Proposed rule calls for review, study, comments

At the FDA’s first public hearing in Washington, D.C., Paul Schwarz shared the tragic story of his father, Paul Schwarz Sr., a World War II veteran awarded two Purple Hearts who struggled with listeriosis from cantaloupe. The elder Schwarz, eventually not even able to feed himself, fought for three months as the infection took hold of his body, and then his brain. His son recalled, “Listeria defeated him. My father was 92 years old.” His was the 31st death from the 2011 outbreak. Afterward, Sandra Eskin of the Pew Charitable Trusts said, “Obviously that was about as compelling testimony as I think we’ll hear all day. I’ll do my best to do something constructive.” Eskin then made suggestions to strengthen the rules in areas such as preventing cross-contamination.
Photos by Bob Ferguson unless otherwise noted.

However, for those facilities affected, the study, analysis and need to comment on this 680-page proposed rule remain far from simple.

Fortunately, the FDA has extended the comment period deadline from May 16, 2013, to September 16, 2013. This extension comes as a result of the many requests from organizations and individuals for more time to fully evaluate and address pertinent issues in the proposed rules.

The comment period deadline for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the produce safety proposed rule) is also extended to September 16, 2013.

Three other proposed rules dictated by the Food Safety Modernization Act (FSMA) – preventive controls for animal food, foreign supplier verification program, and accreditation of third-party auditors – are still under review as of this writing. The FDA has indicated that they will soon be released.

In keeping with its emphasis on prevention of foodborne illnesses, the preventive controls proposed rule contains new provisions requiring Hazard Analysis and Risk-Based Preventive Controls (HARPC). It revises the existing Current Good Manufacturing Practice (CGMP) guidelines. The FDA says the proposed HARPC requirements are similar to the Hazard Analysis and Critical Control Points (HACCP), but operators need to understand potential hazards and put preventive controls in place. The FDA notes that although the proposed rule aligns well with HACCP, it differs in that preventive controls may be required at points other than at critical control points, and critical limits would not be required for all preventive controls.

The FDA proposes to amend the GMP guidelines to make them consistent with this rule. Updates include requiring hygienic practices of all personnel in order to prevent cross-contact with allergens as well as contaminants. Facilities, equipment, supplies, tools, processes and controls must also be designed and managed to prevent the introduction of allergens. Plant design would be required to ensure adequate cleaning and prevention of condensation drip and adequate worker space to protect against contamination of the food, contact surfaces and packaging material. The proposed rules provide more specifics.

Who’s covered?

In general, operations required to register as food facilities in the Bioterrorism Act of 2002 are covered by this proposed rule.

Farms are not included in the preventive controls proposed rule unless they are engaged in processing. Put simply, the FDA indicates that the purpose of a farm is to produce raw agricultural products. The proposed rule includes a table that gives direction on the type of food activities that change a raw agricultural commodity (RAC) to a processed food. Cooling, packing, removal of leaves and husks, washing and waxing do not change the status of an RAC, while canning, chopping, cooking, freezing, pasteurizing, peeling, etc., change an RAC into a processed food. Washing, for example, is identified as part of harvesting under the farm definition. Consequently, farms are covered by the produce safety proposed rule unless that rule exempts them. Operations that produce raw agricultural products with unchanged status and engage in processing are defined as “mixed-type facilities” and are subject to both the produce safety and preventive controls rules.

Modified and qualified exemptions

Very small businesses are subject to the modified preventive control requirements. While exempt from HARPC, the facility must certify that it is implementing and monitoring preventive controls that comply with applicable nonfederal food safety laws. A labeling requirement would apply to those laws. The facility must also maintain records to support any certifications. However, these facilities must comply with CGMPs.

The FDA proposes three options to define a very small business and requests comments on which to use for the final rule. The options range from total annual sales of less than $250,000 to less than $500,000 to less than $1 million, adjusted for inflation.

Facilities with food sales averaging less than $500,000 per year during the last three years that sell to qualified end users are also subject to the modified requirements. Also, food sales must exceed other sales, and these sales must be directly to consumers, restaurants or retail food establishments within the same state or not more than 275 miles away. As with the very small businesses, these facilities must comply with CGMP and certification requirements.

Agronomist Bob Simerly, Fruitland, Idaho, pointed out that the Pacific Northwest vegetable industry embraces safe food. When he asked if the rules’ costs could drive more production offshore, the FDA indicated that imports would be subject to the same rules as domestic production.

Numerous operations are exempt from HARPC, but must comply with CGMPs. These include certain low-risk manufacturing or processing, packing or holding activities conducted by small or very small businesses, such as production of jams, jellies, honey and maple syrup. Also included are food facilities subject to the low-acid canned food regulation; the seafood and juice operations subject to the HACCP regulations in place; alcoholic beverages at certain facilities; and prepackaged food sold in limited quantities at the same facilities. Dietary supplements facilities are included as well, but they must comply with the dietary supplement CGMPs.

Facilities such as warehouses that only store packaged foods that are not exposed to the environment are exempt from HARPC if refrigeration is not required for safety. If refrigeration is required, temperature controls with monitoring, verification and record-keeping apply. In addition, CGMP compliance is required for the facilities.

Warehouse-type facilities that store RACs that are fruits and vegetables intended for further distribution or processing must comply with both HARPC and CGMP. If the warehouse or grain elevator facilities store commodities other than fruits and vegetables, they are exempt, provided they are solely engaged in such storage.

The FDA may withdraw certain exemptions if necessary for the public health or in a foodborne illness outbreak.


As noted, the provisions of the preventive controls proposed rule focus on prevention.

FDA Deputy Commissioner Michael Taylor explains that prevention of foodborne illness is the focus of the FSMA proposals.

This proposed rule mandates a written food safety plan. Moreover, the plan must be specific to each facility. The owner, operator, agent or a third party may prepare the plan, but the owner is responsible for implementation. The plan must be executed and monitored by a “qualified individual,” i.e., one who has completed training in development and application of preventive controls equivalent to curriculum or job training recognized as adequate by the FDA.

This written plan must be analyzed every three years, or if a significant operational change could create a new hazard or increased hazard, or if information such as new research emerges on potential hazards, or any time an ineffective preventive control or system is detected. Any change must be documented.

The plan must include a hazard analysis that identifies and evaluates any foreseeable hazard for each type of food manufactured, processed, packed or held. It must include an assessment of the severity of the illness or injury if the hazard were to occur. A facility with differing food types would demand multiple hazard analyses. These include biological, chemical, physical and radiological hazards. Specific factors such as raw materials and ingredients, facility design, sanitation, storage and distribution, transportation practices, and intended product use must be considered.

The preventive controls in the plan must include critical control points if applicable. Controls would include parameters associated with values that must be controlled to minimize or prevent any reasonably likely hazard. Process, food allergen and sanitation controls, plus a recall plan, are required.

As the Produce Marketing Association’s chief science and technology officer, Dr. Robert Whitaker continues to analyze both plans in depth and urges the need for comments to help set the baseline for all producers.

Monitoring of the plan must be appropriately frequent, consistent and documented in records. Procedures to prevent cross-contamination must be developed. The recall plan must assign responsibility and include steps to notify consignees of return or disposal procedures and verification of the checks and product disposal.

Corrective actions must be taken if preventive controls were not implemented, and the plan must be modified if necessary.

Verification includes validating the adequacy of the controls. This includes calibrating instruments periodically. The FDA recognizes that many in the industry are using commonly accepted science-based verification and seeks comments on these programs.

Record-keeping must document the plan, its monitoring, corrective actions and verification, plus the training of the qualified individual. Specific information is required; for example, actual times and temperatures must be recorded, not simply ratings of satisfactory or unsatisfactory. Records must be maintained for two years and be available. Comments are sought on whether the records should be submitted to the FDA.


As with the produce safety rule, the preventive controls rule would be effective 60 days after the final rule is published. The first compliance date would be one year after publication of the final rule. However, small businesses that employ fewer than 500 people and do not qualify for an exemption have two years to comply; very small businesses would have three years.

Industry assistance

Donna Johnson, Naturipe Farms’ director of food safety and social responsibility, raised the question of how both the produce safety and preventive controls proposed rules would be applicable with multi-farm and production operations.

Within six months of the final rule publication, the FDA will publish a guidance document that provides the requirements in plain language to help compliance with the HARPC requirements. In addition, the FDA helped establish a Food Safety Preventive Controls Alliance to develop a core training curriculum and to disseminate information on hazards and controls. These are designed to help small and midsized businesses comply with the new requirements.


The FDA has requested comments on numerous specifics in the preventive controls proposed rule. An essential part of rulemaking, comments with suggestions by those experienced in the processes and procedures are especially sought.

During a hearing in Washington, D.C., Donna Johnson, director of food safety and social responsibility for Naturipe Farms LLC, pointed to a situation in which the preventive controls proposed rule would apply to a particular packinghouse and another very small farm that would fall into the produce safety proposed rule exemption. Both sell under the same name. “A little more clarification on that would be great,” she explained, needing guidance on how to apply the particular rules. The FDA acknowledged that it was not simple and depended on circumstances, and added that they were seeking comments on those types of situations.

Bob Simerly of McCain Foods USA, Inc., who was also representing the National Onion Association and the Pacific Northwest Vegetable Association, said they have no problem with the preventive rules, and suggested that the low-risk commodity exemptions should be codified. Simerly prefaced his comments by mentioning that several years ago, his teenage son was hospitalized for several days with E. coli.

Dr. Peter Vardon, FDA senior economist, explained the factors employed to quantify the annual $2 billion effects of foodborne illness.

Jeffrey Abels of the American Council of Independent Laboratories suggested that the FDA should use environmental monitoring programs for pathogens and require testing performed by accredited labs. He said that in finished products, “Rigorous testing is an effective intervention.”

Erik Lieberman, regulatory counsel for the Food Marketing Institute (FMI), commented that FMI supports FSMA, and complimented the FDA on its outreach and transparency about the proposed rules. Lieberman cautioned against unnecessary CGMP overreach that does not protect consumer health, such as part of the warehouse modification requirement. Lieberman stressed FMI’s excellent track record.

Dr. Robert Whitaker, chief science and technology officer for the Produce Marketing Association (PMA), along with other produce industry leaders, worked with the FDA at the outset of FSMA. During the public hearing in Washington, D.C., the FDA expressed its appreciation of Whitaker’s food safety work.

Whitaker has repeatedly encouraged his audience to make comments. The PMA is continuing to provide information as the rulemaking process moves forward. “Our goal is clearly to help ensure the final rule incorporates the highest level of food safety to protect consumers in ways that are practical and efficient,” Whitaker stressed. “Food safety has to be everybody’s responsibility.”

How to comment

Comments may be submitted electronically at Written comments can 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 for the preventive controls proposed rule is FDA-2011-N-0920. The docket number must be on the comments, and they must be submitted no later than September 16, 2013.

Note: This article highlights the preventive controls proposed rule; the produce safety proposed rule was covered in the April issue. Visit, where you can review the complete standards, fact sheets, FAQs and other explanatory information. A subscription for updates is also available. Questions for FDA staffers should be directed to In addition, numerous trade associations have been preparing information specifically for commenting on their particular activities. l

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