The US Food and Drug Administration (FDA) held public
meetings over two consecutive days in mid-May to discuss issues
pertaining to petfoods. The first meeting invited comment on
implementation of the FDA Amendments Act of 2007 (FDAAA), while
in the second meeting the agency provided an update on its
Animal Feed Safety System (AFSS).
I've discussed the ramifications of FDAAA on the government
and industry previously (see
Petfood Industry, December 2007
). Among the mandates imposed under the new law, FDA has until
September 2009 to promulgate new regulations relating to
labeling, nutrition and ingredient standards for petfoods.
To assist in the process, FDA provided a series of questions
in a federal register notice on which it sought input. The
questions were open endedfor example, "How can the feeding
directions already present on the label be improved?" and "What
kind of ingredient definitions would provide adequate
information?"and touched on a wide array of petfood issues. It
was hoped these questions would prompt considerable discussion
at the meeting.
While reasonably well attended, the meeting did not spark
much public debate. FDA purposefully had little to say (the
meeting was to collect outside opinions, and assumedly the
agency did not want to hinder that process by espousing any
preconceived positions of its own).
Only three outside groups offered verbal comments:
- The Association of American Feed Control Officials
(AAFCO) made some brief remarks regarding implications new
federal regulations would have on the current state
regulatory oversight of petfoods;
- The American Veterinary Medical Association voiced
support for mandatory calorie content statements on dog and
cat foods and put forth a very interesting proposal to
require a "not evaluated by FDA" disclaimer on petfoods
bearing health-related claims; and
- Defend Our Pets, a consumer advocacy organization formed
as a result of last year's recalls, made the most extensive
comments. The group presented a long list of suggestions,
including some form of country of origin labeling (e.g.,
disclaimers when the product contains ingredients from
countries that do not meet US standards) and "total
elimination" of what it considers confusing and misleading
labeling requirements (apparently from the AAFCO Model Pet
Food Regulations). This organization also recommended actions
beyond FDA's authority to implement on its own (e.g.,
mandatory recall authority, approval of grants by petfood
companies to veterinary schools).
Scheduled for a full day, the meeting lasted only a couple
of hours, even with a long break in the middle. Because the due
date for submission of written comments on this matter was a
month later, most organizations with a stake in the matter
decided to withhold verbal comment until they could evaluate
the comments of others and react at a later time.
In fact, the written comments, posted on
www.regulations.gov
(
re: Docket #FDA-2007-N-0442
), are extensive and include input from many organizations,
including the Pet Food Institute, the American Feed Industry
Association and both the American College and Academy of
Veterinary Nutrition.
FDA has been working on AFSS for a number of years prior to
passage of FDAAA in an effort to develop a comprehensive,
risk-based approach to animal feed safety, including petfood
safety. The agency has held a number of meetings on the subject
over the past few years (see
Petfood Industry
,
August
2007
and
November
2006
).
The May 2008 meeting was held to give an update on FDA's
progress as it further refines the AFSS. Compared to the
previous day's meeting on FDAAA, this meeting did last a much
greater portion of the scheduled full day, primarily because
FDA gave a number of presentations that prompted some questions
from the attendees.
A key point of progress included a revised draft of the AFSS
framework document (
http://www.fda.gov/cvm/AFSS3rdDraftFramework.html
). It identifies gaps FDA sees in the present oversight of
animal feed safety and proposes means by which those gaps can
be addressed.
For example, FDA considers lack of a comprehensive list of
all ingredients allowed in animal feeds as a part of its own
regulations to be a deficiency. However, the recently signed
memorandum of understanding between FDA and AAFCO that allows
the former greater oversight of the latter's ingredient
approval process, as well as plans to finalize and implement
the generally recognized as safe (GRAS) notification rule, is
proposed to help address this gap.
Much of the meeting focused on FDA's continued efforts to
rank the relative risk of chemical and microbiological feed
contaminants for the purpose of establishing, in part,
enforcement priorities and allocation of resources. This is
accomplished by a process of assigning scores to rate the
potential health consequences of and likelihood of exposure to
various contaminants, which eventually results in a number that
can be compared to those calculated for other contaminants.
Unfortunately, the very detailed presentations at the May
meeting on how to do the ranking do not appear to be posted on
the agency's website as of the time of this writing.
AFSS is intended to address petfood as well as livestock
feed safety. To me, this makes sense, as it would allow for a
more effective and efficient program to the benefit of all.
Interestingly enough, Defend Our Pets is adamantly opposed to
grouping petfood with feed in the system. Notwithstanding that
AFSS has been in development since 2003, the consumer group
believes AFSS would "dilute the intent and authority" of
FDAAA.
The US Food and Drug Administration (FDA) held public meetings over two consecutive days in mid-May to discuss issues pertaining to petfoods.In fact, while FDA is currently trying to extend and
incorporate the FDAAA mandates into the system, Defend Our Pets
apparently perceives an AFSS that includes petfood to be little
more than a veiled effort to diffuse attention away from the
petfood industry.