February 28, 2018
 Contact:, 202-224-4343 

WASHINGTON, D.C. – Today, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee passed U.S. Senator Rand Paul’s amendment to S. 2434, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, to bring greater efficiency to the Food and Drug Administration’s approval process for animal feed additives and help provide more certainty to the animal food manufacturing industry regarding the rules they have to follow.
“Kentucky’s farmers and manufacturers are currently faced with a costly, extensive, and repetitive FDA process to get an animal feed additive approved. My amendment would help remove those barriers to success and bring more products to the market without compromising safety, so I am pleased it passed committee today. I look forward to its passage in final legislation in the coming months,” said Dr. Paul.
Dr. Paul’s amendment, which he introduced after hearing about this issue from a Kentucky company, requires the FDA to consider data from studies conducted in other countries when a company submits those studies as part of their food additive petition.
It also requires the FDA to provide a scientific rationale for why additional studies would be needed to supplement the data they have already submitted, and it would repeal 2007 language that brings uncertainty to the long-standing relationship between state-based feed regulators and the FDA. 
You can find more information on Dr. Paul’s amendment below, including background on the issue: 
– The law requires that any substance that is added to or is expected to become a component of animal food, either directly or indirectly, must be used in accordance with a food additive petition, unless it is generally recognized as safe (GRAS).
– While there is a statutory deadline of 90 days for the FDA to approve or deny the petition, the industry reports that many food additive petitions take between three and five years to reach completion, due in part to a lengthy pre-submission process. This process can consist of meetings and calls between the petitioner and the FDA, the submission of preliminary data packages (“white papers”), and the submission of proposed frameworks or “protocols” for animal studies.
– In response to a serious pet food contamination and recall, Congress passed language in the Food and Drug Administration Amendments Act (FDAAA) of 2007 requiring the FDA to establish “ingredient standards and definitions with respect to pet food.” To date, the FDA has not issued these regulations because of their conflicting nature with the FDA’s responsibilities for food additive petitions under section 409 of the United States Federal Food, Drug, and Cosmetic Act (FFDCA). Furthermore, this language has called into question the FDA’s longstanding relationship with the Association of American Feed Control Officials (AAFCO), a voluntary membership association that maintains a published list of animal food ingredient definitions.
Summary of Dr. Paul’s amendment:
– Requires the FDA to review, if submitted by the petitioner, data from studies conducted in foreign countries.
– Requires the FDA to post the following information on its website: the number of petitions for animal food additives that are pending, and how long those petitions have been pending, as well as the number of animal study protocol proposals that have been pending for over 50 days, and those that have received an extension.
– Requires the FDA to provide petitioners with information on the required contents of the petition. If they require additional studies beyond what the petitioner has proposed, the FDA must provide a scientific rationale for that requirement.
– Strikes FDAAA section 1002(a)(1), which requires the FDA to issue regulations establishing “standards and definitions with respect to pet food,” due to its conflicting nature with the FFDCA and to address the uncertainty it causes for the FDA/AAFCO relationship.
– Requires the issuance of guidance, within 18 months, to include the recommended format for submission of existing data related to animal food additives, including foreign data, the number of days in which the FDA will respond to such data, circumstances under which the submission of study protocols are recommended, how the FDA will inform the person submitting those protocols if the review will take longer than 50 days, and best practices for communication between the FDA and industry on the development of pre-submission data packages. 


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