**GAO-04-193R**                      Oct 23, 2003                  

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## Highlights

GAO reviewed the Department of Health and Human Services, Food and Drug Administration's (FDA) new rule on registration of food facilities. GAO found that (1) the rule would require domestic and foreign facilities that manufacture/process, pack or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003; and (2) FDA complied with all applicable requirements in promulgating the rule.

##  Department of Health and Human Services, Food and Drug Administration: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and ResponseAct of 2002, GAO-04-193R, October 23, 2003

B-293038October 23, 2003The Honorable Judd Gregg     Chairman     The Honorable Edward M. Kennedy     Ranking Minority Member     Committee on Health, Education, Labor, and Pensions     United States SenateThe Honorable W.J. Billy Tauzin     Chairman     The Honorable John D. Dingell     Ranking Minority Member     Committee on Energy and Commerce     House of Representatives     Subject:*Department of Health and Human Services, Food and Drug Administration: Registration of Food Facilities Under the Public Health Security    and Bioterrorism Preparedness and Response Act of 2002*Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and    Human Services, Food and Drug Administration (FDA), entitled Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002    (RIN: 0910-AC40). We received the rule on October 10, 2003. It was published in the Federal Register as an interim final rule on October 10, 2003.68 Fed. Reg. 58894.      The interim final rule requires domestic and foreign facilities that manufacture/     process, pack, or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003.  The interim final rule implements the Public Health Security    and Bioterrorism Preparedness Act of 2002.     Enclosed is our assessment of the FDAs compliance with the procedural steps required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule.  Our review    indicates that the FDA complied with the applicable requirements.     If you have any questions about this report, please contact James W. Vickers, Assistant General Counsel, at (202) 512-8210.  The official responsible for GAO evaluation work relating to the    subject matter of the rule is Robert Robinson, Managing Director, Natural Resources and Environment.  Mr. Robinson can be reached at (202) 512-3841.                 signed     Kathleen E. Wannisky     Managing Associate General Counsel     Enclosurecc: Ann Stallion     Regulations Coordinator     Department of Health and       Human Services            ENCLOSURE     ANALYSIS UNDER 5 U.S.C.  801(a)(1)(B)(i)-(iv) OF A MAJOR RULE     ISSUED BY THE     DEPARTMENT OF HEALTH AND HUMAN SERVICES,     FOOD AND DRUG ADMINISTRATION     ENTITLED     "REGISTRATION OF FOOD FACILITIES UNDER THE     PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS     AND RESPONSE ACT OF 2002"     (RIN: 0910-AC40)(i) Cost-benefit analysis     FDA estimates the first-year costs to be $23 million for domestic facilities, $306 million for foreign facilities, and FDA costs of $13.2 million for total first-year costs of $342.2    million. (ii) Agency actions relevant to the Regulatory Flexibility Act, 5 U.S.C.  603-605, 607, and 609     FDA performed a Final Regulatory Flexibility Analysis in connection with the interim final rule.  It found that the interim final rule could have a significant economic impact on a    substantial number of small entities because 99 percent of the 216,271 domestic facilities would be considered small.  A discussion of the options considered was included in the proposed    rule and in the regulatory impact analysis of the interim final rule.  These include the change from the proposed rules requirement of updating information within 30 days to the    60-day timeframe in the interim final rule.(iii) Agency actions relevant to sections 202-205 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C.  1532-1535     FDA has determined that the interim final rule does not impose either an intergovernmental or private sector mandate, as defined in title II, of more than $100 million ($113 million adjusted for    inflation) in any one year and, therefore, is not a significant rule under the act.(iv) Other relevant information or requirements under acts and executive orders     Administrative Procedure Act, 5 U.S.C.  551 etseq.     The interim final rule was issued using the notice and comment procedures found at 5 U.S.C. 553.  On February 3, 2003, the FDA and the Department of the Treasury issued a proposed rule    requiring registration with the FDA.  68 Fed. Reg. 5378.  In response, approximately 350 comments were received and are discussed in the preamble to the interim final rule.  In    addition, comments on the interim final rule may be submitted until December 24, 2003.     Paperwork Reduction Act, 44 U.S.C.  3501-3520     The interim final rule contains information collections that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.  FDA has submitted the    required information to OMB for review and approval--including the number of respondents (216,271 domestic and 205,405 foreign facilities) and the estimated annual burden.  FDA estimates the    annual reporting burden in the first year will be 2,477,426 hours and 521,830 hours in subsequent years.     Statutory authorization for the rule     The interim final rule was promulgated under the authority contained in section 305 of the Public Health Security and Bioterrorism Preparedness Act of 2002 (Pub. L. 107-188, June 12,    2002).     Executive Order No. 12866     The interim final rule was reviewed by OMB and found to be an economically significant regulatory action under the order.     Executive Order No. 13132 (Federalism)     FDA has determined that there are no sufficient federalism implications to warrant the preparation of a federalism assessment.

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