The regulations come into effect on 30 August 2015.
“We are still awaiting the final rule revisions from the US Food and Drug Administration (FDA) so we don’t yet know the full implications of the legislation.
But when it comes down to it, the overriding aim of the FSMA animal food rule is to ensure processes are in place that will drive continuous improvement in a feed manufacturing operation.
We have every faith in the feed industry’s ability to implement the changes required but there is still a lot of work to do, even for those facilities that are ahead of the game such as mills producing medicated feed or those that are third party certified,” Henry Turlington, quality and manufacturing regulatory affairs director, American Feed Industry Association (AFIA), told us.
He said the trade group has been disseminating guidance and providing staggered training so industry is fully aware “of what it is going to take” to get in line with the new legislation.
Turlington said the AFIA, in partnership with the Safe Quality Foods Institute (SQFI), has also recently “revamped its US feed safety certification program, FSC36, to ensure it adheres to the new requirements under the FSMA and that it drives a continuous improvement ethos in accredited feed suppliers.”
Industry-wide usage of CGMPs
Under the new animal feed rule, a feed production facility regulated by the FDA will be required to have a site specific animal food safety plan, perform a hazard analysis and develop risk-based preventive controls (PC) based on known or foreseeable feed hazards.
The FDA is also proposing Current Good Manufacturing Practice (CGMPs) for non-medicated feed as a basis for animal food safety programs in each facility.
CGMPs represent a new requirement for most of the US feed sector, especially for ingredient manufacturers and distributors. Currently, only medicated feed facilities operate under such practices.
The US feed sector comprises 6,718 feed mills in total, out of which 1,012 mills are producing medicated feed.
Phased-in compliance
In comments submitted to the FDA in December 2014, the AFIA said it wants the FDA to revise the rule’s phase-in period to give small to medium-sized feed mills additional time to implement CGMPs followed by the hazard analysis and preventive controls.
The trade group is pushing for one, two and three-year implementation periods for CGMPs and two, three and four year periods for preventive controls based on the mills' size. “This will allow firms more time to adjust to basic programs such as CGMPs before having to adhere to more complicated requirements,” said the lobbyists.
As it stands, the compliance dates under the FSMA animal feed rule are as follows:
- Small business — a business that employs fewer than 500 persons and that does not qualify for an exemption would have to comply two years after publication of the final rule.
- Very small business — a business having less than $2.5 million in total annual sales of animal food, adjusted for inflation, would have three years after publication of the final rule to comply. As 'qualified facilities', they would be subject to modified requirements for preventive controls.
- Other businesses — a business that is not small or very small and does not qualify for an exemption would have to comply one year after publication of the final rule.
The AFIA also reiterated in December the proposed CGMPs should more closely resemble medicated feed CGMP rules, as they are “simply written and already have had industry acceptance and compliance for over 40 years.
Most importantly, the rarity of animal food safety issues related to medicated feed and/or residues in meat, milk, eggs or fish is evidence that current regulations are working in the feed industry,” said the trade group in his comments.
Record-keeping rule ‘counterproductive’
Under the draft FSMA rule, feed production facilities also must maintain paper records to be in line with recordkeeping requirements.
Each firm must create the records in a computer, print and sign the reports and file them in a cabinet for future inspections and access.
“Such paper record maintenance and control will take enormous time and resources and require FDA investigators/auditors considerable time to access and review such clumsy paper records.
AFIA believes such a requirement is extremely counterproductive to the intent of Congress, made clear in several sections of the statute, that the agency should accept and encourage electronic records,” said the US feed industry representatives.
Antibiotic amendments
The AFIA said it has also been supporting feed producers as they prepare for changes to the Veterinary Feed Directive (VFD) that are set to be in place by end of 2016.
December 2013 saw the FDA issue guidelines to get drug companies to voluntarily remove growth enhancement and feed efficiency indications from the approved uses of their human medicine important antimicrobials such as chlortetracycline within three years.
Once manufacturers voluntarily make the changes requested by the agency, the affected antibiotics can then only be used in food-producing animals to treat, prevent or control disease under the order of or by prescription from a licensed veterinarian.
Richard Sellers, AFIA senior vice president of legislative and regulatory affairs, told us:
“Currently, we have a number of working groups set up to review and discuss the issue, train veterinarians and feed industry representatives on VFD and work with the FDA to effect an efficient implementation of the new process to minimize disruption, increase compliance and cooperate on educational efforts.”