42464

Proposed Rules Federal Register Vol. 79, No. 140

Tuesday, July 22, 2014

This section of the FEDERAL REGISTER short comments directly into the FSIS investigators and other public contains notices to the public of the proposed comment field on this Web page or health officials typically use records issuance of rules and regulations. The attach a file for lengthier comments. Go kept at all levels of the food distribution purpose of these notices is to give interested to http://www.regulations.gov. Follow chain, including the retail level, to persons an opportunity to participate in the the online instructions at that site for identify and trace back product that may rule making prior to the adoption of the final rules. submitting comments. be the source of the illness to the • Mail, including CD–ROMs: Send to suppliers that produced the source U.S. Department of Agriculture (USDA), material for the product. The Agency, DEPARTMENT OF AGRICULTURE FSIS, 1400 Independence Avenue SW., however, has often been impeded in its Mailstop 3782, 8–163B, Washington, DC efforts to trace back ground beef Food Safety and Inspection Service 20250–3700. products to the suppliers’ products due • Hand- or courier-delivered items: to the lack of documentation identifying 9 CFR Part 320 Send to U.S. Department of Agriculture all source materials used in its preparation. [Docket No. FSIS–2009–0011] (USDA), FSIS, OPPD, RIMD, Docket Clearance Unit, Patriots Plaza 3, 355 E In some situations, official RIN 0583–AD46 Street SW., 8–163B, Washington, DC establishments and retail stores have not 20250–3700 20024–3221. kept adequate records that would allow Records To Be Kept by Official Instructions: All comments submitted effective traceback 4 and traceforward Establishments and Retail Stores That by mail or electronic mail must include activities.5 Without such records, FSIS Grind Raw Beef Products the Agency name and docket number cannot conduct timely and effective AGENCY: Food Safety and Inspection FSIS–2009–0011. Comments received in consumer foodborne illness Service, USDA. response to this docket will be made investigations and other public health activities throughout the stream of ACTION: Proposed rule. available for public inspection and posted without change, including any commerce. SUMMARY: The Food Safety and personal information, to http:// The President’s Food Safety Working Inspection Service (FSIS) is proposing www.regulations.gov. Group (FSWG), which was formed on to amend its recordkeeping regulations Docket: For access to background March 14, 2009, recommended a new to specify that all official establishments documents or comments received, go to public health-focused approach to food and retail stores that grind raw beef the FSIS Docket Room at the address safety based on three core principles: (1) products for sale in commerce must listed above between 8:30 a.m. and 4:30 Prioritizing prevention; (2) keep records that disclose the identity p.m., Monday through Friday. strengthening surveillance and enforcement; and (3) improving and contact information of the supplier FOR FURTHER INFORMATION CONTACT: of all source materials that they use in response and recovery.6 Contact Victoria Levine, Program One of the objectives of the third the preparation of each lot of raw Analyst, Issuances Staff, Office of Policy ground beef. They must also record the principle is to quickly identify and stop and Program Development, Food Safety outbreaks of foodborne illness. When names of those supplied source and Inspection Service, U.S. Department materials, including any beef people become ill because of consuming of Agriculture, Washington, DC 20250; components and any carryover from one product from the same source material, (202) 720–5627; Fax (202) 690–0486. production lot to the next. The records it is important to identify all remaining would also be required to document lot SUPPLEMENTARY INFORMATION: Under the source material and remove it as quickly numbers, the amount of the beef authority of the Federal Meat Inspection component used in each lot (in pounds), Act (FMIA) (21 U.S.C. 601 et seq.) and exempt from the provisions of the FMIA and the the date and time each lot of raw ground its implementing regulations, FSIS meat inspection regulations with regard to investigates complaints and reports of inspection of the preparation of products, they are beef product was produced, and the not exempt from their sanitary or recordkeeping date and time when grinding equipment consumer foodborne illness associated requirements. and other related food-contact surfaces with FSIS-regulated meat products. 3 Of the 130 outbreaks that FSIS investigated from were cleaned and sanitized. Official Many such investigations into consumer 2007 through 2013, 74 were determined to be establishments and retail stores would foodborne illnesses involve those linked caused by the consumption of ground beef. Of those to the consumption of raw beef ground 1 74, 31 were linked to beef ground at a retail venue. also have to comply with the proposed 4 Traceback actions are those actions taken to recordkeeping requirements with by official establishments or retail identify and document the flow of product back to 23 respect to raw beef products that are stores. the official establishment from which the suspect ground at an individual customer’s product originated from other official request. 1 Raw ground beef products are ground and establishments, retail stores, warehouses, chopped beef (9 CFR 319.15(a)), hamburger (9 CFR distributors, restaurants, or other firms in DATES: Comments must be received on 319.15(b)), beef patties (9 CFR 319.15(c)), ground or commerce. or before September 22, 2014. chopped veal, veal patties, veal or beef patty mix, 5 Traceforward actions are those actions taken to ground veal or beef product with added seasonings, identify other potentially contaminated batches of ADDRESSES: FSIS invites interested and beef manufacturing trimmings produced at an meat that might have originated from the same persons to submit comments on this official establishment or at retail. Raw ground beef official establishment and other establishments, proposed rule. Comments may be products are also ground intact steaks/roasts, bench retail stores, warehouses, distributors, restaurants, submitted by any of the following trim ground from intact steaks/roasts, or a mix these or other firms in commerce that might have been components with trim or coarse ground beef affected by contaminated product. methods: 6 • derived from official establishments. http://www.foodsafetyworkinggroup.gov/ Federal eRulemaking Portal: This 2 See 9 CFR 303.1(d)(2)(iii)(a) through (f) for the ContentKeyFindings/HomeKeyFindings.htm and Web site provides the ability to type definition of a retail store. While retail stores are FSIS News Release No. 0292.09 dated July 8, 2009.

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as possible in order to prevent more maintain those records at his or her materials for the lot of ground beef illnesses. The FSWG has recommended headquarters’ office. 9 CFR 300.6(b)(2) sampled; the establishment of a food tracing requires any person (including any firm 2. The supplier lot numbers and system that shortens the time between or corporation or other business unit) production dates; and any other outbreak detection, resolution, and subject to the recordkeeping information that would be useful to recovery. A system that permits rapid requirements in section 642 of the FMIA suppliers that may have supplied E. coli traceback to the source would protect to allow representatives of the Secretary O157:H7-positive product to official consumers and help industry recover of Agriculture to enter his or her place establishments. contaminated product more quickly and of business to examine and copy the FSIS also stated that it intended to accurately. records specified in § 320.1. Therefore, gather the following information from FMIA Recordkeeping Requirements if records relevant to an outbreak or retail stores at the time it collected a recall investigation are being sample of raw ground beef for E. coli Official establishments and retail maintained at a headquarters’ office O157:H7 testing: stores that grind raw beef products for rather than at the place where the 1. The names and establishment sale in commerce must keep records business is conducted, i.e., the location numbers of the establishments that will fully and correctly disclose all where raw beef is being ground, those supplying the source materials for the transactions involved in their records must be made available to FSIS lot of ground beef sampled; businesses subject to the Act (see 21 personnel conducting traceback and 2. The supplier lot numbers and U.S.C. 642). This is because they engage traceforward activities. Records required production dates; and 7 in the business of preparing products to be maintained under part 320 must be 3. Any other information that would 8 of an amenable species for use as retained for a period of two years after be useful to suppliers if they are later human food, and they engage in the December 31 of the year in which the notified of an E. coli O157:H7 positive business of buying or selling (as meat transaction to which the record relates finding. brokers, wholesalers or otherwise) in has occurred (9 CFR 320.3)). Shortly after issuing the 2002 Federal commerce products of carcasses of an The recordkeeping requirements Register notice, FSIS began collecting amenable species. These businesses contained in the FMIA and 9 CFR 320 the information listed in the notice from must also provide access to, and permit are intended to permit FSIS to trace official establishments that produced inspection of, these records by FSIS product, including raw ground beef ground raw beef products that FSIS personnel.9 product associated with consumer confirmed positive for E. coli O157:H7 Current Regulatory Requirements foodborne illness, from the consumer, or and from retail stores at the time the Under 9 CFR 320.1(a), every person, the place where the product was Agency collected samples of ground raw purchased, back through its distribution beef product from the stores for E. coli firm, or corporation required by section 12 642 of the FMIA to keep records must chain to the establishment that was the O157:H7 testing. FSIS has also been keep records that will fully and source of the product. This will make it collecting supplier information from correctly disclose all transactions easier to determine, if possible, where official establishments at the time FSIS involved in businesses subject to the the contamination originally occurred. collects a sample, just as the Agency Act. Records specifically required to be Investigators should also be able to does when it collects retail samples. kept under § 320.1(b) include, but are conduct effective traceforward Retail stores, however, often do not not limited to: bills of sale, invoices, investigations so as to identify other document and maintain supplier bills of lading, and receiving and potentially contaminated product that information at times other than when shipping papers. With respect to each has been shipped from the point of FSIS collects samples of ground raw origin of its contamination to other beef product from the stores for E. coli transaction, the records must provide, 13 but are not limited to: the name or official establishments, retail stores, O157:H7 testing. As a result, the description of the livestock or article, warehouses, distributors, restaurants, or Agency is unable to respond quickly the net weight of the livestock or article, other firms. FSIS must be able to carry during foodborne disease investigations. the number of outside containers, the out these investigations using records This information, which the Agency name and address of the buyer or seller that should be kept routinely by official expects businesses to obtain from their of the livestock or animal, and the date establishments and retail stores. suppliers pursuant to the requirements and method of shipment.10 In 2002, FSIS published a Federal contained in 9 CFR 320.1, is essential Under 9 CFR 320.2, every person Register notice explaining the Agency’s for effective traceback and traceforward engaged in any business described in views with regard to the records and activities. § 320.1 and required by part 320 to keep information it considered important for In 2009, FSIS provided guidance to a records must maintain them at the place effective traceback and traceforward retail industry association requesting where the business is conducted. activities involving E. coli O157:H7 appropriate records that retail stores However, a person who conducts contamination of beef products.11 should keep to aid in identifying business at multiple locations may Specifically, the notice stated that if the traceback and traceforward on FSIS- Agency confirmed positive E. coli regulated products associated with 7 Prepared means slaughtered, canned, salted, O157:H7 samples of raw ground foodborne illnesses and other food rendered, boned, cut up, or otherwise manufactured products produced at an official safety incidents. The Agency or processed. establishment, the Agency intended to 8 The term ‘‘amenable species,’’ 21 U.S.C. 601(w), collect the following information from 12 FSIS Notice 47–02, dated 11/20/02, ‘‘FSIS was added by section 798(2) of Pub. L. 109–97, Nov. Actions Concerning Suppliers that may be 10, 2005. Section 798(1) of that law amended the the official establishment: Associated with Escherichia coli (E. coli) 0157:H7 FMIA by striking the words ‘‘cattle, swine, goats, 1. The name, point of contact, and Positive Raw Ground Beef Product’’ horses, mules, and other equines’’ in each place it phone number for the official 13 On June 4, 2012, FSIS implemented routine appeared in the Act and inserting ‘‘amenable establishments supplying the source verification testing for six Shiga toxin-producing species’’ in its place. See also 21 U.S.C. 642(a)(2) Escherichia coli (STEC), in addition to E. coli and 9 CFR 320.1(a)(2). O157:H7, in raw beef manufacturing trimmings. See 9 21 U.S.C. 642(a). See also 9 CFR 300.6(a)(1). 11 ‘‘E. coli O157:H7 Contamination of Beef Shiga Toxin-Producing Escherichia coli in Certain 10 9 CFR 320.1(b)(1). Products’’ (67 FR 62325, Oct. 7, 2002). Raw Beef Products (77 FR 31975, May 31, 2012).

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recommended that retail stores keep produced the source materials. Some practices.16 Twenty-two of these records of the lot/batch number of the official establishments and retail stores investigations were for outbreaks that source materials used to prepare the raw still do not keep and maintain the occurred in 2009 or earlier, and the ground beef, as well as the exact name/ records necessary to allow effective remainder occurred after 2009. type of product produced, the traceback activities. FSIS has found that Among the 22 investigations that took manufacturer name of the source the records kept by these businesses place in 2009 or earlier, seven had material used for the product produced, vary in type and quality, and are often complete records, four had incomplete the product code or pack date of the incomplete or inaccurate. records, and 11 had no records. Among source material used, and the Overall, FSIS has concluded that the six investigations that took place establishment number of the source voluntary recordkeeping by retail after 2009, four had complete records product used. FSIS then made the facilities that grind raw beef has not and two had incomplete records. guidance available on the Agency’s Web been sufficiently effective, as evidenced Additionally, in 2013, FSIS participated site. by continuing outbreaks linked to in three outbreaks. In two To further address the issue, on pathogens in raw ground beef that FSIS 15 investigations, no records had been December 9 and 10, 2009, FDA and FSIS cannot trace back to the source. The kept, while in the third complete held a joint public meeting to discuss lack of specific information about records were available. Therefore, while the essential elements of product tracing supplier lot numbers, product codes, the evidence suggests improvement, systems, gaps in then-current product pack dates of source materials used to there remain retail stores or tracing systems, and mechanisms to produce lots of raw ground beef, and establishments that do not maintain enhance product tracing systems for when and whether grinding equipment complete records. food.14 This meeting was followed on has been cleaned and sanitized has March 10, 2010, by an FSIS public prevented or delayed FSIS from Complete records are important for meeting that discussed the Agency’s identifying businesses that produced the successfully identifying adulterated procedures for identifying suppliers of source materials for product that was product and initiating a recall. FSIS was source material used to produce raw positive, the specific product assisted in its traceback and beef product that FSIS has found responsible for an outbreak and, traceforward activities by records in positive for E. coli O157:H7. FSIS also therefore, to accurately identify other each of the 11 investigations identified discussed additional verification product that might also be adulterated. in the study where complete records activities that the Agency planned to The cleaning and sanitization of were available. In situations where conduct at suppliers’ establishments in equipment used to grind raw beef complete records were not available, the response to positive E. coli O157:H7 between lots or batches is important inability to identify product suppliers in results. Moreover, FSIS sought input because it prevents the transfer of E. coli a timely fashion, or at all, hindered FSIS from meeting participants on ways to O157:H7 and other bacteria from one lot in identifying the source of adulteration. improve the Agency’s procedures for of product that may be contaminated to When records were available and identifying product that may be positive another lot of product ground on the complete, such that FSIS could identify for E. coli O157:H7. same equipment that is not. specific production in an establishment, Despite these FSIS actions, the FSIS conducted a retrospective review the Agency was able to institute a recall Agency has continued to experience of 28 foodborne disease investigations of product from the supplying significant impediments in connection from October 2007 through 2012 in establishment in six of 11 with tracebacks of FSIS-regulated which beef products were ground or re- investigations. In contrast, when records products, associated with consumer ground at retail stores to describe their were not available or incomplete, FSIS foodborne illness, to the suppliers that beef grinding and recordkeeping was able to do so only two of 17 times.

Number Number of resulting Status of retail grinding record investigations in recalled product

Available and complete ...... 11 6 Not available ...... 11 1 Available, but incomplete ...... 6 1

For example, in July 2007, an a retail store in New York. Leftover combinations indistinguishable from epidemiologic investigation conducted products collected from the homes of those of the case-patients. Even with by the Suffolk County Health the case-patients and tested by the purchase dates and store invoices, FSIS Department, Suffolk County, New York, Outbreaks Section of FSIS’s Eastern and local health officials were unable to identified two ill persons who reported Laboratory were found to have E. coli definitively identify the supplier of the consuming pre-formed, 80/85-percent O157:H7 with pulsed-field gel beef that was processed into the pre- lean ground beef patties purchased from electrophoresis (PFGE) 17 pattern formed patties because the source

14 Comments and a transcript of this meeting are State and Territorial Epidemiologists; 2012, Jun 4– original survey, FSIS has added two more available at www.regulations.gov at http:// 6; Omaha, NE. A copy of this document is available investigations. www.regulations.gov/ for viewing in the FSIS Docket Room. FSIS selected 17 Pulsed-field gel electrophoresis (PFGE) is a #!searchResults;rpp=10;po=0;s=FDA-2009-N-0523. 28 investigations because the illnesses were standardized method used to subtype (or 15 Recall. presumptively or definitely caused by the fingerprint) foodborne disease-causing bacteria. 16 Ihry, T., White, P., Green A., Duryea, P. Review consumption of ground beef. Beef was ground or re- PFGE can be used to distinguish strains of of the Adequacy of Ground Beef Production ground at one or more retail meat markets, and the Records at Retail Markets for Traceback Activities name of the retail market that sold the ground beef, organisms such as E. coli O157:H7, STECs, During Foodborne Disease Investigations. Poster the name of the product, and the date that it was Salmonella, Listeria, or Campylobacter at the DNA presented at: Annual Conference of the Council of purchased were available. Since the time of the level.

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materials for the product associated from the stores to definitively identify a purchased 85 percent lean ground beef with the outbreak were re-ground and single supplying establishment and the from a regulated federal establishment packaged by the retail store, which did production date of implicated product. with a known production date. This not identify the supplier of the raw beef Successful traceback resulted in a recall time, the establishment recalled used to produce the patties. The of 117,500 lbs. of potentially adulterated approximately 29,000 lbs. of adulterated inability of public health officials to ground beef from an official product. In all of the examples above, identify the supplier of the ground beef establishment. grinder records were necessary in prevented them from identifying other In May and June 2009, officials from identifying the official establishments possibly adulterated product produced FSIS, the Centers for Disease Control that supplied source materials and by the supplier, or other establishments, and Prevention (CDC), and health retailers that distributed the product. retail stores, warehouses, distributors, departments in several states To better ensure that FSIS will be able restaurants, or other firms in commerce investigated an outbreak that involved to conduct effective traceback and that might have received contaminated 20 persons with an indistinguishable traceforward investigations, or product from the supplier. strain of E. coli O157:H7. Eleven people foodborne illness investigations, or to In November 2007, a similar situation were hospitalized; one developed monitor product recalls, the records occurred when FSIS was unable to hemolytic uremic syndrome. The case- kept and maintained by official identify a source of Salmonella patients resided in nine states establishments and retail stores that contamination that accounted for nearly throughout the U.S. All 18 who grind raw beef products must disclose 40 human illnesses associated with provided food histories reported the identity of the supplier, the source fresh ground beef products produced at consuming some type of beef; 16 of all materials that they use in the a single retail grocery chain with stores reported consumption of ground beef. preparation of each lot of raw ground nationwide. In this case, records kept by Ground beef samples from a retail store beef product, including any carryover the grocery chain’s raw ground beef and a small, regulated processing from one production lot to the next, the grinding facility were missing, had no establishment were also positive with amount of the beef component used in entries on the dates of interest, or had the outbreak strain. Twelve case- each lot (in pounds), and the date and incomplete or inaccurate entries. The patients provided consumption histories time each lot of raw ground beef records also did not document all of the that included purchases at nine product is produced. The records also suppliers of the raw beef ground at the supermarkets. Using purchase must document the date and time when facility. information from the case-patients, cleaning and sanitizing occurs because More recently, in December 2011, a investigators were able to determine a cleaning and sanitizing of food-contact Maine-based grocery chain recalled an common supplier for the stores and the equipment after grinding beef may help undetermined amount of fresh ground small processing establishment. The define the lot and limit the scope of a beef products that may have been source establishment had supplied trim recall. contaminated with a multiple drug- and primal or sub-primal cuts to several FSIS is proposing to amend the resistant strain of Salmonella companies which processed them into Federal meat inspection regulations to Typhimurium. This recall was initiated ground beef or intact retail cuts. Using require that official establishments and by the grocery chain in response to information from the retail grinding retail stores that grind raw beef products illnesses caused by an outbreak of logs, investigators were able to keep records that fully disclose the salmonellosis that was associated with determine a specific production day at names, points of contact, phone the use of fresh in-store ground beef the source establishment. The numbers, and establishment numbers of prepared in and purchased at the establishment recalled approximately the establishments supplying the grocery chain’s stores. In its 421,000 lbs. of various potentially materials used to prepare each lot of raw examination of the chain’s records, FSIS adulterated beef cuts. ground beef product; all supplier lot was unable to determine suppliers of In June 2012, FSIS learned of an numbers and production dates; the the beef, which accounted for 15 human outbreak that ultimately involved 46 names of the supplied materials, illnesses. In this case, records kept by persons, 12 of whom were hospitalized. including beef components and any the grocery chain’s raw ground beef The patients resided in nine states, materials carried over from one grinding facility did not list all of the primarily in the northeastern U.S. The production lot to the next; the amount suppliers of the raw beef ground at the CDC determined that all were ill with an of the beef component used in each lot facility. As a result, FSIS could not indistinguishable strain of Salmonella (in pounds); the date and time each lot definitively identify products subject to Enteritidis. Seven of eight case-patients of raw ground beef product is produced; a recall. from two states reported consuming and the date and time when grinding Correspondingly, complete records ground beef prior to illness. A case- equipment and related food-contact are more likely to result in efficient control study showed that shopping in surfaces are cleaned and sanitized.18 recalls. In May 2007, officials from the the Maine-based grocery chain Note that for materials purchased from Minnesota and Virginia state described earlier was statistically a broker or distributor, the departments of health and FSIS significant. State investigators collected establishment number would be on the investigated an outbreak involving nine leftover ground beef from several case- shipping container of the product. ill persons. These nine individuals had patients and from retail supermarkets or Official establishments and retail an indistinguishable strain of E. coli their distribution center. Ground beef stores that prepare raw beef products O157:H7. A case-control study showed from case-patients’ homes tested that are ground at an individual consumption of ground beef purchased positive for the outbreak strain. Eight customer’s request would also be at a local grocery chain was significantly case-patients who shopped at the required to comply with the proposed associated with illness. Left-over ground grocery chain provided purchase recordkeeping requirements with beef from a case-patient’s home was information. The grocery chain had respect to such product. Keeping tested and found positive. Investigators implemented improvements in their complete records for all grinding used purchase date and store location record system and grinding logs for activity will enable FSIS to conduct information from case-patients along products purchased by five case- with complete, accurate grinding logs patients conclusively showed they 18 Proposed 9 CFR 320.1(b)(4)(i).

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effective recalls in a timely manner record that FSIS posted with this 2009 cleaning and sanitizing would be the thereby reducing illnesses or deaths. guidance. As shown in the sample information required to be kept, if this Grinding logs at retail stores are a grinding log (Table 1) below, the date rule is finalized. Information under the good example of a type of record that and time of grind, the amount of other column headings would not be can easily be used to identify the source, carryover, the name of the source required, but some official supplier, and names of all materials material, supplier establishment establishments and retail stores may used in the preparation of raw ground information from the label of the source choose to keep and maintain such beef products. Below is the grinding log material, and the date and time of information.

Executive Orders 12866 and 13563 and harmonizing rules, and of promoting of all transactions involved in their Regulatory Flexibility Act flexibility. This rule has been businesses subject to the FMIA, designated a ‘‘significant regulatory including the identity and supplier of Executive Orders 12866 and 13563 direct agencies to assess costs and action’’ under section 3(f) of Executive all materials used in the preparation of benefits of available regulatory Order 12866. Accordingly, this rule has each lot of raw ground product. The alternatives and, if regulation is been reviewed by the Office of required records are essential to conduct necessary, to select regulatory Management and Budget. efficient foodborne illness investigations. The proposal would approaches that maximize net benefits I. Background (including potential economic, affect retail stores and official environmental, public and safety effects, FSIS is proposing a rule that would establishments. distributive impacts, and equity). require official establishments and retail If adopted, the proposed rule will Executive Order 13563 emphasizes the stores that grind raw beef products for require records to include lot-specific importance of quantifying both costs sale in commerce to keep records that information (i.e., a lot number, a code and benefits, of reducing costs, of will fully and correctly disclose details number, or other identifier). Lot-specific

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information distinguishes one stated above, the Agency has concluded include 64,380 supermarkets, 5,924 production batch from another and can that a policy of voluntary guidelines for meat markets, 4,544 warehouse clubs be a number printed on the packaging recordkeeping has not ensured that all and supercenters, and 1,245 official or some other identifier.19 establishments and retail outlets establishments that engage in grinding Recordkeeping systems are designed maintain complete records that will raw beef products. The number of retail to track the flow of product or product ensure quick identification of stores is based on 2010 Census data 21 attributes through production processes contaminated product. for establishments that grind beef, while or the supply chain. Traceability is the the number of official establishments ability to follow the movement of a food (2) Regulated Weekly Recordkeeping was obtained from the Public Health product through the stages of Program Information System (PHIS). Some of production, processing, and FSIS considered requiring that retail these establishments and retail stores distribution.20 Records are necessary for stores and official establishments already maintain the records required in a good product traceback (traceforward) maintain grinding records such that system. each producer recorded grinding the proposed rule, and would therefore Public and private sector officials activities once per week. This would be not incur any additional costs. often lack information about the sources an improvement over the current Table 2 distinguishes between large of foods or ingredients, making voluntary recordkeeping program in that establishments, defined as those with traceback processes inefficient, which those establishments and retail stores 500 or more employees, and small results in missed opportunities to which are not recording grinding establishments, defined as those with identify contaminated product. This activities would now be required to do fewer than 500 employees. FSIS proposed rule, if adopted, will so, and a weekly recordkeeping task assumes that retail establishments with strengthen traceback systems, leading to would be less burdensome than the 500 or more employees will grind beef quicker identification of adulterated recordkeeping being proposed, which and create a record approximately five product and quicker, more targeted requires firms to record activities times per week, thus assuming 260 recalls, an outcome in keeping with the approximately two to five times per objectives of the FSWG. records per year for these large entities. week. However, a weekly record would For small retail entities, with fewer than II. Need for Rule make it difficult to differentiate between 500 employees, FSIS assumes that these lots of product ground from different Voluntary recordkeeping at retail establishments on average would grind suppliers throughout the week, and stores and official establishments has beef and create a record approximately would therefore result in many of the not been sufficiently effective. twice a week for 50 weeks for the year, same traceback obstacles currently Incomplete and nonexistent grinding for 100 records per year. For official experienced under voluntary records have impeded traceback and recordkeeping. Therefore, FSIS rejected FSIS processing establishments, FSIS traceforward activities by FSIS this alternative. examined data from a 2008 FSIS investigators during food safety events, survey,22 and found that, on average, limiting their ability to identify (3) More Detailed Recordkeeping large official establishments processed implicated product and sources of Program ground beef product 258 days a year and contamination. This rule is needed to FSIS also considered expanding the the small establishments processed enhance FSIS’ ability to protect public recordkeeping requirements to include ground beef about 164 times a year. health by conducting recalls quickly all fields suggested in the 2011 FSIS Small official establishments grind more and efficiently, thereby reducing guidance (all fields in the Table 1 often than small retail establishments illnesses associated with contaminated proposed log). This would provide FSIS ground beef product. because official establishments rely with more detailed records to use more heavily on ground beef production III. Alternatives Considered during an investigation, which may be than retail establishments, which have a (1) Existing Voluntary Recordkeeping particularly useful in instances where wider variety of products for sale. FSIS Program product is ground multiple times per used these values to estimate the day from multiple sources. However, number of grinding log records per year FSIS provided industry voluntary this level of detail would place an for retail establishments. guidelines (see Table 1) in 2009. As unnecessary burden on those establishments that do not grind 19 FSIS acknowledges that most firms use lot or product multiple times per day. For this code numbers to identify specific batches of their 21 Source: U.S. Department of Commerce, U.S. products. However, some may use other reason, FSIS decided to require that Bureau of the Census—Number of Firms, Number technologies such as barcodes. The term ‘other only the most critical information be of Establishments, Employment, and Annual identifier’ is intended to capture any other methods recorded while leaving the remaining that the food industry may be using to identify Payroll by Enterprise Employment Size for the specific lots of product. possible fields as a voluntary United States, All Industries: 2010. 22 20 Codex Alimentarius Commission, ‘‘Procedural component. Results of Checklist and Reassessment of Manual, Seventeenth Edition,’’ 2007. The Codex Control for Escherichia coli O157:H7 in Beef Alimentarius Commission was created in 1963 by IV. Baseline Operations. 2008, available at http:// the Food and Agriculture Organization (FAO) and FSIS expects that this proposed rule www.fsis.usda.gov/wps/wcm/connect/9ce5ce22- the World Health Organization (WHO) to develop f609-4990-bd9a-ce2c323d229b/Ecoli_Reassement__ food standards and guidelines. Available online at: could affect a total of 76,093 retail stores _Checklist.pdf?MOD=AJPERES, accessed July 24, ftp://ftp.fao.org/docrep/fao/010/a1472e/a1472e.pdf. and official establishments. These 2013.

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TABLE 2—NUMBER OF RETAIL FIRMS AND OFFICIAL ESTABLISHMENTS AFFECTED BY RECORDKEEPING REQUIREMENTS ASSOCIATED WITH GROUND RAW BEEF PRODUCTS

Number of firms by size 1 Number of establishments NAICS by firm size 2 codes NAICS description Large Small Total Large Small Total

445110 ..... Supermarket and other grocery (except 314 40,713 41,027 21,028 43,352 64,380 convenience) stores. 445210 ..... Meat Markets...... 9 5,415 5,424 274 5,650 5,924 452910 ..... Warehouse clubs and Supercenters ...... 11 13 24 4,531 13 4,544 PHIS ...... Official establishments ...... 35 1,210 1,245

Total ...... 334 46,141 46,475 25,868 50,225 76,093 1 Large: 500 or more employees; Small: 499 or fewer employees. 2 For official establishments, size category based on establishment HACCP size class distinguishing Large (500 or more employees) from Small and Very Small. Note: NAICS is the North American Industry Classification System. A ‘‘firm’’ refers to the parent company and an ‘‘establishment’’ refers to each distinct facility. Source: U.S. Department of Commerce, U.S. Bureau of the Census—Number of Firms, Number of Establishments, Employment, and Annual Payroll by Enterprise Employment Size for the United States, All Industries: 2010.

The kinds of businesses identified as bread, soda, and snacks, but do not also expects that these businesses potentially subject to the final engage in the business of grinding raw normally obtain buyer and seller contact regulation are: beef. The meat and meat product information during the course of • Supermarkets and other grocery merchant wholesalers industry business. In determining cost to (except convenience) stores. This comprises establishments primarily industry for this rule, though, FSIS did industry comprises establishments engaged in the merchant wholesale not assume that all these establishments generally known as supermarkets and distribution of meats and meat products had complete records that would satisfy grocery stores primarily engaged in (except canned and packaged frozen) or the provisions of this rule. FSIS requests retailing a general line of food, such as lard, but do not engage in the business comments on the extent to which this is canned and frozen foods; fresh fruits of grinding raw beef. Most, if not all already being done. and vegetables; and fresh and prepared supermarkets, meat markets, and Costs would occur because many of meats, fish and poultry. Included in this warehouse clubs sell product from the estimated 76,093 retail stores and industry are delicatessen-type federally inspected establishments and official establishments would need to establishments primarily engaged in derive a significant share of revenue implement new recordkeeping activity retailing a general line of food. from those products. The full-service and make those records available for the • Meat Markets. This industry restaurant industry comprises Agency’s review. To estimate costs to comprises establishments primarily establishments primarily engaged in industry, the Agency used information engaged in retailing fresh, frozen, or providing food services to patrons who based on existing literature and cured meats. Meat markets may butcher order and are served while seated (i.e., discussions with FSIS experts. The animals for their own account, or they waiter/waitress service) and pay after annual recurring cost is due to the time may buy bulk from others. Delicatessen- eating. Limited service refers to fast food requirement for recording information type establishments primarily engaged restaurants, delis, pizza shops, carry out for each daily set of entries. FSIS in retailing fresh meat are included in restaurants, and other similar assumed that, for establishments that this industry. establishments. currently maintain a complete grinding • Warehouse clubs and supercenters. V. Costs log, there would be no additional time This industry comprises establishments requirement. For establishments that known as warehouse clubs, superstores FSIS estimated the costs to industry presently keep a log, but do not include or supercenters primarily engaged in and the Agency for ensuring compliance all of the information required under the retailing a general line of groceries in with the regulation. proposed regulation, FSIS assumed that combination with general lines of new Industry Costs it would take an additional 30 to 60 merchandise, such as apparel, furniture, seconds per daily recordkeeping to and appliances. Official federal— Under the current regulations (9 CFR comply with the rule, and, for inspected establishments that grind raw 320.1(a)(2) and (b)), official establishments that presently do not beef products are included in this establishments are required to keep maintain a grinding log, it would take group. records that fully and correctly disclose 60 to 90 seconds to record each daily There are three major kinds of all transactions involved in their record. FSIS seeks comments on these businesses FSIS does not consider to be business. These records must show the recordkeeping time assumptions. retail establishments, and thus are not name or description of the articles To estimate the numbers of logs that affected by the proposed rule: handled (section 320.1(b)(1)(i)) and the are presently incomplete and the convenience stores, meat and meat name and address of the sellers and number of logs that presently do not product merchant wholesalers, and full- buyers of the articles (section exist but would under the provisions of service and limited-service restaurants. 320.1(b)(1)(iv)). Official establishments this proposed rule, FSIS used a The convenience store or food mart must provide FSIS access to these published 2008 study 23 that reported on (except those with fuel pumps) industry records (section 320.4, 21 U.S.C. 642). comprises establishments that primarily FSIS believes that supplier lot numbers 23 ‘‘Recordkeeping Practices of Beef Grinding engage in retailing a limited line of and production dates are normally made Activities at Retail Establishments.’’ (2011) Hannah goods that generally includes milk, available to official establishments. FSIS Gould, Scott Seys, Karen Everstine, Dawn Norton,

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the recordkeeping practices of retail approximately 3 percent complete (12 Bureau of Labor Statistics labor category stores that grind raw beef. The study percent*(1–78 percent)), 9 percent of ‘‘Butchers and Meat Cutters’’ would found that 74 percent of chain retail incomplete (12 percent*78 percent), and perform the recordkeeping. FSIS stores and 12 percent of independent 88 percent no records. FSIS is seeking assumed a wage per hour from the most retail stores kept grinding logs. Of the comment on these distributions and the recent mean wage rate for this labor stores that kept grinding logs, the study current recordkeeping practices of retail category, $14.42.25 In addition to the reported 78 percent of those logs as stores. base wage, FSIS assumed an additional incomplete.24 For the purposes of the FSIS multiplied the percentages by benefit cost factor of 33 percent 26 to the number of grinding logs that will cost estimate, FSIS used the chain stores account for benefits that the employee exist under this rule to determine the surveyed in the study as a proxy for may receive in addition to the mean present numbers of incomplete and non- large retail and official establishments, hourly wage. These include, but are not existing grinding logs. FSIS multiplied and the independent stores as a proxy these numbers 30 to 60 seconds and 60 limited to, vacation time, sick time, and for small retail and official to 90 seconds respectively, to estimate health care. Consequently, FSIS establishments. Therefore, the the total number of additional hours, assumed a total hourly compensation recordkeeping distribution of large and then multiplied this estimated rate of $14.42 (1+0.33)=$19.18. Table 3 establishments based on the survey range by the average hourly presents the total costs by results is approximately 16 percent compensation rate, derived below, of establishment/retail store (entity) size complete (74 percent*(1–78 percent)), $19.18. class and estimated current 58 percent incomplete (74 percent*78 To estimate the hourly cost of recordkeeping practices. This results in percent), and 26 percent no records. For recordkeeping, FSIS assumed that, an estimated total cost to industry of small establishments, the distribution is primarily, employees that are in the about $2.69 million to $4.39 million.

TABLE 3—ANNUAL ESTIMATED COSTS BY ENTITY SIZE AND CURRENT RECORDKEEPING PRACTICES 1

Added time (h) Annual cost ($1,000) Size Current logs Annual Added time/ records record (s) Low High Low High

Large ...... None ...... 1,726,846 60–90 28,781 43,171 552 828 Incomplete ...... 3,909,648 30–60 32,580 65,161 625 1,250 Complete ...... 1,089,116 0 0 0 ...... Small ...... None ...... 4,499,947 60–90 74,999 112,499 1,438 2,158 Incomplete ...... 469,268 30–60 3,911 7,821 75 150 Complete ...... 130,725 0 0 0 ......

Total ...... 11,825,550 ...... 140,271 228,652 2,690 4,385 1 Numbers in table may not sum to totals due to rounding.

Agency Enforcement Costs: This with this proposed rule will lead to is requesting data on the impact of proposed rule will result in no impact more efficient, accurate, and quicker recordkeeping on reducing the volume on the Agency’s operational costs identification of potentially adulterated of product recalled for official because the Agency will not need to add product. Given everything else being establishments and retail outlets. any staff or incur any non-labor equal, FSIS, therefore, expects a The ground beef industry will also expenditures. decrease in the average volume of benefit from reduced damage to Total Costs product recalled,27 resulting in reputation during food safety events. decreased costs for recalls and for the FSIS estimates the total cost for the The ability of FSIS to trace adulterated proper disposal of the product, i.e., rule to be about $2.69 million to $4.39 product back to its source ensures that relabeling, re-cooking, reworking, or million. in events such as recalls, the number of destroying product. The Agency notes, firms implicated is kept to a minimum. VI. Benefits however, that the expected benefit for By limiting the scope of recalls, Expected benefits would likely result any individual establishment would be traceability through better from this proposed rule, for consumer less than (perhaps substantially less recordkeeping will reduce negative health, the ground beef processing than) the rule-induced cost borne by spillover effects which could industry, and for the Agency. that establishment; otherwise, the unnecessarily burden a large group of Under this rule, FSIS expects the establishment would voluntarily keep otherwise uninvolved ground beef industry to benefit from lower direct complete records even in the absence of producers.28 This level of accountability costs for recalls because compliance a regulatory requirement to do so. FSIS insulates the industry as a whole from

Danny Ripley, David Reimann, Moshe Dreyfuss, Wu While some fields identified in the survey are not Recall Costs,’’ prepared for presentation at the San Chen, and Carol A. Selman. Journal of Food those required in the rule, and some fields required International Association of Agricultural Protection, Vol. 74 (6), 1022–24. in the rule are not identified in the survey, FSIS Economists (IAAE) Triennial Conference, Foz do 24 The study defined a complete log as one that determined that there was enough of an overlap to Iguac¸u, Brazil, 18–24 August, 2012. This paper included, at minimum, the date and time the grind make use of the survey results. presents simulation results of a model that was performed, the type of product produced, the 25 BLS Occupational Employment and Wages, indicated that that presence of a traceability system lot and establishment code of the source beef, May 2013. decreased volumes of recalls by over 90 percent. whether cleanup was performed between grinds, 26 and the whether beef trimmings were included in BLS Employer Costs for Employee 28 Pouliot, Sebastien and Sumner, Daniel A. the grind. An incomplete log was defined as one Compensation, June 2013. ‘‘Traceability, recalls, industry reputation, and that was only partially completed (missing records), 27 Resende-Filho, Moises A. and Brian L. Buhr. product safety.’’ European Review of Agricultural or did not record all of the listed data elements. ‘‘Economics of Traceability for Mitigation of Food Economics. (2013) Volume 40 (1): 121–142.

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losses to reputation and consumer environmental information is million pounds of frozen ground beef confidence. sufficiently convincing to link patties due to E. coli O157:H7 In addition, FSIS expects to benefit consumption of a specific food to a contamination. The recalled product, from lower Agency costs for recalls and cluster of illnesses, investigators can consisting of only six lots but recovery of adulterated product because identify the contaminated product distributed to all 48 contiguous states, the expected increased efficiency of without finding the bacterial strain in led to thirteen PFGE confirmed illnesses identifying potentially adulterated the consumed food. In any by the time the product was recalled. As product will lead to: (1) reduced circumstance, without adequate records, a result of the recall investigation, FSIS inspection program personnel activities rapid identification of the contaminated identified the establishment’s practice at Federal meat establishments and (2) product is not likely to occur. When of carry-over—the process of reworking reduced overtime hours for FSIS FSIS identifies a food product causing the previous day’s product into the next personnel not employed in official illness in commerce, FSIS takes action day’s product—as one of the major establishments, including enforcement, to remove it through a voluntary reasons for the large amount of district office, and recall staff. As recalls product recall. contamination. Following the become more effective because of better It is FSIS’ experience that, before a investigation, FSIS promulgated recordkeeping, FSIS could reduce staff recall takes place, many ill people have guidance to establishments producing travel for conducting recall effectiveness already been confirmed ill from the ground beef instructing them to checks. specific pathogen (STECs or Salmonella implement lot designation procedures FSIS will conduct an ongoing bacteria) through a laboratory test. One and refrain from practicing carry-over.29 retrospective analysis to confirm that ill person could lead to a recall if As a result of the improved guidance the rule positively affects Agency investigators identify the consumed and the incentive to not sustain losses resources and to quantify those benefits. product that led to illness and where the like those seen at this Federal To do so, FSIS will examine the consumer purchased the product, the establishment (sold to a competitor following: point of purchase (POP), and confirm three weeks after the recall), there was • Overtime hours for enforcement, through microbiological tests that the a major response from producers of district office, and recall staff, on a per- identified unconsumed product ground beef.30 outbreak basis. contained the same bacterial strain as Better recordkeeping will facilitate • Number, length, and outcome of that that caused the illness. If complete outbreak investigations and enable FSIS recall effectiveness checks. records existed at the POP, investigators to identify deficiencies in industry • Regulatory noncompliance citations would be able quickly to identify the practices and government policy. This at official establishments for the supplier and the lots involved. With the type of evidence results in proposed revisions to 9 CFR 320.1(b)(4). lot numbers, a supplier would be able improvements at the establishment level This review will enable FSIS to better to identify implicated product, enabling by helping to identify source quantify the benefits of the proposed earlier recalls and a higher proportion of establishments and affording these recordkeeping requirements and product recovered. This would result in establishments the opportunity to identify areas where the regulation averted illnesses and limited outbreaks. diagnose and correct process failures. could be further improved. In addition to identifying implicated FSIS expects improvements due to VII. Public Health Benefits and Related product, complete records will also lessons learned from outbreak Costs allow investigators to identify product investigations to prevent future source establishments, resulting in a outbreaks. Consumers would also FSIS expects public health benefits in better chance of determining the cause benefit from the prevention of future the form of averted illnesses due to of adulteration. The ability of FSIS to foodborne illnesses which are not a part better recordkeeping practices at official determine process failures will help of outbreaks, since lessons learned from and retail establishments. establishments take corrective actions to outbreak investigations will likely lead Epidemiologic, environmental, and prevent future contamination, resulting to improvements which may reduce microbiologic findings and assessments in a reduction in future illnesses. Both isolated foodborne illnesses as well. link illnesses to contaminated food. the costs and benefits of corrective FSIS requests information that could Typically, distributions of outbreak actions would be attributable to this rule help quantify the above or any other illnesses caused by contaminated raw if the actions would not have occurred benefits or costs from this rule. beef produced in FSIS-regulated without being facilitated by the establishments are geographically and proposed new recordkeeping VIII. Net Benefits temporally dispersed. Working together, requirements. FSIS estimates annual costs of epidemiologists and microbiologists Beyond establishment-level approximately $2.69 million to $4.39. may determine that ill persons share a improvements, a better understanding of Costs associated with newly-occurring common bacterial strain (outbreak product adulteration through public health interventions that would strain) and common food exposure. investigations can serve as education for be facilitated by the proposed When these researchers find a common the entire industry as well as regulatory recordkeeping requirements have not exposure, environmental specialists organizations. The identification of been quantified. Benefits would accrue identify food and practices associated potentially hazardous practices can lead to industry due to an expected smaller with production, transportation, and to improved guidance, and the linking volume of recall, given everything else preparation of the food to determine the of such practices to outbreaks and being equal, and due to reduced possibility of contamination of the recalls motivates establishments to industry vulnerability to reputation common-source food. In some refrain from risky behavior. Lessons investigations, microbiologists test learned from successful investigations 29 Ground Beef Processing Guidance Material samples of implicated foods and find can also lead to improvements in the (January 19, 1999, 64 FR 2872). the outbreak strain. Investigators use decision making process for recalls and 30 82 percent of establishments with grinding operations reported using a robust testing program such findings to support the causal regulatory actions. in their rework process. Results of Checklist and association of ill people with the food For example, in August 1997, a Reassessment of Control for Escherichia coli they consumed. If epidemiologic and Federal establishment recalled 25 O157:H7 in Beef Operations (2008) See footnote 25.

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damaging food safety events. The is already maintaining complete records product and identify the names of those Government would benefit in that the and the number of days of production. source materials. rule would enable the Government to For official establishments presently The required records would have to operate in a more efficient manner in with no records, FSIS estimates an include the following information: identifying and tracking recalls of annual cost of $52.42 to $78.63; with (A) The names, points of contact, adulterated raw ground beef products. incomplete records, FSIS estimates an phone numbers, and establishment Consumers would benefit from a annual cost of $26.21 to $52.42. For numbers of the establishments reduction in foodborne illnesses due to retail establishments, FSIS estimated supplying the materials used to prepare quicker recalls, correction of process annual costs are $31.96 to $47.95 for each lot of raw ground beef product. failures at ground beef producing establishments presently with no (B) All supplier lot numbers and establishments, and improved guidance records and $15.98 to $31.96 for those production dates, and industry practices. with incomplete records. (C) The names of the supplied FSIS estimates that the average cost Establishments that are already keeping materials, including beef components per E. coli O157:H7 illness is $3281,31 records as required by the proposal and any materials carried over from one and the average cost per Salmonella would incur no costs because of this production lot to the next, illness is $2423.32 Given the cost rule. (D) The amount of the beef savings incurred for each ground beef- Based on the above analysis, the component used in each lot (in pounds), linked foodborne illness that is averted, Agency has concluded that the rule will (E) The date and time each lot of raw and the potential for this rule to prevent not have a significant economic impact ground beef product is produced, and (F) The date and time when grinding outbreaks and illnesses, FSIS asserts on a substantial number of small equipment and related food-contact that the benefits accrued to industry, entities. Government, and consumers from this surfaces cleaned and sanitized. proposed rule may result in net Executive Order 12988 Estimate of Burden: FSIS estimates that it would take 3.00 hours per economic benefits. This rule has been reviewed under respondent annually. IX. Regulatory Flexibility Analysis Executive Order 12988, Civil Justice Respondents: Official establishments Reform. When this proposed rule is The FSIS Administrator made a and retail stores that grind raw beef preliminary determination that this adopted: (1) All state and local laws and products. proposed rule will not have a significant regulations that are inconsistent with Estimated Number of Respondents: impact on a substantial number of small this rule will be preempted; (2) no 76,093. entities, as defined by the Regulatory retroactive effect will be given to this Estimated Number of Responses per Flexibility Act (5 U.S.C. 601). rule; and (3) administrative proceedings Respondent: 155. The Agency analyzed the potential will not be required before parties may Estimated Total Annual Burden on impact of this proposed rule on affected file suit in court challenging this rule. Respondents: 228,652 hours. small entity retail stores and official Executive Order 13175 Copies of this information collection establishments that grind raw beef assessment can be obtained from Gina products. The number and type of small This final rule has been reviewed in Kouba, Paperwork Reduction Act entity retail stores and official accordance with the requirements of Coordinator, Food Safety and Inspection establishments potentially affected by Executive Order 13175, Consultation Service, USDA, 1400 Independence the final rule is shown in Table 2 to be and Coordination with Indian Tribal Avenue SW., Room 6077, South 50,225, based on number of employees. Governments. The review reveals that Building, Washington, DC 20250. Costs would accrue for maintaining the this proposed regulation will not have Comments are invited on: (a) Whether required records based on the volume of substantial and direct effects on Tribal the proposed collection of information ground raw beef products produced by governments and will not have is necessary for the proper performance the business. The average annual cost to significant Tribal implications. of FSIS’s functions, including whether small establishments for this rule Paperwork Requirements the information will have practical depends on whether the establishment utility; (b) the accuracy of FSIS’s In accordance with section 3507(j) of estimate of the burden of the proposed 31 The FSIS estimate for the cost of E. coli the Paperwork Reduction Act of 1995 collection of information, including the O157:H7 ($3,281 per case—2010 dollars) was (44 U.S.C. 3501 et seq.), the information validity of the methodology and developed using the USDA, ERS Foodborne Illness collection and recordkeeping Cost Calculator: STEC O157 (June 2011) http:// assumptions used; (c) ways to enhance webarchives.cdlib.org/sw1rf5mh0k/http:/ requirements included in this proposed the quality, utility, and clarity of the www.ers.usda.gov/Data/FoodborneIllness/ rule have been submitted for approval to information to be collected; and (d) (archived link—calculator currently being updated). OMB. ways to minimize the burden of the FSIS updated the ERS calculator to incorporate the Title: Records to be kept by Official Scallan (2011) case distribution for STEC O157. collection of information on those who Scallan E. Hoekstra, Angulo FJ, Tauxe RV, Establishments and Retail Stores are to respond, including through the Widdowson MA, Roy SL, et. al. 2011 January. Grinding Raw Beef Products. use of appropriate automated, ‘‘Foodborne Illness Acquired in the United States— Type of Collection: New. electronic, mechanical, or other Major Pathogens’’. Emerg. Infect. Dis. 17: 7–15. 32 The FSIS estimate for the cost of Salmonella Abstract: Under this proposed rule, technological collection techniques or ($2,423 per case,—2010 dollars) was developed FSIS is requiring several information other forms of information technology. using the USDA, ERS Foodborne Illness Cost activities. FSIS is proposing to amend Comments may be sent to both Gina Calculator: Salmonella (June 2011) http:// its recordkeeping regulations to specify Kouba, Paperwork Reduction Act webarchives.cdlib.org/sw1rf5mh0k/http:/ www.ers.usda.gov/Data/FoodborneIllness/ that all official establishments and retail Coordinator, at the address provided (archived link—calculator currently being updated). stores that grind raw beef products for above, and the Desk Officer for FSIS updated the ERS calculator to incorporate the sale in commerce must keep records, for Agriculture, Office of Information and Scallan (2011) case distribution for Salmonella. a period of two years, that disclose the Regulatory Affairs, Office of Scallan E. Hoekstra, Angulo FJ, Tauxe RV, Widdowson MA, Roy SL, et. al. 2011 January. identity of the supplier of all source Management and Budget, Washington, ‘‘Foodborne Illness Acquired in the United States— materials that they use in the DC 20253. To be most effective, Major Pathogens’’. Emerg. Infect. Dis. 17: 7–15. preparation of each lot of raw ground comments should be sent to OMB

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within 60 days of the publication date FSIS public meetings, and other types of ground at an individual customer’s of this proposed rule. information that could affect or would request must keep records that comply be of interest to constituents and with paragraph (4)(i) of this section. E-Government Act Compliance stakeholders. The Update is * * * * * The Food Safety and Inspection communicated via Listserv, a free Done in Washington, DC on July 16, 2014. Service is committed to complying with electronic mail subscription service for the E-Government Act, to promote the industry, trade groups, consumer Alfred V. Almanza, use of the Internet and other interest groups, health professionals, Administrator. information technologies to provide and other individuals who have asked [FR Doc. 2014–17128 Filed 7–21–14; 8:45 am] increased opportunities for citizen to be included. The Update is also BILLING CODE 3410–DM–P access to Government information and available on the FSIS Web page. In services, and for other purposes. addition, FSIS offers an electronic mail USDA Non-Discrimination Statement subscription service which provides NUCLEAR REGULATORY automatic and customized access to COMMISSION No agency, officer, or employee of the selected food safety news and USDA shall, on the grounds of race, information. This service is available at 10 CFR Parts 26 and 73 color, national origin, religion, sex, http://www.fsis.usda.gov/wps/portal/ [NRC–2014–0118] gender identity, sexual orientation, fsis/programs-and-services/email- disability, age, marital status, family/ subscription-service/email-subscription- RIN 3150–AJ41 parental status, income derived from a service. Options range from recalls to Enhanced Security at Fuel Cycle public assistance program, or political export information to regulations, beliefs, exclude from participation in, Facilities; Special Nuclear Material directives and notices. Customers can Transportation deny the benefits of, or subject to add or delete subscriptions themselves, discrimination any person in the United and have the option to password protect AGENCY: Nuclear Regulatory States under any program or activity their accounts. Commission. conducted by the USDA. List of Subjects ACTION: Draft regulatory basis; extension How To File a Complaint of of comment period. Discrimination Meat inspection, Reporting and recordkeeping requirements. SUMMARY: On June 18, 2014, the U.S. To file a complaint of discrimination, For the reasons discussed in the Nuclear Regulatory Commission (NRC) complete the USDA Program preamble, FSIS is proposing to amend 9 published a request for public comment Discrimination Complaint Form, which CFR part 320, as follows: on a draft regulatory basis to support the may be accessed online at http:// ■ 1. The authority citation for part 320 potential amendments to revise a www.ocio.usda.gov/sites/default/files/ number of existing security related _ _ _ _ continues to read as follows: docs/2012/Complain combined 6 8 regulations relating to physical 12.pdf, or write a letter signed by you Authority: 21 U.S.C. 601–695; 7 CFR 2.7, protection of special nuclear material 2.18, 2.53. or your authorized representative. (SNM) at NRC-licensed facilities and in Send your completed complaint form ■ 2. In § 320.1, add paragraph (b)(4) to transit, as well as the fitness-for-duty or letter to USDA by mail, fax, or email: read as follows: programs for security officers at certain Mail § 320.1 Records to be kept. fuel cycle facilities. The public comment period originally was * * * * * U.S. Department of Agriculture, scheduled to close on August 4, 2014. (b) * * * Director, Office of Adjudication, 1400 The NRC has decided to extend the (4)(i) In the case of raw ground beef Independence Avenue SW., public comment period on this products, official establishments and Washington, DC 20250–9410. document to allow more time for retail stores are required to keep records members of the public to develop and Fax that fully disclose: (202) 690–7442 (A) The names, points of contact, submit their comments. phone numbers, and establishment DATES: The due date for comments Email numbers of the establishments requested in the document published on [email protected] supplying the materials used to prepare June 18, 2014 (79 FR 34641) is Persons with disabilities who require each lot of raw ground beef product; extended. Comments must be filed no alternative means for communication (B) All supplier lot numbers and later than October 17, 2014. Comments (Braille, large print, audiotape, etc.) production dates; received after this date will be should contact USDA’s TARGET Center (C) The names of the supplied considered if it is practical to do so, but at (202) 720–2600 (voice and TDD). materials, including beef components the NRC is able to ensure consideration and any materials carried over from one only for comments received before this Additional Public Notification production lot to the next; date. FSIS will announce this proposed (D) The amount of the beef ADDRESSES: You may submit comments rule online through the FSIS Web page component used in each lot (in pounds); by any of the following methods (unless located at http://www.fsis.usda.gov/ (E) The date and time each lot of raw this document describes a different wps/portal/fsis/topics/regulations/ ground beef product is produced; and method for submitting comments on a federal-register/proposed-rules. (F) The date and time when grinding specific subject): FSIS will also make copies of this equipment and other related food- • Federal Rulemaking Web site: Go to Federal Register publication available contact surfaces are cleaned and http://www.regulations.gov and search through the FSIS Constituent Update, sanitized. for Docket ID NRC–2014–0118. Address which is used to provide information (ii) Official establishments and retail questions about NRC dockets to Carol regarding FSIS policies, procedures, stores covered by this regulation that Gallagher; telephone: 301–287–3422; regulations, Federal Register notices, prepare raw beef products that are email: [email protected]. For

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