June 10, 1998
Mr. Richard Williams
Food and Drug Administration
Center for Food Safety
and Applied Nutrition
330 C Street, SW
Washington, DC 20204
Re: Proposed Rule on Labeling of Juice Products; 63 Fed. Reg. 20,486 (April 24, 1998)
Dear Dr. Williams:
Thank you for presenting to the Office of Advocacy information concerning the small business impact of the above-referenced rule during the June 1, 1998 meeting between FDA and my staff. We encourage FDA to continue a dialogue with our office on future rulemakings to address potentially problematic issues regarding small business impact and compliance with the Regulatory Flexibility Act.
Based on your presentation it does not appear that the Office of Advocacy will submit formal comments on the juice labeling rule. However, we wish to address two important issues. First, although the rule seems to minimize the impact on small businesses by providing extended compliance periods and flexible compliance alternatives prior to the labeling requirement going into effect, enforcement issues might be a matter of serious concern as the rule is being implemented. The Office of Advocacy reminds FDA to be aware of the provisions in the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) that direct agencies to develop policies or programs providing for waivers or reductions in civil penalties for good faith violations of regulations. Therefore, rather than closing down a roadside cider stand for failure to display a placard, FDA inspectors should instead provide a placard. The focus should be on compliance and not punishment.
Second, it has been brought to the attention of SBA that FDA has decided to extend unofficially the comment period for a handful of individuals/businesses who requested the extension of time. The Office of Advocacy believes, that in the spirit of equity, and in accordance with proper notice and comment procedure under the Administrative Procedure Act, that the extension should be published in the Federal Register and made public to all who wish to comment.
Once again, we appreciate FDA's efforts to comply with the RFA, and look forward to a cooperative relationship in the future. Please do not hesitate to contact our office regarding any small business matter in the future, 202-205-6933.
Sincerely,
Jere W. Glover
Chief Counsel
Shawne Carter McGibbon
Asst. Chief Counsel for Advocacy