly requested that we adopt language to trap such defective parts, and suggests that the FAA's Transport Airplane Directorate adopt the language used by the Small Airplane Directorate to accomplish this.

We infer that MARPA would like the AD to permit installation of any equivalent PMA parts so that it is not necessary for an operator to request approval of an AMOC in order to install an “equivalent” PMA part. Whether an alternative part is “equivalent” in adequately resolving the unsafe condition can only be determined on a case-by-case basis based on a complete understanding of the unsafe condition. The Transport Airplane Directorate's policy is that, in order for operators to replace a part with one that is not specified in the AD, they must request an AMOC. This is necessary so that we can make a specific determination that an alternative part is or is not susceptible to the same unsafe condition. No change to the AD is necessary in this regard.

MARPA points out that this AD, as written, does not comply with proposed Order 8040.2 (AD Process for Mandatory Continuing Airworthiness Information (MCAI)), which states in the PMA section: “MCAI that require replacement or installation of certain parts could have replacement parts approved under 14 CFR § 21.303 based on a finding of identicality. We have determined that any parts approved under this regulation and installed should be subject to the actions of our AD and included in the applicability of our AD.” MARPA points out that the Small Airplane Directorate has developed a blanket statement that resolves this issue. The statement includes words similar to those in the proposed Order 8040.2.

MARPA also points out that the Engine and Rotocraft Directorates avoid the issue by specifying “airworthy parts” be installed, leaving the determination of exactly which parts to the discretion of the installer.

MARPA further states that because the NPRM differs markedly in treatment of this issue from that of the other directorates, the mandates contained in Section 1, paragraph (b)(10) of Executive Order 12866 are not being met. This paragraph requires that all agencies act uniformly on a given issue. MARPA therefore requests that we take steps to bring the universe of PMA parts under the appropriate scope of this AD both with respect to possible defective PMA parts and the use of possible present or future approved parts.

The NPRM did not address PMA parts, as provided in draft FAA Order 8040.2, because the Order was only a draft that was out for comment at the time. After issuance of the NPRM, the Order was revised and issued as FAA Order 8040.5 with an effective date of September 29, 2006. FAA Order 8040.5 does not address PMA parts in ADs. We acknowledge the need to ensure that unsafe PMA parts are identified and addressed in MCAI-related ADs. We are currently examining all aspects of this issue, including input from industry. Once we have made a final determination, we will consider how our policy regarding PMA parts in ADs needs to be revised. We consider that to delay this AD action would be inappropriate, since we have determined that an unsafe condition exists and that replacement of certain parts must be accomplished to ensure continued safety. Therefore, no change has been made to the final rule in this regard.

We have changed paragraphs (i) and (k) of the final rule to specify more clearly if operators choose to do the terminating action after finding a crack indication, the terminating action must be done before further flight.

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

The following table provides the estimated costs for U.S. operators to comply with this AD. There are approximately 201 U.S.-registered airplanes. The average labor rate is $80 per hour.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

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

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

For the reasons discussed above, I certify that this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

On September 6, 2006, the FAA published in the Federal Register a notice of proposed rulemaking to realign V-2 over the East Central United States (71 FR 52502). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received in response to the proposal.

VOR Federal Airways are published in paragraph 6010 of FAA Order 7400.9P dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. The VOR Federal Airway listed in this document will be published subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 to modify VOR Federal Airway V-2 over the East Central United States. This action supports arrival and departure procedures to DTW that were modified in conjunction with MASE. Further, this action enhances safety and improves the efficient use of the navigable airspace within the areas of responsibility for Chicago and Cleveland ARTCCs.

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

The FAA has determined that this action qualifies for categorical exclusion under the National Environment Policy Act in accordance with 311a., FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures”. This airspace action is not expected to cause any potentially significant environment impacts, and no extraordingary circumstances exist that warrant preparation of environmental assessment.

On March 13 and March 17, 2006, respectively, the U.S. Army and the U.S. Air Force requested that the FAA take action to amend the controlling agency for R-2312, Fort Hauchuca, AZ from “Libby AAF ATCT” to “Albuquerque ARTCC.” The reason for the change is because Libby AAF ATCT is not a 24-hour facility and R-2312 is not fully contained within the airspace delegated to Libby AAF ATCT by Albuquerque ARTCC.

At the request of the U.S. Army and the U.S Air Force, the FAA is amending the controlling agency for R-2312, Fort Hauchuca, AZ from “Libby AAF ATCT” to “Albuquerque ARTCC”. This is an administrative change that does not alter the boundaries, designated altitudes, time of designation, or activities conducted within R-2312. Therefore, notice and public procedures under 5 U.S.C. 553(b) are unnecessary.

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

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with 311d., FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures.” This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In response to public concern, the FAA approached the United States (U.S.) Custom Service and the U.S. Air Force Air Combat Command with a request to reduce the time of designation for R-6320. On June 15, 2006, the U. S. Customs Service and the U.S. Air Force concurred with reducing the time of designation from “Continuous” to “Intermittent by NOTAM.” The reason for the change is because R-6320 is no longer continuously needed for the aerostat balloon.

The FAA is amending the time of designation for R-6320 from “Continuous” to “Intermittent by NOTAM.” This rule makes no other changes to R-6320. This action reduces the burden on the public by reducing the time of designation. Therefore, notice and public procedures under 5 U.S.C. 553(b) are unnecessary.

Section 73.63 of Title 14 CFR part 73 was republished in FAA Order 7400.8M, dated January 6, 2006.

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

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with 311c., FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures”. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

You can get an electronic copy using the Internet by:

(1) Searching the Department of Transportation's electronic Docket Management System (DMS) Web page ( http://dms.dot.gov/search );

(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://dms.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 its local FAA official, or the person listed under FOR FURTHER INFORMATION CONTACT . You can find out more about SBREFA on the Internet at http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

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. 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. This regulation is within the scope of that authority, because it prescribes new safety standards for the design of transport category airplanes.

We issued a notice of proposed rulemaking (NPRM) on April 3, 2006 (71 FR 16678) to extend the compliance date of 49 CFR 121.312(e)(3) because of unforeseen difficulties in establishing acceptable test equipment for showing compliance with that regulation. As discussed in the NPRM, that section requires that transport category airplanes manufactured after September 2, 2007, comply with the provisions of 14 CFR 25.856(b) when entering part 121 service. Section 25.856(b), in turn, requires that thermal/acoustic insulation installed in the lower half of the fuselage of those airplanes resist penetration of an external fire. The performance criteria are contained in Appendix F, part VII of part 25.

Based on difficulties in obtaining and qualifying the necessary test equipment that arose following publication of the requirement, we determined that the compliance date for § 121.312(e)(3) should be extended. This is discussed in detail in the NPRM.

Nine commenters responded to the NPRM. Two commenters, Daher-Lhotellier and Cogebi, are affiliated insulation material manufacturers that do not support extending the compliance date. These commenters contended that materials meeting the rule are available and that compliance within the existing date is possible. They provided no further information. The basis of the proposed extension was that manufacturers were not able to show that materials that are optimized for cost and weight would reliably meet the requirement. We agree there are materials that satisfy the test requirements of the regulation, but these are heavier or more expensive than envisioned by the rule. The commenters did not address this point in their comments. We therefore do not agree the current compliance date should be maintained.

All other commenters (Airbus, Airline Pilots Association (ALPA), Air Transport Association (ATA), Association of European Airlines (AEA), Aerospace Industries Association (AIA), Boeing, and Bombardier) supported an extension to the compliance date.

ALPA agreed that an extension of the compliance date is warranted, but had other comments on the basic requirement. These comments included expanding the number of airplanes affected, and the portion of the airplane that must be protected with insulation meeting the requirement. ALPA had made these same comments during the original rulemaking. These comments went beyond the scope of the NPRM, which simply addresses the compliance date for newly manufactured airplanes. However, as discussed in the original rulemaking, we have determined that broadening the applicability of the rule would have a very small benefit, and significant cost.

Airbus, Boeing, Bombardier, AIA and AEA all contended the test equipment is still not sufficiently developed to support a fixed compliance date. They maintained the scatter in test results is too wide for a certification standard.

We do not agree. The FAA William J. Hughes Technical Center has worked aggressively to resolve the issues with the test equipment, and has made significant progress in eliminating differences between test facilities. The most significant issue was the difference in performance between two test burners with slightly different configurations. We have developed small modifications that bring the two configurations into alignment. These modifications have been distributed to the test facilities that required them. In addition, we have conducted a series of tests with different materials to confirm the modifications do, in fact, work. It should be noted that all test methods, and in particular, fire test methods, have variability. This test method is consistent with other fire test methods in terms of the variation in results from one test to the next. As discussed below, some of the variation in test results is not because of the test method or equipment.

We have also identified variability in materials that can lead to variability in test results. In the tests cited by these commenters, many of the materials tested were “off the shelf” and not necessarily developed to comply with an aviation safety standard. More recent efforts to develop materials whose properties were carefully controlled have shown the test results can be very consistent, if the material being tested is itself very consistent.

Airbus, Boeing, and AIA commented the burner used in the test method is obsolete, and no longer available. They stated this contributes to difficulties in obtaining consistency among facilities and within a facility.

While the burner is no longer commercially available; there are numerous burners already in industry. As discussed above, the FAA Technical Center has developed refinements to the burner that standardize its performance. However, as the supply of burners is limited, we have also developed an alternative burner that eliminates many of the parameters that are currently the source of performance variations. This design will be documented and the plans made available to anyone requesting them. The new burner can be fabricated from standard parts and should eliminate concerns that the old burner is out of production.

Airbus commented there are no commercially available test facilities. At the time the comment was made, no commercial facilities had requested FAA acceptance. However, since the NPRM was published, two facilities have requested and received FAA review and would be eligible to conduct certification testing if they so choose.

Airbus also commented the late availability of the associated advisory circular (AC) 25.856-2 has contributed to the need for further extension. Airbus noted the final AC was published in January 2006, and not concurrently with the final rule. They stated the lack of published guidance affected their ability to begin designing suitable solutions.

Part of the reason the AC publication was delayed was to permit as much consideration as possible of the equipment issues that had arisen. We had to balance the need to issue the AC as soon as possible with the need to make it as comprehensive as possible. The absence of the AC did not, however, limit any manufacturer's ability to propose, and gain acceptance for, methods of compliance. The FAA has worked with each affected manufacturer to develop methods of compliance. While the ideal situation would have been to have the AC available concurrent with the final rule, this should not have inhibited the development of methods of compliance.

Bombardier, Boeing and Airbus, with supporting comments from AEA and AIA, contended there are no, or limited, materials available that satisfy the cost/weight criteria specified in the original rulemaking. We believe that part of this comment stemmed from the prior problems with test equipment, and the potential for certain materials to pass at one facility, but fail at another. Since the material used to establish cost and weight in the original rulemaking is still available, we do not agree there are no materials available. However, we agree the scatter in test results that prompted this rule introduced uncertainty, and reluctance on the part of the manufacturers to commit to a material.

Bombardier commented on specific areas of the airplane that may be more complex to address than others, as well as some alternative approaches to providing protection from flame penetration. These comments were not directly related to the subject of the compliance date. Nonetheless, we agree that some areas of the airplane are more complicated than others, but this was accounted for in the rulemaking. In terms of alternative approaches, an applicant is free to propose an approach that provides an equivalent level of safety.

Boeing expressed a concern that the local Aircraft Certification Offices will not have enough information with which to review, and find acceptable, test facilities. As noted above, two facilities have been reviewed and accepted to date. The FAA plans to make such reviews a priority and there have been no unforeseen difficulties in successfully accomplishing the facility review.

Boeing and Airbus both indicated that they cannot comply, even with a 12 month extension. They stated their current production schedules and design requirements mean that compliance with the existing proposal will cause severe disruption of their schedules and cause them to implement materials that are heavier, or more costly than can be developed soon. This in turn would require them to change configurations twice: once to meet the compliance date, and again to optimize the materials, after they complete their development. They proposed an additional 12 month extension, for a total of 24 months to minimize disruption of their production.

We have carefully considered these comments, as they are fundamental to the impact of the rule. When the original rule was promulgated, we determined that a four year compliance time was sufficient for newly manufactured airplanes. This assessment presumed that materials and test equipment were readily available and that manufacturers would begin to address compliance immediately. However, we have acknowledged the test equipment was not readily available in a condition to always provide reliable test results, and that this brought into question the suitability of certain materials presumed to be acceptable. Since this rule does add weight and cost to the airplane, the balance between the total cost impact and the safety benefit is very important. If the cost of implementating the rule is much more significant than anticipated, the justification for the rule may be revisited. Since we believe the rule provides a significant safety benefit, we must maintain the balance between the cost impact, and the safety benefit provided. Clearly, for various reasons, two major airplane manufacturers are not prepared to comply with the rule, even allowing for a 12 month extension from the original compliance date. While we do not agree that all the reasons for this lie with the issues associated with the test method, we believe that the current proposal will result in significantly greater economic impact than was anticipated.

We have worked closely with each of the affected airplane manufacturers to address compliance questions and certification methodology. This has involved on-site visits and inspection of airplane design details, in addition to numerous discussions. These reviews give us a good appreciation of the magnitude of the design changes required to achieve compliance, which are substantial. Since a significant amount of the compliance time was absorbed with test equipment issues, the airplane manufacturers are significantly behind in implementing designs. Even though we had concluded that a 12 month extension would be sufficient, the two largest airplane manufactures are clearly not postured to accommodate compliance in that timeframe using materials that they consider optimal and that they intend to use for future compliance. We agree that they could not comply within the current proposed timeframe without a substantial cost impact that we did not originally anticipate.

Considering all of the above we have concluded that an additional 12 month extension, for a total of 24 months, is appropriate to implement this requirement in keeping with the original cost/benefit balance of the rule. In making this decision, we have considered that we would very likely receive petitions for exemption to address specific certification programs if the current proposal is maintained. The potential for further extensions is a significant factor in changing the proposal. Barring some unforeseen event, we do not envision any more changes to the compliance date. The final rule is changed accordingly.

Notwithstanding the 24 month extension, we would expect the manufacturers to implement the required design changes as early as possible, to improve the safety of the fleet.

There are no current or new requirements for information collection associated with this amendment.

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:

A two-year postponement of the new thermal acoustic insulation standards would spare manufactures an added setup cost of slightly less than $60 million at an expected societal loss of $4 million in benefits. The Improved Flammability Standards for Thermal/Acoustic Insulation final regulatory evaluation (July, 2002) estimated the new insulation requirements would produce present value benefits of $222.6 million with present value costs of $108.4 million (Table M). The two-year benefit/cost delay dichotomy is because of large set up costs and a relatively short postponement of corresponding benefits. The benefits increase slowly with a gradual increase in the fleet because of annual deliveries of new production airplanes with the new thermal/acoustic insulation.

As shown in the 2002 final regulatory evaluation nearly half of the regulatory evaluation estimated $108 million present value costs are the setup costs ($58.1 million in present value), which are incurred in the two years before installing the improved insulation on new production airplanes. These setup costs occur because of configuration management, or the cost resulting from engineering time to change airplane configuration—such as fully accounting for all parts, tools, and shop manual changes. To be in compliance with the new requirements the industry would first have to install a heavier insulation, before lighter weight insulation becomes fully available. Two different types of insulation materials require configuration management costs to double.

Thus this final rule results in large cost savings with a minor loss in social benefits. The FAA has, therefore, determined that this final rule 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.

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.

With this rule airplane manufacturers will avoid incurring an added configuration management cost. While these manufacturers are not small entities, the small entity operators are expected to save fuel burn expense, as the one-year interim fix insulation is heavier. Thus this rule is cost relieving and does not impose a significant economic impact on a substantial number of small entities.

We did not receive comments following the NPRM about the cost impact on small entities.

Therefore, as the 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 has determined that it provides the same cost relief to 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 FAA has analyzed this final 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, or 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 does not have federalism implications.

Section 1205 of the FAA Reauthorization Act of 1996 (110 Stat. 3213) requires the FAA, when modifying its regulations in a manner affecting intrastate aviation in Alaska, to consider the extent to which Alaska is not served by transportation modes other than aviation, and to establish appropriate regulatory distinctions. In the NPRM, we requested comments on whether the proposed rule should apply differently to intrastate operations in Alaska. We didn't receive any comments, and we have determined, based on the administrative record of this rulemaking, that there is no need to make any regulatory distinctions applicable to intrastate aviation in Alaska.

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 3f 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 (66 FR 28355, May 18, 2001). We have determined that it is not a “significant energy action” under the executive order because it is not a “significant regulatory action” under Executive Order 12866, and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

The Federal Aviation Administration (FAA) published SFAR 106, “Use of Certain Portable Oxygen Concentrator Devices onboard Aircraft,” in the Federal Register on July 12, 2005 (70 FR 40156). We inadvertently failed to attach notes to parts 125 and 135 of Title 14 of the Code of Federal Regulations (14 CFR) that would direct operators subject to those regulations to the body of SFAR 106. When the FAA published the notice of proposed rulemaking (NPRM) that offered the proposed SFAR to the public for comment, we clearly stated that the proposed regulation would apply to civil aircraft in parts 121, 125, and 135. The NPRM was published in the Federal Register on July 14, 2004 (69 FR 42324), and in the heading we noted that the proposal applied to 14 CFR Parts 121, 125, and 135. The applicability for an SFAR to a specific part of 14 CFR is not specifically cited in the Applicability section of the regulatory language, but rather cited in the heading of the SFAR and the parts affected contain an editorial note referring readers to the text of the SFAR. When the final rule was published, we failed to include those notes to parts 125 and 135. This technical amendment will add the editorial notes to parts 125 and 135 that direct the reader to the text of SFAR 106 and ensure that readers know the regulation applies to operations conducted under those parts. This amendment will not impose any additional restrictions on operators affected by these regulations.

SFAR 106 permits passengers to carry on and use certain portable oxygen concentrator devices (POCs) onboard aircraft if the aircraft operator ensures that the conditions specified in the SFAR for their use are met. Aircraft operators can now offer medical oxygen service as they did before SFAR 106 was enacted, or they can arrange for passengers to carry on and use one of the devices covered in SFAR 106. SFAR 106 is an enabling rule, which means that no aircraft operator is required to allow passengers to operate these devices onboard, but they may allow them to be operated onboard. If one of these devices is allowed by the aircraft operator to be carried on board, the conditions in the SFAR must be met. SFAR 106 allows for the use of five specific POC devices the FAA has found to be acceptable.

As stated above, this correction is needed to make clear that the conditions and regulations of SFAR 106 are also applicable to operations conducted under parts 125 and 135, as proposed in the NPRM and intended in the final rule.

The technical amendment will correct the omission of the editorial notes that direct operators under parts 125 and 135 to SFAR 106 in part 121.

The total yearly estimated non-fire related carbon monoxide (CO) deaths for each of the years 1999 through 2002 are 109, 138, 130 and 188, respectively. Since 1999, the percentage of estimated CO poisoning deaths specifically associated with generators has been increasing annually. In 1999, generators were associated with 7 (6%) of the total yearly estimated CO poisoning deaths for that year. In 2000, 2001 and 2002, they were associated with 19 (14%), 22 (17%) and 46 (24%) deaths out of the total estimates for each of those years.

On October 12, 2005, the staff was directed to undertake a thorough review of the status of portable generator safety. As part of this review, the staff was requested to assess the sufficiency of warning labels to address the CO poisoning hazard posed by portable generators that are used within or near residences. In response to this request, CPSC staff prepared a draft notice of proposed rulemaking (NPR), in which the staff proposed that manufacturers be required to label portable generators with a CO-poisoning warning label. On August 15, 2006, the Commission voted unanimously (2-0) to approve the publication of a Federal Register notice issuing an NPR for portable-generator labeling requirements. This notice was published August 24, 2006. 71 FR 50003.

Portable generators offer a means of providing electrical power to a location that either temporarily lacks it or is not provided with electrical service at all. A portable generator has an internal combustion engine to produce rotational energy, which is used to generate electricity. The engine may be fueled by gasoline, diesel, natural gas, or liquid propane. It is the engine that produces carbon monoxide as a byproduct of combustion.

Estimates of sales of portable generators for consumer use vary, but could be more than a million units annually. The most popular of these generators are gasoline-powered and are priced in the $500 to $800 range. The output of the majority of light duty generators sold to consumers in 2005 was in the 3.5 kW to 6.5 kW range. This is the size of most of the units involved in the fatal CO poisoning incidents CPSC staff investigated in which the rating of the involved generator was identified.

Section 27(e) of the Consumer Product Safety Act (CPSA) authorizes the Commission, by rule, to “require any manufacturer of consumer products to provide the Commission with such performance and technical data related to performance and safety as may be required to carry out the purposes of this Act, and to give such notification of such performance and technical data at the time of original purchase to prospective purchasers and to the first purchaser of such product for purposes other than resale, as it determines necessary to carry out the purposes of this Act.” As provided in section 2(b)(1) of the Consumer Product Safety Act (15 U.S.C. 2051(b)(1)), one purpose of the CPSA is “to protect the public against unreasonable risks of injury associated with consumer products.”

Failure to comply with a rule under section 27(e) is unlawful under section 19(a)(8) of the CPSA. 15 U.S.C. 2068(a)(8). Any person who knowingly violates this requirement is subject to a civil penalty of up to $8,000 per violation. 15 U.S.C. 2069; 64 FR 51963.

In 2002, CPSC staff assessed the effectiveness of current CO poisoning warnings found on the product and within the owner's manuals of several models of portable generators found on store shelves. Staff found that the guidance provided for avoiding the hazard was typically twofold: (1) Do not use in a confined or enclosed space, and (2) provide proper ventilation. None of the evaluated warnings defined “confined or enclosed space” or “proper ventilation.”

The Commission believes these instructions and warnings do not adequately advise users how to avoid the CO poisoning hazard. Furthermore, the incident data includes fatalities where it appears that the victims attempted to provide adequate ventilation, to open confined areas, or to do both by, for example, opening doors, opening windows, and running exhaust fans. Prior research has shown that tools with gasoline-powered engines produce CO that “can rapidly accumulate, even in areas that appear to be well-ventilated, resulting in dangerous and fatal concentrations within minutes.”  2 Thus, evidence suggests that the methods consumers typically use to provide ventilation or to open confined areas are insufficient to prevent hazardous levels of CO buildup. Even locating a generator outdoors can be insufficient if the generator is near enough to openings to the home or other occupied structure to allow CO to permeate and subsequently accumulate indoors. CPSC is aware of at least 5 deaths that occurred when a generator was situated outdoors but near openings to the home. In addition, the Centers for Disease Control and Prevention recently reported the results of a study of post-hurricane related generator use in 2005 that found up to 50% of non-fatal CO poisoning incidents involved generators operated outdoors but within one to seven feet from the home. 3

The Commission believes that there are too many unknown variables to be able to recommend one single safe distance for the location of a portable generator relative to a home or dwelling. Variables such as the wind speed and direction relative to openings to indoor spaces, relative proximity of other structures in the area that could create wind vortices, direction in which the engine exhaust is pointing, and a multitude of other factors complicate attempts to define a safe distance. Notwithstanding the issue of defining a safe operating distance, the Commission believes that warning labels must instruct consumers to keep generators outdoors and away from air intakes during use.

In 2003, the staff developed recommended warning language for engine-driven tools, with particular focus on portable generators, as a follow-up to the staff's assessment of the inadequacy of current warnings. This was later provided to the Underwriters Laboratories (UL) voluntary standard development committee. In February 2006, staff developed a further refined warning label for portable generators and presented it to UL in response to their request for CPSC staff comments on a proposed UL Outline of Investigation. UL incorporated staff 's proposed warning label into their Outline of Investigation, which became effective April 2006 and serves as the requirements with which a product must conform in order to be eligible to bear the UL mark. This document is not a consensus standard. The Commission believes a final rule is needed to ensure that all products will bear the proposed warning label as opposed to only those that seek UL's mark.

The warning label appears at fig. 1 (and fig. 3 for the on-package label). The warning label provides technical data, i.e., it indicates the presence of carbon monoxide in the portable generator exhaust and informs that carbon monoxide is a poison you cannot see or smell. The label uses the phrase “you cannot see or smell” rather than terms such as “odorless” and “colorless,” because the latter terminology may be less familiar and understandable to some consumers.

The label also includes statements which connect the technical data with safety concerns. Specifically, the label warns: “Using a generator indoors CAN KILL YOU IN MINUTES.” The phrase “in minutes” is intended to emphasize the imminence of the carbon monoxide poisoning hazard to provide consumers with a better understanding of the speed with which incapacitation can occur. In addition, research indicates that information about hazard scenarios affects consumers' risk judgments. Thus, the label includes a description not just of the hazard, carbon monoxide, but of the primary hazard scenario associated with CO-poisoning deaths, i.e., using a generator indoors. The label also warns, “NEVER use inside a home or garage, EVEN IF doors and windows are open.” The label warns specifically against use in the home and in garages, since these are known places in which consumers have used generators. The label includes prescriptive advice to “Only use OUTSIDE and far away from windows, doors, and vents,” so consumers can know what positive action they can take to avoid the hazard, rather than focusing exclusively on prohibited behaviors, or what consumers should not do. This is consistent with the requirements of ANSI Z535.4-2002, which is the primary U.S. voluntary consensus standard on product safety signs and labels, and with warning design guidelines in general. The accompanying pictograms are based on the pictograms developed by the Underwriters Laboratories Standards Technical Panel. Research shows that labels with pictograms tend to capture a consumer's attention more readily than a label without pictograms.

Portable generators are powered by gasoline, diesel, or propane engines and exhaust CO. If the generator is used in enclosed or even partially enclosed spaces, the CO can very quickly build to hazardous levels. Serious injury can also result when the generator is placed outdoors but near an open window or vent and the exhaust is pulled into a house. In the 6-year period from 2000 through 2005, the Commission is aware of at least 222 deaths related to CO poisoning associated with generators. 4 Non-fatal CO injuries can have serious consequences since permanent brain or neurological damage can result.

A well-designed warning label should inform the consumer of the CO hazard associated with generators and how to avoid the hazard while using the generator. A label placed in a prominent position on the generator is expected to reinforce this information each time the consumer used the generator. For example, the proposed label reminds the consumer that generator exhaust contains CO, which cannot be seen or smelled, and can quickly kill. The label also clarifies that a generator should only be used outside and far away from windows and vents and should not be used inside a home or garage. This information is important since some consumers have apparently been aware that a CO hazard was associated with generators, but believed that they would avoid the hazard by running the generator in a garage with the door open or outside the house, and did not understand that it was necessary to place it away from open windows and vents. 5 The costs of a warning label include the one-time cost of designing the label and the continuing costs of printing and applying the labels to the generators and packages. These costs are expected to be low—less than one dollar per generator. Based on the hazards associated with carbon monoxide poisoning from portable generators, and the low cost of labeling generators, the Commission finds that there is an unreasonable risk of injury associated with portable generators.

The National Environmental Policy Act and the Council on Environmental Quality Act regulations and CPSC procedures for environmental review require the Commission to assess the possible environmental effects associated with the labeling requirement for portable generators. Labeling rules are not expected to have an adverse impact on the environment and are considered to fall within the “categorical exclusions” for the purposes of the National Environmental Policy Act according to the CPSC regulations that cover its “environmental review” procedures (16 CFR Part 1021.5(c)(2)). Thus, the Commission concludes that no environmental assessment or environmental impact statement is required in this proceeding.

When an agency issues a final rule such as the labeling requirement for portable generators, the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 601 et seq. , generally requires the agency to prepare a final regulatory flexibility analysis describing the impact of the rule on small businesses and other small entities. Section 605 of the RFA provides that an agency is not required to prepare a regulatory flexibility analysis if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities.

The Commission's Directorate for Economic Analysis prepared a preliminary assessment of the impact of a rule to require labeling on portable generators. That assessment reported that, while small manufacturers will be responsible for ensuring that their generators are properly labeled, the labeling requirement is not expected to pose a significant burden to small business because the cost of adding the labels per generator is expected to be less than a dollar per generator set. The incremental cost of the rule issued today is likely to be minimal.

Based on the foregoing assessment, the Commission certifies that the rule issued today to require labeling for portable generators will not have a significant adverse impact on a substantial number of small businesses or other small entities.

As provided for in Executive Order 12988 (February 5, 1996), the CPSC states that the preemptive effect of these regulations is as follows. The preemption provisions of section 26 of the CPSA apply only to “consumer product safety standards.” By definition in the CPSA, section 27(e) rules are not consumer product safety standards. There is, therefore, no express preemption for a final rule under section 27(e) of the CPSA. Preemption of state requirements could still occur if, for example, it is impossible to comply with both this rule and a state requirement.

Part 1407 requires a label on any portable generator manufactured or imported on or after May 11, 2007. 6

In response to the Federal Register notice proposing labeling requirements for portable generators, the Commission received 19 comments. The comments were largely positive and supported the proposed labeling, but two comments explicitly requested that the Commission withdraw the NPR. Many of the comments, even those that supported the general intent and approach of the rule, raised specific issues or concerns.

Comments: Two comments claim that the Federal Hazardous Substances Act (FHSA), not the CPSA, is the appropriate statute under which to address through labeling the CO-poisoning risk associated with portable generators. If, as the commenters claim, the risk of injury is one which could be eliminated or reduced by action under the FHSA, then the Commission, pursuant to section 30(d) of the CPSA, would have been required to find by rule that it was in the public interest to regulate the risk of injury under the CPSA (“section 30(d) finding”). 7

These commenters also claim that the label proposed in the NPR appears to be the type of warning that Section 7 of the CPSA contemplates, since the NPR characterizes the risk of CO poisoning associated with generator emission as an “unreasonable risk of injury.”  8

Response: The FHSA defines “hazardous substance” as including any “substance or mixture of substances which (I) is toxic * * * if [it] may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use * * *.” Hazardous substances are misbranded if they do not bear the labeling required by section 2(p)(1) of the FHSA, 15 U.S.C. 1261(p)(1). In order to label a product under the authority of the FHSA, the product must constitute or contain a hazardous substance.

The commenters analogize the labeling of portable generators to the labeling of charcoal packaging under the FHSA, in that charcoal, when burned, generates carbon monoxide. A significant difference between charcoal and portable generators, however, is that charcoal, as a substance which is toxic, constitutes a hazardous substance, and its packaging is therefore required to be labeled under the FHSA. In contrast, portable generators, when sold, are empty. Portable generators as sold thus do not contain any hazardous substance, or any substance, such as gasoline, that would produce the hazardous substance. A more appropriate analogy to portable generators might be gasoline containers that, when sold empty, are subject to the authority of the CPSA. Because the risk of injury associated with carbon monoxide poisoning from portable generators cannot be eliminated or adequately reduced by action under the FHSA, no finding under section 30(d)of the CPSA is required.

Commenters also suggest that the label proposed in the NPR appears to be the type of warning that Section 7 of the CPSA contemplates, since the NPR characterizes the risk of CO poisoning associated with generator emission as an “unreasonable risk of injury.” Section 27(e) of the CPSA authorizes the Commission to issue rules requiring a consumer product manufacturer to provide the Commission and consumers with “performance and technical data related to performance and safety as may be required to carry out the purposes of this Act .” One of the purposes of the CPSA, as provided in section 2(b)(1) of the CPSA, is “to protect the public against unreasonable risks of injury associated with consumer products.” The risk of CO poisoning posed by portable generators was fully addressed in the NPR (71 FR 50003) and the use of section 27(e) to protect the public against risk of injury is completely appropriate. This is not to say that it would be inappropriate to adopt a CO warning label for generators under section 7 of the CPSA. Indeed, the Commission intends to consider that approach in connection with its ongoing generator rulemaking (71 FR 74472).

Comments: Two comments address scope and definition issues related to the proposed rule. One comment seeks clarification on whether fuel-cell portable generators are included within the scope of the rule. Another comment proposes that the definition of a “portable generator” reflect the definition within Underwriters Laboratories' Outline of Investigation for Portable Engine-Generator Assemblies, UL 2201.

Response: The CPSC rule is intended to generally cover the same range of portable generators as UL 2201. Therefore, Section 1407.2(b) is revised to read, “A portable generator is an internal combustion engine-driven electric generator rated no higher than 15 kilowatts and 250 volts that is intended to be moved for temporary use at a location where utility-supplied electric power is not available. It has receptacle outlets for the alternating-current (AC) output circuits, and may have alternating- or direct-current (DC) sections for supplying energy to battery charging circuits. ” As specified in this definition, portable generators that are covered under this rule must have an internal combustion engine and receptacle outlets for AC output circuits. (The generator may have other outlets, for example, for low voltage DC accessories.) Fuel-cell portable generators are not be covered by the rule. The rule also does not cover generators that fall within the definition of “motor vehicle equipment,” or otherwise fall outside the Commission's jurisdiction under the CPSA.

Comments: Three comments from portable generator manufacturers state that they will need at least six months, rather than the 90 days proposed in the NPR, from issuance of the final regulation in the Federal Register to comply with the new requirements.

Response: As noted by the staff of the CPSC Directorate for Economic Analysis, the time and resources required by manufacturers to redesign their portable generator labels are likely to be low since the content and format of the labeling will be specified in the rule. The Commission, therefore, believes that most manufacturers should be able to comply with the requirements within 90 days of publication of the final rule. Nevertheless, some manufacturers may have to reschedule other work and shift resources such as labor from other projects. There would be some costs associated with these adjustments and these costs could be alleviated somewhat by delaying the effective date of the rule. To provide some relief to manufacturers that might have trouble incorporating the label change within 90 days, the Commission has decided to post-pone the effective date of the rule such that the label would be required on any portable generator manufactured or imported 120 days after the publication of the final rule in the Federal Register .

Comments: Five comments address the issue of whether the message text of the proposed labeling should also be required in a language other than English. Two comments support the addition of other languages, and one of these suggests that Spanish be the second language to include. Two comments oppose requiring additional languages. The remaining comment does not take a position on the matter, but suggests that Spanish is the appropriate language to include if another language is added.

Response: The staff's previous analyses of generator-related incident data have revealed no pattern of incidents involving people who could not read English. To confirm this, the staff of the CPSC Directorate for Epidemiology (EP) selected and thoroughly examined a random sample of 25 out of 150 in-depth investigations into generator-related CO-poisoning deaths that occurred in the 2002 to 2005 time frame. None of the examined investigation reports described the victims’ literacy in English, Spanish, or any other language. Consequently, these investigations provide no basis for concluding that labeling in Spanish would have prevented deaths.

According to the 2000 U.S. census, most people who speak a language other than English at home speak Spanish, with Chinese ranking a very distant second (Shin & Bruno, 2003). 9 Additionally, the National Center for Education Statistics (NCES) has found that about 35 percent of American adults who have below basic literacy in English prose  10 spoke Spanish before starting school; only 9 percent could not speak either English or Spanish (NCES, 2005). Adding Spanish to an English-language warning label, therefore, would be expected to improve its readability among the U.S. population more than adding any other language. Nevertheless, the overall impact of adding Spanish to a label may be small. In the case of portable generators, Synovate DuraTrend TM consumer survey data obtained by the EC staff show that only 5.6 percent of generator purchasers in 2005 were Hispanic. Furthermore, many of these people are likely to be literate in English; for example, less than half of all adult Hispanics in the U.S. have below basic literacy in English prose (NCES, 2005). Thus, Hispanics with below basic literacy in English prose—the sub-population most likely to include individuals who cannot read English yet can read Spanish, and who would potentially benefit the most from the addition of Spanish to the proposed warning label—almost certainly represent less than five percent of all generator purchasers in the U.S., and may comprise substantially less than this. Some of these people may also lack basic literacy in Spanish and, therefore, would be unable to read a label even if it included written Spanish. Despite these findings, the Commission does not dismiss the potential usefulness of providing the information in the labeling in Spanish, especially in regions of the country with large Hispanic populations. Thus, the rule does not prohibit manufacturers from providing a Spanish-language version of the labeling in addition to the prescribed English-language label. If the product label is provided by the manufacturer in additional languages, however, the staff believes that additional-language versions of the label should appear adjacent to or below the English-language version of the product label. This formatting is consistent with ANSI Z535.4—2002, the most recent published version of the American National Standard for Product Safety Signs and Labels. The staff further recommends that any additional-language versions of the label, whether they be on the product or on the generator package, be no larger than the English-language version of the label. Thus, the final rule includes these requirements at § 1407.3(a)(1) and § 1407.3(a)(2).

Comments: Four comments assert that the signal word WARNING is more appropriate than DANGER for the proposed labeling. Arguments made by the commenters include that the use of DANGER is inconsistent with the hierarchy specified in the ANSI Z535 series of standards and that its use might reduce the perceived risk associated with the WARNING hazards of fire during refueling, electrocution from use in wet conditions, and electrocution from connection to a commercial power source.

Response: According to the ANSI Z535 series of standards, the selection of a signal word for a hazard label should be made based on the seriousness of the hazard situation or scenario. For example, ANSI Z535.4—2002, the most recent published version of the American National Standard for Product Safety Signs and Labels, defines DANGER as an “imminently hazardous situation which, if not avoided, will result in death or serious injury” (Section 4.13.1). The latest revision of ANSI Z535.4 clarifies that use of the term—will” in this definition indicates an event that is nearly, but not absolutely, certain (Annex E, due for publication 2006). While the mere presence of carbon monoxide in portable generator exhaust could lead to death or serious injury, the use of generators indoors—the hazard scenario specifically highlighted in the label—would almost certainly result in death or serious injury due to a generator's high rate of CO production (for example, see Inkster, 2004). The CPSC continues to believe, therefore, that DANGER is the appropriate signal word for the proposed labeling.

The Commission cannot confirm the assertion that using DANGER for the CO poisoning hazard would necessarily reduce the perceived hazard associated with the WARNING hazards mentioned. One could argue instead that the use of DANGER simply increases the perceived hazard associated with CO poisoning without having any effect on consumer perceptions related to the other hazards being warned about on the product. Additionally, the selection of a signal word for a given hazard is supposed to be based on the standard signal-word definitions (for example, those used in ANSI Z535.4), which denote the seriousness of the hazard situation or scenario, not on how the signal word might impact the perceptions of hazard labels that use other signal words. To the extent that a hazard situation or scenario is serious enough to demand the use of DANGER, one would expect and hope that people exposed to the hazard label would correctly interpret this as meaning that the hazard situation is more serious than a hazard label that relies on a less serious signal word such as WARNING or CAUTION. Accordingly, the final rule requires that the label include the signal word DANGER.

Comments: Five comments are associated with the specific message text of the proposed labeling. Two comments express concerns that the message text has not been independently tested—for example, through the use of focus groups—and suggest various alternatives to the wording of this text. Both also argue that the phrase, “* * * WILL KILL YOU IN MINUTES” is not accurate. One comment includes the results of focus group testing, performed on low-literacy individuals by a contractor for the U.S. Environmental Protection Agency (EPA), which found that some people had difficulty understanding the phrase “partly enclosed area” and misinterpreted the word “gas” as gasoline. The contractor recommended that “partly enclosed area” be deleted from the label. One comment states that the label does not alert consumers to the symptoms of CO poisoning or refer users to the manual for additional instructions. Another comment states that the phrase, “Please read the manual before use,” is already attached to the generator in another label and that, therefore, the packaging label should be identical to the product label if one is used. One comment recommends the addition of the phrase, “FOR OUTDOOR USE ONLY,” after the initial sentence of the proposed labeling.

Response: As referenced in the comment summary, above, an independent contractor performed focus group testing on the proposed product label with low literacy individuals as part of the EPA's efforts to develop a flood-cleanup brochure. This testing identified two specific comprehension problems with the message text of the proposed labeling. First, testing revealed that some low-literacy individuals had difficulty understanding the phrase “partly enclosed area.” The available CPSC data on CO poisoning deaths associated with portable generators show that most incidents in which the generator was reportedly used in an enclosed or partially enclosed area occurred either within the home or in a garage or enclosed carport (Marcy & Ascone, 2005). Thus, the staff believes it would be acceptable to remove “partly enclosed area” from the proposed labeling, as recommended by the EPA's contractor. The staff is concerned, however, about simply deleting this phrase, since its absence could mislead some into believing that generators are only hazardous if used in fully enclosed areas. Thus, the staff recommends adding the phrase, “EVEN IF doors and windows are open,” to the end of the revised portion of the warning. The entire relevant statement, therefore, is changed in the final rule from, “NEVER use in the home or in partly enclosed areas such as garages, ” to, “NEVER use inside a home or garage, EVEN IF doors and windows are open.”

The testing also revealed that “gas” may be misinterpreted as “gasoline” by some low literacy individuals. To address this comment, the label is revised to read as follows: “Exhaust contains carbon monoxide, a poison gas you cannot see or smell,” with, “Generator exhaust contains carbon monoxide. This is a poison you cannot see or smell.” Because they address the specific comprehension problems identified with the message text during testing, these revisions should make the proposed labeling more understandable to all generator users. The CPSC staff believes that an explanation of the intended function of a portable generator, which the EPA 's testing contractor also recommended adding, is unnecessary for a product label since people who do not know this information are unlikely to purchase, rent, borrow, or otherwise use a portable generator. Thus, the final rule does not include an explanation of the intended function of a portable generator.

The staff agrees that the sentence, “Using a generator indoors WILL KILL YOU IN MINUTES,” is questionable because death may occur in a longer time frame than what most people would deem “in minutes” and because generator use indoors may result in severe CO poisoning rather than death. The staff is also concerned that people who have previously used a generator indoors and survived could question the credibility of a label that states death is essentially inevitable. If the label is not credible, people may choose to ignore the safety message. Therefore, the Commission has revised this statement to read, “Using a generator indoors CAN KILL YOU IN MINUTES.” This revision has no effect on the appropriateness of using DANGER as the signal word for this label, as discussed earlier, since the use of generators indoors would still almost certainly result in death or serious injury due to a portable generator's high rate of CO production. The revised phrase simply emphasizes the possibility that death can occur within minutes.

In its 2003 memorandum that proposed warning labels to accompany portable generators, the CPSC staff specifically recommended against including a description of CO-poisoning symptoms within the product label because this information would add a substantial amount of text to the label and was believed to be of limited value for a label to be affixed to the product itself (Smith, 2003). The staff continues to support this position. Regarding the statement, “See product manual for more details,” which originally appeared at the bottom of the on-product label in the staff's 2003 memorandum (Smith, 2003), the staff does not believe this statement should be required on portable generators because the information that is provided in the labeling required in this final rule addresses the key safety information of which people must be aware when using a generator and generator manufacturers may include a statement that refers users to the product manual elsewhere on the generator. As pointed out in one public comment, some manufacturers already include the phrase, “ Please read the manual before use,” in other generator labels. For the packaging label, however, the statements, “Avoid other generator hazards. READ MANUAL BEFORE USE,” are needed since this label may very well be the only label on the packaging that will alert the purchaser to possible hazards associated with generator use. Therefore, the provision has been retained in the final rule.

The CPSC staff believes it would be inappropriate to add the phrase, “FOR OUTDOOR USE ONLY,” after the initial sentence of the message text in the proposed labeling. Placing this phrase after the initial sentence interrupts the logical flow of the warning from the explanation of the hazard situation to the descriptions of the appropriate hazard avoidance behaviors. A more appropriate location for this phrase, if it were used, would be at the beginning of the message text as the first sentence of the warning. However, the staff is concerned that using this phrase as the first sentence would tend to de-emphasize the description of the hazard situation and its consequences (that is, “Using a generator indoors CAN KILL YOU IN MINUTES.”), could lead people to stop reading further because it is a highly familiar phrase that people are likely to believe they already understand, and is redundant with the already-present and more-detailed admonition to use the generator outside and far away from windows, doors, and vents. Thus, although this statement would not add a substantial amount of text to the label, the Commission does not believe it should be added to the labeling and the statement is not included in the final rule. However, manufacturers are not prohibited from including a statement of this kind elsewhere on the product, packaging, or product manual.

Comments: Four comments propose the use of a circle-slash symbol rather than an “X” symbol to indicate prohibited actions in the pictograms that appear in the proposed labeling. Arguments made within these comments in favor of the circle-slash symbol include the fact that it is consistent with the ANSI Z535 series of standards, is internationally recognized, and obscures less of the underlying pictogram than an “X.” One comment states that a transparent circle-slash symbol may be superior since it does not obscure the underlying pictorials.

Response: The CPSC staff acknowledges that the ANSI Z535 series of standards recommends the use of a circle-slash symbol to indicate prohibited actions in pictograms. When developing the proposed labeling, the CPSC staff chose to use “X” symbols rather than circle-slash symbols because both the circle-slash and “X” symbols are commonly recognized as conveying the prohibition concept (Dreyfuss, 1972; Wogalter & Leonard, 1999), there was no evidence that English-reading consumers would have difficulty understanding the meaning of an “X” symbol, and the only known evidence of comprehension problems with either prohibition symbol were those encountered with the circle-slash symbol by some Latin American individuals during charcoal-pictogram testing previously performed for the CPSC (Requirements for Labeling of Retail Containers of Charcoal, 1996). The staff also found that circle-slash symbols tended to obscure more of the underlying pictograms than did “X” symbols of the same size. For example, the circle portion of the circle-slash symbols tended to obscure the outlines of the home and garage pictograms, making these portions of the pictograms difficult to discern. Since publication of the Federal Register notice regarding the NPR, the staff has become aware of an internal Douglas Aircraft research report that identified possible comprehension problems with the use of an “X” to indicate prohibition. For example, the researchers found that a graphic using an “X” to indicate that a part should not be touched was misinterpreted by some as meaning the opposite, indicating where the person should touch (Johnson, 1974, as cited in Johnson, 2006). In light of this research, the staff agrees that the use of “X” symbols rather than circle-slash symbols to indicate prohibition in the proposed labeling may not be preferable. The final rule, therefore, includes the opaque circle-slash symbols rather than “X” symbols. Additionally, to avoid problems with the circle-slash obscuring the outlines of the home and garage, the final rule uses smaller circle-slash symbols, centered over the generator pictograms. Although a transparent circle-slash symbol would not obscure the underlying symbol, its use is inconsistent with the prohibition symbol recommended in the ANSI Z535 series of standards.

Comments: Three comments are associated with the staff's decision to use pictograms depicting hazard avoidance behavior in the proposed labeling. Two comments state that these pictograms have not been independently tested, and question whether the pictograms of the generator will be readily recognized. One of these comments suggests that the standard hazardous gas/vapors pictogram, which shows a person inhaling gas, might be a better choice since it had undergone successful consumer testing. One comment, which includes the results of EPA-sponsored focus group testing on the proposed product label, reports that some low-literacy individuals had difficulty recognizing the generator pictogram. The contractor recommended enlarging this pictogram to improve the likelihood that it will be correctly identified.

Response: The CPSC staff had originally considered the use of the hazardous gas/vapors pictogram referred to in the comments, but expressed reservations about its use since the gas in the pictogram is visible even though carbon monoxide is not (Smith, 2003, 2006). The staff continues to be concerned about this potential for confusion. In addition, although testing has revealed that most people can recognize the referenced pictogram as indicating hazardous gas or vapors (Mayer & Laux, 1989), this pictogram provides no information regarding appropriate hazard-avoidance behaviors. In fact, since this pictogram could indicate hazardous gases with varying degrees of lethality, the appropriate hazard-avoidance behavior may vary substantially among different hazardous gases. For example, some products that release hazardous gases might be safely used within an open garage, but this is not true for an operating portable generator. The final rule uses pictograms depicting appropriate and inappropriate behaviors specific to portable generators to avoid this ambiguity.

As discussed earlier, an independent contractor performed focus-group testing on the proposed product label with low-literacy individuals as part of the EPA's efforts to develop a flood-cleanup brochure. The only identified problem with the pictograms that appear in the proposed labeling was that some people had difficulty recognizing the graphic of the generator. These test results, however, almost certainly underestimate the extent to which the generator graphic would be recognized in a real-life scenario. For example, testing was not performed with the label affixed to a generator. When presented in the appropriate context, generator graphics are more likely to be recognized (Wogalter, Silver, Leonard, & Zaikina, 2006). Additionally, the EPA testing found that some of the participants in the testing did not even know what a generator was. People who do not know the intended function of a portable generator are unlikely to purchase, rent, borrow, or otherwise use a portable generator, and would not be expected to correctly identify a graphic of this product. Nevertheless, to improve the likelihood that people will correctly identify the generator graphic as a portable generator and to increase the overall legibility of the pictograms, the CPSC has slightly increased the size of the pictograms in the final rule, as recommended by the EPA's testing contractor. The Commission also notes that Section 1407.3(a)(1) of the final rule specifies that “[a] different representation of the generator [within the proposed labeling] may be substituted for accuracy if consumers are more likely to recognize the substituted representation as the generator to which this label is affixed.” Manufacturers, therefore, may substitute a graphic of the specific generator to which the label will be affixed if they so choose.

Comments: Five comments are associated with specific features of the hazard-avoidance pictograms that appeared within the proposed labeling. Two comments suggest deleting the symbol depicting the use of a generator within a garage. This pictogram, according to three comments, could be interpreted as meaning that one should not store the generator in a garage. Two comments claim that the two-headed arrow graphic that appears in the pictogram depicting appropriate behavior could be misinterpreted. One of these states that the two-headed arrow graphic could be interpreted as meaning that use both in and away from the home is acceptable; the commenter suggests that this arrow be replaced with a single-headed arrow that points away from the home. The other comment claims that this graphic could be interpreted as meaning that the person should connect the generator by electrical wire to a commercial power supply as a backup, and recommended deleting the pictogram entirely.

Response: The Commission believes that both pictograms that depict inappropriate behaviors—one showing generator use within a home or enclosed space and one showing generator use within a garage—are necessary to convey the key safety message. Relying solely on the pictogram of the generator within a home or enclosed space to indicate inappropriate behavior, as recommended by the commenters, could lead people to believe that generators are only hazardous if used within a completely enclosed space. Many CO-poisoning deaths associated with portable generators occurred when the generator was being used in a garage with the door at least partially open. The pictogram depicting generator use in the garage as being inappropriate directly addresses incidents of this type. Although the CPSC acknowledges that one could infer from these pictograms that generators should not be stored in the home or garage, alternative pictograms such as the poisonous gas/vapors pictogram are also open to various interpretations regarding appropriate and inappropriate behaviors specific to portable generators, as discussed in the response to the previous topic. As demonstrated by the earlier discussion of comprehension problems encountered with common prohibition symbols, virtually no hazard pictogram or symbol will be understood by all people. For this reason, explanatory text is very often recommended or required, 11 especially for complex hazards (Wogalter, Silver, Leonard, & Zaikina, 2006). The CPSC believes that the explanatory message text that appears in the label should limit the extent to which misinterpretations of the pictograms would prevent people from understanding the overall message of the labeling.

Regarding the use of a double-headed arrow in the pictogram depicting the appropriate use of a portable generator, the American National Standard Criteria for Safety Symbols, ANSI Z535.3, recommends the consistent use of arrow graphics to represent different types of movement or spatial relationships. Single-headed arrows are used to represent the motion of objects or components or to represent the exertion of pressure or force; in contrast, double-headed arrows are used to represent the idea of keeping a safe distance away from a hazard (ANSI Z535.3-2002, Figure A1). Thus, the use of a double-headed arrow is appropriate, and the direct replacement of the double-headed arrow with a single-headed one, as recommended by one commenter, would suggest the movement of the home toward the generator, which is opposite the intended meaning and could create critical confusion among the intended audience. Despite this, in the final rule issued today, the original appropriate-use pictogram is replaced with a pictogram that avoids the possible misinterpretations identified by the commenters yet remains consistent with ANSI Z535.3. This pictogram employs a single-headed arrow but places the arrow on the opposite side of the generator pictogram to suggest the movement of the generator away from the home. The length of the arrow has also been shortened so the generator pictogram is not located immediately adjacent to the graphic of the home.

Comments: Six comments point out that the proposed labeling does not include an explicit distance (for example, measured in feet) that should be maintained between the generator and the home or other partially enclosed area. Some suggest that this distance could be inserted within the message text or within the pictogram depicting the generator being kept away from the home. One comment suggests a minimum distance of 10 feet; another comment suggests at least 15 feet.

Response: The CPSC agrees that explicitly identifying a safe operating distance between the generator and the home or other partially enclosed area would be more useful than relying on terms such as “far,” but has been unable to develop a consensus as to what distance is adequate given the widely varying conditions under which portable generators may be used. As discussed in the staff's 2006 briefing package on portable generator safety, some portable generator manufacturers currently provide minimum clearance requirements for placement of the generator; however, these distances appear to represent the clearances needed to allow for adequate combustion and cooling airflow, not to avoid CO poisoning (Buyer, 2006). Variables such as the speed and direction of wind relative to openings to indoor spaces and the relative proximity of other structures to the generator complicate attempts to define a reasonably safe distance.

In a study of nonfatal CO-poisoning incidents following two major hurricanes in 2005, the Centers for Disease Control and Prevention (CDC) found that half of those interviewed who had been involved in generator-related incidents had placed the generator outside in the open, but that all of these individuals had placed the generator within seven feet of the home (CDC, 2006). Thus, a “reasonably safe” distance likely would be greater than seven feet. However, available data do not allow the Commission to reach consensus on how much farther than seven feet would constitute a reasonably safe distance. The phrase “far away,” used in the label required by this final rule, while not as explicit as a specified distance, still emphasizes the need to keep the generator well away from, rather than immediately outside, the home or other partially enclosed areas.

Comments: Three comments address the proposed location or placement of the label on the product. Two comments state that it is not technically feasible to meet a requirement that the label be placed on a part of the generator that, if removed, would impair the operation of the generator. The commenters propose an alternative requirement that the label be placed on a part of the portable generator that cannot be removed without the use of tools. One comment suggests that the label be located close to the “on/off” switch, the starter, or the power outlets, and suggests that the label be more “active” by requiring the user to take an action that draws attention to the label each time the generator is used.

Response: The Commission is not opposed to the commenters' proposed alternative requirement that the label be placed on a part that cannot be removed without the use of tools. Therefore, section 1407.3(a)(1)(iii)(A) of the final rule states, “On a part of the portable generator that cannot be removed without the use of tools.” Regarding the comment about making the label more “active” by requiring the user to take an action that draws attention to the label each time the generator is used, the Commission believes that such a requirement is unnecessary at this time since the label is already required to be placed in a location that is prominent and conspicuous to an operator while performing at least two of the following tasks: Filling the fuel tank, accessing the receptacle panel, and starting the engine (see section 1407.3(a)(1)(iii)(B) of the final rule).

Comments: Two comments propose that the requirement for a packaging label be dropped from the rule. Both believe this label is unnecessary since the packaging will be discarded.

Response: The intent of the packaging label is to directly provide potential purchasers of portable generators with information at the point of purchase emphasizing the danger of CO poisoning, and to reinforce the warning when the generator is removed from the packaging at home, not to assist consumers while they are operating the generator after the packaging is discarded. The packaging label provides the CO poisoning information irrespective of sales staff interaction or other messaging at the point of sale. Without the information presented by the packaging label, purchasers may not discover until they are home that they do not have an appropriate place to operate the generator. Accordingly, the proposed requirement for the packaging label is retained in this final rule.

Comments: One comment notes that a previous CPSC staff memo included a recommendation for a product-manual warning, which included information about CO-poisoning symptoms, and that the NPR does not include a recommendation for such a warning.

Response: The rule does not include specific recommendations for CO-poisoning warnings to appear within the manuals that accompany portable generators because prior analyses of the CO-poisoning information provided on the product and within the product manuals found that the product labeling was often far more deficient (Smith, 2002). Since the on-product labeling is available to consumers even after the product manual is lost, discarded, or otherwise not available, improved product labels are of paramount importance. The Commission does agree, however, that providing more detailed information about CO poisoning within the product manual, including information about the symptoms of CO poisoning, would be advantageous, and the staff may consider additional requirements of this type as part of the CPSC 's ongoing activities associated with improving portable generator safety.

Comments: One comment notes that increasing the distance between the generator and any partially enclosed spaces necessarily increases the distance between the generator and the load, which could result in some consumers using extension cords with insufficient capacity. The commenter suggests that a warning label that states, “ONLY USE PROPERLY SIZED EXTENSION CORDS IN GOOD CONDITION,” be affixed to the generator's electrical panel.

Response: The Commission agrees that the capacity and condition of extension cords to be used with portable generators must be adequate to support the intended load and allow the generator to be kept far away from homes and other partially enclosed areas. However, this issue is outside the scope of this rulemaking.

Comments: Three comments suggest that labeling alone is not sufficient to address the CO-poisoning hazard and recommend technical solutions such as reduced CO emissions or integrated CO monitors that will automatically shut off the generator if necessary.

Response: Specific technical approaches to addressing the CO poisoning hazard associated with portable generators are outside the scope of this rule and are addressed in a separate Commission rulemaking commenced with the recent publication of an advance notice of proposed rulemaking, 71 FR 74472 (December 12, 2006).

For the reasons stated in this preamble, the Commission finds that a requirement for a carbon monoxide warning statement on portable generators is necessary to help protect the public against the risk of CO poisoning associated with such products.

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

From FERC's Home Page on the Internet, this information is available in the eLibrary (formerly FERRIS). The full text of this document is available on eLibrary in PDF and MSWord format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.

User assistance is available for eLibrary and the FERC's Web site during normal business hours by contacting FERC Online Support by telephone at (866) 208-3676 (toll free) or for TTY, (202) 502-8659, or by e-mail at FERCOnlineSupport@ferc.gov.

In the Federal Register of November 25, 2005 (70 FR 71041), FDA published a proposed rule to amend the definition of the nutrient content claim “lean” (21 CFR 101.62) to include foods categorized as “mixed dishes not measurable with a cup” that are regulated by FDA and that meet the criteria in the rule for total fat, saturated fat, and cholesterol. FDA issued this proposed rule in response to a petition filed under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)) and in part 101 (21 CFR part 101) in § 101.69. Section 403(r)(2)(A)(i) of the act (21 U.S.C. 343(r)(2)(A)(i)) states that a nutrient content claim may be made only if the characterization of the level made in the claim uses terms which are defined in regulations of the Secretary of Health and Human Services (the Secretary) (and, by delegation, FDA). Section 403(r)(4) of the act sets out the procedures that FDA is to follow upon receiving a nutrient content claim petition.

On January 9, 2004, Nestlé (the petitioner) submitted a petition requesting that the agency amend the nutrient content claim regulation for “lean” (21 CFR 101.62(e)) to include “mixed dishes not measurable with a cup” as defined in the “Reference amounts customarily consumed per eating occasion” regulation (21 CFR 101.12), based on certain qualifying criteria for total fat, saturated fat, and cholesterol. FDA filed the petition for comprehensive review in accordance with section 403(r)(4) of the act on April 22, 2004.

FDA's definition of the nutrient content claim “lean” includes flesh foods, such as seafood and game meat products, which are foods that are similar to the U.S. Department of Agriculture (USDA)-regulated meat and poultry products, and also includes meal-type products (i.e., main dishes and meal products), which are included in the USDA definition. Prior to the publication of this final rule, FDA's definition of “lean,” did not extend to foods categorized as “mixed dishes not measurable with a cup.” Such foods, e.g., burritos, egg rolls, enchiladas, pizza, quiches, and sandwiches, are generally similar to the foods subject to the definition of “main dish” (21 CFR 101.13(m)) but do not meet the weight criterion for “main dish” foods (6 ounces (oz) per labeled serving). The Reference Amount Customarily Consumed (RACC) for “mixed dishes not measurable with a cup” is 140 grams (g) (5 oz) (21 CFR 101.12(b), Table 2), which is 1 oz less than the 6 oz per labeled serving required to qualify as a “main dish.” Thus, food products categorized as “mixed dishes not measurable with a cup” and that weigh less than 6 oz were not eligible to bear a “lean” nutrient content claim under § 101.62(e).

FDA considered the evidence presented in the petition as part of its review, as well as information previously considered by the agency in the January 6, 1993, nutrient content claim final rule (58 FR 2302). Based on the available evidence, FDA acknowledged the following in the proposed rule (70 FR 71041 at 71044):

• “mixed dishes not measurable with a cup” have found their way into the American diet and serve as a convenient “meals-on-the-go” eating option that is consistent with America's changing lifestyle;

• This category has become a well established product category that consumers have come to rely on; and

• There is a growing interest in healthful alternatives to traditional food options, including vegetarian alternatives.

FDA believes that portable food products, particularly those that are nutrient (i.e., total fat, saturated fat, and cholesterol) and portion controlled, serve a useful purpose in assisting consumers in selecting a diet that is consistent with current dietary recommendations (e.g., Dietary Guidelines for Americans 2005). In this final rule, the agency concludes that providing a “lean” definition for “mixed dishes not measurable with a cup” will provide more consistency with similar USDA products and help consumers construct a diet that is consistent with current dietary recommendations (i.e., limiting dietary intake of saturated fat and cholesterol). The agency determined that the nutrient requirements for “mixed dishes not measurable with a cup” required in this final rule would allow it to achieve criteria which would enable consumers to maintain intakes of fat within current dietary recommendations without being unnecessarily restrictive. The agency is basing the nutrient criteria for total fat, saturated fat, and cholesterol on the current criteria for main dishes (21 CFR 101.13(m)), but applying the criteria to the RACC (140 grams (g)) for “mixed dishes not measurable with a cup” rather than the minimum weight for main dishes (170.1 g). The agency chose the main dish minimum weight requirement of 170.1 g (6 oz) for use in its calculations, rather than the 283.4 g (10 oz) minimum weight requirement for meal products because main dishes are closer to “mixed dishes not measurable with a cup” in portion, size, and contribution to the overall diet.

The agency received comments to the proposed rule from an individual consumer, a food manufacturer, an industry trade organization, a public interest foundation, and the petitioner. Three comments supported the proposed rule. One comment noted the need for consumer education for developing understanding of the nutrient content claim “lean” and the role of calories and nutrients in the diet. The remaining comments requested changes to the proposed rule. The latter comments and FDA's responses are set forth in this section (section II of this document), except the comment addressing the agency's regulatory impact analysis is discussed in the “Analysis of Impact” section of this document.

(Comment 1) One comment opposed the proposed rule because the proposed fat levels are too high. The comment did not provide any specific information or data in support of their position.

(Response) FDA disagrees with the comment. As we discussed in the proposed rule, the agency believes that the method we chose to establish total fat, saturated fat, and cholesterol levels (i.e., calculating the percent of the proportion of the weight of the RACC for “mixed dishes not measurable with a cup” (140 g) to the minimum weight of main dishes (170.1 g) and multiplying the percent by the nutrient criteria for total fat, saturated fat, and cholesterol for main dishes) is less restrictive than the other options considered and would potentially allow more foods for increased consumer choice. Moreover, we stated that consumers could achieve a diet using “lean” “mixed dishes not measurable with a cup” that is consistent with current dietary recommendations (70 FR 71041 at 71047). We retain this view in the final rule and this comment has not provided us with any information to support revising the proposed method for determining total fat, saturated fat, and cholesterol levels.

(Comment 2) Another comment opposing the proposed rule recommended that, if “lean” is considered to be a claim that represents “healthier” food options, nutrient eligibility criteria be modified for both FDA- and USDA- regulated foods to include limitations in “negative” nutrients” (such as sodium) and include “good” nutrient requirements.

(Response) FDA disagrees with the comment. The term “lean” is a description of fat content. As a nutrient content claim, “lean” was first established by the USDA as a descriptor to allow consumers to distinguish between products of varying fat content (56 FR 60302, November 27, 1991). FDA subsequently established the claim “lean” for products that it regulated that had a contribution to the diet that was similar to the USDA-regulated products (i.e., seafood, game meat, meal products, and main dish products) (58 FR 632, January 6, 1993). FDA has already established other nutrient content claims to address a wider range of nutrients other than the nutrients describing fat content (e.g. healthy (21 CFR 101.65(d))). FDA believes that all nutrient requirements for the claim “lean” should remain descriptors of fat content in order for “lean” to continue to allow consumers to distinguish between products of varying fat content. Therefore, FDA is making no changes in response to this comment.

(Comment 3) One comment stated that FDA and USDA nutrient content claim requirements for foods in the “mixed dishes not measurable with a cup” category should be consistent and that different criteria will be confusing and provide no benefit for consumers or manufacturers.

(Response) FDA is aware of the difference between the FDA and USDA nutrient requirements as it acknowledged this difference in the proposed rule, and the agency considered these differences in developing FDA's proposed definition for “lean.” FDA has concluded, as described in the proposed rule, that FDA-regulated “mixed dishes not measurable with a cup” may not play a comparable role in the diet to that of meat and poultry products, may not contribute to the total dietary intake of total fat, saturated fat, and cholesterol like meat and poultry products, and may not be consumed in the same manner as USDA-regulated meal-type products. Because of the similarity in portion size and contribution to the overall diet to FDA-regulated main dishes, FDA has concluded that it is more appropriate to base the nutrient criteria for total fat, saturated fat, and cholesterol on the current criteria for main dishes, but apply the criteria to the RACC for “mixed dishes not measurable with a cup.” Calculating the nutrient criteria for “mixed dishes not measurable with a cup” per RACC from the current nutrient content criteria on the minimum weight for main dishes provides criteria for “mixed dishes not measurable with a cup” that are comparable in their contribution of total fat, saturated fat, and cholesterol on a per 100-g basis to that contributed by main dishes on a per 100-g basis. Moreover, the comment provided no basis for its assertion that the definition provides no benefit and would be confusing to consumers or manufacturers. Therefore, FDA is making no changes in response to this comment.

FDA is adopting as a final rule, without change, the proposed amendment to the “lean” definition in § 101.62(e) by allowing eligible foods categorized as “mixed dishes not measurable with cup” use of the nutrient content claim “lean.”

FDA has examined the impacts of the final rule under Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action as defined by the Executive order.

Regulatory options

We considered regulatory options as follows: (1) Take no new regulatory action; and (2) adopt as final the proposed regulatory action allowing “mixed dishes not measurable with a cup” to contain a “lean” claim based on the proposed criteria of 8 grams of total fat, 3.5 grams or less of saturated fat, and 80 milligrams of cholesterol per reference amount customarily consumed.

Option (1): Take No New Regulatory Action

The first regulatory option, take no action, would require denying the Nestlé petition requesting that FDA authorize a nutrient content claim “lean” for “mixed dishes not measurable with a cup.” Taking no regulatory action to amend the definition of “lean” is the state of the world and our baseline. By convention, we treat the option of taking no new regulatory action as the baseline for determining the costs and benefits of the other options. Therefore, we associate neither costs nor benefits with this option. The consequences of taking no action are reflected in the costs and benefits of the other options.

Option (2): Adopt as Final the Proposed Regulatory Action

• Benefits

In the analysis of the proposed rule, we used sales data from the 1997 Economic Census, the prevalence of reduced-fat claims from FDA's Food Label and Packaging Survey, and the fat contents of representative “mixed dishes not measurable with a cup” from USDA's National Nutrient Database for Standard Reference to estimate the reduction in fat consumption to be between 0 and 0.02 percent, with a mean of 0.01 percent that would result from this rule. Moreover, we suggested that the magnitude of the reduction in total fat intake from consuming “lean” “mixed dishes not measurable with a cup” may be tempered if consumers supplement their “lean” selections with other higher-fat selections from other food categories. Finally, we suggested that there would be a price premium for “mixed dishes not measurable with a cup,” and to the extent that income and overweight status are negatively correlated, consumers at risk of overweight related diseases may be comparatively less likely to purchase “lean” “mixed dishes not measurable with a cup” than their higher-income counterparts with less-acute, weight-related health risks. This could mitigate overall health benefits from what they otherwise would be.

(Comment 4) One comment stated that our estimate of 0.67 percent of total food consumption represented by “mixed dishes not measurable with a cup” that could qualify for the “lean” claim, understates the full impact of this rule because it neglects to account for dynamic aspects of the market including growing consumer interest in healthier diets, and new product development. In addition, the comment suggested that the discussion of possible consumption behavior that would mitigate any reduction in fat intake, such as increased consumption of higher fat-containing foods to compensate for the consumption of reduced fat “lean” “mixed dishes not measurable with a cup,” is inappropriate for policies designed to promote the consumption of lean foods. The comment also stated that the discussion on possible diminishing effect on health benefits if there is a price premium for “lean” “mixed dishes not measurable with a cup,” and if incomes and health risks from overweight status are negatively correlated, is also inappropriate for the same reason. Finally, the comment suggested that any policy measure tending to increase consumption of lean foods, including a successful publicity campaign to increase consumption of green vegetables, could have both the “compensating” and price premium distributional effects.

(Response) FDA disagrees that our estimate of 0.67 percent of total food purchases that could potentially make a “lean” claim is inappropriate for this analysis because it does not consider dynamic aspects of consumption and production that would favor such products. While we do not disagree with the possibility of a general trend toward healthier diets and lifestyles, we believe the trend would just as likely affect the markets for food products from all categories as it would “mixed dishes not measurable with a cup.” Moreover, to characterize uncertainty in our methods used in the analysis, we estimated the upper end of the range for the reduction in fat intake that would result from this rule, to be 100 percent more than the mid-point which was estimated using the 0.67 percent share of total purchases that could potentially make a “lean” claim. Consequently, we believe that our estimated range incorporates a wide range of uncertainty, and is reasonable and based on sound data and assumptions.

In regulatory analyses, it is frequently easier to obtain quantitative estimates of the costs compared to the benefits of a rule because credible cost data is usually easier to obtain. The relative scarcity of quantitative estimates of benefits elevates the importance of qualitative descriptions in the benefits analysis. In the analysis of the proposed rule, FDA framed the qualitative discussion of the benefits from allowing the “lean” claim on “mixed dishes not measurable with a cup” on the theoretical framework used by Teisl and Levy in a study to address a related question (Ref. 1).

Consistent with Teisl and Levy, FDA assumed that consumer demand for a food product depends on its price, taste characteristics, and nutritional characteristics. The results obtained by Teisl and Levy indicate that all three characteristics are important determinants of consumer purchase behavior, and also that there is evidence of “switching” consumption behavior among many food products so that overall nutrient consumption (e.g., fat in that study) tends to remain constant or change less than predicted by a simple comparison of the nutrient contents of the products. In the analysis of the proposed rule we did not quantitatively estimate the size of the “switching” effect, but rather suggested its existence in order to fully describe the range of benefits of the final rule.

Consistent with our theoretical model, we also addressed the implications of a premium on the price for “lean” labeled “mixed dishes not measurable with a cup,” which may affect the size of the health benefits from the rule. The qualitative discussion is of heightened importance since evidence exists of a negative correlation between obesity and health risks from overweight status and income (Ref. 2). We agree that any regulation that promotes the consumption of lean foods, including a successful publicity campaign to increase consumption of green vegetables, could have both the “compensating” and price premium effects, and in the analysis of the proposed rule we applied that concept to “mixed dishes not measurable with a cup.”

• Costs

There were no comments on the analysis of the costs, including estimates made of the voluntarily incurred change-over costs from the proposed rule. All costs incurred by manufacturers of “mixed dishes not measurable with a cup” who choose to label their products as “lean” would be voluntarily incurred because no manufacturer would incur them if it were not profitable to do so. We reproduce the estimated annualized voluntarily incurred re-labeling and reformulation costs estimated in the analysis of the proposed rule using both a 3-percent and 7-percent discount rate.

In table 1 of this document, we report the annualized change-over costs for the proposed rule computed assuming discount rates of 3 percent and 7 percent over an infinite time horizon for assumed 12- and 24-month periods for relabeling and reformulation. For a 12-month period, all costs are assumed to be incurred in the beginning of the second year. For a 24-month period, all costs are assumed to be incurred in the beginning of the third year. Because producers choose the time period for the reformulation and relabeling of products, the actual time periods for the changes can be of any length, with the costs differing from those in the table. From our labeling cost and reformulation models, however, we expect that costs would be substantially higher for time periods under 12 months, and substantially lower for time periods over 24 months (Refs. 3 and 4). We also expect that the time periods chosen would be shorter and the costs higher, the greater the perceived consumer response to these product claims.

We have examined the economic implications of this final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires the agency to analyze regulatory options that would minimize the economic impact of the rule on small entities.

As previously explained, the final rule will not generate any compliance costs for any small entities because it does not require small entities to undertake any new activity. No small business will choose to use the “lean” nutrient content claim authorized by this rule unless it believes that doing so will increase private benefits by more than it increases private costs. Accordingly, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Under the Regulatory Flexibility Act, no further analysis is required.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532(a)) requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing any final rule “that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current (2005) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

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

FDA concludes that the labeling provisions of this final rule are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food labeling nutrient content claim “lean” is a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (5 U.S.C. 1320.3(c)(2)).

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule will have a preemptive effect on State law. Section 4(a) of the Executive Order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Section 403A of the act (21 U.S.C. 343-1) is an express preemption provision. Section 403A(a)(5) of the act (21 U.S.C. 343-1(a)(5)) provides that: * * * no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce— * * * “(5) any requirement respecting any claim of the type described in section 403(r)(1) made in the label or labeling of food that is not identical to the requirement of section 403(r) * * *.”

Currently, this provision operates to preempt States from imposing nutrient content claim labeling requirements concerning the claim “lean” because FDA has imposed such requirements under section 403(r) of the act. This final rule amends existing food labeling regulations to add a definition for the claim “lean” for eligible foods categorized as “mixed dishes not measurable with a cup.” Although this rule has a preemptive effect, in that it would preclude States from promulgating any nutrient content claim labeling requirements for the claim “lean” that are not identical to those required by this final rule, this preemptive effect is consistent with what Congress set forth in section 403A of the act. Section 403A(a)(5) of the act displaces both State legislative requirements and State common law duties. Medtronic v. Lohr , 518 U.S. 470, 503 (1996) (Breyer, J., concurring in part and concurring in judgment); id. at 510 (O'Connor, J., joined by Rehnquist, C.J., Scalia, J., and Thomas, J., concurring in part and dissenting in part); Cipollone v. Liggett Group, Inc. , 505 U.S. 504, 521 (1992) (plurality opinion); id. at 548-49 (Scalia, J., joined by Thomas, J., concurring in judgment in part and dissenting in part).

FDA believes that the preemptive effect of the final rule is consistent with Executive Order 13132. Section 4(e) of the Executive order provides that “when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.” FDA provided the States with an opportunity for appropriate participation in this rulemaking when it sought input from all stakeholders through publication of the proposed rule in the Federal Register on November 25, 2005 (70 FR 71041). FDA received no comments from any states on the proposed rulemaking.

In addition, on February 16, 2006, FDA's Division of Federal and State Relations provided notice by fax and email transmission to State health commissioners, State agriculture commissioners, food program directors, and drug program directors as well as FDA field personnel, of FDA's intended amendment to add a definition for the claim “lean” for eligible foods categorized as “mixed dishes not measurable with a cup” (21 CFR 101.62(e)). The notice provided the States with further opportunity for input on the rule. It advised the States of the publication of the proposed rule and encouraged State and local governments to review the notice and to provide any comments to the docket (docket number 2004P-0183), opened in the November 25, 2005 Federal Register , by a date 75 days from the date of the notice (i.e., by March 2, 2006), or to contact certain named individuals. FDA received no comments in response to this notice. The notice has been filed in the above numbered docket.

In conclusion, the agency believes that it has complied with all of the applicable requirements under the Executive order and has determined that the preemptive effects of this rule are consistent with Executive Order 13132.

The following references have been placed on display in the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

The PBGC's regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets.

Three sets of interest assumptions are prescribed: (1) A set for the valuation of benefits for allocation purposes under section 4044 (found in Appendix B to Part 4044), (2) a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in Appendix B to Part 4022), and (3) a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology (found in Appendix C to Part 4022).

This amendment (1) adds to Appendix B to Part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during February 2007, (2) adds to Appendix B to Part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during February 2007, and (3) adds to Appendix C to Part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology for valuation dates during February 2007.

For valuation of benefits for allocation purposes, the interest assumptions that the PBGC will use (set forth in Appendix B to part 4044) will be 5.13 percent for the first 20 years following the valuation date and 4.80 percent thereafter. These interest assumptions represent an increase (from those in effect for January 2007) of 0.25 percent for the first 20 years following the valuation date and 0.25 percent for all years thereafter.

The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in Appendix B to part 4022) will be 3.00 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. These interest assumptions represent an increase (from those in effect for January 2007) of 0.25 percent in the immediate annuity rate and are otherwise unchanged. For private-sector payments, the interest assumptions (set forth in Appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in Appendix B to part 4022).

The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during February 2007, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

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

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

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of FEMA has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands (BSAI) according to the FMP prepared by the North Pacific Fishery Management Council (Council) under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2007 TAC of Atka mackerel in the Central Aleutian District of the BSAI is 38,000 metric tons (mt) as established by the 2006 and 2007 harvest specification for groundfish in the BSAI (71 FR 19894, March 3, 2006). In accordance with § 679.20(a)(8)(ii), the 2007 A and B season allowances of Atka mackerel in the Central Aleutian District of the BSAI are each 17,575 mt, and the 2007 A and B season Harvest Limit Area (HLA) limits of Atka mackerel in the Central Aleutian District of the BSAI are each 10,545 mt.

The 2007 TAC of Atka mackerel in the Western Aleutian District of the BSAI is 17,500 mt as established by the 2006 and 2007 harvest specification for groundfish in the BSAI (71 FR 19894, March 3, 2006). In accordance with § 679.20(a)(8)(ii), the 2007 A and B season allowances of Atka mackerel in the Western Aleutian District of the BSAI are each 8,750 mt, and the 2007 A and B season Harvest Limit Area (HLA) limits of Atka mackerel in the Western Aleutian District of the BSAI are each 5,250 mt.

In December 2006, the Council recommended a 2007 Atka mackerel TAC of 29,600 mt for the Central Aleutian District and 9,600 mt for the Western Aleutian District. These amounts are less than the TACs as established by the 2006 and 2007 harvest specification for groundfish in the BSAI (71 FR 19894, March 3, 2006). The TACs recommended by the Council are based on the Stock Assessment and Fishery Evaluation report (SAFE), dated November 2006, which NMFS has determined is the best available scientific information for this fishery.

Steller sea lions occur in the same location as the Aleutian Islands Atka mackerel fishery and are listed as endangered under the Endangered Species Act (ESA). Atka mackerel is a principal prey species for Steller sea lions in the Aleutian Islands subarea. The seasonal apportionment of Atka mackerel harvest is necessary to ensure the groundfish fisheries are not likely to cause jeopardy of extinction or adverse modification of critical habitat for Steller sea lions. The regulations at § 679.20(a)(ii)(8)(A) require the Atka mackerel TAC specified for each subarea or district of the BSAI to be divided equally, after subtraction of the jig gear allocation and reserves, into two seasonal allowances corresponding to the A and B seasons defined at § 679.23(e)(3).

In accordance with § 679.25(a)(2)(i)(B), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that, based on the November 2006 SAFE report for this fishery, the current Central and Western Aleutian District Atka mackerel TACs are incorrectly specified. Consequently, the Regional Administrator is adjusting the 2007 Atka mackerel TAC to 29,600 mt in the Central Aleutian District and 9,600 mt in the Western Aleutian District of the BSAI. In accordance with § 679.20(a)(8)(ii) the 2007 A and B season apportionments for Atka mackerel after deducting the CDQ reserve are each adjusted to 13,690 mt in the Central Aleutian District and 4,440 mt in the Western Aleutian District of the BSAI. Consequently, the 2007 A and B season HLA limits are each adjusted to 8,214 mt for the Central Aleutian District and 2,664 mt for the Western Aleutian District of the BSAI.

Pursuant to § 679.20(a)(8), Tables 4, 12, and 14 of the 2006 and 2007 final harvest specifications for groundfish in the BSAI (71 FR 10894, March 3, 2006) are revised for the 2007 Atka mackerel TACs consistent with this adjustment.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) and 679.25(c)(2) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would allow for harvests that exceed the appropriate A and B season apportionments for Atka mackerel based on the best scientific information available. The Atka mackerel fishery is harvested rapidly and completely in the early part of the A season. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of December 13, 2006, and additional time for prior public comment would result in conservation concerns for the ESA-listed Steller sea lions.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until January 29, 2007.

This action is required by § 679.22 and is exempt from review under Executive Order 12866.