FDA’s Strategic Shift From Reaction to Prevention in Full Swing with the Release of Two Proposed Rules Under the Food Safety Modernization Act

Release of Two Proposed Rules Under the Food Safety Modernization Act

February 25, 2013

After much ado, including a lawsuit aimed at forcing release of the proposed rules, on Jan. 4, 2013, exactly two years after President Obama signed the Food Safety Modernization Act (FSMA), the FDA released its proposed rules relating to new requirements for preventative control programs and safety standards for the production of fruits and vegetables. As with much of the FSMA, these recently released proposed rules, required by the FSMA, focus on the means of preventing production and distribution of adulterated and mislabeled food products rather than detection of contaminated food products in commerce and corrective actions. Acknowledging this shift in focus, Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, states, “We’re taking a big step for food safety by proposing the standards that will help us prevent food safety problems rather than just reacting to them.”

Implementation of the FSMA provisions has proven an equally, if not more difficult, task for the FDA as it has for the regulated industry. The standards for implementing a preventative control program released Jan. 4, 2013, by the FDA were due July of 2012. Similarly, the standards for safe production and harvesting of fruits and vegetables, also released by the FDA on Jan. 4, 2013, were due a year earlier, in January of 2012. Industry awaits the FDA’s proposed rules on importers’ foreign supplier verification and accreditation of third-party auditors for imported food.

Industry has 120 days from release, or until May 4, 2013, to comment on the proposed rules. The FDA is bracing for what promises to be an onslaught of industry comment, anticipating the FDA will require at least a year to comb through industry comments prior to issuing the final rules. Covered companies may have two years or more to comply with the proposed rules.

Preventive Controls and FDA’s Proposed Rule

The proposed rule on preventive controls applies to domestic and foreign companies that manufacture, process, package or hold food products regulated by the FDA and requires them to identify potential hazards, implement preventive controls to minimize each of the hazards, monitor the performance of the controls and maintain records substantiating the monitoring and compliance with each control. Although such risk-based preventive controls have been required in USDA-regulated facilities since 1996, the FSMA imposes this requirement for the first time in most FDA-regulated facilities.

The requirement of risk-based preventive controls is not merely limited to enactment of a Hazard Analysis and Critical Control Points (HACCP) program, but rather will likely necessitate a combination of a HACCP program with Current Good Manufacturing Practices, Sanitation Standard Operating Procedures, hygiene training, supplier verification, recall plans, and allergen controls and labeling. This is simply not a one-policy-fits-all requirement. A company’s preventive controls program plan should be composed of multiple policies and procedures that are specifically tailored to address the unique risks associated with a specific food product and the associated processes that may vary by plant, or even by line.

Interestingly, the FDA’s proposed rule does not specifically require finished product testing for pathogens or environmental monitoring as components of a preventative controls program, likely due to outcries of concern from industry. However, the proposed rule leaves the door open to the possibility such requirements may find their way into the final rule. The FDA solicits comment from industry “on when and how other elements of a preventative controls system are an appropriate means of implementing the statutory directives,” including a finished product testing program and an environmental monitoring program. Industry is asked to respond to a series of questions about both these programs — for example, whether product testing for pathogens should be limited to finished product or extend to raw material testing. Issues such as frequency of testing are also in play. Presumably in an effort to ward off industry comments focused on the cost of implementing such programs, the FDA sets forth cost estimates for implementing these programs, estimating it will cost a single facility between $14,000 and $813,000 a year to implement a finished product testing program.

In addition to requiring implementation of a comprehensive preventive controls program, the proposed rule in its current form expands the documentation a company must maintain. Implementation of the plans, validation of the countermeasures, monitoring compliance with the plans and corrective actions must be documented. A company must maintain documented records monitoring its preventive controls and verifying compliance with the countermeasures for at least two years. All such records must be provided to the FDA upon request, which is likely to occur during FDA inspections. This raises concerns over dissemination of proprietary processes, formulations and information to the public through Freedom of Information Act requests. When drafting the various policies that compose a company’s preventive controls program, it is imperative that, to the extent possible, proprietary processes and formulations are not codified in the policies or plans. It is also important to clearly designate all proprietary documents as such.

There are limited exceptions exempting FDA-regulated facilities from this requirement. When the FSMA was considered, substantial debate concerning its effect on small companies occurred. Many advocating on behalf of small farms and producers targeting local and regional markets argued that the more onerous provisions of Section 103 were not only unnecessary but would also put them at a substantial economic disadvantage. These lobbying efforts proved effective, since the FSMA exempts certain smaller facilities from compliance, referred to as “qualified facilities.”

In general, affected companies that are not exempt are likely to have at least one year after the final rule is published to be compliant. Companies qualifying as “small businesses” or “very small businesses” will have longer to be in compliance. For example, a nonexempt company employing fewer than 500 people would likely have two years after publication of the final rule to comply, while even smaller companies may have up to three years to comply.

FDA’s Proposed Standards for Produce Safety

The proposed rule for produce safety is perhaps the first major exercise of FDA authority over food on farms. Anticipating concern over the financial effect such regulations will have on small, local farms, the proposed rule is designed to apply only to fruits and vegetables that are perceived to pose the greatest risk, such as berries, melons, leafy greens and ones that are generally consumed raw. Fruits and vegetables that are intended for further processing, such as canning or cooking, are not subject to the regulations set forth in the proposed rule. Similarly, fruits and vegetables produced for personal or on-farm consumption are not subject to the proposed rule. Additionally, some small farms may be exempt or eligible for a partial exemption based on specified factors, including the monetary value of food sales and identity of customers.

The proposed rule is designed to focus on those areas deemed to present the highest potential risk in growing, harvesting, packing and holding produce on domestic and foreign farms. In doing so, the proposed rule sets specific standards for previously identified routes of contamination, including:

  1. agriculture water, imposing sanitary quality standards and requiring inspection of agricultural water system components;
  2. biological soil amendments of animal origin, imposing specified time intervals between application and crop harvest as well as handling and storage standards;
  3. health and hygiene on the farm, setting forth hygienic practices to prevent transmission of contaminants;
  4. domesticated and wild animals in the growing area, imposing measures to prevent pathogens from being introduced and preventing harvest of contaminated product; and
  5. equipment, tools and building, setting sanitation standards.

The final rule will not be issued until after expiration of the 120-day comment period. Compliance will not be required for at least two years after the final rule is published, and those farms qualifying as “small businesses” or “very small businesses” will have even more time to comply.

For information about how McGuireWoods can assist your company with FSMA issues and compliance, please visit our food and beverage industry page, or contact our author.