The Food Safety Modernization Act (FSMA) was passed into law last year, and the Food and Drug Administration (FDA) has already begun preparing its new guidance for the industry. Food Manufacturing spoke with Tony Pavel of K&L Gates about these new regulatory changes and how food manufacturers can best prepare for implementation.

Q: What are the most important changes the FSMA is bringing to the food industry?

A: FSMA imposes a number of significant new requirements on “registered facilities” — any establishment that manufactures, processes, packs or holds food. New requirements include biennial registration with the FDA, performing hazard analyses and additional recordkeeping requirements, including the preparation of written control plans. The statute also imposes verification requirements for firms’ preventive controls. Any packagers importing food will need to implement verification programs to ensure food safety. Facilities should also prepare for more frequent FDA inspections — a minimum of once every 5 years. In addition, it’s important to know that FSMA gives the FDA greater authority to review a company’s records in situations where the FDA has a reasonable belief that a particular article of food is adulterated and presents a serious health risk. The FDA may access all records relating to that article of food or any other article of food that the agency reasonably believes is likely to be similarly adulterated.

Q: Some are questioning whether the FSMA will receive the needed funding from Congress. What happens if the Act is not funded?

A: That is an excellent question, as the House Appropriations Committee recently recommended $285 million in budget cuts to FDA. Many provisions of the FSMA are self-implementing and will go into effect whether or not FDA has the funds and resources to follow through. The agency staff is working very hard to hold public meetings, produce guidance and work on the many rulemakings the law requires. The most likely outcome is that implementation of FSMA will take many years, perhaps five or more if the agency does not have the resources it needs. Unfortunately, this has the potential to create real problems for industry, as the new laws will be fully enforceable and little guidance regarding compliance may be available.

Q: What guidelines are the FDA providing, and how helpful are they for food companies?

A: FDA is working diligently on guidance; however, very little has been released as of yet. I have spoken with many agency officials, and they are moving as quickly as they can, but the FSMA requires at least 12 rulemakings and about 10 guidance documents. The agency has held several public meetings, seeking information and comments from industry. FDA also recently published an Interim Final Rule to amend the requirements for administrative detention of food and to change the prior notice regulations for imported food. With that said, it will likely be some time until we start seeing substantive guidance on issues such as Preventative Control programs, and these are the types of guidance that will be of greatest use to industry.

Q: What is the Park Doctrine, and how does it affect food companies?

A: The Park Doctrine gets is name from a United States Supreme Court case — United States v. Park 421 U.S. 658 (U.S. Sup. Ct. 1975). The case involved the CEO (Park) of Acme International and held him criminally liable for the unsanitary conditions in a company warehouse. Essentially, under the Park Doctrine, an individual may be held strictly liable for a misdemeanor violation of the Federal Food, Drug, and Cosmetic Act if he or she was a responsible corporate officer and had the power and authority to prevent and detect or correct a violation of the Act from occurring. It is important to note that the Park Doctrine holds up even where an individual does not directly supervise a particular operation or even have knowledge of the violation.

Q: The FDA has recently indicated that it may use the Park Doctrine in food safety cases. Why do you think the FDA has decided to start using the doctrine again now?

A: FDA has threatened to use the Park Doctrine across all industries that it regulates — foods, drugs, devices, etc. In a nutshell, FDA has taken the position that Warning Letters and other enforcement tools have not been as effective as the agency would like during the last several decades. With respect to foods, you must add in the numerous large-scale and high profile food recalls during the last five years, which have resulted in the FDA taking a beating in the press. Accordingly, the FDA is looking to tighten up what it considers to have been an extended period of lax enforcement, as well as to regain the confidence of the American consumer.

Q: What does the FDA’s usage of the doctrine mean for food companies?

A: FDA generally considers the following factors in assessing whether it will use the Park Doctrine:

  • Whether the violation involves actual or potential harm to the public
  • Whether the violation is obvious
  • Whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings
  • Whether the violation is widespread
  • Whether the violation is serious
  • The quality of the legal and factual support for the proposed prosecution
  • Whether the proposed prosecution is a prudent use of agency resources

For food companies, what this means is that they should be carefully reviewing their compliance programs, standard operating procedures and general operations. Companies must be very vigilant in ensuring that any compliance problems do not become so serious as to rise to the level of a Park Doctrine misdemeanor. As a practical matter, the Park Doctrine also means that senior management may be held criminally liable for violations of the Act — including GMP (and eventually HACCP) violations that are widespread and serious.

Q: How should food manufacturers prepare for the enforcement of FSMA and the Park Doctrine?

A: As noted above, manufacturers should start by carefully reviewing their compliance programs, standard operating procedures and operations. If it has been more than a year or two since the last quality audit, a new audit should be performed and the results scrutinized.

As a majority of firms already have some form of HACCP program in place, impact will vary depending on the level of enhancement needed to a company’s control plans and processes. There will be additional recordkeeping requirements that will affect workload, and adjustments will eventually need to be made for certain practices such as having all testing for regulatory purposes performed at a federal laboratory or an accredited non-federal laboratory.

Preparation will require a review of current practices and close monitoring of the FDA’s rulemakings and guidances that will flesh out the requirements of the FSMA over the next two to five years.

Interview By Lindsey Coblentz, Associate Editor