Changes to the Campylobacter Verification Testing Program: Revised Performance Standards for Campylobacter in Not-Ready-To-Eat Comminuted Chicken and Turkey and Related Agency Procedures, 38203-38210 [2019-16765]

Download as PDF Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Notices discussions during the meeting. Written statements on meeting topics may be filed with the Committee before or after the meeting by sending them to the person listed under FOR FURTHER INFORMATION CONTACT. Written statements may also be filed at the meeting. Please refer to Docket No. APHIS–2019–0045 when submitting your statements. This notice of meeting is given pursuant to section 10 of the Federal Advisory Committee Act. Done in Washington, DC, this 30th day of July 2019. Cikena Reid, Committee Management Officer, USDA. [FR Doc. 2019–16758 Filed 8–5–19; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2018–0044] Changes to the Campylobacter Verification Testing Program: Revised Performance Standards for Campylobacter in Not-Ready-To-Eat Comminuted Chicken and Turkey and Related Agency Procedures Food Safety and Inspection Service, USDA. ACTION: Notice and request for comments. AGENCY: The Food Safety and Inspection Service (FSIS) is proposing and requesting comments on revised pathogen reduction performance standards for Campylobacter in notready-to-eat (NRTE) comminuted chicken and turkey products based on a microbiological method change from direct-plating to enrichment. The Agency is taking this step because the enrichment method more effectively recovers Campylobacter in contaminated poultry samples as compared to the direct-plating method. FSIS will consider comments received on this notice before announcing the final standards in the Federal Register and assessing whether establishments are meeting the standards. After collecting sufficient data, FSIS plans to propose and request comments on revised pathogen reduction performance standards for Campylobacter in young chicken and turkey carcasses and in raw chicken parts, also based on the enrichment method. jbell on DSK3GLQ082PROD with NOTICES SUMMARY: Submit comments on or before October 7, 2019. DATES: VerDate Sep<11>2014 19:21 Aug 05, 2019 Jkt 247001 FSIS invites interested persons to submit comments on this notice. Comments may be submitted by one of the following methods: • Federal eRulemaking Portal: This website provides commenters the ability to type short comments directly into the comment field on the web page or to attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the on-line instructions at that site for submitting comments. • Mail, including CD–ROMs, etc.: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250–3700. • Hand- or Courier-Delivered Submittals: Deliver to 1400 Independence Avenue SW, Room 6065, Washington, DC 20250–3700. Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS– 2018–0044. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to https:// www.regulations.gov. Docket: For access to background documents or comments received, call (202) 720–5627 to schedule a time to visit the FSIS Docket Room at 1400 Independence Avenue SW, Room 6065, Washington, DC 20250–3700. FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant Administrator, Office of Policy and Program Development by telephone at (202) 205–0495. SUPPLEMENTARY INFORMATION: FSIS is responsible for verifying that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and properly labeled and packaged. Campylobacter is the most common bacterial cause of foodborne illness in the United States. The Centers for Disease Control and Prevention (CDC) estimate Campylobacter infections affect 1.3 million people every year in the United States.1 During 2018, CDC’s Foodborne Diseases Active Surveillance Network, or FoodNet,2 reported that the incidence of foodborne infection was highest for Campylobacter (19.5 per 100,000 population).3 Most non-dairy, outbreak-associated Campylobacter illnesses are attributed to the ADDRESSES: 1 https://www.cdc.gov/Campylobacter/faq.html. 2 https://www.cdc.gov/foodnet/. 3 https://www.cdc.gov/mmwr/volumes/68/wr/ mm6816a2.htm. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 38203 consumption of poultry.4 Campylobacter outbreaks are not commonly identified considering how often people get sick from this bacteria, but the frequency of outbreaks has been increasing.5 Poultry Carcasses and Raw Chicken Parts FSIS finalized and announced Campylobacter performance standards for establishments that produce young chicken carcasses and turkey carcasses on May 14, 2010 (75 FR 27288). FSIS initially proposed to use the results from both the 1-mL direct-plating analytical method and the 30-mL enrichment analytical method to assess whether establishments were meeting the Campylobacter performance standards for young chicken and turkey carcasses.6 However, on March 21, 2011, after further analysis and in response to public comments, FSIS announced that it would: Only use the direct-plating method results to assess whether young chicken and turkey slaughter establishments were meeting the performance standards; also concurrently analyze young chicken and turkey carcass rinsates using the enrichment method; and conduct an internal analysis of all of these results— direct-plating and enrichment method generated results—to develop additional policy options (76 FR 15282). In July 2011, FSIS began compiling sample sets 7 to generate data to assess whether young chicken and turkey slaughter establishments were meeting the Campylobacter standards. Poultry slaughter establishments subject to the Campylobacter performance standards were assessed against the standards based solely on the results generated using the direct-plating method. However, samples collected as part of these sample sets were analyzed concurrently using the enrichment method. After FSIS completed two sample sets for nearly 90 percent of the young chicken and turkey slaughter establishments, the results generated using both the 1-mL direct-plating and 4 https://www.cdc.gov/foodsafety/ifsac/pdf/P192016-report-TriAgency-508.pdf. 5 https://www.cdc.gov/Campylobacter/outbreaks/ outbreaks.html. 6 FSIS’s direct-plating and enrichment analytical methods are described in the Microbiology Laboratory Guidebook, Chapter 41; at https:// www.fsis.usda.gov/wps/wcm/connect/0273bc3d2363-45b3-befb-1190c25f3c8b/MLG-41.pdf? MOD=AJPERES. 7 At the time, FSIS inspection program personnel were collecting poultry carcass samples over a defined number of sequential days of production to complete a sample set. In May 2015, FSIS began testing poultry carcasses using a continuous sampling program and discontinued the previous set-based verification projects. E:\FR\FM\06AUN1.SGM 06AUN1 38204 Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Notices 30-mL enrichment methods were evaluated. FSIS announced in the Constituent Update on May 31, 2013 that it had evaluated the available Campylobacter sample set data 8 and the analysis at that time showed that the direct-plating method was sufficiently sensitive to identify poultry carcass establishments with substandard process control. Thus, on June 3, 2013, FSIS suspended the use of the 30-mL enrichment method for Campylobacter for young chicken and turkey carcasses.9 However, in July 2016, when FSIS modified its sampling procedure for young chicken and turkey carcasses and raw chicken parts by replacing buffered peptone water (BPW) with neutralizing BPW (nBPW), the Agency began to observe a marked and significant reduction in Campylobacter recovery from turkey carcasses and chicken parts using the 1-mL direct-plating method, suggesting nBPW affected Campylobacter recovery in these products. In May 2018, FSIS further investigated this effect by performing a side-by-side analysis of poultry carcasses and raw chicken parts samples with the direct-plating and enrichment methods and found significantly higher percentages of Campylobacter positive samples, indicating more effective recovery of Campylobacter, using the enrichment method as compared to the direct-plating method for young chicken carcasses (18 percent compared to 1 percent), turkey carcasses (1 percent compared to 0 percent) and chicken parts (16 percent compared to 2 percent). In the near future, FSIS also intends to propose and request comments on revised Campylobacter performance standards for these commodities based on the enrichment method. Comminuted Poultry On January 26, 2015, FSIS proposed new Campylobacter performance standards for NRTE comminuted chicken and turkey products and raw chicken parts, including a cost-benefit analysis (80 FR 3940), and released a risk assessment estimating the effect of these new performance standards on reducing Campylobacter illnesses attributed to these products (2015 Risk Assessment).10 FSIS finalized the jbell on DSK3GLQ082PROD with NOTICES 8 https://www.fsis.usda.gov/wps/wcm/connect/ 9a3a7078-0ff4-4ebc-8de6-ad889382fd7f/Const_ Update_053113.pdf?MOD=AJPERES. 9 FSIS announced full discontinuation of this analysis for poultry carcasses on February 21, 2014 (79 FR 9875). 10 The 2015 Risk Assessment is available at https://www.fsis.usda.gov/wps/wcm/connect/ afe9a946-03c6-4f0d-b024-12aba4c01aef/Effects- VerDate Sep<11>2014 19:21 Aug 05, 2019 Jkt 247001 performance standards on February 11, 2016 (81 FR 7285). These Campylobacter performance standards were based on the 1-mL direct-plating method and, for both NRTE comminuted chicken and turkey products, specified one (1) allowable positive sample in 52 samples. In 2014, before these performance standards were announced, FSIS tested NRTE comminuted chicken, but not NRTE comminuted turkey products using the 30-mL enrichment method and found the enrichment method to have greater Campylobacter recovery and thus generate more positive results. In the February 2015 Federal Register notice, FSIS announced its intention to continue to perform the 30-mL enrichment method concurrently with the 1-mL direct-plating method for both NRTE comminuted chicken and turkey products, and to analyze data generated from both analytical approaches (81 FR at 7292). As part of this effort, all NRTE comminuted chicken and turkey product samples collected between June 2015 and May 2017 were analyzed for the presence of Campylobacter using both the 1-mL direct-plating method and the 30-mL enrichment method. In May 2017, FSIS suspended use of the enrichment method while it analyzed the data. The Agency resumed using the enrichment method concurrent with the direct-plating method on August 27, 2018.11 These results were not affected by the July 2016 switch from BPW to nBPW because nBPW is not used to collect or test NRTE comminuted poultry product samples.12 Enrichment Method As stated above, FSIS originally developed Campylobacter performance standards for NRTE comminuted chicken and turkey products using the 1-mL direct-plating method while simultaneously analyzing the same samples using the 30-mL enrichment method. The enrichment method enhances the probability of recovering Campylobacter from raw poultry samples. For both methods, the test portion consists of 325 grams of NRTE comminuted poultry suspended in 1625 mL of BPW. Because the direct-plating method requires at least 1,950 colony forming units (CFU) in the suspended Performance-Standards-Chicken-PartsComminuted.pdf?MOD=AJPERES. 11 https://www.fsis.usda.gov/wps/portal/fsis/ newsroom/meetings/newsletters/constituentupdates/archive/2018/ConstUpdate082718. 12 The sampling procedures for NRTE comminuted chicken and turkey products can be seen at https://www.fsis.usda.gov/wps/wcm/ connect/801ffca3-a226-45c4-ac68-10670e3ac32b/ NRTE-Comminuted-Poultry-Sampling-Program.pdf? MOD=AJPERES. PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 mixture to be reasonably likely to detect a positive Campylobacter sample, its theoretical limit of detection (LOD) is 6 CFU/gram. The enrichment method requires at least 65 CFU in the suspended mixture for Campylobacter to be detected, giving it a theoretical LOD of 0.2 CFU/gram. The enrichment method includes a two-day enrichment step, which may allow for the repair of bacteria injured by exposure to extremes of pH, temperature, pressure, antimicrobial compounds, or other injurious conditions and growth of any viable bacteria present. Therefore, the enrichment step increases the potential for the growth and recovery of Campylobacter cells injured during comminuted poultry processing steps as compared with the direct- plating method. The enrichment method for Campylobacter is comparable to the enrichment method currently used to assess the pathogen reduction performance standards for Salmonella in raw poultry. The enhanced recovery of the enrichment method compared to the direct-plating method will improve FSIS’s ability to distinguish establishments that are meeting or not meeting the Campylobacter performance standards. The Campylobacter performance standards proposed in this notice were revised to account for a microbiological method change and would retain the same potential benefits and costs as the original, 1-mL directplating-based performance standards. A peer-reviewed manuscript was published which explains the technical details used to determine the mathematical equivalence between the 1-ml direct- plating and 30-mL enrichment methods. The article uses the NRTE comminuted chicken performance standard as an example.13 Brief explanations of FSIS’s process for developing the current Campylobacter performance standards for NRTE comminuted chicken and turkey based on the 1-mL direct-plating method and the revised performance standards for NRTE comminuted chicken and turkey based on the 30-mL enrichment method are provided below. How FSIS Develops Campylobacter Performance Standards The current FSIS Campylobacter and Salmonella performance standards are based on a 2-class attributes sampling plan, which specifies a maximum 13 Williams, M.S., Ebel, E.D., Golden, N.J., 2018. Revising a Constrained 2-Class Attributes Sampling Plan When Laboratory Methods are Changed. Microbial Risk Analysis; https://doi.org/10.1016/ j.mran.2018.12.002. E:\FR\FM\06AUN1.SGM 06AUN1 Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Notices number of positive samples out of a fixed number of total samples. This can also be expressed as a maximum allowable percent positive. Positive samples are those in which the pathogen is detectable using a microbiological assay. Since 2011, FSIS has taken a common approach to determine performance standards for each pathogen-product pair, and this approach is described most recently in the January 26, 2015 Federal Register (80 FR at 3942). Briefly, FSIS measures the public health effect of a performance standard as the number of illnesses avoided each year.14 This effect is calculated from the volume-weighted prevalence of a contaminated poultry product before and after successfully implementing the performance standard. Volume-weighted prevalence means that establishments with higher production volumes have a greater influence on the overall prevalence estimates. Because the volume-weighted prevalence after implementing a performance standard cannot be known when the standard is proposed, FSIS models the impact of the performance standard by assuming that a certain percentage of establishments (and their production volume) would initially not meet the standard but eventually do meet it. This is referred to as the ‘‘compliance fraction.’’ Using the sampling and production volume data collected from each eligible establishment, FSIS can estimate the impact of all possible performance standards. Establishments are classified as meeting or not meeting each possible performance standard. The compliance fraction is then used to estimate the number of avoided or reduced illnesses. FSIS’s current performance standards for Campylobacter in poultry were intended to achieve at least a 33-percent reduction in illnesses, a target based on Healthy People 2020 goals.15 16 The jbell on DSK3GLQ082PROD with NOTICES 14 Ebel, Williams et al. 2012. Simplified framework for predicting changes in public health from performance standards applied in slaughter establishments. Food Control 28:250–257. 15 HHS. (2010). ‘‘Healthy People Topics & Objectives: Food Safety.’’ Reduce infections caused byCampylobacter species transmitted commonly VerDate Sep<11>2014 19:21 Aug 05, 2019 Jkt 247001 proportion of establishments and their production volume initially not meeting the performance standard also allows FSIS to estimate the costs associated with implementing the performance standard (i.e., the costs to industry). How FSIS Developed the Current Campylobacter Performance Standards for NRTE Comminuted Chicken and Turkey Using the 1-mL Direct-Plating Method To estimate the illnesses reduced by the current NRTE comminuted chicken and turkey Campylobacter performance standards, FSIS sampled establishments producing NRTE comminuted chicken and/or turkey products between June 2013 and May 2014. Each sample was tested for Campylobacter using the 1-mL direct-plating method. Three important factors varied across the establishments: Production volume, prevalence of contaminated samples, and the number of samples collected. Underlying all of the results is a statistical distribution of volume-weighted establishment prevalence accounting for these factors.17 This distribution is demonstrated as the smooth line in Figure 1 (a). The risk assessment model uses estimates from the statistical distribution of volume-weighted prevalence and assumes a 50-percent compliance fraction to predict the illness reduction. Figure 1 (b) shows the predicted illnesses reduced by Campylobacter performance standards based on 1-mL direct-plating data collected between 2013 and 2014. Using through food https://www.healthypeople.gov/2020/ topicsobjectives2020/objectiveslist.aspx?topicId=14. Once the Healthy People 2030 objectives have been finalized, FSIS intends to assess whether changes to its performance standards are warranted. 16 Although the Healthy People 2020 goal of 33percent reduction in Campylobacter illnesses was achieved with other poultry products, the most restrictive and achievable performance standard for NRTE comminuted turkey is 1 positive in 52 samples, which would achieve a 19-percent reduction in Campylobacter illnesses. 17 Williams, M.S., Ebel, E.D., Cao, Y., 2013. Fitting distributions to microbial contamination data collected with an unequal probability sampling design. Journal of Applied Microbiology 114, 152– 160. PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 38205 this curve, and FSIS’s stated intent of at least a 33-percent illness reduction for Campylobacter from NRTE comminuted chicken, FSIS selected a performance standard of one (1) allowable positive out of 52 samples, or a maximum allowable percent positive of 1.9. FSIS actually predicted a 37-percent reduction in the illness rate for Campylobacter after implementing the NRTE comminuted chicken performance standard, corresponding to an annual reduction of approximately 1,300 illnesses. The statistical distribution is also used to determine the proportion of NRTE comminuted chicken product that would meet a Campylobacter performance standard of one (1) positive out of 52 samples. Figure 1 (c) shows the proportion of product that would meet the performance standard based on the 1-mL direct-plating data collected from 2013–2014. With a performance standard of one (1) positive out of 52 samples, 56 percent of all NRTE comminuted chicken product (corresponding to 24 percent of eligible establishments) would initially not meet the standard. FSIS used this information to estimate the associated costs. The same procedures were used to determine the Campylobacter performance standard for NRTE comminuted turkey product. FSIS determined that the direct-plating method-based performance standard of one (1) allowable positive in 52 samples in NRTE comminuted turkey product would provide a 19-percent illness reduction, and 20 percent of production volume (which accounts for 9 percent of eligible establishments) would initially not meet the standard.18 BILLING CODE 3410–DM–P 18 FSIS initially intended for Campylobacter performance standards to reduce illness by approximately 33 percent. However, because FSIS found the prevalence for Campylobacter in comminuted turkey to be especially low, the highest practical illness reduction for this product was estimated to be 19 percent. The revised standard based on the 30-mL enrichment method was therefore designed to achieve the same predicted illness reduction of 19 percent. E:\FR\FM\06AUN1.SGM 06AUN1 Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Notices jbell on DSK3GLQ082PROD with NOTICES How FSIS Revised the Campylobacter Performance Standards for NRTE Comminuted Chicken and Turkey Using Data Generated Using the 30-mL Enrichment Method As is discussed above, from June 2015 through May 2017, FSIS tested all NRTE comminuted chicken samples using both the 1-mL direct-plating and 30-mL enrichment methods. There were approximately five times as many samples that tested positive for Campylobacter using the 30-mL enrichment method as compared to the 1-mL direct-plating method (i.e., 267 VerDate Sep<11>2014 19:21 Aug 05, 2019 Jkt 247001 versus 53). FSIS believes this increase was facilitated by a larger test portion size (30-mL compared to 1-mL) and the potential for growth and recovery of injured Campylobacter cells allowed by the enrichment process. FSIS developed a revised Campylobacter performance standard by fitting a statistical distribution of the volume-weighted prevalence and then finding the point that reaches the same illness reduction goal determined for the current, 1-mL direct- plating-based performance standard, which was a 37percent reduction in illnesses. Figure 2 (a) shows the predicted illnesses PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 reduced by potential Campylobacter performance standards based on the 30mL enrichment data collected between 2015 and 2017. A 37-percent reduction in illnesses could be achieved with a 30mL enrichment method-based standard of five (5) positives in 52 samples. That is, the point on the 30-mL curve that reaches a 37-percent reduction in illnesses corresponds to a performance standard of five (5) positives in 52 samples. Similarly, the 1-mL direct-plating and 30-mL enrichment-based curves were used to determine the proportion of NRTE comminuted chicken product that E:\FR\FM\06AUN1.SGM 06AUN1 EN06AU19.045</GPH> 38206 Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Notices jbell on DSK3GLQ082PROD with NOTICES would initially be classified as meeting/ not meeting the standard. Figure 2 (c) shows that a performance standard of five (5) allowable positives in 52 samples would result in 44 percent of production volume meeting the standard. That is, the point on the 30mL curve corresponding to five (5) positives in 52 samples results in 44 percent of the production volume VerDate Sep<11>2014 19:21 Aug 05, 2019 Jkt 247001 meeting the performance standard, and 56 percent not meeting it. A more detailed description of the methodology, and the treatment of statistical uncertainty is presented in the peerreviewed technical manuscript (Williams et al, 2018; citation 12). The same procedures were used to revise the Campylobacter performance standard for NRTE comminuted turkey PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 38207 product. FSIS determined that an enrichment method-based performance standard of five (5) allowable positives in 52 samples would provide a 19percent illness reduction, and 20 percent of production volume (which accounts for 9 percent of eligible establishments) would initially not meet the revised performance standard. E:\FR\FM\06AUN1.SGM 06AUN1 38208 Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Notices jbell on DSK3GLQ082PROD with NOTICES BILLING CODE 3410–DM–C Revised Pathogen Reduction Performance Standards FSIS is proposing revised performance standards to improve the Agency’s ability to identify Campylobacter contamination in NRTE comminuted chicken and turkey VerDate Sep<11>2014 19:21 Aug 05, 2019 Jkt 247001 products using the enrichment method. A summary of the revised Campylobacter performance standards for NRTE comminuted poultry products is provided in Table 1. Should FSIS finalize these proposed performance standards, FSIS will announce the final standards in the Federal Register before assessing whether establishments meet PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 the standards. Any changes to the performance standards for Campylobacter in young chicken and turkey carcasses, and in raw chicken parts, will be proposed in a separate Federal Register notice. As described above, FSIS has revised the pathogen reduction performance standards for Campylobacter in NRTE E:\FR\FM\06AUN1.SGM 06AUN1 EN06AU19.046</GPH> Figure 2. Example of how the predicted illness reduction based on 1-mL direct-plating method generated data was used to revise the Campylobacter performance standard established using 30-mL enrichment method generated data. Panel (a) demonstrates how illness reduction estimates were used to choose a performance standard. A 37-percent reduction in illnesses is predicted by a performance standard of one (1) positive in 52 samples for the 1-mL direct-plating data from 2013-2014, or five (5) positives in 52 samples for the 30-mL enrichment data from 2015-2017. Panel (c) demonstrates how different performance standards would affect the proportion of NRTE comminuted chicken product that would initially meet each potential standard, which FSIS used to calculate the associated costs to industry. A Campylobacter performance standard of either one (1) positive in 52 samples (1-mL direct-plating) or five (5) positives in 52 samples (30-mL enrichment) would predict that 44 percent of production volume would meet the standard, and 56 percent would not meet it. These data are used to determine the associated costs. Note the "direction" of the arrows is reversed from Figures 2 (a) and 2 (b) . FSIS first determines the predicted illness reduction and then uses the corresponding performance standard to determine the associated costs. 38209 Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Notices comminuted chicken and turkey products based on the 30-mL enrichment method, such that the same public health objectives announced in 2015 for the 1-mL direct-plating method-based standards are achieved. Minimum Number of Samples To Assess Performance FSIS uses the following formula to estimate the minimum number of samples (n) needed to assess establishment performance: n = (1/ percent positive allowed) × 100 (80 FR at 3947). Revising the Campylobacter performance standard from one allowable positive per 52 samples (1.9 percent) to five allowable positive samples per 52 samples (9.6 percent) changes the minimum number of samples needed to assess establishments from (1⁄1.9%) × 100), or 52 samples, to (1⁄9.6%) × 100, or 10.4 samples. Because samples are necessarily whole numbers, a fractional number is rounded up to the next highest whole number. Therefore, 11 samples would be the minimum number of samples needed to assess performance for Campylobacter in both NRTE comminuted chicken and comminuted turkey producing establishments under the revised standards. Significantly, since the proposed revised performance standards reduce the minimum number of samples needed to assess establishment performance, FSIS would be able to assess performance for a greater number of otherwise eligible establishments. TABLE 1—REVISED PERFORMANCE STANDARDS FOR Campylobacter IN NRTE COMMINUTED CHICKEN AND TURKEY PRODUCTS Revised performance standard for Campylobacter Product NRTE Comminuted Chicken (325 g sample) ........................................................................ NRTE Comminuted Turkey (325 g sample) .......................................................................... 5 of 52 5 of 52 Revised maximum allowable percent positive * 9.6 9.6 Revised minimum number of samples to assess 11 11 jbell on DSK3GLQ082PROD with NOTICES * Consistent with existing FSIS procedures, if the total number of samples in a 52-week moving window ranges from 11 to 51, FSIS will subtract 1 from the number of positive samples to calculate the percent positive, which is compared to the revised maximum acceptable percent positive determined by dividing 5 by 52 to determine the Category. If the total number of samples in a moving window exceeds 51, FSIS will calculate a percent positive without subtracting 1 from the number of positives. Changes to Related Agency Procedures Once FSIS begins assessing whether establishments meet the revised Campylobacter performance standards, FSIS would use the categorization methodology, as well as the web posting procedures announced in the Federal Register on November 9, 2018 (83 FR 56046; Nov. 9, 2018). As explained in the November 2018 Federal Register notice, the Category status reported on the public website would be based on FSIS sample results during the 52-week window ending the last Saturday of the previous month, and would not include follow-up sampling results, if any were collected and analyzed, as part of the window. In addition, establishments would not be categorized as meeting or not meeting as previously announced in the February 2016 Federal Register notice. Instead, FSIS would categorize eligible establishments using the same 3category system it uses for poultry establishments currently subject to a Salmonella pathogen reduction performance standard. The criteria for each category are as follows: • Category 1: Establishments that have achieved 50 percent or less of the maximum allowable percent positive during the most recently completed 52week moving window. • Category 2: Establishments that meet the maximum allowable percent positive but have results greater than 50 percent of the maximum allowable percent positive during the most VerDate Sep<11>2014 19:21 Aug 05, 2019 Jkt 247001 recently completed 52-week moving window. • Category 3: Establishments that have exceeded the maximum allowable percent positive during the most recently completed 52-week moving window. All other FSIS verification procedures outlined in the February 2016 Federal Register notice are unchanged. Additional Information Should these Campylobacter standards for comminuted poultry products be finalized, FSIS will post aggregate Campylobacter sampling results relative to categories and prevalence estimates for NRTE comminuted chicken and turkey products, consistent with how FSIS handles Salmonella postings.19 FSIS would also announce when it expects to begin posting individual establishment category information in the Federal Register notice that announces final Campylobacter standards for comminuted poultry products. Cost-Benefit Analysis The February 2016 Federal Register notice announcing pathogen reduction performance standards for Salmonella and Campylobacter in NRTE comminuted chicken and turkey products and raw chicken parts 19 The information is posted at https:// www.fsis.usda.gov/wps/portal/fsis/topics/datacollection-and-reports/microbiology/salmonellaverification-testing-program/aggregate-data. PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 included a supplementary cost-benefit analysis (2016 CBA).20 The 2016 CBA estimated the economic effects of the new pathogen reduction performance standards for Salmonella and Campylobacter in both NRTE comminuted poultry and raw chicken parts. The 2016 CBA used estimates on whether establishments would meet the standards and illness reduction estimates from the 2015 Risk Assessment, which relied on results obtained using the direct-plating method. As explained above, FSIS is proposing to revise the pathogen reduction performance standards for Campylobacter in NRTE comminuted chicken and turkey products based on an enrichment method. To ensure the revised performance standards would be statistically equivalent to the previously announced Campylobacter standards for these products, FSIS analyzed 2015– 2017 sample results generated using both the enrichment and direct-plating methods. Based on this analysis, FSIS concluded the revised pathogen reduction performance standards are consistent with the previously announced standards in terms of the estimated reduction in illnesses and the 20 U.S. Department of Agriculture, Food Safety and Inspection Service (FSIS). (2016). Final CostBenefit Analysis Chicken Parts and Not Ready-ToEat Comminuted Poultry Performance Standards; available at: https://www.fsis.usda.gov/wps/wcm/ connect/2f98f0a2-6a89-4316-aa95-86e5b103610f/ CBA-Salmonella-Campy-2014-0023F022016.pdf?MOD=AJPERES. E:\FR\FM\06AUN1.SGM 06AUN1 38210 Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Notices percent of the industry expected to initially not meet the performance standards (Williams et al, 2018; citation 12). Therefore, the associated costs and public health benefits of the revised performance standards remain unchanged from those estimated in the 2016 CBA. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication online through the FSIS web page located at: https:// www.fsis.usda.gov/federal-register. FSIS also will announce and provide a link to it through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at https://www.fsis.usda.gov/subscribe. 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How To File a Complaint of Discrimination To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at https:// www.ocio.usda.gov/sites/default/files/ docs/2012/Complain_combined_6_8_ 12.pdf, or write a letter signed by you or your authorized representative. Send your completed complaint form or letter to USDA by mail, fax, or email: VerDate Sep<11>2014 19:21 Aug 05, 2019 Jkt 247001 Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250–9410. Fax: (202) 690–7442. Email: program.intake@usda.gov. Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA’s TARGET Center at (202) 720–2600 (voice and TDD). Done at Washington, DC: Carmen M. Rottenberg, Administrator. completed in the right locations to increase forest health and productivity, while also contributing to local economies and protecting natural resources. A new NOI will be published for any projects being considered for analysis under an EIS. Dated: July 16, 2019. Frank R. Beum, Acting Associate Deputy Chief, National Forest System. [FR Doc. 2019–16712 Filed 8–5–19; 8:45 am] BILLING CODE 3411–15–P [FR Doc. 2019–16765 Filed 8–5–19; 8:45 am] DEPARTMENT OF AGRICULTURE BILLING CODE 3410–DM–P Forest Service DEPARTMENT OF AGRICULTURE Forest Service Ochoco, Umatilla and WallowaWhitman National Forest; Oregon; Blue Mountain Forest Resiliency Project Forest Service, USDA. Withdrawal of notice of intent to prepare an Environmental Impact Statement. AGENCY: ACTION: The Ochoco, Umatilla and Wallowa-Whitman National Forests are withdrawing their Notice of Intent (NOI) to prepare an Environmental Impact Statement (EIS) for the Blue Mountain Forest Resiliency Project. The original NOI was published in the Federal Register on February 5, 2016. FOR FURTHER INFORMATION CONTACT: Questions concerning this notice should be directed to David Hatfield via mail at Umatilla National Forest Supervisors Office, 72510 Coyote Rd Pendleton, OR 97801; via telephone at 541–278–3855; or via email at david.hatfield@usda.gov. SUPPLEMENTARY INFORMATION: The forest supervisors of the Ochoco, Umatilla and Wallowa-Whitman National Forests have modified the Forest Resiliency Project planning approach from one dedicated interdisciplinary team working across portions of the three national forests to each national forest addressing individual restoration needs through their regular program of work. The forest supervisors decided the most efficient way to ensure successful completion and implementation of this important restoration work would be to transfer all existing data and completed analysis to individual interdisciplinary teams on each forest to more efficiently start and complete local restoration efforts. This decision will also allow each forest to work closely with local communities during project development to ensure the right work is SUMMARY: PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 Southern Region Recreation Resource Advisory Committee Forest Service, USDA. Notice of meeting. AGENCY: ACTION: The Southern Region Recreation Resource Advisory Committee (Recreation RAC) will meet in Decatur, Georgia. The committee is authorized under the Federal Lands Recreation Enhancement Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to provide recommendations to the Secretaries on recreation fees on lands and waters managed by the Forest Service and the Department of the Interior’s Bureau of Land Management in the regions covered by each Committee. Additional Recreation RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following website: https:// www.fs.usda.gov/main/r8/recreation/ racs. DATES: The meetings will be held on the following dates: • Tuesday, August 27, 2019, from 8:30 a.m. to 4:30 p.m., and • Wednesday, August 28, 2019, from 8:30 a.m. to 4:30 p.m., Eastern Standard Time. All Recreation RAC meetings are subject to cancellation. For status of the meeting prior to attendance, please contact Tiffany Williams, by telephone at 404–347–2769 or by email at tiffany.p.williams@usda.gov. ADDRESSES: The meeting will be held at the Courtyard Marriott, 130 Clairemont Avenue, Decatur, Georgia. Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses, when provided, are placed in the record and available for public inspection and copying. The public may inspect comments received SUMMARY: E:\FR\FM\06AUN1.SGM 06AUN1

Agencies

[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Notices]
[Pages 38203-38210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16765]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2018-0044]


Changes to the Campylobacter Verification Testing Program: 
Revised Performance Standards for Campylobacter in Not-Ready-To-Eat 
Comminuted Chicken and Turkey and Related Agency Procedures

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice and request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing and 
requesting comments on revised pathogen reduction performance standards 
for Campylobacter in not-ready-to-eat (NRTE) comminuted chicken and 
turkey products based on a microbiological method change from direct-
plating to enrichment. The Agency is taking this step because the 
enrichment method more effectively recovers Campylobacter in 
contaminated poultry samples as compared to the direct-plating method.
    FSIS will consider comments received on this notice before 
announcing the final standards in the Federal Register and assessing 
whether establishments are meeting the standards.
    After collecting sufficient data, FSIS plans to propose and request 
comments on revised pathogen reduction performance standards for 
Campylobacter in young chicken and turkey carcasses and in raw chicken 
parts, also based on the enrichment method.

DATES: Submit comments on or before October 7, 2019.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by one of the following methods:
     Federal eRulemaking Portal: This website provides 
commenters the ability to type short comments directly into the comment 
field on the web page or to attach a file for lengthier comments. Go to 
https://www.regulations.gov. Follow the on-line instructions at that 
site for submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, 1400 
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
     Hand- or Courier-Delivered Submittals: Deliver to 1400 
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2018-0044. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to https://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202) 720-5627 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant 
Administrator, Office of Policy and Program Development by telephone at 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:  FSIS is responsible for verifying that the 
nation's commercial supply of meat, poultry, and egg products is safe, 
wholesome, and properly labeled and packaged.
    Campylobacter is the most common bacterial cause of foodborne 
illness in the United States. The Centers for Disease Control and 
Prevention (CDC) estimate Campylobacter infections affect 1.3 million 
people every year in the United States.\1\ During 2018, CDC's Foodborne 
Diseases Active Surveillance Network, or FoodNet,\2\ reported that the 
incidence of foodborne infection was highest for Campylobacter (19.5 
per 100,000 population).\3\ Most non-dairy, outbreak-associated 
Campylobacter illnesses are attributed to the consumption of 
poultry.\4\ Campylobacter outbreaks are not commonly identified 
considering how often people get sick from this bacteria, but the 
frequency of outbreaks has been increasing.\5\
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    \1\ https://www.cdc.gov/Campylobacter/faq.html.
    \2\ https://www.cdc.gov/foodnet/.
    \3\ https://www.cdc.gov/mmwr/volumes/68/wr/mm6816a2.htm.
    \4\ https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2016-report-TriAgency-508.pdf.
    \5\ https://www.cdc.gov/Campylobacter/outbreaks/outbreaks.html.
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Poultry Carcasses and Raw Chicken Parts

    FSIS finalized and announced Campylobacter performance standards 
for establishments that produce young chicken carcasses and turkey 
carcasses on May 14, 2010 (75 FR 27288). FSIS initially proposed to use 
the results from both the 1-mL direct-plating analytical method and the 
30-mL enrichment analytical method to assess whether establishments 
were meeting the Campylobacter performance standards for young chicken 
and turkey carcasses.\6\ However, on March 21, 2011, after further 
analysis and in response to public comments, FSIS announced that it 
would: Only use the direct-plating method results to assess whether 
young chicken and turkey slaughter establishments were meeting the 
performance standards; also concurrently analyze young chicken and 
turkey carcass rinsates using the enrichment method; and conduct an 
internal analysis of all of these results--direct-plating and 
enrichment method generated results--to develop additional policy 
options (76 FR 15282). In July 2011, FSIS began compiling sample sets 
\7\ to generate data to assess whether young chicken and turkey 
slaughter establishments were meeting the Campylobacter standards. 
Poultry slaughter establishments subject to the Campylobacter 
performance standards were assessed against the standards based solely 
on the results generated using the direct-plating method. However, 
samples collected as part of these sample sets were analyzed 
concurrently using the enrichment method.
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    \6\ FSIS's direct-plating and enrichment analytical methods are 
described in the Microbiology Laboratory Guidebook, Chapter 41; at 
https://www.fsis.usda.gov/wps/wcm/connect/0273bc3d-2363-45b3-befb-1190c25f3c8b/MLG-41.pdf?MOD=AJPERES.
    \7\ At the time, FSIS inspection program personnel were 
collecting poultry carcass samples over a defined number of 
sequential days of production to complete a sample set. In May 2015, 
FSIS began testing poultry carcasses using a continuous sampling 
program and discontinued the previous set-based verification 
projects.
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    After FSIS completed two sample sets for nearly 90 percent of the 
young chicken and turkey slaughter establishments, the results 
generated using both the 1-mL direct-plating and

[[Page 38204]]

30-mL enrichment methods were evaluated. FSIS announced in the 
Constituent Update on May 31, 2013 that it had evaluated the available 
Campylobacter sample set data \8\ and the analysis at that time showed 
that the direct-plating method was sufficiently sensitive to identify 
poultry carcass establishments with substandard process control. Thus, 
on June 3, 2013, FSIS suspended the use of the 30-mL enrichment method 
for Campylobacter for young chicken and turkey carcasses.\9\
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    \8\ https://www.fsis.usda.gov/wps/wcm/connect/9a3a7078-0ff4-4ebc-8de6-ad889382fd7f/Const_Update_053113.pdf?MOD=AJPERES.
    \9\ FSIS announced full discontinuation of this analysis for 
poultry carcasses on February 21, 2014 (79 FR 9875).
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    However, in July 2016, when FSIS modified its sampling procedure 
for young chicken and turkey carcasses and raw chicken parts by 
replacing buffered peptone water (BPW) with neutralizing BPW (nBPW), 
the Agency began to observe a marked and significant reduction in 
Campylobacter recovery from turkey carcasses and chicken parts using 
the 1-mL direct-plating method, suggesting nBPW affected Campylobacter 
recovery in these products. In May 2018, FSIS further investigated this 
effect by performing a side-by-side analysis of poultry carcasses and 
raw chicken parts samples with the direct-plating and enrichment 
methods and found significantly higher percentages of Campylobacter 
positive samples, indicating more effective recovery of Campylobacter, 
using the enrichment method as compared to the direct-plating method 
for young chicken carcasses (18 percent compared to 1 percent), turkey 
carcasses (1 percent compared to 0 percent) and chicken parts (16 
percent compared to 2 percent). In the near future, FSIS also intends 
to propose and request comments on revised Campylobacter performance 
standards for these commodities based on the enrichment method.

Comminuted Poultry

    On January 26, 2015, FSIS proposed new Campylobacter performance 
standards for NRTE comminuted chicken and turkey products and raw 
chicken parts, including a cost-benefit analysis (80 FR 3940), and 
released a risk assessment estimating the effect of these new 
performance standards on reducing Campylobacter illnesses attributed to 
these products (2015 Risk Assessment).\10\ FSIS finalized the 
performance standards on February 11, 2016 (81 FR 7285).
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    \10\ The 2015 Risk Assessment is available at https://www.fsis.usda.gov/wps/wcm/connect/afe9a946-03c6-4f0d-b024-12aba4c01aef/Effects-Performance-Standards-Chicken-Parts-Comminuted.pdf?MOD=AJPERES.
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    These Campylobacter performance standards were based on the 1-mL 
direct-plating method and, for both NRTE comminuted chicken and turkey 
products, specified one (1) allowable positive sample in 52 samples. In 
2014, before these performance standards were announced, FSIS tested 
NRTE comminuted chicken, but not NRTE comminuted turkey products using 
the 30-mL enrichment method and found the enrichment method to have 
greater Campylobacter recovery and thus generate more positive results. 
In the February 2015 Federal Register notice, FSIS announced its 
intention to continue to perform the 30-mL enrichment method 
concurrently with the 1-mL direct-plating method for both NRTE 
comminuted chicken and turkey products, and to analyze data generated 
from both analytical approaches (81 FR at 7292). As part of this 
effort, all NRTE comminuted chicken and turkey product samples 
collected between June 2015 and May 2017 were analyzed for the presence 
of Campylobacter using both the 1-mL direct-plating method and the 30-
mL enrichment method. In May 2017, FSIS suspended use of the enrichment 
method while it analyzed the data. The Agency resumed using the 
enrichment method concurrent with the direct-plating method on August 
27, 2018.\11\ These results were not affected by the July 2016 switch 
from BPW to nBPW because nBPW is not used to collect or test NRTE 
comminuted poultry product samples.\12\
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    \11\ https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/newsletters/constituent-updates/archive/2018/ConstUpdate082718.
    \12\ The sampling procedures for NRTE comminuted chicken and 
turkey products can be seen at https://www.fsis.usda.gov/wps/wcm/connect/801ffca3-a226-45c4-ac68-10670e3ac32b/NRTE-Comminuted-Poultry-Sampling-Program.pdf?MOD=AJPERES.
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Enrichment Method

    As stated above, FSIS originally developed Campylobacter 
performance standards for NRTE comminuted chicken and turkey products 
using the 1-mL direct-plating method while simultaneously analyzing the 
same samples using the 30-mL enrichment method. The enrichment method 
enhances the probability of recovering Campylobacter from raw poultry 
samples. For both methods, the test portion consists of 325 grams of 
NRTE comminuted poultry suspended in 1625 mL of BPW. Because the 
direct-plating method requires at least 1,950 colony forming units 
(CFU) in the suspended mixture to be reasonably likely to detect a 
positive Campylobacter sample, its theoretical limit of detection (LOD) 
is 6 CFU/gram. The enrichment method requires at least 65 CFU in the 
suspended mixture for Campylobacter to be detected, giving it a 
theoretical LOD of 0.2 CFU/gram.
    The enrichment method includes a two-day enrichment step, which may 
allow for the repair of bacteria injured by exposure to extremes of pH, 
temperature, pressure, antimicrobial compounds, or other injurious 
conditions and growth of any viable bacteria present. Therefore, the 
enrichment step increases the potential for the growth and recovery of 
Campylobacter cells injured during comminuted poultry processing steps 
as compared with the direct- plating method. The enrichment method for 
Campylobacter is comparable to the enrichment method currently used to 
assess the pathogen reduction performance standards for Salmonella in 
raw poultry.
    The enhanced recovery of the enrichment method compared to the 
direct-plating method will improve FSIS's ability to distinguish 
establishments that are meeting or not meeting the Campylobacter 
performance standards. The Campylobacter performance standards proposed 
in this notice were revised to account for a microbiological method 
change and would retain the same potential benefits and costs as the 
original, 1-mL direct-plating-based performance standards. A peer-
reviewed manuscript was published which explains the technical details 
used to determine the mathematical equivalence between the 1-ml direct- 
plating and 30-mL enrichment methods. The article uses the NRTE 
comminuted chicken performance standard as an example.\13\ Brief 
explanations of FSIS's process for developing the current Campylobacter 
performance standards for NRTE comminuted chicken and turkey based on 
the 1-mL direct-plating method and the revised performance standards 
for NRTE comminuted chicken and turkey based on the 30-mL enrichment 
method are provided below.
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    \13\ Williams, M.S., Ebel, E.D., Golden, N.J., 2018. Revising a 
Constrained 2-Class Attributes Sampling Plan When Laboratory Methods 
are Changed. Microbial Risk Analysis; https://doi.org/10.1016/j.mran.2018.12.002.
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How FSIS Develops Campylobacter Performance Standards

    The current FSIS Campylobacter and Salmonella performance standards 
are based on a 2-class attributes sampling plan, which specifies a 
maximum

[[Page 38205]]

number of positive samples out of a fixed number of total samples. This 
can also be expressed as a maximum allowable percent positive. Positive 
samples are those in which the pathogen is detectable using a 
microbiological assay. Since 2011, FSIS has taken a common approach to 
determine performance standards for each pathogen-product pair, and 
this approach is described most recently in the January 26, 2015 
Federal Register (80 FR at 3942). Briefly, FSIS measures the public 
health effect of a performance standard as the number of illnesses 
avoided each year.\14\ This effect is calculated from the volume-
weighted prevalence of a contaminated poultry product before and after 
successfully implementing the performance standard. Volume-weighted 
prevalence means that establishments with higher production volumes 
have a greater influence on the overall prevalence estimates. Because 
the volume-weighted prevalence after implementing a performance 
standard cannot be known when the standard is proposed, FSIS models the 
impact of the performance standard by assuming that a certain 
percentage of establishments (and their production volume) would 
initially not meet the standard but eventually do meet it. This is 
referred to as the ``compliance fraction.''
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    \14\ Ebel, Williams et al. 2012. Simplified framework for 
predicting changes in public health from performance standards 
applied in slaughter establishments. Food Control 28:250-257.
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    Using the sampling and production volume data collected from each 
eligible establishment, FSIS can estimate the impact of all possible 
performance standards. Establishments are classified as meeting or not 
meeting each possible performance standard. The compliance fraction is 
then used to estimate the number of avoided or reduced illnesses. 
FSIS's current performance standards for Campylobacter in poultry were 
intended to achieve at least a 33-percent reduction in illnesses, a 
target based on Healthy People 2020 goals.15 16 The 
proportion of establishments and their production volume initially not 
meeting the performance standard also allows FSIS to estimate the costs 
associated with implementing the performance standard (i.e., the costs 
to industry).
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    \15\ HHS. (2010). ``Healthy People Topics & Objectives: Food 
Safety.'' Reduce infections caused byCampylobacter species 
transmitted commonly through food https://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=14. Once the 
Healthy People 2030 objectives have been finalized, FSIS intends to 
assess whether changes to its performance standards are warranted.
    \16\ Although the Healthy People 2020 goal of 33-percent 
reduction in Campylobacter illnesses was achieved with other poultry 
products, the most restrictive and achievable performance standard 
for NRTE comminuted turkey is 1 positive in 52 samples, which would 
achieve a 19-percent reduction in Campylobacter illnesses.
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How FSIS Developed the Current Campylobacter Performance Standards for 
NRTE Comminuted Chicken and Turkey Using the 1-mL Direct-Plating Method

    To estimate the illnesses reduced by the current NRTE comminuted 
chicken and turkey Campylobacter performance standards, FSIS sampled 
establishments producing NRTE comminuted chicken and/or turkey products 
between June 2013 and May 2014. Each sample was tested for 
Campylobacter using the 1-mL direct-plating method. Three important 
factors varied across the establishments: Production volume, prevalence 
of contaminated samples, and the number of samples collected. 
Underlying all of the results is a statistical distribution of volume-
weighted establishment prevalence accounting for these factors.\17\ 
This distribution is demonstrated as the smooth line in Figure 1 (a).
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    \17\ Williams, M.S., Ebel, E.D., Cao, Y., 2013. Fitting 
distributions to microbial contamination data collected with an 
unequal probability sampling design. Journal of Applied Microbiology 
114, 152-160.
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    The risk assessment model uses estimates from the statistical 
distribution of volume-weighted prevalence and assumes a 50-percent 
compliance fraction to predict the illness reduction. Figure 1 (b) 
shows the predicted illnesses reduced by Campylobacter performance 
standards based on 1-mL direct-plating data collected between 2013 and 
2014. Using this curve, and FSIS's stated intent of at least a 33-
percent illness reduction for Campylobacter from NRTE comminuted 
chicken, FSIS selected a performance standard of one (1) allowable 
positive out of 52 samples, or a maximum allowable percent positive of 
1.9. FSIS actually predicted a 37-percent reduction in the illness rate 
for Campylobacter after implementing the NRTE comminuted chicken 
performance standard, corresponding to an annual reduction of 
approximately 1,300 illnesses.
    The statistical distribution is also used to determine the 
proportion of NRTE comminuted chicken product that would meet a 
Campylobacter performance standard of one (1) positive out of 52 
samples. Figure 1 (c) shows the proportion of product that would meet 
the performance standard based on the 1-mL direct-plating data 
collected from 2013-2014. With a performance standard of one (1) 
positive out of 52 samples, 56 percent of all NRTE comminuted chicken 
product (corresponding to 24 percent of eligible establishments) would 
initially not meet the standard. FSIS used this information to estimate 
the associated costs.
    The same procedures were used to determine the Campylobacter 
performance standard for NRTE comminuted turkey product. FSIS 
determined that the direct-plating method-based performance standard of 
one (1) allowable positive in 52 samples in NRTE comminuted turkey 
product would provide a 19-percent illness reduction, and 20 percent of 
production volume (which accounts for 9 percent of eligible 
establishments) would initially not meet the standard.\18\
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    \18\ FSIS initially intended for Campylobacter performance 
standards to reduce illness by approximately 33 percent. However, 
because FSIS found the prevalence for Campylobacter in comminuted 
turkey to be especially low, the highest practical illness reduction 
for this product was estimated to be 19 percent. The revised 
standard based on the 30-mL enrichment method was therefore designed 
to achieve the same predicted illness reduction of 19 percent.
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BILLING CODE 3410-DM-P

[[Page 38206]]

[GRAPHIC] [TIFF OMITTED] TN06AU19.045

How FSIS Revised the Campylobacter Performance Standards for NRTE 
Comminuted Chicken and Turkey Using Data Generated Using the 30-mL 
Enrichment Method

    As is discussed above, from June 2015 through May 2017, FSIS tested 
all NRTE comminuted chicken samples using both the 1-mL direct-plating 
and 30-mL enrichment methods. There were approximately five times as 
many samples that tested positive for Campylobacter using the 30-mL 
enrichment method as compared to the 1-mL direct-plating method (i.e., 
267 versus 53). FSIS believes this increase was facilitated by a larger 
test portion size (30-mL compared to 1-mL) and the potential for growth 
and recovery of injured Campylobacter cells allowed by the enrichment 
process.
    FSIS developed a revised Campylobacter performance standard by 
fitting a statistical distribution of the volume-weighted prevalence 
and then finding the point that reaches the same illness reduction goal 
determined for the current, 1-mL direct- plating-based performance 
standard, which was a 37-percent reduction in illnesses. Figure 2 (a) 
shows the predicted illnesses reduced by potential Campylobacter 
performance standards based on the 30-mL enrichment data collected 
between 2015 and 2017. A 37-percent reduction in illnesses could be 
achieved with a 30-mL enrichment method-based standard of five (5) 
positives in 52 samples. That is, the point on the 30-mL curve that 
reaches a 37-percent reduction in illnesses corresponds to a 
performance standard of five (5) positives in 52 samples.
    Similarly, the 1-mL direct-plating and 30-mL enrichment-based 
curves were used to determine the proportion of NRTE comminuted chicken 
product that

[[Page 38207]]

would initially be classified as meeting/not meeting the standard. 
Figure 2 (c) shows that a performance standard of five (5) allowable 
positives in 52 samples would result in 44 percent of production volume 
meeting the standard. That is, the point on the 30-mL curve 
corresponding to five (5) positives in 52 samples results in 44 percent 
of the production volume meeting the performance standard, and 56 
percent not meeting it. A more detailed description of the methodology, 
and the treatment of statistical uncertainty is presented in the peer-
reviewed technical manuscript (Williams et al, 2018; citation 12).
    The same procedures were used to revise the Campylobacter 
performance standard for NRTE comminuted turkey product. FSIS 
determined that an enrichment method-based performance standard of five 
(5) allowable positives in 52 samples would provide a 19-percent 
illness reduction, and 20 percent of production volume (which accounts 
for 9 percent of eligible establishments) would initially not meet the 
revised performance standard.

[[Page 38208]]

[GRAPHIC] [TIFF OMITTED] TN06AU19.046

BILLING CODE 3410-DM-C

Revised Pathogen Reduction Performance Standards

    FSIS is proposing revised performance standards to improve the 
Agency's ability to identify Campylobacter contamination in NRTE 
comminuted chicken and turkey products using the enrichment method. A 
summary of the revised Campylobacter performance standards for NRTE 
comminuted poultry products is provided in Table 1. Should FSIS 
finalize these proposed performance standards, FSIS will announce the 
final standards in the Federal Register before assessing whether 
establishments meet the standards. Any changes to the performance 
standards for Campylobacter in young chicken and turkey carcasses, and 
in raw chicken parts, will be proposed in a separate Federal Register 
notice.
    As described above, FSIS has revised the pathogen reduction 
performance standards for Campylobacter in NRTE

[[Page 38209]]

comminuted chicken and turkey products based on the 30-mL enrichment 
method, such that the same public health objectives announced in 2015 
for the 1-mL direct-plating method-based standards are achieved.

Minimum Number of Samples To Assess Performance

    FSIS uses the following formula to estimate the minimum number of 
samples (n) needed to assess establishment performance: n = (1/percent 
positive allowed) x 100 (80 FR at 3947). Revising the Campylobacter 
performance standard from one allowable positive per 52 samples (1.9 
percent) to five allowable positive samples per 52 samples (9.6 
percent) changes the minimum number of samples needed to assess 
establishments from (\1/1\.9%) x 100), or 52 samples, to (\1/9\.6%) x 
100, or 10.4 samples. Because samples are necessarily whole numbers, a 
fractional number is rounded up to the next highest whole number. 
Therefore, 11 samples would be the minimum number of samples needed to 
assess performance for Campylobacter in both NRTE comminuted chicken 
and comminuted turkey producing establishments under the revised 
standards. Significantly, since the proposed revised performance 
standards reduce the minimum number of samples needed to assess 
establishment performance, FSIS would be able to assess performance for 
a greater number of otherwise eligible establishments.

     Table 1--Revised Performance Standards for Campylobacter in NRTE Comminuted Chicken and Turkey Products
----------------------------------------------------------------------------------------------------------------
                                                                                      Revised
                                                                    Revised           maximum         Revised
                           Product                                performance        allowable    minimum number
                                                                  standard for        percent      of samples to
                                                                 Campylobacter      positive *        assess
----------------------------------------------------------------------------------------------------------------
NRTE Comminuted Chicken (325 g sample).......................            5 of 52             9.6              11
NRTE Comminuted Turkey (325 g sample)........................            5 of 52             9.6              11
----------------------------------------------------------------------------------------------------------------
* Consistent with existing FSIS procedures, if the total number of samples in a 52-week moving window ranges
  from 11 to 51, FSIS will subtract 1 from the number of positive samples to calculate the percent positive,
  which is compared to the revised maximum acceptable percent positive determined by dividing 5 by 52 to
  determine the Category. If the total number of samples in a moving window exceeds 51, FSIS will calculate a
  percent positive without subtracting 1 from the number of positives.

Changes to Related Agency Procedures

    Once FSIS begins assessing whether establishments meet the revised 
Campylobacter performance standards, FSIS would use the categorization 
methodology, as well as the web posting procedures announced in the 
Federal Register on November 9, 2018 (83 FR 56046; Nov. 9, 2018). As 
explained in the November 2018 Federal Register notice, the Category 
status reported on the public website would be based on FSIS sample 
results during the 52-week window ending the last Saturday of the 
previous month, and would not include follow-up sampling results, if 
any were collected and analyzed, as part of the window.
    In addition, establishments would not be categorized as meeting or 
not meeting as previously announced in the February 2016 Federal 
Register notice. Instead, FSIS would categorize eligible establishments 
using the same 3-category system it uses for poultry establishments 
currently subject to a Salmonella pathogen reduction performance 
standard. The criteria for each category are as follows:
     Category 1: Establishments that have achieved 50 percent 
or less of the maximum allowable percent positive during the most 
recently completed 52-week moving window.
     Category 2: Establishments that meet the maximum allowable 
percent positive but have results greater than 50 percent of the 
maximum allowable percent positive during the most recently completed 
52-week moving window.
     Category 3: Establishments that have exceeded the maximum 
allowable percent positive during the most recently completed 52-week 
moving window.
    All other FSIS verification procedures outlined in the February 
2016 Federal Register notice are unchanged.

Additional Information

    Should these Campylobacter standards for comminuted poultry 
products be finalized, FSIS will post aggregate Campylobacter sampling 
results relative to categories and prevalence estimates for NRTE 
comminuted chicken and turkey products, consistent with how FSIS 
handles Salmonella postings.\19\ FSIS would also announce when it 
expects to begin posting individual establishment category information 
in the Federal Register notice that announces final Campylobacter 
standards for comminuted poultry products.
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    \19\ The information is posted at https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/salmonella-verification-testing-program/aggregate-data.
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Cost-Benefit Analysis

    The February 2016 Federal Register notice announcing pathogen 
reduction performance standards for Salmonella and Campylobacter in 
NRTE comminuted chicken and turkey products and raw chicken parts 
included a supplementary cost-benefit analysis (2016 CBA).\20\ The 2016 
CBA estimated the economic effects of the new pathogen reduction 
performance standards for Salmonella and Campylobacter in both NRTE 
comminuted poultry and raw chicken parts. The 2016 CBA used estimates 
on whether establishments would meet the standards and illness 
reduction estimates from the 2015 Risk Assessment, which relied on 
results obtained using the direct-plating method.
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    \20\ U.S. Department of Agriculture, Food Safety and Inspection 
Service (FSIS). (2016). Final Cost-Benefit Analysis Chicken Parts 
and Not Ready-To-Eat Comminuted Poultry Performance Standards; 
available at: https://www.fsis.usda.gov/wps/wcm/connect/2f98f0a2-6a89-4316-aa95-86e5b103610f/CBA-Salmonella-Campy-2014-0023F-022016.pdf?MOD=AJPERES.
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    As explained above, FSIS is proposing to revise the pathogen 
reduction performance standards for Campylobacter in NRTE comminuted 
chicken and turkey products based on an enrichment method. To ensure 
the revised performance standards would be statistically equivalent to 
the previously announced Campylobacter standards for these products, 
FSIS analyzed 2015-2017 sample results generated using both the 
enrichment and direct-plating methods. Based on this analysis, FSIS 
concluded the revised pathogen reduction performance standards are 
consistent with the previously announced standards in terms of the 
estimated reduction in illnesses and the

[[Page 38210]]

percent of the industry expected to initially not meet the performance 
standards (Williams et al, 2018; citation 12). Therefore, the 
associated costs and public health benefits of the revised performance 
standards remain unchanged from those estimated in the 2016 CBA.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication online through the FSIS web page located at: 
https://www.fsis.usda.gov/federal-register.
    FSIS also will announce and provide a link to it through the FSIS 
Constituent Update, which is used to provide information regarding FSIS 
policies, procedures, regulations, Federal Register notices, FSIS 
public meetings, and other types of information that could affect or 
would be of interest to our constituents and stakeholders. The 
Constituent Update is available on the FSIS web page. Through the web 
page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at https://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at https://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.) should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Done at Washington, DC:
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-16765 Filed 8-5-19; 8:45 am]
 BILLING CODE 3410-DM-P
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