WASHINGTON — The Food and Drug Administration extended specific compliance dates for regulations under the Food Safety Modernization Act (FSMA) giving an additional year or more for certain facilities to meet the new rules.
Specifically, the changes impact two current good manufacturing practices (CGMP) and preventive controls rules for human and animal food, foreign supplier verification programs (FSVP) and produce safety. None directly involve baking or snack food operations, although one concerns raw agricultural commodities, another covers Grade “A” milk and a third affects imported food contact substances.
Most major provisions of FSMA are being implemented as planned, with Sept. 19, 2016, as the original compliance date. However, four are delayed.
“These changes are part of F.D.A.’s continuing efforts to make the rules as practical as possible while still protecting public health,” the F.D.A. stated.
“The changes include providing more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances and other extensions to align compliance dates for various other food operations or provide time for F.D.A. to resolve specified issues,” the F.D.A. said. “The rule also clarifies the timeframe for agricultural water testing.”
As a reason for these changes, the agency noted that all four rules contain “customer provisions” when food safety controls are applied downstream.
Jan. 26, 2018, is the new date for facilities that only pack and/or hold raw agricultural commodities that qualify as produce or nut hulls and shells. The same date is given for compliance by facilities that qualify as secondary activities farms.
Jan. 28, 2018, is the new date for cotton ginning facilities under the animal food rule.
Sept. 17, 2018, is the new date for facilities producing Grade “A” milk products.
May 28, 2019, is the new date for food contact substances offered by importers subject to FSVP rules.
The F.D.A. is considering future rulemaking to modify the definition of a farm to address ownership issues raised by the compliance deadline extension.
“With deadlines for FSMA’s rules quickly approaching, news from F.D.A. is causing much uncertainty,” said AIB International in an email statement.
“If these provisions do not apply to your facility, you should continue moving full speed ahead with FSMA implementation,” AIB advised. “The path for FSMA compliance may be challenging, but the consequences rest on your shoulders.”
