ABSA Comments on CDC Select Agent Rule
a letter written by Barbara Johnson, Ph.D., RBP
President, American Biological Safety Association
5 February 2003
Select Agent Program
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Mail Stop E-79
Atlanta, GA 30333
February 5, 2003
The American Biological Safety Association (ABSA) is an organization of biological safety practitioners who work in a variety of academic, governmental, and private work environments. We have reviewed the Centers for Disease Control and Prevention (CDC) interim final rule regarding the "Possession, Use, and Transfer of Select Agents and Toxins" which was published in the December 13, 2002 issue of the Federal Register. We also reviewed the U.S. Department of Agriculture (USDA) interim final rule, "Agricultural Bioterrorism Protection Act of 2002, Possession, Use, and Transfer of Biological Agents and Toxins" which was published in the December 13, 2002 issue of the Federal Register. Please consider the following comments:
Title 42 Code of Federal Regulations (CFR) 73.1 Definitions
We recommend the use of the USDA definition for "Responsible Official" (RO). The RO in that rule is, in part, "The individual designated by the entity to act on its behalf." Both rules have detailed duties for RO's. The full USDA definition provides the sufficient clarity needed in order to provide the expected accountability at sites registered by the CDC Select Agent program.
We recommend including a definition for "access." We recommend defining access as "The ability to gain physical control of select agents and toxins." This definition helps clarify the intent of securing select agents from unauthorized individuals. Only those individuals who are authorized to work with select agents and toxins would have actual unescorted access.
Title 42 CFR 73.6 Exemptions Regarding Diagnosis, Verification, and Proficiency Testing
There is a requirement to report diagnostic test results for specific select agents or toxins to the Department of Health and Human Services (DHHS). Laboratories licensed under the Clinical Laboratory Improvement Act (CLIA) typically do not do so because there is no reporting mechanism for direct provision of this information to the DHHS. The exemption should propose interim options for CLIA-licensed laboratories engaged in diagnostic testing for these pathogens. We recommend reporting of test results for the select agents or toxins noted in this section should be through their state licensing agency or designated health department until such time that the DHHS establishes a direct reporting mechanism.
Title 42 CFR 73.7 Registration
We recommend that DHHS and USDA create one office where all registrations are submitted and received. Such consolidation would aid in the timely review and interagency coordination of documents, and help minimize user confusion. An example involves the potential for misapplied requirements for work with overlap select agents or toxins. Someone who works with overlap agents and registers with the CDC may not be fully addressing all of the USDA registration concerns, usage requirements or permitting process.
A facility should also be able to submit a request for a single certificate of registration to cover multiple buildings on an academic or industrial research campus that are under the authority and control of a given RO. Universities may conduct this research in a number of laboratories that are at physically different addresses within the same geographical area. Many of the aspects of the safety and security programs administered by these entities would be identical, and would be managed by the same groups.
Section 73.7 of this standard indicates that no one may possess or use any select agent or toxin without having been granted a registration certificate. However, Section 73.4(f) of this standard provides that certain quantities of specific types of toxins are exempted from the provisions of this rule. Please clarify if entities are doing work with exempted quantities of toxins at the levels specified in 73.4 whether they are required to obtain a registration certificate.
Section 73.7 (g) is inconsistent with Section 73.8 (f) that states that a certificate of registration may be valid for up to five years. Recommend 73.7 (g) be changed to reflect the certificate of registration be valid for up to five years also.
Title 42 CFR 73.8 Security Risk Assessments
Guidance should be provided in the final rule regarding the content of the information to be provided to the Attorney General in their security risk assessment.
The means/method of submission of this document to the Attorney General should be clarified.
Section 73.8 (f) addresses entity requirements for approving individual access to select agents and toxins. We recommend an individuals access approval' be reciprocal in a manner similar to that used by organizations to facilitate a cleared' individuals entry to classified areas or meetings. The approval' like a security clearance' is associated with an individual not restricted to an institute. This would allow an access approved' individual to move and work more effectively with collaborators at their institutes and on different projects.
Title 42 CFR 73.10 Safety
References can be made to consult the CDC publication "Biosafety in Microbiological and Biomedical Laboratories" and the National Institute of Health (NIH) "Guidelines for Research Involving Recombinant DNA Molecules" (NIH Guidelines), as appropriate to the work, as long as they reference the most current versions of these documents. These documents, especially the NIH Guidelines, are dynamic references that these agencies strive to keep current. We recommend against codification of the provisions of the BMBL and NIH Guidelines themselves. Such action would likely bring them into the standard rulemaking process, and at a minimum would make it difficult to make revisions that keep the technical content current.
We recommend that this rule follow or adhere to an established set of safety standards. Members of ABSA who have had the opportunity to be inspected under Section 72.6 have commented that the inspection team holds facilities to a stricter or varied standard in comparison to the recommendations stated in the BMBL and NIH Guidelines.
Title 42 CFR 173.15 Records
It is not feasible to record quantities (i.e. actual real-time numbers) of replicating organisms. Recommend functional or performance based approaches to documenting replicating agents, such as using a logbook/data entry system to record information typically gathered during a research protocol as part of standard practice or GLP (i.e. quantity of material inoculated, quantity of media added during the work, quantity material used/destroyed, final cell count, etc).
We thank you for the opportunity to have provided input on this rule.
Barbara Johnson, Ph.D., RBP
American Biological Safety Association
Barbara Johnson, Ph.D., RBP, President, ABSA - ABSA Comments on CDC Select Agent Rule, American Biological Safety Association (5 February 2003),