The road to FSMA
Oct. 10, 2013
by Laurie Gorton
Like all US food manufacturers, wholesale bakers and snack food makers have many questions about the implementation of the Food Safety Modernization Act (FSMA) and the new regulations these bring to the food manufacturing environment. This will be a hot topic at this fall’s many food industry meetings, especially the International Baking Industry Exposition Oct. 6-9 at Las Vegas.
Baking & Snack recently sat down with Stephen Sundlof, DVM, PhD, senior adviser for animal and human food safety, EAS Consulting Group, Alexandria, VA, to discuss FSMA’s many implications and where this new law will take the food industry.
EAS, which specializes in Food and Drug Administration (FDA) regulatory matters, is staffed with former FDA compliance and inspection officials who are assisted by an extensive network of consultants with many years of FDA and industry experience.
Dr. Sundlof is an internationally recognized leader in food and feed safety, who served in the agency for 18 years, including 14 years as director of the Center for Veterinary Medicine and more than two years as director of the Center for Food Safety and Applied Nutrition. Prior to joining the agency in 1994, he was a professor at the University of Florida’s College of Veterinary Medicine.
Baking & Snack: How will new FSMA rules about raw agricultural commodities affect the baker’s major ingredient, wheat? Or the snack food maker’s potatoes and corn?
Dr. Stephen Sundlof: The proposed rule excludes from the definition of “produce” food grains, meaning the small, hard fruits or seeds of arable crops, or the crops bearing these fruits or seeds, that are grown and processed for use as meal, flour, baked goods, cereals and oils rather than for fresh consumption (including cereal grains, pseudocereals, oilseeds and other plants used in the same fashion). Examples of food grains would include barley, dent- and flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, cotton seed and soybeans.
Potatoes are considered to be “produce” in the proposed rule but are exempt from the regulation because they are on a list of several fruits and vegetables that are rarely consumed raw.
Even though bakers will be largely unaffected by the produce safety regulations, they will be fully subject to the preventive controls regulations.
How will ingredients imported from overseas be affected? What can bakers do to ensure uninterrupted supply?
All ingredients including vitamins must be produced in accordance with the preventive controls requirements of FSMA, whether they are produced in foreign countries or domestically. Furthermore, importers of ingredients will be required to establish a Foreign Supplier Verification Program (FSVP) to ensure that food imported into the US is produced in compliance with processes and procedures that provide the same level of public health protection as foods produced domestically. Under FSMA, FDA shifted much of its responsibility for ensuring the safety of imported food and food ingredients to importers. Once FSMA is fully implemented, it will be illegal to import food or food ingredients if the importer does not have in place an FSVP. This will present an onerous burden on importers who have heretofore not come under FDA regulation.
To guard against potential supply chain disruptions, food manufacturers should require that their suppliers source imported ingredients from importers and brokers with an established FSVP.
What chance does FDA have of meeting the Nov. 30 deadline for releasing proposed FSMA regulations?
The prospects for FDA to meet the court-ordered deadline for issuing the proposed major rules required under FSMA appear to be quite favorable. The five major rules subject to the Nov. 30 deadline are Hazard Analysis and Preventative Controls for Human Food, Preventative Controls for Animal Feed, Produce Safety Standards, Foreign Supplier Verification and Accredited Third-Party Certification.
As of July 26, four of the proposed rules have been published. The proposed rule on Preventive Controls for Animal Feed continues to be held up at the White House Office of Management and Budget (OMB), where it has remained for more than a year and a half. Faced with the court-ordered deadline, OMB is likely to release the last remaining proposed rule by Nov. 30.
It is far less certain whether FDA can meet the June 30, 2015, deadline set by the court to publish the five final rules. While FDA has made a herculean effort to draft these very complex rules, much of the process is outside the agency’s control. All regulations must be cleared through the Department of Health and Human Services and OMB before they can be issued. This can result in considerable delays that would likely push the publication date beyond the deadline.
Do you think Congress will get involved to make sure FSMA deadlines are met?
Congress set mandatory deadlines for FDA to issue proposed and final regulations, which are different from the court-ordered deadlines issued by the US District Court of Northern California in July. For all five proposed rules, FDA was unable to meet Congress’ publication deadline.
It is common practice for Con-gress to set statutory deadlines that agencies are unable to meet. As a result, imembers of Congress chastise the agency for failure to comply; otherwise, there are few repercussions. In this case, it is unlikely that Congress would get involved.
Will fully implemented FSMA change the number or frequency of requested third-party audits? Why?
On July 26, FDA issued a proposed rule on accreditation of third-party auditors. In the proposed rule FDA stated: “Widespread participation and broad acceptance of audits and certifications under the FDA program help increase efficiency and reduce costs by eliminating redundant auditing to assess foreign suppliers’ compliance with the Federal Food, Drug, and Cosmetic Act.”
Inspections conducted by certified third-party auditors would be mandatory only for imported food determined to pose a safety risk and requiring certification by FDA as a condition of granting admission to a food and for issuing foreign facility certifications that will be used by importers to establish eligibility for the Voluntary Qualified Importer Program. However, FDA believes that there will be much broader adoption by the food industry of third-party audits performed by auditors certified by FDA-recognized accreditation bodies. If this turns out to be true, then the need for multiple audits to satisfy the requirements of different customers may be reduced as FDA-accredited third-party audits become the industry-recognized gold standard.