[Federal Register: November 3, 2003 (Volume 68, Number 212)]
[Rules and Regulations]               
[Page 62218-62221]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no03-4]                         

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

9 CFR Part 121

[Docket No. 02-088-3]
RIN 0579-AB47

 
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.

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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 regulations@aphis.usda.gov. 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 (202) 690-2817 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, (301) 734-8758.
    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, (301) 734-3277.

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

[[Page 62219]]

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.
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    \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.
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    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

[[Page 62220]]

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.

0
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

0
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).


0
2. Section 331.0 is revised as follows:


Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  331.11.
    (5) By September 12, 2003, the responsible official must implement 
the security section of the Biocontainment and Security Plan, as 
required in Sec.  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 Sec.  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 Sec.  331.3.
9 CFR Chapter 1

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

0
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).


0
2. Section 121.0 is revised as follows:


Sec.  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 Sec.  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

[[Page 62221]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  121.11.
    (4) By June 12, 2003, the responsible official must submit the 
security section of the Biosafety and Security Plan required in Sec.  
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 
Sec.  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 Sec.  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 Sec.  121.3.

    Done in Washington, DC, this 29th day of October, 2003.
Bobby R. Acord,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-27640 Filed 10-31-03; 8:45 am]

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