Expansion of FSIS Shiga Toxin-Producing Escherichia coli (STEC) Testing to Additional Raw Beef Products, 34397-34402 [2020-12073]

Download as PDF 34397 Notices Federal Register Vol. 85, No. 108 Thursday, June 4, 2020 This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2010–0023] Expansion of FSIS Shiga ToxinProducing Escherichia coli (STEC) Testing to Additional Raw Beef Products Food Safety and Inspection Service, USDA. ACTION: Notice and request for comments. AGENCY: The Food Safety and Inspection Service (FSIS) is announcing plans to expand its routine verification testing for six Shiga toxin-producing Escherichia coli (non-O157 STEC; O26, O45, O103, O111, O121, or O145) that are adulterants, in addition to the adulterant Escherichia coli (E. coli) O157:H7, to ground beef, bench trim, and raw ground beef components other than raw beef manufacturing trimmings (i.e., head meat, cheek meat, weasand (esophagus) meat, product from advanced meat recovery (AMR) systems, partially defatted chopped beef and partially defatted beef fatty tissue, low temperature rendered lean finely textured beef, and heart meat)(hereafter ‘‘other raw ground beef components’’) for samples collected at official establishments. STEC includes nonO157 STEC; O26, O45, O103, O111, O121, or O145, that are adulterants, and E. coli O157:H7. Currently, FSIS tests only its beef manufacturing trimmings samples for these six non-O157 STEC and E. coli O157:H7; all other aforementioned raw beef products are presently tested for E. coli O157:H7 only. FSIS also intends to test for these non-O157 STEC in ground beef samples that it collects at retail stores and in applicable samples it collects of imported raw beef products. FSIS is requesting comments on the proposed sampling and testing of ground beef, bench trim, and other raw ground beef khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:24 Jun 03, 2020 Jkt 250001 components. FSIS will announce the date it will implement the new testing in a subsequent Federal Register notice. Additionally, FSIS is responding to comments on the November 19, 2014, Federal Register notice titled ‘‘Shiga Toxin-Producing Escherichia coli (STEC) in Certain Raw Beef Products.’’ FSIS is also making available its updated analysis of the estimated costs and benefits associated with the implementation of its non-O157 STEC testing on raw beef manufacturing trimmings and the costs and benefits associated with the expansion of its non-O157 STEC testing to ground beef, bench trim, and other raw ground beef components (https://www.fsis.usda.gov/ wps/wcm/connect/c37a7129-639c-41faab75-be6dddcd1c44/placeholderlink?MOD=AJPERES&useDefaultText= 0&useDefaultDesc=0). DATES: Submit comments on or before August 3, 2020. 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– 2010–0023. 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. PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Acting Assistant Administrator, Office of Policy and Program Development by telephone at (202) 720–0399. SUPPLEMENTARY INFORMATION: Background On September 20, 2011, FSIS announced in the Federal Register, its determination that raw, non-intact beef products and raw, intact beef products that are intended for use in raw, nonintact beef products contaminated with non-O157 STEC (O26, O45, O103, O111, O121, or O145) are adulterated under the Federal Meat Inspection Act (21 U.S.C. 601(m)(1)) because they bear or contain a deleterious substance that may be injurious to health (76 FR 58157). In support of this determination, the Agency cited evidence of these nonO157 STEC organisms’ high pathogenicity, low infectious dose, transmissibility from person to person, and thermal resistance high enough to survive ordinary cooking (76 FR 58157, 58158–58159). FSIS also stated that raw, non-intact beef products and raw, intact beef products that are intended for use in raw, non-intact beef products, contaminated with non-O157 STEC are adulterated because they are unhealthful and unwholesome (21 U.S.C. 601(m)(3)) (76 FR 58157, 58159). FSIS also included information on when the Agency considers an isolate to be ‘‘confirmed positive for non-O157 STEC,’’ which is when the isolate contains a stx gene, an eae gene, and one of the target O-groups (O26, O45, O103, O111, O121, or O145) and when the isolate is biochemically confirmed to be E. coli. In the 2011 Federal Register notice, FSIS included a costs and benefits estimate for non-O157 STEC testing in raw beef manufacturing trimmings (76 FR 58157, 58162–58164). The Agency asked for comments on this costs and benefits estimate (76 FR 58157, 58164). FSIS implemented a verification testing program for the six non-O157 STEC in raw beef manufacturing trimmings on June 4, 2012 (77 FR 9888). Beef manufacturing trimmings include beef parts of any size, including primal cuts, subprimal cuts, and smaller pieces of trimmings from subprimal cuts, that the producing slaughter establishment intends for raw, non-intact use (FSIS Directive 10,010.1, Sampling E:\FR\FM\04JNN1.SGM 04JNN1 khammond on DSKJM1Z7X2PROD with NOTICES 34398 Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / Notices Verification Activities for Shiga ToxinProducing Escherichia coli (STEC) in Raw Beef Products https:// www.fsis.usda.gov/wps/wcm/connect/ c100dd64-e2e7-408a-8b27ebb378959071/ 10010.1.pdf?MOD=AJPERES). FSIS did not implement verification testing for non-O157 STEC to ground beef, bench trim, and other raw ground beef components at that time, because the Agency needed to establish additional laboratory capacity to test these products and the Agency wanted to evaluate data gathered from sampling raw beef manufacturing trimmings before expanding its verification testing to include other products (76 FR 58157, 58160). On May 31, 2012, the Agency announced in the Federal Register (77 FR 31975) that it would update and revise the costs and benefits estimate accompanying the September 20, 2011, determination, respond to comments received on the costs and benefits estimate, and assess the economic effects of testing raw beef manufacturing trimmings, ground beef, bench trim, and other raw ground beef components for non-O157 STEC. FSIS also announced that, when the updated costs and benefits estimate was complete, the Agency would announce its availability, request comments on it, assess the comments, and make any necessary changes to the costs and benefits estimate before finalizing it and expanding FSIS non-O157 STEC testing to include other products in addition to beef manufacturing trimmings. On November 19, 2014, FSIS announced in the Federal Register that it had updated the costs and benefits estimate in the 2014 cost benefit analysis (CBA) associated with the implementation of its non-O157 STEC testing on raw beef manufacturing trimmings (79 FR 68843). In the 2014 CBA, FSIS also reported the costs and benefits associated with the potential expansion of its non-O157 STEC testing to other raw beef products. The estimated annual cost for testing beef manufacturing trimmings for non-O157 STEC was $1.37 million ($0.48 million to the Agency and $0.89 million to the industry) in 2013 dollars. The expansion of non-O157 STEC testing to all other raw beef products was estimated to cost $1.0 million ($0.9 million to the Agency and $0.1 million to the industry) in 2013 dollars.1 FSIS also responded to comments that it had 1 The 2014 CBA is available at: https:// www.fsis.usda.gov/wps/portal/fsis/topics/ regulations/federal-register/federal-register-notices. VerDate Sep<11>2014 17:24 Jun 03, 2020 Jkt 250001 received on the previous, September 20, 2011, costs and benefits estimate. Summary of the Updated Costs and Benefits Analysis This notice announces updates to the CBA FSIS published on November 19, 2014. In this revision to the 2014 CBA, FSIS made the following changes: 1. The false-positive rate for industry’s screening test was updated and an estimate of product loss value was included as a cost to the industry, in response to industry comments. 2. Agency cost was updated to reflect the change in FSIS’ laboratory method for STEC testing; the new method screens enriched samples for both E. coli O157:H7 and non-O157 STEC at the same time, which reduces the Agency’s testing costs. 3. Agency cost for conducting forcause Food Safety Assessments (FSAs) was updated using data from the Agency’s analysis of the new FSA methodology.2 4. We quantified the benefit from prevented outbreak-related recalls, in response to comments, using survey data from the Grocery Manufacturers Association (whose name changed to Consumer Brands Association in January 2020). When including all of the aforementioned updates, the estimated annual cost for testing beef manufacturing trimmings for non-O157 STEC is $42.2 million ($0.1 million to the Agency, and $42.1 million to the industry). The estimated cost of expanding non-O157 STEC testing to all other raw beef products is $6.4 million ($0.5 million to the Agency and $5.9 million to the industry). Most of the increase in estimated costs above the cost estimates in the 2014 CBA is from the inclusion of the lost value of products to the industry. When establishments do not do confirmation testing, there is a loss of value from disposed of beef products after they have screened positive because some of these are false positives. The estimated benefits of the new testing are reduced illnesses and deaths, reduced outbreak-related recalls, and improved business practices. Through recall investigations, FSIS and industry are able to determine process failures to help establishments take corrective actions to prevent future contamination 2 In June 2015, FSIS changed the methodology for conducting FSAs. For details, see FSIS Directive 5100.4. Enforcement, Investigations and Analysis Officer (EIAO) Public Health Risk Evaluation (PHRE) Methodology Implementation, 5/22/2015, available at https://www.fsis.usda.gov/wps/wcm/ connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/ 5100.4.pdf?MOD=AJPERES. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 and investigation can serve as the basis for education that will benefit the entire industry as well as regulatory organizations. The Agency estimated the benefit from reduced outbreak-related recalls to be at least $51.6 million per year. There are also benefits from reduced illnesses and improved industry practices, which were not quantified. Therefore, the total benefit of FSIS testing for non-O157 STEC outweighs the total cost. Expanding FSIS Non-O157 STEC Testing to Ground Beef, Bench Trim, and Other Raw Ground Beef Components FSIS intends to expand its non-O157 STEC verification testing to ground beef, bench trim, and other raw ground beef components. Slaughter establishments are in the best position to prevent nonO157 STEC contamination because the introduction of the contaminant to the exterior surface of beef products can occur during the slaughter and dressing operation. Processing establishments that receive product for grinding also have an important role in addressing non-O157 STEC. Hazard Analysis and Critical Control Point (HACCP) regulations require establishments to conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur in their production processes and to identify the preventive measures an establishment can apply to control those hazards in the production of particular products (see 9 CFR 417.2(a)). Processing establishments can control or reduce STEC to below detectable levels by using preventive measures, including validated antimicrobial interventions. Processing establishments can also establish as a preventive measure purchase specification that requires suppliers to provide source materials with no detectable STEC. Processing establishments can then verify that these control measures are working as intended through their own product testing (see 67 FR 62326). Exposure to non-O157 STEC is linked to serious, life-threatening human illnesses. On March 28, 2019, FSIS was notified of an outbreak of E. coli O103 illnesses.3 One hundred and ninety-six (196) case-patients in ten (10) states were linked to this outbreak. Twentyeight (28) case-patients were hospitalized. Case-patient and traceback information indicated raw ground beef as the likely source of this outbreak and prompted two recalls (Recall #047–2019 3 More information on this outbreak is available at https://www.cdc.gov/ecoli/2019/o103-04-19/ index.html. E:\FR\FM\04JNN1.SGM 04JNN1 Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES and Recall #048–2019). Additionally, on August 16, 2018, FSIS was notified of an outbreak of E. coli O26 illnesses.4 Eighteen (18) case-patients in four (4) states were linked to this outbreak. Six (6) people were hospitalized, and one (1) died. Case-patient and traceback information for this outbreak also indicated raw ground beef as the likely source, prompting two recalls (Recall #072–2018 and Recall #081–2018). Because of these recent outbreaks, illnesses and a death, FSIS is moving ahead with its plans to expand its nonO157 STEC sampling to ground beef, bench trim, and other raw ground beef components. Product sampling and testing is one of several activities establishments conduct to verify the effectiveness of their HACCP systems. Since the initiation of FSIS’s non-O157 STEC testing program, many grinders and suppliers of raw ground beef components have instituted programs to routinely test their raw beef products for both E. coli O157:H7 and for non-O157 STEC. Before a foreign country can export meat products to the United States, it must demonstrate that its meat inspection system is equivalent to the system FSIS has established under the FMIA and its implementing regulations. After FSIS expands its STEC verification sampling, FSIS will require foreign countries to test the same products for non-O157 STEC and verify that the establishments address STEC as a hazard through an establishments hazard analysis and HACCP plans. If a country chooses to take a different approach, then the country would need to submit an Individual Sanitary Measure (ISM) equivalence determination. Sampling Beef Manufacturing Trimmings, Ground Beef, Bench Trim, and Other Raw Ground Beef Components To sample beef manufacturing trimmings and bench trim, FSIS inspection program personnel (IPP) use the N60 technique to collect 60 pieces of meat from across a production lot (see FSIS Directive 10,010.1, https:// www.fsis.usda.gov/wps/wcm/connect/ c100dd64-e2e7-408a-8b27ebb378959071/ 10010.1.pdf?MOD=AJPERES). To sample other raw ground beef components, FSIS IPP randomly select one component type that the establishment produces and aseptically 4 More information on this outbreak is available at https://www.cdc.gov/ecoli/2018/o26-09-18/ index.html. VerDate Sep<11>2014 17:24 Jun 03, 2020 Jkt 250001 collect a grab sample from one or more components from a production lot consisting of many boxes (typically 100 boxes in very large establishments) (see FSIS Directive 10,010.1). The sampling protocol used for other raw ground beef components, specifically collecting samples from a limited number of units from a given production lot, may reduce the chance of getting a positive since pathogens are not homogeneously distributed throughout a production lot. FSIS is aware that some establishments are collecting samples of beef manufacturing trimmings and other raw ground beef components using a sponge or cloth device that is either attached to a conveyor belt that comes into direct, continuous contact with product, or that is used by establishment employees to rub products in boxes or combos. More surface area is sampled using these techniques which theoretically may yield results that better represent the production lot as compared to the sampling methods currently used by FSIS for sampling beef manufacturing trimmings and other raw ground beef components. FSIS is evaluating alternatives to FSIS’s current sampling procedures for beef manufacturing trimmings, bench trim, and other raw ground beef components; the Agency is looking for alternatives that provide samples that are more representative of production lots and that are less time intensive and more user-friendly for IPP to use. If FSIS makes changes to its sampling methodology for beef manufacturing trimmings, bench trim and/or other raw ground beef components, it will issue updated sampling instructions to field personnel. Recent Changes to FSIS’s Laboratory Method On February 4, 2019, FSIS began using a new laboratory method for the initial screening of regulatory samples for STEC.5 The instructions for using this method are found in Chapter 5C of the Microbiology Laboratory Guidebook (MLG) and associated appendices.6 This updated laboratory method allows FSIS to utilize a single, combined workflow to screen samples for the presence of E. coli O157:H7 and the six non-O157 STEC that FSIS considers adulterants (O26, O45, O103, O111, O121, or O145). Merging the screening for these seven 5 See https://www.fsis.usda.gov/wps/portal/fsis/ newsroom/meetings/newsletters/constituentupdates/archive/2019/ConstUpdate020119. 6 The FSIS MLG can be found at: https:// www.fsis.usda.gov/wps/portal/fsis/topics/science/ laboratories-and-procedures/guidebooks-andmethods/microbiology-laboratory-guidebook/ microbiology-laboratory-guidebook. PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 34399 STEC adulterants into a single laboratory workflow saves time, money, and resources for the Agency without sacrificing sensitivity and specificity. Planned Changes in Scheduling Samples As FSIS announced with its proposed Salmonella performance standards for ground beef and beef manufacturing trimmings (84 FR 57688, 57690), FSIS’s goal is to collect and analyze at least 48 samples per year for each establishment producing greater than 50,000 pounds per day of ground beef or beef manufacturing trimmings by increasing the sample collection frequency from a maximum of four times per month to once per week for these product classes. To achieve this goal, FSIS plans to change how it assigns STEC samples and thus Salmonella samples (as all raw beef samples currently are analyzed for STEC and Salmonella) in higher-volume beef establishments producing ground beef and/or beef manufacturing trimmings by increasing the sample collection frequency to once per week or four samples per month for these product classes. FSIS intends to implement this change by reallocating resources from lower-volume beef establishments (i.e., those producing 50,000 pounds or less per day) in a manner that is resource—neutral. The Agency requests comments on the proposed change in sampling frequency. Response to Comments FSIS received three comment letters in response to the 2014 Federal Register notice on the CBA associated with testing raw beef manufacturing trimmings for non-O157 STEC and the potential costs and benefits of testing raw ground beef, bench trim, and all other raw ground beef components for non-O157 STEC. Specifically, FSIS received comments from a beefproducing company, a testing provider, and an industry organization. The three comment letters FSIS received on the notice did not support the expansion of non-O157 STEC testing by the Agency. Commenters stated that testing just for E. coli O157:H7, rather than for both E. coli O157:H7 and non-O157 STEC, was adequate. A summary of the comments received and responses to the comments is below. Quantify Benefits and Recalls Comment: Both the company and the industry organization questioned why FSIS did not quantify the benefits of its non-O157 STEC testing. These commenters also questioned the use in the CBA of two non-O157 STEC-related recalls (Recall #045–2013 and Recall E:\FR\FM\04JNN1.SGM 04JNN1 34400 Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES #010–2014) as evidence of public-health benefits because they were not outbreakrelated. Response: FSIS has now quantified the estimated benefit from prevented outbreak-related recalls in the CBA associated with this Federal Register notice, using survey data from the Grocery Manufacturers Association 7 (whose name changed to Consumer Brands Association in January 2020), and Agency recall data. The Agency estimated the benefit from reduced outbreak-related recalls to be at least $51.6 million per year. There are also benefits from reduced illnesses and improved industry practices, which are not quantified. Therefore, the total benefit of FSIS testing for non-O157 STEC outweighs the total cost. The recalls of products contaminated with non-O157 STEC exemplify the preventive approach FSIS takes with respect to product contamination events, as the recalled products could have potentially led to illnesses and outbreaks. While the historical frequency of outbreaks attributable to non-O157 STEC may be lower than that for outbreaks attributable to E. coli O157:H7, clinical methods are being developed to better detect and identify non-O157 STEC illnesses (discussed later). In testing beef manufacturing trimmings for STEC, FSIS has found more positive non-O157 STEC than O157 STEC. FSIS conducts verification sampling and testing and other inspection activities to ensure establishments have appropriate controls and verification procedures in place to prevent such illnesses. Since FSIS started its non-O157 STEC verification testing, there have been 19 Class-I recalls associated with raw beef products contaminated with these STEC.8 Four of these recalls were associated with a ground beef outbreak. Two of the recalls were associated with the O103 serogroup and the other two with the O26 serogroup. The other 15 recalls were conducted based on positive non-O157 STEC results obtained through testing by FSIS, establishments, or various states; these recalls occurred before any attributed illnesses were reported.9 7 Grocery Manufacturers Association. 2011. Capturing Recall Costs: Measuring and Recovering the Losses. Retrieved from https:// www.gma.maxx.matrixdev.net/forms/store/Product FormPublic/capturing-recall-costs. 8 The list of recalls is available at: https:// www.fsis.usda.gov/wps/portal/fsis/topics/recallsand-public-health-alerts/current-recalls-and-alerts/ current-recalls-and-alerts. 9 The list of recalls is available at: https:// www.fsis.usda.gov/wps/portal/fsis/topics/recallsand-public-health-alerts/current-recalls-and-alerts/ current-recalls-and-alerts. VerDate Sep<11>2014 17:24 Jun 03, 2020 Jkt 250001 On February 8, 2013, FSIS implemented a new policy that requires official establishments and importers of record to maintain control of products produced from livestock that are sampled and tested by FSIS for adulterants and not allow such products to enter commerce until negative test results have been received. This policy, often referred to as FSIS’s ‘‘hold and test’’ policy, has reduced the number of recalls conducted due to FSIS raw ground beef verification samples that test positive for STEC. This policy applies to non-intact raw beef product or intact raw beef product intended for non-intact use that is sampled and tested by FSIS for STEC (77 FR 73401; Dec. 10, 2012). False-Positive Rate Comment: A major concern of both the company and the industry organization that commented on the proposal was the high false-positive rate for non-O157 STEC screening tests used by industry. The company stated that it was concerned about the rate of false positives obtained using available nonO157 STEC screening tests because of the decisions that are made immediately after and on the basis of the initial screening test results. According to the commenters, industry may hold lots of product with screen-positive test results for non-O157 STEC while waiting for confirmation of the results. Industry may also conduct product traceback in response to non-O157 STEC screen-positive test results, take action during high-event periods based on non-O157 STEC screen-positive test results, and may have difficulty filling orders on time because of screenpositive test results that limit the availability of raw beef. Also, the commenters were concerned about FSIS conducting additional FSAs in response to industry’s non-O157 STEC screenpositive test results. The same commenters stated that screen-positive test results may result in loss of product value. Therefore, the commenters stated, the Agency underestimated the costs of the false-positive rate on industry in the CBA for the proposal. Response: The Agency’s 2018 data show, before the February 2019 change in technology, that 90 percent of the FSIS non-O157 STEC presumptive positive test results are confirmed positive.10 A presumptive positive result in FSIS testing means the sample has first been determined to be a nonO157 STEC potential positive (equivalent to an industry screen10 Data are from the Office of Public Health Science (OPHS), FSIS. PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 positive non-O157 STEC test result) and then an FSIS microbiologist identifies an isolate from the enriched sample. Note that FSIS confirmed only 7 percent of the Agency’s non-O157 STEC potential positive test results before the February 2019 change in technology. FSIS’s revised cost estimate, using a range of false-positive rates equivalent to the Agency’s 2018 range of false positive rates of STEC potential positive test results of 81 to 100 percent,11 12 showed that the lost product value from industry’s testing of raw beef products would be high—about $47.0 million. However, there are more sensitive screening tests available to industry that have lower false-positive rates for nonO157 STEC, and industry may choose the test that has the desired cost and benefit result.13 (FSIS expects that, over time, the cost of both STEC screening and confirmatory tests will decrease as the industry conducts more tests and as the test kits improve. Since implementing STEC testing, FSIS has taken steps to improve the effectiveness of its microbiological testing program for E. coli O157:H7 and non-O157 STEC, including implementing the new laboratory method mentioned above. Also, FSIS does not conduct FSAs at establishments based solely on positive industry test results. Morbidity and Mortality Weekly Report Comment: In reference to the Centers for Disease Control and Prevention (CDC) Foodborne Diseases Active Surveillance Network (FoodNet) program Morbidity and Mortality Weekly Report (MMWR) (https:// www.cdc.gov/mmwr/preview/ mmwrhtml/mm6418a4.htm), the company and industry organization asked if the report would affect FSIS’s proposed expansion of non-O157 STEC testing. Response: At this time, the information in the report does not change the Agency’s plans to move forward with expanding non-O157 STEC testing. According to the summary 11 Since we assumed that the industry would not change to FSIS’s new laboratory method in the near future, FSIS used the most recent false positive rates of the Agency’s laboratory method before February 2019 to estimate industry costs. 12 Data are from the Office of Public Health Science (OPHS), FSIS for 2018. The false positive rates of the potential screening are as follows: 93 percent for beef manufacturing trimming, 100 percent for bench trim, 94 percent for other raw ground beef components, and 81 percent for ground beef. 13 Examples of test kits can be found on the FSIS website: https://www.fsis.usda.gov/wps/wcm/ connect/f97532f4-9c28-4ecc-9aee-0e1e6cde1a89/ validated-test-kit.pdf?MOD=AJPERES. E:\FR\FM\04JNN1.SGM 04JNN1 Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES of the most recent MMWR,14 compared with the 2015–2018 average annual STEC incidence (infections), the 2018 incidence of STEC was higher when compared to the 2015–2017 rates. Various factors contribute to the increase in reported illnesses. This includes the use of updated clinical laboratory methods. Further, the illnesses reported by the FoodNet program are not specific to FSISregulated products; reported data encompasses all reported illnesses, regardless of food source. E. coli O157:H7 as Indicator of NonO157 STEC and Collection of Data by FSIS Comment: The industry organization asserted that E. coli O157:H7 can serve as an indicator organism for non-O157 STEC. The industry organization also commented that E. coli O157:H7 is a logical indicator organism for non-O157 STEC, if one uses the definition of an indicator organism presented in a research paper by Saini and others. This research paper states, ‘‘the term ‘indicator’ implies that common causes affect the levels of both indicator microorganisms and pathogens and that these causes can be identified and controlled. The use of measured levels of an indicator organism within statistical process control (SPC) is based on the basic premise that the process can be improved over time, by identifying a cause of higher-thanexpected indicator organism levels and taking an action that would result in a decrease of levels of the indicator organism, which in turn could also decrease levels and incidence of pathogens on the product.’’ 15 The commenter also stated that, given the history of non-O157 STEC outbreaks and the industry’s success in reducing E. coli O157:H7 prevalence in beef products, E. coli O157:H7 is likely the best microorganism to target in reducing risk when consuming beef products because the number of confirmed illnesses within the U.S. has been attributed more to E. coli O157:H7 than to non-O157 STEC. Additionally, the industry organization stated that FSIS has collected data on non-O157 STEC through testing since 2012. The commenter stated that the data should be reviewed to ascertain the costs and benefits of expanded testing for the six 14 https://www.cdc.gov/mmwr/volumes/68/wr/ mm6816a2.htm?s_cid=mm6816a2_w. 15 Saini PK, Marks HK, Dreyfuss MS, Evans P, Cook Jr LV, and Dessai U. 2011. Indicator organisms in meat and poultry slaughter operations; their potential use in process control and the role of emerging technologies. J. Food Prot. 74: 1387–1394. VerDate Sep<11>2014 17:24 Jun 03, 2020 Jkt 250001 non-O157 STEC adulterants to include raw ground beef and other components used in raw ground beef in addition to raw beef manufacturing trimmings. Response: FSIS has reviewed its STEC verification sampling results obtained since 2012; positive samples for E. coli O157:H7 and non-O157 STEC have been observed. While FSIS screening and confirmation methods used collectively permit detection of both E. coli O157:H7 and non-O157 STEC in an isolate from a sample, our data indicates that an isolate from a sample is rarely positive for both E. coli O157:H7 and non-O157 STEC. Therefore, FSIS verification sample results do not support using E. coli O157:H7 as an indicator organism for non-O157 STEC. Rather, the results indicate a need for FSIS to conduct additional verification testing of products for non-O157 STEC. Analysis of FSIS raw beef manufacturing trimmings STEC verification sample results indicate that positive samples are not occurring in clusters, and are distributed among various states and regions of the U.S. Specifically, between June 2012 and December 2018, raw beef manufacturing trimming sample positives for E. coli O157:H7 were from 47 individual establishments in 25 States, while raw beef manufacturing trimming sample positives for non-O157 STEC were from 87 individual establishments in 34 States. FSIS began verification testing of raw beef manufacturing trimmings (MT60 sampling project) for non-O157 STEC (in addition to E. coli O157:H7) in June 2012. Aggregate data by calendar year are publicly available on FSIS’s website. In calendar year (CY) 2012, 17 of 32 STEC positive beef manufacturing trimmings samples were positive for non-O157 STEC (see https:// www.fsis.usda.gov/wps/portal/fsis/ topics/data-collection-and-reports/ microbiology/ec/stec-annual-report/ stec-annual-report-2012, Table 2, Trim Verification [MT60] data). Similarly, in CY 2013, 16 of 25 STEC positive beef manufacturing trimmings samples were positive for non-O157 STEC (see https:// www.fsis.usda.gov/wps/portal/fsis/ topics/data-collection-and-reports/ microbiology/ec/stec-annual-report/ stec-annual-report-2013, Table 2, Trim Verification data). Non-O157 STEC were found in both samples identified as just ‘‘beef’’ and in beef products identified as ‘‘veal.’’ Forty-eight (48) of 69 (70 percent) and 23 of 39 (58 percent) of STEC positive samples of raw beef manufacturing trimmings (MT60 sampling project), raw ground beef follow-up samples (MT44 sampling project) and follow-up samples from PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 34401 originating slaughter suppliers (MT52 sampling project) collected in CY 2012 and CY 2013, respectively were positive for non-O157 STEC. From CY 2014–CY 2018 (see https://www.fsis.usda.gov/ wps/portal/fsis/topics/data-collectionand-reports/microbiology/ec/positiveresults-current-cy/2015-ecoli-positives), 105 beef manufacturing trimmings (MT60) samples were positive for nonO157 STEC, and 32 samples were positive for E. coli O157:H7. The Agency has incorporated data from Agency testing in the updated CBA, including an updated false positive rate and Agency testing costs. Antimicrobial Use and Multiple Interventions Comment: The industry organization commented that according to three studies funded by the North American Meat Institute, current antimicrobial compounds used by the meat industry to destroy E. coli O157:H7 are effective against non-O157 STEC. Response: FSIS considers controls for E. coli O157:H7 to be effective against non-O157 STEC when implemented appropriately. However, FSIS testing finds both E. coli O157:H7 and nonO157 STEC positive results in its verification testing programs. As stated above, FSIS laboratories rarely find positives for E. coli O157:H7 and nonO157 STEC in the same sample. With the sporadic nature of STEC contamination, FSIS believes these results support the need for the Agency to conduct verification testing for nonO157 STEC in additional raw beef products. Products To Sample Comment: The company and industry organization commented that FSIS should not sample and test raw ground beef and bench trim for non-O157 STEC. While conceding that verification sampling of raw beef manufacturing trimmings yields data that provides insights into the slaughter process, these commenters stated that verification sampling of raw ground beef products is not useful. According to these commenters, FSIS most often takes samples of raw ground beef product that is a blend of raw ground beef components from multiple suppliers; therefore, the commenters stated it is not possible to know which component was contaminated or to provide feedback of any value to the source establishments. The company and the industry organization also stated that FSIS may question beef manufacturing trimmings and other raw ground beef component suppliers when downstream E:\FR\FM\04JNN1.SGM 04JNN1 34402 Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / Notices establishments that grind raw beef components from multiple suppliers produce product that tests positive for non-O157 STEC. Response: The Agency agrees that FSIS verification sampling and testing of product from slaughter establishments for non-O157 STEC provides useful information on the establishment’s process control. The Agency also recognizes that traceback of ground beef made using raw beef components from multiple suppliers to a single slaughter establishment is more difficult than traceback of product made with raw beef components from a single supplier. Moreover, FSIS notes that the 2018 and 2019 outbreaks involved nonO157 STEC from ground beef. Thus, the Agency intends to expand non-O157 STEC sampling and testing to include ground beef, bench trim, and other raw ground beef components, which comprise the other 75 percent of the samples analyzed annually for E. coli O157:H7. This will help FSIS verify that certain products (such as bench trim) are not adulterated before they are ground, and that the resulting ground beef is not adulterated. khammond on DSKJM1Z7X2PROD with NOTICES Food Safety Assessment Estimate Comment: With expanded non-O157 STEC testing, the industry organization commented that FSAs based on FSIS non-O157 STEC positive test results alone will unnecessarily increase FSIS and industry expenses. The industry organization noted that FSIS estimated the cost of an FSA to FSIS at $1,400 in 2014 but in September 2011 estimated that the Agency’s FSA cost was $14,000. Response: The $14,000 estimate for FSAs in 2011 resulted from high assumptions regarding the resources needed to conduct FSAs related to nonO157 STECs (76 FR 58157) before 2014. For example, it used to take an Enforcement, Investigation, and Analysis Officer (EIAO) over 30 days to complete the in-plant portion of the investigation. The Agency modified the assumptions and the cost estimates for the 2014 CBA based on the new FSA methodology, using the Public Health Risk Evaluation to determine whether an FSA is necessary, which reduced the total number of FSAs. With the new methodology, an EIAO can complete the in-plant portion of the FSA in 5 to 7 days, instead of an average of 38 days, leading to a significant reduction in FSA cost to FSIS. Data collected for FY 2016 suggest that the average STEC-related FSA under the new methodology costs VerDate Sep<11>2014 17:24 Jun 03, 2020 Jkt 250001 the Agency about $4,800.16 FSIS has updated the CBA using this new number. 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: 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). Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: https:// www.fsis.usda.gov/federal-register. FSIS will also 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 16 Based on OCFO (Office of Chief Financial Officer) preliminary analysis of average cost per FSA under new FSA methodology, FY 2016. PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 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. Done in Washington, DC. Paul Kiecker, Administrator. [FR Doc. 2020–12073 Filed 6–3–20; 8:45 am] BILLING CODE 3410–DM–P BROADCASTING BOARD OF GOVERNORS Sunshine Act Meeting Notice Wednesday, June 3, 2020, 12:00 p.m.–1:00 p.m. ET. TIME AND DATE: PLACE: Teleconference. The U.S. Agency for Global Media’s (USAGM) Board of Governors (Board) may conduct a telephonic meeting closed to the public at the time listed above pursuant to 5 U.S.C. 552b(c)(9)(B) in order to protect and prevent disclosure of a discussion which would be likely to significantly frustrate implementation of a proposed Agency action. The Board also determined that shorter than usual notice for a meeting was required by official Agency business and delayed availability of required information. The meeting is being called pursuant to Section 2.15 of the USAGM’s Board bylaws. In accordance with the Government in the Sunshine Act and USAGM policies, any such meeting will be recorded and a transcript of the proceedings, subject to the redaction of information protected by 5 U.S.C. 552b(c)(6), will be made available to the public. The publicly-releasable transcript will be available for download at www.usagm.gov within 21 days of the date of the meeting. Information regarding member votes to close the meeting and expected attendees can also be found on the Agency’s public website. MATTERS TO BE CONSIDERED: CONTACT PERSON FOR MORE INFORMATION: Persons interested in obtaining more information should contact Oanh Tran at (202) 920–2004. Chelsea Milko, Special Assistant to the CEO Office. [FR Doc. 2020–12281 Filed 6–2–20; 4:15 pm] BILLING CODE 8610–01–P E:\FR\FM\04JNN1.SGM 04JNN1

Agencies

[Federal Register Volume 85, Number 108 (Thursday, June 4, 2020)]
[Notices]
[Pages 34397-34402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12073]

========================================================================
Notices
Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.

========================================================================

Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 /
Notices

[[Page 34397]]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2010-0023]

Expansion of FSIS Shiga Toxin-Producing Escherichia coli (STEC)
Testing to Additional Raw Beef Products

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 announcing
plans to expand its routine verification testing for six Shiga toxin-
producing Escherichia coli (non-O157 STEC; O26, O45, O103, O111, O121,
or O145) that are adulterants, in addition to the adulterant
Escherichia coli (E. coli) O157:H7, to ground beef, bench trim, and raw
ground beef components other than raw beef manufacturing trimmings
(i.e., head meat, cheek meat, weasand (esophagus) meat, product from
advanced meat recovery (AMR) systems, partially defatted chopped beef
and partially defatted beef fatty tissue, low temperature rendered lean
finely textured beef, and heart meat)(hereafter ``other raw ground beef
components'') for samples collected at official establishments. STEC
includes non-O157 STEC; O26, O45, O103, O111, O121, or O145, that are
adulterants, and E. coli O157:H7. Currently, FSIS tests only its beef
manufacturing trimmings samples for these six non-O157 STEC and E. coli
O157:H7; all other aforementioned raw beef products are presently
tested for E. coli O157:H7 only. FSIS also intends to test for these
non-O157 STEC in ground beef samples that it collects at retail stores
and in applicable samples it collects of imported raw beef products.
FSIS is requesting comments on the proposed sampling and testing of
ground beef, bench trim, and other raw ground beef components. FSIS
will announce the date it will implement the new testing in a
subsequent Federal Register notice.
Additionally, FSIS is responding to comments on the November 19,
2014, Federal Register notice titled ``Shiga Toxin-Producing
Escherichia coli (STEC) in Certain Raw Beef Products.'' FSIS is also
making available its updated analysis of the estimated costs and
benefits associated with the implementation of its non-O157 STEC
testing on raw beef manufacturing trimmings and the costs and benefits
associated with the expansion of its non-O157 STEC testing to ground
beef, bench trim, and other raw ground beef components (https://www.fsis.usda.gov/wps/wcm/connect/c37a7129-639c-41fa-ab75-be6dddcd1c44/placeholder-link?MOD=AJPERES&useDefaultText=0&useDefaultDesc=0).

DATES: Submit comments on or before August 3, 2020.

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-2010-0023. 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: Rachel Edelstein, Acting Assistant
Administrator, Office of Policy and Program Development by telephone at
(202) 720-0399.

SUPPLEMENTARY INFORMATION:

Background

On September 20, 2011, FSIS announced in the Federal Register, its
determination that raw, non-intact beef products and raw, intact beef
products that are intended for use in raw, non-intact beef products
contaminated with non-O157 STEC (O26, O45, O103, O111, O121, or O145)
are adulterated under the Federal Meat Inspection Act (21 U.S.C.
601(m)(1)) because they bear or contain a deleterious substance that
may be injurious to health (76 FR 58157). In support of this
determination, the Agency cited evidence of these non-O157 STEC
organisms' high pathogenicity, low infectious dose, transmissibility
from person to person, and thermal resistance high enough to survive
ordinary cooking (76 FR 58157, 58158-58159). FSIS also stated that raw,
non-intact beef products and raw, intact beef products that are
intended for use in raw, non-intact beef products, contaminated with
non-O157 STEC are adulterated because they are unhealthful and
unwholesome (21 U.S.C. 601(m)(3)) (76 FR 58157, 58159). FSIS also
included information on when the Agency considers an isolate to be
``confirmed positive for non-O157 STEC,'' which is when the isolate
contains a stx gene, an eae gene, and one of the target O-groups (O26,
O45, O103, O111, O121, or O145) and when the isolate is biochemically
confirmed to be E. coli.
In the 2011 Federal Register notice, FSIS included a costs and
benefits estimate for non-O157 STEC testing in raw beef manufacturing
trimmings (76 FR 58157, 58162-58164). The Agency asked for comments on
this costs and benefits estimate (76 FR 58157, 58164).
FSIS implemented a verification testing program for the six non-
O157 STEC in raw beef manufacturing trimmings on June 4, 2012 (77 FR
9888). Beef manufacturing trimmings include beef parts of any size,
including primal cuts, subprimal cuts, and smaller pieces of trimmings
from subprimal cuts, that the producing slaughter establishment intends
for raw, non-intact use (FSIS Directive 10,010.1, Sampling

[[Page 34398]]

Verification Activities for Shiga Toxin-Producing Escherichia coli
(STEC) in Raw Beef Products https://www.fsis.usda.gov/wps/wcm/connect/c100dd64-e2e7-408a-8b27-ebb378959071/10010.1.pdf?MOD=AJPERES). FSIS did
not implement verification testing for non-O157 STEC to ground beef,
bench trim, and other raw ground beef components at that time, because
the Agency needed to establish additional laboratory capacity to test
these products and the Agency wanted to evaluate data gathered from
sampling raw beef manufacturing trimmings before expanding its
verification testing to include other products (76 FR 58157, 58160).
On May 31, 2012, the Agency announced in the Federal Register (77
FR 31975) that it would update and revise the costs and benefits
estimate accompanying the September 20, 2011, determination, respond to
comments received on the costs and benefits estimate, and assess the
economic effects of testing raw beef manufacturing trimmings, ground
beef, bench trim, and other raw ground beef components for non-O157
STEC. FSIS also announced that, when the updated costs and benefits
estimate was complete, the Agency would announce its availability,
request comments on it, assess the comments, and make any necessary
changes to the costs and benefits estimate before finalizing it and
expanding FSIS non-O157 STEC testing to include other products in
addition to beef manufacturing trimmings.
On November 19, 2014, FSIS announced in the Federal Register that
it had updated the costs and benefits estimate in the 2014 cost benefit
analysis (CBA) associated with the implementation of its non-O157 STEC
testing on raw beef manufacturing trimmings (79 FR 68843). In the 2014
CBA, FSIS also reported the costs and benefits associated with the
potential expansion of its non-O157 STEC testing to other raw beef
products. The estimated annual cost for testing beef manufacturing
trimmings for non-O157 STEC was $1.37 million ($0.48 million to the
Agency and $0.89 million to the industry) in 2013 dollars. The
expansion of non-O157 STEC testing to all other raw beef products was
estimated to cost $1.0 million ($0.9 million to the Agency and $0.1
million to the industry) in 2013 dollars.\1\ FSIS also responded to
comments that it had received on the previous, September 20, 2011,
costs and benefits estimate.
---------------------------------------------------------------------------

\1\ The 2014 CBA is available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/federal-register-notices.
---------------------------------------------------------------------------

Summary of the Updated Costs and Benefits Analysis

This notice announces updates to the CBA FSIS published on November
19, 2014. In this revision to the 2014 CBA, FSIS made the following
changes:
1. The false-positive rate for industry's screening test was
updated and an estimate of product loss value was included as a cost to
the industry, in response to industry comments.
2. Agency cost was updated to reflect the change in FSIS'
laboratory method for STEC testing; the new method screens enriched
samples for both E. coli O157:H7 and non-O157 STEC at the same time,
which reduces the Agency's testing costs.
3. Agency cost for conducting for-cause Food Safety Assessments
(FSAs) was updated using data from the Agency's analysis of the new FSA
methodology.\2\
---------------------------------------------------------------------------

\2\ In June 2015, FSIS changed the methodology for conducting
FSAs. For details, see FSIS Directive 5100.4. Enforcement,
Investigations and Analysis Officer (EIAO) Public Health Risk
Evaluation (PHRE) Methodology Implementation, 5/22/2015, available
at https://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

4. We quantified the benefit from prevented outbreak-related
recalls, in response to comments, using survey data from the Grocery
Manufacturers Association (whose name changed to Consumer Brands
Association in January 2020).
When including all of the aforementioned updates, the estimated
annual cost for testing beef manufacturing trimmings for non-O157 STEC
is $42.2 million ($0.1 million to the Agency, and $42.1 million to the
industry). The estimated cost of expanding non-O157 STEC testing to all
other raw beef products is $6.4 million ($0.5 million to the Agency and
$5.9 million to the industry). Most of the increase in estimated costs
above the cost estimates in the 2014 CBA is from the inclusion of the
lost value of products to the industry. When establishments do not do
confirmation testing, there is a loss of value from disposed of beef
products after they have screened positive because some of these are
false positives.
The estimated benefits of the new testing are reduced illnesses and
deaths, reduced outbreak-related recalls, and improved business
practices. Through recall investigations, FSIS and industry are able to
determine process failures to help establishments take corrective
actions to prevent future contamination and investigation can serve as
the basis for education that will benefit the entire industry as well
as regulatory organizations. The Agency estimated the benefit from
reduced outbreak-related recalls to be at least $51.6 million per year.
There are also benefits from reduced illnesses and improved industry
practices, which were not quantified. Therefore, the total benefit of
FSIS testing for non-O157 STEC outweighs the total cost.

Expanding FSIS Non-O157 STEC Testing to Ground Beef, Bench Trim, and
Other Raw Ground Beef Components

FSIS intends to expand its non-O157 STEC verification testing to
ground beef, bench trim, and other raw ground beef components.
Slaughter establishments are in the best position to prevent non-O157
STEC contamination because the introduction of the contaminant to the
exterior surface of beef products can occur during the slaughter and
dressing operation. Processing establishments that receive product for
grinding also have an important role in addressing non-O157 STEC.
Hazard Analysis and Critical Control Point (HACCP) regulations require
establishments to conduct a hazard analysis to determine the food
safety hazards that are reasonably likely to occur in their production
processes and to identify the preventive measures an establishment can
apply to control those hazards in the production of particular products
(see 9 CFR 417.2(a)). Processing establishments can control or reduce
STEC to below detectable levels by using preventive measures, including
validated antimicrobial interventions. Processing establishments can
also establish as a preventive measure purchase specification that
requires suppliers to provide source materials with no detectable STEC.
Processing establishments can then verify that these control measures
are working as intended through their own product testing (see 67 FR
62326).
Exposure to non-O157 STEC is linked to serious, life-threatening
human illnesses. On March 28, 2019, FSIS was notified of an outbreak of
E. coli O103 illnesses.\3\ One hundred and ninety-six (196) case-
patients in ten (10) states were linked to this outbreak. Twenty-eight
(28) case-patients were hospitalized. Case-patient and traceback
information indicated raw ground beef as the likely source of this
outbreak and prompted two recalls (Recall #047-2019

[[Page 34399]]

and Recall #048-2019). Additionally, on August 16, 2018, FSIS was
notified of an outbreak of E. coli O26 illnesses.\4\ Eighteen (18)
case-patients in four (4) states were linked to this outbreak. Six (6)
people were hospitalized, and one (1) died. Case-patient and traceback
information for this outbreak also indicated raw ground beef as the
likely source, prompting two recalls (Recall #072-2018 and Recall #081-
2018). Because of these recent outbreaks, illnesses and a death, FSIS
is moving ahead with its plans to expand its non-O157 STEC sampling to
ground beef, bench trim, and other raw ground beef components.
---------------------------------------------------------------------------

\3\ More information on this outbreak is available at https://www.cdc.gov/ecoli/2019/o103-04-19/.
\4\ More information on this outbreak is available at https://www.cdc.gov/ecoli/2018/o26-09-18/.
---------------------------------------------------------------------------

Product sampling and testing is one of several activities
establishments conduct to verify the effectiveness of their HACCP
systems. Since the initiation of FSIS's non-O157 STEC testing program,
many grinders and suppliers of raw ground beef components have
instituted programs to routinely test their raw beef products for both
E. coli O157:H7 and for non-O157 STEC.
Before a foreign country can export meat products to the United
States, it must demonstrate that its meat inspection system is
equivalent to the system FSIS has established under the FMIA and its
implementing regulations. After FSIS expands its STEC verification
sampling, FSIS will require foreign countries to test the same products
for non-O157 STEC and verify that the establishments address STEC as a
hazard through an establishments hazard analysis and HACCP plans. If a
country chooses to take a different approach, then the country would
need to submit an Individual Sanitary Measure (ISM) equivalence
determination.

Sampling Beef Manufacturing Trimmings, Ground Beef, Bench Trim, and
Other Raw Ground Beef Components

To sample beef manufacturing trimmings and bench trim, FSIS
inspection program personnel (IPP) use the N60 technique to collect 60
pieces of meat from across a production lot (see FSIS Directive
10,010.1, https://www.fsis.usda.gov/wps/wcm/connect/c100dd64-e2e7-408a-8b27-ebb378959071/10010.1.pdf?MOD=AJPERES). To sample other raw ground
beef components, FSIS IPP randomly select one component type that the
establishment produces and aseptically collect a grab sample from one
or more components from a production lot consisting of many boxes
(typically 100 boxes in very large establishments) (see FSIS Directive
10,010.1). The sampling protocol used for other raw ground beef
components, specifically collecting samples from a limited number of
units from a given production lot, may reduce the chance of getting a
positive since pathogens are not homogeneously distributed throughout a
production lot.
FSIS is aware that some establishments are collecting samples of
beef manufacturing trimmings and other raw ground beef components using
a sponge or cloth device that is either attached to a conveyor belt
that comes into direct, continuous contact with product, or that is
used by establishment employees to rub products in boxes or combos.
More surface area is sampled using these techniques which theoretically
may yield results that better represent the production lot as compared
to the sampling methods currently used by FSIS for sampling beef
manufacturing trimmings and other raw ground beef components. FSIS is
evaluating alternatives to FSIS's current sampling procedures for beef
manufacturing trimmings, bench trim, and other raw ground beef
components; the Agency is looking for alternatives that provide samples
that are more representative of production lots and that are less time
intensive and more user-friendly for IPP to use. If FSIS makes changes
to its sampling methodology for beef manufacturing trimmings, bench
trim and/or other raw ground beef components, it will issue updated
sampling instructions to field personnel.

Recent Changes to FSIS's Laboratory Method

On February 4, 2019, FSIS began using a new laboratory method for
the initial screening of regulatory samples for STEC.\5\ The
instructions for using this method are found in Chapter 5C of the
Microbiology Laboratory Guidebook (MLG) and associated appendices.\6\
This updated laboratory method allows FSIS to utilize a single,
combined workflow to screen samples for the presence of E. coli O157:H7
and the six non-O157 STEC that FSIS considers adulterants (O26, O45,
O103, O111, O121, or O145). Merging the screening for these seven STEC
adulterants into a single laboratory workflow saves time, money, and
resources for the Agency without sacrificing sensitivity and
specificity.
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\5\ See https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/newsletters/constituent-updates/archive/2019/ConstUpdate020119.
\6\ The FSIS MLG can be found at: https://www.fsis.usda.gov/wps/portal/fsis/topics/science/laboratories-and-procedures/guidebooks-and-methods/microbiology-laboratory-guidebook/microbiology-laboratory-guidebook.
---------------------------------------------------------------------------

Planned Changes in Scheduling Samples

As FSIS announced with its proposed Salmonella performance
standards for ground beef and beef manufacturing trimmings (84 FR
57688, 57690), FSIS's goal is to collect and analyze at least 48
samples per year for each establishment producing greater than 50,000
pounds per day of ground beef or beef manufacturing trimmings by
increasing the sample collection frequency from a maximum of four times
per month to once per week for these product classes. To achieve this
goal, FSIS plans to change how it assigns STEC samples and thus
Salmonella samples (as all raw beef samples currently are analyzed for
STEC and Salmonella) in higher-volume beef establishments producing
ground beef and/or beef manufacturing trimmings by increasing the
sample collection frequency to once per week or four samples per month
for these product classes. FSIS intends to implement this change by
reallocating resources from lower-volume beef establishments (i.e.,
those producing 50,000 pounds or less per day) in a manner that is
resource--neutral. The Agency requests comments on the proposed change
in sampling frequency.

Response to Comments

FSIS received three comment letters in response to the 2014 Federal
Register notice on the CBA associated with testing raw beef
manufacturing trimmings for non-O157 STEC and the potential costs and
benefits of testing raw ground beef, bench trim, and all other raw
ground beef components for non-O157 STEC. Specifically, FSIS received
comments from a beef-producing company, a testing provider, and an
industry organization. The three comment letters FSIS received on the
notice did not support the expansion of non-O157 STEC testing by the
Agency. Commenters stated that testing just for E. coli O157:H7, rather
than for both E. coli O157:H7 and non-O157 STEC, was adequate. A
summary of the comments received and responses to the comments is
below.

Quantify Benefits and Recalls

Comment: Both the company and the industry organization questioned
why FSIS did not quantify the benefits of its non-O157 STEC testing.
These commenters also questioned the use in the CBA of two non-O157
STEC-related recalls (Recall #045-2013 and Recall

[[Page 34400]]

#010-2014) as evidence of public-health benefits because they were not
outbreak-related.
Response: FSIS has now quantified the estimated benefit from
prevented outbreak-related recalls in the CBA associated with this
Federal Register notice, using survey data from the Grocery
Manufacturers Association \7\ (whose name changed to Consumer Brands
Association in January 2020), and Agency recall data. The Agency
estimated the benefit from reduced outbreak-related recalls to be at
least $51.6 million per year. There are also benefits from reduced
illnesses and improved industry practices, which are not quantified.
Therefore, the total benefit of FSIS testing for non-O157 STEC
outweighs the total cost.
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\7\ Grocery Manufacturers Association. 2011. Capturing Recall
Costs: Measuring and Recovering the Losses. Retrieved from https://www.gma.maxx.matrixdev.net/forms/store/ProductFormPublic/capturing-recall-costs.
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The recalls of products contaminated with non-O157 STEC exemplify
the preventive approach FSIS takes with respect to product
contamination events, as the recalled products could have potentially
led to illnesses and outbreaks. While the historical frequency of
outbreaks attributable to non-O157 STEC may be lower than that for
outbreaks attributable to E. coli O157:H7, clinical methods are being
developed to better detect and identify non-O157 STEC illnesses
(discussed later). In testing beef manufacturing trimmings for STEC,
FSIS has found more positive non-O157 STEC than O157 STEC. FSIS
conducts verification sampling and testing and other inspection
activities to ensure establishments have appropriate controls and
verification procedures in place to prevent such illnesses. Since FSIS
started its non-O157 STEC verification testing, there have been 19
Class-I recalls associated with raw beef products contaminated with
these STEC.\8\ Four of these recalls were associated with a ground beef
outbreak. Two of the recalls were associated with the O103 serogroup
and the other two with the O26 serogroup. The other 15 recalls were
conducted based on positive non-O157 STEC results obtained through
testing by FSIS, establishments, or various states; these recalls
occurred before any attributed illnesses were reported.\9\
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\8\ The list of recalls is available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/current-recalls-and-alerts/current-recalls-and-alerts.
\9\ The list of recalls is available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/current-recalls-and-alerts/current-recalls-and-alerts.
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On February 8, 2013, FSIS implemented a new policy that requires
official establishments and importers of record to maintain control of
products produced from livestock that are sampled and tested by FSIS
for adulterants and not allow such products to enter commerce until
negative test results have been received. This policy, often referred
to as FSIS's ``hold and test'' policy, has reduced the number of
recalls conducted due to FSIS raw ground beef verification samples that
test positive for STEC. This policy applies to non-intact raw beef
product or intact raw beef product intended for non-intact use that is
sampled and tested by FSIS for STEC (77 FR 73401; Dec. 10, 2012).

False-Positive Rate

Comment: A major concern of both the company and the industry
organization that commented on the proposal was the high false-positive
rate for non-O157 STEC screening tests used by industry. The company
stated that it was concerned about the rate of false positives obtained
using available non-O157 STEC screening tests because of the decisions
that are made immediately after and on the basis of the initial
screening test results. According to the commenters, industry may hold
lots of product with screen-positive test results for non-O157 STEC
while waiting for confirmation of the results.
Industry may also conduct product traceback in response to non-O157
STEC screen-positive test results, take action during high-event
periods based on non-O157 STEC screen-positive test results, and may
have difficulty filling orders on time because of screen-positive test
results that limit the availability of raw beef. Also, the commenters
were concerned about FSIS conducting additional FSAs in response to
industry's non-O157 STEC screen-positive test results. The same
commenters stated that screen-positive test results may result in loss
of product value. Therefore, the commenters stated, the Agency
underestimated the costs of the false-positive rate on industry in the
CBA for the proposal.
Response: The Agency's 2018 data show, before the February 2019
change in technology, that 90 percent of the FSIS non-O157 STEC
presumptive positive test results are confirmed positive.\10\ A
presumptive positive result in FSIS testing means the sample has first
been determined to be a non-O157 STEC potential positive (equivalent to
an industry screen-positive non-O157 STEC test result) and then an FSIS
microbiologist identifies an isolate from the enriched sample. Note
that FSIS confirmed only 7 percent of the Agency's non-O157 STEC
potential positive test results before the February 2019 change in
technology. FSIS's revised cost estimate, using a range of false-
positive rates equivalent to the Agency's 2018 range of false positive
rates of STEC potential positive test results of 81 to 100
percent,^{11 12} showed that the lost product value from
industry's testing of raw beef products would be high--about $47.0
million. However, there are more sensitive screening tests available to
industry that have lower false-positive rates for non-O157 STEC, and
industry may choose the test that has the desired cost and benefit
result.\13\ (FSIS expects that, over time, the cost of both STEC
screening and confirmatory tests will decrease as the industry conducts
more tests and as the test kits improve. Since implementing STEC
testing, FSIS has taken steps to improve the effectiveness of its
microbiological testing program for E. coli O157:H7 and non-O157 STEC,
including implementing the new laboratory method mentioned above. Also,
FSIS does not conduct FSAs at establishments based solely on positive
industry test results.
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\10\ Data are from the Office of Public Health Science (OPHS),
FSIS.
\11\ Since we assumed that the industry would not change to
FSIS's new laboratory method in the near future, FSIS used the most
recent false positive rates of the Agency's laboratory method before
February 2019 to estimate industry costs.
\12\ Data are from the Office of Public Health Science (OPHS),
FSIS for 2018. The false positive rates of the potential screening
are as follows: 93 percent for beef manufacturing trimming, 100
percent for bench trim, 94 percent for other raw ground beef
components, and 81 percent for ground beef.
\13\ Examples of test kits can be found on the FSIS website:
https://www.fsis.usda.gov/wps/wcm/connect/f97532f4-9c28-4ecc-9aee-0e1e6cde1a89/validated-test-kit.pdf?MOD=AJPERES.
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Morbidity and Mortality Weekly Report

Comment: In reference to the Centers for Disease Control and
Prevention (CDC) Foodborne Diseases Active Surveillance Network
(FoodNet) program Morbidity and Mortality Weekly Report (MMWR) (https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6418a4.htm), the company and
industry organization asked if the report would affect FSIS's proposed
expansion of non-O157 STEC testing.
Response: At this time, the information in the report does not
change the Agency's plans to move forward with expanding non-O157 STEC
testing. According to the summary

[[Page 34401]]

of the most recent MMWR,\14\ compared with the 2015-2018 average annual
STEC incidence (infections), the 2018 incidence of STEC was higher when
compared to the 2015-2017 rates. Various factors contribute to the
increase in reported illnesses. This includes the use of updated
clinical laboratory methods. Further, the illnesses reported by the
FoodNet program are not specific to FSIS-regulated products; reported
data encompasses all reported illnesses, regardless of food source.
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\14\ https://www.cdc.gov/mmwr/volumes/68/wr/mm6816a2.htm?s_cid=mm6816a2_w.
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E. coli O157:H7 as Indicator of Non-O157 STEC and Collection of Data by
FSIS

Comment: The industry organization asserted that E. coli O157:H7
can serve as an indicator organism for non-O157 STEC. The industry
organization also commented that E. coli O157:H7 is a logical indicator
organism for non-O157 STEC, if one uses the definition of an indicator
organism presented in a research paper by Saini and others. This
research paper states, ``the term `indicator' implies that common
causes affect the levels of both indicator microorganisms and pathogens
and that these causes can be identified and controlled. The use of
measured levels of an indicator organism within statistical process
control (SPC) is based on the basic premise that the process can be
improved over time, by identifying a cause of higher-than-expected
indicator organism levels and taking an action that would result in a
decrease of levels of the indicator organism, which in turn could also
decrease levels and incidence of pathogens on the product.'' \15\ The
commenter also stated that, given the history of non-O157 STEC
outbreaks and the industry's success in reducing E. coli O157:H7
prevalence in beef products, E. coli O157:H7 is likely the best
microorganism to target in reducing risk when consuming beef products
because the number of confirmed illnesses within the U.S. has been
attributed more to E. coli O157:H7 than to non-O157 STEC.
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\15\ Saini PK, Marks HK, Dreyfuss MS, Evans P, Cook Jr LV, and
Dessai U. 2011. Indicator organisms in meat and poultry slaughter
operations; their potential use in process control and the role of
emerging technologies. J. Food Prot. 74: 1387-1394.
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Additionally, the industry organization stated that FSIS has
collected data on non-O157 STEC through testing since 2012. The
commenter stated that the data should be reviewed to ascertain the
costs and benefits of expanded testing for the six non-O157 STEC
adulterants to include raw ground beef and other components used in raw
ground beef in addition to raw beef manufacturing trimmings.
Response: FSIS has reviewed its STEC verification sampling results
obtained since 2012; positive samples for E. coli O157:H7 and non-O157
STEC have been observed. While FSIS screening and confirmation methods
used collectively permit detection of both E. coli O157:H7 and non-O157
STEC in an isolate from a sample, our data indicates that an isolate
from a sample is rarely positive for both E. coli O157:H7 and non-O157
STEC. Therefore, FSIS verification sample results do not support using
E. coli O157:H7 as an indicator organism for non-O157 STEC. Rather, the
results indicate a need for FSIS to conduct additional verification
testing of products for non-O157 STEC.
Analysis of FSIS raw beef manufacturing trimmings STEC verification
sample results indicate that positive samples are not occurring in
clusters, and are distributed among various states and regions of the
U.S. Specifically, between June 2012 and December 2018, raw beef
manufacturing trimming sample positives for E. coli O157:H7 were from
47 individual establishments in 25 States, while raw beef manufacturing
trimming sample positives for non-O157 STEC were from 87 individual
establishments in 34 States.
FSIS began verification testing of raw beef manufacturing trimmings
(MT60 sampling project) for non-O157 STEC (in addition to E. coli
O157:H7) in June 2012. Aggregate data by calendar year are publicly
available on FSIS's website. In calendar year (CY) 2012, 17 of 32 STEC
positive beef manufacturing trimmings samples were positive for non-
O157 STEC (see https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/ec/stec-annual-report/stec-annual-report-2012, Table 2, Trim Verification [MT60] data). Similarly, in CY
2013, 16 of 25 STEC positive beef manufacturing trimmings samples were
positive for non-O157 STEC (see https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/ec/stec-annual-report/stec-annual-report-2013, Table 2, Trim Verification data). Non-
O157 STEC were found in both samples identified as just ``beef'' and in
beef products identified as ``veal.'' Forty-eight (48) of 69 (70
percent) and 23 of 39 (58 percent) of STEC positive samples of raw beef
manufacturing trimmings (MT60 sampling project), raw ground beef
follow-up samples (MT44 sampling project) and follow-up samples from
originating slaughter suppliers (MT52 sampling project) collected in CY
2012 and CY 2013, respectively were positive for non-O157 STEC. From CY
2014-CY 2018 (see https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/ec/positive-results-current-cy/2015-ecoli-positives), 105 beef manufacturing trimmings (MT60)
samples were positive for non-O157 STEC, and 32 samples were positive
for E. coli O157:H7.
The Agency has incorporated data from Agency testing in the updated
CBA, including an updated false positive rate and Agency testing costs.

Antimicrobial Use and Multiple Interventions

Comment: The industry organization commented that according to
three studies funded by the North American Meat Institute, current
antimicrobial compounds used by the meat industry to destroy E. coli
O157:H7 are effective against non-O157 STEC.
Response: FSIS considers controls for E. coli O157:H7 to be
effective against non-O157 STEC when implemented appropriately.
However, FSIS testing finds both E. coli O157:H7 and non-O157 STEC
positive results in its verification testing programs. As stated above,
FSIS laboratories rarely find positives for E. coli O157:H7 and non-
O157 STEC in the same sample. With the sporadic nature of STEC
contamination, FSIS believes these results support the need for the
Agency to conduct verification testing for non-O157 STEC in additional
raw beef products.

Products To Sample

Comment: The company and industry organization commented that FSIS
should not sample and test raw ground beef and bench trim for non-O157
STEC. While conceding that verification sampling of raw beef
manufacturing trimmings yields data that provides insights into the
slaughter process, these commenters stated that verification sampling
of raw ground beef products is not useful. According to these
commenters, FSIS most often takes samples of raw ground beef product
that is a blend of raw ground beef components from multiple suppliers;
therefore, the commenters stated it is not possible to know which
component was contaminated or to provide feedback of any value to the
source establishments.
The company and the industry organization also stated that FSIS may
question beef manufacturing trimmings and other raw ground beef
component suppliers when downstream

[[Page 34402]]

establishments that grind raw beef components from multiple suppliers
produce product that tests positive for non-O157 STEC.
Response: The Agency agrees that FSIS verification sampling and
testing of product from slaughter establishments for non-O157 STEC
provides useful information on the establishment's process control. The
Agency also recognizes that traceback of ground beef made using raw
beef components from multiple suppliers to a single slaughter
establishment is more difficult than traceback of product made with raw
beef components from a single supplier. Moreover, FSIS notes that the
2018 and 2019 outbreaks involved non-O157 STEC from ground beef. Thus,
the Agency intends to expand non-O157 STEC sampling and testing to
include ground beef, bench trim, and other raw ground beef components,
which comprise the other 75 percent of the samples analyzed annually
for E. coli O157:H7. This will help FSIS verify that certain products
(such as bench trim) are not adulterated before they are ground, and
that the resulting ground beef is not adulterated.

Food Safety Assessment Estimate

Comment: With expanded non-O157 STEC testing, the industry
organization commented that FSAs based on FSIS non-O157 STEC positive
test results alone will unnecessarily increase FSIS and industry
expenses. The industry organization noted that FSIS estimated the cost
of an FSA to FSIS at $1,400 in 2014 but in September 2011 estimated
that the Agency's FSA cost was $14,000.
Response: The $14,000 estimate for FSAs in 2011 resulted from high
assumptions regarding the resources needed to conduct FSAs related to
non-O157 STECs (76 FR 58157) before 2014. For example, it used to take
an Enforcement, Investigation, and Analysis Officer (EIAO) over 30 days
to complete the in-plant portion of the investigation. The Agency
modified the assumptions and the cost estimates for the 2014 CBA based
on the new FSA methodology, using the Public Health Risk Evaluation to
determine whether an FSA is necessary, which reduced the total number
of FSAs. With the new methodology, an EIAO can complete the in-plant
portion of the FSA in 5 to 7 days, instead of an average of 38 days,
leading to a significant reduction in FSA cost to FSIS. Data collected
for FY 2016 suggest that the average STEC-related FSA under the new
methodology costs the Agency about $4,800.\16\ FSIS has updated the CBA
using this new number.
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\16\ Based on OCFO (Office of Chief Financial Officer)
preliminary analysis of average cost per FSA under new FSA
methodology, FY 2016.
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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).

Additional Public Notification

Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication on-line through the FSIS web page located at:
https://www.fsis.usda.gov/federal-register.
FSIS will also 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.

Done in Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2020-12073 Filed 6-3-20; 8:45 am]
BILLING CODE 3410-DM-P

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