[Federal Register Volume 79, Number 140 (Tuesday, July 22, 2014)]
[Proposed Rules]
[Pages 42464-42474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17128]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 79, No. 140 / Tuesday, July 22, 2014 / 
Proposed Rules  

[[Page 42464]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 320

[Docket No. FSIS-2009-0011]
RIN 0583-AD46


Records To Be Kept by Official Establishments and Retail Stores 
That Grind Raw Beef Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend its recordkeeping regulations to specify that all official 
establishments and retail stores that grind raw beef products for sale 
in commerce must keep records that disclose the identity and contact 
information of the supplier of all source materials that they use in 
the preparation of each lot of raw ground beef. They must also record 
the names of those supplied source materials, including any beef 
components and any carryover from one production lot to the next. The 
records would also be required to document lot numbers, the amount of 
the beef component used in each lot (in pounds), the date and time each 
lot of raw ground beef product was produced, and the date and time when 
grinding equipment and other related food-contact surfaces were cleaned 
and sanitized. Official establishments and retail stores would also 
have to comply with the proposed recordkeeping requirements with 
respect to raw beef products that are ground at an individual 
customer's request.

DATES: Comments must be received on or before September 22, 2014.

ADDRESSES: FSIS invites interested persons to submit comments on this 
proposed rule. Comments may be submitted by any of the following 
methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the online instructions at that site for 
submitting comments.
     Mail, including CD-ROMs: Send to U.S. Department of 
Agriculture (USDA), FSIS, 1400 Independence Avenue SW., Mailstop 3782, 
8-163B, Washington, DC 20250-3700.
     Hand- or courier-delivered items: Send to U.S. Department 
of Agriculture (USDA), FSIS, OPPD, RIMD, Docket Clearance Unit, 
Patriots Plaza 3, 355 E Street SW., 8-163B, Washington, DC 20250-3700 
20024-3221.
    Instructions: All comments submitted by mail or electronic mail 
must include the Agency name and docket number FSIS-2009-0011. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at the address listed above between 8:30 a.m. 
and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Contact Victoria Levine, Program 
Analyst, Issuances Staff, Office of Policy and Program Development, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250; (202) 720-5627; Fax (202) 690-0486.

SUPPLEMENTARY INFORMATION: Under the authority of the Federal Meat 
Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and its implementing 
regulations, FSIS investigates complaints and reports of consumer 
foodborne illness associated with FSIS-regulated meat products. Many 
such investigations into consumer foodborne illnesses involve those 
linked to the consumption of raw beef ground \1\ by official 
establishments or retail stores.2 3
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    \1\ Raw ground beef products are ground and chopped beef (9 CFR 
319.15(a)), hamburger (9 CFR 319.15(b)), beef patties (9 CFR 
319.15(c)), ground or chopped veal, veal patties, veal or beef patty 
mix, ground veal or beef product with added seasonings, and beef 
manufacturing trimmings produced at an official establishment or at 
retail. Raw ground beef products are also ground intact steaks/
roasts, bench trim ground from intact steaks/roasts, or a mix these 
components with trim or coarse ground beef derived from official 
establishments.
    \2\ See 9 CFR 303.1(d)(2)(iii)(a) through (f) for the definition 
of a retail store. While retail stores are exempt from the 
provisions of the FMIA and the meat inspection regulations with 
regard to inspection of the preparation of products, they are not 
exempt from their sanitary or recordkeeping requirements.
    \3\ Of the 130 outbreaks that FSIS investigated from 2007 
through 2013, 74 were determined to be caused by the consumption of 
ground beef. Of those 74, 31 were linked to beef ground at a retail 
venue.
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    FSIS investigators and other public health officials typically use 
records kept at all levels of the food distribution chain, including 
the retail level, to identify and trace back product that may be the 
source of the illness to the suppliers that produced the source 
material for the product. The Agency, however, has often been impeded 
in its efforts to trace back ground beef products to the suppliers' 
products due to the lack of documentation identifying all source 
materials used in its preparation.
    In some situations, official establishments and retail stores have 
not kept adequate records that would allow effective traceback \4\ and 
traceforward activities.\5\ Without such records, FSIS cannot conduct 
timely and effective consumer foodborne illness investigations and 
other public health activities throughout the stream of commerce.
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    \4\ Traceback actions are those actions taken to identify and 
document the flow of product back to the official establishment from 
which the suspect product originated from other official 
establishments, retail stores, warehouses, distributors, 
restaurants, or other firms in commerce.
    \5\ Traceforward actions are those actions taken to identify 
other potentially contaminated batches of meat that might have 
originated from the same official establishment and other 
establishments, retail stores, warehouses, distributors, 
restaurants, or other firms in commerce that might have been 
affected by contaminated product.
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    The President's Food Safety Working Group (FSWG), which was formed 
on March 14, 2009, recommended a new public health-focused approach to 
food safety based on three core principles: (1) Prioritizing 
prevention; (2) strengthening surveillance and enforcement; and (3) 
improving response and recovery.\6\
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    \6\ http://www.foodsafetyworkinggroup.gov/ContentKeyFindings/HomeKeyFindings.htm and FSIS News Release No. 0292.09 dated July 8, 
2009.
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    One of the objectives of the third principle is to quickly identify 
and stop outbreaks of foodborne illness. When people become ill because 
of consuming product from the same source material, it is important to 
identify all remaining source material and remove it as quickly

[[Page 42465]]

as possible in order to prevent more illnesses. The FSWG has 
recommended the establishment of a food tracing system that shortens 
the time between outbreak detection, resolution, and recovery. A system 
that permits rapid traceback to the source would protect consumers and 
help industry recover contaminated product more quickly and accurately.

FMIA Recordkeeping Requirements

    Official establishments and retail stores that grind raw beef 
products for sale in commerce must keep records that will fully and 
correctly disclose all transactions involved in their businesses 
subject to the Act (see 21 U.S.C. 642). This is because they engage in 
the business of preparing \7\ products of an amenable species \8\ for 
use as human food, and they engage in the business of buying or selling 
(as meat brokers, wholesalers or otherwise) in commerce products of 
carcasses of an amenable species. These businesses must also provide 
access to, and permit inspection of, these records by FSIS 
personnel.\9\
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    \7\ Prepared means slaughtered, canned, salted, rendered, boned, 
cut up, or otherwise manufactured or processed.
    \8\ The term ``amenable species,'' 21 U.S.C. 601(w), was added 
by section 798(2) of Pub. L. 109-97, Nov. 10, 2005. Section 798(1) 
of that law amended the FMIA by striking the words ``cattle, swine, 
goats, horses, mules, and other equines'' in each place it appeared 
in the Act and inserting ``amenable species'' in its place. See also 
21 U.S.C. 642(a)(2) and 9 CFR 320.1(a)(2).
    \9\ 21 U.S.C. 642(a). See also 9 CFR 300.6(a)(1).
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Current Regulatory Requirements

    Under 9 CFR 320.1(a), every person, firm, or corporation required 
by section 642 of the FMIA to keep records must keep records that will 
fully and correctly disclose all transactions involved in businesses 
subject to the Act. Records specifically required to be kept under 
Sec.  320.1(b) include, but are not limited to: bills of sale, 
invoices, bills of lading, and receiving and shipping papers. With 
respect to each transaction, the records must provide, but are not 
limited to: the name or description of the livestock or article, the 
net weight of the livestock or article, the number of outside 
containers, the name and address of the buyer or seller of the 
livestock or animal, and the date and method of shipment.\10\
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    \10\ 9 CFR 320.1(b)(1).
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    Under 9 CFR 320.2, every person engaged in any business described 
in Sec.  320.1 and required by part 320 to keep records must maintain 
them at the place where the business is conducted. However, a person 
who conducts business at multiple locations may maintain those records 
at his or her headquarters' office. 9 CFR 300.6(b)(2) requires any 
person (including any firm or corporation or other business unit) 
subject to the recordkeeping requirements in section 642 of the FMIA to 
allow representatives of the Secretary of Agriculture to enter his or 
her place of business to examine and copy the records specified in 
Sec.  320.1. Therefore, if records relevant to an outbreak or recall 
investigation are being maintained at a headquarters' office rather 
than at the place where the business is conducted, i.e., the location 
where raw beef is being ground, those records must be made available to 
FSIS personnel conducting traceback and traceforward activities. 
Records required to be maintained under part 320 must be retained for a 
period of two years after December 31 of the year in which the 
transaction to which the record relates has occurred (9 CFR 320.3)).
    The recordkeeping requirements contained in the FMIA and 9 CFR 320 
are intended to permit FSIS to trace product, including raw ground beef 
product associated with consumer foodborne illness, from the consumer, 
or the place where the product was purchased, back through its 
distribution chain to the establishment that was the source of the 
product. This will make it easier to determine, if possible, where the 
contamination originally occurred. Investigators should also be able to 
conduct effective traceforward investigations so as to identify other 
potentially contaminated product that has been shipped from the point 
of origin of its contamination to other official establishments, retail 
stores, warehouses, distributors, restaurants, or other firms. FSIS 
must be able to carry out these investigations using records that 
should be kept routinely by official establishments and retail stores.
    In 2002, FSIS published a Federal Register notice explaining the 
Agency's views with regard to the records and information it considered 
important for effective traceback and traceforward activities involving 
E. coli O157:H7 contamination of beef products.\11\ Specifically, the 
notice stated that if the Agency confirmed positive E. coli O157:H7 
samples of raw ground products produced at an official establishment, 
the Agency intended to collect the following information from the 
official establishment:
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    \11\ ``E. coli O157:H7 Contamination of Beef Products'' (67 FR 
62325, Oct. 7, 2002).
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    1. The name, point of contact, and phone number for the official 
establishments supplying the source materials for the lot of ground 
beef sampled;
    2. The supplier lot numbers and production dates; and any other 
information that would be useful to suppliers that may have supplied E. 
coli O157:H7-positive product to official establishments.
    FSIS also stated that it intended to gather the following 
information from retail stores at the time it collected a sample of raw 
ground beef for E. coli O157:H7 testing:
    1. The names and establishment numbers of the establishments 
supplying the source materials for the lot of ground beef sampled;
    2. The supplier lot numbers and production dates; and
    3. Any other information that would be useful to suppliers if they 
are later notified of an E. coli O157:H7 positive finding.
    Shortly after issuing the 2002 Federal Register notice, FSIS began 
collecting the information listed in the notice from official 
establishments that produced ground raw beef products that FSIS 
confirmed positive for E. coli O157:H7 and from retail stores at the 
time the Agency collected samples of ground raw beef product from the 
stores for E. coli O157:H7 testing.\12\ FSIS has also been collecting 
supplier information from official establishments at the time FSIS 
collects a sample, just as the Agency does when it collects retail 
samples.
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    \12\ FSIS Notice 47-02, dated 11/20/02, ``FSIS Actions 
Concerning Suppliers that may be Associated with Escherichia coli 
(E. coli) 0157:H7 Positive Raw Ground Beef Product''
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    Retail stores, however, often do not document and maintain supplier 
information at times other than when FSIS collects samples of ground 
raw beef product from the stores for E. coli O157:H7 \13\ testing. As a 
result, the Agency is unable to respond quickly during foodborne 
disease investigations. This information, which the Agency expects 
businesses to obtain from their suppliers pursuant to the requirements 
contained in 9 CFR 320.1, is essential for effective traceback and 
traceforward activities.
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    \13\ On June 4, 2012, FSIS implemented routine verification 
testing for six Shiga toxin-producing Escherichia coli (STEC), in 
addition to E. coli O157:H7, in raw beef manufacturing trimmings. 
See Shiga Toxin-Producing Escherichia coli in Certain Raw Beef 
Products (77 FR 31975, May 31, 2012).
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    In 2009, FSIS provided guidance to a retail industry association 
requesting appropriate records that retail stores should keep to aid in 
identifying traceback and traceforward on FSIS-regulated products 
associated with foodborne illnesses and other food safety incidents. 
The Agency

[[Page 42466]]

recommended that retail stores keep records of the lot/batch number of 
the source materials used to prepare the raw ground beef, as well as 
the exact name/type of product produced, the manufacturer name of the 
source material used for the product produced, the product code or pack 
date of the source material used, and the establishment number of the 
source product used. FSIS then made the guidance available on the 
Agency's Web site.
    To further address the issue, on December 9 and 10, 2009, FDA and 
FSIS held a joint public meeting to discuss the essential elements of 
product tracing systems, gaps in then-current product tracing systems, 
and mechanisms to enhance product tracing systems for food.\14\ This 
meeting was followed on March 10, 2010, by an FSIS public meeting that 
discussed the Agency's procedures for identifying suppliers of source 
material used to produce raw beef product that FSIS has found positive 
for E. coli O157:H7. FSIS also discussed additional verification 
activities that the Agency planned to conduct at suppliers' 
establishments in response to positive E. coli O157:H7 results. 
Moreover, FSIS sought input from meeting participants on ways to 
improve the Agency's procedures for identifying product that may be 
positive for E. coli O157:H7.
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    \14\ Comments and a transcript of this meeting are available at 
www.regulations.gov at http://www.regulations.gov/#!searchResults;rpp=10;po=0;s=FDA-2009-N-0523.
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    Despite these FSIS actions, the Agency has continued to experience 
significant impediments in connection with tracebacks of FSIS-regulated 
products, associated with consumer foodborne illness, to the suppliers 
that produced the source materials. Some official establishments and 
retail stores still do not keep and maintain the records necessary to 
allow effective traceback activities. FSIS has found that the records 
kept by these businesses vary in type and quality, and are often 
incomplete or inaccurate.
    Overall, FSIS has concluded that voluntary recordkeeping by retail 
facilities that grind raw beef has not been sufficiently effective, as 
evidenced by continuing outbreaks linked to pathogens in raw ground 
beef that FSIS cannot trace back to the source.\15\ The lack of 
specific information about supplier lot numbers, product codes, pack 
dates of source materials used to produce lots of raw ground beef, and 
when and whether grinding equipment has been cleaned and sanitized has 
prevented or delayed FSIS from identifying businesses that produced the 
source materials for product that was positive, the specific product 
responsible for an outbreak and, therefore, to accurately identify 
other product that might also be adulterated. The cleaning and 
sanitization of equipment used to grind raw beef between lots or 
batches is important because it prevents the transfer of E. coli 
O157:H7 and other bacteria from one lot of product that may be 
contaminated to another lot of product ground on the same equipment 
that is not.
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    \15\ Recall.
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    FSIS conducted a retrospective review of 28 foodborne disease 
investigations from October 2007 through 2012 in which beef products 
were ground or re-ground at retail stores to describe their beef 
grinding and recordkeeping practices.\16\ Twenty-two of these 
investigations were for outbreaks that occurred in 2009 or earlier, and 
the remainder occurred after 2009.
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    \16\ Ihry, T., White, P., Green A., Duryea, P. Review of the 
Adequacy of Ground Beef Production Records at Retail Markets for 
Traceback Activities During Foodborne Disease Investigations. Poster 
presented at: Annual Conference of the Council of State and 
Territorial Epidemiologists; 2012, Jun 4-6; Omaha, NE. A copy of 
this document is available for viewing in the FSIS Docket Room. FSIS 
selected 28 investigations because the illnesses were presumptively 
or definitely caused by the consumption of ground beef. Beef was 
ground or re-ground at one or more retail meat markets, and the name 
of the retail market that sold the ground beef, the name of the 
product, and the date that it was purchased were available. Since 
the time of the original survey, FSIS has added two more 
investigations.
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    Among the 22 investigations that took place in 2009 or earlier, 
seven had complete records, four had incomplete records, and 11 had no 
records. Among the six investigations that took place after 2009, four 
had complete records and two had incomplete records. Additionally, in 
2013, FSIS participated in three outbreaks. In two investigations, no 
records had been kept, while in the third complete records were 
available. Therefore, while the evidence suggests improvement, there 
remain retail stores or establishments that do not maintain complete 
records.
    Complete records are important for successfully identifying 
adulterated product and initiating a recall. FSIS was assisted in its 
traceback and traceforward activities by records in each of the 11 
investigations identified in the study where complete records were 
available. In situations where complete records were not available, the 
inability to identify product suppliers in a timely fashion, or at all, 
hindered FSIS in identifying the source of adulteration.
    When records were available and complete, such that FSIS could 
identify specific production in an establishment, the Agency was able 
to institute a recall of product from the supplying establishment in 
six of 11 investigations. In contrast, when records were not available 
or incomplete, FSIS was able to do so only two of 17 times.

------------------------------------------------------------------------
                                                        Number resulting
  Status of retail grinding record        Number of        in recalled
                                       investigations        product
------------------------------------------------------------------------
Available and complete..............                11                 6
Not available.......................                11                 1
Available, but incomplete...........                 6                 1
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    For example, in July 2007, an epidemiologic investigation conducted 
by the Suffolk County Health Department, Suffolk County, New York, 
identified two ill persons who reported consuming pre-formed, 80/85-
percent lean ground beef patties purchased from a retail store in New 
York. Leftover products collected from the homes of the case-patients 
and tested by the Outbreaks Section of FSIS's Eastern Laboratory were 
found to have E. coli O157:H7 with pulsed-field gel electrophoresis 
(PFGE) \17\ pattern combinations indistinguishable from those of the 
case-patients. Even with purchase dates and store invoices, FSIS and 
local health officials were unable to definitively identify the 
supplier of the beef that was processed into the pre-formed patties 
because the source

[[Page 42467]]

materials for the product associated with the outbreak were re-ground 
and packaged by the retail store, which did not identify the supplier 
of the raw beef used to produce the patties. The inability of public 
health officials to identify the supplier of the ground beef prevented 
them from identifying other possibly adulterated product produced by 
the supplier, or other establishments, retail stores, warehouses, 
distributors, restaurants, or other firms in commerce that might have 
received contaminated product from the supplier.
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    \17\ Pulsed-field gel electrophoresis (PFGE) is a standardized 
method used to subtype (or fingerprint) foodborne disease-causing 
bacteria. PFGE can be used to distinguish strains of organisms such 
as E. coli O157:H7, STECs, Salmonella, Listeria, or Campylobacter at 
the DNA level.
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    In November 2007, a similar situation occurred when FSIS was unable 
to identify a source of Salmonella contamination that accounted for 
nearly 40 human illnesses associated with fresh ground beef products 
produced at a single retail grocery chain with stores nationwide. In 
this case, records kept by the grocery chain's raw ground beef grinding 
facility were missing, had no entries on the dates of interest, or had 
incomplete or inaccurate entries. The records also did not document all 
of the suppliers of the raw beef ground at the facility.
    More recently, in December 2011, a Maine-based grocery chain 
recalled an undetermined amount of fresh ground beef products that may 
have been contaminated with a multiple drug-resistant strain of 
Salmonella Typhimurium. This recall was initiated by the grocery chain 
in response to illnesses caused by an outbreak of salmonellosis that 
was associated with the use of fresh in-store ground beef prepared in 
and purchased at the grocery chain's stores. In its examination of the 
chain's records, FSIS was unable to determine suppliers of the beef, 
which accounted for 15 human illnesses. In this case, records kept by 
the grocery chain's raw ground beef grinding facility did not list all 
of the suppliers of the raw beef ground at the facility. As a result, 
FSIS could not definitively identify products subject to a recall.
    Correspondingly, complete records are more likely to result in 
efficient recalls. In May 2007, officials from the Minnesota and 
Virginia state departments of health and FSIS investigated an outbreak 
involving nine ill persons. These nine individuals had an 
indistinguishable strain of E. coli O157:H7. A case-control study 
showed consumption of ground beef purchased at a local grocery chain 
was significantly associated with illness. Left-over ground beef from a 
case-patient's home was tested and found positive. Investigators used 
purchase date and store location information from case-patients along 
with complete, accurate grinding logs from the stores to definitively 
identify a single supplying establishment and the production date of 
implicated product. Successful traceback resulted in a recall of 
117,500 lbs. of potentially adulterated ground beef from an official 
establishment.
    In May and June 2009, officials from FSIS, the Centers for Disease 
Control and Prevention (CDC), and health departments in several states 
investigated an outbreak that involved 20 persons with an 
indistinguishable strain of E. coli O157:H7. Eleven people were 
hospitalized; one developed hemolytic uremic syndrome. The case-
patients resided in nine states throughout the U.S. All 18 who provided 
food histories reported consuming some type of beef; 16 reported 
consumption of ground beef. Ground beef samples from a retail store and 
a small, regulated processing establishment were also positive with the 
outbreak strain. Twelve case-patients provided consumption histories 
that included purchases at nine supermarkets. Using purchase 
information from the case-patients, investigators were able to 
determine a common supplier for the stores and the small processing 
establishment. The source establishment had supplied trim and primal or 
sub-primal cuts to several companies which processed them into ground 
beef or intact retail cuts. Using information from the retail grinding 
logs, investigators were able to determine a specific production day at 
the source establishment. The establishment recalled approximately 
421,000 lbs. of various potentially adulterated beef cuts.
    In June 2012, FSIS learned of an outbreak that ultimately involved 
46 persons, 12 of whom were hospitalized. The patients resided in nine 
states, primarily in the northeastern U.S. The CDC determined that all 
were ill with an indistinguishable strain of Salmonella Enteritidis. 
Seven of eight case-patients from two states reported consuming ground 
beef prior to illness. A case-control study showed that shopping in the 
Maine-based grocery chain described earlier was statistically 
significant. State investigators collected leftover ground beef from 
several case-patients and from retail supermarkets or their 
distribution center. Ground beef from case-patients' homes tested 
positive for the outbreak strain. Eight case-patients who shopped at 
the grocery chain provided purchase information. The grocery chain had 
implemented improvements in their record system and grinding logs for 
products purchased by five case-patients conclusively showed they 
purchased 85 percent lean ground beef from a regulated federal 
establishment with a known production date. This time, the 
establishment recalled approximately 29,000 lbs. of adulterated 
product. In all of the examples above, grinder records were necessary 
in identifying the official establishments that supplied source 
materials and retailers that distributed the product.
    To better ensure that FSIS will be able to conduct effective 
traceback and traceforward investigations, or foodborne illness 
investigations, or to monitor product recalls, the records kept and 
maintained by official establishments and retail stores that grind raw 
beef products must disclose the identity of the supplier, the source of 
all materials that they use in the preparation of each lot of raw 
ground beef product, including any carryover from one production lot to 
the next, the amount of the beef component used in each lot (in 
pounds), and the date and time each lot of raw ground beef product is 
produced. The records also must document the date and time when 
cleaning and sanitizing occurs because cleaning and sanitizing of food-
contact equipment after grinding beef may help define the lot and limit 
the scope of a recall.
    FSIS is proposing to amend the Federal meat inspection regulations 
to require that official establishments and retail stores that grind 
raw beef products keep records that fully disclose the names, points of 
contact, phone numbers, and establishment numbers of the establishments 
supplying the materials used to prepare each lot of raw ground beef 
product; all supplier lot numbers and production dates; the names of 
the supplied materials, including beef components and any materials 
carried over from one production lot to the next; the amount of the 
beef component used in each lot (in pounds); the date and time each lot 
of raw ground beef product is produced; and the date and time when 
grinding equipment and related food-contact surfaces are cleaned and 
sanitized.\18\ Note that for materials purchased from a broker or 
distributor, the establishment number would be on the shipping 
container of the product.
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    \18\ Proposed 9 CFR 320.1(b)(4)(i).
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    Official establishments and retail stores that prepare raw beef 
products that are ground at an individual customer's request would also 
be required to comply with the proposed recordkeeping requirements with 
respect to such product. Keeping complete records for all grinding 
activity will enable FSIS to conduct

[[Page 42468]]

effective recalls in a timely manner thereby reducing illnesses or 
deaths.
    Grinding logs at retail stores are a good example of a type of 
record that can easily be used to identify the source, supplier, and 
names of all materials used in the preparation of raw ground beef 
products. Below is the grinding log record that FSIS posted with this 
2009 guidance. As shown in the sample grinding log (Table 1) below, the 
date and time of grind, the amount of carryover, the name of the source 
material, supplier establishment information from the label of the 
source material, and the date and time of cleaning and sanitizing would 
be the information required to be kept, if this rule is finalized. 
Information under the other column headings would not be required, but 
some official establishments and retail stores may choose to keep and 
maintain such information.
[GRAPHIC] [TIFF OMITTED] TP22JY14.000

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    Executive Orders 12866 and 13563 direct agencies to assess costs 
and benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public and safety 
effects, distributive impacts, and equity). Executive Order 13563 
emphasizes the importance of quantifying both costs and benefits, of 
reducing costs, of harmonizing rules, and of promoting flexibility. 
This rule has been designated a ``significant regulatory action'' under 
section 3(f) of Executive Order 12866. Accordingly, this rule has been 
reviewed by the Office of Management and Budget.

I. Background

    FSIS is proposing a rule that would require official establishments 
and retail stores that grind raw beef products for sale in commerce to 
keep records that will fully and correctly disclose details of all 
transactions involved in their businesses subject to the FMIA, 
including the identity and supplier of all materials used in the 
preparation of each lot of raw ground product. The required records are 
essential to conduct efficient foodborne illness investigations. The 
proposal would affect retail stores and official establishments.
    If adopted, the proposed rule will require records to include lot-
specific information (i.e., a lot number, a code number, or other 
identifier). Lot-specific

[[Page 42469]]

information distinguishes one production batch from another and can be 
a number printed on the packaging or some other identifier.\19\
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    \19\ FSIS acknowledges that most firms use lot or code numbers 
to identify specific batches of their products. However, some may 
use other technologies such as barcodes. The term `other identifier' 
is intended to capture any other methods that the food industry may 
be using to identify specific lots of product.
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    Recordkeeping systems are designed to track the flow of product or 
product attributes through production processes or the supply chain. 
Traceability is the ability to follow the movement of a food product 
through the stages of production, processing, and distribution.\20\ 
Records are necessary for a good product traceback (traceforward) 
system.
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    \20\ Codex Alimentarius Commission, ``Procedural Manual, 
Seventeenth Edition,'' 2007. The Codex Alimentarius Commission was 
created in 1963 by the Food and Agriculture Organization (FAO) and 
the World Health Organization (WHO) to develop food standards and 
guidelines. Available online at: ftp://ftp.fao.org/docrep/fao/010/a1472e/a1472e.pdf.
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    Public and private sector officials often lack information about 
the sources of foods or ingredients, making traceback processes 
inefficient, which results in missed opportunities to identify 
contaminated product. This proposed rule, if adopted, will strengthen 
traceback systems, leading to quicker identification of adulterated 
product and quicker, more targeted recalls, an outcome in keeping with 
the objectives of the FSWG.

II. Need for Rule

    Voluntary recordkeeping at retail stores and official 
establishments has not been sufficiently effective. Incomplete and 
nonexistent grinding records have impeded traceback and traceforward 
activities by FSIS investigators during food safety events, limiting 
their ability to identify implicated product and sources of 
contamination. This rule is needed to enhance FSIS' ability to protect 
public health by conducting recalls quickly and efficiently, thereby 
reducing illnesses associated with contaminated ground beef product.

III. Alternatives Considered

(1) Existing Voluntary Recordkeeping Program

    FSIS provided industry voluntary guidelines (see Table 1) in 2009. 
As stated above, the Agency has concluded that a policy of voluntary 
guidelines for recordkeeping has not ensured that all establishments 
and retail outlets maintain complete records that will ensure quick 
identification of contaminated product.

(2) Regulated Weekly Recordkeeping Program

    FSIS considered requiring that retail stores and official 
establishments maintain grinding records such that each producer 
recorded grinding activities once per week. This would be an 
improvement over the current voluntary recordkeeping program in that 
those establishments and retail stores which are not recording grinding 
activities would now be required to do so, and a weekly recordkeeping 
task would be less burdensome than the recordkeeping being proposed, 
which requires firms to record activities approximately two to five 
times per week. However, a weekly record would make it difficult to 
differentiate between lots of product ground from different suppliers 
throughout the week, and would therefore result in many of the same 
traceback obstacles currently experienced under voluntary 
recordkeeping. Therefore, FSIS rejected this alternative.

(3) More Detailed Recordkeeping Program

    FSIS also considered expanding the recordkeeping requirements to 
include all fields suggested in the 2011 FSIS guidance (all fields in 
the Table 1 proposed log). This would provide FSIS with more detailed 
records to use during an investigation, which may be particularly 
useful in instances where product is ground multiple times per day from 
multiple sources. However, this level of detail would place an 
unnecessary burden on those establishments that do not grind product 
multiple times per day. For this reason, FSIS decided to require that 
only the most critical information be recorded while leaving the 
remaining possible fields as a voluntary component.

IV. Baseline

    FSIS expects that this proposed rule could affect a total of 76,093 
retail stores and official establishments. These include 64,380 
supermarkets, 5,924 meat markets, 4,544 warehouse clubs and 
supercenters, and 1,245 official establishments that engage in grinding 
raw beef products. The number of retail stores is based on 2010 Census 
data \21\ for establishments that grind beef, while the number of 
official establishments was obtained from the Public Health Information 
System (PHIS). Some of these establishments and retail stores already 
maintain the records required in the proposed rule, and would therefore 
not incur any additional costs.
---------------------------------------------------------------------------

    \21\ 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.
---------------------------------------------------------------------------

    Table 2 distinguishes between large establishments, defined as 
those with 500 or more employees, and small establishments, defined as 
those with fewer than 500 employees. FSIS assumes that retail 
establishments with 500 or more employees will grind beef and create a 
record approximately five times per week, thus assuming 260 records per 
year for these large entities. For small retail entities, with fewer 
than 500 employees, FSIS assumes that these establishments on average 
would grind beef and create a record approximately twice a week for 50 
weeks for the year, for 100 records per year. For official FSIS 
processing establishments, FSIS examined data from a 2008 FSIS 
survey,\22\ and found that, on average, large official establishments 
processed ground beef product 258 days a year and the small 
establishments processed ground beef about 164 times a year. Small 
official establishments grind more often than small retail 
establishments because official establishments rely more heavily on 
ground beef production than retail establishments, which have a wider 
variety of products for sale. FSIS used these values to estimate the 
number of grinding log records per year for retail establishments.
---------------------------------------------------------------------------

    \22\ Results of Checklist and Reassessment of Control for 
Escherichia coli O157:H7 in Beef Operations. 2008, available at 
http://www.fsis.usda.gov/wps/wcm/connect/9ce5ce22-f609-4990-bd9a-ce2c323d229b/Ecoli_Reassement___Checklist.pdf?MOD=AJPERES, 
accessed July 24, 2013.

[[Page 42470]]



  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 by firm size
                                   ---------------------------------------                  \2\
  NAICS codes    NAICS description                                        --------------------------------------
                                       Large        Small        Total        Large        Small        Total
----------------------------------------------------------------------------------------------------------------
445110.........  Supermarket and            314       40,713       41,027       21,028       43,352       64,380
                  other grocery
                  (except
                  convenience)
                  stores.
445210.........  Meat Markets.....            9        5,415        5,424          274        5,650        5,924
452910.........  Warehouse clubs             11           13           24        4,531           13        4,544
                  and Supercenters.
PHIS...........  Official           ...........  ...........  ...........           35        1,210        1,245
                  establishments.
                                   -----------------------------------------------------------------------------
    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 potentially subject to the 
final regulation are:
     Supermarkets and other grocery (except convenience) 
stores. This industry comprises establishments generally known as 
supermarkets and grocery stores primarily engaged in retailing a 
general line of food, such as canned and frozen foods; fresh fruits and 
vegetables; and fresh and prepared meats, fish and poultry. Included in 
this industry are delicatessen-type establishments primarily engaged in 
retailing a general line of food.
     Meat Markets. This industry comprises establishments 
primarily engaged in retailing fresh, frozen, or cured meats. Meat 
markets may butcher animals for their own account, or they may buy bulk 
from others. Delicatessen-type establishments primarily engaged in 
retailing fresh meat are included in this industry.
     Warehouse clubs and supercenters. This industry comprises 
establishments known as warehouse clubs, superstores or supercenters 
primarily engaged in retailing a general line of groceries in 
combination with general lines of new merchandise, such as apparel, 
furniture, and appliances. Official federal--inspected establishments 
that grind raw beef products are included in this group.
    There are three major kinds of businesses FSIS does not consider to 
be retail establishments, and thus are not affected by the proposed 
rule: convenience stores, meat and meat product merchant wholesalers, 
and full-service and limited-service restaurants. The convenience store 
or food mart (except those with fuel pumps) industry comprises 
establishments that primarily engage in retailing a limited line of 
goods that generally includes milk, bread, soda, and snacks, but do not 
engage in the business of grinding raw beef. The meat and meat product 
merchant wholesalers industry comprises establishments primarily 
engaged in the merchant wholesale distribution of meats and meat 
products (except canned and packaged frozen) or lard, but do not engage 
in the business of grinding raw beef. Most, if not all supermarkets, 
meat markets, and warehouse clubs sell product from federally inspected 
establishments and derive a significant share of revenue from those 
products. The full-service restaurant industry comprises establishments 
primarily engaged in providing food services to patrons who order and 
are served while seated (i.e., waiter/waitress service) and pay after 
eating. Limited service refers to fast food restaurants, delis, pizza 
shops, carry out restaurants, and other similar establishments.

V. Costs

    FSIS estimated the costs to industry and the Agency for ensuring 
compliance with the regulation.

Industry Costs

    Under the current regulations (9 CFR 320.1(a)(2) and (b)), official 
establishments are required to keep records that fully and correctly 
disclose all transactions involved in their business. These records 
must show the name or description of the articles handled (section 
320.1(b)(1)(i)) and the name and address of the sellers and buyers of 
the articles (section 320.1(b)(1)(iv)). Official establishments must 
provide FSIS access to these records (section 320.4, 21 U.S.C. 642). 
FSIS believes that supplier lot numbers and production dates are 
normally made available to official establishments. FSIS also expects 
that these businesses normally obtain buyer and seller contact 
information during the course of business. In determining cost to 
industry for this rule, though, FSIS did not assume that all these 
establishments had complete records that would satisfy the provisions 
of this rule. FSIS requests comments on the extent to which this is 
already being done.
    Costs would occur because many of the estimated 76,093 retail 
stores and official establishments would need to implement new 
recordkeeping activity and make those records available for the 
Agency's review. To estimate costs to industry, the Agency used 
information based on existing literature and discussions with FSIS 
experts. The annual recurring cost is due to the time requirement for 
recording information for each daily set of entries. FSIS assumed that, 
for establishments that currently maintain a complete grinding log, 
there would be no additional time requirement. For establishments that 
presently keep a log, but do not include all of the information 
required under the proposed regulation, FSIS assumed that it would take 
an additional 30 to 60 seconds per daily recordkeeping to comply with 
the rule, and, for establishments that presently do not maintain a 
grinding log, it would take 60 to 90 seconds to record each daily 
record. FSIS seeks comments on these recordkeeping time assumptions.
    To estimate the numbers of logs that are presently incomplete and 
the number of logs that presently do not exist but would under the 
provisions of this proposed rule, FSIS used a published 2008 study \23\ 
that reported on

[[Page 42471]]

the recordkeeping practices of retail stores that grind raw beef. The 
study found that 74 percent of chain retail stores and 12 percent of 
independent retail stores kept grinding logs. Of the stores that kept 
grinding logs, the study reported 78 percent of those logs as 
incomplete.\24\ For the purposes of the cost estimate, FSIS used the 
chain stores surveyed in the study as a proxy for large retail and 
official establishments, and the independent stores as a proxy for 
small retail and official establishments. Therefore, the recordkeeping 
distribution of large establishments based on the survey results is 
approximately 16 percent complete (74 percent*(1-78 percent)), 58 
percent incomplete (74 percent*78 percent), and 26 percent no records. 
For small establishments, the distribution is approximately 3 percent 
complete (12 percent*(1-78 percent)), 9 percent incomplete (12 
percent*78 percent), and 88 percent no records. FSIS is seeking comment 
on these distributions and the current recordkeeping practices of 
retail stores.
---------------------------------------------------------------------------

    \23\ ``Recordkeeping Practices of Beef Grinding Activities at 
Retail Establishments.'' (2011) Hannah Gould, Scott Seys, Karen 
Everstine, Dawn Norton, Danny Ripley, David Reimann, Moshe Dreyfuss, 
Wu San Chen, and Carol A. Selman. Journal of Food Protection, Vol. 
74 (6), 1022-24.
    \24\ The study defined a complete log as one that included, at 
minimum, the date and time the grind was performed, the type of 
product produced, the lot and establishment code of the source beef, 
whether cleanup was performed between grinds, and the whether beef 
trimmings were included in the grind. An incomplete log was defined 
as one that was only partially completed (missing records), or did 
not record all of the listed data elements. While some fields 
identified in the survey are not those required in the rule, and 
some fields required in the rule are not identified in the survey, 
FSIS determined that there was enough of an overlap to make use of 
the survey results.
---------------------------------------------------------------------------

    FSIS multiplied the percentages by the number of grinding logs that 
will exist under this rule to determine the present numbers of 
incomplete and non-existing grinding logs. FSIS multiplied these 
numbers 30 to 60 seconds and 60 to 90 seconds respectively, to estimate 
the total number of additional hours, and then multiplied this 
estimated range by the average hourly compensation rate, derived below, 
of $19.18.
    To estimate the hourly cost of recordkeeping, FSIS assumed that, 
primarily, employees that are in the Bureau of Labor Statistics labor 
category of ``Butchers and Meat Cutters'' would perform the 
recordkeeping. FSIS assumed a wage per hour from the most recent mean 
wage rate for this labor category, $14.42.\25\ In addition to the base 
wage, FSIS assumed an additional benefit cost factor of 33 percent \26\ 
to account for benefits that the employee may receive in addition to 
the mean hourly wage. These include, but are not limited to, vacation 
time, sick time, and health care. Consequently, FSIS assumed a total 
hourly compensation rate of $14.42 (1+0.33)=$19.18. Table 3 presents 
the total costs by establishment/retail store (entity) size class and 
estimated current recordkeeping practices. This results in an estimated 
total cost to industry of about $2.69 million to $4.39 million.
---------------------------------------------------------------------------

    \25\ BLS Occupational Employment and Wages, May 2013.
    \26\ BLS Employer Costs for Employee Compensation, June 2013.

                                 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 proposed rule will result in no 
impact on the Agency's operational costs because the Agency will not 
need to add any staff or incur any non-labor expenditures.

Total Costs

    FSIS estimates the total cost for the rule to be about $2.69 
million to $4.39 million.

VI. Benefits

    Expected benefits would likely result from this proposed rule, for 
consumer health, the ground beef processing industry, and for the 
Agency.
    Under this rule, FSIS expects the industry to benefit from lower 
direct costs for recalls because compliance with this proposed rule 
will lead to more efficient, accurate, and quicker identification of 
potentially adulterated product. Given everything else being equal, 
FSIS, therefore, expects a decrease in the average volume of product 
recalled,\27\ resulting in decreased costs for recalls and for the 
proper disposal of the product, i.e., relabeling, re-cooking, 
reworking, or destroying product. The Agency notes, however, that the 
expected benefit for any individual establishment would be less than 
(perhaps substantially less than) the rule-induced cost borne by that 
establishment; otherwise, the establishment would voluntarily keep 
complete records even in the absence of a regulatory requirement to do 
so. FSIS is requesting data on the impact of recordkeeping on reducing 
the volume of product recalled for official establishments and retail 
outlets.
---------------------------------------------------------------------------

    \27\ Resende-Filho, Moises A. and Brian L. Buhr. ``Economics of 
Traceability for Mitigation of Food Recall Costs,'' prepared for 
presentation at the International Association of Agricultural 
Economists (IAAE) Triennial Conference, Foz do Igua[ccedil]u, 
Brazil, 18-24 August, 2012. This paper presents simulation results 
of a model that indicated that that presence of a traceability 
system decreased volumes of recalls by over 90 percent.
---------------------------------------------------------------------------

    The ground beef industry will also benefit from reduced damage to 
reputation during food safety events. The ability of FSIS to trace 
adulterated product back to its source ensures that in events such as 
recalls, the number of firms implicated is kept to a minimum. By 
limiting the scope of recalls, traceability through better 
recordkeeping will reduce negative spillover effects which could 
unnecessarily burden a large group of otherwise uninvolved ground beef 
producers.\28\ This level of accountability insulates the industry as a 
whole from

[[Page 42472]]

losses to reputation and consumer confidence.
---------------------------------------------------------------------------

    \28\ Pouliot, Sebastien and Sumner, Daniel A. ``Traceability, 
recalls, industry reputation, and product safety.'' European Review 
of Agricultural Economics. (2013) Volume 40 (1): 121-142.
---------------------------------------------------------------------------

    In addition, FSIS expects to benefit from lower Agency costs for 
recalls and recovery of adulterated product because the expected 
increased efficiency of identifying potentially adulterated product 
will lead to: (1) reduced inspection program personnel activities at 
Federal meat establishments and (2) reduced overtime hours for FSIS 
personnel not employed in official establishments, including 
enforcement, district office, and recall staff. As recalls become more 
effective because of better recordkeeping, FSIS could reduce staff 
travel for conducting recall effectiveness checks.
    FSIS will conduct an ongoing retrospective analysis to confirm that 
the rule positively affects Agency resources and to quantify those 
benefits. To do so, FSIS will examine the following:
     Overtime hours for enforcement, district office, and 
recall staff, on a per-outbreak basis.
     Number, length, and outcome of recall effectiveness 
checks.
     Regulatory noncompliance citations at official 
establishments for the proposed revisions to 9 CFR 320.1(b)(4).

    This review will enable FSIS to better quantify the benefits of the 
proposed recordkeeping requirements and identify areas where the 
regulation could be further improved.

VII. Public Health Benefits and Related Costs

    FSIS expects public health benefits in the form of averted 
illnesses due to better recordkeeping practices at official and retail 
establishments. Epidemiologic, environmental, and microbiologic 
findings and assessments link illnesses to contaminated food. 
Typically, distributions of outbreak illnesses caused by contaminated 
raw beef produced in FSIS-regulated establishments are geographically 
and temporally dispersed. Working together, epidemiologists and 
microbiologists may determine that ill persons share a common bacterial 
strain (outbreak strain) and common food exposure. When these 
researchers find a common exposure, environmental specialists identify 
food and practices associated with production, transportation, and 
preparation of the food to determine the possibility of contamination 
of the common-source food. In some investigations, microbiologists test 
samples of implicated foods and find the outbreak strain. Investigators 
use such findings to support the causal association of ill people with 
the food they consumed. If epidemiologic and environmental information 
is sufficiently convincing to link consumption of a specific food to a 
cluster of illnesses, investigators can identify the contaminated 
product without finding the bacterial strain in the consumed food. In 
any circumstance, without adequate records, rapid identification of the 
contaminated product is not likely to occur. When FSIS identifies a 
food product causing illness in commerce, FSIS takes action to remove 
it through a voluntary product recall.
    It is FSIS' experience that, before a recall takes place, many ill 
people have already been confirmed ill from the specific pathogen 
(STECs or Salmonella bacteria) through a laboratory test. One ill 
person could lead to a recall if investigators identify the consumed 
product that led to illness and where the consumer purchased the 
product, the point of purchase (POP), and confirm through 
microbiological tests that the identified unconsumed product contained 
the same bacterial strain as that that caused the illness. If complete 
records existed at the POP, investigators would be able quickly to 
identify the supplier and the lots involved. With the lot numbers, a 
supplier would be able to identify implicated product, enabling earlier 
recalls and a higher proportion of product recovered. This would result 
in averted illnesses and limited outbreaks.
    In addition to identifying implicated product, complete records 
will also allow investigators to identify product source 
establishments, resulting in a better chance of determining the cause 
of adulteration. The ability of FSIS to determine process failures will 
help establishments take corrective actions to prevent future 
contamination, resulting in a reduction in future illnesses. Both the 
costs and benefits of corrective actions would be attributable to this 
rule if the actions would not have occurred without being facilitated 
by the proposed new recordkeeping requirements.
    Beyond establishment-level improvements, a better understanding of 
product adulteration through investigations can serve as education for 
the entire industry as well as regulatory organizations. The 
identification of potentially hazardous practices can lead to improved 
guidance, and the linking of such practices to outbreaks and recalls 
motivates establishments to refrain from risky behavior. Lessons 
learned from successful investigations can also lead to improvements in 
the decision making process for recalls and regulatory actions.
    For example, in August 1997, a Federal establishment recalled 25 
million pounds of frozen ground beef patties due to E. coli O157:H7 
contamination. The recalled product, consisting of only six lots but 
distributed to all 48 contiguous states, led to thirteen PFGE confirmed 
illnesses by the time the product was recalled. As a result of the 
recall investigation, FSIS identified the establishment's practice of 
carry-over--the process of reworking the previous day's product into 
the next day's product--as one of the major reasons for the large 
amount of contamination. Following the investigation, FSIS promulgated 
guidance to establishments producing ground beef instructing them to 
implement lot designation procedures and refrain from practicing carry-
over.\29\ As a result of the improved guidance and the incentive to not 
sustain losses like those seen at this Federal establishment (sold to a 
competitor three weeks after the recall), there was a major response 
from producers of ground beef.\30\
---------------------------------------------------------------------------

    \29\ Ground Beef Processing Guidance Material (January 19, 1999, 
64 FR 2872).
    \30\ 82 percent of establishments with grinding operations 
reported using a robust testing program in their rework process. 
Results of Checklist and Reassessment of Control for Escherichia 
coli O157:H7 in Beef Operations (2008) See footnote 25.
---------------------------------------------------------------------------

    Better recordkeeping will facilitate outbreak investigations and 
enable FSIS to identify deficiencies in industry practices and 
government policy. This type of evidence results in improvements at the 
establishment level by helping to identify source establishments and 
affording these establishments the opportunity to diagnose and correct 
process failures. FSIS expects improvements due to lessons learned from 
outbreak investigations to prevent future outbreaks. Consumers would 
also benefit from the prevention of future foodborne illnesses which 
are not a part of outbreaks, since lessons learned from outbreak 
investigations will likely lead to improvements which may reduce 
isolated foodborne illnesses as well.
    FSIS requests information that could help quantify the above or any 
other benefits or costs from this rule.

VIII. Net Benefits

    FSIS estimates annual costs of approximately $2.69 million to 
$4.39. Costs associated with newly-occurring public health 
interventions that would be facilitated by the proposed recordkeeping 
requirements have not been quantified. Benefits would accrue to 
industry due to an expected smaller volume of recall, given everything 
else being equal, and due to reduced industry vulnerability to 
reputation

[[Page 42473]]

damaging food safety events. The Government would benefit in that the 
rule would enable the Government to operate in a more efficient manner 
in identifying and tracking recalls of adulterated raw ground beef 
products. Consumers would benefit from a reduction in foodborne 
illnesses due to quicker recalls, correction of process failures at 
ground beef producing establishments, and improved guidance and 
industry practices.
    FSIS estimates that the average cost per E. coli O157:H7 illness is 
$3281,\31\ and the average cost per Salmonella illness is $2423.\32\ 
Given the cost savings incurred for each ground beef-linked foodborne 
illness that is averted, and the potential for this rule to prevent 
outbreaks and illnesses, FSIS asserts that the benefits accrued to 
industry, Government, and consumers from this proposed rule may result 
in net economic benefits.
---------------------------------------------------------------------------

    \31\ The FSIS estimate for the cost of E. coli O157:H7 ($3,281 
per case--2010 dollars) was developed using the USDA, ERS Foodborne 
Illness Cost Calculator: STEC O157 (June 2011) http://webarchives.cdlib.org/sw1rf5mh0k/http:/www.ers.usda.gov/Data/FoodborneIllness/ (archived link--calculator currently being 
updated). FSIS updated the ERS calculator to incorporate the Scallan 
(2011) case distribution for STEC O157. Scallan E. Hoekstra, Angulo 
FJ, Tauxe RV, Widdowson MA, Roy SL, et. al. 2011 January. 
``Foodborne Illness Acquired in the United States--Major 
Pathogens''. Emerg. Infect. Dis. 17: 7-15.
    \32\ The FSIS estimate for the cost of Salmonella ($2,423 per 
case,--2010 dollars) was developed using the USDA, ERS Foodborne 
Illness Cost Calculator: Salmonella (June 2011) http://webarchives.cdlib.org/sw1rf5mh0k/http:/www.ers.usda.gov/Data/FoodborneIllness/ (archived link--calculator currently being 
updated). FSIS updated the ERS calculator to incorporate the Scallan 
(2011) case distribution for Salmonella. Scallan E. Hoekstra, Angulo 
FJ, Tauxe RV, Widdowson MA, Roy SL, et. al. 2011 January. 
``Foodborne Illness Acquired in the United States--Major 
Pathogens''. Emerg. Infect. Dis. 17: 7-15.
---------------------------------------------------------------------------

IX. Regulatory Flexibility Analysis

    The FSIS Administrator made a preliminary determination that this 
proposed rule will not have a significant impact on a substantial 
number of small entities, as defined by the Regulatory Flexibility Act 
(5 U.S.C. 601).
    The Agency analyzed the potential impact of this proposed rule on 
affected small entity retail stores and official establishments that 
grind raw beef products. The number and type of small entity retail 
stores and official establishments potentially affected by the final 
rule is shown in Table 2 to be 50,225, based on number of employees. 
Costs would accrue for maintaining the required records based on the 
volume of ground raw beef products produced by the business. The 
average annual cost to small establishments for this rule depends on 
whether the establishment is already maintaining complete records and 
the number of days of production. For official establishments presently 
with no records, FSIS estimates an annual cost of $52.42 to $78.63; 
with incomplete records, FSIS estimates an annual cost of $26.21 to 
$52.42. For retail establishments, FSIS estimated annual costs are 
$31.96 to $47.95 for establishments presently with no records and 
$15.98 to $31.96 for those with incomplete records. Establishments that 
are already keeping records as required by the proposal would incur no 
costs because of this rule.
    Based on the above analysis, the Agency has concluded that the rule 
will not have a significant economic impact on a substantial number of 
small entities.

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. When this proposed rule is adopted: (1) All state and 
local laws and regulations that are inconsistent with this rule will be 
preempted; (2) no retroactive effect will be given to this rule; and 
(3) administrative proceedings will not be required before parties may 
file suit in court challenging this rule.

Executive Order 13175

    This final rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this proposed 
regulation will not have substantial and direct effects on Tribal 
governments and will not have significant Tribal implications.

Paperwork Requirements

    In accordance with section 3507(j) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection and 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to OMB.
    Title: Records to be kept by Official Establishments and Retail 
Stores Grinding Raw Beef Products.
    Type of Collection: New.
    Abstract: Under this proposed rule, FSIS is requiring several 
information activities. FSIS is proposing to amend its recordkeeping 
regulations to specify that all official establishments and retail 
stores that grind raw beef products for sale in commerce must keep 
records, for a period of two years, that disclose the identity of the 
supplier of all source materials that they use in the preparation of 
each lot of raw ground product and identify the names of those source 
materials.
    The required records would have to include the following 
information:
    (A) The names, points of contact, phone numbers, and establishment 
numbers of the establishments supplying the materials used to prepare 
each lot of raw ground beef product.
    (B) All supplier lot numbers and production dates,
    (C) The names of the supplied materials, including beef components 
and any materials carried over from one production lot to the next,
    (D) The amount of the beef component used in each lot (in pounds),
    (E) The date and time each lot of raw ground beef product is 
produced, and
    (F) The date and time when grinding equipment and related food-
contact surfaces cleaned and sanitized.
    Estimate of Burden: FSIS estimates that it would take 3.00 hours 
per respondent annually.
    Respondents: Official establishments and retail stores that grind 
raw beef products.
    Estimated Number of Respondents: 76,093.
    Estimated Number of Responses per Respondent: 155.
    Estimated Total Annual Burden on Respondents: 228,652 hours.
    Copies of this information collection assessment can be obtained 
from Gina Kouba, Paperwork Reduction Act Coordinator, Food Safety and 
Inspection Service, USDA, 1400 Independence Avenue SW., Room 6077, 
South Building, Washington, DC 20250.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of FSIS's 
functions, including whether the information will have practical 
utility; (b) the accuracy of FSIS's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on those who 
are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology.
    Comments may be sent to both Gina Kouba, Paperwork Reduction Act 
Coordinator, at the address provided above, and the Desk Officer for 
Agriculture, Office of Information and Regulatory Affairs, Office of 
Management and Budget, Washington, DC 20253. To be most effective, 
comments should be sent to OMB

[[Page 42474]]

within 60 days of the publication date of this proposed rule.

E-Government Act Compliance

    The Food Safety and Inspection Service is committed to complying 
with the E-Government Act, to promote the use of the Internet and other 
information technologies to provide increased opportunities for citizen 
access to Government information and services, and for other purposes.

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 http://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

    FSIS will announce this proposed rule online through the FSIS Web 
page located at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/proposed-rules.
    FSIS will also make copies of this Federal Register publication 
available 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 constituents and 
stakeholders. The Update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade groups, 
consumer interest groups, health professionals, and other individuals 
who have asked to be included. The Update is also available on the FSIS 
Web page. In addition, FSIS offers an electronic mail subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at http://www.fsis.usda.gov/wps/portal/fsis/programs-and-services/email-subscription-service/email-subscription-service. Options range from 
recalls to export information to regulations, directives and notices. 
Customers can add or delete subscriptions themselves, and have the 
option to password protect their accounts.

List of Subjects

    Meat inspection, Reporting and recordkeeping requirements.

    For the reasons discussed in the preamble, FSIS is proposing to 
amend 9 CFR part 320, as follows:

0
1. The authority citation for part 320 continues to read as follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.7, 2.18, 2.53.

0
2. In Sec.  320.1, add paragraph (b)(4) to read as follows:


Sec.  320.1  Records to be kept.

* * * * *
    (b) * * *
    (4)(i) In the case of raw ground beef products, official 
establishments and retail stores are required to keep records that 
fully disclose:
    (A) The names, points of contact, phone numbers, and establishment 
numbers of the establishments supplying the materials used to prepare 
each lot of raw ground beef product;
    (B) All supplier lot numbers and production dates;
    (C) The names of the supplied materials, including beef components 
and any materials carried over from one production lot to the next;
    (D) The amount of the beef component used in each lot (in pounds);
    (E) The date and time each lot of raw ground beef product is 
produced; and
    (F) The date and time when grinding equipment and other related 
food-contact surfaces are cleaned and sanitized.
    (ii) Official establishments and retail stores covered by this 
regulation that prepare raw beef products that are ground at an 
individual customer's request must keep records that comply with 
paragraph (4)(i) of this section.
* * * * *

    Done in Washington, DC on July 16, 2014.
Alfred V. Almanza,
Administrator.
[FR Doc. 2014-17128 Filed 7-21-14; 8:45 am]
BILLING CODE 3410-DM-P