FDA Adds Info on Third-Party Auditors, Cost, Traceability to FAQ on FSMA
The Food and Drug Administration has added new information to its frequently asked questions document on the Food Safety Modernization Act. The additions are on leveraging non-FDA resources for compliance inspections; the timeline for third party accreditation and the authorities and tools third-party auditors will have; the effect of the FSMA on compensation for wrongly detained or recalled products; estimated costs of a new FSMA “inspection system”; and the timeline for the pilots on food traceability.
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Working on 3rd-Party Accreditation Regs that Affect Importer Program, High-Risk Food Imports
When asked if it has considered using the private sector Global Food Safety Initiative (GFSI) program1 for third party accreditation, FDA said that it was too early to answer as it is currently developing regulations and model accreditation standards.
FDA does state however, that the FSMA directs it to look to existing standards to avoid unnecessary duplication of costs and efforts. In addition, once the third-party rulemaking is final, accreditation bodies can begin to seek FDA recognition and third-party auditors can begin to seek accreditation from an FDA-recognized accreditation body. FDA adds that direct accreditation of third-party auditors may take place only under certain conditions and after the program has been in effect for two years.
(The FSMA requires FDA to develop a Voluntary Qualified Importer Program (VQIP) which is a user-fee funded program to expedite entry into the U.S. of imported food from qualified importers who offer food for importation from a facility that has a certification by an accredited third party. In addition, based on risk considerations, FDA may require an article of food offered for import into the U.S. to be accompanied by certifications (issued by designated foreign governments or accredited third parties) or other assurances that the food complies. See ITT’s Online Archives 11030720 and 11010426 for summaries of these import provisions involving third-party auditors.)
Third-Party Auditors Will not Have FDA's Authorities
FDA states that accredited third-party auditors will not be commissioned by FDA to have the same authorities and tools of FDA when qualifying imported food companies for entry into the U.S., nor will they otherwise be in the role of regulatory authority, acting on FDA's behalf. This is true regardless of whether the accredited certification body is itself a government (i.e., public) entity.
FSMA Does not Affect Current Tort Law for Wrongly Detained or Recalled Products
According to FDA, there is nothing in the FSMA that changes existing rules regarding compensation available for those whose products are determined to have been recalled or detained without cause, such as, for example, the Federal Tort Claims Act.
FDA Expects Some Costs when Facility Controls & Produce Safety Regs in Place
FDA states that it is too soon to know what the costs will be for consumers and farmers of the new “FSMA inspection system,” described in a question as including new inspectors, new processing, additional labs, and reporting to Congress. However, FDA anticipates there will be some initial costs with other regulations on facility preventive controls and the produce safety.
(See ITT’s Online Archives 11110215 and 11071128 for summaries of FDA reopening the comment period on food facility preventive controls and stating it expected to issue a proposed rule on produce safety by Spring 2012.)
Product Tracing Pilots to be Priority as "Inspection & Compliance"
Regarding a question on the timeline for its two product tracing pilots (one for processed foods and one for produce), FDA states that it is clear that it cannot meet all of the deadlines in the statute. Therefore, it is focusing first on those with the greatest public health benefit, such as preventive controls, inspection and compliance, and the import provisions. Product tracing is a component of the Inspection and Compliance Team. FDA adds that as new information becomes available on the pilots and prioritization, as well as other aspects of FSMA, FDA will update its website.
(See ITT’s Online Archives 11090811 and 11110425 for summaries of the pilots and of FDA stating that its FSMA priorities are facility controls, produce, foreign verification, and certification.)
FDA Working Group Looking at Engaging Partners to Conduct Inspections, Etc.
FDA was asked to elaborate on how it is looking to engage partners, particularly NGOs, within the regulated community to conduct compliance inspection and facilitate reporting to better leverage limited governmental resources and staff. FDA replied that it has formed a work group to look at how to engage partners and has a field management directive that outlines improvements in communications between FDA and state agencies.
1GFSI is a collaboration of global food safety experts from retailer, manufacturer and food service companies, as well as service providers associated with the food supply chain. It sets requirements for food safety schemes through a benchmarking process in order to improve cost efficiency throughout the food supply chain.