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The Food Safety Modernization Act – The Produce Safety Rule

The Food Safety Modernization Act.The Food Safety Modernization Act. What is it? How will it change how fruits and vegetables are produced and handled?

The Food Safety Modernization Act (FSMA) is the food safety legislation passed by Congress in December 2010 and signed into law by the President in January 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from reacting to food contamination to preventing it. The burden of foodborne illness is considerable. FSMA gives the US Food and Drug Administration a legislative mandate to require comprehensive, prevention-based, food safety-focused controls across the food supply. As part of this mandate, FDA now can require manufacturers to recall food products.

Putting FSMA to Work

Under the new food safety law, FDA has issued a number of rules. The following five proposed rules establish FSMA’s framework for food safety.

  • Produce Safety Standards - Published Jan. 2013; deadline for comments extended to November 13, 2013
  • Preventive Controls for Human Food – CGMP’s and HARPSC - Published January 2013; deadline for comments extended to November 13, 2013
  • Foreign Supplier Verification Program – Published July 2013; comments due within 120 days.
  • Accredited Third Party Certification – Published July 2013; comments due within 120 days.
  • Preventive Controls for Animal Food – Published October 2013; comments due within 120 days.

Produce Safety Standards Rule

FSMA requires FDA to establish science-based standards for the safe production and harvesting of fruits and vegetables to minimize the risk of serious illnesses or death. In response, FDA has issued the Produce Safety Standards Rule. The rule includes standards associated with identified routes for microbial contamination of produce; they include (1) agricultural water; (2) biological soil amendments of animal origin (3) health and hygiene (4) animals in the growing area and (5) equipment, tools and buildings. The proposed rule includes additional provisions related to sprouts. The proposed produce rule covers most fruits and vegetables while they are in their raw or natural (unprocessed) state. It would not apply to raw agricultural commodities that are rarely consumed raw, those produced for personal or on-farm consumption, and (with certain documentation) those destined for commercial processing, such as canning, that will adequately reduce microorganisms of public health concern. Some farms would not be covered by the rule, or would be eligible for a partial exemption based on factors including the monetary value of their food sales and to whom they sell. The partial exemption would still subject eligible farms to certain modified requirements, and could be withdrawn in certain circumstances. FDA is proposing that the requirements be effective 60 days after a final rule is published in the Federal Register. Recognizing that small and very small businesses may need more time to comply with the requirements, compliance dates would be phased in based on business size.

Who is Covered by the Rule?

The proposed rule will establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce in its raw or natural (unprocessed) state on farms. For the proposed rule, produce means fruits and vegetables grown for human consumption. Examples include lettuce, spinach, cantaloupe, tomatoes, sprouts, mushrooms, onions, peppers, cabbage, citrus, strawberries, and walnuts. The FDA proposed produce safety rule considers the specific produce; the practices associated with growing, harvesting, packing and holding the produce; and how the produce will be used and consumed after it leaves the farm. The proposed produce rule provides growers flexibility in their approach to on-farm food safety, so that food safety practices being taken by farmers can be appropriate for the scale of production and type of agricultural practices being used.

Farm mixed-type facilities (farms engaged in activities outside the definition of “farm” that require food facility registration) may be subject to both the proposed produce safety rule and the proposed preventive controls rule, depending on whether any exemptions apply. Example: An establishment that grows and harvests produce may also process fresh-cut produce that requires it to be registered with FDA. Only the establishment’s “farm” activities would be subject to the proposed produce safety rule.

Limitations on Coverage of the Proposed Rules

Farms would be partially exempt from the proposed rule if they meet two requirements. First, their food sales must average less than $500,000 per year during the last three years. Second, their sales to qualified end-users must exceed their sales to others during the same period. A qualified end-user either is a consumer or is a restaurant or retail food establishment located in the same State as the farm or not more than 275 miles away from the farm. Note that FDA may withdraw this partial exemption if the farm is directly linked to an outbreak, or if FDA determines it is necessary to protect the public health and prevent or mitigate an outbreak based on conditions or conduct that create the potential for the farm’s produce to cause an outbreak.

In addition, the proposed rule excludes certain produce that constitute the lowest risk with respect to biological hazards. Examples include produce that is rarely consumed raw, such as potatoes, or that is destined for further processing that includes a kill step (with certain documentation), such as green beans destined for a canning operation. The proposed rule also would not apply to produce for personal or on-farm consumption. FDA also proposes that the smallest farms—those with an average annual value of food sold during the previous three-year period of $25,000 or less—would not be covered. 

Highlights of the Proposed Rule  

FDA proposes to establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. The proposed rule focuses on identified routes of microbial contamination of produce, including: 

  • Agricultural Water. Water used for produce production presents different microbial quality demands depending on its use. Water can be a carrier of many different microorganisms of public health concern. The proposed rule would require that all agricultural water be safe and of adequate sanitary quality for its intended use. “Agricultural water” would be defined in part as water that is intended to, or likely to, contact covered produce or food-contact surfaces. The proposed rule would require that, at the beginning of the growing season, the agricultural water system components under a farm’s control be inspected to identify conditions that are reasonably likely to introduce pathogens to produce or food-contact surfaces. FDA is proposing that specific criteria for the quality of agricultural water be established for water that is used for certain purposes, with proposed requirements for periodic analytical testing.
  • Biological Soil Amendments of Animal Origin. Biological soil amendments of animal origin, such as composted manure, may contain pathogens of public health concern.  Thus the rule proposes three types of measures to reduce the risk: types of treatment, methods of application, and time intervals between the application of a biological soil amendment of animal original and crop harvest.  The proposed rule also has provisions pertaining to the handling and storage of biological soil amendments of animal origin.
  • Health and Hygiene. Bacteria, viruses, and parasites are frequently transmitted from person to person and from person to food, particularly through the fecal-oral route. The proposed rule would require that farm personnel use hygienic practices, including hand washing and maintaining adequate personal cleanliness.
  • Domesticated and Wild Animals. Pathogens can be introduced into fruit and vegetable production systems via animal feces. Where there is a reasonable probability that animals will contaminate produce, the rule proposes certain requirements, such as an adequate waiting period between grazing of domesticated animals and harvesting produce from that growing area. Similarly, for working animals used where a produce crop has been planted, farms would be required to take measures to prevent pathogens from being introduced onto the produce. In addition, farms would be required to monitor for significant wild animal intrusion events both immediately before harvest, and, as needed during the growing season, and not harvest produce that is visibly contaminated with animal excreta.
  • Equipment, tools and buildings.  Among other things, the proposed rule also would set standards for certain equipment and tools, buildings, and sanitation used for produce operations on farms.

Other areas addressed in the standards include:

  • Sprouts: Sprouts present a unique risk because the warm, moist, and nutrient-rich conditions required to produce sprouts are the same conditions that are also ideal for the growth of pathogens. The proposed rule would require treating seed before sprouting, testing spent sprout irrigation water (or sprouts, in some cases) for pathogens and monitoring the growing environment for Listeria species or Listeria monocytogenes.
  • Training: The proposed rule would require training for farm personnel who handle the produce or food-contact surfaces, and for supervisors.
  • Alternatives and Variances: The proposed rule would provide that farms may establish alternatives to certain requirements related to water and biological soil amendments of animal origin if the alternative is scientifically established to provide the same amount of protection as the requirement in the proposed rule without increasing the risk of adulteration.
  • Recordkeeping: The proposed rule would require certain records, for example, to document that certain of the standards are being met. However, it would not require duplication of records already kept for other purposes.

FDA is proposing the following effective and compliance dates. The effective date is the date on which the rule would be codified in the Code of Federal Regulations. FDA recognizes that the farming community, especially small and very small farms, would need time to comply with the provisions of the rule and is proposing extended times for compliance dates. Effective Date: 60 days after a final rule is published. Compliance Dates: For farms that would be covered by the proposed rule, the following definitions and compliance dates would apply:

  • Very Small Businesses—a very small business sells an average annual value of food during the previous three years of no more than $250,000. These farms would have four years after the effective date to comply; for some of the water requirements, they would have six years.
  • Small Businesses—a small business is defined sells an average annual value of food during the previous three years of no more than $500,000.  These farms would have three years after the effective date to comply; for some of the water requirements, they would have five years.
  • Other Businesses—other businesses would have to comply two years after the effective date. For some of the water requirements, they would have four years to comply.

For reference, the following outlines the rulemaking process for FDA.

  • Step 1: FDA Proposes Rule and Requests Comments. The proposed rule is published in the Federal Register so that the public can review it and send comments to FDA. The public is given a period of time to submit comments. The proposed rule and supporting documents are also filed in FDA's official docket on http://www.regulations.gov7.
  • Step 2: FDA Considers Comments and Issues Final Rule. FDA considers comments, considers revising the rule based on the comments and issues a final rule. This final rule is also published in the Federal Register and FDA’s official docket on http://www.regulations.gov8.
  • Step 3: Companies Comply with Rule Based on “Effective Date”. When a final rule is published, it may have an effective or compliance date in the future.

Additional Tool: FDA Issues Guidance Documents to Assist Industry. An FDA rule may not address every specific issue faced by a regulated industry so FDA often issues “guidance” or FDA’s current thinking for regulated industry.


FDA Food Safety Modernization Act (FSMA)

FSMA - Produce Safety Proposed Rule - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “What Does the New Food Safety Law Mean for You?” January 05, 2011.