As it appears in the full-sized produce safety rule, here is the executive summary of the proposed regulation. A bite-sized morsel, as it were, compared to the full-length version. Initial industry reaction to the proposed rule appears measured, with some real disappointment that "low risk" commodities like citrus and tree fruit are not treated differently than vegetables grown on the ground.
Readers are welcome to react to what they read in the comments section. The FDA will be taking comments until May 16.
From the FDA:
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) requires FDA to publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which we have determined such standards minimize the risk of serious adverse health consequences or death. Further, new section 419 also requires FDA to adopt a final regulation based on known safety risks, setting forth procedures, processes, and practices that we determine to minimize the risk of serious adverse health consequences or death, including those that are reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into produce and to provide reasonable assurances that produce is not adulterated under section 402 of the FD&C Act.
This proposed rule focuses on microbiological hazards related to produce growing, harvesting, packing, and holding. We conducted a “Draft Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce” and considered the findings of this assessment in developing this proposed rule. While we acknowledge the potential for chemical, physical or radiological contamination of produce, for reasons discussed in this proposed rule, we are not proposing specific standards for these hazards in this rulemaking.
Scope of Coverage of the Proposed Rule
The proposed rule would apply to both domestic and imported produce. However, as explained in the remainder of this document, the proposed rule contains several exemptions:
• The proposed rule would not apply to certain specified produce commodities that are rarely consumed raw.
• The proposed rule also would not apply to produce that is used for personal or on-farm consumption, or that is not a raw agricultural commodity.
• The proposed rule would provide an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms (e.g. a “kill step”) as long as certain documentation is kept.
• The proposed rule would not cover farms that have an average annual value of food sold during the previous three-year period of $25,000 or less.
• The proposed rule would provide a qualified exemption and modified requirements for farms that meet two requirements: (1) the farm must have food sales averaging less than $500,000 per year during the last three years; and (2) the farm’s sales to qualified endusers must exceed sales to others.
A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same State as the farm or not more than 275 miles away. Instead, these farms would be required to include their name and complete business address either on the label of the produce that would otherwise be covered (if a label is required under the FD&C Act and its implementing regulations) or at the point-of-purchase.
This exemption may be withdrawn in the event of an active investigation of an outbreak that is directly linked to the farm, or if it is necessary to protect the public health and prevent or mitigate an outbreak based on conduct or conditions on the farm that are material to the safety of the produce. As explained in the Preamble, these entities are either exempt from all the requirements of the rule or are subject to a narrower set of requirements.
Summary of the Major Provisions of the Regulatory Action
The proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. We propose new standards in the following major areas:
• Worker Training and Heath and Hygiene
o Establish qualification and training requirements for all personnel who handle (contact) covered produce or food-contact surfaces and their supervisors (proposed §§ 112.21, 112.22, and 112.23);
o Require documentation of required training (proposed § 112.30); and
o Establish hygienic practices and other measures needed to prevent persons, including visitors, from contaminating produce with microorganisms of public health significance (proposed §§ 112.31, 112.32, and 112.33).
• Agricultural Water
o Require that all agricultural water must be of safe and sanitary quality for its intended use (proposed § 112.41). Agricultural water is defined in part as water that is intended to, or likely to, contact the harvestable portion of covered produce or food-contact surfaces (proposed § 112.3(c));
o Establish requirements for inspection, maintenance, and follow-up actions related to the use of agricultural water, water sources, and water distribution systems associated with growing, harvesting, packing, and holding of covered produce (proposed §§ 112.42 and 112.46);
o Require treatment of agricultural water if you know or have reason to believe that the water is not safe and of adequate sanitary quality for its intended use, including requirements for treating such water and monitoring its treatment (proposed § 112.43);
o Establish specific requirements for the quality of agricultural water that is used for certain specified purposes, including provisions requiring periodic analytical testing of such water (with exemptions provided for use of public water supplies under certain specified conditions or treated water), and requiring certain actions to be taken when such water does not meet the quality standards (proposed §§ 112.44 and 112.45); and provide for alternative requirements for certain provisions under certain conditions (proposed § 112.12); and
o Require certain records, including documentation of inspection findings, scientific data or information relied on to support the adequacy of water treatment methods treatment monitoring results, water testing results, and scientific data or information relied on to support any permitted alternatives to requirements (proposed § 112.50).
• Biological Soil Amendments
o 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 (proposed §§ 112.51, 112.52)
o Prohibit the use of human waste for growing covered produce except in compliance with EPA regulations for such uses or equivalent regulatory requirements (proposed § 112.53);
o Establish requirements for treatment of biological soil amendments of animal origin with scientifically valid, controlled, physical and/or chemical processes or composting processes that satisfy certain specific microbial standards (proposed §§ 112.54 and 112.55); and provide for alternative requirements for certain provisions under certain conditions (proposed § 112.12);
o Establish application requirements and minimum application intervals for untreated and treated biological soil amendments of animal origin (proposed § 112.56); and provide for alternative requirements for certain provisions under certain conditions (proposed § 112.12); and
o Require certain records, including documentation of application and harvest dates relevant to application intervals; documentation from suppliers of treated biological soil amendments of animal origin, periodic test results, and scientific data or information relied on to support any permitted alternatives to requirements (proposed § 112.60).
• Domesticated and Wild Animals
o If animals are allowed to graze or are used as working animals in fields where covered produce is grown and under the circumstances there is a reasonable probability that grazing or working animals will contaminate covered produce, require, at a minimum, an adequate waiting period between grazing and harvesting for covered produce in any growing area that was grazed, and measures to prevent the introduction of known or reasonably foreseeable hazards into or onto covered produce (proposed § 112.82); and
o If under the circumstances there is a reasonable probability that animal intrusion will contaminate covered produce, require monitoring of those areas that are used for a covered activity for evidence of animal intrusion immediately prior to harvest and, as needed, during the growing season (proposed § 112.83).
• Equipment, Tools, and Buildings
o 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 (proposed §§ 112.121-134); and
o Require certain records related to the date and method of cleaning and sanitizing equipment used in growing operations for sprouts, and in covered harvesting, packing, or holding activities (proposed § 112.140).
o Establish measures that must be taken related to seeds or beans for sprouting (proposed § 112.141);
o Establish measures that must be taken for the growing, harvesting, packing, and holding of sprouts (proposed § 112.142);
o Require that you test the growing environment for Listeria spp. or L.monocytogenes and that you test each production batch of spent irrigation water or sprouts for E. coli O157:H7 and Salmonella species and take appropriate follow-up actions (proposed §§ 112.143, 112.144, 112.145, 112.146); and
o Require certain records, including documentation of your treatment of seeds or beans for sprouting, a written environmental monitoring plan and sampling plan, test results, and certain methods used (proposed § 112.150).
As proposed, the effective date is 60 days after a final rule is published, however, we are providing for a longer timeline for farms to come into compliance. Small businesses (i.e., those subject to proposed part 112 and, on a rolling basis, the average annual monetary value of food sold during the previous three-year period is no more than $500,000) would have three years after the effective date to comply; for some of the water requirements, they would have five years. In addition, very small businesses (i.e., those subject to proposed part 112 and, on a rolling basis, the average annual monetary value of food sold during the previous three-year period is no more than $250,000) would have four years after the effective date to comply; for some of the water requirements, they would have six years. All other farms would have two years after the effective date to comply; for some of the water requirements, they would have four years to comply.
Costs and Benefits
The baseline estimate for preventing all illnesses associated with microbial contamination of produce covered by this proposed regulation is $1.6 billion; however, we do not expect that we will eliminate all illnesses associated with covered produce. Instead, we expect that the proposed produce safety regulation will prevent some portion of this illness burden from recurring. We estimate the number of foodborne illness prevented by this regulation to be 1.75 million, with an associated benefit of $1.04 billion, annually. As described in the Preliminary Regulatory Impact Analysis (PRIA), making a precise estimate of the rule’s likely effectiveness is extremely difficult, because FDA has only limited data that would establish a clear baseline estimate of how contamination occurs and the likely impact of the proposed provisions on that baseline, with respect to causing human illness. We estimate the costs of the proposed rule to be $459.56 million annually for domestic farms, $170.62 million annually for foreign farms covered by the rule (for a grand total of $630.18 million annually), resulting in $406.22 million annually in estimated potential net benefits.