Equivalence: Current Procedures in the United States for Food and Drug Administration Regulated Foods

Transcription

1 2018/SCSC/WKSP4/006 Session: 4 Equivalence: Current Procedures in the United States for Food and Drug Administration Regulated Foods Submitted by: United States Workshop on Trade Facilitation Through the Recognition of Food Safety Systems Equivalence Lima, Peru June 2018

2 Equivalence Current Procedures in the United States for FDA Regulated Foods Camille E. Brewer Director, International Affairs Staff & Office of Food and Veterinary Medicine Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration

3 Points to Cover Background The U.S. food safety system FDA/CFSAN regulated foods Equivalence and FDA s Cooperative Programs Grade A Dairy Shellfish Partnership Programs/Systems Recognition Systems Equivalence Questions going forward 2

4 U.S. Food Safety System Department of Health and Human Services Food and Drug Administration (FDA) Centers for Disease Control and Prevention Department of Agriculture Food Safety and Inspection Service (FSIS) Animal and Plant Health Inspection Service (APHIS) Environmental Protection Agency (EPA) Department of Commerce/NOAA/NMFS Bureau of Customs and Border Protection (CBP) Alcohol and Tobacco Tax and Trade Bureau (TTB) State and Local Health and Agriculture Agencies 3

5 FDA/Center for Food Safety and Applied Nutrition (CFSAN) 4

6 5 Mission CFSAN, in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. 5

7 Scope 25 cents of every consumer dollar is spent on FDAregulated products. Of that amount, approximately 75% is spent on food. CFSAN regulates $417 billion in domestic food, $49 billion in imported food, and $60 billion in cosmetics. The American food industry accounts for 20% of Gross National Product and employs 14 million. 6

8 Products Regulated by CFSAN * containing < 2% poultry or beef 7 7

9 State Roles and Responsibilities in Food Safety

10 Federal/State Cooperative Programs Molluscan Shellfish Compliance Program National Shellfish Sanitation Program (NSSP) Interstate Shellfish Shippers List Milk Safety Program Interstate Milk Shippers List Retail Food Protection (FDA Food Code)

11 Partnership Agreements FDA has signed partnership agreements with various state/local regulatory agencies, associations, industry and academia A partnership is a working relationship characterized by mutual participation and joint interest Contracts FDA has entered into contract agreements with their state counterparts to: perform inspections collect samples share data

12 Equivalence Determinations Can apply to individual measures, groups of measures, or control systems. Equivalence is a pre-market condition for ONLY TWO FDA-regulated products: molluscan shellfish and Grade A dairy foods. Our processes assess whether foreign sanitary measures, while different, achieve same public health results as domestic measures. Where significant differences are identified: a foreign competent authority agrees to implement additional controls to come into compliance; or the parties will pursue an equivalence determination; or no resolution found and imports restricted One or more on-site audits are conducted to verify the adequate implementation of the foreign controls and measures. 11

13 Grade A Dairy -- Regulatory Approaches Grade A milk products (including fluid milks and creams, yogurts, cottage cheese) are regulated by FDA in cooperation with the states (and Puerto Rico) We regulate via standards and procedures that have been agreed upon under the aegis of the National Conference on Interstate Milk Shipments (NCIMS) This co-operation with the states through the NCIMS is referred to by FDA as a co-operative program 12

14 The PMO Foremost among the standards used to regulate Grade A milk and milk products is the Pasteurized Milk Ordinance (PMO) The PMO is a model ordinance (or statute) that is maintained and published by FDA and which is adopted as law in all 50 U.S. states and Puerto Rico The PMO is NOT a federal law. It is a model statute that all 50 U.S. states and Puerto Rico adopted 13

15 The PMO The PMO contains standards for all aspects of Grade A milk production and processing, including: animal health and disease control (these standards are adoptions of USDA APHIS requirements for Brucellosis and Tuberculosis) milk collection, storage and transportation dairy farm construction water supplies cleaning and sanitizing products analysis including raw milk analysis for drug residues pasteurizer design, operation and control. 14

16 FIMA The Federal Import Milk Act passed in 1927 it is still current law FDA has promulgated regulations implementing FIMA FDA has narrowed the scope of application of the regulation to milk and cream from cows (genus Bos) So milks and creams would require an import permit 15

17 Options to Ensure Admissibility The NCIMS has agreed upon four options that can be used to enable foreign-manufacturers to ensure that once entered into the USA, their Grade A milk products will not be embargoed by the states: (1) A country or a subdivision of a country (e.g. a province or state) can become a member of the NCIMS. (2) A 3rd party certifier can work with a firm in a foreign country to get it and its milkshed approved as Grade A so that the firm can be IMS-listed. 16

18 Options (3) A country can be determined to have a regulatory program for Grade A milk and Milk products which is equivalent to that of the USA. (4) A participant in the NCIMS (e.g. a state) can determine that a firm and its milkshed can be approved as Grade A and thus the firm can be IMS-listed. 17

19 Utilization of Options Several of these options have been utilized historically Third party certifiers have listed firms and milksheds from several different countries, including Mexico At least one American state has listed a firm from a European country in the past 18

20 Equivalency Determinations - Framework The equivalence process which FDA has developed for Grade A equivalency determinations is based on Codex guidance See CAC/GL , Guidelines on the judgement of equivalence of sanitary measures associated with food inspection and certification systems After a request to conduct an equivalence determination has been received and agreement has been reached to undertake an equivalency determination, FDA will work with the competent authority of the requesting country to progress the work 19

21 Equivalency Determinations - Process Paper review -- FDA will then evaluate what has been provided Audit -- If the statutes and regulations provided to FDA are found by FDA to correspond with the PMO and thus describe a regulatory system which might be equivalent to the Grade A regulatory system, FDA will progress to an onsite evaluation of the system and its implementation Report -- Once the on-site evaluation is completed, FDA will draft a report and then the work towards finalizing the evaluation commences. 20

22 Equivalence Process Define scope Specific measures (HACCP, testing methods, inspection frequencies) Specific areas (residues, labs, inspections, pathogens, HACCP) Facilities (processors, importers, warehouses) Partial systems (e.g., shellfish and Grade A, seafood, additives, supplements) Whole systems/countries/regions Define approaches to comparing differences: Quantitative (log reductions, performance standards, public health metrics, temperatures) Qualitative (training, oversight, authority, resources, etc.) Broad food safety goals and public health purposes Experts: reliance on SMEs and supported conclusions. 21

23 Equivalence Determinations Reliance on Expert Evaluation Apply the knowledge and experience of subject matter experts (SMEs) from both countries. Their knowledge of domestic regulatory controls enables expert judgments on whether foreign systems are capable of delivering the same level of public health protection as the U.S. The findings of the technical experts form the basis of a preliminary equivalence determination. Under the URAA, FDA must publish its equivalence determinations in the Federal Register and consider public comment before finalizing the determination. 19 U.S.C. 2578a 22

24 Shellfish -- Framework Molluscan shellfish include bivalves such as oysters, clams, mussels and scallops The National Shellfish Sanitation Program, FDA, and other federal agencies work together in a cooperative program to keep shellfish safe Components Shellfish Growing Area Classification Control of Harvest Element (e.g., prevent harvest of unsafe shellfish) Plant sanitation and Shipping Laboratories Vibrio Risk Analysis and Control 23

25 Shellfish -- Process The Interstate Shellfish Shippers Conference (ISSC) fosters and promotes shellfish sanitation through the cooperation of state and federal regulatory agencies Foreign entities must address NSSP requirements The process includes a written submission, audit, and report. 24

26 FDA and Equivalence Equivalence is NOT needed for the vast majority of FDA-regulated imported foods FDA does NOT have certification or listing requirements that attest to food safety FDA does NOT have food safety questionnaire requirements 25

27 Systems Recognition is a Regulatory Partnership Program FDA s Systems Recognition Program is NOT an Equivalence Program Not a market access tool. A tool for regulatory partnership with foreign governments of which FDA has knowledge, experience (established trade) and confidence in the food safety regulatory capacity An option where a country s food safety system provides a similar, though not necessarily identical, system of protections; and the food safety authority provides similar oversight and monitoring. Systems Recognition helps us better allocate resources to areas of greater risk. 26

28 Equivalence and Systems Recognition Why the confusion? Both Equivalence and Systems Recognition involve evaluations of foreign food safety systems Both processes are used in different ways to demonstrate that foreign food safety systems either achieve the same level of public health protection or the same food safety outcomes SR focuses on domestic regulatory capacity and oversight. 27

29 Systems Equivalence What are the advantages to economies with strong food safety systems? Is there an expectation that agreements will be reciprocal? What are the efficiencies for developing countries in recognizing equivalence? How are needs and interests of importing countries addressed? How are the principles that a country has a right to set its own (science-based) level of protection considered? 28

30 Systems Equivalence Will equivalence for a set of measures be treated in the same manner as equivalence for the entire food safety system? Should processes be different? Why? Why not? What is the practical impact of including TBT measures such as labelling and quality in draft guidelines? What is the impact of references to expedited processes? Are such references realistic? 29

31 Systems Equivalence Should all products, ingredients, additives, MRLs be included? What is the process for defining the scope of the equivalence determination? If country x has a systems equivalence agreement with country y and country z. What are the implications for countries z and x? Are they automatically equivalent? 30

32 In summary The costs/benefits/expectations regarding systems recognition warrant robust debate FDA is honored to be a part of this important discussion 31

33 THANK YOU! 32