Federal Register, Volume 79 Issue 140 (Tuesday, July 22, 2014)

[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]

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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
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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 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
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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]
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