[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Notices]
[Pages 45451-45455]
From the Federal Register Online via the Government Publishing Office 
[FR Doc No: 2016-16642]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2014-0032]


Establishment-Specific Data Release Strategic Plan

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice; response to comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of its final Establishment-Specific Data Release 
Strategic Plan (the Plan) for sharing data on federally inspected meat 
and poultry establishments with the public. FSIS is also responding to 
comments received on a draft version of the Plan that FSIS posted on 
its Web site and announced in January 2015 in the Federal Register.

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

SUPPLEMENTARY INFORMATION:

Background

    The Food Safety and Inspection Service (FSIS) administers a 
regulatory program under the Federal Meat Inspection Act (FMIA) (21 
U.S.C. 601 et seq.), the Poultry Products Inspection Act (PPIA) (21 
U.S.C. 451 et seq.), and the Egg Products Inspection Act (EPIA) (21 
U.S.C. 1031 et seq.) to protect the health and welfare of consumers. 
The Agency is responsible for ensuring that the nation's commercial 
supply of meat,

[[Page 45452]]

poultry, and egg products is safe, wholesome, not adulterated, and 
correctly labeled and packaged.
    FSIS inspects these products at official slaughtering and 
processing establishments, verifying that the establishments meet 
regulatory requirements and enforcing those requirements as necessary.
    Additionally, FSIS employees (including inspectors, veterinarians, 
laboratorians, and Enforcement, Investigations, and Analysis Officers 
(EIAOs)) perform a variety of activities, including conducting 
inspections, ensuring compliance with existing regulations, and 
collecting and testing microbiological and chemical residue samples to 
verify that establishments are maintaining Hazard Analysis and Critical 
Control Point (HACCP) plans or other food safety systems that address 
these hazards.
    While conducting these activities and performing many other key 
functions, FSIS collects a large volume of establishment-specific data. 
Using the data, FSIS produces reports for internal use, and publicly 
shares data and reports through the Agency's Web site \1\ and other 
public communication venues. Most of the data that FSIS shares with the 
public is aggregated or in summary format; however, FSIS releases a 
large volume of disaggregated, establishment-specific data to the 
public through formal Freedom of Information Act (FOIA) requests.\2\
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    \1\ For more information, please visit: www.fsis.usda.gov.
    \2\ The Freedom of Information Act 5 U.S.C. 552, As Amended by 
Public Law 104-231, 110 Stat. 3048. Available at: http://www.justice.gov/oip/amended-foia-redlined.pdf.
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    In a notice published in the Federal Register on January 15, 2015, 
FSIS announced that the Agency had developed a plan for sharing data on 
federally inspected meat, poultry, and processed egg product 
establishments with the public (80 FR 2092). The Agency developed the 
Plan in response to policy documents issued by President Obama and the 
Office of Management and Budget (OMB), and to reduce the administrative 
burden FOIA requests have placed on the Agency.
    In 2009, President Obama and OMB released policy documents that 
called for increased data sharing and greater transparency in Federal 
agencies, including President Obama's January 21, 2009 ``Memorandum on 
Transparency and Open Government,'' \3\ OMB's February 24, 2009 
memorandum on ``The President's Memorandum on Transparency and Open 
Government--Interagency Collaboration'' \4\ and OMB's December 8, 2009 
``Open Government Directive.'' \5\ President Obama subsequently issued 
policy documents instructing agencies to develop plans for making 
information on regulatory compliance and enforcement activities 
available in machine-readable format, and accessible, downloadable, and 
searchable online.\6\
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    \3\ ``Transparency and Open Government: Memorandum for the Heads 
of Executive Departments and Agencies''. (74 FR 4685; Jan. 26, 
2009), pp. 4685-4686. Available at: http://www.whitehouse.gov/the_press_office/TransparencyandOpenGovernment.
    \4\ ``Memorandum for the Heads of Executive Departments and 
Agencies: President's Memorandum on Transparency and Open 
Government--Interagency Collaboration.'' Memorandum Number: M-09-12. 
24 February, 2009. Available at: http://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_fy2009/m09-12.pdf.
    \5\ ``Memorandum for the Heads of Executive Departments and 
Agencies: President's Memorandum on Transparency and Open 
Government--Interagency Collaboration.'' Memorandum Number: M-10-06. 
8 December, 2009. Available at: http://www.whitehouse.gov/open/documents/open-government-directive.
    \6\ ``Memorandum on Regulatory Compliance.'' 76 FR 3825 (January 
21, 2011); ``Making Open and Machine Readable the New Default for 
Government Information.'' Executive Order 13642. 78 FR 28111 (May 
14, 2013).
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    Upon the recommendation of the National Advisory Committee on Meat 
and Poultry Inspection (NACMPI), FSIS asked the National Research 
Council (NRC) within the National Academies to study the potential food 
safety benefits and consequences of releasing establishment-specific 
data to the public. The NRC convened a committee in 2011 and issued a 
report that analyzed the costs and benefits of releasing establishment-
specific data, recommending that FSIS develop a strategic plan to guide 
the Agency's efforts to release the data.\7\
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    \7\ National Research Council, Committee on a Study of Food 
Safety and Other Consequences of Publishing Establishment-Specific 
Data. ``The Potential Consequences of Public Release of Food Safety 
and Inspection Service Establishment-Specific Data.'' 2011. 
Available at: http://www.nap.edu/catalog.php?record_id=13304.
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    FSIS also convened an internal committee to conduct its own in-
depth review of Federal data sharing procedures and resources, which 
culminated in the development of the draft version of the Plan. NACMPI 
reviewed the draft plan in January 2014 and FSIS incorporated its 
feedback in the announced version of the draft Plan.

Final Revision of the Plan

    After carefully reviewing the submitted comments, FSIS made minor 
changes to the draft Plan. These changes include updated preliminary 
lists of datasets identified for release and considered for future 
release, as well as an expanded explanation of how FSIS will determine 
the level of aggregation for each dataset. The final revision of the 
Plan can be viewed on the Agency's Web site at http://www.fsis.usda.gov/wps/wcm/connect/0803f8a0-a3cc-4945-87b6-f992acdcfa9b/Establishment-Specific-Data-Plan-Final.pdf?MOD=AJPERES.
    The Plan establishes FSIS's process for releasing establishment-
specific data on Data.gov. The Plan includes an overview of FSIS data 
collection processes and structures, dataset selection criteria, data 
release procedures, a preliminary list of Agency datasets for public 
release, and performance measures for evaluating the effectiveness of 
data release.
    The preliminary list of Agency datasets for public release includes 
a ``demographic'' dataset of all regulated establishments that 
incorporates both information currently included in the Meat, Poultry 
and Egg Product Inspection Directory (name, number, address, grant 
date, slaughter and/or processing, meat and/or poultry) and additional 
information to facilitate data analysis (e.g., variables specifically 
created to allow different datasets to be correctly combined). The 
preliminary list also includes data on Listeria monocytogenes and 
Salmonella in ready-to-eat (RTE) products and processed egg products; 
data on Shiga Toxin-producing Escherichia coli (STEC) and Salmonella in 
raw, non-intact beef products; data on Salmonella and Campylobacter in 
young chickens and young turkeys, comminuted poultry, and chicken 
parts; routine chemical residue testing data in meat and poultry 
products; and advanced meat recovery (AMR) testing data. Of these, 
Salmonella in raw, non-intact beef products; Listeria monocytogenes and 
Salmonella in processed egg products; and Salmonella and Campylobacter 
in young chickens and young turkeys, comminuted poultry, and chicken 
parts are new additions to the Plan.
    Agency datasets identified for the first release include the 
demographic dataset and Listeria and Salmonella data in RTE products. 
FSIS will release these datasets by October 12, 2016. The preliminary 
list of Agency datasets will not all be released at the same time, and 
before the release of final datasets, FSIS intends to publish a 
Constituent Update with a link to a sample dataset for stakeholder 
review. For each dataset to be released, FSIS will determine and 
announce, on a case-by-case basis, the appropriate level of 
aggregation. For example, datasets could be aggregated at the national 
level or not aggregated at all, depending on FSIS's determination.

[[Page 45453]]

    Besides the preliminary datasets that the Agency intends for 
release, FSIS is considering additional data sources for future release 
of both aggregate and individual establishment data. These include: 
Individual establishment inspection task data associated with 
verification of compliance with each regulation; humane handling task 
data; and import sampling task data relating to STEC, Salmonella, and 
residue testing.
    The following is a summary of the comments received and FSIS's 
responses.

Summary of Comments and Responses

    FSIS received 19 comments in response to the January 2015 notice. 
The comments were from trade groups representing the meat and poultry 
industry, consumer groups, animal welfare groups, veterinary 
associations, a corporation that produces meat and poultry products, 
and three private citizens.

National Research Council (NRC) Study

    Comment: Several commenters stated that the release of 
establishment-specific data could damage the reputation of product 
brands because consumers will relate products to the specific 
establishments producing those products. These commenters suggested 
that the data released could create competitive disparity within the 
industry or cause harm to the U.S. food industry. Because of this, 
according to the commenters, the release of establishment-specific data 
would be akin to FSIS's endorsing certain brands over others.
    One commenter agreed that some brands may develop an unwanted 
reputation based on data released to the public, but believed that this 
could actually benefit FSIS by weeding out bad actors.
    Other commenters stated that the Plan will have a limited impact on 
brand reputation because consumers do not relate products to the 
specific establishments producing those products.
    Response: While consumers could relate brands to the specific 
establishments producing their products, FSIS will not endorse certain 
brands over others through sharing data. FSIS maintains information on 
establishments, not brand information. When evaluating datasets for 
release, FSIS will thoroughly examine whether releasing datasets could 
have an adverse impact on the industry, including whether releasing the 
dataset would create market disparity. However, the NRC Committee 
thought that one potential benefit of releasing establishment-specific 
data would be that consumers would be able to make more informed 
choices, and that resulting consumer pressure could motivate 
corporations to improve performance in order to protect brand 
reputation.

Criteria for Evaluating FSIS Datasets for Public Posting

    Comment: Some commenters stated that data released under the Plan 
could contain confidential information such as Personally Identifiable 
Information (PII), or proprietary information such as trade secrets. 
Other commenters suggested that the release of certain establishment-
specific data to the public could incentivize foreign countries to 
erect trade barriers against the United States or individual companies. 
One commenter noted that the release of certain establishment-specific 
data could expose establishments to vulnerabilities in food defense. 
The commenter also stated that the publication of the establishment's 
name, address, and size, along with the types of products produced, 
could direct potential terrorists to more desirable targets.
    Response: FSIS will thoroughly examine candidate datasets, using 
multiple FSIS personnel, to ensure the datasets do not contain PII, 
confidential information or proprietary information. The Agency will 
not release data that contains confidential information, including PII, 
on either FSIS staff or establishment employees.
    In addition, FSIS will consider potential security risks associated 
with release of data based on the evolving threat landscape. The 
release of establishment-specific demographic data, such as the name, 
address, and type of product produced, does not pose a significant 
security risk to food defense. Most of this information is already 
available to the public in the Meat, Poultry, and Egg Product 
Directory. The Agency continues to recommend that establishments 
voluntarily adopt and implement food defense measures to mitigate 
potential vulnerabilities.
    Comment: Several commenters stated that the release of 
disaggregated, establishment-specific data may mislead the public if 
there is a lack of context. For example, the public may misconstrue the 
meaning and significance of NRs received by establishments if the 
corrective actions, enforcement actions, and appeals are not also 
provided. These commenters worried that misinterpretation of the data 
could be harmful to the image of the individual establishments and the 
industry as a whole.
    Some commenters recommended FSIS adopt a due-process mechanism to 
prevent the release of data that can be easily misinterpreted. These 
commenters requested that the industry be allowed to examine data and 
user guides concerning the data before they are released to the public. 
One commenter recommended that FSIS incorporate the user guides into 
the same document containing the datasets to increase the likelihood 
that the public will consult the guides when reviewing the data. 
Another commenter recommended that FSIS use consumer test panels to 
evaluate whether readers understand the data. The same commenter also 
recommended that FSIS allow the industry to provide comments along with 
the datasets to help give the public some context in interpreting the 
data.
    Response: FSIS staff will thoroughly evaluate every dataset to 
determine the potential for misinterpretation. If it is highly likely 
that the public will misinterpret the released data, the Agency will 
evaluate the dataset to determine if additional explanatory or 
contextual information would reduce that likelihood. If additional 
information will not reduce the potential for misinterpretation, the 
Agency will remove the dataset from consideration for release.
    In addition, the Plan provides a thorough list of context-providing 
documentation that will be included in user guides with each dataset 
released, including: (1) A dataset overview and explanation; (2) 
database-specific dictionaries; (3) historical information on changes 
to sampling methods and scheduling or collection to inform changes to 
time-series; (4) the context in which the data was collected; (5) 
sources of variability and specificity of methods used; (6) the 
dataset's relationship to other released datasets; (7) data use 
limitations; and (8) links to analyses conducting using the data to be 
released. FSIS will share these user guides with industry stakeholders 
prior to the release of datasets to ensure the accuracy of the 
information; however, there is no plan at this time to include industry 
comments with the released datasets.
    Comment: Some commenters stated that the Plan did not articulate 
how the release of establishment-specific data aligns with FSIS's 
goals. Specifically, these commenters requested that FSIS articulate 
how each data release aligns with a public health objective.
    Response: Every dataset released will align with the primary 
mission of FSIS:

[[Page 45454]]

To ensure that the Nation's commercial supply of meat, poultry, and egg 
products is safe, wholesome, and correctly labeled and packaged. 
Because of its importance, for every dataset it considers for release, 
FSIS will separately evaluate whether the data released will be used to 
benefit the public's health and reduce foodborne illness.
    Comment: Some commenters expressed concern about the potential cost 
for the Agency to implement the Plan. One commenter stated that too 
many FSIS resources would be expended in implementing the Plan and 
requested the inclusion of additional information about cost savings.
    Response: The monetary and personnel costs associated with 
implementing the Plan will be minimal. Under the Plan, FSIS will 
consider both the Agency's personnel and monetary costs when 
determining which datasets to release. Accordingly, data that will 
create a heavy administrative burden through excessive documentation or 
manual redaction will not be released. To further reduce the 
administrative costs, FSIS will develop an automated algorithm that 
will identify and collect datasets intended for release.

Prioritization for Data Release

    Comment: Several commenters identified additional datasets that 
should be considered for release, such as import inspection data, 
humane handling task data, Food-Safety Assessments (FSAs), codes for 
inspections tasks that were not performed and whether establishments 
participate in the new poultry inspection system.
    A few commenters requested the release of information on tissue 
residue violations in cull dairy cows. These commenters stated that the 
information, which was published on the Agency's Web site until March 
2011, is a valuable resource for the dairy industry to target outreach 
efforts and reduce the probability that repeat violations will occur.
    Response: After considering these comments, FSIS has decided to add 
import inspection data, FSAs, and inspection tasks that were not 
performed to the preliminary list of data sources to be considered for 
future release. Humane handling task data is already on the preliminary 
list. FSA data will be limited to exclude free-text fields that may 
include PII or proprietary information.
    FSIS announced in the 2016 Federal Register Notice titled ``New 
Performance Standards for Salmonella and Campylobacter in Not-Ready-to-
Eat Comminuted Chicken and Turkey Products and Raw Chicken Parts . . 
.'' that it will begin posting, based on FSIS sampling results and 
depending on the standard for the particular product, whether an 
establishment meets the FSIS pathogen reduction performance standards, 
or what category an establishment is in.
    FSIS does not intend to resume the publication of a monthly Residue 
Violator List that includes the name of any producer with at least one 
residue violation in the previous 12-months. The Agency stopped 
publishing the monthly Residue Violator List in 2011 to prevent 
potential economic harm to producers with only one violation. Instead, 
FSIS will continue to publish a weekly Residue Repeat Violator List, 
which identifies producers with multiple residue violations within a 
12-month period.\8\ FSIS notes that many first time violators do not go 
on to become repeat violators within the designated 12-month period. In 
addition, repeat violators have an incentive to improve operations and 
prevent violative residues in order to remove their names from the 
Repeat Violator List.
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    \8\ The FSIS Repeat Residue Violator List can be downloaded at 
http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/chemistry/residue-chemistry.
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    Comment: A few commenters requested that FSIS release noncompliance 
records (NRs) filed by FSIS inspection personnel, subsequent appeals, 
and their eventual resolutions.
    Several commenters requested that NRs not be released because 
consumers could easily misinterpret their significance and regulatory 
meaning. Those same commenters argued that it would waste FSIS 
resources to review and redact each NR before releasing the data.
    Response: FSIS does not intend to release NRs as a stand-alone data 
set at this time. FSIS will consider releasing the compliance status of 
individual inspection tasks and regulations if FSIS decides to release 
inspection task data in the future. Free-text fields will never be 
released because of the possible presence of PII and because manual 
redaction is costly. However, general information, such as whether or 
not an NR was recorded, the date the NR was issued, which regulations 
it cited, whether an appeal was filed, and whether the appeal was 
granted, will be considered for release.
    Comment: One commenter encouraged FSIS to release historical data 
from older data systems in addition to the Public Health Information 
System (PHIS) data it currently plans to release.
    Response: At this time, only data collected since the 
implementation of PHIS in 2012 will be considered for release. The 
historical data from before the implementation of PHIS would be too 
burdensome for the Agency to release. FSIS will consider releasing 
historical data from older data systems at a later date if Agency 
resources permit.

Data Release Procedures

    Comment: One commenter asked that FSIS release data more frequently 
than on a quarterly basis. The commenter stated that because PHIS 
collects data in real time, FSIS should be able to release data every 
month.
    Response: At this time, one new dataset from the Priority List is 
scheduled to be released no more frequently than on a quarterly basis. 
This will provide the Agency sufficient time to select and verify the 
accuracy of the data, as well as release a sample data set and 
documentation through an FSIS Constituent Update to interested 
stakeholders for review.
    Comment: Some commenters recommended that FSIS ``blind'' or 
aggregate the datasets. The blind or aggregated data would allow 
interested parties to see how industry and the Agency are performing in 
various areas without compromising individual companies and creating 
market disparity.
    Response: As part of the review process, FSIS will determine the 
most appropriate level of aggregation for each dataset. FSIS will 
continue to release at a national level of aggregation datasets that 
are currently so aggregated. For other datasets, FSIS intends to assess 
feedback from stakeholders and other users of the data to determine if 
additional levels of aggregation would be useful. Also, for each 
dataset planned for initial release, FSIS plans to release 
establishment-specific information, including the establishment's name 
and number.

Measurement of Effectiveness of Data Release

    Comment: One commenter stated that some of the metrics presented in 
the draft Plan to measure effectiveness are too narrow to fully capture 
the ways in which the data is used. For instance, according to the 
commenter, a metric for the number of presentations on related data by 
FSIS staff at professional meetings does not account for presentations 
on other topics that use the data as a portion of their presentations. 
Similarly, the commenter stated that a metric for the number of peer-
reviewed reports generated using

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the establishment-specific data does not include papers that use the 
data that are not peer-reviewed.
    Another commenter recommended that FSIS reassess the Plan after one 
year. If after one year FSIS determines that the data release program 
is not achieving its intended goals, the Agency should change the Plan.
    Response: FSIS acknowledges that it is impossible to anticipate 
every way in which the released establishment-specific data will be 
used. The Plan, however, presents a framework of performance measures 
that will adequately inform future data releases. This framework 
includes a combination of the seven quantitative metrics listed, along 
with qualitative measures, such as assessments of how data are 
interpreted and used by stakeholders. FSIS will regularly review these 
metrics and use them to guide future choices for data release.

USDA Nondiscrimination 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.
    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
program.intake@usda.gov

    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.) should contact 
USDA's TARGET Center at (202)720-2600 (voice and TDD).

Additional Public Notification

    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.

    Done at Washington, DC, on July 11, 2016.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2016-16642 Filed 7-13-16; 8:45 am]
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