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Petition Asks FSIS to Declare 31 Salmonella Strains as Adulterants

23 января 2020 г.

Marler Clark LLP filed a petition on behalf of several individuals and consumer groups on January 19, asking USDA’s Food Safety and Inspection Service (FSIS) to issue an interpretive rule declaring 31 salmonella strains as per se adulterants in meat and poultry products. These strains, which the petition refers to as the “Salmonella Outbreak Serotypes,” include four antibiotic-resistant strains—Salmonella hadar, heidelberg, newport, and typhimurium—as well as Salmonella dublin, enteritidis, and infantis. The petition seeks expedited review of its request on the grounds that these strains have been shown to be linked to foodborne illness outbreaks and/or product recalls and, as such, constitute an imminent threat to public health.

According to the petition, declaring these 31 strains as adulterants would promote the goals of the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act to protect public health by encouraging the meat and poultry industry to implement more effective safeguards and oversight measures. The petition relies heavily on its interpretation of precedent established following the 1993 Escherichia coli, when USDA declared Escherichia coli O157:H7 a per se adulterant in raw ground beef through interpretive rulemaking.

Petitioners

Along with Food & Water Watch, Consumer Federation of America, and Consumer Reports, petitioners include Rick Schiller, Steven Romes, and the Porter family. The petition states that Schiller, from San Jose, California, developed reactive arthritis and colonic diverticulitis after becoming infected by Salmonella heidelberg in 2013. Romes, from Gilbert, Arizona, developed irritable bowel syndrome as a result of a 2018 outbreak caused by Salmonella newport. The Porter family, from Rainier, Washington, were three of the 192 reported victims of the 2015 Salmonella I 4,[5],12:i:- outbreak.

Arguments

The petition focuses on the interpretive rulemaking process followed by USDA in 1994 to declare Escherichia coli O157:H7 a per se adulterant in raw ground beef. It argues that FSIS has the authority to declare the 31 salmonella strains per se adulterants through interpretive rulemaking because the proposed rule would meet the criteria set out in American Mining Congress v. Mine Safety & Health Administration, 995 F.2d 1106, 1112 (D.C. Cir. 1993), and reaffirmed in Texas Food Industry Ass’n v. Espy, 870 F. Supp. 143, 147-48 (W.D. Tex. 1994). More specifically, the petition argues that because the FMIA does not require USDA to engage in substantive rulemaking to determine whether a particular substance is an adulterant, the agency has “‘the discretion to proceed through case-by-case adjudication and interpretive orders, rather than through the rulemaking process.’” Espy, 870 F. Supp. at 147 (quoting Avoyelles Sportsmen’s League, Inc. v. Marsh, 715 F.2d 897, 909 (5th Cir. 1983)).

The petition also argues that the issuance of such a rule would not be arbitrary or capricious or not in accordance with law. First, it notes that the court in Espy held that the agency may declare substances to be adulterants to “spur[] industry to take greater preventive measures” and when the agency’s “changing policy is a rational response to an emerging problem.” Espy, 870 F. Supp. at 148. The petition contends that, similarly, FSIS can effectively ban these 31 strains in order to encourage the meat and poultry industry to engage in more effective preventive measures against salmonella outbreaks as it did with Escherichia coli O157:H7. Second, the petition argues that despite the Espy court’s acknowledgement that salmonella is not a per se adulterant, these 31 strains are adulterants in both meat and poultry products because of the following reasons:

  1. They do not occur naturally in the final products.
  2. A long history of outbreaks has shown that they render final products that are injurious to human health.
  3. FSIS recognizes them as adulterants when contaminated final products cause a foodborne illness.
  4. Scientific studies have shown that the salmonella pathogen is more resilient than previously thought.
  5. The prevalence and severity of cross-contamination—primarily caused by poor sanitation and cooking practices among consumers—is greater than previously recognized.
  6. Consumer education on proper sanitation and cooking practices has failed to prevent salmonella illnesses and outbreaks.

Implications

As this summary suggests, the petition’s arguments hinge largely on the applicability of the Espy precedent to current issues involving salmonella, notwithstanding circumstances unique to the processing and consumption of ground beef and related products that were recognized at that time. It also relies heavily on the assertion that salmonella should not be classified as a naturally occurring substance in finished products, notwithstanding longstanding agency policy to the contrary.

At a broader policy level, the central questions for all interested parties to evaluate are, first, what public health benefits would be achieved if the relief requested here were granted? And, second, what would the practical consequences be throughout the entire food chain?

Hopefully these issues will become clearer on the public record in the wake of this submission.