Document Reviews of Foreign Food Regulatory Systems: New Web-based Self-Reporting Tool, 9428-9431 [2015-03576]

Download as PDF 9428 Notices Federal Register Vol. 80, No. 35 Monday, February 23, 2015 This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2014–0039] Document Reviews of Foreign Food Regulatory Systems: New Web-based Self-Reporting Tool Food Safety and Inspection Service, USDA. ACTION: Response to comments; notice of availability. AGENCY: FSIS is making available to the public its new Web-based SelfReporting Tool (SRT) that it will be sending to foreign countries to report information on their food regulatory systems for the purpose of establishing that the systems are, or continue to be, equivalent to that of the United States’ system. The Agency will send a letter to foreign countries with instructions on how to access and use the Web-based SRT. FSIS is also responding to the comments on its document review process for determining and verifying equivalence that the Agency received in response to the Federal Register notice that it published on January 25, 2013, on the use of the SRT. FSIS evaluates the information provided in the SRT and uses it, along with the results of onsite systems audits and port-of-entry (POE) reinspections, to make a determination on equivalence. DATES: On February 17, 2015, FSIS will make available to the public the new Web-based SRT. To ensure that a complete and up-to-date SRT is being considered as part of FSIS’s annual assessment of country performance, countries that are currently eligible to export meat, poultry, and egg products to the United States must submit their completed SRTs to FSIS before May 18 of 2015 and annually before May 18 thereafter. FSIS will send SRTs to all countries currently eligible to export meat, poultry, and egg products to the Rmajette on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:19 Feb 20, 2015 Jkt 235001 United States on December 1 of each year in the future. Countries applying for initial equivalence determinations after February 23, 2015 must submit their completed SRTs within one year of receiving the SRT. FOR FURTHER INFORMATION CONTACT: Dr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205–0495. SUPPLEMENTARY INFORMATION: Background In a notice published in the Federal Register of January 25, 2013 (78 FR 5409) (hereafter ‘‘the Federal Register notice’’), FSIS described how it conducts ongoing equivalence verifications of the food regulatory systems of countries that export meat, poultry, or processed egg products to the United States. FSIS uses a three-part approach that includes (1) document reviews, (2) on-site system audits, and (3) POE reinspections. FSIS determines the scope and frequency of on-site systems audits based on its analysis of the results of its document reviews and ongoing assessment of a country’s performance. This performance-based approach allows FSIS to direct its audit resources to foreign food regulatory systems that appear to pose a greater risk to public health than other foreign systems. FSIS invited interested persons to submit comments on its new methodology by March 26, 2013. FSIS received approximately 31 comments from foreign countries, trade consulting groups, consumer groups, private citizens, a trade association representing the meat industry, and a member of the U.S. Congress. Twelve of those comments concerned the Agency’s document review process. In this notice, FSIS is responding only to the comments that it received on its document review process. A summary of comments on the Agency’s document review process and the Agency’s responses are below. The Agency will address the other comments in a future Federal Register document. On the basis of information provided by commenters, FSIS’s experience in conducting document reviews, and the Agency’s analysis of available SRT data, FSIS has decided to make two changes to its document review process. The PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 changes are explained below and are discussed in more detail in the Agency’s responses to comments. Improvements to the Document Review Process A foreign country interested in exporting to the United States is required to submit information concerning its food regulatory system to FSIS (see 9 CFR 327.2(a)(2)(iii), 381.196(a)(2)(iii), and 590.910). As explained in the January 2013 Federal Register notice, FSIS uses the equivalence questionnaire, called the SRT, to collect this information for the Agency’s document review of the food regulatory system of foreign countries that are listed in the regulations as eligible to export meat, poultry, or egg products to the United States and for countries interested in becoming eligible (78 FR 5411). The SRT is a repository for key documents about a foreign food safety inspection system (e.g., inspection system laws, regulations, and policy issuances) that FSIS uses, in addition to on-site audits, to verify whether the laws, regulations, and implementing policies of a foreign country establish an inspection system that is equivalent to the U.S. system. It also allows FSIS to evaluate whether a country maintains system effectiveness and to assess any impacts that an administrative or legislative change has had on a foreign food regulatory system. FSIS conducts a document review at least annually. The information in the SRT allows FSIS to conduct a comprehensive assessment of a foreign country’s food safety regulatory system. These comprehensive assessments inform the Agency’s determination of whether a country’s system should be found equivalent and the country eligible to export product into the United States. FSIS also assesses information in the SRT on an ongoing basis to verify whether a country maintains equivalence. In the past, the SRT was available in a Microsoft Word format, and once completed by the country, it was submitted to FSIS along with corresponding supporting documentation either by mail or email communication. A PDF copy of the Microsoft Word version of the SRT is available on FSIS’s Web site at: http:// www.fsis.usda.gov/wps/wcm/connect/ E:\FR\FM\23FEN1.SGM 23FEN1 Rmajette on DSK2VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 35 / Monday, February 23, 2015 / Notices 7893547e-d0d2-4fa9-a984fdc17228bfcd/SRT.pdf?MOD=AJPERES. On February 17, 2015, FSIS will launch a Web-based version of the SRT within its Public Health Information System (PHIS) to more efficiently capture up-todate information about foreign food regulatory systems. PHIS is a comprehensive Web-based dataanalytics and inspection system that automates and replaces many of FSIS’s paper-based processes. The Web-based SRT will be beneficial for countries exporting meat, poultry, and egg products to the United States; countries interested in exporting product to the United States and applying for equivalence; and FSIS personnel. With the Web-based SRT, countries can link supporting documentation to each question. With the Microsoft Word version, the supporting documentation is provided as a supplement to the SRT. As a result, during the review process, FSIS must sift through documents to match up information with the corresponding questions in the SRT. FSIS anticipates that use of the Web-based SRT will decrease the time it takes the Agency to review an SRT submission and thereby allow for a quicker response to an equivalence request. Using PHIS as a platform for the SRT allows for a more secure exchange of information between FSIS and foreign countries because countries will be accessing the SRT through a secure USDA Web site that requires a unique ID and password acquired through an authentication process. To guarantee that the security of the Web-based SRT in PHIS is maintained and to gain access to the system, each potential user will have to register for a USDA eAuthentication (eAuth) Level 2 account and complete the authentication process. FSIS will send a letter to foreign countries with instructions on obtaining an eAuth account and using the Web-based version of the SRT. FSIS strongly encourages countries to use the Webbased SRT. However, the use of the Web-based SRT is voluntary, and FSIS will continue to accept the current Microsoft Word version of the SRT. To ensure that the transition to the Webbased SRT is as seamless as possible, FSIS pre-entered into PHIS the SRT responses and supporting documentation that countries actively exporting meat, poultry, or egg products to the United States have provided to FSIS. FSIS requests that countries review the pre-entered responses for completeness and accuracy. In addition to a Web-based version of the SRT, foreign countries will note that VerDate Sep<11>2014 14:19 Feb 20, 2015 Jkt 235001 the revised SRT asks fewer and more targeted questions necessary for FSIS to verify system equivalence. FSIS expects countries to answer all the targeted questions in the SRT to facilitate the review process. FSIS may not be able to make an equivalence determination without answers to all of these questions. The SRT also includes questions for FSIS to use in assessing how frequently to conduct on-site audits of the country. FSIS refers to these questions as level of advancement (LOA) questions. As explained in the Federal Register notice, the sum of the LOA responses is one of the factors that FSIS considers as part of an annual analysis of country performance to determine the frequency and scope of on-site audits (78 FR 5412). FSIS uses the results from the analysis to place exporting countries into one of three categories, based on food safety performance, with corresponding audit frequencies: Well-performing countries are to be audited every three years. Average-performing countries are to be audited every two years. Adequatelyperforming countries are to be audited every year. Thus, the completeness of a country’s SRT contributes to FSIS’s assessment of that country’s performance and to FSIS’s determination of the appropriate audit frequency for that country. Countries with incomplete SRTs will not be considered ‘‘well-performing’’ because they will not have provided the Agency enough information to give the Agency confidence in their food safety systems. FSIS will provide more information on LOAs in a subsequent Federal Register notice that addresses all comments received in the January 2013 Federal Register notice and provides additional updates on the FSIS equivalence determination process. To ensure that a complete and up-todate SRT is being considered as part of FSIS’s annual assessment of country performance, countries must submit their completed SRTs to FSIS before May 18, 2015, and on an annual basis moving forward. If a country submits partial or inaccurate information, FSIS personnel will follow up with additional questions until all outstanding issues are resolved. FSIS must have complete and accurate information to verify that the foreign country’s food regulatory system is robust, transparent, and science-based. If a country does not provide FSIS with documentation showing its system is equivalent, or if it continues to submit inadequate documentation, FSIS will not have sufficient information to determine the viability of the food safety system and may have to pursue a series PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 9429 of actions directed at product presented for reinspection (e.g., intensified testing for microbial adulterants, indicator organisms, chemical residues, or species) to address the absence of a government-supplied explanation of inspection system controls. In addition, FSIS likely would begin refusing to list establishments newly certified by the foreign government, or to relist certified establishments, because of a lack of confidence in the government-supplied explanation of its inspection system. FSIS may conduct specially designed in-country audits to obtain information. FSIS may, within a reasonable period of time, refuse entry to products exported from that country. Finally, if it becomes necessary, FSIS will take steps to remove the country from the list of countries eligible to export meat, poultry, or processed egg products. Any country can apply for eligibility to export meat, poultry, or egg products to the United States. The application process begins with a letter to FSIS from a foreign country asking for consideration to export its products for sale in the United States. FSIS responds to these letters with a standard package that contains information on the SRT and information on gaining eAuthentication. More information on how to apply for initial equivalence is available on FSIS’s Web site at: http:// www.fsis.usda.gov/wps/portal/fsis/ topics/international-affairs/importingproducts/equivalence/equivalenceprocess-apply-for-initial-equivalence. FSIS asks that a foreign country applying for initial equivalence submit a complete SRT to FSIS in PHIS within one year of receiving the questionnaire. If FSIS needs additional information, or if FSIS’s regulations change, the Agency will request that the country update its SRT to provide additional information to demonstrate that the country has an equivalent food regulatory system to the United States’ system. If FSIS’s document review supports that the foreign country’s food regulatory system may be equivalent to the United States’ system, the Agency will conduct an onsite audit. However, if a foreign government applying for initial equivalence does not submit a complete SRT or fails to respond to additional requests for information within one year of receiving the SRT, FSIS will not be able to determine that the country maintains an inspection system equivalent to FSIS’s system and will discontinue its analysis. FSIS will accept information submitted in any one of the three official languages of the World Trade Organization (WTO)—English, French, or Spanish. Please note that it may take E:\FR\FM\23FEN1.SGM 23FEN1 9430 Federal Register / Vol. 80, No. 35 / Monday, February 23, 2015 / Notices Rmajette on DSK2VPTVN1PROD with NOTICES the Agency a longer period of time to review documents submitted in French or Spanish because the information will have to be translated. Summary of Comments Comment: Several commenters were pleased to see improvements in the document review process; however, they asked FSIS to provide more guidance on how the SRT will be used. They also asked the Agency to share the content of the SRT with the public. A few commenters asked FSIS to clarify whether the document review process is limited to the information collected in the SRT, or if it also includes information from other sources. The commenters asked FSIS to explain how data outside the SRT would be used in the document review process, how the Agency would validate the quality of data, and how often FSIS would collect and use the data. One commenter stated that both the National Advisory Committee on Meat and Poultry Inspection’s (NACMPI’s) recommendations and the Codex document cited in the Federal Register notice (78 FR 5409) support third-party audits as a means of informing importing countries about the knowledge, experience, and confidence of an exporting country’s food regulatory system. Response: The SRT is used to inform a determination that a country has or has not met the United States’ level of protection and is eligible to export product into the United States. It is reviewed on an ongoing basis to verify whether the country maintains equivalence. FSIS requires countries to update the SRT at least annually and as changes are made in the foreign country’s food regulatory system. FSIS personnel may review outside information, such as third-party audit reports, in preparation for an on-site audit (see FSIS Notice 35–14, Ongoing Foreign Equivalence Verification Audits). The outside information could affect the scope of an on-site audit. Comment: Two commenters were concerned about the amount of time it takes to complete the SRT. One commenter asked FSIS to reduce the number of questions in the SRT. Another commenter requested that FSIS limit the level of detail required for responses. The commenter stated that the SRT focuses too much on individual components of the foreign inspection system, rather than taking a more holistic approach to assessing whether defined food safety outcomes are met. The commenter recommended that FSIS focus more on an evaluation of whether food safety and suitability outcomes VerDate Sep<11>2014 14:19 Feb 20, 2015 Jkt 235001 have been achieved rather than whether various activities and processes have been replicated. The commenter suggested that FSIS change the design of the SRT so that it is more like the ‘‘outcome-focused’’ design of the United States Food and Drug Administration’s (FDA’s) International Comparability Tool. Response: FSIS reduced the number of questions in the SRT to focus on those most necessary to determine or to verify whether a country’s food regulatory system is equivalent and those necessary to help inform the necessary on-site audit frequency. In the past, the SRT included approximately 500 questions. The new, streamlined version has approximately 200 questions. Foreign countries may receive fewer questions depending on the number of classes of products produced. In addition, the Web-based version of the SRT is more accessible. Foreign countries will be able to log onto PHIS at any time to view and update their responses and supporting documentation. Countries will also be able to view the status of their individual SRT, as well as a date and time stamp for each status update. FDA’s International Comparability Tool does not provide the information that FSIS needs to verify that a foreign country’s food regulatory system is equivalent to FSIS’s system. The SRT focuses on individual components of a foreign food regulatory system and compares them to components within FSIS’s regulations because the Acts and regulations (9 CFR 372.2, 381.196, and 590.910) require that foreign countries maintain equivalent requirements to those that apply to United States domestic meat, poultry, and egg products. Comment: A few commenters stated that FSIS’s review of information in the SRT should not be a substitute for onsite audits by FSIS because countries may not always report information fully or accurately. The commenters argued that FSIS will be forced to rely more heavily on self-reported data from countries, as well as POE reinspections, and that these data sources are not an adequate substitute for in-person inspection. Response: The SRT is not a substitute for on-site audits. The SRT is one of three components to FSIS’s equivalence process. As mentioned above and in the January 2013 Federal Register notice, the SRT provides FSIS with initial information that is verified through periodic on-site audits and POE reinspections (78 FR 5411). FSIS will get more accurate information through PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 the SRT that will better inform FSIS’s audit scheduling. In addition, information from the SRT may be used to inform reinspection assignments. For example, based on information from the SRT, FSIS may perform targeted testing for residues or pathogens in product from certain countries. It should also be noted that every country now eligible to export meat, poultry, or egg products to the United States has a food inspection system that FSIS has determined to be equivalent to the FSIS domestic inspection system. FSIS is committed to protecting the health of U.S. consumers, and it will continue to make every effort to ensure that meat, poultry, and egg products imported into the United States are as safe as products produced in this country. 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 Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS Web page located at: http:// www.fsis.usda.gov/federal-register. FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS E:\FR\FM\23FEN1.SGM 23FEN1 Federal Register / Vol. 80, No. 35 / Monday, February 23, 2015 / Notices policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is available on the FSIS Web page. Through the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email 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, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts. Done in Washington, DC on: February 18, 2015. Alfred V. Almanza, Acting Administrator. [FR Doc. 2015–03576 Filed 2–20–15; 8:45 am] BILLING CODE 3410–DM–P DEPARTMENT OF AGRICULTURE Forest Service Tahoe National Forest; California; Tahoe National Forest Over-Snow Vehicle (OSV) Use Designation Environmental Impact Statement Forest Service, USDA. Notice of intent to prepare an environmental impact statement. AGENCY: ACTION: The Forest Service, U.S. Department of Agriculture will prepare an Environmental Impact Statement (EIS) on a proposal to designate oversnow vehicle (OSV) use on National Forest System (NFS) roads, NFS trails, and areas on NFS lands within the Tahoe National Forest; and to identify snow trails for grooming within the Tahoe National Forest. In addition, the Forest Service is proposing to establish snow depths for OSV use and snow grooming. DATES: Comments concerning the scope of the analysis must be received by March 25, 2015. The draft environmental impact statement is expected in January 2016, and the final environmental impact statement is expected in August 2016. ADDRESSES: Send written comments to Michael Woodbridge, on behalf of Tom Quinn, Forest Supervisor, Tahoe National Forest, 631 Coyote Street, Nevada City, CA 95959. Comments may also be sent via facsimile to 530–478– 6109 or submitted on the Tahoe Rmajette on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:19 Feb 20, 2015 Jkt 235001 National Forest OSV Designation Web page: http://www.fs.fed.us/nepa/nepa_ project_exp.php?project=45914. FOR FURTHER INFORMATION CONTACT: Michael Woodbridge, Public Affairs Officer, USDA Forest Service, Tahoe National Forest, 631 Coyote Street, Nevada City, CA 95959; phone 530– 478–6205; email mjwoodbridge@ fs.fed.us. Hours for personal communication at the Supervisor’s Office are between 8:00 a.m. and 4:30 p.m. Pacific Time, Monday through Friday. Individuals with a hearing or speech disability may dial 711 for Telecommunication Relay Services. SUPPLEMENTARY INFORMATION: Snow Trail Grooming Program: For over 30 years, the Forest Service, Pacific Southwest Region, in cooperation with the California Department of Parks and Recreation Off-Highway Motor Vehicle Recreation (OHMVR) Division has enhanced winter recreation, and more specifically snowmobiling recreation, by maintaining NFS trails (snow trails) by grooming snow for snowmobile use. Most groomed snow trails are co-located on underlying NFS roads. Some grooming occurs on county roads and closed snow-covered highways. Most grooming activities are currently funded by the state off-highway vehicle trust fund. The Forest Service manages OSV use on the Tahoe National Forest consistent with management direction contained in the Tahoe National Forest Land and Resource Management Plan (Forest Plan). The following summarizes current management of OSV use on approximately 829,510 acres of NFS lands in the Tahoe National Forest: 1. Approximately 236 miles of designated NFS OSV trails; 2. Of the approximately 236 miles of designated NFS OSV trails, approximately 188 miles are OSV trails available for grooming; 3. Approximately 105 miles of NFS trail (Pacific Crest Trail) is closed to OSV use; 4. Approximately 48,756 acres of NFS land is restricted to designated routes only; 5. Approximately 1,408 acres of NFS land is closed to OSV use from September 15 through December 31. 6. Approximately 669,537 acres of NFS land is open to off-trail crosscountry OSV use; and 7. Approximately 109,808 acres of NFS land is closed to OSV use. The final amended Subpart C of the Travel Management Rule was issued on January 28, 2015 (80 FR 4500, Jan. 28, 2015), and becomes effective on PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 9431 February 27, 2015. The final rule states: ‘‘Over-snow vehicle use on NFS roads, on NFS trails, and in areas on NFS lands shall be designated by the Responsible Official on administrative units or Ranger Districts, or parts of administrative units or Ranger Districts, of the NFS where snowfall is adequate for that use to occur, and, if appropriate, shall be designated by class of vehicle and time of year . . .’’ (36 CFR 212.81 (a)). Further, under 36 CFR 261.14, it is prohibited to possess or operate an OSV on NFS lands in that administrative unit or Ranger District other than in accordance with those designations. OSV designations made as a result of the analysis in this Environmental Impact Statement would conform to the final Subpart C of the Travel Management Rule. Purpose and Need for Action One purpose of this project is to effectively manage OSV use on the Tahoe National Forest to provide access, ensure that OSV use occurs when there is adequate snow, promote the safety of all users, enhance public enjoyment, minimize impacts to natural and cultural resources, and minimize conflicts among the various uses. There is a need to provide a manageable, designated OSV system of trails and areas within the Tahoe National Forest that is consistent with and achieves the purposes of the Forest Service Travel Management Rule at 36 CFR part 212. This action responds to direction provided by the Forest Service’s Travel Management Rule at 36 CFR part 212 and Subpart C of the Travel Management Rule. The existing system of OSV trails and areas open for OSV use on the Tahoe National Forest results from implementation of Forest Plan management direction for OSV use. Public OSV use of the majority of this existing system continues to be manageable and consistent with current travel management regulations. Exceptions have been identified, based on internal and informal public input and the criteria listed at 36 CFR 212.55. These include needs to protect natural resources, provide improved access for OSV users, provide improved quiet winter recreation opportunities and ensure consistency with overall management area direction contained in the Forest Plan. These exceptions represent additional needs for change, and in these cases, changes are proposed to meet the overall objectives. The snow trail grooming analysis would also address the need to provide a high quality snowmobile trail system on the Tahoe National Forest that is E:\FR\FM\23FEN1.SGM 23FEN1

Agencies

[Federal Register Volume 80, Number 35 (Monday, February 23, 2015)]
[Notices]
[Pages 9428-9431]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03576]


========================================================================
Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

========================================================================


Federal Register / Vol. 80, No. 35 / Monday, February 23, 2015 / 
Notices

[[Page 9428]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2014-0039]


Document Reviews of Foreign Food Regulatory Systems: New Web-
based Self-Reporting Tool

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Response to comments; notice of availability.

-----------------------------------------------------------------------

SUMMARY: FSIS is making available to the public its new Web-based Self-
Reporting Tool (SRT) that it will be sending to foreign countries to 
report information on their food regulatory systems for the purpose of 
establishing that the systems are, or continue to be, equivalent to 
that of the United States' system. The Agency will send a letter to 
foreign countries with instructions on how to access and use the Web-
based SRT. FSIS is also responding to the comments on its document 
review process for determining and verifying equivalence that the 
Agency received in response to the Federal Register notice that it 
published on January 25, 2013, on the use of the SRT. FSIS evaluates 
the information provided in the SRT and uses it, along with the results 
of on-site systems audits and port-of-entry (POE) reinspections, to 
make a determination on equivalence.

DATES: On February 17, 2015, FSIS will make available to the public the 
new Web-based SRT. To ensure that a complete and up-to-date SRT is 
being considered as part of FSIS's annual assessment of country 
performance, countries that are currently eligible to export meat, 
poultry, and egg products to the United States must submit their 
completed SRTs to FSIS before May 18 of 2015 and annually before May 18 
thereafter. FSIS will send SRTs to all countries currently eligible to 
export meat, poultry, and egg products to the United States on December 
1 of each year in the future.
    Countries applying for initial equivalence determinations after 
February 23, 2015 must submit their completed SRTs within one year of 
receiving the SRT.

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

SUPPLEMENTARY INFORMATION: 

Background

    In a notice published in the Federal Register of January 25, 2013 
(78 FR 5409) (hereafter ``the Federal Register notice''), FSIS 
described how it conducts ongoing equivalence verifications of the food 
regulatory systems of countries that export meat, poultry, or processed 
egg products to the United States. FSIS uses a three-part approach that 
includes (1) document reviews, (2) on-site system audits, and (3) POE 
reinspections. FSIS determines the scope and frequency of on-site 
systems audits based on its analysis of the results of its document 
reviews and ongoing assessment of a country's performance. This 
performance-based approach allows FSIS to direct its audit resources to 
foreign food regulatory systems that appear to pose a greater risk to 
public health than other foreign systems.
    FSIS invited interested persons to submit comments on its new 
methodology by March 26, 2013. FSIS received approximately 31 comments 
from foreign countries, trade consulting groups, consumer groups, 
private citizens, a trade association representing the meat industry, 
and a member of the U.S. Congress. Twelve of those comments concerned 
the Agency's document review process. In this notice, FSIS is 
responding only to the comments that it received on its document review 
process. A summary of comments on the Agency's document review process 
and the Agency's responses are below. The Agency will address the other 
comments in a future Federal Register document.
    On the basis of information provided by commenters, FSIS's 
experience in conducting document reviews, and the Agency's analysis of 
available SRT data, FSIS has decided to make two changes to its 
document review process. The changes are explained below and are 
discussed in more detail in the Agency's responses to comments.

Improvements to the Document Review Process

    A foreign country interested in exporting to the United States is 
required to submit information concerning its food regulatory system to 
FSIS (see 9 CFR 327.2(a)(2)(iii), 381.196(a)(2)(iii), and 590.910). As 
explained in the January 2013 Federal Register notice, FSIS uses the 
equivalence questionnaire, called the SRT, to collect this information 
for the Agency's document review of the food regulatory system of 
foreign countries that are listed in the regulations as eligible to 
export meat, poultry, or egg products to the United States and for 
countries interested in becoming eligible (78 FR 5411). The SRT is a 
repository for key documents about a foreign food safety inspection 
system (e.g., inspection system laws, regulations, and policy 
issuances) that FSIS uses, in addition to on-site audits, to verify 
whether the laws, regulations, and implementing policies of a foreign 
country establish an inspection system that is equivalent to the U.S. 
system. It also allows FSIS to evaluate whether a country maintains 
system effectiveness and to assess any impacts that an administrative 
or legislative change has had on a foreign food regulatory system. FSIS 
conducts a document review at least annually.
    The information in the SRT allows FSIS to conduct a comprehensive 
assessment of a foreign country's food safety regulatory system. These 
comprehensive assessments inform the Agency's determination of whether 
a country's system should be found equivalent and the country eligible 
to export product into the United States. FSIS also assesses 
information in the SRT on an ongoing basis to verify whether a country 
maintains equivalence.
    In the past, the SRT was available in a Microsoft Word format, and 
once completed by the country, it was submitted to FSIS along with 
corresponding supporting documentation either by mail or email 
communication. A PDF copy of the Microsoft Word version of the SRT is 
available on FSIS's Web site at: http://www.fsis.usda.gov/wps/wcm/
connect/

[[Page 9429]]

7893547e-d0d2-4fa9-a984-fdc17228bfcd/SRT.pdf?MOD=AJPERES. On February 
17, 2015, FSIS will launch a Web-based version of the SRT within its 
Public Health Information System (PHIS) to more efficiently capture up-
to-date information about foreign food regulatory systems. PHIS is a 
comprehensive Web-based data-analytics and inspection system that 
automates and replaces many of FSIS's paper-based processes.
    The Web-based SRT will be beneficial for countries exporting meat, 
poultry, and egg products to the United States; countries interested in 
exporting product to the United States and applying for equivalence; 
and FSIS personnel. With the Web-based SRT, countries can link 
supporting documentation to each question. With the Microsoft Word 
version, the supporting documentation is provided as a supplement to 
the SRT. As a result, during the review process, FSIS must sift through 
documents to match up information with the corresponding questions in 
the SRT. FSIS anticipates that use of the Web-based SRT will decrease 
the time it takes the Agency to review an SRT submission and thereby 
allow for a quicker response to an equivalence request.
    Using PHIS as a platform for the SRT allows for a more secure 
exchange of information between FSIS and foreign countries because 
countries will be accessing the SRT through a secure USDA Web site that 
requires a unique ID and password acquired through an authentication 
process. To guarantee that the security of the Web-based SRT in PHIS is 
maintained and to gain access to the system, each potential user will 
have to register for a USDA eAuthentication (eAuth) Level 2 account and 
complete the authentication process. FSIS will send a letter to foreign 
countries with instructions on obtaining an eAuth account and using the 
Web-based version of the SRT. FSIS strongly encourages countries to use 
the Web-based SRT. However, the use of the Web-based SRT is voluntary, 
and FSIS will continue to accept the current Microsoft Word version of 
the SRT. To ensure that the transition to the Web-based SRT is as 
seamless as possible, FSIS pre-entered into PHIS the SRT responses and 
supporting documentation that countries actively exporting meat, 
poultry, or egg products to the United States have provided to FSIS. 
FSIS requests that countries review the pre-entered responses for 
completeness and accuracy.
    In addition to a Web-based version of the SRT, foreign countries 
will note that the revised SRT asks fewer and more targeted questions 
necessary for FSIS to verify system equivalence. FSIS expects countries 
to answer all the targeted questions in the SRT to facilitate the 
review process. FSIS may not be able to make an equivalence 
determination without answers to all of these questions.
    The SRT also includes questions for FSIS to use in assessing how 
frequently to conduct on-site audits of the country. FSIS refers to 
these questions as level of advancement (LOA) questions. As explained 
in the Federal Register notice, the sum of the LOA responses is one of 
the factors that FSIS considers as part of an annual analysis of 
country performance to determine the frequency and scope of on-site 
audits (78 FR 5412). FSIS uses the results from the analysis to place 
exporting countries into one of three categories, based on food safety 
performance, with corresponding audit frequencies: Well-performing 
countries are to be audited every three years.
    Average-performing countries are to be audited every two years. 
Adequately-performing countries are to be audited every year. Thus, the 
completeness of a country's SRT contributes to FSIS's assessment of 
that country's performance and to FSIS's determination of the 
appropriate audit frequency for that country. Countries with incomplete 
SRTs will not be considered ``well-performing'' because they will not 
have provided the Agency enough information to give the Agency 
confidence in their food safety systems. FSIS will provide more 
information on LOAs in a subsequent Federal Register notice that 
addresses all comments received in the January 2013 Federal Register 
notice and provides additional updates on the FSIS equivalence 
determination process.
    To ensure that a complete and up-to-date SRT is being considered as 
part of FSIS's annual assessment of country performance, countries must 
submit their completed SRTs to FSIS before May 18, 2015, and on an 
annual basis moving forward. If a country submits partial or inaccurate 
information, FSIS personnel will follow up with additional questions 
until all outstanding issues are resolved. FSIS must have complete and 
accurate information to verify that the foreign country's food 
regulatory system is robust, transparent, and science-based. If a 
country does not provide FSIS with documentation showing its system is 
equivalent, or if it continues to submit inadequate documentation, FSIS 
will not have sufficient information to determine the viability of the 
food safety system and may have to pursue a series of actions directed 
at product presented for reinspection (e.g., intensified testing for 
microbial adulterants, indicator organisms, chemical residues, or 
species) to address the absence of a government-supplied explanation of 
inspection system controls. In addition, FSIS likely would begin 
refusing to list establishments newly certified by the foreign 
government, or to relist certified establishments, because of a lack of 
confidence in the government-supplied explanation of its inspection 
system. FSIS may conduct specially designed in-country audits to obtain 
information. FSIS may, within a reasonable period of time, refuse entry 
to products exported from that country. Finally, if it becomes 
necessary, FSIS will take steps to remove the country from the list of 
countries eligible to export meat, poultry, or processed egg products.
    Any country can apply for eligibility to export meat, poultry, or 
egg products to the United States. The application process begins with 
a letter to FSIS from a foreign country asking for consideration to 
export its products for sale in the United States. FSIS responds to 
these letters with a standard package that contains information on the 
SRT and information on gaining eAuthentication. More information on how 
to apply for initial equivalence is available on FSIS's Web site at: 
http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/equivalence/equivalence-process-apply-for-initial-equivalence.
    FSIS asks that a foreign country applying for initial equivalence 
submit a complete SRT to FSIS in PHIS within one year of receiving the 
questionnaire. If FSIS needs additional information, or if FSIS's 
regulations change, the Agency will request that the country update its 
SRT to provide additional information to demonstrate that the country 
has an equivalent food regulatory system to the United States' system. 
If FSIS's document review supports that the foreign country's food 
regulatory system may be equivalent to the United States' system, the 
Agency will conduct an on-site audit.
    However, if a foreign government applying for initial equivalence 
does not submit a complete SRT or fails to respond to additional 
requests for information within one year of receiving the SRT, FSIS 
will not be able to determine that the country maintains an inspection 
system equivalent to FSIS's system and will discontinue its analysis.
    FSIS will accept information submitted in any one of the three 
official languages of the World Trade Organization (WTO)--English, 
French, or Spanish. Please note that it may take

[[Page 9430]]

the Agency a longer period of time to review documents submitted in 
French or Spanish because the information will have to be translated.

Summary of Comments

    Comment: Several commenters were pleased to see improvements in the 
document review process; however, they asked FSIS to provide more 
guidance on how the SRT will be used. They also asked the Agency to 
share the content of the SRT with the public. A few commenters asked 
FSIS to clarify whether the document review process is limited to the 
information collected in the SRT, or if it also includes information 
from other sources. The commenters asked FSIS to explain how data 
outside the SRT would be used in the document review process, how the 
Agency would validate the quality of data, and how often FSIS would 
collect and use the data. One commenter stated that both the National 
Advisory Committee on Meat and Poultry Inspection's (NACMPI's) 
recommendations and the Codex document cited in the Federal Register 
notice (78 FR 5409) support third-party audits as a means of informing 
importing countries about the knowledge, experience, and confidence of 
an exporting country's food regulatory system.
    Response: The SRT is used to inform a determination that a country 
has or has not met the United States' level of protection and is 
eligible to export product into the United States. It is reviewed on an 
ongoing basis to verify whether the country maintains equivalence. FSIS 
requires countries to update the SRT at least annually and as changes 
are made in the foreign country's food regulatory system.
    FSIS personnel may review outside information, such as third-party 
audit reports, in preparation for an on-site audit (see FSIS Notice 35-
14, Ongoing Foreign Equivalence Verification Audits). The outside 
information could affect the scope of an on-site audit.
    Comment: Two commenters were concerned about the amount of time it 
takes to complete the SRT. One commenter asked FSIS to reduce the 
number of questions in the SRT. Another commenter requested that FSIS 
limit the level of detail required for responses. The commenter stated 
that the SRT focuses too much on individual components of the foreign 
inspection system, rather than taking a more holistic approach to 
assessing whether defined food safety outcomes are met. The commenter 
recommended that FSIS focus more on an evaluation of whether food 
safety and suitability outcomes have been achieved rather than whether 
various activities and processes have been replicated. The commenter 
suggested that FSIS change the design of the SRT so that it is more 
like the ``outcome-focused'' design of the United States Food and Drug 
Administration's (FDA's) International Comparability Tool.
    Response: FSIS reduced the number of questions in the SRT to focus 
on those most necessary to determine or to verify whether a country's 
food regulatory system is equivalent and those necessary to help inform 
the necessary on-site audit frequency. In the past, the SRT included 
approximately 500 questions. The new, streamlined version has 
approximately 200 questions. Foreign countries may receive fewer 
questions depending on the number of classes of products produced.
    In addition, the Web-based version of the SRT is more accessible. 
Foreign countries will be able to log onto PHIS at any time to view and 
update their responses and supporting documentation. Countries will 
also be able to view the status of their individual SRT, as well as a 
date and time stamp for each status update.
    FDA's International Comparability Tool does not provide the 
information that FSIS needs to verify that a foreign country's food 
regulatory system is equivalent to FSIS's system. The SRT focuses on 
individual components of a foreign food regulatory system and compares 
them to components within FSIS's regulations because the Acts and 
regulations (9 CFR 372.2, 381.196, and 590.910) require that foreign 
countries maintain equivalent requirements to those that apply to 
United States domestic meat, poultry, and egg products.
    Comment: A few commenters stated that FSIS's review of information 
in the SRT should not be a substitute for on-site audits by FSIS 
because countries may not always report information fully or 
accurately. The commenters argued that FSIS will be forced to rely more 
heavily on self-reported data from countries, as well as POE 
reinspections, and that these data sources are not an adequate 
substitute for in-person inspection.
    Response: The SRT is not a substitute for on-site audits. The SRT 
is one of three components to FSIS's equivalence process. As mentioned 
above and in the January 2013 Federal Register notice, the SRT provides 
FSIS with initial information that is verified through periodic on-site 
audits and POE reinspections (78 FR 5411). FSIS will get more accurate 
information through the SRT that will better inform FSIS's audit 
scheduling. In addition, information from the SRT may be used to inform 
reinspection assignments. For example, based on information from the 
SRT, FSIS may perform targeted testing for residues or pathogens in 
product from certain countries.
    It should also be noted that every country now eligible to export 
meat, poultry, or egg products to the United States has a food 
inspection system that FSIS has determined to be equivalent to the FSIS 
domestic inspection system. FSIS is committed to protecting the health 
of U.S. consumers, and it will continue to make every effort to ensure 
that meat, poultry, and egg products imported into the United States 
are as safe as products produced in this country.

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

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS

[[Page 9431]]

policies, procedures, regulations, Federal Register notices, FSIS 
public meetings, and other types of information that could affect or 
would be of interest to our constituents and stakeholders. The Update 
is available on the FSIS Web page. Through the Web page, FSIS is able 
to provide information to a much broader, more diverse audience. In 
addition, FSIS offers an email 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, 
regulations, directives, and notices. Customers can add or delete 
subscriptions themselves, and have the option to password protect their 
accounts.

    Done in Washington, DC on: February 18, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-03576 Filed 2-20-15; 8:45 am]
BILLING CODE 3410-DM-P