10 things to know about the produce safety rule

On Jan. 17, the Produce Marketing Association (PMA) held a webinar outlining the top 10 things growers, harvesters, packers and others need to know about the Food & Drug Administration’s (FDA’s) proposed produce safety rule.

Bob Whitaker, chief science and technology officer for PMA, outlined the 10 items most likely to impact those who grow and handle produce once the rule is voted in. He also encouraged involvement on all levels as the FDA accepts comments on the rule. The comments period ends May 16.

The top 10 need-to-know items outlined in the webinar (and in PMA’s online rules summary sheets) include the following:

-Who the rule applies to. The proposed rule applies to fruits and vegetables for human consumption and sets standards for the growing, harvesting, packing and holding of such produce. Produce that is rarely consumed raw, grown for personal or on-farm consumption, or destined to undergo commercial processing to reduce microorganisms are exempt from the requirements, as are very small farms (less than $25,000/year in sales). Other farms may be eligible for partial exemption.

-What the rule covers. The rule covers only microbiological hazards, not those related to chemical, physical or radiological contamination of produce. The rule does not require farms to conduct operational risk assessments or devise a written food safety plan, and only sprouts will require product testing. The FDA claims these items are consistent with the USDA’s National Organic Program.

-Whether the rule is commodity specific. FDA decided against regulating commodity by commodity, Whitaker said, except in the case of sprouts. Rather, the rule takes a risk-based approach, looking at processes by which a particular commodity is produced, its biological properties, etc.

-What sort of records must be kept. The proposed rule requires that records be kept demonstrating compliance with the requirements for soil amendments, agricultural water, worker training and health, domesticated animals and animal intrusion, building equipment and sanitation management, and sprout production. Records must include basic information and must be stored for two years, but they do not have to be submitted as a matter of routine to the FDA.

-Ability to develop alternatives to the FDA standards. The proposed rule does allow farms to establish alternative standards for testing requirements and subsequent actions for agricultural water and composting treatment processes, as well as minimum application intervals for untreated soil amendments, composted amendments and compost teas. However, adequate data must support the alternatives. FDA is not completely certain what would qualify as adequate scientific data to support the alternatives at this time, Whitaker said.

-Requirements for personnel. All workers who handle produce must receive training on the principals of food hygiene and safety and the importance of personal cleanliness. Harvesters must undergo training on product inspection (when not to harvest due to a hazard), as well as on corrective action when hazards are observed. Visitors to farms must be trained to follow basic safety tenets as well.

-Key elements regarding agricultural water. Any water used in the growing, harvesting and packing of produce where the water is reasonably likely to contact the produce is subject to inspection. This includes the entire water system (source and distribution). The water cannot be used when there is reason to believe it is not safe, and farmers cannot resume use of the water until the system is inspected and changes have been made or waster is treated with an appropriate disinfectant. No detectable generic e coli is permitted when water is used as sprout irrigation water or if water is applied in any manner that results in direct contact with produce after harvest. This also applies to water used to make teas or for handwashing. Water can be used with detectable levels of e coli if it is used in growing activities and has 235 CFU (colony forming units) generic e coli per 100 mL of any single sample, or 126 CFU/100 mL on a rolling geometric mean. Water must be tested at the start of each growing season and every three months thereafter unless it is water coming from a certified public water system. Surface water sources must be tested every seven to 30 days during growing season, depending on characteristics of the source.

-Key elements regarding soil amendments. Soil amendments must be handled, transported and stored so as to not contaminate products, food contact surfaces, water sources or other soil amendments in storage. Treatment processes must be scientifically validated, and there are specified application intervals based on amendment and how it is applied.

-Other specified standards. Standards regarding domesticated and wild animals apply only when a covered activity takes place in an outdoor area or a partially enclosed building and when there is a reasonable probability that animals will contaminate covered produce. If animals graze or if they are used as working animals in fields where covered produce is grown, farmers must establish an adequate waiting period between grazing and harvesting for covered produce. They must also establish measures to prevent the introduction of known or reasonably foreseeable hazards into or onto the covered produce. Covered produce must be kept separate from other products not covered by the rule. Additionally, practices must be put in place to assess contamination prior to harvest, and produce must be handled in a way that protects against contamination. Packaged produce must not support c botulinum growth, and packaging material must be adequate for its intended use. 

-What you can do now. It’s important to become engaged in the process now, Whitaker says. Become familiar with the rules (see PMA’s FSMA Resource Center). FDA will accept comments on the proposed rule until May 16, 2013.