Phase 2 of the Food Safety Modernization Act (FSMA) implementation, which involves putting in place new public health prevention measures and a risk-based industry accountability framework, was the focus of an FDA public meeting held in Chicago, Illinois on October 20, 2015.
During the meeting, entitled “FDA Food Safety Modernization Act Final Rules on Preventive Controls for Human and Animal Food,” senior FDA officials, state department of agriculture officials, food industry representatives, researchers from educational institutions, and professional association experts combined to provide a basic understanding of:
- the FSMA preventive controls final rules for both human and animal food;
- the role of public/private partnerships in the implementation of preventive controls strategies;
- the FDA’s FSMA implementation efforts to date;
- the FDA’s FSMA technical assistance network;
- education, outreach, and training provided through the Food Safety Preventive Controls Alliance; and
- future regulatory actions.
A transcript of the FDA meeting is available on the FDA’s FSMA website.
FSMA (P.L. 111-353), signed into law on January 4, 2011, amended the federal Food, Drug, and Cosmetic Act (FDC Act) to require the FDA to issue regulations requiring preventive controls for human food and animal food, setting standards for produce safety, and requiring importers to perform certain activities to help ensure that the food they bring into the United States is produced in a manner consistent with U.S. standards.
To comply with FSMA, in 2013, the FDA proposed amendments to its regulations for current good manufacturing practices (CGMPs) in manufacturing, packing, or holding of human food (78 FR 3646, see FDA implements HACCP requirements for facilities registered under the FD&C Act, Health Law Daily, January 16, 2013) and animal food (78 FR 64735, see New standards proposed for pet food makers, Health Law Daily, October 29, 2013).
Then, based on public comments, in September 2014, the FDA issued supplements to the 2013 proposed rules for human food (79 FR 58524, see FDA serves up second proposal for human food manufacturing requirements, Health Law Daily, September 29, 2014) and animal food (79 FR 58476, see FDA takes another proposed bite at manufacturing requirements for animal food, Health Law Daily, September 29, 2014) to make the original proposed rules more practicable, flexible, and effective for industry. At that time, the FDA also reopened the comment period, but only with respect to specific issues identified in the supplemental proposed rules.
On September 17, 2015, the FDA issued its final rules for human food (80 FR 55908, see Food safety rules finally deemed well done (cook time: years), Health Law Daily, September 17, 2015) and animal food (80 FR 56170, see FDA finally finalizes animal food safety rule under FSMA, Health Law Daily, September 17, 2015). The final rules contain elements of both the original and amended proposed rules and new requirements based on public input received during the comment period of both proposals. For example, flexibility has been built into key requirements, including control of the supply chain, and the definition of farms (which are exempt from the regulations) has been significantly changed to reflect modern farming practices.
Preventive controls applying to both human and animal food
Many of the preventive controls regulations for human and animal food are identical. According to the FDA officials, these key joint requirements include:
- Establishment and implementation of a food safety system that includes an analysis of hazards and risk-based preventive controls. The rules set requirements for a written food safety plan that includes hazard analysis, preventive controls, and oversight and management of preventive controls. The oversight and management functions must include appropriate monitoring, corrections and corrective actions, and verification.
- Operations defined as ‘farms’ are not subject to the preventive controls rule. The rules clarify that the definition of a ‘farm’ covers two types of farm operations: (1) a primary production farm, and (2) a secondary activities farm. The primary production farm is an operation under one management in one general, but not necessarily contiguous location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. The secondary activities farm must be majority-owned by the primary production farm and consists of an operation not located on the primary production farm that is devoted to harvesting, packing and/or holding raw agricultural commodities.
- A more flexible supply-chain program. The rules mandate that a manufacturing/processing facility must have a risk-based supply chain program for those raw material and other ingredients for which it has identified a hazard requiring a supply chain applied control. Manufacturing/processing facilities that control a hazard using preventive controls, or who follow requirements applicable when relying on a customer to controls hazards, do not need to have a supply-chain program for that hazard.
CGMPs for human food
The human food rule updates the human food CGMPs to make certain previously nonbinding provisions, such as education and training, binding. For example, management now is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties. As such, employees must have the necessary combination of education, training, and/or experience needed to manufacture, process, pack, or hold clean and safe food. In addition, the FDA’s longstanding position that CGMPs address allergen cross-contact is now explicit in the regulatory text.
CGMPs for animal food
The animal food rule updates the animal food CGMPs by finalizing baseline standards for producing safe animal food. For animal food processors already implementing human food safety requirements, they do not need to implement additional preventive controls or CGMP regulations when supplying a by-product for animal food, except to prevent physical and chemical contamination when holding and distributing the by-product. Further processing a by-product for use as animal food requires companies to process the by-product to ensure the animal food’s safety and to make sure that the processing does not introduce hazards to the animal food.
Vertically integrated feed mills
Under the animal food rule, feed mills associated with fully, vertically integrated farming operations (i.e., farms where the feed mill, animals, land, and establishment are all owned by the same entity) generally meet the definition of a farm and are therefore not subject to the animal food rule. FDA officials, however, remain concerned that not having these operations subject to the preventive controls for animal food leaves a protection gap because these feed mill operations manufacture significant amounts of animal food. As such, the FDA stated that it intends to publish a future proposed rule that would require some feed mill operations that currently are part of a farm to implement the CGMPs established by the animal food rule.
After the overview of the preventive control and CGMPs requirements, the FDA officials gave an update on FSMA implementation. Their update described the promulgation of the human and animal food final rules as Phase 1 of FSMA implementation; gaining, maintaining, and overseeing industry compliance with the rules as Phase 2; and monitoring, evaluating, and refreshing transition strategies and performance metrics from design to operational to evaluate success as Phase 3. Phase 2, the current focus, involves the facilitation of industry compliance through guidance, industry alliances, and technical assistance networks.
During the question & answer (Q&A) sessions of the meeting, numerous inquiries focused on the individual concerns of specific stakeholders. While FDA officials were able to answer most of these questions by pointing to either specific language in the new regulations or in the preambles to the final rules, it was apparent that the answers to some questions would have to wait for additional guidance from the FDA. One major concern of stakeholders was what to do in the situation where an FDA inspector makes a finding that is contrary to previous FDA guidance or an earlier inspection. While FDA officials did not answer this question directly, it was perhaps answered implicitly by their promise that FDA inspectors will be subject to rigorous training on FSMA implementation.
The FDA officials indicated that the agency is also committed to educating the industry on the requirements of the human and animal food rules. To that end, the officials stated that the FDA is currently developing guidance that will cover the following topics: (1) animal food CGMP requirements; (2) hazard analysis and preventive controls for human and animal food; (3) human food by-products for use as animal food; (4) human food environmental monitoring; (5) human food allergen controls; (6) validation of process controls for human food; and (7) a small entity compliance guide for human and animal food.
From the private sector, Daisuke Ito, Director of Agriculture and Research at Japan External Trade Organization (JETRO) in Chicago, Illinois offered the assistance of JETRO to the FDA in preparing guidance for international stakeholders. Tim Jackson, Director of Food Safety, Nestle USA, Nestle Canada, and Nestle Professional North America, spoke on behalf of the members of the Grocery Manufacturers Association (GMA). Jackson indicated that GMA desires to move toward a better, systems-based, inspection process, rather than simply a checklist. In addition, he offered GMA assistance in educating FDA inspectors on the latest food production technology.
Training and technical assistance
Plans for training and technical assistance are also underway for the industry and inspectors, according to the FDA officials. For industry, they include: (1) establishing a Food Safety Technical Assistance Network within the FDA to provide a central source of information to support industry understanding and implementation of FSMA; (2) collaborating with the Illinois Institute of Technology’s Institute for Food Safety and Health, a nationally-recognized leader in food safety, in the creation of a Food Safety Preventive Controls Alliance (FSPCA) designed to establish training and technical assistance programs; and (3) partnering with the National Institute of Food and Agriculture in the U.S. Department of Agriculture to administer a grant program to provide technical assistance to small and mid-size farms and small food processors.
Robert Brackett, Vice President and Director, Illinois Institute of Technology’s Institute for Food Safety and Health, spoke about the development of the FSPCA. He described FSPCA as a public/private alliance made up of key industry, academic, and government stakeholders who are working to support safe food production through the development of a nationwide core curriculum, with training and outreach programs to assist domestic and international companies producing human and animal food in complying with the FSMA preventive controls regulations. He also spoke of the need for qualified individuals in industry to apply to become FSPCA instructors.
To ask a question to the FDA regarding FSMA Technical Assistance Network, stakeholders were told by FDA officials to go to: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm and click on “Submit Inquiry.”
Future FDA regulatory actions
The FDA officials also made note of additional FSMA final rules that are pending. Three of these rules are expected to be finalized by October 31, 2015. They are: (1) the Produce Safety Rule; (2) the Foreign Supplier Verification Program Rule; and (3) the Accreditation of Third-Party Auditors Rule.
Two other important rules are: (1) the Sanitary Transportation of Human and Animal Food Rule – expected to be finalized by March 31, 2016; and (2) the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration Rule – expected to be finalized by May 31, 2016.