USDA, FDA Announce Formal Agreement to Bolster Coordination and Collaboration

U.S. Agriculture Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb, M.D. announced at the White House a formal agreement aimed at making the oversight of food more efficient and effective by bolstering coordination between the two agencies. The formal agreement outlines efforts to increase interagency collaboration, efficiency, and effectiveness on produce safety and biotechnology activities while providing clarity to manufacturers.

“Today, Commissioner Gottlieb and I signed a formal agreement to promote coordination and the streamlining of capacities and obligations on shared concerns and jurisdiction,” said Secretary Perdue. “Congress passed the Food Safety Modernization Act and assigned responsibilities to the USDA and the FDA. The USDA has the knowledge and expertise to support the FDA’s work related to farming. We at the USDA have a motto: Do Right, and Feed Everyone. We believe this joint effort will help us move one step closer to that goal.”

The FDA and the USDA have worked closely over the years to oversee the nation’s food supply. The USDA oversees the safety of most meat, poultry, catfish and certain egg products while the FDA has authority over all other foods such as dairy, seafood, produce and packaged foods. The USDA and the FDA are partnering in many key areas, including the implementation of produce safety measures and biotechnology efforts.

“Secretary Perdue and I share a deep commitment to further strengthening our nation’s food safety system in the most effective and transparent way,” said FDA Commissioner Scott Gottlieb, M.D. “Over the last several months, the Secretary and I have worked closely and identified several areas where we can strengthen our collaboration to make our processes more efficient, predictable, and potentially lower cost to industry; while also strengthening our efforts to ensure food safety. This agreement not only formalizes this ongoing coordination but presents a great opportunity to expand those efforts through better integration and increased clarity to the agriculture and food processing sectors. Our coordination with these sectors plays an integral role in helping to keep our nation’s food supply safe and secure.”

This agreement is the agencies’ newest initiative to expand those efforts and take new steps to streamline regulatory responsibilities and use government resources more efficiently to protect public health. It aims to increase clarity, efficiency and potentially reduce the number of establishments subject to the dual regulatory requirements of the USDA and the FDA. For example, when a facility, such as a canned soup facility, produces both chicken noodle soup and tomato soup, it is currently subject to regulation by both agencies. The agreement tasks both government organizations with identifying ways to streamline regulation and reduce inspection inefficiencies, while steadfastly upholding safety standards for dual-jurisdiction facilities. This can reduce costs on industry and free government resources to better target efforts to areas of risk.

The agreement also commits the USDA and the FDA to identify ways the agencies can better align and enhance their efforts to develop regulatory approaches to biotechnology, as each agency works to fulfill commitments outlined in the September 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products and the more recent Task Force on Agriculture and Rural Prosperity Report. These initiatives established a vision for increasing transparency, predictability and efficiency of the regulatory processes for biotechnology products.

The agreement also calls for the FDA and the USDA to enhance their collaboration and cooperation on produce safety activities. The FDA is implementing the FDA Food Safety Modernization Act (FSMA), which shifts the food safety paradigm from one of reaction to prevention of foodborne illness. Under FSMA, the FDA coordinates with state and/or territorial government agencies, which will conduct most farm inspections under FSMA’s Produce Safety rule.

For more information:

Formal Agreement

FSMA Final Rule on Produce Safety

State Produce Cooperative Agreement Program

1999 MOU between the USDA and FDA

Modernizing the Regulatory System for Biotechnology Products

USDA Rural Prosperity Task Force Report

Cattle Health and FDA rule changes for antibiotics labeling | Podcast

MSGA 2nd Vice President, Bryan Mussard, helped attendees learn more about the services MSGA offers Affiliate members across the state.

MSGA 2nd Vice President, Bryan Mussard, helped attendees learn more about the services MSGA offers Affiliate members across the state.

On today’s podcast, we’ll follow up on discussions held during the recent summer cattle industry conference held in Denver Colorado. In this section we’ll focus on several issues related to cattle health.

The Cattle Health and Well-Being committee passed policy regarding foreign animal diseases, which could cause a widespread quarantine and possible massive depopulation of the U.S. cattle herd. A resolution was passed to oppose the importation of live cattle, beef, and/or beef products into the U.S. from foreign countries with histories of significant chronic animal diseases and lack of strict animal disease control and eradication measures.

This committee also focused on discussion and explanation of changes in FDA rules regarding feed through antibiotics use in livestock production. This would include label changes on antibiotics, feed additives and veterinary feed directives, which would make access to these medications more difficult for ranchers. MSGA’s 2nd Vice President, Bryan Mussard from Dillon attended the meeting and has more comments in the podcast below.

Conference attendees also had the opportunity to receive an update from CattleFax senior market analyst, Kevin Good, which described the industry as transitioning from a liquidation to an expansion phase. Good said the industry is accelerating the rate of expansion, and “it’s a great opportunity to take advantage of the trend.” However, while the fundamentals are “friendly,” he said, “the market will have a correction.” And that correction could be soon. “Something needs to give,” he said. “You have to be prepared for that ceiling.”

Bryan also provides us with a great take-home message coming out of the meetings in Denver which should serve as an encouragement for Montana ranchers working with MSGA. Find out more about these topics in the podcast below, and be sure to listen to parts 1 and 2 shared in posts earlier in the week.

National Cattlemens Beef USA logo

An Overview of the FDA Final Guidance 213 and Proposed Veterinary Feed Directive (VFD)

National Cattlemens Beef USA logoBy Dr. Kathy Simmons, DVM, NCBA Chief Veterinarian

On Dec. 12, the Food and Drug Administration (FDA) published their final Guidance #213 and a proposal for revisions to the current Veterinary Feed Directive (VFD). These revisions proposed for the VFD are in response to complaints from stakeholders that the current VFD process can be burdensome. This current guidance is part of FDA’s larger strategy for judicious use of the antibiotics that are most important for use in human medicine and are currently used in feed and water for food-producing animals. Guidance #213 is directed toward the use of these products in feed and water and pertains to the medically important antibiotic classes listed in Appendix A of Guidance 152. The specific drugs or product applications affected by Guidance #213 can be found in a list on the FDA website here.

Guidance #213 does not pertain to the ionophores, such as monensin, unless used in a combination product with a medically important antibiotic.

Guidance #213 is a follow up to final Guidance #209, which states that the antibiotics important to human health should only be used in animal agriculture in ways that are necessary to maintain animal health and with veterinary oversight. Guidance #213 establishes the roadmap for the animal drug manufacturers to phase out the growth promotion use of these products in feed and water over the next three years and revise product labels as needed for use indications of control, prevention and therapy. All medically important antibiotics used in feed and water will require a veterinary prescription or a VFD in order to obtain these products for control, prevention and treatment use.

What is the objective of this FDA guidance? Doubtless, most everyone is aware of the global concern for increasing antibiotic resistance and the problems that antibiotic resistance creates for effectively treating infections in humans and animals. FDA has responsibly chosen to address the concern of antibiotic resistance and its threat to public health. FDA guidance seeks to eliminate the subtherapeutic use of medically important antibiotics in feed and water for growth promotion. The cattle industry, through the Beef Quality Assurance program, also supports this stance by stating in the Judicious Antibiotic Use Guidelines that, “Subtherapeutic Antibiotic Use is Discouraged: Antibiotic use should be limited to prevent or control disease and should not be used if the principle intent is to improve performance.”

So, what does this guidance really mean for cattlemen and women? The loss of the medically important antibiotics for growth promotion has only a minimal impact as there are really very few of these products used for growth promotion in the cattle industry. Our current use of antibiotics in feed is primarily for the prevention and control of conditions/diseases such as liver abscesses, coccidiosis and anaplasmosis. The use of these products will still be available in feed and water for control, treatment and prevention through the oversight of the veterinarian by Rx or VFD. It is extremely important to cattlemen and women to have an efficient and dtreamlined VFD process in order to facilitate the timely and uninterrupted access to these