Rules of Practice for Certain Adjudicatory Proceedings; Possession, Use, and Transfer of Select Agents and Toxins, 32787-32788 [E9-16195]

Agencies

• Office of the Secretary
• DEPARTMENT OF AGRICULTURE

[Federal Register Volume 74, Number 130 (Thursday, July 9, 2009)]
[Rules and Regulations]
[Pages 32787-32788]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16195]



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Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Rules 
and Regulations

[[Page 32787]]



DEPARTMENT OF AGRICULTURE

Office of the Secretary

7 CFR Part 1

[Docket No. APHIS-2009-0039]


Rules of Practice for Certain Adjudicatory Proceedings; 
Possession, Use, and Transfer of Select Agents and Toxins

AGENCY: Office of the Secretary, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the administrative regulations of the Office 
of the Secretary of Agriculture to provide that the rules of practice 
contained in those regulations shall be applicable to adjudicatory 
proceedings under the Animal and Plant Health Inspection Service's 
regulations pertaining to the possession, use, and transfer of select 
agents and toxins. This final rule is necessary to clarify the rules of 
practice that will apply to the adjudication of a violation of 
regulations pertaining to the regulation of select agents and toxins.

DATES: Effective Date: July 9, 2009.

FOR FURTHER INFORMATION CONTACT: Mr. Steve O'Neill, Chief, Regulatory 
Analysis and Development, PPD, APHIS, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238; (301) 734-8682.

SUPPLEMENTARY INFORMATION: 

Background

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002, Title II, ``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), 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.
    In accordance with those statutory provisions, on August 12, 2002, 
APHIS published in the Federal Register (67 FR 52383-52389) an interim 
rule that established the initial lists of biological agents and toxins 
and set out the manner in which persons in possession of listed agents 
and toxins were to provide notice of such possession.
    Section 212 of the Act also required the Secretary of Agriculture 
to provide by regulation for the establishment and enforcement of 
standards and procedures governing the possession, use, and transfer of 
listed biological agents and toxins in order to protect animal and 
plant health, and animal and plant products. Specifically, sections 
212(b) and (c) required that the Secretary:
     Establish and enforce safety procedures for listed agents 
and toxins, including measures to ensure proper training and 
appropriate skills to handle agents and toxins, and proper laboratory 
facilities to contain and dispose of agents and toxins;
     Establish and enforce safeguard and security measures to 
prevent access to listed agents and toxins for use in domestic or 
international terrorism or for any other criminal purpose;
     Establish procedures to protect animal and plant health, 
and animal and plant products, in the event of a transfer or potential 
transfer of a listed agent or toxin in violation of the safety 
procedures and safeguard and security measures established by the 
Secretary; and
     Ensure appropriate availability of biological agents and 
toxins for research, education, and other legitimate purposes.
    In an interim rule published in the Federal Register on December 
13, 2002 (67 FR 76908-76938) and effective on February 11, 2003, APHIS 
established regulations in 7 CFR part 331 and 9 CFR part 121 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, to animal health, to plant health, or to 
animal or plant products. APHIS adopted its December 2002 interim rule 
as a final rule in a document published in the Federal Register on 
March 18, 2005 (70 FR 13242-13292).
    Section 212(i) of the Act provides that persons who violate the 
regulations are subject to civil penalties not to exceed $250,000 in 
the case of an individual and $500,000 in the case of any other person. 
APHIS is amending the administrative regulations of the Office of the 
Secretary in 7 CFR 1.31 to provide that the uniform rules of practice 
for the Department of Agriculture promulgated in 7 CFR part 1, subpart 
H, are applicable to adjudicatory, administrative proceedings to assess 
civil penalties for violations of APHIS' regulations governing the 
possession, use, and transfer of select agents and toxins.
    This final rule also amends the regulations in 7 CFR 1.131 by 
removing references to statutory provisions that were repealed by the 
Animal Health Protection Act (7 U.S.C. 8301 et seq.). Specifically, in 
paragraph (a) of that section we are removing the following references:
     Act of May 29, 1884, commonly known as the Animal Industry 
Act, section 7, as amended (21 U.S.C. 117),
     Act of August 30, 1890, section 6, as amended (21 U.S.C. 
104),
     Act of February 2, 1903, commonly known as the Cattle 
Contagious Diseases Act of 1903, section 3, as amended (21 U.S.C. 122),
     Act of March 3, 1905, section 6, as amended (21 U.S.C. 
127),
     Act of July 2, 1962, section 6(a), as amended (21 U.S.C. 
134e), and
     Act of May 6, 1970, section 2, as amended (21 U.S.C. 
135a).
    Along those same lines, in paragraph (b) of Sec.  1.131, we are 
replacing a reference to ``the Animal Quarantine and Related Laws (21 
U.S.C. 111 et seq.)'' with a reference to the Animal Health Protection 
Act.
    This rule relates to internal agency management. Therefore, this 
rule is exempt from the provisions of Executive Orders 12866 and 12988. 
Moreover,

[[Page 32788]]

pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity 
for comment are not required for this rule, and it may be made 
effective less than 30 days after publication in the Federal Register. 
In addition, under 5 U.S.C. 804, this rule is not subject to 
congressional review under the Small Business Regulatory Enforcement 
Fairness Act of 1996, Public Law 104-121. Finally, this action is not a 
rule as defined by 5 U.S.C. 601 et seq., the Regulatory Flexibility 
Act, and thus is exempt from the provisions of that Act.

Paperwork Reduction Act

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

List of Subjects in 7 CFR Part 1

    Administrative practice and procedure, Agriculture, Antitrust, 
Claims, Cooperatives, Courts, Equal access to justice, Fraud, Freedom 
of information, Government employees, Lawyers, Motion pictures, 
Penalties, Privacy.

0
Accordingly, we are amending 7 CFR part 1 as follows:

PART 1--ADMINISTRATIVE REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority:  5 U.S.C. 301, unless otherwise noted.

Subpart H--Rules of Practice Governing Formal Adjudicatory 
Proceedings Instituted by the Secretary Under Various Statutes


Sec.  1.131  [Amended]

0
2. Section 1.131 is amended as follows:
0
a. In paragraph (a), by removing the entries for ``Act of May 29, 1884, 
commonly known as the Animal Industry Act, section 7, as amended (21 
U.S.C. 117).'', ``Act of August 30, 1890, section 6, as amended (21 
U.S.C. 104).'', ``Act of February 2, 1903, commonly known as the Cattle 
Contagious Diseases Act of 1903, section 3, as amended (21 U.S.C. 
122).'', ``Act of March 3, 1905, section 6, as amended (21 U.S.C. 
127).'', ``Act of July 2, 1962, section 6(a), as amended (21 U.S.C. 
134e).'', and ``Act of May 6, 1970, section 2, as amended (21 U.S.C. 
135a).''.
0
b. In paragraph (a), by adding, in alphabetical order, an entry for 
``Agricultural Bioterrorism Protection Act of 2002, section 212(i) (7 
U.S.C. 8401(i)).''.
0
c. In paragraph (b)(2), by removing the words ``Animal Quarantine and 
Related Laws (21 U.S.C. 111 et seq.)'' and adding the words ``Animal 
Health Protection Act (7 U.S.C. 8301 et seq.)'' in their place.

    Dated: June 29, 2009.
Thomas J. Vilsack,
Secretary of Agriculture.
[FR Doc. E9-16195 Filed 7-8-09; 8:45 am]
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