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.
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.
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 The partial exemption would still subject eligible farms to certain modified requirements, and could be withdrawn in certain circumstances.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:
Other areas addressed in the standards include:
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:
For reference, the following outlines the rulemaking process for FDA.
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) http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm
FSMA - Produce Safety Proposed Rule - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm
Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “What Does the New Food Safety Law Mean for You?” January 05, 2011. http://www.foodsafety.gov/blog/fsma.html