Overview of the FSMA Rules

Transcription

1 Overview of the FSMA Rules February 4, 2016 Andrew Stephens U.S. Food and Drug Administration

2 Why is FSMA needed? Foodborne illness is a significant burden. About 48 million (1 in 6 Americans) get sick each year; 128,000 are hospitalized; and 3,000 die. Globalization 15 percent of U.S. food supply is imported. Food supply is more high-tech and complex. More foods in the marketplace New hazards in foods not previously seen Shifting demographics Growing population (about 30%) of individuals are especially at risk for foodborne illness. 2

3 The 7 Major FSMA Rules Preventive Controls for Human Food (PCHF) Produce Safety Standards Foreign Supplier Verification Program Preventive Controls (Animal Food) Third Party Accreditation Sanitary Transport Intentional Adulteration 3

4 FSMA Preventive Controls Human Food (PCHF) published Sept. 17, 2015 Requires facilities that must register (with some exceptions) to Conduct a hazard analysis Implement preventive controls (PCs) for hazards Monitor PCs, verify PCs, take corrective actions, keep records The facilities are domestic and foreign facilities producing food for consumption in the U.S. 4

5 FSMA PC Food Safety Plan Hazard analysis Preventive controls Supply-chain program Recall plan Procedures for monitoring Corrective action procedures Verification procedures 5

6 FSMA Food Safety Plan vs. HACCP Plan Hazard analysis Food Safety Plan Preventive controls (PCs) Hazard analysis HACCP Plan CCPs to control food hazards * Critical limits Monitoring** Corrective actions** Verification** Records Monitoring Corrective actions Verification Records *Process controls have, as appropriate, parameters and min./max. values **As appropriate to ensure the effectiveness of the PCs, taking into account the nature of the PC 6

7 What are Preventive Controls? Measures required to ensure that hazards are significantly minimized or prevented (SMOP). In , these include: Process controls Food allergen controls Sanitation controls Supply-chain controls Recall plan 7

8 Not all hazards require a preventive control Definition: Hazard requiring a preventive control A hazard for which a knowledgeable person would, based on the outcome of a hazard analysis assessing the severity and probability would establish one or more preventive controls as appropriate to the food and facility to significantly minimize or prevent the hazard in a food 8

9 PC Qualified Individual A qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system. 9

10 Responsibilities of a FSMA PC Qualified Individual Preparation of the food safety plan Validation of preventive controls Review of records Reanalysis 10

11 PC Supply-Chain Program (General requirements ) Use of approved suppliers Determine appropriate supplier verification activities Conduct and document supplier verification activities When applicable, obtain documentation of verification by another entity Flexibility 11

12 Supplier Verification Activities (b) Onsite audits (default for most serious hazards) see also: (b) Sampling and testing Review of relevant food safety records Other as appropriate Activity and frequency based on nature of hazard, where it is controlled, and supplier performance 12

13 Onsite Audits Must be performed by a qualified auditor defined in 117.3, see also: Government employee Third-party (e.g., agent of a certification body) Employee of receiving facility Another entity in the supply chain 13

14 FSMA PC Auditor Requirements Qualified auditor means a person who is a qualified individual as defined in this part and has technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function. Examples of potential qualified auditors include: (1) A government employee, including a foreign government employee; and (2) An audit agent of a certification body that is accredited in accordance with [the FSMA 3 rd party rule] 14

15 FSMA PC Compliance Dates for Businesses Very small businesses (less than $1 million in annual food sales): Three years (except for certain records). Small businesses (a business with fewer than 500 full-time equivalent employees): Two years All other businesses: One year 15

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17 FSMA Produce Safety Standards Requirements for the production of covered fruits and vegetables for microbiological hazards. Includes standards for Health and Hygiene Agricultural Water Biological Soil Amendments Growing, Harvesting, Packing and Holding Activities Equipment, Tools, Buildings, and Sanitation Applies to domestic and foreign farms producing fresh produce for consumption in the U.S. 17

18 Coverage of FSMA Produce Rule Covers Domestic and imported produce Produce for human consumption Does not cover Produce for personal or on-farm consumption Produce not a raw agricultural commodity Certain specified produce rarely consumed raw Farms with produce sales of $25,000 per year Eligible for exemption (with modified requirements) Produce that will receive commercial processing ( killstep or other process that adequately minimizes hazards) Qualified exemption 18 18

19 Overview of Foreign Supplier Verification Programs (FSVP) Rule Requires importers to share responsibility for ensuring safety of imported food Risk-based (according to types of hazards, importers, and suppliers) Flexibility in meeting requirements (assessing activities conducted by others) Alignment with PC supply-chain provisions 19

20 Who Must Comply? Importer is U.S. owner or consignee of a food at time of U.S. entry. If no U.S. owner or consignee at entry, importer is U.S. agent or representative of the foreign owner or consignee, as confirmed in signed statement of consent. 20

21 Definition of foreign supplier? 1.500: Foreign supplier means, for an article of food, the establishment that manufactures / processes the food, raises the animal, or harvests the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing /processing that consists solely of the addition of labeling or any similar activity of a de minimis nature

22 FSVP Verification Activities Determine appropriate verification activities (and frequency) based on food and supplier evaluation Activities may include: onsite auditing; sampling and testing; review of supplier records; other appropriate measures Annual onsite auditing is default approach when a food has a SAHCODHA hazard. 22

23 Final Rule Accredited Third-Party Certification

24 What Does The FSMA 3 rd Party Certification Rule Do? It establishes a voluntary program for the accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. 24

25 When Are Certifications Needed? Importers will not generally be required to obtain certifications. Certifications will be for two purposes: 1. Facility certifications will be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food. 25

26 When Are Certifications Needed? 2. Food or facility certifications will be used for admissibility of a food subject to a risk-based determination by FDA. Requires a specific determination by FDA under section 801(q) of the FD&C Act Factors include consideration of the capability of the regulatory system of the exporting nation to ensure compliance with U.S. safety standards for the food. 26

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28 What Must Accreditation Bodies Do? FDA requires accreditation bodies to: Assess third-party certification bodies for accreditation Monitor the performance of third-party certification bodies they accredit Assess and correct problems in their own performance Submit reports and other notifications to FDA Maintain and provide FDA access to certain records 28

29 What Are Certification Bodies? An CB can be a foreign government or other third-party entity. A CB may use documentation of its conformance with ISO/IEC or ISO/IEC 17065, supplemented as necessary, in meeting FDA requirements. 29

30 What Must Certification Bodies Do? Ensure their audit agents are competent and objective Verify the effectiveness of facilities corrective actions to address identified deficiencies Assess and correct any problems in their own performance Maintain and provide FDA access to certain records 30

31 Audit Requirements When performing audits under this program, accredited third-party CBs must: Perform facility audits unannounced Notify FDA on discovering a condition that could cause or contribute to a serious risk to public health Submit regulatory audit reports (key data) Maintain consultative audit reports in records, accessed only under section

32 3 rd Party Rule Implementation Program will launch after the final user fee rule takes effect. Accreditation bodies could begin to apply when the program goes into effect. Third-party certification bodies could seek accreditation after one or more FDArecognized accreditation bodies begin accepting applications. 32

33 For More Information Web site: Subscription feature available To contact FDA about FSMA and find the new online form for submitting questions: FSMA/ucm htm 33