Compliance

Select Agent Regulations

The National Select Agents Registry Program, part of the Federal Government Center for Disease Control and Prevention (CDC) Division of Select Agents and Toxins, oversees the activities of possession of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products. The NSAR currently requires registration of facilities including government agencies, universities, research institutions, and commercial entities that possess, use or transfer biological agents and toxins.

Recently, the Select Agent regulations have been amended. The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121) in the Federal Register on October 05, 2012 . All provisions of the final rules supersede those contained in the previous final rules. (This information comes directly from the National Select Agent Registry Webpage. On December 4, 2012, the following Sections of became effective: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 13, 16, 17, 18, 19, 20, and 21.  On April 3, 2013, the following sections will become effective: 11, 12, 14, and 15.  See the Emerging Compliance Issues/ Concerns for information on how the regulations have changed.

Applicable Laws and Regulations

Amended Regulations Effective December 4, 2012

7 C.F.R. Part 331, TITLE 7—AGRICULTURE, CHAPTER III--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE, PART 331 - POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS

9 C.F.R. Part 121, TITLE 9--ANIMALS AND ANIMAL PRODUCTS, CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE, PART 121- POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS

42 C.F.R. Part 73, TITLE 42—PUBLIC HEALTH, CHAPTER I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES, PART 73-POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS

USDA Final Rule, Federal Register Vol. 77 Friday, No. 194 October 5, 2012 Part II; Department of Agriculture Animal and Plant Health Inspection Service
7 CFR Part 331, 9 CFR Part 121 Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations

Emerging Compliance Issues/ Concerns

HHS Federal Register Notice, Vol. 77 Friday, No. 194 October 5, 2012, Part III, Department of Health and Human Services, 42 CFR Part 73, Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review; Final Rule; Published on the Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage

Regulatory Impact Analysis, Regulatory Impact Analysis & Final Regulatory Flexibility Analysis, Final Rule; Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Reorganization of the Select Agent and Toxin List; Published on the Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage

List of Select Agents and Toxins; Published on the Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage

Comparison Table of Changes on HHS Select Agent Regulations; Published on the Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage

Federal Register Notice from September 14, 2012 to announce changes; Published on the Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage

Resources

National Select Agent Registrywebpage, on the Federal Government Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage

Select Agent Regulations webpage, on the Federal Government Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage

Guidance Documents for Final Rules Compliance Assistance on the National Select Agent Registry Webpage, hosted on the Centers for Disease Control and Prevention, Divison of Select Agents and Toxins webpage
This website contains information that offers guidance on complying with the requirements of the Select Agent Regulations, and includes the following guidance documents that were issued on October 1, 2012:

•  Guidance for Meeting Training Requirements of the Select Agent Regulations
• Guidance for Suitability Assessments
• Guidance on the Inventory Requirements for Select Agents and Toxins
• Occupational Health Program Guidance Document for Working with Tier 1 Select Agents and Toxins
• Incident Response Plan Guidance Document
• Information Systems Security Control Guidance Document
• Responsible Official Guidance Document
• Security Guidance for Select Agent or Toxin Facilities

Anonoymous Reporting of Select Agent Regulation Violations
The Federal Government Office of Inspector General allows for Anonymous Reporting of violations related to the Select Agent regulations to "provide a mechanism for you to report safety, security, or other concerns associated with select agents and toxins, Department of Health & Human Services, Office of Inspector General (OIG) maintains a hotline which offers a confidential means for reporting this vital information."   
OIG Hotline contact information:
Voice: 1-800-HHS-TIPS (800-447-8477); Fax: 1-800-223-8164; Web Form Submission: http://oig.hhs.gov/fraud/hotline; Mail: Office of Inspector General, Department of Health & Human Services, Attn: Hotline , P.O. Box 23489, Washington, DC 20026

The information contained on the SUNY Compliance website is for general campus guidance only and is not intended, nor can be relied upon, as legal advice or the imposition on SUNY campuses of specific policies or requirements.  The site is intended to be an informational-only clearinghouse for some of the laws, rules, and regulations that may impact the State University of New York’s campuses.  Additionally, given the rapid, changing nature of laws, rules and regulations, there may be delays or omissions contained on this site which therefore cannot be relied upon as complete.    For complete compliance information, consult your campus compliance officials or the SUNY Compliance Administrator.  For legal advice, consult your lawyer.