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Federal Register / Vol. 86, No. 128 / Thursday, July 8, 2021 / Notices
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Comment: The poultry industry association said that the guideline includes prescriptive practices that are neither reasonable nor necessary and that are not conducive to chicken processing. For example, the association stated that sanitizing hand-held knives between each carcass is not reasonable, nor would it result in significant pathogen reduction on final products.
According to the association, sanitization between each carcass would increase handling time and create more opportunity for pathogen outgrowth, thereby increasing food-safety risks.
Response: The guideline recommends sanitizing knives in 180-degree water or an antimicrobial solution after cutting or trimming each carcass, which should result in the reduced transfer of pathogens from one carcass to the next.
FSIS guidance is intended to offer practical solutions to food safety problems, with some recommendations likely more useful in small and very small establishments and others more suitable for large establishments. Most of the information in this guidance should be useful to all establishments, including small and very small establishments. Although bacterial outgrowth is not a result of time alone, it would certainly be one consideration for an establishment contemplating this factor in its process.
Comment: The poultry industry association added that other recommendations in the guidelines, such as that to limit solution reuse during injection marinating to prevent contamination, is not supported by scientific evidence.
Response: FSIS updated the guidelines to include citations to scientific studies indicating that marination of non-heat-treated poultry parts can result in larger bacterial populations on the poultry,1 depending on the type of marinade used.2 Injection or other contact across carcasses can introduce a potential point for crosscontamination. A prime example in the guidance showing this mechanism of internalizing pathogens is an outbreak of Escherichia coli O157:H7 in beef steaks that occurred in 2007.3
1 See Hinton, et al., ARS abstract for International Association for Food Protection 2004, Comparison of psychrotrophic bacterial flora of fresh and marinated chicken breast fillets during refrigerated storage.
2 See R. Thanissery and D.P. Smith, Effect of Marinade Containing Thyme and Orange Oils on Broiler Breast Fillet and Whole Wing Aerobic Bacteria During Refrigerated Storage, in The Journal of Applied Poultry Research 23 2: 228
232; May 2014
3 See FSIS. 2007. Pennsylvania Firm Recalls Beef Products for Possible E. coli O157:H7 Recall Release. Available at: https www.fsis.usda.gov/

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Establishments should consider the effects of injected solutions in their hazard analyses 9 CFR 417.2a and support all decisions made in the hazard analysis, 9 CFR 417.5a1. At this step in a process, an establishment could address the risk in several ways, depending on its process. One approach described in the guidelines is the use of an ultraviolet light intervention applied to the marinade solution between uses.4
Additionally, the formulation of a marinade may include antimicrobial components, to achieve a specific pH or antimicrobial activity; examples of acceptable ingredients for this use are listed in the lookup table of FSIS
Directive 7120.1, Safe and Suitable Ingredients.
Lotting Practices Comment: A poultry industry association asked the Agency to revise its recommendations on lotting practices to remove the emphasis on microbiological independence relating to pathogens that do not legally adulterate raw product by their presence alone, or per se.
Response: FSIS did not make changes to its recommendations on lotting practices. Concepts related to microbiological independence, or the unlikelihood of cross-contamination, apply to all pathogens. Considering lotting practices in such cases can help to maximize the value of testing and process control throughout production.
Under HACCP, establishments may test for pathogens to verify that they are adequately addressing microbial hazards.
Also, as discussed in the December 6, 2012, Federal Register Notice on HACCP-plan reassessment for notready-to-eat NRTE comminuted poultry products 77 FR 72686, at 72689, when a NRTE product is credibly linked to an outbreak of illness caused by a pathogen, FSIS may consider the product to be adulterated, even if the pathogen does not adulterate the implicated NRTE product per se.
Comment: The poultry industry association said that, in addition to the above concerns regarding microbiologically-based lotting practices, the Agency should be aware that: Lot-traceback information may be commercially sensitive; separation in time and space is difficult in wps/wcm/connect/5a217ede-de72-474a-b3846643a8ac12f8/Recall_019_2007_
Release.pdf?MOD=AJPERES.
4 Beers KL, Cook PE, Coleman CW, and Waldroup AL. 2010. Efficacy of ultraviolet light systems for control of microorganisms in poultry and beef brine and marinade solutions. Poult Sci. 89 ESupplement 1: 615.

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establishments running multiple lines and mixing flocks; and microbiological testing takes days to completetoo late for processed poultry already in commerce. For these reasons, according to the poultry industry association, the Agency should remove these recommendations from the guideline.
Response: As mentioned in the previous response, in situations where pathogenic organisms in NRTE products have been linked to foodborne illness outbreaks, FSIS has deemed the products to be adulterated. FSIS and members of the regulated industry have been interested in preventing situations like those. Accordingly, the guideline contains recommendations for lot separation, traceback, and microbiological testing. These approaches to monitoring, tracking, and controlling potentially contaminated products can help in preventing pathogen spread and illness outbreaks.
Comment: The poultry industry association said that recordkeeping recommendations must be relevant to establishment operations and must allow for flexibility according to establishment size and resources.
Response: The recordkeeping recommendations in the guideline are premised on the assumption that the establishment already has records that meets the HACCP, Sanitation Standard Operating Procedures, and other regulatory requirements. Establishments have significant flexibility in meeting these recordkeeping requirements and recordkeeping will vary in technical and other aspects from establishment to establishment. Additionally, the guideline sets out recordkeeping elements that are associated with sampling and testing and that are fairly basic and general. As such, FSIS has not revised the recordkeeping guidance.
Process Control Comment: A poultry industry association requested that the Agency clarify key concepts and terms used in the guidance. For example, the association said that, while FSIS states throughout the guidance that establishments should reduce pathogens to acceptable levels, the guideline is not clear enough about what those acceptable levels are. The poultry industry association suggested that FSIS
use its pathogen reduction performance standards as examples of acceptable levels and state that other metrics than prevalence might be used in evaluating acceptable levels.
Response: In the context used in the guidelines, acceptable levels of pathogens are defined by an establishment for use as control
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