Vol. 77 Friday, No. 194 October 5, 2012

Part II

Department of Agriculture

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

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DEPARTMENT OF AGRICULTURE 2, Riverdale, MD 20737–1231; (301) 1. Modification of the select agent and 851–3300, option 1. toxin list: • Animal and Plant Health Inspection SUPPLEMENTARY INFORMATION: The following agents would no Service longer be considered PPQ select agents Executive Summary or toxins, or would be excluded from 7 CFR Part 331 On July 29, 2010, we published in the compliance with the select agent Federal Register (75 FR 44724–44725, regulations: Any subspecies of Ralstonia 9 CFR Part 121 Docket No. APHIS–2009–0070) an solanacearum except race 3, biovar 2 advance notice of proposed rulemaking and all subspecies of Sclerophthora [Docket No. APHIS–2009–0070] and request for comments (ANPR)1 and rayssiae except var. zeae, and Xylella fastidiosa, citrus variegated chlorosis RIN 0579–AD09 On October 3, 2011, we published in the Federal Register (76 FR 61228–61244, (CVC) strain. • Agricultural Bioterrorism Protection Docket No. APHIS–2009–0070) a The following agents would no Act of 2002; Biennial Review and proposal2 regarding our intent to amend longer be considered VS select agents or Republication of the Select Agent and and republish the list of select agents toxins, or would be excluded from Toxin List; Amendments to the Select and toxins that have the potential to compliance with the select agent Agent and Toxin Regulations pose a severe threat to animal or plant regulations: Any low pathogenic strains health, or to animal or plant products, of virus, any strain of AGENCY: Animal and Plant Health reorganize the list of select agents and Newcastle disease virus which does not Inspection Service, USDA. toxins based on the relative potential of meet the criteria for virulent Newcastle ACTION: Final rule. each select agent or toxin to be misused disease virus, all subspecies to adversely affect human, plant, or Mycoplasma capricolum except SUMMARY: In accordance with the animal health, and amend the subspecies capripneumoniae Agricultural Bioterrorism Protection Act regulations in order to add definitions (contagious caprine pleuropneumonia), of 2002, we are amending and and clarify language concerning and all subspecies Mycoplasma republishing the list of select agents and security, training, , mycoides except subspecies mycoides toxins that have the potential to pose a , and incident response. small colony (Mmm SC) (contagious severe threat to animal or plant health, Specifically, the ANPR solicited bovine pleuropneumonia), Akabane or to animal or plant products. The Act comments regarding whether there are virus; Bluetongue virus (exotic), Bovine requires the biennial review and other select agents or toxins that should spongiform encephalopathy agent; republication of the list of select agents be added to the Plant Protection and Camel pox virus; Ehrlichia ruminantium and toxins and the revision of the list as Quarantine (PPQ) and Veterinary (Heartwater); necessary. This action implements the Services (VS) lists of select agents and virus; Malignant catarrhal fever virus findings of the third biennial review of toxins, whether any of the select agents (Alcelaphine herpesvirus type 1); the list. In addition, we are reorganizing or toxins on the PPQ or VS lists should Menangle virus; and Vesicular the list of select agents and toxins based be removed, whether the PPQ and VS stomatitis virus (exotic): Indiana on the relative potential of each select subtypes VSV–IN2, VSV–IN3. lists of select agents and toxins should • agent or toxin to be misused to be tiered based on the relative The following agent would no adversely affect human, plant, or animal bioterrorism risk presented by each longer be considered a VS/Department health. Such tiering of the list allows for select agent or toxin, and whether the of Health and Human Services (HHS) the optimization of security measures security requirements for select agents overlap select agent: Venezuelan Equine for those select agents or toxins that or toxins in the highest tier should be Encephalitis Virus (subtypes ID and IE). present the greatest risk of deliberate stratified based on type of use or other 2. Tiering of the select agent and toxin misuse with the most significant factors. Comments received as a result lists: potential for mass casualties or Tier 1 select agents and toxins: of the ANPR were used in order to • devastating effects to the economy, PPQ select agents and toxins: None. inform our discussions on the content of • VS select agents and toxins: Foot- critical infrastructure, or public the select agent list and our confidence. We are also making a and-mouth disease virus and determination regarding reorganization virus. number of amendments to the of the list in the proposed rule. We • regulations, including the addition of VS/HHS overlap select agents and solicited comments concerning our toxins: Bacillus anthracis, Burkholderia definitions and clarification of language proposal for 60 days ending December concerning security, training, biosafety, mallei, and Burkholderia pseudomallei. 2, 2011. We reopened and extended the 3. Establishing physical security biocontainment, and incident response. deadline for comments until January 17, standards for entities possessing Tier 1 These changes will increase the 2012, in a document published in the select agents and toxins, including the usability of the select agent regulations Federal Register on December 15, 2011 requirement to conduct pre-access as well as provide for enhanced program (76 FR 77914, Docket No. APHIS–2009– assessments and ongoing monitoring of oversight. 0070). We received 30 comments by that personnel with access to Tier 1 agents DATES: The amendments to 7 CFR 331.1 date. They were from researchers, and toxins; through 331.10, 331.13, and 331.16 scientific organizations, laboratories, 4. Miscellaneous revisions to the through 331.20 and 9 CFR 121.1 through and universities. regulations to clarify regulatory 121.10, 121.13, 121.16, 121.17, and Changes to the current regulations language concerning security, training, 121.20 are effective December 4, 2012. detailed in this final rule include: biosafety, and incident response. The remaining provisions of this final Costs of the Rule: Entities affected by rule are effective April 3, 2013. 1 To view the ANPR and the comments we the rule include research and diagnostic FOR FURTHER INFORMATION CONTACT: Mr. received, go to http://www.regulations.gov/ facilities; Federal, State, and university #!docketDetail;D=APHIS–2009–0070. laboratories; and private commercial Charles L. Divan, Acting Director, 2 To view the proposed rule and the comments APHIS Agriculture Select Agent we received, go to http://www.regulations.gov/ and non-profit enterprises. The Program, APHIS, 4700 River Road Unit #!docketDetail;D=APHIS–2009–0070. regulations require registering the

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possession, use, and transfer of select as the Bioterrorism Response Act) or plant health, or animal or plant agents or toxins. In addition, the entity provides for the regulation of certain products. is required to ensure that the facility biological agents that have the potential We use the term ‘‘select agents and where the agent or toxin is housed has to pose a severe threat to both human toxins’’ throughout the preamble of this adequate biosafety and containment and animal health, to animal health, to final rule. Unless otherwise specified, measures, that the physical security of plant health, or to animal and plant the term ‘‘select agents and toxins’’ will the premises is adequate, that all products. The Animal and Plant Health refer to all agents or toxins listed by individuals with access to select agents Inspection Service (APHIS) has the APHIS. When it is necessary to specify or toxins have the appropriate primary responsibility for implementing the type of select agent or toxin, we will education, training, and/or experience the provisions of the Act within the use the following terms: ‘‘PPQ select to handle such agents or toxins, and that Department of Agriculture (USDA). agents and toxins’’ (for the plant agents complete records concerning activities Veterinary Services (VS) select agents and toxins listed in 7 CFR 331.3), ‘‘VS related to the select agents or toxins are and toxins are those that have been select agents and toxins’’ (for the animal maintained. determined to have the potential to pose agents and toxins listed in 9 CFR 121.3), The rule will further reduce or a severe threat to animal health or or ‘‘overlap select agents and toxins’’ minimize the risk of misuse of select animal products. Plant Protection and (for the agents and toxins listed in both agents and toxins that have the potential Quarantine (PPQ) select agents and 9 CFR 121.4 and 42 CFR 73.4). to pose a severe threat to human, animal toxins are those that have the potential On October 3, 2011, we published in or plant health, or to animal or plant to pose a severe threat to plant health the Federal Register (76 FR 61228– products. APHIS and HHS recognize or plant products. Overlap select agents 61244, Docket No. APHIS–2009–0070) a that several of the required measures of and toxins are those that have been proposal 3 to amend and republish the the regulations may impose certain determined to pose a severe threat to list of select agents and toxins that have operational costs upon affected entities, human and animal health or animal the potential to pose a severe threat to particularly entities that have the newly products. Overlap select agents are animal or plant health, or to animal or designated Tier 1 select agents and subject to regulation by both APHIS and plant products, reorganize the list of toxins. In many cases, however, the the Centers for Disease Control and select agents and toxins based on the affected entities already employ some or Prevention (CDC), which has the relative potential of each select agent or all of the required measures. primary responsibility for implementing toxin to be misused to adversely affect Compliance costs actually incurred will the provisions of the Act for the human, plant, or animal health, and therefore vary from one entity to the Department of Health and Human amend the regulations in order to add next. Services (HHS). definitions and clarify language While information on the specific Subtitle B (which is cited as the concerning security, training, biosafety, changes that would need to occur at ‘‘Agricultural Bioterrorism Protection biocontainment, and incident response. individual sites and the associated costs Act of 2002’’ and referred to below as We solicited comments concerning was not readily available during the Act), section 212(a), provides, in our proposal for 60 days ending proposed rulemaking, some general part, that the Secretary of Agriculture December 2, 2011. We reopened and observations regarding the potential (the Secretary) must establish by extended the deadline for comments costs were presented. These general cost until January 17, 2012, in a document observations can be found in Table 2 of regulation a list of each and each toxin that the Secretary published in the Federal Register on the Regulatory Impact Analysis located December 15, 2011 (76 FR 77914, at: www.regulations.gov and at http:// determines has the potential to pose a severe threat to animal or plant health, Docket No. APHIS–2009–0070). We www.selectagents.gov. received 30 comments by that date. Benefits of the Rule: The objectives of or to animal or plant products. Paragraph (a)(2) of section 212 requires They were from researchers, scientific the final rule is to create a means of organizations, laboratories, and ensuring enhanced oversight in the the Secretary to review and republish the list every 2 years and to revise the universities. They are discussed below transfer, storage, and use of select agents by topic. and toxins; define the security list as necessary. In this document, we procedures and suitability assessments are amending and republishing the list Guidance Documents for pre-access suitability and continual of select agents and toxins based on the findings of our third biennial review of In the proposed rule, we specifically monitoring of individuals with access to requested comment from the regulated Tier 1 select agents and toxins; and the list. In determining whether to include an community and any other interested require that entities in possession of persons on the need for and desirability such agents and toxins develop and agent or toxin on the list, the Act requires that the following criteria be of guidance documents that would serve implement effective means of biosafety, to assist regulated entities in meeting information security, and physical considered: • The effect of exposure to the agent the requirements of regulations. We security. The overall benefit of the were particularly interested in public amended provisions will be a reduced or the toxin on animal and plant health, and on the production and marketability comment regarding Web sites, articles, likelihood of the accidental or or other sources useful in developing intentional release of a select agent or of animal or plant products; • The pathogenicity of the agent or such guidance documents. We received toxin and the avoidance of costs a number of comments on the issue of associated with such a release. The goal the toxin and the methods by which the agent or toxin is transferred to animals guidance, which are discussed below. of the amended regulations is to Two commenters suggested the use of or plants; enhance the protection of human, specific documents in creating • The availability and effectiveness of animal, and plant health and safety. guidance: The Laboratory Biorisk pharmacotherapies and prophylaxis to Management Standard, which was Background treat and prevent any illness or disease The Public Health Security and caused by the agent or toxin; and • 3 To view the proposed rule and the comments Bioterrorism Preparedness and Any other criteria that the Secretary we received, go to http://www.regulations.gov/ Response Act of 2002 (referred to below considers appropriate to protect animal #!docketDetail;D=APHIS-2009-0070.

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developed by the European Committee PPQ Select Agents and Toxins meant to decrease the burden on for Standardization, and the report We proposed to amend the list of PPQ researchers and focus attention on ‘‘Guidance for Enhancing Personnel select agents and toxins listed in 7 CFR agents and toxins judged to be of Reliability and Strengthening the 331.3 by removing Xylella fastidiosa, greatest concern. Culture of Responsibility,’’ which was citrus variegated chlorosis (CVC) strain, The list of PPQ select agents and developed by the National Science from the list as it no longer meets the toxins includes an entry for Advisory Board for Biosecurity. criteria for use as an agroterrorism Xanthomonas oryzae. While we did not propose any changes to the entry for We agree with the commenters and agent. Xanthomonas oryzae, one commenter have utilized both sources in developing One commenter stated that the stated that it should be removed from guidance. scientific basis for the removal of Xylella fastidiosa from the list was the list of select agents and toxins and One commenter stated that the select unclear and requested clarification offered a number of arguments, which agent program should develop a concerning our decision. The are discussed below. standardized template that addresses commenter additionally stated that if The commenter proposed the removal each item required by the regulations, the review process for such removal of Xanthomonas oryzae based on the both for regulated entities and were to be transparent, with expert assertion that Xanthomonas oryzae inspectors. The commenter went on to opinion from the public and private populations are adapted only to local say that the templates should be posted sector, including a sound scientific conditions and do not persist upon on the select agent Web site. analysis and an assessment of the introduction to new environments. The National Select Agent Registry at biosecurity risk of each agent, other Given that the major natural host for Xanthomonas oryzae is rice, the www.selectagents.gov includes plant pathogens on the list of select commenter also compared cultivation checklists, guidance documents, and agents and toxins could potentially be practices utilized in domestic templates that we have developed to aid removed. commercial rice production with those entities in meeting the requirements of We are making no changes as a result utilized in Asian commercial rice the regulations. The select agent of this comment. Each agent on the select agent and toxin list was production. The commenter argued that program also conducts regular inspector domestic commercial cultivation training in order to standardize considered for retention or removal based on a variety of factors, including, practices eliminate transmission of the inspector understanding of the pathogen since rice seeds are directly regulations and inspection process. We but not limited to, the scientific concerns cited by the commenter. planted whereas in Asia rice seedlings accept entity feedback regarding the are cultivated elsewhere and then inspection process and incorporate it Further, the select agent program did employ subject-matter experts as part of transplanted, and wounds created into our training program as during such handling and transplant are appropriate. the decision-making process as recommended by the commenter in important modes of transmission for the Another commenter stated that the addition to soliciting public comment. pathogen to healthy seedlings. In involvement of regulated entities in the Experts in the biology of these agents addition, the commenter said that development of guidance is crucial, as and toxins evaluated their ‘‘potential for domestic weather patterns are not it will ensure that the new regulations mass casualties or devastating effects to conducive to dissemination and that may be implemented without the economy, critical infrastructure, or quarantines can prevent seed-borne unsustainable increases in cost to those public confidence.’’ This evaluation disease. The commenter claimed that entities. included assessments of morbidity and field-to-field spread of Xanthomonas oryzae in Asia is largely dependent on The guidance documents developed mortality, communicability, low the strong winds and driving rains that in conjunction with this rule are, in infectious dose, availability of countermeasures, and economic impact occur frequently during typhoon season. part, a response to the questions and We are making no changes to the issues raised by the commenters of a potential attack. Each agent and toxin was then assessed for its ‘‘risk of regulations as a result of this comment. regarding various aspects of the Natural spread or persistence of the proposed rule. We also consulted HHS deliberate misuse,’’ including its history of weaponization and/or known interest pathogen in a particular location is not and USDA subject matter experts and at issue; it is the risk of deliberate other sources including National by State or non-State adversaries. These evaluations, combined with input misuse leading to the most significant Science Advisory Board for Biosecurity, potential for mass casualties or the National Academies, the Department received as a result of the publication of an advance notice of proposed devastating effects to the economy, of Defense Security Engineering critical infrastructure, or public Facilities Planning Manual, and Director rulemaking and request for comments 4 confidence. The issue of standard of Central Intelligence Directive Number (ANPR) in the Federal Register on July 29, 2010, and relevant findings in recent commercial planting practices for rice in 6/9. Regarding the commenter’s cost a domestic versus Asian setting is not concerns, the guidance developed by government and non-government reports, formed the basis for relevant to the discussion of the select agent program does not set out Xanthomonas oryzae’s potential for use a prescriptive series of procedures that deliberations concerning which agents should constitute the list. It is important as a biological weapon. APHIS analyzed must be followed by all regulated to note that removal of pathogens from and assessed this pathogen using the entities; rather, it establishes examples the list of select agents and toxins does criteria discussed earlier in this of ways in which an entity may choose not mean that they are not of potential document. Based on that analysis and to meet the requirements of the concern, but rather that the risk they assessment and the knowledge that regulations. We have purposefully left represent has been reevaluated using the Xanthomonas oryzae has been modified the regulations in their general state in above criteria. Reduction of the list is for use as a biological weapon in the order to allow for the wide variety of past, it has been retained on the list of regulated entities to meet the regulatory 4 To view the ANPR and the comments we PPQ select agents and toxins. standard in a way that is most cost- received, go to http://www.regulations.gov/ The commenter also stated that effective for each. #!docketDetail;D=APHIS-2009-0070. Xanthomonas oryzae should be

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removed from the list of select agents U.S. where potatoes are commercially We are making no changes as a result and toxins because it is endemic in the grown. of these comments. The decision to United States and any foreign strains We disagree with the commenters’ remove the CVC strain from the list of introduced in the future would prove claim that Ralstonia solanacearum, race select agents and toxins was based on unlikely to establish and spread. 3, biovar 2 is only a serious pathogen in the completion of extensive review and While we disagree with the the developing world as the bacterium analysis of the criteria for inclusion on commenter’s assertion regarding has been shown to establish itself in the list. In particular, the creation of Xanthomonas oryzae’s pathogenicity, northern Europe by over-wintering in detection methods and the use of these arguments are unrelated to the weeds, thereby posing a severe threat to geostatistical analysis with relation to work of the select agent program as a Solanaceae species (e.g., potato, monitoring in order to facilitate a whole as the select agent regulations do eggplant, and tomato) in cool climates response to any purposeful introduction not allow for the environmental release such as those found both in northern are both key components in our of listed agents and toxins. Whether or Europe and North America. In addition, decision to delist CVC. As discussed not a given select agent or toxin is as discussed earlier in this document, earlier in this document, the evaluation endemic in the United States is not the the evaluation process for select agents process for select agents includes a only determining factor in the select includes broad criteria that not only broad number of criteria that not only agent or toxin’s inclusion on the list. focus on the biological characteristics of focus on the biological characteristics of The regulations govern use of listed a given pathogen, but also that a given pathogen but also that select agents and toxins in laboratory pathogen’s ability to produce a pathogen’s ability to produce a settings only. In this regard, the case for devastating effect on the economy and devastating effect on the economy and maintaining Xanthomonas oryzae on the threat that pathogen represents if it the threat that pathogen represents if it the list of those select agents and toxins were to be used as a biological weapon. were to be used as a biological weapon. whose deliberate misuse represents the We are making no changes as a result of Based on that analysis and assessment most significant potential for mass these comments. Ralstonia solanacearum, race 3, biovar The commenters also stated that casualties or devastating effects to the 2 will remain on the list of select agents retaining Ralstonia solanacearum, race economy, critical infrastructure, or and toxins. 3, biovar 2 on the list of select agents public confidence, is compelling as Commenters said that eradicating and toxins would further constrain work was done on Xanthomonas oryzae Ralstonia solanacearum, race 3, biovar research in the field of Ralstonia in the 1970s which led to its 2 introduced into the United States research. The commenters attributed classification as a bioterrorism agent by through infected geraniums cost such listing with registration time for the security community. commercial greenhouses and importers use, transfer, or possession of select millions of dollars as a direct result of The list of PPQ select agents and agents and toxins in excess of 18 its presence on the list of select agents toxins includes an entry for Ralstonia months prior to the initiation of and toxins. solanacearum, race 3, biovar 2. While research and difficulty in meeting the We are making no changes as a result we did not propose any changes to the registration requirements. of these comments. The presence of entry for Ralstonia solanacearum, race We are making no changes in Ralstonia solanacearum, race 3, biovar 3, biovar 2, five commenters stated that response to these comments. While 2 on the list of select agents and toxins it should be removed from the list of there are added requirements had no bearing on the eradication select agents and toxins. concerning physical security, personnel program instituted by APHIS. The cost The commenters argued that, based authorization, recordkeeping, of this eradication program to on the biological and historical climate biocontainment, and site inspections, commercial greenhouses and importers data for North America, Ralstonia we do not believe these requirements was the same as the cost of eradicating solanacearum, race 3, biovar 2 does not will impede research as, in many cases any other quarantine plant pathogen not have the potential to pose a severe these regulations serve to codify systems known to be present in the United threat to plant health or plant products and procedures already in use by a States. in the context of U.S. agriculture. The majority of regulated entities. Further, commenters stated that Ralstonia entity registration for use, transfer, or Identification of Strains solanacearum, race 3, biovar 2 is only possession of select agents and toxins The list of VS select agents and toxins a serious problem in the developing does not take, nor has ever taken, 18 includes an entry for virulent Newcastle world in those areas of cool highland months. On average, new entity disease virus. While we did not propose tropics where annual temperature registration takes 6 months from the any changes to the entry for virulent profiles differ significantly from those date the request is received by the select Newcastle disease virus, one commenter found in the major potato growing agent program and the issuance of the stated that, by not considering all forms regions in the United States (i.e., registration certificate. The security risk of Newcastle disease virus as select Colorado, Idaho, Maine, Minnesota, assessment (SRA) takes less than 45 agents, APHIS has created a period of North Dakota, and Wisconsin). The days and runs parallel to the entity uncertainty prior to the completion of commenters argued that, unlike the registration process. These timeframes the sequencing necessary to identify northern States, the cool highland are all based on the assumption that the whether a form of Newcastle disease tropics experience few hard freezes and entity registration submission and the virus is virulent or not. The commenter no long winters. Since, the commenters SRA submission are complete and requested clarification as to whether claimed, epidemiological and laboratory accurate for select agent program review laboratories would be required to treat research data show that Ralstonia prior to the required on-site inspection. uncharacterized Newcastle disease virus solanacearum, race 3, biovar 2 is Commenters additionally stated that as a select agent given this uncertainty. intolerant of freezing and freeze-thaw Ralstonia solanacearum, race 3, biovar We agree with the commenter’s point. cycles and does not generally survive 2 should be removed from the list for We have therefore revised the list of VS winters in regions with sustained low the same reasons that were cited for the only select agents and toxins in order to temperatures, the bacterium is unlikely proposed removal of Xylella fastidiosa, list certain select agents and toxins not to become established in the northern CVC strain. by specific strains but by the generic

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taxonomic classifications for those Although we did not receive any Ehrlichia ruminantium (Heartwater); select agents. The specific VS only comments on this issue as it concerns Japanese encephalitis virus; Malignant select agents and toxins affected are: PPQ only select agents and toxins, in catarrhal fever virus (Alcelaphine Avian influenza virus (highly order to strengthen the regulations as herpesvirus type 1); Menangle virus; pathogenic), mycoplasma capricolum discussed previously as well as to and Vesicular stomatitis virus (exotic): subspecies capripneumoniae maintain parity between the VS and Indiana subtypes VSV–IN2, VSV–IN3. (contagious caprine pleuropneumonia), PPQ regulations, we are revising the list One commenter recommended that mycoplasma mycoides subspecies of PPQ only select agents and toxins in we exclude the Texas GB strain of mycoides small colony (Mmm SC) order to list certain select agents and Newcastle disease virus from select (contagious bovine pleuropneumonia), toxins not by specific strains but by the agent status. The commenter stated that and virulent Newcastle disease virus, generic taxonomic classifications for the exclusion is warranted since, which we have altered to read avian those select agents. The specific PPQ although Newcastle disease virus is influenza virus, mycoplasma only select agents and toxins affected widespread in the environment, there is capricolum, mycoplasma mycoides, and are: Ralstonia solanacearum, race 3, little illness if a flock is exposed Newcastle disease virus, respectively. In biovar 2 and Sclerophthora rayssiae var. because nearly all commercial poultry is order to capture the applicable strains, zeae which we have altered to read vaccinated against the disease. The subtypes, or pathogenicity levels we Ralstonia solanacearum and commenter observed that the Texas GB have also added exemptions for those Sclerophthora rayssiae, respectively. In strain of Newcastle disease virus is used strains, subtypes, or pathogenicity levels order to capture the applicable strains, by vaccine manufacturers as the of certain select agents and toxins which subtypes, or pathogenicity levels we challenge organism to verify the potency are not considered to have the potential have also added exemptions for those of Newcastle disease virus vaccines and to pose a severe threat to animal health strains, subtypes, or pathogenicity levels this fact gives poultry producers a high or animal products. of certain select agents and toxins which degree of assurance that their flocks are The list of overlap select agents and are not considered to have the potential protected against the Texas GB strain. toxins contains an entry for Venezuelan to pose a severe threat to plant health Given these factors, the commenter equine encephalitis. One commenter or plant products. concluded that the Texas GB strain is stated that, by not considering all With the changes described above, we not a biosecurity threat to the domestic subtypes of Venezuelan equine clearly establish that when an agent or poultry industry, and the strain should toxin is initially identified to a be excluded from APHIS’s definition of encephalitis as select agents, APHIS has taxonomic level, in the case of an agent, virulent Newcastle disease virus. created a period of uncertainty prior to or by its toxicological properties, in the We are making no change in this final the completion of the typing necessary case of a toxin, it is regulated under the rule as a result of this comment. Texas to identify whether a form of select agent regulations until further GB strain of Newcastle disease virus is Venezuelan equine encephalitis is testing is accomplished to exclude the a highly virulent form of Newcastle among the subtypes classified by APHIS particular agent by strain, subtype, disease virus and, as such, is as select agents. The commenter pathogenicity levels, or a particular appropriately included in the general requested clarification as to whether toxin by properties. We believe it is category of ‘‘virulent Newcastle disease laboratories would be required to treat important that laboratories treat these virus.’’ While vaccine manufacturers do untyped Venezuelan equine agents as select agents until further use the Texas GB strain of Newcastle encephalitis as a select agent given this testing can be conducted to verify disease virus as a challenge organism for uncertainty. whether the agent is of a strain, subtype, Newcastle disease virus vaccines, this is We agree with the commenter’s point. or pathogenicity level that presents a on account of its high level of virulence. As stated previously, we have therefore higher level of danger to animal health A vaccine effective against the Texas GB revised the list of overlap select agents and safety. These changes will not have strain of Newcastle disease virus can and toxins in order to list certain select any impact on the exemption for therefore be assumed to be effective agents and toxins not by specific strains diagnostic laboratories or alter the against less virulent forms of Newcastle but by the generic taxonomic process of receiving diagnostic samples disease virus. classifications for those select agents. and forwarding any potentially The list of VS select agents and toxins The specific overlap select agent is identified select agents for further includes an entry for avian influenza Venezuelan equine encephalitis virus: testing. They also do not change the virus (highly pathogenic) (HPAI). While Epizootic Subtypes IAB, IC, which we reporting criteria for those agents we did not propose any changes to the have altered to read Venezuelan equine confirmed to be select agents. Finally, entry for HPAI, one commenter encephalitis virus. In order to capture they do not change the current lists of proposed that we change the guidance the applicable strains, subtypes, or select agents and toxins but alters the by which influenza strains are pathogenicity levels we have also added fashion in which select agents and categorized as HPAI. The commenter exemptions for those strains, subtypes, toxins are listed with specific argued that extensive evidence has been or pathogenicity levels of certain select exemptions included to ensure that obtained to support the conclusion that, agents and toxins which are not appropriate verification of the agents by while the HA polybasic cleavage site is considered to have the potential to pose strains, subtypes, or pathogenicity level the primary determinant for HPAI a severe threat to animal or human occurs. strains, strains with removed HA health or animal products. We do note polybasic cleavage sites have been that we have specifically included VS Select Agents and Toxins created, tested, and ultimately excluded Bacillus anthracis (Pasteur strain) in the We proposed to remove nine VS from select agent status. The commenter list of overlap select agents and toxins. select agents and toxins from the list set stated that, as a result of these This is necessary in order to distinguish out in § 121.3(b). Specifically, we experiments and history, APHIS should this strain, which we do not consider to proposed to remove the following: specify that avian influenza strains be a Tier 1 select agent, from all other Akabane virus; Bluetongue virus without the HA polybasic cleavage site strains of Bacillus anthracis, which are (exotic), Bovine spongiform are not HPAI viruses and, therefore, not classified as Tier 1 select agents. encephalopathy agent; Camel pox virus; subject to the select agent regulations.

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The commenter further argued that derived from a 1AB isolate, this analogous to the Bacillus anthracis continuing to consider strains of avian molecularly cloned strain has properties Sterne strain, which is excluded since it influenza with removed HA polybasic that render it incapable of causing was determined not to pose a severe cleavage sites as select agents until such epizootic or epidemic transmission. The threat to public health and safety, time as an exclusion is granted would commenter stated that mutations animal health, or animal products. The impede vaccine availability in the event selected after only a handful of passages commenter argued that Bacillus of an HPAI pandemic in either the make the virus avirulent in adult mice anthracis Pasteur strain should not be human or avian population. The and dramatically increases its clearance considered as a select agent given that commenter stated that the lead from the bloodstream of mice following the only way to create an agent that candidates for the seed viruses that intravenous inoculation. Further, the poses a severe threat would be via would be used to make vaccines against vanishingly low titers of strain 3014 combination of the Pasteur strain with HPAI viruses during such an event will consist of envelope glycoprotein gene a non-regulated strain. The commenter likely be attenuated strains with mutations, which allow the strain to pointed out that other agents that pose mutated polybasic cleavage sites. The bind heparin sulfate; such binding is little harm individually, but could be commenter stated that the current also associated with the attenuated modified genetically to become harmful process by which avian influenza phenotype of Venezuelan equine are not included on the select agent list strains that lack the polybasic cleavage encephalitis strain TC–83, which is also because of this potential threat. site are granted exclusions takes weeks derived from the 1AB Trinidad donkey Another commenter claimed that the or months, an untenable timeline in the strain by passage in culture that has designation of Bacillus anthracis event of an HPAI pandemic. already been excluded from select agent Pasteur strain as a select agent would We are making no changes in status. not serve to prevent an authorized response to this comment. APHIS We are making no changes as a result person from intentionally or standards are based on existing of this comment. Since Venezuelan accidentally facilitating the combination internationally recognized requirements equine encephalitis strain 3014 is of plasmids from Sterne and Pasteur established by the World Animal Health derived from a listed overlap select types of strains to create a wild type Organization (OIE). In the event of a agent, the commenter’s proposal for its phenotype. The commenter stated that future HPAI pandemic such as the one removal is more appropriately combination of these two strains can be described by the commenter, APHIS addressed via the exclusion process for accomplished no matter what sort of would work in conjunction with HHS to overlap select agents and toxins as physical security may be employed to address any vaccine availability issues. detailed in 9 CFR 121.6. We have prevent access, theft, loss, or release of Finally, attenuated strains of select contacted the commenter and provided the agent. The commenter concluded agents officially approved for human guidance regarding how they may that more effective preventive measures vaccination purposes by the Food and initiate this process. can be achieved through training and Drug Administration (FDA) or other We proposed to designate Bacillus educating microbiologists on how to recognized national or international anthracis as a Tier 1 select agent. A avoid accidentally combining these two organizations continue to be exempt number of commenters objected to such strains and by penalizing any from the select agent regulations as a blanket designation, arguing instead individuals who intentionally try to specified by the regulations in § 121.5(c) that the Bacillus anthracis Pasteur strain combine them. and (d). should be exempted from consideration We agree with the commenters that both as a Tier 1 select agent and as a Bacillus anthracis Pasteur strain is Overlap Select Agents and Toxins select agent in general. attenuated and poses a significantly We proposed to modify the list of One commenter argued that given the lower risk than wild type Bacillus overlap select agents and toxins by fact that Laboratory Response Network anthracis strains. We also agree that the removing certain subtypes of (LRN) laboratories maintain live Pasteur strain is not likely to have the Venezuelan equine encephalitis virus cultures of non-pathogenic Bacillus potential for mass casualties or from the list of overlap select agents and anthracis Pasteur strain for use in devastating effects to the economy, toxins set out in 9 CFR 121.4(b), and to quality control testing, designation of critical infrastructure, or public clarify that only Venezuelan equine Bacillus anthracis as a Tier 1 select confidence and therefore does not meet encephalitis subtypes IAB and IC would agent therefore has the potential to the criteria used to apply the Tier 1 remain on the list. These subtypes impact the willingness or ability of LRN designation. In addition, we note that contain the only recognized strains of laboratories to maintain inventories of the Pasteur strain has been used Venezuelan equine encephalitis that can Bacillus anthracis Pasteur strain due to successfully as a veterinary and human suddenly affect a large number of the regulatory and financial burdens vaccine, which further demonstrates the animals over a large area (i.e., associated with possession of Tier 1 attenuation of this strain. Therefore we epizootic). The remaining subtypes, ID select agents and toxins. The commenter have determined that the Bacillus and IE, are strains prevalent among went on to state that this situation could anthracis Pasteur strain should not be existing animal populations (i.e., potentially impact national health and designated as a Tier 1 select agent. enzootic) and do not represent the same safety given that the potential use of While we agree that the Bacillus type of risk. Other viruses within the Bacillus anthracis spores as a anthracis Pasteur strain does not meet Venezuelan equine encephalitis bioweapon remains a viable threat and the criteria for inclusion as a Tier 1 complex (subtypes IF and II through IV) increased burdens, particularly on small select agent, we do not agree with the are separate viruses and are not laboratories, could lead to the overall argument that regulating the Bacillus included in the list of overlap select decrease in the number of laboratories anthracis Pasteur strain would not serve agents and toxins. that would otherwise serve to ensure to prevent the accidental (or intentional) Another commenter recommended that the LRN has sufficient capacity to generation of a wild type Bacillus that we remove Venezuelan equine detect and respond to a deliberate anthracis strain by the combination of encephalitis strain 3014 from the list of release of Bacillus anthracis. the Bacillus anthracis Pasteur strain select agents and toxins. The commenter Three commenters stated that the with the Bacillus anthracis pXO1+/ argued that, although strain 3014 was Bacillus anthracis Pasteur strain is pXO2- Sterne strain. Retaining the

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Bacillus anthracis Pasteur strain as a and toxins met the minimum criteria for judged to be those that were select agent will allow for continued inclusion on the proposed Tier 1 select appropriately given a Tier 1 designation. oversight of laboratories in which the agents and toxins list. All other select Two commenters pointed out that the accidental (or intentional) combination agents and toxins would continue to be categorization of select agents and of this strain with the Bacillus anthracis subject to the current requirements toxins has already been carefully Sterne strain could occur to produce the concerning select agents and toxins. stratified into four biological safety wild type phenotype of Bacillus One commenter argued that levels (BSL) as specified by the CDC, anthracis de novo. Failure to retain the and Burkholderia with each BSL based on infectivity, Bacillus anthracis Pasteur strain as a pseudomallei should not be classified as virulence, and ease of transmission of select agent could result in an Tier 1 select agents. The commenter the material in question. The environment in which the probability of stated that these two select agents do commenters further observed that the creation of virulent wild type Bacillus not represent the same level of concern Tier 1 designation implies the existence anthracis strains by the combination of as the other select agents proposed for of a Tier 2 category which would non-regulated strains would be inclusion in Tier 1 and should therefore require less attention to security. The enhanced. Therefore, we have chosen be assigned non-Tier 1 status. commenters concluded that the process not to exclude the Bacillus anthracis Another commenter observed that of tiering will only add confusion and Pasteur strain from the list of select Bacillus anthracis is less virulent than administrative and financial burden to agents in this rulemaking. We will either or Francisella the current BSL grouping of select continue to evaluate exclusion requests tularensis, which are on the list of HHS agents and toxins. as additional information becomes only select agents and toxins. The Two additional commenters stated available in this area. commenter additionally stated that the that the proposed rule did not do As explained above under the heading virulence of all three is far less than that enough to reduce the regulatory burden ‘‘VS Select Agents and Toxins,’’ avian of the hemorrhagic fever viruses and the associated with non-Tier 1 agents. The influenza virus (highly pathogenic) is encephalitis viruses that were not commenters said that reduced levels of currently on the list of VS only select proposed for inclusion on the list of Tier security requirements for personnel and agents and toxins. One commenter 1 select agents and toxins. The facilities should be considered for non- recommended that, in light of recent commenter stated that significant Tier 1 agents. studies whereby researchers have advances have been made in the In designating certain select agents generated derivatives of influenza virus development of products for and toxins as ‘‘Tier 1,’’ the select agent A (H5N1) capable of efficient aerosol environmental decontamination and program considered and rejected the transmission, we add ‘‘Replication prophylaxis against inhalation of idea of designating the remaining select competent forms of influenza virus A Bacillus anthracis. agents and toxins as ‘‘Tier 2.’’ The aim (H5N1) capable of efficient aerosol We are making no changes to the of establishing the Tier 1 category is to transmission in ferrets or primates regulations as a result of these account for and respond to the containing any portion of the coding comments. The process by which we particular risks associated with the regions of all eight gene segments determined which select agents and agents and toxins in this category by [influenza virus A (H5N1) capable of toxins should be designated as Tier 1 increasing their handling and security efficient aerosol transmission in ferrets was multi-faceted and we are confident requirements accordingly. The or primates]’’ to the list of overlap select in the results of that process. Our establishment of the Tier 1 category is agents and toxins. The commenter also determinations were not based on one in no way intended to imply that the recommended that this type of avian aspect of each of the proposed select non-Tier 1 select agents and toxins pose influenza virus be classified as a Tier 1 agents or toxins only. In order to a lesser risk to public health and safety agent given the historical 50 percent determine which select agents and than they have previously. In case-fatality rate of avian influenza virus toxins should be given Tier 1 status, a accordance with that fact, we have not A (H5N1) in humans. two-part risk analysis was conducted on decreased the handling and security The select agent program is currently each. First, experts in the biology of requirements for those non-Tier 1 in discussions regarding this issue and these agents and toxins evaluated their agents. Biosafety levels describe the may address it in future rulemaking. potential for mass casualties or required combination of lab practices Given the stage these discussions are in, devastating effects to the economy, and techniques, safety equipment, and however, we are not making any critical infrastructure, or public lab facilities appropriate for the changes in this final rule based on this confidence. This process included operations being performed using comment. assessments of morbidity and mortality, potentially harmful materials such as communicability, low infectious dose, select agents and toxins while the Tier Reorganization of the Current List of availability of countermeasures, and 1 designation institutes security Select Agents and Toxins economic impact of a potential attack. measures applicable to the agents and We proposed to establish a number of Second, each select agent and toxin was toxins themselves. For this reason there select agents and toxins as ‘‘Tier 1’’ assessed for its risk of deliberate misuse, is no conflict that exists between BSL select agents and toxins within the lists including its history of weaponization classifications and Tier 1 select agents of VS and overlap select agents and and/or known interest by State or non- and toxins. toxins. Specifically, we proposed to list State adversaries. These evaluations, Two commenters expressed concern foot-and-mouth disease (FMD) virus and combined with input from public regarding the proposal to list rinderpest rinderpest virus as Tier 1 VS select comments received on our July 2010 virus as a Tier 1 agent, given that there agents and toxins and Bacillus ANPR and relevant findings in recent are already special conditions in place anthracis, Burkholderia mallei, and government and non-government as contained in §§ 121.3(f)(3)(i), Burkholderia pseudomallei as Tier 1 reports, formed the basis for 121.5(a)(3)(i), and 121.9(c)(1) overlap select agents and toxins. We did deliberations on which agents should concerning its handling and tracking. not include PPQ select agents and constitute the Tier list. Agents that The commenters suggested that an toxins in this proposed reorganization scored highly on both the public health alternative approach would be for because none of the PPQ select agents and biothreat sets of criteria were APHIS to designate rinderpest virus as

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a pathogen with very special handling 5. The potential for creating disease or agents and toxins was responsive to requirements that is not considered to illness; regulated community concerns received be part of either category of select 6. The relative environmental stability during the comment period for the agents. The commenters argued that this of a select agent or toxin by itself and advance notice of proposed rulemaking approach is justified due to the fact that how well it survives in the environment as well as for the proposed rule. rinderpest has now been officially in which it is formulated or One commenter asked why the eradicated worldwide. disseminated; requirements for working with plant We disagree with the commenters’ 7. The amount of select agent or toxin pathogens had not been lessened. The suggestion to classify rinderpest virus as necessary to induce illness; commenter stated that a transparent a separate type of agent apart from 8. The relative ease with which a process does not exist that is inclusive either of the select agent categories of particular select agent or toxin might be of expert opinion from both the private designation. While it is true that disseminated or transmitted from one and public sectors to determine which rinderpest was declared to be officially animal or person to another or into the agents should be removed or added to eradicated by the OIE on May 25, 2011, environment where it could produce a the list of select agents and toxins. this development does not render the deleterious effect upon animal, plant, or We are making no changes as a result disease any less of a concern as a select human health; of this comment. In creating the Tier 1 agent with potential for misuse. 9. Whether the target population has class of agents, the Select Agent Enacting the suggestion that rinderpest innate immunity to the select agent or Program considered and rejected the virus be treated as a pathogen with toxin or whether immunity has been idea of designating the remaining agents ‘‘very special handling requirements’’ acquired from a source such as vaccines; as ‘‘Tier 2.’’ The aim of establishing the and not as either a Tier 1 or non-Tier 1 10. The potential for the select agent Tier 1 category is to account for and select agent would only serve to create or toxin to create morbidity (i.e., any respond to the particular risks a further level of required non-fatal illness that renders partial associated with the agents and toxins in administrative oversight for regulated dysfunction to an animal or human this category by increasing their entities. lasting weeks or months that will handling and security requirements One commenter stated that the eventually resolve with medical, accordingly. The establishment of the proposed tiering system poses veterinary, and/or supportive care); Tier 1 category is in no way intended to significant questions as to the nature of 11. The burden placed on the human, imply that the non-Tier 1 agents pose a the risk assessment process. veterinary, or plant health system by the lesser risk to public health and safety Specifically, the commenter questioned deliberate release of the select agent or than they have previously. In listing as Tier 1 agents bacterial diseases toxin; accordance with that fact, we have not that are treated with licensed 12. The ability to detect a release of decreased the handling and security antibiotics, that are not commonly the select agent or toxin into the requirements for those non-Tier 1 spread person to person, and that are environment, food, water, or soil; agents. Further, we determined that the present in the environment of the 13. The ability of the human and establishment of more varying levels of United States, while viruses that have agricultural health authorities to risk would serve to create the need for no known therapy and that pose accurately and rapidly diagnose and increased administrative oversight and extreme risk to Western populations are treat the disease presented by a release complication for regulated entities. We absent. The commenter further stated of the select agent or toxin; believe that the process by which these that the 20 criteria used for evaluation 14. The existence of countermeasures determinations were made was sensitive of each select agent and toxin should be to prevent, treat, or mitigate the to public and expert opinion via the made available to the regulated symptoms of a disease caused by the comment period on the initial advance community for review and assessment. release of a select agent or toxin and/or notice of proposed rulemaking as well We are making no changes as a result its spread through a population; as on the proposed rule. of this comment. The relative ease by 15. The potential for high animal, Security Measures for Tier 1 Select which exposure to a select agent or plant, or human mortality rates with Agents or Toxins toxin may be treated is only one aspect delivery of medical countermeasures; considered by the select agent program 16. The potential for high animal, We also proposed additions to the VS when determining the tier status of plant, or human mortality rates without regulations that would allow for the each. The 20 criteria referenced by the delivery of medical countermeasures; optimization of security measures for commenter are those employed by the 17. The short-term economic impact those select agents or toxins that are Federal Experts Security Advisory Panel of a single outbreak of a disease or designated as Tier 1. These (FESAP) in providing recommendations release of a toxin; requirements included: • to the select agent program. The criteria 18. The human, monetary, and other Additions regarding the assessment that the FESAP used in its risk resource costs of making an area, of persons prior to their access to Tier assessment process are: building, industrial plant, farm, or field 1 select agents and toxins that would be 1. The relative ease with which a safe for humans, animals or plants to made to the security plan currently select agent or toxin might be acquired inhabit following the release of the required to be developed by all entities from a laboratory or commercial source; select agent or toxin; seeking approval for the possession, use, 2. The relative ease of production of 19. The pathogen’s ability to persist in and transfer of select agents and toxins; a select agent or toxin; the environment or to find a reservoir ongoing oversight of those persons with 3. The relative ease by which a select that makes its recurrence more likely; access to Tier 1 select agents and toxins; agent or toxin might be modified in and and the role of the entity’s responsible order to enhance its pathogenicity, 20. The long-term health or economic official in coordinating and assuring the transmissibility, or ability to evade consequences caused by a single release security of Tier 1 select agents and medical and non-medical of the select agent or toxin. toxins; countermeasures; We believe that the process by which • Security enhancements that include 4. The potential for easy deliberate determinations were made regarding the provisions for security barriers, dissemination; Tier 1 or non-Tier 1 status of the select intrusion detection and monitoring,

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delay/response force, access control, recommendations, as well as enhancements.’’ We are removing the and information security; recommendations from other sources words ‘‘prescribe and/or’’ for the • Additions to the biosafety plan (e.g., National Science Advisory Board purposes of clarity. Our original intent currently required to be developed by for Biosecurity), in developing the in creating that provision was to require all entities seeking approval for the proposed rule and suitability the use of the security enhancements in possession, use, and transfer of select assessment guidance documents; question by those entities with Tier 1 agents and toxins that would describe however, we are not adopting all of the select agents or toxins. By removing the implementation of an occupational specific recommendations found in words ‘‘prescribe and/or’’ we are health program for individuals with these studies. While we have created eliminating a potential loophole by access to Tier 1 select agents and toxins; specific guidance to aid in compliance which entities may have been able to • Development of security policies with this section of the revised establish but not fulfill these and procedures describing the entity’s regulations, we are deliberately leaving requirements while remaining in response to a failure of an intrusion the regulatory text in its broadly-written compliance with the regulations. detection or alarm system and state in order to allow entities a measure Regarding the proposed language in 9 notification procedures for the Federal of flexibility in how they meet the CFR 121.11(e)(4)(i), one commenter Bureau of Investigation (FBI) in the requirements. Given our experience stated that the use of the phrase event of theft or suspicious activity that with the select agent and toxin ‘‘trustworthy and behaving in a manner may be criminal in nature involving a regulations and the wide variety of that upholds public health and safety, Tier 1 select agent or toxin. These regulated entities the regulations cover, the protection of animal or plant health policies and procedures would be we have found this to be the most and animal or plant products, security, required as part of the entity’s incident effective approach. The guidance and the integrity of the scientific response plan; and enterprise’’ would establish a regulatory • document developed in conjunction Required annual insider threat with this rule is, in part, a response to standard that would prove difficult or awareness briefings focused on how to the questions and issues raised by the impossible to enforce due to its identify and report suspicious commenters. Issues addressed in this subjective nature. behaviors. document include, but are not limited We agree with the commenter’s We have made changes to some of to: observation and have changed the these proposed requirements, which are • language to require that entities discussed in detail below. Understanding the risks and reasons for suitability assessments; possessing Tier 1 select agents or toxins Many commenters had questions or • prescribe and implement ‘‘procedures concerns regarding the additions to the Delineating the roles and responsibilities of individuals to ensure that will limit access to a Tier 1 select security plan for those entities agent or toxin to only those individuals optimal security; possessing a Tier 1 select agent or toxin who are approved by the HHS Secretary • Requesting information about as proposed in 9 CFR 121.11(e). Specific or Administrator, following a security individuals in a standardized manner issues addressed by the commenters risk assessment by the Attorney General, and assessing individuals in the context included: Conduct of pre-access have had an entity-conducted pre-access of safety and security; suitability assessments, ongoing suitability assessment, and are subject to • Responding to reports in a suitability assessments, and self- and the entity’s procedures for ongoing consistent, prompt, and confidential peer-reporting of incidents or conditions suitability assessment.’’ We believe that manner; and that could affect an individual’s ability this establishes a more specific set of • Providing training for recognizing to safely have access to or work with requirements for regulated entities. select agents and toxins. Commenters and reporting suspicious behavior. In 9 CFR 121.11(e)(4)(iv) we proposed generally fell into two categories in their Full guidance on this and other issues that regulated entities with Tier 1 select responses to the proposed additions: may be found on the National Select agents and toxins establish a minimum Some felt that the requirements were too Agent Registry at www.selectagents.gov. of three barriers where each subsequent vague to prove useful, creating In 9 CFR 121.11(e)(4)(i), we proposed barrier is different and adds to the delay administrative burden without that regulated entities with Tier 1 select in reaching secured areas where select improving the overall security of Tier 1 agents and toxins prescribe and/or agents and toxins are used or stored. select agents and toxins, while others implement ‘‘procedures that limit access Barriers would be required to be felt that the requirements could or to registered space only to those monitored in such a way as to detect would require entities to behave in a approved by the HHS Secretary or the and assess intentional and unintentional manner contrary to local laws, privacy Administrator and meet the criteria of circumventing of established access laws, or union contracts. the entity’s program that will ensure control measures under all conditions For the most part, we anticipate that individuals with access approval to (day/night, severe weather, etc.) Two these requirements are already being select agents and toxins are trustworthy commenters requested clarification met and that these regulations will and behaving in a manner that upholds regarding what was meant by the term merely require those entities possessing public health and safety, the protection ‘‘barrier’’ and asked for examples of a Tier 1 select agent or toxin to codify of animal or plant health and animal or what constitutes a barrier. The and document the systems and plant products, security, and the commenters suggested that a definition processes currently in place. It should integrity of the scientific enterprise.’’ for ‘‘barrier’’ be added to the definitions be noted that many of the specific We are making a minor change to the sections in 7 CFR 331.1 and 9 CFR concerns raised by commenters proposed language in 9 CFR 121.11(e)(4) 121.1. regarding potential violation of laws or in order to stipulate that entities must We agree with the commenters and union contracts arose as a result of the implement these security we have added a definition for security commenters’ examination of those enhancements, not merely prescribe barrier to read as follows: ‘‘A physical recommendations given to the select and/or implement them. The proposed structure that is designed to prevent agent program by the FESAP. As a rule stated that ‘‘Entities with Tier 1 entry by unauthorized persons, animals, matter of clarification, the select agent select agents and toxins must prescribe or materials.’’ In addition, we have program considered the FESAP and/or implement the following security altered the language concerning security

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barriers in 9 CFR 121.11(f)(4)(iv) in and HHS regulations, we are amending The issue of multiple false alarms and order to clearly indicate that the final the text to stipulate that only those the potential costs associated with such security barrier must limit access to the entities with powered access control a situation as raised by the commenter select agent or toxin to personnel systems will need to fulfill this is more appropriately addressed at the approved by the HHS Secretary or requirement. We have also reworded the entity level. Administrator and following a security requirement to clarify that the aim is In 9 CFR 121.11(e)(4)(ix) we proposed risk assessment by the Attorney General. maintenance of physical security to require that entities conduct complete In 9 CFR 121.11(e)(4)(v), we proposed standards in the case of a power inventory audits of all Tier 1 select that all registered space and areas that disruption and that this maintenance agents and toxins in long-term storage reasonably afford access to the may, among the alternatives, take the upon the physical relocation of a registered space must be protected by an form of backup power. collection or inventory of select agents intrusion detection system (IDS) unless In 9 CFR 121.11(e)(4)(viii) we or toxins for those Tier 1 select agents physically occupied. One commenter proposed that response time for security or toxins in the collection or inventory, stated that the proposed requirement forces or local police must not exceed upon the departure or arrival of a contained a potential loophole by which 15 minutes from the time of an intrusion principal investigator for those Tier 1 an entity could argue that the presence alarm or report of a security incident for select agents or toxins under the control of a janitor or similar personnel in any entity with Tier 1 select agents and of that principal investigator, or in the registered space outside of normal toxins. One commenter stated that such event of a theft or loss of a Tier 1 select working hours would allow that entity a requirement would be burdensome, agent or toxin. to avoid installation of an IDS. The unattainable, and cost-prohibitive We have reevaluated this provision in commenter suggested that such a depending upon the number and nature light of comments received on the CDC situation could be avoided by adding a of the alarms. The commenter went on rule and, based on our experience with stipulation that an IDS would need to be to state that the security system at their the select agent program, we believe that used when the entity was not entity sounds an alarm when a door is this requirement needs to be applied to ‘‘physically occupied by the routine held open longer than a preset length of all select agents and toxins, and not contingent of working, approved time and that most alarms occur during only Tier 1 select agents and toxins. employees.’’ working hours, primarily as the result of This change serves to codify our current We disagree with the commenter’s staff holding the door open too long. policy concerning inventory audits. We observation as it is unlikely that the The commenter explained that requiring have therefore revised the language to entity would be occupied at all hours, security respond to all these alarms is address inventory verification for all thus creating the loophole that would unwarranted, excessive, and costly. The select agents and toxins. allow an entity to fail to install an IDS. commenter suggested that a better In the case of those entities which We are also not adopting the alternative would be for a laboratory possess FMD and rinderpest virus, we commenter’s suggestion to add language supervisor or manager to be notified of proposed to require four barriers, regarding the presence of approved and investigate these incidents, including one barrier that is a perimeter employees as we believe that would therefore allowing entities to respond in security fence or equivalent. These create confusion concerning the number a manner commensurate with the requirements were listed in proposed 9 of employees that could be described as severity of the incident that triggered CFR 121.11(e)(5)(i). One commenter ‘‘the routine contingent.’’ Further, the the alarm. inquired as to what the equivalent to a IDS is one aspect of the security Our selection of the 15 minute perimeter security fence would be. The measures required for regulated entities. response time is based on Department of commenter also wished to know if an In the scenario proposed by the Defense (DOD) and DHS standards for IDS would be considered a barrier. commenter, the IDS would not be high value assets and also on our One equivalent to a perimeter security engaged if a janitor or other personnel analysis of incident response plans fence would be a perimeter wall were present in the entity outside of provided by the regulated community surrounding a specific building, normal working hours; however, the since 2003. However, based on this complex, compound, or campus, with other required physical security comment and others received by CDC, 24 hour a day, 7 days a week measures would serve to protect the we have modified the language in this monitoring. Such a wall would serve a entity at that time. Finally, the training section. We have retained the 15 minute purpose identical to a perimeter security and employee suitability assessments response time goal for security forces or fence. We have developed guidance to required for those employees with local police, but we have also provided assist entities with the security barrier access to select agents and toxins would additional flexibility for entities to requirement, which covers the issue of also serve to ensure that those develop systems in line with the perimeter fencing. Guidance documents employees who work in registered areas optimal achievable response time in may be found on National Select Agent understand and can employ the their area. Entities may either Registry at www.selectagents.gov. As to necessary security and safeguarding incorporate the 15 minute response time the commenter’s question regarding the measures to maintain the physical into their security plans or determine an IDS: As stated above, a security barrier security of the entity. alternate response time calculated in would include only natural or man- In 9 CFR 121.11(e)(4)(vii), we conjunction with security forces or local made obstacles preventing or delaying proposed to require that entities provide police. Response time can be the movement of persons, animals, or backup power and energy sources to determined many ways. For example, an materials. While an IDS may alert ensure that information security entity can: security or other personnel to potential networks and integrated access controls • Enter into a formal agreement with incidents, the IDS itself would not be and related systems will maintain local law enforcement. considered to be a security barrier since power during emergencies. While we • Discuss with local law enforcement. it does not actively create an obstacle or did not receive any comments on this • Discuss with the IDS service delay. issue, in response to comments received provider. Another commenter asked whether by CDC and in the interests of • Conduct an exercise with the guard the proposed requirements would make maintaining parity between the APHIS force. it illegal for U.S. veterinary diagnostic

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laboratories to perform diagnostic and/ impractical security measures would this training should be required for all or surveillance testing following an provide any additional benefit since registered entities possessing, storing, or FMD outbreak on U.S. soil if the existing measures have proven adequate transferring select agents, not just those laboratories in question did not have a to protect the security of these agents. with Tier 1 select agents or toxins. fourth security barrier. The commenter We are making no changes as a result We are making no changes in recommended that we revise the of this comment. It was our response to this comment. Due to the paragraph in order to clarify our intent. determination, based on the information greater level of concern associated with We are making no changes as a result available to us, that the additional Tier 1 select agents and toxins the select of this comment. The select agent security requirements would not agent program needs to ensure that program recognizes the critical role of constitute an economic burden on the entity safety protocols are in place. diagnostic laboratories in the early regulated entities. In many cases these Regulated entities should use their detection of and response to outbreaks regulations serve to codify systems and discretion and judgment in considering of select agent and toxin-related disease procedures already in use in these whether the creation of an annual in humans and agriculture. While all of regulated entities. insider threat awareness training the Tier 1 regulatory requirements will The regulations in 9 CFR 121.12 program applicable to those employees apply to entities that maintain concern the development of a biosafety working with non-Tier 1 select agents permanent stocks of Tier 1 select agents plan that establishes measures sufficient and toxins is needed. Guidance on the and toxins, in the case of a public health to contain the select agent or toxin (e.g., development of annual insider threat or agricultural emergency, a diagnostic physical structure and features of the awareness training may be found on the laboratory may request to retain the entity, and operational and procedural National Select Agent Registry at select agent or toxin under the safeguards). We proposed to add a www.selectagents.gov. provisions contained in 9 CFR 121.6(e). paragraph that would stipulate that Another commenter asked for Two commenters recommended that entities registered to possess Tier 1 clarification and guidance regarding the the select agent program consult with select agents or toxins establish an requirement for annual insider threat administrators and laboratory managers occupational health program for awareness briefings. The commenter from public and private research individuals with access to Tier 1 select asked that the content of these threat institutions prior to the development of agents and toxins. One commenter awareness briefings be made available to any framework of suitability that can be recommended that the occupational public health laboratories so that it used to address security concerns. health program requirements be could then be specifically customized We will engage subject matter experts instituted for all select agents and for various regions of the country. as necessary in the development of toxins, regardless of their categorization. While we have created specific guidance documents which may be We are making no changes in guidance regarding this section of the found on the National Select Agent response to this comment. Due to the revised regulations, that guidance does Registry at www.selectagents.gov. The greater level of concern associated with not take the form of a prescriptive select agent program welcomes feedback Tier 1 select agents and toxins the select program with content that may then be on the usability and usefulness of agent program needs to ensure that adapted and distributed as the existing guidance documents at any entity safety protocols are in place. commenter requests. Given our time. Further, after considering the issue and experience with the select agent and One commenter suggested that the in light of the fact that it caused toxin regulations and the wide variety of minimum security provisions for Tier 1 confusion amongst some commenters on regulated entities those regulations select agents and toxins should include the CDC proposed rule, we are cover, we have found a broader video monitoring of all select agents and eliminating the sentence that reads, approach to be most effective. The toxins work and storage areas, a two- ‘‘The occupational health program may guidance documents developed in person rule for entry into select agents also be made available to individuals conjunction with this rule are, in part, and toxins work and storage areas, and without access to Tier 1 select agents a response to the questions and issues psychological assessment and and toxins.’’ While we believe that raised by the commenters. The monitoring of those employees working regulated entities should use their documents will contain specific with select agents and toxins. discretion and judgment in considering examples of best practices that we We are making no changes as a result whether the creation of an occupational believe entities would be well served in of this comment. The specific measures health program applicable to those adopting including, but not limited to, the commenter suggested were employees working with non-Tier 1 a designated person to manage the considered and rejected in favor of the select agents and toxins is needed, such assessment of laboratory personnel, more general requirements listed. The a suggestion is not appropriately laboratorian involvement in threat select agent program is highly conscious contained in the regulations. Guidance migration, and those behaviors of of the need to balance biosecurity and on the development of an occupational concern which may indicate a possible biocontainment concerns with allowing health program may be found on the insider threat. Full guidance on this and entities the necessary flexibility so as to National Select Agent Registry at other issues may be found on the not impede their research unduly. Since www.selectagents.gov. National Select Agent Registry at there is variety in the type and size of The regulations in 9 CFR 121.15 www.selectagents.gov. entities covered under the regulations, concern required mandatory training for we believe this approach is warranted. staff and visitors who work in or visit Miscellaneous Changes We would note that the regulations do areas where select agents or toxins are We proposed to make several smaller- not preclude any given entity from handled or stored. In 9 CFR 121.15(b), scale changes to the regulations, adopting the approach suggested by the we proposed to add a requirement that including the addition of definitions commenter, among others. entities with Tier 1 select agents and and clarification of language concerning One commenter stated that, while toxins must conduct annual insider security, training, biosafety, many of the proposed security changes threat awareness briefings on how to biocontainment, and incident response. are already in place, some are not and identify and report suspicious These changes are intended to increase it was unclear that additional costly or behaviors. One commenter stated that the usability of the select agent

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regulations as well as provide for Recombinant DNA Advisory Committee We proposed to state that the ‘‘inactive enhanced program oversight. (NIH–RAC). The commenter suggested form of a select toxin’’ may be excluded In 7 CFR 331.1 and 9 CFR 121.1, we that if the select agent program finds it from regulation under each respective proposed to add definitions for necessary to introduce a new definition part subject to the application adjudicated as a mental defective, alien, for recombinant and synthetic nucleic procedure. We also proposed to update committed to any mental institution, acids, that we follow the leadership of the Web site address in paragraph (e)(1) controlled substance, crime punishable the NIH–RAC and establish a simpler of each section as all information by imprisonment for a term exceeding 1 definition that is not focused on the concerning the Select Agent Program is year, indictment, lawfully admitted for underlying mechanism of production of now centralized on the National Select permanent residence, mental the nucleic acids. Agent Registry at http:// institution, and unlawful user of any We disagree with the commenter’s www.selectagents.gov/. Finally, we controlled substance. These definitions, assertion regarding the broad impact of proposed to remove the language stating which described specific aspects of the the definitions used by the select agent that exclusions will be published in the proposed definition of restricted person, program. Our scope of oversight is Federal Register. At the time the were intended to assist regulated limited to the list of select agents and regulations were initially created we entities as well as those seeking toxins and therefore does not extend to anticipated publication of exclusions approval to access select agents and all synthetic biology. However, we do both in the Federal Register and on the toxins to better understand what status agree that any definition adopted for use Internet; however, we have found that or activities, past or present, might in the regulations should be based on publication on the National Select prohibit such access. the most current information available Agent Registry Web site only has served Four commenters stated that these from subject matter experts. Following to provide the most up-to-date definitions needed to be further extensive consultation with the NIH, we information to the regulated clarified. The commenters generally have updated the definition of community. characterized the proposed definitions recombinant and synthetic nucleic acids One commenter suggested that, in as either overly restrictive or vague. to reflect the most current thinking on addition to publication of exclusions on After careful consideration we have the subject. In addition, we have the National Select Agent Registry Web agreed with the commenters and have separated the definition of recombinant site we should also develop and decided not to include these definitions nucleic acids from the definition of maintain an email distribution list so or a definition for restricted person in synthetic nucleic acids for purposes of that registered facilities could be the final rule. We will look to develop clarity. notified when updates are added to the additional guidance in this area. We proposed to add a definition for Web site. We proposed to add a definition for occupational exposure to the VS We currently engage in the type of recombinant and synthetic nucleic regulations in 9 CFR 121.1 as it is used email updates that the commenter acids. This addition was deemed in the regulations but not defined. This suggests. Emails are sent to responsible necessary, as the term ‘‘synthetic definition was based on that used in the officials and alternate responsible nucleic acids’’ is employed in the Occupational Safety and Health officials at all registered entities. proposed changes to the select agent Administration regulations in 29 CFR Dissemination of that information is at regulations. We proposed to include 1910.1030. We did not propose to add the discretion of the responsible synthetic nucleic acids in the a corresponding definition to the PPQ officials and alternate responsible regulations because, while synthetic regulations in 7 CFR 331.1 since PPQ officials. We plan on issuing guidance nucleic acids have the same potential select agents and toxins do not pose a and suggestions regarding information for harm as recombinant nucleic acids, severe threat to human health and, dissemination, which we believe will the process of production is different. therefore, it is unnecessary to address enable further information sharing One commenter stated that the personnel safety and health. One within regulated entities. proposed definition has implications in commenter suggested that we expand Another commenter asked that we all areas currently impacted by the definition to specify that, due to add a timeline to the regulations synthetic biology technology, such as aerosol transmission, such exposure indicating when the person requesting industrial enzymes, renewable incidents may impact other employees the exclusion should expect to receive chemicals for pharmaceutical and working in the same area. a written response. The commenter industrial applications, bio-based We agree with the commenter that the stated that, in the case of grant products, personal care products, proposed definition did not adequately applications, it may be difficult to meet renewable specialty chemicals, biofuels, address the possibility of aerosol deadlines if the applicant has no idea and healthcare products. The transmission and have amended the how long a response from the select commenter argued that consequences of language accordingly. agent program will take. adopting the proposed definition could Additionally, we are also removing We are making no changes as a result impede the growth of sustainable references to rickettsiae in the of this comment. Due to the wide products from emerging fields such as definitions for biological agent and variety of material submitted for synthetic biology technology. The toxin. This change is necessary because consideration for exclusions, commenter therefore recommended that there are no rickettsiae select agents or establishment of a timeline as the we not adopt the new definition of toxins regulated by APHIS on the list of commenter recommends is impractical. recombinant and synthetic nucleic acids select agents and toxins. The select agent program necessarily as stated in the proposed rule, arguing We proposed to amend 7 CFR examines each application on a case-by- that the existing language of the 331.3(e), 9 CFR 121.3(e) and 9 CFR case basis. We strive to make the regulation is sufficient to cover the 121.4(e). These paragraphs specify that process as efficient as possible. current uses of synthetic nucleic acids. attenuated strains of select agents or The regulations in 9 CFR 121.6 set out The commenter further stated that the toxins may be excluded from the guidelines for those instances where proposed definition utilizes language requirements of the select agent overlap select agents and toxins may be that was proposed to, but rejected by, regulations subject to an official request considered exempt from the regulations. the National Institutes of Health and supporting scientific information. Specifically, § 121.6(e) concerns

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procedures by which an individual or the entity to decide how best to relation to the requirement that the entity may be exempted from the designate a responsible official who responsible official’s principal duty requirements of the regulations if meets the requirements of the station be the physical location of the necessary in order to respond to a regulations. registered entity and the impact of the domestic or foreign agricultural Another commenter said that the requirement assessed. The commenters’ emergency involving an overlap select absence of specific requirements request was based on their agent or toxin. Upon further regarding responsible official understanding that an entity has to be consideration, in order to eliminate an qualifications will establish an contiguous and that laboratories unnecessary burden on such an inspection process that is subjective and separated on a campus constitute individual or entity, we have removed ineffectual. The commenter asked that separate entities. The commenters the provision stating that the individual we add a section that explains and/or concluded that having separate or entity must complete APHIS/CDC defines what we consider the responsible officials in this case would Form 5 in order to request such an ‘‘appropriate training or expertise’’ be burdensome. exemption. Guidance on requesting an necessary for an entity’s responsible We realize that many entities are exemption for an individual or entity in official. located on a campus with several the case of a domestic or foreign We have established the regulations registered laboratories in different agricultural emergency involving an regarding the training and expertise of buildings. The intent of this overlap select agent or toxin may be the responsible official in order that requirement is not to ensure that a found on the National Select Agent they provide maximum flexibility to responsible official is assigned to each Registry at www.selectagents.gov. regulated entities. The reasons for this physical laboratory but to ensure that The regulations in 7 CFR 331.9 and 9 are twofold: First, given the quickly the responsible official is physically CFR 121.9 set out requirements for developing and changing fields of located on the campus. entities requesting to work with select biosafety and biosecurity, any attempt We proposed to amend the agents and toxins to designate a on our part to strictly define required regulations in 7 CFR 331.10 and 9 CFR responsible official, who ensures that training and expertise within the 121.10. These regulations establish the entity continues to meet the regulations would likely become parameters for restricting access to requirements of the regulations. We obsolete as the parameters continue to select agents and toxins and the process proposed to explicitly require that all evolve; second, given the wide variety by which individuals may be approved designated responsible officials possess of entities covered by the regulations, for access to select agents and toxins the appropriate training or expertise to there is a need to maintain flexibility so after the completion of a security risk execute their required duties. We also that they may remain applicable to all assessment by the Attorney General. proposed to clarify the role of alternate of those entities. We have removed the Specifically, we proposed to add new responsible official in order to reference to ‘‘appropriate training or provisions by which individuals may definitively establish that the alternate expertise’’ and will continue to assess have access to select agents at entities responsible official must have the the performance of the responsible other than the individual’s ‘‘home’’ knowledge and authority to act for the official based on his or her efficacy in entity. We also proposed to decrease the responsible official in his/her absence. implementing the regulatory maximum length of time for which a Finally, we proposed to add a requirements at his or her entity. With security risk assessment will be valid requirement that the responsible an eye to the non-specificity of the from 5 years to 3 years in order to more official’s principal duty station be the regulations, we have developed expeditiously identify individuals who physical location of the registered guidance documents regarding this and may have fallen into one of the entity. other aspects of entity compliance. They prohibited or restricted categories. One commenter stated that the are available on the National Select One commenter asked whether, language concerning responsible Agent Registry at www.selectagents.gov. during the time period in which an officials is not clear and may cause Five commenters requested further individual has access to select agents at institutions to unnecessarily create new clarification regarding the proposed entities other than the individual’s administrative structures and positions requirement that the responsible ‘‘home’’ entity, that individual would to meet this requirement. The official’s principal duty station be the have access to select agents at both commenter urged the select agent physical location of the registered facilities, or if the access approval program to work with research entity. The commenters inquired would be transferred so that the institutions in order to identify the most whether this requirement would mean individual would only have access to appropriate level of administration for that the principal duty station should be the select agents and toxins at the new the responsible official. in the same building or only at the same entity for the time specified. The We are making no change in response institution. commenter stated that, from a biosafety to this comment. The responsible In response to these comments and and biosecurity perspective, limiting official should be an individual who can others received by the CDC, we are access to only one entity at the time perform all of the duties required for modifying the language in 7 CFR 331.9 would be appropriate. that position. The regulations were and 9 CFR 121.9 to stipulate that the During this timeframe, the individual designed to place the responsibility for responsible official must have a will maintain access to select agents at ensuring entity compliance with the physical (as opposed to a telephonic or both facilities. We believe that such an regulations in one position. Given the audio-visual link) presence at the arrangement will serve to facilitate wide variety of entities covered by the registered entity to ensure that the entity collaboration between registered entities regulations, establishing more is in compliance with the regulations. as well as enabling various entities to prescriptive guidelines would decrease The responsible official will also be use their time and funds most efficiently the flexibility and usefulness of the more quickly able to respond to any on- in order to continue ongoing research. regulations to those entities. We neither site incidents involving select agents We do not agree with the commenter’s require nor prohibit the establishment of and toxins if he or she is on-site. assertion that this procedure would a separate administrative position for Three commenters asked that the threaten biosecurity or biosafety in any the responsible official as we leave it to definition of ‘‘entity’’ be clarified in way since all registered entities are

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required to undergo the same security safeguarding of animals or plants and animals that are possessed by and screening process as established by the intentionally or accidentally exposed to controlled by the registered entity. regulations. or infected with a select agent, against One commenter suggested that we Two commenters stated that unauthorized access, theft, loss or alter the wording from a requirement to decreasing the maximum length of time release. We also proposed to add a safeguard animals or plants for which a security risk assessment will requirement that the security plan ‘‘intentionally or accidentally exposed be valid from 5 years to 3 years would include procedures that require the to or infected with a select agent’’ to a represent an undue burden on registered responsible official to immediately requirement to safeguard animals or entities. One commenter cited the notify the FBI in order to initiate a plants ‘‘intentionally exposed to, or generally low rate of turnover at these threat assessment process in the event infected with, select agents.’’ The entities, while the other stated that the that he or she becomes aware of commenter stated that the suggested existing policy, with renewal every 5 suspicious activity which is criminal in language would be clearer. years, has proven to be both sufficient nature, related to the facility, its We are making no changes based on and cost effective since the personnel, or select agents. We also this comment. We believe that animals establishment of the select agent proposed to add provisions for or plants accidentally exposed to or regulations. The first commenter information security, including the need infected with a select agent should be suggested that we allow for less frequent for backup measures if the entity relies handled as select agents and risk assessments in the case of those on information systems for security. We safeguarded in the same manner as an individuals working with non-Tier 1 also proposed to codify current animal or plant intentionally exposed to select agents and toxins only. The practices for shipping, receiving, and a select agent. second commenter recommended storage of select agents and toxins to In the preamble to the proposed rule, making no changes to the 5-year ensure that the entity has documented we stated that we were not proposing to interval. processes for securing and monitoring require the security plan to address The decision to begin processing the shipment, receipt, and storage of animals and plants exposed to select security risk assessments at 3-year these items. Finally, we proposed to toxins. This is because recovering the rather than 5-year intervals was made as amend paragraph (e) in 7 CFR 331.11 toxin from within an animal or plant a result of the recommendations from a and 9 CFR 121.11, which previously subject is highly difficult and such working group comprised, in part, of directed individuals creating a security removal does not produce a reasonable representatives from the DOD and the plan to guidance for developing such yield of recovery. In addition, there is HHS as well as various subject matter documents contained in the ‘‘Morbidity uncertainty as to whether or not the experts. Based on input from the and Mortality Weekly Report’’ from toxin would remain active when working group as well as the FBI, we December 2002. We proposed that recovered from the animal or plant. For have determined that conducting applicants would instead be directed to these reasons it is highly unlikely that security risk assessment approvals every the ‘‘Security Information Document’’ once introduced into an animal or plant, 3 years is an effective method for and the ‘‘Security Plan Template’’ on a sufficient amount of toxin could be increasing the security of our entities. the National Select Agent Registry Web recovered to pose a significant hazard to Furthermore, the select agent program site. public health, agriculture, or agriculture has been processing security risk Two commenters requested products. One commenter questioned assessments on a 3-year basis since June clarification concerning the proposed that rationale, stating that while toxins 1, 2011. Since that date, we have not requirement that entities address are unlikely to be amplified or move received any comments from the procedures concerning animals or into multiple hosts outside a given regulated community regarding plants accidentally or intentionally facility, there is still concern that additional financial or administrative exposed to or infected with a select amplification of toxins could occur in burden associated with the changed agent. Specifically, the commenters animals or insects during the course of practice. Regarding the first requested clarification as to whether the an experiment. commenter’s suggestion to process requirement would be limited to We disagree with the commenter’s security risk assessments differently for experimental plants and animals that assertion. Select toxins do not amplify those individuals working with non- are possessed and controlled by the the way select agents do. Toxins in an Tier 1 select agents and toxins only, the registered entity. One commenter animal or insect would prove deadly to establishment of the Tier 1 category is suggested two additions to the that organism before it could reach a in no way intended to imply that the requirements: One stipulating that the level at which extraction would become non-Tier 1 agents pose a lesser risk to incident response plan only cover those possible. public health and safety than they have animals or plants possessed and One commenter stated that our previously. In accordance with that fact, controlled by the entity and the second proposal to add a requirement that the we have not decreased the handling and a certifying statement confirming that security plan include procedures for the security requirements for those non-Tier the State animal health official (or plant- responsible official to notify the FBI of 1 agents. associated equivalent) has an incident suspicious activity that may be criminal We proposed to require that the response plan in place to address in nature and related to the entity, its security plan described in 7 CFR 331.11 intentional or accidental exposure to personnel, or its select agents or toxins and 9 CFR 121.11 that must be select agents for animals or plants contradicts guidance contained in the developed by all registered entities be throughout the State, including those Nationwide Suspicious Activity submitted for initial registration, plants or animals that are not possessed Reporting (SAR) Initiative (NSI) renewals of registration, and at any or controlled by the entity but may be established by the Department of other time upon request to replace the located on the premises (e.g., wild Justice, creates a conflict within those existing requirement that they be animals). entities that have their own recognized provided upon request only. We also We are making no changes based on law enforcement agencies, and proposed that the security plan contain these comments. It was always our unnecessarily adds confusion due to the provisions for the control of access to intent that the entity’s incident response potential for concurrent jurisdiction. select agents and toxins, including the plan be limited to those exposed plants Two other commenters questioned the

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rationale for requiring FBI reporting and toxins themselves. Therefore, we surveillance devices are rendered given that the select agent program is have revised the language in order to inoperable’’ should be clarified. jointly administered by APHIS and CDC clearly indicate that the information Again, we note that, further details and, in the past, security concerns were security provisions in question should regarding these and other aspects of the directed to those agencies. only be for access to the entity’s information security requirements may We do not believe that there exists registered space and records pertaining be found in the guidance documents any conflict between the security to select agents and toxins, as identified mentioned above, which may be found requirements in 7 CFR 331.11 and 9 in sections 7 CFR 331.11, 9 CFR 121.11, on the National Select Agent Registry at CFR 121.11 and the guidance offered by 7 CFR 331.17, and 9 CFR 121.17. www.selectagents.gov. the NSI. The intent of this requirement Another commenter stated that the We proposed to require that an is to facilitate the involvement of information security requirement entity’s security plan contain provisions antiterrorism resources which will represents an added regulatory burden, and policies for shipping, receiving, and increase the security of select agents and and the impact of this requirement storage of select agents and toxins, toxins. FBI field offices, which are should be evaluated. including documented procedures for centrally located in major metropolitan For the most part, we anticipate that receiving, monitoring, and shipping of areas across the United States, can assist these requirements are already being all select agents and toxins. These entities by working closely with them met and will merely require entities to provisions would provide that an entity on crime threats. However, we agree codify and document the systems and must properly secure containers on site with the commenters that it may be processes currently in place. The and have a written contingency plan for appropriate that notification of guidance documents developed in unexpected shipments. One commenter suspicious activity first be given to local conjunction with this rule are, in part, requested clarification regarding the law enforcement. We have therefore a response to the questions and issues meaning of the term ‘‘unexpected changed the language in 7 CFR raised by the commenter. Issues shipments.’’ 331.11(c)(8) and 9 CFR 121.11(c)(8) to addressed in this document include, but We believe that the term ‘‘unexpected read: ‘‘Describe procedures for how the are not limited to: Information shipments’’ is self-explanatory and Responsible Official will be informed of technology security, network security, believe that the security plan should suspicious activity that may be criminal computer security, peripheral devices contain procedures for these handling in nature and related to the entity, its and data storage, physical security and unexpected shipments (e.g., when an personnel, or its select agents or toxins; its application to information security, entity receives a shipment of a select and describe procedures for how the risk management, and training. Full agent that it had neither requested nor entity will notify the appropriate guidance on information security may coordinated for, and therefore was not Federal, State, or local law enforcement be found on the National Select Agent expecting). agencies of such activity.’’ Registry at www.selectagents.gov. The regulations in 7 CFR 331.13 and Another commenter suggested that we Another commenter said that the 9 CFR 121.13 concern restricted require FBI notification for any proposed requirement that authorized experiments, which are those suspicious activity involving select and authenticated users only be granted experiments that may not be performed agents or toxins and not just activity access to select agent and toxin related by regulated entities without the that may be criminal in nature. The information, files, equipment (e.g., approval of the Administrator. In commenter argued that it is more servers or mass storage devices), and addition to the existing prohibition on appropriate for the FBI to determine applications as necessary to fulfill their conducting restricted experiments, we whether or not the activity in question roles and responsibilities, and that their proposed to state that entities would not is criminal in nature. access be modified when the user’s roles be authorized to possess the products of We are making no changes in and responsibilities change or when restricted experiments without the response to this comment. The intent of their access to select agents and toxins approval of the Administrator. this section of the regulations is to avoid is suspended or revoked, would require We also proposed to expand the excessive reporting to the FBI. It is our registration and security risk restricted experiment approval belief that a reasonable person would be assessments for all staff managing requirement to include all experiments able to determine if the behavior in records pertaining to select agent work. involving the creation of drug resistant question constitutes a potential criminal The commenter argued that this select agents that are not known to act, which would therefore necessitate requirement would increase the burden acquire that resistance naturally, if such FBI reporting. on manufacturers and institutions who acquisition could compromise the use of One commenter requested that we utilize administrative or information the drug to control disease agents in provide further details concerning the technology staff for such document humans, veterinary medicine, or proposed requirements for additions to management. agriculture, regardless of the method or the security plan, specifically as it The security requirements referenced technology used to create the resistance. relates to information security. by the commenter refer only to those Previously, the restricted experiment The purpose of the requirement in persons who have either physical access language concerned only those question is to clarify the language in 7 to select agents and toxins or who have experiments involving recombinant CFR 331.11(c)(9)(i) and 9 CFR the capability to alter security access to DNA. We proposed this change because, 121.11(c)(9)(i) of the regulations that select agents and toxins. Guidelines while the introduction of a drug requires the entity to have procedures in concerning security requirements such resistance trait would normally place for information systems control. as these may be found on the National eliminate that drug as a therapeutic This is an overarching requirement that Select Agent Registry at option to control the disease, there may covers electronic and non-electronic www.selectagents.gov. be alternative drugs available to control information oversight by the regulated Another commenter stated that the the disease. community. Our intent is not to regulate meaning of the phrases ‘‘network In addition, we are adding a reference experimental data or the results of connectivity monitoring’’ and ‘‘backup to ‘‘chemical resistance traits,’’ to the studies involving select agents and security measures in the event that PPQ regulations in 7 CFR 331.13 in toxins but to regulate the select agents access control systems and/or order to capture the potential transfer of,

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or selection for, such traits that could any time. The commenter wished to when appropriate, we have engaged the adversely affect plant and agricultural know if the possession of such a advice of subject matter experts from health. Chemical resistant traits include, previously unknown antibiotic resistant outside the government. but are not limited to herbicide select agent would mean that all such The regulations in 7 CFR 331.14 and resistance, fungicide resistance, and organisms would be required to be 9 CFR 121.14 concern development of pesticide resistance. We did not propose destroyed. The commenter expressed an entity’s incident response plan. We to add a corresponding definition to the concern that such a requirement might proposed to specify that each incident VS regulations in 9 CFR 121.13 since inadvertently prevent research in the response plan be based upon a site- chemical resistance traits are exclusive case of a select agent that suddenly specific risk assessment. We also to plant biology. It should be noted that developed new antibiotic resistance proposed that the incident response restricted experiments are not traits. procedures contain stipulations prohibited experiments; an entity must We are making no changes to the concerning animals and plants seek permission prior to the initiation of regulations as a result of this comment. accidentally or intentionally exposed to a restricted experiment and receive Regardless of whether the select agent or infected with a select agent. approval from the Administrator or HHS develops a new trait, it is still One commenter argued that the Secretary. Approval for the performance considered and treated as a select agent requirements in 7 CFR 331.14(a) and 9 of a restricted experiment or the from a biosafety or biocontainment CFR 121.14(a), which stipulate that possession of a product of a restricted perspective. The aspect of the process regulated entities must develop and experiment may involve meeting that makes a select agent the subject of implement a written incident response additional safety and/or security a restricted experiment is the purposeful plan based on a site-specific risk requirements as prescribed by the select generation of antibiotic resistant assessment, are misleading. The agent program. Many experiments that properties. If a select agent developed commenter stated that, since there is no involve the deliberate transfer of a drug new antibiotic resistance spontaneously, standard methodology for conducting resistant trait do not meet the definition then it would be included in the such risk assessments, the addition of of a restricted experiment because the category of select agents considered specific issues that must be addressed drug is not used to control disease in ‘‘known to acquire the resistance by a risk assessment should be included humans, veterinary medicine, or naturally’’ as specified in 7 CFR in order to provide additional guidance agriculture. The select agent program 331.13(a)(1) and 9 CFR 121.13(b)(1). for the regulated community. The encourages anyone who intends to Another commenter wanted to know commenter further observed that, in conduct a select agent experiment whether the use of the terms ‘‘the select general, the risk assessment utilizing drug resistance markers to agent program’’ and ‘‘the requirements for agricultural select submit that experiment for review so Administrator,’’ which refer to two agents and toxins are somewhat that they may be advised regarding different entities, indicates that different from those for human select whether the experiment would be restricted experiments would require agents and toxins. The commenter considered a restricted experiment and the approval of both the select agent concluded that a one size fits all therefore require approval prior to its program and the Administrator. approach may be overly burdensome or initiation. Terms in this context are scientifically inaccurate. Two commenters were concerned interchangeable, as the APHIS We are making no changes based on about the proposed revisions classifying Administrator has delegated authority this comment. The site-specific risk those experiments that introduce drug for establishing and enforcing the assessments required by the regulations resistance to a select agent as restricted. regulations to the select agent program. in 7 CFR 331.14(a) and 9 CFR 121.14(a) The commenters suggested aligning the Approval is therefore only needed from are necessary in order to ensure the language concerning restricted the select agent program. physical security of regulated entities. experiments with the recombinant DNA Another commenter stated that an The risks cited by the commenter are guidelines issued by the NIH, which ombudsman, in the form of additional matters of the biological risk presented restrict and require approval only for working groups, should be included in by various select agents and toxins, those experiments with pathogens the approval process for restricted which is a separate issue from the involving drug resistance for experiments. The commenter said that physical security of these select agents therapeutically useful agents against involvement of such groups in this and toxins. The regulations are intended that pathogen. The commenters stated capacity would serve to engage those to prevent the theft, loss, or release of that the proposed language was too regulated scientists while furthering select agents and toxins. We also broad. their understanding of the select agent disagree with the commenter’s assertion We made no changes as a result of program. that there is no standard methodology these comments. Contrary to the We are making no changes as a result for conducting site-specific risk commenters’ assertion, we have not of this comment. In reviewing assessments. We have developed expanded the definition of a restricted applications to conduct restricted guidance on this subject that may be experiment to include all experiments experiments, the select agent program found on the National Select Agent utilizing select agents or toxins with utilizes the expertise of the Registry at www.selectagents.gov. drug resistant traits, but only to those Intragovernmental Select Agents and We proposed to amend the utilizing select agents or toxins with Toxins Technical Advisory Committee regulations in 7 CFR 331.15 and 9 CFR resistance to those drugs used to control (ISATTAC), which is composed of 121.15, which concern provision of disease in humans, veterinary medicine, Federal scientists from the CDC, NIH, mandatory training for staff and visitors or agriculture. The definition of a FDA, APHIS, the Agricultural Research who work in or visit areas where select restricted experiment contained in the Service (ARS), APHIS’ Center for agents or toxins are handled or stored. regulations is already aligned with the Veterinary Biologics (CVB), and DOD, We proposed to require all registered NIH recombinant DNA guidelines. and its USDA counterpart, the entities to provide security awareness One commenter argued that antibiotic Agricultural ISATTAC, which is and incident response training. We also resistance not previously present could composed of Federal scientists from proposed to establish that training for emerge in one or more select agents at ARS, APHIS, and CVB. In the past, escorted personnel would be based on

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the risk associated with accessing areas procedures as defined by the entity in a select agent (including number and where select agents and toxins are used question; however, we are leaving the species, location, and appropriate and/or stored. We further proposed to regulations in their broadly written state disposition). As previously stated, we require that refresher training, currently in order to provide the greatest amount did not propose to require regulated required on an annual basis, also be of flexibility for the wide variety of entities to keep records regarding provided if a registered entity’s security, entities subject to the requirements. animals or plants exposed to select incident response, biosafety, or We proposed to amend the toxins. biocontainment plans are substantively regulations in 7 CFR 331.16 and 9 CFR Four commenters argued that altered. Finally, we proposed to specify 121.16, which concern the transfer of counting individual vials of replicating that the responsible official ensure select agents and toxins from one biological agents is costly, burdensome, maintenance of training records. registered entity to another, in order to and a major source of frustration for Currently there is no particular person codify practices for shipping, receiving, investigators. The commenters went on designated as the entity’s required and storage of select agents and toxins to say that the requirement to measure recordkeeper, only that a training record to ensure that all registered entities have volumes within each vial is problematic must be kept. documented processes for securing and given both the ease with which volumes One commenter suggested that 7 CFR monitoring the shipment, receipt, and can change through natural processes 331.15(a) should specify that storage of select agents and toxins that and the difficulty in correctly assessing information and training on both make it extremely unlikely that such them in the frozen state during biocontainment and biosafety be materials would be made available to an inventory verifications. The commenters provided, as only information and unauthorized individual. stated that both counting vials and training on biosafety had been specified Two commenters asserted that the measuring volumes of individual vials in the proposed rule. provisions concerning transfer are are not effective means of increasing We agree with the commenter and unclear with regard to the subject of the security. have amended 7 CFR 331.15(a) in order transfer of materials covered by the We are making no changes to the to reflect the proper terminology in exemptions for diagnostic or clinical regulations based on these comments. dealing with plant pathogens. laboratories under 7 CFR 331.5, 9 CFR While we are aware of the burden We proposed that the regulations in 7 121.5, and 9 CFR 121.6. The resulting from the requirement to CFR 331.15(a)(ii) concerning escorted commenters requested that we clearly maintain an accurate and current personnel stipulate that training for establish whether the new requirements inventory of each select agent and toxin such individuals must be based on the supersede the existing provisions for held in long-term storage, we believe risk associated with accessing areas transfer by exempt entities. this is an essential element in where select agents and toxins are used We are making no changes as a result establishing the security of select agents and/or stored. One commenter inquired of this comment. Those materials which or toxins. We recognize that it may still what would represent an ‘‘appropriate qualify for exemption from the be possible for an insider to steal a level of training.’’ The commenter regulations have always been sample of an agent either from working further wished to know how an entity considered separately from the rest of stock or from an inventory without would determine the risk associated the listed select agents or toxins. This being detected; however, if an entity has with accessing such areas. Finally, the may be a result of the exemptions a robust inventory management system, commenter asserted that there should be granted for diagnostic or clinical such incidents have a better chance of no need for non-approved individuals to laboratories, a result of a specific being detected. To assist registered potentially access areas where select exemption request, or for other reasons entities in meeting the requirements for agents and toxins are used and/or stored which may be found in 7 CFR 331.5, 9 maintaining accurate inventories of given that unsecured select agents or CFR 121.5, and 9 CFR 121.6. As a result, materials in long term storage, we have toxins could be moved elsewhere prior these materials are not subject to the developed guidance that may be found to the arrival of any escorted personnel. regulations, including those portions of on the National Select Agent Registry at We disagree with the commenter’s the regulations concerning transfers, www.selectagents.gov. It should be assertion that non-approved individuals apart from those sections pertaining to noted that, while the volume would never need to access areas where exemptions. measurements the commenter select agents and toxins are used and/ However, given that some references are required for inventories of or stored. For example, there may be a commenters on the CDC proposed rule select toxins, they are not required in need for the repair of a refrigeration unit expressed confusion associated with the the case of inventory of select agents in a laboratory where employees are proposed provision, we have revised the held in long-term storage due, in part, utilizing select agents or toxins as a part language in order to clarify our original to the points raised by the commenter. of concurrent research work. In intent. Packaging of select agents and However, we disagree with the addition, inventories of select agents toxins for transfer must be made by an commenter’s assessment that measuring and toxins may be large enough to make APHIS or CDC-approved individual. volume in the case of select toxins and moving them impractical and overly The regulations in 7 CFR 331.17 and counting vials in general as part of time-consuming. It is therefore 9 CFR 121.17 concern required required inventory tracking of both necessary for any visitors to know and recordkeeping procedures for regulated select agents and toxins for registered understand the biological risks entities as those records relate to select entities is not necessary. associated with the select agents or agents and toxins. We proposed to add Another commenter stated that there toxins used and/or stored in the area to language to address synthetic select is concern that the additional which they will have access. This agent organisms and animals and plants requirements for inventory each time a training would necessarily vary inoculated with select agents. We also select agent is moved will adversely depending upon the areas that the proposed to add recordkeeping impact the viability and quality of the escorted personnel would need to requirements whereby regulated entities material in question. access, which would be determined by maintain an accurate, current inventory We are making no changes as a result the entity. Visitors should ideally be of any animals or plants intentionally or of this comment. In the case of those made aware of the safety and security accidentally exposed to or infected with select agents and toxins in long-term

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storage, collections of vials of materials for implementation of the new compliance with 7 CFR 331.11, 331.12, can be recorded and grouped into requirements should be considered and 331.14, and 331.15 and 9 CFR 121.11, tamper-evident containers and audits disclosed to affected entities. 121.12, 121.13, 121.14, and 121.15. made of intact containers rather than A cornerstone of the select agent The staggered effective dates for the audits of individual vials. This practice program is to establish and enforce provisions of the final rule are based on is stipulated in the current guidance safety and security measures to prevent the effective dates previously used for a document regarding long term storage, access to select agents and toxins for use final rule published by the Select Agent which is available on the National in domestic or international terrorism or Program on March 18, 2005 (70 FR Select Agent Registry at for any other criminal purpose. An 13242–13292, Docket No. 02–088–4). If www.selectagents.gov. Those select equally important function of the select the regulated community has concerns agents and toxins that are part of an agent program is to ensure the about the established timeline, they can entity’s working stock are already in appropriate availability of biological contact the Federal select agent program regular use and we therefore do not agents and toxins for research, for technical assistance. anticipate adverse effects arising from education, and other legitimate Therefore, for the reasons given in the any required accounting. purposes. To achieve both requires proposed rule and in this document, we Based on comments received on the balancing the need for continuing are adopting the proposed rule as a final CDC rule, we now recognize that there biological research with requiring a rule, with the changes discussed in this has been some confusion between those level of safety and security document. animals (including arthropods) and commensurate with the risks posed by Executive Orders 12866 and 13563 and plants considered to be ‘‘working stock’’ these select agents and toxins. We Regulatory Flexibility Act and those considered to be ‘‘inventory.’’ understand that safety and security To that end, we have developed requirements cost money and that This final rule has been determined to guidance that will enable entities to money in the area of biological research be significant/economically significant better differentiate between these two is often a scarce commodity. We are, for the purposes of Executive Order categories. This guidance is available at however, also aware that a lack of 12866 and, therefore, has been reviewed www.selectagents.gov. It was not our adequate safety and security by the Office of Management and intent to require a formal inventory of requirements could result in damages Budget. animals or plants intentionally or measured not only in dollars but in We have prepared an economic accidentally exposed to or infected with human lives. It is our determination, analysis for this rule. The economic a select agent, but merely to state that based on the information available to us, analysis provides a cost-benefit analysis, entities should keep some record of that the additional requirements would, as required by Executive Orders 12866 such animals or plants. In order to in many cases, codify systems and and 13563, which direct agencies to clarify our intent regarding ‘‘working procedures already in use by a majority assess all costs and benefits of available stock’’ and ‘‘inventory,’’ we are revising of regulated entities. regulatory alternatives and, if regulation 7 CFR 331.17(a)(2) and 9 CFR We are also renumbering several is necessary, to select regulatory 121.17(a)(2) to require an accurate, sections of the PPQ regulations so that approaches that maximize net benefits current accounting of any animals or they will match the numbering of the (including potential economic, plants intentionally or accidentally VS regulations, which we believe may environmental, public health and safety exposed to or infected with a select be useful for those entities housing both effects, and equity). Executive Order agent (including number and species, PPQ select agents and toxins and VS 13563 emphasizes the importance of location, and appropriate disposition) select agents and toxins. As proposed, quantifying both costs and benefits, of instead of an accurate, current inventory the section numbering did not match up reducing costs, of harmonizing rules, of those animals or plants. because we did not propose to classify and of promoting flexibility. The any PPQ select agents and toxins as Tier economic analysis also provides a final Indirect and Economic Consequences 1, so there were sections being added to regulatory flexibility analysis that Eight commenters requested that we the VS regulations that were not examines the potential economic effects consider the indirect consequences of included in the PPQ regulations. of this rule on small entities, as required continuing to include agents and toxins by the Regulatory Flexibility Act. The on the select agent list, the negative Effective Date economic analysis is summarized effect of the proposed rule changes on In response to comments received by below. Copies of the full analysis are the potential workforce for select agent the CDC requesting guidance and a available on the Regulations.gov Web research, and the possibility that timetable of when the proposed changes site (see footnote 1 in this document for additional regulations concerning Tier 1 would need to be addressed, we have a link to Regulations.gov) or by agents and toxins will mandate more included a phase-in period for the contacting the person listed under FOR Federal oversight and institutional effective date for certain requirements of FURTHER INFORMATION CONTACT. compliance requirements, resulting in the revised regulations, which should Based on information obtained increased costs to taxpayers both allow entities to comply without through site-specific inspections, we directly and indirectly through reduced causing disruption or termination of believe most registered entities already research efficiency. Commenters research or educational projects. As have in place many of the information requested that the full economic and noted in the ‘‘Dates’’ portion of this security requirements set forth in the scientific impact of these added document, 60 days from the publication final rule, and compliance costs of the requirements be carefully assessed prior of the final rule, entities will be required rules are therefore expected to be to implementation, especially the to be in compliance with 7 CFR 331.1 minimal. Entities more likely to be increased costs to academic institutions through 331.10, 331.13, and 331.16 affected will be laboratories and other with no associated funding, and the through 331.20 and 9 CFR 121.1 through institutions conducting research and increased burden on investigators 121.10, 121.13, 121.16, 121.17, and related activities that involve the use of already having difficulty finding time 121.20. One hundred and eighty days select agents and toxins categorized as for research and experimentation. The after the publication of the final rule, Tier 1. These entities will be required to commenters also stated that the timeline entities will be required to be in conduct a pre-access suitability

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assessment of individuals with access to ranging and devastating impacts to the E-Government Act Compliance a Tier 1 select agent or toxin, as well as economy, other disruptions to society, The Animal and Plant Health enroll these individuals in an and diminished confidence in public Inspection Service is committed to occupational health program. and private institutions. compliance with the E-Government Act The rule would reduce the period that The amended regulations will to promote the use of the Internet and FBI background checks are valid from enhance the protection of human, other information technologies, to five to three years. This increased animal, and plant health and safety. The provide increased opportunities for frequency would effectively increase the final rules will reduce likelihood of the citizen access to Government cost of background checks by 67 accidental or intentional release of a information and services, and for other percent. Based on the current number of select agent or toxin. Benefits of the purposes. For information pertinent to individuals required to have the rules will derive from the greater E-Government Act compliance related background checks, we estimate that the probability that a release will be to this rule, please contact Mrs. Celeste present value of these government-borne prevented from occurring. While the Sickles, APHIS’ Information Collection costs over five years will increase by total cost of implementing the Coordinator, at (301) 851–2908. $1.96 million across all registered regulations is estimated to range entities. The annual increase in costs between $2.8 million–$4.4 million List of Subjects will total about $432,000. across all entities with a Tier 1 agent or 7 CFR Part 331 While we expect few if any of the toxin and approximately $2.4 million in registered entities to incur significant annual cost across all registered entities Agricultural research, Laboratories, compliance costs, required and the Federal Government, we believe Plant diseases and pests, Reporting and documentation of measures already many of these costs are currently recordkeeping requirements. regularly performed with respect to incurred by affected entities as generally 9 CFR Part 121 biocontainment/biosafety, incident recognized practices. response, information security, and Agricultural research, Animal ongoing suitability assessment may Executive Order 12372 diseases, Laboratories, Medical research, require additional time of personnel. We This program/activity is listed in the Reporting and recordkeeping estimate additional recurring costs Catalog of Federal Domestic Assistance requirements. related to information security, such as under No. 10.025 and is subject to Accordingly, we are amending 7 CFR for software updates, could total about Executive Order 12372, which requires part 331 and 9 CFR part 121 as follows: $2 million per year, or about $5,500 per intergovernmental consultation with entity, in the unlikely event that none State and local officials. (See 7 CFR part Title 7 of the entities already uses equivalent 3015, subpart V.) information security measures. As PART 331—POSSESSION, USE, AND noted, many of these costs are already Executive Order 12988 TRANSFER OF SELECT AGENTS AND currently borne by entities in their This final rule has been reviewed TOXINS conduct of generally recognized best under Executive Order 12988, Civil ■ 1. The authority citation for part 331 practices. Justice Reform. This rule: (1) Preempts continues to read as follows: For entities possessing a Tier 1 agent all State and local laws and regulations or toxin, the costs of pre-access that are inconsistent with this rule; (2) Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, suitability assessments and has no retroactive effect; and (3) does and 371.3. occupational health programs are not require administrative proceedings ■ 2. Section 331.1 is amended as estimated to total between $2.8 million before parties may file suit in court follows: and $4.4 million, or between about challenging this rule. ■ a. In the introductory text of the $9,600 and $15,100 per entity, on definition of biological agent, by average. Again, actual costs incurred are Executive Order 13175 removing the word ‘‘rickettsiae,’’; unlikely to reach these maximum cost This rule has been reviewed in ■ b. By adding, in alphabetical order, ranges; we expect that many of the accordance with the requirements of definitions of information security, entities with a Tier 1 agent or toxin Executive Order 13175, Consultation recombinant nucleic acids, security already conduct assessments and have and Coordination with Indian Tribal barrier, and synthetic nucleic acids; and health programs similar or equivalent to Governments. The review reveals that ■ c. In the introductory text of the those required by the final rules. this regulation will not have substantial definition of toxin, by removing the The benefits of strengthened and direct effects on Tribal governments word ‘‘rickettsiae,’’. safeguards against the unintentional or and will not have significant Tribal The additions read as follows: deliberate release of a select agent or implications. toxin greatly exceed compliance costs of § 331.1 Definitions. the rules. As an example of losses that Paperwork Reduction Act * * * * * can occur, the October 2001 anthrax In accordance with section 3507(d) of Information security. Protecting attacks caused 5 fatalities and 17 the Paperwork Reduction Act of 1995 information and information systems illnesses, disrupted business and (44 U.S.C. 3501 et seq.), the information from unauthorized access, use, government activities (including $2 collection or recordkeeping disclosure, disruption, modification, or billion in lost revenues for the Postal requirements included in this final rule destruction in order to provide: Service), and required more than $23 have been submitted for approval to the (1) Integrity, which means guarding million to decontaminate one Senate Office of Management and Budget against improper information office building and $3 billion to (OMB). When OMB notifies us of its modification or destruction, and decontaminate postal facilities and decision, we will publish a document in includes ensuring information procure mail-sanitizing equipment. the Federal Register providing notice of authenticity; Deliberate introduction greatly increases the assigned OMB control numbers or, (2) Confidentiality, which means the probability of a select agent if approval is denied, providing notice preserving authorized restrictions on becoming established and causing wide- of what action we plan to take. access and disclosure, including means

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for protecting personal privacy and toxin may be excluded from the (e) A person with valid approval from proprietary information; and requirements of this part based upon a the HHS Secretary or Administrator to (3) Availability, which means determination by the Administrator that have access to select agents or toxins ensuring timely and reliable access to the attenuated strain or inactivated may request, through his or her and use of information. toxin does not pose a severe threat to Responsible Official, that the HHS * * * * * plant health or plant products. Secretary or Administrator provide their Recombinant nucleic acids. (1) (1) To apply for exclusion, an approved access status to another Molecules that are constructed by individual or entity must submit a registered individual or entity for a joining nucleic acid molecules and that written request and supporting specified period of time. can replicate in a living cell (i.e., scientific information. A written * * * * * recombinant nucleic acids); or decision granting or denying the request ■ 6. Section 331.11 is amended as (2) Molecules that result from the will be issued. An exclusion will be follows: replication of those described in effective upon notification to the ■ a. By revising paragraph (b); paragraph (1) of this definition. applicant. Exclusions will be listed on ■ b. By revising paragraph (c)(2); * * * * * the National Select Agent Registry Web ■ c. In paragraph (c)(6), by removing the Security barrier. A physical structure site at http://www.selectagents.gov/. word ‘‘and’’; that is designed to prevent entry by (2) If an excluded attenuated strain or ■ d. In paragraph (c)(7), by removing the unauthorized persons, animals, or inactivated toxin is subjected to any period and adding a semicolon in its materials. manipulation that restores or enhances place; * * * * * its virulence or toxic activity, the ■ e. By adding new paragraphs (c)(8), Synthetic nucleic acids. (1) Molecules resulting select agent or toxin will be (9), and (10); that are chemically or by other means subject to the requirements of this part. ■ f. By redesignating paragraphs (e) and synthesized or amplified, including * * * * * (f) as paragraphs (g) and (h), respectively; those that are chemically or otherwise ■ 4. Section 331.9 is amended as modified but can base pair with ■ g. By adding new paragraphs (e) and follows: reserved (f); and naturally occurring nucleic acid ■ a. In paragraph (a)(4), by removing the molecules (i.e., synthetic nucleic acids); ■ h. By revising newly redesignated word ‘‘and’’; paragraph (g). or ■ b. By redesignating paragraph (a)(5) as (2) Molecules that result from the The revisions and additions read as paragraph (a)(6); follows: replication of those described in ■ c. By adding a new paragraph (a)(5); paragraph (1) of this definition. ■ d. By revising the first sentence of § 331.11 Security. * * * * * paragraph (b) * * * * * ■ 3. Section 331.3 is amended as The addition and revision read as (b) The security plan must be follows: follows:. designed according to a site-specific risk ■ a. By revising paragraph (b); assessment and must provide graded ■ § 331.9 Responsible official. b. In paragraph (c) introductory text, protection in accordance with the risk of by adding the words ‘‘and/or synthetic’’ (a) * * * the select agent or toxin, given its after the word ‘‘recombinant’’ each time (5) Have a physical (and not merely a intended use. A current security plan it appears. telephonic or audio/visual) presence at must be submitted for initial ■ c. In paragraph (c)(2) introductory the registered entity to ensure that the registration, renewal of registration, or text, by adding the words ‘‘and/or entity is in compliance with the select when requested. synthetic’’ after the word agent regulations and be able to respond (c) * * * ‘‘Recombinant’’. in a timely manner to onsite incidents (2) Contain provisions for the control ■ d. By adding paragraph (d)(3); and involving select agents and toxins in ■ of access to select agents and toxins, e. By revising paragraph (e) accordance with the entity’s incident The revisions and addition read as including the safeguarding of animals response plan; and follows:. (including arthropods) or plants * * * * * intentionally or accidentally exposed to § 331.3 PPQ select agents and toxins. (b) An entity may designate one or or infected with a select agent, against * * * * * more individuals to serve as an alternate unauthorized access, theft, loss or (b) PPQ select agents and toxins: responsible official who acts for the release. Peronosclerospora philippinensis responsible official in his/her absence. * * * * * (Peronosclerospora sacchari); Phoma *** (8) Describe procedures for how the glycinicola (formerly Pyrenochaeta * * * * * Responsible Official will be informed of glycines); Ralstonia solanacearum; ■ 5. Section 331.10 is amended as suspicious activity that may be criminal Rathayibacter toxicus; Sclerophthora follows: in nature and related to the entity, its rayssiae; Synchytrium endobioticum; ■ a. By redesignating paragraphs (e) personnel, or its select agents or toxins; Xanthomonas oryzae. through (i) as paragraphs (f) through (j) and describe procedures for how the * * * * * respectively; entity will notify the appropriate (d) * * * ■ b. By adding a new paragraph (e); and Federal, State, or local law enforcement (3) Any subspecies of Ralstonia ■ c. In newly redesignated paragraph (i), agencies of such activity. solanacearum except race 3, biovar 2 by removing the number ‘‘5’’ and adding (9) Contain provisions for information and all subspecies of Sclerophthora the number ‘‘3’’ in its place. security that: rayssiae except var. zeae, provided that The addition reads as follows: (i) Ensure that all external the individual or entity can verify that connections to systems which manage the agent is within the exclusion § 331.10 Restricting access to select security for the registered space are category. agents and toxins; security risk isolated or have controls that permit (e) An attenuated strain of a select assessments. only authorized and authenticated agent or an inactive form of a select * * * * * users;

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(ii) Ensure that authorized and ■ a. By revising paragraph (a); § 331.14 Incident response.5 authenticated users are only granted ■ b. By redesignating paragraph (d) as (a) An individual or entity required to access to select agent and toxin related paragraph (e); and register under this part must develop information, files, equipment (e.g., ■ c. By adding reserved paragraph (d). and implement a written incident servers or mass storage devices), and The revision reads as follows: response plan 6 based upon a site applications as necessary to fulfill their specific risk assessment. * * * roles and responsibilities, and that § 331.12 Biocontainment. (b) The incident response plan must access is modified when the user’s roles (a) An individual or entity required to fully describe the entity’s response and responsibilities change or when register under this part must develop procedures for the theft, loss, or release their access to select agents and toxins and implement a written of a select agent or toxin; inventory is suspended or revoked; biocontainment plan that is discrepancies; security breaches (iii) Ensure that controls are in place commensurate with the risk of the select (including information systems); severe that are designed to prevent malicious agent or toxin, given its intended use.4 weather and other natural disasters; code (such as, but not limited to, The biocontainment plan must contain workplace violence; bomb threats and computer viruses, worms, spyware) sufficient information and suspicious packages; and emergencies from compromising the confidentiality, documentation to describe the such as fire, gas leak, explosion, power integrity, or availability of information containment procedures for the select outage, and other natural and man-made systems which manage access to spaces agent or toxin, including any animals or events. registered under this part or records as plants intentionally or accidentally (c) The response procedures must specified in § 331.17; exposed to or infected with a select account for hazards associated with the (iv) Establish a robust configuration agent. select agent or toxin and appropriate management practice for information * * * * * actions to contain such select agent or systems to include regular patching and toxin, including any animals (including ■ 8. Section 331.13 is amended by updates made to operating systems and arthropods) or plants intentionally or removing footnote 5 and revising individual applications; and accidentally exposed to or infected with paragraph (a) to read as follows: (v) Establish procedures that provide a select agent. backup security measures in the event § 331.13 Restricted experiments. * * * * * that access control systems, surveillance (a) An individual or entity may not ■ 10. Section 331.15 is revised to read devices, and/or systems that manage the conduct, or possess products resulting as follows: requirements of § 331.17 are rendered from, the following experiments unless § 331.15 Training. inoperable. approved by and conducted in (10) Contain provisions and policies accordance with the conditions (a) An individual or entity required to for shipping, receiving, and storage of prescribed by the Administrator: register under this part must provide select agents and toxins, including (1) Experiments that involve the information and training on documented procedures for receiving, deliberate transfer of, or selection for, a biocontainment, biosafety, security monitoring, and shipping of all select drug or chemical resistance trait to (including security awareness), and agents and toxins. These provisions select agents that are not known to incident response to: must provide that an entity will acquire the trait naturally, if such (1) Each individual with access properly secure containers on site and acquisition could compromise the approval from the HHS Secretary or have a written contingency plan for control of disease agents in humans, Administrator before that individual has unexpected shipments. veterinary medicine, or agriculture. such access to select agents and toxins. The training must address the particular * * * * * (2) Experiments involving the needs of the individual, the work they (e) Entities must conduct complete deliberate formation of synthetic or will do, and the risks posed by the inventory audits of all affected select recombinant nucleic acids containing select agents or toxins; and agents and toxins in long-term storage genes for the biosynthesis of select (2) Each individual not approved for when any of the following occur: toxins lethal for vertebrates at an access to select agents and toxins by the (1) Upon the physical relocation of a LD[50]<100 ng/kg body weight. collection or inventory of select agents HHS Secretary or Administrator before or toxins for those select agents or * * * * * that individual enters areas where select toxins in the collection or inventory; ■ 9. Section 331.14 is amended as agents or toxins are handled or stored (2) Upon the departure or arrival of a follows: (e.g., laboratories, growth chambers, principal investigator for those select ■ a. In the section heading, by animal rooms, greenhouses, storage agents and toxins under the control of redesignating footnote 6 as footnote 5; areas, shipping/receiving areas, that principal investigator; or ■ b. By revising the first sentence in production facilities, etc.). Training for (3) In the event of a theft or loss of a paragraph (a); escorted personnel must be based on the select agent or toxin, all select agents ■ c. By redesignating footnote 7 as risk associated with accessing areas and toxins under the control of that footnote 6; where select agents and toxins are used principal investigator. ■ d. By revising paragraph (b); and/or stored. (f) [Reserved] ■ e. By redesignating paragraphs (c) and (b) [Reserved] (g) In developing a security plan, an (d) as paragraphs (d) and (f), (c) Refresher training must be individual or entity should consider the respectively; and provided annually for individuals with documents entitled, ‘‘Security Guidance ■ f. By adding new paragraphs (c) and access approval from the HHS Secretary for Select Agent or Toxin Facilities.’’ reserved (e). or Administrator or at such time as the This document is available on the The revisions and additions read as 5 National Select Agent Registry at follows: Nothing in this section is meant to supersede or http://www.selectagents.gov/. preempt incident response requirements imposed by other statutes or regulations. ■ 7. Section 331.12 is amended as 4 Technical assistance and guidance may be 6 Technical assistance and guidance may be follows: obtained by contacting APHIS. obtained by contacting APHIS.

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registered individual or entity synthetic nucleic acids, and organisms The additions read as follows: significantly amends its security, containing recombinant and/or incident response, or biocontainment synthetic nucleic acids) held in long- § 121.1 Definitions. plans. term storage (placement in a system * * * * * (d) The responsible official must designed to ensure viability for future Information security. Protecting ensure a record of the training provided use, such as in a freezer or lyophilized information and information systems to each individual with access to select materials), including: from unauthorized access, use, agents and toxins and each escorted * * * * * disclosure, disruption, modification, or individual (e.g., laboratory workers, (2) An accurate, current accounting of destruction in order to provide: visitors, etc.) is maintained. The record any animals or plants intentionally or (1) Integrity, which means guarding must include the name of the accidentally exposed to or infected with against improper information individual, the date of the training, a a select agent (including number and modification or destruction, and description of the training provided, species, location, and appropriate includes ensuring information and the means used to verify that the disposition); authenticity; employee understood the training. (2) Confidentiality, which means * * * * * preserving authorized restrictions on ■ 11. Section 331.16 is amended as access and disclosure, including means follows: § 331.19 [Amended] for protecting personal privacy and ■ a. By redesignating footnote 8 as ■ 13. Section 331.19 is amended as proprietary information; and footnote 7; follows: (3) Availability, which means ■ b. By redesignating paragraphs (e) ■ a. By removing paragraph (b)(1)(iv); ensuring timely and reliable access to through (h) as paragraphs (h), (i), (j), and and and use of information. (f) respectively; ■ b. By redesignating paragraphs ■ c. By adding a new paragraph (e); (b)(1)(v) through (b)(1)(viii) as * * * * * ■ d. In newly redesignated paragraph paragraphs (b)(1)(iv) through (b)(1)(vii), Occupational exposure. Any (f), by removing the words ‘‘packaging respectively. reasonably anticipated skin, eye, mucous membrane, parenteral contact, and’’; and ■ 14. Section 331.20 is revised to read or respiratory aerosol exposure to select ■ e. By adding a new paragraph (g). as follows: The additions read as follows: agents or toxins that may result from the § 331.20 Administrative review. performance of an employee’s duties. § 331.16 Transfers. (a) An individual or entity may appeal * * * * * * * * * * a denial, revocation, or suspension of Recombinant nucleic acids. (1) (e) After authorization is provided by registration under this part. The appeal Molecules that are constructed by APHIS or CDC, the packaging of the must be in writing, state the factual joining nucleic acid molecules and that select agent(s) and toxin(s) is performed basis for the appeal, and be submitted can replicate in a living cell; or by an individual approved by the HHS to the Administrator within 30 calendar (2) Molecules that result from the Secretary or Administrator to have days of the decision. replication of those described in access to select agents and toxins and is (b) An individual may appeal a paragraph (1) of this definition. in compliance with all applicable laws denial, limitation, or revocation of * * * * * concerning packaging. access approval under this part. The Security barrier. A physical structure * * * * * appeal must be in writing, state the that is designed to prevent entry by (g) Transportation in commerce starts factual basis for the appeal, and be unauthorized persons. when the select agent(s) or toxin(s) are submitted to the Administrator within * * * * * packaged for shipment and ready for 180 calendar days of the decision. Synthetic nucleic acids. (1) Molecules receipt by a courier transporting select (c) The Administrator’s decision that are chemically or by other means agent(s) or toxin(s) and ends when the constitutes final agency action. synthesized or amplified, including package is received by the intended Title 9 those that are chemically or otherwise recipient who is an individual approved modified but can base pair with by the HHS Secretary or Administrator PART 121—POSSESSION, USE, AND naturally occurring nucleic acid to have access to select agents and TRANSFER OF SELECT AGENTS AND molecules (i.e., synthetic nucleic acids); toxins, following a security risk TOXINS or assessment by the Attorney General. (2) Molecules that result from the * * * * * ■ 15. The authority citation for part 121 replication of those described in continues to read as follows: ■ 12. Section 331.17 is amended as paragraph (1) of this definition. follows: Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, * * * * * ■ a. By revising paragraph (a)(1) and 371.4. ■ 17. Section 121.3 is amended as introductory text; ■ 16. Section 121.1 is amended as follows: ■ b. By redesignating paragraphs (a)(2) follows: ■ a. By adding a sentence at the end of through (6) as paragraphs (a)(3) through ■ a. In the introductory text of the paragraph (a); (7), respectively; and definition of biological agent, by ■ b. By revising paragraph (b); ■ c. By adding a new paragraph (a)(2). removing the word ‘‘rickettsiae,’’; ■ c. In paragraph (c) introductory text, The revision and addition read as ■ b. By adding, in alphabetical order, by adding the words ‘‘and/or synthetic’’ follows: definitions of information security, after the word ‘‘recombinant’’ each time occupational exposure, recombinant it appears; § 331.17 Records. nucleic acids, security barrier, and ■ d. In paragraph (c)(2), by adding the (a) * * * synthetic nucleic acids; and words ‘‘and/or synthetic’’ after the word (1) An accurate, current inventory for ■ c. In the introductory text of the ‘‘Recombinant’’; each select agent (including viral definition of toxin, by removing the ■ e. By adding paragraph (d)(3); genetic elements, recombinant and/or word ‘‘rickettsiae,’’. ■ f. By revising paragraph (e); and

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■ g. In paragraph (f)(3)(i), by removing (2) If an excluded attenuated strain or will be issued. An exclusion will be the words ‘‘Newcastle disease inactivated toxin is subjected to any effective upon notification to the virus‘‘(velogenic)’’ and adding the manipulation that restores or enhances applicant. Exclusions will be listed on words ‘‘virulent Newcastle disease its virulence or toxic activity, the the National Select Agent Registry Web virus’’ in their place. resulting select agent or toxin will be site at http://www.selectagents.gov/. The revisions and additions read as subject to the requirements of this part. (2) If an excluded attenuated strain or follows: * * * * * inactivated toxin is subjected to any manipulation that restores or enhances § 121.3 VS select agents and toxins. ■ 18. Section 121.4 is amended as its virulence or toxic activity, the (a) * * * The select agents and toxins follows: ■ a. By adding a sentence at the end of resulting select agent or toxin will be marked with an asterisk (*) are subject to the requirements of this part. designated as Tier 1 select agents and paragraph (a); ■ * * * * * toxins and are subject to additional b. By revising paragraph (b); ■ c. In paragraph (c) introductory text, requirements as listed in this part. § 121.5 [Amended] (b) VS select agents and toxins: by adding the words ‘‘and/or synthetic’’ ■ African horse sickness virus; African after the word ‘‘recombinant’’ each time 19. In § 121.5, paragraph (a)(3)(i) is it appears; amended by removing the words swine fever virus; Avian influenza ■ virus; Classical swine fever virus; *Foot- d. In paragraph (c)(2) introductory ‘‘bovine spongiform encephalopathy and-mouth disease virus; Goat pox text, by adding the phrase ‘‘and/or agent,’’. virus; Lumpy skin disease virus; synthetic’’ after the word ■ 20. Section 121.6 is amended as ‘‘Recombinant’’; follows: Mycoplasma capricolum; Mycoplasma ■ 1 e. By adding paragraph (d)(3); ■ a. In paragraph (a)(3)(i) by removing mycoides; Newcastle disease virus; ■ Peste des petits ruminants virus; f. By revising paragraph (e); and the words ‘‘Brucella melitensis, Hendra ■ g. In paragraph (f)(3)(i), by removing *Rinderpest virus; Sheep pox virus; virus, Nipah virus, the words ‘‘Brucella melitensis, Hendra Swine vesicular disease virus. virus, and Venezuelan equine virus, Nipah virus, Rift Valley fever * * * * * encephalitis virus’’ and adding the virus, and Venezuelan equine words ‘‘Burkholderia mallei, and (d) * * * encephalitis virus’’ and adding the (3) Any low pathogenic strains of Burkholderia pseudomallei’’ in their words ‘‘Burkholderia mallei, and place; and avian influenza virus, any strain of Burkholderia pseudomallei’’ in their Newcastle disease virus which does not ■ b. By revising paragraph (e) to read as place. follows: meet the criteria for virulent Newcastle The revisions and additions read as disease virus, all subspecies follows: § 121.6 Exemptions for overlap select Mycoplasma capricolum except agents and toxins. subspecies capripneumoniae § 121.4 Overlap select agents and toxins. * * * * * (contagious caprine pleuropneumonia), (a) * * * The select agents and toxins (e) The Administrator may exempt an and all subspecies Mycoplasma marked with an asterisk (*) are mycoides except subspecies mycoides individual or entity from the designated as Tier 1 select agents and requirements of this part for 30 calendar small colony (Mmm SC) (contagious toxins and are subject to additional bovine pleuropneumonia), provided days if it is necessary to respond to a requirements as listed in this part. domestic or foreign agricultural that the individual or entity can verify (b) Overlap select agents and toxins: that the agent is within the exclusion emergency involving an overlap select *Bacillus anthracis; Bacillus anthracis agent or toxin. The Administrator may category. (Pasteur strain); Brucella abortus; (e) An attenuated strain of a select extend the exemption once for an Brucella melitensis; Brucella suis; additional 30 days. agent or an inactive form of a select *Burkholderia mallei; *Burkholderia toxin may be excluded from the pseudomallei; Hendra virus; Nipah * * * * * requirements of this part based upon a virus; Rift Valley fever virus; ■ 21. Section 121.9 is amended as determination by the Administrator that Venezuelan equine encephalitis virus. follows: the attenuated strain or inactivated * * * * * ■ a. In paragraph (a)(4), by removing the toxin does not pose a severe threat to (d) * * * word ‘‘and’’; animal health or to animal products. (3) Any subtypes of Venezuelan ■ b. By redesignating paragraph (a)(5) as (1) To apply for exclusion, an equine encephalitis virus except for paragraph (a)(6); individual or entity must submit a Subtypes IAB or IC, provided that the ■ c. By adding a new paragraph (a)(5); written request and supporting individual or entity can verify that the ■ d. By revising the first sentence of scientific information. A written agent is within the exclusion category. paragraph (b); and decision granting or denying the request (e) An attenuated strain of a select ■ e. By revising the first sentence of will be issued. An exclusion will be agent or an inactive form of a select paragraph (c)(1). effective upon notification to the toxin may be excluded from the The addition and revisions read as applicant. Exclusions will be listed on requirements of this part based upon a follows: the National Select Agent Registry Web determination by the HHS Secretary or site at http://www.selectagents.gov/. Administrator that the attenuated strain § 121.9 Responsible official. or inactivated toxin does not pose a (a) * * * 1 A virulent Newcastle disease virus (avian paramyxovirus serotype 1) has an intracerebral severe threat to public health and safety, (5) Have a physical (and not merely a pathogenicity index in day-old chicks (Gallus to animal health or to animal products. telephonic or audio/visual) presence at gallus) of 0.7 or greater or has an amino acid (1) To apply for exclusion, an the registered entity to ensure that the sequence at the fusion (F) protein cleavage site that individual or entity must submit a entity is in compliance with the select is consistent with virulent strains of Newcastle disease virus. A failure to detect a cleavage site that written request and supporting agent regulations and be able to respond is consistent with virulent strains does not confirm scientific information. A written in a timely manner to onsite incidents the absence of a virulent virus. decision granting or denying the request involving select agents and toxins in

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accordance with the entity’s incident (b) The security plan must be select agents and toxins, including response plan; and designed according to a site-specific risk documented procedures for receiving, * * * * * assessment and must provide graded monitoring, and shipping of all select (b) An entity may designate one or protection in accordance with the risk of agents and toxins. These provisions more individuals to serve as an alternate the select agent or toxin, given its must provide that an entity will responsible official who acts for the intended use. A current security plan properly secure containers on site and responsible official in his/her absence. must be submitted for initial have a written contingency plan for *** registration, renewal of registration, or unexpected shipments. (c) * * * when requested. * * * * * (1) The identification of any of the (c) * * * (e) Entities must conduct complete following select agents or toxins must be (2) Contain provisions for the control inventory audits of all affected select immediately reported by telephone, of access to select agents and toxins, agents and toxins in long-term storage facsimile, or email: African horse including the safeguarding of animals or when any of the following occur: sickness virus, African swine fever plants intentionally or accidentally (1) Upon the physical relocation of a virus, avian influenza virus (highly exposed to or infected with a select collection or inventory of select agents pathogenic), Bacillus anthracis, agent, against unauthorized access, or toxins for those select agents or Burkholderia mallei, Burkholderia theft, loss or release. toxins in the collection or inventory; pseudomallei, classical swine fever * * * * * (2) Upon the departure or arrival of a virus, foot-and-mouth disease virus, (8) Describe procedures for how the principal investigator for those select virulent Newcastle disease virus, responsible official will be informed of agents and toxins under the control of rinderpest virus, and swine vesicular suspicious activity that may be criminal that principal investigator; or disease virus. * * * in nature and related to the entity, its (3) In the event of a theft or loss of a * * * * * personnel, or its select agents or toxins; select agent or toxin, all select agents ■ 22. Section 121.10 is amended as and describe procedures for how the and toxins under the control of that follows: entity will notify the appropriate principal investigator. ■ a. By redesignating paragraphs (e) Federal, State, or local law enforcement (f) In addition to the requirements through (j) as paragraphs (f) through (k), agencies of such activity. contained in paragraphs (c) and (d) of respectively; (9) Contain provisions for information this section, the security plan for an ■ b. By adding a new paragraph (e); and security that: individual or entity possessing a Tier 1 ■ c. In newly redesignated paragraph (j), (i) Ensure that all external select agent or toxin must also: by removing the number ‘‘5’’ and adding connections to systems which manage (1) Describe procedures for the number ‘‘3’’ in its place. security for the registered space are conducting a pre-access suitability The addition reads as follows: isolated or have controls that permit assessment of persons who will have only authorized and authenticated access to a Tier 1 select agent or toxin; § 121.10 Restricting access to select users; (2) Describe procedures for how an agents and toxins; security risk (ii) Ensure that authorized and entity’s responsible official will assessments. authenticated users are only granted coordinate their efforts with the entity’s * * * * * access to select agent and toxin related safety and security professionals to (e) A person with valid approval from information, files, equipment (e.g., ensure security of Tier 1 select agents the HHS Secretary or Administrator to servers or mass storage devices), and and toxins and share, as appropriate, have access to select agents or toxins applications as necessary to fulfill their relevant information; and may request, through his or her roles and responsibilities, and that (3) Describe procedures for the Responsible Official, that the HHS access is modified when the user’s roles ongoing assessment of the suitability of Secretary or Administrator provide their and responsibilities change or when personnel with access to a Tier 1 select approved access status to another their access to select agents and toxins agent or toxin. The procedures must registered individual or entity for a is suspended or revoked; include: specified period of time. (iii) Ensure that controls are in place (i) Self- and peer-reporting of * * * * * that are designed to prevent malicious incidents or conditions that could affect ■ 23. Section 121.11 is amended as code (such as, but not limited to, an individual’s ability to safely have follows: computer viruses, worms, spyware) access to or work with select agents and ■ a. By revising paragraph (b); from compromising the confidentiality, toxins, or to safeguard select agents and ■ b. By revising paragraph (c)(2); integrity, or availability of information toxins from theft, loss, or release; ■ c. In paragraph (c)(6), by removing the systems which manage access to spaces (ii) The training of employees with word ‘‘and’’; registered under this part or records as access to Tier 1 select agents and toxins ■ d. By adding new paragraphs (c)(8), specified in § 121.17; on entity policies and procedures for (9), and (10); (iv) Establish a robust configuration reporting, evaluation, and corrective ■ e. By redesignating paragraphs (e) and management practice for information actions concerning the assessment of (f) as paragraphs (g) and (h), systems to include regular patching and personnel suitability; and respectively; updates made to operating systems and (iii) The ongoing suitability ■ f. By adding new paragraphs (e) and individual applications; and monitoring of individuals with access to (f); and (v) Establish procedures that provide Tier 1 select agents and toxins. ■ g. By revising newly redesignated backup security measures in the event (4) Entities with Tier 1 select agents paragraph (g). that access control systems, surveillance and toxins must prescribe the following The revisions and additions read as devices, and/or systems that manage the security enhancements: follows: requirements of § 121.17 are rendered (i) Procedures that will limit access to inoperable. a Tier 1 select agent or toxin to only § 121.11 Security. (10) Contain provisions and policies those individuals who are approved by * * * * * for shipping, receiving, and storage of the HHS Secretary or Administrator

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following a security risk assessment by (5) Entities that possess foot-and- Select Agent Registry at http:// the Attorney General, have had an mouth disease virus and rinderpest www.selectagents.gov/. entity-conducted pre-access suitability virus must have the following (2) * * * This document is available assessment, and are subject to the additional security requirements: on the National Select Agent Registry at entity’s procedures for ongoing (i) A minimum of four barriers, one of http://www.selectagents.gov/. suitability assessment; which must be a perimeter security * * * * * (ii) Procedures that limit access to fence or equivalent which is monitored laboratory and storage facilities outside 24 hours a day, 7 days a week (24/7) to (d) The biosafety plan must include of normal business hours to only those detect the presence of unauthorized an occupational health program for specifically approved by the responsible persons, vehicles, materials, or individuals with access to Tier 1 select official or designee; unauthorized activities; agents and toxins, and those individuals (iii) Procedures for allowing visitors, (ii) Onsite 24/7 armed security must be enrolled in the occupational their property, and vehicles at the entry response force with roving patrol. health program. and exit points to the registered space, Response time must not exceed 5 * * * * * or at other designated points of entry to minutes from the time of an intrusion ■ 25. Section 121.13 is amended by the building, facility, or compound that alarm or report of a security incident; removing footnote 10 and revising are based on the entity’s site-specific (iii) CCTV surveillance with 24/7 paragraphs (a) and (b) to read as follows: risk assessment; monitoring and recording; and (iv) A minimum of three security (iv) Transport vehicle with GPS § 121.13 Restricted experiments. barriers where each security barrier tracking designed to serve as a adds to the delay in reaching secured containment vehicle. (a) An individual or entity may not areas where select agents and toxins are (g) In developing a security plan, an conduct, or possess products (i.e., select used or stored. One of the security individual or entity should consider the agents that are not known to acquire a barriers must be monitored in such a document entitled, ‘‘Security Guidance drug resistance trait naturally, if such way as to detect intentional and for Select Agent or Toxin Facilities.’’ acquisition could compromise the unintentional circumventing of This document is available on the control of disease agents in humans, established access control measures Internet at veterinary medicine, or agriculture, or under all conditions (day/night, severe http://www.selectagents.gov/. recombinant and/or synthetic nucleic acids containing genes for the weather, etc.) The final barrier must * * * * * biosynthesis of select toxins lethal for limit access to the select agent or toxin ■ 24. Section 121.12 is amended as to personnel approved by the HHS vertebrates at an LD[50] < 100 ng/kg follows: body weight) resulting from, the Secretary or Administrator, following a ■ a. By revising paragraph (a); following experiments unless approved security risk assessment by the Attorney ■ b. By revising paragraph (c)(1); by and conducted in accordance with General. ■ c. By adding a second sentence to the conditions prescribed by the (v) All registered space or areas that paragraph (c)(2); reasonably afford access to the ■ d. In paragraph (c)(3), by removing the Administrator: registered space must be protected by an address ‘‘http://www.aphis.usda.gov/ (b) Restricted experiments: (1) intrusion detection system (IDS) unless programs/ag_selectagent/index.html ’’ Experiments that involve the deliberate physically occupied; and adding in its place ‘‘http:// transfer of, or selection for, a drug (vi) Personnel monitoring the IDS www.selectagents.gov/ ’’; resistance trait to select agents that are must be capable of evaluating and ■ e. By redesignating paragraph (d) as not known to acquire the trait naturally, interpreting the alarm and alerting the paragraph (e); and if such acquisition could compromise designated security response force or ■ f. By adding a new paragraph (d). the control of disease agents in humans, law enforcement; The revisions and addition read as veterinary medicine, or agriculture. (vii) For powered access control follows: (2) Experiments involving the systems, describe procedures to ensure deliberate formation of synthetic or that security is maintained in the event § 121.12 Biosafety. recombinant nucleic acids containing of the failure of access control systems (a) An individual or entity required to genes for the biosynthesis of select due to power disruption affecting register under this part must develop toxins lethal for vertebrates at an registered space; and implement a written biosafety plan LD[50]<100 ng/kg body weight. (viii) The entity must: that is commensurate with the risk of (A) Determine that the response time the select agent or toxin, given its * * * * * for security forces or local police will intended use.9 The biosafety plan must ■ 26. Section 121.14 is amended as not exceed 15 minutes where the contain sufficient information and follows: response time is measured from the time documentation to describe the biosafety ■ a. In the section heading, by of an intrusion alarm, or report of a and containment procedures for the redesignating footnote 11 as footnote 10; security incident, to the arrival of the select agent or toxin, including any responders at the first security barrier animals (including arthropods) or plants ■ b. In paragraph (a), by redesignating or; intentionally or accidentally exposed to footnote 12 as footnote 11 and revising (B) Provide security barriers that are or infected with a select agent. the first sentence of paragraph (a); sufficient to delay unauthorized access * * * * * ■ c. By revising paragraph (b); until the response force arrives in order (c) * * * ■ d. By redesignating paragraphs (c) and to safeguard the select agents and toxins (1) The CDC/NIH publication, (d) as paragraphs (d) and (f), from theft, intentional release, or ‘‘Biosafety in Microbiological and respectively; and unauthorized access. The response time Biomedical Laboratories.’’ This ■ e. By adding new paragraphs (c) and is measured from the time of an document is available on the National intrusion alarm, or report of a security (e). incident, to the arrival of the responders 9 Technical assistance and guidance may be The revisions and additions read as at the first security barrier. obtained by contacting APHIS. follows:

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§ 121.14 Incident response.10 (2) Each individual not approved for recipient who is an individual approved (a) An individual or entity required to access to select agents and toxins by the by the HHS Secretary or Administrator register under this part must develop HHS Secretary or Administrator before to have access to select agents and and implement a written incident that individual enters areas where select toxins, following a security risk response plan 11 based upon a site agents or toxins are handled or stored assessment by the Attorney General. specific risk assessment. * * * (e.g., laboratories, growth chambers, * * * * * (b) The incident response plan must animal rooms, greenhouses, storage ■ 29. Section 121.17 is amended as fully describe the entity’s response areas, shipping/receiving areas, follows: procedures for the theft, loss, or release production facilities, etc.). Training for ■ of a select agent or toxin; inventory escorted personnel must be based on the a. By revising paragraph (a)(1) discrepancies; security breaches risk associated with accessing areas introductory text; (including information systems); severe where select agents and toxins are used ■ b. By redesignating paragraphs (a)(2) weather and other natural disasters; and/or stored. through (6) as paragraphs (a)(3) through workplace violence; bomb threats and (b) Entities with Tier 1 select agents (7), respectively; and suspicious packages; and emergencies and toxins must conduct annual insider ■ c. By adding a new paragraph (a)(2). such as fire, gas leak, explosion, power threat awareness briefings on how to The revision and addition read as outage, and other natural and man-made identify and report suspicious follows: events. behaviors. (c) The response procedures must (c) Refresher training must be § 121.17 Records. account for hazards associated with the provided annually for individuals with (a) * * * select agent or toxin and appropriate access approval from the HHS Secretary (1) An accurate, current inventory for actions to contain such select agent or or Administrator or at such time as the each select agent (including viral toxin, including any animals (including registered individual or entity genetic elements, recombinant and/or arthropods) or plants intentionally or significantly amends its security, synthetic nucleic acids, and organisms accidentally exposed to or infected with incident response, or biosafety plans. containing recombinant and/or a select agent. (d) The responsible official must synthetic nucleic acids) held in long- * * * * * ensure a record of the training provided term storage (placement in a system (e) Entities with Tier 1 select agents to each individual with access to select designed to ensure viability for future and toxins must have the following agents and toxins and each escorted use, such as in a freezer or lyophilized additional incident response policies or individual (e.g., laboratory workers, materials), including: procedures: visitors, etc.) is maintained. The record * * * * * must include the name of the (1) The incident response plan must (2) An accurate, current accounting of individual, the date of the training, a fully describe the entity’s response any animals or plants intentionally or description of the training provided, procedures for failure of intrusion accidentally exposed to or infected with and the means used to verify that the detection or alarm system; and a select agent (including number and employee understood the training. (2) The incident response plan must species, location, and appropriate ■ describe procedures for how the entity 28. Section 121.16 is amended as disposition); follows: will notify the appropriate Federal, * * * * * State, or local law enforcement agencies ■ a. By redesignating footnote 14 as of suspicious activity that may be footnote 12; ■ 30. Section 121.20 is revised to read criminal in nature and related to the ■ b. By redesignating paragraphs (f) as follows: through (i) as paragraphs (i), (j), (k), and entity, its personnel, or its select agents § 121.20 Administrative review. or toxins. (g), respectively; ■ c. By adding a new paragraph (f); (a) An individual or entity may appeal * * * * * ■ d. In newly redesignated paragraph a denial, revocation, or suspension of ■ 27. Section 121.15 is revised to read (g), by removing the words ‘‘packaging registration under this part. The appeal as follows: and’’; and must be in writing, state the factual ■ § 121.15 Training. e. By adding a new paragraph (h). basis for the appeal, and be submitted The additions read as follows: to the Administrator within 30 calendar (a) An individual or entity required to days of the decision. register under this part must provide § 121.16 Transfers. (b) An individual may appeal a information and training on biosafety, * * * * * denial, limitation, or revocation of security (including security awareness), (f) After authorization is provided by access approval under this part. The and incident response to: APHIS or CDC, the packaging of the appeal must be in writing, state the (1) Each individual with access select agent(s) and toxin(s) is performed factual basis for the appeal, and be approval from the HHS Secretary or by an individual approved by the HHS submitted to the Administrator within Administrator before that individual has Secretary or Administrator to have 180 calendar days of the decision. such access to select agents and toxins. access to select agents and toxins and is The training must address the particular in compliance with all applicable laws (c) The Administrator’s decision needs of the individual, the work they concerning packaging. constitutes final agency action. will do, and the risks posed by the * * * * * Done in Washington, DC, this 28th day of select agents or toxins; and (h) Transportation in commerce starts September 2012. when the select agent(s) or toxin(s) are Edward Avalos, 10 Nothing in this section is meant to supersede packaged for shipment and ready for Under Secretary for Marketing and Regulatory or preempt incident response requirements Programs. imposed by other statutes or regulations. receipt by a courier transporting select 11 Technical assistance and guidance may be agent(s) or toxin(s) and ends when the [FR Doc. 2012–24434 Filed 10–2–12; 11:15 am] obtained by contacting APHIS. package is received by the intended BILLING CODE 3410–34–P

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