FSMA update

September 2013

“Foodborne illness is not just a stomach ache,” cautioned Daniel G. McChesney during his presentation at the 119th Annual Summer Convention of the International Oil Mill Superintendents Association (IOMSA; www.iomsa.org) held in Denver, Colorado, USA, in June 2013. “It can cause life-long chronic disease.”

McChesney is uniquely positioned to give an insider’s view of food safety as director of the US Food and Drug Administration’s (FDA) Office of Surveillance and Compliance in FDA’s Center for Veterinary Medicine in Rockville, Maryland. Although his presentation came six weeks before the release on July 26 of the next two proposed regulations under FSMA, it still provides insight into how FDA plans to proceed with implementation.

Today’s food safety system must meet the demands of a food supply system vastly different from 100 years ago—or even 10 years ago, he noted. “Our food supply is truly global,” he said, adding that food imports are at an all-time high. Fully 75% of seafood, 20% of vegetables, and 50% of fruit are imported, according to FDA data.

The Food Safety Modernization Act (FSMA), which was enacted by the US Congress in 2010, was signed into law by President Barack Obama in January 2011. It mandates a change in how FDA does its work. The current system is reactive to problems but is “not so good at prevention,” McChesney said. “We can’t keep reacting to everything with around 100,000 domestic human food manufacturers and 12,000–15,000 manufacturers of animal feed. We need a better approach.”

The new food safety system will require more on the part of manufacturers, he said. To meet the vision, industry must employ risk-based preventive measures at all appropriate points and manage its supply chains to ensure appropriate measures are being implemented as routine practice. FDA is committed to developing guidance for industry on “how to do it on a day-to-day basis,” he stressed. “But in the end, it is industry that must primarily be responsible for food safety.”

According to McChesney, vegetable oil processing is a relatively low-risk industry in terms of food safety. “I had a hard time coming up with problems in this industry,” he said, with the exception of past issues with distillates and dioxins from bleaching clay.

McChesney also addressed the timing of the regulations. Because the proposed FSMA rules are being published in a piecemeal fashion, the scheduling of final implementation is problematic. For example, the proposed regulations concerning produce safety and preventive controls for human foods were published in January 2013; the comment period for preventive controls has been extended until October 2013. The proposed regulations on preventive controls for animal foods, foreign supplier verification program, and third-party certification remain under review at the Office of Management and Budget (OMB).

The proposed regulation on preventive controls for animal feed establishes current good manufacturing practices (CGMP)—which has not yet been released—does not include allergens as a hazard, McChesney said. The elements of CGMP include: personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, and warehousing and distribution. He noted that the CGMP concerning equipment and utensils does not apply to suppliers.

“Is your equipment easily cleaned out? That might be a selling point,” he advised the equipment suppliers in the audience.

Once hazards are identified, manufacturers must have a written plan about how to control them. In the oilseed crushing industry, “hazards are more likely to be found on the by-product/co-product side,” he noted.

The exemptions and modified requirements for the preventive controls for animal feed “probably do not apply” to the vegetable oil processing industry, McChesney said. It is possible, however, that facilities that sell castoffs into the animal feed industry could qualify on the feed side of their businesses for exemptions and modified requirements.

One of the definitions of facilities that qualify for exemptions are those in which the total annual food sales average less than $500,000 per year during the last three years and in which sales to qualified end users exceed sales to others.

FDA estimates that about 4,500 pet and animal feed firms qualify as small businesses and produce roughly 87% of manufactured pet food and animal feed based on sales. Very small businesses have less than $1 million in annual sales. “If you run a mixed business with very little on the animal feed side, you might qualify,” McChesney said.

The safety of imported foods under FSMA will require importer accountability for knowing where the foreign food is coming from and that it meets the standards set by the United States. “If products can’t be inspected, they will be blocked,” he cautioned.

“We want your input,” McChesney stressed. “Come visit or talk by phone.” General questions can be emailed to FSMA@fda.hhs.gov and more information about the regulations is available at www.fda.gov/fsma.

Questions from the floor raised specific issues regarding FSMA. One questioner had problems registering his facility on the FDA website. “I don’t know if I succeeded or not,” he complained. McChesney suggested anyone with similar concerns contact him directly at Daniel.McChesney@fda.hhs.gov.

After a question regarding the staggered comment periods for the various pieces of FSMA, McChesney said: “We will have to sync up the comment periods. The vision now is that we will leave the comment periods open until everything is synchronized. If the preventive controls for animal feed regulations are not released [during the third quarter of 2013], it is likely that the comment period for the preventive controls for human food will stay open. We have told OMB that this is a package and that we can’t do them sequentially.”

McChesney also advised supervisors of facilities that are currently following preventive controls for human food to use those controls for everything, including co-products going into animal feed. The alternative, he said, would be to separate out the animal feed product “if there’s a split in the processing.”

Lawsuit Determination and Farm Bill Complications

About 10 days after the IOMSA Annual Summer Convention, Judge Phyllis Hamilton of the US District Court of Northern California issued a ruling regarding the lawsuit brought against FDA by two watchdog groups (the Center for Food Safety and the Center for Environmental Health) for the agency’s failure to meet FSMA implementation deadlines. Hamilton rejected FDA’s proposed timelines for completion of the regulations, which suggested “target timelines” of 2015–2016 for publication of all final rules.

According to Hamilton’s ruling, FDA must publish all of the regulations required under FSMA by June 30, 2015. While finding the deadlines submitted by FDA to be “too fluid,” Hamilton also recognized the complexity of FDA’s task.

Further complicating implementation of FSMA was a provision added to the farm bill that passed the US House of Representatives in June 2013 requiring FDA to conduct a “scientific and economic analysis” of FSMA rules before they can advance. Industry observers suggested that the US Senate likely would strip the measure from the bill when the House and Senate versions are reconciled in conference.

Imported Food Safety Regs Released

McChesney’s remarks about FDA’s desire to synchronize comment periods were substantiated when the agency released the next two proposed regulations under FSMA on July 26.

The two rules concern Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors. In brief, importers must verify that their suppliers meet US safety standards for domestic producers. Comment on the two new rules are due on November 26; the comment periods for the produce safety and preventive controls in human foods regulations have been extended until November 15.

As for the missing piece of the FSMA puzzle, FDA told Inform in an email that “it is FDA’s intention to publish the proposed rule for Preventive Controls for Food for Animals prior to November 30, 2013.”