Exactly two years after President Barack Obama signed the Food Safety Modernization Act (FSMA) into law, the Federal Drug Administration has released two sets of proposed, and long awaited, implementing regulations aiming to prevent the spread of foodborne illnesses.
The proposed rules, released on January 4, 2013, help lay the cornerstone of the prevention-based, modern food safety system envisioned in the FSMA. They also have wide-ranging effects on a varied group of industries, including every link in the global food supply chain.
The rules are available for comment over the next four months, with a deadline of May 16, 2013. The proposed rules include:
Current Good Manufacturing Practice and Hazard Analysis and Risk-based Controls for Human Food (Preventive Controls Rule), requiring food companies to create written plans on how to prevent and respond to contaminations and outbreaks. See this proposed rule and the FDA’s fact sheet about it.
Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Produce Safety Rule), implementing the requirement that FDA publish minimum standards for the safe production and harvesting of fruits and vegetables. See this proposed rule and the FDA’s fact sheet about it.
Three additional sets of proposed FSMA regulations may be released in the near future. They include (1) preventive control regulations for feed and pet food facilities; (2) foreign supplier verification program regulations, which require companies to verify that foreign suppliers are meeting US safety standards; and (3) accredited third-party certification regulations for imported foods that strive to strengthen the quality of third-party food safety audits overseas.
Key provisions of the Preventive Controls Rule
The preventive controls regulations form much of the backbone of FSMA. Pursuant to the rules, regulated facilities − which include US and foreign facilities that process, package or store foods to be sold in the US − will need to create written plans that show their analysis and implementation of preventive controls and document verification and monitoring of the controls.
Written plans will be required to include:
an analysis of the potential sources of contamination
ways to prevent contamination, based on the risks posed by each hazard
procedures for monitoring for contamination
corrective actions to take in the event of contamination
Notably, the proposed rules require that a “qualified individual” develop and oversee the food safety plan. To be qualified, an individual would be required to successfully complete training in accordance with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system.
The preventive controls rely on a science-based set of measures intended to prevent foodborne illnesses and resemble Hazard Analysis and Critical Control Points (HACCP) systems that are already required by FDA for juice and seafood processors. The controls are “preventive” and “flexible,” which means that the rules require controls only where necessary to prevent hazards to public health. In other words, the rule would exempt certain facilities from requirements or modify requirements for certain low-risk activities.
Along with preventive controls, FDA has also released overhauled Current Good Manufacturing Practices (CGMP), which, among other things, are modified to impose additional requirements to prevent outbreaks (e.g., mandatory training for employees and supervisors, more protection against cross-contact contamination with food allergens, mandatory cleaning of non-food-contact surfaces).
There is a 120-day comment period for the proposed rule. The final rule will become effective 60 days after publication. After the final rules issues, affected members of the food industry will have one year to comply with the Rule, with some small and very small businesses receiving two or three years.
Key provisions of the Produce Safety Rule
The Produce Safety Rule establishes safety standards for the production of raw fruits and vegetables and only applies to farms that grow, harvest, pack or hold produce in a raw or unprocessed state. This rule marks the first time the FDA has had authority to regulate food on farms.
The rule sets science and risk-based minimum safety standards and focuses on identified routes of microbial contamination of produce, including:
irrigation and other agricultural water
materials put into soil (e.g., manure)
farm worker health and hygiene
intrusion of animals in growing areas
sanitation condition affecting equipment, tools and buildings
In other words, farmers will be required to take new precautions against contamination to include, for example, making sure workers’ hands are washed, irrigation water is clean and that animals stay out of the fields.
The produce regulations are tailored to apply to fruits and vegetable that pose the greatest risk, like berries, leafy greens, cantaloupe, tomatoes, sprouts and other foods that are usually eaten raw. The rules do not apply to raw agricultural commodities that are rarely consumed raw (such as artichokes, asparagus, beets, cranberries and potatoes); those produced for personal or on-farm consumption; and those destined for commercial processing that will adequately reduce microorganisms of concern. So, for example, a farm that grows green beans for canning and cooking would not be subject to the regulations.
The rules are also designed to provide flexibility so that food safety practices can be appropriate for the scale of production and type of agricultural practices being used. The rules take into account the risks associated with the commodity, including past illness outbreaks and recalls; the practices associated with growing, harvesting, packing and holding the produce; and how the produce may be used and consumed after it leaves a farm.
There is a 120-day comment period for the rule and the final rule will become effective 60 days after publication, with a compliance date for all but small and very small businesses beginning 26 months after publication. Small and very small farms would have additional time to comply, and all farms would have additional time to comply with certain requirements related to water quality.
Going forward: getting ready to comply with the new rules
According to Michael Taylor, FDA’s deputy commissioner for foods, FDA may need an additional year to review and respond to comments after the four-month comment period expires and before publishing a final rule. This, coupled with the significant comment and implementation periods associated with the rules, means that affected parties may not be required to comply with the proposed rules until 2014 or later.
While it could be years before the rules are preventing outbreaks, a benefit of the lengthy period of time between rollout of the rules and mandatory compliance is that the food industry should have sufficient time to come into conformance with the rules. Further, many food companies that are familiar with HACCP or have written food safety plans already in place will be able to comply easily.
FDA will also be providing assistance to the industry and will be releasing guidance documents, creating training materials, and holding a number of public hearings to help businesses comply with the new requirements. These resources are particularly geared toward small and very small businesses who will likely need more assistance in setting up food safety systems that comply with the rules.
Much of the food industry understands the goal of these rules − to make food safer, ensure a common set of rigorous standards for the industry and level the playing field – and thus is largely on board with the new regulations. Pamela Bailey, president of the Grocery Manufacturers Association, has said that the food safety law “can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal.” In fact, an alliance of consumer advocates and industry groups persuaded Congress to increase the FDA’s funding by nearly 3 percent from last year’s level to US$3.8 billion. Of all the additional money that FDA secured, the new food safety program captured the largest amount: US$39 million.
Nonetheless, the comment period will reveal whether members of the food industry will resist any of the new requirements as being too onerous. Will there be complaints, for example, that the proposed requirements may cause hiring and training costs, as well as documentation costs, to skyrocket?
Another potential hurdle to successful implementation is having enough “qualified individuals” at the industry level with a high enough understanding of food science to design the required food safety systems. There will also be a need for agency employees, such as inspectors, to be qualified to at least the same level (and pursuant to the same standards) that FDA is requiring of the industry.
Yet another hurdle to successful implementation? Despite successful lobbying efforts to increase funding for FSMA initiatives, FDA may still not have enough resources to adequately enforce the rules. Thus, there may be a significant shortfall in funding, which may mean many of the programs FDA is envisioning will not be implemented, at least initially. If this occurs, the FDA will likely focus its limited resources on a few high-profile non-compliant companies in high-risk sectors to make an example and create a deterrent for the rest of the industry. Nonetheless, efforts continue to be underway to make sure that FDA has sufficient resources. In response to publication of the proposed rules, Congresswoman Rosa DeLauro (D-CT) states, “I will continue to press my colleagues to ensure the FDA has necessary funding to ensure the safety of our food.”
Additional proposed FSMA rules to come
As for the three additional sets of proposed rulemakings that are expected to be released in the near future, they are also long overdue. Indeed, the Produce Safety Rule and Preventive Controls Rule were due January 2012 and July 2012, respectively. While the FDA has stated that the three new proposed rules will be released soon, whether that will translate into a few months or years is uncertain.
What is certain is that stakeholders will continue to pressure the agency to finalize FSMA’s food safety rules. An August 2012 lawsuit filed by two consumer groups (the Center for Food Safety and the Center for Environmental Health) against the FDA and the Office of Management and Budget charged they had missed seven FSMA rulemaking deadlines. The lawsuit seeks to require FDA to immediately promulgate all of FSMA’s implementing regulations. A full hearing on whether the case should be dismissed is scheduled for March 27, 2013. Similarly, Representative DeLauro , expressing disappointment that “only two of the long overdue rules have been released,” said that she “will continue to advocate for robust, timely implementation of the FDA Food Safety Modernization Act.”
DLA Piper will continue to monitor FDA’s implementation of FSMA and provide updates. If you have questions or concerns regarding the comment process or seek further information on how these regulations could affect your business, please contact Stefanie Fogel or Michelle Anderson.