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1. Section 101 – Emergency records access Effective immediately 2. Section 102 – Registration/Suspension of Registration Bi-annual registration – starts in 2012 – even-numbered years after 3. Section 103 – Hazard Analysis and Risk-Based Preventive Controls Final rules within 18 months Guidance (no time specified) Become effective in 18 months, even without regulations or guidance 4. Section 104 – Performance Standards See CFSRS FSMA Comparison with SQF 5. Section 105 – Produce Safety Final rules within one year of close of comments period 6. Section 106 – Protection Against Intentional Contamination Final rules within 18 months: how to assess risk, how to mitigate risk 7. Section 107 – Authority to Collect Fees Re-inspection fees, recall & export certificate fees began in Oct. 2011 8. Section 111 – Sanitary Transport of Food Regulations under prior law required within 18 months 9. Section 113 – New Dietary Ingredients Guidance on NDI submissions within 6 months (Completed) 10. Section 115 – Port shopping Prohibition & Penalties 11. Section 116 – Alcohol-related facilities Exempt 12. Section 201 – Risk-based inspections High risk/low risk distinction 13. Section 202 – Laboratory Accreditation. FDA to establish program within 2 years Within 30 months (2 ½ years), certain food subject to testing in accredited laboratories, with test results sent directly to FDA 14. Section 204 – Tracking and Tracing of Food Applies to “high risk” foods and fresh fruits and vegetables. FDA to conduct pilots and 15. Section 206 – Mandatory Recall Authority Limited to Class 1 recalls & effective immediately 16. Section 207 – Administrative Detention of Food Effective as July 1, 2011 17. Section 211 – Improving the Reportable Food Registry Within 18 months FDA may require consumer-oriented information (1-page summary) for Class 1 recalls, Grocery stores required to post recall information for consumers 18. Section 301 – Foreign Supplier Verification Program Regulations and guidance within one year. Effective in 2 years, even without regulations or guidance, Effective in 2 years, even without regulations or guidance 19. Section 302 – Voluntary Qualified Importer Program FDA to establish within 18 months. Fee-for-service program. Fee for service program 20. Section 303 – Import Certifications of Food Authority to require import certifications on “for cause” basis. May depend upon risks of 21. Section 304 – Prior notice of imports Completed an in effect 22. Section 306 – Inspection of Foreign Food Facilities Import to be refused if foreign facility refuses inspection 23. Section 307 – Accreditation of Third-Party Auditors Applies only to imported food. Within 2 years, FDA to establish system for accreditation of third-party auditors, recognition of accreditation bodies and model accreditation standards. FDA may accredit third-party auditors after 2 years if no accreditation bodies recognized to do so 24. Section 309 – Smuggled Foods FDA strategy required within 180 days 25. Section 403 – Jurisdictions; authorities Existing authorities preserved, i.e. HHS/FDA, USDA, DHS/Customs, and Treasury/Alcohol 3/14 eFOOD-Lab international 17 FSMA Section of the Law Brief Explanation information gathering before proposing regulations the food, risks of the country, territory or region of origin and Tobacco Tax and Trade Bureau state trade, either with incoming raw materials and ingredients or outgoing finished products. Today, if an FDA field inspector/ investigator determines that they have “reason to believe” that a plant’s product is contaminated, then almost all types of plantgenerated records must be made available upon request for review or copying, with the exception of farm-based records, restaurant based records, product recipes, financial data, employee medical and personal information, product pricing data and research data. This would be applicable to any non-US food processing plant shipping food or food ingredients into the US market for consumption. • Prohibition against “port-shopping’ whereby if a food is rejected at one US port, it is returned to the owner, who in some cases in the past shipped it to another US port with the hope it would be allowed into the US marketplace. This prohibition gives US FDA the power to seize the food if it has already been rejected at one US port and have it destroyed versus returning it to the owner for shipment out of the US. The non-self enacting provisions of FSMA required US FDA to publish proposed rule or regulation. From the Spring of 2012 until early in 2014, US FDA did in fact publish seven (7) separate rules that were required by the law. It has been reported that the proposed “Preventive Controls” regulation alone had over 10,000 comments submitted for US FDA to review. During 2013, a US-based consumer advocacy group sued US FDA for taking too much time before publishing these seven (7) regulations for comment. Below is a table that identifies each of the seven (7) FSMA proposed regulations (“legs to the table”). In addition to a brief description of each proposed regulation, the dates


eFOODLab_International_03_2014
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