1/29/2016. IFVGA 2016 FSMA Produce Rule Summary FDA FOOD SAFETY MODERNIZATION ACT FSMA FDA: FSMA PRODUCE SAFETY REGULATIONS

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1 IFVGA 2016 FSMA Produce Rule Summary Dr. Angela Shaw Assistant Professor and Extension and Outreach in Food Safety FDA FOOD SAFETY MODERNIZATION ACT FSMA The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 2011 It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing FDA: FSMA PRODUCE SAFETY REGULATIONS 1

2 Exemptions Does not apply to product that is for personal or on-farm consumption Not for raw agricultural commodities Produce that received commercial processing that reduces microorganisms Farms that have an average annual value of $25,000 or less in previous 3 years Tester s Act Exceptions Qualified facilities 3 previous years sold majority of their food (greater than half) directly to qualified end-users and have an average yearly value of the food sold of less than $500,000 Qualified end-users are consumers, restaurants, or retail food establishments that sell directly to consumers and are located in the same state as the qualified facilities or located no further than 275 miles from them If you are a Qualified Exemption then General Requirement (Subpart B) Records (Subpart O) Compliance and Enforcement (Subpart Q) Withdrawal of Qualified Exemption (Subpart R) Must have a food packaging label Records Documentation to demonstrate that the farm satisfied the criteria for qualified exemption Records indicating annual review and verification of your farms continued eligibility for the exemption 2

3 Labels Must have their name, complete business address either on the label of the produce that would otherwise be covered or to display the same information at the point of purchase Business address of the farm where the produce was grown, on a label, poster, sign, placard, or document delivery contemporaneously with normal course of business or an electronic notice for internet Subpart B-General Requirements Must take appropriate measures to minimize the risk of serious adverse health consequences or death form the use of, or exposure to, covered produce, including those measures reasonably necessary to prevent the information of known or reasonably foreseeable hazards into covered produce and to provide reasonable assurance that the produce is not adulterated under FDC&A Preventive Controls: Human/Animal In general, facilities that manufacture, process, pack or hold food Facilities required to register with FDA under Bioterrorism Act Not farms or retail food establishments Applies to domestic and imported food There are some exemptions and modified requirements for certain facilities What is covered? All fruits and vegetables typically eaten raw (entire list in 112.2) Mixed intact fruits and vegetables (such as fruit baskets) 11 3

4 Definitions Very small business Average sale of produce sold during previous 3 years of no more than $250,000 Small business Average sale of produce sold during previous 3 years of no more than $500,000 What s not covered Produce for personal consumption or produced for consumption farm or another farm under same management Raw agricultural commodities Produce that is rarely consumed raw Asparagus, beans, beets, cashews, sour cherries, chickpeas, coca beans, collards, cranberries, dates, dill, eggplant, pigs, ginger, hazelnuts, peanuts, pecans, peppermint, potatoes, pumpkins, squash, sweet potatoes, water chestnuts What s not covered Further processed produce for microbial reduction Must obtain written assurance from customer of processing Must establish and maintain documentation of compliance Documents must disclose microbial risk Must act consistently with assurance and document that has been provided Withdrawal from Exemption Before withdrawing an exemption, first consider other steps (e.g. warning letter, injunction) and the actions taken by the facility to correct the problem Explicitly provide for notification and opportunity for response before determining to withdraw an exemption Provide process for reinstatement of exemption that has been withdrawn 4

5 Compliance Dates 6 Focus Areas Emphasized Size of Covered Farm Covered activities involving sprouts Covered activities involving all other covered produce: Water Covered activities involving all other covered produce: All other Qualified Exempt: Retention of Records Qualified Exempt: Modified( (b)(1) Qualified Exempt: All other (112.6 and 7) Very Small 3 years 6 years 4 years Now 1/1/ years Small 2 years 5 years 3 years Now 1/1/ years All other 1 years 4 years 2 years Now 1/1/2020 N/A 1. Worker Training and Health and Hygiene 2. Agricultural Water 3. Biological Soil Amendments 4. Domesticated and Wild Animals 5. Equipment, Tools, and Buildings 6. Sprouts Worker Training and Health and Hygiene Establish qualification and training requirements for all personnel who handle (contact) covered produce or foodcontact surfaces and their supervisors ( , , ) Require documentation of required training and corrective actions ( ) Establish hygienic practices and measures needed to prevent persons, including visitors, form contaminating produce with microorganisms ( , , ) Agricultural Water All agricultural water must be safe and of adequate sanitary quality for its intended use ( ) Agricultural water is defined in part as water that is intended to, or is likely to, contact the harvestable portion of covered produce or food-contact surfaces ( 112.3(c)) Establish requirements for inspection, maintenance, and certain other actions related to the use of agricultural water, water sources, and water distribution systems association with growing, harvesting, packing, and holding of covered produce ( , ) 5

6 Agricultural Water If a farm chooses to treat the agricultural water to meet relevant requirements for its intended use, establish requirements related to methods of treatment and monitoring such treatment ( ) Agricultural Water Establish specific requirements for the microbial quality of agricultural water, including provisions requiring periodic analytical testing of such water, and requiring certain actions to be taken when such water is not safe or of adequate sanitary quality for its intended use and/or does not meet the microbial quality requirements ( , , , ); and provide for the use of alternative requirements for certain provisions under certain conditions ( ,112.49) Agricultural Water Require certain records, including documentation of inspection findings, water testing results, scientific data or information relied on to support the adequacy of water treatment methods, treatment monitoring results, scientific data or information relied on to support microbial die-off or removal rates or any permitted alternatives to requirements, time intervals or log reductions applied, and corrective actions ( ) Subpart E: Agricultural Water (Water quality ) No generic E.coli in 100 ml of water Must not use untreated surface water for any of these purposes Used as sprout irrigation water Applied directly onto covered produce during or after harvest activities (e.g. washing or cooling activities or applied of harvested crops for dehydration before cooling) Used to contact food contact surfaces or to make ice Washing hands during or after harvest 6

7 Subpart E: Agricultural Water (Water quality ) Must not use untreated surface water for any of these purposes Direct water application unless you establish and use alternative criteria Geometric meal of 126 of less colony of generic E.coli per 100 ml of water AND statistical threshold value of 410 or less generic E.coli per 100 ml of water Subpart E: Agricultural Water (Water quality ) What happens if you do not meet these? Immediately discontinue use and before you may use the water source and/or distribution system again for the intended use Inspect the entire water system to identify and correct the problem Treat the water to meet the standards Subpart E: Agricultural Water (Water quality ) Apply a time interval (in days) and/or a (calculated) log reduction by: Applying a time interval between last irrigation and harvest using either Microbial die-off rate of 0.5 log per day to achieve geometric mean and statistical threshold, but no greater than a maximum time interval of 4 consecutive days or Subpart E: Agricultural Water (Water quality ) Apply a time interval (in days) and/or a (calculated) log reduction by: Applying a time interval between last irrigation and harvest using either An alternative microbial die-off rate and maximum time interval Harvest to end of storage microbial die-off rate such as use of commercial wash and any maximum time interval reduction as appropriately supported by scientific data and information 7

8 Subpart E: Agricultural Water (Water quality ) Then must re-inspect the entire affect water system to ensure adequate measures were taken for the agricultural water to meet the microbial quality criteria Subpart E: Agricultural Water (Water testing ) No requirement to test any agricultural water subjected to the standards If you receive public water system, you must obtain results or certification of compliance that the water meets the requirements If it doesn t then you can treat that water as described before Must conduct an initial survey of the water quality profile Subpart E: Agricultural Water (Water testing ) Untreated surface water Must take a minimum of 20 samples over a minimum of 2 years, but not greater than 4 years Sample must be a representative of the water used as close to harvest time Must demonstrate the water standards are met Must conduct an annual assessment of the water quality profile to ensure the standards still meet Must take five samples after the initial assessment of the water annually Subpart E: Agricultural Water (Water testing ) Untreated ground water Must take a minimum of 4 samples of the water during the growing season or over a period of 1 year Must demonstrate the water standards are met Must conduct an annual assessment of the water quality profile to ensure the standards still meet Must take 1 sample each year after this initial survey 8

9 Biological Soil Amendments Establish requirements for determining the status of a biological soil amendment of animal origin as treated or untreated, and for their handling, conveying, and storing ( ,112.52) Prohibit the use of human waste for growing covered produce except in compliance with EPA regulations for such uses or equivalent regulatory requirements ( ); Biological Soil Amendments Establish requirements for treatment of biological soil amendments of animal origin with scientifically valid, controlled, biological, physical and/or chemical processes that satisfy certain specific microbial standards ( ,112.55), including examples of such processes; Establish application requirements and minimum application intervals for untreated and treated biological soil amendments of animal origin ( ); Biological Soil Amendments Require certain records, including documentation from suppliers of treated biological soil amendments of animal origin, documentation that process controls were achieved, and corrective actions ( ) Domesticated and Wild Animals If there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate covered produce, require measures to assess as needed relevant areas during growing and, If significant evidence of potential contamination is found, take measures reasonably necessary to assist later during harvest when the farm must identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard ( , ) 9

10 Equipment, Tools, and Buildings Establish requirements related to equipment and tools that contact covered produce and instruments and controls (including equipment used in transport), buildings, domesticated animals in and around fully-enclosed buildings, pest control, hand-washing and toilet facilities, sewage, trash, plumbing, and animal excreta ( ); Require certain records related to the date and method of cleaning or sanitizing equipment used in growing operations for sprouts, and in covered harvesting, packing, or holding activities, and corrective actions ( ) Sprouts Establish scope of applicability of sprout provisions ( ) Establish measures that must be taken related to seeds or beans for sprouting ( ); Establish measures that must be taken for the growing, harvesting, packing, and holding of sprouts ( ); Sprouts Require testing the growing environment for Listeria spp. or L. monocytogenes and testing each production batch of spent sprout irrigation water or sprouts for E. coli O157:H7, Salmonella spp. and, under certain conditions, other pathogen(s), and taking appropriate follow-up actions ( ); Require certain records, including documentation of treatment of seeds or beans for sprouting, a written environmental monitoring plan and sampling plan, test results, certain test methods used, and corrective actions ( ) WHAT ELSE? 10

11 Subpart O: Records( General) (a) Except as otherwise specified, all records required under this part must: (1) Include, as applicable: (i) The name and location of your farm; (ii) Actual values and observations obtained during monitoring; (iii) An adequate description (such as the commodity name, or the specific variety or brand name of a commodity, and, when available, any lot number or other identifier) of covered produce applicable to the record; Subpart O: Records( General) (a) Except as otherwise specified, all records required under this part must: (1) Include, as applicable: (iv) The location of a growing area (e.g. a specific field) or other area (e.g. a specific packing shed) applicable to the record; and (v) The date and time of the activity documented; (2) Be created at the time an activity is performed or observed; Subpart O: Records( General) (a) Except as otherwise specified, all records required under this part must: (3) Be accurate, legible, and indelible; and 4) Be dated, and signed or initialed by the person who performed the activity documented. Subpart O: Records( General) (b) Records required under 112.7(b): records support eligibility (b)(2): training records (b)(2), (4), and (6): water testing; water treatment results; time interval documentation (b)(2): treatment of biological soil (b)(1) and (2): equipment cleaning and sanitizing (b)(1), (4), and (6): seeds or beans treatment records; analytical results; action taken results 11

12 Subpart O: Records( General) Records must be reviewed, dated, and signed, within a reasonable time after the records are made, by a supervisor or responsible party. Subpart O: Records Offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. Electronic records are considered to be onsite at your farm if they are accessible from an onsite location at your farm. Existing records (e.g., records that are kept to comply with other Federal, State, or local regulations, or for any other reason) do not need to be duplicated if they contain all of the required information and satisfy the requirements of this part. Subpart O: Records You must keep records required by this part for at least 2 years past the date the record was created You must keep records as: (a) Original records; (b) True copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records); or (c) Electronic records. 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Subpart O: Records You must have all records required under this part readily available and accessible during the retention period for inspection and copying by FDA upon oral or written request, except that you have 24 hours to obtain records you keep offsite and make them available and accessible to FDA for inspection and copying. Records obtained by FDA in accordance with this part are subject to the disclosure requirements under part 20 of this chapter. (21 CFR Part 20) 12

13 Subpart Q: Compliance and Enforcement ( Applicability and Status) (a) The failure to comply with the requirements of this part, issued under section 419 of the FD&C Act, is a prohibited act under section 301(vv) of the FD&C Act. (b) The criteria and definitions in this part apply in determining whether a food is: (1) Adulterated within the meaning of: (i) Section 402(a)(3) of the FD&C Act in that the food has been grown, harvested, packed, or held under such conditions that it is unfit for food; or Subpart Q: Compliance and Enforcement ( Applicability and Status) (b) The criteria and definitions in this part apply in determining whether a food is: (1) Adulterated within the meaning of: (ii) Section 402(a)(4) of the FD&C Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (2) In violation of section 361 of the Public Health Service Act (42 U.S.C. 264). Subpart R: Withdrawal of Qualified Exemption ( ) (a) We may withdraw your qualified exemption under 112.5: (1) In the event of an active investigation of a foodborne illness outbreak that is directly linked to your farm; or (2) If we determine that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with your farm that are material to the safety of the food that would otherwise be covered produce grown, harvested, packed or held at your farm. Subpart R: Withdrawal of Qualified Exemption ( ) (b) Before FDA issues an order to withdraw your qualified exemption, FDA: (1) May consider one or more other actions to protect the public health and prevent or mitigate a foodborne illness outbreak, including a warning letter, recall, administrative detention, refusal of food offered for import, seizure, and injunction; 13

14 Subpart R: Withdrawal of Qualified Exemption ( ) (b) Before FDA issues an order to withdraw your qualified exemption, FDA: (2) Must notify the owner, operator, or agent in charge of the farm, in writing, of circumstances that may lead FDA to withdraw the exemption, and provide an opportunity for the owner, operator, or agent in charge of the farm to respond in writing, within 15 calendar days of the date of receipt of the notification, to FDA s notification; and (3) Must consider the actions taken by the farm to address the circumstances that may lead FDA to withdraw the exemption. Subpart R: Withdrawal of Qualified Exemption What procedure will FDA use to withdraw an exemption What information must FDA include in an order to withdraw a qualified exemption? What must I do if I receive an order to withdraw a qualified exemption applicable to my farm? Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm? What is the procedure for submitting an appeal? What is the procedure for requesting an informal hearing? Subpart R: Withdrawal of Qualified Exemption What requirements are applicable to an informal hearing Who is the presiding officer for an appeal and for an informal hearing What is the timeframe for issuing a decision on an appeal? When is an order to withdraw a qualified exemption applicable to a farm revoked? If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption? AQUAPONICS/ HYDROPONICS 14

15 Rule Comments They are NOT Exempt to the rule Aquaponic farming and covered produce grown in aquaponic systems is subject to the same potential for contamination from agricultural water, biological soil amendments of animal origin, and animals as covered produce grown using non-aquaponic systems. When covered produce is grown in an aquaponic system in which the water is not intended or likely to contact the harvestable portion of the produce, that water is not agricultural water for purposes of this rule. Rule Comments When covered produce is grown in an aquaponic system in which water is intended or likely to contact the harvestable portion of the produce, that water is agricultural water for purposes of this rule and must meet the applicable standards of subpart E (agricultural water), including the relevant microbial quality requirements in and the relevant water testing requirements in Rule Comments The (a) exception from water testing requirements applies only when water received from a public water system (as in (a)(1)) or a public water supply (as in (a)(2)) is not held under your control in a way that meets the definitions of ground water or surface water before you use it as agricultural water. Rule Comments: Examples Water For example, where under the circumstances the water used in the aquaponic system is agricultural water (because it is intended to, or likely to, contact covered produce), if that water is from a surface water source (or held in a surface water capacity), it must meet the surface water testing requirements in For example, the testing requirements in (b) for untreated surface water apply to an aquaponic system that is established in an outdoor stream or pond, if under the circumstances the water meets the definition of agricultural water. 15

16 Rule Comments: Fish and E.coli With regard to the comments that asserted that fish do not carry E. coli, we note that information submitted or otherwise available to us demonstrates that fish can become carriers of human pathogens, including E. coli and Salmonella, if they are exposed to contaminated feed (Ref. 15), waters or sediment (Ref. 16) (Ref. 17). Rule Comments: Fish and E.coli Studies show that fish have natural defenses against bacterial colonization of human pathogens, but as the population of the pathogen is elevated the fish become stressed and are no longer able to mitigate harboring the pathogens, becoming more susceptible to carrying human pathogens and becoming infected with other fish pathogens (Ref. 18). Fish are also natural carriers of Vibrio spp. (Ref. 19), a zoonotic pathogen. Rule Comments: Growth media With regard to subpart F of this rule (Biological Soil Amendments of Animal Origin and Human Waste), we consider growth media to include solid or semi-solid matrices in which plants are grown; we do not consider liquid-only matrices to be growth media. If a liquid matrix in which covered produce is grown is intended to or is likely to contact the harvestable portion of the crop, the water is agricultural water subject to all applicable requirements in subpart E (Agricultural Water). Rule Comments: Domesticated and Wild Animals and Agricultural Water Subpart I of this rule (Domesticated and Wild Animals) applies only in outdoor areas and partially-enclosed buildings. Subpart I is not intended to address potential contamination from fish used as part of an aquaculturing system. We conclude that the risks presented by fish used in aquaculture are better suited to regulation via the requirements for agricultural water in subpart E (when the water meets the definition of agricultural water) and the requirements related to harvesting in

17 Subpart I: Domesticated and Wild Animals ( Harvest) Must take all measures to identify and NOT harvest covered product that is reasonably likely to be contaminated (e.g. visible animal excreta) Requires a visual assessment of growing area prior to harvesting (pre-harvest walk through) Rule Comments: Agricultural Water Example, if covered produce is reasonably likely to have become contaminated by water containing fish waste that is not managed in compliance with subpart E s requirements for agricultural water does not apply to fish used in aquaculture operations Subpart I does apply to aquaculture operations conducted in outdoor areas or partially-enclosed buildings when, under the circumstances, there is a reasonable probability that animals other than the fish used in the aquaculture operation will contaminate covered produce. Subpart I: Domesticated and Wild Animals (112.81) Covers activities that take place in an outdoor area or a partially-enclosed building and when, there is reasonable probability that animals will contaminate covered produce DOES NOT APPLY TO Fish used in aquaculture operations Covered activities takes place in a fully enclosed building (hydroponics or greenhouse) Rule Comments: Pest management We will consider issuing additional guidance related to the application of this rule to aquaculture operations, as appropriate. 17

18 Rule Comments: Sprouts An aquaponic or hydroponic system used to grow covered produce other than sprouts is not subject to the requirements in subpart M. Likewise, spent sprout irrigation water is defined as water that has been used in the growing of sprouts ; thus, the term spent sprout irrigation water, and the requirements for testing spent sprout irrigation water in subpart M, only apply to the water used for growing sprouts, and not to water used in an aquaponic or hydroponic operation growing produce other than sprouts. Subpart M: Sprouts ( Sprouts) The requirements of this subpart apply to growing, harvesting, packing, and holding of all sprouts, except soilor substrate-grown sprouts harvested without their roots. Rule Comments: Sprouts However, to the extent the specific aquaponic or hydroponic production systems used to grow produce other than sprouts may present risks similar to those associated with sprouts, we encourage aquaponic and hydroponic operations to consider voluntarily implementing the standards in subpart M. Rule Comments: Sprouts We are not establishing additional standards specifically applicable to aquaponic or hydroponic production of crops other than sprouts. Sprouts present a special concern with respect to human pathogens compared to other covered produce because of the warm, moist, and nutrient-rich conditions required to produce sprouts, the same conditions that are also ideal for the proliferation of pathogens if present (Ref. 20) (Ref. 21). 18

19 Rule Comments: Sprouts Sprouts also have been frequently associated with foodborne illness outbreaks and, as a result, we issued our first commodity- specific guidance for sprouts. Likewise, the Codex Alimentarius Commission (or the Codex ) supplemented the Codex Code of Practice for Fresh Fruits and Vegetables (the Codex Guide) (Ref. 22) with a Sprout Annex (Ref. 23). Therefore, we believe it is necessary to incorporate additional subpart M establishing standards specific to sprouts (including soil- or substrate- grown sprouts harvested with roots). Rule Comments: Sprouts Unlike sprouts, we believe that the production methods and safety considerations associated with aquaponics, generally, as well as with hydroponic production of crops other than sprouts, are sufficiently addressed through the provisions of the rule that are generally applicable to covered produce, including the provisions for water in subpart E, for soil amendments of animal origin in subpart F (which include growth media that serve as the entire substrate during the growth of covered produce), and for harvesting in Rule Comments: Sprouts We will consider issuing guidance on these topics in the future, as appropriate. Aquaponic and/or hydroponic operations growing produce other than sprouts may also voluntarily choose to follow the standards in subpart M. Additional Questions Dr. Angela Shaw Iowa State University Assistant Professor/ Extension and Outreach 2577 Food Science Building, Ames, IA angelaml@iastate.edu Phone: