Safeguarding Animal Health 1 Proposed BSE Comprehensive Rule: A New Approach to BSE Rulemaking Dr....

Safeguarding Animal Health1

Proposed BSE Comprehensive Rule: A New Approach to BSE

Rulemaking

Dr. Christopher Robinson

Assistant Director, NCIE

BSE Comprehensive Rule Project Manager


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?


Goals of Proposed Rule

• Adopt science-based, internationally recognized BSE standards

• Streamline process for recognizing BSE status of regions

• Maintain consistent message to stakeholders


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.


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


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


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


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


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


Differences: Categories

Current Regulations Comprehensive 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


Differences: Recognition Process


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.


Differences: Rulemaking


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.


Differences: Traded Commodities


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


Differences: Other OIE-recognized diseases

BSE FMD 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


Supporting the Rule

• Risk document• Economic analysis• Environmental assessment• Interagency discussions


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.


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


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


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


Environmental Assessment

• Proposed rule will be compared with “No Action” alternative

• Potential environmental impacts that will be addressed:• Public health• Physical environment• Cumulative impacts


Interagency Discussions

Ongoing discussions with FDA, FSIS, and CDC about content of the rule, particularly areas or commodities that might fall under their jurisdiction


ConclusionThis 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

Safeguarding Animal Health 1 Proposed BSE Comprehensive Rule: A New Approach to BSE Rulemaking Dr....

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