This September, the USDA published its final rule to modernize swine slaughter inspection. The Final Rule for the Modernization of Swine Slaughter Inspection amends the federal meat inspection regulations. The New Swine Inspection System (NSIS) is the culmination of a 20-year process spanning four presidential administrations and is aimed at modernizing the swine slaughter inspection system. It represents the first major overhaul of federal swine slaughter regulations in more than 50 years.
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Extraordinary advancements in science and technology have fundamentally altered our understanding of food safety. As a result, the predominantly organoleptic inspections conducted by the federal government since the early 20th century are approaching the point of obsolescence. According to Sonny Perdue, who heads the USDA, the NSIS is “the culmination of a science-based and data-driven rule-making process which builds on the food safety improvements made in 1997, when USDA introduced a system of preventive controls for industry.”
According to the executive summary published in the final rule, the USDA Food Safety Inspection Service (FSIS) established the new rule with three primary goals in mind: to improve the effectiveness of inspection, to more efficiently and effectively use USDA’s limited resources, and to facilitate industry innovation by revoking maximum line speeds and allowing establishments to reconfigure evisceration lines. Collectively, the FSIS hopes the new rules will reduce the presence of pathogens in pork products and improve compliance with the Humane Methods of Slaughter Act. The rule applies to establishments that slaughter swine market hogs. Establishments that slaughter swine other than market hogs are not eligible to operate under the NSIS unless they obtain a waiver under the Salmonella Initiative Program.
The NSIS has generated significant controversy and at least one lawsuit has already been filed to challenge the law. Here’s what you need to know about the rule, the controversy surrounding it, and how the new rules may inform the future trajectory of regulatory oversight in the food industry.
The Slaughter Rules
Unlike most regulatory regimes, the NSIS offers companies the choice of whether to adopt the new inspection protocols. Companies that elect not to operate pursuant to the NSIS will remain subject to traditional inspection protocols. Some of the amended regulations, however, will affect all swine slaughter establishments, regardless of the inspection system under which they operate.
Specifically, all swine slaughter establishments will be required to develop, implement, and maintain written procedures to prevent contamination by enteric pathogens, and to eliminate visible fecal material, ingesta, and milk throughout slaughter and dressing operations. These procedures must be memorialized in Hazard Analysis Critical Control Point (HACCP) Plans, sanitation standard operating procedures, or other prerequisite programs. Additionally, the procedures must include microbial sampling and analysis to monitor process control for enteric pathogens. Establishments will be required to collect and test at least two carcass samples for microbial organisms, one at pre-evisceration and one at post-chill (after completion of all slaughter interventions). Importantly, companies must prove the measures are effective in controlling illness-causing pathogens.
For companies participating in the NSIS, establishment personnel will now be tasked with sorting and removing unfit animals before ante-mortem inspection. Previously, this task was undertaken by FSIS inspectors. Although this is one of the more controversial aspects of the new rule, FSIS inspectors will continue to conduct 100 percent of ante-mortem and carcass inspections and will still conduct post-mortem inspections after personnel have identified and trimmed any defects. Companies must also develop written procedures ensuring that unfit animals do not enter the food supply, and personnel must tag, tattoo, or otherwise mark swine that are deemed unfit.
The rule mandates maintaining records documenting the total number of animals and carcasses sorted and removed per day and the reasons for their removal. If, during sorting activities, personnel identify any animals suspected to have a reportable or foreign animal disease, they are to immediately notify FSIS inspectors. Among the other changes to recordkeeping requirements, companies will now be required to maintain records documenting that ready-to-cook pork products comply with the new regulations. That is, ready-to-cook products must be evaluated to ensure they are free of visible defects or materials that would render them unsuitable for cooking without further processing.
Another key component of the rule is aimed at more effectively utilizing USDA resources. The general idea is that by streamlining deployment of inspectors, the agency will be able to conduct more offline inspection activities, which are ostensibly more effective in terms of ensuring food safety. Put differently, the agency posits that shifting inspection personnel from on-line inspection to offline verification activities will improve inspection efficacy overall, and thus improve food safety outcomes. While that may at first seem counterintuitive, it isn’t necessarily so. Emerging food safety issues are often detectable in the context of trends, i.e., gradual increases in the presence of indicator organisms. Such increases would of course be invisible to on-line inspectors.
Finally, the rule revokes maximum line speeds. As a result, companies will now be able to set their own line speeds, provided they are able “to maintain process control for preventing fecal contamination and meeting microbial performance measures for carcasses during the slaughter operation.” Importantly, the FSIS will still retain the ability to slow or stop the line if necessary. According to the USDA, based on the results of its pilot programs over the last 15 years, revoking maximum line speeds is unlikely to result in a higher prevalence of Salmonella.
For companies that intend to operate under the NSIS, the deadline to notify their FSIS District Office is March 30, 2020. Establishments that do not notify their District Office of their intent by March 30, 2020, will be deemed to have chosen to continue operating under their existing inspection system. The regulations that prescribe procedures for controlling contamination throughout the slaughter and dressing process, and the regulations governing new recordkeeping requirements, will take effect on Dec. 30, 2019, in companies with 500 or more employees. Companies with 10 to 499 employees will have until Jan. 29, 2020.
Critics of the new rule argue that it puts the fox in charge of the henhouse. Unfortunately, much of the backlash has been based on misleading or inaccurate information. The provisions generating the most controversy have been those placing establishment personnel in roles previously occupied by USDA inspectors. Critics further argue that placing personnel in an inspection or “sorting” role creates an inherent conflict of interest, whereby employees might be faced with the prospect of reprisals if they are perceived as too aggressive in ferreting out animals. But, in fact, most companies are contractually protected against having to pay for unfit animals. And while it is true that by the USDA’s own estimates, there could be a 40 percent reduction of on-line inspection personnel in some facilities, it is also true that the FSIS will continue inspecting 100 percent of animals before slaughter and 100 percent of carcasses by carcass inspection. Thus, the fears appear to be largely groundless.
Another oft-criticized aspect of the new rules is the revocation of maximum line speeds. Under the new rule, establishments will be allowed to determine for themselves what line speeds are adequate to effectively eliminate fecal contamination and comply with microbial standards. The argument against this rule is that abolishing maximum line speeds will incentivize companies to put profits over the safety of workers and consumers. Notwithstanding these concerns, FSIS inspectors will retain authority to reduce line speeds if they believe an establishment is operating unsafely. If it appears to FSIS inspectors that a plant is operating outside of safe parameters, they will be able to step in and take action. Thanks to the more efficient deployment of FSIS inspectors under the new rules, the FSIS will be better positioned to identify emerging problems.
To this point, industry has been largely supportive of the new regulations. The general consensus appears to be that the amended regulations will give establishments greater operational autonomy to pursue novel food safety improvements. Likewise, the science itself supports the notion that reducing the number of on-line inspectors, more efficiently deploying agency resources, and fostering industry innovation will ultimately enhance overall food safety. Specifically, the USDA conducted a quantitative probabilistic food safety risk assessment to evaluate the potential changes in Salmonella illness risks that would result from modification of FSIS inspection allocation. The peer-reviewed findings confirmed that the rule’s measures are likely to lead to an overall reduction of foodborne illness. This is what it means to modernize. Stated differently, maintaining historical numbers of on-line inspectors is, increasingly, a waste of the USDA’s already limited resources. Those resources would be better devoted to performing other food safety related roles.
Unfortunately, in the realm of science and regulation, more effective policies are not necessarily more popular. Likewise, the extraordinary science and years of careful research underlying the changes are difficult to distill into a readily consumable format. As a result, we are likely to see continued controversy in the food industry as we continue to refine and modernize food safety in years to come.
Chappelle is a food industry lawyer and consultant at Food Industry Counsel, LLC. Reach him at firstname.lastname@example.org. Stevens, also a food industry attorney, is a founding member of Food Industry Counsel, LLC. Reach him at email@example.com.