WASHINGTON — After languishing 15 years in regulatory limbo, a proposed rule to create a set of general principles to use when considering whether to establish, revise or eliminate a food standard of identity has been put on the front burner by the U.S. Food and Drug Administration.
The F.D.A. on Feb. 20 said it was reopening the comment period on the proposed rule titled “Food Standards; General Principles and Food Standards Modernization,” which originally was submitted for comment jointly by the F.D.A. and the U.S. Department of Agriculture in May 2005. The F.D.A.’s request for fresh comments was published in the Feb. 21 Federal Register. Comments will be accepted until April 21.
As the F.D.A. and U.S.D.A. stated in 2005, the proposed rule aimed to better promote honesty and fair dealing in the interest of consumers and protect the public; allow for technological advances in food production; be consistent with international food standards to the extent feasible; and be clear, simple and easy to use for both manufacturers and the agencies that enforce compliance with the standards.
The U.S.D.A. and F.D.A. did not finalize the proposed rule in 2005 “due to resource constraints and competing priorities.”
The F.D.A. reopened the comment period only for F.D.A.-specific aspects contained in the proposed rule, including the agency’s proposed 13 general principles for food standards modernization. The agency said it would continue to engage with the U.S.D.A. on standards of identity modernization even while moving forward with its request for stakeholder comments.
“The F.D.A. began establishing food standards of identity to promote honesty and fair dealing in the interest of consumers shortly after the Federal Food, Drug, and Cosmetic Act was enacted in 1938,” commented Claudine Kavanaugh, Ph.D., director, Office of Nutrition Labeling in the F.D.A.’s Center for Food Safety and Applied Nutrition. “Standards of identity describe in detail what a food product must contain, how it must be proportioned and sometimes how it must be manufactured.
“Given that many standards of identity are now 75 and even 80 years old, we feel the time is right to finalize general principles for when we will consider establishing, revising or revoking a food standard of identity,” Dr. Kavanaugh said. “We want to ensure that as we review these standards of identity, we do so in a fair and consistent manner.”
Modernizing food standards of identity is part of the F.D.A.’s comprehensive, multi-year Nutrition Innovation Strategy, Dr. Kavanaugh added.
“Even as we reopen the comment period on this proposed rule, we are continuing our efforts to revoke or amend certain standards of identity — including those for frozen cherry pie, French dressing and yogurt — especially when the standard of identity is inconsistent with modern manufacturing processes or creates barriers to innovation,” she said.
The F.D.A. said it was reopening the comment period now because of changes that have occurred in manufacturing, food technology, market trends and nutrition science since 2005. The move was preceded by meetings with stakeholders convened by the F.D.A. in July 2018 and more recently on Sept. 27, 2019, with sessions devoted to modernizing the F.D.A.’s standards of identity program. At those sessions, participants indicated support for reopening the comment period on the 2005 proposed rule to enable the F.D.A. to solicit new information and data.
The F.D.A. said it would consider comments on any F.D.A. aspects of the 2005 proposed rule, but it posed six questions for stakeholders’ consideration.
First, should the F.D.A. finalize the proposed rule, and why or why not?
Second, are there general F.D.A. principles that should be added, eliminated, revised or retained? The F.D.A. in the proposed rule offered 13 general principles to guide the process of revoking, revising or adding standards of identity. The principles are described in the Feb. 21 Federal Register notice announcing the reopening of the comment period. The F.D.A. asked that comments should specify the individual principle or principles that a stakeholder believes should be added, eliminated, revised or retained.
Third, what specific revisions should the F.D.A. make to the proposed rule’s principles or framework to better reflect its modernization goals?
Fourth, how should the F.D.A. weigh the general principles?
Fifth, what explanation is needed to provide more clarity, certainty or context regarding the rationale for the principles; how the F.D.A. will consider the principles when evaluating whether to eliminate, revise or establish a food standard, and how stakeholders should use the principles to inform the preparation of petitions requesting the F.D.A. to eliminate, revise or establish a food standard?
And sixth, what additional information should the F.D.A. consider when evaluating the costs, benefits and estimates of the annual reporting burden of the proposed rule?