IDFA, along with other members of the Food and Beverage Industry Alliance, last month called on the Food and Drug Administration to extend the compliance dates for provisions of two Food Safety Modernization Act rules set to go into effect this spring. The Alliance recommended harmonizing the first compliance dates for the rules on Preventive Controls for Human Foods and Foreign Supplier Verification and extending them until May 28, 2018.
The first compliance date for the preventive controls rule is March 17, while the first date for compliance with the foreign supplier verification rule is May 30.
According to the coalition, the supplier verification provisions included in these two rules will require considerable time and effort for compliance, and it’s unlikely that critical FDA draft guidance will be released before the provisions to go into effect. In addition to IDFA, the coalition comprises 16 food and beverage organizations, including the Food Marketing Institute and the Grocery Manufacturers Association.
In the Alliance letter to Stephen Ostroff, M.D., FDA acting commissioner, the group noted the difficulty that many food and beverage companies face in complying with the provisions, which are the first FDA regulations to require intensive recordkeeping for sources of all domestically produced and imported foods.
“Compliance with the regulation is not as simple as just getting a copy of a reputable third-party audit for each supplier,” the coalition said in the letter. “Conducting individualized assessments of each supplier and preparing supporting documentation for the program is not an easy endeavor. We continue to receive many questions from our members regarding the legal requirements and compliance strategies, but often have to advise that we need to wait for further input from FDA on these issues.”
The coalition also expressed concern that FDA guidance for complying with the provisions may be held up by the current White House freeze on regulatory publications.
“Even if FDA were to issue draft guidance before these compliance dates, there would not be enough time for companies to adapt their programs to implement the guidance,” the coalition said, adding that it would take less time for officials to review and approve the extensions than to approve the guidance.
IDFA also wrote separately to Ostroff, noting that the lack of guidance is the biggest concern for member companies.
“Having enforcement delayed until guidance is issued and industry has ample time to adjust will be key,” IDFA said.
For more information, contact John Allan, IDFA vice president of regulatory affairs and international standards, at firstname.lastname@example.org.