The United States Department of Agriculture (USDA) has published a Final Rule codifying internal procedures that must be followed when issuing agency guidance documents. The Final Rule amends USDA’s administrative regulations by adding procedural regulations for the review and issuance of USDA guidance documents. The Final Rule adds a new Subpart Q, “Review and Issuance of Agency Guidance Documents,” to 7 CFR Part 1. The new procedures are in some ways similar to the Food and Drug Administration’s (FDA) “Good Guidance Practices” regulations which for two decades have governed the procedural steps FDA follows when developing guidance documents. Although the Final Rule is positioned as an internal agency procedural requirement not conferring rights on third parties, regulated companies may wish to consider whether the agency properly followed these procedures when commenting on future agency guidance.

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Photo of Gary Kushner Gary Kushner

Partner, Washington, D.C.

Gary Jay Kushner knows the food industry inside and out as he has been a part of it for almost 40 years. His clients are some of the largest food corporations in the world as well as their trade associations.

Partner, Washington, D.C.

Gary Jay Kushner knows the food industry inside and out as he has been a part of it for almost 40 years. His clients are some of the largest food corporations in the world as well as their trade associations. Because of his extensive exposure to the industry at all levels, Gary approaches his clients’ challenges from the perspective of a food industry executive.
Gary has participated in the development of virtually every law and regulation affecting the food industry in the last four decades. Gary analyzes legislation considered by the U.S. Congress and state legislatures and regulations proposed by the U.S. Department of Agriculture, Food and Drug Administration, and other federal and state government agencies, and evaluates their impact on the food industry from farm to table. His insight allows him to anticipate how these initiatives might change the way his clients do business so they can plan most effectively.

Gary also helps companies address regulatory compliance issues, advising them on labeling, advertising, inspection, and representing them in enforcement proceedings before government agencies and the courts.

Previously, Gary served as vice president and general counsel for the American Meat Institute where he directed the organization’s legal, regulatory, and legislative activities. He began his food industry career as staff counsel for Scientific Affairs for the Grocery Manufacturers of America, and began his legal career as law clerk to the Honorable John R. Hess in the Superior Court for the District of Columbia.

Photo of Brian Eyink Brian Eyink

Counsel, Washington, D.C.

Drawing on experience throughout the supply chain — from animal production to food processing to distribution and retail sale — Brian Eyink brings vast and cross-cutting industry knowledge to help clients find practical solutions to regulatory problems. Brian is particularly…

Counsel, Washington, D.C.

Drawing on experience throughout the supply chain — from animal production to food processing to distribution and retail sale — Brian Eyink brings vast and cross-cutting industry knowledge to help clients find practical solutions to regulatory problems. Brian is particularly sensitive to risk management issues as companies adapt to a regulatory and political environment increasingly focused on inspections, enforcement, and investigations.

Brian helps food and agriculture companies navigate increasingly complex and high-stakes federal and state regulatory issues. He draws on deep experience with the USDA, FDA, and FTC, as well as state, local, and self-regulatory bodies, litigation, and acquisitions to solve clients’ regulatory and business problems. Brian advises clients on the full scope of regulatory issues facing the food and agriculture sectors, ranging from USDA and FDA enforcement actions and federal investigations to regulatory compliance, import and export issues, litigation support, comment preparation, legislative drafting, policy development, trade association governance, advertising disputes, and labeling issues.

Brian also represents food and agriculture trade associations, advising on issues including general counseling and governance, influencing policy and public perspective, and implementation of industry initiatives.

Before joining Hogan Lovells, Brian served as a judicial law clerk to the Honorable Gerald Bard Tjoflat of the United States Court of Appeals for the Eleventh Circuit. While in law school, he served as an executive editor of the Duke Law Journal.

Photo of Christine Forgues Christine Forgues

Senior Associate, Washington, D.C.

Chris Forgues provides business-oriented legal and scientific solutions to food and agriculture companies and trade associations.
She advises clients on state and federal regulatory issues that arise throughout the entire food supply chain and production line, ranging from USDA…

Senior Associate, Washington, D.C.

Chris Forgues provides business-oriented legal and scientific solutions to food and agriculture companies and trade associations.
She advises clients on state and federal regulatory issues that arise throughout the entire food supply chain and production line, ranging from USDA and FDA enforcement actions and federal investigations to regulatory compliance, import and export issues, litigation support, comment preparation, advertising disputes, and labeling issues.

Chris’s background in life science (chemistry and pharmacology) assists her in her science-based food law practice. Chris’s unique educational background and regulatory scientist experience provides valuable context to complex scientific issues as they relate to the governing regulatory requirements.

When she joined Hogan Lovells, Chris brought with her more than nine years of regulatory consulting experience. A part-time student by night and a regulatory scientist by day, Chris worked throughout law school at a firm in Washington, D.C., focusing on product review, development, and post-marketing in the life sciences sphere, with experience handling matters under the Food and Drug Administration (FDA), the Department of Agriculture (USDA), and the Environmental Protection Agency (EPA), the Federal Trade Commission (FTC), the National Advertising Division (NAD), the Consumer Product Safety Commission (CPSC), as well as state regulatory bodies.