This article was originally written by Vicam.
INTRODUCTION
Full implementation of the Food Safety Modernization Act (FSMA) ushers in a new regulatory climate that raises profound implications for every food and agricultural industry stakeholder. This sweeping reform of food safety law not only calls for stricter FDA oversight of the way agricultural commodities are cultivated, transported, stored, processed, tested, and verified as fit for their intended use, but also authorizes the agency to enforce consistent industry-wide standards. The acquisition of these expanded powers marks a turning point in the FDA’s 110-year history. By mandating proactive measures to prevent harmful substances from entering the supply stream, FSMA replaces the agency’s longstanding policy of responding to outbreaks of contamination after the fact with a more assertive and far-seeing approach to food safety. This white paper outlines the key changes in the FDA’s stance on food safety since the passage of FSMA, the compliance challenges these changes raise, and the growing importance of upstream mycotoxin testing as a FSMA-informed strategy for staying one step ahead of a costly food safety problem.
BEFORE AND AFTER THE FSMA
The main impetus for the new food safety legislation was a spate of highly publicized food-borne illness outbreaks. Continuing concerns about not only the risk of a bioterror attack on the food supply, but also the challenges of maintaining safety and quality across an increasingly globalized supply chain also helped drive the push for stricter regulatory control. Over the years, industry efforts to improve food safety have included increasingly widespread implementation of FDA-sanctioned approaches to contamination control such as Hazard Analysis Critical Control Points (HACCP) plans and Current Good Manufacturing Practices (CGMPs). Before the passage of FSMA, however, the adoption of many of the FDA’s safety recommendations remained voluntary for most of the industry, as did the decision to recall contaminated products. Inspections of food facilities were typically sporadic, rarely included farms or grain elevators, and, in some cases, entailed no meaningful consequences for deviations from FDA guidelines.With the shift from reactive to proactive regulatory policies, the FDA’s emphasis on inspections and enforcement has increased significantly. As this change in the agency’s focus reshapes the food safety landscape, the challenges of adapting to its defining features will require companies at every point in the supply chain to fortify their contamination control strategies with an extra measure of vigilance.
THE NEW REGULATORY SCENE: WHAT TO PREPARE FOR
Legally binding HARPC rules: FDA-registered food and feed facilities must now develop and carry out a food safety plan that identifies all reasonably foreseeable biological, chemical, and physical hazards. The plan must also stipulate appropriate control measures, such as CGMPs and ingredient and product testing, for each hazard. This new Hazard Analysis and Risk-Based Preventive Controls (HARPC) function incorporates many elements of the FDA’s existing HACCP guidelines, but unlike those recommendations, it comprises legally binding rules for an extensive range of food and feed facilities,* including packing and shipping operations. These facilities must not only monitor the progress of their food safety plan but also keep written records detailing the results of their control efforts, including any food safety lapses that occur, subsequent remedial measures, and the effectiveness of those measures. Failure to provide this information at the request of an FDA inspector can result in corrective action.
While the deadline for HARPC compliance has already passed for larger companies, small businesses (i.e., those with fewer than 500 employees) have till August 20, 2017, to satisfy this requirement. Companies that meet the FDA’s “very small business” specifications have an additional year.More frequent, far-ranging, and consequential inspections: In 2011, the FDA inspected more than 19,000 facilities,1 nearly double the number conducted in 20012 and issued 52 percent more warning letters than it did in 2010.3The agency plans to schedule regular inspections of not only food and feed processing plants, but also farms, packing and shipping operations, and grain elevators and other storage facilities.
The frequency of FDA visits will be based on the known safety risks of the food within a facility’s purview and that facility’s compliance history, as well as the rigor and effectiveness of the facility’s food safety plan and preventive controls. Facilities deemed “high-risk” will be inspected at least every 3 years; visits to those that fall outside the high-risk category will occur at least every 7 years. Expanded authority over the feed industry: FSMA requires feed and pet food manufacturers to comply with newly established CGMP rules and supply chain controls that emphasize preventing contamination in raw ingredients. Mandatory recalls: FSMA authorizes the FDA to require responsible parties to recall products in cases of suspected as well as proven contamination. Companies that are required to recall products, as well as those that do so voluntarily, must develop a plan to prevent a reoccurrence of the problem and submit it to the FDA. Stronger control of the global supply chain safety: Under FSMA, importers must verify that their foreign suppliers conform to the same safety standards, including preventive controls, as U.S. food producers.† Recommended methods of confirming suppliers’ compliance include annual audits of suppliers’ facilities, contaminant testing, or review of their food safety records.
Foreign Supplier Verification Programs (FSVP) must be in place by April 31, 2017.Enforceable safety standards for produce farms: In place of recommended guidelines, mandatory science-based safety requirements will apply to all fruits and vegetables that are consumed raw and not destined for processing. As defined by the FDA, the term “produce” also extends to raw mushrooms, sprouts, peanuts, tree nuts, and herbs. The deadline for compliance with these requirements is December 31, 2017, with the exception of small and very small businesses, which must comply by December 31, 2018, and December 31, 2019, respectively.Tougher sanctions: Under FSMA, the FDA has gained the necessary clout to make sure its tougher safety standards stick. Breaches of these standards can lead to heavy financial and legal fallout, including steep re-inspection fees as well as complete shutdowns for facilities that fail inspections. In cases where food safety or purity is in doubt, regulators no longer need compelling evidence to take action.
For instance, the FDA can suspend a company’s registration, revoking its license to ship and import food commodities, if the agency has reason to suspect that one of the company’s products poses a serious health hazard. A reasonable suspicion of contamination or adulteration also serves as sufficient grounds for temporarily detaining shipments. In addition, the agency aims to impose greater accountability on corporate officials, with updated policies recommending criminal prosecution of officials for food safety violations that happen on their watch, even if the official’s failure to prevent the violation was unintentional. Individuals who commit serious violations can face up to 1 year of imprisonment and/or a maximum fine of $100,000 or $250,000, depending on whether or not the violation led to fatalities. For companies, the maximum fine for non-fatal offenses is $200,000; violations that result in death may entail fines of up to half a million dollars.
*Businesses that are exempt from this rule include grain elevators and facilities that meet the FDA’s definition of a primary production or secondary activities farm. Farms that also engage in manufacturing and some types of processing may be subject to either the full requirements or a modified version of the rule. Seafood and juice processors that are already subject to a legally binding HACCP regulation are also exempt from HARPC requirements. (For more details see http://sustainableagriculture.net/blog/pc-rule-analysis-part-1/.) † Manufacturers that are already subject to HARPC rules are exempt from this requirement.‡ The produce rule does not apply to farms that meet certain FDA-defined criteria.
(See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm.)
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