[Federal Register Volume 79, Number 156 (Wednesday, August 13, 2014)]
[Pages 47424-47427]
From the Federal Register Online via the Government Printing Office 
[FR Doc No: 2014-19172]



Food Safety and Inspection Service

[Docket No. FSIS-2009-0034]

Pre-Harvest Management To Reduce Shiga Toxin-Producing 
Escherichia coli Shedding in Cattle

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and opportunity for comments.


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of its updated guidance document on pre-harvest 
management controls and intervention options for reducing Shiga toxin-
producing Escherichia coli (STEC) shedding in cattle. In addition, this 
notice summarizes and responds to comments received on the guidance 
document and on the pre-harvest management issues that FSIS raised in a 
previous Federal Register notice and public meeting.

DATES: Written comments may be submitted until 30 days after issuance 
of this notice.

ADDRESSES: FSIS invites interested persons to submit comments on the 
guidance document for the pre-harvest management controls and 
intervention options for reducing STEC. Comments may be submitted by 
either 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 on-line instructions at that site for submitting comments.
    Mail, including CD-ROMs, etc.: Send to Docket Room Manager, U.S. 
Department of Agriculture, Food Safety and Inspection Service, Patriots 
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163B, 
Washington, DC 20250-3700.
    Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3, 
355 E. Street

[[Page 47425]]

SW., Room 8-163B, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2009-0034. 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 Patriots Plaza 3, 355 E. Street SW., Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday 
through Friday.
    A downloadable version of the revised guidance document is 
available to view and print at (add link to CG). No hard copies of the 
guidance document have been published.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495, or by Fax: (202) 720-2025.



    On May 14, 2010, FSIS announced the availability of a guidance 
document on pre-harvest management to reduce STEC shedding in cattle 
and requested comment on the guidance (75 FR 27288). The guidance 
provided beef slaughter establishments with an informational resource 
on pre-harvest management controls and interventions for reducing the 
shedding of STEC in feces during cattle production. The document 
provided an overview of the status of pre-harvest control and 
intervention strategies discussed in the scientific literature to 
reduce STEC shedding in cattle. The document covered the intervention 
strategies, state of findings, and links to additional scientific 
references for the strategies discussed.
    The guidance explained that STEC shedding by cattle is a hazard 
that occurs at pre-harvest and in the holding pens at the 
establishment. STEC shedding may result in contamination of the hides 
and transfer of STEC to the carcass during carcass dressing. 
Establishments may address this hazard by incorporating into their 
HACCP plans or prerequisite programs purchase specifications, other 
programs, or agreements that require that their suppliers implement 
certain pre-harvest management controls.
    As the guidance also explained, FSIS recommends pre-harvest 
interventions as the first control steps in an integrated beef products 
safety system. FSIS recommends that slaughter establishments receive 
their cattle from beef producers that implement one or more documented 
pre-harvest management practices to reduce STEC shedding.
    In September 2011, FSIS declared six STEC strains--O26, O45, O103, 
O111, O121, and O145--in addition to O157:H7, as adulterants in beef 
(76 FR 58157). FSIS has updated the guidance document to address the 
additional adulterant STEC. In addition, in response to comments, FSIS 
removed statements from the document that may have recommended a 
particular pre-harvest intervention or practice over another.
    On November 9, 2011, FSIS, the Animal and Plant Health Inspection 
Service (APHIS), and the Agricultural Research Service (ARS) hosted a 
public meeting seeking input on pre-harvest pathogen control strategies 
designed to reduce the likelihood that beef will be contaminated with 
pathogens of public health concern, such as Shiga toxin-producing E. 
coli and Salmonella, during the slaughter process. One of FSIS's goals 
for the public meeting was to obtain information that it could use to 
improve the pre-harvest guidance (76 FR 63901) that it had issued.
    At the public meeting, presentations were made on ``The Control of 
Foodborne Pathogens in Cattle: Efficacy, Adoption, and Impact on Public 
Health'' and ``Public Health and Pre-Harvest Interventions--What is the 
potential.'' Additionally, round table discussions were held on ``What 
factors influence the shedding of Salmonella and E. coli O157:H7 and 
other STEC (e.g., age of cattle, stress conditions),'' ``What effective 
and practical mitigations are available to reduce the pathogen load in 
general, and Salmonella and STECs specifically, in cattle before 
slaughter,'' and ``How can producers, processors, and government work 
together to promote adoption of pre-harvest food safety mitigations.'' 
Individuals from all three Federal Agencies, industry, and industry 
associations were present. (See links to the meeting records later in 
this document.)
    Meeting participants sought clarification of what super shedders 
are, and how they would be identified during production. They felt 
strongly that the United States should build upon successful 
mitigations used in foreign countries; allow the market to drive the 
value of any particular mitigation technology, including vaccines; and 
streamline the regulatory approval process. They recommended also that 
there be sustained discussions among Federal, industry, and academic 
partners to identify and put into practice pre-harvest mitigations for 
reducing foodborne hazards and beef.
    FSIS has reviewed the comments from the public meeting, and based 
on its review, it has developed the updated guidance document whose 
availability FSIS is announcing. The updated document sets out 
innovative ways to control pathogens in beef at pre-harvest and pre-
harvest pathogen control strategies for animals presented for 

Comments and Responses

    FSIS received four comments in response to the May 2010 
announcement of the availability of the guidance document. In 
adddition, the Agency received three comments in response to the 
October 2011 notice ``Pre-harvest Food Safety for Cattle Public 
Meeting'' (76 FR 63901), and five comments at the November 2011 public 
meeting. The comments were from consumer groups and industry trade 
associations. Following is a summary of the comments in response to the 
guidance and the public meeting and FSIS's responses.

General Comments

    Comment: Industry trade associations expressed concern that the 
guidance document established requirements. One commenter was 
especially concerned that FSIS' inspection program personnel would use 
the guidance to take regulatory action.
    Response: This guidance document, like all FSIS guidance documents, 
represents the Agency's current thinking on pre-harvest intervention 
strategies and does not establish requirements. There are no regulatory 
requirements for establishments embodied in the intervention and 
management practices outlined in this document. The Agency removed from 
the pre-harvest guidance document any statements that could indicate a 
preference for one pre-harvest intervention over another. An 
establishment is not required to use the interventions or management 
practices outlined in the guidance document and may take an alternative 
approach to reduce STEC shedding in cattle for slaughter.
    Comment: Several comments stated that USDA should be more involved 
in pre-harvest food safety research. An advocacy group suggested that 
bacterial isolates collected from a statistically valid and nationally 
representative sample of cattle entering slaughter could provide 
information about the bacterial load on the animals. A University 
professor asked that the Agency

[[Page 47426]]

consider a research exemption to study STEC in industry environments to 
overcome the reluctance of packers to permit scientists to carry out 
studies in their facilities.
    Response: FSIS recognizes the importance of determining the 
incoming bacterial load on cattle presented for slaughter, and of 
giving researchers access to the industry environment. However, FSIS 
does not advocate the introduction of pathogens into official 
establishments. Raw non-intact beef or intact beef intended to be used 
to produce raw non-intact beef is adulterated if contaminated with the 
STEC that FSIS has identified as adulterants. Therefore, establishments 
would have to take steps to effectively address any STEC detected 
during research that could contaminate raw non-intact product.
    FSIS food safety research priorities include pre-harvest research 
initiatives, such as research on the effect of pre-harvest 
interventions on finished products; on the effectiveness of integration 
of one or more pre-harvest or post-harvest interventions as a control 
strategy; and identification or development of pre- and post-harvest 
interventions to reduce pathogen and chemical hazards in veal.
    See FSIS Web site: http://www.fsis.usda.gov/wps/portal/fsis/topics/science/food-safety-research-priorities.

Vaccines, New Technologies, and Best Practices

    Comment: Several commenters recognized that FSIS does not have 
authority to approve or regulate vaccines but encouraged the Agency to 
collaborate with APHIS' Center for Veterinary Biologics to provide a 
comprehensive view of the steps required for vaccine approval, one that 
covers foodborne illness pathogens as well as animal disease pathogens. 
Commenters underscored the need for industry to use new technologies 
and best practices, such as developed vaccines or the sanitary care of 
animals. An animal health care company noted that any of the 
interventions used on the farm would show increasing benefit the longer 
they are used on the live animal. A trade group representing meat 
packing and processing establishments recommended that the above-
mentioned agencies collaborate with beef stakeholders through the E. 
coli Coalition and other industry efforts focused on beef safety.
    Response: Hosting the public meeting is a clear example of 
successful collaboration among the three agencies. Additionally, the 
guidance document provides innovative ways to control pathogens in beef 
pre-harvest and when presented for slaughter. FSIS disagrees that any 
intervention used on the farm would show increasing benefit the longer 
it is used on the live animal. The effectiveness of select 
interventions may increase, e.g., husbandry practices, but not all the 
interventions described in the guidance document will provide an 
increasing benefit over time.
    Additionally, FSIS's Office of Policy and Program Development 
provided updates to the National Advisory Committee on Meat and Poultry 
Inspection (NACMPI) on Salmonella and pre-harvest initiatives based on 
a NACMPI committee 2013 recommendation, which included that FSIS will 
continue to have discussions on pre-harvest issues among the federal 
government, industry, and academia and to re-issue the pre-harvest 
guidance document and respond to comments on the previous Federal 
Register Notice (78 FR 77643 and http://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/past-meetings).
    Regarding working with external partners, FSIS is bringing together 
the groups that actually review the submissions that come to them on 
pre-harvest interventions along with ARS, which develops a lot of the 
research, to see whether FSIS and ARS could facilitate an expedited 
process. FSIS has met with the Food and Drug Administration on the pre-
harvest intervention submissions that have been received by that agency 
and on the criteria that it uses to review them. Additionally, FSIS is 
in contact with APHIS regarding vaccines. Finally, FSIS is working with 
industry and academic partners to identify and incorporate pre-harvest 
mitigation strategies for reducing foodborne hazards in beef and 
poultry into guidance documents.

Antimicrobial Resistance

    Comment: Two advocacy groups expressed concern about the use of 
antibiotics in cattle that may lead to antibiotic resistance and 
requested that FSIS take a more active role in promoting pre-harvest 
steps aimed at reducing the selection from and spread of antimicrobial 
resistance. One commenter suggested that current production practices, 
involving dependence on the non-therapeutic use of antibiotics and 
overcrowding in feedlots, create conditions that are ideal for the 
development and spread of antibiotic-resistant pathogens.
    Response: FSIS recognizes the complexity of the antimicrobial 
resistance issue. Given this complexity, and the limits on FSIS's 
ability to address this issue, in the guidance document, FSIS discusses 
studies that focus on the effects of various strategies to reduce STEC 
shedding in cattle. These strategies include the use of medications, 
such as antibiotics, as well as non-medicinal approaches. The guidance 
document discusses the use of antibiotics, such as ionophores, neomycin 
sulfate, tetracycline, and oxytetracycline, in cattle and their effect 
on STEC shedding.
    FSIS participates in the National Resistance Monitoring System 
(NARMS) sampling program, which is a surveillance sampling program that 
provides FSIS, FDA, and other interested agencies with data on the 
presence of selected enteric microorganisms in food animal species. The 
sampling for antibiotic residues is conducted as part of NARMS.
    Comment: A consumer advocacy group stated that, while the pre-
harvest meeting discussions focused mainly on the control of E. coli, 
FSIS should recognize that there are significant pre-harvest issues 
related to the control of Salmonella. The commenter noted that it has 
petitioned FSIS to declare four strains of Salmonella to be adulterants 
when antibiotic resistant and when found in FSIS-regulated products, 
considering it to be within FSIS' authority to declare these 
antimicrobial resistant strains to be adulterants.
    Response: FSIS is reviewing the group's petition and expects to 
respond to the petition in the coming months and will post the response 
on the FSIS Web site.
    More broadly, FSIS's focus for the guidance document is to provide 
beef slaughter establishments with an informational resource on pre-
harvest management controls and interventions for reducing STEC 
shedding in beef cattle production. In regards to Salmonella, FSIS 
announced an action plan posted at: http://www.fsis.usda.gov/wps/wcm/connect/aae911af-f918-4fe1-bc42-7b957b2e942a/SAP-120413.pdf?MOD=AJPERES.
    Pre-harvest contamination can affect the level of Salmonella on 
FSIS-regulated products. Synthesizing information on pre-harvest 
interventions from previous and on-going FSIS activities, and other 
information available from industry, could help decrease the prevalence 
or levels of Salmonella on FSIS-regulated products. As stated in the 
action plan, FSIS will continue to work with industry members to 
identify best practices for pre-harvest. FSIS will also organize and 
host a meeting to focus on pre-harvest issues for poultry. FSIS will 
then use the information gathered at

[[Page 47427]]

that meeting to inform future policies and best-practice guidelines.

Communication With Stakeholders

    Comment: An animal health care company encouraged the public 
meeting organizers to follow-up with participants by communicating 
potential results or implications of the meeting.
    Response: The Agency agrees that stakeholders should be kept 
informed. The transcript of the meeting is available on the Agency's 
Web site at http://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/past-meetings/past-meetings-2011. Notes from the round table 
discussions held at the meeting are available at http://www.fsis.usda.gov/wps/wcm/connect/2091b3b8-2d81-4531-81b7-f05369a9a16f/Pre-Harvest_FS_Notes.pdf?MOD=AJPERES. An outgrowth of the meeting is 
the Agency's updated guidance document. FSIS fully considered the 
comments made during and in response to the meeting in updating the 
    Comment: Three commenters stated that the May 2010 guidance 
document lacked scientific rigor, was inconsistent in the 
recommendations, and generally included practices that did not work. 
For example, a trade association disagreed that antibiotics would be 
effective in preventing shedding of E. coli O157:H7 in cattle. One 
commenter felt there would be confusion in the use of both scientific 
and trade names for antibiotics.
    Response: It is important that establishments, particularly small 
and very small establishments, have access to a full range of 
scientific and technical information to assist them in establishing 
safe and effective HACCP systems, including information on pre-harvest 
management strategies that an establishment may choose to incorporate 
to reduce the incoming bacterial load into their process. For example, 
the guidance draws on a number of studies on feed types, feed 
additives, fasting, and their effects on E. coli O157:H7 shedding, with 
some studies showing a decrease in E. coli O157:H7 shedding, while 
others showed an increase or no difference in E. coli O157:H7 shedding. 
In some studies, ractopamine was shown to decrease E. coli O157:H7 
shedding, while in other studies it was shown to increase E. coli 
O157:H7 shedding. The Agency's intent in re-issuing the guidance 
document is to provide industry with a review of the literature on, and 
the current status of, pre-harvest interventions, management practices, 
and ongoing research. FSIS has removed statements from the document 
that may have recommended any particular pre-harvest intervention or 
practice over another one.
    As stated above, there is no regulatory requirement for 
establishments to use the interventions or management practices 
outlined in the guidance document.
    FSIS regards the use of both scientific and trade names for 
antibiotics as justified because the use of both is common in the 
scientific literature on pre-harvest interventions and management 

Additional Public Notification

    FSIS will announce this notice online through the FSIS Web page 
located at http://www.fsis.usda.gov/federal-register.
    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/subscribe.
    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.

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 
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:


    U.S. Department of Agriculture, Director, Office of Adjudication, 
1400 Independence Avenue SW., Washington, DC 20250-9410.


    (202) 690-7442.


    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).

    Dated: August 8, 2014.
Alfred V. Almanza,
[FR Doc. 2014-19172 Filed 8-12-14; 8:45 am]