Safeguarding Animal Health 1 Proposed BSE Comprehensive Rule: A New Approach to BSE Rulemaking Dr. Christopher Robinson Assistant Director, NCIE BSE Comprehensive Rule Project Manager

Safeguarding Animal Health 2 Overview 1.Why do we need the BSE comprehensive rule? 2.What are our current BSE regulations and rulemaking process? 3.What will the proposed rule do? 4.What are the differences?

Safeguarding Animal Health 3 Goals of Proposed Rule Adopt science-based, internationally recognized BSE standards Streamline process for recognizing BSE status of regions Maintain consistent message to stakeholders

Safeguarding Animal Health 4 Current BSE Regulations Prohibit importation of live ruminants and certain ruminant products from regions that have BSE or present an undue risk for BSE. Are less restrictive for commodities from minimal- risk regions (currently only Canada). Recognize Japan as the only country with BSE, not a minimal-risk region, and allowed to import certain cuts of beef.

Safeguarding Animal Health 5 Current BSE Rulemaking Process Country requests APHIS evaluation for recognition as a BSE minimal risk region APHIS conducts a risk assessment Notice and comment rulemaking (both proposed and final) is required to add a country as a minimal risk region in the CFR Lengthy process

Safeguarding Animal Health 6 Framing the Proposed Rule – Risk Classification Adopt OIE’s BSE categories (negligible, controlled, or undetermined risk) Describe and adopt OIE criteria for classification (supported by risk document) Recognize OIE evaluations after public comments Evaluate countries without OIE classification Require evaluation to determine date of effective enforcement of feed ban for imports of live bovines

Safeguarding Animal Health 7 Framing the Proposed Rule – Import Requirements Align BSE import requirements with OIE guidelines List commodities eligible for unrestricted trade Base other import requirements on BSE risk status Incorporate regulations related to minimal risk regions and boneless beef from Japan

Safeguarding Animal Health 8 Framing the Proposed Rule – Implementation Eliminate need for rulemaking specific to country/region or commodity For OIE-classified countries: Informational Notice, request for comments (e.g., Canada, New Zealand, Australia) For live bovine imports: Notice of Availability, feed ban enforcement information, request for comments (e.g., Mexico) For APHIS-evaluated countries: Notice of Availability, supporting documents, request for comments

Safeguarding Animal Health 9 Framing the Proposed Rule – Timing Effective date of final rule will be 60 days (or more) after publication Concurrent with publication of final rule, publish Notice recognizing OIE-classified countries, request public comments To minimize trade disruptions with Mexico, concurrent with publication of final rule APHIS could publish Notice, evaluation of effective enforcement date for feed ban, and request comments for 30 days

Safeguarding Animal Health 10 Differences: Categories Current RegulationsComprehensive Rule 9 CFR 94 lists countries as:  having BSE; or  having an undue risk for BSE; or  having a minimal risk for BSE. Will use OIE categories:  negligible risk  controlled risk  undetermined risk

Safeguarding Animal Health 11 Differences: Recognition Process Current RegulationsComprehensive Rule Restricted countries must request APHIS evaluation for recognition as a BSE minimal risk region. APHIS performs a risk assessment of the country’s BSE status. All other countries are unrestricted for BSE. APHIS will recognize the OIE BSE classifications. For countries not already classified, APHIS will conduct independent evaluations using OIE criteria, upon request. All other countries will be undetermined risk.

Safeguarding Animal Health 12 Differences: Rulemaking Current RegulationsComprehensive Rule Rulemaking is required each time a country is added to the CFR for recognition as minimal risk. APHIS would need to conduct new rulemaking to establish additional classifications or commodities. APHIS will add countries to an online list through publication of Federal Register Notices.

Safeguarding Animal Health 13 Differences: Traded Commodities Current RegulationsComprehensive Rule Prohibit live ruminants and certain products from countries with BSE or at an undue risk. Allow live ruminants and ruminant products from minimal risk countries, with certain restrictions. Allow fresh cuts of boneless beef from Japan. Allow live bovines and certain bovine products, based on BSE risk status. – Certain commodities will be eligible for importation from countries of any risk status, even undetermined risk – Risk mitigations will vary, based on risk status

Safeguarding Animal Health 14 Differences: Other OIE-recognized diseases BSEFMD  Provisions in OIE Code match APHIS risk evaluation process  Not highly contagious - Food-borne  Effective U.S. mitigations: Feed ban, removal of SRMs  APHIS conducts rigorous site evaluation; OIE does not  Highly contagious - Aerosol transmission - Mechanical transmission - Food-borne  Few effective U.S. mitigations, if disease enters country

Safeguarding Animal Health 15 Supporting the Rule Risk document Economic analysis Environmental assessment Interagency discussions

Safeguarding Animal Health 16 Risk Document Not a traditional risk assessment Evaluates OIE’s process for assigning classifications and supporting science Criteria for recognizing a region’s BSE status Commodities that can be safely traded based on BSE category of the exporting region Peer-reviewed scientific evidence Risk assessments will be conducted as part of OIE process or APHIS evaluation.

Safeguarding Animal Health 17 OIE Classification Criteria Risk assessment Compulsory notification and investigation, with BSE awareness program BSE history and epidemiological situation in the region BSE surveillance and monitoring system, including appropriate laboratory diagnostic procedures These information requirements match those APHIS requires for risk assessments

Safeguarding Animal Health 18 OIE Recognition Process Countries submit documentation and supporting evidence Team of international subject matter experts evaluates submission and recommends classification to Commission If Commission accepts recommendation, circulates proposal to Member Countries Member Countries have 60 days to register objections based on scientific or technical grounds Adoption of resolution by International Committee at General Session is necessary for official recognition Negligible and controlled risk countries must provide updated information annually to retain status

Safeguarding Animal Health 19 Economic Analysis Will assess benefits and costs derived from potential impact on U.S. trade in live bovines and bovine products Will analyze impacts on trade with Mexico, Canada, Australia, New Zealand, Uruguay, among others Will not address impacts from risk of exposure and establishment of BSE in the United States

Safeguarding Animal Health 20 Environmental Assessment Proposed rule will be compared with “No Action” alternative Potential environmental impacts that will be addressed: Public health Physical environment Cumulative impacts

Safeguarding Animal Health 21 Interagency Discussions Ongoing discussions with FDA, FSIS, and CDC about content of the rule, particularly areas or commodities that might fall under their jurisdiction

Safeguarding Animal Health 22 Conclusion This approach: Adopts internationally recognized standards Aligns regulations and trade policy with most current science Demonstrates support for OIE Streamlines process to recognize BSE status Allows more effective use of VS resources Consistent with promises to stakeholders