FSMA Takes Effect, Ushering in a New Era of industry Responsibility

The countdown to the Food Safety Modernization Act of 2011 is complete.

As of this weekend, large scale food manufacturing operations in the U.S. and abroad must be in compliance with the sweeping new law, known by its acronym FSMA. This follows five years of regulation writing and review by the Food and Drug Administration, many revisions, deletions and additions, and enough controversies to last a lifetime.

The prolonged process from enactment to implementation is hardly surprising in view of the scope of the new law and the huge, sprawling industry it oversees. According to the Department of Labor’s Bureau of Labor Statistics, food manufacturing in the U.S. alone consists of 32,200 processing plants and employs 1.5 million people, not even counting agricultural workers, grocery store employees or restaurants!

Following is an overview of the new regulations and what they mean to the food industry and food safety.


FSMA covers human and animal food production from harvest through distribution. Foods imported from overseas are now covered, as well. However, meat, poultry and seafood products are excluded because they are regulated by separate agencies within the Department of Agriculture (FDA’s parent agency). Also excluded are supermarkets and restaurants, which are regulated by state and local statutes.

Bakery_pastry_conveyor_belt_production_referenceThe new law’s focus is squarely on manufacturing and that sector’s vast supplier network. The rationale for this focus is that most food safety outbreaks are the result of breakdowns in the production and distribution of products. Despite the universal belief that America’s food supply is the safest in the world, each year around 48 million Americans become sick due to a foodborne illness. Some 3,000 die as a result, according to the Centers for Disease Control and Prevention.

Under old food safety regulations, first enacted in 1937, the FDA exerted a largely passive role, reacting to food illness outbreaks after the fact, and working with the industry to encourage voluntary recalls when needed.

With FSMA, that approach is changing dramatically.


The basic concept underlying the new food safety law is proactive prevention. Under FSMA, regulated companies must undertake a series of internal measures to meet compliance standards and avoid contaminations. Responsibility for food safety falls more than ever on the shoulders of the firms that make and distribute our food. The law also is broadly based. It covers companies in the supplier network, all of which must be able to verify the safety of their products (such as food grade lubricants for machines) for use in food production.

The key provisions are as follows (directly from FDA’s website):

  • Preventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. Final rule issued: Sept. 10, 2015.
  • Preventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals. Final rule issued: Sept. 10, 2015.
  • Produce Safety: Establishes science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. Final rule issued: Nov. 13, 2015.
  • Foreign Supplier Verification Program: Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers. Final rule issued: Nov. 13, 2015.
  • Third Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals. Final rule issued: Nov. 13, 2015.
  • Sanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food. Final rule issued: Apr. 5, 2016.
  • Intentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm. Final rule deadline was May 31, 2016.

These provisions, however, don’t offer a full reckoning of what’s required to insure business compliance. For example, putting in place preventive controls for human (or animal) food will require manufacturers to have conducted a thorough hazard analysis of their facilities to identify trouble spots (hard-to-clean equipment, leaky roofs, etc.), from which a plant specific Food Safety Plan must be created. That plan requires a training requirement for the relevant employees in each facility. Moreover, the plans must be reviewed and updated every 2-3 years, and they also are subject to 24-hour notice by FDA inspectors.

During FSMA’s rollout, much concern was expressed about the ability of companies to meet these requirements, especially smaller-sized suppliers with limited budgets. As a result, there are different compliance deadlines for smaller businesses, but by September 2017, all manufacturing in the U.S. must be in FSMA compliance.


No company likes being subject to a food recall. They are costly, they cause tremendous internal upheaval, and they can sabotage a company’s brands and overall reputation.

To encourage compliance, FSMA takes the threat of recalls a step further by holding company executives directly responsible for food safety breakdowns. Under the so-called Park Doctrine, the Department of Justice is able to extend civil and criminal liabilities to executives who fail to actively manage food safety practices in their organization. The significance of the Park Doctrine can not be understated. The doctrine means that businesses that food products for humans and animals now have an affirmative duty to ensure the safety of their products.

That said, and given the scope and complexity of the new requirements, the FDA’s initial post-compliance strategy is to emphasize industry education over regulatory enforcement. Experience suggests that no matter how long the lead time, many organizations procrastinate or operate in a state of virtual denial that they will be subject to the new laws. Additionally, FSMA’s requirements are very complicated, and in places, contradictory. That’s why FDA in August began issuing “guidance” documents for manufacturers on various parts of the new law, beginning with what’s expected in the area of preventive controls. Other guidance reports will be issued periodically to assist companies in understanding their regulatory obligations. A few weeks ago, additionally,

Does this mean that there’s a grace period for the industry to attain compliance? No. The FDA has made it clear that it will take enforcement action against egregious food safety violations under existing regulatory law.


FDA’s budget for carrying out these myriad duties is still under discussion. According to latest figures, Congress has recommended an increase of $103 million in funding for the FDA (including user fee revenue) for Fiscal Year 2017, of which some $40.2 million has been set aside for increased food safety regulation. By Washington standards, that’s a paltry amount and hardly adequate for the FDA to implement industry oversight.

As an acknowledgement of limited budgets, the FDA has built into FSMA provisions that envision a larger regulatory role for state health departments and third-party inspection services. FSMA also imposes new user fees for such things as re-inspection of facilities following non-compliance findings, and for a voluntary qualified importer program.

The law also mandates an “enhanced partnership” program to help the FDA build enforcement capacity. According to the National Council of State Legislatures (NCSL), these are some of the most important collaborations FSMA envisions:

  • State and local capacity building: FSMA directs the FDA to implement strategies that bolster food safety and food defense capabilities of state and local food and health agencies;
  • Foreign capacity building: FDA must create and implement plans to to address food safety training of foreign governments, as well as technical and scientific initiatives to enhance bilateral cooperation for exporters, such as electronic data sharing, and the sharing of the latest laboratory techniques;
  • Reliance on inspections by other agencies: FDA is explicitly authorized to rely on inspections of other Federal, state and local agencies to meet its increased inspection mandate for domestic facilities. FDA also is encouraged to enter into interagency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.


 Given the current number of food recalls, foodborne illnesses, and the changing dynamics of the food supply, it goes without saying that decades-old food safety regulations needed updating. With FSMA, prevention has taken center stage and, along with it, heightened responsibility placed on business to treat preventive food safety programs as a top management priority.

The FDA still seeks (and prefers) voluntary cooperation on the part of the food industry, but it is backing that position with a tough new standard that makes food safety vigilance mandatory. FSMA provides the agency with new enforcement tools such as mandatory recall authority and the ability to withdraw facility registration so a firm would not be able to receive, process or ship food products. While the FDA will encourage compliance through education, it will also, under the Park Doctrine, hold food company executives personally responsible for preventable safety breakdowns.

Whether the new law makes the overall food supply safer is certainly the bottom-line measure of success. It is all but certain that food recalls will plague the industry going forward. Even so, FSMA is important if for no other reason that it contains a essential food safety goal: bringing business and government into close alignment on the basic premise that food safety issues are now an over-arching, and shared, responsibility.