E9-19737. Possession, Use, and Transfer of Select Agents and Toxins-Chapare virus

AGENCY:

Department of Health and Human Services (HHS).

ACTION:

Notice of proposed rulemaking.

SUMMARY:

We are proposing to add Chapare virus to the list of HHS select agents and toxins. We are proposing this action because Chapare virus has been phylogenetically identified as a Clade B arenavirus and is closely related to other currently regulated South American arenaviruses that cause haemorrhagic fever, particularly Sabia virus.

DATES:

Written comments must be received on or before October 19, 2009.

ADDRESSES:

Comments on the proposed change to the list of HHS select agents and toxins should be marked “Comments on Chapare virus” and mailed to: Centers for Disease Control and Prevention, Select Agent Program, 1600 Clifton Road, NE., Mailstop A-46, Atlanta, Georgia 30333. Comments may be e-mailed to: [e-mail].

FOR FURTHER INFORMATION CONTACT:

Robbin Weyant, Director, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Mailstop A-46, Atlanta, GA 30333. Telephone: [phone].

SUPPLEMENTARY INFORMATION:

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Act) authorizes the Secretary to regulate the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. These regulations are set forth at 42 CFR part 73.

Criteria used to determine whether a select agent or toxin should be included under the provisions of these regulations are based on:

• The effect on human health as a result of exposure to the agent or toxin,
• The degree of contagiousness of the agent or toxin,
• The methods by which the agent or toxin is transferred to humans,
• The availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin, and
• Any other criteria, including the needs of children and other vulnerable populations that the HHS Secretary considers appropriate.

Based on these criteria, we are proposing to amend the list of HHS select agents and toxins by adding Chapare virus to the list.

After consulting with subject matter experts from CDC, the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), USDA/CVB (Center for Veterinary Biologics), and the Department of Defense (DOD)/United States Army Medical Research Institute for Infectious Diseases (USAMRIID) and review of relevant published studies, (including Delgado S, Erickson BR, Agudo R, Blair PJ, Vallejo E, et al. Chapare Virus, a newly Discovered Arenavirus Isolated from a Fatal Hemorrhagic Fever Case in Bolivia. PLoS Pathog 4(4): e1000047, April 2008. Available at http://www.plospathogens.org), we believe the Chapare virus should be added to the list of HHS select agents and toxins.

The select agents and toxins that were first listed in part 73 included “South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito).” South American arenaviruses are rodent-borne viruses, some of which can be associated with large haemorrhagic fever outbreaks, and untreated case fatalities can be in excess of 30 percent. CDC prepared the list of select agents and toxins for a notice of intent to issue regulations after receiving extensive input from a group of scientists from 21 Federal government entities. Some public comments on the notice objected to the inclusion of certain other viruses. For example, one commenter indicated that monkeypox virus is not easily transmissible to humans and has not been demonstrated to result in high levels of mortality. CDC included monkeypox on the final rule list, however, in part because it has similarities with smallpox virus in that monkeypox has a similar clinical presentation. No commenters objected to the listing of South American haemorrhagic fever viruses.

In December 2003 and January 2004, a small number of South American haemorrhagic fever cases were reported in rural Bolivia. Specimens were available from one fatal case, which had a clinical course that included fever, headache, arthralgia, myalgia, and vomiting with subsequent deterioration and multiple haemorrhagic signs. Isolated virus from two patient serum samples were tested for genetic similarity with other Clade B arenaviruses known to cause haemorrhagic fever. The complete genome analysis showed that the virus identified was a distinct new virus, subsequently named Chapare. Chapare virus was found to be most closely related to Sabia virus (causative agent for Brazilian haemorrhagic fever).

We will consider comments that are received within 60 days of publication of this notice in the Federal Register. 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 that will be made to the rule as a result of the comments.

If the proposed change is made, we would also consider whether the effective date for the regulation of the possession, use, and transfer of this agent should be phased in over a period of time greater than a 30-day effective date. We recognize that entities that currently possess an agent that would become regulated as a result of this proposed amendment to the regulations may need time to come into full compliance with the requirements of the regulations. In order to accommodate these entities, we are proposing that the Responsible Official at all unregistered entities must submit registration paperwork to include the new agent(s) and any new laboratory areas, as required in 42 CFR part 73 by 30 days after the effective date and all previously unregistered entities must be in full compliance with the regulations by 180 days after the effective date to minimize the disruption of research.

Regulatory Analyses

Paperwork Reduction Act

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

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been determined to be significant for the purposes of Executive Order 12866 and has been reviewed by the Office of Management and Budget.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires an agency to review regulations to assess their impact on small entities unless the agency determines that a rule is not expected to have a significant impact on a substantial number of small entities.

Entities most likely to be affected by this rule are laboratories and other institutions conducting research and related activities that involve the use of an agent that would become regulated as a result of this proposed amendment. Even though we believe the impact of these changes is expected to be minimal, we will consider comments on the impact of this proposed rule to determine if there will be a significant impact on small businesses.

Unfunded Mandates

The Unfunded Mandates Reform Act at 2 U.S.C. 1532 requires that agencies prepare an assessment of anticipated costs and benefits before developing any rule that may result in expenditure by State, local, or tribal governments, in the aggregate, or by the private sector of $100 million or more (adjusted for inflation) in any given year. This proposed rule is not expected to result in any one-year expenditure that would exceed this amount.

Executive Order 12988

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

Executive Order 13132

This Notice of Proposed Rulemaking has been reviewed under Executive Order 13132, Federalism. The notice does not propose any regulation that would preempt State, local, and Indian tribe requirements, or that would have any substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

List of Subjects in 42 CFR Part 73

• Biologics
• Incorporation by reference
• Packaging and containers
• Penalties
• Reporting and recordkeeping requirements
• Transportation

Dated: August 5, 2009.

Kathleen Sebelius,

Secretary.

For the reasons stated in the preamble, we are proposing to amend 42 CFR part 73 as follows:

PART 73—SELECT AGENTS AND TOXINS

1. The authority citation for part 73 continues to read as follows:

Authority: 42 U.S.C. 262a; sections 201-204, 221 and 231 of Title II of Public Law 107-188, 116 Stat. 637 (42 U.S.C. 262a). 2. Amend § 73.3 by revising the entry for “South American Haemorrhagic Fever viruses” in paragraph (b) and the reference to it in paragraph (f)(3)(i) to read as follows:

§ 73.3

HHS select agents and toxins.

* * * * *

(b) * * *

South American Haemorrhagic Fever viruses (Chapare, Junin, Machupo, Sabia, Flexal, Guanarito)

* * * * *

(f) * * *

(3) * * *

(i) * * * South American Haemorrhagic Fever viruses (Chapare, Junin, Machupo, Sabia, Flexal, Guanarito) * * *.

* * * * *

§ 73.5

[Amended]

3. Amend paragraph (a)(3)(i) of § 73.5 by removing the phrase “South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)” and adding in its place “South American Haemorrhagic Fever viruses (Chapare, Junin, Machupo, Sabia, Flexal, Guanarito)”.

§ 73.9

[Amended]

4. Amend paragraph (c)(1) of § 73.9 by removing the phrase “South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)” and adding in its place “South American Haemorrhagic Fever viruses (Chapare, Junin, Machupo, Sabia, Flexal, Guanarito)”.