Even before the Food Safety and Modernization Act (FSMA) was
enacted back on January 4, 2011, the petfood industry was very well aware that
sweeping reforms were coming about. We all heard that FSMA was a call for
prevention-oriented food safety practices in the US and that FSMA would be the
most significant change in food regulation since the establishment of the Food
and Drug Administration (FDA) under the Food, Drug and Cosmetics Act in
The process of proposed rulemaking by FDA would occur through
a series of proposed rules published in the Federal Register that would affect
the way our companies do business. The most important (to us) would be the
proposed rule governing animal feed. We were also very well aware that we, as
the petfood industry, would have an opportunity to respond to the proposed
rules in an effort to help FDA create the most effective regulations possible to
help our industry continue to make safe petfood.
In the months prior
to the release of the animal food rule, members of the Pet Food Institute (PFI)
began preparing to respond to these new proposed regulations from FDA. In
public statements prior to publication of the animal food rule, FDA indicated
that the rule would be very similar in most respects to the human food rule,
which was published in January 2013. With this knowledge, PFI members began
forming teams of experts organized by subject matter in order to study and
evaluate specific sections of the human food rule in anticipation of
publication of the proposed rule for animal food.
These teams, along with their areas of expertise, included: Administrative
(editing and consistency), Technical/QA (hazard analysis, preventive controls
and food safety), Good Manufacturing Practices (compare and evaluate versus
other established approaches to cGMPs) and Miscellaneous (analyze the
appendices, role of testing and non-categorized material). For more information
on the composition of the groups, please see “FSMA response teams.”
On October 29, 2013, the rule was published in the Federal
Register and the wait was over. Titled, “Current Good Manufacturing Practice
and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals,”
the rule contained more than 400 pages of text and was indeed virtually
identical to the human food rule except that sections on food allergen controls
and certain sanitation requirements were replaced with proposed regulations on
nutrient imbalance since animals often depend on commercially-made products as
their sole source of nutrition.
Following the release
of the proposed regulations, the petfood industry’s response plan moved
into full force. PFI’s legal counsel reviewed
the publication and issued a summary of the most essential aspects of it. The
four working groups then began their detailed review of the proposed rule to build
industry positions. Each working group met via conference calls and/or webinars
at least once a week. PFI hosted several two-day working sessions in Washington
D.C. to allow the volunteers to share ideas face-to-face. Another work session was held at the Midyear
Meeting of the Association of American Feed Control Officials (AAFCO) in New
Orleans, in January 2014.
PFI hosted a
webinar in December 2013 with Dan McChesney, director of the Office of
Surveillance and Compliance for the Center for Veterinary Medicine, FDA. This
event provided information to the industry concerning the thought process FDA
used in developing the proposed rule. McChesney then answered dozens of
questions from the working group leaders regarding specific provisions and
language in the proposed rule.
Each of the teams was then able to consider the complexities
found within the rule and, after thorough discussion, develop industry positions
that demonstrated group consensus.
Once positions were
formed, the drafting process began. After several editing sessions the
comments began to look like a final product. In total, more than 80 pages were
submitted in response to FDA’s proposal for animal food.
In the final comments, the petfood industry expressed to FDA
that while we share the same goals of safe food for animals and we want to work
together to achieve that goal, there are some issues in the proposed rule in
which we disagree with the agency. Although modelling the animal food rule
after the human rule gave us a head-start on the analysis, overall we were
disappointed that the animal food rule was based so strongly on human food and
does not reflect the distinctions between the two. We urged FDA to provide for
sufficient discretion and flexibility to account for these differences.
A good example of this is our concern with FDA’s decision to
write new cGMP regulations based on human food practices instead of adopting or
incorporating either AAFCO cGMPs or PAS 222:2011. Both of these are programs
are already accepted by many within the industry as they were developed
specifically for animal food manufacturers with input from FDA.
As one of the co-chairs of PFI’s FSMA response (along with
Allen Bingham of Bil-Jac Foods) I can say that I feel
very proud to have helped lead this campaign. The dedication of the industry
was amazing. Our comments reflect countless hours of careful thought and
discussion as to how PFI members will continue striving to produce the safest
foods for dogs and cats under FSMA.