Prior published document in this proceeding: Proposed Rule and invitation for comments on proposed USDA Farmers Market guidelines and information collection, Published February 17, 2005 [70 FR 8040].

This 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.

AMS has analyzed this rule under Executive Order 13132, Federalism, and have determined that it does not have Federalism implications to warrant the preparation of a Federalism assessment under that order.

The Agricultural Marketing Act of 1946 authorizes this final rule. The Act directs and authorizes the Secretary of Agriculture to conduct, assist, and foster research, investigation, and experimentation to determine the best methods of processing, preparation for market packaging, handling, transporting, distributing, and marketing agricultural products, 7 U.S.C. 1622(a). Moreover, 7 U.S.C. 1622(f) directs and authorizes the Secretary to conduct and cooperate in consumer education for more effective utilization and greater consumption of agricultural products. In addition, 7 U.S.C. 1622(n) authorizes the Secretary to conduct services and to perform activities that will facilitate the marketing and utilization of agricultural products through commercial channels. Pursuant to 7 CFR 2.79, the Under Secretary for Marketing and Regulatory Programs has re-delegated these authorities to the Administrator of AMS.

On February 17, 2005, AMS published a proposed rule in the Federal Register [70 FR 8040] inviting comments on a proposal of guidelines to establish (a) Procedures to administer the USDA Farmers Market at 12th Street & Independence Avenue, SW., Washington, DC; (b) rules for the establishment of vendor criteria, selection procedures, and guidelines for governing the operation of the USDA Farmers Market; and (c) a one-time yearly submission information collection in the form of a required application form.

Interested parties were provided 60 days to comment on the proposed guidelines that applied only to the USDA Farmers Market at headquarters on the corner of 12th Street and Independence Avenue, SW., Washington, DC.

Six (6) comments were received from the public; two by mail, the remaining by e-mail. Of the six comments received, three (3) were from students from Tufts University, one (1) was from an individual, and the remaining two (2) provided no comments on the proposed rule.

Three of the four significant comments were supportive of AMS's efforts and the proposed guidelines and procedures. The commenters also indicated that the information collection was necessary and ensured the Agency's performance of its responsibility to properly maintain a functioning market.

The comments received fall largely into a broad category that involves administrative and procedural issues. One issue addresses the USDA Farmers Market hours of operation, the second involves the data collection estimated time requirement, and the third addresses where products sold at the market come or are produced from.

Two commenters thought that the hours of operation, 10 a.m.-2 p.m., were too short or inconvenient for those in the immediate vicinity of the market.

This rule applies only to the USDA Farmers Market at USDA headquarters just outside of the USDA complex buildings in Washington, DC. There are four USDA complex buildings: the USDA Whitten and South buildings, located on either side of the Independence Avenue, SW., between 14th and 12th Streets; the third, USDA Cotton Annex, located at the corner of 12th and C Streets; and the fourth, the USDA Forestry building, is located on the corner of 14th and Independence. The USDA Farmers Market, operating June-October annually, is located in a parking area at the corner of 12th Street and Independence Avenue, SW., Washington, DC.

There is a “mall” area on the other side of the USDA Whitten building, which is a large grassy area which extends between the Washington Monument and the U.S. Capital building. Buildings on the opposite side of this mall area are Smithsonian museums.

The remaining closest buildings in the vicinity of the USDA Farmers Market and USDA complex are office buildings and museums: The Holocaust Museum, a Smithsonian museum, the Department of Energy, and two U.S. Treasury buildings.

The majority of shopping customers at the USDA Farmers Market are Federal employees working in this immediate vicinity and tourists visiting various museums in the area.

Beginning with the first market in 1996, the USDA Farmers Market operation hours of 10 a.m.-2 p.m. were mutually agreed upon by participating farmers and AMS. Federal employees generally ventured from work to the market just before, during, and after lunch hours from 11 a.m.-1:30 p.m. This shopping pattern remains unchanged.

Farmers participating in the market drive in from Virginia, Maryland, and Pennsylvania. Generally speaking, traffic into and out of Washington, DC is much lighter just after 9 a.m. and before 3 p.m. The one hour window, from 2-3 p.m. in the afternoon, allows participating farmers and other vendors an opportunity to break-down their tents, pack-up or glean any remaining food items, clean-up their assigned selling market spaces, and leave before traffic begins to increase.

With this information in mind, the 10 a.m.-2 p.m. hours of operation was and is the logical choice for farmers and visiting employee customers in the vicinity. AMS plans no changes to the market's hours of operation from 10 a.m.-2 p.m.

One commenter was concerned that the new information collection, the required USDA Farmers Market Application form, would take longer than an average of 0.08 hours or 4.8 minutes to complete.

Specifically, the information requested on the application form includes contact information including the farmer and farm names, other farm employees, and the farm mailing address, phone, and e-mail. This information is critical for AMS to provide timely information to each farmer about the market's operating guidelines. Additionally, an unexpected condition such as weather related storms or other security issues could require AMS to close the market. Should this ever happen in the future, AMS will be able to contact each farmer prior to the date of the closure.

Although not required for participation, AMS also requests the number of farm acreage (numeric response), whether the farm is certified organic (yes/no response), and whether liability insurance coverage (name of company) is maintained on the product and farm (yes/no responses).

The farm acreage information is gathered to ensure that vendors can and are producing the products provided on the application. AMS also visits farm locations to verify compliance with market criteria and guidelines. Information regarding certified organic farms is gathered to assist market managers in determining a diverse mix of products offered. The insurance liability coverage information, which includes off-farm liability insurance and product liability insurance, is asked to protect USDA from lawsuits and customers from financial harm caused by accidents. This information is gathered only for AMS's records.

Lastly a list of over 45 fruits, vegetables, and other products has been provided on each form. Farmers are asked to provide the month the corresponding products will be available for sale at the market. This information provides AMS with information about the type, variety, and availability of products during the months of June-October.

AMS began the voluntary use of this form in 1998 and rarely does the information requested require farmers and vendors to look-up their responses. AMS plans to make no changes to the estimated time burden for participants to complete the application form. The questions are general in nature and each farmer should already know his or her responses.

One commenter expressed concern regarding whether the products produced from China would make their way into this market.

AMS recruits farmers and vendors through local farm organizations in the Washington DC metropolitan area and State Departments of Agriculture in the mid-Atlantic region including, Virginia, West Virginia, Maryland, Delaware, and Pennsylvania. Upon receiving a list of potential farmers and vendors from the organizations and the State Departments of Agriculture, an information packet, which includes an application and this rule, is mailed to each potential participant identified by the contacts.

AMS utilizes selection criteria designed to ensure a consistently high level of quality and diverse products are available at the market, while operating in the constraints of space available at the market site as defined in section 170.12. The criteria include:

(a) The participant must be a producer-only farmer or producer, seller of value-added products, or specialized non-produce vendor, as defined in section 170.4.

(b) AMS selects participants to ensure that a balanced mix of wide range of fresh farm fresh fruits and vegetables will be maintained throughout the season.

(c) Participants should commit to supporting the USDA food gleaning/food recovery initiative. This commitment requires farmers and vendors to donate surplus food and food products at the end of each market day to a local nonprofit organization identified by USDA.

(d) Participants must commit to the entire market season and be willing to participate on a regular basis.

(e) AMS reserves the right to select several farmers or vendors based on previous participation in the program (grandfather provision), consistency in providing quality products, and compliance with operating guidelines.

AMS also provides the USDA Farmers Market operating guidelines (section 170.13) to each participant, and visits farms/businesses as necessary.

Because AMS is involved in the farmer/vendor selection and visits these local farm operations, we do not agree that products brought to the market will be produced from China.

In accordance with Office of Management and Budget (OMB) regulations [5 CFR 1320], which implement the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements that are imposed by this rule were submitted and approved by OMB under 0581-0229. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

Form TM-28, USDA Farmers Market Application, was described in the proposed rule as requiring a one-time yearly submission of the information on the application with information on contacts, farm location, type of farming operation, types of products grown, and business practices, including insurance coverage. This signed application also provides a list of over 45 fruits, vegetables, and other products produced by farmers and the months the corresponding products, as requested for AMS to know when products will be available for sale at the market.

As a result of the comments received, the USDA Farmers Market Application has been revised to clarify two existing requests for information.

First, the application will be revised to request the names of other farmers or employees that will be participating at the market with the farm contact person, instead of a list of other farmers and/or employees who work at the applicant farm. This information is required for USDA security personnel to assist in providing security about who will have access to the USDA property.

Second, the application will be revised to request the estimated months the corresponding products will be available for sale at the market. This information will provide AMS with an estimate not only as to when, but how long each of the products may be available for sale at the market.

These revisions and clarifications have no effect on the burden or description of the form. The information collection will be used only by AMS staff to (a) communicate efficiently and effectively with, and (b) provide operating guidelines and procedures to farmers and vendors participating in the USDA Farmers Market.

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

The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538, requires Federal agencies to assess the effects of their regulatory actions not specifically required by law on state, local and tribal governments. This rule contains no Federal mandates that would result in the expenditure of $100 million or more for these groups or for the private section. Therefore, no written statement or cost-benefit analysis is required under this act.

AMS reviewed the proposed rule under the Regulatory Flexibility Act, 5 U.S.C. 601-612, and determined that it will not have a significant economic impact on a substantial number of small entities. This program does not impose requirements on small entities that are not eligible to participate in the program, and imposes on small entities applying for and participating in the program only minimum requirements necessary for proper administration and oversight of this program. Therefore, a regulatory flexibility analysis is not required and was not performed.

Agricultural commodities, Farmers.

The regulations in 7 CFR 319.56 through 319.56-8 (referred to below as the regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are new to or not widely distributed within the United States.

The regulations have not previously included provisions authorizing the importation of fragrant pears from China. However, the national plant protection organization of China requested that the Animal and Plant Health Inspection Service (APHIS) amend the regulations to allow fragrant pears from the Korla region of Xinjiang Province in China to be imported into the United States.

Under section 412(a) of the Plant Protection Act, the Secretary of Agriculture may prohibit or restrict the importation and entry of any plant product if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States or the dissemination within the United States of a plant pest or noxious weed. The Secretary has determined that it is not necessary to prohibit the importation of fragrant pears from the Korla region of Xinjiang Province in China in order to prevent the introduction into the United States or the dissemination within the United States of a plant pest or noxious weed. 1

Accordingly, on May 23, 2003, we published in the Federal Register (68 FR 28161-28166, Docket No. 02-049-1) a proposal to amend the fruits and vegetables regulations to allow the importation of fragrant pears from China under certain conditions. Among other things, we proposed that the fragrant pears be packed in insect-proof containers that are labeled in accordance with § 319.56-2(g). However, upon further consideration, we are amending the packing and shipping requirements in this final rule to make clear that the fragrant pears must be packed in cartons that are labeled in accordance with § 319.56-2(g), shipped in insect-proof containers, and safeguarded during transport to the United States in a manner that will prevent pest infestation. These changes will clarify the packing and shipping requirements and be more consistent with current packing and shipping practices for pears.

We solicited comments concerning our proposal for 60 days ending on July 22, 2003. We received seven comments by that date. They were from private citizens, a professional organization, and representatives of State and foreign governments. The comments are discussed by subject below.

One commenter requested that we provide the scientific name for fragrant pear. In the January 1997 pest risk assessment, we indicated that the scientific name for fragrant pear from China was Pyrus ussuriensis Maxim. However, in 2005, the national plant protection organization of China informed APHIS that the scientific name for fragrant pear is Pyrus sp. nr. communis. Accordingly, we will use Pyrus sp. nr. communis, rather than Pyrus ussuriensis Maxim, as the scientific name for fragrant pear.

Another commenter requested that APHIS identify the specific government organization that serves as the “national plant protection organization for China.” Currently, the national plant protection organization for China is known as the Administration for Quality Supervision, Inspection and Quarantine (AQSIQ). We used the generic term “national plant protection organization of China” in the proposed rule and continue to do so in this final rule because the name of the national plant protection organization of China has changed several times in recent years. Our use of this more generic term is consistent with international standards.

One commenter recommended that APHIS fully disclose all information collected and used in generating the proposed rule. This commenter also recommended that APHIS delay action on the proposed rule until it has developed and circulated for peer review the following documents: A detailed plan documenting the incidence of specific quarantine pests in the Korla region, survey information for those pests for which free area status is proposed, in-orchard monitoring plans for those pests known to occur in the region, and greater detail of the post-harvest inspection protocols which will be implemented.

We do not believe it is necessary to delay action on the proposed rule pending development and peer review of the documents listed by the commenter. The Secretary has determined that it is not necessary to prohibit the importation from the Korla region of Xinjiang Province in China in order to prevent the introduction into the United States or the dissemination within the United States of a plant pest or noxious weed. This determination is based on the finding that the remedial measures contained in this final rule will provide the protection necessary to prevent the introduction and dissemination of plant pests into the United States. In making this determination, the Secretary considered the conclusions of a pest risk assessment, program analysis, survey information, and site visits. Our analysis is documented in a September 2005 information memorandum, which is available on the Internet at http://www.regulations.gov. 2 This memorandum updates a June 2003 information memorandum on the same subject. We do not believe that additional documents need to be developed and circulated for peer review.

With respect to the disclosure of all information collected and used in generating the proposed rule, we note that the proposed rule stated that the pest risk assessment and supporting documents could be obtained from the person listed under FOR FURTHER INFORMATION CONTACT , and we provided several individuals with the information they requested. The information and data provided by China are summarized in the September 2005 information memorandum and the documents on which the information memorandum is based are on file with APHIS. Due to the large volume of material provided by China, we would ask that persons wishing to view those documents make arrangements with the person listed under FOR FURTHER INFORMATION CONTACT for viewing the file or obtaining copies of specific documents.

One commenter indicated that fragrant pears should not be imported from China because the risk of fruit flies is too great, especially since “APHIS is already not doing its job with imports.”

We do not agree that the risk of fruit flies is too great to allow the importation of fragrant pears from China. As documented in the September 2005 information memorandum, the Korla region of Xinjiang Province has been determined to be free of fruit flies. China conducted trapping for fruit flies for 3 years in the Korla region with negative results. Furthermore, in the unlikely event a fruit fly is introduced into the region, climatic conditions and production practices there would significantly reduce the likelihood of establishment. The commenter provided no scientific documentation to support his suggestion that we continue to prohibit the importation of fragrant pears from the Korla region of Xinjiang Province in China.

Another commenter stated that “as a matter of equity, USDA should continue to postpone the implementation of this proposed rule until such time as the Chinese Government allows U.S. pear growers access to its market for U.S. pears since we believe that we have provided ample scientific justification for such access.”

Other countries make decisions as to whether to allow the importation of U.S. products only when formally requested. APHIS has already formally requested that China allow the importation of U.S. pears, and we are working with the U.S. pear industry to address concerns raised by the national plant protection organization of China. Moreover, under the Plant Protection Act, our decisionmaking related to allowing or denying the importation of commodities must be based on phytosanitary considerations rather than the goal of reciprocal market access.

Several commenters stated that APHIS' pest risk assessment did not consider all pests of quarantine concern. One commenter noted that the pest risk assessment did not include the following pests: Carposina sasakii Matsimura, Coleophora hemerobiella Scopoli, Leucoptera malifoliella (Costa), Synanthedon hector (Butler), and Cydia inopinata Heinrich. Another commenter identified 29 insect species of quarantine concern that were not identified in APHIS' pest risk assessment. However, the commenter noted that some of these pests may be synonymous with APHIS-listed species. This commenter also noted that a January 2003 proposed import risk assessment for Shandong pears published by the Australian Government identified a number of species that are not addressed by APHIS' pest risk assessment.

We have reviewed the scientific literature for each pest identified by the commenters. For various reasons (e.g., post-harvest handling practices, the pest does not attach to fruit, the pest is a surface pest and easily detected), we believe that none of these pests will follow the pathway into the United States. Carposina sasakii and Cydia inopinata (syn. Grapholita inopinata ) are absent from the fragrant pear production areas and the province of Xinjiang as a whole. Leucoptera malifoliella has been found not likely to follow the pathway. Coleophora hemerobiella may follow the pathway as hitchhikers but, since they are external, can be easily detected during inspection. Synanthedon hector does occur in China but does not attack pears since it is a pest of apples.

One commenter stated that one of the mites of concern, Tetranychus viennensis , occurs in Heshuo in Xinjiang Province. This commenter also stated that Canada has intercepted mites on fragrant pear shipments from China.

The Hawthorn spider mite, Tetranychus viennensis , was found in Heshuo Farm in Xinjiang Province in 1996. Heshuo Farm is located approximately 50 miles from the production sites in the Korla region and is difficult to reach due to poor road conditions. There is no commercial production of pears or apples in Heshuo, and there is very little commercial activity between Heshuo and Korla. To date, the Hawthorn spider mite has not been found in the Korla region. According to the September 2005 information memorandum, this mite was not found in the Korla region during general surveys in the 1970s, 1980s, and 1990s or during several intensive surveys for mites in 1996-1997. Moreover, based on information provided by Canada, the Hawthorn spider mite has been intercepted on Ya pear shipments from China, not fragrant pears. Ya pears are grown in the Hebei Province of China, which is separated from the Korla region by the Gobi Desert.

One commenter stated the proposed rule is overly strict and not scientifically justified. This commenter went on to note that the listed pests include non-quarantine saprophytes (organisms that obtain food from dead organic matter). The commenter suggested that APHIS delete these saprophytes from the quarantine pest table or determine which species will be recognized as quarantine pests.

We disagree with the commenter's claim that the proposed rule is overly strict and not scientifically justified. The provisions in the proposed rule and in this final rule are based on the conclusions of a pest risk assessment, program analysis, survey information, and site visits, and will provide the protection necessary to prevent the introduction and dissemination of plant pests into the United States. The commenter did not provide the names of those saprophytes he considered to be non-quarantine pests, and we continue to believe that the saprophytes listed in the pest risk assessment are properly characterized as quarantine pests.

One commenter requested that APHIS provide scientific documentation showing that Hoplocampa pyricola is not an internal feeder. This commenter also asked if the Hawthorn spider mite lays eggs in calices of fruit like the Tetranychus urticae .

Although little is known about the biology of the sawfly, Hoplocampa pyricola , the available scientific information indicates that sawfly eggs are deposited in the ovary of the flower. The larvae then feed on the ovary and the fruit. Once the larvae reach maturity, the infested fruit prematurely drops from the tree and the larvae enter the soil to pupate. Given the external damage and premature dropping of the fruit, we believe that inspections in China and the United States will mitigate the risk of this pest.

The Hawthorn spider mite primarily feeds on the underside of a leaf, preferably the underside of a cherry leaf. Female mites overwinter in the cracks and under the bark of stems and branches. When mite populations are high, the female mite may overwinter in the calyx crevices or in the depression on the stem-end of mature fruit, like the Tetranychus urticae .

Several commenters asked why APHIS had denied so many permits for pears from China in the past. These commenters wondered how these permit requests differed from the current request that APHIS allow fragrant pears from the Korla region of Xinjiang Province in China to be imported into the United States.

As previously discussed, the regulations prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are new to or not widely distributed within the United States. Prior to this final rule, the regulations did not authorize the importation of fragrant pears from China. Each year APHIS receives many requests for permits to import fruits and vegetables into the United States. Some of these requests are for nonadmissible items. Prior to 1995, when the importation of Ya pears from Hebei and Shandong Provinces was authorized, we had only allowed the importation of sand pears from China. Therefore, all requests for permits to export pears, other than sand pears, into the United States from China were denied prior to 1995, and since 1995, permits have been issued only for sand pears and Ya pears from China. This final rule amends the regulations to allow the importation of fragrant pears from China under certain conditions, thus making the issuance of permits for fragrant pears possible.

Another commenter noted that the pest risk assessment states that there were no pest interceptions on pear imports from China between 1985 and 1995. To better evaluate this statement, the commenter requested that APHIS provide the total number of shipments imported into the United States during that time and the number of shipments that were sampled. The commenter also asked for the sample rate used by APHIS on other imported pear species from China.

The inspectors routinely sample 2 percent of fruit presented for inspection. There were 10 shipments of sand pears from China in 1994 and 15 shipments of sand pears in 1995, all of which were inspected. Our records show there were no interceptions of quarantine significance from commercial shipments or passenger baggage from 1984 through 1995.

One commenter noted that the pest risk assessment indicates that sweep nets and blacklight traps were used to survey for mites in the area. The commenter indicated that these are inappropriate survey tools to detect mites and expressed concern that inspection upon entry may not provide sufficient protection from the introduction of Hawthorn spider mite into the United States and more stringent measures may be needed.

Sweep nets and blacklight traps were reported as having been used by general survey teams working in the region between 1971 and 1975; those teams were engaged in surveys for a variety of pests, i.e., not just for mites. Subsequent intensive surveys for mites were conducted after Chinese officials provided advanced identification training to their extension agents in the Korla region. None of the species of mites collected are considered to be of quarantine significance by the United States.

As previously discussed, the Hawthorn spider mite has been found in Heshuo in Xinjiang Province, but not in the Korla region. According to the September 2005 information memorandum, the Hawthorn spider mite was not found in the Korla region during general surveys in the 1970s, 1980s, and 1990s. Moreover, the Hawthorne spider mite was not identified during several intensive surveys for mites in 1996-1997. Indeed, no mites of quarantine significance were identified during these intensive surveys. We believe that current production practices in China and the mitigation measures in this final rule will provide the protection necessary to prevent the introduction and dissemination of the Hawthorn spider mite into the United States. Therefore, we are making no changes based on this comment.

Several commenters noted there is very little information about what it takes for a site to become registered (e.g., grower practices or surveys of pest populations). These commenters indicated there is insufficient information about the registration process to evaluate the effectiveness of that proposed requirement and whether the national plant protection organization of China has the authority and resources to maintain and evaluate such registrations.

The proposed rule and this final rule do not provide specific information about how a site becomes registered by the national plant protection organization of China because the national plant protection organization of China determines the requirements for registration, not APHIS. In general, a production site seeking to register would be subject to control practices and pest surveys mandated by the local and national plant protection organizations of China. This registration system is already being used by China to export fragrant pears to Canada and other countries. We are confident that the registration system, in addition to the other mitigation measures set forth in this rule, will be sufficient to protect against the introduction of plant pests into the United States. Accordingly, we are making no changes based on these comments.

One commenter requested proof that the growing area is free of fruit flies. As previously discussed, all available data indicates that the Korla region of Xinjiang Province is free of fruit flies. The Chinese Government conducted trapping for Bactrocera dorsalis for 3 years in the Korla region with negative results. Furthermore, our trading partners have not reported any interceptions of fruit fly larvae in fragrant pears from Xinjiang Province. In the unlikely event a fruit fly is introduced into the region, climatic conditions and production practices there would significantly reduce the likelihood of establishment.

Another commenter asked if the Korla region is currently free of the pests identified in the proposed rule and pest risk assessment. If so, the commenter requested that the supporting data be made available for review by independent experts.

As noted in our response to a comment earlier in this document, the proposed rule announced the availability of the pest risk assessment and supporting documents, and the information and data provided by China are summarized in the September 2005 information memorandum. The September 2005 information memorandum identifies 17 pests of concern; of these, 1 pest ( Tetranychus kanzawai Kishida) is not considered a quarantine pest, 1 pest (pear rusty skin viroid, also known as apple scar skin viroid) is not expected to follow the pathway, and there is no evidence of the remaining 15 quarantine pests in Korla. We believe that the information memorandum fully identifies, summarizes, and analyzes the available scientific data, but, as stated previously, persons wishing to review the large volume of material provided by China may do so by making arrangements with the person listed under FOR FURTHER INFORMATION CONTACT .

One commenter requested information about the sampling protocols used to detect pests. As discussed in the proposed rule, fragrant pears would be subject to both pre-harvest and post-harvest inspections by the national plant protection organization of China or officials authorized by the national plant protection organization of China. The national plant protection organization of China would establish the sampling protocols used to detect pests. However, the national plant protection organization of China would have to provide APHIS with information on pest detections and pest detection practices, and APHIS would have to approve the pest detection practices.

One commenter stated that the proposed rule did not mention any interceptions of quarantine diseases on Ya pears in 2001 and 2002, nor did it discuss interceptions of quarantine pests by Canada on both Ya and fragrant pears. The commenter recommended that APHIS conduct and publish a survey of other Chinese pome fruit importing countries to determine their experience with pest interception on Chinese pears and apples.

As part of APHIS' pest risk analysis, we reviewed information about interceptions of quarantine pests and diseases on all species of pears. Information obtained from Canada indicates that two pests of quarantine concern to APHIS were intercepted on pears from China during the 2002-2003 season—the Aphanostigma sp. poss. jackusiensis (phylloxeran) and the Hawthorn spider mite. The phylloxeran was intercepted on both Ya pears and fragrant pears from China while the Hawthorn spider mite was intercepted only on Ya pears. Nevertheless, we believe that the origin requirements and remedial measures contained in this final rule will provide the protection necessary to prevent the introduction and dissemination of these pests into the United States. Phylloxeran causes damage on the surface of the fruit that is easily detected by inspection and, as previously discussed, the Hawthorn spider mite does not occur in the Korla region and it is unlikely to become established in that region due to climatic conditions and production practices. In response to the Canadian interceptions of phylloxeran on fragrant pears, we have added that pest to the list in § 319.56-2nn(a)(4)(ii) of pests that, if detected, could lead to APHIS' rejection of the lot or consignment and a prohibition on the importation into the United States of fragrant pears from the production site for the season.

In December 2003, after the close of the comment period for the proposed rule, APHIS suspended imports of Ya pears from China due to detections of Chocolate spot ( Alternaria yaliinficiens ). In March 2005, APHIS negotiated revisions to the Ya pear work plan with China, strengthening the mitigation measures applied to prevent further introductions of quarantine significant Alternaria spp. in Ya pears. Upon signing the new agreement, the Ya pear market was reopened. We note that this final rule requires that if any listed quarantine pest, including Alternaria spp., is found during the pre-harvest inspection or at any other time, the national plant protection organization of China must notify APHIS immediately. APHIS may then reject the lot or consignment and prohibit the importation into the United States of fragrant pears from the production site for the season, and imports may not resume until an investigation is conducted and APHIS and the national plant protection organization of China agree that appropriate remedial action has been taken.

One commenter asked what would happen if different pests were found in different sites, and if that would be regarded in the same manner as if a single type of pest was found at more than one production site. Another commenter recommended that APHIS prohibit the importation of fragrant pears into the United States if any pests or more than one species of different pests are detected in more than one registered production site.

APHIS' response to a pest detection would depend upon the pest. Upon detection of Oriental fruit fly ( Bactrocera dorsalis ) during the pre-harvest inspection or at any other time, APHIS could prohibit the importation into the United States of fragrant pears from China until an investigation is conducted and APHIS and the national plant protection organization of China agree that appropriate remedial action has been taken. In addition, APHIS could prohibit the importation into the United States of fragrant pears from a production site for the season if any of the following pests are detected on that production site during the pre-harvest inspection or at any other time: Peach fruit borer ( Carposina sasaki ), yellow peach moth ( Conogethes punctiferalis ), apple fruit moth ( Cydia inopinata ), Hawthorn spider mite ( Tetranychus viennensis ), red plum maggot ( Cydia funebrana ), brown rot ( Monilinia fructigena ), Asian pear scab ( Venturia nashicola ), pear trellis rust ( Gymnosporangium fuscum ), Asian pear black spot ( Alternaria spp. ), and phylloxeran ( Aphanostigma sp. poss. jackusiensis ). Thus, if peach fruit borer is detected in one production site and yellow peach moth is detected in another, APHIS could prohibit the importation into the United States of fragrant pears from each production site for the season. However, if any of the pests listed above is detected in more than one registered production site, APHIS could prohibit the importation into the United States of fragrant pears from China until an investigation is conducted and APHIS and the national plant protection organization of China agree that appropriate remedial action has been taken.

One commenter indicated that it would be difficult to make sure that fragrant pears absolutely do not carry Asian pear black spot or Hawthorn spider mite. Thus, the commenter stated, it would be better if APHIS prohibited the importation of fragrant pears from the production sites where those pests are detected, instead of prohibiting the importation of all fragrant pears from China.

We do not agree that it would be too difficult to ensure that fragrant pears do not carry Asian pear black spot or Hawthorn spider mite. We believe that the mitigation measures in this rule will provide the protection necessary to prevent the introduction into and dissemination within the United States of plant pests. However, if Asian pear black spot or Hawthorn spider mite is detected on a production site during the pre-harvest inspection or at any other time, APHIS could prohibit the importation into the United States of fragrant pears from that production site for the season. Moreover, if Asian pear black spot or Hawthorn spider mite is detected in more than one registered production site during the pre-harvest inspection or at any other time, APHIS could prohibit the importation into the United States of fragrant pears from China until an investigation is conducted and APHIS and the national plant protection organization of China agree that appropriate remedial action has been taken. We are making no changes based on this comment.

One commenter noted that pest-specific remedial measures are not described in the proposed rule. The commenter contacted several experts in temperate orchard pest management to review the risk assessment and the proposed remedial measures. These experts indicated that they needed more information about the proposed remedial measures to determine if these measures would be adequate.

In the proposed rule, we proposed to allow the importation of fragrant pears from China under certain conditions. Specifically, we proposed to require that the fragrant pears be grown in the Korla region of Xinjiang Province in a production site that is registered with the national plant protection organization of China and that these production sites be free of certain pests. Furthermore, we provided that detection of certain pests could result in a prohibition on the importation into the United States of fragrant pears from a particular production site for the season or from all of the production sites in the Korla region of Xinjiang Province until an investigation is conducted and APHIS and the national plant protection organization of China agree that appropriate remedial action has been taken. Accordingly, the burden is on the national plant protection organization of China to provide remedial measures that are appropriate for the pest and agreeable to APHIS.

One commenter stated that the labeling and transport of fragrant pears must preclude the pears from being commingled with fruit from non-approved areas of China. Several commenters requested clarification about how the fragrant pears would be isolated from other fruits (e.g., would the pears need to be stacked on different pallets or different stacks on a pallet, in different cold rooms, or stored in facilities separated by distance or physical barrier?).

We agree that the labeling and transport of fragrant pears must preclude the commingling of fruit from non-approved areas of China. In the proposed rule, we proposed to require that the fragrant pears be safeguarded at the cold storage facility while awaiting export. Specifically, we proposed that the fragrant pears be isolated from fruit from unregistered production sites. To allow for greater flexibility in meeting this requirement, we did not specify the manner in which the fragrant pears are to be isolated. The fragrant pears could be isolated from fruit from unregistered production sites by stacking them on different pallets at the cold storage facility, by holding the pears and other fruits in separate rooms, or by holding the pears and other fruits in separate cold storage facilities. Any of these options would satisfy the requirement to isolate pears held in a cold storage facility from fruit from unregistered production sites.

One commenter stated that the cost/benefit assessment in the proposed rule may not be accurate because it is based on Ya pear imports, and fragrant pears are a different species with different sensory characteristics. The commenter also pointed out that an assessment of the short-term impacts is not appropriate for long-lived perennial crops such as pears.

The analysis in the proposed rule recognized that Ya pears and fragrant pears are different species with different sensory characteristics. Because fragrant pears have not been imported into the United States from China, the analysis used Ya pear data to estimate the potential economic effects of importing fragrant pears from China. In order to estimate the economic effects of importing fragrant pears, the analysis assumed that demand for Ya pears and fragrant pears will be similar, but it is not necessary to assume that the physical characteristics are the same.

Short-term and long-term impacts depend on consumer acceptance of, and demand for, fragrant pears, not on the length of the production cycle or the expected life of the tree. The short-run analysis is based on data from a similar good, Ya pears. There are no comparable data available for a long-run analysis. Accordingly, the analysis in the proposed rule focused on the short term impacts of importing fragrant pears from China into the United States.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.

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 fruits and vegetables regulations to allow the importation of fragrant pears from China under certain conditions. This action will allow fragrant pears to be imported from China while continuing to provide protection against the introduction of plant pests into the United States.

The following economic analysis examines whether this rule might have a significant economic impact on a substantial number of small entities, as required by the Regulatory Flexibility Act. There are three reasons why we believe this will not be the case. First, the risk of quarantine pests being introduced into the United States via this pathway is extremely low. Second, fragrant pears are not produced in the United States and fragrant pear import levels are expected to be low relative to domestic pear availability. In addition, our analysis suggests that fragrant pears from China will not be a close substitute for domestically produced pears; therefore, profit losses, if any, for domestic pear producers are expected to be extremely low, at least over the next several years. Third, allowing the importation of a pear variety that is not produced domestically will lead to gains for small importers and pear consumers in the United States.

Fragrant pears are grown in an area surrounding Korla, a city in Xinjiang Province, which makes up the northwest corner of China, and are not grown anywhere else in the world. The production area, which is west of the Gobi Desert and just north of the Taklamakan Desert, experiences extremely hot summers, cold winters, and very little rainfall, and is geographically, as well as culturally, isolated. In addition, while agricultural commodities are exported from the region, there is little if any incoming trade. As a result, the potential for pests of quarantine significance being introduced into the area is extremely low. Furthermore, in the unlikely event a pest was introduced into the region, climatic conditions and production practices there would significantly reduce the likelihood of establishment.

Approximately 15,000 hectares are devoted to fragrant pear production in Xinjiang Province, yielding roughly 90,718 metric tons per year, of which 10 percent is exported. We expect that exports to the United States would come mainly from the farm units known as Regiments 28, 29, 30, 33, and Shayi Dong Farms, although additional quantities could come from Regiments 31 and 32. The land belongs to the government, and the proper maintenance of every orchard is under the direct supervision of China's national plant protection organization, AQSIQ, which stations one supervisor to each regiment in the export area. The AQSIQ supervisor is in contact with the growers on a weekly basis and directs the work of several survey teams. 3 The survey teams are in the orchards every day and are responsible for maintaining traps, extension work, fruit cutting and inspection, checking to see that orchards are maintained properly, participating in annual pest surveys, and checking on other crops. If it is determined that an orchard is not being managed properly, AQSIQ assigns it to another grower.

Because pest risks associated with this pathway are extremely low, we expect regulatory costs associated with quarantine pest introductions to be negligible. In addition, because fragrant pears are not produced in the United States and because quantities designated for export are expected to be low, at least during the next several years, we do not expect fragrant pears to compete with domestically produced pears over the short run. However, imports of fragrant pears from China may increase over time, as has been the case for U.S. Ya pear imports and Canadian Ya and fragrant pear imports from China (table 1).

As indicated in Table 1, after the initial rapid expansion in Ya pear imports from 1998 to 2000, growth continued at a slower rate. Over the 4-year period 2000-2003, U.S. imports of Ya pears from China increased an average of about 8 percent per year. During this 4-year period, the quantity of Ya pears imported from China was equivalent to about 1.3 percent of domestic pear production, and the average price of Ya pears was about one-and-a half times the average price of domestically produced pears.

Import restrictions on Ya and fragrant pear imports from China imposed by the Canadian Food Inspection Agency are somewhat similar to those in this rule and, as a result, Canadian imports of Chinese Ya and fragrant pears provide additional information regarding potential future U.S. imports of these commodities. During the same 4-year period, 2000-2003, Canadian imports of pears from China increased an average of about 24 percent per year.

We used time-series data on U.S. Ya pear imports from China, domestic fresh pear production and prices, and total domestic expenditures on fruit to estimate the rate of substitution between Ya pears and domestically produced pears in order to glean information about the potential rate of substitution between fragrant pear imports and domestic pears. In particular, we estimated a linear relationship between fresh domestic pear prices and a constant, fresh domestic production, and Ya pear imports from China. The coefficient estimate on Ya pear imports was found to be negative but not statistically different from zero, indicating that Ya pears do not substitute for domestically produced pears. If the relationship between imported fragrant pears and domestically grown pears is found to be similar to the modeled relationship between imported Ya pears and domestically grown pears, then the results of the regression analysis indicate that U.S. imports of fragrant pears from China will not compete with domestically produced pears during the next several years.

Notwithstanding the expected insignificant effects of the rule on domestic pear production, allowing the importation of fragrant pears from China will provide benefits to U.S. importers and merchants of Chinese fragrant pears. The U.S. Small Business Administration defines a small pear importer (North American Industry Classification System [NAICS] category 424480, Fresh Fruit and Vegetable Merchant Wholesalers) as one that employs not more than 100 persons. In 1997, 4 more than 96 percent (5,456 of 5,657) of fresh fruit and vegetable wholesalers would be considered small by SBA standards. 5 There are no data to indicate directly the level of benefits that may accrue to small pear importers and merchants in the United States, but any new trade of a commodity (in this case, fragrant pears from China) can be expected to benefit entities dealing in that commodity.

We expect that allowing the importation of fragrant pears from China will not have a significant economic impact on a substantial number of small entities. Fragrant pears from China will not directly compete with domestically produced pears, assuming the demand for imported fragrant pears will be similar to that for imported Ya pears. If imports of fragrant pears increase over time, as has been the case for U.S. Ya pear imports and Canadian Ya and fragrant pear imports, it is possible that fragrant pears could compete with some varieties of domestically produced pears in the future, but only marginally given the small quantity of fragrant pears expected to be imported compared to domestic pear production. Fragrant pear importers and merchants, most of which are likely to be small entities, will benefit from the importation of fragrant pears from China.

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 final rule allows fragrant pears to be imported into the United States from the Korla region of Xinjiang Province in China. State and local laws and regulations regarding fragrant pears imported under this rule will be preempted while the fruit is in foreign commerce. Fresh fruits and vegetables are generally imported for immediate distribution and sale to the consuming public, and remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. No retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this rule have been approved by the Office of Management and Budget (OMB) under OMB control number 0579-0227.

The Animal and Plant Health Inspection Service is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. For information pertinent to GPEA compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

On December 15, 2005, a final rule for Airspace Docket No. 05-ASW-2 was published in the Federal Register (70 FR 74197). This rule established three RNAV routes (Q-20, Q-22, and Q-24) over the Southwestern and South Central United States. In the description for Q-20, the latitude for the HONDS fix was inadvertently listed as lat. 33°33′60″ N. rather than lat. 33°34′00″ N. This action corrects that error.

Accordingly, pursuant to the authority delegated to me, the legal description for Q-20 as published in the Federal Register on December 15, 2005 (70 FR 74197), and incorporated by reference in 14 CFR 71.1, are corrected as follows:

On August 8, 2005, the FAA published in the Federal Register a notice of proposed rulemaking to modify the Orlando International Airport, FL, Class B airspace area, establish the Orlando Sanford International Airport Class C airspace, and revoke the existing Sanford Airport Class D airspace (70 FR 45599). The FAA proposed to realign the MCO Class B airspace area (within the existing lateral boundaries) due to the commissioning of runway 17L/35R; to ensure that MCO arrivals and departures are retained within Class B airspace; and adjust the configuration of the Class B airspace area to accommodate the Orlando Sanford International Airport Class C airspace area. The FAA proposed to establish the SFB Class C airspace area to enhance safety and improve the management of air traffic in the terminal area.

Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. In response to the NPRM, the FAA received 20 written comments. Many of the commenters identified themselves as pilots who operate within, or through, the local area. All comments received were considered before making a determination on the final rule. An analysis of the comments received and the FAA's responses are contained in the “Discussion of Comments” section, below.

Three commenters (a commercial carrier, a flight instructor, and a local flying club) wrote in support of the proposed action. The remaining commenters objected to various aspects of the proposal, with most opposition directed at the proposed establishment of Class C airspace at SFB.

One commenter felt that changes to the MCO Class B to accommodate the proposed SFB Class C airspace might be unsafe. Concern was expressed that modification of the east-west visual flight rules (VFR) flyway between SFB and Orlando Executive Airport would compress traffic due to the locations of VFR practice areas and the Bithlo television towers.

FAA Response: The FAA does not agree. The modification of the MCO Class B airspace area to accommodate the SFB Class C airspace will not adversely impact operations to or from MCO. In addition, raising the floor of Class B airspace from 1,600 feet MSL to 2,000 feet MSL around Orlando Executive Airport will provide additional airspace for VFR aircraft to utilize while remaining below the floor of the MCO Class B airspace. The east-west flyway will be moved only one or two miles south of its current location and will remain north of the Bithlo towers and north of the Lake Apopka practice area. The modifications will provide additional flyway and transition airspace for VFR aircraft as compared to the present airspace configuration.

A number of commenters, including the Aircraft Owners and Pilots Association (AOPA) cited the excellent safety record at SFB as evidence that Class C airspace is not needed at that location.

FAA Response: The FAA agrees that SFB has had an excellent safety record. However, during calendar year 2004, SFB experienced an increase in runway incursions. During calendar year 2005, SFB undertook proactive measures that successfully reduced the number of runway incursions. Based on growing passenger enplanements, traffic mix, and complexity, the FAA believes that the designation of Class C airspace at SFB is a necessary step toward maintaining that record by further improving safety and enhancing the management of air traffic operations in the area. Receiving Class C radar services will improve safety for aircraft operating at SFB and for VFR aircraft transitioning the area.

One commenter said the FAA should pursue nonregulatory alternatives to Class C airspace at SFB such as: Adjust staffing to address safety and controller workload concerns; modify the MCO Class B airspace area or the existing SFB Class D airspace area to contain aircraft beyond the four-mile final; and delegate the sequencing of SFB arrivals to MCO approach control by letter of agreement rather than by establishing additional regulatory airspace.

FAA Response: FAA policy requires that, prior to considering designation of Class C airspace at a given location, nonregulatory alternatives that would provide an acceptable level of safety must be utilized such as: Improved radar services, pilot/controller education programs, and safety seminars. As discussed in the NPRM, a number of nonrulemaking actions were taken to address safety in the SFB area, including: (1) The installation of Digital Bright Radar Tower Equipment at SFB ATCT; (2) annual Operation Rain Check pilot-controller forums; (3) periodic user group meetings and safety meetings; (4) procedural initiatives to keep larger arriving aircraft at higher altitudes away from slower traffic and rerouting of arrivals to avoid a flight training area; (5) set up of standard VFR arrival areas; and (6) development of various procedures for more efficient handling of flight school operations in the Orlando area. These nonregulatory efforts have, indeed, contributed to enhanced safety at SFB. However, traffic conflicts in the SFB area remain a concern and the FAA believes that, considering rising passenger enplanements, and the traffic mix and volume in the Central Florida terminal area, additional action is needed in the form of Class C airspace to maintain the excellent safety record. The commenter's suggestion to adjust staffing as a means to reduce SFB tower controller workload would not be feasible to resolve the problem. A concern at SFB is the mix of small and large aircraft that use runway 9L/27R and operate in the airspace along the SFB final approach and departure areas. One controller works runway 9L/27R traffic, and splitting the position responsibilities is not possible. Therefore, additional staffing would not alleviate the workload concerns. Another suggested alternative for reducing SFB Tower workload was to delegate the sequencing of SFB arrivals to MCO approach control by a letter of agreement rather than establishing Class C airspace. However, such a procedure would not eliminate initial call-ups to the Tower by VFR aircraft operating in the area. It was also suggested that, instead of establishing Class C airspace at SFB, the FAA should expand the MCO Class B or the SFB Class D airspace areas to address the issue of SFB air carrier arrivals exiting Class B or D airspace prior to the four-mile point on final approach. Expanding the MCO Class B airspace area to cover this airspace would not be appropriate because Class B airspace is not needed in that area to support MCO operations. Additionally, expanding Class B airspace to encompass SFB final approach operations would hamper VFR operations at SFB by placing additional regulatory requirements on VFR pilots operating at SFB. Class D airspace design criteria do not allow for the length of extensions that would be required to contain the SFB ILS final approach course. The FAA believes that enhanced traffic flow and increased safety will be achieved through the designation of the SFB Class C airspace area.

Several commenters questioned the adequacy of air traffic controller staffing levels to handle the workload resulting from the modification of the MCO Class B and designation of the SFB Class C airspace.

FAA Response: Staffing and equipment resources are already in place to support the MCO Class B modifications and the establishment of the SFB Class C airspace. Procedures have been developed to operate SFB with Class C airspace. Further, MCO TRACON has added an additional sector and radio frequency, and requested an additional VFR code block, in preparation for the expected additional volume to be generated by the airspace changes. Class C airspace will generate an increased workload for the SFB Clearance Delivery position, but that position is prepared to handle the increase. Staffing and equipment levels are adequate to provide all Class C services without impacting safety or efficiency and the FAA does not expect staffing to be an issue for MCO or SFB. However, should circumstances arise that indicate a need for additional resources, action will be taken to obtain them.

One commenter questioned the justification for Class C airspace at SFB based on the passenger enplanement count, stating the enplanement data alone do not tell the full story, and two commenters questioned the validity of Class C airspace at SFB because the SFB operations count has declined below the criteria threshold.

FAA Response: The FAA agrees that enplanements are not the sole factor in determining a need for Class C airspace. Instrument operations and passenger enplanement data are used to identify an airport as a possible candidate for Class C airspace. For an airport to be identified as a candidate for Class C airspace, the airport must be serviced by an operational airport traffic control tower and a radar approach control. In addition, the airport must meet at least ONE of the following: (1) An annual instrument operations count of 75,000 at the primary airport; (2) an annual instrument operations count of 100,000 at the primary and secondary airports in the terminal area hub; or (3) an annual count of 250,000 enplaned passengers at the primary airport. These criteria only identify an airport as a candidate for possible Class C airspace designation. Since the enplaned passenger count for SFB exceeds 600,000, it is a legitimate candidate for Class C airspace. A range of other factors must also be considered when determining if a need for Class C airspace exists. However, a need to enhance safety is the main consideration in evaluating these factors. SFB ranks as the 24th busiest tower in the United States. SFB serves a combination of large aircraft with high passenger counts mixed with general aviation operations, and a high level of flight training activities. The FAA believes that the SFB Class C airspace area is justified to provide a safer environment for this mix of operations.

The Greater Orlando Airports Authority (GOAA) expressed concerns about the impact on safety for pilots flying to Orlando Executive Airport. The GOAA noted that Orlando Executive Airport, with Class D airspace, will be located between two more restrictive types of airspace; that is, Class B at MCO and Class C at SFB. The GOAA believes that the FAA did not use a regional approach in studying the terminal area airspace, and requested that the FAA implement Class C airspace at Orlando Executive concurrent with the designation of Class C airspace at SFB.

FAA Response: The FAA does not agree with GOAA's concerns regarding the extent or validity of the airspace study. FAA directives list the factors to be examined in the airspace staff study when considering Class B and Class C airspace proposals. These include an examination of VFR and IFR traffic flows into, out of, and through the terminal area; air traffic at each satellite airport in the area; and a description of overall air traffic operations in the overall area. Considering the close proximity of Orlando Executive Airport, MCO, and SFB, operations at each airport must be taken into account when examining the terminal area. Due to the size of the area encompassed by the MCO Class B airspace, a study of air traffic operations and airspace in that area must necessarily include a regional perspective. In 2003, the FAA completed a preliminary staff study to examine the need for Class C airspace at Orlando Executive Airport. However, the instrument operations count for the airport dropped below the 75,000 criteria, so further action was not pursued. The FAA believes that implementation of Class C airspace at Orlando Executive Airport at this time would be overly restrictive to VFR operations at Orlando Executive Airport. It should be noted that FAA policy directives call for terminal airspace designations to be reviewed every two years; therefore, airspace requirements at Orlando Executive Airport will be subject to further review. The FAA does not believe that this rulemaking action will adversely affect safety for pilots operating to or from Orlando Executive Airport, nor should pilots experience delays as a result. A similar situation exists in southern Florida and safety has not been compromised.

One pilot wrote that the proposed SFB Class C airspace configuration might be unsafe, citing the amount of restricted or otherwise controlled airspace already in the area (R-2910, MCO Class B, Daytona Beach Class C, etc.). The commenter objected to placing Class C airspace around SFB that would extend farther north than the current MCO Class B airspace boundary. This would crowd VFR aircraft into less space, particularly to the northwest of the proposed outer ring where two towers extend to over 1,700 feet MSL.

FAA Response: The commenter is incorrect regarding the extent of the SFB 10-NM ring. The original configuration of the proposed SFB Class C airspace did include a full 10-NM ring north of the airport. However, based on feedback from the ad hoc committee meetings, and as described in the NPRM, the proposed SFB Class C airspace design was changed so that the 10-NM ring was eliminated north of the current northern boundary of the MCO Class B airspace area along latitude 28°53′00″ N. Therefore, Class C airspace will not extend into the airspace in question near the towers nor will the SFB Class C airspace result in additional crowding of VFR aircraft between the Daytona Beach Class C airspace area and the current northern edge of the MCO Class B airspace area. Similarly, to the south of SFB, the Class C 10-NM ring was cutoff along latitude 28°41′36″ N. This modification provides additional airspace in the east-west VFR flyway located between Orlando Executive and SFB.

A majority of the commenters stated that the SFB Class C airspace would adversely impact, and place undue burdens on, VFR operations to, from, and transiting the terminal area. Several writers commented that they currently are able to operate to and from SFB without problems or delays. Several commenters felt that the existing MCO Class B airspace dominates the region and currently restricts VFR flying and that adding the SFB Class C airspace would make flying in the area more confusing. Commenters were also concerned that the implementation of Class C airspace might cause congestion and bottlenecks on approach control frequencies and otherwise result in limitations on general aviation access to the airspace.

FAA Response: The FAA does not agree. Current traffic routings and proposed Class C routings were compared and it was found that the new Class C airspace would have minimal negative impact on users. Procedures for the Class C airspace operation will allow SFB users to continue flying much as they do today. The FAA believes that this rule will provide an additional level of safety for VFR aircraft operating at SFB and in the Orlando terminal area. A minimal increase in flying miles (five miles further west or east of SFB) may be required for pilots desiring to transit outside the SFB Class C and MCO Class B airspace areas. With Class C airspace, all VFR aircraft flying to SFB will receive radar service. ATC will utilize three arrival sectors for handling inbound aircraft. This will result in less difficulty arriving at SFB and may reduce flying time to enter the traffic pattern. The modifications to the MCO Class B airspace will also provide additional airspace for VFR aircraft in the area to the north of Orlando Executive Airport and south of the SFB Class C airspace area. A new north-south VFR flyway is being added to the east of the SFB Class C airspace area. The FAA is also establishing two new VFR waypoints (VPAPO southwest of SFB at lat. 28°40′15″ N., long. 81°31′31″ W.; and VPBIT southeast of SFB at lat. 28°39′54″ N., long. 81°01′18″ W.). The new waypoints will assist VFR navigation through the expanded east-west VFR flyway that lies between Orlando Executive Airport and SFB, and the north-south flyways to the east and west of the SFB Class C airspace area. The FAA will allow SFB VFR departures, on pilot request, to remain on SFB ATCT frequency and terminate service at the 5-mile Class C airspace ring. The FAA also will continue the procedure whereby departing VFR aircraft at Orlando Executive Airport may request a transponder code on the ground. Currently, most Orlando Executive VFR northbound departures fly around the SFB Class D airspace. The addition of the SFB Class C airspace will only slightly increase flying miles as noted above. Since the changes implemented by this rulemaking action lie totally within the existing MCO mode C veil, no additional aircraft equipment requirements are imposed in order to operate in the area. As discussed under the comments regarding staffing, above, the FAA has taken steps to ensure that MCO approach control is prepared to handle the workload generated by the implementation of the SFB Class C airspace area.

A suggestion was made that the floor of the SFB Class C airspace in the 5-10 mile ring be raised from 1,300 feet MSL to 1,600 feet MSL to allow transiting VFR aircraft to fly beneath the area at 1,500 feet MSL.

FAA Response: The FAA does not agree with the suggestion. The crossing altitudes at the final approach fixes are 1,500 feet MSL and 1,600 feet MSL. Raising the floor as suggested would result in conflicts that the Class C airspace is designed to eliminate.

One commenter suggested that a north-south VFR flyway be established directly over SFB.

FAA Response: The FAA does not agree. Currently, aircraft transitioning over SFB at 1,500 feet MSL, as approved by SFB Tower, total only about five per day. With the implementation of the SFB Class C airspace area, a transition over SFB at 2,500 feet MSL would be possible for aircraft in contact with MCO approach control. A VFR flyway directly over SFB would not be feasible. VFR flyways provide general flight paths for pilots planning flights into, out of, through, or near complex terminal airspace so as to avoid Class B airspace. Flyway altitudes must avoid airspace that requires prior authorization or clearance to enter. A flyway over SFB would result in departures being restricted below the flyway altitude until clear of the flyway. The airspace between 2,000 feet MSL and 3,000 feet MSL over SFB is used to transition arrivals and departures to/from Orlando Executive Airport. Due to the complexity of the airspace in the SFB area, the suggested flyway is not feasible because it would impact SFB operations, and/or require pilots to obtain a Class B clearance or establish communications in order to enter Class C airspace.

Several commenters, including AOPA, argued that the FAA did not follow the ad hoc committee process, ignored public input, and/or did not obtain sufficient user involvement in developing this airspace proposal.

FAA Response: Substantial user input was obtained in developing the MCO/SFB airspace proposal. Ad hoc user meetings were held on January 14, February 25, and March 17, 2003. The FAA did encounter a delay in mailing of the announcement of the two Informal Airspace Meetings held in November 2003. As a result, supplemental notifications were made to various organizations via e-mail and the information was displayed on the MCO Tower web site. The NPRM also provided a 60-day comment period, which resulted in 20 written comments being submitted to the FAA. Additionally, discussions on the project have been included at regular local airport user meetings since early 2003. The comment that the FAA ignored public input is without basis. In fact, the NPRM specifically addressed at least seven specific issues that were raised in a letter submitted to the FAA by an aviation organization as a result of public meetings. The NPRM also discussed a number of recommendations that resulted from the ad hoc committee meetings and included issues discussed at the November 2003 Informal Airspace Meetings.

The following is a summary of the ad hoc committee recommendations:

1. Reduce the Class C 10-mile ring north of SFB to align with the current Class B boundary.

2. Include a cutout from the Class C airspace area to accommodate the Cedar Knoll Flying Ranch Airport.

3. Provide a procedure allowing SFB VFR departures to remain with the Tower and terminate services at the five-mile ring, below the Class C airspace outer area.

4. Permit Orlando Executive Airport VFR departures to obtain a transponder code on the ground.

5. Establish an uncontrolled VFR flyway over SFB at 2,500 feet MSL and a new flyway east of the proposed SFB Class C airspace.

6. Realign the eastern edge of the proposed Class C airspace to follow the shore of Lake Harney.

7. Raise the floor of the proposed SFB Class C from 1,300 feet MSL to 1,600 feet MSL within the 5-10 mile ring to enable VFR aircraft to fly beneath it at 1,500 feet MSL.

8. Establish Class C airspace at Orlando Executive Airport concurrent with the SFB Class C airspace implementation.

With the exception of the VFR flyway over SFB, the alignment of the Class C boundary along Lake Harney, the requested 1,600 feet MSL floor in the 5-10 mile ring, and the designation of Class C airspace at Orlando Executive Airport, the above recommendations were adopted.

This action amends Title 14 Code of Federal Aviation Regulations (14 CFR) part 71 to modify the MCO Class B airspace area, establish the SFB Class C airspace area, and revoke the SFB Class D airspace area. The specifics of this action (depicted on the attached chart) are summarized in the following paragraphs. In addition, this rule revokes the Class E airspace extension to the SFB Class D airspace area.

The Sanford Class C airspace area is described as follows:

That airspace extending upward from the surface to but not including 3,000 feet MSL within a 5-mile radius of the Sanford International Airport (SFB), excluding that airspace from the surface to but not including 700 feet MSL in the vicinity of Cedar Knoll Flying Ranch Airport within the area beginning at lat. 28°50′00″ N., long. 81°10′00″ W., thence clockwise along the SFB 5-mile radius arc to lat. 28°43′20″ N., long. 81°10′00″ W., thence north to the point of beginning; and that airspace extending upward from 1,300 feet MSL to but not including 3,000 feet MSL within the area beginning northeast of the primary airport at the intersection of the SFB 10-mile radius arc and lat. 28°53′00″ N., thence clockwise along the SFB 10-mile radius arc to lat. 28°41′36″ N., then west along lat. 28°41′36″ N. to the intersection of the SFB 10-mile radius arc, then clockwise along the SFB 10-mile radius arc to lat. 28°53′00″ N., then east along lat. 28°53′00″ N., to the point of beginning.

The SFB Class C airspace area will be effective during times when the Orlando Sanford International ATCT is in operation. These times will be published in the appropriate volume of the Airport/Facility Directory.

The Sanford Class C airspace will replace the existing Sanford Class D airspace area, which will be revoked through this rule. In addition, although not addressed in the NPRM, this action also revokes the existing Class E airspace extension to the SFB Class D airspace area. Since the Class D airspace area is being revoked, the Class E extension is no longer required.

This action modifies several areas within the Orlando Class B airspace to accommodate the new Sanford Class C airspace area; reflect the adjustment of the Orlando International Airport ARP as a result of the commissioning of the fourth runway at Orlando International Airport; and provide additional Class B airspace to ensure that Orlando International Airport arrivals and departures are contained within Class B airspace. The existing outer-most boundaries of the Orlando Class B airspace area remain unchanged by these modifications.

The following describes the revisions to the Orlando Class B airspace area:

Area A. Area A is recentered on lat. 28°25′46″ N., long. 81°18′32″ W. This represents a shift of Area A slightly to the east to recenter the area on the revised Orlando International Airport ARP, which was adjusted due to the addition of the fourth runway at Orlando International.

Area B. The eastern boundary of Area B is shifted approximately 1 NM east to long. 81°10′00″ W. to accommodate the new Orlando International Airport runway.

Area C. The section of Area C in the vicinity of Sanford International Airport is removed and replaced by the Sanford Class C airspace area up to but not including 3,000 feet MSL, and by Area E from 3,000 feet MSL up to and including 10,000 feet MSL. Area C in the vicinity of Orlando Executive Airport is reduced in size. The airspace removed from Area C to the west, north, and northeast of Orlando Executive Airport is incorporated into Area D with its higher Class B airspace floor of 2,000 feet MSL. This change increases the amount of airspace available to VFR aircraft allowing them to utilize that area below 2,000 feet and remain outside of Class B airspace. Also, the eastern boundary of the Area C segments located to the north and south of Orlando International Airport is modified by moving the eastern boundary one degree east to long. 81°10′00″ W. to accommodate the new runway.

Area D. Area D is expanded in size in the vicinity of Orlando Executive Airport by incorporating the airspace removed from Area C, as described above. This change also raises the floor of Class B airspace in the affected area from 1,600 feet MSL to 2,000 feet MSL, providing additional VFR flyway airspace between Sanford International Airport and Orlando Executive Airport while still protecting Orlando International Airport arrivals. Also, the eastern boundary of Area D is moved eastward to long. 81°10′00″ W. to accommodate the new runway at Orlando International Airport.

Area E. The boundary of Area E to the east of Orlando International, currently defined by long. 81°11′00″ W., is moved eastward one degree to long. 81°10′00″ W. This modification accommodates the new Orlando International Airport runway. Additionally, Area E is expanded in the vicinity of Sanford so that Area E overlies the Sanford Class C airspace area and incorporates the airspace from 3,000 feet MSL up to and including 10,000 feet MSL over Sanford, that was formerly in Area C. Also, the southern boundary of Area E, located to the south of Sanford, is moved further south by approximately 2.5 NM to align it with the southern boundary of the Sanford Class C airspace area, along lat. 28°41′36″ N.

Area F. That airspace described as Area F in the existing Orlando Class B airspace area is renamed “Area G.” A new Area F is inserted to the west of Orlando International, adjacent to, and west of, Area D and Area E. This new Area F consists of that airspace located between long, 81°27′30″ W. and long. 81°32′00″ W., and bounded by the ORL VORTAC 30-mile radius on the south, and by lat. 28°53′00″ N., on the north. The floor of the new Area F is set at 4,000 feet MSL instead of the 6,000 feet MSL floor in the existing Area F. The lower floor provided by the new Area F ensures that departures climbing westbound off MCO and arrivals on downwind leg for landing at Orlando International remain within Class B airspace.

Area G. The remaining sections of the existing Area F are renamed Area G as a result of the addition of a new Area F, described above.

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 requires agencies to analyze the economic effect of regulatory changes on small businesses and other small entities. Third, the Office of Management and Budget directs agencies to assess the effect of regulatory changes on international trade. In conducting these analyses, the FAA has determined that this final rule: (1) Will generate benefits that justify its minimal costs and is not a “significant regulatory action” as defined in the Executive Order; (2) is not significant as defined in the Department of Transportation's Regulatory Policies and Procedures; (3) will not have a significant impact on a substantial number of small entities; (4) will not constitute a barrier to international trade; and (5) will not contain any Federal intergovernmental or private sector mandate. These analyses are summarized here in the preamble, and the full Regulatory Evaluation is in the docket.

The FAA proposed to change the Orlando Class B and the Orlando Sanford Airport Class D airspace areas. The Orlando Class B airspace area modification will maintain the 10,000 feet MSL airspace ceiling and redefine the lateral limits of several of the existing subareas to improve the management of air traffic operations in the Orlando terminal area. The Orlando Sanford Airport Class D airspace area upgrade to a Class C airspace area will lower the airspace area from 3,000 to 1,600 feet MSL and will include a radius of 4.4 NM from the Orlando Sanford Airport up to but not including 1,600 feet MSL.

The FAA has determined that the changes to the Orlando Class B and the Orlando Sanford Airport Class D airspace areas will improve the operational efficiency while maintaining aviation safety in the terminal airspace area. Also, clearer boundary definition and changes to lateral and vertical limits of some subareas will provide additional airspace for use by VFR aircraft transitioning to and from satellite airports. This proposal will impose only negligible costs on some airspace users but could potentially reduce circumnavigation costs to other airspace users.

The final rule will result in negligible additional administrative costs to the FAA and no additional operational costs for personnel or equipment to the agency. Printing of aeronautical charts which reflect the changes to the Class B area and the upgrade to Class C airspace area will be accomplished during a scheduled chart printing, and will result in no additional costs for plate modification and updating of charts. Furthermore, no staffing changes will be required to maintain the modified Class B airspace area and the upgraded Class D airspace area. Potential increase in FAA operations workload could be absorbed by current personnel and equipment.

In view of the negligible cost of compliance, enhanced aviation safety, and improved operational efficiency, the FAA has determined that the final rule will be cost-beneficial.

The Regulatory Flexibility Act of 1980 establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objective of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the business, organizations, and governmental jurisdictions subject to regulation.” To achieve that principal, the Act requires agencies to solicit and consider flexible regulatory proposals and to explain the rationale for their actions. The Act 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 proposed or final rule will have a significant economic impact on a substantial number of small entities. If the determination is that it will, the agency must prepare a regulatory flexibility analysis (RFA) as described in the Act.

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

The FAA has determined that the final rule will have a de minimus impact on small entities. All commercial and general aviation operators who presently use the Orlando International Airport are equipped to operate within the modified Class B airspace area. As for aircraft that regularly fly through the Orlando Sanford International Airport Class D airspace area, since the airport is situated within the established Orlando Mode C Veil, all aircraft should already have the necessary equipment to transition the modified Class B airspace area. Therefore, there will be no additional equipment cost to these entities.

Accordingly, pursuant to the Regulatory Flexibility Act, 5 U.S.C. 605(b), as the Administrator of the Federal Aviation Administration, I certify that this rule will not have a significant economic impact on a substantial number of small entities.

The Trade Agreement Act of 1979 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 (proposed/final) rule and determined that it will have only a domestic impact and therefore no affect on any trade-sensitive activity.

The Unfunded Mandates Reform Act of 1995 (the Act) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of the Act 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) 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 $120.7 million in lieu of $100 million.

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

In accordance with the Paperwork Reduction Act of 1980 (Pub. L. 96-511), there are no requirements for information collection associated with this action.

On February 26, 2004, the FAA published in the Federal Register a notice of proposed rulemaking to establish a prohibited area over the U.S. Naval Submarine Base, Kings Bay, GA (69 FR 8884). The FAA proposed this action, at the request of the U.S. Navy, to enhance the security of the Kings Bay facility. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. The comment period ended April 12, 2004. A total of 124 comments were received in response to the notice. All comments received were considered in this rulemaking action, including six comments received by the Document Management System after the closing date.

One commenter wrote in support of the proposed action. All other commenters opposed the establishment of the prohibited area. The following is a discussion of the substantive comments received.

Many commenters contended that there is no credible terrorist threat and adequate justification has not been provided for establishing a prohibited area at Kings Bay, GA.

FAA Response: The purpose of establishing Prohibited Area P-50 is to be proactive in preventing terrorism rather than reactive. The September 11, 2001, attacks identified some weaknesses in the defense of certain critical U.S. assets, and some analysts still claim that necessary steps to prevent future terrorist attacks have not been taken. P-50 is just one part of the U.S. Navy's integrated, layered defense plan for the Kings Bay facility. The submarines berthed at Kings Bay are vital assets that require continual protection, not just during periods of heightened security.

A number of commenters stated that a prohibited area would do nothing to enhance actual security at Kings Bay. It would provide no deterrence to terrorists because they do not follow the rules anyway. Commenters expressed doubt that a prohibited area would provide adequate time for the Navy to react to a threat. Further, the area would only serve to limit the freedom of law-abiding pilots and possibly put an aircraft at risk of a shoot down in the event of an inadvertent penetration of the prohibited area caused by an aircraft emergency or malfunction, lost pilot, or some other innocent circumstance.

FAA Response: The FAA agrees that a prohibited area designation, in itself, presents no physical impediment to stop an attack. However, the Navy is aggressively pursuing a multitude of defensive measures at Kings Bay to prevent an airborne attack. Each of these measures includes the identification of hostile aircraft. P-50 will enhance the protection of U.S. assets by reducing low altitude aircraft overflights of the facility and provide a better means for identifying potentially hostile aircraft. The purpose of P-50, then, is not to provide a sterile environment for airborne assets to engage a hostile aircraft. An aircraft intruding into the prohibited area will draw the attention of ground security forces and may provide the “heads up” notice required to take proper action to prevent or lessen the severity of an attack. An incursion into P-50 would not automatically equate to hostile intent or trigger a defensive response.

Several commenters stated that general aviation (GA) aircraft are too small to be a viable threat to the submarines at the Kings Bay facility. One commenter cited the January 2002 intentional crash by a suicidal pilot of a small aircraft into a Tampa, FL, office building as evidence that GA aircraft are not capable of causing significant damage to buildings or equipment.

FAA Response: The FAA does not agree. Submarine characteristics and design information is classified and, therefore, cannot be discussed here. However, the potential for serious damage to the vessels does exist whether it is the result of a direct impact or collateral damage.

Numerous commenters, including the Aircraft Owners and Pilots Association (AOPA) and the General Aviation Manufacturers Association (GAMA), said that the FAA should consider alternatives to a permanent prohibited airspace designation. They cited a number of actions taken by the Federal government since September 11, 2001, to enhance aviation security, including: advanced screening of pilot data bases, flight training restrictions and background checks for foreign nationals seeking flight training, and various requirements pertaining to flight school operations. In addition, AOPA's nationwide Airport Watch program was initiated to improve the security of airports and aircraft. AOPA called for the FAA to issue an advisory for pilots, similar to that contained in the current Notice to Airmen (NOTAM) that advises pilots to avoid flight near nuclear power plants, instead of implementing the prohibited area.

FAA Response: The FAA agrees that the initiatives described above have contributed to aviation system security. However, these general initiatives do not negate the need for specific measures at the Kings Bay Naval Base. Regarding the suggestion that the FAA issue an advisory avoidance NOTAM instead of establishing a prohibited area, it should be noted that the “power plant” NOTAM discussed above is a voluntary measure and does not prohibit aircraft overflight of a facility. By prohibiting flight in the airspace above the base, the Navy's defense force can more easily focus on the identification of a potential threat and react accordingly.

The majority of the commenters, including AOPA, GAMA, and the St. Marys Airport Authority, opposed the prohibited area because it would severely impact the operation of the nearby St. Marys Airport (4J6), St. Marys, GA. The airport has been continuously impacted by various TFR over the Kings Bay Naval Base since September 13, 2001. The commenters cited numerous adverse impacts on the airport and community, including: cancellation of the only instrument approach procedure serving the airport, thereby reducing the airport to Visual Flight Rules only operations; adverse impact on the safety and usefulness of the airport due to the proximity of the TFR/prohibited area to the main airport runway 4/22 (which is the only runway with lighting for night operations); reluctance of user to conduct flight training at the airport due to the risk of unintentional penetration of the TFR/prohibited area; the airport has become less attractive to commercial operators; and, loss of jobs and lessened economic growth in the local area. Some commenters added that, because of the restrictions, the government should pay to install runway lighting and establish instrument approach procedures for the remaining runway 13/31. Other commenters said the government should pay to relocate St. Marys Airport to a site unaffected by the Kings Bay restrictions.

FAA Response: The FAA agrees that the restrictions imposed by the current TFR adversely affect St. Marys Airport operations. These restrictions will continue to exist under the proposed prohibited area. The airport's close proximity to the Kings Bay base limits the options available to offset the restrictions imposed by the TFR and the proposed prohibited area. Until recently, the only instrument approach serving the St. Marys Airport was the surveillance radar approach to runway 4 (ASR RWY 4). The close proximity of the TFR rendered the missed approach portion of that procedure unusable, therefore the approach was suspended. On September 30, 2004, a revised ASR RWY 4 approach was authorized with a relocated missed approach point that provides additional space for aircraft to execute a left climbing turn away from the current TFR. On November 25, 2004, two area navigation (RNAV) Global Positioning System (GPS) approaches were published serving runways 13 and 31. However, because these runways are not lighted, the RNAV GPS approaches are not authorized for use at night.

Currently, a St. Marys Airport relocation feasibility and site selection effort is in progress involving the City of St. Marys, the State of Georgia, and the FAA. A line item for a proposed replacement of the airport was included in the FAA's National Plan of Integrated Airport Systems (2005-2009). Environmental analysis of various alternatives is being conducted. No decisions about relocating the airport have been made at this time.

One commenter wrote that numerous U.S. military facilities such as Fort Campbell, KY; Fort Benning, GA; McConnell Air Force Base (AFB), KS; and Eglin AFB, FL, are located in close proximity to civilian airports without a similar airspace restriction.

FAA Response: The commenter is correct; however, other military installations do not have the same operational requirements or mission as that of the Naval Submarine Base, Kings Bay, GA.

The FAA Administrator has broad authority under Title 49 of the United States Code (49 U.S.C.) to regulate the use of the navigable airspace. In exercising that authority, the Administrator is required to give consideration to the requirements of national defense and commercial and general aviation, and the public right of freedom of transit through the navigable airspace (49 U.S.C. 40101). The Administrator is also empowered to develop plans and policy for the use of the navigable airspace and assign by regulation or order the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace (49 U.S.C. 40103(b)). Additionally, the Administrator shall, in consultation with the Secretary of Defense, establish areas in the airspace the Administrator decides are necessary in the interest of national defense (49 U.S.C. 40103(b)(3)(A)).

This action amends Title 14 Code of Federal Regulations (14 CFR) part 73 by designating Prohibited Area P-50 at Kings Bay, GA. Prohibited Area P-50 consists of that airspace, from the surface to, but not including 3,000 feet MSL, within a 2-NM radius of Lat. 30°48′00″ N., long. 81°31′00″ W. In accordance with 14 CFR § 73.83 and § 91.133, no person may operate an aircraft within a prohibited area unless authorization has been granted by the using agency. The dimensions of P-50 are identical to those contained in the TFR now in effect over the Kings Bay facility via NOTAM number 5/9063. NOTAM number 5/9063 will be cancelled on the effective date of Prohibited Area P-50.

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 a categorical exclusion from further environmental analysis under the National Environmental Policy Act in accordance with FAA Order 1050.1E, Environmental Impacts: Policies and Procedures, paragraphs 303d and 312d.

The Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Public Law 101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. One aspect of the 1990 amendments was that they clarified FDA's authority to regulate health claims on food labels and in food labeling. We issued several new regulations in 1993 that implemented the health claim provisions of the 1990 amendments. Among these were § 101.14 (21 CFR 101.14), Health Claims: General Requirements (58 FR 2478, January 6, 1993), which sets out the rules for the authorization and use of health claims, and § 101.70 (21 CFR 101.70), Petitions for Health Claims (58 FR 2478, January 6, 1993), which sets out a process for petitioning the agency to authorize health claims about substance-disease relationships, and sets out the types of information that any such petition must include. Each of these regulations became effective on May 8, 1993.

When implementing the 1990 amendments, we also conducted a review of evidence for a relationship between dietary fiber and cardiovascular disease (CVD). Based on this review, we concluded that the available scientific evidence did not justify authorization of a health claim relating dietary fiber to reduced risk of CVD (58 FR 2552, January 6, 1993). However, we did conclude there was significant scientific agreement that the totality of publicly available scientific evidence supported an association between types of foods that are low in saturated fat and cholesterol and that naturally are good sources of soluble dietary fiber (i.e., fruits, vegetables, and grain products) and reduced risk of CHD 1 . We therefore authorized a health claim about the relationship between diets low in saturated fat and cholesterol and high in vegetables, fruit, and grain products that contain soluble fiber and a reduced risk of CHD (21 CFR 101.77; 58 FR 2552 at 2572). In the preamble to the 1993 dietary fiber and CVD final rule, FDA commented that if a manufacturer could document with appropriate evidence that consumption of the type of soluble fiber in a particular food has the effect of lowering blood low density lipoprotein (LDL) cholesterol, and has no adverse effects on other heart disease risk factors (e.g., high density lipoprotein (HDL) cholesterol), it should petition for authorization of a health claim specific for that particular dietary fiber-containing food (58 FR 2552 at 2567).

In 1995, FDA received a petition for a health claim on the relationship between oat bran and rolled oats and reduced risk of CHD. FDA concluded there was significant scientific agreement that the totality of publicly available scientific evidence supported the relationship between consumption of whole oat products and reduced risk of CHD. FDA further concluded that the type of soluble fiber found in whole oats, i.e., beta-glucan soluble fiber, is the component primarily responsible for the hypocholesterolemic effects associated with consumption of whole oat foods as part of a diet that is low in saturated fat and cholesterol (62 FR 3584 at 3597-3598, January 23, 1997). As such, the final rule authorized a health claim relating the consumption of beta-glucan soluble fiber in whole oat foods, as part of a diet low in saturated fat and cholesterol, and reduced risk of CHD (the oat beta-glucan health claim). The source of beta-glucan soluble fiber in foods bearing this health claim had to be one of three eligible whole oat products; i.e., oat bran, rolled oats, or whole oat flour (see § 101.81(c)(2)(ii)(A)). In 2002, FDA amended this health claim regulation to add oatrim as a fourth eligible source of beta-glucan soluble fiber (67 FR 61733, October 2, 2002). Oatrim is the soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour.

In the 1997 oat beta-glucan health claim final rule, we anticipated the likelihood that other sources and types of soluble fibers will also affect blood lipid levels, and thus, may reduce heart disease risk (62 FR 3584 at 3587). At that time, FDA considered structuring the final rule as an umbrella regulation authorizing the use of a claim for “soluble fiber from certain foods” and risk of CHD. Such action would have allowed flexibility in expanding the claim to other specific food sources of soluble fiber when consumption of those foods has been demonstrated to help reduce the risk of heart disease. However, the agency concluded that it was premature to do so inasmuch as FDA had not reviewed the totality of publicly available evidence on other, non-whole oat sources of soluble fiber (62 FR 3584 at 3588). In 1998, in response to a health claim petition, FDA concluded that soluble fiber of psyllium seed husk, similar to beta-glucan soluble fiber from whole oats, may reduce the risk of CHD by lowering blood cholesterol levels (63 FR 8103, February 18, 1998). In that final rule, FDA broadened § 101.81 to include soluble fiber from psyllium seed husk, and also modified the heading in § 101.81 from, “* * * Soluble fiber from whole oats and risk of coronary heart disease” to “* * *Soluble fiber from certain foods and risk of coronary heart disease (CHD).”

The National Barley Foods Council (petitioner), submitted a health claim petition to FDA on August 3, 2004, under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)). The petition requested that the agency amend the “Soluble fiber from certain foods and coronary heart disease health claim” at § 101.81 to include barley and barley products as an additional source of beta-glucan soluble fiber eligible for the health claim (Ref. 1). On November 10, 2004, we notified the petitioner that we had completed our initial review of the petition and that the petition had been filed for further action in accordance with section 403(r)(4) of the act. If the agency does not act, by either denying the petition or issuing a proposed regulation to authorize the health claim, within 90 days of the date of filing for further action, the petition is deemed to be denied unless an extension is mutually agreed upon by the agency and the petitioner (section 403(r)(4)(A)(i) of the act and § 101.70(j)(3)(iii)). On February 4, 2005, FDA and the petitioner mutually agreed to extend the deadline to publish the agency's decision on the petition until August 9, 2005. On August 3, 2005, FDA and the petitioner agreed to further extend the deadline to December 31, 2005. The petitioner requested that FDA issue an interim final rule by which labeling of barley-containing foods could bear the health claim prior to publication of a final rule.

The petitioner requests that § 101.81 be amended to include barley in addition to oats as a source of beta-glucan soluble fiber associated with reducing the risk of CHD. The petitioner further requests that whole grain barley (dehulled or hulless), and certain dry milled barley products, i.e., pearl, flakes, grits, meal, flour, beta-glucan enriched meal fractions, and bran, be determined as eligible barley sources of beta-glucan soluble fiber.

The substance which is the subject of the existing oat beta-glucan health claim is beta-glucan soluble fiber from oat sources listed in § 101.81(c)(2)(ii)(A). The requested amendment will expand the substance of the claim to include both oat and barley sources of beta-glucan soluble fiber. From an analytical perspective, beta-glucan soluble fiber from barley is the same substance as beta-glucan soluble fiber from oat sources. The method now specified in § 101.81(c)(2)(ii)(A) for the measurement of beta-glucan soluble fiber from oat sources, AOAC Official Method 992.28, is a method designated by AOAC INTERNATIONAL to be used for both oat and barley fractions and it is the same analytical method identified by the petition for measurement of beta-glucan soluble fiber from barley sources.

The petition characterizes the barley sources of beta-glucan soluble fiber as dehulled or hulless whole grain barley and barley products produced from dehulled or hulless clean, sound barley grain by standard dry milling processes, which may include steaming or tempering, and that provide at least 4 percent (dry weight basis (dwb)) of beta-glucan soluble fiber and total dietary fiber content of at least 8 percent (dwb) (flour, grits, flakes, and meal), or at least 5.5 percent (dwb) of beta-glucan soluble fiber and at least 15 percent (dwb) total dietary fiber (bran and beta-glucan enriched barley fractions). For whole grain (dehulled and hulless) barley, the petition specified the minimum beta-glucan soluble fiber content as 4 percent (dwb) and the minimum total dietary fiber content as 10 percent (dwb).

Most barley varieties have a tough fibrous adherent hull covering the grain which must be removed for the grain to be edible. There are also hulless barley varieties in which, similar to wheat, the hull falls away during harvesting and the grain can be processed directly into food products without dehulling. The petition thus has specified the eligible sources of the barley beta-glucan soluble fiber to include both dehulled and hulless whole barley grain.

In addition to dehulled or hulless whole barley grain, the petition has specified that dry milled barley products that are eligible sources of the beta-glucan soluble fiber be produced from dehulled or hulless barley grain by standard dry milling processes. The petition includes dry milled barley products only and does not include beta-glucan extracts produced through “wet milling” processes. Wet milling processes used to extract or concentrate the beta-glucan soluble fiber component of barley are likely to alter physiochemical properties of fiber and other components of the grain. All but two of the dry milled barley products specified in the petition have been formally defined by the American Association of Cereal Chemists (AACC) in a “Barley Glossary” which is published in AACC Approved Methods (Ref. 2). Two additional dry milled barley products, which are not defined in the AACC Barley Glossary, i.e., barley meal and beta-glucan enriched barley fractions, are included in the petition as beta-glucan soluble fiber sources. The petition characterizes barley meal as differing from barley flour only in that it is unsifted and thus has a higher portion of bran and germ present than sifted barley flour. The petition has defined “beta-glucan enriched barley fractions” as fractions of dry milled barley that are enriched in endosperm cell walls by either mechanical sifting or air classification and that provide at least 5.5 percent (dwb) of beta-glucan soluble fiber and a total dietary fiber content of at least 15 percent (dwb). The beta-glucan content of barley endosperm cell walls is greater than that of barley endosperm cell contents. During milling, endosperm cell walls break up into larger particles than do endosperm cell contents. Sieving or air classification milling steps can be used to separate milled barley flour or meal by particle size to produce endosperm cell wall-enriched fractions. Since barley endosperm cells walls have a greater beta-glucan content than do barley endosperm cell contents, these endosperm cell wall-enriched barley fractions have a greater beta-glucan content than of the starting flour or meal. For simplicity, in this document we will be referring to endosperm cell wall-enriched barley fractions as “sieved barley meal.”

The petition specifies that the dry milled barley products which are the subject of this petition, with the exception of barley bran and sieved barley meal, have a minimum beta-glucan soluble fiber content of at least 4 percent (dwb), and a minimum total dietary fiber content of at least 8 percent (dwb). The petition specifies that eligible barley bran and sieved barley meal have a minimum beta glucan soluble fiber and total dietary fiber content of 5.5 percent (dwb) and 15 percent (dwb) respectively. The petition specifies that eligible whole grain barley (dehulled and hulless) have a minimum beta glucan soluble fiber and total dietary fiber content of 4 percent dwb and 10 percent dwb respectively. The petitioner selected the minimum beta-glucan soluble fiber and total dietary fiber content specifications for the whole grain barley and dry milled barley products that are eligible sources of beta-glucan soluble fiber to be inclusive of most all commercially available dry milled barley products, while excluding barley products such as barley brewers grain in which the soluble fiber has been depleted.

CHD continues to be a disease that has a large impact on mortality and morbidity in the general adult U.S. population. As explained in the existing oat beta-glucan health claim (§ 101.81(b)), FDA recognizes the CHD risk reduction benefit of certain foods that are sources of soluble dietary fiber resulting from effects on lowering blood total and LDL-cholesterol. Although age-adjusted CHD mortality rates in the United States had been steadily decreasing since approximately 1960, recent evidence has suggested that the decline in CHD mortality has slowed (Ref. 3). Heart disease has been recognized as the leading cause of death in the United States for at least the last 50 years (Ref. 3). Based on these facts, FDA concludes that, as required in § 101.14(b)(1), CHD is a disease for which the U.S. population is at risk.

The substance which is the subject of the existing oat beta-glucan health claim is beta-glucan soluble fiber from specified oat sources, i.e., oat bran, rolled oats, whole oat flour, and oatrim (§ 101.81(c)(2)(ii)(A)). The petitioner requests an amendment to extend the eligible sources of beta-glucan soluble fiber to include those from whole grain barley and certain dry milled barley products. Barley grain is a commonly consumed human food and beta-glucan soluble fiber is a nutrient component of this food, thus the beta-glucan soluble fiber from whole grain barley and dry milled barley products that include bran, flakes, grits, pearl, flour, meal, and sieved barley meal is a “substance” as defined by § 101.14(a)(2). Health claim general requirements provide that where a substance is to be consumed at “other than decreased dietary levels” the substance must contribute taste, aroma, nutritive value, or any other technical effect as listed in 21 CFR 170.3(o), and must retain that attribute when consumed at levels necessary to justify the claim (§ 101.14(b)(3)(i)). Whole grain barley and dry milled barley products are consumed by humans for their nutritive value, and retain that attribute when consumed at levels necessary to justify the claim. Thus the agency concludes that the requirement of § 101.14(b)(3)(i) is satisfied.

Section 101.14(b)(3)(ii) requires that the substance be a food or a food ingredient or a component of a food ingredient whose use at the levels necessary to justify a claim has been demonstrated by the proponent of the claim, to FDA's satisfaction, to be safe and lawful under the applicable food safety provisions of the act. The petition states that dry milled barley grain is a human food of natural biological origin that has been widely consumed in the United States for its nutrient properties prior to January 1, 1958, without known detrimental effects, which is subject only to conventional processing as practiced prior to January 1, 1958, and for which no known safety hazard exists. The petitioner's description of the use of dry milled barley grain as a food ingredient and the use of whole grain barley, as sources of barley beta-glucan soluble fiber, are consistent with FDA's definition of food ingredients ordinarily regarded as “generally recognized as safe” (GRAS) (21 CFR 170.30(d)). FDA is satisfied that the petitioner has demonstrated the use of barley beta-glucan soluble fiber, from whole grain barley and dry milled barley grain product sources that are included in this rule, is safe and lawful under the applicable food safety provision of the act.

FDA has identified the following endpoints to use in identifying CHD risk reduction for purposes of a health claim evaluation: Coronary events (myocardial infarction, ischemia), cardiovascular death, atherosclerosis, high blood pressure, elevated serum total cholesterol, and elevated serum LDL-cholesterol. FDA considers high blood pressure, elevated serum total cholesterol, and elevated serum LDL-cholesterol levels as surrogate endpoints for CHD (Ref. 4). FDA considers low HDL-cholesterol levels a risk factor for CHD (National Institutes of Health Consensus Conference, 1993). Elevated levels of serum total and LDL cholesterol, a prerequisite for atherosclerotic disease, is a major cause of CHD (Ref. 4). To evaluate the potential effects of beta-glucan soluble fiber from whole grain barley and dry milled barley products on CHD risk, FDA focused on serum total and LDL cholesterol levels to evaluate the relationship between barley beta-glucan and CHD risk. This focus is consistent with existing § 101.81, in which FDA concluded that there was significant scientific agreement that the relationship between consumption of whole grain oats and CHD risk is mediated primarily by the effect of dietary beta-glucan soluble fiber on serum lipids.

FDA previously concluded that there is significant scientific agreement regarding the relationship between consumption of soluble fiber-containing whole oat foods and reduced risk of CHD (62 FR 3584 at 3598). FDA concluded that the type of soluble fiber found in whole oat foods, i.e., beta-glucan soluble fiber, is primarily responsible for the observed association between consumption of whole oat foods and the lowering of blood cholesterol. As such, to evaluate the evidence supporting the petitioned request to extend the beta-glucan soluble fiber from whole oat health claim to include beta-glucan soluble fiber from whole grain barley and dry milled barley products, FDA focused on evidence from human clinical studies of the effects of consuming beta-glucan soluble fiber from whole grain barley and dry milled barley products on blood lipids.

A health claim characterizes the relationship between a substance and a disease or health-related condition (21 CFR 101.14(a)(1)). The substance must be associated with a disease or health-related condition for which the general U.S. population, or an identified U.S. population subgroup, is at risk (§ 101.14(b)(1)). Health claims characterize the relationship between the substance and a reduction in risk of contracting a particular disease. 2

FDA's review of the evidence to support the petitioned amendment of the oat beta-glucan health claim was conducted consistent with FDA published guidance on significant scientific agreement in the review of health claims (Ref. 5) and focused on evidence from intervention studies.

This petition identified reports of 11 human clinical studies with data on barley consumption and serum lipids (Refs. 6 to 16). We excluded six of these reports from our review because no scientific conclusions relative to effects of barley beta-glucan soluble fiber on CHD risk could be drawn from them. One of these excluded reports (Ref. 6) was available only as an abstract and therefore did not provide sufficient information about the study for FDA to determine critical elements, such as the study population characteristics and the composition of the products used. In addition, the lack of a detailed study description prevents FDA from determining whether the study is flawed in critical elements such as design, conduct, and data analysis. FDA must be able to review the critical elements of a study to determine whether any scientific conclusions relevant to the health claim can be drawn from it. These problems are not limited to abstracts, but include other similar publications, such as meta-analyses 3 and review articles, 4 book chapters, letters to the editor, and committee reports.

A second excluded report, Lupton et al., 1994 (Ref. 7), tested potential cholesterol-lowering effects of spent brewer's grain barley and of barley oil, neither of which contains beta-glucan soluble fiber. Because this report did not provide information about the substance that is the subject of the health claim, it was excluded from further review. Another excluded report, Keogh et al., 2003 (Ref. 8), tested potential cholesterol-lowering effects of a beta-glucan concentrate product extracted from barley bran. The whole grain barley and dry milled barley products which are the sources of beta-glucan soluble fiber in the petition do not include wet milled barley products such as the beta-glucan concentrate used in Keogh et al., 2003. Beta-glucan extraction processes (e.g., hot water or alcohol washes, and extreme pH conditions), unlike dry milling processes, are likely to alter physiochemical properties of soluble fiber and other components of grain and will alter the relative proportions of beta-glucan soluble fiber and other components of the grain. The composition of wet milled barley beta-glucan products may be substantially different from that of dry milled barley products and thus the results of Keogh et al., 2003 do not assist our evaluation of evidence supporting a health claim for dry milled barley products. The three other excluded reports (Refs. 9, 10, and 11) did not contain enough information to estimate the barley beta-glucan soluble fiber in the test diets. Without knowing the amount of barley beta-glucan soluble fiber added to these studies' diets, FDA was unable to draw any conclusions as to the effect of barley beta-glucan soluble fiber on CHD risk from this evidence. The remaining 5 of the 11 reports of human clinical studies (Refs. 12 to 16) were of a sufficient quality for us to consider in our review of the evidence supporting the relationship between reduced risk of CHD and consumption of beta-glucan soluble fiber from whole grain barley and dry milled barley products included as sources of beta-glucan soluble fiber in this petition.

The study reported in Behall et al., 2004a (Ref. 12) investigated the effects of dry milled barley products (barley flour, barley flakes, and pearled barley) incorporated into a controlled whole-grain diet on blood lipids of mildly hypercholesterolemic men. The study included 18 mildly hypercholesterolemic adult males (mean age 46 years; mean baseline total cholesterol 238 milligrams/deciliter (mg/dL); mean baseline LDL-cholesterol 155 mg/dL). The test diet was a Step I diet (total fat 31 percent of energy, saturated fat 7.6 percent of energy, total dietary fiber 27 grams (g)/day) that included whole grain test foods (pancakes, spice cake, no-bake cookies, hot cereal, toasted flakes, steamed pilaf, and muffins). The test personnel prepared three versions of the whole grain test diet differing in levels of dry milled barley products. One version of the test diet, made with whole wheat flour, wheat flakes, and brown rice, but no barley, contained only trace amounts of beta-glucan soluble fiber. Another version of the test diet made with barley flour, barley flakes, and pearled barley replacing the wheat and rice in test foods, provided 6 g barley soluble fiber per day. The third version of the test diet was made with half whole wheat/brown rice and half barley to provide 3 g barley soluble fiber per day. The three whole grain test diets were designed to provide approximately the same amount of total dietary fiber per day, and vary only in the amount of barley beta-glucan soluble fiber. Following a 2-week run-in period consuming the test diet without barley to allow subjects to adjust to the dietary fiber level, the study administered each the three test diets (0, 3, or 6 g per day barley soluble fiber) to each participant in random order over three consecutive 5-week periods. In comparison to the 0 g per day barley soluble fiber diet period, there was a statistically significant (p < 0.05) 7.5 percent reduction of serum total cholesterol following the 6 g per day barley soluble fiber diet. Similarly, there was a statistically significant 8.5 percent reduction in serum LDL-cholesterol level following the 6 g per day barley soluble fiber period compared to the 0 g per day period. Reductions in serum total and LDL-cholesterol following the 3 g per day soluble barley fiber period were not statistically significant. Serum HDL cholesterol levels were not significantly different among the three diet periods.

Another study by Behall et al., (Ref. 13) investigated the effects of dry milled barley products (barley flour, barley flakes, and pearled barley) in a controlled whole-grain diet on blood lipids of mildly hypercholesterolemic adults. The study included 25 mildly hypercholesterolemic adult men and women (average baseline total cholesterol 223 mg/dL; average baseline LDL-cholesterol 145 mg/dL). The test diet was the same as in the previous Behall et al. study (Ref. 12), i.e., a STEP I diet including whole grain test foods and with barley ingredients substituted for whole wheat/brown rice ingredients to produce three versions of test diet providing 0 g, 3 g, or 6 g per day of barley beta-glucan, but each with approximately the same amount of total dietary fiber. As in the previous study, the 17-week experimental period consisted of a 2-week run-in period followed by three consecutive 5-week periods during which each participant was administered each of the three versions of test diet in random order. In comparison to the 0 g per day barley beta-glucan diet period, there were statistically significant (p < 0.05) reductions of serum total cholesterol following both the 3 g and 6 g per day barley beta-glucan diets (5 percent and 6 percent reductions, respectively). Similarly, there were statistically significant reductions of serum LDL-cholesterol following both the 3 g and 6 g per day barley beta-glucan diets compared to the 0 g per day diet (10 percent and 13 percent reductions, respectively). Serum HDL cholesterol levels were not different among the three diet periods.

The study reported in McIntosh et al., 1991 (Ref. 14) investigated the effects of dry milled barley products (barley bran and barley flakes), as compared to wheat, on blood lipids of mildly hypercholesterolemic men. The study included 21 mildly hypercholesterolemic adult males (mean age 43 years; mean baseline total cholesterol 240 mg/dL; mean baseline LDL-cholesterol 177 mg/dL). Throughout the study, participants consumed their customary diets but replaced their customary grain-based foods with similar test foods (bread, muesli, pasta, and biscuits) provided by study personnel. The test foods were made with either whole wheat flour, or with barley bran and barley flakes replacing portions of the whole wheat flour. The grain-based test foods provided about 50 percent of total caloric intake and about 65 percent of total dietary fiber intake. The whole wheat test foods and the barley test foods were equivalent in content of energy, total fat, saturated fat, total dietary fiber, and soluble dietary fiber content. The diet with whole wheat test foods provided 1.5 g beta-glucan per day, whereas the diet with barley test foods provided 8 g beta-glucan per day. Following a 3-week run-in period with the usual diets, the participants consumed the diets supplemented with either whole wheat test foods or barley test foods in random order during two consecutive 4-week periods. In comparison to the whole wheat test food period, there were statistically significant (p < 0.05) reductions of serum total cholesterol (6 percent reduction) and of serum LDL-cholesterol (7 percent reduction) following the barley test food period. Serum HDL cholesterol levels were not different between the two diet periods.

The study reported in Newman et al., 1989 (Ref. 15) investigated the effects of dry milled barley (barley flour), in comparison to wheat, on blood lipids of adult men. The study included 14 adult males (age greater than 35 years; total cholesterol range 140-247 mg/dL; LDL-cholesterol range 71-187 mg/dL). During the study, the participants consumed their customary diets but with three servings per day of test foods (muffins, applesauce bars, breads, muffins, cookies, and cereal) made with either whole wheat flour and wheat bran or with barley flour replacing similar foods of the customary diet. Both the wheat and barley grain-based test foods provided about 42 g total dietary fiber per day. The barley test foods provided approximately 3 g soluble beta-glucan per day. The 4-week study was a randomized, blinded study with one half of the participants consuming the wheat flour/bran test foods for 4 weeks, and the other half receiving the barley test foods for 4 weeks. At the end of the test period, mean serum total and LDL-cholesterol levels were significantly (p < 0.05) lower in the barley group than in the wheat group.

The study reported in Li et al., 2003 (Ref. 16) investigated the effects of whole grain barley on blood lipids of young healthy female Japanese. The study included 10 healthy Japanese medical students (average age 20 years; average baseline total cholesterol 140 mg/dL; average baseline LDL-cholesterol 53 mg/dL). During the study, participants consumed a typical Japanese diet (approximately 2,000 kcal/day, 35 percent fat) that the investigators provided. During the barley diet period, barley replaced 30 percent of the daily rice intake. The barley provided approximately 5 g per day of soluble dietary fiber. Each participant consumed the control diet (rice only) and barley diet (70 percent rice, 30 percent barley) in random order during two 4-week periods separated by a 4-week interval. In comparison to the control diet period, there were statistically significant (p < 0.05) reductions of blood total cholesterol (14.5 percent reduction) and of blood LDL-cholesterol (21 percent reduction) following the barley diet period. Blood HDL cholesterol levels were not different between the two diet periods.

In summary, the five clinical trials included in our review which tested the impact of consuming whole grain barley and dry milled barley products (bran, flakes, flour and pearled barley) on serum lipids (Refs. 12 through 16), consistently reported statistically significant lower serum total and LDL-cholesterol levels following 4 to 5 weeks of consuming diets in which whole grain barley or dry milled barley product ingredients replaced wheat and rice ingredients. Serum HDL cholesterol levels were not affected by consuming the barley foods. The lowest daily dietary intake of barley beta-glucan fiber effective in significantly lowering serum total and LDL-cholesterol reported in these studies was 3 g per day.

The oat beta-glucan health claim, at § 101.81(c)(2)(ii)(A), lists four eligible oat sources of beta-glucan soluble fiber; i.e., oat bran, rolled oats, whole oat flour, and oatrim. FDA is amending § 101.81(c)(2)(ii)(A) to add dehulled and hulless whole grain barley and certain dry milled barley products to this list of eligible sources of beta-glucan soluble fiber.

Below, the agency describes the eligible sources of barley beta-glucan soluble fiber from dry milled barley products and the specifications for all eligible sources.

The five clinical trials with barley cited previously used the following barley sources in their test foods: Whole grain barley, barley bran, barley flour, barley flakes, and pearled barley. Each dry milled product used in the clinical studies is processed only to the extent that milling has altered the particle size of the intact grain, and in some cases the product is also subjected to a particle size separation process (e.g., sifting). The barley sources of beta-glucan soluble fiber in this rule, i.e., dehulled or hulless whole grain barley, barley bran, flakes, grits, pearl, flour, meal, and sieved barley meal, are produced from dry milling processes only. Wet milling, as opposed to dry milling, involves slurrying the grain under pH, temperature, chemical, or enzyme conditions that cause changes other than just particle size. The one barley clinical trial that was excluded from our review because the product tested was a wet milled barley beta-glucan extract (Ref. 8) reported finding no effect of the barley beta-glucan extract on serum lipids.

There are many variations in dry milling processes for barley, most of the resulting dry milled barley products are defined in the AACC “Barley Glossary” (Ref. 2), including barley bran, flakes, grits, pearl, and flour. The petition describes two additional dry milled barley products: Barley meal and sieved barley meal. Barley meal is unsifted, ground, whole grain barley. The petition described sieved barley meal as endosperm cell wall-enriched fractions of barley meal or barley flour resulting from including a particle size separation step (either sieving or air classification) in the dry milling process. Although the petitioner's term for this barley product was “beta-glucan enriched barley fractions,” we are using the term “sieved barley meal” in this rulemaking as that is descriptive of the how this dry milled barley product is produced and to clarify that a barley “beta-glucan enriched” product produced by any other process is not included as an eligible source of barley beta-glucan soluble fiber.

The petition requests that the eligible barley sources of beta-glucan soluble fiber added to § 101.81 include, in addition to the whole grain barley and dry milled barley products used in the clinical studies FDA included in its review (i.e., barley bran, flakes, flour, and pearl barley), three dry milled barley products that were not used in the reviewed clinical studies (i.e., barley grits, meal, and sieved barley meal). FDA agrees with the petitioner that the additional barley products represent variations of the extent of dry milling and as such involve more textural difference and not compositional differences that would result in an outcome that is different from that in clinical trials. FDA is amending § 101.81(c)(2)(ii)(A) to add as eligible barley sources of beta-glucan soluble fiber, whole grain barley, barley bran, barley flakes, barley grits, barley flour, barley meal, sieved barley meal, and pearl barley. The petition has specified the minimum beta-glucan soluble fiber content of eligible dry milled barley products, with the exception of sieved barley meal and barley bran, to be at least 4 percent (dwb), and the minimum total dietary fiber content to be at least 8 percent (dwb). The minimum beta-glucan soluble fiber and total fiber content specified in the petition for eligible barley bran and sieved barley meal is at least 5.5 percent (dwb) and 15 percent (dwb), respectively. The minimum beta-glucan soluble fiber and total fiber content specified in the petition for eligible whole grain barley is at least 4 percent (dwb) and 10 percent (dwb), respectively. The petition states that these dietary fiber content specifications were selected based on typical analyses of commercially available dry milled barley products in the United States. FDA is adopting the dietary fiber content specifications recommended by the petitioner that must be met in order for the listed sources of beta-glucan soluble fiber to be considered eligible sources.

Evidence from five clinical trials (Refs. 12 through 16) consistently demonstrate that consuming whole grain barley and dry milled barley products, such as barley bran, flakes, flour and pearled barley that provide at least 3 g beta-glucan fiber per day, is effective in lowering serum total and LDL-cholesterol levels, which in turn may reduce the risk of CHD. The cholesterol-lowering effects of beta-glucan soluble fiber in dry milled barley products is comparable to that of the oat sources of beta-glucan now listed in § 101.81(c)(2)(ii)(A). When issuing the oat beta-glucan health claim the agency concluded that the beta-glucan soluble fiber component of oat products plays a significant role in the relationship between whole grain oats and the risk of CHD based, in part, on evidence that there is a dose response between the level of beta-glucan soluble fiber from whole oats and the level of reduction in serum LDL cholesterol, and evidence that intakes at or above 3 g per day were more effective in lowering serum lipids than lower intake levels (62 FR 3584 at 3585). The petition notes that a comparison of the serum cholesterol lowering evidence for barley beta-glucan soluble fiber, which has been submitted with the petition, and the oat beta-glucan soluble fiber/cholesterol-lowering dose-response evidence, which was cited in the oat beta-glucan health claim rulemaking, shows that the cholesterol lowering efficacy of the oat and the barley sources of beta-glucan soluble fiber are very similar. FDA agrees that the effect, on serum cholesterol, of consuming whole grain oat and dry milled barley sources of beta-glucan soluble fiber appears equivalent. FDA also agrees that the scientific evidence supports a minimum daily effective intake of beta-glucan soluble fiber from dry milled barley products the same as that which was previously found for beta-glucan soluble fiber from whole oat sources, i.e., 3 g per day. Therefore, FDA is amending § 101.81(c)(2)(i)(G)(1) to include 3 g or more per day of barley sources of beta-glucan soluble fiber, alone or in combination with whole oat sources of such fiber.

Barley beta-glucan can be measured by the same quantitative analytical method as is currently specified in § 101.81 for the determination of oat beta-glucan. Based on the totality of the publicly available scientific evidence, FDA concludes there is significant scientific agreement, among experts qualified by scientific training and experience, for a claim about the relationship between certain beta-glucan soluble fiber sources and reduced risk of CHD. Thus, we are amending § 101.81(c)(2)(ii)(A) to include dehulled or hulless whole grain barley and certain dry milled barley products as additional sources of beta-glucan soluble fiber. We also find that the serum cholesterol-lowering efficacy of barley beta-glucan soluble fiber and of oat beta-glucan are comparable and, like oat beta-glucan, 3 g per day of barley beta-glucan is a sufficient daily dietary intake to achieve a reduction in serum total and LDL cholesterol.

The barley products that are to be included in this amendment as eligible sources of beta-glucan soluble fiber include dehulled and hulless whole grain barley, and certain dry milled barley products including barley bran, barley flakes, barley flour, barley grits, and pearl barley as they are defined in the AACC Barley Glossary (Ref. 2), barley meal which is an unsifted ground barley grain, and sieved barley meal which is an endosperm cell-wall enriched fraction resulting from sieving or air classification of barley flour or barley meal to separate fractions based on particle size. The sieved barley meal fraction retains the coarser particles that originate from endosperm cell wall. Minimum dietary fiber content specifications for these barley products, recommended in the petition as representative of commercially available barley products in the United States are a minimum of 4 percent beta-glucan soluble fiber and 10 percent total dietary fiber for dehulled and hulless whole grain barley; a minimum of 5.5 percent beta-glucan soluble fiber and 15 percent total dietary fiber for barley bran and sieved barley meal; and a minimum of 4 percent beta-glucan soluble fiber and 8 percent total dietary fiber for all other dry milled barley products. All dietary fiber values are on a dwb.

The oat beta-glucan health claim requires that a food bearing the claim on its label include one of the whole grain ingredients listed within § 101.81(c)(2)(ii)(A), and that the whole oat ingredient provide at least 0.75 gram of beta-glucan soluble fiber per reference amount customarily consumed of the food product (§ 101.81(c)(2)(iii)(A)). FDA arrived at this value based on a standard assumption that the daily dietary intake is divided over four eating occasions (three meals and a snack). FDA concluded that in adding whole oat flour to the eligible whole oat sources of beta-glucan soluble fiber that were included in the final rule there would be sufficient numbers and types of whole oat-containing food products available to increase the likelihood that whole oat food products will be consumed at four eating occasions per day (62 FR 3584 at 3592). Adding whole grain barley and dry milled barley products as additional eligible sources of beta-glucan soluble fiber will further increase the type and number of qualifying food products and make it easier for consumers to select whole grain barley, dry milled barley or whole oat containing food products at four eating occasions per day. Thus, FDA is retaining under the “Nature of the food eligible to bear the claim” section of this regulation the criterion that foods eligible to bear the claim contain at least 0.75 gram of soluble fiber (§ 101.81(c)(2)(iii)(A)( 1 )).

FDA authorized use of the oat beta-glucan health claim in 1997, in part, on the basis of clinical evidence demonstrating that consumption of whole oat foods such as oat bran, oatmeal, and whole oat flour lowers serum cholesterol. FDA also considered scientific evidence for a dose-response between the amount of beta-glucan consumed and the cholesterol-lowering effect (Ref. 17), and evidence that at least 3 grams of soluble fiber consumed per day in whole oat foods is sufficient for effective cholesterol lowering (Ref. 18). Information provided in the oat beta-glucan health claim petition indicated that the soluble fiber content of whole oats is predominantly beta-glucan. Therefore, FDA concluded that the total soluble fiber content of whole oats significantly reflects the beta-glucan present in whole oats (62 FR 3584 at 3588).

Although FDA had concluded that oat beta-glucan soluble fiber plays a significant role in the relationship between whole grain oats and reduced risk of CHD (62 FR 3584 at 3585), FDA had considered the term “beta-glucan” a technical term that presumably would not be widely understood, and that the term “soluble fiber” is more familiar to consumers because soluble fiber can be used on the nutrition label under 21 CFR 101.9(c)(6)(i)(A). As such, this health claim statement must identify the substance using the term “soluble fiber” (62 FR 3584 at 3588).

The standard method for measurement of beta-glucan in oat and barley (AOAC Official Method 992.28) measures total beta-glucan content of the grain product without differentiating soluble and insoluble fractions. There is no standard method, nor a single definition for, soluble beta-glucan. Typically a grain product is analyzed for either soluble fiber or for total beta-glucan. Information in the original oat beta-glucan health claim petition convinced FDA that the total soluble fiber content of whole oats significantly reflects the beta-glucan content (62 FR 3584 at 3588). Information and data provided in the current petition demonstrate that the solubility of beta-glucan in oats and barley are similar and that the test for total beta-glucan is an adequate marker for the cholesterol-lowering functionality of whole oat, whole grain barley, and dry milled barley in foods. Therefore, FDA is requiring that the barley beta-glucan health claim identify the substance with the term “soluble fiber,” although the substance is to be measured as total beta-glucan.

There is strong and consistent scientific evidence that diets high in saturated fat and cholesterol are associated with elevated serum total and LDL cholesterol, and that elevated serum cholesterol levels are a major modifiable risk factor for CHD. Expert groups recommend lowering dietary saturated fat and cholesterol as a primary lifestyle change for reducing heart disease risk (Ref. 4). Comments to the 1997 oat beta-glucan health claim final rule expressed concern that a CHD risk claim that does not include a reference to a low saturated fat, low cholesterol diet may mislead consumers into thinking that the single food, e.g., oat products, would appear to be a “magic bullet” (62 FR 3584 at 3594). Further, based on the scientific evidence, the role of soluble fiber from whole oats in the diet is generally recognized as being of smaller magnitude in reducing CHD risk compared to consumption of a low saturated fat, low cholesterol diet. When authorizing the oat beta-glucan health claim FDA concluded that although selection of foods with soluble fiber from whole oats is a useful adjunct to selection of diets low in saturated fat and cholesterol in reducing CHD risk, it would not be in the best interest of public health nor consistent with the scientific evidence to imply that selecting diets with soluble fiber from whole oats is a substitute for consuming diets low in saturated fat and cholesterol (id.). Therefore, FDA required that the oat beta-glucan health claim statement include the phrase “diets that are low in saturated fat and cholesterol and that include soluble fiber from * * *” (§ 101.81(c)(2)(i)(A)).

Barley beta-glucan soluble fiber functions comparably to oat beta-glucan soluble fiber in its effect on reducing LDL and total cholesterol. Barley beta-glucan soluble fiber sources are a useful adjunct to selection of diets low in saturated fat and cholesterol to reduce CHD risk. Thus, the agency is requiring the barley beta-glucan health claim to include the information that selection of barley foods containing beta-glucan soluble fiber should “be part of a diet low in saturated fat and cholesterol,” consistent with § 101.81(c)(2)(i)(A). Including a reference to a low saturated fat, low cholesterol diet in the health claim will enable the public to understand the relative significance of the information in the context of a total daily diet (21 U.S.C. 343(r)(3)(A)(iii)).

Specific requirements of the “nature of the claim” paragraph in § 101.81(c)(2)(i) of the soluble fiber from certain foods and risk of CHD health claim include, in part, that the claim specify the daily dietary intake of the soluble fiber source associated with coronary heart disease risk reduction. FDA is amending § 101.81(c)(2)(i)(G)( 1 ) to indicate that the source of the 3 g or more per day of beta-glucan soluble fiber may be from whole oats or barley or a combination of oats and barley. FDA is amending § 101.81(c)(2)(ii)(A) to add barley sources of beta-glucan soluble fiber in addition to whole oat sources. In addition, FDA is amending § 101.81(c)(2)(ii)(A) by adding § 101.81(c)(2)(ii)(A)( 5 ) to list dehulled and hulless whole grain barley and specific dry milled barley products as eligible sources of beta-glucan soluble fiber. The specific dry milled barley products include, barley bran, barley flakes, barley grits, pearl barley, barley flour, barley meal, and sieved barley meal produced from clean, sound dehulled or hulless barley grain using standard dry milling techniques, which may include steaming or tempering. Eligible dehulled and hulless whole grain barley has a beta-glucan soluble fiber content of at least 4 percent (dwb) and a total dietary fiber content of at least 10 percent (dwb). Eligible barley flakes, barley grits, pearl barley, barley flour, and barley meal have a beta-glucan soluble fiber content of at least 4 percent (dwb) and total dietary fiber content of at least 8 percent (dwb). Eligible barley bran and sieved barley meal have a beta-glucan soluble fiber content of at least 5.5 percent (dwb) and total dietary fiber content of at least 15 percent (dwb). FDA is incorporating by reference in new § 101.81(c)(2)(ii)(A)( 5 ) the Barley Glossary (AACC Method 55-99), published in Approved Methods of the American Association of Cereal Chemists, that contains definitions for barley bran, barley flakes, barley flour, barley grits, pearl barley, dehulled barley, and hulless barley. FDA is amending the “nature of the food eligible to bear the claim” paragraph at § 101.81(c)(2)(iii)(A)( 1 ) to indicate that the eligible sources of beta-glucan fiber will include both whole oat and barley foods.

FDA is amending the “optional information” paragraph of this section (at § 101.81(d)(5)) to indicate that the eligible sources of beta-glucan fiber will include both whole oat and barley foods.

We are issuing this rule as an interim final rule, effective immediately, with an opportunity for public comment. Section 403(r)(7) of the act authorizes us to make proposed regulations issued under section 403(r) of the act effective upon publication pending consideration of public comment and publication of a final regulation, if the agency determines that such action is necessary for public health reasons. This authority enables us to act promptly on petitions that provide for information that will help: (1) Enable consumers to develop and maintain healthy dietary practices, (2) enable consumers to be informed promptly and effectively of important new knowledge regarding nutritional and health benefits of food, or (3) ensure that scientifically sound nutritional and health information is provided to consumers as soon as possible. Proposed regulations made effective upon publication under this authority are deemed to be final agency action for purposes of judicial review. The legislative history indicates that such regulations should be issued as interim final rules (H. Conf. Rept. No. 105-399, at 98 (1997)).

We are satisfied that each of the three criteria in section 403(r)(7)(A) of the act have been met in the petition submitted by the National Barley Foods Council. This health claim will enable consumers to develop and maintain healthy dietary practices, such as increasing consumption of foods containing types of soluble dietary fiber shown to help reduce CHD risk. The health claim also will provide consumers with important new knowledge regarding the effects of consuming whole grain barley and dry milled barley products on blood cholesterol, and will provide consumers with scientifically sound information about an additional dietary choice which may help reduce the risk of CHD. Therefore, we are using the authority given to us in section 403(r)(7)(A) of the act to issue an interim final rule authorizing a health claim relating consumption of barley beta-glucan soluble fiber and CHD risk, effectively immediately.

FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period. Interested persons may submit to Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this interim final rule. This regulation is effective upon publication in the Federal Register . The agency will address comments and confirm or amend the interim final rule in a final rule.

FDA has examined the impacts of the interim final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

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). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including having an annual effect on the economy in a material way, adversely affecting competition, or adversely affecting jobs. A regulation is also considered a significant regulatory action if it raises novel legal or policy issues. FDA has determined that this interim final rule is not a significant regulatory action as defined by Executive Order 12866.

Current labeling regulations do not permit foods containing threshold amounts of beta-glucan soluble fiber from the whole grain barley or dry milled barley to claim health benefits that link their intake with a reduction in the risk of CHD. Such claims are authorized for foods containing threshold amounts of beta-glucan soluble fiber-containing whole oat foods, and scientific evidence links consumption of foods with the same amount of beta-glucan soluble fiber from barley with the same health benefits. Allowing foods containing beta-glucan soluble fiber from barley to claim the same health benefits as those containing beta-glucan soluble fiber from whole oats will improve diet-related information available on food labels. Making this information available to consumers may facilitate disease risk-reducing dietary choices.

The regulatory options include: (1) No regulatory action and (2) the interim final rule.

The absence of any regulatory action is considered the baseline option for comparison with the regulatory option. There would be no compliance costs and no benefits in the absence of regulatory action.

a. Benefits from the interim final rule —The benefit from the interim final rule is the reduced CHD risk that may result from consumers' substituting barley foods containing beta-glucan soluble fiber for currently consumed, less healthful alternatives. Heart disease is the leading cause of death and permanent disability in the United States (Ref. 19). The National Center for Health Statistics in the Centers for Disease Control and Prevention (CDC) reports that in 2002 there were approximately 23 million non-institutionalized adults diagnosed with heart disease, resulting in approximately 700,000 deaths. According to the same source, heart disease patients made approximately 20.8 million office-based physician visits and approximately 1.1 million hospital outpatient visits in that year. In addition, there were approximately 4.4 million hospital discharges of heart disease patients, with average lengths of stay of approximately 4.4 days. As an indication of the extent to which this disease is disabling, the CDC reports that approximately 66 percent of heart patients fail to fully recover (Ref. 20).

This interim final rule may result in a reduction in the risk of heart disease by enabling at-risk consumers to make healthier food choices. We first describe the theoretical framework for estimating the increase in the market shares and healthful consumption as a result of this interim final rule. We use results from FDA's 2001 Food Label and Packaging Survey (FLAPS) to compute the total sales of products with health claims from soluble fiber from whole oats to estimate a potential market share of foods containing beta-glucan soluble fiber from barley (Ref. 21). We describe the FLAPS data set, and use the estimated market share of foods claiming health benefits from beta-glucan soluble fiber from barley as the upper bound for the increase in healthful consumption from this interim final rule. We account for existing consumption of foods that are equally as healthful as the new foods containing beta-glucan soluble fiber from barley to adjust the upper bound in order to estimate the increase in healthful food consumption. We then suggest a link between any estimated increase in healthful food consumption and a reduction in the incidence of CHD. Finally, we suggest further adjustments to any estimated reductions in health risks from more healthful food consumption based on an assumed uneven distribution of diet-related health risks across the population.

We assume that prices, taste, and health attributes determine consumer demand for food products within a food group, and that an increase in the consumer demand for an item within a food group results in an offsetting decrease in demand for other items within that group. In addition, we assume that an increase in the consumption of healthful products in the aggregate may result if there is a decrease in the relative price of healthful products compared with products in general. However, a decrease in the relative price of one healthful product may also result in a decrease in the demand for other healthful products.

We assume that the total sales of products within a general product group remain constant, so any increase in consumption of healthful products as a result of this interim final rule would be offset by a decrease in consumption of other products within the same product group; these other products may be more, less, or equally healthful. To the extent that aggregate consumption of products from an entire product group increases, aggregate consumption of products from other groups will decrease. In this analysis, however, we do not consider the effects of changes in aggregate consumption of product groups that do not contain products with health claims.

We use results from FDA's 2001 FLAPS to estimate the increase in market shares of foods containing beta-glucan soluble fiber from barley (Ref. 21). The 2001 FLAPS survey contains label information on 1,281 products selected from 238 food types from 57 food groups. The information includes detailed descriptions of the labels including any health claims, structure-and-function claims, and nutrient content claims. We combine the label information with total sales information obtained from the Information Resources Incorporated (IRI) data used to design the sampling methodology for the FLAPS survey to estimate that products with health claims that link fiber from whole oats to reduced risk from CHD account for approximately 0.6 percent of all product sales. Moreover, products with these health claims are concentrated in the hot and cold cereals product groups: 5.1 percent of sales of cold cereals and 75.5 percent of sales of hot cereals claim these health benefits.

We acknowledge the potential sampling bias in the FLAPS survey, which selects brand name products with the largest sales within a product group. This sampling method likely overestimates the prevalence of health claims on labels (because large brand names may be more likely to make claims than their smaller, less-known competitors). However, FLAPS sampled these products because they represent an overwhelming share of total sales within their product groups. Consequently, the effect of the overestimation bias on the estimated consumption (and resulting health benefits) of healthier products may be small.

We characterize the uncertainty in the FLAPS estimates by assuming that the true percentages of sales of cold and hot and cereal products that currently make fiber from oats health claims are distributed lognormally with means of 75.5 percent and 5.1 percent (i.e., the estimates reported from the FLAPS data), both with variances of 10 percent relative to their means. The lognormal distribution is appropriate to use since it incorporates the idea that the true market shares of cold and hot cereal products that currently make health claims about fiber from oats is not too different from the mean estimate computed using FLAPS as would be implied by the use of a normal distribution. The parameters that describe the lognormal distribution are the natural logarithms of the mean and variance of a normal distribution.

Manufacturers may formulate new products to use barley as a principal ingredient if the ability to claim health benefits makes this option profitable. In addition, we assume current products with threshold amounts of beta-glucan soluble fiber from barley would be able to make the health claim if they incur the cost of changing labels. We do not know how many current products would use the health claim, and we do not know how many new products would be formulated to use the claim. We assume that the current market shares of products that claim health benefits from soluble fiber from oats can be used to estimate of the potential market share for products likely to claim health benefits from soluble fiber from barley.

We first assume that the potential market share from newly formulated cold cereals and hot cereals that claim health benefits from soluble fiber from barley would result from sales that would have otherwise been for less-healthful alternatives. We also assume that the potential market shares of newly formulated hot cereals and cold cereals claiming health benefits from soluble fiber from barley would be no larger than those for hot cereals and cold cereals currently claiming health benefits from soluble fiber from oats. Consequently, we estimate that the potential market share of hot cereals that claim health benefits from soluble fiber from barley would be 24.5 percent of the market for all hot cereals, and that the potential market share of cold cereals that claim benefits from soluble fiber from barley would be 5.1 percent of the market for all cold cereals.

The increases in market shares of more healthful food products may be less than that reflected in the potential market shares estimated previously if consumers of newly formulated and labeled hot and cold cereals claiming health benefits from soluble fiber from barley would have otherwise selected hot and cold cereals currently claiming health benefits from soluble fiber from oats. Increases in market shares of healthful food products may also be less than those reflected by the potential market shares estimated previously if consumers of newly formulated and labeled hot and cold cereals claiming health benefits from soluble fiber from barley would have otherwise selected existing hot and cold cereals that contain the threshold level of beta- glucan soluble fiber from barley but are currently not allowed to make a health claim. We assume that half of the estimated potential market shares of newly formulated and labeled hot and cold cereals claiming health benefits from soluble fiber from barley would reflect purchases by consumers who otherwise would have selected hot and cold cereals currently claiming health benefits from soluble fiber from oats. We further assume that half of the remaining sales of newly formulated and labeled barley products would reflect purchases of existing products that contain the threshold level of beta-glucan soluble fiber from barley but are not currently allowed to make a health claim. Consequently, we estimate that one-quarter (i.e., one-half times one-half) of the potential market shares of newly formulated barley products would reflect purchases by consumers who otherwise would have selected less-healthful hot and cold cereal alternatives, or 1.3 percent of the cold cereal market (i.e., 0.25 times 5.1 percent), and 6.1 percent of the hot cereal market (i.e., 0.25 times 24.5 percent) would reflect increases in healthful food purchases as a result of this interim final rule.

To characterize the uncertainty in our methods, we assume that the estimates of the percent increases in market shares of healthful hot and cold cereal products due to this interim final rule are uniformly distributed with minimums equal to one-half of the previously estimated increases in healthful sales, and maximums of one and one-half times the previously estimated increases in healthful sales. Consequently, we estimate a range of between 0.5 to 2 percent with a mean of 1 percent (rounded to the nearest half-percent) increase in market share of more healthful cold cereal products, and between 3 and 9 percent with a mean of 6 percent (rounded to the nearest half-percent) increase in the market share of more healthful hot cereal products as a result of this interim final rule. We assume that increases in market shares of more healthful food products containing threshold levels of beta-glucan soluble fiber from barley would reflect more healthful food consumption which may decrease the risk of diet-related disease, including CHD.

The increase in healthful consumption by those consumers not at risk for diet-related diseases, including CHD, may mitigate the health benefits from the estimated increase in healthful consumption. As suggested earlier, healthful characteristics are just one of several considerations, including taste and price, consumers use when making food purchases. Consumers who choose newly formulated barley products over less healthful alternatives may include both those at risk of these diseases as well as those who are not at risk. We assume that those who are at risk of CHD will contribute to half of the increase in the healthful consumption of hot and cold cereal products. Consequently, we estimate an increase in healthful consumption of cold cereals by consumers who are at risk for CHD to be between 0.25 and 1 percent, with a mean of 0.5 percent of that market, and an increase in healthful consumption of hot cereals by consumers who are at risk for CHD to be between 1.5 and 4.5 percent with a mean of 3 percent of that market due to this interim final rule.

Finally, the incremental expansion of the health claim for foods that contain psyllium seed husk and beta-glucan soluble fiber from oats to include beta-glucan soluble fiber from barley raises the possibility that soluble fiber from other grains may also result in the same health benefits. In this analysis we have assumed that hot and cold cereal products that currently do not claim health benefits from soluble fiber from oats are less healthful than those that do make that claim. To the extent that hot and cold cereals contain threshold quantities of soluble fiber from other grains that reduce the risk for CHD, in addition to barley, yet are not permitted to make health claims, the changes in healthful consumption estimated for this interim final rule may be overstated. In the extreme case, if all current hot and cold cereal products were manufactured with grains having identical health benefits as those from beta-glucan soluble fiber from oats and barley, then the health benefits from allowing soluble fiber from barley to claim health benefits estimated for the interim final rule would be zero, because consumers would switch among equally healthful alternatives.

b. Costs —The costs incurred by manufacturers of foods that are newly developed or relabeled to claim health benefits from soluble fiber from barley would be voluntarily incurred. No manufacturer would incur these costs if it were not profitable to do so and, consequently they are not considered mandatory compliance costs. Nevertheless, we do anticipate a voluntarily incurred allocation of resources devoted to re-labeling and new product development as a result of this interim final rule, and that the magnitude of this resource allocation is important for characterizing the broader economic impact on society. We refer to these voluntarily incurred costs as change-over costs.

Although the mandatory compliance costs of this interim final rule are zero, the voluntarily incurred change-over costs that would result include costs of re-labeling products that contain threshold levels of beta-glucan soluble fiber from barley but are currently not allowed to claim health benefits, as well as the costs for developing products specifically to make the soluble fiber from barley health claim. The new product development change-over costs include the costs of idea generation, laboratory testing of new recipes that meet the threshold levels of beta-glucan soluble fiber from barley, process testing, shelf life studies, production related market research, production testing in increasingly large batch sizes, and consumer testing and marketing evaluations. At any stage in the development process a product may be dropped from consideration. Products that undergo a portion of the process but that are eventually dropped from consideration also constitute a new product development cost. Re-labeling change-over costs for products that contain threshold amounts of beta-glucan soluble fiber from barley but are currently not allowed to claim health benefits, include the costs of testing food products to verify that the levels of beta-glucan soluble fiber are consistent with that required for the health claim, the fixed and variable printing costs for the new label, and the storage costs associated with disposing old labels.

We use the FDA Reformulation Cost Model (Ref. 22) and the FDA Labeling Cost Model (Ref. 23) to estimate the new product development and labeling change-over costs from making health claims for beta-glucan soluble fiber from barley. Data on industry categories that are available to use in these models include from the North American Industry Classification System (NAICS) code 311230, Breakfast Cereals Manufacturing which includes both hot and cold cereals. Based on the earlier results, we estimate that the potential market shares for breakfast cereals that claim health benefits from soluble fiber from barley would be 24.5 percent of the market for all hot cereals, and 5.1 percent of the market for all cold cereals.

In order to separate the broad NAICS category into hot and cold cereals, we use estimates obtained from the FLAPS and IRI data sets indicating cold cereal sales of approximately $6.5 billion, and hot cereals sales of approximately $0.6 billion (Ref. 21). Consequently, the hot cereal market is approximately 8 percent (i.e., 100 x $0.6 billion / $7.1 billion) of the size of the breakfast cereals market, and the cold cereal market is approximately 92 percent (i.e., 100 x $6.5 billion / $7.1 billion) of the breakfast cereals market. In addition, we estimate that approximately 5 percent (i.e., 5.1 percent x 92 percent rounded to the nearest percent) of the sales from NAICS 311230 reflects the market share of cold cereals that would claim health benefits from barley, and that 2 percent (i.e., 24.5 percent x 8 percent rounded to the nearest percent) of the sales from NAICS 311230 reflects that market share of hot cereals that would claim health benefits from barley. Consequently, we estimate that 7 percent of NAICS 311230 (i.e., 5 percent plus 2 percent) would either develop new products or re-label existing products in order to claim health benefits from beta-glucan soluble fiber from barley.

Based on the earlier discussion, we expect that one-half of all hot and cold cereals that would claim health benefits from soluble fiber from barley would be newly developed products (i.e., 3.5 percent of NAICS 311230), while one-half would be re-labeled existing products (i.e., 3.5 percent of NAICS 311230) that currently meet the soluble fiber from barley content requirements for making a health claim. To incorporate uncertainty surrounding our methodology, we estimate a uniform distribution between 2 and 5 percent of NAICS 311230 would re-label and between 2 and 5 percent of NAICS 311230 would be from new products developed in order to claim health benefits from soluble fiber from barley.

We ran the Reformulation Cost Model for the case when major production process changes are necessary to approximate the change-over costs for new product development. These costs were estimated assuming a 12-month voluntary compliance period. We assume that product lines would become discontinued as a result of this interim final rule due to insufficient consumer demand, reflecting the assumption that growth in total breakfast cereal consumption will not change. However, we do not estimate the costs of discontinued product lines. High, low and medium estimates are generated from the model based on experts opinions, and are reported in table 1 for assumed market shares of 2 percent 3.5 percent, and 5 percent of the sales of breakfast cereals from new products developed to claim health benefits from soluble fiber from barley.

We ran the Labeling Cost Model assuming a 12-month voluntary compliance period to estimate the change-over costs for re-labeling existing products that meet the soluble fiber from barley requirements but are currently unable to claim health benefits. High, low and medium estimates of the change-over costs are generated from the model based on experts opinions, and are reported in table 2 for assumed market shares of 2 percent 3.5 percent, and 5 percent of the sales of breakfast cereals from re-labeled products.

In table 3 we report the annualized voluntarily incurred change-over costs for the interim final rule computed assuming discount rates of 3 percent and 7 percent over a 10-year horizon. All costs are assumed to be incurred in the beginning of the second year following promulgation of the interim final rule and there would be no recurring annual change-over costs after the second year. The low, medium, and high estimates for the voluntarily incurred re-labeling and new product development change-over costs were added together, and the appropriate discount rate applied. This total cost was then divided by 10 to get the annualized costs. Because producers choose the time period for the development and re-labeling of new products, the actual time periods for the changes can be different from the assumed 12 months assumed in the models and reported in the tables. We expect that the time periods chosen would be shorter and the voluntarily incurred costs higher, the greater the perceived consumer response to the health claims from soluble fiber from barley.

Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501, filed NADA 141-247 for CYDECTIN (moxidectin) Oral Drench for Sheep, used for the treatment and control of various internal parasites in sheep. The NADA is approved as of November 30, 2005, and the regulations are amended in part 520 (21 CFR part 520) by adding § 520.1454 and in part 556 (21 CFR part 556) by revising § 556.426 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 573(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2), this approval qualifies for 7 years of exclusive marketing rights beginning November 30, 2005, because the new animal drug has been declared a designated new animal drug by FDA under section 573(a) of the act.

FDA has determined under 21 CFR 25.33(d)(4) that this action is of a 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.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

In 1994, the Attorney General established a Professional Responsibility Office (PRO) Program and the Professional Responsibility Advisory Board to assist Department attorneys in resolving professional responsibility issues. Over time, experience and a number of developments have emphasized the importance of creating a centralized resource for Department attorneys and PROs. Thus, on March 30, 1999, the Attorney General created the Professional Responsibility Advisory Office (PRAO) to coordinate the Department's position regarding various professional responsibility issues and to ensure that the advice and guidance provided to Department attorneys and the PROs are correct and consistent throughout the United States.

The PRAO serves several functions. It provides definitive advice to Department attorneys on issues relating to professional responsibility. It is responsible for assembling and maintaining reference materials, including the codes of ethics and relevant interpretative decisions and bar opinions of the District of Columbia and every state and territory, and for serving as a central repository for briefs and pleadings as cases arise. The PRAO provides coordination with the litigating components of the Department to defend attorneys in any disciplinary or other hearing in which it is alleged that they failed to meet their obligations under applicable rules of professional conduct. It coordinates with other Department components to conduct training for Department attorneys and client agencies to provide them with the tools to make informed judgments about matters which implicate professional responsibility issues. The PRAO serves as liaison with the state and federal bar associations in matters related to the implementation of Section 530B of title 28 of the United States Code pertaining to ethical standards for attorneys for the government, and amendments and revisions to the various rules of professional conduct. The PRAO also serves as advisory counsel on professional responsibility to the Attorney General, the Deputy Attorney General, the Associate Attorney General, the Solicitor General, and their designees, and to the Attorney General's Advisory Committee. Nothing in the final rule shall be construed as affecting the functions or overriding the authority of the Office of Legal Counsel as established by 28 CFR 0.25.

This rule is a rule of agency organization and is therefore exempt from the notice requirement of 5 U.S.C. 553(b), and is made effective upon issuance.

The Attorney General in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities because it pertains to personnel and administrative matters affecting the Department. A Regulatory Flexibility Analysis was not required to be prepared for this final rule since the Department was not required to publish a general notice of proposed rulemaking for this matter.

This action has been drafted and reviewed in accordance with Executive Order 12866 Regulatory Planning and Review, § 1(b), Principles of Regulation. This rule is limited to agency organization, management and personnel as described by Executive Order 12866 § 3(d)(3) and, therefore, is not a “regulation” or “rule” as defined by its Executive Order. Accordingly, this action has not been reviewed by the Office of Management and Budget.

This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant a certification.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This action pertains to agency management, personnel and organizations and does not substantially affect the rights or obligations of non-agency parties and, accordingly, is not a “rule” as that term is used by the Congressional Review Act (Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996). Therefore, the reporting requirement of 5 U.S.C. 801 does not apply.

On September 12, 2005 (70 FR 53746), EPA proposed approval of a redesignation request and maintenance plan submitted by the Commonwealth of Virginia for the Fredericksburg area. On September 30, 2005 (70 FR 57238), EPA withdrew the September 12, 2005 proposed rule.

On November 2, 2005 (70 FR 66316), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Virginia. The NPR proposed approval of both Virginia's redesignation request and a SIP revision that establishes a maintenance plan for the Fredericksburg area that sets forth how the Fredericksburg area will maintain attainment of the 8-hour ozone NAAQS for the next 10 years. The formal SIP revision was submitted by the VADEQ on May 2, 2005 and May 4, 2005. Other specific requirements of Virginia's redesignation request SIP revision for the maintenance plan, and the rationale for EPA's proposed action are explained in the NPR and will not be restated here. No public comments were received on the NPR.

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information (1) that are generated or developed before the commencement of a voluntary environmental assessment; (2) that are prepared independently of the assessment process; (3) that demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts * * *.” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the Clean Air Act, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the Clean Air Act is likewise unaffected by this, or any, state audit privilege or immunity law.

EPA is approving the Commonwealth of Virginia's May 2, 2005 redesignation request and May 4, 2005 maintenance plan because the requirements for approval have been satisfied. EPA has evaluated Virginia's redesignation request, submitted on May 2, 2005, and determined that it meets the redesignation criteria set forth in section 107(d)(3)(E) of the CAA. EPA believes that the redesignation request and monitoring data demonstrate that the Fredericksburg area has attained the 8-hour ozone standard. The final approval of this redesignation request will change the designation of the Fredericksburg area from nonattainment to attainment for the 8-hour ozone standard. EPA is approving the associated maintenance plan for this area, submitted on May 4, 2005, as a revision to the Virginia SIP. EPA is approving the maintenance plan for the Fredericksburg area because it meets the requirements of section 175A. EPA is also approving the MVEBs submitted by Virginia for this area in conjunction with its redesignation request. The Fredericksburg area is subject to the CAA's requirements for moderate ozone nonattainment areas until and unless it is redesignated to attainment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Redesignation of an area to attainment under section 107(d)(3)(e) of the Clean Air Act does not impose any new requirements on small entities. Redesignation is an action that affects the status of a geographical area and does not impose any new regulatory requirements on sources. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely proposes to affect the status of a geographical area, does not impose any new requirements on sources, or allow the state to avoid adopting or implementing other requirements, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Redesignation is an action that affects the status of a geographical area and does not impose any new requirements on sources. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued under the executive order.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 21, 2006. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

This action, to approve the redesignation request, maintenance plan and adequacy determination for MVEBs for the Fredericksburg area, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

The contents of today's preamble are listed in the following outline:

A delisting petition is a request made by a hazardous waste generator to exclude one or more of his/her wastes from the lists of RCRA-regulated hazardous wastes in §§ 261.31, 261.32, and 261.33 of Title 40 of the Code of Federal Regulations (40 CFR 261.31, 261.32, and 261.33). The regulatory requirements for a delisting petition are in 40 CFR 260.20 and 260.22. EPA, Region 6 has prepared a guidance manual, Region 6 Guidance Manual for the Petitioner, which is recommended by EPA Headquarters in Washington, DC and all EPA Regions, and can be down-loaded from Region 6's Web Site at the following URL address: http://www.epa.gov/earth1r6/6pd/rcra_c/pd-o/dlistpdf.htm.

On January 16, 1981, as part of its final and interim final regulations implementing section 3001 of RCRA, EPA published an amended list of hazardous wastes from non-specific and specific sources. This list has been amended several times, and is published in 40 CFR 261.31 and 261.32. These wastes are listed as hazardous because they exhibit one or more of the characteristics of hazardous wastes identified in subpart C of part 261 (i.e., ignitability, corrosivity, reactivity, and toxicity) or meet the criteria for listing contained in § 261.11(a)(2) or (a)(3). Discarded commercial chemical product wastes which meet the listing criteria are listed in § 261.33(e) and (f).

Individual waste streams may vary, however, depending on raw materials, industrial processes, and other factors. Thus, while a waste that is described in these regulations generally is hazardous, a specific waste from an individual facility meeting the listing description may not be.

For this reason, §§ 260.20 and 260.22 provide an exclusion procedure, allowing persons to demonstrate that a specific waste from a particular generating facility should not be regulated as a hazardous waste.

To have their wastes excluded, petitioners must show, first, that wastes generated at their facilities do not meet any of the criteria for which the wastes were listed. See § 260.22(a) and the background documents for the listed wastes. Second, the Administrator must determine, where he/she has a reasonable basis to believe that factors (including additional constituents) other than those for which the waste was listed could cause the waste to be a hazardous waste, that such factors do not warrant retaining the waste as a hazardous waste. Accordingly, a petitioner also must demonstrate that the waste does not exhibit any of the hazardous waste characteristics (i.e., ignitability, reactivity, corrosivity, and toxicity), and must present sufficient information for the EPA to determine whether the waste contains any other toxicants at hazardous levels. See § 260.22(a), 42 U.S.C. 6921(f), and the background documents for the listed wastes. Although wastes which are “delisted” (i.e., excluded) have been evaluated to determine whether or not they exhibit any of the characteristics of hazardous waste, generators remain obligated under RCRA to determine whether or not their wastes continue to be nonhazardous based on the hazardous waste characteristics (i.e., characteristics which may be promulgated subsequent to a delisting decision.).

In addition, residues from the treatment, storage, or disposal of listed hazardous wastes and mixtures containing listed hazardous wastes are also considered hazardous wastes. See 40 CFR 261.3(a)(2)(iv) and (c)(2)(i), referred to as the “mixture” and “derived-from” rules, respectively.

Such wastes are also eligible for exclusion and remain hazardous wastes until excluded. On December 6, 1991, the U.S. Court of Appeals for the District of Columbia vacated the “mixture/derived-from” rules and remanded them to the EPA on procedural grounds. Shell Oil Co. v. EPA, 950 F.2d 741 (D.C. Cir. 1991). On March 3, 1992, EPA reinstated the mixture and derived-from rules, and solicited comments on other ways to regulate waste mixtures and residues (57 FR 7628). These rules became final on October 30, 1992 (57 FR 49278), and should be consulted for more information regarding waste mixtures and solid wastes derived from treatment, storage, or disposal of a hazardous waste. The mixture and derived-from rules are codified in 40 CFR 261.3 (b)(2) and (c)(2)(i). EPA plans to address waste mixtures and residues when the final portion of the Hazardous Waste Identification Rule (HWIR) is promulgated. On October 10, 1995, the Administrator delegated to the Regional Administrators the authority to evaluate and approve or deny petitions submitted in accordance with §§ 260.20 and 260.22 by generators within their Regions (National Delegation of Authority 8-19) in States not yet authorized to administer a delisting program in lieu of the Federal program. On March 11, 1996, the Regional Administrator of EPA, Region 4, redelegated delisting authority to the Director of the Waste Management Division (Regional Delegation of Authority 8-19).

Saturn manufactures Saturn automobiles, and is seeking a delisting for the WWTP sludge generated from conversion coating on aluminum. The WWTP sludge does not meet a hazardous waste listing definition when steel-only automobile bodies are manufactured. However, the wastewater treatment sludge generated at automobile manufacturing plants where aluminum is used as a component of automobile bodies, meets the listing definition F019 in § 261.31.

Saturn petitioned EPA, Region 4, on December 13, 2004, to exclude this F019 waste on a generator-specific basis from the lists of hazardous wastes in 40 CFR part 261, subpart D.

The hazardous constituents of concern for which F019 was listed are hexavalent chromium and cyanide (complexed). Saturn petitioned the EPA to exclude its F019 waste because Saturn does not use either of these constituents in the manufacturing process. Therefore, Saturn does not believe that the waste meets the criteria of the listing. Saturn claims that its F019 waste will not be hazardous because the constituents of concern for which F019 is listed will be present only at low concentrations and will not leach out of the waste at significant concentrations. Saturn also believes that this waste will not be hazardous for any other reason (i.e., there will be no additional constituents or factors that could cause the waste to be hazardous). Review of this petition included consideration of the original listing criteria, as well as the additional factors required by the Hazardous and Solid Waste Amendments (HSWA) of 1984. See section 222 of HSWA, 42 U.S.C. 6921(f), and 40 CFR 260.22(d)(2)-(4). As a result of the EPA's evaluation of Saturn's petition, the Agency is granting a delisting to Saturn with conditions described below, on December 23, 2005. Today's rulemaking addresses public comments received on the proposed rule and finalizes the proposed decision to grant Saturn's petition for delisting.

Saturn petitioned EPA, Region 4, on December 13, 2004, to exclude a maximum annual weight of 3,000 cubic yards of its F019 waste, on a generator-specific basis, from the lists of hazardous wastes in 40 CFR part 261, subpart D. Saturn manufactures Saturn automobiles, and is seeking a delisting for the WWTP sludge that will be generated by treating wastewater from Saturn's chemical conversion coating of aluminum.

In support of its petition, also described in the proposed rule on August 31, 2005 (see 70 FR 51696-51705, August 31, 2005), Saturn has submitted laboratory analysis of its WWTP sludge. The laboratory analysis submitted includes the following: (1) Analysis performed on samples of its dewatered WWTP sludge taken and analyzed by EPA (2) analysis of the dewatered WWTP sludge performed by Saturn on split samples provided to the facility by EPA and (3) analysis of the dewatered WWTP sludge performed by Saturn on samples taken by the facility.

The analysis performed by Saturn on the split samples of the WWTP sludge provided to the facility by EPA was submitted for laboratory testing for the entire 40 CFR part 264 Appendix IX constituent list (including volatile organic compounds (VOCs), semi-volatile organic compounds (SVOCs), metals, and PCBs) and hexavalent chromium, TCLP metals, cyanide, and total solids. Based on the laboratory data, data validation results, and Saturn's communications with the EPA, Saturn prepared a Sampling and Analysis Plan which was submitted to the EPA and approved.

In accordance with the approved Sampling and Analysis Plan and to support its petition, Saturn collected additional WWTP sludge samples for laboratory testing. The samples were collected from six roll-off containers representing waste generated at Saturn over a seven-week period. The samples were analyzed as follows: (1) Samples for VOC analyses (total and TCLP) were collected from six roll-off containers. The first sample was analyzed for the 40 CFR part 264 Appendix IX VOC constituent list (total and TCLP). VOCs (total and TCLP) detected in the first sample were tested in the samples collected from the second through the sixth roll-off containers. (2) Samples from the six roll-off containers were analyzed for total and TCLP bis(2-ethylhexyl)phthalate. (3) Samples from the six roll-off containers were analyzed for total and TCLP metals (antimony, arsenic, barium, beryllium, chromium, cobalt, copper, lead, mercury, nickel, thallium, tin, vanadium, and zinc) and for hexavalent chromium. (4) Samples from the six roll-off containers were analyzed for corrosivity, total and TCLP cyanide, ignitability, sulfide, oil and grease, and total solids. The Toxicity Characteristic Leaching Procedure (TCLP), SW-846 Method 1311, was used as the extraction procedure for testing the volatile and semi-volatile constituents of concerns. Leachable metals were tested using the Extraction Procedure for Oily Wastes (OWEP), SW-846 Method 1330A. The pH of each sample was measured using SW-846 Method 9045C, and a determination was made that the waste was not ignitable, corrosive, or reactive (see 40 CFR 261.21-261.23). Oil and grease was analyzed using SW-846 Method 9071B, total sulfide was tested using SW-846 Method 9034, and total cyanide was performed using Method SW-846 Method 9012A.

Composite and grab samples of dewatered WWTP sludge were collected in accordance with the approved Sampling and Analysis Plan on August 19, 2004 and submitted for laboratory testing.

Upon receipt of the laboratory testing results, the data was validated by a third party. The maximum values of constituents detected in any sample of the WWTP sludge or in a TCLP extract of the WWTP sludge are summarized in Table 1.

For reasons stated in both the proposal and this final rule, EPA believes that Saturn's petitioned waste should be excluded from hazardous waste control. EPA, therefore, is granting a final generator-specific exclusion to Saturn, of Spring Hill, Tennessee, for a maximum annual generation rate of 3,000 cubic yards of the waste described in its petition as EPA Hazardous Waste Number F019. This waste is required to undergo verification testing before being considered as excluded from Subtitle C regulation. Requirements for waste to be land disposed have been included in this exclusion. The exclusion applies only to the waste as described in Saturn's petition, dated December 2004.

Although management of the waste covered by this petition is relieved from Subtitle C jurisdiction, the generator of the delisted waste must either treat, store, or dispose of the waste in an on-site facility, or ensure that the waste is delivered to an off-site storage, treatment, or disposal facility, either of which is permitted, licensed or registered by a State to manage municipal or industrial solid waste. Alternatively, the delisted waste may be delivered to a facility that beneficially uses or reuses, or legitimately recycles or reclaims the waste, or treats the waste prior to such beneficial use, reuse, recycling, or reclamation. See 40 CFR part 260, appendix I. Nonhazardous waste management is subject to all applicable Federal, state, and local regulations.

In the rule proposed on August 31, 2005 (see 70 FR 51696-51705, August 31, 2005), delisting levels were calculated using the Delisting Risk Assessment Software program (DRAS), a Windows-based software tool. The DRAS estimated the potential release of hazardous constituents from the petitioned waste and predicted the risk associated with those releases. The DRAS uses EPA's Composite Model for Leachate Migration with Transformation Products (EPACMTP) to predict the potential for release of hazardous constituents to groundwater from landfilled wastes and subsequent potential routes of exposure to a receptor. In the DRAS model, the EPA used the maximum estimated waste volume and maximum reported total and leachate concentrations in the groundwater, soil, surface water or air. The DRAS program back calculated a maximum allowable concentration level that would not exceed protective levels in both the waste and the leachate for each constituent at the annual waste volume of 3,000 cubic yards.

The maximum allowable levels for constituents detected in the WWTP sludge or the leachate from the sludge are summarized in Table 1, above. Table 1 also includes the maximum allowable levels in groundwater at a potential receptor well, as evaluated by the DRAS.

In conclusion, Saturn must dispose of the WWTP sludge in a lined Subtitle D landfill which is permitted, licensed, or registered by a State to manage industrial waste. This exclusion applies only to a maximum annual volume of 3,000 cubic yards and is effective only if all conditions contained in this rule are satisfied. Specifically, concentrations measured in the TCLP (or OWEP, where appropriate) extract of Saturn's WWTP sludge must not exceed the following levels (mg/l): antimony—0.494; arsenic—0.224; total chromium—3.71; lead—5.0; nickel—68; thallium—0.211; and zinc—673.

If Saturn violates the terms and conditions established in the exclusion, the EPA will initiate procedures to withdraw the exclusion. Where there is an immediate threat to human health and the environment, the EPA will evaluate the need for enforcement activities on a case-by-case basis.

This rule is effective on December 23, 2005. The Hazardous and Solid Waste Amendments of 1984 amended section 3010 of RCRA to allow rules to become effective in less than six months when the regulated community does not need the six-month period to come into compliance. That is the case here, because this rule reduces the existing requirements for persons generating hazardous wastes. In light of the unnecessary hardship and expense that would be imposed on this petitioner by an effective date six months after publication and the fact that a six-month deadline is not necessary to achieve the purpose of section 3010, EPA believes that this exclusion should be effective immediately upon final publication.

These reasons also provide a basis for making this rule effective immediately, upon final publication, under the Administrative Procedure Act, pursuant to 5 U.S.C. 553(d).

The final exclusion being granted today is issued under the Federal RCRA delisting program. States, however, are allowed to impose their own non-RCRA regulatory requirements that are more stringent than EPA's, pursuant to section 3009 of RCRA. These more stringent requirements may include a provision which prohibits a Federally-issued exclusion from taking effect in the States. Because a petitioner's waste may be regulated under a dual system (i.e., both Federal (RCRA) and State (non-RCRA) programs), petitioners are urged to contact State regulatory authorities to determine the current status of their wastes under the State laws.

Furthermore, some States are authorized to administer a delisting program in lieu of the Federal program, i.e., to make their own delisting decisions. Therefore, this exclusion does not apply in those authorized States. If the petitioned waste will be transported to and managed in any State with delisting authorization, Saturn must obtain delisting authorization from that State before the waste may be managed as nonhazardous in that State.

EPA received public comments on the proposed rule published in 70 FR 51696-51705, August 31, 2005, from Saturn Corporation, Spring Hill, Tennessee (Saturn), the petitioner, and Alliance of Automobile Manufacturers, Washington, DC.

Comment: Saturn stated that it supports EPA's efforts to delist the WWTP sludge generated at its Spring Hill, Tennessee facility. In addition to its support, Saturn also highlighted a few minor typing errors as well as a few minor wording changes for clarification concerning the quarterly verification sampling in Table 1 of Appendix IX to part 261 as well as the submittals of the quarterly and annual sampling verification testing in Table 1 of Appendix IX to Part 261.

Response: EPA incorporated Saturn's suggested minor typing errors and clarifications into today's final rule.

Comment: Alliance of Automobile Manufacturers state that it is also in support of EPA in granting this delisting petition and that it believes that the F019 listing itself should be revised to exclude wastewater treatment sludges from automotive industry conversion coating on aluminum when hexavalent chromium and cyanides are not used in the process.

Response: Today's final rule is site-specific and waste-specific; it applies only to Saturn's plant in Spring Hill, Tennessee, and only to the petitioned waste. A revision of the F019 listing would require a separate rule-making. EPA understands the Alliance's concern about the need to revise the F019 listing, but is unable to address this concern at this time.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a rule of general applicability and therefore is not a “regulatory action” subject to review by the Office of Management and Budget. Because this action is a rule of particular applicability relating to a facility, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), or to sections 202, 204, and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Because the rule will affect only one facility, it will not significantly or uniquely affect small governments, as specified in section 203 of UMRA, or communities of tribal governments, as specified in Executive Order 13084 (63 FR 27655, May 10, 1998). For the same reason, this rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant. This rule does not involve technical standards; thus, the requirements of section 12(c) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

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

Under Executive Order 12875, EPA may not issue a regulation that is not required by statute and that creates a mandate upon a state, local, or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments. If the mandate is unfunded, EPA must provide to the Office of Management and Budget a description of the extent of EPA's prior consultation with representatives of affected state, local, and tribal governments, the nature of their concerns, copies of written communications from the governments, and a statement supporting the need to issue the regulation. In addition, Executive Order 12875 requires EPA to develop an effective process permitting elected officials and other representatives of state, local, and tribal governments “to provide meaningful and timely input in the development of regulatory proposals containing significant unfunded mandates.” Today's rule does not create a mandate on state, local or tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 1(a) of Executive Order 12875 do not apply to this rule.

When HHS first established its Departmental Grant Appeals Board (now the Departmental Appeals Board), there was no provision for the Department's subordinate agencies to first review the disputed actions of officials prior to appeal at the Departmental level. However, it quickly became apparent that a number of disputes could, and would, be resolved quickly by informal means if the grantees' complaints were surfaced to management levels within the HHS subordinate agencies. As a result, the regulations at 45 CFR part 16 were revised to permit subordinate agencies to interpose an “informal” level of appeal prior to submission of an appeal to the Departmental Appeals Board. Various agencies in the Public Health Service (which has since been reorganized) instituted an intermediate informal review process as is currently described in 42 CFR part 50, subpart D. The intermediate level of appeal provided these agencies with an opportunity to relatively quickly and economically reverse erroneous Federal decisions, or to reassure grantees that a decision adverse to them was indeed an “agency” decision. At the time these regulations were instituted, this informal process was of significant benefit to both grantees and the subordinate agencies. Based on the lessons learned from this process and other means, HRSA instituted a policy of reviewing carefully the adverse determinations of their employees prior to permitting them to be issued so as to avoid erroneous determinations which would be subject to reversal upon appeal at the informal level. HRSA believes that it has reached the point where the adverse determinations being issued in recent years generally represent its best judgment.

HHS therefore believes that, for these agencies and their grantees, this informal process is no longer of benefit, and the cost in time and expense to the grantee is no longer warranted. Consequently, HHS proposed amending 42 CFR part 50, subpart D, to remove HRSA from the list of agencies to which the regulations apply. As a result, under this proposal, grantees wishing to appeal HRSA's eligible adverse determinations would be entitled to appeal such determinations directly to the Departmental Appeals Board.

We announced our plans to amend the current regulations in a notice of proposed rulemaking (NPRM) published in the Federal Register , June 7, 2005 (70 FR 33053-33054). The NPRM provide for a sixty-day comment period. We received no comments. Consequently, the final rule is the same as the proposed rule published in June of this year.

We provide the following information for the public.

Executive Order (EO) 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits. We have determined that the rule is not a significant regulatory action under Section 3(f) of the EO and does not require an assessment of the potential costs and benefits under section 6(a)(3) of that EO. Under the EO, the Office of Management and Budget (OMB) has exempted it from review.

The Regulatory Flexibility Act (5 U.S.C. Chapter 6) requires that regulatory actions be analyzed to determine whether they will have a significant impact on a substantial number of small entities. We have determined that this is not a “major” rule under this Act and therefore does not require a regulatory flexibility analysis.

The Unfunded Mandates Reform Act requires that agencies prepare an assessment of anticipated costs and benefits before developing any rule that may result in an expenditure by States, local or tribal governments, or by the private sector of $100 million or more in any given year. This rule does not have cost implications for the economy of $100 million or more, nor otherwise meet the criteria for a major rule under Executive Order 12291, and therefore does not require a regulation impact analysis.

Executive Order 13132 requires that Federal agencies consult with State and local government officials in the development of regulatory policies with federalism implications. We received no comments.

Executive Order 13175 requires the Department to develop an accountable process to ensure Ameaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” We received no comments.

There are no new paperwork requirements subject to the Office of Management and Budget approval under the Paperwork Reduction Act of 1995.

On August 4, 2005, we published a final rule entitled, “Hospice Wage Index for Fiscal Year 2006 ( Federal Register Doc. 05-15290, 70 FR 45130). On September 30, 2005, we published a correction notice ( Federal Register Doc. 05-19609, 70 FR 57174) to correct a number of technical errors that had appeared in the final rule. Based on further review of the August 2005 final rule, we are correcting additional typographical and formatting errors that appeared in Table A and C of the addendum. Specifically, in Table A of the addendum, we are correcting the asterisk that corresponds to the footnotes that appear at the end of the table, as appropriate. We are correcting the wage index values for CBSA codes where the numerical numbers contained typographical errors or where numbers were transposed. In addition, in Table C of the addendum, we are correcting the wage index value figures for the CBSA code 24780, Pitt County, NC, and the CBSA code for 32820, Crittenden County, TN.

This correction notice is consistent with the published hospice wage index values used to make payment as of October 1, 2005. In section II below, we provide a description of the errors and the changes being made to correct the errors.

In FR Doc. 05-15290, published on August 4, 2005 (70 FR 45130), we are making the following corrections:

1. On page 45147, in the fourth column, in the 4th through 23rd entry, for CBSA code 12060, change the MSA code “520” to “0520”.

2. On page 45148, in the third column, in lines 37 through 39, for CBSA code 13980, remove the asterisk from the urban area county codes for “Montgomery, VA; Pulaski, VA; and Radford City, VA.”

3. On page 45149, in the first column, in the 10th entry, for CBSA code 6580, change the CBSA code “6580” to “16580.”

4. On page 45150—

A. In the fourth column, in the 15th entry, for CBSA code 17140, wage index 0.9207, urban area county code for Bracken, KY*, change the MSA code “14” to “18.”

B. In the third column, in the 15th entry from the bottom, for CBSA code 17980, change the urban area county “Russell, AL,” to “Russell, AL*.”

5. On page 45153—

A. In the fourth column, in the first entry, for CBSA code 22744, change the MSA code “2860” to “2680.”

B. In the third column, for CBSA code 23540 as previously corrected on September 30, 2005 (70 FR 57176) change the wage index number for Alachua, FL* from “0.9642” to “1.0033” and the wage index number for “Gilchrist, FL* from “1.0033” to “0.9642.”

C. In the second column, for CBSA code 24660, for urban area county code Randolph, NC*, remove the wage index number “0.9382” and add the wage index number “0.9382” to the urban area county code “Rockingham, NC*.”

6. On page 45160 as corrected on September 30, 2005 (70 FR 57176) in the second column—

A. In the second entry from the bottom, for the CBSA code 38540, change the wage index number for “Bannock, ID*” from “0.9773” to “1.0183.”

B. In the first entry from the bottom, for the CBSA code 38540, change the wage index number for “Power, ID*” from “1.0183” to “0.9773.”

1. On page 45177, in the 6th column, in the 20th line, for the county name of Stanly, NC, change the special hospice wage index code “50192” to “50092.”

2. On page 45188, in the 7th column, in the 25th line from the bottom, for the county name Pitt, NC, change the wage index number “0.09740” to “0.9740.”

3. On page 45190, in the 7th column, in the 27th line, for the county name, Crittenden, TN, change the wage index number “0.09785” to “0.9785.”

We ordinarily publish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a rule take effect in accordance with section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we can waive this notice and comment procedure if the Secretary finds that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice.

The revisions contained in this rule correct formatting and typographical errors in various sections of Table A and Table C of the addendum. These corrections are necessary to ensure that the final rule accurately reflects the correct hospice wage index values. Since they are not substantive, but merely technical, we find that public comments on these revisions are both unnecessary and impracticable. Therefore, we find good cause to waive notice and comment procedures.

In addition, the Administrative Procedure Act (APA) normally requires a 30-day delay in the effective date of a final rule. Since this notice simply makes technical modifications to a final rule that has previously gone through notice-and-comment rulemaking and the corrections are only to formatting errors, we believe good cause also exists under the APA to waive the 30-day delay in the effective date.

Section 1871(e)(1)(A) of the Act, as amended by section 903(a) of Pub .L. 108-173, provides that a substantive change in regulations shall not be applied retroactively to items and services furnished before the effective date of the change, unless the Secretary finds that such retroactive application is necessary to comply with statutory requirements or failure to apply the change retroactively would be contrary to the public interest. Although this correction notice is retroactive, it makes no substantive changes, but only corrects minor technical errors. Failure to make these changes retroactive to October 1, 2005, is contrary to the public interest because the published wage index values do not match the actual wage index values utilized by CMS as of October 1, 2005. Actual payments made by CMS to hospice providers will not change. Therefore, we believe there is sufficient cause to make the corrections retroactive.

In FR Doc. 05-22136 (70 FR 68515), we have identified a number of technical errors that we have described in the “Summary of Errors” section and corrected in the “Correction of Errors” section below. The provisions in this correction notice are effective as if they had been included in the CY 2006 final rule with comment period. Accordingly, the corrections are effective January 1, 2006.

On November 10, 2005, we published the CY 2006 Hospital Outpatient Prospective Payment System (OPPS) final rule with comment period. Included in that document were several technical and typographical errors that we are correcting in section III of this notice.

We are correcting the following technical errors that were included in the CY 2006 OPPS final rule with comment period affecting drug administration code C8596, estimated expenditures, regulation text, hospital coding for sodium hyaluronate products, and Addendum L.

On page 68680, we neglected to remove the first row, referencing HCPCS code C8956, from Table 31 and the accompanying discussion regarding C8956 from the response to the comment included in the third column, third paragraph. We are correcting these errors in this notice.

On page 68726, we referred to the transfer from the Federal government to Medicare providers in billions rather than millions in the accounting table. We are correcting the error in this notice.

On page 68728, we omitted a reference to pass-through devices in the regulation text as stated in the preamble text at 68559. We correct this omission in this notice.

On page 68643 and in Addendum B we erroneously referred to the creation of a code by the National HCPCS Panel, specifically the creation of HCPCS code J7318. This was incorrect as this code was not created by the National HCPCS Panel. Our error was discovered after publication, and we are taking this opportunity to revise Addendum B to reflect the CY 2006 payment for Sodium Hyaluronate products using HCPCS codes J7317 and J7320, as originally included in the CY 2006 OPPS proposed rule.

On pages 68752-68913 we published Addendum B—Payment Status by HCPCS Code and Related Information—CY 2006. We excluded several codes from this table. In section III of this correction notice we correct this error by publishing the omitted codes.

On pages 68964 through 68980, we published Addendum L—Out-Migration Wage Adjustment CY 2006. We excluded several providers from this table. In Section III of this correction notice, we republish Addendum L.

We are also correcting typographical, formatting, and other technical errors that were contained in the CY 2006 OPPS final rule with comment period.

We ordinarily publish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a notice such as this takes effect in accordance with section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). We also ordinarily provide a 30-day delay in the effective date of the provisions of a notice in accordance with section 553(d) of the APA (5 U.S.C. 553(d)). However, we can waive both the notice and comment procedure and the 30-day delay in effective date if the Secretary finds, for good cause, that it is impracticable, unnecessary or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice.

The policies and payment methodology finalized in the CY 2006 OPPS final rule with comment period have previously been subjected to notice and comment procedures. This correction notice merely provides technical corrections to the CY 2006 OPPS final rule with comment period that was promulgated through notice and comment rulemaking, and does not make substantive changes to the policies or payment methodology that were finalized in the final rule with comment period. For example, this notice corrects typographical errors, makes clarifications to the preamble and regulations text, and revises inaccurate tabular data. Therefore, we find it unnecessary to undertake further notice and comment procedures with respect to this correction notice. We also believe it is in the public interest to waive notice and comment procedures and the 30-day delay in effective date for this notice. This correction notice is intended to ensure that the CY 2006 OPPS final rule with comment period accurately reflects the policies expressed in the final rule, and that the corrected information is made available to the public prior to January 1, 2006, the date on which the final rule becomes effective.

For the reasons stated above, we find that both notice and comment and the 30-day delay in effective date for this correction notice are unnecessary and that it is in the public interest to make this notice effective in conjunction with the final rule to which the corrections apply. Therefore, we find there is good cause to waive notice and comment procedures and the 30-day delay in effective date for this correction notice.

In FR Doc. 05-22136 (70 FR 68515), make the following corrections:

1. On page 68516, in column 3, in the second full paragraph, line 3, the term “OPPA” is corrected to read “OPPS.”

2. On page 68517, in column 1, in the 15th paragraph, line 1, the phrase “(Cost center specific)” is removed.

3. On page 68518, in column 1, in the 11th paragraph, line 2, the phrase “and0651” is corrected to read “and 0651.”

4. On page 68537,

a. In column 3, in the first full paragraph, lines 5 to 6, the phrase “of the proposed rule (76 FR 42690)” is removed.

b. In column 3, in the first full paragraph, line 6, the word “contained” is corrected to read “contains.”

5. On page 68549,

a. In column 2, in the first full paragraph, line 7, the amount “$246.04” is corrected to read “$245.91.”

b. In column 2, in the first full paragraph, line 8, the amount “$49.21” is corrected to read “$49.18.”

6. On page 68551, in column 3; in the second full paragraph, line 12, the term “TEFRA” is removed.

7. On page 68552,

a. In column 1, in the second partial paragraph, line 32, the term “TEFRA” is removed.

b. In column 2, in the first partial paragraph carried over from column 1, line 14, the term “TEFRA” is removed.

c. In column 2, in the first partial paragraph carried over from column 1, line 15, the line is corrected by inserting the phrase “paid under the OPPS but not under the IPPS” between the words “hospitals” and “will.”

d. In column 3, in the first partial paragraph carried over from column 2, line 3, the term “TEFRA” is removed.

e. In column 3 in the first partial paragraph carried over from column 2, line 5, the term “TEFRA” is corrected to read “these.”

f. In column 3, in the first partial paragraph carried over from column 2, line 10, the term “TEFRA” is corrected to read “these.”

g. In column 3, in the first partial paragraph carried over from column 2, line 17, the term “TEFRA” is removed.

h. In column 3, in the first partial paragraph carried over from column 2, line 18, the line is corrected by inserting the phrase term “not paid under the IPPS” between the words “hospitals” and “that”.

8. On page 68556, in column 2, in the second full paragraph, in line 20, the sentence is corrected by adding the following bolded text “payments, brachytherapy seeds, and any service”.

9. On page 68559,

a. In column 1, below the table footnotes, line 14, following “biologicals” the word “and” is removed.

b. In column 1, below the table footnotes, line 16 is corrected adding, “, and brachytherapy seeds.” after “payment policy”.

10. On page 68561,

a. In column 1, line 7, add a “,” after term “rural hospitals”.

b. In column 1, in the last partial paragraph, line 7, remove the word “because” and add “as” in its place.

c. In column 2, in the first partial paragraph carried over from column 1, line 11, “2 percent” is corrected to read “−2 percent”.

11. On page 68565, column 1, in the fifth full paragraph, line 5, “2005” is corrected to read “2006”.

12. On page 68578, column 1, in the last partial paragraph, line 2, the number “0042” is corrected to read “0429.”

13. On page 68596, column 2, in the first full paragraph,

a. Line 8, the amount “$2,662.62” is corrected to read “$2,709.14.”

b. Line 12, the amount “$2,975.50” is corrected to read “$3,051.67.”

14. On page 68606, in column 1, in the first full paragraph, line 10, the number “0442” is corrected to read “0422.”

15. On page 68628,

a. In column 2, in the first partial paragraph carried over from column 1, line 5, the word “where” is corrected to read “when.”

b. In column 2, in the third full paragraph, line 17, the phrase “November 13, 2000 final rule” is corrected to read “November 13, 2000 interim final rule with comment period.”

16. On page 68630,

a. In column 1, in the first partial paragraph carried over from page 68629, line 4, the date “August 3” is corrected to read “November 13.”

b. In column 2, in the first full paragraph, line 13, the date “August 3” is corrected to read “November 13.”

c. In column 2, in the first full paragraph, line 13, the line is corrected by inserting “with comment period” at the end of the sentence.

d. In column 2, in the first full paragraph, line 33, the date “August 3” is corrected to read “November 13.”

17. On page 68637, in Table 22, the footnote is removed from the column one heading.

18. On page 68679, in column 1; in the first partial paragraph at the bottom of the page, line 6, the number “31” is corrected to read “30.”

19. On page 68680,

a. In column 3, in the third paragraph, line 3, the term “codes” is corrected to read “code.”

b. In column 3, in the third paragraph, lines 3 through 8, the sentence is corrected by removing the phrase “C8956 (Refilling and maintenance of portable or implantable pump or reservoir for drug delivery for therapy/diagnosis, systemic ( e.g. , intravenous, intra-arterial)) and.”

c. In Table 31, the table is corrected by removing row 1.

20. On page 68717, in column 1, first partial paragraph continued from the previous page, line 24, the line is corrected by inserting the phrase “brachytherapy seeds,” after the word “* * * biologicals,”.

21. On page 68719, in column 1, the third partial paragraph, line 9, the sentence is corrected by inserting the phrase “at least” between the word “of” and the number “0.2.”

22. On page 68720, in column 3, in the second full paragraph, line 30, the number “3.2” is corrected to read “3.0.”

23. On page 68726, in table 41, in column 2, row 2, “$660 Billion.” is corrected to read “$660 Million.”

1. On page 68736, for APC 0339, row 22, column 3, “Q” is corrected to read “S.”

2. On page 68738, for APC 0430, row 27, is removed.

3. On page 68743, for APC 1491, row 23, column 6, “$2.00” is removed.

4. On page 68746, APC 1611 is added in numerical order as follows:

a. Column 2 reads “Hylan G-F 20 injection,”

b. Column 3 reads “K,”

c. Column 4 is blank,

d. Column 5 reads “$199.09,”

e. Column 6 is blank,

f. Column 7 reads “$39.82.”

5. On page 68748,

a. APC 1706, row 18, is removed.

b. For APC 1713, row 25, column 2, “Inj Fe-based MR contrast, ml” is corrected to read “Inj Fe-base MR contrast, 1m1.”

6. On page 68749, APC 7316 is added as follows:

a. Column 2 reads “Sodium hyaluronate injection,”

b. Column 3 reads “K,”

c. Column 4 is blank,

d. Column 5 reads “$106.70,”

e. Column 6 is blank,

f. Column 7 reads “$21.34.”

7. On page 68750,

a. For APC 9119, row 19, column 2, “Pentastarch 10% solution” is corrected to read “Injection, pegfilgrastim 6mg.”

b. For APC 9126, row 25, column 2, “Injection, Natalizumab, 1mg” is corrected to read “Natalizumab injection.”

8. On page 68751, for APC 9164, row 7, column 2, “Inj Gad-base MR contrast, ml” is corrected to read “Inj Gad-base MR contrast, 1ml.”

1. On page 68876,

a. For HCPCS code 95965, row 9,

i. In column 4, “T” is corrected to read “S,”

ii. In column 5, “0430” is corrected to read “1523,”

iii. In column 6, “10.8452” is removed,

iv. In column 7, “$645.41” is corrected to read “$2,750.00,”

v. In column 9, “$129.08” is corrected to read “$550.00.”

b. For HCPCS code 95966, row 10,

i. In column 4, “T” is corrected to read “S,”

ii. In column 5, “0430” is corrected to read “1514,”

iii. In column 6, “10.8452” is deleted,

iv. In column 7, “$645.41” is corrected to read “$1,250.00,”

v. In column 9, “$129.08” is corrected to read “$250.00.”

c. For HCPCS code 95967, row 11,

i. In column 4, “T” is corrected to read “S,”

ii. In column 5, “0430” is corrected to read “1510,”

iii. In column 6, “10.8452” is deleted,

iv. In column 7, “$645.41” is corrected to read “$850.00,”

v. In column 9, “$129.06” is corrected to read “$170.00.”

2. On page 68880,

a. For HCPCS code 0001F, row 1, column 4, “D” is corrected to read “E.”

b. For HCPCS code 0005F, row 7, column 4, “D” is corrected to read “E.”

3. On page 68888, for HCPCS code C8956, row 14,

a. In column 4, “T” is corrected to read “D,”

b. In column 5, “0125” is removed,

c. In column 6, “1.9021” is removed,

d. In column 7, “$113.20” is removed,

e. In column 9, “$22.64” is removed.

4. On page 68895,

a. For HCPCS code G0375, row 36, column 8, “$2.00” is removed.

b. For HCPCS code G0376, row 37, column 8, “$2.00” is removed.

5. On page 68901,

a. For HCPCS code J2505, row 20, column 2, “Pentastarch 10% solution” is corrected to read “Injection, pegfilgrastim 6mg.”

b. For HCPCS code J2510, row 21, column 2, “Sincalide injection” is corrected to read “Penicillin g procaine inj.”

6. On page 68902, for HCPCS code J3070, row 26, column 2, “Pentazocine hcl injection” is corrected to read “Pentazocine injection.”

7. On page 68904,

a. For HCPCS code J7317, row 12, column 4,

i. “D” is corrected to read “K,”

ii. In column 5, “7316” is added,

iii. In column 7, “$106.70” is added,

iv. In column 9, “$21.34” is added.

b. For HCPCS code J7318, row 13,

i. In column 4, “K” is corrected to read “D,”

ii. In column 5, “1706” is removed,

iii. In column 7, “$7.20” is removed,

iv. In column 9, “$1.44” is removed,

c. For HCPCS code J7320, row 14,

i. In column 4, “D” is corrected to read “K,”

ii. In column 5, “1611” is added,

iii. In column 7, “$199.09” is added,

iv. In column 9, “$39.82” is added.

8. On page 68907, for HCPCS code K0105, row 8, column 4, “D” is corrected to read “Y.”

9. On page 68912,

a. For HCPCS code Q4079, row 15, column 2, “Injection, Natalizumab, 1 MG” is corrected to read “Natalizumab injection.”

b. For HCPCS code Q9946, row 21, column 2, “LOCM <=149 mg/ml iodine, 1ml” is corrected to read “LOCM 150-199 mg/ml iodine, 1ml.”

c. For HCPCS code Q9952, row 27, column 2, “Inj Gad-base MR contrast, ml” is corrected to read “Inj Gad-base MR contrast, 1ml.”

d. For HCPCS code Q9953, row 28, column 2, “Inj Fe-based MR contrast, ml” is corrected to read “Inj Fe-based MR contrast, 1ml.”

10. The following HCPCS codes were inadvertently omitted from the Addendum B. We correct this error by listing the omitted codes below.

Addendum L represents all hospitals that are eligible to have their wage index increased by the out-migration adjustment. In the final rule with comment period, we inadvertently did not list all hospitals eligible for the adjustment. We correct this in this notice by replacing Addendum L in its entirety; however we retain the footnote language as published in the final rule.