Source: https://www.federalregister.gov/documents/2011/10/03/2011-25520/agricultural-bioterrorism-protection-act-of-2002-biennial-review-and-republication-of-the-select
Timestamp: 2018-07-21 16:30:21
Document Index: 490217140

Matched Legal Cases: ['art 121', '§\u2009121', '§\u2009331', '§\u2009331', '§\u2009331', 'art 121', '§\u2009121', '§\u2009121']

A Proposed Rule by the Animal and Plant Health Inspection Service on 10/03/2011
We will consider all comments that we receive on or before December 2, 2011.
61227-61244 (18 pages)
https://www.federalregister.gov/d/2011-25520 https://www.federalregister.gov/d/2011-25520
Start Preamble Start Printed Page 61228
In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are proposing to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action would implement the findings of the third biennial review of the list. In addition, we are proposing to reorganize the list of select agents and toxins based on the relative potential of each select agent or toxin to be misused to adversely affect human, plant, or animal health. Such tiering of the list would allow for the optimization of security measures for those select agents or toxins that present the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence. We are also proposing a number of amendments to the regulations, including the addition of definitions and clarification of language concerning security, training, biosafety, biocontainment, and incident response. These changes would increase the usability of the select agent regulations as well as provide for enhanced program oversight.
Federal eRulemaking Portal: Go to http://www.regulations.gov/​#!documentDetail;​D=​APHIS-2009-0070-0001.
Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2009-0070 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (referred to below as the Bioterrorism Response Act) provides for the regulation of certain biological agents that have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products. The Animal and Plant Health Inspection Service (APHIS) has the primary responsibility for implementing the provisions of the Act within the Department of Agriculture (USDA). Veterinary Services (VS) select agents and toxins are those that have been determined to have the potential to pose a severe threat to animal health or animal products. Plant Protection and Quarantine (PPQ) select agents and toxins are those that have the potential to pose a severe threat to plant health or plant products. Overlap select agents and toxins are those that have been determined to pose a severe threat to both human and animal health or animal products. Overlap select agents are subject to regulation by both APHIS and the Centers for Disease Control and Prevention (CDC), which has the primary responsibility for implementing the provisions of the Act for the Department of Health and Human Services (HHS).
We use the term “select agents and toxins” throughout the preamble of this proposed rule. Unless otherwise specified, the term “select agents and toxins” will refer to all agents or toxins listed by APHIS. When it is necessary to specify the type of select agent or toxin, we will use the following terms: “PPQ select agents and toxins” (for the plant agents and toxins listed in 7 CFR 331.3), “VS select agents and toxins” (for the animal agents and toxins listed in 9 CFR 121.3), or “overlap select agents and toxins” (for the agents and toxins listed in both 9 CFR 121.4 and 42 CFR 73.4).
On July 29, 2010, we published in the Federal Register (75 FR 44724-44725, Docket No. APHIS-2009-0070) an advance notice of proposed rulemaking and request for comments (ANPR) [1] in order to announce our intention to review and reorganize the select agent list. We solicited comments regarding potential additions and deletions from the list of select agents and toxins as well as comments on reorganization of the list based on the relative potential of each select agent or toxin to be misused to adversely affect human, plant, or animal health. We requested recommendations as to what criteria should be utilized to designate high risk select agents and toxins and incorporated those recommendations Start Printed Page 61229into the interagency working group discussions on the matter. We solicited comments for 30 days ending August 30, 2010. We received 30 comments by that date. They were from scientists, scientific organizations, private individuals, and industry groups. Suggestions in these comments were used in order to inform our discussions on the content of the select agent list and our determination regarding reorganization of the list.
APHIS's PPQ program convened an interagency working group to review the list of PPQ select agents and toxins and develop recommendations regarding possible changes to that list. Using the four criteria for listing found in the Act, economic crop data, current Federal quarantine notices, and new scientific information, the working group revisited the currently listed PPQ select agents and toxins and evaluated a number of new plant pathogens for inclusion on the list. Based on this review, APHIS is proposing to amend the list of PPQ select agents and toxins listed in 7 CFR 331.3 by removing Xylella fastidiosa, citrus variegated chlorosis (CVC) strain, from the list as it no longer meets the criteria for use as an agroterrorism agent. Since CVC was first included on the list, extensive research on this select agent has been completed. New scientific information has led to creation of detection methods that provide for better early response and control methods. These new technologies can be applied regardless of how the agent might be introduced, including purposeful introduction for harmful purposes. Furthermore, the use of geostatistical analysis in citrus production areas using geographic information systems is now well-developed with relation to monitoring and facilitating a response to any purposeful introduction. As a result of this new research, as well as the development of new regulatory systems for CVC, the likelihood that someone would use CVC as an agent of bioterrorism is reduced, and our ability to manage an introduction is increased.
APHIS's VS program also convened an interagency working group to review the list of VS select agents and toxins and the list of overlap select agents and toxins in 9 CFR part 121 in order to update and revise the lists as necessary.
We are proposing to remove nine VS select agents and toxins from the list set out in § 121.3(b). Specifically, we are proposing to remove the following: Akabane virus; Bluetongue virus (exotic), Bovine spongiform encephalopathy agent; Camel pox virus; Ehrlichia ruminantium (Heartwater); Japanese encephalitis virus; Malignant catarrhal fever virus (Alcelaphine herpesvirus type 1); Menangle virus; and Vesicular stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3.
With respect to the remaining agents:
Camel pox only affects camels, which are a minor species in the US;
Bovine spongiform encephalopathy agent is only known to be transmitted through the ingestion of infected tissues.
All of these circumstances make transmission from animal-to-animal difficult, which greatly lessens the chance of an outbreak either accidental or intentional. Consequently, the extent to which Federal, State, and/or local officials need to take special action in planning for a major animal health disaster as a result of any of these organisms is decreased in light of these factors. Therefore, in considering these reasons as well as recommendations provided in previous reports such as “The Report of the Working Group on Strengthening the Biosecurity of the United States” [2] and the “Federal Experts Security Advisory Panel: Recommendations Concerning the Select Agent Program” [3] as well as comments received on the ANPR, APHIS has determined those pathogens listed here are not likely to be used as agroterrorism agents and no longer need to be designated as VS select agents.
We are also proposing to modify the listing for one of the overlap select agents by removing certain subtypes of Venezuelan equine encephalitis virus from the list of overlap select agents and toxins set out in 9 CFR 121.4(b), and to clarify that only Venezuelan equine encephalitis subtypes IAB and IC would remain on the list. These subtypes contain the only recognized strains of Venezuelan equine encephalitis that can suddenly affect a large number of animals over a large area (i.e., epizootic). The remaining subtypes, ID and IE, are strains prevalent among existing animal populations (i.e., enzootic) and do not represent the same type of risk. Other viruses within the Venezuelan equine encephalitis complex (subtypes IF and II through IV) are separate viruses and are not included in the list of overlap select agents and toxins. Accordingly, CDC will also be proposing a parallel change to its overlap select agent regulations.
We are proposing to establish a number of select agents and toxins as “Tier 1” select agents and toxins within the lists of VS and overlap select agents and toxins. We are not including PPQ select agents and toxins in this proposed reorganization because none of the proposed Tier 1 select agents and toxins are from the plant list. All other select agents and toxins would continue to be subject to the current requirements concerning select agents and toxins. All select agents and toxins were scored against 20 criteria by over 60 subject Start Printed Page 61230matter experts representing the Federal life sciences, public health, law enforcement, security, and intelligence communities. These criteria included:
APHIS and CDC determined that two VS select agents and three overlap select agents should be given Tier 1 status. Based on the criteria listed above, we are proposing to list foot-and-mouth disease virus and rinderpest virus as Tier 1 VS select agents and toxins and Bacillus anthracis, Burkholderia mallei, and Burkholderia pseudomallei as Tier 1 overlap select agents and toxins. We are also proposing to amend the list of overlap select agents and toxins whose seizure by any Federal law enforcement agency requires reporting to APHIS or CDC within 24 hours (located in 9 CFR 121.4(f)(3)(i)) to include only those overlap agents designated as Tier 1. The current list, which is comprised of Bacillus anthracis, Brucella melitensis, Hendra virus, Nipah virus, Rift Valley fever virus, and Venezuelan equine encephalitis virus was initially adapted from a different system of threat assessment categorization. The proposed changes would bring the list in line with the listing of Tier 1 agents, which was developed as a result of the experience and expertise of the select agent program. These changes, in tandem with the enhanced practices for physical and information security detailed below, would serve to further mitigate the potential for deliberate misuse of these select agents and toxins that could result in devastating effects to the economy, critical infrastructure, or public confidence.
Accordingly, we are also proposing additions to the VS regulations that would allow for the optimization of security measures for those select agents or toxins that present the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence, i.e., Tier 1 select agents and toxins. These requirements would include:
Additions regarding the assessment of persons who will have access to Tier 1 select agents and toxins that would be made to the security plan currently required to be developed by all entities seeking approval for the possession, use, and transfer of select agents and toxins; ongoing oversight of those persons with access to Tier 1 select agents and toxins; and the role of the entity's responsible official in coordinating and assuring the security of Tier 1 select agents and toxins;
Required annual insider threat awareness briefings focused on how to identify and report suspicious behaviors.
These changes would serve to further mitigate the potential for deliberate misuse of these select agents and toxins that could result in devastating effects to the economy, critical infrastructure, or public confidence.
All of these proposed changes are based on established Government and security industry standards with respect to securing high risk material and developed in accordance with the experience and expertise of the Select Agent Program. They are necessary in order to further ensure the safety and security of those select agents and toxins that pose the most potential harm to the animal and human environment. As stated previously, the requirements for working with all other select agents and toxins would remain unchanged with the exception of certain Start Printed Page 61231miscellaneous changes, which are detailed below.
We are proposing to make several smaller-scale changes to the regulations, including the addition of definitions and clarification of language concerning security, training, biosafety, biocontainment, and incident response. These changes, which are described in detail below, would increase the usability of the select agent regulations as well as provide for enhanced program oversight.
We are also proposing to add a definition for information security to the Start Printed Page 61232regulations in 7 CFR 331.1 and 9 CFR 121.1 as it is used but not defined. This definition would be identical to that used in the “Information Security” subchapter of the U.S. Code (44 U.S.C. 3542).
We are proposing to amend 7 CFR 331.3(e), 9 CFR 121.3(e) and 9 CFR 121.4(e). These paragraphs specify that attenuated strains of select agents or toxins may be excluded from the requirements of the select agent regulations subject to an official request and supporting scientific information. We are proposing to state that the “inactive form of a select toxin” may be excluded from regulation under each respective part subject to the application procedure. This change is necessary because the current term, “attenuated strain of toxin,” is scientifically inaccurate. Attenuated is a term that is applied to living organisms, and toxins are not living organisms. “Inactive form of a select toxin” is a more accurate term and we are therefore proposing to amend the regulations to include the correct terminology. We are also proposing to update the Web site address in paragraph (e)(1) of each section as all information concerning the Select Agent Program is now centralized on the National Select Agent Registry Web site at http://www.selectagents.gov/​. Finally, we are proposing to remove the language stating that exclusions will be published in the Federal Register. This change is necessary because, while we anticipated publication of exclusions both in the Federal Register and on the Internet at the time the regulations were initially created, we have found that publication on the select agent Web site only has served to provide the most up-to-date information to the regulated community. We are therefore proposing to update the regulations to accurately reflect the way in which we handle the listing of exclusions.
Details of the changes we are proposing to each plan individually may be found below. Generally, we are proposing to require that the security plan, biocontainment/biosafety plan, and incident response plan include provisions to address the safeguarding of animals or plants that have been intentionally or accidentally exposed to or infected with select agents against unauthorized access, theft, loss or release. This would enhance the comprehensiveness of the regulations as well as provide necessary guidance regarding handling of animals and plants inoculated with select agents. We would not require the plan to address animals and plants exposed to select toxins, however. Recovering the toxin from within an animal or plant subject is highly difficult and such removal does not produce a reasonable yield of recovery. In addition, there is uncertainty as to whether or not the toxin would remain active when recovered from the animal or plant. For these reasons it is highly unlikely that once introduced into an animal or plant, a sufficient amount of toxin could be recovered to pose a significant hazard to public health, agriculture or agriculture products.
Currently, the security plan described in 7 CFR 331.11 and 9 CFR 121.11 must be developed by all regulated entities and submitted for review only upon request. We are now proposing to require that the security plan be submitted for initial registration and renewals of registration as well as at any other time upon request. We are also proposing to add a requirement that the security plan include procedures that require the responsible official to immediately notify the FBI in order to initiate a threat assessment process in the event that he or she becomes aware Start Printed Page 61233of suspicious activity which is criminal in nature, related to the facility, its personnel, or select agents. This addition would provide for added security and establish a framework for communication between regulated entities and the FBI. We are also proposing to add provisions for information security, including the need for backup measures if the entity relies on information systems for security. These provisions would include network connectivity monitoring, restriction of user permissions so that only mission-specific files and applications may be accessed, measures to prevent network infiltration by malicious code, and configuration management including regular patching and system and software updates. We believe these additions are necessary in order to establish requirements for a more comprehensive security plan. We are also proposing to codify current practices for shipping, receiving, and storage of select agents and toxins to ensure that the entity has documented processes for securing and monitoring the shipment, receipt, and storage of these items. These changes would serve to decrease the chance that such materials would be made available to an unauthorized individual or an individual without a legitimate use for the material. Finally, we are proposing to amend paragraph (e) in 7 CFR 331.11 and 9 CFR 121.11, which currently directs individuals creating a security plan to guidance for developing such documents contained in the “Morbidity and Mortality Weekly Report” from December 2002. Applicants would instead be directed to the “Security Information Document” and the “Security Plan Template” on the select agents Web site.
We are proposing to update the specific Web site address references to various CDC and National Institutes of Health guidance publications found in 9 CFR 331.12(c)(1) and (c)(3). The regulations in 7 CFR 331.13 and 9 CFR 121.13 concern restricted experiments, which are those experiments that may not be performed by regulated entities without the approval of the Administrator. We are proposing to state that, in addition to the existing prohibition on conducting restricted experiments, entities may not possess the products of restricted experiments without the approval of the Administrator. We are also proposing to remove recombinant technology as a determining factor for a restricted experiment. This is because the current regulations regarding restricted experiments focus solely on the use of recombinant technology in the generation of drug resistant select agents or biosynthesis of toxins lethal to vertebrates. Since synthetic DNA or other methods (e.g., selection in sublethal exposures) may also be used to generate such products, we are proposing to expand the category of restricted experiments to include passive selection, recombinant, and synthetic DNA. Finally, we are proposing to add language in order to clarify the requirement that all experiments involving the creation of drug resistant select agents must be submitted to the Select Agent Program for approval.
The regulations in 7 CFR 331.17 and 9 CFR 121.17 concern required recordkeeping procedures for regulated entities as those records relate to select agents and toxins. We are proposing to add language to address synthetic select agent organisms and animals and plants inoculated with select agents. This change would improve oversight of the select agent program as it relates to synthetic select agent organisms. We are also proposing to add recordkeeping requirements whereby regulated entities maintain an accurate, current inventory of any animals or plants intentionally or accidentally exposed to or infected with a select agent (including number and species, location, and appropriate disposition). As previously stated, we are not proposing to require regulated entities to keep records regarding animals or plants exposed to select toxins.
The regulations in 7 CFR 331.20 and 9 CFR 121.20 concern the guidelines for administrative review of an individual's or entity's denial, revocation, or suspension of registration and access approval. We are proposing to modify the current regulations in order to allow individuals more time to gather the necessary components of their appeal following the denial, limitation, or Start Printed Page 61234revocation of access approval. Currently, this process must be completed in 30 calendar days. We are proposing to extend the deadline to 180 calendar days. This change is necessary because, thus far, all appeal requests from individuals regarding their access approval have been received after the 30-day deadline has passed. Because of specific program procedures, these individuals receive no advance notice of a denial, limitation, or revocation of their access approval. Given this situation and the requirements for submitting a formal appeal, we believe it is appropriate to extend the deadline in order to allow individuals to gather the necessary background data for their appeals. We are not proposing to grant a similar extension for entities which have had their registration denied, revoked, or suspended, as these entities typically have had advance notice of such a determination and are thus able to document and prepare their appeals within the existing 30-day timeframe.
Given that we are reorganizing 7 CFR 331.20 and 9 CFR 121.20 in order to more clearly spell out the way in which an individual or an entity may appeal the denial, revocation, or suspension of registration and access approval, we are also proposing to remove footnote 9 from the regulations in 7 CFR 331.20 and corresponding footnote 15 in 9 CFR 121.20. This proposed change is necessary because these footnotes would offer redundant information concerning the appeals process in light of both sections' reorganization. Finally, we are proposing to remove the provision stating that a request for review of a denial, limitation, or revocation of access approval will be forwarded to the Attorney General by the Administrator for further review. Forwarding a request for review to the Attorney General describes an internal process. This proposed change is necessary because the current language implies a level of decisionmaking on the part of the Attorney General that does not exist and the change would more clearly establish that the decision to grant access approval rests solely with the Administrator.
We are specifically requesting comment from the regulated community and any other interested persons on the need for and desirability of guidance documents that would serve to assist regulated entities in preparation of the elements that comprise various aspects of the select agent regulations.
Provisions for information security;
Layered protection of assets for entities housing Tier 1 select agents and toxins.
We welcome public comment on Web sites, articles, or other sources that may be used to develop such guidance documents, in addition to suggestions as to what elements should be included as useful examples. These documents would serve as a resource to the regulated community as a whole.
This proposed rule would update the APHIS, CDC, and overlap select agent and toxin lists. The regulation of select agents and toxins is intended to prevent their misuse and thereby reduce the potential for those pathogens to harm humans, animals, animal products, plants or plant products in the United States. Should any select agent or toxin be intentionally or unintentionally released into the environment, the consequences would be significant. Consequences could include disruption of markets, difficulties in sustaining an adequate food and fiber supply, and the potential spread of disease infestations over large areas. The entities most likely to be affected by this rule would be those laboratories and other institutions conducting research and related activities that involve the use of the newly categorized Tier 1 select agents and toxins. The impact of the changes to the regulations is expected to be minimal, however. Based on information obtained through site-specific inspections, indications are that very few entities would incur significant costs for compliance. Many of the proposed changes to the regulations would impose an added cost of the time spent on documenting measures already required for compliance, with respect to security, biocontainment/biosafety, and incident response plans, information security, and ongoing background checks. While the total costs imposed by the proposed regulations are estimated to range between $5.30 million and $6.95 million, including costs to government, we believe many of these costs are incurred through observance of Start Printed Page 61235generally recognized industry standards. Costs actually incurred would depend upon the extent to which current facility practices will need to be enhanced based on the proposed requirements. The expected benefits of strengthened safeguards against the costs associated with unintentional or deliberate release of select agents or toxins would greatly exceed the estimated costs of the proposed measures. The cost associated with a single outbreak have been known to exceed $100 million as outlined in the Regulatory Impact Analysis. Deliberate introduction greatly increases the probability of a select agent or toxin becoming established and causing wide-ranging and devastating impacts on an economy, loss of market access for consumer goods and services, disruption to society, and diminished confidence in public and private institutions.
§ 331.8
4. In § 331.8, paragraph (a)(1) is amended by removing the words “within any of the categories described in 18 U.S.C. 175b” and adding the words “a restricted person” in their place.
6. Section 331.10 is amended as follows:Start Printed Page 61238
(e) In developing a security plan, an individual or entity should consider the documents entitled, “Select Agents and Toxins Security Information Document” and “Select Agents and Toxins Security Plan Template.” These documents are available on the Internet at http://www.selectagents.gov/​.
(a) An individual or entity required to register under this part must develop and implement a written biocontainment plan that is commensurate with the risk of the select agent or toxin, given its intended use.[4] The biocontainment plan must contain sufficient information and documentation to describe the containment procedures for the select agent or toxin, including any animals or plants intentionally or accidentally exposed to or infected with a select agent.
(a) An individual or entity required to register under this part must develop and implement a written incident response plan [6] based upon a site specific risk assessment. * * *
§ 331.20
16. The authority citation for part 121 continues to read as follows:
Adjudicated as a mental defective. A determination by a court, board, commission, or other lawful authority that a person, as a result of marked subnormal intelligence, or mental illness, incompetency, condition, or disease is a danger to himself/herself or to others or lacks the mental capacity to contract or manage his/her own affairs. The term includes a finding of insanity by a court in a criminal case and those persons found incompetent to stand trial or found not guilty by reason of lack of mental responsibility pursuant to Start Printed Page 61240articles 50a and 72b of the Uniform Code of Military Justice, 10 U.S.C. 850a, 876b.
b. By revising paragraph (b) to read as set forth below.Start Printed Page 61241
* Foot-and-mouth disease virus;
* Rinderpest virus;
Virulent Newcastle disease virus.[1]
* Bacillus anthracis;
* Burkholderia mallei;
*Burkholderia pseudomallei;
20. In § 121.5, paragraph (a)(3)(i) is amended by removing the words “bovine spongiform encephalopathy agent,”.
21. In § 121.6, paragraph (a)(3)(i) is amended by removing the words “Hendra virus, Nipah virus, Rift Valley fever virus, and Venezuelan equine encephalitis virus” and adding the words “Burkholderia mallei, and Burkholderia pseudomallei” in their place.
(b) An entity may designate one or more individuals to serve as an alternate responsible official who acts for the responsible official in his/her absence. * * *Start Printed Page 61242
(i) Procedures that limit access to registered space only to those approved by the HHS Secretary or the Administrator and meet the criteria of the entity's program that will ensure individuals with access approval to select agents and toxins are trustworthy and behaving in a manner that upholds public health and safety, the protection of animal or plant health and animal or plant products, security, and the integrity of the scientific enterprise. In developing these procedures, an individual or entity may consider the guidance documents available on the Internet at http://www.selectagents.gov/​.;​
(iii) Procedures for allowing visitors, their property, and vehicles at the entry and exit points to the registered space, or at other designated points of entry to the building, facility, or compound Start Printed Page 61243based on the entity's site-specific risk assessment;
(f) In developing a security plan, an individual or entity should consider the documents entitled “Select Agents and Toxins Security Information Document” and “Select Agents and Toxins Security Plan Template.” These documents are available on the Internet at http://www.selectagents.gov/​.
c. In paragraph (c)(3), by removing the address “http://www.aphis.usda.gov./​programs/​ag_​selectagent/​index.html and replacing it with the address “http://www.selectagents.gov/​.
(a) An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use.[9] The biosafety plan must contain sufficient information and documentation to describe the biosafety and containment procedures for the select agent or toxin, including any animals or plants intentionally or accidentally exposed to or infected with a select agent.
(1) The CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories.” This document is available on the Internet at http://www.selectagents.gov/​.
b. In paragraph (a), by adding the words “, or possess products (i.e., select agents that are not known to acquire the resistance naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture, or recombinant and or synthetic DNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD[50] 100 ng/kg body weight) resulting from,” after the word “conduct” both times it appears.
Incident response.[10]
(a) An individual or entity required to register under this part must develop and implement a written incident response plan [11] based upon a site specific risk assessment. * * *
(e) Entities with Tier 1 select agents and toxins must have the following Start Printed Page 61244additional incident response policies or procedures:
1. To view the ANPR and the comments we received, go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2009-0070.
2. Available on the Internet at http://www.phe.gov/​Preparedness/​legal/​boards/​biosecurity/​Documents/​biosecreportfinal102309.pdf.
3. Available on the Internet at http://www.phe.gov/​Preparedness/​legal/​boards/​fesap/​Documents/​fesap-recommendations-101102.pdf.
6. Technical assistance and guidance may be obtained by contacting APHIS.
9. Technical assistance and guidance may be obtained by contacting APHIS.
10. Nothing in this section is meant to supersede or preempt incident response requirements imposed by other statutes or regulations.
[FR Doc. 2011-25520 Filed 9-30-11; 8:45 am]