Vol. 76 Monday, No. 191 October 3, 2011

Part V

Department of Agriculture

Animal and Plant Health Inspection Service 7 CFR Part 331 9 CFR Part 121 Agricultural Protection Act of 2002; Biennial Review and Republication of the and Toxin List; Amendments to the Select Agent and Toxin Regulations; Proposed Rule

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DEPARTMENT OF AGRICULTURE and Development, PPD, APHIS, Station determines has the potential to pose a 3A–03.8, 4700 River Road Unit 118, severe threat to animal or plant health, Animal and Plant Health Inspection Riverdale, MD 20737–1238. or to animal or plant products. Service Supporting documents and any Paragraph (a)(2) of section 212 requires comments we receive on this docket the Secretary to review and republish 7 CFR Part 331 may be viewed at http:// the list every 2 years and to revise the www.regulations.gov/ list as necessary. In this document, we 9 CFR Part 121 #!docketDetail;D=APHIS-2009-0070 or are proposing to amend and republish [Docket No. APHIS–2009–0070] in our reading room, which is located in the list of select agents and toxins based room 1141 of the USDA South Building, on the findings of our third biennial RIN 0579–AD09 14th Street and Independence Avenue, review of the list. SW., Washington, DC. Normal reading In determining whether to include an Agricultural Bioterrorism Protection room hours are 8 a.m. to 4:30 p.m., agent or toxin on the list, the Act Act of 2002; Biennial Review and Monday through Friday, except requires that the following criteria be Republication of the Select Agent and holidays. To be sure someone is there to considered: Toxin List; Amendments to the Select help you, please call (202) 690–2817 • The effect of exposure to the agent Agent and Toxin Regulations before coming. or the toxin on animal and plant health, AGENCY: Animal and Plant Health FOR FURTHER INFORMATION CONTACT: Mr. and on the production and marketability Inspection Service, USDA. Charles L. Divan, Branch Chief, APHIS of animal or plant products; • The pathogenicity of the agent or ACTION: Proposed rule. Agriculture Select Agent Program, APHIS, 4700 River Road Unit 2, the toxin and the methods by which the SUMMARY: In accordance with the Riverdale, MD 20737–1231; (301) 734– agent or toxin is transferred to animals Agricultural Bioterrorism Protection Act 5960. or plants; • The availability and effectiveness of of 2002, we are proposing to amend and SUPPLEMENTARY INFORMATION: republish the list of select agents and pharmacotherapies and prophylaxis to toxins that have the potential to pose a Background treat and prevent any illness caused by severe threat to animal or plant health, The Public Health Security and the agent or toxin; and • Any other criteria that the Secretary or to animal or plant products. The Act Bioterrorism Preparedness and considers appropriate to protect animal requires the biennial review and Response Act of 2002 (referred to below or plant health, or animal or plant republication of the list of select agents as the Bioterrorism Response Act) products. and toxins and the revision of the list as provides for the regulation of certain We use the term ‘‘select agents and necessary. This action would implement biological agents that have the potential toxins’’ throughout the preamble of this the findings of the third biennial review to pose a severe threat to both human proposed rule. Unless otherwise of the list. In addition, we are proposing and animal health, to animal health, to specified, the term ‘‘select agents and to reorganize the list of select agents and plant health, or to animal and plant toxins’’ will refer to all agents or toxins toxins based on the relative potential of products. The Animal and Plant Health listed by APHIS. When it is necessary to each select agent or toxin to be misused Inspection Service (APHIS) has the specify the type of select agent or toxin, to adversely affect human, plant, or primary responsibility for implementing we will use the following terms: ‘‘PPQ animal health. Such tiering of the list the provisions of the Act within the select agents and toxins’’ (for the plant would allow for the optimization of Department of Agriculture (USDA). agents and toxins listed in 7 CFR 331.3), security measures for those select agents Veterinary Services (VS) select agents ‘‘VS select agents and toxins’’ (for the or toxins that present the greatest risk of and toxins are those that have been animal agents and toxins listed in 9 CFR deliberate misuse with the most determined to have the potential to pose 121.3), or ‘‘overlap select agents and significant potential for mass casualties a severe threat to animal health or toxins’’ (for the agents and toxins listed or devastating effects to the economy, animal products. Plant Protection and critical infrastructure, or public in both 9 CFR 121.4 and 42 CFR 73.4). Quarantine (PPQ) select agents and On July 29, 2010, we published in the confidence. We are also proposing a toxins are those that have the potential number of amendments to the Federal Register (75 FR 44724–44725, to pose a severe threat to plant health Docket No. APHIS–2009–0070) an regulations, including the addition of or plant products. Overlap select agents definitions and clarification of language advance notice of proposed rulemaking and toxins are those that have been and request for comments (ANPR) 1 in concerning security, training, , determined to pose a severe threat to , and incident response. order to announce our intention to both human and animal health or review and reorganize the select agent These changes would increase the animal products. Overlap select agents usability of the select agent regulations list. We solicited comments regarding are subject to regulation by both APHIS potential additions and deletions from as well as provide for enhanced program and the Centers for Disease Control and oversight. the list of select agents and toxins as Prevention (CDC), which has the well as comments on reorganization of DATES: We will consider all comments primary responsibility for implementing the list based on the relative potential of that we receive on or before December the provisions of the Act for the each select agent or toxin to be misused 2, 2011. Department of Health and Human to adversely affect human, plant, or ADDRESSES: You may submit comments Services (HHS). animal health. We requested Subtitle B (which is cited as the by either of the following methods: recommendations as to what criteria • ‘‘Agricultural Bioterrorism Protection Federal eRulemaking Portal: Go to should be utilized to designate high risk Act of 2002’’ and referred to below as http://www.regulations.gov/ select agents and toxins and the Act), section 212(a), provides, in #!documentDetail;D=APHIS-2009-0070- incorporated those recommendations 0001. part, that the Secretary of Agriculture • Postal Mail/Commercial Delivery: (the Secretary) must establish by 1 To view the ANPR and the comments we Send your comment to Docket No. regulation a list of each received, go to http://www.regulations.gov/ APHIS–2009–0070, Regulatory Analysis and each toxin that the Secretary #!docketDetail;D=APHIS-2009-0070.

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into the interagency working group (exotic), Bovine spongiform to which Federal, State, and/or local discussions on the matter. We solicited encephalopathy agent; Camel pox virus; officials need to take special action in comments for 30 days ending August Ehrlichia ruminantium (Heartwater); planning for a major animal health 30, 2010. We received 30 comments by virus; Malignant disaster as a result of any of these that date. They were from scientists, catarrhal fever virus (Alcelaphine organisms is decreased in light of these scientific organizations, private herpesvirus type 1); Menangle virus; factors. Therefore, in considering these individuals, and industry groups. and Vesicular stomatitis virus (exotic): reasons as well as recommendations Suggestions in these comments were Indiana subtypes VSV–IN2, VSV–IN3. provided in previous reports such as used in order to inform our discussions The interagency working group ‘‘The Report of the Working Group on on the content of the select agent list considered each of the VS select agents Strengthening the of the and our determination regarding and toxins with respect to the four United States’’ 2 and the ‘‘Federal reorganization of the list. criteria for listing found in the Act and Experts Security Advisory Panel: based on the group’s analysis, APHIS Recommendations Concerning the PPQ Select Agents and Toxins has determined that the nine VS select Select Agent Program’’ 3 as well as APHIS’s PPQ program convened an agents and toxins listed above should be comments received on the ANPR, interagency working group to review the removed from the list. These agents APHIS has determined those pathogens list of PPQ select agents and toxins and were judged not to pose a significant listed here are not likely to be used as develop recommendations regarding threat to animal health, either because agroterrorism agents and no longer need possible changes to that list. Using the the disease risk is not significant (e.g., to be designated as VS select agents. four criteria for listing found in the Act, low mortality rate in the event of Overlap Select Agents and Toxins economic crop data, current Federal infection), they affect only minor (i.e., quarantine notices, and new scientific not economically significant) species, or We are also proposing to modify the information, the working group they are not likely to be used as an listing for one of the overlap select revisited the currently listed PPQ select agroterrorism agent (e.g., difficulty of agents by removing certain subtypes of agents and toxins and evaluated a transmission from animal to animal). Venezuelan equine encephalitis virus number of new plant pathogens for For example, Japanese encephalitis from the list of overlap select agents and inclusion on the list. Based on this virus primarily affects horses and pigs toxins set out in 9 CFR 121.4(b), and to review, APHIS is proposing to amend and is transmitted via a mosquito bite. clarify that only Venezuelan equine the list of PPQ select agents and toxins It is not directly contagious between encephalitis subtypes IAB and IC would listed in 7 CFR 331.3 by removing animals. Horses represent a dead-end remain on the list. These subtypes Xylella fastidiosa, citrus variegated host for the disease; mosquitoes biting contain the only recognized strains of chlorosis (CVC) strain, from the list as an infected horse will not pick up virus Venezuelan equine encephalitis that can it no longer meets the criteria for use as to transmit to any new animals. Pigs suddenly affect a large number of an agroterrorism agent. Since CVC was represent an amplifying host, but animals over a large area (i.e., first included on the list, extensive modern pig husbandry practices in the epizootic). The remaining subtypes, ID research on this select agent has been U.S. minimize exposure of the herd to and IE, are strains prevalent among completed. New scientific information mosquitoes and make it difficult to existing animal populations (i.e., has led to creation of detection methods establish and sustain a natural enzootic) and do not represent the same that provide for better early response transmission cycle. type of risk. Other viruses within the and control methods. These new Likewise, a sustained transmission Venezuelan equine encephalitis technologies can be applied regardless cycle of malignant catarrhal fever virus complex (subtypes IF and II through IV) of how the agent might be introduced, (Alcelaphine herpesevirus type 1) are separate viruses and are not including purposeful introduction for requires the presence of the reservoir included in the list of overlap select harmful purposes. Furthermore, the use host (African wildlife) in close physical agents and toxins. Accordingly, CDC of geostatistical analysis in citrus association with the susceptible will also be proposing a parallel change production areas using geographic domestic species (cattle and bison). to its overlap select agent regulations. information systems is now well- With respect to the remaining agents: • Reorganization of the Current List of developed with relation to monitoring Camel pox only affects camels, Select Agents and Toxins and facilitating a response to any which are a minor species in the US; purposeful introduction. As a result of • Akabane virus, bluetongue virus We are proposing to establish a this new research, as well as the (exotic), Ehrlichia ruminantium number of select agents and toxins as development of new regulatory systems (Heartwater), and vesicular stomatitis ‘‘Tier 1’’ select agents and toxins within for CVC, the likelihood that someone virus (exotic): Indiana subtypes VSV– the lists of VS and overlap select agents would use CVC as an agent of IN2, VSV–IN3 all utilize insect vectors and toxins. We are not including PPQ bioterrorism is reduced, and our ability as a mode of transmission and are not select agents and toxins in this proposed to manage an introduction is increased. usually spread by direct contact reorganization because none of the between animals; proposed Tier 1 select agents and toxins VS Select Agents and Toxins • Menangle virus transmission is are from the plant list. All other select APHIS’s VS program also convened associated with certain species of fruit agents and toxins would continue to be an interagency working group to review bats, which are native only to Australia subject to the current requirements the list of VS select agents and toxins and Southeast Asia; and concerning select agents and toxins. All and the list of overlap select agents and • Bovine spongiform encephalopathy select agents and toxins were scored toxins in 9 CFR part 121 in order to agent is only known to be transmitted against 20 criteria by over 60 subject update and revise the lists as necessary. through the ingestion of infected tissues. We are proposing to remove nine VS All of these circumstances make 2 Available on the Internet at http://www.phe.gov/ select agents and toxins from the list set transmission from animal-to-animal Preparedness/legal/boards/biosecurity/Documents/ difficult, which greatly lessens the biosecreportfinal102309.pdf. out in § 121.3(b). Specifically, we are 3 Available on the Internet at http://www.phe.gov/ proposing to remove the following: chance of an outbreak either accidental Preparedness/legal/boards/fesap/Documents/fesap- Akabane virus; Bluetongue virus or intentional. Consequently, the extent recommendations-101102.pdf.

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matter experts representing the Federal confidence, i.e., Tier 1 select agents and milk, artificial insemination, and life sciences, public health, law toxins. These requirements would inhalation of infectious aerosols. It is enforcement, security, and intelligence include: not found in the United States and the communities. These criteria included: • Additions regarding the assessment U.S. domestic animal population is • The relative ease with which a of persons who will have access to Tier therefore considered highly susceptible. particular select agent or toxin might be 1 select agents and toxins that would be Foot-and-mouth disease virus can cause disseminated or transmitted from one made to the security plan currently infection and disease in close to 100 animal to another or into the required to be developed by all entities percent of susceptible animals. The environment where it could produce a seeking approval for the possession, use, potential exists for severe economic deleterious effect upon animal or plant and transfer of select agents and toxins; impacts through loss of animal health; ongoing oversight of those persons with production and products and trade • The potential for high animal or access to Tier 1 select agents and toxins; restrictions. Because of these factors, plant mortality rates; and the role of the entity’s responsible • this select agent is considered to have a The potential for a major animal or official in coordinating and assuring the high potential as a weapon of plant health impact; security of Tier 1 select agents and • bioterrorism and we are therefore Select agents or toxins whose toxins; proposing to require that it be handled • misuse might result in public panic or Security enhancements that include only in high containment facilities other social or economic disruption; and provisions for security barriers, which provide enhanced biosafety and • Select agents or toxins whose use intrusion detection and monitoring, biosecurity features in order to might require Federal, State, and/or delay/response force, access control, safeguard its distribution. local officials to take special action in and information security; is a contagious viral planning for major animal or plant • Additions to the biosafety plan disease of cattle, buffalo, and some wild health disasters. currently required to be developed by species of cloven-hoofed animals, such APHIS and CDC determined that two all entities seeking approval for the as giraffe and wildebeest. Like foot-and- VS select agents and three overlap select possession, use, and transfer of select mouth disease virus, it is not native to agents should be given Tier 1 status. agents and toxins that would describe the United States and can cause 100 Based on the criteria listed above, we implementation of an occupational percent illness if susceptible animals are proposing to list foot-and-mouth health program for individuals with come in contact with infected animals disease virus and rinderpest virus as access to Tier 1 select agents and toxins; Tier 1 VS select agents and toxins and • Development of security policies or contaminated surfaces. As the result Bacillus anthracis, , and procedures describing the entity’s of an extensive international campaign and Burkholderia pseudomallei as Tier response to a failure of an intrusion consisting of vaccinations, clinical 1 overlap select agents and toxins. We detection or alarm system and disease research, serological are also proposing to amend the list of notification procedures for the Federal surveillance sampling, contingency overlap select agents and toxins whose Bureau of Investigation (FBI) in the planning, and laboratory support in seizure by any Federal law enforcement event of theft or suspicious activity that affected regions, the World Organization agency requires reporting to APHIS or may be criminal in nature involving a for Animal Health declared rinderpest CDC within 24 hours (located in 9 CFR Tier 1 select agent or toxin. These to be globally eradicated in May 2011. 121.4(f)(3)(i)) to include only those policies and procedures would be Post-eradication efforts will include overlap agents designated as Tier 1. The required as part of the entity’s incident surveillance of all international current list, which is comprised of response plan; and laboratories with existing stocks of the Bacillus anthracis, Brucella melitensis, • Required annual insider threat virus, consensus regarding laboratories Hendra virus, Nipah virus, Rift Valley awareness briefings focused on how to authorized to retain the agent and the fever virus, and Venezuelan equine identify and report suspicious type of laboratory work which will encephalitis virus was initially adapted behaviors. continue, and destruction of all other from a different system of threat These changes would serve to further inventoried stocks. Also, conditions for assessment categorization. The mitigate the potential for deliberate laboratory storage will be developed in proposed changes would bring the list misuse of these select agents and toxins order to ensure biosafety and security of in line with the listing of Tier 1 agents, that could result in devastating effects to the agent. The proposed enhanced which was developed as a result of the the economy, critical infrastructure, or security measures are necessary in order experience and expertise of the select public confidence. to ensure that the United States will be agent program. These changes, in We are also proposing to add required able to maintain inventories of tandem with the enhanced practices for physical security measures in addition rinderpest virus under secure and safe physical and information security to the proposed general Tier 1 required conditions. detailed below, would serve to further security measures for those entities All of these proposed changes are mitigate the potential for deliberate working with foot-and-mouth disease based on established Government and misuse of these select agents and toxins virus and rinderpest virus due to the security industry standards with respect that could result in devastating effects to particular dangers posed by these two to securing high risk material and the economy, critical infrastructure, or viruses. developed in accordance with the public confidence. Foot-and-mouth disease is an experience and expertise of the Select Accordingly, we are also proposing extremely contagious viral disease of Agent Program. They are necessary in additions to the VS regulations that domesticated cloven-hoofed animals order to further ensure the safety and would allow for the optimization of (e.g., cattle, sheep, goats, and pigs) and security of those select agents and security measures for those select agents many wild animals. It is easily toxins that pose the most potential harm or toxins that present the greatest risk of transmissible from infected animals to to the animal and human environment. deliberate misuse with the most susceptible animals through contact As stated previously, the requirements significant potential for mass casualties with contaminated objects, for working with all other select agents or devastating effects to the economy, consumption of contaminated meat and toxins would remain unchanged critical infrastructure, or public products or ingestion of contaminated with the exception of certain

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miscellaneous changes, which are the proceedings were held. Any respect to the Bioterrorism Response detailed below. conviction which has been set aside or Act, the government is regulating access nullified as a matter of law or for which to biological agents and toxins which Miscellaneous Changes a person has been pardoned shall not be the government has recognized as We are proposing to make several considered a conviction for purposes of having the potential to be used in the smaller-scale changes to the regulations, this part.’’ Contrary to definition of this wrong hands as weapons of mass including the addition of definitions term used under the Gun Control Act, destruction. and clarification of language concerning we have decided that foreign offenses We are specifically requesting security, training, biosafety, should be considered a disqualifier. In comments on the use of a foreign biocontainment, and incident response. doing so we are aware of the Supreme conviction as a predicate for denying These changes, which are described in Court’s decision in Small v. United access to select agents and toxins. We detail below, would increase the States, 544 US 385 (2005) in which the recognize that there can be significant usability of the select agent regulations court, interpreting the provisions of 18 differences between foreign convictions as well as provide for enhanced program U.S.C. 922(g)(1), held that the phrase and domestic convictions. For example, oversight. ‘‘convicted in any court’’ refers only to foreign legal systems may not provide In 7 CFR 331.1 and 9 CFR 121.1, we U.S. courts, not to foreign courts. In its the same due process safeguards are proposing to add definitions for opinion interpreting the Gun Control afforded to citizens of the United States, adjudicated as a mental defective, alien, including impartial tribunals and jury committed to any mental institution, Act, the court stated that ‘‘the statute itself and its history offer only trials. Additionally, foreign countries controlled substance, crime punishable may punish conduct that is permitted congressional silence’’ as to whether by imprisonment for a term exceeding 1 under domestic law or may require Congress considered whether the year, indictment, lawfully admitted for more severe penalties than under statutory language included foreign permanent residence, mental domestic law. We note that in the past, convictions. In the case of the institution, restricted person, and courts have applied the criteria set forth Bioterrorism Response Act, we believe unlawful user of any controlled in Section 482 of the Restatement (third) Congress spoke clearly about their substance. We believe that these of Foreign Relations Law of the United desire to limit or deny access to select definitions would assist regulated States (1986) in determining whether a agents and toxins for those who have entities as well as those seeking foreign judgment should be recognized approval to access select agents and committed serious crimes regardless of in the United States. That Section toxins to better understand what status where those crimes were committed. As provides that a court in the United or activities, past or present, might a part of the safeguard and security States may not recognize a judgment of prohibit such access. section of the Bioterrorism Response the court of a foreign state if the Although these terms were undefined Act, Congress not only put select agents judgment was rendered under a judicial in the Bioterrorism Response Act, it is and toxins off limits to a ‘‘restricted system that does not provide impartial evident that Congress modeled many of person,’’ as that term is defined by 18 tribunals or procedures compatible with them after the disqualifiers that are used U.S.C. 175b, but to the those who are due process of law or the court that by the Bureau of Alcohol, Tobacco, ‘‘reasonably suspected by any Federal rendered the judgment did not have Firearms, and Explosives (ATF) when law enforcement or intelligence agency jurisdiction over the defendant in enforcing the Gun Control Act of 1968. of’’ (1) Committing a ‘‘Federal crime of accordance with the law of the Because the purpose of the Select Agent terrorism’’ transcending national rendering state. It further provides that Program differs from ATF’s enforcement boundaries (18 U.S.C. 2332b); (2) the a court in the United States need not actions under the Gun Control Act, we knowing involvement with an recognize a judgment of the court of a do not believe that these terms must be organization that engages in domestic or foreign state if the court that rendered defined exactly the same. The Gun international terrorism or with any other the judgment did not have jurisdiction Control Act regulates access to firearms, organization that engages in of the subject matter of the action, the while the Bioterrorism Response Act international crimes of violence; or (3) defendant did not receive notice of the regulates access to biological agents and being an agent of a foreign power. We proceedings in sufficient time to enable toxins that the government has believe it would be an inconsistent him to defend, the judgment was recognized as having the potential to be reading of statutory authority to allow obtained by fraud, the cause of action on used as weapons of mass destruction by the Secretary to limit or deny access to which the judgment was based, or the the wrong hands. select agents and toxins to someone judgment itself, is repugnant to the Nevertheless, we looked at the identified by the Attorney General as public policy of the United States or of statutory and regulatory definitions of being only reasonably suspected of the State where recognition is sought, these terms under the Gun Control Act committing a Federal crime of terrorism the judgment conflicts with another when drafting our definitions. With the transcending national boundaries but to final judgment that is entitled to exception of the term ‘‘crime punishable be powerless in cases where a person recognition, or the proceeding in the by imprisonment for a term exceeding 1 had actually been convicted of a serious foreign court was contrary to an year,’’ we decided to adopt the crime in a foreign country. We believe agreement between the parties to submit applicable definitions used by ATF. that in light of the threat of bioterrorism the controversy on which the judgment The definition of crime punishable by attacks, Congress would not want to is based to another forum. We are imprisonment for a term exceeding 1 exclude an individual convicted of a seeking comment on whether these year would be established as ‘‘any U.S. offense from having access to select criteria should be applied in Federal, State, or foreign offense for agents and toxins, but still allow access considering whether access to select which the maximum penalty, whether to an individual convicted in a foreign agents and toxins should be denied or not imposed, is capital punishment court of a similar offense. We also based on a foreign conviction or or imprisonment in excess of 1 year. believe that the instances of regulation whether other criteria or factors would What constitutes a conviction of such a can be distinguished in that with regard be appropriate to consider. crime shall be determined in accordance to the Gun Control Act the government We are also proposing to add a with the law of the jurisdiction in which is regulating access to guns while, with definition for information security to the

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regulations in 7 CFR 331.1 and 9 CFR on the select agent Web site only has for measures sufficient to contain the 121.1 as it is used but not defined. This served to provide the most up-to-date select agent or toxin (e.g., physical definition would be identical to that information to the regulated structure and features of the entity, and used in the ‘‘Information Security’’ community. We are therefore proposing operational and procedural safeguards); subchapter of the U.S. Code (44 U.S.C. to update the regulations to accurately and 3542). reflect the way in which we handle the • An incident response plan, as We are also proposing to add a listing of exclusions. described in the regulations in 7 CFR definition for occupational exposure to The regulations in 7 CFR 331.9 and 9 331.14 and 9 CFR 121.14, that provides the VS regulations in 9 CFR 121.1 as it CFR 121.9 set out requirements for for measures that the registered entity is used in the regulations but not entities requesting to work with select will implement in the event of theft, defined. This definition is based on that agents and toxins to designate a loss, or release of a select agent or toxin; used in the Occupational Safety and responsible official, who ensures that inventory discrepancies; security Health Administration regulations in 29 the entity continues to meet the breaches (including information CFR 1910.1030. We are not proposing to requirements of the regulations. We are systems); severe weather and other add a corresponding definition to the proposing to explicitly require that all natural disasters; workplace violence; PPQ regulations in 7 CFR 331.1 since designated responsible officials possess bomb threats and suspicious packages; PPQ select agents and toxins do not the appropriate training or expertise to and emergencies such as fire, gas leak, pose a severe threat to human health execute their required duties. We are explosion, power outage, etc. The and, therefore, it is unnecessary to also proposing to clarify the role of response procedures must account for address personnel safety and health. alternate responsible official in order to hazards associated with the select agent Finally, we are proposing to add a definitively establish that the alternate or toxin and appropriate actions to definition for recombinant and responsible official must have the contain such agent or toxin. synthetic nucleic acids. This addition is knowledge and authority to act for the Details of the changes we are necessary, as the term ‘‘synthetic responsible official in his/her absence. proposing to each plan individually nucleic acids’’ is employed in the Finally, we are proposing to add a may be found below. Generally, we are proposed changes to the select agent requirement that the responsible proposing to require that the security regulations. We are proposing to include official’s principal duty station be the plan, biocontainment/biosafety plan, synthetic nucleic acids in the physical location of the registered and incident response plan include regulations because, while synthetic entity. These changes would clarify the provisions to address the safeguarding nucleic acids have the same potential requirements that a person must meet in of animals or plants that have been for harm as recombinant nucleic acids, order to serve as a responsible official or intentionally or accidentally exposed to the process of production is different. alternate responsible official. or infected with select agents against We are proposing to amend 7 CFR We are proposing to amend the unauthorized access, theft, loss or 331.3(e), 9 CFR 121.3(e) and 9 CFR regulations in 7 CFR 331.10 and 9 CFR release. This would enhance the 121.4(e). These paragraphs specify that 121.10. These regulations establish comprehensiveness of the regulations as attenuated strains of select agents or parameters for restricting access to well as provide necessary guidance toxins may be excluded from the select agents and toxins and the process regarding handling of animals and requirements of the select agent by which individuals may be approved plants inoculated with select agents. We regulations subject to an official request for access to select agents and toxins would not require the plan to address and supporting scientific information. after the completion of a security risk animals and plants exposed to select We are proposing to state that the assessment by the Attorney General. toxins, however. Recovering the toxin ‘‘inactive form of a select toxin’’ may be Specifically, we are proposing to add from within an animal or plant subject excluded from regulation under each new provisions by which individuals is highly difficult and such removal respective part subject to the application may have access to select agents at does not produce a reasonable yield of procedure. This change is necessary entities other than the individual’s recovery. In addition, there is because the current term, ‘‘attenuated ‘‘home’’ entity. We are also proposing to uncertainty as to whether or not the strain of toxin,’’ is scientifically decrease the maximum length of time toxin would remain active when inaccurate. Attenuated is a term that is for which a security risk assessment will recovered from the animal or plant. For applied to living organisms, and toxins be valid from 5 years to 3 years in order these reasons it is highly unlikely that are not living organisms. ‘‘Inactive form to more expeditiously identify once introduced into an animal or plant, of a select toxin’’ is a more accurate individuals who may have fallen into a sufficient amount of toxin could be term and we are therefore proposing to one of the prohibited or restricted recovered to pose a significant hazard to amend the regulations to include the categories. public health, agriculture or agriculture correct terminology. We are also The regulations require registered products. proposing to update the Web site entities to develop and implement a Currently, the security plan described address in paragraph (e)(1) of each number of plans in order to ensure the in 7 CFR 331.11 and 9 CFR 121.11 must section as all information concerning safety and security of the select agents be developed by all regulated entities the Select Agent Program is now they handle. These are: and submitted for review only upon centralized on the National Select Agent • A security plan, as described by the request. We are now proposing to Registry Web site at http:// regulations in 7 CFR 331.11 and 9 CFR require that the security plan be www.selectagents.gov/. Finally, we are 121.11, that provides for measures submitted for initial registration and proposing to remove the language sufficient to safeguard the select agent renewals of registration as well as at any stating that exclusions will be published or toxin against unauthorized access, other time upon request. We are also in the Federal Register. This change is theft, loss, or release; proposing to add a requirement that the necessary because, while we anticipated • A biocontainment plan, in the case security plan include procedures that publication of exclusions both in the of PPQ select agents, or a biosafety plan, require the responsible official to Federal Register and on the Internet at in the case of VS select agents, as immediately notify the FBI in order to the time the regulations were initially described in the regulations in 7 CFR initiate a threat assessment process in created, we have found that publication 331.12 and 9 CFR 121.12, that provides the event that he or she becomes aware

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of suspicious activity which is criminal recombinant technology in the 121.16, which concern the transfer of in nature, related to the facility, its generation of drug resistant select agents select agents and toxins from one personnel, or select agents. This or biosynthesis of toxins lethal to registered entity to another. The addition would provide for added vertebrates. Since synthetic DNA or proposed additions would serve to security and establish a framework for other methods (e.g., selection in codify practices for shipping, receiving, communication between regulated sublethal exposures) may also be used and storage of select agents and toxins entities and the FBI. We are also to generate such products, we are and ensure that all registered entities proposing to add provisions for proposing to expand the category of have documented processes for securing information security, including the need restricted experiments to include and monitoring the shipment, receipt, for backup measures if the entity relies passive selection, recombinant, and and storage of select agents and toxins on information systems for security. synthetic DNA. Finally, we are that make it extremely unlikely that These provisions would include proposing to add language in order to such materials would be made available network connectivity monitoring, clarify the requirement that all to an unauthorized individual. restriction of user permissions so that experiments involving the creation of The regulations in 7 CFR 331.17 and only mission-specific files and drug resistant select agents must be 9 CFR 121.17 concern required applications may be accessed, measures submitted to the Select Agent Program recordkeeping procedures for regulated to prevent network infiltration by for approval. entities as those records relate to select malicious code, and configuration Additionally, we are proposing to agents and toxins. We are proposing to management including regular patching specify in 7 CFR 331.14 and 9 CFR add language to address synthetic select and system and software updates. We 121.14 that each entity’s incident agent organisms and animals and plants believe these additions are necessary in response plan be based upon a site- inoculated with select agents. This order to establish requirements for a specific risk assessment. This change change would improve oversight of the more comprehensive security plan. We would further ensure the specificity and select agent program as it relates to are also proposing to codify current quality of the plan. In addition, we are synthetic select agent organisms. We are practices for shipping, receiving, and proposing that the incident response also proposing to add recordkeeping storage of select agents and toxins to procedures contain stipulations requirements whereby regulated entities ensure that the entity has documented concerning animals and plants maintain an accurate, current inventory processes for securing and monitoring accidentally or intentionally exposed to of any animals or plants intentionally or the shipment, receipt, and storage of or infected with a select agent. This accidentally exposed to or infected with these items. These changes would serve change would provide specific guidance a select agent (including number and to decrease the chance that such and further elaborate our requirements species, location, and appropriate materials would be made available to an for incident response plans. disposition). As previously stated, we We are proposing to amend the unauthorized individual or an are not proposing to require regulated regulations in 7 CFR 331.15 and 9 CFR individual without a legitimate use for entities to keep records regarding 121.15, which concern provision of the material. Finally, we are proposing animals or plants exposed to select mandatory training for staff and visitors to amend paragraph (e) in 7 CFR 331.11 toxins. who work in or visit areas where select We are proposing to amend the and 9 CFR 121.11, which currently agents or toxins are handled or stored. regulations in 7 CFR 331.19, which directs individuals creating a security We are proposing to require all concern requirements for notification of plan to guidance for developing such registered entities to provide security theft, loss, or release of select agents. documents contained in the ‘‘Morbidity awareness and incident response Specifically, we are proposing to and Mortality Weekly Report’’ from training. This is in addition to the remove paragraph (b)(1)(vi), which December 2002. Applicants would existing training requirements, which states that an individual entity must instead be directed to the ‘‘Security are concerned with biocontainment and report certain information to APHIS or Information Document’’ and the security practices in the case of PPQ CDC immediately upon discovery of a ‘‘Security Plan Template’’ on the select select agents, and biosafety and security release of a select agent or toxin outside agents Web site. practices in the case of VS select agents. of the primary barriers of the We are proposing to update the We are also proposing to establish that biocontainment area. Currently we specific Web site address references to training for escorted personnel would be require that the number of individuals various CDC and National Institutes of based on the risk associated with potentially exposed at the entity be Health guidance publications found in 9 accessing areas where select agents and reported. We are proposing to remove CFR 331.12(c)(1) and (c)(3). The toxins are used and/or stored. Currently, this requirement as PPQ select agents regulations in 7 CFR 331.13 and 9 CFR refresher training is required to be and toxins do not pose a severe threat 121.13 concern restricted experiments, provided once a year. We are proposing to human health and, therefore, it is which are those experiments that may to require that such training also be unnecessary to address personnel safety not be performed by regulated entities provided if a registered entity’s security, and health in the same manner as they without the approval of the incident response, biosafety, or are addressed in the VS regulations. The Administrator. We are proposing to state biocontainment plans are substantively notification requirements in 9 CFR that, in addition to the existing altered. Finally, we are proposing to 121.19 would remain unchanged. prohibition on conducting restricted specify that the responsible official The regulations in 7 CFR 331.20 and experiments, entities may not possess ensure maintenance of training records. 9 CFR 121.20 concern the guidelines for the products of restricted experiments Currently there is no particular person administrative review of an individual’s without the approval of the designated as the entity’s required or entity’s denial, revocation, or Administrator. We are also proposing to record keeper, only that a training suspension of registration and access remove recombinant technology as a record must be kept. The above changes approval. We are proposing to modify determining factor for a restricted are necessary in order to provide clarity the current regulations in order to allow experiment. This is because the current and ease of use to the regulations. individuals more time to gather the regulations regarding restricted We are proposing to amend the necessary components of their appeal experiments focus solely on the use of regulations in 7 CFR 331.16 and 9 CFR following the denial, limitation, or

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revocation of access approval. 1. Aspects of the required security on a substantial number of small Currently, this process must be plan. These may include, but are not entities. The entities are those completed in 30 calendar days. We are limited to: laboratories and other institutions proposing to extend the deadline to 180 • Provisions for information security; conducting research and related calendar days. This change is necessary • Development of suitability or activities entities in possession of Tier because, thus far, all appeal requests personnel reliability practices, 1 select agents or toxins, and, to a from individuals regarding their access including pre-access and ongoing somewhat lesser extent, those entities approval have been received after the assessment of persons who will have possessing the newly added select 30-day deadline has passed. Because of access to Tier 1 select agents or toxins; agents and toxins. The economic specific program procedures, these • Procedures for the method by analysis presents categories and individuals receive no advance notice of which an entity’s responsible official information from the Department of a denial, limitation, or revocation of will coordinate his or her efforts with Commerce and the Small Business their access approval. Given this the entity’s safety and security Administration for those entities we situation and the requirements for professionals to ensure security of Tier have identified as most likely to be submitting a formal appeal, we believe 1 select agents or toxins; affected by this rule. While we believe • it is appropriate to extend the deadline Development of a self- and peer- affected entities are contained within in order to allow individuals to gather reporting program to track incidents or these categories, we are seeking further the necessary background data for their conditions that could affect an information regarding how many appeals. We are not proposing to grant individual’s ability to safely access or entities fall specifically into each a similar extension for entities which work with Tier 1 select agents and category, and are therefore, inviting have had their registration denied, toxins; and • comments on potential effects. In revoked, or suspended, as these entities Layered protection of assets for particular, we are interested in typically have had advance notice of entities housing Tier 1 select agents and determining the number and kind of such a determination and are thus able toxins. small entities that may incur benefits or to document and prepare their appeals 2. Aspects of the required biosafety costs from the implementation of this within the existing 30-day timeframe. plan, e.g., components of an proposed rule. Given that we are reorganizing 7 CFR occupational health program for This proposed rule would update the 331.20 and 9 CFR 121.20 in order to individuals with access to Tier 1 select APHIS, CDC, and overlap select agent more clearly spell out the way in which agents and toxins; and an individual or an entity may appeal 3. Aspects of the required training, and toxin lists. The regulation of select the denial, revocation, or suspension of e.g., best practices for development of a agents and toxins is intended to prevent registration and access approval, we are security awareness training program. their misuse and thereby reduce the also proposing to remove footnote 9 We welcome public comment on Web potential for those pathogens to harm from the regulations in 7 CFR 331.20 sites, articles, or other sources that may humans, animals, animal products, and corresponding footnote 15 in 9 CFR be used to develop such guidance plants or plant products in the United 121.20. This proposed change is documents, in addition to suggestions as States. Should any select agent or toxin necessary because these footnotes to what elements should be included as be intentionally or unintentionally would offer redundant information useful examples. These documents released into the environment, the concerning the appeals process in light would serve as a resource to the consequences would be significant. of both sections’ reorganization. Finally, regulated community as a whole. Consequences could include disruption of markets, difficulties in sustaining an we are proposing to remove the Executive Orders 12866 and 13563 and provision stating that a request for adequate food and fiber supply, and the Regulatory Flexibility Act review of a denial, limitation, or potential spread of disease infestations revocation of access approval will be This proposed rule has been over large areas. The entities most likely forwarded to the Attorney General by determined to be significant for the to be affected by this rule would be the Administrator for further review. purposes of Executive Order 12866 and, those laboratories and other institutions Forwarding a request for review to the therefore, has been reviewed by the conducting research and related Attorney General describes an internal Office of Management and Budget. activities that involve the use of the process. This proposed change is We have prepared an economic newly categorized Tier 1 select agents necessary because the current language analysis for this rule. The economic and toxins. The impact of the changes implies a level of decisionmaking on the analysis provides a cost-benefit analysis, to the regulations is expected to be part of the Attorney General that does as required by Executive Orders 12866 minimal, however. Based on not exist and the change would more and 13563, and an initial regulatory information obtained through site- clearly establish that the decision to flexibility analysis that examines the specific inspections, indications are that grant access approval rests solely with potential economic effects of this very few entities would incur significant the Administrator. proposed rule on small entities, as costs for compliance. Many of the required by the Regulatory Flexibility proposed changes to the regulations Guidance Documents Act. The economic analysis is would impose an added cost of the time We are specifically requesting summarized below. Copies of the full spent on documenting measures already comment from the regulated community analysis are available by contacting the required for compliance, with respect to and any other interested persons on the person listed under FOR FURTHER security, biocontainment/biosafety, and need for and desirability of guidance INFORMATION CONTACT or on the incident response plans, information documents that would serve to assist Regulations.gov Web site (see security, and ongoing background regulated entities in preparation of the ADDRESSES above for instructions for checks. While the total costs imposed by elements that comprise various aspects accessing Regulations.gov). the proposed regulations are estimated of the select agent regulations. Based on the information we have, to range between $5.30 million and The areas where such guidance there is no reason to conclude that $6.95 million, including costs to documents may be useful include, but adoption of this proposed rule would government, we believe many of these are not limited to: result in any significant economic effect costs are incurred through observance of

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generally recognized industry standards. and CDC–2011–0012. Please send a APHIS and CDC are asking OMB to Costs actually incurred would depend copy of your comments to: (1) Docket approve, for 3 years, the use of these upon the extent to which current facility Nos. APHIS–APHIS–2009–0070 and information collections, associated with practices will need to be enhanced CDC–2011–0012, Regulatory Analysis its efforts to more closely regulate select based on the proposed requirements. and Development, PPD, APHIS, Station agents or toxins that could be used to The expected benefits of strengthened 3A–03.8, 4700 River Road Unit 118, commit acts of domestic or international safeguards against the costs associated Riverdale, MD 20737–1238, and (2) terrorism. We are soliciting comments with unintentional or deliberate release Clearance Officer, OCIO, USDA, room from the public (as well as affected of select agents or toxins would greatly 404–W, 14th Street and Independence agencies) concerning this information exceed the estimated costs of the Avenue, SW., Washington, DC 20250. A collection activity. APHIS and CDC proposed measures. The cost associated comment to OMB is best assured of need this outside input to help with a single outbreak have been known having its full effect if OMB receives it accomplish the following: to exceed $100 million as outlined in within 30 days of publication of this (1) Evaluate whether the proposed the Regulatory Impact Analysis. proposed rule. information collection is necessary for Deliberate introduction greatly increases The Bioterrorism Preparedness Act is the proper performance of our agency’s the probability of a select agent or toxin designed to prevent, prepare for and functions, including whether the becoming established and causing wide- respond to bioterrorism and other information will have practical utility; ranging and devastating impacts on an public health emergencies. The law (2) Evaluate the accuracy of our economy, loss of market access for requires individuals possessing agents estimate of the burden of the proposed consumer goods and services, or toxins deemed a severe threat to information collection, including the disruption to society, and diminished human, animal, or plant health, or to validity of the methodology and confidence in public and private animal or plant products, to be assumptions used; registered with the Secretary of institutions. (3) Enhance the quality, utility, and Agriculture or the Secretary of Health clarity of the information to be Executive Order 12372 and Human Services, unless they have collected; and This program/activity is listed in the been specifically exempted. This proposed rule entails the use of (4) Minimize the burden of the Catalog of Federal Domestic Assistance information collection on those who are under No. 10.025 and is subject to a number of separate forms designed to obtain critical information concerning to respond (such as through the use of Executive Order 12372, which requires appropriate automated, electronic, intergovernmental consultation with individuals or entities in possession of certain agents or toxins, as well as the mechanical, or other technological State and local officials. (See 7 CFR part collection techniques or other forms of 3015, subpart V.) specific characteristics of the agents or toxins—including name, strain, and information technology; e.g., permitting Executive Order 12988 genetic information. This data is electronic submission of responses). This proposed rule has been reviewed needed, in part, to allow APHIS and Estimate of burden: Public reporting under Executive Order 12988, Civil CDC to determine the of burden for this collection of information Justice Reform. If this proposed rule is an entity as well as the entity’s is estimated to average 2.3187883 hours adopted: (1) All State and local laws and biosecurity situation. This, in turn, per response. regulations that are inconsistent with helps APHIS and CDC ensure that Respondents: Researchers, this rule will be preempted; (2) no appropriate safeguard, containment, and universities, research and development retroactive effect will be given to this disposal requirements commensurate organizations, commercial rule; and (3) administrative proceedings with the risk of the agent or toxin are manufacturers, non-profit institutions, will not be required before parties may present at the entity, thus preventing diagnostic laboratories and other file suit in court challenging this rule. access to such agents and toxins for use interested parties who possess, use, or in domestic or international terrorism. transfer agents or toxins deemed a Paperwork Reduction Act Facilities containing select agents will severe threat to human, animal or plant In accordance with section 3507(d) of be required to maintain records on health, or to animal or plant products. the Paperwork Reduction Act of 1995 animals and plants, and revise their Estimated annual number of (44 U.S.C. 3501 et seq.), the information Biosafety/Biocontainment Plan and respondents: 386. collection or recordkeeping Incident Response Plan for review by Estimated annual number of requirements included in this proposed APHIS and CDC upon request. responses per respondent: 12.230569. rule have been submitted for approval to Information to determine that Estimated annual number of the Office of Management and Budget individuals seeking to register have a responses: 4,721. (OMB). Please send written comments lawful purpose to possess, use, or Estimated total annual burden on to the Office of Information and transfer agents or toxins will also be respondents: 10,947 hours. (Due to Regulatory Affairs, OMB, Attention: requested as part of the registration averaging, the total annual burden hours Desk Officer for APHIS, Washington, DC process. In addition, we will be may not equal the product of the annual 20503. Please state that your comments requesting submission of their Security number of responses multiplied by the refer to Docket Nos. APHIS–2009–0070 Plan for our review. reporting burden per response.)

Average Number of Number of burden per Total burden Section Form name respondents responses per response hours respondent (in hours)

9 CFR 121.5 and 6, 7 CFR 331.5, Report of Identification of a Select 161 3 1 299 43 CFR 73.5 and 6. Agent or Toxin. § 121.7, § 331.7, § 73.7 ...... Application for Registration ...... 7 1 5 35 § 121.7, § 331.7, § 73.7 ...... Amendment to a Certificate of Reg- 380 7 1 1,955 istration.

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Average Number of Number of burden per Total burden Section Form name respondents responses per response hours respondent (in hours)

§ 121.11, § 331.11, § 73.11 ...... Security Plan ...... 380 1 5 1,900 § 121.12, § 331.12, § 73.12 ...... Biosafety/Biocontainment Plan ...... 380 1 8 3,040 § 121.13, § 331.13, § 73.13 ...... Request Regarding a Restricted Ex- 160 1 2 320 periment. § 121.14, § 331.14, § 73.14 ...... Incident Response Plan ...... 380 1 5 1,900 § 121.15, § 331.15, § 73.15 ...... Training ...... 380 1 1 380 § 121.16, §331.16, §73.16 ...... Request to Transfer Select Agents 290 1 2 580 and Toxins. § 121.17, § 331.17, § 73.17 ...... Records ...... 295 1 0.5 148 § 121.19, §331.19, §73.19 ...... Notification of Theft, Loss, or Re- 195 1 2 390 lease.

Copies of this information collection term exceeding 1 year, indictment, include distilled spirits, wine, malt can be obtained from Mrs. Celeste information security, lawfully admitted beverages, or tobacco, as those terms are Sickles, APHIS’ Information Collection for permanent residence, mental defined or used in Subtitle E of the Coordinator, at (301) 851–2908. institution, recombinant and synthetic Internal Revenue Code of 1986, as nucleic acids, restricted person, and amended. E-Government Act Compliance unlawful user of any controlled Crime punishable by imprisonment The Animal and Plant Health substance to read as follows: for a term exceeding 1 year. Any Inspection Service is committed to Federal, State, or foreign offense for § 331.1 Definitions. compliance with the E-Government Act which the maximum penalty, whether to promote the use of the Internet and Adjudicated as a mental defective. A or not imposed, is capital punishment other information technologies, to determination by a court, board, or imprisonment in excess of 1 year. provide increased opportunities for commission, or other lawful authority What constitutes a conviction of such a citizen access to Government that a person, as a result of marked crime shall be determined in accordance information and services, and for other subnormal intelligence, or mental with the law of the jurisdiction in which purposes. For information pertinent to illness, incompetency, condition, or the proceedings were held. Any E-Government Act compliance related disease is a danger to himself/herself or conviction which has been set aside or to others or lacks the mental capacity to to this proposed rule, please contact nullified as a matter of law or for which contract or manage his/her own affairs. Mrs. Celeste Sickles, APHIS’ a person has been pardoned shall not be The term includes a finding of insanity Information Collection Coordinator, at considered a conviction for the by a court in a criminal case and those (301) 851–2908. purposes of this part. persons found incompetent to stand List of Subjects trial or found not guilty by reason of * * * * * Indictment. A formal written 7 CFR Part 331 lack of mental responsibility pursuant to articles 50a and 72b of the Uniform accusation originating with a prosecutor Agricultural research, Laboratories, Code of Military Justice, 10 U.S.C. 850a, and issued by a grand jury against a Plant diseases and pests, Reporting and 876b. party charged with a crime. For the recordkeeping requirements. * * * * * purpose of these regulations the term 9 CFR Part 121 Alien. Any person not a citizen or indictment includes an ‘‘information,’’ national of the United States. which is a formal accusation of a crime, Agricultural research, Animal differing only in that it is being diseases, Laboratories, Medical research, * * * * * Committed to any mental institution. presented by a competent public officer Reporting and recordkeeping on his oath of office, instead of a grand requirements. A formal commitment of a person to any mental institution by a court, board, jury. Accordingly, we propose to amend 7 commission, or other lawful authority. Information security. Protecting CFR part 331 and 9 CFR part 121 as The term includes a commitment to a information and information systems follows: mental institution involuntarily. The from unauthorized access, use, TITLE 7—[AMENDED] term includes commitment for mental disclosure, disruption, modification, or defectiveness or mental illness. It also destruction in order to provide: PART 331—POSSESSION, USE, AND includes commitments for other (1) Integrity, which means guarding TRANSFER OF SELECT AGENTS AND reasons, such as for drug use. The term against improper information TOXINS does not include a person in a mental modification or destruction, and institution for observation or a includes ensuring information 1. The authority citation for part 331 nonrepudiation and authenticity; continues to read as follows: voluntary admission to a mental institution. (2) Confidentiality, which means Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, Controlled substance. A drug or other preserving authorized restrictions on and 371.3. substance, or immediate precursor, as access and disclosure, including means 2. Section 331.1 is amended by ‘‘controlled substance’’ is defined in for protecting personal privacy and adding, in alphabetical order, section 102 of the Controlled Substances proprietary information; and definitions of adjudicated as a mental Act, 21 U.S.C. 802. The term includes, (3) Availability, which means defective, alien, committed to any but is not limited to, marijuana and ensuring timely and reliable access to mental institution, controlled substance, scheduled depressants, stimulants, and and use of information. crime punishable by imprisonment for a narcotic drugs. The term does not * * * * *

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Lawfully admitted for permanent regulation, a person who uses a Synchytrium endobioticum; residence. The status of having been controlled substance and has lost the Xanthomonas oryzae. lawfully accorded the privilege of power of self-control with reference to * * * * * residing permanently in the United the use of that controlled substance; and (e) An attenuated strain of a select States as an immigrant in accordance any person who is a current user of a agent or an inactive form of a select with the immigration laws, such status controlled substance in a manner other toxin may be excluded from the not having changed. than as prescribed by a licensed requirements of this part based upon a Mental institution. Includes mental physician. Such use is not limited to the determination that the attenuated strain health facilities, mental hospitals, use of drugs on a particular day, or or inactivated toxin does not pose a sanitariums, psychiatric facilities, and within a matter of days or weeks before, severe threat to plant health or plant other facilities that provide diagnoses by but rather that the unlawful use has products. licensed professionals of mental occurred recently enough to indicate (1) To apply for exclusion, an retardation or mental illness, including that the individual is actively engaged individual or entity must submit a a psychiatric ward in a general hospital. in such conduct. A person may be an written request and supporting * * * * * unlawful current user of a controlled scientific information. A written Recombinant and synthetic nucleic substance even though the substance is decision granting or denying the request acids. (1) Recombinant nucleic acid not being used at the precise time the will be issued. An exclusion will be molecules that are constructed by person seeks to have access to a select effective upon notification to the joining nucleic acid molecules and that agent or toxin. An inference of current applicant. Exclusions will be listed on can replicate in a living cell; use may be drawn from evidence of a the National Select Agent Registry Web (2) Synthetic nucleic acid molecules recent use or possession of a controlled site at http://www.selectagents.gov/. that are chemically, or by other means, substance or a pattern of use or (2) If an excluded attenuated strain or synthesized or amplified nucleic acid possession that reasonably covers the inactivated toxin is subjected to any molecules that may wholly or partially present time, e.g., a conviction for use manipulation that restores or enhances contain functional equivalents of or possession of a controlled substance its virulence or toxic activity, the nucleotides; or within the past year; multiple arrests for (3) Molecules that result from the resulting select agent or toxin will be such offenses within the past 5 years if subject to the requirements of this part. replication of those described in the most recent arrest occurred within * * * * * paragraph (1) or (2) of this definition. the past year, or persons found through * * * * * a drug test to use a controlled substance § 331.8 [Amended] Restricted person. An individual who: unlawfully, provided that the test was (1) Is under indictment for a crime 4. In § 331.8, paragraph (a)(1) is administered within the past year. For amended by removing the words punishable by imprisonment for a term a current or former member of the exceeding 1 year; ‘‘within any of the categories described Armed Forces, an inference of current in 18 U.S.C. 175b’’ and adding the (2) Has been convicted in any court of use may be drawn from recent a crime punishable by imprisonment for words ‘‘a restricted person’’ in their disciplinary or other administrative place. a term exceeding 1 year; action based on confirmed drug use, (3) Is a fugitive from justice; 5. Section 331.9 is amended as (4) Is an unlawful user of any e.g., court-martial conviction, follows: controlled substance (as ‘‘controlled nonjudicial punishment, or an a. By redesignating paragraphs (a)(3) substance’’ is defined in section 102 of administrative discharge based on drug through (a)(5) as paragraphs (a)(4), the Controlled Substances Act (21 use or drug rehabilitation failure. (a)(5), and (a)(7) respectively. U.S.C. 802)); * * * * * b. By adding a new paragraph (a)(3) to (5) Is an alien illegally or unlawfully 3. Section 331.3 is amended as read as set forth below. in the United States; follows: c. In newly redesignated paragraph (6) Has been adjudicated as a mental a. By revising paragraph (b) to read as (a)(5), by removing the word ‘‘and’’. defective or has been committed to any set forth below. d. By adding a new paragraph (a)(6) mental institution; b. In paragraph (c) introductory text, to read as set forth below. (7) Is an alien (other than an alien by adding the words ‘‘and/or synthetic’’ e. By revising the first sentence of lawfully admitted for permanent after the word ‘‘recombinant’’ each time paragraph (b) to read as set forth below. residence) who is a national of a country it appears. § 331.9 Responsible official. as to which the Secretary of State, c. In paragraph (c)(2) introductory pursuant to section 6(j) of the Export text, by adding the words ‘‘and/or (a) * * * Administration Act of 1979 (50 U.S.C. synthetic’’ after the word (3) Have the appropriate training or App. 2405(j)), section 620A of chapter 1 ‘‘Recombinant’’. expertise to competently implement and of part M of the Foreign Assistance Act d. By revising paragraph (e) to read as manage the requirements of this part; of 1961 (22 U.S.C. 2371), or section set forth below. * * * * * 40(d) of chapter 3 of the Arms Export (6) Have their principal duty station at Control Act (22 U.S.C. 2780(d)), has § 331.3 PPQ select agents and toxins. the physical location of the entity; and made a determination (that remains in * * * * * * * * * * effect) that such country has repeatedly (b) PPQ select agents and toxins: (b) An entity may designate one or provided support for acts of Peronosclerospora philippinensis more individuals to serve as an alternate international terrorism; or (Peronosclerospora sacchari); responsible official who acts for the (8) Has been discharged from the Phoma glycinicola (formerly responsible official in his/her absence. Armed Services of the United States Pyrenochaeta glycines); *** under dishonorable conditions. Ralstonia solanacearum, race 3, biovar * * * * * * * * * * 2; Unlawful user of any controlled Rathayibacter toxicus; 6. Section 331.10 is amended as substance. For purposes of this Sclerophthora rayssiae var. zeae; follows:

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a. By redesignating paragraphs (e) personnel, or its select agents or toxins; commensurate with the risk of the select through (i) as paragraphs (f) through (j) and how the responsible official will agent or toxin, given its intended use.4 respectively. notify the Federal Bureau of The biocontainment plan must contain b. By adding a new paragraph (e) to Investigation (FBI) of such activity; sufficient information and read as set forth below. (9) Contain provisions for information documentation to describe the c. In newly redesignated paragraph security that: containment procedures for the select (g)(1), by removing the words ‘‘within (i) Ensure that all external agent or toxin, including any animals or any of the categories described in 18 connections to systems which control plants intentionally or accidentally U.S.C. 175b’’ and adding the words ‘‘a security of the facility are isolated or exposed to or infected with a select restricted person’’ in their place. have controls that permit and monitor agent. d. In newly redesignated paragraph for only authorized and authenticated * * * * * (i), by removing the number ‘‘5’’ and user access; adding the number ‘‘3’’ in its place. (ii) Ensure that authorized and § 331.13 [Amended] authenticated users are only granted 9. Section 331.13 is amended as § 331.10 Restricting access to select access to select agent and toxin related follows: agents and toxins; security risk information, files, equipment (e.g., a. By removing footnote 5. assessments. servers or mass storage devices) and b. In paragraph (a) introductory text, * * * * * applications as necessary to fulfill their by adding the words ‘‘, or possess (e) A person who has a valid approval roles and responsibilities, and that products (i.e., select agents that are not from the HHS Secretary or access is modified when the user’s roles known to acquire the resistance Administrator for access to a select and responsibilities change or when naturally, if such acquisition could agent or toxin may request the HHS their access to select agent and toxin is compromise the use of the drug to Secretary or Administrator to provide suspended or revoked; control disease agents in humans, the person’s approval status to another (iii) Ensure that controls are in place veterinary medicine, or agriculture, or registered individual or entity for a that are designed to prevent malicious recombinant and or synthetic DNA specified period of time. code (such as, but not limited to, containing genes for the biosynthesis of * * * * * computer viruses, worms, and spyware) select toxins lethal for vertebrates at an 7. Section 331.11 is amended as from compromising the confidentiality, LD[50] < 100 ng/kg body weight) follows: integrity, or availability of information resulting from,’’ after the word a. By revising paragraph (b) to read as systems; ‘‘conduct’’. c. In paragraph (a)(1), by removing the set forth below. (iv) Establish a robust configuration words ‘‘Experiments utilizing b. By revising paragraph (c)(2) to read management practice for information recombinant DNA that involve the as set forth below. systems to include regular patching and deliberate transfer of’’ and replacing c. In paragraph (c)(6), by removing the updates made to operating systems and them with the words ‘‘Experiments that word ‘‘and’’. individual applications; and involve the deliberate transfer of, or d. In paragraph (c)(7), by removing the (v) Establish procedures that provide backup security measures in the event selection for,’’. period and adding a semicolon in its d. In paragraph (a)(2), by adding the place. that access control systems and/or surveillance devices are rendered words ‘‘synthetic or’’ before the word e. By adding new paragraphs (c)(8), ‘‘recombinant’’. (c)(9), and (c)(10) to read as set forth inoperable. (10) Contain provisions and policies below. 10. Section 331.14 is amended as for shipping, receiving, and storage of f. By revising paragraph (e) to read as follows: select agents and toxins, including set forth below. a. By redesignating footnote 6 as documented procedures for receiving, footnote 5. § 331.11 Security. monitoring, and shipping of all select b. By revising the first sentence in * * * * * agents and toxins. These provisions paragraph (a) to read as set forth below. (b) The security plan must be must provide that an entity will c. By redesignating footnote 7 as designed according to a site-specific risk properly secure containers on site and footnote 6. assessment and must provide graded have a written contingency plan for d. By revising paragraph (b) to read as protection in accordance with the risk of unexpected shipments. set forth below. the select agent or toxin, given its * * * * * e. By redesignating paragraphs (c) and intended use. A current security plan (e) In developing a security plan, an (d) as paragraphs (d) and (e), must be submitted for initial individual or entity should consider the respectively. f. By adding a new paragraph (c) to registration, renewal of registration, or documents entitled, ‘‘Select Agents and read as set forth below. when requested. Toxins Security Information Document’’ (c) * * * and ‘‘Select Agents and Toxins Security § 331.14 Incident response.5 (2) Contain provisions for the control Plan Template.’’ These documents are (a) An individual or entity required to of access to select agents and toxins, available on the Internet at http:// register under this part must develop including the safeguarding of animals or www.selectagents.gov/. and implement a written incident plants intentionally or accidentally * * * * * response plan 6 based upon a site exposed to or infected with a select 8. Section 331.12 is amended by specific risk assessment. * * * agent, against unauthorized access, revising paragraph (a) to read as follows: theft, loss or release. 4 Technical assistance and guidance may be * * * * * § 331.12 Biocontainment. obtained by contacting APHIS. (8) Describe procedures for how the (a) An individual or entity required to 5 Nothing in this section is meant to supersede or preempt incident response requirements imposed responsible official will be informed of register under this part must develop by other statutes or regulations. suspicious activity that may be criminal and implement a written 6 Technical assistance and guidance may be in nature and related to the entity, its biocontainment plan that is obtained by contacting APHIS.

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(b) The incident response plan must a. By redesignating footnote 8 as § 331.19 [Amended] fully describe the entity’s response footnote 7. 14. Section 331.19 is amended as procedures for the theft, loss, or release b. By redesignating paragraphs (e) follows: of a select agent or toxin; inventory through (h) as paragraphs (h), (i), (j), and a. By removing paragraph (b)(1)(iv). discrepancies; security breaches (f) respectively. b. By redesignating paragraphs (including information systems); severe c. By adding a new paragraph (e) to (b)(1)(v) through (b)(1)(viii) as weather and other natural disasters; read as set forth below. paragraphs (b)(1)(iv) through (b)(1)(vii), workplace violence; bomb threats and d. In newly redesignated paragraph respectively. (f), by removing the words ‘‘packaging suspicious packages; and emergencies 15. Section 331.20 is revised to read and’’. such as fire, gas leak, explosion, power as follows: outage, etc. e. By adding a new paragraph (g) to (c) The response procedures must read as set forth below. § 331.20 Administrative review. account for hazards associated with the § 331.16 Transfers. (a) An individual or entity may appeal select agent or toxin and appropriate a denial, revocation, or suspension of * * * * * actions to contain such select agent or registration under this part. The appeal (e) After authorization is provided by toxin, including any animals or plants must be in writing, state the factual APHIS or CDC, the select agent(s) or intentionally or accidentally exposed to basis for the appeal, and be submitted toxin(s) are packaged for shipment in or infected with a select agent. to the Administrator within 30 calendar compliance with all applicable laws * * * * * days of the decision. concerning packaging by an individual 11. Section 331.15 is revised to read (b) An individual may appeal a approved by the HHS Secretary or as follows: denial, limitation, or revocation of Administrator to have access to select access approval under this part. The § 331.15 Training. agents and toxins, following a security appeal must be in writing, state the (a) An individual or entity required to risk assessment by the Attorney General. factual basis for the appeal, and be register under this part must provide * * * * * submitted to the Administrator within information and training on (g) Transportation in commerce starts 180 calendar days of the decision. biocontainment, security (including when the select agent(s) or toxin(s) are (c) The Administrator’s decision security awareness), and incident packaged for shipment and ready for constitutes final agency action. response to: receipt by a courier transporting select (1) Each individual with access agent(s) or toxin(s) and ends when the TITLE 9—[AMENDED] approval from the HHS Secretary or package is received by the intended Administrator before that individual has recipient who is an individual approved PART 121—POSSESSION, USE, AND such access to select agents and toxins. by the HHS Secretary or Administrator TRANSFER OF SELECT AGENTS AND The training must address the particular to have access to select agents and TOXINS needs of the individuals, the work they toxins, following a security risk 16. The authority citation for part 121 will do, and the risks posed by the assessment by the Attorney General. continues to read as follows: select agents or toxins; and (2) Each individual not approved for * * * * * Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, access to select agents and toxins by the 13. Section 331.17 is amended as and 371.4. HHS Secretary or Administrator before follows: 17. Section 121.1 is amended by that individual enters areas where select a. By revising paragraph (a)(1) adding, in alphabetical order, agents or toxins are handled or stored introductory text to read as set forth definitions of adjudicated as a mental (e.g., laboratories, growth chambers, below. defective, alien, committed to any animal rooms, greenhouses, storage b. By redesignating paragraphs (a)(2) mental institution, controlled substance, areas, shipping/receiving areas, through (a)(6) as paragraphs (a)(3) crime punishable by imprisonment for a production facilities, etc.). Training for through (a)(7), respectively. term exceeding 1 year, indictment, escorted personnel must be based on the c. By adding a new paragraph (a)(2) to information security, lawfully admitted risk associated with accessing areas read as set forth below. for permanent residence, mental where select agents and toxins are used institution, occupational exposure, and/or stored. § 331.17 Records. (a) * * * recombinant and synthetic nucleic (b) Refresher training must be acids, restricted person, and unlawful provided annually or at such time as the (1) An accurate, current inventory for each select agent (including viral user of any controlled substance to read registered individual or entity as follows: significantly amends its security, genetic elements, recombinant and/or incident response, or biocontainment synthetic nucleic acids, and § 121.1 Definitions. plans. recombinant and/or synthetic Adjudicated as a mental defective. A (c) The responsible official must organisms) held in long-term storage determination by a court, board, ensure a record of the training provided (placement in a system designed to commission, or other lawful authority to each individual with access to select ensure viability for future use, such as that a person, as a result of marked agents and each escorted individual in a freezer or lyophilized materials), subnormal intelligence, or mental (e.g., laboratory workers, visitors, etc.) is including: illness, incompetency, condition, or maintained. The record must include * * * * * disease is a danger to himself/herself or the name of the individual, the date of (2) An accurate, current inventory of to others or lacks the mental capacity to the training, a description of the training any animals or plants intentionally or contract or manage his/her own affairs. provided, and the means used to verify accidentally exposed to or infected with The term includes a finding of insanity that the employee understood the a select agent (including number and by a court in a criminal case and those training. species, location, and appropriate persons found incompetent to stand 12. Section 331.16 is amended as disposition); trial or found not guilty by reason of follows: * * * * * lack of mental responsibility pursuant to

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articles 50a and 72b of the Uniform includes ensuring information as to which the Secretary of State, Code of Military Justice, 10 U.S.C. 850a, nonrepudiation and authenticity; pursuant to section 6(j) of the Export 876b. (2) Confidentiality, which means Administration Act of 1979 (50 U.S.C. * * * * * preserving authorized restrictions on App. 2405(j)), section 620A of chapter 1 Alien. Any person not a citizen or access and disclosure, including means of part M of the Foreign Assistance Act national of the United States. for protecting personal privacy and of 1961 (22 U.S.C. 2371), or section * * * * * proprietary information; and 40(d) of chapter 3 of the Arms Export Committed to any mental institution. (3) Availability, which means Control Act (22 U.S.C. 2780(d)), has A formal commitment of a person to any ensuring timely and reliable access to made a determination (that remains in mental institution by a court, board, and use of information. effect) that such country has repeatedly commission, or other lawful authority. * * * * * provided support for acts of The term includes a commitment to a Lawfully admitted for permanent international terrorism; or mental institution involuntarily. The residence. The status of having been (8) Has been discharged from the term includes commitment for mental lawfully accorded the privilege of Armed Services of the United States defectiveness or mental illness. It also residing permanently in the United under dishonorable conditions. includes commitments for other States as an immigrant in accordance * * * * * reasons, such as for drug use. The term with the immigration laws, such status Unlawful user of any controlled does not include a person in a mental not having changed. substance. For purposes of this institution for observation or a Mental institution. Includes mental regulation, a person who uses a voluntary admission to a mental health facilities, mental hospitals, controlled substance and has lost the institution. sanitariums, psychiatric facilities, and power of self-control with reference to Controlled substance. A drug or other other facilities that provide diagnoses by the use of that controlled substance; and substance, or immediate precursor, as licensed professionals of mental any person who is a current user of a defined in section 102 of the Controlled retardation or mental illness, including controlled substance in a manner other Substances Act, 21 U.S.C. 802. The term a psychiatric ward in a general hospital. than as prescribed by a licensed includes, but is not limited to, Occupational exposure. Any physician. Such use is not limited to the marijuana and scheduled depressants, reasonably anticipated skin, eye, use of drugs on a particular day, or stimulants, and narcotic drugs. The term mucous membrane, or parenteral within a matter of days or weeks before, does not include distilled spirits, wine, contact with blood or other potentially but rather that the unlawful use has malt beverages, or tobacco, as those infectious materials or toxins that may occurred recently enough to indicate terms are defined or used in Subtitle E result from the performance of an that the individual is actively engaged of the Internal Revenue Code of 1986, as employee’s duties. in such conduct. A person may be an amended. * * * * * unlawful current user of a controlled Crime punishable by imprisonment Recombinant and synthetic nucleic substance even though the substance is for a term exceeding 1 year. Any acids. (1) Recombinant nucleic acid not being used at the precise time the Federal, State, or foreign offense for molecules that are constructed by person seeks to have access to a select which the maximum penalty, whether joining nucleic acid molecules and that agent or toxin. An inference of current or not imposed, is capital punishment can replicate in a living cell; use may be drawn from evidence of a or imprisonment in excess of 1 year. (2) Synthetic nucleic acid molecules recent use or possession of a controlled What constitutes a conviction of such a that are chemically, or by other means, substance or a pattern of use or crime shall be determined in accordance synthesized or amplified nucleic acid possession that reasonably covers the with the law of the jurisdiction in which molecules that may wholly or partially present time, e.g., a conviction for use the proceedings were held. Any contain functional equivalents of or possession of a controlled substance conviction which has been set aside or nucleotides; or within the past year; multiple arrests for nullified as a matter of law or for which (3) Molecules that result from the such offenses within the past 5 years if a person has been pardoned shall not be replication of those described in the most recent arrest occurred within considered a conviction for the paragraph (1) or (2) of this definition. the past year, or persons found through purposes of this part. * * * * * a drug test to use a controlled substance * * * * * Restricted person. An individual who: unlawfully, provided that the test was Indictment. A formal written (1) Is under indictment for a crime administered within the past year. For accusation originating with a prosecutor punishable by imprisonment for a term a current or former member of the and issued by a grand jury against a exceeding 1 year; Armed Forces, an inference of current party charged with a crime. For the (2) Has been convicted in any court of use may be drawn from recent purpose of these regulations the term a crime punishable by imprisonment for disciplinary or other administrative indictment includes an ‘‘information,’’ a term exceeding 1 year; action based on confirmed drug use, which is a formal accusation of a crime, (3) Is a fugitive from justice; e.g., court-martial conviction, differing only in that it is being (4) Is an unlawful user of any nonjudicial punishment, or an presented by a competent public officer controlled substance (as defined in administrative discharge based on drug on his oath of office, instead of a grand section 102 of the Controlled Substances use or drug rehabilitation failure. jury. Act (21 U.S.C. 802)); * * * * * Information security. Protecting (5) Is an alien illegally or unlawfully information and information systems in the United States; 18. Section 121.3 is amended as from unauthorized access, use, (6) Has been adjudicated as a mental follows: disclosure, disruption, modification, or defective or has been committed to any a. By adding a new sentence at the destruction in order to provide: mental institution; end of paragraph (a) to read as set forth (1) Integrity, which means guarding (7) Is an alien (other than an alien below. against improper information lawfully admitted for permanent b. By revising paragraph (b) to read as modification or destruction, and residence) who is a national of a country set forth below.

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c. In paragraph (c) introductory text, applicant. Exclusions will be listed on decision granting or denying the request by adding the words ‘‘and/or synthetic’’ the National Select Agent Registry Web will be issued. An exclusion will be after the word ‘‘recombinant’’ each time site at http://www.selectagents.gov/. effective upon notification to the it appears. (2) If an excluded attenuated strain or applicant. Exclusions will be listed on d. In paragraph (c)(2), by adding the inactivated toxin is subjected to any the National Select Agent Registry Web words ‘‘and/or synthetic’’ after the word manipulation that restores or enhances site at http://www.selectagents.gov/. ‘‘Recombinant’’. its virulence or toxic activity, the (2) If an excluded attenuated strain or e. By revising paragraph (e) to read as resulting select agent or toxin will be inactivated toxin is subjected to any set forth below. subject to the requirements of this part. manipulation that restores or enhances f. In paragraph (f)(3)(i), by removing * * * * * its virulence or toxic activity, the the words ‘‘Newcastle disease virus 19. Section 121.4 is amended as resulting select agent or toxin will be (velogenic)’’ and adding the words follows: subject to the requirements of this part. ‘‘virulent Newcastle disease virus’’ in a. By adding a new sentence at the * * * * * their place. end of paragraph (a) to read as set forth § 121.5 [Amended] § 121.3 VS select agents and toxins. below. b. By revising paragraph (b) to read as 20. In § 121.5, paragraph (a)(3)(i) is (a) * * * The select agents and toxins set forth below. amended by removing the words marked with an asterisk (*) are c. In paragraph (c) introductory text, ‘‘bovine spongiform encephalopathy designated as Tier 1 select agents and by adding the words ‘‘and/or synthetic’’ agent,’’. toxins and are subject to additional after the word ‘‘recombinant’’ each time § 121.6 [Amended] requirements as listed in this part. it appears. (b) VS select agents and toxins: d. In paragraph (c)(2) introductory 21. In § 121.6, paragraph (a)(3)(i) is African horse sickness virus; text, by adding the phrase ‘‘and/or amended by removing the words African swine fever virus; synthetic’’ after the word ‘‘Hendra virus, Nipah virus, Rift Valley virus (highly ‘‘Recombinant’’. fever virus, and Venezuelan equine pathogenic); e. By revising paragraph (e) to read as encephalitis virus’’ and adding the Classical swine fever virus; set forth below. words ‘‘Burkholderia mallei, and * Foot-and-mouth disease virus; f. In paragraph (f)(3)(i), by removing Burkholderia pseudomallei’’ in their Goat pox virus; the words ‘‘Brucella melitensis, Hendra place. Lumpy skin disease virus; virus, Nipah virus, § 121.8 [Amended] Mycoplasma capricolum subspecies virus, and Venezuelan equine 22. In section 121.8, paragraph (a)(1) capripneumoniae (contagious encephalitis virus’’ and adding the is amended by removing the words caprine pleuropneumonia); words ‘‘Burkholderia mallei, and ‘‘within any of the categories described Mycoplasma mycoides subspecies Burkholderia pseudomallei’’ in their in 18 U.S.C. 175b’’ and adding the mycoides small colony (Mmm SC) place. (contagious bovine words ‘‘a restricted person’’ in their pleuropneumonia); § 121.4 Overlap select agents and toxins. place. Peste des petits ruminants virus; (a) * * * The select agents and toxins 23. Section 121.9 is amended as * Rinderpest virus; marked with an asterisk (*) are follows: Sheep pox virus; designated as Tier 1 select agents and a. By redesignating paragraphs (a)(3) Swine vesicular disease virus; toxins and are subject to additional through (a)(5) as paragraphs (a)(4), 1 Virulent Newcastle disease virus. requirements as listed in this part. (a)(5), and (a)(7) respectively. * * * * * (b) Overlap select agents and toxins: b. By adding a new paragraph (a)(3) to * Bacillus anthracis; read as set forth below. * * * * * Brucella abortus; c. In newly redesignated paragraph (e) An attenuated strain of a select Brucella melitensis; (a)(5), by removing the word ‘‘and’’. agent or an inactive form of a select Brucella suis; d. By adding a new paragraph (a)(6) toxin may be excluded from the * Burkholderia mallei; to read as set forth below. requirements of this part based upon a *Burkholderia pseudomallei; e. By revising the first sentence of determination by the Administrator that Hendra virus; paragraph (b) to read as set forth below. the attenuated strain or inactivated Nipah virus; f. By revising the first sentence of toxin does not pose a severe threat to Rift Valley fever virus; paragraph (c)(1) to read as set forth animal health or to animal products. Venezuelan equine encephalitis virus: below. (1) To apply for exclusion, an Epizootic Subtypes IAB, IC. § 121.9 Responsible official. individual or entity must submit a * * * * * written request and supporting (e) An attenuated strain of a select (a) * * * scientific information. A written agent or an inactive form of a select (3) Have the appropriate training and decision granting or denying the request toxin may be excluded from the expertise to competently implement and will be issued. An exclusion will be requirements of this part based upon a manage the requirements of this part; effective upon notification to the determination by the HHS Secretary or * * * * * Administrator that the attenuated strain (6) Have their principal duty station at 1 A virulent Newcastle disease virus (avian the physical location of the entity; and paramyxovirus serotype 1) has an intracerebral or inactivated toxin does not pose a pathogenicity index in day-old chicks (Gallus severe threat to public health and safety, * * * * * gallus) of 0.7 or greater or has an amino acid to animal health or to animal products. (b) An entity may designate one or sequence at the fusion (F) protein cleavage site that (1) To apply for exclusion, an more individuals to serve as an alternate is consistent with virulent strains of Newcastle disease virus. A failure to detect a cleavage site that individual or entity must submit a responsible official who acts for the is consistent with virulent strains does not confirm written request and supporting responsible official in his/her absence. the absence of a virulent virus. scientific information. A written ***

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(c) * * * the select agent or toxin, given its (e) In addition to the requirements (1) The identification of any of the intended use. A current security plan contained in paragraphs (c) and (d) of following select agents or toxins must be must be submitted for initial this section, the security plan for an immediately reported by telephone, registration, renewal of registration, or individual or entity possessing a Tier 1 facsimile, or e-mail: African horse when requested. select agent or toxin must also: sickness virus, African swine fever (c) * * * (1) Describe procedures for virus, avian influenza virus (highly (2) Contain provisions for the control conducting a pre-access suitability pathogenic), Bacillus anthracis, Brucella of access to select agents and toxins, assessment of persons who will have melitensis, Burkholderia mallei, including the safeguarding of animals or access to a Tier 1 select agent or toxin; plants intentionally or accidentally Burkholderia pseudomallei, classical (2) Describe procedures for how an exposed to or infected with a select swine fever virus, foot-and-mouth entity’s responsible official will agent, against unauthorized access, disease virus, virulent Newcastle coordinate their efforts with the entity’s theft, loss or release. disease virus, rinderpest virus, and safety and security professionals to swine vesicular disease virus. * * * * * * * * ensure security of Tier 1 select agents * * * * * (8) Describe procedures for how the and toxins and share, as appropriate, responsible official will be informed of relevant information; and 24. Section 121.10 is amended as suspicious activity that may be criminal (3) Describe procedures for the follows: in nature and related to the entity, its a. By redesignating paragraphs (e) personnel, or its select agents or toxins; ongoing assessment of the suitability of through (j) as paragraphs (f) through (k), and how the responsible official will personnel with access to a Tier 1 select respectively. notify the Federal Bureau of agent or toxin. The procedures must b. By adding a new paragraph (e) to Investigation (FBI) of such activity; include: read as set forth below. (9) Contain provisions for information (i) Self- and peer-reporting of c. In newly redesignated paragraph security that: incidents or conditions that could affect (g)(1), by removing the words ‘‘within (i) Ensure that all external an individual’s ability to safely have any of the categories described in 18 connections to systems which control access to or work with select agents and U.S.C. 175b’’ and adding the words ‘‘a security of the facility are isolated or toxins, or to safeguard select agents and restricted person’’ in their place. have controls that permit and monitor toxins from theft, loss, or release; d. In newly redesignated paragraph for only authorized and authenticated (ii) The training of all entity (j), by removing the number ‘‘5’’ and user access; employees on entity policies and adding the number ‘‘3’’ in its place. (ii) Ensure that authorized and procedures for reporting, evaluation, authenticated users are only granted and corrective actions concerning the § 121.10 Restricting access to select access to select agent and toxin related agents and toxins; security risk assessment of personnel suitability to assessments. information, files, equipment (e.g., access Tier 1 agents and toxins; and servers or mass storage devices) and (iii) The ongoing suitability * * * * * applications as necessary to fulfill their (e) A person who has a valid approval monitoring of individuals with access to roles and responsibilities, and that Tier 1 select agents and toxins. from the HHS Secretary or access is modified when the user’s roles Administrator for access to a select (4) Entities with Tier 1 select agents and responsibilities change or when and toxins must prescribe and/or agent or toxin may request the HHS their access to select agent and toxin is implement the following security Secretary or Administrator to provide suspended or revoked; enhancements: the person’s approval status to another (iii) Ensure that controls are in place registered individual or entity for a that are designed to prevent malicious (i) Procedures that limit access to specified period of time. code (such as, but not limited to, registered space only to those approved * * * * * computer viruses, worms, and spyware) by the HHS Secretary or the Administrator and meet the criteria of 25. Section 121.11 is amended as from compromising the confidentiality, integrity, or availability of critical the entity’s program that will ensure follows: individuals with access approval to a. By revising paragraph (b) to read as information systems; (iv) Establish a robust configuration select agents and toxins are trustworthy set forth below. and behaving in a manner that upholds b. By revising paragraph (c)(2) to read management practice for information systems to include regular patching and public health and safety, the protection as set forth below. of animal or plant health and animal or c. In paragraph (c)(6), by removing the updates made to operating systems and individual applications; and plant products, security, and the word ‘‘and’’. integrity of the scientific enterprise. In d. By adding new paragraphs (c)(8), (v) Establish procedures that provide developing these procedures, an (c)(9), and (c)(10) to read as set forth backup security measures in the event individual or entity may consider the below. that access control systems and/or guidance documents available on the e. By redesignating paragraphs (e) and surveillance devices are rendered Internet at (f) as paragraphs (f) and (g), respectively. inoperable. http://www.selectagents.gov/.; f. By adding a new paragraph (e) to (10) Contain provisions and policies read as set forth below. for shipping, receiving, and storage of (ii) Procedures that limit access to g. By revising newly redesignated select agents and toxins, including laboratory and storage facilities outside paragraph (f) to read as set forth below. documented procedures for receiving, of normal business hours to only those monitoring, and shipping of all select specifically approved by the responsible § 121.11 Security. agents and toxins. These provisions official or designee; * * * * * must provide that an entity will (iii) Procedures for allowing visitors, (b) The security plan must be properly secure containers on site and their property, and vehicles at the entry designed according to a site-specific risk have a written contingency plan for and exit points to the registered space, assessment and must provide graded unexpected shipments. or at other designated points of entry to protection in accordance with the risk of * * * * * the building, facility, or compound

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based on the entity’s site-specific risk documents entitled ‘‘Select Agents and could compromise the use of the drug assessment; Toxins Security Information Document’’ to control disease agents in humans, (iv) A minimum of three barriers and ‘‘Select Agents and Toxins Security veterinary medicine, or agriculture, or where each subsequent barrier is Plan Template.’’ These documents are recombinant and or synthetic DNA different and adds to the delay in available on the Internet at http:// containing genes for the biosynthesis of reaching secured areas where select www.selectagents.gov/. select toxins lethal for vertebrates at an agents and toxins are used or stored. * * * * * LD[50] < 100 ng/kg body weight) Barriers must be monitored in such a resulting from,’’ after the word way as to detect and assess intentional 26. Section 121.12 is amended as ‘‘conduct’’ both times it appears. and unintentional circumventing of follows: c. In paragraph (b)(1), by removing the established access control measures a. By revising paragraph (a) to read as words ‘‘Experiments utilizing under all conditions (day/night, severe set forth below. recombinant DNA that involve the weather, etc.); b. By revising paragraph (c)(1) to read deliberate transfer of’’ and adding the (v) All registered space or areas that as set forth below. words ‘‘Experiments that involve the reasonably afford access to the c. In paragraph (c)(3), by removing the deliberate transfer of, or selection for,’’ address ‘‘http://www.aphis.usda.gov./ registered space must be protected by an _ in their place. intrusion detection system (IDS) unless programs/ag selectagent/index.html’’ d. In paragraph (b)(2), by adding the physically occupied; and replacing it with the address words ‘‘synthetic or’’ before the word (vi) Personnel monitoring the IDS ‘‘http://www.selectagents.gov/’’. ‘‘recombinant’’. must be capable of evaluating and d. By redesignating paragraph (d) as 28. Section 121.14 is amended as interpreting the alarm and alerting the paragraph (e). follows: designated security response force or e. By adding a new paragraph (d) to a. In the section heading, by law enforcement; read as set forth below. redesignating footnote 11 as footnote 10. (vii) Provide backup power and § 121.12 Biosafety. b. In paragraph (a), by redesignating energy sources to power information footnote 12 as footnote 11 and revising (a) An individual or entity required to the first sentence to read as set forth security networks and integrated access register under this part must develop controls and related systems during below. and implement a written biosafety plan c. By revising paragraph (b) to read as emergencies; that is commensurate with the risk of (viii) Response time for security forces set forth below. the select agent or toxin, given its or local police must not exceed 15 d. By redesignating paragraphs (c) and intended use.9 The biosafety plan must minutes from the time of an intrusion (d) as paragraphs (d) and (f), contain sufficient information and alarm or report of a security incident; respectively. documentation to describe the biosafety (ix) Entities must conduct complete e. By adding a new paragraph (c) to and containment procedures for the inventory audits of all Tier 1 select read as set forth below. select agent or toxin, including any agents and toxins in long-term storage f. By adding a new paragraph (e) to animals or plants intentionally or when any of the following occur: read as set forth below. accidentally exposed to or infected with (A) Upon the physical relocation of a § 121.14 Incident response.10 collection or inventory of select agents a select agent. * * * * * (a) An individual or entity required to or toxins for those Tier 1 select agents register under this part must develop or toxins in the collection or inventory; (c) * * * (1) The CDC/NIH publication, and implement a written incident (B) Upon the departure or arrival of a response plan 11 based upon a site principal investigator for those Tier 1 ‘‘Biosafety in Microbiological and Biomedical Laboratories.’’ This specific risk assessment. * * * select agents or toxins under the control (b) The incident response plan must of that principal investigator; or document is available on the Internet at http://www.selectagents.gov/. fully describe the entity’s response (C) In the event of a theft or loss of procedures for the theft, loss, or release a Tier 1 select agent or toxin. * * * * * of a select agent or toxin; inventory (5) Entities that possess foot-and- (d) The biosafety plan must include discrepancies; security breaches mouth disease virus and rinderpest an occupational health program for (including information systems); severe virus must have the following individuals with access to Tier 1 select weather and other natural disasters; additional security requirements: agents and toxins, and those individuals workplace violence; bomb threats and (i) A minimum of four barriers, one of must be enrolled in the occupational suspicious packages; and emergencies which must be a perimeter security health program. The occupational such as fire, gas leak, explosion, power fence or equivalent which is monitored health program may also be made outage, etc. 24 hours a day, 7 days a week (24/7) to available to individuals without access (c) The response procedures must detect the presence of unauthorized to Tier 1 select agents and toxins. account for hazards associated with the persons, vehicles, materials, or * * * * * select agent or toxin and appropriate unauthorized activities; actions to contain such select agent or (ii) Onsite 24/7 armed security § 121.13 [Amended] toxin, including any animals or plants response force with roving patrol. 27. Section 121.13 is amended as intentionally or accidentally exposed to Response time must not exceed 5 follows: or infected with a select agent. minutes from the time of an intrusion a. In the section heading, by removing alarm or report of a security incident; footnote 10. * * * * * (e) Entities with Tier 1 select agents (iii) CCTV surveillance with 24/7 b. In paragraph (a), by adding the and toxins must have the following monitoring and recording; and words ‘‘, or possess products (i.e., select (iv) Transport vehicle with GPS agents that are not known to acquire the tracking designed to serve as a 10 Nothing in this section is meant to supersede resistance naturally, if such acquisition or preempt incident response requirements containment vehicle. imposed by other statutes or regulations. (f) In developing a security plan, an 9 Technical assistance and guidance may be 11 Technical assistance and guidance may be individual or entity should consider the obtained by contacting APHIS. obtained by contacting APHIS.

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additional incident response policies or to each individual with access to select b. By redesignating paragraphs (a)(2) procedures: agents and each escorted individual through (a)(6) as paragraphs (a)(3) (1) The incident response plan must (e.g., laboratory workers, visitors, etc.) is through (a)(7), respectively. fully describe the entity’s response maintained. The record must include c. By adding a new paragraph (a)(2) to procedures for failure of intrusion the name of the individual, the date of read as set forth below. detection or alarm system; and the training, a description of the training (2) The incident response plan must provided, and the means used to verify § 121.17 Records. describe notification procedures for the that the employee understood the (a) * * * FBI in the event of a theft or suspicious training. (1) An accurate, current inventory for activity that may be criminal in nature each select agent (including viral 30. Section 121.16 is amended as involving a Tier 1 select agent or toxin. genetic elements, recombinant and/or follows: * * * * * synthetic nucleic acids, and a. By redesignating footnote 14 as recombinant and/or synthetic 29. Section 121.15 is revised to read footnote 12. organisms) held in long-term storage as follows: b. By redesignating paragraphs (f) (placement in a system designed to through (i) as paragraphs (i), (k), and (g), § 121.15 Training. ensure viability for future use, such as respectively. (a) An individual or entity required to in a freezer or lyophilized materials), register under this part must provide c. By adding a new paragraph (f) to including: information and training on biosafety, read as set forth below. d. In newly redesignated paragraph * * * * * security (including security awareness), (2) An accurate, current inventory of and incident response to: (g), by removing the words ‘‘packaging and’’. any animals or plants intentionally or (1) Each individual with access accidentally exposed to or infected with approval from the HHS Secretary or e. By adding a new paragraph (h) to read as set forth below. a select agent (including number and Administrator before that individual has species, location, and appropriate such access to select agents and toxins. § 121.16 Transfers. disposition); The training must address the particular needs of the individuals, the work they * * * * * * * * * * will do, and the risks posed by the (f) After authorization is provided by 32. Section 121.20 is revised to read select agents or toxins; and APHIS or CDC, the select agent(s) and as follows: (2) Each individual not approved for toxin(s) are packaged for shipment in access to select agents and toxins by the compliance with all applicable laws § 121.20 Administrative review. HHS Secretary or Administrator before concerning packaging by an individual (a) An individual or entity may appeal that individual works in or otherwise approved by the HHS Secretary or a denial, revocation, or suspension of enters areas where select agents or Administrator to have access to select registration under this part. The appeal toxins are handled or stored (e.g., agents and toxins, following a security must be in writing, state the factual laboratories, growth chambers, animal risk assessment by the Attorney General. basis for the appeal, and be submitted rooms, greenhouses, storage areas, * * * * * to the Administrator within 30 calendar shipping/receiving areas, production (h) Transportation in commerce starts days of the decision. facilities, etc.). Training for escorted when the select agent(s) or toxin(s) are (b) An individual may appeal a personnel must be based on the risk packaged for shipment and ready for denial, limitation, or revocation of associated with accessing areas where receipt by a courier transporting select access approval under this part. The select agents and toxins are used and/ agent(s) or toxin(s) and ends when the appeal must be in writing, state the or stored. package is received by the intended factual basis for the appeal, and be (b) Entities with Tier 1 select agents recipient who is an individual approved submitted to the Administrator within and toxins must conduct annual insider by the HHS Secretary or Administrator 180 calendar days of the decision. threat awareness briefings on how to to have access to select agents and (c) The Administrator’s decision identify and report suspicious toxins, following a security risk constitutes final agency action. behaviors. assessment by the Attorney General. (c) Refresher training must be Done in Washington, DC, this 29th day of * * * * * provided annually or at such time as the September 2011. registered individual or entity 31. Section 121.17 is amended as Gregory L. Parham, significantly amends its security, follows: Administrator, Animal and Plant Health incident response, or biosafety plans. a. By revising paragraph (a)(1) Inspection Service. (d) The responsible official must introductory text to read as set forth [FR Doc. 2011–25520 Filed 9–30–11; 8:45 am] ensure a record of the training provided below. BILLING CODE 3410–34–P

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