WASHINGTON — In the inaugural issue of Pet Food Processing, two themes became abundantly clear. One, more and more Americans are welcoming pets into their homes, proving the demand for high-quality, safe and nutritious pet food will only continue to grow. And two, as consumers’ health and food preferences change, so are their pet food purchasing decisions, requiring the marketplace to adapt and continue providing a variety of affordable options that meet the needs of all consumers.
To meet this growing and ever-evolving demand, pet food processors and ingredient suppliers continually research new ingredients to improve the pet food supply. In recent years, many new ingredients entered the marketplace with attributes to improve the safety, quality and nutrition of pet food.
But the process for getting a new ingredient approved at the federal level has not evolved with the times. Ingredient suppliers and pet food processors are regularly hitting costly roadblocks that prevent new and innovative products from entering the market.
The American Feed Industry Association (AFIA), which has represented the business, legislative and regulatory interests of the U.S. animal feed and pet food processing industry and its suppliers for more than a century, has been working to improve the regulatory environment at the federal level for pet food processors, so they can get back to doing what they do best: keeping pets in the U.S., and around the world, happy and healthy.
Navigating the approval process
The U.S. Food and Drug Administration (F.D.A.)’s Center for Veterinary Medicine (CVM) is responsible for reviewing and approving new ingredients for use in animal food through the food additive petition, the Generally Recognized As Safe (GRAS) notification program and the ingredient review process of the Association of American Feed Control Officials (AAFCO). The regulatory agency ensures that all 900 or so ingredients currently approved for use in feed and pet food in the country are safe for animals to eat.
Over the past few years, ingredient approvals have slowed dramatically. A recent study by Informa Economics found that for every year of delay in the approval process, submitting companies across the animal food industry were losing an average $1.75 million in revenue. The average review time is now three to five or more years. These costly delays are impacting the research and development of new technologies 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-and-forth 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?
F.D.A. 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 F.D.A. 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 commerce, 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 F.D.A.’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 F.D.A. 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 F.D.A. Amendments Act that requires F.D.A. to establish “ingredient standards and definitions with respect to pet food,” due to the uncertainty it creates between F.D.A. and AAFCO.
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 F.D.A. 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 four-legged 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.
Leah Wilkinson is vice president of public policy and education for the American Feed Industry Association.
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