CDC STATISTICS FOOD SAFETY MODERNIZATION ACT (FSMA) (FSMA) RULEMAKING PROCESS AND HOW TO SUBMIT COMMENTS 02/12/13

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1 EVERY YEAR: CDC STATISTICS 48 MILLION PEOPLE (1 IN 6) GET SICK 128,000 HOSPITALIZED 3,000 DIE From foodborne diseases: Hepatitis A Botulism Listeriosis Laurie George Extension Educator Small Farms/Local Foods Escherichia coli Salmonellosis FOOD SAFETY MODERNIZATION ACT (FSMA) FOOD SAFETY MODERNIZATION ACT (FSMA) Signed into law January 4, 2011 Designed to ensure U.S. food supply is safe Focuses on preventing contamination rather than responding to it Will have 5 proposed rulemakings RULEMAKING PROCESS AND HOW TO SUBMIT COMMENTS Both proposed rules are published in the Federal Register so the public can review it and submit comments. FDA considers comments received during the comment period and then considers revising the rules, based on the comments, before issuing a final rule. Proposed and final rules and supporting documents are filed in FDA s official docket on and also can be accessed on the FSMA website. 1

2 2 proposed rules released for public comment: 1. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (released January 4, 2013) 2. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (released January 4, 2013 re-released January 16, 2013) PROPOSED RULE #1 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Docket #: FDA-2011-N Science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms Proposed produce rule covers most fruits and vegetables while they are in their raw or natural (unprocessed) state*. FDA proposing requirements be effective 60 days after a final rule is published. Compliance dates would be phased in based on business size *produce means fruits and vegetables grown for human consumption Who is covered by this rule? Farm mixed-type facilities grows and harvests produce and conducts activities such as processing fresh-cut produce that requires the establishment to be registered. Only the establishment s farm activities would be subject to the proposed rule. Partial-Exempt farms must meet 2 requirements: Have food sales averaging less than $500,000 per year during the last three years (adjusted for inflation) Sales to qualified end-users* must exceed their sales to others during the same period. * end-user = consumer, restaurant, or retail food establishment located in same state as the farm or not more than 275 miles away from the farm. Partial-Exempt farms if qualify labeling requirements would apply Label currently required on produce = name/address of business where produce was grown (tomatoes in clam shell) No label currently required = name and business address of farm where produce was grown must be displayed at point of purchase (poster) Certain produce is excluded: Low risk produce with respect to biological hazards Rarely eaten raw (potatoes) Produce destined for further processing that includes a kill step Other proposed exemptions: Produce for personal or on-farm consumption The smallest farms those with an average annual value of food sold during the previous three year period of $25,000 or less 2

3 Does your farm grow, harvest, pack or hold produce? You are T covered by this rule Is your produce rarely consumed raw? This produce is T covered by this rule PROPOSED STANDARDS FOR PRODUCE SAFETY COVERAGE AND EXEMPTIONS/EXCLUSIONS FOR PROPOSED 21 PART 112 Is your produce for personal/on-farm consumption? Does your farm manufacture/process, pack, or hold produce that is not a Raw Agricultural Commodity (RAC)? Is your produce intended for commercial processing with a kill step? Does your farm on average (in the previous 3 yrs) have <$25K annual food sales? Does your farm on average (in the previous 3 yrs) : Have <$500K annual food sales, AND A majority of the food (by value) sold directly to qualified end-users? Qualified end-user Section 112.3(c) means: *the consumer for the food (not a business) This produce is T covered by this rule Produce that is not a RAC is T covered by this rule This produce is T covered by this rule, EXCEPT as per Sections 112.(b)(2) and (3) You are T covered by this rule You are EXEMPT from this rule except as per OR Section * a restaurant or retail food establishment that is located in the same State as the farm that produced the food; OR *No more than 275 miles from such a farm You are COVERED by this rule Focuses on identified routes of microbial contamination of produce, including: Agricultural water establish criteria for quality of water and require periodic analytical testing Agricultural Water = in part as water that is intended or likely to contact covered produce or food-contact surfaces Beginning of growing season, the water system components be inspected to identify conditions that are likely to introduce pathogens to produce or food-contact surfaces Biological soil amendments of Animal Origin 3 measures to reduce risk: 1. types of treatment 2. methods of application 3. time intervals between application and crop harvest Provisions pertaining to the handling and storage of biological soil amendments of animal origin Focuses on identified routes of microbial contamination of produce, including: Health and Hygiene farm personnel use hygienic practices hand washing and personal cleanliness Domesticated and Wild Animals introduction into production systems via animal feces. 1. adequate waiting period between grazing of domesticated or working animals and harvesting produce. 2. Monitor for significant wild animal intrusion events before harvest and as needed during growing season. Do not harvest produce visibly contaminated. Focuses on identified routes of microbial contamination of produce, including: Equipment, tools, and buildings set standards for certain equipment and tools, buildings, and sanitation used for produce operations on farms. OTHER AREAS: Sprouts treating seed before sprouting, testing spent irrigation water for pathogens, monitoring growing environment Training would be required for farm personnel and supervisors Recordkeeping require certain records to document that standards are being met 3

4 Very small businesses = having, on a rolling basis, an average annual monetary value of food sold during the previous 3 years of no more than $250,000 will have four years after the effective date to comply. For some of the water requirements, would have 6 years Other Businesses = comply two years after the effective date. For some of the water requirements, would have 4 years to comply. Small businesses = having, on a rolling basis, an average annual monetary value of food sold during the previous 3 years of no more than $500,000 will have three years after the effective date to comply. For some of the water requirements, would have 5 years. PROPOSED RULE #2 Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food Docket #: FDA-2011-N Preventative controls for human food that focuses on preventing problems that can cause foodborne illness Applies to many domestic and foreign firms that manufacture, process, pack or hold human food Require written plans that identify hazards, specify steps to minimize hazards, identify monitoring procedures, record results, and specify actions to correct problems that arise FDA will evaluate the plans and inspect facilities Who is covered by this rule? Applies to facilities that manufacture, process, pack or hold human food Facilities required to register include manufacturers, processors, warehouses, storage tanks and grain elevators. Exemptions: Exemptions and modified requirements for preventive controls for human food can be found at: 4

5 Two major features: 1. New provisions requiring hazard analysis and risk-based preventive controls 2. Would revise the existing Current Good Manufacturing Practice (CGMP) requirements The new preventive control requirements and the modified CGMPs would be placed in a new Part 117: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Control for Human Food Hazard Analysis and Risk-Based Preventive Controls Owner, operator, agent in charge of facilities required to register (with exceptions), will comply with hazard analysis and risk-based preventive controls Require controls only where necessary to prevent hazards to public health Exempt certain facilities from requirements or modify requirements for certain low-risk activities Firms could develop preventive controls that fit their products and operations as long as is adequate to significantly minimize or prevent all food safety hazards that are reasonably likely to occur Hazard Analysis and Risk-Based Preventive Controls Similar to Hazard Analysis and Critical Control Points (HACCP) systems (juice and seafood) Differs in that the proposed rule may require preventive controls at points other than at critical control points and critical limits would not be required for all preventive controls Each covered facility will be required to prepare and implement a written food safety plan, which would include: 1. A Hazard Analysis ID s and evaluates known hazards for each type of food manufactured, processed, or held at the facility 2. Preventive Controls process, food allergens, sanitation, and recall plan 3. Monitoring to assure controls are performed 4. Corrective actions should controls not be implemented properly 5. Verification - to ensure controls are implemented and effective 6. Recordkeeping food safety plan, controls, etc Revisions to the Current Good Manufacturing Practices Current CGMP provision requiring protection against contamination of food also require protection against cross-contact of food by allergens FDA requesting comment on whether it should mandate training for employees, supervisors, and whether it should require (rather than recommend) certain provisions such as cleaning non-food contact surfaces of equipment as frequently as necessary to protect against contamination of food and food-contact surfaces Very small businesses = 3 proposal options to define Less than $250,000 in total annual sales of food Less than $500,000 in total annual sales of food Less than $1,000,000 in total annual sales of food Would have to comply 3 years after publication of final rule 5

6 Small businesses = business that employs fewer than 500 persons that does not qualify for an exemption would have to comply 2 years after publication of the final rule. Other Businesses a business that is not small or very small and does not qualify for an exemption would have to comply 1 year after publication of the final rule. COMMENTS FOR BOTH PROPOSED RULES ARE DUE BY MAY 16, ADDITIONAL DOCKETS OPEN FOR COMMENT What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide Guidance for Industry Docket Number: FDA-2012-D , comments submitted anytime Questions and Answers Regarding Food Facility Registration (Fifth Edition) 7 Guidance for Industry Docket Number: FDA-2012-D , comments submitted anytime Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories 9 Guidance for Industry Docket Number: FDA-2012-D , comments submitted anytime Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) 11 Guidance for Industry Docket Number: FDA-2011-D , comments submitted anytime What You Need to Know About Administrative Detention of Foods 13 Guidance for Industry Docket Number: FDA-2011-D , comments submitted anytime Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act 15 Guidance for Industry Docket Number: FDA-2011-D , comments submitted anytime FOOD SAFETY (GAPs) TRAINING February 19, 2013 Food Safety on the Farm Ogle county March 12, 2013 Food Safety on the Farm Sangamon Co. April 8 29, 2013 Good Agricultural Practices Webinars Kankakee County - 6-8pm attend from home 6