On January 4, 2013, the Food and Drug Administration (FDA) proposed the two food safety rules that FDA Commissioner Dr. Margaret Hamburg recognized as the first concrete step toward implementing the Food Safety Modernization Act (FSMA). In the first FSMA public meeting on February 28, 2013, Hamburg said, “They really lay the foundation for a modern, science-based food safety system that will work to prevent foodborne illness, including the large-scale outbreaks of the type that have so plagued our nation in recent years.”

Annually, foodborne illness sickens one in six people, hospitalizes more than 100,000 and kills 3,000, according to Hamburg. Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine, said, “Our first obligation is to do everything we can to reduce these numbers.”

Hamburg said, “I encourage Americans to review and comment on these rules.” Taylor stressed his desire for “as much input from the public as possible before we finalize the rules.”

The new proposed rules are part of a suite of rules mandated by FSMA. Both domestic and foreign farms are covered by the “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” often referred to as the produce rule.

The preventive controls rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,” establishes standards for food facilities. Any operation that was required to register with FDA will likely be subject to this rule. This proposed rule is not limited to produce; it applies to food facilities in general.

Depending on its activities, an operation may be subject to both rules. For example, a mixed-type facility engaged in growing produce may also be packing or selling for another farm, or in processing its own or another farm’s produce.

Brian Snyder, executive director,Pennsylvania Association forSustainable Agriculture, commentedthat implementation of the rules mustbe clear regarding federal-state boundariesand build upon state-based foodsafety authority structures.

Brian Snyder, executive director, Pennsylvania Association for Sustainable Agriculture, commented that implementation of the rules must be clear regarding federal-state boundaries and build upon state-based food safety authority structures.
Photos by Bob Ferguson.

Produce rule exemptions

The proposal does not apply to personal or on-farm consumption. The Tester-Hagan amendment to FSMA provides for exemptions and modified requirements. If a farm’s average annual value of food sold during a three-year period is $25,000 or less, it is not subject to the rule. Also, if a farm has sales averaging less than $500,000 during the last three years and the majority of the sales are to qualified end users, it is exempt. A qualified end user is either the consumer of the food or a restaurant or retail food establishment located in the same state as the farm or not more than 275 miles away. Such farms, however, would be required to label produce with their name and complete business address.

In addition, under the current Federal Food, Drug and Cosmetic Act, the FDA has authority to withdraw an exemption in the event of an outbreak, or if material conditions warrant withdrawal to protect public health.

Dr. David Gombas, senior vice president, food safety and technology, United Fresh Produce Association, said that United’s board advocated mandatory standards in 2007, and in 2010 lobbied Congress for provisions to support that goal. While commending the FDA on the produce rule, Gombas expressed concern that exempt small producers can sidestep food safety. “After all,” he said, “pathogens don’t know what size operation they’re on.”

Brian Snyder, executive director, Pennsylvania Association for Sustainable Agriculture, noted in the hearing that every farmer he works with feels responsible for food safety. Snyder pointed out that the new generation of farmers is far more knowledgeable about food safety than its predecessors, and they are stepping up. But he added that their greatest worry and concern on behalf of the general public is that improperly applied rules will have a dampening effect on the enthusiasm and success of newer farmers in particular. “Let’s get the Tester-Hagan provisions right, and prevent that from happening,” he urged.

David Gombas, senior vice president, food safety andtechnology, United Fresh Produce Association, told theFDA that the industry appreciates its transparency andcommunication in drafting the produce rule.

David Gombas, senior vice president, food safety and technology, United Fresh Produce Association, told the FDA that the industry appreciates its transparency and communication in drafting the produce rule.

Produce rule coverage

The proposed produce rule does not apply to produce that undergoes commercial processing, such as canning, that adequately reduces microorganisms with a “kill step.” Documentation must be kept.

Also, the proposal would not apply to certain specified produce that is rarely consumed raw. The FDA developed this list of non-covered produce, which includes beets, collard greens, eggplant, kale, parsnips, potatoes, sweet corn and more, by analyzing consumption data.

At USDA’s Agricultural Outlook Forum on February 21, 2013, Sarah Klein, senior staff attorney, Center for Science in the Public Interest (CSPI), questioned noncoverage of kale, which is now being used raw more frequently, plus the potential for cross-contamination in produce such as potatoes. Sandra Eskin, director of the food safety campaign for the Pew Charitable Trusts, explained during the February 28 hearing, “We are concerned that the potential for cross-contamination has not been factored into the exemption for agricultural commodities that are rarely consumed raw.” Also at the hearing, Scott Horsfall, CEO, California Leafy Greens Marketing Agreement, concurred that kale is increasingly consumed raw and should be covered.

Produce rule requirements

The general requirements for growing, harvesting, packing and holding activities include keeping covered produce separate, taking measures not to harvest any covered produce that is reasonably likely to be contaminated, protecting covered produce from hazards when handling, not distributing covered produce that drops to the ground prior to harvest unless it is destined for commercial processing, using packaging to prevent hazards, and using adequate packing materials and refraining from reuse unless they are cleaned and sanitized.

The proposal includes detailed standards dealing with possible routes of microbial contamination of produce. These are agricultural water, biological soil amendments, health and hygiene, domestic and wild animals, and equipment, tools and buildings. Special requirements are also set for sprouts.

Syed Hassan, food safety, PepsiCo, and Gurmail Mudahar, vice president,Tanimura & Antle, confer with Michael Taylor, FDA deputy commissioner. Mudahar, whose company produces lettuce, commented thatthe FDA should consider environmental factors such as flying birds, windand dust, as well as educate consumers regarding food safety.

Syed Hassan, food safety, PepsiCo, and Gurmail Mudahar, vice president, Tanimura & Antle, confer with Michael Taylor, FDA deputy commissioner. Mudahar, whose company produces lettuce, commented that the FDA should consider environmental factors such as flying birds, wind and dust, as well as educate consumers regarding food safety.

Agricultural water in the proposal is water used in covered activities where it is intended to, or is likely to, contact covered produce or food-contact surfaces. It includes directly applied irrigation water, crop sprays, and washing or cooling water. The standards require inspection, maintenance, monitoring and follow-up actions or treatments, with documentation. For example, if a test of sprout irrigation water detects any generic E. coli in 100 milliliters (mL), the grower must discontinue that source and take action, including retesting.

For growing activities using direct water application, if there are more than 235 colony-forming units (CFU) of generic E. coli per 100 mL for any single sample, or a rolling geometric mean (n=5) of more than 126 CFU per 100 mL, corrective action must be taken. During a teleconference hosted by the Produce Safety Alliance, several growers pointed to the difficulties presented by the lack of time for testing when frost abatement becomes critical in a matter of hours. The FDA representatives urged making comments on the situation, with grower suggestions.

Biological soil amendment standards depend on the source and the timing. Amendments of animal origin consist of manure or non-fecal byproducts, or table waste. The standards note that compost safety is not regulated by any federal agency, but some state and local regulations provide oversight.

Depending on the amendment used and the application method, the crop harvest time interval is zero days, 45 days or nine months. For example, untreated manure must be applied in a manner that does not contact covered produce and minimizes the potential for such contact, and the interval is nine months. With compost treated in accordance with the microbial tolerances set forth in the proposal’s standards and applied so as to minimize contact during and after application, a crop can be harvested after 45 days. The zero-day interval has a higher microbial standard. Human waste may not be used, except for sewage sludge biosolids consistent with Environmental Protection Agency standards.

Health and hygiene standards for personnel focus on food safety training, hygienic practices such as proper hand washing, maintaining personal cleanliness and items such as gloves, avoiding contact with nonworking animals and minimizing contact with working animals. Measures to prevent contamination from any person with an applicable health condition are included, plus measures to ensure that visitors do not contaminate covered produce.

Domesticated and wild animal standards do not require fencing, habitat destruction or clearing of farm borders. If grazing is allowed, or if working animals are used in produce fields, the standards require waiting an adequate amount of time to harvest any growing area. Also, measures must be implemented to prevent introducing hazards to covered produce. For example, establish horse paths to segregate the animals from the produce.

The FDA has indicated that it recognizes the problems associated with wild animals. Nevertheless, if there is a reasonable probability of animal intrusion, the standards require monitoring and evaluation of whether covered produce can be safely harvested.

Equipment and tools that contact covered produce, such as knives, harvesters, cooling and sizing equipment, containers and bins, must be designed for adequate sanitation and maintenance, and be prevented from attracting and harboring pests. Instruments for temperature control and measuring sanitizer efficacy must be precise and adequate for their designated uses.

Buildings must be suitable for maintenance and sanitary operations, and include sufficient space for equipment and storage. Precautions must be taken to reduce the potential for contamination, with design and construction that can be sanitized and maintained in good repair. Adequate, readily accessible toilet and hand washing facilities, proper plumbing systems and drainage must be provided. Trash, litter and waste must be disposed of properly. Measures to protect against animals and pests must be implemented.

Sprout requirements are more specific, because their warm, moist and nutrient-rich production environment is ideal for pathogen growth. The seeds and shipment packaging must be inspected for potential contamination. All production must be in a fully enclosed building. All contact surfaces must be sanitized. The producer must treat the seeds with a scientifically valid method immediately before sprouting. The growing, harvesting, packing and holding environment and the spent irrigation water for each production batch must be tested for Listeria spp. or L. monocytogenes, E. coli O157:H7 and Salmonella species, and appropriate follow-up actions must be taken. Sprout growers need to keep written plans for monitoring and sampling.


Farms may establish alternatives to certain requirements of the agricultural water and biological soil amendment provisions. However, it must be scientifically established and documented that any alternatives provide the same amount of protection without increasing the risk of adulteration. In presentations, FDA officials have noted that academic journals and cooperative extension sources may be able to provide data.

At the Washington, D.C., hearing, CSPI’s Klein urged the FDA to strengthen the documentation on alternative methods, require farm users to notify the FDA, and maintain a database on their effectiveness so other farms can learn from them.

Sarah Klein, senior staff attorney forthe Center for Science in the PublicInterest, said the FDA should requiremore records.

Sarah Klein, senior staff attorney for the Center for Science in the Public Interest, said the FDA should require more records.


A state or a foreign country may petition the FDA for a variance from some or all provisions of a proposed rule if the state or country determines it is necessary for local growing conditions. As with alternatives, the practices in a proposed variance must provide the same level of public health protection.


Records must be dated and signed, and include documentation as noted. They may be electronic and need not be duplicative if existing records include the required information. Sprout producers must document actions taken. The proposal does not require records to be submitted to the FDA; however, they must be available during an inspection.

At the FDA's first public hearing, numerous officials explained the analysisand scientific data review processes to develop the produce safety proposals.From left, Donald Kraemer, senior adviser; Dr. Jim Gorny, senioradviser; and Dr. Samir Assar, director, produce safety staff. Each works forthe FDA Center for Food Safety and Applied Nutrition.

At the FDA’s first public hearing, numerous officials explained the analysis and scientific data review processes to develop the produce safety proposals. From left, Donald Kraemer, senior adviser; Dr. Jim Gorny, senior adviser; and Dr. Samir Assar, director, produce safety staff. Each works for the FDA Center for Food Safety and Applied Nutrition.


The proposal is effective 60 days after publication of the final rule. However, the compliance dates are staggered. Very small businesses, defined as average annual sales of no more than $250,000 during the previous three years, would have four years from the effective date to comply, and six years for some of the agricultural water requirements. Small businesses, with average sales of no more than $500,000 annually, would have three years, and five years for some of the water requirements. All other businesses need to comply within two years after the effective date, and four years for some of the water requirements.

Economic impact

In assessing the cost of the produce rule, the FDA estimated the benefit of foodborne illness prevention at $1.04 billion annually. The annualized cost to domestic farms covered was estimated to be $459.56 million, and $170.62 million for foreign farms. The projected average annual cost per farm ranges from $4,697 for a very small farm to $12,972 for a small farm and $30,566 for a large farm.

More to come

In addition to the produce and the preventive controls proposed rules, the FDA’s proposed rules on imports and on product tracing will be forthcoming. During the first public hearing, Taylor said they would be released soon.

Scott Horsfall, CEO, California Leafy GreensMarketing Agreement, told the FDA that they werehappy that the standards closely reflect the foodsafety practices fundamental to the group.

Scott Horsfall, CEO, California Leafy Greens Marketing Agreement, told the FDA that they were happy that the standards closely reflect the food safety practices fundamental to the group.

How to comment

Throughout the public meetings, webinars, presentations, teleconferences and published materials such as fact sheets, the FDA has urged public comments. Both proposals are lengthy and complex. Because producers may be concerned about particular applications, the FDA solicits comments that can include helpful suggestions and solutions.

In addition to the issues raised by the public, the FDA requests comments on specific issues, including non-covered produce, dropped produce, sprouts, testing protocols, postharvest handling and more. These are set forth in a produce rule fact sheet at www.fda.gov/fsma.

Comments may be submitted electronically at www.regulations.gov. Written comments may be faxed to 301-827-6870, or mailed to Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, HFA-305, Rockville, MD 20852. The docket number (FDA-2011-N-0921) must be on all comments.

Comments on both the produce safety and the preventive controls proposals must be submitted by May 16, 2013. After that, the FDA will review and consider the comments, and then develop the final rules.

Note: This article highlights the proposed produce safety rule; the preventive controls rule will be covered in a later issue. Growers should review the complete standards, which are accessible, along with fact sheets, FAQs and other explanatory information, at www.fda.gov/fsma. A subscription for updates is available as well. Questions for FDA staffers should be directed to FSMA@fda.hhs.gov.

The author is a writer/researcher specializing in agriculture. She currently resides in central Pennsylvania.