Streamlining US Regulatory Reviews of Modified Microbial Ingredients for Use in Animal Feed

U.S. Grains Council. A Guide to Distiller's Dried Grains with Solubles (DDGS), 3rd Edition, Washington, DC. 2012. Available at www.grains.org/buyingselling/ddgs/ddgs-user-handbook (Last accessed August 2016 ).

Biofuels Coproducts in Animal Feeds. University of Minnesota. Available at www.biofuelscoproducts.umn.edu/general-information/overview (Last accessed August 2016 ).

Biofuel coproducts as livestock feed—Opportunities and challenges. Makkar HPS , eds. Food and Agricultural Organization of the United Nations, Rome (2012).

U.S. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act (FD&C Act). Available at www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/ (Last accessed August 2016 ).

U.S. Food and Drug Administration Center for Veterinary Medicine. Ingredients and Additives. Available at www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/IngredientsAdditives/default.htm (Last accessed August 2016 ).

U.S. Food and Drug Administration Center for Veterinary Medicine. Generally Recognized as Safe (GRAS) notification program. www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/GenerallyRecognizedasSafeGRASNotifications/default.htm (Last accessed August 2016 ).

Smedley KO . Comparison of approval process and risk-assessment procedures for feed ingredients. International Feed Industry Federation, 2011.

Smedley KO . Comparison of regulatory management of authorized ingredients, approval processes, and risk-assessment procedures for feed ingredients. International Feed Industry Federation, 2013. Available at www.ifif.org/uploadImage/2013/7/19/272ee931adc6dacaadd762c71f8110a31374224070.pdf (Last accessed August 2016 ).

U.S. Food and Drug Administration Center for Food Safety and Nutrition. Substances Generally Recognized as Safe; Proposed Rule, Federal Register, Vol. 62, No. 74, April 17, 1997, pages 18937–18964.

U.S. Food and Drug Administration Center for Food Safety and Nutrition. About the GRAS Notification Program. Available at www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm2006851.htm (Last accessed August 2016 ).

U.S. Food and Drug Administration Center for Veterinary Medicine. Substances Generally Recognized as Safe added to food for animals: Notice of pilot program. Federal Register, Vol. 75, No. 107, June 4, 2010, pages 31800–31803.

Association of American Feed Control Officials, Inc.. Welcome to AAFCO. Available at http://www.aafco.org (Last accessed August 2016 ).

U.S. Food and Drug Administration. Memorandum of understanding between the United States Food and Drug Administration and the Association of American Feed Control Officials. Available at www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm115778.htm (Last accessed September 2016 ).

Association of American Feed Control Officials, Inc.. Ingredient Definitions Committee. www.aafco.org/Regulatory/Committees/Ingredient-Definitions (Last accessed August 2016 ).

Association of American Feed Control Officials, Inc.. A guide to submitting new ingredient definitions to AAFCO. Available at www.aafco.org/Portals/0/SiteContent/Regulatory/Committees/Ingredient-Definitions/definition_request_guidelines_020112.pdf (Last accessed August 2016 ).

Schill SR . Yearning For New Yeasts: What's holding up approvals for modified microorganisms? Ethanol Producer Magazine. 2015. Available at http://ethanolproducer.com/articles/12004/yearning-for-new-yeasts (Last accessed August 2016 ).

U.S. Food and Drug Administration Center for Veterinary Medicine. Current animal food GRAS notices inventory. Available at www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/GenerallyRecognizedasSafeGRASNotifications/ucm243845.htm (Last accessed August 2016 ).

U.S. Food and Drug Administration Center for Food Safety and Nutrition. GRAS Notice Inventory. Available at www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm (Last accessed August 2016 ).

Association of American Feed Control Officials, Inc.. 2016 Official Publication. Champaign, IL (2016), pp. 443–444.

Wenger KS , Kenealy W . Development of bioengineered yeast for the grain ethanol industry. Available at www.bio.org/sites/default/files/Wenger%20Presentation%20Bio%20Pacific%20Rim%20Dec%202013.pdf (Last accessed August 2016 ).

Office of Science and Technology Policy. Coordinated framework for regulation of biotechnology. Federal Register Vol. 51, No. 123, pages 23302–23350, June 26, 1986, p. 23313.

Bergeson LL . Industrial biotechnology: Coordinated framework make-over and lots more. Ind Biotechnol, 2015; 11(5):237–245.

D. Glass Associates, Inc.. Comment on Docket No. FDA-2015-N-3403. Available at www.regulations.gov/document?D=FDA-2015-N-3403-0266 (Last accessed August 2016 ).

U.S. Food and Drug Administration. Consultation procedures under FDA's 1992 statement of policy—Foods derived from new plant varieties. Available at www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm096126.htm (Last accessed August 2016 ).

U.S. Food and Drug Administration. Statement of policy: Foods derived from new plant varieties, Federal Register, Volume 57, page 22984 (May 29, 1992).

U.S. Food and Drug Administration. Biotechnology consultations on food from GE plant varieties. Available at www.accessdata.fda.gov/scripts/fdcc/?set=Biocon (Last accessed August 2016 ).

U.S. Right to Know website. The FDA does not test whether GMOs are safe. Available at http://usrtk.org/the-fda-does-not-test-whether-gmos-are-safe/ (Last accessed August 2016 ).

Organic Consumers Association website. Five Ways the FDA Has Failed Consumers on Genetically Engineered Foods. Available at www.organicconsumers.org/news/five-ways-fda-has-failed-consumers-genetically-engineered-foods (Last accessed August 2016 ).

U.S. Food and Drug Administration Center for Veterinary Medicine. Guidance for Industry #221, recommendations for preparation and submission of animal food additive petitions. Available at: www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM367746.pdf (Last accessed August 2016 ).

U.S. Food and Drug Administration Center for Veterinary Medicine. How to submit a GRAS notice to CVM. Available at www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/GenerallyRecognizedasSafeGRASNotifications/ucm192219.htm (Last accessed August 2016 ).

Cornell University Law School Legal Information Institute. 40 CFR Part 725 - Reporting requirements and review processes for microorganisms. Available at www.law.cornell.edu/cfr/text/40/part-725 (Last accessed July 2016 ).

Jaffe G . Regulatory slowdown on GM crop decisions. Nat Biotechnol, 2006; 24:748–749.