Proposed FDA Food Safety Rules
The FDA recently released a proposed change to the food safety laws that affect growers, with a comment period for the rules running until November, 2013. The National Young Farmers Coalition will be analyzing how the rules will affect young and beginning farmers and ranchers and is also actively seeking input from its constituency, after which it will issue its official comments. Please read further details below and add your concerns, comments, and questions by participating in the NYFC discussion forum on FSMA.
Also check out NYFC’s Potential Questions and Concerns on FSMA to get you started on analyzing the rules.
Signed into law in January 2011, the Food Safety Modernization Act (FSMA) sought to update food policy in a way that had not been done since 1930. With food borne illness so prevalent and so preventable, the FDA is using the FSMA as a way to hold producers accountable in every step of food production. Despite a year’s lag in producing any policy change, they recently released new guidelines focusing on produce safety and preventative controls for food. The proposed rules are currently available for public comment. Comments are due by November, after which the FDA will write and publish the final rule.
Proposed Rule Overview:
The FDA identified five areas that pose a significant risk to microbial contamination of produce and have begun to form policies that would prevent diseases. These are:
- Agricultural Water: new methods to make sure it is safe and adequately sanitary for use on food and regularly tested for pathogens
- Biological Soil Amendments: animal compost must be applied under new restrictions and in the correct time-frame to reduce risk of transmitted disease
- Health and Hygiene: farm personnel must use appropriate hygienic practices, and farms need to make facility improvements to ensure hygiene is achieved.
- Domesticated and Wild Animals: farms must take action to prevent produce contamination from working animals, domesticated animals and wild animals during production and prior to harvest
- Equipment, Tools and Buildings: must be clean and sanitary, with additional regulations on cleaning processes and record-keeping.
Any farm with sales less than $500,000 per year averaged over three years (adjusted for inflation) and with a majority of sales coming from local* consumer, retail location, or restaurant sales would be partially exempt from these guidelines. Read the exact requirements for the exemption here. Those partially exempt farms would still be subject to certain food labelling and point-of-sales farm identification requirements.
The time-line for complying with these rules is two years for farms with more than $500,000 in sales per year, three years for a farm averaging $500,000 or less in sales and four years for a farm averaging $250,000 or less in sales. Farms with sales under $25,000 per year are completely exempt. The rules are also specifically created to not interfere or contradict regulations for organic production. Congress hopes these policies help smaller producers adapt to the new rules when they are implemented.
A number of agricultural advocacy groups have commented on the proposed FDA guidelines. Ariane Lotti of the National Sustainable Agriculture Coalition stated that NSAC would be closely following the FDA’s implementation of Congress’ guidelines to make sure small farmers are not adversely effected by these policy changes. Similarly, the National Young Farmers Coalition will be issuing a response to the proposed rules after sufficient analysis and input from beginning farmers. Please add your concerns, comments, and questions by participating in the NYFC discussion forum on FSMA.
- For an overview of the section relating to produce growers, read the fact sheet for the proposed rule for the Growing, Harvesting, Packing, and Holding of Produce.
- Also check out NYFC’s Potential Questions and Concerns on FSMA to get you started on analyzing the rules.
- And the proposed rule in its entirety is available here.
* Local is defined as within the same state or within 275 miles of the farm.
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, such as composted manure, may contain pathogens of public health concern. To address this, 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.
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.
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.
Among other things, the proposed rule also would set standards for certain equipment and tools, buildings, and sanitation used for produce operations on farms.
Proposed Sec. 112.5(d) i defines the small farm exemption eligibility as:
During the previous 3-year period preceding the applicable calendar year, the average annual monetary value of the food you sold directly to qualified end-users during such period exceeded the average annual monetary value of the food you sold to all other buyers during that period (Sec. 112.5(a)(1)); and
The average annual monetary value of all food you sold during the 3-year period preceding the applicable calendar year was less than$500,000, adjusted for inflation (Sec. 112.5(a)(2)).
Proposed Sec. 112.5(b) provides that, for the purpose of determining whether the average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation, the baseline year for calculating the adjustment for inflation is 2011. The conditions related to average annual monetary value established in section 419(f)(1)(B) of the FD&C Act allow adjustment for inflation. To establish a level playing field for all farms that may satisfy the criteria for the qualified exemption, we are proposing to establish the baseline year for the calculation in proposed Sec. 112.5(a)(2). We are proposing to establish 2011 as the baseline year for inflation because 2011 is the year that FSMA was enacted into law.
proposed Sec. 112.6(b)(1) would require that, when a food packaging label is required on food that would otherwise be covered produce under the FD&C Act or its implementing regulations, you include prominently and conspicuously on the food packaging label the name and complete business address of the farm where the produce was grown. Proposed Sec. 112.6(b)(2) requires that, when a food packaging label is not required on food that would otherwise be covered produce under the FD&C Act, you prominently and conspicuously display, at the point of purchase, the name and complete business address of the farm where the produce was grown. As proposed, the name and address of the farm must be displayed on a label, poster, sign, placard, or documents delivered contemporaneously with the produce in the normal course of business, or, in the case of Internet sales, in an electronic notice.
That is, if a label is otherwise required on the produce that would otherwise be covered (for example, tomatoes in a “clam shell” package) then the label must include the name and business address of the farm where the produce was grown. If a label is not required (for example, unpackaged tomatoes) then the name and business address of the farm where the produce was grown must be displayed at the point of purchase (such as on a poster, for example). These proposed provisions reflect our interpretation of section 419(f)(2)(A)(i) and (ii) as applying only to food that would otherwise be covered produce but for the qualified exemption. We tentatively conclude that this interpretation is reasonable because applying these consumer notification requirements to food that would not otherwise be covered produce would mean applying requirements to food that bears no relationship to the subject of this rulemaking (e.g., to milk from a farm that also grows and harvests produce and that meets the criteria for the qualified exemption from this proposed rule).