Share on facebook
Share on twitter
Share on linkedin

Five Unresolved Questions the Food Industry Should Be Looking for Answers to in FDA’s Final FSMA Regulations

It’s August, which in Washington means Congress recesses, the President and much of the bureaucracy go on vacation and the wheels of government move more slowly than usual.

However, that slower pace is going to be short-lived for the food industry. On or about August 30, just two weeks from now, FDA, under court ordered deadlines, will begin publishing final regulations implementing the Food Safety Modernization Act (FSMA).

The court-mandated schedule for rolling out the final rules looks like this:

  •  CGMPs and Preventive Controls for Human Food

Final rule: August 30, 2015

  •  CGMPs and Preventive Controls for Animal Food

Final rule: August 30, 2015

  •  Foreign Supplier Verification Programs (FSVP)

Final rule: October 31, 2015

  •  Accreditation of Third Party Auditors

Final rule: October 31, 2015

  •  Produce Safety Standards

Final rule: October 31, 2015

Although the court-ordered deadlines for the last three final rules is October 31, FDA recently said those final rules would publish in early November. (Other final rules are due in 2016):

  •  Sanitary Transportation of Food and Feed

Final rule: March 31, 2016

  •  Focused Mitigation Strategies to Protect Food from Intentional Adulteration

Final rule: May 31, 2016

The final rules will be lengthy and complex. The Agency has provided stakeholders with opportunities for comment and has conducted a number of public meetings to discuss controversial aspects of its proposed rules, and in some cases, issued supplemental proposed regulations modifying its positions. Yet, despite all the preparations, the agency has still left some key questions unresolved. Will the final regulations provide definitive answers? That remains to be determined.

With regard to the Preventative Control rules for Human Food, companies may want to look for answers to the following questions in the final rule:

1. When will FDA require product testing? Under FDA’s supplemental proposed rule, product testing would be required as a verification measure “as appropriate to the facility, the food, and the nature of the preventive control” being verified. Will FDA provide greater clarity regarding when product testing will be required in the regulation, or will companies be left guessing until formal guidance is issued?

2. Will FDA include additional training requirements for plant personnel beyond the “qualified individual” in either the CGMP regulations or the Preventive Controls regulations?  

With regard to the Foreign Supplier Verification Program, importers, overseas manufacturers, auditors and certifiers should be particularly interested in the following matters:

3. Under Section 303 of FSMA, FDA may require that foods imported into the U.S. be accompanied by a certification issued by an accredited third party for foods identified by the agency as posing special risks. FSMA provides some standards for the FDA to use to determine when a certification will be required, but the agency has not said which foods or food categories will be covered. Will this be specified in the final rule? The industry would like to know.

4. Under Section 307 of FSMA, an accredited auditor/certification body must immediately notify FDA electronically (in English), when any of its audit agents discovers any condition, found during a regulatory or consultative audit that could cause or contribute to a “serious risk” to the public health.  FDA requested comment on whether the notification standard should encompass risks that would result in a Class I recall (i.e., reasonable probability that the product will cause serious adverse health consequences or death) and risks that would result in a Class II recall (i.e., product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote).   Will the Agency limit the final reporting requirement to Class I recalls? That remains to be seen.

With regard to the final rule on Accreditation of Third Party Auditors:

5. The industry is wondering whether the FDA will recognize standards and practices approved by the Global Food Safety Initiative. Auditors are also seeking greater FDA guidance on auditor competency standards. Will the Agency address these key issues at the time it issues its final regulation?   We will know shortly.

OFW Law has been closely following FSMA developments for years. See, this link to our Ag/FDA blog. Stay tuned as FDA starts to issue its final regulations in just a couple weeks.

More From


Subscribe to receive OFW’s Food & Agriculture World Insights Newsletter.