MEMORANDUM



AFIA Policy Priorities 2020The American Feed Industry Association (AFIA), based in Arlington, Va., is the world’s largest organization devoted exclusively to representing the business, legislative and regulatory interests of the U.S. animal food industry and its suppliers. There are 5,715 animal feed mills and 517 pet food manufacturing facilities in the U.S., producing more than 236 million tons of finished feed and 9.8 million tons of pet food each year. AFIA’s members include nearly 700 domestic and international companies, such as livestock feed and pet food manufacturers, integrators, pharmaceutical companies, ingredient suppliers, equipment manufacturers and supply companies that provide other products or services to feed manufacturers. Several state, national and regional associations are also AFIA members.The feed industry plays a critical role in the production of healthy, wholesome meat, milk, fish and eggs and supports policies that uphold U.S. food and feed safety, ensure the proper nutrition of animals and protect the environment. More than 75% of the feed in the United States is manufactured by AFIA members. AFIA’s members also manufacture approximately 70% of the country’s non-whole grain ingredients, including soybean meal, distillers co-products, vitamins, minerals, amino acids, yeast products and other miscellaneous and specialty ingredients.Trade and Market Access Priorities:The U.S. animal food industry’s ability to grow relies on filling the growing increasing for animal protein in export markets. In 2019, the U.S. exported $12.6 billion in animal food, animal food ingredients and pet food. Trade grows animal food demand directly through the export of additional animal food products to international customers. Trade would also increase feed demand indirectly through the export of U.S. meat, milk and egg products. Both direct and indirect demand enhances the value of the U.S. animal food industry – allowing it to grow, be sustainable and create more jobs. For the U.S. animal food industry to meet this global demand and continue to thrive and grow, policy and regulatory constraints that currently prohibit market access for U.S. animal food products and the value-added products (i.e., meat, milk and eggs) must be addressed and remedied. Free Trade Agreements: The AFIA values free and fair global trade and mutual respect between trading partners and is a strong advocate for negotiating new trade agreements to maintain and further enhance U.S. export markets. The AFIA supports current efforts to negotiate new trade agreements, building off the momentum and success of the U.S.-Mexico-Canada Agreement (USMCA), specifically the language of the sanitary and phytosanitary chapter. The AFIA recognizes the significance of new trade agreements to set new standards and expectations for subsequent agreements between the U.S. and other trading partners. Position: AFIA seeks continued commitment to negotiating ambitious and comprehensive trade agreements with the U.K., Kenya, Japan and India – agreements that address issues beyond tariffs, such as technical and regulatory challenges.China Phase One Implementation: While much of the increased demand for animal protein is concentrated in the Asia-Pacific region, the U.S. animal food industry faces challenges in accessing new customers in this region. U.S. agriculture faces increasing competition globally. New trade agreements among other countries within this region continue to block opportunities for the U.S. animal food industry and its value-added products to capture new demand. Position: AFIA requests the USTR hold China accountable to all commitments made under the U.S.-China phase one agreement, specifically Annex 12, and to strive for China’s removal of additional tariffs on U.S. animal food exports to China.Science-based Standards: The AFIA is committed to science-based standards and is pushing for the removal of tariffs and other regulatory barriers that have restricted U.S. animal food manufacturers from fully accessing export markets. Position: AFIA requests the U.S. administration continue active support, participation and leadership in the Codex Alimentarius and other international standard-setting bodies to facilitate setting global food safety standards that are based on science and that the U.S. can rely on for enforcing fair trade with our trading partners.World Trade Organization: The AFIA recognizes the importance of the World Trade Organization in supporting the implementation of U.S.-supported trade agreements that yield progress on a wide variety of international agricultural trade concerns. While not a perfect organization, seeking reform in the institution is best done as a member of the organization and the AFIA is, therefore, vehemently opposed to withdrawing the U.S.’s membership in the WTO.Position: AFIA asks the administration to maintain the United States’ membership in the WTO and to seek reform of the WTO from within.Legislative Concerns: The AFIA generally supports legislation and policy solutions that foster economic certainty and growth and promote business competitiveness. This includes initiatives that: 1) improve the quantity and quality of labor; 2) reduce unnecessary and burdensome regulations; 3) reduces the cost or time constraints of regulatory compliance; 4) provide tax relief and incentives for compliance with government guidance; 5) provide safety nets for critical components of the supply chain, such as agricultural producers, during times of economic crisis; and 6) support and improve the viability and stability of the broader agriculture industry. COVID-19COVID-19 has negatively impacted the animal food sector with disrupted supply lines, interrupted labor and unpredictable market impacts.Position: AFIA supports: stimulus and relief for livestock producers; future continuation of such low-interest loan programs as the Paycheck Protection Program, and its use for operational costs; tax deductibility of pandemic related expenses; and general support of initiatives that promote the continued, long-term growth of the national economy and economic stability of business – particularly those in the broader food and agriculture industries. Appropriate Funding for Regulatory Bodies: The AFIA sees many opportunities soon for industry challenges to be addressed through regulatory innovation. With this in mind, the association supports the proper funding of the respective regulatory bodies that have the capability to address these challenges. The association stresses the need for regulatory bodies to be funded in a manner that is adequate for all review, approval and inspection teams to continuously remain fully staffed. Position: AFIA is seeking an appropriated funding increase of $3 million to the FDA’s Center for Veterinary Medicine for FY2021 to improve the processes for reviewing animal food ingredients and assessing future regulatory innovation. Agricultural Research: The AFIA broadly supports the funding of agricultural research and innovation. This particularly includes the research of animal health, infectious diseases and their response coordination, genome to phenome projects, and funding of the Agriculture Advanced Research and Development Authority (AGARDA).Position: Allocate research funding to AGARDA and animal health. Infrastructure and Transportation: The AFIA member companies depend upon reliable, timely and economical transportation networks to deliver their goods throughout the supply chain, to and from agricultural producers, and to international markets. Position: AFIA supports legislation that: 1) fully funds and improves inland waterway systems that increase competitiveness of producers and manufacturers moving goods bound for foreign destinations; 2) funds programs to maintain and reduce closures of rural roads, bridges and related infrastructure; 3) ensures dependability, accountability and access to rail and truck networks; 4) allows flexibility in Hours-of-Service requirements to drivers hauling live animals; and 5) encourages regulatory innovation that improves efficiency, sustainability and access to labor for moving goods throughout the supply chain. Rural Competitiveness and Connectivity: A significant majority of AFIA’s member facilities are located in rural areas and communities across the nation. As such, these companies struggle to retain the reliable high-speed connectivity needed to run a modern business, collect and secure the data and records needed for regulatory compliance and business analytics, and to participate in foreign markets. The association believes the most equitable, prompt and long-term sustainable solution includes a universal service mandate similar to those already employed by the Federal Communications Commission to ensure rural access to telephone communications.Position: AFIA supports legislation that funds rural broadband access and infrastructure expansion and fosters private investment. We also support a universal service mandate for broadband access. Liability Protection: The Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) designated the majority of AFIA’s member companies as “essential” businesses, allowing – and in some instances, even mandating – them to remain functional as a critical component of the national supply chain during major disruptions such as the COVID-19 pandemic. Position: AFIA supports legislation that limits the liability from frivolous legal action of employers acting in good faith to continue operations. Climate Change: The AFIA believes that animal agriculture has the opportunity to be a solution provider for climate change mitigation. The association supports science-based legislative initiatives that incentivize increased participation in sustainability practices by agricultural producers. Additionally, the AFIA recognizes the need for legislation to modernize the regulatory approval process for innovations necessary to bring new technology to market that offers livestock producers tools to increase efficiency, productivity and sustainability of their animals. Position: Support science-based and incentive-based sustainability initiatives and regulatory modernization to facilitate development of innovative solutions.Regulatory Priorities:The AFIA is committed to the production of healthy, wholesome meat, milk, fish and eggs and supports policies that uphold U.S. food and feed safety, ensure the proper nutrition of animals and protect the environment. There are several areas where improving or reducing the regulatory burden on the industry can be achieved while not compromising our industry’s critical role in U.S. animal agriculture.Review of Ingredients for Use in Animal Food:The Food and Drug Administration’s Center for Veterinary Medicine (CVM) plays a significant role in the review and approval of ingredients used in animal food through the food additive petition, generally recognized as safe notification program and the ingredient review process of the Association of American Feed Control Officials (AAFCO). Over the last several years, resources within the CVM’s Division of Animal Feed have been pulled away from ingredient reviews to other priority issues and staff positions were not replaced as people retired or left the division. This tightening of resources, in combination with several areas where the CVM has excess policy interpretations on animal food ingredients, has caused significant delays in gaining approvals for new animal food ingredients. According to a study conducted by Informa Economics, for every year of delay in the approval process, the company loses an average $1.75 million in revenue.The agency and industry have worked to secure new resources to hire dedicated staff for the ingredient review process, including 12 new full-time staff. This added staff and recent reorganization within the agency will help with greater predictability about timing, deadlines and consistency in submission reviews. Position: We appreciate the efforts to hire additional staff and request expedited onboarding of these new resources. These new resources help relieve pressure on this regulatory system but will not alleviate the entire problem. Product Label Claims:The animal food industry is interested in bringing to market innovative ingredients that improve animal nutrition, animal health, the environment and the safety of animal and human food. Some of these products use claims that challenge the boundary of traditional thinking in the agency about nutrition, taste and aroma. Currently, the FDA’s Policy and Procedure Guide 1240.3605 prohibits animal production claims for food. The AFIA believes this, and interpretations of other policies on health, structure/function or other claims, provides a significant impediment to bringing valuable and highly desired animal food ingredients to the companion animal nutrition and the animal agriculture industry. Position: Request the adoption of a modernized approach to the review of product label claims for animal food ingredients to move the U.S. toward harmonization with the international animal food community. This change will open the doors to further innovation and has the potential to revolutionize animal nutrition. Elimination of Part 11 Requirements for Veterinary Feed Directive and Medicated Feed Records: The AFIA has filed two citizen petitions requesting an exemption for Part 11 Veterinary Feed Directive (VFD) and medicated feed Current Good Manufacturing Practice (CGMP) records, based on the wholesale exemption the FDA granted for Food Safety Modernization Act (FSMA) records. The FDA, on its own initiative, granted an exemption to the Part 11 requirements in the final FSMA rules for produce and human and animal food. The animal food industry believes the FDA should also grant such an exemption for VFD and medicated feed records and urges swift rulemaking to reduce this onerous requirement.Initial responses to both petitions were received and the agency mentioned that “…legal and policy…” issues still need to be reviewed. The AFIA believes the removal of these regulatory burdens should be simple policy changes that would bring meaningful regulatory reform for the licensed medicated feed mills and those facilities handling VFD records. Position: The association urges swift action to exempt the animal food industry from both VFD and CGMP medicated record requirements. Elimination of Drug Establishment Registration for Feed Mills: Medicated feed mills which manufacture feed using Category II, Type A medicated articles must submit duplicative information to the FDA for the annual Drug Establishment Registration (DER) and Medicated Feed Mill License applications.?The AFIA believes this complicated DER process is not necessary for feed mills and the FDA can eliminate the requirement as allowed by rule and by law, since the DER requirement is primarily meant for drug manufacturers.Position: Request FDA eliminate the requirement to complete the DER for licensed medicated feed mills. ................
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