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The Essential 13: Processed Food

Preventive Controls for Processed Food: What's at Stake?

From frozen meals and spices to nut butters and cheeses, processed foods are a nearly ubiquitous part of the American diet. They also account for a growing number of foodborne illness outbreaks, which in today’s modern industrialized food system can be breathtaking in scale and devastating in impact. In early 2013, for example, various Farm Rich frozen products infected with a virulent strain of E. coli, sickened at least 35 people across 19 states. In all, about 10 million products, including the company’s Mozzarella Bites and Mini Quesadillas, were recalled in response to the outbreak. Roughly 300,000 pounds of the recalled products had been purchased by schools, and the overwhelming majority of those affected by the tainted food were children.[i] More recently, Listeria-tainted cheese products produced by Roos Foods led to at least one death while causing at least seven reported cases of illnesses, including three cases in infants.[ii] The number of people actually harmed in these and other food illness outbreaks is likely much larger as the vast majority of cases often go undiagnosed or unreported. The Centers for Disease Control, for instance, estimate that for every reported case of Salmonella poisoning, another 38 go unreported.[iii]

The most infamous food illness outbreak related to processed foods in recent years was the massive Salmonella outbreak caused by peanut butter and peanut paste products manufactured by the now-defunct Peanut Corporation of America. Throughout 2007 and 2008, the company—then among the largest peanut-processing plants in the country—began shipping out products it knew were contaminated with Salmonella.[iv] These shipments triggered a 48-state outbreak, killing nine people and sickening at least 714 others, half of whom were children.[v] The outbreak led to the largest food recall in U.S. history, involving hundreds of companies and thousands of products.[vi] Following the outbreak, federal food safety investigators found deplorable conditions at the Peanut Corporation of America’s processing plants, including leaking roofs, widespread mold contamination, standing water, and even dead rodents. It was well known among many industry insiders that these conditions had existed at the company’s facilities for decades.[vii] Since then, top executives from Peanut Corporation of America, including the owner Stewart Parnell, have been convicted of various federal crimes for their role in the outbreak.[viii]

Beyond the immediate health impacts, outbreaks can be economically damaging for the entire industry involved. For example, companies that sourced peanut products from the Peanut Corporation of America had to undertake costly recalls of their own. The owner of one small business estimated that her company suffered around $1 million in losses related to the recall.[ix] Even companies that were not involved suffered substantial losses, as many consumers were scared off from buying all brands of peanut butter, resulting in decreased sales of roughly 25 percent.[x]

Bacteria and other pathogens are not the only threats posed by processed foods; the processing system also introduces the risk of contaminating foods with common allergens such as dairy products, tree nuts, or peanuts. Typically, food items that contain these common allergens must carry a label declaring their presence, so that individuals with allergies can avoid becoming unwittingly exposed. Processed foods that have been accidentally contaminated with these allergens would likely lack such a label, which could endanger the health of individuals with allergies. In fact, the presence of so-called “undeclared” allergens arising from the manufacturing process has become the most common reason for initiating recalls of processed foods—and the health risks they pose can be severe.[xi] According to one Food and Drug Administration (FDA) study, 520 recalls were undertaken between 2005 and 2010 due to undeclared allergens; roughly 10 to 15 percent of the victims of the tainted food experienced anaphylaxis, the most severe—and potentially fatal—form of allergic reaction.[xii]

Processed animal foods can also be a dangerous source of outbreaks, endangering not only the animals that consume the foods but also the humans that live or work with them. In 2012, for example, Diamond Pets Foods initiated a large recall of its products that had been contaminated by Salmonella during the manufacturing process. Several dogs became ill or died as a result, and at least 14 people were also sickened through contact with the food or the infected dogs.[xiii]

To better address these risks, the FDA is working on separate preventive controls rules for the manufacture of processed human and animal foods. These two rulemakings are part of the agency’s efforts to implement the 2011 Food Safety Modernization Act (FSMA), a law designed to overhaul the U.S. food safety system so that it focuses on preventing foodborne illness rather than reacting to outbreaks after they have already begun.

What’s the Holdup?

The FDA’s development of preventive controls for human and animal foods is already years behind schedule. The FSMA mandated that the FDA issue its final rule on preventive controls for human food no later than July 2012; for the preventive controls for animal food, the FDA was supposed to have issued a proposed rule by October 2011 and the final rule within nine months of the end of the comment period on the proposal. The agency blew past all of these deadlines. The proposal for human food was not issued until January 2013 and the proposal for animal food was not issued until October 2013. Since then, the FDA has fallen even further behind schedule, announcing in December 2013 that it would undertake the unusual step of issuing re-proposals to address some of the early comments it received on the initial proposals.[xiv] The agency only recently issued those re-proposals, in September 2014.[xv] Rather than go through the unnecessary delay caused by issuing these re-proposals, the agency should have simply incorporated any relevant changes made in response to the public comments as it developed the final rules.

Industry opposition has contributed to the FDA’s slow development of the initial proposals as well as the later decision to re-propose each of the preventive controls rules. While at the Office of Information and Regulatory Affairs (OIRA)—where the initial proposals languished for well over a year, causing the FDA to miss a statutory deadline—White House economists significantly weakened both rules by removing several key monitoring and training requirements. Since then, powerful industry trade groups, including the Grocery Manufacturers Association and the Food Marketing Institute, have sought to prevent the FDA from fixing those holes as it worked toward a final rule.[xvi] The trade associations’ efforts have apparently succeeded, as the agency has dedicated much of the re-proposals to addressing their arguments and justifying its ability to reinstate the provisions excised by OIRA.

What Should the Rules Do?

The rules will require covered food processors to develop and implement a Hazard Analysis and Risk-Based Preventive Controls (HARPC) system. The HARPC system is, in essence, self-regulation because food manufacturers are responsible for identifying the potential hazards in their processes and then implementing controls to minimize or prevent those hazards. The FDA’s role is limited to reviewing some companies’ HARPC plans to ensure they meet basic standards. This kind of self-regulation is risky, but many food safety advocates consider its proactive and preventive approach an improvement over the current system, which is almost entirely reactive to outbreaks.

Combined, the initial proposals and later re-proposals offer a good start on improving the safety of processed human and animal foods as compared to the status quo, but they can be strengthened in important ways. The rules should require that processors develop HARPC systems that employ the best available methods for preventing food-safety hazards—including those related to pathogens and allergens—that are justified by current science and that address the risks presented by their operations. The controls rule for human foods should be amended to require: reviews of consumer complaints; environmental monitoring for pathogens reasonably likely to occur; finished product testing; supplier approval and verification programs; and reviews of the records associated with these activities. The FDA should also narrow the exemptions in the rules. For human foods, only processors with less than $250,000 in annual sales should be exempt from the requirement to develop HARPC plans. For animal foods, only processors with less than $500,000 in annual sales should be exempt. As drafted, the proposals’ current exemptions allow room for unnecessary exposures to risk from companies that can afford safe procedures.

The rules will also seek to modernize the current good manufacturing practices (CGMP) regulations that apply to processed human foods, while extending these CGMP requirements to animal food processors for the first time. The CGMP requirements can be strengthened by establishing additional requirements covering basic sanitation and training.

What’s Next?

Update: In November 2015, following years of delay, the FDA published its final Foreign Supplier Verification Program and Accreditation of Third Parties rules in the Federal Register.  The agency was under a court-ordered deadline to complete the rule by October 2015, which was set after the FDA had failed to issue the rules according to the statutory deadlines.

For both rules, the final versions largely tracked what the FDA had set out in the supplemental proposals.  Together, they establish what amounts to a complex system of self-regulation for foreign-based food producers that import products to the United States. Generally speaking, systems of self-regulation rarely inspire much confidence.  But, compared to the current approach—which is basically to do nothing—these new rules still represent a huge advance. And with more and more of the food on U.S. tables and store shelves coming from abroad, they are now more important than ever.  As with the other rules that make up the FDA’s new food safety program, the ultimate success of its new regulations addressing imported food safety will largely turn on whether Congress sees fit to provide the FDA with adequate resources to perform robust oversight of both the importers and the third-party auditors to ensure effective compliance.  In the short- to medium-term, it appears unlikely that such resources will be made available.

For more on the final rules, see this statement from CPR's Thomas McGarity.

Next: Produce safety

 


[i] Carla Gillespie, Farm Rich E. coli Outbreak Sickened 35, Food Poisoning Bulletin, Apr. 1, 2014, http://foodpoisoningbulletin.com/2014/farm-rich-e-coli-outbreak-sickened-35/ (last visited Oct. 30, 2014).

[ii] U.S. Dept. of Health & Human Servs., Ctrs. for Disease Control & Prevention, Multistate Outbreak of Listeriosis Linked to Roos Foods Dairy Products (Final Update) (Apr. 18, 2014), http://www.cdc.gov/listeria/outbreaks/cheese-02-14/ (last visited Oct. 30, 2014).

[iii] Andrew C. Voetsch et al., FoodNet Estimate of the Burden of Illness Caused by Nontyphoidal Salmonella Infections in the United States, 38(Supplement 3) Clinical Infectious Diseases S127 (2004), available at http://cid.oxfordjournals.org/content/38/Supplement_3/S127.full.

[iv] Officials Call for Criminal Probe into Salmonella Recall, USA Today, Jan. 28, 2009, available at http://usatoday30.usatoday.com/news/health/2009-01-27-peanut-salmonella_N.htm.

[v] Jesse Newman, Peanut Executive Found Guilty in Salmonella Trial, Wall St. J., Sept. 19, 2014, available at http://online.wsj.com/articles/head-of-company-that-distributed-salmonella-tainted-peanuts-found-guilty-1411149368.

[vi] Julie Schmit & Elizabeth Weise, Peanut Product Recalls Spread Fast, USA Today, Feb. 2, 2009), available at http://usatoday30.usatoday.com/money/industries/food/2009-02-01-peanut-butter-recall-salmonella_N.htm; Karla Cook, Peanut Recall’s Ripples Feel Like a Tidal Wave for Some Companies, N.Y. Times, Feb. 25, 2009, available at http://www.nytimes.com/2009/02/26/business/smallbusiness/26sbiz.html.

[vii] Lyndsey Layton & Nick Miroff, The Rise and Fall of a Peanut Empire, Wash. Post, Feb. 15, 2009, available at http://www.washingtonpost.com/wp-dyn/content/article/2009/02/14/AR2009021401758.html?hpid=topnews.

[viii] Newman, supra note 27.

[ix] Cook, supra note 28.

[x] Andrew Martin & Liz Robbins, Fallout Widens as Buyers Shun Peanut Butter, N.Y. Times, Feb. 6, 2009, available at http://www.nytimes.com/2009/02/07/business/07peanut.html?_r=0.

[xi] Undeclared Allergens Top Reason for Second-Quarter Recalls, Food Safety News, Aug. 21, 2013, http://www.foodsafetynews.com/2013/08/undeclared-allergens-top-reason-for-second-quarter-recalls/#.VCM0xfldV8E (last visited Oct. 30, 2014).

[xii] Jonel Aleccia, Hidden Danger: Undeclared Allergens Lurk in Many Foods, NBC News, June 6, 2014, http://www.nbcnews.com/health/allergies/hidden-danger-undeclared-allergens-lurk-many-foods-n124626 (last visited Oct. 30, 2014).

[xiii] Juan Carlos Rodriguez, Costco, Diamond Pay $2M To Settle Dog Food Salmonella Suit, Law360, Jan. 29, 2014, http://www.law360.com/articles/505144/costco-diamond-pay-2m-to-settle-dog-food-salmonella-suit (last visited Oct. 30, 2014).

[xiv] Press Release, Michael Taylor, Deputy Comm’r for Foods & Vetrinary Med., U.S. Dept. of Health & Human Servs., Food & Drug Admin., Statement on Key Provisions of the Proposed FSMA Rules Affecting Farmers (Dec. 19, 2013), available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm379397.htm; Press Release, U.S. Dept. of Health & Human Servs., Food & Drug Admin., Update on Proposed Rules under the FDA Food Safety Modernization Act (Mar. 19, 2014), available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm389696.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.

[xv] Paul Jenks, FDA Unveils Details on Proposed Food Safety Rules, Roll Call: Healthopolis, Sept. 19, 2014, http://blogs.rollcall.com/healthopolis/fda-unveils-details-on-proposed-food-safety-rules/?dcz (last visited Oct. 30, 2014).

[xvi] See Daniel Arrieta, Docs Outlining OMB's Preventive Control Changes Re-Ignite Testing Debate, InsideHealthPolicy, Mar. 29, 2013.

[xvii] Almond Hullers & Processors Association, FDA Releases Updated FSMA Proposals, http://ahpa.net/current-issues/food-safety-modernization-act-fsma/fda-releases-new-fsma-rules/ (last visited Oct. 30, 2014).

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