PET Food Processing - June 2018 - 35
Submitting companies across the animal food industry
lose an average $1.75 million in revenue for every
year of delay in the approval process. The average
review time is now three to five or more years.
and ingredients that could improve the quality, safety
and nutritional value of the pet food supply.
Part of the issue stems from a tightening of resources
within the CVM. Staff have been pulled away from completing ingredient reviews to take on other priority issues,
and as jobs have opened up, they have not been replaced.
Another issue is that the CVM has overextended its regulatory authority and taken broad interpretations of policy,
which has only lengthened the approval process.
Many AFIA members have submitted the necessary
paperwork for a food additive petition review of their
ingredients, and at the end of the 180-day statutory
review period, the CVM has instead asked follow-up
questions or requested additional studies or data, which
restarts the 180-day review process. After the petitioning company responds, the submission goes back in the
queue for another review. This inefficient back-andforth process takes years to complete.
Another troubling issue that came out of the Informa
Economics report is the decrease in manufacturing jobs.
As the regulatory requirements to achieve ingredient
approvals have increased, companies across the animal
food industry have been forced to hire consultants, lawyers and researchers to decipher the legal language and
complete all the necessary paperwork, as well as usher
the ingredients through the process. Meanwhile, construction on new facilities or the expansion of existing
facilities has been delayed or canceled, resulting in the
loss of $103 million in construction and nearly 300 jobs.
What can be done?
FDA recently asked stakeholders how it could reduce the
regulatory burden - both on the CVM and the regulated industry - without compromising animal health
and safety. AFIA responded to this request outlining
several actions that seek to improve the review and approval process, starting with adopting through rulemaking and/or a guidance document the ingredient definitions in AAFCO's Official Publication. AFIA was pleased
to see the FDA took some of the industry's concerns into
consideration and inserted language into a Food Safety
Modernization Act guidance for industry stating it will
continue to accept the listing of ingredients in the AAFCO
Official Publication for their marketing in interstate com-
merce, provided there are no food safety concerns.
Meanwhile, AFIA has also been working with members of Congress to educate them on the ingredient
approval issue, so they can provide a legislative fix. In
February, the Senate Health, Education, Labor and
Pensions Committee passed an amendment to S. 2434,
the Animal Drug and Animal Generic Drug User Fee
Amendments Act of 2018 (ADUFA and AGDUFA), that
will streamline FDA's approval process for new animal
feed additives and clarify existing rules and regulations.
Sponsored by Sen. Rand Paul (R-Ky.), the amendment
will, among other things, require FDA to post information on its website on the number of pending petitions it is reviewing and a scientific rationale for why
the agency requires additional studies beyond the ones
originally submitted by companies. For pet food specifically, it will also strike the conflicting language in the
FDA Amendments Act that requires FDA to establish
"ingredient standards and definitions with respect to pet
food," due to the uncertainty it creates between FDA and
As of late April, S. 2434 still awaits a vote. On April 25,
the House Energy and Commerce Health Subcommittee
marked up its version of ADUFA and AGDUFA, including similar ingredient approval language as Sen. Paul's
amendment. AFIA expects both chambers of Congress
to continue working on ADUFA and AGDUFA, the authorization bills that dictate the user fees FDA can collect
when reviewing new and generic animal drugs, through
the spring as the program's funding ends Sept. 30.
AFIA will continue to be engaged in this issue and
encourages pet food processors to contact its legislative
and regulatory team to discuss how the ingredient review and approval process has impacted its businesses.
Every pet owner wants what's best for their fourlegged furry friends and feeding them correctly plays a
major role in their growth and development. As the industry continues to research the ingredients and formulas that will help generations of animals live longer and
healthier lives than preceding generations, AFIA hopes
the nation's leaders will recognize their role in assisting
pet food processors and suppliers in delivering these
critical products to market. If they don't, AFIA believes
others around the world will.
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