03-27640. Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Interim rule and request for comments.

SUMMARY:

We are amending the regulations governing the possession, use, and transfer of listed biological agents and toxins in order to allow for the issuance of provisional registration certificates for individuals and entities and provisional grants of access to listed biological agents and toxins for individuals. These provisional measures are designed to provide additional time for the Attorney General to complete security risk assessments for those individuals and entities for which the Attorney General has received, by November 12, 2003, all of the information required to conduct a security risk assessment. This action is necessary to ensure that research and educational programs are not disrupted.

DATES:

This interim rule is effective on November 3, 2003. We will consider all comments that we receive on or before January 2, 2004.

ADDRESSES:

You may submit comments by postal mail/commercial delivery or by e-mail. If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 02-088-3, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 02-088-3. If you use e-mail, address your comment to [e-mail]. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 02-088-3” on the subject line.

You may read any comments that we receive on this docket in our reading room. The reading room 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 [phone] before coming.

APHIS documents published in the Federal Register, and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at http://www.aphis.usda.gov/​ppd/​rad/​webrepor.html.

FOR FURTHER INFORMATION CONTACT:

For information concerning the regulations in 7 CFR part 331, contact Dr. Robert Flanders, Chief, Pest Permit Evaluations Branch, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236, [phone].

For information concerning the regulations in 9 CFR part 121, contact Dr. Denise Spencer, Senior Staff Veterinarian, Technical Trade Services, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737-1231, [phone].

SUPPLEMENTARY INFORMATION:

Background

On June 12, 2002, the President signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188). Title II of Pub. L. 107-188, “Enhancing Controls on Dangerous Biological Agents and Toxins” (sections 201 through 231), provides for the regulation of certain biological agents and toxins by the Department of Health and Human Services (subtitle A, sections 201-204) and the Department of Agriculture (subtitle B, sections 211-213, cited as the “Agricultural Bioterrorism Protection Act of 2002”), and provides for interagency coordination between the two departments regarding overlap agents and toxins (subtitle C, section 221). For the Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC) has been designated as the agency with primary responsibility for implementing the provisions of the Act; the Animal and Plant Health Inspection Service (APHIS) is the agency fulfilling that role for the Department of Agriculture. The Criminal Justice Information Services (CJIS) Division of the Federal Bureau of Investigation has been designated as the agency with primary responsibility for implementing the Attorney General's responsibilities under the Act (i.e., the security risk assessments).

In accordance with the requirements of the Act, on December 13, 2002, we published in the Federal Register (67 FR 76908-76938, Docket No. 02-088-1) an interim rule that established the standards and procedures governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal health (referred to as overlap agents and toxins), to animal health, to plant health, or to animal and plant products (7 CFR part 331 for the plant-related provisions and 9 CFR part 121 for the overlap and animal-related provisions; referred to below collectively as the regulations). Also on December 13, 2002, the CDC published in the Federal Register (67 FR 76886-76905) an interim rule that established the standards and procedures governing the possession, use, and transfer of other select agents (42 CFR part 73).

The regulations require that individuals or entities possessing, using, or transferring biological agents or toxins listed in 7 CFR 331.3 or 9 CFR 121.3(d) must register with APHIS, while individuals or entities possessing, using, or transferring overlap agents or toxins must register with either APHIS or CDC. As part of the registration process, the responsible official(s), the alternate responsible official(s), the entity, and, where applicable, the individual(s) who owns or controls the entity must undergo a security risk assessment by the CJIS Division. Moreover, those individuals identified by an entity as having a legitimate need to handle or use listed biological agents or toxins must undergo a security risk assessment by the CJIS Division.

To minimize the disruption of research or educational projects involving biological agents or toxins that were underway as of the effective date of the regulations, we established a phase-in period that gave individuals and entities until November 12, 2003 to reach full compliance with the regulations. In recognition of the potential delays in registering entities under these regulations during the first year of implementation and the potential for subsequent delays in research, we also afforded additional time to reach full compliance with the regulations to individuals and entities who did not possess biological agents or toxins as of the effective date of the interim rule (February 11, 2003). Specifically, we required that such individuals and entities must be in compliance with the provisions of the regulations that are applicable for current possessors at the time of application, as provided in 7 CFR 331.0 or 9 CFR 121.0.

To date, the CJIS Division has received a large number of incomplete applications. ^[1] We anticipate that many of these applications will be completed and submitted to the CJIS Division just before the November 12, 2003 deadline. Because of the expected volume of last-minute submissions, the CJIS Division will need additional time to complete the necessary security risk assessments.

We are aware that many individuals and entities submitted all required information in a timely manner to ensure that it was received by the CJIS Division by November 12, 2003. In recognition of this good faith effort to comply with the regulations, and so as not to disrupt research and educational programs involving listed biological agents and toxins, we are amending the regulations to allow for the issuance of provisional registration certificates for individuals and entities and provisional grants of access to biological agents and toxins for individuals pending the completion of their security risk assessments.

To accomplish this, we are amending 7 CFR 331.0 and 9 CFR 121.0 to provide that APHIS may issue a provisional registration certificate to current possessors if, as of November 12, 2003: (1) The Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of the entity, including any individual who owns or controls the entity; and (2) the entity otherwise meets all of the requirements of the regulations. In addition, we are amending both parts to provide that APHIS may issue a provisional registration certificate to individuals and entities that did not possess listed biological agents or toxins as of February 11, 2003, if, as of November 12, 2003: (1) The Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of the entity, including any individual who owns or controls the entity; (2) the entity otherwise meets all of the requirements of the regulations; and (3) the Administrator finds that circumstances warrant such action in the interest of the health of plants or plant products or national security (for the plant-related provisions in 7 CFR part 331) or the health of animals or animal products or national security (for the overlap and animal-related provisions in 9 CFR part 121). In either case, a provisional registration certificate will be effective until APHIS either issues a certificate of registration or suspends or revokes the provisional registration.

We are also amending both parts to provide that APHIS may issue a provisional grant of access for individuals identified by an entity as having a legitimate need to handle or use listed biological agents or toxins if, as of November 12, 2003, the Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of that individual. Such a provisional grant of access will be effective until APHIS grants or denies access to listed biological agents and toxins.

Since we expect the CJIS Division to receive a large volume of mail just before the November 12, 2003, deadline, the CJIS Division will likely need additional time to process its mail, and this may result in delays in the issuance of some provisional registration certificates and provisional grants of access.

For overlap agents and toxins, the regulations provide that an entity may submit all of the information and documentation required in the registration package to either APHIS or CDC. We note that the agency (either APHIS or CDC) that has the responsibility for processing an application for registration will be responsible for issuing a provisional registration certificate or provisional grant of access, as appropriate. If an entity has any questions about which agency is processing its registration application, the responsible official may contact the person listed under FOR FURTHER INFORMATION CONTACT.

Immediate Action

Immediate action is necessary in order to prevent the disruption of research and educational projects. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this action effective less than 30 days after publication in the Federal Register.

We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the Federal Register. The document will include a discussion of any comments we receive and any amendments we are making to the rule.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

This emergency situation makes timely compliance with section 604 of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) impracticable. We are currently assessing the potential economic effects of this action on small entities. Based on that assessment, we will either certify that the rule will not have a significant economic impact on a substantial number of small entities or publish a final regulatory flexibility analysis.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

Paperwork Reduction Act

This interim rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects

7 CFR Part 331

• Agricultural research
• Laboratories
• Plant diseases and pests
• Reporting and recordkeeping requirements

9 CFR Part 121

• Agricultural research
• Animal diseases
• Laboratories
• Medical research
• Reporting and recordkeeping requirements

Accordingly, we are amending 7 CFR part 331 and 9 CFR part 121 as follows:

7 CFR Chapter III

PART 331—POSSESSION, USE, AND TRANSFER OF BIOLOGICAL AGENTS AND TOXINS

1. The authority citation for part 331 continues to read as follows:

Authority: Secs. 211-213, Title II, Pub. L. 107-188, 116 Stat. 647 (7 U.S.C. 8401).

2. Section 331.0 is revised as follows:

§ 331.0

Effective and applicability dates.

(a) The regulations in this part are effective on February 11, 2003. On and after that date, any person possessing, using, or transferring any agent or toxin listed in § 331.3 must be in compliance with the provisions of this part. However, so as not to disrupt research or educational projects involving listed agents or toxins that were underway as of the effective date of this part, any person possessing such agents or toxins as of the effective date (current possessors) will be afforded additional time to reach full compliance with this part. Any provision not specifically cited in paragraphs (a)(1) through (a)(6) of this section will be applicable as of February 11, 2003. In addition, any individual or entity who does not possess listed agents or toxins by the effective date of this part, but who wishes to initiate a research or educational project prior to November 12, 2003, must be in compliance with the provisions of this part that are applicable for current possessors at the time of application, as provided in paragraphs (a)(1) through (a)(5) of this section.

(1) During the period from February 11, 2003, to November 12, 2003, biological agents or toxins listed in § 331.3 may only be transferred to an individual or entity that is not registered under this part if the individual or entity has been issued a permit by the Administrator under part 330 of this chapter to import or move interstate that specific agent or toxin. If an individual or entity has not been issued a permit under part 330 of this chapter, the individual or entity may apply for a permit. To receive an agent or toxin, an individual or entity will also be required to submit APHIS Form 2041, in accordance with § 331.13(c). Because USDA permits do not cover intrastate movement, an individual or entity may not receive a listed agent or toxin that is being moved intrastate until that individual or entity is registered in accordance with this part.

(2) By March 12, 2003, the responsible official must submit the registration application package as required in § 331.8. In addition, the responsible official must submit to the Attorney General the names and identifying information for the responsible official; alternate responsible official, where applicable; entity; and, where applicable, the individual who owns or controls the entity.

(3) By April 11, 2003, the responsible official must submit to the Attorney General the names and identifying information for all individuals whom the responsible official has identified as having a legitimate need to handle or use listed agents or toxins, and who have the appropriate training and skills to handle such agents or toxins, as required in § 331.10.

(4) By June 12, 2003, the responsible official must submit to APHIS the security section of the Biocontainment and Security Plan required in § 331.11.

(5) By September 12, 2003, the responsible official must implement the security section of the Biocontainment and Security Plan, as required in § 331.11, and provide security training in accordance with 7 CFR 331.12.

(6) By November 12, 2003, the registration application process must be complete and the entity in full compliance with the regulations in this part, except as otherwise provided in paragraphs (b) and (c) of this section.

(b) Provisional registration. (1) Notwithstanding the provisions in paragraph (a) of this section, APHIS may issue a provisional registration certificate to current possessors if, as of November 12, 2003:

(i) The Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of the entity, including any individual who owns or controls the entity; and

(ii) The entity otherwise meets all of the requirements of this part.

(2) Notwithstanding the provisions in paragraph (a) of this section, APHIS may issue a provisional registration certificate to individuals and entities that did not possess listed biological agents or toxins as of February 11, 2003, if, as of November 12, 2003:

(i) The Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of the entity, including any individual who owns or controls the entity;

(ii) The entity otherwise meets all of the requirements of this part; and

(iii) The Administrator finds that circumstances warrant such action in the interest of the health of plants or plant products or national security.

(3) A provisional registration certificate will be effective until APHIS either issues a certificate of registration or suspends or revokes the provisional registration.

(c) Notwithstanding the provisions in paragraph (a) of this section, APHIS may issue a provisional grant of access for individuals identified by an entity as having a legitimate need to handle or use agents or toxins listed in § 331.3 if, as of November 12, 2003, the Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of that individual. A provisional grant of access will be effective until APHIS grants or denies access to biological agents or toxins listed in § 331.3.

9 CFR Chapter 1

PART 121—POSSESSION, USE, AND TRANSFER OF BIOLOGICAL AGENTS AND TOXINS

1. The authority citation for part 121 continues to read as follows:

Authority: Secs. 211-213, Title II, Pub. L. 107-188, 116 Stat. 647 (7 U.S.C. 8401).

2. Section 121.0 is revised as follows:

§ 121.0

Effective and applicability dates.

(a) The regulations in this part are effective on February 11, 2003. On and after that date, any person possessing, using, or transferring any agent or toxin listed in § 121.3 must be in compliance with the provisions of this part. However, so as not to disrupt research or educational projects involving listed agents or toxins that were underway as of the effective date of this part, any person possessing such agents or toxins as of the effective date (current possessors) will be afforded additional time to reach full compliance with this part. Any provision not specifically cited in paragraphs (a)(1) through (a)(6) of this section will be applicable as of February 11, 2003. In addition, any person who does not possess listed agents or toxins by the effective date of this part, but who wishes to initiate a research or educational project prior to November 12, 2003, must be in compliance with the provisions of this part that are applicable for current possessors at the time of application, as provided in paragraphs (a)(1) through (a)(5) of this section.

(1) During the period from February 11, 2003, to November 12, 2003, biological agents or toxins listed in § 121.3 may only be transferred to an individual or entity that is not registered under this part if:

(i) The individual or entity is registered by CDC for that specific overlap agent or toxin in accordance with 42 CFR part 72; or

(ii) The individual or entity has been issued a permit by the Administrator under part 122 of this subchapter to import or move interstate that specific agent or toxin. If an individual or entity has not been issued a permit under part 122 of this subchapter, the individual or entity may apply for a permit. To receive an agent or toxin, an individual or entity will also be required to submit APHIS Form 2041, in accordance with § 121.14(c). Because USDA permits do not cover intrastate movement, unless registered by CDC under 42 CFR part 72, an individual or entity may not receive a listed agent or toxin that is being moved intrastate until that individual or entity is registered in accordance with this part.

(2) By March 12, 2003, the responsible official must submit the registration application package as required in § 121.9. In addition, the responsible official must submit to the Attorney General the names and identifying information for the responsible official; alternate responsible official, where applicable; entity; and, where applicable, the individual who owns or controls the entity.

(3) By April 11, 2003, the responsible official must submit to the Attorney General the names and identifying information for all individuals whom the responsible official has identified as having a legitimate need to handle or use listed agents or toxins, and who have the appropriate training and skills to handle such agents or toxins, as required in § 121.11.

(4) By June 12, 2003, the responsible official must submit the security section of the Biosafety and Security Plan required in § 121.12 to APHIS or, for overlap agents or toxins, to APHIS or CDC.

(5) By September 12, 2003, the responsible official must implement the security section of the Biosafety and Security Plan, as required in § 121.12, and provide security training in accordance with 9 CFR 121.13.

(6) By November 12, 2003, the registration application process must be complete and the entity in full compliance with the regulations in this part, except as otherwise provided in paragraphs (b) and (c) of this section.

(b) Provisional registration. (1) Notwithstanding the provisions in paragraph (a) of this section, APHIS may issue a provisional registration certificate to current possessors if, as of November 12, 2003:

(i) The Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of the entity, including any individual who owns or controls the entity; and

(ii) The entity otherwise meets all of the requirements of this part.

(2) Notwithstanding the provisions in paragraph (a) of this section, APHIS may issue a provisional registration certificate to individuals and entities that did not possess listed biological agents or toxins as of February 11, 2003, if, as of November 12, 2003:

(i) The Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of the entity, including any individual who owns or controls the entity;

(ii) The entity otherwise meets all of the requirements of this part; and

(iii) The Administrator finds that circumstances warrant such action in the interest of the health of plants or plant products or national security.

(3) A provisional registration certificate will be effective until APHIS either issues a certificate of registration or suspends or revokes the provisional registration.

(c) Notwithstanding the provisions in paragraph (a) of this section, APHIS may issue a provisional grant of access for individuals identified by an entity as having a legitimate need to handle or use agents or toxins listed in § 121.3 if, as of November 12, 2003, the Attorney General has received all of the information, including fingerprint cards, required by the Attorney General to conduct a security risk assessment of that individual. A provisional grant of access will be effective until APHIS grants or denies access to biological agents or toxins listed in § 121.3.

Done in Washington, DC, this 29th day of October, 2003.

Bobby R. Acord,

Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  To avoid delays related to incomplete applications, individuals and entities should submit their FD-961 forms and fingerprint cards to the CJIS Division in one package. However, this does not apply to applicants who are submitting follow-up information or fingerprint cards for an existing incomplete application.