Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331 and 9 CFR Part 121

[Docket No. 02-088-4]

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:

Final rule.

SUMMARY:

We are adopting as a final rule, with changes, an interim rule that established regulations 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 public health and safety, to animal health, to plant health, or to animal or plant products. This action is necessary to protect animal and plant health, and animal and plant products.

DATES:

Effective Date:

The amendments to the list of PPQ select agents and toxins in 7 CFR 331.3(b) are effective March 10, 2005. The remaining provisions of this final rule are effective April 18, 2005.

FOR FURTHER INFORMATION CONTACT:

For information concerning the regulations in 7 CFR part 331, contact Dr. Charles L. Divan, Senior Agricultural Microbiologist, Pest Permit Evaluations, Biological and Technical Services, 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. Lee Ann Thomas, Director, Animals, Organisms and Vectors, and Select Agents, VS, APHIS, 4700 River Road Unit 2, Riverdale, MD 20737-1231, (301) 734-5960.

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), and provides for interagency coordination between the two departments regarding overlap agents and toxins (subtitle C, section 221). Subtitle D (section 231) provides for criminal penalties regarding certain biological agents and toxins. 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 (USDA). 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 subtitle B (which is cited as the “Agricultural Bioterrorism Protection Act of 2002” and referred to below as the Act ), section 212(a) provides, in part, that the Secretary of Agriculture (the Secretary) must establish by regulation a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act further requires (under section 213(b)) that all persons in possession of any listed biological agent or toxin must, within 60 days of the publication of that regulation, notify the Secretary of such possession.

In accordance with these statutory requirements, on August 12, 2002, we published in the

Federal Register

(67 FR 52383-52389, Docket No. 02-082-1) 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 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, Docket No. 02-088-1) and effective on February 11, 2003, we 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. These CFR parts are referred to below as the regulations. We solicited comments concerning the interim rule for 60 days ending February 11, 2003. We received 36 written comments. They were from academic institutions, professional associations, corporations, nonprofit organizations, individuals, and representatives of State and Federal Governments. These comments, as well as oral comments presented at a public meeting on December 16, 2002, are discussed by topic below.

Also on December 13, 2002, 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 certain biological agents and toxins (referred to by CDC as select agents and toxins) (42 CFR part 73).

On November 3, 2003, APHIS and CDC published in the

Federal Register

(68 FR 62218-62221, Docket No. 02-088-3; and 68 FR 62245-62247) interim rules that amended both agencies' regulations 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 provided additional time for the Attorney General to complete security risk assessments for those individuals and entities for which the Attorney General received, by November 12, 2003, all of the information required to conduct a security risk assessment. We solicited comments concerning the

interim rules for 60 days ending January 2, 2004. We did not receive any comments by that date.

APHIS and CDC collaborated closely on the December 13, 2002, and November 3, 2003, interim rules, as well as on this final rule and CDC's final rule also issued in today's

Federal Register

. Below is a summary of the changes we are making to the regulations in this final rule. We refer to the regulations in place prior to the effective date of this final rule as the “interim” regulations, or “interim” 7 CFR 331.4, for example, when we need to distinguish between the regulations established by the interim rules of December 2002 and November 2003 and this final rule.

Summary of Changes Made in Final Rule

1. We are revising the format of the regulations in 7 CFR part 331 and 9 CFR part 121 so that the sections numbers and, to the extent possible, the section titles and the information contained in each section is the same in 7 CFR part 331, 9 CFR part 121, and 42 CFR part 73.

2. We are changing the terms “biological agents and/or toxins,” “listed agents and/or toxins,” and “high consequence livestock pathogens” to “select agents and toxins” or “select agents or toxins” throughout 7 CFR part 331 and 9 CFR part 121. In addition, in 9 CFR part 121, we are removing the term “overlap agents” each time it appears and adding “overlap select agents and/or toxins” in its place.

3. We are changing the title of 7 CFR part 331 and 9 CFR part 121 from “Possession, Use, and Transfer of Biological Agents and Toxins” to “Possession, Use, and Transfer of Select Agents and Toxins.”

4. We are removing

Phakopsora pachyrhizi

and plum pox

potyvirus

from the list of PPQ select agents and toxins.

5. We are removing Newcastle disease virus (VVND) from the list of VS select agents and toxins and adding Newcastle disease virus (velogenic) in its place to make it clear that we are regulating all of the velogenic strains.

6. We are removing

Clostridium botulinum

from the list of overlap select agents and toxins but we are continuing to list Botulinum neurotoxin producing species of

Clostridium

.

7. We are adopting CDC's approach for genetic elements and, therefore, we will consider the following to be select agents and toxins:

• Nucleic acids that can produce infectious forms of any of the select agent viruses listed in either 7 CFR part 331 or 9 CFR part 121;

• Recombinant nucleic acids that encode for the functional forms of any toxin listed in either 7 CFR part 331 or 9 CFR part 121 if the nucleic acids: (1) Can be expressed

in vivo

or

in vitro

; or (2) are in a vector or recombinant host genome and can be expressed

in vivo

or

in vitro

; and

• Select agents and toxins listed in either 7 CFR part 331 or 9 CFR part 121 that have been genetically modified.

8. We are broadening the scope of the overlap toxin exclusion to cover overlap toxins under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor.

9. We are amending the exemption provisions by requiring, as another condition of exemption, that the select agent or toxin be secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin.

10. We are amending the exemption provisions in 9 CFR part 121 by requiring immediate reporting after identification of specified select agents and toxins; identification of the other select agents and toxins must be reported within 7 calendar days after identification.

11. We are amending the exemption provisions to allow the Administrator to make exceptions to the timeframes for transfer or destruction of a select agent or toxin, as necessary.

12. We are amending the registration sections to set out a new framework for submitting registration applications to APHIS or CDC.

13. We are amending the registration sections in 7 CFR part 331 and 9 CFR part 121 to provide:

• Federal, State, or local governmental agencies, including public institutions of higher education, are exempt from the security risk assessment for the entity and the individual who owns or controls such entity.

• For a private institution of higher education, an individual will be deemed to own or control the entity if the individual is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity.

• For entities other than institutions of higher education, an individual will be deemed to own or control the entity if the individual: (1) Owns 50 percent or more of the entity, or is a holder or owner of 50 percent or more of its voting stock; or (2) is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity.

• An entity will be considered to be an institution of higher education if it is an institution of higher education as defined in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)), or is an organization described in 501(c)(3) of the Internal Revenue Code of 1986, as amended (26 U.S.C. 501(c)(3)).

14. We are amending the registration sections to provide that a certificate of registration will be valid for one physical location (a room, a building, or a group of buildings) where the responsible official will be able to perform the responsibilities required in this part, for specific select agents or toxins, and for specific activities.

15. We are amending the registration sections to require that, prior to any change, the responsible official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application.

16. We are amending the registration sections to provide that an entity must immediately notify APHIS or CDC if it loses the services of its responsible official. An entity may continue to possess or use select agents or toxins only if it appoints as the responsible official another individual who has been approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General and who meets the requirements of the regulations.

17. We are amending the sections pertaining to denial, revocation, and suspension of registration by requiring that, upon notification of suspension or revocation, an individual or entity must:

• Immediately stop all use of each select agent or toxin covered by the revocation or suspension order;

• Immediately safeguard and secure each select agent or toxin covered by the revocation or suspension order from theft, loss, or release; and

• Comply with all disposition instructions issued by the Administrator for each select agent or toxin covered by the revocation or suspension.

18. We are amending the responsible official sections to require the responsible official to report the identification and final disposition of any select agent or toxin contained in a specimen presented for diagnosis or verification. We are also amending the responsible official section in 9 CFR 121.9 to require the responsible official to report the identification and final disposition of any select agent or toxin

contained in a specimen presented for proficiency testing.

19. We are amending the provisions relating to access approvals to state that an individual will be deemed to have access at any point in time if the individual has possession of a select agent or toxin (

e.g.

, carries, uses, or manipulates) or the ability to gain possession of a select agent or toxin.

20. We are amending the provisions pertaining to access approval to provide that an individual's access approval may be revoked if the individual is within any of the categories specified in the regulations.

21. We are amending the security sections to clarify that the security plan must be sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release.

22. We are adding the provisions for restricted experiments to 7 CFR part 331 and we are amending these provisions in 7 CFR part 331 and 9 CFR part 121 to indicate that these experiments must be conducted under any conditions prescribed by the Administrator.

23. We are amending the training sections to require that information and training on biocontainment/biosafety and security be provided to each individual with access approval from the Administrator or the HHS Secretary before he/she has access and to each individual not approved for access by the Administrator or the HHS Secretary before he/she works in or visits areas where select agents or toxins are handled or stored (

e.g.

, laboratories, growth chambers, animal rooms, greenhouses, storage areas, etc.).

24. We are amending the transfer section in 9 CFR 121.16 to set out the requirements for transfer of a select agent or toxin contained in a specimen for proficiency testing.

25. We are amending the transfer sections to provide that, on a case-by-case basis, the Administrator may authorize a transfer of a select agent or toxin not otherwise eligible for transfer under the regulations under conditions prescribed by the Administrator.

26. We are amending the transfer sections to provide that an authorization for a transfer shall be valid only for 30 calendar days after issuance, except that such an authorization becomes immediately null and void if any facts supporting the authorization changes (

e.g.

, change in the certificate of registration for the sender or recipient, change in the application for transfer).

27. We are amending the records sections to require the maintenance of an accurate, current inventory for each toxin held and for each select agent held in long-term storage (placement in a system designed to ensure viability for future use, such as in a freezer or lyophilized materials).

28. We are amending the section pertaining to notification of theft, loss, or release in 7 CFR part 331 to require that APHIS or CDC be notified immediately upon discovery of a release of a select agent or toxin outside of the primary barriers of the biocontainment area and we are amending this section in 9 CFR part 121 to require that APHIS or CDC be notified immediately upon discovery of a release of a select agent or toxin causing occupational exposure or a release outside of the primary barriers of the biocontainment area.

29. We are amending the administrative review sections to allow an individual to appeal revocation of access approval.

Format of the Regulations

APHIS and CDC are revising the format of the regulations in the final rules so that the section numbers and, to the extent possible, the section titles and the information contained in each section is the same in 7 CFR part 331, 9 CFR part 121, and 42 CFR part 73. These changes should make the regulations easier to use and facilitate compliance. The chart below sets out the format of 7 CFR part 331 and 9 CFR part 121 set by the interim rules (interim regulations) and the new format for the regulations in 7 CFR part 331 and 9 CFR part 121 (final rule).

Interim regulations

Final rule

331.0

Effective and applicability dates

121.0

Effective and applicability dates

331.1

Definitions

331.1

Definitions.

121.1

Definitions

121.1

Definitions.

331.2

Purpose and scope

331.2

Purpose and scope.

121.2

Purpose and scope

121.2

Purpose and scope.

331.3

List of biological agents and toxins

331.3

PPQ select agents and toxins.

121.3

List of biological agents and toxins

121.3

VS select agents and toxins.

331.4

Exemptions

331.4

[Reserved].

121.4

Exemptions for overlap agents or toxins

121.4

Overlap select agents and toxins.

331.5

Registration; who must register

331.5

Exemptions.

121.5

Exemptions for animal agents and toxins

121.5

Exemptions for VS select agents and toxins.

331.6

Registration; general provisions

331.6

[Reserved]

121.6

Registration; who must register

121.6

Exemptions for overlap select agents and toxins.

331.7

Denial, revocation, or suspension of registration

331.7

Registration and related security risk assessments.

121.7

Registration; general provisions

121.7

Registration and related security risk assessments.

331.8

Registration; how to register

331.8

Denial, revocation, or suspension of registration.

121.8

Denial, revocation, or suspension of registration

121.8

Denial, revocation, or suspension of registration.

331.9

Responsibilities of the responsible official

331.9

Responsible official.

121.9

Registration; how to register

121.9

Responsible official.

331.10

Restricting access to biological agents and toxins

331.10

Restricting access to select agents and toxins; security risk assessments.

121.10

Responsibilities of the responsible official

121.10

Restricting access to select agents and toxins; security risk assessments.

331.11

Biocontainment and security plan

331.11

Security.

121.11

Restricting access to biological agents and toxins

121.11

Security.

331.12

Training

331.12

Biocontainment.

121.12

Biosafety and security plan

121.12

Biosafety.

331.13

Transfer of biological agents and toxins

331.13

Restricted experiments.

121.13

Training

121.13

Restricted experiments.

331.14

Records

331.14

Incident response.

121.14

Transfer of biological agents and toxins

121.14

Incident response.

331.15

Inspections

331.15

Training.

121.15

Records

121.15

Training.

331.16

Notification in the event of theft, loss, or release of a biological agent or toxin

331.16

Transfers.

121.16

Inspections

121.16

Transfers.

331.17

Administrative review

331.17

Records.

121.17

Notification in the event of theft, loss, or release of a biological agent or toxin

121.17

Records.

121.18

Administrative review

331.18

Inspections.

121.18

Inspections.

331.19

Notification of theft, loss, or release.

121.19

Notification of theft, loss, or release.

331.20

Administrative review.

121.20

Administrative review.

General Comments

A commenter suggested that APHIS and CDC adopt consistent terminology when referring to biological agents and toxins. The commenter pointed out that the regulations use the following terms: biological agents and toxins, select agents and toxins, overlap agents, and high consequence pathogens.

We agree that APHIS and CDC should use consistent terminology. Therefore, in this final rule, we are removing the terms “biological agents and/or toxins,” “listed agents and/or toxins,” and “high consequence livestock pathogens” each time they appear in 7 CFR part 331 and/or 9 CFR part 121 and adding “select agents and/or toxins” in their place. In addition, in 9 CFR part 121, we are removing the term “overlap agents” each time it appears and adding “overlap select agents and/or toxins” in its place. To reflect this change in terminology, we are also changing the title of both parts from “Possession, Use, and Transfer of Biological Agents and Toxins” to “Possession, Use, and Transfer of Select Agents and Toxins.” In accordance with these changes, we will be using the term “select agent and/or toxin” throughout the preamble of this rule. When it is necessary to specify the type of select agent or toxin, we will use the following terms: “PPQ select agent and/or toxin” (for the plant agents and toxins), “VS select agent and/or toxin” (for the animal agents and toxins), or “overlap select agent and/or toxin.” Unless otherwise specified, the term “select agent and/or toxin” will refer to all agents or toxins listed by APHIS.

One commenter stated that APHIS and CDC should harmonize the regulations and provide consistent guidance to entities. This commenter also recommended close collaboration between the agencies for registration, enforcement, and compliance assistance. Another commenter recommended that APHIS and CDC establish one regulatory and reporting mechanism and one office of compliance assistance and enforcement in order to enhance coordination between APHIS and CDC.

We agree that APHIS and CDC should harmonize the regulations and provide consistent guidance to entities. APHIS and CDC have worked closely together to identify and resolve differences between the regulations. This final rule is consistent with CDC's final rule in both structure and substance. APHIS and CDC have also established procedures that will allow an entity to interact with only one agency—either APHIS or CDC—with respect to most matters involving select agents and toxins. These changes will ensure the close coordination of APHIS and CDC and create a uniform and consistent approach to the regulation of select agents and toxins. APHIS and CDC are also developing a single shared web-based system that will allow the regulated community to conduct transactions electronically with APHIS and CDC via a single web portal. By providing a single web portal, APHIS and CDC will be able to interact efficiently and effectively with the regulated community while reducing the burden on the public. We envision that this system will enable the entity to dynamically communicate with APHIS and CDC in a digitally secured environment using a single web portal. The web portal will provide a platform for electronic exchange of information. It will allow entities to access data related to their own registration data and allow them to create, amend, and submit registration applications; requests for approvals for transfers, exemptions, or exclusions; and any other required forms without the need to print, mail, or e-mail hard copies. Hard copy registration materials and other required forms will still be accepted. The single web portal will be available in winter 2005.

A number of commenters expressed concern about the effect of the regulations on the scientific community. Several commenters stated that the regulations will limit the free exchange of scientific information and make it difficult to recruit foreign researchers and technical workers in areas of short supply in the United States. Several commenters asserted that the costs of the regulations (especially the security requirements) will result in the termination of important research projects and the destruction of specimens. One commenter stated that research programs will be terminated because researchers will not want to deal with the new regulatory requirements or their institutions will not want to be liable for violations of the regulations. This commenter also noted that the costs of adhering to the regulations will limit the money available for the research. Another commenter stated that scientists will end up spending more time dealing with bureaucratic requirements rather than working in the laboratory or supervising their employees.

The Act requires the Secretary to establish, by regulation, 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. In an interim rule published in the

Federal Register

on December 13, 2002, and effective on February 11, 2003, APHIS established the regulations required under the Act. To date, the commenters' concerns about the costs or difficulties of complying with the regulations have failed to materialize. Accordingly, we are making no changes in response to these comments.

Several commenters requested that APHIS and CDC create a grant program to assist entities with the costs of implementing the security requirements.

At this time APHIS is unable to assist entities with the costs of implementing the security requirements because

Congress has not appropriated any funds to establish such a grant program. Accordingly, we are making no change based on these comments.

One commenter requested that APHIS specify in the final rule that it is the regulatory agency for the veterinary biologics industry.

An entity in the veterinary biologics industry may be regulated by APHIS and/or CDC, depending on the agent or toxin that it possesses, uses, or transfers—overlap select agents and toxins are regulated by both APHIS and CDC, while VS select agents and toxins are regulated only by APHIS. For this reason, we are making no change in response to this comment.

A commenter stated that the regulations should be revoked and replaced with prohibitions on owning, working with, or importing any of the agents or products. This commenter recommended that the penalty for possession of a select agent be a fine of $500,000 or imprisonment for up to 25 years.

The Act does not authorize APHIS to prohibit the possession, use, or transfer of biological agents and toxins. Rather, section 212 of the Act directs APHIS to establish, by regulation, 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, to animal health, to plant health, or to animal or plant products. The Act also sets forth the civil and criminal penalties for violations of the Act. For these reasons, we are making no changes based on this comment.

One commenter warned of the potential for international travelers to bring biological “suitcase bombs” into the United States from countries with bovine spongiform encephalopathy, foot-and-mouth disease, or other exotic animal disease pathogens.

This commenter appears to be concerned about the introduction of animal disease pathogens into the United States in the luggage of international travelers. This comment is outside the scope of this rulemaking. However, we note that VS select agents or toxins and overlap select agents or toxins may only be imported into the United States in accordance with 9 CFR parts 121 and 122. We are making no change based on this comment.

Protection of Information Collected by APHIS

Several commenters expressed concern about APHIS’ ability to protect the information collected under the regulations. One commenter asked how APHIS would store and protect the information collected. Another commenter stated that USDA should ensure that the information collected is not available through Freedom of Information Act requests.

Section 212(h) of the Act sets forth the requirements relating to the disclosure of information by APHIS and other Federal agencies. Specifically, section 212(h)(1) provides that the specified Federal agencies may not disclose under 5 U.S.C. 552 any of the following: (1) Any registration or transfer documentation, permits issued prior to the enactment of the Act, or information derived therefrom to the extent that it identifies the agent or toxin possessed, used, or transferred by a specific person or discloses the identity or location of a specific person; (2) the national database or any other compilation of the registration or transfer information to the extent that such compilation discloses site-specific registration or transfer information; (3) any portion of a record that discloses the site-specific or transfer-specific safeguard and security measures used by a registered person to prevent unauthorized access to agents and toxins; (4) any notification of a theft, loss, or release of an agent or toxin; and (5) any portion of an evaluation or report of an inspection of a specific registered person that identifies the agent or toxin possessed by a specific registered person if the agency determines that public disclosure of the information would endanger animal or plant health, or animal or plant products. We believe the Act provides sufficient protection for the information collected under the regulations. Accordingly, we are making no changes based on these comments.

A commenter stated the rule should explicitly state that the security risk assessment is confidential.

As previously noted, we believe the Act provides sufficient protection for the information collected under the regulations. We do not believe it is necessary to state in the regulations that the security risk assessment is confidential. Therefore, we are making no change based on this comment.

Another commenter asserted that the information collected by APHIS for the security risk assessment should not be used more broadly than to determine who is a “restricted person.” The commenter noted that California State law prohibits discrimination in employment based upon citizenship and prohibits the disclosure of citizenship information to a third party in a manner that links that information to the individual, except in limited and compelling circumstances. The commenter expressed concern that the data collected for registration or a security risk assessment might be used inappropriately by a Federal agency to assess a proposal for funding. The commenter recommended that APHIS, CDC, and the Department of Justice take steps to ensure the security and confidentiality of submitted information.

In accordance with the Act, the information submitted by an individual as part of a security risk assessment may only be used to determine if an individual is a restricted person under 18 U.S.C. 175b or is reasonably suspected by any Federal law enforcement or intelligence agency of (1) committing a crime set forth in 18 U.S.C. 2332b(g)(5), (2) knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence, or (3) being an agent of a foreign power as defined in 50 U.S.C. 1801. We believe that the Act and other applicable Federal laws, such as the Privacy Act, are sufficient to ensure the confidentiality of the submitted information. We are making no change in response to this comment.

A commenter asked how APHIS inspectors will mark and protect their inspection reports. APHIS inspection reports and related documents will be protected in accordance with the Act and agency and departmental policies.

Economic Impact

Several commenters argued that the costs of compliance were grossly understated in the economic analysis for the December 2002 interim rule. One commenter stated that the one-time cost to retrofit existing facilities will easily exceed $1 million and that recurring annual costs could top $100,000.

Although the commenter didn't specify, we believe that the commenter is referring to the costs to upgrade security. In our December 2002 economic analysis, we provided estimates of the costs of the interim security requirements. However, we noted that these estimates may not apply to every entity due to the diversity in existing security levels and security needs, as well as the various methods of meeting the interim security requirements. In the economic analysis in this final rule, we reiterate that the costs to comply with the security requirements are site specific and will vary accordingly.

Another commenter stated that the interim rule ignored or grossly underestimated financial costs,

including the costs of verifying the baseline inventory and the costs of responding to lost vial reports. The commenter estimated that the one-time cost to verify the baseline inventory will be $2 million with recurring costs of about $1 million per year. The commenter also estimated that it will cost about $5 million per year to respond to reports of lost vials of select agents because the response would require, at least, a verification of the inventory.

In response to this comment, the economic analysis in this final rule provides more information about the costs of the inventory recordkeeping requirements. In this final rule, we estimate that it would cost an entity $7,200 to create a baseline inventory (assuming an average of 10 freezers and 3 toxin containers per entity). Assuming that registered entities would have to re-inventory one-half of their freezers each year to maintain an accurate and current inventory, we estimate the total yearly inventory cost for all affected entities to be $274,000. Finally, in the event of a theft or loss, we expect an entity would conduct an inventory of the affected storage freezer or toxin container. We estimate that such an inventory would cost $560 per occurrence.

Effective and Applicability Dates

Interim 7 CFR 331.0 and 9 CFR 121.0 provided that the regulations in each part became effective on February 11, 2003. To minimize the disruption of research or educational projects, both sections also provided additional time for individuals and entities to reach full compliance with the regulations in each part (

i.e.

, a phase-in period). Finally, as established in the November 3, 2003, interim rule, both sections provided for the issuance of provisional certificates of registration and provisional grants of access for individuals under certain conditions.

A number of commenters requested clarification of the provisions for the phase-in period and several commenters requested additional time to comply with certain provisions. Given that all of the dates in 7 CFR 331.0 and 9 CFR 121.0 have passed, the sections are no longer applicable and the issues raised by the commenters are moot. Accordingly, in this final rule, we are removing 7 CFR 331.0 and 9 CFR 121.0.

Definitions

In 7 CFR 331.1 and 9 CFR 121.1, we define the terms used in the regulations. We are adding definitions of

diagnosis

and

verification

in both sections in this final rule.

Diagnosis

is defined as “the analysis of specimens for the purpose of identifying or confirming the presence or characteristics of a select agent or toxin provided that such analysis is directly related to protecting the public health or safety, animal health or animal products, or plant health or plant products.”

Verification

is defined as “the demonstration of obtaining established performance (

e.g.

, accuracy, precision, and the analytical sensitivity and specificity) specifications for any procedure used for diagnosis.” In addition, in 9 CFR 121.1, we are amending the definition of

proficiency testing. Proficiency testing

is defined as “the process of determining the competency of an individual or laboratory to perform a specified test or procedure.” Finally, we are deleting the definition for

diagnostic laboratory

in both sections and we are deleting the definition for

clinical laboratory

in 9 CFR 121.1. These changes will clarify the exemption provisions and help to ensure that APHIS and CDC consistently apply these provisions.

To be consistent with CDC's definitions, we are adopting CDC's definitions for

HHS Secretary

and

HHS select agent and/or toxin

in both sections in this final rule.

HHS Secretary

is defined as “the Secretary of the Department of Health and Human Services or his or her designee, unless otherwise specified.”

HHS select agent and/or toxin

is defined as “a biological agent or toxin listed in 42 CFR 73.3.”

A commenter suggested that APHIS and CDC adopt consistent terminology when referring to biological agents and toxins. As previously noted, in this final rule we are adopting the terms “select agents and/or toxins” and “overlap select agents and/or toxins.” To reflect this change in terminology, we are adding several additional definitions to the regulations.

In 7 CFR 331.1 and 9 CFR 121.1, we are adding a definition for the term

select agent and/or toxin.

However, due to differences between the plant-related regulations in 7 CFR part 331 and the animal-related regulations in 9 CFR part 121, the term

select agent and/or toxin

is defined differently in both parts. In 7 CFR 331.1,

select agent and/or toxin

is defined as “a biological agent or toxin listed in § 331.3” while in 9 CFR 121.1 it is defined as “unless otherwise specified, all of the biological agents and toxins listed in §§ 121.3 and 121.4.” The latter definition takes into account the fact that overlap select agents and toxins are also regulated under 9 CFR part 121.

In 9 CFR 121.1, we are removing the definition for

overlap agent or toxin

and adding a definition for

overlap select agent and/or toxin

in its place.

Overlap select agent and/or toxin

is defined as “a biological agent or toxin that is listed in 9 CFR 121.4 and 42 CFR 73.4.” We are also adding definitions for

VS

and

VS select agent and/or toxin

in § 121.1.

VS

is defined as “the Veterinary Services Programs of the Animal and Plant Health Inspection Service” and

VS select agent and/or toxin

is defined as “a biological agent or toxin listed in § 121.3.”

One commenter claimed that the term “entity” is subject to interpretation. The commenter stated that it does not make sense for a large multi-campus university to base cumulative limits on toxins or the designation of the responsible official on the entity when the actual labs are separated by hundreds of miles. Another commenter stated the definition of “entity” should be amended to permit a responsible official to discharge his or her responsibilities at several adjacent addresses.

These issues are addressed below in the registration section. We are making no change to the definitions section in 7 CFR 331.1 and 9 CFR 121.1 based on these comments.

One commenter recommended that APHIS and CDC adopt a common definition for the term “responsible official.” The commenter noted that APHIS defines the term “responsible official” but CDC does not. The commenter stated that APHIS indicates a responsible manager should be the responsible official for an entity, while CDC would allow a biosafety officer to assume this role. The commenter stated that, in general, a biosafety officer would not have direct control over either the affected staff or budgets in order to ensure compliance with the regulations.

We agree that APHIS and CDC should adopt a common definition for the term “responsible official.” Accordingly, we are amending the definition for

responsible official

in this final rule. In 7 CFR 331.1 and 9 CFR 121.1, we define

responsible official

as “the individual designated by an entity with the authority and control to ensure compliance with the regulations in this part.” CDC is adopting the same definition in its final rule.

A commenter stated that APHIS should clarify the term “facility.” The commenter said the term appears to refer to a complete building or complex in some parts of the rule but to an individual laboratory/room in other parts of the rule.

APHIS uses the term “facility” in the definition for

diagnostic laboratory

in 7 CFR 331.1 and in the definitions for

clinical laboratory

and

diagnostic

laboratory

in 9 CFR 121.1. The term does not appear elsewhere in the regulations. Accordingly, we are making no change based on this comment.

A commenter recommended that APHIS define the term “access” to mean actual, physical contact with the agent or the realistic opportunity for same.

This issue is addressed below in the sections relating to security risk assessments and security. We are making no change to the definitions in 7 CFR 331.1 or 9 CFR 121.1 based on this comment.

One commenter stated that 9 CFR 121.1 should define the term “exotic” so that the term can be removed from the list of agents.

This issue is addressed below in the section relating to the lists of VS and overlap select agents and toxins. Therefore, we are making no change to the definitions in 9 CFR 121.1 in response to this comment.

Purpose and Scope

Interim 7 CFR 331.2 and 9 CFR 121.2 set out the purpose and scope of the regulations. Specifically, 7 CFR 331.2(a) stated that part 331 sets forth the requirements for possession, use, and transfer of biological agents or toxins that have been determined to have the potential to pose a severe threat to plant health or plant products, while 9 CFR 121.2(a) stated that part 121 sets forth the requirements for possession, use, and transfer of biological agents or toxins that have been determined to have the potential to pose a severe threat to both human and animal health, or to animal health or animal products. Both sections noted that the purpose of the regulations is to ensure the safe handling of such agents or toxins, and to protect against the use of such agents or toxins in domestic or international terrorism or for any other criminal purpose.

In this final rule, we are amending both sections to clarify that each part implements the provisions of the Agricultural Bioterrorism Protection Act of 2002. Furthermore, we are amending 9 CFR 121.2 to clarify that overlap select agents and toxins are subject to regulation by both APHIS and CDC.

In interim 7 CFR 331.2 and 9 CFR 121.2, paragraphs (b) and (c) summarized the regulatory requirements. Since these provisions are already set forth in other sections of the regulations, we believe it is unnecessary to summarize them in these sections. Therefore, in this final rule, we are removing paragraphs (b) and (c) in 7 CFR 331.2 and 9 CFR 121.2, and removing the paragraph designation for paragraph (a) in both sections since it is no longer necessary.

List of Biological Agents and Toxins

In accordance with the Act, interim 7 CFR 331.3 and 9 CFR 121.3 listed certain biological agents and toxins.

Section 212(a)(2) of the Act requires that the lists of biological agents and toxins be reviewed and republished biennially, or more often as needed, and revised as necessary. In addition, the Act requires that, when determining whether to include an agent or toxin, the Secretary shall consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups.

This final rule serves as APHIS’ republication of the lists of select agents and toxins in 7 CFR 331.3 and 9 CFR 121.3, and in newly designated 9 CFR 121.4. As part of APHIS' review of the lists of agents and toxins, we reviewed current scientific information and studies and consulted with other Federal agencies. We also reviewed and considered the comments to the December 2002 interim rule on the lists of agents and toxins.

As previously noted, in this final rule, we are amending the structure of both parts to be consistent with CDC's select agent regulations. In 9 CFR part 121, we are creating separate sections for the lists of VS select agents and toxins and overlap select agents and toxins—§§ 121.3 and 121.4, respectively. We are also adding a new paragraph (a) to 7 CFR 331.3, containing introductory text, so that the format of the section is consistent with the format in 9 CFR 121.3 and 9 CFR 121.4.

One commenter recommended that APHIS include in the regulations a summary of the risk assessment data that supports the listing of each agent and toxin. The commenter stated that the data will heighten awareness of the risk characteristics of the listed agents and will promote safe practice and proficiency in handling such agents.

APHIS does not include risk assessment data in the regulations; rather, such information is discussed in a rule's preamble. As noted in the preamble of the August 2002 interim rule, the Act requires APHIS to consider the following criteria in determining whether to list an agent or toxin: (1) The effect of exposure to the agent or toxin on animal or plant health, and on the production and marketability of animal or plant products; (2) the pathogenicity of the agent or the toxicity of the toxin and the methods by which the agent or toxin is transferred to animals or plants; (3) the availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; and (4) any other criteria the Secretary considers appropriate to protect animal or plant health, or animal or plant products.

We do not believe it is necessary to provide a summary of the risk assessment data that supports the listing of each select agent or toxin in order to heighten awareness of the risk characteristics of such agents and toxins and promote safe practice and proficiency in handling of such agents and toxins. Information about the risk characteristics of a select agent or toxin and safe handling practices is available in scientific literature and other publications (

e.g.

, the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories”). For these reasons, we are making no change based on this comment.

Interim 7 CFR 331.3(a) (newly designated § 331.3(b)) listed the biological agents and toxins that have been determined to pose a severe threat to plant health or to plant products (PPQ select agents and toxins).

In this final rule, we are removing

Phakopsora pachyrhizi,

also known as Asian soybean rust, from the list of PPQ select agents and toxins. Asian soybean rust has been introduced into the United States by natural means and now it would have virtually no impact if used as a weapon of terrorism. Asian soybean rust was detected in the United States in November 2004. All available evidence suggests that spores were blown into the United States during a series of hurricanes in 2004. Detection surveys indicate that it is present in at least nine southeastern States; however, USDA is conducting additional surveys to determine the full extent of the introduction. Because Asian soybean rust has a host range of more than 90 plant species and its spores disperse naturally on wind currents, this disease will continue to spread naturally and it cannot be controlled effectively. We expect that this disease will quickly reach the full extent of its ecological range in the United States. As a result, there is an urgent need for timely research on effective means to manage the disease in the United States. For all of these reasons, we are removing

Phakopsora pachyrhizi

from the list of PPQ select agents and toxins. However, we note that a permit will still be required for importation or interstate movement of Asian soybean rust (7 CFR part 330).

A commenter claimed that, pursuant to the rules of the International Code of Nomenclature of Bacteria, two bacteria

have been renamed; thus,

Liberobacter africanus

should be

Candidatus

Liberobacter africanus, and

Liberobacter asiaticus

should be

Candidatus

Liberobacter asiaticus.

We agree. Therefore, in this final rule, we are replacing the entry for

Liberobacter africanus

with

Candidatus

Liberobacter africanus and replacing

Liberobacter asiaticus

with

Candidatus

Liberobacter asiaticus. In addition, we are placing

Candidatus

Liberobacter africanus and

Candidatus

Liberobacter asiaticus on separate lines in order to make it clear that each one is a select agent.

One commenter argued that plum pox

potyvirus

should not be listed as a select agent because it is only naturally transmitted by aphids, and, without the insect vector to transmit the disease from one plant to another, the possibility of the virus being used as a weapon of terrorism is extremely small. The commenter stated that laboratory research of this agent, in the absence of its natural vector and only known means of transmission, poses little to no risk to plant health or plant products.

We agree that plum pox

potyvirus

(PPV) has limited potential as a weapon of terrorism given its biological characteristics. PPV is not easily transmitted and does not spread easily. The natural host range is limited to plants in the genus

Prunus

(

e.g.

, plums and other stone fruits). The natural spread of the disease requires insect vectors (aphids), and is a complex biological process, and artificial spread requires grafting, which is labor intensive and time-consuming. PPV is not spread by pollen or seed. While systemic treatments are not completely effective at mitigating the disease, destruction of infected trees mitigates the effects of the disease, removal of the diseased trees and other susceptible hosts removes the source of infection, and transmission can be halted by removing host material from the area. Furthermore, most strains of PPV attack only a few varieties of stone fruits, which limits the affect of an outbreak on the production and marketability of stone fruits. For these reasons, in this final rule, we are removing plum pox

potyvirus

from the list of PPQ select agents and toxins. However, we note that PPV continues to be a quarantine pest under the domestic plant regulations (7 CFR 301.74 through 301.74-5).

Another commenter asserted that

Ralstonia solanacearum,

race 3, biovar 2, should not be listed as a select agent. This commenter stated that the bacterium is unlikely to become established in the northern United States, where potatoes are commercially grown, because it is intolerant of freezing and does not generally survive winters in regions with sustained temperatures below 20 °F. The commenter claimed that, even if the bacterium became established, it is unlikely to cause an economically damaging disease outbreak in the climactic conditions characteristic of North America. The commenter went on to note that the bacterium has been repeatedly introduced into the United States without impact.

APHIS has determined that

Ralstonia solanacearum,

race 3, biovar 2, has the potential to pose a severe threat to plant health or plant products. The bacterium is known to attack a number of economically significant hosts (

e.g.

, geraniums and tomatoes), not just potatoes. Some of the known hosts are grown in greenhouses (

e.g.

, geraniums), which protect them from local climatic conditions, and some hosts are grown in fields throughout the United States (

e.g.

, tomatoes and potatoes). With regard to potatoes, scientific data indicate the potential range of the bacterium would include the potato-growing regions in the United States.

Ralstonia solanacearum,

race 3, biovar 2, occurs in Europe as far north as the 56th parallel (southern Scandinavia), which parallels regions of Canada. Furthermore, there are a number of wild hosts that would contribute to the spread of the bacterium if it were introduced into the United States. For these reasons, we are making no changes based on this comment.

Interim 9 CFR 121.3(d) (newly designated § 121.3(b)) listed the biological agents and toxins that have been determined to have the potential to pose a severe threat to animal health or to animal products (VS select agents and toxins).

A commenter asserted that listing Japanese encephalitis virus (JEV) as a select agent will negatively impact research on this disease, as well as on West Nile virus and dengue virus. This commenter stated that there does not appear to be sufficient justification for making Japanese encephalitis virus a select agent.

We disagree that there is insufficient justification for listing Japanese encephalitis virus as a VS select agent. The virus can cause severe disease in horses and swine for which there is no effective treatment and no domestically available veterinary vaccine. While the select agent regulations may affect research on JEV, we expect it will have a negligible effect on associated research on West Nile virus and dengue virus. For these reasons, we are making no change in response to this comment.

Several commenters questioned the inclusion of malignant catarrhal fever virus (exotic) on the list of select agents. One commenter stated the disease malignant catarrhal fever virus is caused be a variety of herpes viruses, none of which is known as malignant catarrhal fever virus. The commenter stated that Alcelaphine herpesvirus type 1 infects most wildebeest and spreads to domestic cattle causing malignant catarrhal fever in Africa. The commenter argued that malignant catarrhal fever virus (exotic) should be replaced with Alcelaphine herpesvirus type 1. Another commenter argued that the biological features of malignant catarrhal fever viruses prevent them from being effective bioterror agents. The commenter noted that Alcelaphine herpesvirus type 1 can only be transmitted by parenteral injection and cow-to-cow transmission does not occur under natural conditions. This commenter also argued that it is misleading to label malignant catarrhal fever as “exotic” since it is present wherever there are wildebeests, from zoos to exotic game farms.

We agree that clarification is needed with regard to the term malignant catarrhal fever virus. Accordingly, in this final rule we are replacing the entry for malignant catarrhal fever virus with malignant catarrhal fever virus (Alcelaphine herpesevirus type 1). However, we disagree that the biological features of malignant catarrhal fever viruses prevent them from being effective bioterror agents. Malignant catarrhal fever virus (Alcelaphine herpesevirus type 1) causes severe disease in cattle, and it may be possible for the virus to be transmitted from cow to cow. Currently, this virus is not found in U.S. cattle populations, and a widespread outbreak of the disease would likely result in widespread animal movement restrictions that could be long term, at least with respect to exports. We are making no change in response to this comment.

One commenter suggested that Newcastle disease virus (VVND) be replaced with Newcastle disease virus (velogenic). The commenter stated the background information indicated that only velogenic strains are to be regulated; however, the acronym VVND indicates viscerotropic, velogenic Newcastle disease.

In the December 2002 interim rule, we replaced the entry for Newcastle disease virus (exotic) with Newcastle disease virus (VVND) to make it clear that we are regulating only velogenic strains. Viscerotropic, velogenic Newcastle

disease (VVND) is a velogenic strain. To ensure that we are regulating all of the velogenic strains, in this final rule we are replacing the entry for Newcastle disease virus (VVND) with Newcastle disease virus (velogenic).

A commenter stated the distinction between domestic and exotic vesicular stomatitis virus cannot be justified scientifically. Therefore, it would be more logical to list all vesicular stomatitis viruses except specific viruses that are generally recognized as attenuated (

e.g.

, the VSV-Indiana Lab strain).

We do not believe it is necessary to regulate all strains of vesicular stomatitis virus, especially those strains that have limited morbidity and mortality in the United States. Therefore, we are making no change based on this comment.

Interim 9 CFR 121.3(b) (newly designated § 121.4(b)) listed the 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, or to animal products (overlap select agents and toxins).

Several commenters pointed out that

Clostridium botulinum

is listed in the APHIS regulations but not in the CDC regulations.

APHIS inadvertently listed both

Clostridium botulinum

and Botulinum neurotoxin producing species of

Clostridium

as overlap agents in the December 2002 interim rule. We always intended to only list Botulinum neurotoxin producing species of

Clostridium

in order to be consistent with CDC. Accordingly, we are removing

Clostridium botulinum

from the list of overlap select agents and toxins in this final rule.

A number of commenters argued that overlap agents that are endemic, widespread, and easily isolated from natural sources should not be included in the list of overlap select agents. For these reasons, one commenter recommended that

Francisella tularensis

and

Coxiella burnetii

be removed from the list of overlap agents. Several commenters stated that

Coccidioides immitis

should not be included in the list of overlap select agents because it is endemic in California's Central Valley and is found in many areas of the southwest. Another commenter argued that

Coxiella burnetii

should be removed from the overlap list because “it is so ubiquitous in nature that its identification as a select agent is meaningless.” One commenter argued that Eastern equine encephalitis virus should be removed from the overlap list because it is endemic and even if it were intentionally introduced into people, horses, or other domestic animals, there would be little or no chance of spread to cause an adverse agricultural event.

We agree that

Coxiella burnetii, Coccidioides immitis,

and

Francisella tularensis

are endemic, widespread, and easily isolated from natural sources. However, these factors are not sufficient reason to remove these agents from the list of overlap select agents and toxins. Furthermore, we disagree that there is little risk of an adverse agricultural event involving Eastern equine encephalitis virus because it can cause high mortality in horses, and there is no mandatory vaccination program in the United States. We are making no changes based on this comment.

A commenter stated that it is pointless to regulate trichothecenes such as T-2 toxin as select agents if highly toxigenic strains of the toxin-producing organism are not also regulated.

We are regulating T-2 toxin, and not the organism that produces it, because we believe the toxin has the potential to pose a severe threat to public health and safety, to animal health, and to animal products. Accordingly, we are making no change in response to this comment.

Interim 7 CFR 331.3(c)(2), 9 CFR 121.3(c), and 9 CFR 121.3(f)(2) (newly designated 7 CFR 331.3, 9 CFR 121.3, and 9 CFR 121.4) set out the provisions for genetic elements.

One commenter stated there are differences between the APHIS and CDC regulations regarding genetic elements. For example, the regulations seem to imply that no bacterial sequences are regulated, except those from animal agents.

We agree. In the interim regulations, CDC provided that infectious viral sequences of HHS and overlap select agents are regulated, while APHIS provided that infectious viral sequences of overlap agents are regulated and infectious viral and bacterial sequences of PPQ and VS select agents are regulated. To resolve these differences, in this final rule we are adopting CDC's approach for genetic elements. Specifically, newly designated 7 CFR 331.3, 9 CFR 121.3, and 9 CFR 121.4 provide that the following will be considered select agents and toxins:

• Nucleic acids that can produce infectious forms of any of the select agent viruses listed in either 7 CFR part 331 or 9 CFR part 121;

• Recombinant nucleic acids that encode for the functional forms of any toxin listed in either 7 CFR part 331 or 9 CFR part 121 if the nucleic acids: (1) Can be expressed

in vivo

or

in vitro;

or (2) are in a vector or recombinant host genome and can be expressed

in vivo

or

in vitro

; and

• Select agents and toxins listed in either 7 CFR part 331 or 9 CFR part 121 that have been genetically modified.

Another commenter stated that interim 9 CFR 121.3(c) and 121.3(f) conflict—§ 121.3(c) seems to include fragments, while § 121.3(f) exempts them. The commenter pointed out that all genetic elements that cause disease can be fragmented into pieces that cannot cause disease, but that can be reconstituted simply and quickly.

We believe the changes in this final rule will address the differences identified by this commenter. Accordingly, we are making no change based on this comment. However, we note that fragments are not subject to the regulations until reconstituted.

One commenter asked if cDNA is regulated. This commenter also asked how sequence data of select agents will be protected, since it can be used to make a select agent.

A cDNA fragment will be subject to the regulations if it can produce either an infectious form of toxin or a select agent. Sequence data of select agents is already in the public domain, and APHIS cannot protect this information. However, we note that an individual or entity that uses sequence data to produce an infectious agent or toxin will be subject to the select agent regulations. We are making no changes based on this comment.

Interim 7 CFR 331.3(b) and 9 CFR 121.3(e) stated that any biological agent or toxin that is in its naturally occurring environment will not be subject to the requirements of either part, provided that the biological agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.

To be consistent with CDC, we are adopting the phrase “excluded from the requirements of this part” in place of the phrase “will not be subject to the requirements of this part.” Thus, in this final rule, newly designated 7 CFR 331.3(d)(1), 9 CFR 121.3(d)(1), and 9 CFR 121.4(d)(1) state that a select agent or toxin that is in its naturally occurring environment is excluded from the requirements of the regulations, provided that the agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.

One commenter stated that the naturally occurring environment of a virus is its host. The commenter pointed out that

Coxiella burnetii

can be found in milk samples and asked if the truck moving milk to a processing plant would be subject to the regulations or if

the milk sample submitted to a laboratory for mastitis testing would be subject to the regulations as the milk sample is being collected.

Coxiella burnetii

that is contained in milk in a truck or in a diagnostic sample is considered to be in its naturally occurring environment as long as it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. We are making no changes in response to these comments.

Another commenter stated that the regulations suggest that an agent found in the lymph node of a slaughtered animal (found on histopathology but not cultivated or extracted) is in its naturally occurring environment and, therefore, exempt from notification.

This comment appears to combine the requirements for exclusions and exemptions. A select agent or toxin that has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source is considered to be in its naturally occurring environment and, therefore, excluded from the requirements of the regulations. The exemption provisions for overlap select agents and toxins are set forth in newly designated 9 CFR 121.6. Histopathology alone is not a definitive identification of a select agent. However, a select agent that has been identified by a histopathology method that has been validated would need to be reported to APHIS or CDC in accordance with the regulations. We are making no changes in response to this comment.

A commenter stated that any naturally occurring organism expressing a Shigatoxin should be specifically excluded from the list of select agents and toxins.

As previously noted, we are regulating the toxin and not the organisms that produce the toxin. Therefore, it is not necessary to exclude from the requirements of the regulations any naturally occurring organism expressing a Shigatoxin. However, we note that Shigatoxin under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor is excluded from the requirements of 9 CFR part 121 if the aggregate amount does not, at any time, exceed 100 mg (newly designated 9 CFR 121.4(d)(3)).

Interim 7 CFR 331.3(c)(1) (newly designated 7 CFR 331.3(d)(2)) provided that nonviable agents that are, bear, or contain listed agents or toxins will not be subject to the requirements of the part because they do not have the potential to pose a severe threat to plant health or plant products. Similarly, interim 9 CFR 121.3(f) (newly designated 9 CFR 121.3(d)(2) and 121.4(d)(2)) provided that nonviable agents or fixed tissues that are, bear, or contain listed agents or toxins will not be subject to the requirements of the part because they do not have the potential to pose a severe threat to both human and animal health, or to animal health or animal products.

In this final rule, we are amending both sections to clarify that these provisions apply to nonviable agents and nonfunctional toxins. These changes will make the provisions in the APHIS and CDC regulations consistent.

A commenter requested clarification of the terms “nonviable” and “nonfunctional” select agents or toxins. The commenter noted that some organisms can survive in nature, others only under lab conditions, and others not under any conditions.

A nonviable agent is not capable of replicating, infecting a plant or animal, or causing disease, while a nonfunctional toxin is not able to produce a toxic effect. These terms are generally understood in the scientific community, and we do not believe that further clarification is needed in the regulations. Therefore, we are making no change in response to this comment.

Footnotes in interim 9 CFR 121.3 stated that the importation and interstate movement of nonviable agents and genetic elements are subject to the permit requirements under 9 CFR part 122.

One commenter asked why a permit is needed for nonviable agents and genetic elements that are excluded from regulation under 9 CFR part 121. The commenter argued that nonviable agents and genetic elements that are not capable of causing disease do not meet the definition of “organism” in part 122. Another commenter requested clarification of the permit requirement for nonviable agents or fixed tissues. The commenter stated that the provision seems to suggest that, for as long as you retain the tissues, you would need to get yearly interstate transport permits even though no further receipt/transport is taking place.

The regulations in 9 CFR part 122 pertain to the movement of organisms and vectors. A nonviable agent or genetic material could serve as a vector of a disease agent through ineffective or insufficient processing methods, and, therefore, require a permit for importation or interstate movement. However, since a permit may not always be required, in this final rule we are revising the footnotes so that, in newly designated 9 CFR 121.3 and 121.4, they state that a permit may be needed for nonviable agents and genetic elements. We note that permits may contain restrictions that extend beyond the expiration of the permit if the agent/genetic element is not destroyed. If so, an individual or entity would be required to obtain a new permit as long as the nonviable agent or genetic element is possessed by the permittee.

A commenter asked if a positive chain reaction (PCR) test done on formalin fixed tissue that detects Eastern equine encephalitis virus would be exempt because it is nonviable.

This comment is not entirely clear. We believe the commenter is asking about the reporting requirements for identifications of a select agent or toxin. If Eastern equine encephalitis virus is identified from formalin tissue, an individual or entity must report the identification to APHIS in accordance with either newly designated 9 CFR 121.6 or 121.9, whichever is applicable. However, nonviable overlap select agents or nonfunctional toxins are excluded from the regulations (newly designated 9 CFR 121.4(d)(2)). We are making no changes in response to this comment.

Interim 9 CFR 121.3(f)(3) provided an exclusion from the regulations for “[o]verlap toxins under the control of a principal investigator (or equivalent), if the total aggregate amount does not, at any time, exceed the following amounts: 0.5 mg of Botulinum neurotoxins (types A-G), 100 mg of

Clostridium perfringens

epsilon toxin, 100 mg of Shigatoxin, 5 mg of Staphylococcal enterotoxins, and 1,000 mg of T-2 toxin.

APHIS and CDC have determined that this exclusion is too narrow and has the unintended consequence of requiring treating physicians or veterinarians and commercial manufacturers or distributors that possess, use, or transfer otherwise excluded toxins to register. Accordingly, in this final rule, we are broadening the scope of the overlap toxin exclusion to cover overlap toxins under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor (newly designated § 121.4(d)(3)). To be consistent with CDC, we are also removing the words “(types A-G)” after Botulinum neurotoxins.

One commenter requested that APHIS clarify that there is no limit to the amount of overlap toxins an individual or entity may possess or use, as long as the amount of toxin under the control of each principal investigator does not exceed the specified amounts.

We believe that newly designated § 121.4(d)(3) clearly indicates that the exclusion is based upon the amount of

overlap toxin under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor. Therefore, we are making no change based on this comment.

Another commenter asked if the toxin amounts refer to quantities of isolated toxin (

i.e.

, toxin that has been extracted and is separate from the cell) or toxin that is in the process of being produced by living cells and may increase in quantity. The commenter stated that measuring the exact quantities of a toxin can only reasonably be achieved if the toxin has been isolated from the cell.

We agree that an exact measurement of a toxin can only reasonably be achieved if the toxin has been isolated from the cell. The amounts listed in newly designated § 121.4(d)(3) refer to the amount of toxin that has been isolated from the cell, not the amount of toxin that is being produced in living cells. We are making no change based on this comment.

Interim 9 CFR 121.3(g) (newly designated §§ 121.3(e) and 121.4(e)) provided a procedure by which an individual or entity may request a determination by the Administrator that an attenuated strain of a biological agent does not pose a severe threat to both human and animal health, or to animal health or animal products.

In this final rule, we are adding this provision to 7 CFR 331.3 so that the regulations in part 331 are consistent with the regulations in 9 CFR part 121. We are also amending both parts to clarify the requirements and streamline the process for excluding an attenuated strain of a select agent or toxin. Specifically, paragraph (e) in 7 CFR 331.3, 9 CFR 121.3, and 9 CFR 121.4 provides that an individual or entity may apply for an exclusion by submitting a written request and supporting scientific information. A written decision granting or denying the request will be issued and the exclusion will be effective upon notification of the applicant. Exclusions will be published periodically in the notice section of the

Federal Register

and will be listed on the Internet at

http://www.aphis.usda.gov/programs/ag_selectagent/index.html.

Paragraph (e) also provides that, if an excluded attenuated strain is subjected to any manipulation that restores or enhances its virulence, the resulting select agent or toxin will be subject to the requirements of each part. This has always been the way the exclusion for attenuated strains has been interpreted; however, we are adding this provision to both parts to facilitate compliance.

One commenter claimed that the microbiological community, not just government agency representatives, must be involved in the process for excluding attenuated strains. The commenter recommended the establishment of a broadly representative group to act as an advisory body to APHIS and CDC. This commenter also stated that the regulations should state that determinations regarding overlap agents require the concurrence of APHIS and CDC.

APHIS may exclude attenuated strains of select agents or toxins after consultation with subject matter experts, including those in the microbiology community. For overlap select agents and toxins, APHIS may exclude attenuated strains after consultation with subject matter experts and CDC. We do not believe it is necessary to include these administrative procedures in the regulations. Accordingly, we are making no change based on this comment.

A commenter stated that APHIS should specify the criteria for exclusion of attenuated strains because the current standard (“poses a severe threat”) is insufficiently specific.

The Act requires APHIS to regulate the possession, use, and transfer of biological agents and toxins that have been determined to pose a severe threat to public health and safety, to animal health, to plant health, or to animal or plant products. Thus, the Act establishes the standard by which APHIS may exclude an attenuated strain (

i.e.

, the strain does not pose a severe threat). We are making no change to the regulations in response to this comment.

A commenter asserted that the excluded attenuated strains should be listed in the regulations so that an entity may be able to determine if an agent is excluded before registering the strain and installing any additional security.

APHIS is not including the lists of excluded attenuated strains of select agents or toxins in the regulations because any change to the lists of exclusions would require rulemaking. To minimize the potential delays related to rulemaking, in this final rule we are providing that exclusions will be published periodically in the notices section of the

Federal Register

and will be listed on the Internet at

http://www.aphis.usda.gov/programs/ag_selectagent/index.html.

We believe these measures will provide sufficient notice to the public.

A commenter stated that the exclusion for attenuated strains would not make agents such as the Sterne strain of

Bacillus anthracis

and the vaccine strain of

Brucella abortus

available for the critical need of quality control, without registration of the laboratory.

An attenuated strain of a select agent may be excluded from the requirements of regulations based upon a determination that the attenuated strain does not pose a severe threat to plant health or plant products (newly designated 7 CFR 331.3(e)) or to public health and safety, to animal health, or animal products (newly designated 9 CFR 121.3(e) and 121.4(e)). Once an attenuated strain of a select agent has been excluded, it may be used for quality control or for other purposes, as long as its virulence is not restored or enhanced. To date, a number of attenuated strains have been excluded, including

Bacillus anthracis

Sterne, pX01

+

pX02

−

and

Brucella abortus

strain RB51 (vaccine strain). For these reasons, we are making no change in response to this comment.

One commenter asked if the TC-83 vaccine strain of Venezuelan equine encephalitis is subject to the regulations. The commenter pointed out that the CDC regulations specifically exclude this strain from regulation but the APHIS regulations do not.

Both APHIS and CDC have excluded the TC-83 vaccine strain of Venezuelan equine encephalitis virus from the requirements of the regulations. We note that a current list of exclusions is available on the Internet at

http://www.aphis.usda.gov/programs/ag_selectagent/index/html.

We are making no change based on this comment.

To address concerns raised by Federal law enforcement agencies related to seizures (

i.e.

, possession) of select agents or toxins, in this final rule we are adding a new paragraph (f) to 7 CFR 331.3, 9 CFR 121.3, and 9 CFR 121.4 to address situations in which the select agents or toxins have been identified prior to seizure. In the event that a Federal law enforcement agency seizes a suspected select agent or toxin or unknown material, this material will be regarded as a specimen presented for diagnosis or verification and, therefore, will not be subject to the regulations until it has been identified as a select agent or toxin.

Paragraph (f) provides that any select agent or toxin seized by a Federal law enforcement agency will be excluded from the requirements of the regulations during the period between seizure of the agent or toxin and the transfer or destruction of such agent or toxin provided that:

• As soon as practicable, the Federal law enforcement agency transfers the

seized agent or toxin to an entity eligible to receive such agent or toxin or destroys the agent or toxin by a recognized sterilization or inactivation process;

• The Federal law enforcement agency safeguards and secures the seized agent or toxin against theft, loss, or release and reports any theft, loss, or release of such agent or toxin; and

• The Federal law enforcement agency reports the seizure of the select agent or toxin to APHIS or CDC.

This provision will allow Federal law enforcement agencies to conduct certain law enforcement activities (

e.g.

, collecting evidence from a laboratory crime scene) without being in violation of the regulations. We note, however, that this provision does not authorize the seizure of a select agent or toxin by a Federal law enforcement agency; rather, it establishes the conditions under which a Federal law enforcement agency may seize a select agent or toxin without violating the regulations. Seizure of a select agent or toxin by a Federal law enforcement agency would have to be in accord with that agency's statutory authority.

Exemptions

Interim 7 CFR 331.4, 9 CFR 121.4, and 9 CFR 121.5 (newly designated 7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6) set out exemptions.

Interim 9 CFR 121.4(a) provided that clinical or diagnostic laboratories and other entities possessing, using, or transferring overlap agents or toxins that are contained in specimens presented for diagnosis or verification will be exempt from the requirements of part 121, provided that the identification of such agents or toxins is immediately reported to APHIS or CDC, and to other appropriate authorities when required by Federal, State, or local law; and, within 7 days after identification, such agents or toxins are transferred or inactivated, and APHIS Form 2040 is submitted to APHIS or CDC. Interim 7 CFR 331.4(a) and 9 CFR 121.5(a) contained similar exemption provisions for diagnostic laboratories (the term clinical laboratories is not applicable to the plant-related regulations in 7 CFR part 331 or the animal-related regulations in 9 CFR part 121). Exemption provisions for laboratories and other entities that perform proficiency testing were set out in interim 9 CFR 121.4(b) and 121.5(b).

In this final rule, we are amending both parts to clarify the exemption provisions related to clinical or diagnostic laboratories and other entities (for overlap select agents and toxins) and diagnostic laboratories and other entities (for PPQ and VS select agents and toxins). Specifically, paragraph (a) in newly designated 7 CFR 331.5 and paragraphs (a) and (b) in newly designated 9 CFR 121.5 and 121.6 make clear that laboratories and other entities must meet the exemption requirements for each select agent or toxin contained in a specimen that it possesses, uses, or transfers. This change takes into account situations in which a diagnostic laboratory or other entity could be registered for a select agent or toxin but still meet the exemption requirements for other select agents or toxins contained in specimens. We are also amending both parts to clarify that, as a condition of exemption, clinical or diagnostic laboratories and other entities must transfer a select agent or toxin in accordance with the transfer requirements in each part (newly designated 7 CFR 331.16 and 9 CFR 121.16, respectively) or destroy the agent or toxin on-site by a recognized sterilization or inactivation process.

In this final rule, we are also deleting in both parts the requirement that the identification of a select agent or toxin be reported to appropriate authorities when required by Federal, State, or local law (interim 7 CFR 331.4, 9 CFR 121.4, and 9 CFR 121.5). Because this provision merely indicates that additional reporting requirements may exist under Federal, State, or local law, it is not necessary to include this provision in the regulations. It is the entity's responsibility to be familiar with all legal requirements for select agents and toxins.

In addition, newly designated 9 CFR 121.5 and 121.6 require immediate reporting after identification for specified select agents and toxins; identification of the other select agents and toxins must be reported within 7 calendar days after identification. This change will reduce the reporting burden on the public while continuing to provide information that will help us to identify outbreaks and to monitor activities related to select agents and toxins.

Finally, we are deleting footnote 1 in interim 7 CFR 331.4 (newly designated 7 CFR 331.5) because this information is contained in the transfer section in this final rule (newly designated § 331.16). We are also deleting the application and contact information contained in footnotes in interim 7 CFR 331.4, 9 CFR 121.4, and 9 CFR 121.5 because addresses and telephone numbers are subject to change. Information about the submission of forms, notices, and requests for exemptions or exclusions is available on the Internet at

http://www.aphis.usda.gov/programs/ag_selectagent/index/html.

A commenter asserted that clinical or diagnostic laboratories should be required to secure the agent or toxin prior to transfer or destruction.

We agree. Taking into account the risks posed by select agents and toxins and the security requirements for registered entities, it is reasonable to require that a clinical or diagnostic laboratory or other entity secure the agent or toxin prior to transfer or destruction. Furthermore, we believe it is reasonable to require that a clinical or diagnostic laboratory or other entity report any theft, loss, or release of a select agent or toxin prior to transfer or destruction. Therefore, newly designated 7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6 require, as another condition of exemption, that the select agent or toxin be secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and that any theft, loss, or release of such agent or toxin be reported.

Another commenter argued that the exemptions for clinical and diagnostic laboratories should require, at the very least, that employees of such labs be subject to security risk assessments by the Attorney General.

The Act does not require security risk assessments for employees of entities that are exempt from registration under the regulations (section 212(e)). We believe that the conditions for exemption in this final rule provide adequate safeguard and security measures to protect animal and plant health, and animal and plant products. Accordingly, we are making no change based on this comment.

One commenter requested that APHIS define the term “identification.” The commenter asked if a PCR positive reaction constituted identification or simply detection. This commenter also wondered if an entity must report an identification done on a nonviable organism.

If a PCR test is recognized in the scientific community as an identification method, then a result utilizing this test must be reported. If not, reporting is not required. An individual or entity must report an identification done on a nonviable organism in accordance with the regulations. We require this reporting in order to obtain surveillance information about select agents or toxins. We are making no changes in response to this comment.

Several commenters argued that the requirement to transfer an agent or toxin

within 7 calendar days of identification was unrealistic. One commenter stated that delays in transfer approval by APHIS or CDC could result in delays in shipping the samples. Several commenters expressed concern about this deadline due to the unreliability of shippers. Another commenter stated that it is unreasonable and counterproductive to require diagnostic labs to destroy or transfer select agents within 7 days after identification. The commenter said that some labs may process hundreds or thousands of samples each week and generate large numbers of select agent isolates, and transferring these isolates to a qualified lab within 1 week will be very difficult and costly. The commenter claimed that most labs will simply destroy the isolates and that such destruction will result in the loss of valuable scientific material.

Based on information provided by CDC and APHIS' National Veterinary Services Laboratories (NVSL), and taking into consideration the risks posed by select agents and toxins, we believe that 7 days will provide ample time after identification to destroy the agent or toxin, or to make transfer arrangements and to transfer the agent or toxin. However, in this final rule, we are amending newly designated 7 CFR 331.5(a) and 9 CFR 121.5(a) to allow the Administrator to make exceptions to these timeframes, as necessary. We are also amending newly designated 9 CFR 121.6(a) to allow the Administrator or the HHS Secretary to make exceptions to these timeframes for overlap select agents or toxins, as necessary. Finally, we are making similar changes to newly designated 9 CFR 121.5(b) and 9 CFR 121.6(b) to allow for exceptions to the timeframes for proficiency testing, which require that an agent or toxin be transferred or destroyed within 90 calendar days of receipt.

Another commenter recommended a longer holding period for agents and toxins before mandatory inactivation—30 to 45 days instead of 7 days—because the destruction of isolates of select agents after only 7 days is counter to good quality control in labs, which often specifies that isolates and specimens be kept for 30 days, and labs often have cases pending for at least 30 days awaiting additional results. The commenter went on to note that it is good lab practice to maintain the original sample until a case is complete, and labs often maintain samples so that additional testing can be done as needed.

The exemption provisions in interim 7 CFR 331.4(a), 9 CFR 121.4(a), and 9 CFR 121.5(a) (newly designated 7 CFR 331.5(a), 9 CFR 121.5(a), and 9 CFR 121.6(a)) do not require mandatory inactivation of a select agent or toxin. To qualify for an exemption, an individual or entity must satisfy the conditions for exemption, including transferring or destroying the select agent or toxin within 7 calendar days of identification unless directed otherwise by the Administrator or HHS Secretary. However, an individual or entity could continue to hold a select agent or toxin if it registers with APHIS or, for overlap select agents and toxins, if it registers with APHIS and CDC. While we recognize that the select agent regulations may have an effect on internal quality assurance procedures, lengthening the time that a diagnostic laboratory or other entity can possess a sample without being registered is inconsistent with the intent of the Act. We are making no changes based on this comment.

One commenter asked if diagnostic facilities could preregister for potential isolates they might obtain from future diagnostic cases. The commenter stated the regulations suggest that a facility has to have the agent before it can register. The commenter stated that, once an agent is isolated, it appears that the facility would only have 7 days to become registered before it would have to destroy or transfer the agent. The commenter noted that even the process to amend a certificate of registration would likely take longer than 7 days.

The regulations do not preclude preregistration for a select agent or toxin. A certificate of registration may be issued to an entity as long as the entity meets the regulatory requirements for such agent or toxin, even if the entity does not currently possess that particular agent or toxin.

The regulations (interim 7 CFR 331.4(b) and 9 CFR 121.5(f); newly designated 7 CFR 331.5(b) and 9 CFR 121.5(f)) provide that the Administrator may grant exemptions from the requirements of 7 CFR part 331 and 9 CFR part 121 upon a showing of good cause and a determination that such an exemption is consistent with protecting animal or plant health or animal or plant products.

A commenter stated that APHIS should establish timelines for responding to requests for exemptions. APHIS is committed to processing requests for exemptions in a timely manner. We do not believe it is necessary to include in the regulations timelines for responding to requests for exemptions. Therefore, we are making no change based on this comment.

Interim 9 CFR 121.4(c) and 121.5(d) provided that, unless the Administrator by order determines that additional regulation is necessary to protect animal health, or animal products, an individual or entity possessing, using, or transferring products that are, bear, or contain agents or toxins will be exempt from the requirements of this part if the products have been cleared, approved, licensed, or registered pursuant to:

(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301

et seq.

);

(2) Section 351 of the Public Health Service Act (42 U.S.C. 262);

(3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or

(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 131

et seq.

).

In this final rule, newly designated §§ 121.5(d) and 121.6(c) clarify that the product is exempt from the requirements of the regulations. This change is designed to address those situations in which an entity produces an exempt product but conducts other activities that would require registration under this part.

A commenter requested that APHIS and CDC provide a list of agents exempted under the Federal laws listed in interim 9 CFR 121.4(c) so that investigators would know if the agents they possess or wish to study are exempt.

It is not administratively feasible for APHIS to maintain a list of select agents exempted under the Federal laws described above. The regulations provide sufficient information for an individual or entity to determine if the agents they possess or wish to study are exempt. Accordingly, we are making no changes based on this comment.

In interim 9 CFR 121.5(c), we provided that an individual or entity receiving diagnostic reagents and vaccines that are, bear, or contain select agents or toxins that are produced at USDA diagnostic facilities will be exempt from the requirements of part 121.

A commenter stated that agents approved by APHIS' Center for Veterinary Biologics for use in USDA licensed facilities should be exempt from the requirements of the rule.

We disagree. We included this provision in the regulations in order to exempt products, not agents, that would be cleared, approved, licensed, or registered pursuant to the Virus-Serum-Toxin Act (21 U.S.C. 151-159), but for the fact that they are produced by USDA. In order to clarify that this exemption applies to products, in this final rule, newly designated 9 CFR 121.5(c) provides that diagnostic reagents and vaccines that are, bear, or contain VS select agents or toxins that

are produced at USDA diagnostic facilities will be exempt from the requirements of this part.

The regulations (interim 9 CFR 121.4(e); newly designated § 121.6(e)) provide that the Administrator may exempt an individual or entity from the requirements of the part for 30 days if it is necessary to respond to a domestic or foreign agricultural emergency involving an overlap agent or toxin. This exemption may be extended for an additional 30 days.

One commenter argued that the 30-day special exemption granted during an emergency is insufficient to deal with a foreign animal or outbreak emergency. This commenter stated that neither exotic Newcastle disease or the low pathogenic avian influenza outbreaks were resolved in 60 days.

Section 212(g)(1)(D) of the Act sets forth the exemption for agricultural emergencies involving overlap select agents and toxins. The Act specifies that such exemptions may not exceed 60 days. Accordingly, we are making no changes based on this comment.

Registration

Interim 7 CFR 331.5, 331.6, and 331.8 and 9 CFR 121.6, 121.7, and 121.9 (newly designated 7 CFR 331.7 and 9 CFR 121.7) set out registration requirements and procedures.

One commenter stated that the regulations do not contemplate or address a situation where an entity has employees that possess, use, or transfer select agents at locations owned and controlled by another entity. The commenter stated that it is a nonprofit organization that provides medical research personnel to Federal agencies. The commenter asserted that the regulations and the registration application should be revised to require registration for the entity that owns or controls the location where agents and toxins are used and stored.

This final rule requires that, unless exempted under the regulations, an individual or entity that possesses, uses, or transfers select agents or toxins must register with APHIS or, for overlap select agents or toxins, APHIS and CDC. The regulations provide for both individuals and entities, even though we expect that most registrants will be entities. Using the example given by the commenter, the Federal agency that possesses, uses, or transfers select agents or toxins would be required to register and restrict access to such agents or toxins to only those individuals approved by the Administrator or HHS Secretary following a security risk assessment by the Attorney General. We are making no change based on this comment.

One commenter requested that USDA and CDC consider a single clearinghouse for registration of select agents. The commenter said the rules require an entity that possesses only human and animal/plant agents (no overlaps) to register separately with each agency; however, this would place an undue burden on the entity by requiring dual registration packages and safety/security plans. Another commenter recommended that APHIS indicate what an entity can do to assist or mitigate conflict between APHIS and CDC on registration applications for overlap agents.

To simplify the registration process and minimize the burden on the public, APHIS and CDC have established a framework by which individuals and entities with various combinations of select agents and toxins may submit their registration applications to either APHIS or CDC. For instance, to apply for a certificate of registration for only PPQ or VS select agents or toxins, or for PPQ and VS select agents or toxins, an individual or entity must submit the registration application package to APHIS. However, to apply for a certificate of registration for overlap select agents or toxins, overlap select agents or toxins and any combination of PPQ or VS select agents or toxins, or HHS select agents or toxins and any combination of PPQ or VS select agents or toxins, an individual or entity must submit the registration application package to APHIS or CDC, but not both. In this final rule, we are amending both sections to set out this new framework for submitting registration applications (newly designated 7 CFR 331.7(d) and 9 CFR 121.7(d)).

As previously discussed, APHIS and CDC are also developing a single shared web-based system that will allow the regulated community to conduct transactions electronically with either agency via a single web portal. By providing a single web portal, APHIS and CDC will be able to interact efficiently and effectively with the regulated community while reducing the burden on the public. We envision that this system will enable the entity to dynamically communicate with APHIS and CDC in a digitally secured environment using a single web portal. The web portal will provide a platform for electronic exchange of information. It will allow entities to access data related to their own registration data and allow them to create, amend, and submit registration applications; requests for approvals for transfers, exemptions, or exclusions; and any other required forms without the need to print, mail, or e-mail hard copies. Hard copy registration materials and other required forms will still be accepted. The single web portal will be available in winter 2005.

Several commenters requested more information about the registration process. One commenter asked how long will it take to receive a certificate of registration after all the paperwork has been submitted. The commenter urged APHIS to promptly process registration applications so as not to disrupt valuable research and impede academic planning. Another commenter suggested that APHIS add information to the final rule to indicate when an entity should submit renewal applications (

i.e.

, at least 90 days prior to expiration).

We are committed to promptly processing initial registration applications and renewal applications. The time needed to process a registration application and issue a certificate of registration depends on the complexity and completeness of the application. However, to provide more guidance about the submission of renewal applications, we recommend that the registration application and the information necessary to conduct the required security risk assessments be submitted at least 8 weeks prior to the expiration of the date of the certificate of registration.

Interim 7 CFR 331.6(b)(1) and 9 CFR 121.7(b)(1) (newly designated 7 CFR 331.7 and 9 CFR 121.7) indicated that, as one of the conditions of registration, the owner or controller of an entity must be approved by APHIS following a security risk assessment by the Attorney General.

A commenter asked who would be deemed to own or control the entity in the context of an academic institution. Another commenter thought the phrase “individual who controls the facility” meant the senior administrators to whom the responsible official reports and not the members of the Board of Trustees.

The determination of who is an owner or controller of an academic institution (

i.e.

, institution of higher education) depends on whether it is a public or private institution of higher education. Federal, State, or local governmental agencies, including public institutions of higher education, are exempt from the security risk assessment for the entity and the individual who owns or controls such entity. However, for a private institution of higher education, an individual will be deemed to own or control the entity if the individual is in a managerial or executive capacity with

regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity. We consider an entity to be an institution of higher education if it is an institution of higher education as defined in the Higher Education Act of 1965 (20 U.S.C. 1001(a)) or an organization described in the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3)). Because entities that meet this criteria do not have an owner, the individual(s) in control of the entity must be approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General. For all other entities, an individual will be deemed to own or control the entity if the individual: (1) Owns 50 percent or more of the entity, or is a holder or owner of 50 percent or more of its voting stock, or (2) is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity.

To clarify the requirements for owners or controllers of an entity, we are making several changes to the registration sections in this final rule. We are making clear that the individuals must be approved by the Administrator or HHS Secretary based on a security risk assessment by the Attorney General (7 CFR 331.7(c)(1) and 9 CFR 121.7(c)(1)). We are also moving the information contained in footnote 4 in interim 7 CFR 331.6 and footnote 7 in interim 9 CFR 121.7 to a new paragraph in both sections, 7 CFR 331.7(c)(2) and 9 CFR 121.7(c)(2), which states that Federal, State, or local governmental agencies, including public institutions of higher education, are exempt from the security risk assessment for the entity and the individual who owns or controls such entity. In addition, we are adding the following paragraphs to both 7 CFR 331.7 and 9 CFR 121.7 to clarify who will be deemed to own or control an entity and to indicate the criteria by which an entity will be considered an institution of higher education:

• For a private institution of higher education, an individual will be deemed to own or control the entity if the individual is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity.

• For entities other than institutions of higher education, an individual will be deemed to own or control the entity if the individual: (1) Owns 50 percent or more of the entity, or is a holder or owner of 50 percent or more of its voting stock; or (2) is in a managerial or executive capacity with regard to the entity's select agents or toxins or with regard to the individuals with access to the select agents or toxins possessed, used, or transferred by the entity.

• An entity will be considered to be an institution of higher education if it is an institution of higher education as defined in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)), or is an organization described in 501(c)(3) of the Internal Revenue Code of 1986, as amended (26 U.S.C. 501(c)(3)).

Finally, we are adding a footnote to 7 CFR 331.7 and 9 CFR 121.7 to clarify that more than one individual may meet the criteria for ownership or control of an entity.

Interim 7 CFR 331.6(b)(2) and 9 CFR 121.7(b)(2) provided that APHIS may issue a certificate of registration if, among other things, the Administrator approves an entity's biosafety, containment, and security.

In drafting this provision, we intended to stress to the regulated community the importance of the biosafety, containment, and security requirements. However, we did not intend to suggest that an individual or entity did not have to meet the other requirements of the regulations. Since the issuance of a certificate of registration is an administrative action taken by APHIS, it is not necessary to include this provision in the regulations. Accordingly, we are deleting this provision in both sections.

Interim 7 CFR 331.6(b)(3) and 9 CFR 121.7(b)(3) provided that APHIS may issue a certificate of registration if, among other things, the Administrator determines that the individual or entity seeking to register has a lawful purpose to possess, use, or transfer agents or toxins.

One commenter stated that it is unclear how APHIS will determine if the entity has an unlawful purpose to possess, use, or transfer select agents. The commenter asked what information APHIS will use to make this determination.

To determine whether an entity has a lawful purpose to possess, use, or transfer select agents or toxins, APHIS will consider the information contained in the registration application and any other information available to APHIS about the entity. This determination will be made on a case-by-case basis. However, since this is an administrative action taken by APHIS, it is unnecessary to include this provision in the regulations. Accordingly, we are deleting this provision in both sections. In addition, we are amending newly designated 7 CFR 331.7(f) and 9 CFR 121.7(f) to clarify that the issuance of a certificate of registration may be contingent upon inspection or submission of additional information, such as the security plan, biocontainment/biosafety plan, incident response plan, or any other documents required to be prepared under each part. These changes will make the APHIS and CDC regulations consistent.

In interim 7 CFR 331.5(b) and 9 CFR 121.6(b), we provided that each entity must designate an individual to be its responsible official and that this individual must have the authority and control to ensure compliance with the regulations. Furthermore, in interim 7 CFR 331.6(c) and 9 CFR 121.7(d), we provided that a certificate of registration will be valid for only the specific agents or toxins and specific activities and locations listed on the certificate.

One commenter stated an entity should be able to apply for a single certificate of registration to cover activities at all buildings on a campus or site under the control and authority of the responsible official, which would include both contiguous and dispersed sites within a local geographical area. The commenter stated that it is overly burdensome to require separate registrations for each general physical location (defined as a building or a complex of buildings at a single mailing address). The commenter claimed that the administrative and control functions at research and academic institutions are efficiently managed by a centralized department responsible for more than one physical location. Similarly, a commenter stated that the provisions concerning location should be amended to cover a single administrative organization under a single responsible official. Another commenter requested that the final regulations allow campuses to designate responsible officials with responsibility for an entire campus.

APHIS designed these provisions to ensure that the responsible official has the requisite authority and control to ensure compliance with the select agent regulations. We reasoned that a responsible official would be better able to ensure compliance with the regulations if he/she managed only one general physical location. While we still believe that to be true, we recognize that some responsible officials will be able to ensure compliance for an entire campus or business complex. Therefore, in this final rule, the registration sections (newly designated 7 CFR 331.7(g) and 9 CFR 121.7(g)) provide that a certificate

of registration will be valid for one physical location (a room, a building, or a group of buildings) where the responsible official will be able to perform the responsibilities required in this part, for specific select agents or toxins, and for specific activities. We believe this change will provide more flexibility and guidance to entities seeking to register.

In interim 7 CFR 331.6(d) and 9 CFR 121.7(e), we provided that a certificate of registration may be amended to reflect changed circumstances and that the responsible official must immediately notify APHIS of such changes in circumstances that occur after submission of the application for registration or after receipt of a certificate of registration.

A commenter said that it is unclear how great a change would require notification of APHIS or CDC. The commenter suggested that investigators should instead submit annual reports of projects done and projects planned. Another commenter stated that there is no specific information in the regulations about what information must be reported and what constitutes immediately (

i.e.

, within 24 hours). The commenter indicated that, if the entire registration application must be resubmitted, then APHIS should allow a minimum of 7 to 10 business days.

To clarify the requirements for amending a registration application and a certificate of registration, in this final rule we are deleting the provisions of interim 7 CFR 331.6(d) and 9 CFR 121.7(e). In their place, we are adding a new paragraph (e) in newly designated 7 CFR 331.7 and 9 CFR 121.7 that requires the responsible official to provide prompt notification of any changes in the registration application by submitting the relevant page(s) of the registration application. In addition, we are adding a new paragraph (h) in both sections to require that, prior to any change, the responsible official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application. Finally, to clarify the requirements for when an entity loses the services of its responsible official, we are adding a new paragraph (i) in both sections to require an entity to immediately notify APHIS or CDC if it loses the services of its responsible official. These paragraphs also provide that an entity may continue to possess or use select agents or toxins only if it appoints as the responsible official another individual who has been approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General and who meets the requirements of the regulations.

Interim 7 CFR 331.6(e) and 9 CFR 121.7(f) stated that a responsible official who wishes to discontinue possessing, using, or transferring an agent or toxin may inactivate the agent or toxin or he/she may transfer the agent or toxin to a registered entity. Both sections further provided that APHIS must be notified 5 business days prior to a planned inactivation so that APHIS may have the opportunity to observe the inactivation.

One commenter asked when APHIS will observe the destruction of a select agent. Another commenter asked if a responsible official for a diagnostic laboratory is required to notify APHIS 5 business days prior to destroying a select agent or toxin.

In the final rule, we are deleting these paragraphs and simply providing that a certificate of registration will be terminated upon the written request of the entity if the entity no longer possesses or uses any select agents or toxins and no longer wishes to be registered (newly designated 7 CFR 331.7(j) and 9 CFR 121.7(j)). This change should eliminate any confusion between this reporting requirement and the reporting requirements for diagnostic exemptions.

The regulations (interim 7 CFR 331.6(f) and 9 CFR 121.7(g); newly designated 7 CFR 331.7(k) and 9 CFR 121.7(k)) state that a certificate of registration will be valid for a maximum of 3 years.

A commenter recommended that certificates of registration be valid for 5 years to be consistent with the security risk assessments, simplify paperwork requirements for the entity, and reduce cost to government.

We believe it is reasonable to provide that a certificate of registration will be valid for a maximum of 3 years. A 3-year registration period takes into consideration the burden on the public and the risks posed by select agents and toxins. In addition, it is consistent with APHIS’ permit systems and other established programs for laboratory certification or registration (e.g., Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP)), which are generally valid for 2 to 3 years. Accordingly, we are making no change based on this comment.

Denial, Revocation, and Suspension of Registration

Interim 7 CFR 331.7(a)(3) and 9 CFR 121.8(a)(3) provided that APHIS may deny an application for registration or revoke registration if the responsible official does not have a lawful purpose to possess, use, or transfer listed agents or toxins. In addition, interim 7 CFR 331.7(a)(4) and 9 CFR 121.8(a)(4) provided that APHIS may deny an application for registration or revoke registration if the responsible official is an individual who handles or uses listed agents or toxins and he/she does not have the necessary training or skills to handle such agents or toxins. To be consistent with CDC, we are deleting these provisions in this final rule.

Interim 7 CFR 331.7(a)(5) provided that APHIS may deny an application for registration or revoke registration if the entity does not meet the containment and security requirements prescribed by the Administrator, while interim 9 CFR 121.8(a)(5) provided that APHIS may deny an application for registration or revoke registration if the entity does not meet the biosafety, containment, and security requirements prescribed by the Administrator. In addition, interim 7 CFR 331.7(a)(6) provided that APHIS may deny an application for registration or revoke registration if there are egregious or repeated violations of the containment or security requirements, while interim 9 CFR 121.8(a)(6) provided that APHIS may deny an application for registration or revoke registration if there are egregious or repeated violations of the biosafety, containment, or security requirements.

In drafting these provisions, we wished to stress to the regulated community the importance of the biosafety, containment, and security requirements. However, we never intended to suggest that an entity did not have to meet the other requirements of each part. Therefore, we are amending these provisions in this final rule to provide that an application may be denied or a certificate of registration revoked or suspended if the individual or entity does not meet the requirements of the applicable part (newly designated 7 CFR 331.8(a)(3) and 9 CFR 121.8(a)(3)). These changes will clarify the registration requirements and make both sections consistent with CDC's regulations.

In addition, in this final rule, we are clarifying the actions an entity must take in the event that APHIS suspends or revokes a certificate of registration. Specifically, we are adding a paragraph to require that, upon notification of suspension or revocation, an individual or entity must: (1) Immediately stop all use of each select agent or toxin covered by the revocation or suspension order; (2) immediately safeguard and secure each select agent or toxin covered by the revocation or suspension order from theft, loss, or release; and (3) comply with all disposition instructions issued

by the Administrator for each select agent or toxin covered by the revocation or suspension (newly designated 7 CFR 331.8(b) and 9 CFR 121.8(b)).

In a footnote to interim 7 CFR 331.7(a)(5) and 9 CFR 121.8(a)(5), we indicated that APHIS may provide technical assistance and guidance on the biosafety, containment, and security requirements. A commenter requested information on when and to what degree APHIS will provide such assistance.

As discussed below in the biocontainment/biosafety and security sections, in this final rule we are providing a list of documents in each part that an entity should consider in developing a biocontainment/biosafety or security plan. We recommend that an entity review these documents before contacting APHIS for technical assistance. We will provide technical assistance and guidance upon request.

Interim 7 CFR 331.7(b) and 9 CFR 121.8(b) provided that APHIS may summarily revoke or suspend registration for any of the reasons set forth in each section.

To clarify the provisions for denial, suspension, and revocation of registration, in this final rule, we are deleting interim paragraph (b) in both sections and simply providing that an application may be denied or a certificate of registration revoked or suspended for the reasons set forth in each section (newly designated 7 CFR 331.8(a) and 9 CFR 121.8(a)).

Interim 7 CFR 331.7(d) and 9 CFR 121.9(d) provided that the denial of an application for registration, revocation of registration, and suspension of registration may be appealed under each part. In this final rule, newly designated 7 CFR 331.8(c) and 9 CFR 121.8(c) provide that the denial of an application for registration and revocation of registration may be appealed under each part. Furthermore, both paragraphs provide that any denial of an application for registration or revocation of a certificate of registration will remain in effect until a final agency decision has been rendered. These changes will clarify the status of an application for registration or a certificate of registration during the appeal process.

Responsibilities of the Responsible Official

To facilitate compliance with the regulations, the regulations (interim 7 CFR 331.9 and 9 CFR 121.10; newly designated 7 CFR 331.9 and 9 CFR 121.9) set out the responsibilities of the responsible official.

One commenter stated that the APHIS and CDC regulations should have the same responsibilities for the responsible official and that these responsibilities should be better defined.

We agree that the APHIS and CDC regulations should contain the same provisions for the responsible official. Therefore, in this final rule, we are amending newly designated 7 CFR 331.9(a) and 9 CFR 121.9(a) to require that an individual or entity required to register under each part designate an individual to be the responsible official. Paragraph (a) further requires that the responsible official:

• Be approved by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General;

• Be familiar with the requirements of this part;

• Have the authority and responsibility to act on behalf of the entity;

• Ensure compliance with the requirements of this part; and

• Ensure that annual inspections are conducted for each laboratory where select agents or toxins are stored or used in order to determine compliance with the requirements of this part. The results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected.

In addition, we are deleting the provision for the alternate responsible official(s) from the registration section and adding it to the responsible official section (newly designated 7 CFR 331.9(b) and 9 CFR 121.9(b)). These changes will make the APHIS and CDC regulations consistent.

A commenter recommended that APHIS add the following language to the regulations: “This does not preclude the assignment of activities in §§ 121.10(a)(1) through 121.10(a)(8) to other individuals, provided the activities are performed or supervised by a person approved under § 121.11 and the results are reviewed and approved by the Responsible Official or Alternate Responsible Official.” The commenter stated that it would be inappropriate for the responsible official to participate in the actual transferring of an agent or to perform data entry to maintain records.

In response to this comment, in this final rule we are amending the regulations to provide that the individual or entity required to register under each part, and not the responsible official, must provide training, maintain records, and provide notice of theft, loss, or release of select agents or toxins (newly designated 7 CFR 331.15 and 9 CFR 121.15, 7 CFR 331.17 and 9 CFR 121.17, and 7 CFR 331.19 and 9 CFR 121.19). This change will allow the responsible official to delegate certain responsibilities. For instance, interim 7 CFR 331.14(a) and 9 CFR 121.15(a) stated that the responsible official must maintain complete, up-to-date records of information necessary to give an accounting of all of the activities related to listed agents or toxins. In this final rule, we are amending the regulations to require the individual or entity to maintain such records (newly designated 7 CFR 331.17 and 9 CFR 121.17).

Interim 7 CFR 331.9(b) and 9 CFR 121.10(b) (newly designated 7 CFR 331.9 and 9 CFR 121.9) required the responsible official for a diagnostic laboratory, or other entity possessing, using, or transferring listed agents or toxins that are contained in specimens presented for diagnosis to immediately report the identification of such agents or toxins to the Administrator and to other appropriate authorities when required by Federal, State, or local law. Furthermore, both paragraphs provided that the Administrator may require less frequent reporting during agricultural emergencies or outbreaks, or in endemic areas.

In this final rule, we are amending newly designated 7 CFR 331.9(c) and 9 CFR 121.9(c) to require the responsible official to report the identification and final disposition of any select agent or toxin contained in a specimen for diagnosis or verification. In addition, we are adding a new paragraph (d) to 9 CFR 121.9 to require the responsible official to report the identification and final disposition of any select agent or toxin contained in a specimen presented for proficiency testing. This information will help us to identify outbreaks and to monitor activities related to select agents and toxins.

We are also amending newly designated 9 CFR 121.9(c) to require the responsible official to immediately report the identification of specified select agents and toxins with a report of the final disposition of the agent or toxin due within 7 calendar days after identification. The responsible official must report the identification and final disposition of the other select agents and toxins within 7 calendar days after identification. This will make the reporting requirements for registered entities consistent with those in the exemption sections (newly designated 9 CFR 121.5 and 121.6). Finally, we are deleting in both sections the requirement that the identification of a select agent or toxin be reported to appropriate authorities when required

by Federal, State, or local law (interim 7 CFR 331.9(b) and 9 CFR 121.10(b)). This change corresponds to a similar change made in the exemption sections (interim 7 CFR 331.4, 9 CFR 121.4, and 9 CFR 121.5).

One commenter requested clarification of the diagnostic exemptions and the provisions of interim 9 CFR 121.10(b) requiring the responsible official for a diagnostic laboratory to report identifications. The commenter noted that exempt diagnostic laboratories are not required to have a responsible official.

The reporting requirements in interim 9 CFR 121.10(b) (newly designated 7 CFR 331.9(c) and 9 CFR 121.9(c)) pertain to

registered

diagnostic laboratories. The regulations require that both exempt and registered entities report the identification of a select agent or toxin. We adopted these reporting requirements because this information will help us to identify outbreaks and to monitor activities related to select agents and toxins. Accordingly, we are making no change in response to this comment.

Restricting Access/Security Risk Assessments

Interim 7 CFR 331.10 and 9 CFR 121.11 stated that an individual may not have access to listed agents and toxins unless approved by APHIS or, for overlap agents, APHIS or CDC. Both sections provided that APHIS will grant, limit, or deny access approval and, interim 9 CFR 121.11, provided that APHIS or CDC will make this determination for overlap agents or toxins. Interim 7 CFR 331.10 and 9 CFR 121.11 further provided that the responsible official is responsible for ensuring that only approved individuals within the entity have access to agents or toxins.

In this final rule, we are amending these sections to clarify that an individual must be approved for access by the Administrator or the HHS Secretary following a security risk assessment by the Attorney General (newly designated 7 CFR 331.10 and 9 CFR 121.10). In addition, we are deleting the provision that the responsible official is responsible for ensuring that only approved individuals have access to select agents or toxins. This change will make it clear that the registrant and the individual are responsible for ensuring that the individual does not have access to any select agent or toxin unless approved by the Administrator or the HHS Secretary.

Several commenters requested information about the security risk assessments conducted by the Attorney General.

To obtain a security risk assessment, an individual or entity must submit a completed FBI Form FD-961 and two legible fingerprint cards, printed by a local law enforcement agency, to the Criminal Justice Information Services (CJIS) Division of the Federal Bureau of Investigation. Fingerprint cards and FBI Form FD-961 may be obtained by calling (304) 625-4900. FBI Form FD-961 is also available on the Internet at

http://www.fbi.gov/terrorinfo/bioterrorfd961.htm.

It would be impractical to include this information in the regulations because the Attorney General determines the information and processes required for a security risk assessment. Accordingly, we are making no change based on these comments.

One commenter recommended that security risk assessments be completed within 2 weeks. Another commenter stated that a person should be permitted to work with select agents or toxins under the direct supervision of an approved person if the individual subject to the background check suffers a delay in excess of 10 working days.

Security risk assessments are conducted by the Attorney General, not APHIS. The time required to complete a security risk assessment depends on the completeness of the application and the results of the database search. In general, a security risk assessment may be completed in 45 days. However, in certain cases, additional time may be needed to verify the results of the database search. We are making no changes based on these comments.

A commenter asserted that personnel screening should include, at a minimum, a criminal background check, credit check, and random drug screening.

In accordance with the Act, each individual identified by the responsible official must undergo a security risk assessment. The Act does not require a credit check or random drug screening. However, this does not preclude an entity from having more stringent personnel screening for individuals with access to select agents or toxins. Accordingly, we are making no changes based on this comment.

Interim 7 CFR 331.10(b) and 9 CFR 121.11(b) required the responsible official to request access approval for only those individuals who have a legitimate need to handle or use listed agents or toxins, and who have the appropriate training and skills to handle such agents and toxins.

APHIS received a number of comments dealing with the term “access.” A commenter stated that judgments about an individual's need to handle agents and the adequacy of their training and skills is a matter for the responsible official, not APHIS. This commenter recommended that APHIS rely upon the responsible official to make informed judgments about an individual's need for access and their proficiency in handling select agents and toxins. One commenter noted the term “access” is used to describe two distinct situations—access to select agents and toxins by individuals who are authorized to handle and use them, and approved entry to an area where select agents or toxins are present by individuals who are not authorized to handle or use such agents or toxins. Several commenters recommended that APHIS define the term “access” as the “ability to gain physical control of select agents and toxins.” Another commenter suggested the word “access” be changed to “handle or use” throughout the regulations. The commenter noted that many people may have access to a containment space but never handle or use agents or toxins. Similarly, one commenter argued that the regulations are conceptually flawed because they focus on restricting access to the laboratory rather than to the select agent or toxin. The commenter said that numerous individuals need to access lab space for a variety of reasons and that it is unnecessary and burdensome to require that they be continually escorted or undergo security risk assessments. Another commenter recommended that APHIS define the term “entry,” which would refer to admission of unapproved individuals into an area where select agents and toxins are present.

In the December 2002 interim rule, we provided that an individual may not have access to listed agents or toxins unless approved by APHIS or, for overlap agents or toxin, APHIS or CDC. We required access approval for each individual with a legitimate need to handle or use agents or toxins, and the necessary training and skills to handle such agents or toxins. We continue to believe that individuals that handle or use select agents or toxins must be approved for such access. However, we agree with the commenters that access approval should also be required for individuals who have the ability to gain possession. Therefore, this final rule provides that an individual will be deemed to have access at any point in time if the individual has possession of a select agent or toxin (

e.g.,

carries, uses, or manipulates) or the ability to gain possession of a select agent or toxin (newly designated 7 CFR 331.10(b) and 9 CFR 121.10(b)). In addition, we are

requiring in both sections that each individual with access to select agents or toxins have the appropriate education, training, and/or experience to handle or use such agents or toxins (newly designated 7 CFR 331.10(c) and 9 CFR 121.10(c)). However, in this final rule, we are removing the requirement that the responsible official submit information about an individual's training and skills to APHIS (interim 7 CFR 331.10(e) and 9 CFR 121.11(e)). These changes will make it clear that the registered individual or entity, and not APHIS, is responsible for ensuring that an individual with access to select agents or toxins has the appropriate education, training, and/or experience to handle such agents or toxins.

Several commenters argued that access approval should be portable from entity to entity, from location to location, and from project to project for the duration of the valid period. A commenter stated that delays in access approval could be avoided if an individual's approval was portable. Another commenter asked if an individual will need a new security risk assessment if he or she has already been cleared at one entity but will visit another entity to conduct research.

We do not believe it is necessary to make an individual's access approval portable in order to avoid delays in such approval. The Administrator or the HHS Secretary may grant access approval to an individual following a security risk assessment by the Attorney General. A security risk assessment may be completed in 45 days unless additional time is needed to verify the database search results. However, in recognition of the need for flexibility for visiting researchers, APHIS, CDC, and the Attorney General have developed procedures by which an approved individual may visit another registered entity without having to undergo another security risk assessment by the Attorney General. Specific guidance on these procedures is available on the Internet at

http://www.aphis.usda.gov/programs/ag_selectagent/index/html.

We note that an individual who ceases to be employed by the entity at which he/she originally received access approval must obtain new access approval through his/her new employer. We are making no changes to the regulations in response to these comments.

A commenter asserted that the L or Q clearances (or their equivalent) granted in Department of Energy laboratories should be considered synonymous with the security risk assessment, and, therefore, approved.

Section 212(e) of the Act requires that registered persons provide access to select agents and toxins to only those individuals that have a legitimate need to handle or use such agents and toxins, and that those individuals undergo a security risk assessment by the Attorney General. The Act provides no exemption for Federal clearances. Accordingly, we are making no change based on this comment.

The regulations (interim 7 CFR 331.10(f) and 9 CFR 121.11(f); newly designated 7 CFR 331.10(e) and 9 CFR 121.10(e)) provide that the access approval process for individuals may be expedited upon request by the responsible official and a showing of good cause.

Several commenters stated that APHIS and the Attorney General should establish timelines for responding to requests for expedited review for security risk assessments.

We do not believe it is necessary to establish timelines for responding to requests for expedited review for security risk assessments. In our experience, an expedited security risk assessment can be completed within a week, barring any complications. Therefore, we are making no change based on this comment.

Another commenter asked what constituted “good cause” for expedited review of access approval. This commenter asserted that Federal clearances should be a reason for expedited review.

This final rule cites several examples of good cause to expedite a security risk assessment (

e.g.,

public health or agricultural emergencies, national security, a short-term visit by a prominent researcher). We do not believe that a Federal clearance alone is sufficient reason to expedite a security risk assessment. Thus, we are making no change in response to this comment.

Interim 7 CFR 331.10(h) and 9 CFR 121.11(h) provided that APHIS may deny or limit access of an individual to agents or toxins if:

• The Attorney General identifies the individual as a restricted person under 18 U.S.C. 175b;

• The Attorney General identifies the individual as reasonably suspected by any Federal law enforcement or intelligence agency of (1) committing a crime set forth in 18 U.S.C. 2332b(g)(5), (2) knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence, or (3) being an agent of a foreign power as defined in 50 U.S.C. 1801;

• The Administrator determines that the individual does not have a legitimate need to handle listed agents or toxins;

• The individual does not have the necessary training and skills to handle listed agents or toxins; or

• The Administrator determines that such action is necessary to protect plant health or plant products, or animal health or animal products.

In this final rule, newly designated 7 CFR 331.10(f) and 9 CFR 121.10(f) provide that an individual's access approval may be denied, limited, or

revoked

if the individual is a restricted person under 18 U.S.C. 175b or is reasonably suspected by any Federal law enforcement or intelligence agency of committing a crime set forth in 18 U.S.C. 2332b(g)(5), knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence, or being an agent of a foreign power as defined in 50 U.S.C. 1801. This has always been the way these provisions have been interpreted; however, we are making this change to both sections for clarification purposes.

To be consistent with a change made in the section pertaining to denial, revocation, or suspension of registration (newly designated 7 CFR 331.8 and 9 CFR 121.8), in this final rule we are deleting the provision that the Administrator may deny, limit, or revoke an individual's access approval if the individual does not have a legitimate need to handle select agents or toxins. In addition, we are deleting the provision pertaining to an individual's training and skills to be consistent with CDC's regulations.

A commenter stated that limited access, whereby the individual can only handle or use the agent or toxin under the direct supervision of an approved individual, is impractical. The commenter noted that each faculty member, postdoctoral fellow, or student who is a member of a research team is expected to make significant, independent contributions to research; also, it would be too burdensome for institutions to track whether individuals have full or limited access. The commenter stated that provisions for limited access would be unnecessary if the regulations included a precise definition of access.

Section 212(e)(2) of the Act provides for limited access approval. The Administrator will determine what constitutes limited access on a case-by-case basis. The determination will take into consideration all of the facts at

hand and be commensurate with the risks posed by the select agent or toxin. We are making no change based on this comment.

One commenter argued that the Attorney General should allow the research community to comment on how the definition of “restricted person” will be interpreted and applied. This commenter stated that, while the Attorney General is bound by statutory language in the respective categories, interpretation will be required to make the definitions operational. For instance, the commenter asked if a scientist who has fled political persecution in another country, and who may therefore have an outstanding foreign arrest warrant, would be considered a restricted person. Another commenter recommended that the Administrator reserve the authority, in exceptional circumstances, to allow individuals deemed ineligible to have access to select agents and toxins for a limited time. The commenter stated that it is in the national interest to take a nuanced approach that takes into account the contributions the individual may be able to make to the country. This commenter stated there should be an opportunity for individuals and their sponsoring institutions to make the argument that an individual has exceptional talent and insight that should be used to advance research, and that an individual does not present a security risk, even if he or she meets the criteria for a restricted person.

The statutory requirements are clear, and it is not necessary for the research community to assist in the interpretation and application of the term ‘restricted person.’ In accordance with the Act, the Administrator may limit or deny access to PPQ and VS select agents and toxins to individuals whom the Attorney General has identified as a “restricted person” under 18 U.S.C. 175b. Furthermore, the Administrator must deny access to overlap select agents and toxins to individuals whom the Attorney General has identified as a “restricted person.” According to 18 U.S.C. 175b, “the term “restricted person” means an individual who:

• Is under indictment for a crime punishable for a term exceeding 1 year;

• Has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year;

• Is a fugitive from justice;

• Is an unlawful user of any controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802));

• Is an alien illegally or unlawfully in the United States;

• Has been adjudicated as a mental defective or has been committed to any mental institution;

• Is an alien (other than an alien lawfully admitted for permanent residence) who is a national of a country as to which the Secretary of State, pursuant to section 6(j) of the Export Administration Act of 1979 (50 U.S.C. App. 2405(j), section 620A of chapter 1 of part M of the Foreign Assistance Act of 1961 (22 U.S.C. 2371), or section 40(d) of chapter 3 of the Arms Export Control Act (22 U.S.C. 2780(d)), has made a determination (that remains in effect) that such country has repeatedly provided support for acts of international terrorism; or

• Has been discharged from the Armed Services of the United States under “dishonorable conditions.”

Based on the foregoing, we are making no change in response to this comment.

Interim 7 CFR 331.10(g) and 9 CFR 121.11(g) provided that APHIS will notify the responsible official if an individual is granted full or limited access, or denied access to listed agents or toxins. Both sections further provided that APHIS will notify the individual if he/she is denied access or is granted only limited access.

Several commenters recommended that any entities or individuals denied access to select agents and toxins be notified of the reasons for the denial; otherwise, they are unable to make a meaningful request for an administrative review.

APHIS will provide written notice of any denial, limitation, or revocation of access approval, including the reason(s) therefore. However, since this is an administrative action “taken” by APHIS, it is unnecessary to include this information in the regulations. Accordingly, we are deleting this paragraph in both sections in this final rule.

The regulations (interim 7 CFR 331.10(j) and 9 CFR 121.11(k); newly designated 7 CFR 331.10(h) and 9 CFR 121.10(i)) provide that access approval is valid for a maximum of 5 years.

One commenter recommended that APHIS reconsider the timeframes for renewal of registration packages (3 years) and access approval (5 years). The commenter stated that it would be easier for the regulated community if the renewals were concurrent and could be sent at one time.

In establishing the timeframe for registration, we took into consideration the risks of the select agents and toxins and the fact that APHIS’ permits are valid for a similar timeframe, while, in establishing the timeframe for access approvals, we took into consideration the burden on the public and the fact that the Act allows for approvals to be valid for up to 5 years. We believe that these timeframes are reasonable and consistent with the requirements of the Act. We do not believe that it will be easier for the regulated community if the renewals are concurrent and can be sent at one time. Access approvals are granted by the Administrator or the HHS Secretary on a rolling basis due to frequent staff changes at entities and variations in the time it takes for the Attorney General to conduct an individual's security risk assessment. If APHIS adopted the same timeframe for registration and access approval, it is likely that some individuals in an entity would have to renew their access approvals in a much shorter timeframe than other individuals in the same entity. We believe this would cause undue burden on the public. Accordingly, we are making no changes based on this comment.

The regulations (interim 7 CFR 331.10(k) and 9 CFR 121.11(l); newly designated 7 CFR 331.10(i) and 9 CFR 121.10(j)) require immediate notification when an individual's access to agents or toxins is terminated by the entity and the reasons therefore.

A commenter requested clarification as to what constitutes “immediately.” The commenter stated that large entities would find it difficult to provide written notices within 24 hours. The commenter recommended that APHIS require an initial notification by phone or fax within 72 hours that is followed up by a written notice within 7 business days.

The regulations do not require written notice of a termination of access. Notice of a termination of access may be provided by telephone, fax, or e-mail. We are making no change in response to this comment.

Security

Interim 7 CFR 331.11 required that an individual or entity develop and implement a Biocontainment and Security Plan. Interim 9 CFR 121.12 contained similar requirements for a Biosafety and Security Plan. In both sections, paragraph (a)(2) stated that the security systems and procedures must be designed according to a site-specific risk assessment and provide graded protection in accordance with the threat posed by the agent or toxin. Both sections also set out the types of information that should be contained in the security plan.

A commenter asserted that biological lab security should be administered by only one Federal agency (

i.e,

the Department of Homeland Security) to ensure consistency.

Section 212(b) of the Act requires APHIS to establish and enforce safeguard and security measure to prevent access to select agents and toxins for use in domestic or international terrorism or for any other criminal purpose. In addition, the Act provides for interagency coordination between APHIS and CDC regarding overlap select agents and toxins. As discussed below, APHIS and CDC have amended the regulations so that the security requirements are identical and APHIS and CDC have established procedures to ensure consistent regulation of select agents and toxins. For these reasons, we are making no change in response to this comment.

A commenter recommended that APHIS and CDC adopt identical security provisions. Several commenters asked whose security, inspection, and compliance standards will be used for overlap agents—APHIS' or CDC's. These commenters also asked what will happen if APHIS and CDC do not concur.

Both the APHIS and CDC select agent regulations apply to overlap select agents and toxins. To eliminate confusion about whose security standards will be used for overlap select agents and toxins, we are amending the security sections in this final rule so that the APHIS and CDC security requirements are identical (newly designated 7 CFR 331.11 and 9 CFR 121.11). These changes are discussed in detail below. We believe these changes will help to ensure consistent regulation of select agents and toxins by APHIS and CDC, including compliance inspections. We note that compliance inspections for security will be based on the regulations and that inspectors will be looking for security that provides graded protection commensurate with the risk of the select agent or toxin, given its intended use.

Several commenters expressed concern that the regulations do not provide for preclearance of security plans before an entity invests in a security system.

In this final rule, we recommend that an individual or entity consider the following document when developing a security plan—“Laboratory Security and Emergency Response Guidance for Laboratories Working With Select Agents,” in Morbidity and Mortality Weekly Report. An individual or entity should review this document before contacting APHIS for technical assistance. We will provide technical assistance and guidance upon request. However, in recognition of the commenters' concerns, we note that APHIS and CDC are working with interagency groups and security experts to draft a document that will provide additional guidance about the security required for select agents and toxins. This document will be available in spring 2005. We will provide this guidance document to the regulated community when it is available.

A commenter stated that the regulations should clearly distinguish between lab security and entity security, especially for large academic settings where a secure lab may coexist with educational and research labs.

We disagree. The security regulations are designed to prevent unauthorized access, theft, loss, or release of select agents and toxins. The regulations require that an entity's security plan be designed according to a site-specific risk assessment. Such a risk assessment would take into consideration the security needed for a select agent lab in a large academic setting. Therefore, we are making no change based on this comment.

One commenter asked what constituted an adequate description of safety and security in the required plans. Another commenter asked who will judge the adequacy of a security plan.

A security plan must be sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release. APHIS or CDC will determine if a security plan is adequate. We are making no changes in response to these comments.

The introductory text in interim 7 CFR 331.11(a)(2) and 9 CFR 121.12(a)(2) stated that the security systems and procedures must be designed according to a site-specific risk assessment and must provide graded protection in accordance with the threat posed by the agent or toxin. Both sections further provided that the site-specific risk assessment should involve a threat assessment and risk analysis in which threats are defined, vulnerabilities examined, and risks associated with those vulnerabilities identified. Both sections also stated that the security systems and procedures must be tailored to address site-specific characteristics and requirements, ongoing programs, and operational needs and must mitigate the risks identified.

A commenter suggested replacing the phrase “in accordance with the threat posed by the agent” with the phrase “in accordance with the consequences posed by the agent or toxin.” Another commenter pointed out that the terms “risk assessment,” “threat assessment,” “vulnerability assessment,” and “threats” are confusing to those with little experience in this area and should be clarified. A commenter suggested that APHIS replace the phrase “risks associated with those vulnerabilities are mitigated” with the phrase “consequences associated with those vulnerabilities are mitigated.”

In response to these comments, in this final rule we are deleting this text in both sections and adding in its place the requirement that an entity's security plan be sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release (newly designated 7 CFR 331.11(a) and 9 CFR 121.11(a)). In addition, we are amending both sections to require that the security plan be designed according to a site-specific risk assessment and provide graded protection in accordance with the risk of the select agent or toxin, given its intended use. We believe these changes will clarify the requirements and make the text in this section consistent with other sections in the regulations (

e.g.

, biocontainment/biosafety).

One commenter recommended that entities be required to comply with Appendix F of the BMBL as well as the specific USDA manuals cited in the rule. The commenter stated that this would mandate the use of state-of-the-art approaches for safety and security. A commenter stated that the security regulations are inadequate (

i.e.

, key locks and key control) and recommended that the pathogens be secured with a modern access control system. Another commenter stated that the regulations should specify minimum security standards. The commenter recommended the following: (1) A minimum of three levels of access control (

e.g.

, access to the building, access to the wing of the building, and access to the laboratory); (2) a minimum of two levels of access control with video surveillance; (3) a minimum of one level of access control with security personnel; and (4) a minimum of one level of access control with an alarm system with off-site monitoring.

On the other hand, several commenters recommended a performance standard for compliance with the regulations. One commenter stated that Appendix F of the BMBL does not provide appropriate guidance for developing a performance-based security program because it implies the need for a rigorous security program applicable uniformly to all biosafety levels. The commenter noted that overly prescriptive requirements will impede the development of effective and affordable plans and will result in constraining the availability of select agents and toxins for the legitimate

purposes specified in the Act. Another commenter stated that toxins should not be subject to the same biocontainment and security measures as viruses, bacteria, fungi, and plant pathogens (which are capable of replication). The commenter suggested a two-tiered approach, with a higher level of security and biocontainment for materials that can be propagated. Similarly, a commenter stated the security requirements should recognize that not all listed agents are equal from a weaponization perspective; therefore, a set of graded protection requirements should be established so that the most dangerous pathogens and the most likely to be weaponized are protected at higher levels than the majority of the select agents.

Because different select agents and toxins pose differing degrees of risk, we believe it would be counterproductive to attempt to prepare a detailed list of prescriptive requirements for entities (

i.e.

, a “one size fits all” design standard). Therefore, the regulations contain performance standards for biocontainment/biosafety, security, and incident response that take into account the risks presented by a particular agent or toxin, given its intended use.

With regard to security, newly designated 7 CFR 331.11 and 9 CFR 121.11 require each individual or entity required to register under each part to develop and implement a written security plan. This security plan must be designed according to a site-specific risk assessment and must provide graded protection in accordance with the risk of the select agent or toxin, given its intended use. In addition, newly designated 7 CFR 331.11 and 9 CFR 121.11 require the individual or entity to adhere to specified security requirements or implement measures to achieve an equivalent or greater level of security. We believe these security provisions provide enough flexibility and specificity to allow an individual or entity to develop and implement a security plan that will safeguard the select agent or toxin against unauthorized access, theft, loss, or release.

However, in recognition of the commenters' concerns, we reiterate that APHIS and CDC are working with interagency groups and security experts to draft a document that will provide additional guidance about the security required for select agents and toxins. This document will be available in spring 2005. The 5th edition of the BMBL, which is under development, will provide additional guidance on laboratory security.

Interim 7 CFR 331.11(a)(2)(iii) and 9 CFR 121.12(a)(2)(iii) required that the security plan describe, among other things, cybersecurity.

One commenter recommended that the term cybersecurity be replaced with “information and cybersecurity.” The commenter also recommended spelling out the assets that should be protected and how they are to be protected.

In this final rule, we are amending these provisions by removing the word “cybersecurity” and adding in its place the words “information systems control” (newly designated 7 CFR 331.11(c)(1) and 9 CFR 121.11(c)(1)). This change is consistent with changes made throughout this final rule to ensure that information about select agents and toxins is protected.

Interim 7 CFR 331.11(a)(2)(iv) and 9 CFR 121.12(a)(2)(iv) provided that, with respect to areas containing listed agents or toxins, an entity or individual must adhere to the specified security requirements or implement measures to achieve an equivalent or greater level of security.

Two commenters requested clarification of the term “area” with regard to large multi-use laboratories. One commenter stated there is little benefit in terms of security to require access control, specialized training, and personnel background checks for individuals who are only sharing lab space with individuals working with select agents or toxins. Another commenter suggested that the regulations should be flexible enough to allow local solution of this issue (

i.e.

, allowing the entity to designate a portion of the lab as a select agent area for which use and entry restrictions would be governed by the regulations). A commenter recommended that, where labs are used intermittently for select agent research, free access be permitted when select agents and toxins are not in use and when the agents/toxins are secured in a safe or other secured storage.

As previously noted, the security requirements are designed to prevent unauthorized access, theft, loss, or release of select agents and toxins. We believe the regulations provide enough flexibility for an entity to determine the best way to accomplish this goal. However, since the term “area” appears to be confusing, in this final rule we are deleting the phrase “with respect to areas containing listed agents or toxins” (newly designated 7 CFR 331.11(d) and 9 CFR 121.11(d)).

Interim 7 CFR 331.11(a)(2)(iv)(A) and 9 CFR 121.12(a)(2)(iv)(A) stated that an entity must allow unescorted access only to those approved indivi

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