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IDFA Clarifies Concept of 'Transfer' in Comments to FDA

Jul 23, 2010

Responding to a call for comments from the Food and Drug Administration, IDFA said control of a product, not physical possession, should be the determining factor when deciding whether a company must submit a reportable food report. Companies that use a third-party warehouse or other facility to store products still retain control over product distribution and have the ability to correct or remove reportable foods before they ever reach the public.

"IDFA asserts that unless a food manufacturer has relinquished title or control over a product's subsequent distribution, it is irrelevant whether the product has been physically transferred to another person," the comments stated. "The appropriate and efficient way to handle the transfer issue is to focus on transfers where a food manufacturer does not control the food's entry into commerce."

The Reportable Food Registry portal, which became active last September, is intended to improve FDA's ability to ensure the safety of the domestic food supply. It requires a company to file a report when there is reason to believe that an adulterated food, other than infant formula, will cause serious adverse health consequences or death to humans or animals.

FDA asked for comments on its interpretation of transfer in May when it released updated guidance for the federal Reportable Food Registry, "Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)."

According to the guidance, companies are not required to submit a report if the adulteration originated at the company, it was discovered before being transferred and it was corrected or destroyed. However, if companies have transferred an adulterated food product to other persons, they are obligated to report.

Under the current interpretation, if a product leaves the company's physical possession and then tests positive for the presence of a pathogen, it must be reported. IDFA believes that a change in physical possession in many cases does not equate to a change in control. Many food processors use third-party warehouses but retain full control over their products.

"When the affected product is in a food manufacturer's facility or under their control in a third-party warehouse, the ultimate disposition is the same; the food will not present any risk to the public," the comments stated.

IDFA believes FDA has a good understanding of the issues that concern dairy processors and expects the agency will likely make improvements to the requirements once the rulemaking process has concluded.

Read the comments here.

Members with questions may contact Clay Detlefsen, IDFA vice president of regulatory affairs, at or (202) 220-3554.


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