"We appreciate FDA's consideration of our recommendations to its proposed requirements, and for the open and collaborative process the agency used to solicit input from a wide range of stakeholders," NGFA's vice president of feed services David Fairfield stated in a news release. "Sufficient compliance timelines and important regulatory distinctions were included in the final rule."
For example, the FDA included distinctions between human food and animal food in the final rule – sparing the animal feed industry unnecessary regulatory obligations.
In a press conference held late last week, American Feed Industry Association’s (AFIA) senior vice president of legislative and regulatory affairs, Richard Sellers, discussed the portions of the rule he feels are the most critical to U.S. feed manufacturers.
Compliance phase-inOriginally, the FDA recommended an overarching one-, two- and three-year phase-in period for all aspects of the rule based on the size of the firm. In the end, it honored AFIA's request for a 1-2-3 year policy for CGMPs and a 2-3-4 year policy for implementation of hazard analysis and preventive controls.
Meaning, “regular-sized” firms (i.e. large companies) will have one year to comply with CGMPs and two years to comply with any hazard analysis and preventive controls they would need to create; small business, two years to comply with CGMPs, three years preventive controls; and very small firms, three years and four years to comply, respectively.
According to Sellers, 80 to 90 percent of 19,000 animal feed facilities will fall under the small business (less than 500 employees) category and will be allowed two years to comply with the CGMP rules and three years to implement hazard analysis and preventive controls.
“Probably one of the greatest victories we can claim is the phase-in of compliance,” notes Sellers. “Those phase-in dates will lower the costs significantly and allow companies to better adapt to the new provision.”
FSMA’s cost to the feed industryThe FDA estimates the annual cost of FSMA implementation will run between $135-170 million over the next 10 years. However, AFIA feels the cost will actually be considerably higher, but hesitates to offer a dollar amount.
For example, the FDA estimates the cost of creating a hazard control program to sit around $17,000 per facility. In reality, for a large company to properly implement the program, it will need to hire a full-time “qualified individual” to oversee and adjust its hazard analysis and related activities – adding a salary ranging from $60,000-$80,000 to a company’s payroll.
When reviewing earlier versions of the rule with the FDA, AFIA sought ways to reduce costs for feed manufacturers through clarification exercises. Specific changes in the final rule that will produce cost savings:
- Livestock feed operations are not required to use preventive controls (the costly side of the rule) if they can control their hazards through by CGMPs.
- New Supply Chain Program will replace the Foreign Supplier Verfication Program (FSVP). For example, if the ingredient supplier can provide documents proving vertified preventive controls and hazard analysis procedures have been taken, the feed mill will not need to duplicate the efforts.
Other significant changesFDA has clarified its definition of “significant hazard” by breaking it in to two categories: a hazard versus a hazard requiring a preventive control. The “hazard requiring a preventive control” verbiage pertains primarily to pet food manufacturing and ingredient facilities that need to control pathogens due to the Salmonella-negative standard.
Sellers also notes the recordkeeping exemption, which will spare feed manufacturers the costly administrative burden posed by the Part 11 electronic records and signatures requirement.
AFIA aids in FSMA implementationFSMA requires all registered feed mills create a facility hazard analysis plan. Given the complexity of such a plan, AFIA has partnered with the University of Minnesota College of Veterinary Medicine to create a hazard analysis template for feed mills over the coming months. Sellers notes that facilities that will use this program will need to tailor it to their facility and have it authorized by a qualified individual.
The final rule will legally go into effect November 17, 2015.
In the coming months, AFIA will roll out a series of FSMA webinars and meeting. Visit www.AFIA.org for more information.