FOOD SAFETY REGULATIONS. Fred Boadu, Ph.D.; J.D.

Transcription

1 FOOD SAFETY REGULATIONS BY Fred Boadu, Ph.D.; J.D.

2 Objectives Explain: WHY WHO HOW of Food Safety Regulations Using BSE as Case Study

3 Total Regulations versus FSIS Budget, Regulation Budget

4 Production (Mill. Lbs Per Year) Price ($ per Lb) Relationship Between Beef Production and Price, , , , , ,000 23,000 22, Year Production Price

5 Total Final Regulations Per Year Exports (Mill. Lbs.) Relationship Between Total Regulations and Beef Exports, Year TTOREG Exports 0

6 Total Final Regulation Per Year DISOUT Total Regulations and Food-Related Disease Outbreak, Year 0 TTOREG DISOUT

7 Total Final Regulation Per Year RECTOT Total Regulations and Food Products Recalls, Year - Total Regulations - Recalls in a Year Year 0 TTOREG RECTOT

8 Total Final Regulation Per Year Average Length of Time (Months) Total Regulations and Average Length of Time from Proposal to Final Regulation, Year - Total Regulations - Average Length of Time Year 0 TTOREG Months

9 Who is Responsible for Food Safety Regulation? 4 Key Federal Agencies The United States Department of Agriculture (USDA) The Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS) The Environmental Protection Agency (EPA) The National Marine Fisheries Service (NMFS)

10 Breakdown of Agency Expenditures

11 Programmatic Distribution of Expenditures

12 Sometimes the Regulatory Agencies Work Together Ex. BSE Rule FSIS Interim Final Rule Prohibition on the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non- Ambulatory Disabled Cattle 9 CFR 301, 309 et. seq. FOCUS: Cattle slaughter and processing plants.

13 Agencies Collaboration- cntd. FDA - FDA'S New Interim Final Rule Prohibiting Use of Certain Cattle Materials that May Carry the Risk of Bovine Spongiform Encephalopathy in Human Foods and Cosmetics, and II. FDA's Proposed Rule on Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle Products Covered: Dietary supplements and dietary ingredients Infant formula Canned and frozen foods Bakery goods, snack food, and candy (including chewing gum) Food ingredients, including GRAS substances Food additives, including food-contact substances Cosmetics and cosmetic ingredients.

14 Agencies Collaboration- cntd. APHIS - Bovine Spongiform Encephalopathy: Minimal Risk Regions and Importation of Commodities FINAL RULE 9 CFR Parts 93, 94, 95, 96

15 Sometimes the Jurisdiction of the Agencies Conflict For example, bagel dog ( a hotdog wrapped in bagel dough and baked) is under FDA Jurisdiction but Corn Dogs and Sausage Turnovers are under FSIS Jurisdiction. Closed-faced sandwiches FDA Jurisdiction but Meat burritos, meat egg rolls FSIS Jurisdiction

16 HOW - The BSE Rule Background BSE in North America May 20, 2003 BSE first detected in North America in 8-year old cow in Alberta, Canada. December BSE discovered in the United States in a 6.5 year-old downer dairy cow in Washington State. The cow was imported from Alberta, Canada in January year older dairy cow from Alberta, Canada tested positive for BSE. Animal was born in 1996 prior to the introduction of the feed ban in 1997 June year old beef cow born and raised in Texas was confirmed BSE positive and most likely infected before FDA s feed ban. January 11, 2005 BSE detected in beef cow (just under 7 years old) from Alberta January nearly 6-year old cow tested positive for BSE in

17 USDA RESPONSE- Emergency Interim Final Rule, January 12, 2004 Designate certain materials from cattle as SRMs, declare that SRMs are inedible, and prohibit the use of SRMs for human food (applies to cattle 30 months or older). Require that all non-ambulatory disabled cattle be condemned when offered for slaughter. Establish measures to ensure that AMR systems are not a means of introducing CNS tissue and prohibit bones designated as SRMs for use as source materials in AMR systems. Declare that MS (beef) is inedible and prohibit its use for human food. Prohibit the use of stunning devices that deliberately inject air into the cranial cavity of cattle.

18 FDA s Responses - post December 2003 July 14,2004 Interim final rule (IFR) to prohibit use of certain cattle materials including SRMs, small intestine of all cattle, material from non-ambulatory disabled cattle, material from cattle not inspected and passed for human consumption and MSB. Sept. 7, 2005 Amend IFR to allow use of intestine with distal ileum removed, and clarifying milk and milk products, hides and hide-derived products and tallow derivatives are not prohibited cattle materials. October 7, 2005, Rule published to include prohibition from animal feed brain and spinal cord for cattle older than 30 months. December 20, 2005 Public comment period ended with 800 comments received. Spring 2006 Final rule to be published.

19 APHIS Responses post December 2003 November 4, proposed rule to amend the regulations regarding the importation of animals and animal products to recognize a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States via live ruminants and ruminant products, and to add Canada to this category. On January 4, final rule to the proposed rule, to become effective March 7, 2005.

20 ..and 80 of uncoiled Ileum from portion marked with white arrow The Distal Ileum Part of Intestine

21 Risk Mitigation Scenarios Harvard/FSIS Regulatory Alternatives Tot. Potential Human Exposure Mean ID50S % Exposure Base Case Importing 10 Infected Cattle 1. Ban on Non-Ambulatory Cattle to Food No SRMs from Cattle 30 Months No SRMs from Cattle 24 Months No SRMs from Cattle 12 Months Ban non-ambulatory +No SRMs 30 Mo Ban non-ambulatory + No SRMs 24 Mo Ban non-ambulatory +No SRMs 12 Mo

22 What is the Importance of Circular A-4? Agencies must conduct regulatory impact analysis of economically significant regulations under Executive Order Under the Regulatory Right to Know Act, OMB must issue guidelines to agencies to standardize: measures of costs and benefits; and the format of accounting statements. Circular A-4 Implements EO 12866

23 There are Four Main Elements in Regulatory Analysis The Need for Federal Regulatory Action Alternative Regulatory Approaches Alternative Analytical Approaches Accounting Statement

24 Analytical Approaches Benefit-Cost Analysis do BCA if valid monetary values are available Cost-Effectiveness Analysis must prepare CEA if primary benefits are public health and safety outcomes Distributional Effects

25 Example Truncated CEA for BSE Rule Regulatory Alternative (1) Prohibit Nonambulatory disabled cattle % Reduction in Exposure % Incremental Reduction Cumulative Cost $, 000 Incremental Cost $, % 2.63% 13,410 13,410 (2) SRM removal -30- months age cutoff 57.89% 56.76% 182, ,737 (3) (1) + (2) 57.89% 0.00% 195,238 13,091

26 Executive (Presidential) Oversight over Agencies Primary oversight responsibility lies with the Office of Management and Budget s (OMB) Office of Information and Regulatory Affairs (OIRA) - responsible for the regulatory review process on behalf of the President. OIRA's oversight is governed by EO OIRA reviews "significant" agency regulatory actions before they are proposed for public comment, and again before they are issued in final form. Regulatory action" includes all substantive action by an agency that is expected to lead to the issuance of a final rule. OMB s Circular A-4 explains compliance under EO Other executive oversight requirements are summarized in

27 Evolution of Current Regulatory Regime - EOs Year President EO # Main Feature 1971 Nixon Quality of Life Review reduce business cost 1974 Ford Inflation Impact Analysis - CWPS 1978 Carter Regulatory Analysis Review Group 1981 Reagan CWPS = OIRA Regulate only if B>C. Reviews 1985 Reagan Introduced Regulatory planning process Bush I Introduced Competitiveness Council 1993 Clinton Use of B-C. Transparency in review process OMB Introduced Best Practices Manual for Regs Clinton Examine impact of regulation on Children 2001 Bush II Prepare statement on Energy Effects of Regs 2003 OMB Circ. A-4 Tightened EO Requires B-C & CEA

28 OMB s Related Statutory and Executive Obligations Source Title Purpose 5 U.S.C Chapter 6 Regulatory Flexibility Act Impact on Small Entities 2 U.S.C 1532 Unfunded Mandate Act Effects on State, Local $ Tribal Govts. 44 U.S.C Chapt. 35 Paperwork Reduction Act Information, paperwork, Recordkeeping 67 FR 8452 Information Quality Law Minimum Information Quality Standards 42 U.S.C National Env. Policy Act Environmental Impact Statement EO Protection of Children Health and Safety Risks of Children EO Energy Impacts Energy Supply, Distribution & Use

29 Has OIRA s Oversight Been Effective?

30 Some Concerns about OMB Oversight Tendency to underestimate costs and overestimate benefits. See below two cost comparison s for 3 Federal Agencies. Source: (Susan Dudley, Director, Regulatory Studies Program, George Mason University, 2005)

31 Citizens Oversight of Regulatory Activity Statutory Basis: Section 553 of APA After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments with or without opportunity for oral presentation. (5 U.S.C. 553 (c)

32 Citizens Oversight, contd. KEY: The traditional view of section 553 procedure as a process for educating the agency has been gradually replaced, in practice if not in theory, by the belief that informal rulemaking procedure should provide interested persons an opportunity to challenge the factual assumptions on which the agency is proceeding and to show in what respect such assumptions are erroneous Jeffrey S. Lubbers, A Guide to Federal Agency Rulemaking American Bar Association, June 23, 2003, p. 197

33 The Office of Policy, Program, and Employee Development (OPPED) VISION An innovative, science based policy, training, and program development team dedicated to protecting and enhancing public health MISSION Develop, implement, and communicate policy to enhance FSIS ability to protect public health with respect to meat, poultry, and egg products (OPPED, Strategic Plan, )