Food Safety Law and Regulations. Edna Negrón, PhD, CFSP

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1 Food Safety Law and Regulations Edna Negrón, PhD, CFSP

2 Food Safety Regulatory Agencies Federal and State Agencies 1. Food and Drug Administration (FDA) 2. United State Department of Agriculture / Food Safety and Inspection Service USDA/FSIS Code of Federal Regulations 3. State Health Department Food Code 4. State Department of Agriculture 5. Environmental Protection Agency 6. Department of Commerce - National Oceanic and Atmospheric Administration (NOAA), National Marine Services

3 Principium Only safe food can go into commerce Rules and regulations are based in science. Government oversee compliance of the regulations Food Processors, distributors, brokers are responsible of following and comply with laws and are liable. Process are transparent and accessible to the public

4 1. FDA Department of Health and Human Services (DHHS) Oversee all food that enter into interstate commerce except meat, poultry and egg products. Develop food safety standards Audits food plants and take samples Oversees compliance of pesticides tolerances

5 Laws and regulations Good Manufacturing Practices Procedures for i.e. Safe and Sanitary Processing and Importing of Fish and Fishery Products (1995) Sea food HACCP Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice (2001)

6 21 CFR part 123- Fish and Seafood Products Definitions GMP HACCP Corrective Actions Verification Records Education Sanitary Standard operating procedures Special requirements for imported products

7 FDA regulations Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice (2001) Grade "A" Pasteurized Milk Ordinance 2003 Revision Guide to Reduce the Microbial Contamination of Fresh Produce

8 Bioterrorism Act of 2002 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) 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.

9 2. US Department of Agriculture (USDA) Food Safety and Inspection Services (FSIS) Oversee domestic and imported meat, poultry and egg products Every meat product that contains more than 2% of cooked meat and 3 % or more than raw meat and processed eggs (liquid, frozen or dry) National Residue Program Pesticides, drugs and other

10 Laws and Regulations Meat Inspection Act of 1906) 21 USC 601 et seq. Inspection anti mortem Inspection post mortem Inspection during process Bulls, pork, lamb and other

11 Laws and regulations Poultry products inspection law passed in USC 451 et seq. Egg products inspection law followed in USC 1031 et seq. Federal Law for Meat Inspection Federal Law for Poultry Inspection (1967) State laws

12 Both rules prohibit adulterates food entering food chain in interstate commerce and established the food inspection system for meat products.

13 Inspection System FSIS 21 USC 601, 451, 1031 et seq. Examine animals and meat and poultry carcasses Eggs processing plants Dry, liquid or frozen eggs

14 FSIS Destroy condemn product Approve ingredient Standard of Identity Labeling Sanitation requirements Imports products Audit local and meat for export

15 Mega Rule Final rule for Pathogen Reductiona and HACCP implementation in meat and poultry industries. (July, 1996) - PR/HACCP

16 Mega Rule It won t rely on organoleptics observations Decisions are base in science More flexibility More industry responsibility Inspectors can do other verification and reassessments assignments Industry used to rely in plant inspections, to react and developed corrective actions as needed, rather than a preventive system.

17 Changes in the Inspection System Written SSOP s Written HACCP plan Sampling Program for Salmonella, E. coli and Listeria for(rte) Action plan Stop process Prevent unsafe food enter the food chain Recall program Noncompliance can be prosecuted

18 Exceptions Back yard slaughter for personal consumption Retail and food service that sells directly to consumer and there is no food processing

19 Sanitation Requirements 21 CFR 110 General Establishments - FDA 21 CFR 123 Fish and fis sea foof products - FDA 9 CFR 308 y 381 Meat and Poultry USDA/FSIS 21 CFR Juices

20 Industry Responsibilities Will not rely of FSIS to provide safe food Continuous improvement culture and search for new solutions or technologies for solving problems Compliance with laws and regulations established. Develop SSOP, SPS and HACCP plans

21 Industry Responsability Can be liable by the consumer Must comply with meat and poultry productos laws and regulations Develop written SSOP s, HACCP Plan for Pathogens reduction (E. coli and Salmonella) Develop Implement Validate Reassess.

22 Inspector responsibility- FSIS Turn food regulations into standard Establish standards. Monitor regulations compliance Verification of the effectiveness of the control processes established. Adopt HACCP.

23 Adopt HACCP Observe Evaluate Analyze Decide Document non compliance Take adequate actions in order to verify compliance. Critical thinking, provide solutions to situations, make decisions Think before execute

24 3. State Health Department Environmental Hygiene Division General rule #6090 February 4, 200o Food Code adoption in P.R. Chapter I, Article IX Section 2.00 Inspections Section 3.00 Sanitary Licensee Section 4.00 Resistance o disability Section 5.00 Sample analysis Section 6.00 Decommissions and embargos Section 7.00 Health Certificate Chapter II Adoptions CFR and Food code Chapter III Penalties

25 Milk Hygiene Program Regulation #138 June 3, 1993 (PMO) Goal: Reduce the risk of contamination of milk and milk products for human consumption. Grade A compliance.

26 4. State Agriculture Department Regulation No. 1 Office of Rules and promotion of local meat industry. Published on: 06/28/2004

27 5. EPA Environmental Protection Agency Oversees potable water quality Regulates toxic waste disposal Pesticides safety tolerances in food Publish instructions for safe applications of pesticides

28 6. National Marine Services Department of Commerce - National Oceanic and Atmospheric Administration (NOAA), Oversees fish and seafood products Audit and certify fish boats, seafood plants and seafood retail stores.

29 Other Agencies Agriculture Marketing Services (USDA's, AMS) Grading, standardization, and inspections services GAP s Good Agricultural Practices for Horticultural Crops Federal Grain Inspection Services (FGIS) Inspection corn, sorghum, rice for aflatoxin, and quality for domestic and products for export State Department of Consumer Affair

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