Unknown. Final rule; correction

29,277 words·~133 min read·/register/2006/07/25/06-6436

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2006-07-25.xml --- 71 142 Tuesday, July 25, 2006 Contents Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Commodity Credit Corporation See Food Safety and Inspection Service See Forest Service Animal Animal and Plant Health Inspection Service RULES Plant-related quarantine, domestic and foreign: Gypsy moth Correction, 42176 Z6-11431 Civil Civil Rights Commission NOTICES Meetings;

State advisory committees: Florida, 42079-42080 E6-11841 E6-11842 Kentucky, 42080 E6-11843 Commerce Commerce Department See Foreign-Trade Zones Board See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration See National Telecommunications and Information Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 42080-42082 E6-11810 E6-11812 E6-11813 E6-11814 Commodity Commodity Credit Corporation RULES Loan and purchase programs:

Storage warehouses; approval standards Correction, 42017 E6-11762 Comptroller Comptroller of the Currency RULES Practice and procedure: Fees assessment, 42017-42018 E6-11804 Consumer Consumer Product Safety Commission RULES Consumer Product Safety Act: Substantial product hazard reports, 42028-42031 E6-11758 Customs Customs and Border Protection Bureau NOTICES Automation program test: Automated Commercial Environment— Truck carrier accounts; automated truck manifest data; deployment schedule, 42103-42104 E6-11849 Customhouse broker license cancellation, suspension, etc., E6-11778 E6-11779 E6-11780 42104-42110 E6-11781 Defense Defense Department NOTICES Meetings:

Science Board task forces, 42088 06-6437 Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 42088-42089 E6-11756 E6-11757 Employment Employment and Training Administration NOTICES Adjustment assistance; applications, determinations, etc.: A.W. Bohanan Co., Inc., 42122 E6-11857 Briggs Plumbing Products, Inc., 42122 E6-11858 Coe Manufacturing, 42122 E6-11853 Collins & Aikman Products Co., 42122 E6-11854 Cooper Hand Tools, 42122-42123 E6-11867 Ford Motor Co., 42123 E6-11856 Gyrus ACMI Corp., 42123 E6-11869 Hoffman-La Roche, Inc., et al., 42123-42125 E6-11871 Hospira, 42125 E6-11868 IPC Print Services, 42125 E6-11870 Johnson Controls, Inc., 42125 E6-11863 JPMorgan Chase & Co., 42125 E6-11866 Microtronic, Inc., 42126 E6-11862 Quality Cleaning Service, 42128 E6-11859 Re-Source America, Inc., 42126 E6-11864 Rose Art Industries Inc., 42126 E6-11855 Smart Papers, 42126 E6-11852 Suntron Corp., 42127 E6-11865 Tower Automotive et al., 42127-42128 E6-11860 York Group Metal Casket Assembly, 42128 E6-11861 Agency information collection activities; proposals, submissions, and approvals, 42128-42129 E6-11851 Energy Energy Department See Energy Efficiency and Renewable Energy Office Energy Energy Efficiency and Renewable Energy Office PROPOSED RULES Energy conservation:

Consumer products and commercial and industrial equipment— Test procedures and certification, compliance, and enforcement requirements, 42178-42219 06-6395 EPA Environmental Protection Agency NOTICES Air programs: Ambient air monitoring reference and equivalent methods— Particulate matter

(PM10)and nitrogen dioxide (NO2); two new reference methods designation, 42089-42091 E6-11820 Superfund; response and remedial actions, proposed settlements, etc.: Superior Waste Rock Site, MT, 42091 E6-11822 Water pollution control: National Pollutant Discharge Elimination System— Idaho; aquaculture facilities; general permit reissuance, 42091-42092 E6-11815 Export Export-Import Bank NOTICES Saudi Arabia; petrochemicals facility; equipment and services; finance application, 42092 E6-11759 FAA Federal Aviation Administration RULES Airworthiness directives: Airbus, 42021-42023, 42026-42028 E6-11700 E6-11713 Construcciones Aeronauticas, S.A., 42019-42021, 42023-42026 E6-11701 E6-11706 PROPOSED RULES Airworthiness directives: BAE Systems (Operations) Ltd., 42065-42067 E6-11806 McDonnell Douglas, 42062-42065 E6-11805 Airworthiness standards: Normal and transport category rotorcraft— Performance and handling qualities requirements, 42222-42232 E6-11726 Federal Highway Federal Highway Administration NOTICES Highway planning and construction; licenses, permits, approvals, etc.: Providence County, RI, 42169-42170 06-6439 Federal Motor Federal Motor Carrier Safety Administration NOTICES Motor carrier safety standards: Commercial driver's license standards; exemption applications— Isuzu Motors America, Inc., 42170-42171 E6-11766 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Formations, acquisitions, and mergers, 42092 E6-11818 Permissible nonbanking activities, 42092-42093 E6-11819 Reports and guidance documents; availability, etc.: Payments system risk; daylight overdrafts measuring procedures; policy statement, 42093 E6-11765 Fish Fish and Wildlife Service NOTICES Comprehensive conservation plans; availability, etc.: Izembek, Togiak, Tetlin, and Kanuti National Wildlife Refuges, AK, 42116-42117 E6-11801 Endangered and threatened species: Incidental take permits— Brevard County, FL; Florida scrub-jay, 42115-42116 E6-11802 Food Food and Drug Administration RULES Food for human consumption: Food labeling— Raw fruits, vegetables, and fish; voluntary nutrition labeling, 42031-42047 06-6436 Organization, functions, and authority delegations: Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research; address information; technical amendment, 42048 E6-11777 NOTICES Agency information collection activities; proposals, submissions, and approvals, 42096 E6-11776 Meetings: Anti-Infective Drugs Advisory Committee, 42096-42097 E6-11772 Medical Devices Advisory Committee, E6-11773 42097-42098 E6-11775 Nonprescription Drugs Advisory Committee, 42098 E6-11774 Food Food Safety and Inspection Service NOTICES Meetings: Codex Alimentarius Commission— Fresh Fruits and Vegetables Codex Committee, 42075-42076 E6-11787 Foreign Foreign Assets Control Office NOTICES Sanctions, blocked persons, specially designated nationals, terrorists and narcotics traffickers, and foreign terrorist organizations: Liberia; specially designated national; unblocking, 42174 E6-11798 MISSING FOR: Foreign-Trade Zones Board Foreign-Trade Zones Board NOTICES *Applications, hearings, determinations, etc.:* Georgia Eastman Kodak Co.; x-ray film, color paper, digital media, inkjet paper, entertainment imaging, and health imaging, 42082 E6-11873 Forest Forest Service NOTICES Appealable decisions; legal notice: Southern Region, 42076-42078 06-6438 Meetings: Resource Advisory Committees— Eastern Arizona Counties, 42078-42079 06-6435 Reports and guidance documents; availability, etc.: Forest Service Manual; native plant material policy, 42079 E6-11838 GSA General Services Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 42093-42096 E6-11760 Health Health and Human Services Department See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Customs and Border Protection Bureau NOTICES Foreign airport security determinations: Port-au-Prince International Airport, Haiti; aircraft security and transiting passengers safety, 42103 E6-11761 Housing Housing and Urban Development Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 06-6441 42110-42111 06-6442 Grant and cooperative agreement awards: Indian Community Development Block Grant Program, 42111-42115 E6-11816 Interior Interior Department See Fish and Wildlife Service IRS Internal Revenue Service RULES Employment taxes and collection of income taxes at source: Flat rate supplemental wage withholding, 42049-42058 E6-11764 International International Trade Administration NOTICES Antidumping: Canned pineapple fruit from— Thailand, 42082-42083 E6-11839 Carbon and alloy steel wire rod from— Canada, 42083-42084 E6-11840 Silicomanganese from— Brazil, 42084 E6-11837 Silicon metal from— China, 42084-42085 E6-11835 International International Trade Commission NOTICES Import investigations: Personal computers, monitors, and components, 42117-42118 E6-11753 Pipe and tube from— Various countries, 42118 E6-11755 Stainless steel wire rod from— Various countries, 42118 E6-11836 Justice Justice Department NOTICES Privacy Act; system of records, 42118-42122 E6-11803 Labor Labor Department See Employment and Training Administration See Mine Safety and Health Administration NOTICES Committees; establishment, renewal, termination, etc.: Policy Planning Board, 42238-42239 06-6446 Organization, functions, and authority delegations: Assistant Secretary for Policy, 42234-42235 06-6445 Legal Legal Services Corporation NOTICES Meetings; Sunshine Act, 42133-42134 06-6470 Maritime Maritime Administration NOTICES Coastwise trade laws; administrative waivers: CHARMER, 42171-42172 E6-11767 GITANA, 42172 E6-11769 LUNA DANNS, 42172-42173 E6-11768 MALIA KAI, 42173 E6-11771 TWOCAN, 42173-42174 E6-11770 Mine Mine Safety and Health Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 42129-42133 E6-11834 E6-11848 E6-11850 National Archives National Archives and Records Administration RULES Public availability and use: Research room and museum hours; changes, 42058-42060 E6-11763 National Institute National Institute of Standards and Technology NOTICES Committees; establishment, renewal, termination, etc.: Earthquake Hazards Reduction Advisory Committee, 42085-42086 E6-11830 NIH National Institutes of Health NOTICES Meetings: National Cancer Institute, 06-6452 42098-42099 06-6459 06-6461 06-6463 National Center for Complementary and Alternative Medicine, 42099 06-6454 National Center for Research Resources, 42100 06-6455 National Eye Institute, 42100 06-6456 National Heart, Lung, and Blood Institute, 42100-42101 06-6453 National Human Genome Research Institute, 42101 06-6462 National Institute of Mental Health, 42101-42102 06-6458 National Institute on Alcohol Abuse and Alcoholism, 42101 06-6451 Scientific Review Center, 42102-42103 06-6457 06-6460 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management: Alaska; fisheries of Exclusive Economic Zone— Northern rockfish, 42060-42061 06-6449 Pelagic shelf rockfish, 42061 06-6448 NOTICES Coastal zone management programs and estuarine sanctuaries: State programs— Intent to evaluate performance, 42086-42087 E6-11844 Fishery conservation and management: Magnuson-Stevens Act provisions— Georges Bank Cod Hook Sector; partial approval of operations plan and agreement, 42087 06-6450 Marine mammals: Incidental taking; authorization letters, etc.— Monterey Bay National Marine Sanctuary; professional fireworks displays; California sea lions and Pacific harbor seals, 42087-42088 E6-11846 National Telecommunications National Telecommunications and Information Administration PROPOSED RULES Digital-to-analog converter boxes; coupon program, 42067-42074 E6-11754 Nuclear Nuclear Regulatory Commission NOTICES Environmental statements; availability, etc.: ExxonMobil Corp., 42137-42139 E6-11833 *Applications, hearings, determinations, etc.:* Union Electric Co., 42134-42137 E6-11832 SEC Securities and Exchange Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, E6-11789 42139-42141 E6-11790 E6-11791 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 42141-42142 E6-11795 Chicago Board Options Exchange, Inc., 42142-42145 E6-11793 E6-11794 NASDAQ Stock Market LLC, 42145-42151 E6-11788 E6-11796 NYSE Arca, Inc., 42151-42155 E6-11797 Philadelphia Stock Exchange, Inc., 42156-42158 E6-11792 SBA Small Business Administration NOTICES Disaster loan areas: New York, 42158 E6-11785 Pennsylvania, E6-11783 42158-42159 E6-11786 Social Social Security Administration NOTICES Privacy Act; systems of records, 42159-42169 E6-11782 E6-11784 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration See Maritime Administration Treasury Treasury Department See Comptroller of the Currency See Foreign Assets Control Office See Internal Revenue Service Veterans Veterans Affairs Department NOTICES Meetings: Gulf War Veterans’ Illnesses Research Advisory Committee, 42174 06-6465 Rehabilitation Research and Development Service Scientific Merit Review Board, 42174-42175 06-6466 Separate Parts In This Issue Part II Energy Department, Energy Efficiency and Renewable Energy Office, 42178-42219 06-6395 Part III Transportation Department, Federal Aviation Administration, 42222-42232 E6-11726 Part IV Labor Department, 42234-42235 06-6445 Part V Labor Department, 42238-42239 06-6446 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 71 142 Tuesday, July 25, 2006 Rules and Regulations DEPARTMENT OF AGRICULTURE Commodity Credit Corporation 7 CFR Part 1423 RIN 0560-AE50 Standards for Approval of Warehouses for Storage of CCC Commodities AGENCY: Commodity Credit Corporation, USDA. ACTION: Final rule; correction. SUMMARY: This document corrects the final rule published on June 22, 2006, amending the regulations covering the storage of commodities owned by the Commodity Credit Corporation (CCC). A correction is needed because the amended rule contains an incorrect reference to a regulatory provision. DATES: Effective Date: June 22, 2006. FOR FURTHER INFORMATION CONTACT: Phillip Elder, Regulatory Review Group, Economic and Policy Analysis Staff, Farm Service Agency (FSA), United States Department of Agriculture (USDA), Stop 0572, 1400 Independence Ave., SW., Washington, DC 20250-0572. Telephone:

(202)690-8104; e-mail: *Phillip.Elder@wdc.usda.gov* . Persons with disabilities who require alternative means for communication (Braille, large print, audio tape, etc.) should contact the USDA Target Center at

(202)720-2600 (voice and TDD). SUPPLEMENTARY INFORMATION: Background This rule corrects the final rule published in the **Federal Register** on June 22, 2006 (71 FR 35771) that amended regulations covering the storage of commodities owned by the Commodity Credit Corporation (CCC). Section 1423.8

(b)of the final rule inadvertently contained a reference to section 1423.4(c)(5), which does not exist. This document removes that reference. List of Subjects in 7 CFR Part 1423 Agricultural commodities, Approval of warehouses, Dairy products, Feed grains, Oilseeds, Price support programs, Processed commodities, Surplus agricultural commodities. For this reason, 7 CFR part 1423 is amended as follows: PART 1423—COMMODITY CREDIT CORPORATION APPROVED WAREHOUSES 1. The authority citation for part 1423 continues to read as follows: Authority: 15 U.S.C. 714b and 714c. 2. Amend § 1423.8

(b)by revising the third sentence to read as follows: § 1423.8 Approval or rejection.

(b)* * * CCC will reconsider a warehouse for approval when the warehouse operator establishes that the reasons for rejection have been remedied or requests reconsideration of the action and presents to the Director, KCCO, in writing, information in support of such request. Signed in Washington, DC, on July 17, 2006. Teresa C. Lasseter, Executive Vice President, Commodity Credit Corporation. [FR Doc. E6-11762 Filed 7-24-06; 8:45 am] BILLING CODE 3410-05-P DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency 12 CFR Part 8 [Docket No. 06-08] RIN 1557-AC96 Assessment of Fees AGENCY: Office of the Comptroller of the Currency, Treasury. ACTION: Final rule. SUMMARY: The Office of the Comptroller of the Currency

(OCC)is adopting in final form, without change, an interim final rule that amended our regulations at 12 CFR part 8 concerning the timing of payments of OCC assessments. The interim rule replaced the process used to determine the amount of assessment due to the OCC. Previously, national banks were required to make the initial calculation of the amount due to the OCC. Under the interim rule, the OCC, rather than each national bank, calculates the semiannual assessment based on the most recent Consolidated Reports of Condition and Income (Call Report). The assessment is due by March 31 and September 30 of each year, two months later than under the previous process. Thus, payments that would have been due on January 31 of each year are instead due on March 31, and payments that would have been due on July 31 are due on September 30 of each year. The OCC will notify each national bank of the amount of its semiannual assessment and automatically deduct that amount from each bank's designated account on the payment due date. The interim rule changed the assessment collection process only; it did not make any changes to the method for calculating assessments due from national banks. DATES: *Effective Date:* This rule is adopted as final, effective August 24, 2006. FOR FURTHER INFORMATION CONTACT: Jean Campbell, Senior Attorney, or Mitchell Plave, Counsel, Legislative and Regulatory Activities Division,

(202)874-5090; or Colette Baylson, Accounting Operations Manager, Financial Management,

(202)874-4403, Office of the Comptroller of the Currency, 250 E Street, SW., Washington, DC 20219. SUPPLEMENTARY INFORMATION: I. Background The National Bank Act authorizes the OCC to collect assessments, fees, or other charges as necessary or appropriate to carry out its responsibilities. 12 U.S.C. 482. Under this authority, the OCC collects semiannual assessments from national banks, as described in 12 CFR part 8 and in the Notice of Comptroller of the Currency Fees, which is published no later than the first business day of December each year. 1 Prior to adoption of the interim final rule on November 17, 2005, 70 FR 69641, part 8 required each national bank to compute the amount of its semiannual assessment and pay that amount to the OCC by January 31 and July 31 of each year. Banks based their assessments on the data each bank submitted in its most recent Call Report. 1 Under part 8, the OCC also collects assessments from Federal branches and Federal agencies. The changes provided for in this final rule will also apply to payment of assessments by Federal branches and Federal agencies. Under the procedure in effect prior to November 17, 2005, the OCC reviewed each assessment computation after receiving Call Report data from the Federal Deposit Insurance Corporation

(FDIC)in March and September of each year. When the OCC found an overpayment or underpayment of a semiannual assessment, we contacted the national bank, explained the error, and refunded (or collected, as the case may be) the funds electronically. This assessment collection process was cumbersome and outdated, and the procedure for reviewing and correcting miscalculations was inefficient. For these reasons the OCC revised the assessment process as described below. II. The Interim and Final Rules On November 17, 2005, the OCC published and requested comment on an interim rule amending 12 CFR part 8. The comment period ended on December 17, 2005, and no comments were received. Accordingly, the OCC is adopting the interim rule as a final rule with no modifications. Calculation of the Semiannual Assessment Fee The final rule provides that the OCC will calculate the semiannual assessment due from each bank based on the most recent Call Report data. Under the new assessment process, the OCC will send each national bank an assessment collection notification no later than 7 business days prior to March 31 and September 30 of each year. The assessment covers the six-month period beginning on January 1 and July 1 before each payment date. The OCC will automatically deduct the assessed amount from the bank's designated account on March 31 and September 30. By delaying the assessment calculation date by two months, the OCC will collect assessments based on final Call Report data, and thus eliminate the cumbersome correction process that we previously used. Under the final rule, a national bank can notify the OCC of any errors in the calculation of semiannual assessments or errors in the electronic transfer process, and the Comptroller is required to respond to such notices within 30 days of receipt. This streamlining of the OCC's assessment collection process reduces regulatory burden for national banks and is therefore consistent with the objectives of section 2222 of the Economic Growth and Regulatory Paperwork Reduction Act of 1996, 2 which calls for the periodic review of the OCC's regulations and the elimination of unnecessary burden. 2 Pub. L. 104-208, § 2222, 110 Stat. 3009-414 to 3009-415 (Sept. 30, 1996). Technical and Conforming Amendments The final rule eliminates an erroneous sentence in § 8.7(a) regarding delinquent semiannual assessment payments. The final rule also makes conforming changes to § 8.7(b) to describe the new streamlined procedure to correct errors in the assessment process. The final rule makes non-substantive changes to conform part 8 to the new assessment collection process and other minor technical changes. Finally, in § 8.6(a)(1), (2), and (4), and § 8.7(a), the final rule eliminates references to “District of Columbia,” “District of Columbia banks” and “each district bank” to reflect the provisions of the 2004 District of Columbia Omnibus Authorization Act, section 8, Public Law 108-386, 118 Stat. 2228 (2004), which shifted regulatory responsibility of District of Columbia banks from the OCC to the FDIC and Board of Governors of the Federal Reserve System. Effective Date This final rule takes effect 30 days after publication in the **Federal Register** . 5 U.S.C. 553(d). Under 12 U.S.C. 4802(b)(1), Federal banking agency regulations or amendments to regulations “which impose additional reporting, disclosure, or other requirements on insured depository institutions” must be effective on the first day of a calendar quarter which begins on or after the date on which the regulations are published in final form. As described above, this final rule imposes no new requirements on national banks. Accordingly, the delayed effective date requirement in section 4802(b)(1) does not apply to this final rule. Regulatory Flexibility Act Analysis The Regulatory Flexibility Act (Pub. L. 96-354, Sept. 19, 1980)

(RFA)applies only to rules for which an agency publishes a general notice of proposed rulemaking

(NPRM)pursuant to 5 U.S.C. 553(b). 3 Because the OCC did not publish an NPRM, the RFA does not apply to this final rule. In any case, however, the final rule affects only the process for calculating the semiannual assessment and the timing of required payment. It does not affect the amount of assessment a bank must pay. 3 5 U.S.C. 601(2). Executive Order 12866 The OCC has determined that this final rule is not a significant regulatory action under Executive Order 12866. Unfunded Mandates Reform Act of 1995 Determinations Section 202 of the Unfunded Mandates Reform Act of 1995 4 (Unfunded Mandates Act) requires that an agency prepare a budgetary impact statement before promulgating any rule likely to result in a Federal mandate that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. If a budgetary impact statement is required, section 205 of the Unfunded Mandates Act also requires the agency to identify and consider a reasonable number of regulatory alternatives before promulgating the rule. The OCC has determined that this final rule will not result in expenditures by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. Accordingly, the OCC has not prepared a budgetary impact statement or specifically addressed any regulatory alternatives. 4 2 U.S.C. 1532. Paperwork Reduction Act In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Ch. 3506; 5 CFR 1320 Appendix A.1), we have reviewed the final rule to determine whether it contains any information collections. There are no collections of information as defined by the Paperwork Reduction Act in the final rule. Lists of Subjects in 12 CFR Part 8 Assessment of fees. PART 8—ASSESSMENT OF FEES Accordingly, the interim final rule amending 12 CFR part 8 which was published at 70 FR 69641 on November 17, 2005, is adopted as a final rule without change. Dated: July 18, 2006. John C. Dugan, Comptroller of the Currency. [FR Doc. E6-11804 Filed 7-24-06; 8:45 am] BILLING CODE 4810-33-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2005-22504; Directorate Identifier 2003-NM-281-AD; Amendment 39-14691; AD 2006-15-11] RIN 2120-AA64 Airworthiness Directives; Construcciones Aeronauticas, S.A. (CASA), Model C-212-CC Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: The FAA is adopting a new airworthiness directive

(AD)for certain CASA Model C-212-CC airplanes. This AD restricts the operation of the airplane to carrying either passengers or cargo (but not both) in the same compartment, unless the airplane is modified to include an approved protective liner between the passengers and the cargo. This AD results from our determination that affected airplanes, when carrying both cargo and passengers in the same compartment, cannot achieve the required level of performance. We are issuing this AD to prevent a hazardous quantity of smoke, flames, and/or fire extinguishing agent from the cargo compartment from entering a compartment occupied by passengers or crew. DATES: This AD becomes effective August 29, 2006. ADDRESSES: You may examine the AD docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC. FOR FURTHER INFORMATION CONTACT: Della Swartz, Aerospace Engineer, ACE-115N, FAA, Anchorage Aircraft Certification Office, 222 West 7th Avenue, Unit 14, Room 128, Anchorage, Alaska 99513; telephone

(907)271-2672; fax

(907)271-6365. SUPPLEMENTARY INFORMATION: Examining the Docket You may examine the airworthiness directive

(AD)docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone

(800)647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section. Discussion The FAA issued a notice of proposed rulemaking

(NPRM)to amend 14 CFR part 39 to include an AD that would apply to certain CASA Model C-212-CC series airplanes. That NPRM was published in the **Federal Register** on September 22, 2005 (70 FR 55604). That NPRM proposed to restrict the operation of the airplane to carrying either passengers or cargo (but not both) in the same compartment, unless the airplane is modified to include an approved protective liner between the passengers and the cargo. Comments We provided the public the opportunity to participate in the development of this AD. We have considered the comments received. Request for Conformance to Technical Standard Order

(TSO)The Modification and Repair Parts Association (MARPA) recommends that we place additional requirements on the type of smoke detectors that could be used for this application ( *i.e.* , that they must fully meet all requirements of the associated technical standard order (TSO)). In addition, the MARPA feels that 14 CFR part 39 does not permit the modification of other parts of the CFR, such as 21.303, for economic or other seemingly quixotic rationale. The MARPA concludes that it would appear we do not possess the legal authority in part 39 to waive other requirements of the CFR for reasons that do not contribute to continued airworthiness. We considered the comments, but for the reasons below do not concur. The use of appliances that are not “FAA-approved” is not without precedent. Handheld fire extinguishers, for example, are not specifically approved by the FAA. We also permit smoke detectors that do not meet TSO requirements to be used in lavatories on commercial airplanes because the presence of flight attendants and passengers makes it unlikely that a fire could transition from a small smoldering fire to a flaming fire without notice. Regarding Model C-212-CC series airplanes, the presence of two smoke detectors that do not meet TSO requirements, the close proximity of the cargo to passengers, and flammability test data for fire containment covers led us to conclude that there was no need to require smoke detectors that fully meet TSO requirements in this application. It should be noted that these detectors are placed on the cargo; the cargo and detectors are then placed within fire containment covers, which must completely surround the cargo and detectors. Two detectors are required for each enclosed cargo to be carried on the airplane. We have determined that this provides an acceptable level of safety. Regarding 14 CFR 21.303, the MARPA apparently misunderstands the requirements of § 21.303. This section regulates production of parts, and requires FAA parts manufacturer approval

(PMA)for persons who produce parts “for sale for installation on type certificated products.” ADs, on the other hand, impose requirements on operators and do not affect requirements for parts production. In this case, the phrase, “building-type smoke detectors” refers to parts that are presumably not produced for sale for installation on a type-certificated product; i.e., they are produced for use in buildings. Therefore, this AD neither modifies nor conflicts with § 21.303. Regarding the FAA's authority under part 39, § 39.5 identifies the criteria for issuing ADs: “* * * an unsafe condition exists in a product and it is likely to exist or develop in other products of the same type design.” Those criteria are clearly met in this case. Nothing in part 39 limits the actions that we may require to address the unsafe condition. In fact, § 39.11 provides us with maximum flexibility in defining necessary corrective actions: “Airworthiness directives specify inspections you must carry out, conditions and limitations you must comply with, and any actions you must take to resolve the unsafe condition.” This certainly includes installation of smoke detectors that we have determined to adequately fulfill the safety needs in the unusual circumstances of this AD. Clarification of Alternative Method of Compliance

(AMOC)Paragraph We have revised this action to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies. Explanation of Change to Applicability We have revised the applicability of the proposed AD to identify model designations as published in the most recent type certificate data sheet for the affected models. Conclusion We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that the changes will neither increase the economic burden on any operator nor increase the scope of the AD. Exemption Granted On May 16, 2003, an operator of certain CASA Model C-212-CC and -CD airplanes (not affected by this AD) in Alaska was granted Exemption 7779A to provide an acceptable level of fire protection that will allow those airplanes to be operated in the combi configuration. (Documents related to the exemption may be viewed at *http://dms.dot.gov,* under docket number FAA-2001-11150.) The exemption was granted based on public interest, with the following limitations: 1. A means will be provided to extinguish or control a fire without requiring a crewmember to enter the compartment. Fire containment covers

(FCCs)of woven fiberglass-based materials that will pass the oil burner test of FAR Part 25, Appendix F, Part II, must be used. FCCs will completely surround all cargo, including being underneath the cargo, except for obviously non-flammable items, such as metal stock, machinery, and non-flammable fluids without flammable packaging. Cargo restraint nets will be installed over the FCCs. A valve will be installed in the FCCs to allow fire-fighting attempts without removing or loosening the FCCs. 2. A means will be provided to exclude hazardous quantities of smoke, flames, or extinguishing agent from any compartment occupied by the crew or passengers. There is an approved procedure for elimination of smoke and fumes in the airplane flight manual (AFM). 3. A separate approved smoke detector or fire detector system will be installed in the cargo area and a fire/smoke warning indicator will be provided in the cockpit. Smoke or fire detectors placed within each FCC fully enclosed volume provide such a means. The use of non-TSO'd inexpensive building-type smoke detectors is permitted. Detectors may be wired or wireless, as long as they incorporate provisions for sensor redundancy, testing, and remote cockpit indication. At least two detectors must be placed within each FCC fully enclosed volume. 4. Crew members must receive training in the use of the fire extinguishers and the cargo fire containment covers; they must also receive training in the use of the approved procedure for the elimination of smoke and fumes that is specified in the AFM. 5. Two additional fire extinguishers must be carried on the airplane. 6. Limitations 1 through 5 must be documented as operating limitations in the limitations section of the Airplane Flight Manual Supplement. We anticipate that adherence to these six terms and conditions, in a method approved by the FAA, would be considered a means of compliance with this AD. Costs of Compliance We estimate that 5 airplanes of U.S. registry will be affected by this AD. We recognize that the operational restrictions may impose indirect and adverse economic effects on operators from a potential loss of revenue. Those indirect costs are difficult to calculate because the lost revenue from combi-operated flights is not readily measurable. Nevertheless, because of the severity of the identified unsafe condition, we have determined that continued operational safety necessitates these costs to the operators. An operator may choose to modify the cargo compartment rather than restrict its operations. However, since a modification commensurate with the requirements of this AD has not been developed, we cannot provide specific information regarding the number of work hours or the cost of parts to accomplish that modification. Further, modification costs would likely vary, depending on the airplane configuration. The compliance time of 12 months should provide ample time for the development, approval, and installation of an appropriate modification, and also ensure the necessary level of flight safety. Based on a similar modification accomplished previously, we can reasonably estimate that the modification may take 40 work hours, at an average labor rate of $65 per work hour. The cost of required parts will be about $1,800 per airplane. A required proof of function flight test will cost about $4,000 including the services of a Designated Engineering Representative, pilot, test airplane, and test equipment. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $8,400 per airplane. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD:

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

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

(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration

(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **2006-15-11 Construcciones Aeronauticas, S.A. (CASA):** Amendment 39-14691. Docket No. FAA-2005-22504; Directorate Identifier 2003-NM-281-AD. Effective Date

(a)This AD becomes effective August 29, 2006. Affected ADs

(b)None. Applicability

(c)This AD applies to CASA Model C-212-CC airplanes, certificated in any category, modified in accordance with Supplemental Type Certificate

(STC)ST02177AK, or by field approval using STC ST02177AK as a basis for the field approval. Unsafe Condition

(d)This AD was prompted by our determination that affected airplanes, when carrying both cargo and passengers in the same compartment, cannot achieve the required level of performance. We are issuing this AD to prevent a hazardous quantity of smoke, flames, and/or fire extinguishing agent from the cargo compartment from entering a compartment occupied by passengers or crew. Compliance

(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Modification

(f)As of 12 months after the effective date of this AD, no person may operate an airplane in the combi configuration, unless the actions specified by either paragraph (f)(1) or (f)(2) are done in accordance with a method approved by the Manager, Anchorage Aircraft Certification Office (ACO), FAA.

(1)Modify the airplane to incorporate a protective liner between the passengers and the cargo and to ensure compliance with § 25.855 (“Cargo or baggage compartment”) of the Federal Aviation Regulations (14 CFR 25.855).

(2)Comply with the terms and conditions specified in paragraphs (f)(2)(i) through (f)(2)(vi) of this AD.

(i)There are means to extinguish or control a fire without requiring a crewmember to enter the compartment.

(ii)There are means to exclude hazardous quantities of smoke, flames, or extinguishing agent from any compartment occupied by the crew or passengers.

(iii)There is a separate approved smoke detector or fire detector system to give warning at the pilot or flight engineer station.

(iv)Crew members must receive training in the use of the fire extinguishers and the cargo fire containment covers; they must also receive training in the use of the approved procedure for the elimination of smoke and fumes that is specified in the airplane flight manual (AFM).

(v)Two additional fire extinguishers must be carried on the airplane.

(vi)Limitations (f)(2)(i) through (f)(2)(v) must be documented as operating limitations in the Limitations section of the CASA C-212-CC AFM supplement. Special Flight Permits

(g)Special flight permits may be issued in accordance with §§ 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the airplane can be modified (if the operator elects to do so), provided no passengers are onboard. Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, Anchorage ACO, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.

(2)Before using any AMOC approved in accordance with 14 CFR 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Material Incorporated by Reference

(i)None. Issued in Renton, Washington, on July 14, 2006. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E6-11701 Filed 7-24-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2005-22630; Directorate Identifier 2001-NM-323-AD; Amendment 39-14690; AD 2006-15-10] RIN 2120-AA64 Airworthiness Directives; Airbus Model A300 B4-600, B4-600R, and F4-600R Series Airplanes, and Model C4-605R Variant F Airplanes (Collectively Called A300-600 Series Airplanes); and Airbus Model A310-200 and -300 Series Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: The FAA is adopting a new airworthiness directive

(AD)for all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model C4-605R Variant F airplanes (collectively called A300-600 series airplanes); and Model A310-200 and -300 series airplanes. This AD requires a one-time inspection of the trimmable horizontal stabilizer actuator (THSA), corrective actions if necessary, and follow-on repetitive tasks. This AD results from reports of THSAs that have reached their design operational life. We are issuing this AD to extend the operational life of the THSA to prevent a possible failure of high-time THSAs, which could result in reduced controllability of the airplane. DATES: This AD becomes effective August 29, 2006. The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of August 29, 2006. ADDRESSES: You may examine the AD docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC. Contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France, for service information identified in this AD. FOR FURTHER INFORMATION CONTACT: Thomas Stafford, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone

(425)227-1622; fax

(425)227-1149. SUPPLEMENTARY INFORMATION: Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone

(800)647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section. Discussion The FAA issued a supplemental notice of proposed rulemaking

(NPRM)to amend 14 CFR part 39 to include an AD that would apply to all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model C4-605R Variant F airplanes (collectively called A300-600 series airplanes); and Model A310-200 and -300 series airplanes. That supplemental NPRM was published in the **Federal Register** on May 18, 2006 (71 FR 28821). That supplemental NPRM proposed to require a one-time inspection of the trimmable horizontal stabilizer actuator, corrective actions if necessary, and follow-on repetitive tasks. Comments We provided the public the opportunity to participate in the development of this AD. No comments have been received on the supplemental NPRM or on the determination of the cost to the public. Explanation of Change to the Supplemental NPRM Paragraph

(g)of the supplemental NPRM specifies making repairs using a method approved by either the FAA or the Direction Générale de l'Aviation Civile

(DGAC)(or its delegated agent). The European Aviation Safety Agency

(EASA)has assumed responsibility for the airplane model[s] subject to this AD. Therefore, we have revised paragraph

(g)of this AD to specify making repairs using a method approved by either the FAA or the EASA (or its delegated agent). Conclusion We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD. Costs of Compliance The following table provides the estimated costs for U.S. operators to comply with this AD. Estimated Costs Action Work hours Average labor rate per hour Parts Cost per airplane Number of U.S.-reg. airplanes Fleet cost Inspection 3 $80 None required $240 146 $35,040. Repetitive follow-on tasks 12 80 $0 $960, per inspection cycle 146 $140,160, per inspection cycle. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD:

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

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

(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration

(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **2006-15-10 Airbus:** Amendment 39-14690. Docket No. FAA-2005-22630; Directorate Identifier 2001-NM-323-AD. Effective Date

(a)This AD becomes effective August 29, 2006. Affected ADs

(b)None. Applicability

(c)This AD applies to all of the following Airbus airplanes, certificated in any category: Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes Model A300 B4-605R and B4-622R airplanes Model A300 F4-605R and F4-622R airplanes Model A300 C4-605R Variant F airplanes Model A310-203, -204, -221, and -222 airplanes Model A310-304, -322, -324, and -325 airplanes Unsafe Condition

(d)This AD results from reports of trimmable horizontal stabilizer actuators (THSAs) that have reached their design operational life. We are issuing this AD to extend the operational life of the THSA to prevent a possible failure of high-time units, which could result in reduced controllability of the airplane. Compliance

(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Service Bulletin References

(f)Unless otherwise specified in this AD, the term “service bulletin,” as used in this AD, means the applicable required service bulletin identified in Table 1 of this AD. The service bulletins refer to Goodrich Actuation Systems Service Bulletin 47142-27-11, Revision 3, dated April 25, 2005, as an additional source of service information for the required actions. Table 1.—Service Bulletins Required Airbus Service Bulletin Approved Airbus service bulletin version for actions done before the effective date of this AD Airbus airplane model A300-27-6044, Revision 04, dated September 10, 2001 A300-27-6044, Revision 02, dated August 26, 2000; or Revision 03, dated June 28, 2001 A300 B4-601, B4-603, B4-620, and B4-622. A300 B4-605R and B4-622R. A300 F4-605R and F4-622R. A300 C4-605R Variant F. A310-27-2089, Revision 02, dated June 28, 2001 A310-27-2089, Revision 01, dated August 25, 2000 A310-203, -204, -221, and -222. A310-304, -322, -324, and -325. Inspection

(g)At the applicable time specified in paragraph (g)(1) or (g)(2) of this AD, do a detailed inspection of specified components of the THSA in accordance with paragraph 1.E.(2)(a) and the Accomplishment Instructions of the applicable service bulletin. Repair any discrepancy before further flight in accordance with a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency

(EASA)(or its delegated agent). TRW Aeronautical Systems/Lucas Aerospace Component Maintenance Manual 27-44-13, dated September 14, 2001, is one acceptable method for the repair.

(1)If the flight hours accumulated on the THSA can be positively determined: Inspect at the earlier of:

(i)Before the accumulation of 47,000 total flight hours on the THSA, or within 600 flight hours after the effective date of this AD, whichever occurs later.

(ii)Within 25 years since the THSA was new or within 600 flight hours after the effective date of this AD, whichever occurs later.

(2)If the flight hours accumulated on the THSA cannot be positively determined: Inspect before the accumulation of 47,000 total flight hours on the airplane, or within 600 flight hours after the effective date of this AD, whichever occurs later. Note 1: For the purposes of this AD, a detailed inspection is: “An intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirror, magnifying lenses, etc., may be necessary. Surface cleaning and elaborate procedures may be required.” Follow-on Repetitive Tasks

(h)After the inspection required by paragraph

(g)of this AD: Do the repetitive tasks in accordance with the Accomplishment Instructions and at the times specified in paragraph 1.E.(2)(b) of the service bulletin, as applicable, except as provided by paragraph

(i)of this AD. The repetitive tasks are valid only until the THSA operational life exceeds 65,000 flight hours, 40,000 flight cycles, or 25 years, whichever occurs first. Before the THSA is operated beyond these extended life goals, it must be replaced with a new THSA, except as required by paragraph

(i)of this AD. THSA Replacement

(i)For any THSA, whether discrepant or not, that is replaced with a new THSA: Within 47,000 flight hours or 25 years, whichever occurs first, after the THSA is replaced, do the applicable tasks specified in paragraph 1.E.(2)(a) and the Accomplishment Instructions of the applicable service bulletin. Thereafter repeat the tasks within the repetitive intervals specified in paragraph 1.E.(2)(b) of the applicable service bulletin. Alternative Methods of Compliance (AMOCs) (j)(1) The Manager, International Branch, ANM-116, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.

(k)French airworthiness directive 2001-242(B), dated June 27, 2001, also addresses the subject of this AD. Material Incorporated by Reference

(l)You must use Airbus Service Bulletin A300-27-6044, Revision 04, dated September 10, 2001; and Airbus Service Bulletin A310-27-2089, Revision 02, dated June 28, 2001; as applicable, to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approved the incorporation by reference of these documents in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France, for a copy of this service information. You may review copies at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Room PL-401, Nassif Building, Washington, DC; on the Internet at *http://dms.dot.gov* ; or at the National Archives and Records Administration (NARA). For information on the availability of this material at the NARA, call

(202)741-6030, or go to *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* . Issued in Renton, Washington, on July 14, 2006. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E6-11700 Filed 7-24-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2005-22505; Directorate Identifier 2003-NM-283-AD; Amendment 39-14692; AD 2006-15-12] RIN 2120-AA64 Airworthiness Directives; Construcciones Aeronauticas, S.A. (CASA), Model C-212-CC Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: The FAA is adopting a new airworthiness directive

(907)271-2672; fax

(907)271-6365. SUPPLEMENTARY INFORMATION: Examining the Docket You may examine the airworthiness directive

(800)647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section. Discussion The FAA issued a notice of proposed rulemaking

(NPRM)to amend 14 CFR part 39 to include an AD that would apply to certain CASA Model C-212-CC series airplanes. That NPRM was published in the **Federal Register** on September 22, 2005 (70 FR 55602). That NPRM proposed to restrict the operation of the airplane to carrying either passengers or cargo (but not both) in the same compartment, unless the airplane is modified to include an approved protective liner between the passengers and the cargo. Comments We provided the public the opportunity to participate in the development of this AD. We have considered the comments received. Request for Conformance to Technical Standard Order

(TSO)The Modification and Repair Parts Association (MARPA) recommends that we place additional requirements on the type of smoke detectors that could be used for this application (i.e., that they must fully meet all requirements of the associated technical standard order (TSO)). In addition, the MARPA feels that 14 CFR 39 does not permit the modification of other parts of the CFR, such as 21.303, for economic or other seemingly quixotic rationale. The MARPA concludes that it would appear we do not possess the legal authority in Part 39 to waive other requirements of the CFR for reasons that do not contribute to continued airworthiness. We considered the comments, but for the reasons below do not concur. The use of appliances that are not “FAA-approved” is not without precedent. Handheld fire extinguishers, for example, are not specifically approved by the FAA. We also permit smoke detectors that do not meet TSO requirements to be used in lavatories on commercial airplanes because the presence of flight attendants and passengers makes it unlikely that a fire could transition from a small smoldering fire to a flaming fire without notice. Regarding Model C-212-CC series airplanes, the presence of two smoke detectors that do not meet TSO requirements, the close proximity of the cargo to passengers, and flammability test data for fire containment covers led us to conclude that there was no need to require smoke detectors that fully meet TSO requirements in this application. It should be noted that these detectors are placed on the cargo; the cargo and detectors are then placed within fire containment covers, which must completely surround the cargo and detectors. Two detectors are required for each enclosed cargo to be carried on the airplane. We have determined that this provides an acceptable level of safety. Regarding 14 CFR 21.303, the MARPA apparently misunderstands the requirements of § 21.303. This section regulates production of parts, and requires FAA parts manufacturer approval

(AMOC)Paragraph We have revised this action to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies. Explanation of Change to Applicability We have revised the applicability of the proposed AD to identify model designations as published in the most recent type certificate data sheet for the affected models. Conclusion We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that the changes will neither increase the economic burden on any operator nor increase the scope of the AD. Exemption Granted On May 16, 2003, an operator of certain CASA Model C-212-CC and -CD airplanes (not affected by this AD) in Alaska was granted Exemption 7779A to provide an acceptable level of fire protection that will allow those airplanes to be operated in the combi configuration. (Documents related to the exemption may be viewed at *http://dms.dot.gov* , under docket number FAA-2001-11150.) The exemption was granted based on public interest, with the following limitations: 1. A means will be provided to extinguish or control a fire without requiring a crewmember to enter the compartment. Fire containment covers

(FCCs)of woven fiberglass-based materials that will pass the oil burner test of FAR Part 25, Appendix F, Part II, must be used. FCCs will completely surround all cargo, including being underneath the cargo, except for obviously non-flammable items, such as metal stock, machinery, and non-flammable fluids without flammable packaging. Cargo restraint nets will be installed over the FCCs. A valve will be installed in the FCCs to allow fire-fighting attempts without removing or loosening the FCCs. 2. A means will be provided to exclude hazardous quantities of smoke, flames, or extinguishing agent from any compartment occupied by the crew or passengers. There is an approved procedure for elimination of smoke and fumes in the airplane flight manual (AFM). 3. A separate approved smoke detector or fire detector system will be installed in the cargo area and a fire/ smoke warning indicator will be provided in the cockpit. Smoke or fire detectors placed within each FCC fully enclosed volume provide such a means. The use of non-TSO'd inexpensive building-type smoke detectors is permitted. Detectors may be wired or wireless, as long as they incorporate provisions for sensor redundancy, testing, and remote cockpit indication. At least two detectors must be placed within each FCC fully enclosed volume. 4. Crew members must receive training in the use of the fire extinguishers and the cargo fire containment covers; they must also receive training in the use of the approved procedure for the elimination of smoke and fumes that is specified in the AFM. 5. Two additional fire extinguishers must be carried on the airplane. 6. Limitations 1 through 5 must be documented as operating limitations in the limitations section of the Airplane Flight Manual Supplement. We anticipate that adherence to these six terms and conditions, in a method approved by the FAA, would be considered a means of compliance with this AD. Costs of Compliance We estimate that 5 airplanes of U.S. registry will be affected by this AD. We recognize that the operational restrictions may impose indirect and adverse economic effects on operators from a potential loss of revenue. Those indirect costs are difficult to calculate because the lost revenue from combi-operated flights is not readily measurable. Nevertheless, because of the severity of the identified unsafe condition, we have determined that continued operational safety necessitates these costs to the operators. An operator may choose to modify the cargo compartment rather than restrict its operations. However, since a modification commensurate with the requirements of this AD has not been developed, we cannot provide specific information regarding the number of work hours or the cost of parts to accomplish that modification. Further, modification costs would likely vary, depending on the airplane configuration. The compliance time of 12 months should provide ample time for the development, approval, and installation of an appropriate modification, and also ensure the necessary level of flight safety. Based on a similar modification accomplished previously, we can reasonably estimate that the modification may take 40 work hours, at an average labor rate of $65 per work hour. The cost of required parts will be about $1,800 per airplane. A required proof of function flight test will cost about $4,000 including the services of a Designated Engineering Representative, pilot, test airplane, and test equipment. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $8,400 per airplane. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD:

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

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

(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **2006-15-12 Construcciones Aeronauticas, S.A. (CASA):** Amendment 39-14692. Docket No. FAA-2005-22505; Directorate Identifier 2003-NM-283-AD. Effective Date

(a)This AD becomes effective August 29, 2006. Affected ADs

(b)None. Applicability

(c)This AD applies to CASA Model C-212-CC airplanes, certificated in any category, modified in accordance with Supplemental Type Certificate

(STC)ST02129AK, or by field approval using STC ST02129AK as a basis for the field approval. Unsafe Condition

(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Modification

(1)Modify the airplane to incorporate a protective liner between the passengers and the cargo and to ensure compliance with section 25.855 (“Cargo or baggage compartment”) of the Federal Aviation Regulations (14 CFR 25.855).

(2)Comply with the terms and conditions specified in paragraphs (f)(2)(i) through (f)(2)(vi) of this AD.

(i)There are means to extinguish or control a fire without requiring a crewmember to enter the compartment.

(ii)There are means to exclude hazardous quantities of smoke, flames, or extinguishing agent from any compartment occupied by the crew or passengers.

(iii)There is a separate approved smoke detector or fire detector system to give warning at the pilot or flight engineer station.

(v)Two additional fire extinguishers must be carried on the airplane.

(vi)Limitations (f)(2)(i) through (f)(2)(v) must be documented as operating limitations in the Limitations section of the CASA C-212-CC AFM supplement. Special Flight Permits

(g)Special flight permits may be issued in accordance with sections 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the airplane can be modified (if the operator elects to do so), provided no passengers are onboard. Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, Anchorage ACO, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.

(i)None. Issued in Renton, Washington, on July 14, 2006. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E6-11706 Filed 7-24-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2006-24779; Directorate Identifier 2006-NM-044-AD; Amendment 39-14689; AD 2006-15-09] RIN 2120-AA64 Airworthiness Directives; Airbus Model A300 Airplanes; Model A310 Airplanes; and Model A300 B4-600, B4-600R, and F4-600R Series Airplanes, and Model C4-605R Variant F Airplanes (Collectively Called A300-600 Series Airplanes) AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: The FAA is adopting a new airworthiness directive

(AD)for all Airbus Model A300 airplanes and Model A310 airplanes, and for certain Airbus Model A300-600 series airplanes. This AD requires an inspection of the wing and center fuel tanks to determine if certain P-clips are installed and corrective action if necessary. This AD also requires an inspection of electrical bonding points of certain equipment in the center fuel tank for the presence of a blue coat and related investigative and corrective actions if necessary. This AD also requires installation of new bonding leads and electrical bonding points on certain equipment in the wing, center, and trim fuel tanks, as necessary. This AD results from fuel system reviews conducted by the manufacturer. We are issuing this AD to ensure continuous electrical bonding protection of equipment in the wing, center, and trim fuel tanks and to prevent damage to wiring in the wing and center fuel tanks, due to failed P-clips used for retaining the wiring and pipes, which could result in a possible fuel ignition source in the fuel tanks. DATES: This AD becomes effective August 29, 2006. The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of August 29, 2006. ADDRESSES: You may examine the AD docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC. Contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France, for service information identified in this AD. FOR FURTHER INFORMATION CONTACT: Tom Stafford, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone

(425)227-1622; fax

(425)227-1149. SUPPLEMENTARY INFORMATION: Examining the Docket You may examine the airworthiness directive

(800)647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section. Discussion The FAA issued a notice of proposed rulemaking

(NPRM)to amend 14 CFR part 39 to include an AD that would apply to all Airbus Model A300 airplanes and Model A310 airplanes, and for certain Airbus Model A300 B4-600, B4-600R, and F4-600R Series Airplanes, and Model C4-605R Variant F airplanes (collectively called A300-600 series airplanes). That NPRM was published in the **Federal Register** on May 17, 2006 (71 FR 28611). That NPRM proposed to require an inspection of the wing and center fuel tanks to determine if certain P-clips are installed and corrective action if necessary. That NPRM also proposed to require an inspection of electrical bonding points of certain equipment in the center fuel tank for the presence of a blue coat and related investigative and corrective actions if necessary. That NPRM also proposed to require installation of new bonding leads and electrical bonding points on certain equipment in the wing, center, and trim fuel tanks, as necessary. Comments We provided the public the opportunity to participate in the development of this AD. We received no comments on the NPRM or on the determination of the cost to the public. Conclusion We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed. Costs of Compliance There are about 29 Model A300 airplanes, 63 Model A310 airplanes, and 102 Model A300-600 series airplanes of the affected design in the U.S. fleet. The following table provides the estimated costs, at an average labor rate of $80 per hour, for U.S. operators to comply with this AD. For some actions, the estimated work hours and cost of parts in the following table depend on the airplane configuration. Estimated Costs Model Action Work hours Parts Cost per airplane Number of U.S.-registered airplanes Fleet cost A300 airplanes Inspect wing and center fuel tanks for P-clips 40 None $3,200 29 $92,800 Install bonding leads/points in wing and center fuel tank 136-155 $3,800-5,200 14,680-17,600 29 425,720- 510,400 A310 airplanes Inspect wing and center fuel tanks for P-clips 40 None 3,200 63 201,600 Install bonding leads/points in wing and center fuel tank 248-285 $8,840-9,190 28,680-31,990 63 1,806,840- 2,015,370 Inspect and install bonding leads/points in the trim fuel tank 53-61 $50-70 4,290-4,950 63 270,270- 311,850 A300-600 series airplanes Inspect wing and center fuel tanks for P-clips 40 None 3,200 102 326,400 Install bonding leads/points in wing and center fuel tank 157-185 $8,840-9,190 21,400-23,990 102 2,182,800- 2,446,980 Inspect and install bonding leads/points in the trim fuel tank 2-61 50-70 210-4,950 102 21,420- 504,900 Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD:

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

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

(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration

(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **2006-15-09 Airbus:** Amendment 39-14689. Docket No. FAA-2006-24779; Directorate Identifier 2006-NM-044-AD. Effective Date

(a)This AD becomes effective August 29, 2006. Affected ADs

(b)None. Applicability

(c)This AD applies to the Airbus airplanes identified in paragraphs (c)(1) and (c)(2) of this AD, certificated in any category.

(1)All Model A300 airplanes and Model A310 airplanes.

(2)Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes; Model A300 B4-605R and B4-622R airplanes; Model A300 F4-605R and F4-622R airplanes; and Model A300 C4-605R Variant F airplanes; except those airplanes identified in paragraphs (c)(2)(i) and (c)(2)(ii) of this AD.

(i)Airplanes not equipped with trim fuel tanks on which Airbus Modifications 12226, 12365, and 12308 have been incorporated in production.

(ii)Airplanes equipped with trim fuel tanks on which Airbus Modifications 12226, 12365, 12308, 12294, and 12476 have been incorporated in production. Unsafe Condition

(d)This AD results from fuel system reviews conducted by the manufacturer. We are issuing this AD to ensure continuous electrical bonding protection of equipment in the wing, center, and trim fuel tanks and to prevent damage to wiring in the wing and center fuel tanks, due to failed P-clips used for retaining the wiring and pipes, which could result in a possible fuel ignition source in the fuel tanks. Compliance

(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Service Bulletin References

(f)The term “service bulletin,” as used in this AD, means the Accomplishment Instructions of the service bulletin identified in Table 1 of this AD, as applicable. Table 1.—Service Bulletin References For Airbus— And the actions specified in— Use Airbus Service Bulletin— Dated— Model A300 airplanes Paragraph

(g)of this AD A300-28-0081 July 20, 2005. Paragraph

(h)of this AD A300-28-0079 September 29, 2005. Model A310 airplanes Paragraph

(g)of this AD A310-28-2143 July 20, 2005. Paragraph

(h)of this AD A310-28-2142 August 26, 2005. Paragraph

(i)of this AD A310-28-2153 July 20, 2005. Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes; Model A300 B4-605R and B4-622R airplanes; Model A300 F4-605R and F4-622R airplanes; and Model A300 C4-605R Variant F airplanes Paragraph

(g)of this AD Paragraph

(h)of this AD Paragraph

(i)of this AD A300-28-6068 A300-28-6064 A300-28-6077 July 20, 2005. July 28, 2005. July 25, 2005. Inspection and Corrective Actions

(g)Within 59 months after the effective date of this AD: Do a general visual inspection of the right and left wing fuel tanks and center fuel tank, if applicable, to determine if any NSA5516-XXND and NSA5516-XXNJ type P-clips are installed for retaining wiring and pipes in any tank, and do all applicable corrective actions before further flight after the inspection, by accomplishing all the actions specified in the service bulletin. Note 1: For the purposes of this AD, a general visual inspection is: “A visual examination of an interior or exterior area, installation, or assembly to detect obvious damage, failure, or irregularity. This level of inspection is made from within touching distance unless otherwise specified. A mirror may be necessary to ensure visual access to all surfaces in the inspection area. This level of inspection is made under normally available lighting conditions such as daylight, hangar lighting, flashlight, or droplight and may require removal or opening of access panels or doors. Stands, ladders, or platforms may be required to gain proximity to the area being checked.” Installation of Bonding Leads and Points for Wing and Center Fuel Tanks

(h)Within 59 months after the effective date of this AD: Do the actions specified in paragraphs (h)(1) and (h)(2) of this AD, by accomplishing all the actions specified in the service bulletin.

(1)In the center fuel tank, if applicable, do a general visual inspection of the electrical bonding points of the equipment identified in the service bulletin for the presence of a blue coat, and do all related investigative and corrective actions before further flight after the inspection.

(2)In the left and right wing fuel tanks and center fuel tank, if applicable, install bonding leads and electrical bonding points on the equipment identified in the service bulletin. Installation of Bonding Leads and Points for the Trim Fuel Tank

(i)For Model A310 airplanes; Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes; Model A300 B4-605R and B4-622R airplanes; Model A300 F4-605R and F4-622R airplanes; and Model A300 C4-605R Variant F airplanes; equipped with a trim fuel tank: Within 59 months after the effective date of this AD, install a new bonding lead(s) on the water drain system of the trim fuel tank and install electrical bonding points on the equipment identified in the service bulletin in the trim fuel tank, by accomplishing all the actions specified in the service bulletin, as applicable. Parts Installation

(j)As of the effective date of this AD, no person may install any NSA5516-XXND or NSA5516-XXNJ type P-clip for retaining wiring and pipes in any wing, center, or trim fuel tank, on any airplane. Alternative Methods of Compliance (AMOCs) (k)(1) The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.

(2)Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Related Information

(l)French airworthiness directive F-2006-031, dated February 1, 2006, also addresses the subject of this AD. Material Incorporated by Reference

(m)You must use the Airbus service bulletins identified in Table 2 of this AD to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approved the incorporation by reference of these documents in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France, for a copy of this service information. You may review copies at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW., Room PL-401, Nassif Building, Washington, DC; on the Internet at *http://dms.dot.gov* ; or at the National Archives and Records Administration (NARA). For information on the availability of this material at the NARA, call

(202)741-6030, or go to *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* . Table 2.—Material Incorporated by Reference Airbus Service Bulletin— Dated— A300-28-0079 September 29, 2005. A300-28-0081 July 20, 2005. A300-28-6064 July 28, 2005. A300-28-6068 July 20, 2005. A300-28-6077 July 25, 2005. A310-28-2142 August 26, 2005. A310-28-2143 July 20, 2005. A310-28-2153 July 20, 2005. Issued in Renton, Washington, on July 14, 2006. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E6-11713 Filed 7-24-06; 8:45 am] BILLING CODE 4910-13-P CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1115 Substantial Product Hazard Reports AGENCY: Consumer Product Safety Commission. ACTION: Final interpretative rule. SUMMARY: Section 15(b) of the Consumer Product Safety Act, 15 U.S.C. 2064(b), requires manufacturers, distributors, and retailers of consumer products to report potential product hazards to the Consumer Product Safety Commission. On May 26, 2006, the Commission solicited comments on proposed revisions to its interpretative rule advising manufacturers, distributors, and retailers how to comply with the requirements of section 15(b). The proposed revisions identified additional factors the Commission and staff consider when assessing whether a product is defective or not. The proposed revisions also clarified that compliance with voluntary or mandatory product safety standards may be considered by the Commission in making certain determinations under section 15. After considering public comments, the Commission issues the accompanying final rule. 1 1 The Commission voted 2-1 to issue the final interpretative rule, Commissioner Thomas Moore dissenting. Chairman Stratton and Commissioner Nord filed statements which are available from the Office of the Secretary or on the Commission's Web site at *http://www.cpsc.gov.* DATES: This final rule becomes effective on July 25, 2006. FOR FURTHER INFORMATION CONTACT: John Gibson Mullan, Assistant Executive Director, Compliance and Field Operations at

(301)504-7626. SUPPLEMENTARY INFORMATION: A. Background To provide further guidance, clarity and transparency on reporting obligations under section 15(b) of the Consumer Product Safety Act (CPSA), 15 U.S.C. 2064(b), the Commission, on May 26, 2006 (71 FR 30350) proposed revisions to its interpretative rules regarding reporting of possible substantial product hazards. Section 15(b) of the CPSA requires that every manufacturer (including an importer), distributor or retailer of a consumer product who obtains information which reasonably supports the conclusion that its product fails to comply with an applicable consumer product safety rule or with a voluntary consumer product safety standard upon which the Commission has relied under section 9 of the CPSA, or contains a defect which could create a substantial product hazard as defined in section 15(a)(2) of the CPSA, or creates an unreasonable risk of serious injury or death, shall immediately inform the Commission of such failure to comply, of such defect, or of such risk, unless the manufacturer, distributor or retailer has actual knowledge that the Commission has been adequately informed. In 1978, the Commission first published an interpretative rule, 16 CFR part 1115, which explained the section 15(b) reporting requirement and provided guidance on filing section 15(b) reports. In this notice the Commission finalizes revisions to the interpretative rule to clarify factors relevant to section 15(b) reporting determinations. These revisions are not intended to reduce the number of reports to the Office of Compliance, to reduce or change the types of information reported, or to suggest a diminished need to report. The Commission received 14 comments in response to the proposed revisions. Joint comments were submitted by four ATV companies (Kawaski Motors Corp., USA; American Honda Motor Co., Inc.; Polaris Industries Inc., and Yamaha Motor Corporation, U.S.A.). Joint comments were also submitted by four consumer groups (Consumers Union, Consumer Federation of America, Kids In Danger, and U.S. Public Interest Research Group). Eight commenters supported the revisions; two of the eight suggested clarifications to certain provisions. Six commenters opposed the revisions; five of the six suggested that the Commission not adopt the revisions and one of the six suggested that the Commission keep the record open. The Commission received a number of comments in support of a regulation related to the assessment of civil penalties pursuant to section 20 of the CPSA, 15 U.S.C. 2069(b), (c). A separate **Federal Register** notice is being issued for public comment on this issue. The Commission received a number of comments that went beyond the scope of the proposed revisions. These included a suggestion for a new appeal process for preliminary determinations relating to substantial product hazards, issues concerning the hazards presented by counterfeit products, more widespread notice about the Fast Track recall process, General Counsel review of recommendations of proposed administrative complaints, and provisions in the adjudicative rules for joinder and intervention. The Commission is not incorporating any of these suggestions since they were not part of the proposed revisions. A summary of the comments on the proposed revisions and our responses appear below. B. Section 1115.4 Defect The first revision clarifies the Commission's discussion of “defect” by adding additional criteria Commission staff use to evaluate whether a risk of injury is the type of risk that will render a product defective, thus possibly triggering a reporting obligation under section 15(b). The rule currently states that in determining whether the risk of injury associated with a product is the type of risk which will render a product defective, the Commission and staff consider, as appropriate: the utility of the product involved; the nature of the risk of injury which the product presents; the necessity for the product; the population exposed to the product and its risk of injury; the Commission's own experience and expertise; the case law interpreting Federal and State public health and safety statutes; the case law in the area of products liability; and other factors relevant to the determination. The Commission proposed to add the following factors as considerations: the obviousness of such risk; the adequacy of warnings and instructions to mitigate such risk; the role of consumer misuse of the product, and the foreseeability of such misuse. The commenters who opposed the revisions suggested that inclusion of these additional factors does not clarify a firm's reporting obligations but weakens the intent of the original regulation by giving firms additional factors upon which to argue that a particular product is not defective and thereby avoid reporting. Several commenters also suggested that a firm could rely on just one of the factors—like consumer misuse—to negate a reporting obligation. The Commission's intent in adopting this revision is to give further guidance to firms about reporting defects in their products. The determination of whether a product is defective is a threshold issue in evaluating reporting obligations under section 15(b) of the CPSA and is one of the most critical determinations a company is required to make under the CPSA. A firm must report if it obtains information which reasonably supports the conclusion that a product it manufactures and/or distributes contains a defect which could create a substantial product hazard. 15 U.S.C. 2064(b)(2). The regulatory criteria for evaluating whether a product presents a risk of injury that may render it defective have been in effect since 1978. In the nearly 30 years since then, the Commission and staff have evaluated thousands of products using many criteria, including, as appropriate, the criteria now being adopted. The Commission has concluded, based on experience and practice in applying the criteria, that the additional factors—the obviousness of such risk; the adequacy of warning and instructions to mitigate such risk; the role of consumer misuse of the product and the foreseeability of such misuse—help clarify the existing factors in the regulation and enable a better analysis of whether the risk of injury associated with a product is the type of risk which will render it defective. This regulation contemplates consideration of a number of appropriate factors in making such a determination. Reliance on one factor alone cannot negate a reporting obligation if other factors, as applied, reasonably support the conclusion that a defect exists. The Commission staff already considers the proposed factors in making decisions about potential defects. The current defect regulation specifies that the Commission and staff will, as appropriate, consider the case law in the area of product liability. Two commenters pointed out that the case law in the product liability area, as reflected in the Restatement of Torts, uses all of the additional criteria proposed. Thus, the regulation only makes explicit what was already implicit in the Commission's regulation. C. Section 1115.12(g)(1)(ii) Number of Defective Products Distributed In Commerce The Commission proposed adding the following statement to an evaluation of the number of defective products distributed in commerce when making a substantial product hazard determination: “The Commission also recognizes that the risk of injury from a product may decline over time as the number of products being used by consumers decreases.” Three commenters objected to this provision. One commenter contended that the proposed regulatory change is untrue because the individual risk to a user from a defective product bears no relationship to the number of products in use. Commenters opposed to the provision also stated that the proposal gave manufacturers an incentive to wait to report and to hide problems until a product is older. The Commission has clarified the language of this provision in response to comments. By this provision, the Commission is merely recognizing that the number of products remaining in consumers hands at any given time is relevant to a substantial product hazard determination and that determination can be influenced by a decline over time in the number of products remaining in use. The current regulation can be misleading because it suggests that the number of products originally distributed is the only relevant number in deciding whether a defective product presents a substantial risk of injury. When a potential hazard first appears long after a product was sold, however, the more relevant number is not the number of products originally sold but the number still with consumers. A firm may still have a reporting obligation in such circumstances. The Commission stresses that firms should never delay reporting in anticipation of, or because of, a decrease in the number of products in use. Firms that delay reporting for such reasons will be subject to civil penalties. The final regulation is reworded to avoid use of the term “risk” which generated some confusion. D. Section 1115.8 Compliance With Product Safety Standards The proposed revisions also add a new section § 1115.8, “Compliance with Product Safety Standards.” This section is intended to further explain how the Commission views compliance with applicable voluntary or mandatory standards, particularly in the context of decisions under section 15 of the CPSA. Three of the commenters raised the objection that this new provision creates a safe harbor for companies by negating a reporting obligation when a product complies with a voluntary or mandatory standard. *Voluntary Standards.* The opposing commenters mistake the scope and intent of this provision. It provides no safe harbor from a reporting obligation. The text of the rule states that compliance with voluntary standards “may be relevant” to preliminary determinations. This language clearly does not foreclose the possibility that the staff may make a preliminary determination that a product presents a substantial product hazard notwithstanding compliance with all applicable voluntary standards. Although the Commission strongly supports voluntary standards, such standards are not always adequate. In some cases, a defect may involve a product characteristic or aspect of performance not addressed by a standard that is adequate in other respects, or a product that meets voluntary standards by design may be taken out of compliance by a manufacturing defect. In short, if a voluntary standard exists and addresses a product hazard, and the product complies with such a standard, then that compliance may be relevant to considering whether a product preliminarily presents a substantial product hazard. Compliance with a voluntary standard does not preclude a determination that a substantial product hazard exists, nor will it relieve a firm of the requirement to report when a substantial product hazard may exist. Firms must not treat compliance with standards as an excuse not to report. They should report if a substantial product hazard may exist and allow the staff to consider the significance of the standard. In the past, the Commission has sought recalls for products that have complied with voluntary standards as well as products that did not comply. Compliance with an applicable voluntary standard, as stated in the final regulation, is merely one factor in this evaluation. *Mandatory Standards.* For reasons similar to those stated above, the Commission's provision for mandatory standards does not negate a reporting obligation nor provide safe harbor for the failure to report. There have been a number of occasions in the experience of the Commission staff when a product is determined to contain a defect that could create a substantial product hazard even though such product complies with a mandatory standard. The statute and regulations contemplate a report in such a circumstance. In fact, reports are especially important in such cases because they may be the Commission's only indication that the mandatory standards are in need of revision. At the same time, the Commission appreciates that it is generally inappropriate to hold firms to a higher standard for products retroactively. As stated in the regulation, which is slightly reworded in the final text, compliance with a mandatory standard should play a role in the staff's determination as to whether a corrective action is necessary. List of Subjects in 16 CFR Part 1115 Administrative practice and procedure, Business and Industry, Consumer protection, Reporting and recordkeeping requirements. Accordingly, 16 CFR part 1115 is amended as follows: PART 1115—SUBSTANTIAL PRODUCT HAZARD REPORTS 1. The authority citation for part 1115 continues to read as follows: Authority: 15 U.S.C. 2061, 2064, 2065, 2066(a), 2068, 2070, 2071, 2073, 2076, 2079 and 2084. 2. In § 1115.4, amend the concluding text by adding a new phrase after the phrase, “the population exposed to the product and its risk of injury;” to read as follows: § 1115.4 Defect. * * * the obviousness of such risk; the adequacy of warnings and instructions to mitigate such risk; the role of consumer misuse of the product and the foreseeability of such misuse;” * * * 3. Section 1115.8 is added to read as follows: § 1115.8 Compliance with product safety standards.

(a)*Voluntary standards.* The CPSA and other federal statutes administered by the Commission generally encourage the private sector development of, and compliance with voluntary consumer product safety standards to help protect the public from unreasonable risks of injury associated with consumer products. To support the development of such consensus standards, Commission staff participates in many voluntary standards committees and other activities. The Commission also strongly encourages all firms to comply with voluntary consumer product safety standards and considers, where appropriate, compliance or non-compliance with such standards in exercising its authorities under the CPSA and other federal statutes, including when making determinations under section 15 of the CPSA. Thus, for example, whether a product is in compliance with applicable voluntary safety standards may be relevant to the Commission staff's preliminary determination of whether that product presents a substantial product hazard under section 15 of the CPSA.

(b)*Mandatory standards.* The CPSA requires that firms comply with all applicable mandatory consumer product safety standards and to report to the Commission any products which do not comply with either mandatory standards or voluntary standards upon which the Commission has relied. As is the case with voluntary consumer product safety standards, compliance or non-compliance with applicable mandatory safety standards may be considered by the Commission and staff in making relevant determinations and exercising relevant authorities under the CPSA and other federal statutes. Thus, for example, while compliance with a relevant mandatory product safety standard does not, of itself, relieve a firm from the need to report to the Commission a product defect that creates a substantial product hazard under section 15 of the CPSA, it will be considered by staff in making the determination of whether and what type of corrective action may be required. 4. Section 1115.12 is amended by adding a new sentence at the end of paragraph (g)(1)(ii) to read as follows: § 1115.12 Information which should be reported; evaluating substantial product hazard.

(g)* * *

(1)* * *

(ii)* * * The Commission also recognizes that the number of products remaining with consumers is a relevant consideration. Dated: July 18, 2006. Todd A. Stevenson, Secretary, Consumer Product Safety Commission. [FR Doc. E6-11758 Filed 7-24-06; 8:45 am] BILLING CODE 6355-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. 2001N-0548] (formerly Docket No. 01N-0548) Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is amending the voluntary nutrition labeling regulations by updating the names and the nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States and clarifying guidelines for the voluntary nutrition labeling of these foods. Availability of the updated nutrition labeling values in retail stores and on individually packaged raw fruits, vegetables, and fish will enable consumers to make better purchasing decisions to reflect their dietary needs. EFFECTIVE DATE: January 1, 2008. FOR FURTHER INFORMATION CONTACT: Mary Brandt, Center for Food Safety and Applied Nutrition (HFS-840), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1788. SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Comments on the 2002 Proposed Rule and 2005 Reopening of the Comment Period A. General Comments B. Consistency Among Government Agencies in Providing Nutrient Information C. Need for Additional Research and Data D. Consumer Support for Labeling of Raw Fruits, Vegetables, and Fish E. Allowable Nutrient Content Claims F. Declaration of “Vitamin A” or “Carotenoid” G. Updating of Reference Amounts H. Inclusion of Magnesium in Nutrition Labeling I. Guidelines for Presentation of the Nutrition Labeling Values 1. Clarity in Guidelines for Raw Fruits and Vegetables and for Raw Fish 2. *Trans* Fatty Acid Labeling J. Identification of the 20 Most Frequently Consumed Raw Fruits, Vegetables, and Fish in the United States 1. Fruits and Vegetables 2. Fish K. Nutrition Labeling Values for the 20 Most Frequently Consumed Raw Fruits, Vegetables, and Fish 1. FDA Analysis of Data a. 95 Percent Prediction Intervals b. Precision in Estimates c. Adjusting Values for Total Carbohydrate 2. Nutrition Labeling of Raw Fruits and Vegetables a. Apple b. Avocado c. Banana d. Kiwifruit e. Pear f. Strawberries g. Potato 3. Changes to Nutrition Labeling Values Based Upon Reassessment of 95 Percent Prediction Intervals 4. Summary of Changes for Fruits and Vegetables L. Nutrition Labeling of Raw Fish M. Effective Date III. Final Regulatory Impact Analysis IV. Final Regulatory Flexibility Analysis V. Unfunded Mandates VI. Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) VII. Paperwork Reduction Act of 1995 VIII. Analysis of Environmental Impact IX. Federalism X. References I. Background In response to requirements of the Nutrition Labeling and Education Act of 1990 (“the 1990 amendments”) (Public Law 101-135), which amended the Federal Food, Drug, and Cosmetic Act (the act), FDA

(we)published final regulations in the **Federal Register** of November 27, 1991 (56 FR 60880) (hereinafter identified as “the 1991 final rule”), and corrections in the **Federal Registers** of March 6, 1992 (57 FR 8174), and March 26, 1992 (57 FR 10522), that:

(1)Identified the 20 most frequently consumed raw fruits, vegetables, and fish in the United States, which are those varieties purchased raw but not necessarily consumed raw;

(2)established guidelines for the voluntary nutrition labeling of these foods; and

(3)set the criteria for food retailers to meet substantial compliance with these guidelines. The 1991 final rule also required FDA to publish proposed updates of the nutrition labeling data for the 20 most frequently consumed raw fruits, vegetables, and fish (or a notice that the data sets have not changed) at least every 2 years (56 FR 60880 at 60888 and 60891). Next, FDA published a proposed rule on the voluntary nutrition labeling program in the **Federal Register** of July 18, 1994 (59 FR 36379) (hereinafter identified as “the 1994 proposed rule”), a correction in the **Federal Register** of July 21, 1994 (59 FR 37190), and a final rule in the **Federal Register** of August 16, 1996 (61 FR 42742) (hereinafter identified as “the 1996 final rule”). In the 1996 final rule, among other actions, FDA revised the following:

(1)The nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States and

(2)the guidelines for the voluntary nutrition labeling of these foods. FDA also modified the guidelines in § 101.45(b) (21 CFR 101.45(b)), in response to comments, to state that FDA would publish every 4 years (rather than 2 years) proposed updates of the nutrition data or a notice that the data sets have not changed from the previous publication (comment 12, 61 FR 42742 at 42746 and 42760). FDA then published a proposed rule on the voluntary nutrition labeling program in the **Federal Register** of March 20, 2002 (67 FR 12918) (hereinafter identified as “the 2002 proposed rule”), and a correction to the Docket number and extension of the comment period in the **Federal Register** of June 6, 2002 (67 FR 38913). The 2002 proposed rule:

(1)Updated the names and nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States and

(2)clarified the guidelines for the voluntary nutrition labeling of these foods. Subsequently, FDA again reopened the comment period until June 3, 2005 (70 FR 16995, April 4, 2005) (hereinafter identified as “the 2005 reopening of the comment period”), to allow all interested parties the opportunity to review its tentative nutrition labeling values based upon data FDA received within and after the comment period for the 2002 proposed rule, and to comment on the additional nutrient data for some of the 20 most frequently consumed raw fruits, vegetables, and fish. FDA also stated that it would evaluate any new data submissions during the reopened comment period and would consider use of those data in a final rule. II. Comments on the 2002 Proposed Rule and 2005 Reopening of the Comment Period FDA received 21 responses to the 2002 proposed rule and 30 responses to the tentative nutrition labeling values set forth in its 2005 reopening of the comment period document, each of which contained one or more comments. New data also were submitted in response to the 2005 reopening of the comment period. Comments generally supported the 2002 proposed rule, including the new values set forth in the 2005 reopening of the comment period document. A number of comments that were received are not considered here because they are beyond the scope of this regulation, including those comments on labeling of meat, poultry, and pork products; labeling of possible positive or ill side effects of consuming raw produce and fish; expiration dating; physical exercise; inclusion of additional nutrients and amino acids; protection of the public from profiteers; genetically modified products; pesticide residues, chemicals, and processes; and monosodium glutamate (MSG). Several comments suggested modification and revision in various provisions of the 2002 proposed rule, as revised by the 2005 reopening of the comment period. These latter comments are discussed in detail in this section of the document. To make it easier to identify comments and FDA's responses to the comments, the word “Comment” will appear in parenthesis before the description of the comment, and the word “Response” will appear in parenthesis before FDA's response. We have also numbered each comment to make it easier to identify a particular comment. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was submitted. A. General Comments (Comment 1) One comment, which supported the agency's efforts to establish accurate, meaningful nutrition information, requested that FDA post this information on its Web site and permit retailers who have developed Web sites to incorporate links from the retailer Web site to the FDA nutrition information. (Response) FDA agrees with this suggestion and has posted the nutrition labeling values on the Internet at *www.cfsan.fda.gov* . We encourage retailers, industry, trade associations, academia, and other government agencies to provide links to that information. B. Consistency Among Government Agencies in Providing Nutrient Information (Comment 2) Several comments expressed concern that the proposed changes to some of the nutrient values appear inconsistent from the U.S. Department of Agriculture

(USDA)Nutrient Database for Standard Reference

(SR)(Ref. 1) and from its data source, the USDA National Nutrient Data Bank

(NNDB)(Ref. 2). One comment suggested that whenever possible, FDA should consider SR values in addition to the agency's own 95 percent prediction limit when determining label values. (Response) FDA agrees that some of its nutrient values differ from data found in the USDA SR and NNDB. As we explained in the 1996 final rule (61 FR 42742 at 42743), FDA does not agree that mean values from USDA databases are appropriate for nutrition labeling. We support use of the USDA NNDB and associated USDA SR for many nutritional purposes and recognize the USDA SR as the most comprehensive nutrient database in the United States and the basis of much nutrition software. For this reason, we have used all data submitted by USDA to update the nutrition labeling values for raw fruits and vegetables, including the data from its 2001-2002 nationwide sampling study of fruits and vegetables for 16 of the 20 most frequently consumed raw fruits and 12 of the 20 most frequently consumed raw vegetables that it submitted in response to the 2002 proposed rule (see *http://www.fda.gov/ohrms/dockets/dailys/02/Aug02/080602/01n-0548-c000006-vol1.pdf* ) and (see *http://www.fda.gov/OHRMS/DOCKETS/98fr/01n-0548-bkg0002-03-Tab-01-vol4.pdf* ) and its data for raw mushrooms in response to the 2005 reopening of the comment period, as well as data from other sources, as described later in this final rule. In addition, we used data from the USDA NNDB to establish nutrient levels for Chinook salmon in response to comments to the 2002 proposed rule. Raw nutrient data (individual analytical data points) from the USDA NNDB also provide the basis of the nutrient levels for most of the raw fish. Because of the lack of data for vitamin A and vitamin C in raw fish, we have based the values for most fish in the voluntary nutrition labeling program on data published in the USDA SR, which are mean values. As stated in the 1996 final rule (61 FR 42742 at 42743), some of USDA's food composition data published in the SR are not fully representative because they are based on small sample sizes or do not take into account specific variables, such as geographic area. We obtained data for many of the raw fruits, vegetables, and fish from the USDA NNDB and SR, but, where possible, instead of using the mean values, we applied compliance calculations based on 95 percent prediction intervals to those data (as well as to other data sources) and used the resulting adjusted values that account for variability in the nutrient. To meet the requirements for compliance in § 101.9(g)(4) and (g)(5) (21 CFR 101.9(g)(4) and (g)(5)), the agency encourages manufacturers to use FDA compliance calculations based on 95 percent prediction intervals to determine the nutrition labeling values for their products. We provide guidance explaining this calculation and for industry to use to develop nutrition labeling values in the “FDA Nutrition Labeling Manual—A Guide for Developing and Using Databases” (the Nutrition Labeling Manual) (Ref. 3). The Nutrition Labeling Manual more fully explains the rationale and process for conducting and using compliance calculations based upon 95 percent prediction intervals. (Comment 3) Several comments stated that it is important to have consistency in the nutrition information that is communicated to the public and that FDA should do more to bring greater harmony among the government's nutrition information, including ensuring that nutrient values are consistent with the nutrition messages publicized by the 2005 Dietary Guidelines for Americans. (Response) We believe it is important to have consistency in the nutrition information that is communicated to the public; however, there are some fundamental differences in the nutrient values being established in this final rule and the nutrition messages publicized by the 2005 Dietary Guidelines for Americans. The Dietary Guidelines for Americans (Ref. 4) recommends the increased intake of fruits, vegetables, and fish and cites nutrient data from the USDA SR in the report that they released January 12, 2005. The data provided by the 2005 Dietary Guidelines for Americans were mean values per 100 gram

(g)of product and were not on the same metric as the nutrition labeling values in Appendices C and D to part 101 (21 CFR part 101), which are provided on a serving size basis and are required in § 101.45(b) for labeling of the 20 most frequently consumed raw fruits, vegetables, and fish to ensure uniformity in declared values. Thus, some differences in nutrient levels are likely to be noted. C. Need for Additional Research and Data (Comment 4) Five comments requested that the final rule not be finalized at this time because they needed an additional 12 months to plan, execute, and evaluate additional nutrient research so that nutrient data are as complete and extensive as possible. The comments asserted that this additional time will allow for sampling products at different times of the year which will give them a more accurate reflection of the seasonal impact on nutrient content values. One of the comments stated the additional time also would allow the industry to establish more data points and thus increase the sample size of analytical values, which may help in calculating a more reliable mean value and improving the standard deviation, both factors needed to calculate the one-sided 95 percent prediction interval. (Response) The data submitted to FDA in response to the 2002 proposed rule were available for public review for almost 3 years. We believe that this is more than an adequate amount of time for interested persons to complete nutrient analyses, provide additional data and information on market shares, determine the seasonal impact on nutrient content values, and establish more data points for calculating a more reliable nutrient value. We therefore have concluded that the requested additional time is not warranted. However, we do encourage the produce and fish industries to continue to conduct research on nutrient values and to submit new data to FDA for consideration in future updates, in accord with § 101.45(b). (Comment 5) One comment urged that FDA utilize all credible data available and not a limited set of data from one study. (Response) FDA agrees that it should utilize all credible data available in developing its nutritional values for raw fruit, vegetables, and fish. We recognize that additional nutrient data are needed to support the voluntary nutrition labeling of raw produce and fish because some of the current values are based on small sample sizes or older data and should be updated. However, many of the commodity groups and organizations that represent the produce and fish industries have not submitted new data to support the updating and refinement of the nutrient levels. We therefore can only use the data we have in updating and refining these nutrient levels. As stated in the response to comment 4 of this document, we encourage and will continue to encourage the produce and fish industries to conduct additional nutrient analyses to support the labeling of these foods and to submit those data to FDA for consideration in updating the nutrient levels in the next review of the voluntary nutrition labeling of raw produce and fish. D. Consumer Support for Labeling of Raw Fruits, Vegetables, and Fish (Comment 6) One comment recommended that FDA establish nutrition labeling values for more than just the 20 most frequently consumed raw products identified in the proposal. (Response) Section 403(q)(4)(B) of the act (21 U.S.C. 343(q)(4)(B)) provides that FDA establish by regulation a list of the 20 varieties of vegetables, fruits, and raw fish most frequently consumed in a year. Therefore, we are not granting the comment's request in this final rule. However, we have provided for the nutrition labeling of raw fruits, vegetables, and fish that are not among the 20 most frequently consumed in § 101.45(c). In that regulation, FDA states that databases of nutrient values may be used to develop nutrition labeling values for specific varieties, species, or cultivars of those foods not among the 20 most frequently consumed raw fruits, vegetables, and fish. The food names and descriptions for the fruits, vegetables, and fish in nutrition labeling or in databases developed and submitted to FDA under this regulation should clearly identify these foods as distinct from foods among the most frequently consumed list for which we have provided data. Guidance in the development of databases for these foods may be found in the FDA Nutrition Labeling Manual (Ref. 3). (Comment 7) Two comments requested that FDA make the voluntary guidelines mandatory and require retailers to provide nutrition information for raw fruits, vegetables, and fish products. (Response) FDA disagrees with the comments. The compliance surveys we conducted in 1992, 1994, and 1996 (Ref. 5) do not support taking such action at this time. These surveys found that retailers exceeded the 60 percent substantial compliance standard set in § 101.43(c) by a large enough margin to provide confidence that the levels were not invalidated by statistical error. Levels of compliance for 1992, 1994, and 1996 were 76.9 percent, 81.4 percent, and 77.8 percent for raw produce and 74.3 percent, 76.8 percent, and 74.0 percent for raw fish. As our surveys have found substantial compliance over several years, we have no reason to evaluate the marketplace differently than we have in past years because there is no evidence that substantial compliance does not continue at the present time. Absent information suggesting otherwise, our evaluation of the available compliance data and our projections based on those data indicate that compliance remains substantial at this time. Thus, at this time, we continue to encourage retailers to provide quantitative nutrition information for raw fruits, vegetables, and fish but will not publish regulations to make the provision of nutrition information mandatory. E. Allowable Nutrient Content Claims (Comment 8) One comment expressed concern that changing the existing nutrition label values for several key fruits and vegetables will weaken their perceived nutrient values (e.g., a fruit or vegetable that was previously an “excellent source” would now be considered a “good source”) and some micronutrient claims would have to be dropped altogether because these fruits and vegetables will not be able to bear the same nutrient content claims that they once did under § 101.54. This situation could cause only fortified processed foods to be able to use the claim “excellent source” for some nutrients. The comment stated that the changes the agency is making would mean the loss of positive nutrition content claims for several vegetables and fruits that are currently considered to be the “gold standard” of nutrition among consumers. (Response) We recognize and agree that based upon new data, some of the fruits and vegetables may no longer be able to bear the same nutrient content claims. We want to clarify, however, that as described in § 101.54, nutrient content claims must be based on the reference amounts customarily consumed (RACCs) and not on the serving sizes of products, which are derived from the RACCs. Specifically, § 101.54(b) states the provisions for “high claims” (“high,” “rich in,” or “excellent source of”), and § 101.54(c) provides those for “good source claims” (“good source,” “contains,” or “provides”). Section 101.12(b) states that reference amounts shall be used as the basis for determining serving sizes for specific products. The RACCs shown in Table 2 of § 101.12 for fruits, vegetables, and fish in the voluntary nutrition labeling program include 140 g for fresh fruits, 30 g for avocado, 280 g for watermelon, 55 g for lemon and lime, 30 g for green onion, 110 g for fresh potatoes, 85 g for fresh vegetables, and 85 g for cooked, plain fish and shellfish. The serving sizes of raw produce displayed in Appendix C to part 101, while based on the RACCs, are generally not equivalent to the RACCs, which are listed in grams only, but are provided on the basis of a “household measure” of a food as well as in g and ounces (oz), such as 1 medium banana (126 g per (/) 4.5 oz) or 5 asparagus spears (93 g/3 oz). The serving size for all raw fish displayed in Appendix D to part 101 is 84 g/3 oz. F. Declaration of “Vitamin A” or “Carotenoid” (Comment 9) One comment stated that fruits and vegetables contain carotenoid, which is the precursor of vitamin A, but not vitamin A itself, so the term “vitamin A” for fruits and vegetables should be changed to “carotenoid”. (Response) We believe it would be inaccurate to change the term “Vitamin A” to “carotenoids” for fresh fruit and vegetables given the understanding of the term “Vitamin A” and the relatively limited understanding of the functions of the hundreds of naturally occurring carotenoids. Vitamin A comprises a family of molecules containing a 20-carbon structure with a methyl substituted cyclohexenyl ring and a tetraene side chain with a hydroxy group (retinol), aldehyde group (retinal), carboxylic acid group (retinoic acid) or ester group (retinyl ester) at carbon 15. The term “Vitamin A” includes provitamin A carotenoids that are dietary precursors of retinol. The term “retinoids” refers to retinol, its metabolites, and synthetic analogues that have a similar structure. Carotenoids are polyisoprenoids, of which more than 600 forms exist. Of the many carotenoids in nature, several have provitamin A nutritional activity. Food composition data are available for only three (alpha-carotene, beta-carotene, and beta-crypotoxanthin). Because the term “Vitamin A” typically encompasses pro-vitamin A carotenoids, and most carotenoids have no food composition data available at this time, the suggested change would be inaccurate. G. Updating of Reference Amounts (Comment 10) One comment recommended that FDA not revise nutrient values for the 20 most frequently consumed raw fruits, vegetables, and fish until we finalized the April 4, 2005 (70 FR 17010) Advanced Notice of Proposed Rulemaking (ANPRM) (the April 2005 ANPRM), that requested comments on, among other issues, whether we should update the RACCs, the basis for serving size. The comment was of the view that we should wait until the reference amounts are revised to reflect what is currently available in the U.S. market. (Response) FDA disagrees with the comment. We believe we should publish this final rule at this time and not wait until completion of the rulemaking process that we initiated by the April 2005 ANPRM. We are currently reviewing comments submitted in response to the ANPRM and have not determined whether or when we will update the RACCs. If we do decide to go forward with that rulemaking and revise the RACCs, we will then update the serving sizes of raw fruits, vegetables, and fish to reflect those revisions in future rulemaking for the voluntary nutrition labeling program. H. Inclusion of Magnesium in Nutrition Labeling (Comment 11) One comment suggested that FDA include the magnesium content of seafood in the voluntary nutrition labeling regulations. Cooked fish, the comment noted, can provide substantial amounts of magnesium in the U.S. diet, which would provide health benefits to American consumers. Another comment requested that magnesium be added to the banana's nutrition labeling profile in Appendix C to part 101. The latter comment noted that the 2005 Dietary Guidelines for Americans recommend that both adults and children increase their intake of magnesium from food sources. (Response) FDA is not granting either of these requests. We note that the 2005 Dietary Guidelines state that based on dietary intake data or evidence of public health problems, intake levels of magnesium may be of concern for both adults and children (Ref. 4). However, none of the comments included nutrient data for magnesium for any of the fish in the voluntary nutrition labeling program, and we do not have access to magnesium data for any of the fish or the raw fruits and vegetables. Thus we cannot grant the request in the comment without such supporting data. However, we consider magnesium an optional nutrient for both mandatory nutrition labeling and the voluntary nutrition labeling of raw fruits, vegetables, and fish. In the 1996 final rule, we noted that providing information on optional nutrients for foods in the voluntary program will be useful, and declarations of optional nutrients included on individual labels should follow the requirements under § 101.9(c). I. Guidelines for Presentation of the Nutrition Labeling Values 1. Clarity in Guidelines for Raw Fruits and Vegetables and for Raw Fish To provide clarity and consistency in the voluntary nutrition labeling of raw fruits, vegetables, and fish, FDA proposed in § 101.45(a)(3) to:

(1)Divide current § 101.45(a)(3)(iii) into two parts (i.e., into § 101.45(a)(3)(iii) and (a)(3)(iv)) so that § 101.45(a)(3)(iii) pertains only to raw fruits and vegetables and § 101.45(a)(3)(iv) pertains only to raw fish and

(2)revise the wording for consistency and increased readability. No comments were received, and therefore these guidelines were adopted as proposed. 2. *Trans* Fatty Acid Labeling FDA stated in the 2002 proposed rule that *trans* fatty acids would not be expected to be present in raw produce and that the footnote required in proposed § 101.45(a)(3)(iii) should be revised to state: “Most fruits and vegetables provide negligible amounts of saturated fat, *trans* fat, and cholesterol * * *.” Comments supported FDA's proposed revisions to § 101.45(a)(3)(iii), and therefore we have adopted it as proposed. Also, FDA requested comments that provide data on the *trans* fat content of raw fish (or cooked fish without the addition of any ingredients, e.g., fat, breading, or seasoning). (Comment 12) Several comments requested that FDA revise § 101.45(a)(3)(iv) to state that fish provide only negligible amounts of *trans* fat, or no *trans* fat. A comment from the fish industry noted that, unlike some animals, fish do not typically accumulate measurable levels of *trans* fat as a result of their metabolized food sources, and it is particularly true of wild-caught fish. (Response) FDA agrees with the comments and has revised § 101.45(a)(3)(iv) to read as follows: “When retailers provide nutrition labeling information for more than one raw fish on signs or posters or in brochures, notebooks, or leaflets, the listings for *trans* fat, dietary fiber and sugars may be omitted from the charts or individual nutrition labels if the following footnote is used, ‘Fish provide negligible amounts of *trans* fat, dietary fiber, and sugars’.” Appendices C and D to part 101 will show 0 g of *trans* fat for all varieties of raw fruits, vegetables, and fish. J. Identification of the 20 Most Frequently Consumed Raw Fruits, Vegetables, and Fish in the United States 1. Fruits and Vegetables There were no comments that recommended changing the top 20 most frequently consumed raw fruits and the top 20 most frequently consumed raw vegetables. For ease of use and to be consistent with the food names in Appendix C to part 101, we revised § 101.44(a) and

(b)by listing the items in alphabetical order and by using the plural form of the food name when the serving size is more than one unit. Revised § 101.44(a) reads as follows: “The 20 most frequently consumed raw fruits are: Apple, avocado (California), banana, cantaloupe, grapefruit, grapes, honeydew melon, kiwifruit, lemon, lime, nectarine, orange, peach, pear, pineapple, plums, strawberries, sweet cherries, tangerine, and watermelon.” Revised § 101.44(b) reads as follows: “The 20 most frequently consumed raw vegetables are: Asparagus, bell pepper, broccoli, carrot, cauliflower, celery, cucumber, green

(snap)beans, green cabbage, green onion, iceberg lettuce, leaf lettuce, mushrooms, onion, potato, radishes, summer squash, sweet corn, sweet potato, and tomato.” 2. Fish (Comment 13) Two comments requested that FDA revise § 101.45(a)(3)(iv) to add Chinook salmon to the salmon species. One comment stated that the vast majority of Chinook salmon is sold raw to the U.S. consumer, and the nutrient profile is most similar to the proposed category for the values for Atlantic/coho/sockeye salmon. (Response) We agree with this suggestion and have revised 101.45(a)(3)(iv) to combine Atlantic, coho, Chinook and sockeye into one subgroup of salmon based upon similarity in nutrient values. (Comment 14) One comment requested that FDA report information for farmed salmon separately from that for wild salmon because food supply and water quality greatly affect nutrition value of the food whether it is raised or caught. (Response) We are not granting this request because there were no nutrient data submitted that supported providing nutrition information separately for farmed versus wild species of salmon or other types of fish. K. Nutrition Labeling Values for the 20 Most Frequently Consumed Raw Fruits, Vegetables, and Fish 1. FDA Analysis of the Data FDA considered the data from all of the sources identified in sections II.K.2 and II.K.3 of this final rule and used these data as the basis for deriving the updated nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in Appendices C and D to part 101. Reference 6 of this document provides complete documentation of the derivation of each nutrition labeling value for the raw fruits, vegetables, and fish covered in this final rule. The documentation also includes the actual (unrounded) values for total fat, total carbohydrate, and protein used to calculate calories and calories from fat for each food. To the extent possible (i.e., for those nutrients for which sufficient data were available), we used the statistical methodology recommended in the FDA Nutrition Labeling Manual to produce the nutrition labeling values. The recommended statistical methodology uses compliance calculations that take into account the variation of nutrients in foods, as described in greater detail in the 2002 proposed rule. a. *95 Percent Prediction Intervals* . (Comment 15) One comment stated that proposed values appear to be imprecise and not representative when calculating for the one-sided 95 percent prediction interval. As a solution, the comment recommended that FDA use predicted values that fall within the range of the actual data points. (Response) We agree with the comment that the 95 percent predicted value should fall within the range of the interval of all raw data points and have reviewed all nutrient data for all foods. If the 95 percent predicted value falls within the interval of all raw data points, then it is reasonable that it represent the nutrient level of the product. If for any reason, the 95 percent predicted value shows an invalid complete absence of a nutrient, if it is a negative value, or if it does not fall within the interval of all raw data points, it is likely that the mean will provide a better estimate of the nutrient than the predicted value. We also noted in the 2002 proposed rule that we frequently find that the mean and the predicted value round to the same value. In addition, we found that when the sample size was small (e.g., three or fewer analytical data points), the values derived from compliance calculations (using 95 percent prediction intervals) were less likely than the mean to represent the nutrient level. Thus, after a careful review of statistical and analytical data and considering all criteria listed in section II.K.1 of this document, we selected those values that more appropriately represent the nutrient level in the food. (Comment 16) One comment asked that FDA provide clarification of the agency's compliance with the Data Quality Act in issuing the proposed nutrient labeling values. (Response) In the Information Quality Act (IQA), Public Law No. 106-554, section 515 (2000), see 44 U.S.C. 2516 note, Congress directed the Office of Management and Budget

(OMB)to issue governmentwide guidelines designed to ensure and maximize the “quality, objectivity, utility, and integrity of information * * * disseminated by Federal agencies,” and in turn required agencies to issue their own guidelines concerning information quality and to establish administrative mechanisms to allow affected persons to seek and obtain correction of information maintained and disseminated by the agency that does not comport with the agency's guidelines. OMB's guidelines were published in the **Federal Register** of February 22, 2002 (67 FR 8452); HHS's guidelines were announced in the **Federal Register** of September 30, 2002 (67 FR 61343), and can be found at *http://aspe.hhs.gov/infoquality/guidelines/fda.shtml* . (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site after this document publishes in the **Federal Register** .) The nutrition labeling values that we provide in the voluntary nutrition labeling program are developed using a transparent process that provides data that are reproducible and are otherwise in compliance with FDA's IQA guidelines and the IQA. The process of setting and updating these values is identified in § 101.45(b) and

(c)and in the FDA Nutrition Labeling Manual, described in § 101.45(b) and (c). The manual provides the general methodology that we recommend and follow to determine nutrition labeling values based on 95 percent prediction intervals, and FDA has provided detailed explanations of its methodology in the proposed rule and in response to comments in this preamble. In addition to the FDA Nutrition Labeling Manual, FDA staff members are available to answer questions and to provide further direction on the analytical, statistical, and methodological questions that arise concerning determination of nutrition labeling values. Stakeholders with new or additional nutrient data for any of the most frequently consumed raw fruits, vegetables, and fish are encouraged in § 101.45(b) and

(c)to submit data to the agency for review and evaluation by the agency, and these data may be incorporated into subsequent revisions of the nutrition labeling information. b. *Precision in Estimates* . (Comment 17) One comment suggested that USDA and FDA emphasize in the regulation that the [serving] sizes given for produce items are expressed for the edible portion even though, as another comment noted, consumers buy foods in “as purchased” quantities. For example, a consumer buying a fruit with a large amount of inedible content (e.g., cantaloupe or peach), would likely believe that they are getting more nutrients than they are. The comment stated that having yield conversion factors would be necessary to make the nutrient information truly usable to the consumer. (Response) We do not believe the emphasis requested is necessary, as we are not aware of consumer research that describes consumers' perceptions of the size of fruits and vegetables they purchase with respect to interpretation of nutrient information available on signs in retail outlets, which is based on a serving size set by FDA and reflects the amount customarily consumed. We are therefore not convinced that most consumers will require the precision in knowing at the point of purchase the yield information of the raw fruits and vegetables they purchase. (Comment 18) One comment expressed concern that the proposed changes in nutrient levels mislead the public because listing the weight of any fruit or vegetable in unrounded numbers gives an impression of an unwarranted level of accuracy, when in fact fruits and vegetables vary in size. (Response) FDA agrees that fruits and vegetables vary in size but disagrees that listing the weight in unrounded numbers gives an impression of an unwarranted level of accuracy. The nutrition labeling values in Appendix C to part 101 provide serving sizes for each fruit and vegetable that is expressed in a visual unit of measure (e.g., 1 medium apple; 2 slices pineapple; 5 spears asparagus; 1/2 medium summer squash; 1 medium, 5′ long, 2′ diameter sweet potato), as well as the gram and ounce equivalent. Visual units of measure vary and are not intended to be precise. We expect that consumers will treat them as an approximation but will also have the option of referring to the gram and ounce serving size measures if greater precision is needed. c. *Adjusting Values for Total Carbohydrate* . (Comment 19) One comment objected to FDA adjusting the total carbohydrate values where the sum of sugars and dietary fiber exceeded the value for total carbohydrate. The comment stated that the sugar value should be adjusted when sugars and fibers exceed total carbohydrate, and the sugar values are from a different source than the proximate, fiber, and other nutrient values. This, the comment stated, would more accurately represent the sugar and carbohydrate content, as well as the caloric value, of the samples from which most of the nutrition labeling values have been derived. (Response) We disagree that the sugars value should be adjusted. The sum of the sugars and dietary fiber values, which were derived from analytical data submitted by USDA, exceeded the value for total carbohydrate for cantaloupe, honeydew melon, and watermelon. For these foods only, we adjusted the value for total carbohydrate to reflect the sum of sugars and dietary fiber. As stated in the 2002 proposed rule, we consider this adjustment to be appropriate because the values for sugars and dietary fiber are determined by laboratory analysis, and therefore, are more accurate than the value for total carbohydrate, which is determined “by difference” (i.e., the weight remaining after subtracting the sum of the protein, fat, moisture, and ash from the total weight of the food (§ 101.9(c)(6))). 2. Nutrition Labeling of Raw Fruits and Vegetables In the 2002 proposed rule, FDA updated nutrition labeling values for 12 of the 20 raw fruits and 9 of the 20 raw vegetables. We used new data for six of the fruits from the California Avocado Commission (CAC); the California Table Grape Commission; the California Tree Fruit Agreement

(CTFA)for peach, plums, and nectarine; and the California Cherry Advisory Board for fat in sweet cherries. We also used new data for four vegetables from the National Potato Protection Board and the USDA NNDB for green onion, sweet corn, and sweet potatoes. In other nutrition label changes, we corrected slight errors in sugars, total carbohydrate, calories, and calories from fat values in a few fruits and vegetables (cantaloupe, orange, strawberries, sweet cherries, tangerine, watermelon, asparagus, celery, green

(snap)beans, and tomato) and corrected the serving size for grapefruit, carrot, and sweet potato. As indicated in section II.B of this final rule, USDA submitted data in response to the 2002 proposed rule from its 2001-2002 nationwide sampling study of fruits and vegetables, which it incorporated into its NNDB and SR, for 16 of the 20 most frequently consumed raw fruits (apple, avocado (California), banana, cantaloupe, grapefruit, honeydew melon, kiwifruit, nectarine, orange, peach, pear, pineapple, plums, strawberries, sweet cherries, and watermelon) and 12 of the 20 most frequently consumed raw vegetables (bell pepper, broccoli, carrot, celery, cucumber, iceberg lettuce, leaf lettuce, onion, potato, radish, sweet potato, and tomato). At the time USDA submitted the comment, the data results for vitamin C, sodium, and potassium were not yet available, and the analysis of carotenoids for carrots, sweet potatoes, cucumbers, onions, and sweet peppers had not been completed. In June and July of 2003, after the close of the comment period, USDA provided sodium, potassium, and some carotenoid values that it did not submit earlier, including vitamin C values for pineapple. In other comments to the 2002 proposed rule, the Citrus Research Board and Food Research, Inc., provided nutrient data from 1998 for oranges, grapefruit, tangerines (Mandarin oranges), and lemons. We used all of the new data to update the nutrition labeling values in the 2005 reopening of the comment period. In response to the 2005 reopening of the comment period, the Pear Bureau Northwest submitted market share data for four varieties of pears; USDA submitted data for raw mushrooms; Food Research, Inc., submitted data for total fat in kiwifruit; and the California Strawberry Commission

(CSC)submitted data for sugars, calcium, and iron in strawberries. After the close of the comment period, the U.S. Apple Association (USApple) submitted data for fiber and new serving size information. We considered all data submitted in response to the 2005 reopening of the comment period and used those data to update the nutrition labeling values for raw fruits and vegetables in this final rule. The following will address individual fruits and vegetables for which we received data in response to the 2005 reopening of the comment period. a. *Apple* . (Comment 20) USApple requested that FDA use its new serving size information and new data for dietary fiber for five varieties of apples (Red Delicious, Golden Delicious, Granny Smith, Gala, and Fuji) in updating the nutrient values for apples. USApple stated that based on current market data, retailers are selling significantly larger apples than those represented by the existing serving size of 154 g or 5.5 oz edible portion, which is based on 1975 market data. They noted that the 154 g serving size for apples does not reflect the majority of apples for sale in the retail market and that a large apple (264 g whole, 242 g edible portion) is customarily consumed in the United States. They stated apple growers have adapted to consumers' tastes and preferences by growing and marketing larger apples, and, as a result, apple production and the apple market have changed significantly. In addition, only small and large apple sizes exist in today's marketplace. There is no inventory management or price look-up

(PLU)sticker that designates a “medium” size apple at the retail level, and smaller apples typically go to processing. USApple recommended that a large apple (242 g edible portion) should be listed as the serving size. (Response) We agree with the USApple request. We are convinced by the data submitted by USApple that “1 large (242 g/8 oz)” better represents the serving size for apple. Thus, we combined the data for dietary fiber from the USApple research study (n=8) with data provided by USDA for the same five varieties of apples in response to the 2002 proposed rule (n=15) and conducted weighted compliance calculations of all nutrients based on market share using 95 percent prediction intervals (Ref. 7). Based upon our analysis of the data, we determined that there would be changes in nutrition labeling values for calories (130 from 80), potassium (260 milligrams (mg), 7 percent daily value (DV), from 160 mg, 5 percent DV), total carbohydrate (34 g, 11 percent DV, from 21 mg, 7 percent DV), dietary fiber (5 g, 20 percent DV, from 3 g, 12 percent DV), sugars (25 g from 16 g), protein (1 g from 0 g), calcium (2 percent DV from 0 percent DV), and iron (2 percent DV from 0 percent DV). Table 1 of this document includes changes in nutrition labeling values for apples, and Appendix C to part 101 provides the listing of all values. **Table 1.—Changes to the Nutrition Labeling Information for Raw Fruits and Vegetables** Food and Nutrient 2005 Reopening Comment Period Values % DV Final Rule Values % DV Apples (242 g) (154 g) (242 g) Calories 80 130 Potassium 160 mg 5% 260 mg 7% Total Carbohydrate 21 mg 7% 34 mg 11% Dietary Fiber 3 g 12% 5 g 20% Sugars 16 g 25 g Protein 0 g 1 g Calcium 0% 2% Iron 0% 2% Avocado (30 g) Calories from Fat 45 g 35 Total Fat 5 g 8% 4.5 g 7% Saturated Fat 1 g 5% 0.5 g 3% Total Carbohydrate 2 g 1% 3 g 1% Iron 0% 2% Banana (126 g) Sodium 5 mg 0% 0 mg 0% Dietary Fiber 2 g 8% 3 g 12% Vitamin A 0% 2% Cantaloupe (134 g) Calcium 0% 2% Honeydew melon (134 g) Calcium 0% 2% Kiwifruit (148 g) Total Fat 1.5 g 2% 1 g 2% Lemon (58 g) Dietary Fiber 1 g 4% 2 g 8% Nectarine (140 g) Dietary Fiber 1 g 4% 2 g 8% Orange (154 g) Vitamin A 0% 2% Pear (166 g) Potassium 180 mg 5% 190 mg 5% Total Carbohydrate 25 g 8% 26 g 9% Dietary Fiber 4 g 16% 6 g 24% Protein 0 g 1 g Calcium 0% 2% Pineapple (112 g) Iron 0% 2% Plums (151 g) Dietary Fiber 1 g 4% 2 g 8% Iron 0% 2% Strawberries (147 g) Sugars 6 g 8 g Calcium 0% 2% Iron 0% 2% Tangerine (109 g) Sodium 5 mg 0% 0 g 0% Broccoli (148 g) Total Carbohydrate 10 g 3% 8 g 3% Protein 2 g 4 g Iron 4% 6% Carrot (78 g) Iron 0% 2% Celery (110 g) Dietary Fiber 1 g 4% 2 g 8% Cucumber (99 g) Calories 15 10 Total Carbohydrate 3 g 1% 2 g 1% Sugars 2 g 1 g Protein 0 g 1 g Green Onion (25 g) Iron 0% 2% Leaf Lettuce (85 g) Calcium 4% 2% Mushrooms (84 g) Sodium 0 g 0% 15 g 0% Onion (148 g) Potassium 160 mg 5% 190 g 5% Calcium 2% 4% Radishes (85 g) Potassium 160 mg 5% 190 mg 5% Tomato (148 g) Sodium 35 mg 1% 20 mg 1% b. *Avocado* . (Comment 21) In comments submitted in response to the 2005 reopening of the comment period, CAC requested that FDA establish a nutrition labeling value of 0.5 g for saturated fat, 2 g for dietary fiber, and 150 mg for potassium. CAC also submitted a comment in response to the 2002 proposed rule stating that it is well established that the fat content of an avocado varies and increases throughout the season and asked that we consider seasonal data in determining the content of fat. To support their request, CAC also noted that the State of California regulates the percent oil

(fat)that must be present in an avocado before it can be sold. Not only does the fat content vary throughout the season, but as with many fruit crops, avocado sales start slow, build and then decline at the end of the season. Seasons and corresponding market share for avocado include: Primary season (January through September), 93 percent of crop; pre-season (November and December), 2.4 percent of crop; and post-season (October), 4.6 percent of crop. (Response) We agree with the comment on the seasonal variation of fat in avocados and reevaluated the total fat and saturated fat levels for this final rule. We used the seasonal market share data that CAC provided along with their nutrient data, combined these data with those provided by USDA in response to the 2002 proposed rule, and conducted weighted compliance calculations based on 95 percent prediction intervals (Ref. 8). The resulting nutrition labeling value for saturated fat is 0.5 g. In addition, we found that other nutrient levels changed from those we published in the reopening of the comment period for total fat (4.5 g, 7 percent DV, from 5 g, 8 percent DV), calories from fat (35 from 45), total carbohydrate (3 g, 1 percent DV, from 2 g, 1 percent DV), and iron (2 percent DV from 0 percent DV). We have also provided a correction in this final rule in § 101.45(a)(3)(iii) that “* * * avocados contain 1 gram

(g)of fat per ounce” should read “* * * avocados contain 0.5 gram

(g)of saturated fat per ounce.” In addition, we have revised the footnote that follows in § 101.45(a)(3)(iii) that states “avocados provide 1 g of saturated fat per ounce” to read “avocados provide 0.5 g of saturated fat per ounce.” We will make no changes to the nutrition labeling values for dietary fiber and potassium. We completed weighted compliance calculations based on 95 percent prediction intervals with nutrient data submitted by CAC and USDA, and determined that the 95 percent predicted value for dietary fiber fell outside the interval of the raw data points. We selected the mean value for dietary fiber, with a resulting nutrition labeling value of 1 g. For potassium, the 95 percent predicted value of 142.9 mg fell within the interval of the raw data points, so we selected the rounded value of 140 mg for nutrition labeling. Thus, FDA calculated final values for dietary fiber and potassium, in accord with the statistical methods described in the 2002 proposed rule, the 2005 reopening of the comment period, and in response to comments in this final rule. Table 1 of this document includes all changes in nutrition labeling values for avocado, and Appendix C to part 101 provides the listing of all values. c. *Banana* . (Comment 22) The International Banana Association (IBA), in response to the 2005 reopening of the comment period, questioned the accuracy of FDA's calculations for the 95 percent prediction intervals for bananas. Specifically, IBA recommended that the nutrition labeling values for sodium, dietary fiber, and sugars be 0 mg, 3 g, and 16 g, respectively. (Response) We agree that the nutrition labeling values for sodium and dietary fiber in banana should be changed to the levels recommended by IBA (0 mg from 5 mg for sodium, and 3 g, 12 percent DV, from 2 g, 8 percent DV for dietary fiber) (Ref. 9). Based upon our review of the USDA data submitted in response to the 2002 proposed rule and reassessment of 95 percent prediction intervals, as discussed in section II.K.3 of this document, we determined that there would be changes in the values for sodium, fiber, and vitamin A (2 percent DV from 0 percent DV). However, we did not find reason to change the nutrition labeling value for sugars and have not changed the 19 g listed in Appendix C to part 101. Table 1 of this document provides changes in nutrition labeling values for banana, and Appendix C to part 101 lists all values. d. *Kiwifruit* . (Comment 23) Food Research Inc., on behalf of kiwifruit growers that combined represent an estimated 98.75 percent of all kiwifruit sold in the United States, recommended that FDA label total fat as 0.5 g (1 percent DV) per serving. The comment stated that because a large coefficient of variation due to two high values in the USDA data raise uncertainties, and because so much of the sample information, country of origin, and method of analysis were not reported, it would be more appropriate to use the results of the Food Research Inc., study for the basis of labeling total fat. In support of their request, the comment provided nutrient data for total fat in kiwifruit from three of the countries they represent, which account for 88 percent of the kiwifruit sold in the United States (Chile, the United States (California), and New Zealand). (Response) We do not agree with the 0.5 g (1 percent DV) total fat value recommended by the comment. We combined the data for total fat from the kiwifruit research study (n=6) to data provided by USDA in response to the 2002 proposed rule (n=8) and conducted weighted compliance calculations based on 95 percent prediction intervals (Ref. 10). The resulting nutrition labeling values for total fat are 1 g, 2 percent DV, a change from the 1.5 g, 2 percent DV published in the 2005 reopening of the comment period (see table 1 of this document). Appendix C to part 101 provides the listing of all nutrition labeling values for kiwifruit. e. *Pear* . (Comment 24) The Pear Bureau Northwest (Pear Bureau) submitted market share data for four varieties of pears and requested that FDA use these data to weight the nutrient data submitted by USDA in response to the 2002 proposed rule. The varieties and market share include Bartlett (37 percent), Bosc (17 percent), Green Anjou (2 percent), and Red Anjou (28 percent), accounting for 84 percent of fresh pears sold domestically. The Pear Bureau requested nutrition labeling values for dietary fiber and total carbohydrate be updated to 5 g and 26 g, respectively. (Response) We agree that the market share data submitted by the Pear Bureau should be used to weight the nutrient data for pears. We reviewed the market share data for pears submitted by the Pear Bureau and used their market share percentages to weight USDA nutrient data for the four varieties of pears and derive nutrition labeling values using compliance calculations based on 95 percent prediction intervals (Ref. 11). The resulting nutrition labeling values include changes for potassium (190 mg from 180 mg, both 5 percent DV), total carbohydrate (26 g, 9 percent DV, from 25 g, 8 percent DV), dietary fiber (6 g, 24 percent DV, from 4 g, 16 percent DV), protein (1 g from 0 g), and calcium (2 percent DV from 0 percent DV). Table 1 of this document includes changes in nutrition labeling values for pear, and Appendix C to part 101 provides the listing of all values. f. *Strawberries* . (Comment 25) CSC requested nutrition labeling values of 8 g for sugars and 2 percent DV for calcium and iron. In support of their request, CSC submitted the results of analytical research conducted by Food Research, Inc., to determine the sugars, calcium, and iron content of fresh strawberries. Twelve 16-oz containers or six 32-oz containers of four brands of strawberries were purchased in May 2005 and delivered on the same day to the laboratory for analysis. (Response) We agree with the changes recommended by CSC. We have evaluated the CSC nutrient data, combined those data with the data USDA submitted in response to the 2002 proposed rule, and conducted weighted compliance calculations based on 95 percent intervals (Ref. 12). The resulting nutrition labeling value for sugars is 8 g (from 6 g) and for calcium and iron is 2 percent DV (from 0 percent DV). Table 1 of this document includes changes in nutrition labeling values for strawberries, and Appendix C to part 101 provides the listing of all values. g. *Potato* . (Comment 26) The U.S. Potato Board

(USPB)commented, in response to the 2002 proposed rule, that the 2000 market basket data that Ketchum (a public relations firm) submitted to FDA on their behalf and that FDA used in proposing to update the nutrition labeling values for potatoes in the 2002 proposed rule should not be used because the data contain inaccuracies due to unusually high moisture content and did not represent the average potato that a consumer would eat. USPB recommended that FDA use the preliminary data that USDA submitted in response to the 2002 proposed rule, as those data were more in line with the nutrition labeling values for potato. USPB also noted that the data in the current USDA SR are more appropriate for labeling purposes than the data that they submitted and that we used in the 2002 proposed rule. USPB also, in response to the 2005 reopening of the comment period, requested that FDA retain the current nutrition labeling and not use the values that FDA published in the 2005 reopening of the comment period document, which were derived from the new data that USDA submitted in response to the 2002 proposed rule. USPB said they saw no compelling reason to have one set of data negatively impact a nutrition label that has been acceptable to FDA for the past 10 years. (Response) We disagree with the comment. We have determined that the Produce Marketing Association nutrient data we used to support the nutrition labeling values for potato in the 1996 final rule were based upon nutrient data analyzed in 1983 and 1984 and are not likely to be valid because they are outdated. In the 2005 reopening of the comment period, we used new nutrient data for four types of potatoes that USDA submitted in response to the 2002 proposed rule, and conducted compliance calculations based on 95 percent prediction intervals to determine nutrition labeling values (Ref. 13). Having received no additional nutrient data for potato, we are using these nutrition labeling values in Appendix C to part 101 to replace the nutrient data that are more than 20 years old. 3. Changes to Nutrition Labeling Values Based Upon Reassessment of 95 Percent Prediction Intervals As indicated in section II.K.1.a of this final rule, upon completion of all statistical analyses to calculate compliance calculations based on 95 percent prediction intervals (Refs. 7 through 19), we reviewed all nutrient data for all foods to determine if the 95 percent predicted value fell within the range of the interval of all raw data points for each nutrient and food. If the nutrient level derived from the 95 percent prediction interval was selected as the more appropriate nutrient value (versus the mean), and that level fell within the interval of all raw data points, then we determined it would be a reasonable choice to represent the nutrient for the raw food. However, if the nutrient level based on the 95 percent prediction interval did not fall within the interval of all raw data points, we determined the mean would be a better estimate of the nutrient level for the raw food. As a result of the reassessment of all nutrient levels based on 95 percent prediction intervals, we updated the nutrient values for 11 of the raw fruits and 9 of the raw vegetables: Avocado (iron), banana (sodium, dietary fiber, vitamin A), cantaloupe (calcium), honeydew melon (calcium), lemon (dietary fiber), nectarine (dietary fiber), orange (vitamin A), pineapple (iron), plums (dietary fiber, iron), strawberries (calcium, iron), tangerine (sodium), broccoli (total carbohydrate, protein, iron), carrot (iron), celery (dietary fiber), cucumber (calories, total carbohydrate, protein), green onion (iron), mushrooms (sodium), onion (potassium, calcium), radishes (potassium), and tomato (sodium). These changes are listed among changes to nutrition labeling values in table 1 of this document. 4. Summary of Changes for Fruits and Vegetables Table 1 of this document shows a summary of the changes from the nutrition labeling values for 25 raw fruits and vegetables for this final rule versus those published in the 2005 reopening of the comment period. L. Nutrition Labeling of Raw Fish For the 2002 proposed rule, we obtained new data from USDA NNDB for cooked Atlantic salmon and rainbow trout and for the following raw fish: Catfish (only on fat content), flounder/sole, orange roughy, coho and sockeye salmon, shrimp, swordfish, tilapia, and tuna. We also obtained new information on the cooking yield for mollusks, discovered a slight error in the raw weight used to calculate the nutrient values for finfish and crustaceans, and obtained new data on nutrient retention factors. Therefore, in addition to updating the nutrient values based on new data, we reanalyzed the data from USDA NNDB for the remaining fish and adjusted the nutrient values accordingly (Ref. 20). Chinook Salmon (Comment 27) As indicated in section II.J.2 of this document, two comments recommended that FDA include Chinook salmon along with Atlantic, coho, and sockeye salmon and use USDA nutrient data to support nutrition labeling. (Response) We obtained data for Chinook salmon

(raw)from the USDA NNDB and added those data to the USDA NNDB data we already had for Atlantic salmon (cooked, farmed); coho salmon (raw, farmed); sockeye salmon (raw). We subjected the data to FDA compliance calculations where possible using 95 percent prediction intervals and used the data in deriving the nutrition labeling values for these fish (Ref. 20). There were no changes in nutrition labeling values for fish in this final rule as compared with those in the 2005 reopening of the comment period. Appendix D to part 101 contains a comprehensive listing of all raw fish and all nutrients in the voluntary nutrition labeling program. M. Effective Date (Comment 28) One comment opposed the proposed changes because they will result in unnecessary reprinting costs to industry and those producing nutrition education materials. (Response) FDA periodically establishes, by final rule in the **Federal Register** , uniform effective dates for compliance with food labeling regulations (see, e.g., the **Federal Register** of December 23, 1998 (63 FR 71015)). This final rule will become effective in accordance with the uniform effective date for compliance with food labeling requirements, which is January 1, 2008. However, we will not object to voluntary compliance immediately upon publication of the final rule. We believe that the effective date should allow industry and nutrition educators adequate time to update nutrition labeling information. III. Final Regulatory Impact Analysis FDA has examined the impacts of the final rule under Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order. Option 1 of this document is for no new regulatory action, and provides the baseline with which all other options are compared. Option 2 of this document is for the provision of updated nutrition information based on the current data and methodology for computation. *Option 1: No New Regulatory Action* There would be no costs or benefits if no new regulatory action were taken to update the nutrition information for the 20 most frequently consumed raw fruits, vegetables, and fish. *Option 2: Costs of Updated Guidelines* We anticipate, as a result of these guidelines, that some firms will expend resources to redesign signs near produce items at retail outlets. These expenditures will be voluntary, and we assume that no firms will make them if they do not judge that it is in their best interests to do so. These are considered in this analysis in order to quantify the extent to which nutrition updates likely influence resource expenditures. While there were no comments on the estimate costs in the proposed guidelines, we used 2003 County Business Pattern

(CBP)data (Ref. 21) collected by the U.S. Census Bureau to update estimates of the number of firms that will voluntarily change signs because of these guidelines. There are approximately 67,000 supermarkets under the North American Industry Classification System (NAICS) code 44511, approximately 2,000 fish and seafood markets under NAICS 44522, approximately 3,000 fruits and vegetables markets under NAICS 44523, and approximately 15,000 other specialty markets under NAICS 44529. We assume that many of the markets in NAICS codes 44522, 44523, and 44529 have annual sales of less than $500,000 and therefore have been exempted by Congress from coverage by these guidelines. We use the number of supermarkets in NAICS 44511 as a low estimate of the number of establishments under consideration, and all establishments in NAICS codes 44522, 44523, and 44529 as well as 44511 as an upper bound. Based on the most recent survey of adoption of our guidelines, we assume that 72 percent of establishments (between 48,000 and 63,000 establishments) will continue to choose to follow these guidelines. We estimated the total voluntary expenditures using the revised number of establishments, and the assumptions of expenditure per establishment. Consistent with the methodology used in the 2002 proposed rule, we assume a normal cycle for retailers to redesign their labels to be once every 3 years, and that one-half of the 48,000 to 68,000 stores would redesign after the third year following publication of these guidelines. The updating cost expenditures for a partial redesign, incurred in the first and second years, are assumed to be $50 per store, and the updating costs of a full redesign, incurred in the third year, are assumed to be $100 per store. Table 2 of this document shows these assumptions and estimates. We compute the present value of total expenditures for each year using both a 7 percent and 3 percent discount rate. The present value of the total of voluntary expenditures is between $3,257,000 for the low estimate assuming a 7 percent discount rate, and $4,593,000 for the high assuming a 3 percent discount rate (i.e., the sum of the present values of the expenditures in rows

(e)and

(f)of table 2 of this document for 2006, 2007, and 2008). **Table 2.—Adoption Schedule and Voluntary Expenditures**

(a)Adoption Year Adoption Schedule and Voluntary Expenditures 2006 2007 2008

(b)Number of Stores 12,000 to 16,000 12,000 to 16,000 24,000 to 32,000

(c)Expenditures per Store $50 $50 $100

(d)Total Expenditures $600,000 to $800,000 $600,000 to $800,000 $2,400,000 to $3,200,000

(e)Present Value (assuming a 7% discount rate) $600,000 to $800,000 $561,000 to $736,000 $2,096,000 to $2,800,000

(f)Present Value (assuming a 3% discount rate) $600,000 to $800,000 $582,000 to $761,000 $2,262,000 to $2,970,000 *Option 2: Benefits of the Updated Guidelines* The benefits from updating nutrition information on the 20 most frequently consumed raw fruits, vegetables, and fish derive from maintaining the accuracy of the information over the long term, and giving consumers current information to use in making healthful dietary choices. The larger the difference between the updated information and the current information, the more likely that consumption behavior will change if consumers are aware of the changes made in this final rule. A greater change in behavior is likely to provide greater potential for improved dietary choices. The potential for this particular update to improve dietary choices is likely to be small since modest changes in the nutrient profile of a food are likely to have a small influence on the demand for that food. Table 3 of this document summarizes the extent of changes in foods and the nutrient profiles in the proposed and final rules. **Table 3.—Changes to Guidelines in Proposed Rule and Final Rule** Changes to Guidelines in Proposed Rule 1 Fruits and Vegetables Fish Changes to Guidelines in Final Rule 2 Fruits and Vegetables No. of foods with changes 21 21 20 No. of nutrients with changes 40 107 38 1 Computed from values in tables 1 and 2 of the 2002 proposed rule. 2 Computed from the values in this final rule. The substantial changes made in this final rule to the current nutrition information indicate the importance of updates in nutrition information. We proposed changes for approximately one-half of all of the most frequently consumed varieties of fruits, vegetables, and fish, with an average number of revisions to nutrient information per food item of approximately two for fruits and vegetables (i.e., 40 nutrients / 21 whole food items) and approximately five for fish (i.e., 107 nutrients / 21 whole food items). The guidelines in this final rule contain additional revisions for one-half of all of the most frequently consumed fruits and vegetables, with an average of approximately 2 revised nutrients per revised food item (i.e., 38 nutrients / 20 whole food items). Consumers may use this updated information in making their dietary choices. If they use it, the updated information will allow them to be more effective at achieving the results that they intend than if they were using outdated information. We are not able to quantify the benefit that having this updated information will provide. Because only substantial compliance with these guidelines is mandated by the statute, aggregate costs may be less than would occur if they were mandatory for all establishments. Moreover, confusion on the part of consumers may arise during the transition period as retail stores adopt these guidelines at different times. Confusion may arise, for example, if one store displayed an updated set of nutrient values while another store displayed an out-dated set of nutrient values for otherwise identical raw fruits, vegetables, or fish. Any such confusion will reduce the benefit of updating the values in these guidelines. As discussed previously in this document, the unquantified benefits of providing accurate information for consumers to use in making their dietary choices are believed to outweigh the costs associated with this rule. IV. Final Regulatory Flexibility Analysis FDA has examined the impacts of the final rule under the Regulatory Flexibility Act (5 U.S.C. 601-612). The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Although many of the estimated 48,000 to 63,000 stores that may choose to update their nutrition displays are small entities, because these guidelines are voluntary, no small entity would be required to display the information set forth here. Consequently, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. V. Unfunded Mandates FDA has examined the impacts of the final rule under the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, that includes any “Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $115 million, using the most current

(2003)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. VI. Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) SBREFA (Public Law 104-121) defines a major rule for the purpose of congressional review as having caused or being likely to cause one or more of the following: An annual effect on the economy of $100 million or more; a major increase in costs or prices; significant adverse effects on competition, employment, productivity, or innovation; or significant adverse effects on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets. In accordance with SBREFA, OMB has determined that this final rule is not a major rule for the purpose of congressional review. VII. Paperwork Reduction Act of 1995 FDA concludes that this final rule contains no collection of information. Therefore clearance by OMB under the Paperwork Reduction Act of 1995 is not required. VIII. Analysis of Environmental Impact We have determined under 21 CFR 25.30(k) 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. IX. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule will have a preemptive effect on State law. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Section 403A of the act (21 U.S.C. 343-1) is an express preemption provision. Section 403A(a)(4) of the act provides that “no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce— * * *

(4)any requirement for the voluntary nutrition labeling of food that is not identical to the requirement of section 403(q).” Currently, this provision operates to preempt States from imposing nutrition labeling requirements for raw fruits, vegetables, and fish because no such requirement had been imposed by FDA under section 403(q) of the act. This final rule amends existing food labeling regulations by updating the names and the nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States and by revising the guidelines for further clarity and consistency. Although this rule would have a preemptive effect, in that it would preclude States from issuing any nutrition labeling requirements for raw fruits, vegetables, and fish that are not identical to those required by this final rule, this preemptive effect is consistent with what Congress set forth in section 403A of the act. Section 403A(a)(5) of the act displaces both State legislative requirements and State common law duties. FDA believes that the preemptive effect of the final rule would be consistent with Executive Order 13132. Section 4(e) of the Executive Order provides that “when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.” FDA provided the States with an opportunity for appropriate participation in this rulemaking when it sought input from all stakeholders through publication of the proposed rule in the **Federal Register** of March 20, 2002 (67 FR 12918), and the reopening of the comment period on April 4, 2005 (70 FR 16995). FDA received no comments from any States on the proposed rulemaking. In addition, on May 16, 2006, FDA's Division of Federal and State Relations provided notice via fax and e-mail transmission to State health commissioners, State agriculture commissioners, food program directors, and drug program directors as well as FDA field personnel of FDA's intended final rule to update the guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish. The notice provided the States with further opportunity for input on the rule. It advised the States of the publication of the final rule and encouraged State and local governments to review the notice and to provide any comments to the docket (Docket No. 2001N-0548) by June 28, 2006, or to contact certain named individuals. FDA received no comments in response to this notice. The notice has been filed in the above numbered docket. In conclusion, the agency believes that it has complied with all of the applicable requirements under the Executive order and has determined that the preemptive effects of this rule are consistent with Executive Order 13132. X. References The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but we are not responsible for subsequent changes to the Web sites after this document publishes in the **Federal Register** .) 1. U.S. Department of Agriculture, Agricultural Research Service, USDA Nutrient Database for Standard Reference, Release 18, 2005. Available on the Internet at USDA's Nutrient Data Laboratory Home Page, *http://www.ars.usda.gov/main/site_main.htm?modecode=12354500* . 2. U.S. Department of Agriculture, National Nutrient Data Bank, maintained at the Nutrient Data Laboratory, Agricultural Research Service, Beltsville Human Nutrition Research Center, Beltsville, MD. 3. Bender, M. M., J. I. Rader, and F. D. McClure, “Guidance for Industry, FDA Nutrition Labeling Manual—A Guide for Developing and Using Databases,” Center for Food Safety and Applied Nutrition, FDA, 1998. Available on the Internet at *http://vm.cfsan.fda.gov/dms/nutrguid.html* . 4. U.S. Department of Health and Human Services and U.S. Department of Agriculture, *Dietary Guidelines for Americans, 2005* , 6th ed. Washington DC: U.S. Government Printing Office, January, 2005. Available on the Internet at *http://www.healthierus.gov/dietaryguidelines/* . 5. Retail Diagnostics, Inc., *Food and Drug Administration Nutrition Labeling Information Study December 1996* , Oradell, NJ, March 10, 1997. 6. Brandt, M. M. “Documentation for the Nutrition Labeling Values for the 20 Most Frequently Consumed Raw Fruits, Vegetables, and Fish,” Center for Food Safety and Applied Nutrition, FDA, January 2006. 7. O'Neill, K. R., “Statistical Derivation of Nutrition Label for Raw Apples from 2001-2002 United States Department of Agriculture