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IDFA Comments on Draft Guidance for FDA Records Access

May 30, 2012

Because the Food Safety Modernization Act expanded the scope of government authority for access to company records during a food safety emergency, the Food and Drug Administration recently issued updated guidance for industry comment. In a letter sent last week, IDFA recommended revisions and clarifications that would provide safeguards for due process, ensure consistency and contain the requests to documents that are relevant and helpful to emergency situations.

Noting that current agency guidance details specific conditions that must be met before FDA invokes its authority, IDFA said the same safeguards need to be included in the updated guidance. The letter mentioned two specific examples. The current guidance requires input and consensus from the appropriate FDA Center, as well as the agency's Office of Enforcement and the Office of the General Counsel, before emergency access is authorized. FDA also must provide companies with a "Notice of inspection – Request for Records" form when it intends to use its authority.

"Although the Draft Guidance explains FDA's plans for using the expanded authority provided by FSMA, it omits these important sections of the Current Guidance," IDFA said. "These safeguards provide due process for industry and ensure consistency of the agency's approach in the field."

IDFA also called for the same procedural safeguards to be followed before FDA can access records about another food that could be "affected in a similar manner."

In addition, IDFA encouraged FDA to limit the scope of requests to specific documents that relate to the suspect article of food and to consult with facilities to determine whether the scope can be narrowed even further.

"Facilities are likely to have a better understanding of what documents are most relevant for the investigation and may be able to assist FDA in quickly identifying the most useful documents," IDFA said.

In closing, IDFA said training for all investigators would ensure the same procedures and limits are applied consistently to all companies.  

For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at

Upcoming Webinar: FSMA & the FDA Inspection Process

IDFA will host a free webinar, "FSMA & the FDA Inspection Process," on June 19 from 1:00 to 3:00 p.m. The webinar will help member dairy companies understand the rule changes that have already taken place, the ones that will occur in the near future and others that will occur this summer.

The "FSMA & the FDA Inspection Process" webinar will feature food safety expert Joseph A. Levitt, a partner in the Washington, D.C., office of Hogan Lovells US LLP. Before joining the firm in 2004, Levitt worked at FDA for 25 years, where he served as director of FDA’s Center for Food Safety and Applied Nutrition from 1998 through 2003. He currently serves as outside regulatory counsel to IDFA.

Participation in the webinar is free, but registration is required. For webinar information, contact Patrick Crosson, IDFA meetings registrar, at or (202) 220-3524.

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