On January 24, 2020, the Food Safety Inspection Service (FSIS) announced that it had received a Petition by Marler Clark LLP, on behalf of several individuals (victims of food poisoning from Salmonella containing meat or poultry products) and three consumer advocacy organizations (Food & Water Watch, Consumer Federation of America, and Consumer Reports), requesting that FSIS declare 31 salmonella serotypes adulterants; Petitioners identified the 31 serotypes because they have been implicated in one or more outbreaks associated with poultry or meat or product recalls.
Petitioners request that FSIS act through interpretive rulemaking. According to Petitioners, an interpretative rule is the appropriate action. Pointing to an FSIS action in 1994 when the Agency declared E. coli O157:H7 in ground beef an adulterant, they discuss that the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) do not require that FSIS engage in substantive rulemaking requiring notice and comment procedures. In fact, under the Administrative Procedures Act, 5 U.S.C. § 553(b)(3)(A), FSIS may issue “interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice.”
Whether Salmonella is an adulterant has been a topic of discussion for decades. Most recently in 2011, when the Center for Science in the Public Interest petitioned FSIS to classify four strains of antibiotic resistant (ABR) Salmonella as adulterants. In 2014, FSIS denied CSPI’s petition because, according to the Agency, there was insufficient information to support the requested action; among other things, FSIS concluded that the CSPI petition provided insufficient information about differences between ABR and non-ABR Salmonella.
The current Petition specifically identifies the 31 Salmonella serotypes as are adulterants because:
- they are not naturally present in the final products but a result of contamination during processing after slaughter, and
- the serotypes’ associations with outbreaks due to consumption of meat and poultry demonstrates that the serotypes ordinarily render meat and poultry products injurious to human health.
Thus, the Petitioners claim, the 31 Salmonella serotypes are “added substances,” and they must only meet the “may be injurious,” rather than the ordinary injurious criterion to be deemed adulterants. That said, even if FSIS were to disagree that the Salmonella in meat and poultry is an added substance, Petitioners assert and discuss evidence that the identified serotypes are “ordinarily injurious.” Thus, they claim, the serotypes are adulterants under the FMIA, 21 U.S.C. § 601(m)(1), and the PPIA, 21 U.S.C. § 453(g)(1).
Petitioners discuss at some length the argument that cooking will inactivate the pathogens; FSIS and others have asserted that Salmonella in meat and poultry can be inactivated by cooking. To counter this argument, Petitioners present evidence that some Salmonella serotypes are more heat resistant than previously believed. Moreover, it is not just undercooking; the bigger threat comes from cross-contamination and studies show that consumers are uninformed about the proper way to handle (Salmonella-containing) meat and poultry. The continued reliance on inexpert consumers to prevent foodborne outbreaks due to Salmonella contamination of meat and poultry has been shown ineffective; Petitioners believe FSIS should become proactive and place the responsibility on the industry to avoid the introduction of Salmonella into meat and poultry.
As mentioned above, Petitioners claim that FSIS does not need to engage in substantive rulemaking as a predicate to interpret the FMIA and PPIA and deem a substance an adulterant. Although FSIS could continue to make such determinations on a case-by-case basis, Petitioners believe that an interpretive rule declaring the Salmonella serotypes adulterants would encourage the meat and poultry industry to engage in more effective oversight measures and create and implement effective preventative measures. Petitioners point to the effect of the 1994 interpreted rule on E. coli O157:H7 incidence in meat and poultry as evidence of the effectiveness of the requested action.
FSIS opened a docket on regulations.gov. Comments are due Mar. 23, 2020.