The Food Safety Modernization Act (FSMA)
The Food Safety Modernization Act (FSMA), the most sweeping reform of our country’s food safety laws since the 1950s, was signed into law by the president on Jan. 4, 2011. The law was a bipartisan-supported bill backed by the food and feed industries. FSMA’s goal is to ensure U.S. food, which includes animal food, is safe by shifting from responding to contamination to prevention of contamination tactics.
It authorizes the Food and Drug Administration to promulgate new rules for preventive controls, develop performance standards, create new administrative detention rules, provides authority for mandatory recall of adulterated products and authority for hiring more than 4,000 new field staff among other provisions. It is unclear whether Congress will provide sufficient funding authorization to fully implement the law.
FSMA affects ingredient processors, feed and pet food manufacturers, feed and ingredient importers, and the transportation industry, all of which are AFIA members.
The American Feed Industry Association, assisted by its FSMA working groups, submitted comments on various FSMA draft rules applicable to animal feed. At the beginning of 2017, seven final FSMA-related rules had been released. Four of the seven final rules affect the animal food industry: preventive controls for animal food; foreign supplier verification program; accreditation of third-party auditors/certification bodies; and sanitary transportation. The largest of the rules that affect animal food is the preventive controls for animal food; formally known as “Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals,” which was published Sept. 17, 2015.
The rule exempts some “farms,” as defined in the regulations. Many of the new regulatory requirements are practices the industry already utilizes in their facilities; the difference the rule brings will be in the documentation and costs.
To assist its membership in meeting FSMA animal food rule compliance dates, AFIA and its foundation, the Institute for Feed Education & Research, have dedicated immense resources, funding and time to industry compliance. Face-to-face, video and webinar trainings have been conducted since the final animal food rule’s release, as AFIA and industry recognizes time is limited to implement the necessary requirements.
|Business Size||Compliance date for CGMPs and related requirements||Compliance date for Hazard Analysis & Risk-based PCs and 21 CFR 507.7|
|Business other than small and very small||September 19, 2016||September 18, 2017|
|Small business (a business, including any subsidiaries and affiliates, employing fewer than 500 full-time equivalent employees)||September 18, 2017||September 17, 2018|
|Very small business (a business, including any subsidiaries and affiliates, averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (e.g., held for a fee or supplied to a farm without sale).||September 17, 2018||September 17, 2019, except for records to support its status as a very small business (January 1, 2017)|
The association, in partnership with Feedstuffs, offered a —available through 2017 online—which covers FSMA history to Current Good Manufacturing Practices to FSMA rules in addition to the animal food rule to pet food. AFIA hosted in-person courses required for certain facility personnel, such as the Preventive Controls Qualified Individual training, and AFIA’s foundation, IFEEDER, co-funded a research project conducted by the University of Minnesota to do a hazard analysis literature search and database to assist facilities in the creation of their own hazard analysis, a component of the animal food safety plans required by FSMA.
AFIA also produced a training video for qualified individuals within a facility. A qualified individual is defined in the regulation as “a person who has the education, training or experience (or a combination thereof) necessary to manufacture, process, pack or hold safe animal food as appropriate to the individual's assigned duties." These individuals must receive training in the principles of animal food hygiene and animal food safety, including the importance of employee health and personal hygiene, as appropriate to the person's assigned duties. Thus, the qualified individuals are nearly all employees in a facility.
The video and related material are an AFIA member benefit and . It can also be purchased by non-members .
In the future, AFIA plans to continue its pushback on the burdensome cost-to-benefit ratio of the animal food rule. Third parties have shown the benefits of these rules were between $16 and $30 million—significantly less than the $87 to $129 million in costs that FDA estimated. Industry groups have also shown that FDA underestimated the costs. This means that even in the best-case scenario, the costs of this rule will be $50 to $100 million more than the benefit. The gap between costs and benefits is likely even greater. AFIA believes the costs are potentially some $600-plus million more than the benefits.
To keep track of FSMA updates from FDA, visit the FSMA webpage, , and sign up for email updates. To access the library of FSMA materials AFIA has developed for its members, contact regarding membership.