Source: https://www.federalregister.gov/documents/2011/12/28/2011-33206/information-from-foreign-regions-applying-for-recognition-of-animal-health-status
Timestamp: 2018-08-18 15:02:25
Document Index: 467914627

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A Proposed Rule by the Animal and Plant Health Inspection Service on 12/28/2011
We will consider all comments that we receive on or before February 27, 2012.
76 FR 81404
81404-81408 (5 pages)
Regions Historically Free of a Disease
Initiation of an Evaluation
Information Received With Requests
https://www.federalregister.gov/d/2011-33206 https://www.federalregister.gov/d/2011-33206
Federal eRulemaking Portal: Go to http://www.regulations.gov/​#!documentDetail;​D=​APHIS-2007-0158-0001.
Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2007-0158, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.
Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2007-0158 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.
Dr. Kelly Rhodes, Regionalization Evaluation Services, Sanitary Trade Issues Team, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.
Section 92.2 of the regulations requires that such requests be accompanied by information regarding the region that will enable the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture to evaluate the request. Currently, the provisions in paragraph (b) of § 92.2 state that each request must include the following information, which APHIS commonly refers to as “the 11 factors”:
The authority, organization, and infrastructure of the veterinary services organization in the region.
Disease status, i.e., is the restricted disease agent known to exist in the region? If “yes,” at what prevalence? If “no,” when was the most recent diagnosis?
The status of adjacent regions with respect to the agent.
The extent of an active disease control program, if any, if the agent is known to exist in the region.
The vaccination status of the region. When was the last vaccination? What is the extent of vaccination if it is currently used, and what vaccine is being used?
The degree to which the region is separated from adjacent regions of higher risk through physical or other barriers.
The extent to which movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity regarding such movements.
Livestock demographics and marketing practices in the region.
The type and extent of disease surveillance in the region, e.g., is it passive and/or active; what is the quantity and quality of sampling and testing?
Diagnostic laboratory capabilities.
Policies and infrastructure for animal disease control in the region, i.e., emergency response capacity.
Current paragraph (e) of § 92.2 provides that if, after evaluating the information submitted, APHIS believes the action being requested can be safely taken, the Agency will publish a proposed rule in the Federal Register proposing to take such action and will provide a period of time during which the public may comment on the proposal. Current paragraph (f) of § 92.2 provides that, during the comment period, the public will have access both to the information upon which APHIS based its analysis of risk and the analysis itself. Once APHIS reviews and considers all comments received, it makes a final decision regarding the request and publishes that decision in the Federal Register.
In order to conduct a valid evaluation of a region's animal health status and any risk that might be associated with the action requested, it is important that APHIS have complete and pertinent information regarding the region, its disease history, its animal health practices and capabilities, and any effect its import practices or relationship to adjacent regions might have on disease risk.
The 11 factors listed in § 92.2(b) specify the types of information APHIS needs to accomplish its evaluation. To assist foreign governments making a request under § 92.2, APHIS also makes available on its Web site detailed guidance as to the types of information required. This guidance is forth in a document titled “Clarification of Information Requested for Recognition of a Region,” which can be viewed at http://www.aphis.usda.gov/​import_​export/​downloads/​info_​request.pdf.
Each year, APHIS receives a number of requests to evaluate the animal health status of foreign regions. However, the evaluation process is often hindered because, even with the assistance of the Start Printed Page 81405guidance, the initial information sent to APHIS is incomplete and requires APHIS to contact the requesting government for additional information.
Based on our experience, we believe it is advisable to clarify further what information is necessary for APHIS to initiate an evaluation of risk. Therefore, we are proposing to revise the list of factors in § 92.2(b) and to make available more detailed guidance as to the specific types of information encompassed by each factor.
Our experience dealing with requests from foreign governments indicates that the list of 11 factors can be confusing because the information requested in some of the factors overlaps with information requested in other factors. For instance, one of the factors asks for information regarding the degree to which the region is separated from adjacent regions of higher risk through physical or other barriers. A separate factor asks for information regarding the extent to which movement of animals and animal products is controlled from regions of higher risk and the level of biosecurity regarding such movements.
To eliminate such overlap, we propose to consolidate the 11 factors into 8 factors, listed as follows:
The type of information required would not change substantively from what we currently require to conduct an evaluation. It would simply be described in what we believe is a more helpful way. More detailed guidance as to the specific types of information encompassed by each factor would be set forth in a guidance document available on the APHIS Web site or by contacting APHIS. Instructions for accessing or obtaining the guidance document would be set forth in § 92.2(b) of the regulations. The revised guidance document, “Clarification of Information Requested for Recognition of a Region,” is available for review and comment as part of this rulemaking and may be viewed on the Regulations.gov Web site or in our reading room. Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule. In addition, a copy may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT.
An overview of the information required for each of the factors, as explained in the guidance document, is as follows:
1. Scope of the evaluation being requested. This factor would require identification of the disease(s) for which an APHIS evaluation is requested; a detailed description of the region, including maps; identification of the animal commodities proposed for export to the United States; and an estimate of the projected annual volume of export for each commodity. Although this type of information is not specifically referenced in the current regulations and guidance document, it is standard practice for APHIS to require such information from a requesting region before beginning an evaluation.
2. Veterinary control and oversight. This factor would require sufficient information for APHIS to assess the infrastructure of the official veterinary services in the region and the ability of the veterinary services to oversee animal health activities, monitor for disease, and implement disease control measures.
3. Disease history and vaccination practices. This factor would require sufficient information to enable APHIS to understand the history of the disease(s) being evaluated in the region, including prior control measures, revisions to those measures as applicable, and the vaccination status and history in the region.
4. Livestock demographics and traceability. This factor would require sufficient information for APHIS to assess the geographic distribution of livestock and wildlife species that are susceptible to the disease(s) under evaluation, patterns of livestock movement within the region, and the ability of the official veterinary services of the region to trace livestock movements in the event of a disease outbreak.
5. Epidemiological separation from potential sources of infection. This factor would require sufficient information to enable APHIS to evaluate the ability of the region to prevent incursions of the disease(s) under evaluation. Relevant risk factors that we would evaluate include the presence of the disease(s) in adjacent regions or in regions with epidemiological links to the requesting region, natural and manmade barriers to disease introduction, trading practices, and inspection practices.
6. Surveillance. This factor would require sufficient information to enable APHIS to determine whether the surveillance system in the region is sufficient to ensure early detection of the disease(s) under evaluation. Countries would need to submit information regarding active and/or passive surveillance as applicable.[1] Documentation regarding collection and analysis of disease and infection data must be sufficient to provide confidence in the disease status of the region.
7. Diagnostic laboratory capabilities. This factor would require sufficient information to enable APHIS to determine whether the animal health laboratory system, diagnostic procedures, and quality assurance measures in the region are sufficient to effectively support surveillance for the disease(s) under evaluation.
8. Emergency preparedness and response. This factor would require information sufficient for APHIS to assess emergency preparedness measures and response capabilities in the region, as well as procedures in place to notify trading partners and other international entities of a disease outbreak.
In regions in which a significant period of time has elapsed since a particular disease or infection has occurred, if it has ever occurred, certain information required as part of the eight factors listed above would not be applicable or necessary. An example of this would be some of the information on surveillance, particularly active pathogen-specific surveillance. In the guidance document for the eight factors above, APHIS asks for detailed information regarding surveillance specific to the pathogen under consideration, including the following: Target populations, targeted prevalence for detection and estimated confidence level, sampling plan, types of samples collected, frequency of sampling, and the targeted and actual numbers of samples collected and the results of screening and confirmatory testing for the past 3 years.Start Printed Page 81406
However, if a particular disease or infection has not occurred in a region for many years, the benefit of active surveillance specifically targeting that pathogen would be minimal. In such a case, it would not be necessary for APHIS to receive detailed information from the region regarding active pathogen-specific surveillance. However, to be recognized as free of a disease, it would still be necessary for the region to demonstrate an effective early detection system for the disease(s) under evaluation, as described below.
The World Organization for Animal Health (OIE), of which the United States is a Member country, is the internationally recognized standard-setting body that develops science-based recommendations for the safe trade of animals and animal products. The World Trade Organization has recognized the OIE as the international forum for setting animal health standards, reporting global animal disease events, and presenting guidelines and recommendations on sanitary measures relating to animal health. The OIE recommends criteria for recognizing a country or zone free of a disease based on a significant period of time having elapsed since the disease was last reported, if it was ever reported.[2] Such an area is described by the OIE as being historically free of a disease.
In its Terrestrial Animal Health Code (Code), the OIE recommends that a region may be recognized as historically free of a disease if the disease has never occurred in the region or has not occurred for at least the past 25 years, provided the following conditions have been met for at least the past 10 years:
The disease has been a notifiable disease; [3]
An early detection system has been in place for all relevant species;
Measures to prevent disease/infection introduction have been in place and no vaccination against the disease has been carried out unless otherwise provided in the Code; and
There has been no evidence of infection in wildlife in the region.
Based on APHIS' experience evaluating the animal health status of foreign regions, we concur with the OIE's recommended criteria for being recognized as historically free of a disease, and we are proposing to add a new paragraph (c) in § 92.2 of the regulations that would list the factors we will consider in evaluating whether to recognize a region as historically free. Much of the information is the same as that required for the eight factors discussed above. However, consistent with OIE guidelines, APHIS' evaluations for historically free status will focus on verifying an effective early detection system for the disease(s) under consideration, disease reporting requirements, and measures in place to prevent introduction. Therefore, certain information encompassed by the eight factors would not be required.
In evaluating whether a region can be considered historically free of a disease, we would consider the following six factors:
Disease reporting;
As with the eight factors discussed earlier in this document, more detailed guidance as to the specific types of information encompassed by each factor for regions historically free of a disease would be set forth in a guidance document available on the APHIS Web site or by contacting APHIS. Instructions for accessing or obtaining the guidance document would be set forth in § 92.2(c) of the regulations. The guidance document, “Clarification of Information Requested for Recognition of a Historically Free Region,” is available for review and comment as part of this rulemaking and may be viewed on the Regulations.gov Web site or in our reading room.
Consistent with the OIE guidelines, proposed § 92.2(c) would indicate that, for a region to be considered historically free of a disease, the disease must not have occurred in domestic livestock for at least the past 25 years and must not have been reported in wildlife for at least the past 10 years. An overview of the information required for each of the factors, as explained in the guidance document, is as follows.
1. Scope of the evaluation being requested. The information we would require for this factor is the same as that described for the eight factors, above.
2. Veterinary control and oversight. This factor would require sufficient information to enable APHIS to determine whether the veterinary services in the region have had and continue to have sufficient legal authority, organization, and infrastructure to effectively investigate, diagnose, and report the disease(s) under evaluation, if detected.
3. Disease history and vaccination practices. For this factor, the requesting authority would need to indicate when each disease under evaluation was last reported, if ever, in domestic livestock and wildlife in the region. Additionally, if vaccination against the disease(s) has occurred within the past 10 years, the request must include information indicating the reasons for vaccination, the source and type of vaccines used, target populations, recordkeeping requirements, and procedures to distinguish vaccinated animals.
4. Disease reporting. This factor would require sufficient information to enable APHIS to determine whether each disease under evaluation has been legally notifiable in the region for at least the past 10 years.
5. Disease detection. This factor would require sufficient information for APHIS to determine whether an effective early detection system has been in place for at least the past 10 years for the disease(s) under evaluation. An effective early detection system would include, among other things, representative coverage of susceptible animal populations by field services, a training program for detecting and reporting unusual animal health incidents, the ability to undertake effective disease investigation and reporting, and access to laboratories capable of diagnosing and differentiating relevant diseases.
6. Barriers to disease introduction. This factor would require sufficient information for APHIS to determine whether measures have been in place for at least the past 10 years to prevent introduction of the disease(s) under evaluation.
Historically, the evaluations APHIS has conducted in accordance with part 92 have been at the request of a representative of a foreign jurisdiction. We expect that to continue to be the case the great majority of the time. However, there might be instances where APHIS initiates an evaluation on its own initiative. As with evaluations done at the request of a foreign region, we would consider the factors set forth in this proposed rule and, if our intent is to recognize the health status of the region, would give notice in the Federal Register of that intent, make the Start Printed Page 81407relevant information and data and our evaluation available to the public, and accept public comment regarding our intent. After reviewing and considering any comments received, we would give notice to the public of our final determination. In this proposed rule, we include a footnote to § 92.2(a) that references such situations.
Current § 92.2(d) states that the information sent to APHIS with requests submitted in accordance with part 92 will be made available to the public prior to initiation by APHIS of any rulemaking action on the request. Current § 92.2(f) provides that, in cases where APHIS does publish a proposed rule based on a request, the public will be provided a period of time to comment on the proposal and that, during the comment period, the public will have access to the information upon which APHIS based its analysis supporting the proposal, as well as its methodology in conducting the analysis.
We believe that the wording of current § 92.2(d) can be confusing. The intent of that paragraph is to give notice to the public that, at the time a proposal is published, information supporting the proposal will have been made available to the public. Such information is posted on the APHIS Web site. However, the wording of current § 92.2(d) does not indicate how early in the process such information will be made available to the public. It has been APHIS' practice to make such information available immediately before publication of a proposed rule. APHIS does not begin an evaluation until it has sufficient information to conduct a valid analysis of a request, and does not take the further action of publishing a proposed rule in the Federal Register unless it believes the results of the evaluation support the action being requested. We believe that, until a proposed rule is ready for publication, it can be confusing and misleading for the public to review what APHIS considers partial information or information with regard to which further action may not be taken. However, we believe it could be useful to the public to know which foreign regions have requested APHIS' recognition of their animal health status. Therefore, in this document, we are proposing to remove the statement in § 92.2(d) that supporting information will be made available to the public prior to initiation of rulemaking and to replace it with the statement that a list of regions that have requested recognition of their animal health status is available to the public. We will continue to make available to the public by the time APHIS publishes a proposal in the Federal Register any relevant information received from a requesting country.
As noted above, current paragraph (e) of § 92.2 provides that if, after evaluating the information submitted with a region's request for APHIS' recognition of its animal health status, APHIS believes the action being requested can be safely taken, the Agency will publish a proposed rule in the Federal Register proposing to take such action and will provide a period of time during which the public may comment on the proposal. However, recent rulemaking by APHIS has made it incorrect to say that a proposed rule will be used in all cases to give notice of APHIS' intent. On January 24, 2011, we published in the Federal Register an interim rule (76 FR 4046-4056, Docket No. APHIS-2006-0074) concerning highly pathogenic avian influenza (HPAI) as it applies to the importation of live birds and poultry and the products of birds and poultry. In that interim rule, we provide for a method of notifying the public of APHIS' intent regarding the HPAI status of a region that differs somewhat from the method currently provided for in § 92.2(e). Instead of publishing a proposed rule, as provided for in current § 92.2(e), the HPAI interim rule indicates that a region will be removed from the list of regions where HPAI is considered to exist only after APHIS makes its evaluation available for public comment through a notice published in the Federal Register. The interim rule provides that, following the close of the comment period, APHIS will publish another notice responding to comments and announcing APHIS' decision.
In order to account for such situations where a notice, rather than proposed rule, will be used to solicit comment regarding APHIS' evaluation of the animal health status of a foreign region, we are proposing to revise paragraph (e) of § 92.2 to provide that, if APHIS believes a request from a foreign region for APHIS' recognition of its animal health status can be safely granted, APHIS will indicate its intent and make its evaluation available for public comment through a document published in the Federal Register. Paragraph (f) of § 92.2 would indicate that, during the comment period, the public will have access to the information upon which APHIS based its evaluation, as well as the evaluation itself, and that, once APHIS has reviewed all comments received, it will make a final determination regarding the request and will publish that determination in the Federal Register.
Additionally, in this document, we are clarifying which requests are governed by § 92.2. The scope of § 92.2 is reflected in its heading, which reads “Application for recognition of the animal health status of a region.” Requests submitted to APHIS in accordance with part 92 are evaluated by the Regionalization Evaluation Services staff of APHIS' Veterinary Services. However, the wording in paragraphs (b), (c), and (e) of current § 92.2 indicates that the section also governs requests for approval to export a particular type of animal or animal product to the United States from a foreign region. Although the evaluations conducted by the Regionalization Evaluation Services staff can ultimately affect which commodities are allowed importation into the United States and under what conditions, requests to import specific types of animals or animal products are governed by parts in 9 CFR other than part 92. To clarify the scope of part 92, we are proposing to remove from that part the references to exportation of a particular type of animal or animal product to the United States from a foreign region.
Currently, § 92.2(c) indicates where requests for recognition of a region, and information supporting such a request, should be sent. That paragraph also requests that, where possible, a copy of the request and supporting information be submitted on a 3.5-inch floppy disk in ASCII or a word processing format. In this proposal, we include the address to which requests and supporting information should be sent in § 92.2(a) instead of § 92.2(c) and propose to remove the request for submission on a 3.5-inch floppy disk. Such disks are no longer commonly used. In proposed § 92.2(a), we request that, where possible, a copy of the request and accompanying information be included in electronic format.
We are also proposing several nonsubstantive wording changes to § 92.2 for the sake of clarity.
We have prepared an economic analysis for this action. The analysis identifies importers and producers of animals and animal products as the small entities most likely to be affected by this action and considers the Start Printed Page 81408reduction in time it would take under this proposal for APHIS to initiate and complete an evaluation of the animal disease status of a region. Based on the information presented in the analysis, we expect that decreasing the amount of time and APHIS resources required to initiate and complete such an evaluation would not have a significant economic effect on the entities affected. We invite comment on our economic analysis, which is posted with this proposed rule on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov) and may also be obtained from the person listed under FOR FURTHER INFORMATION CONTACT.
Animal diseases, Imports, Livestock, Poultry and poultry products, Region, Reporting and recordkeeping requirements.
(b) Requests for recognition of the animal health status of a region, other than requests submitted in accordance with paragraph (c) of this section, must include, in English, the following information about the region. More detailed information regarding the specific types of information that will enable APHIS to most expeditiously conduct an evaluation of the request is available at [address to be added in final rule] or by contacting the Director, Sanitary Trade Issues Team, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737.
(c) Requests for recognition that a region is historically free of a disease based on the amount of time that has elapsed since the disease last occurred in a region, if it has ever occurred, must include, in English, the following information about the region. More detailed information regarding the specific types of information that will enable APHIS to most expeditiously conduct an evaluation of the request is available at [address to be added in final rule] or by contacting the Director, Sanitary Trade Issues Team, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737. For a region to be considered historically free of a disease, the disease must not have been reported in domestic livestock for at least the past 25 years and must not have been reported in wildlife for at least the past 10 years.
(d) A list of those regions that have requested APHIS' recognition of their animal health status is available at [address to be added in final rule].
1. Active surveillance is defined in § 92.1 of the regulations as sample collection using a systematic or statistically designed survey methodology to actively seek out and find cases of animals with a restricted disease agent, or to determine the prevalence of the restricted disease agent in the population. Passive surveillance is defined as a surveillance system that does not depend on active participation by the responsible agency to seek out and monitor a restricted disease agent. The definition explains, further, that such a system relies on mandatory reporting, a pool of trained investigators, diagnostic submission procedures and laboratory support, and periodic public information and continuing education programs on diseases.
2. When discussing areas with regard to animal diseases, OIE's use of the terms “country” and “zone” is equivalent to APHIS' use of the term “region.” In § 92.1, a region is defined as any of the following: (1) A national entity (country); (2) part of a national entity (zone, county, department, municipality, parish, Province, State, etc.; (3) parts of several national entities combined into an area; or (4) a group of national entities combined into a single area.
3. The Code defines a notifiable disease as one listed by the Veterinary Authority in a region that, as soon as it is detected or suspected, must be brought to the attention of the Veterinary Authority in accordance with national regulations.
[FR Doc. 2011-33206 Filed 12-27-11; 8:45 am]