[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Proposed Rules]
[Pages 13286-13294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04478]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / 
Proposed Rules  

[[Page 13286]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. APHIS-2006-0124]
RIN 0579-AC08


Sharing Certain Business Information Regarding the Introduction 
of Genetically Engineered Organisms With State and Tribal Government 
Agencies

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend our regulations regarding 
genetically engineered organisms regulated by the United States 
Department of Agriculture by adding provisions for sharing certain 
business information with State and Tribal government agencies. The 
proposed provisions would govern the sharing of certain information 
contained in permit applications and notifications for importations, 
interstate movements, or releases into the environment of regulated 
articles. The procedures would allow the Animal and Plant Health 
Inspection Service (APHIS) to share certain business information with 
State and Tribal governments without impairing our ability to protect 
confidential business information from disclosure. APHIS currently 
withholds such information when it shares applications with non-Federal 
Government agencies. This action would improve our collaborative and 
cooperative efforts with State and Tribal governments as well as 
improve the effectiveness of our notification and permitting procedures 
as APHIS continues to regulate certain genetically engineered 
organisms.

DATES: We will consider all comments that we receive on or before April 
29, 2013.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2006-0124-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2006-0124, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2006-
0124 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) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Ms. Chessa Huff-Woodard, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 146, Riverdale, MD 
20737-1236; (301) 851-3943.

SUPPLEMENTARY INFORMATION:

Background

    The Animal and Plant Health Inspection Service (APHIS) regulates 
the introduction (importation, interstate movement, or release into the 
environment) of organisms altered or produced through genetic 
engineering that are plant pests or that there is reason to believe are 
plant pests under 7 CFR part 340, ``Introduction of Organisms and 
Products Altered or Produced Through Genetic Engineering Which Are 
Plant Pests or Which There Is Reason to Believe Are Plant Pests'' 
(referred to below as the regulations or as part 340). The regulations 
refer to such genetically engineered (GE) organisms and products as 
``regulated articles.'' The purpose of the regulations is to prevent 
the dissemination of plant pests.
    With certain limited exceptions, the regulations prohibit the 
introduction (importation, interstate movement, or release into the 
environment) of any regulated article unless APHIS has issued a permit 
for the introduction in accordance with Sec.  340.4, or unless APHIS 
has been notified in accordance with Sec.  340.3 for certain GE plants 
that meet specified eligibility requirements and performance standards. 
Before APHIS authorizes the introduction, APHIS makes a determination 
on whether the actions under notification or permit are likely to 
result in the risk of introduction of a plant pest. In order to make 
that determination, APHIS requires applicants to provide essential 
information, some of which is designated by the applicant as 
confidential business information (CBI).
    As provided in Sec. Sec.  340.3 and 340.4, APHIS shares 
notifications and applications for permits for introductions, minus any 
information designated as confidential business information identified 
by the submitter, with State regulatory officials in the States of 
introduction. We now propose to share certain business information with 
State and Tribal regulatory officials. APHIS proposes to share certain 
business information only with those specific State or Tribal agencies 
that have legal jurisdiction over genetically engineered agricultural 
crops and/or products. No other State or Tribal agencies would have any 
access to the shared CBI. This information sharing would allow APHIS to 
share issues of concern with the officials of the State where the 
introduction is planned and would also enable the States to better 
review and comment on notifications and permits and provide 
information, advice, and recommendations to APHIS. APHIS would also 
share certain business information in notifications and applications 
for permits with Tribal government officials when introductions of 
regulated articles are proposed for Tribal lands.
    Permit applications, notifications, and other information submitted 
to APHIS under the regulations frequently contain business information 
designated by the submitter to be confidential in nature and marked as 
such on the submission. CBI is protected from mandatory public 
disclosure under the Freedom of Information Act (FOIA), exemption 4 (5 
U.S.C. 552(b)(4)). Exemption 4 covers two broad categories of 
information in Federal agency records: (1) Trade secret information and 
(2) information that is commercial or financial, obtained from a person 
and privileged or confidential. It has been APHIS policy \1\ not to 
release

[[Page 13287]]

designated CBI to State or Tribal government officials. The APHIS FOIA 
Office oversees any information release requested under FOIA.
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    \1\ See 50 FR 38561-38563, ``Policy Statement on the Protection 
of Privileged or Confidential Business Information'' in the Federal 
Register September 23, 1985. The instructions for submitting 
designated CBI consistent with this policy are found in the BRS 
document titled ``USDA-APHIS Biotechnology Regulatory Services 
User's Guide'' (version 2/5/2008, on pp. 8-11). This information may 
be viewed on the Internet at http://www.aphis.usda.gov/brs/pdf/Doc_Prep_Guidance.pdf or obtained from the person listed under FOR 
FURTHER INFORMATION CONTACT.
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    APHIS' notification and permit procedures require that if an 
applicant claims submitted information to be CBI, that information must 
be clearly designated as such. In accordance with the regulations and 
guidance documents,\2\ persons submitting either notifications or 
permit applications by mail who believe their submission contains CBI 
must submit two copies, one with all CBI material clearly marked and 
another with all CBI material deleted. For submissions by means of 
ePermits, the applicant encloses CBI material within brackets and 
appropriate versions are automatically generated for State distribution 
with the designated CBI deleted. APHIS may review the designated CBI 
material and may propose that the applicant make changes to the 
designated CBI material if APHIS determines that some of the designated 
CBI material is in fact not CBI material and should not be designated 
as CBI.
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    \2\ 7 CFR 340.4(a) and ``USDA-APHIS Biotechnology Regulatory 
Services User's Guide.''
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    Currently, APHIS shares only ``CBI-deleted'' copies of notification 
or permit submissions with appropriate State or Tribal regulatory 
officials. State and Tribal officials may provide comments on the 
applications sent them, but are not required to do so.
    Historically, applicants have claimed a wide range of information 
that they have to submit to APHIS as being CBI. For example, applicants 
have claimed the exact location of an introduction (facility address or 
GPS coordinates for an environmental release) as CBI. Applicants have 
also claimed confidentiality for genes, the gene donor, production 
details, and particular details about phenotype of the regulated 
article. Permit applications generally have more material designated as 
CBI than do notifications because permit applications have more 
detailed descriptions of the phenotype of the regulated article 
(described in Sec.  340.4(b)(5)) than do notifications (described in 
Sec.  340.3(d)(2)). Permit applications also contain a description of 
the methods for confinement of the regulated article during the 
introduction. Other material often claimed as CBI in permit 
applications specifically for release into the environment includes the 
purpose of the environmental release, descriptions of the release, 
proposed procedures and confinement methods, and other safeguards and 
mitigation measures to prevent dissemination or persistence following 
the environmental release.
    Currently, if a State or Tribal official desires to see information 
from notification or permit applications, acknowledged notifications, 
or issued permits and that information has been designated as CBI by 
the applicant, the official would need to contact the applicant for the 
information. However, APHIS has not always withheld designated CBI from 
State or Tribal regulatory officials. Around 1988, APHIS began sharing 
certain business information designated by submitters as CBI with State 
authorities if the State's attorney general submitted a letter to APHIS 
agreeing to protect the confidentiality of the information to be 
shared. Only a few States were authorized to receive designated CBI 
from APHIS using this mechanism. In 2001, this policy was discontinued 
because of concerns that sharing designated CBI with States could be 
deemed to constitute a waiver of the applicable exemption from 
disclosure under FOIA. During the period when we shared designated CBI 
with the States, the only shared records were paper documents, and 
there were no reports that a State's process to protect designated CBI 
shared with them by APHIS had failed, or that any such business 
information had been released to unauthorized persons.
    On June 7, 2004, APHIS convened a meeting with the National 
Association of State Directors of Agriculture (NASDA). One of the main 
purposes of the meeting was to evaluate the quality of interactions 
between APHIS and State governments, especially with respect to 
biotechnology issues. At that meeting, State officials expressed the 
view that cooperation and collaboration between APHIS and the States in 
regulatory activities for agricultural biotechnology may not be as 
effective as possible because information withheld as CBI from 
notification and permit applications often appeared to be important to 
the State's review. State officials expressed concern about the 
adequacy of reviews conducted when important information was not 
available to them.
    The discussions regarding sharing of designated CBI information 
initiated at the 2004 NASDA meeting have continued over time, along 
with discussions covering a range of regulatory activities and 
compliance and enforcement issues arising within agricultural 
biotechnology. These discussions focused on methods of sharing 
designated CBI with the States that would be consistent with the 
ability of the States to prevent disclosure under State FOIA laws and 
other applicable disclosure statutes or policies of the States. As a 
result of these discussions, APHIS has developed this proposed rule to 
allow the sharing of certain business information desired by State and 
Tribal government authorities.

Purpose and Effects of the Proposed Rule

    This proposed rule would establish a mechanism for APHIS to share 
certain information designated as CBI with State and Tribal government 
agencies. This sharing would provide benefits to APHIS, and to the 
States and Tribal governments, and strengthen the relationship between 
the Federal and other governments. For APHIS, a provision to share 
certain business information will benefit compliance activities, 
improve the efficiency of the permit and notification processes, and 
facilitate inspections by State regulators under the supervision of 
APHIS. For the State and Tribal governments, the proposed changes would 
enhance participation in the assessment process and encourage these 
entities to be more fully informed and involved. The proposed sharing 
of certain business information would be accomplished without 
compromising the protection afforded CBI under FOIA's Exemption 4.

Benefits to APHIS' Emergency Response Activities

    Sharing certain business information with State and Tribal 
governments would support better contingency planning and disaster 
responses. In the event of a local emergency, such as a hurricane, 
tornado, or flooding, there may be a need to assess and potentially 
remediate locations where regulated articles were present as part of an 
environmental release or were in a containment facility that became 
damaged. In these events, State and Tribal government officials in 
proximity to the area of concern may be better prepared to respond to 
this situation if they already have knowledge of the regulated article, 
the location of the site, and the identities of the personnel 
responsible for the site. Because such business information is often 
designated as CBI, and if APHIS could not share certain CBI with the 
appropriate State and Tribal authorities, participation of the State or 
Tribes may be hampered,

[[Page 13288]]

making appropriate remedial action more difficult and a timely response 
less likely.

Improved Efficiency of Permits and Notification Process

    The ability to share CBI would aid APHIS and State and Tribal 
governments by improving the efficiency of the notification and 
permitting processes. The proposed sharing of certain business 
information would help avoid the delays that frequently occur in the 
current APHIS permitting and notification process. These delays may 
occur when a State or Tribal government decides it must ask the 
developer of the regulated article for business information about a 
proposed introduction of the regulated article. The business 
information requested is often part of the CBI information the 
developer submitted in its application to APHIS, but deleted when the 
application was forwarded to the State or Tribal government. From 
previous experience, APHIS understands that such requests by State 
agencies or Tribal officials for certain business information from 
applicants can sometimes be lengthy processes. Because the applicant 
may not have a routine procedure to respond to a State or Tribal 
agency, requests for information may not be processed in a timely 
manner by the applicant.

State and Tribal Participation in the Assessment and Permitting Process

    Under this proposed rule, only the appropriate State and Tribal 
agencies would be able to review the conditions assigned by APHIS for 
introduction of a regulated article and also to confer with APHIS on 
any additional issues related to a permit or notification. For example, 
feedback provided by State and Tribal agencies about the site of an 
environmental release or nearby areas may help APHIS to further review 
assigned confinement conditions. The goal of these conditions is to 
prevent possible unauthorized dissemination of plant pests. State and 
Tribal agencies may wish to discuss with APHIS any information 
regarding activities, commerce, and traffic in the area of an 
environmental release. Such local information may further inform APHIS 
about appropriate confinement conditions for an environmental release, 
ensure better compliance with the conditions of the permit, or help the 
applicant meet the performance standards for notifications.
    In some cases, a State or Tribal regulatory official could assess 
citizen, consumer, or grower concerns about introductions at certain 
locations, and then convey these issues to APHIS. In these situations, 
APHIS would receive valuable inputs from the State and Tribal agencies 
that would be used to confirm confinement protocols and advise product 
developers. Yet other activities might be facilitated by sharing of 
certain business information about the regulated crop and its planting 
location. In other cases, by working closely with State agencies or 
Tribal nations in possession of authorized shared CBI, APHIS may obtain 
certain information about environmental releases to assist in complying 
with other Federal statutes, e.g., the Endangered Species Act.
    This proposal would improve Federal transparency because the 
appropriate State and Tribal government agencies receiving certain 
business information from APHIS would be better informed about 
introductions within their jurisdictions. Furthermore, when the State 
or Tribal agencies have accurate and detailed information about 
introductions, they would be better prepared to explain to their 
citizens the proposed introduction of genetically engineered organisms 
at publicly undisclosed sites within their jurisdiction. Consequently, 
the proposed sharing could increase public confidence in Federal, State 
and Tribal oversight of introductions of regulated articles.

Facilitating State Agency Inspections of Release Sites

    Recent APHIS experience has demonstrated the value of sharing 
certain business information with States and Tribal governments. In 
2005, APHIS initiated an ongoing pilot inspection project with some 
State plant regulatory agencies. APHIS evaluated whether State 
inspectors could supplement APHIS officers by performing inspections of 
environmental release sites for regulated articles. For this pilot 
project, State inspectors received the same training as APHIS officers, 
and then were to conduct inspections on behalf of APHIS. In the course 
of this pilot project, APHIS' lack of authority to share CBI with State 
cooperators prevented full employment of State inspectors to accomplish 
APHIS' regulatory objectives. Because CBI-deleted documents may not 
contain certain business information crucial to inspections, such as 
the contact information for the applicant's site cooperator, or the 
exact location of the environmental release, State inspectors had to 
obtain this information from the applicant. This extra step added time 
and uncertainty to the necessary inspections, which are scheduled to 
correspond with the timing of certain biological and business 
activities related to the regulated article (pollination, harvest, 
etc.). This step of requesting information from the applicant may cause 
unacceptable delays that potentially interfere with timely completion 
of inspections.

Balancing the Benefits of Information Sharing and Confidentiality and 
Privacy Interests

    Overall, APHIS anticipates that this new sharing activity for 
certain business information would benefit APHIS' compliance 
activities, enhance the effectiveness and efficiency of the permitting 
process, and allow the fullest use of State-employed inspectors. 
Increased participation by the States and Tribal governments in the 
permitting and notification processes would allow them to engage APHIS 
in mutually beneficial and constructive collaborations. By informing 
these governments about introductions into their State or Tribal lands, 
the sharing of certain business information will initiate a new level 
of transparency for APHIS with State and Tribal government stakeholders 
and enhance their ability to represent the interests of the public they 
represent
    Despite the benefits of this proposed activity, APHIS is required 
to choose a procedure that does not publicly disclose CBI submitted by 
the applicant. Except for the brief period 1988-2001, APHIS' 
communication with the States and Tribal governments generally had the 
same status as communication with any member of the public. In 
accordance with 5 U.S.C. 552(a)(3)(A), any record of the Agency that is 
disclosed in an authorized manner to any member of the public is 
available for disclosure to all members of the public.
    There are times when public disclosure of information would 
undermine legitimate private rights and governmental responsibilities. 
As discussed above, FOIA Exemption 4 (5 U.S.C. 552(b)(4)) states that 
disclosure requirements do not apply to ``trade secrets and commercial 
or financial information obtained from a person and privileged or 
confidential.'' This exemption applies to all notification and permit 
information that applicants designate as CBI and that APHIS accepts and 
treats as CBI as required by applicable Federal laws. Another FOIA 
exemption that is applicable to some or all of this material is 
Exemption 5 (5 U.S.C. 552(b)(5)), ``inter-agency or intra-agency 
memorandums or letters which would not be available by law to a party 
other than an agency in litigation with

[[Page 13289]]

the agency.'' To the extent that applicant designated CBI is contained 
in APHIS inter-agency or intra-agency memorandums or letters, APHIS 
will review such documents to determine if such CBI material should be 
withheld pursuant to the applicable Federal laws. Exemption 6 (5 U.S.C. 
552(b)(6)), ``personnel and medical files and similar files the 
disclosure of which would constitute a clearly unwarranted invasion of 
personal privacy,'' would also apply in some cases where the disclosed 
information would, for example, lead to the identity of the landowner 
or leaseholder where the field test was being conducted.
    Our proposed provisions for the sharing of certain business 
information would include a statement that the appropriate State and 
Tribal agencies receiving the shared information are not members of the 
public for purposes of disclosure of designated CBI submitted to APHIS 
by notification or permit applicants as required by part 340. 
Accordingly, disclosure of the authorized information by APHIS to the 
State or Tribal government would not constitute a waiver of any FOIA 
exemption protection.

Mechanisms for Safeguarding Shared Information

    APHIS proposes to establish a new Sec.  340.10 that would contain 
requirements for safeguarding shared business information and would 
also describe what types of CBI could be shared with States and Tribal 
governments. We propose that if any of this information is to be 
retained by the State or Tribal governments, only paper copies would be 
authorized for retention. Currently, APHIS is examining various 
electronic options to share certain business information, but a method 
for doing so has not been selected. We considered allowing regulators 
in authorized States and Tribal governments to share certain business 
information that was downloaded to a secure APHIS server, and then 
granting access to the authorized government entities. However, 
providing a new and separate secure system was not likely to be 
economically viable for APHIS. Although secured access to electronic 
records containing certain business information is not possible at this 
time, APHIS will continue to explore the possibility of sharing this 
information with authorized State or Tribal government officials by 
this means in the future. If APHIS finds an electronic means to share 
certain business information with these agencies, APHIS will deploy a 
system that conforms to all appropriate Federal cyber security 
requirements and ensures the confidentiality and integrity of the CBI 
data. Also, as part of the implementation plan for this rule, APHIS 
will survey State and Tribal government agencies 6 and 12 months after 
initiating that system to determine whether the electronic means of 
sharing CBI meets the needs of the appropriate State and Tribal 
regulatory officials.
    The Administrator may authorize sharing of information under 
proposed Sec.  340.10 provided that five conditions are met by the 
appropriate State or Tribal government authority desiring the shared 
information, as stated in a written agreement between the State or 
Tribal governments and APHIS. Proposed Sec.  340.10 (a)(1) would 
require the State or Tribal government officials to state their 
authority to protect from public disclosure permit and compliance 
information that has been designated CBI in the written agreement. 
Based on our preliminary review of State authorities, APHIS realizes 
that only some States have the legal authority to protect the specified 
types of business information from public disclosures. For example, the 
four States currently participating in the APHIS pilot program in 
2009--Arkansas, Florida, Kansas, and North Carolina--were able to 
provide letters indicating that shared confidential business 
information could be protected if disclosed to State inspectors by the 
applicant. However, we particularly invite comments on whether limits 
to statutory authority in any State would preclude its participation in 
the proposed information sharing program.
    Proposed Sec.  340.10(a)(2) would require the State or Tribal 
government to have in place suitable procedures to ensure the security 
of the shared confidential business information and to specify and 
restrict which specific State or Tribal agency or agencies and their 
respective officials are allowed access to it. These officials would be 
required to complete the same annual ``Confidential Business 
Information and Records Management'' training that APHIS requires of 
employees handling CBI. State and Tribal procedures would have to be 
equivalent to those currently used by APHIS, which are specified in 
APHIS' ``Policy Statement on the Protection of Privileged or 
Confidential Business Information'' cited above. At this time, APHIS 
would not allow State or Tribal agencies to store in electronic form or 
otherwise create any records of any CBI received from APHIS. 
Nevertheless, APHIS is exploring and seeking input on sharing certain 
business information with State and Tribal government agencies by 
electronic means. This issue is discussed further in the first 
paragraph of this section above.
    The goal of these security measures would be to safeguard documents 
containing information disclosed under the proposed provisions, i.e., 
to account for the location of documents at all times, control access 
to documents, and provide for secure transmittal, destruction, or 
return of documents to APHIS. If State or Tribal agencies employ 
methods equivalent to those used by APHIS, we are confident that they 
can review this information while effectively maintaining document 
security. Adaptations of these procedures that achieve an equivalent 
effect would be specified in the required written agreement between 
APHIS and a State or Tribal government agency.
    Proposed Sec.  340.10(a)(3) would require a commitment in the 
written agreement between APHIS and the State or Tribal government not 
to disclose CBI without the written permission of the submitter or 
written confirmation from APHIS that the information is no longer 
considered CBI as determined by APHIS pursuant to the applicable 
Federal laws. Proposed Sec.  340.10(a)(4) would require a commitment in 
the written agreement by the State or Tribal government that all 
persons authorized to have access to CBI provided by APHIS will be 
trained by the State or Tribal authority on how to maintain the 
security of the shared CBI before having access to it. APHIS would 
provide the content of the required training.
    This training requirement would also apply to situations where a 
State or Tribal authority needs to share certain business information 
with State or Tribal employees who are not regulatory officials (such 
as faculty of State universities) and APHIS agrees to allow the non-
regulatory State or Tribal employees access to the shared CBI. Such 
persons would need training to protect this information from disclosure 
and in these cases, the parties would need to establish additional 
safeguards within the written agreement before those non-regulatory 
State or Tribal employees were allowed access to the shared CBI. For 
example, the State or Tribal authority would have to agree to appoint 
regulatory officials to oversee confidentiality rules and 
responsibilities for safeguarding business information shared with 
these other employees.
    Each government agency entering into a written agreement with APHIS 
to receive certain business information would be obligated under the 
terms of the written agreement to safeguard the entrusted information. 
If a State or Tribal government intentionally or even

[[Page 13290]]

unintentionally releases certain authorized business information, APHIS 
would make a determination of whether or not to immediately void the 
written agreement and revoke the agency's privilege to receive future 
authorized information or whether to impose appropriate corrective 
actions, conditions, and/or requirements into the written agreement for 
the agency. Also, individuals who release protected information may be 
subject to penalties under applicable State or Tribal laws for the 
protection of trade secrets and confidential business information.
    The final provision for the written agreement, proposed Sec.  
340.10(a)(5), would require inclusion of other needed terms agreed to 
by APHIS and the State or Tribal government regarding the shared 
information. This provision could take into account and incorporate 
administrative procedures or authorities that are unique to a State or 
Tribe.

Description of Information To Be Shared

    Proposed Sec.  340.10(b) describes the types of CBI from 
notifications and permit applications, acknowledged notifications, or 
issued permits that APHIS proposes to share with States and Tribal 
governments. APHIS developed these information categories based on our 
experience working with States and Tribes and our observations of what 
types of information prevented optimal cooperation from States or 
Tribes in application review, inspection, and other activities under 
the regulations. APHIS also used responses to a questionnaire developed 
and distributed by NASDA that identified information needs perceived by 
State regulatory officials. Respondents identified the following 
information as useful during their State review: Information about the 
regulated article and its phenotype, the location and contact 
information of any cooperators for the introduction, activity dates 
during the introduction (e.g., planting, inoculation, harvest dates for 
environmental releases), and protocols used during the introduction.
    When information sharing is requested by the State or Tribal 
government agency, APHIS proposes to share:
     Information about the regulated article(s) being used 
during the introduction, including information in the notification or 
permit application, the acknowledged notification, or the issued permit 
regarding the phenotypic designation, and the phenotypic description of 
anticipated expression of the altered genetic material in the regulated 
article compared to the expression in the non-modified parental 
organism;
     The location(s) of the introduction identified by the 
applicant within the territory of the State or Tribal nation of the 
requester, including the cooperator's address; GPS coordinates 
corresponding to multiple sites within the particular State or Tribe; 
and the number of acres for an environmental release;
     The dates of activity during the environmental release, 
including planting dates and termination dates for the release;
     The methods of confinement as they are approved by APHIS 
at the time of application (for permits, APHIS would share the 
mandatory and supplemental conditions required by APHIS and those cited 
in the permit application; for notifications, APHIS would provide 
design protocols for the regulated articles); and
     The name and contact information for the responsible 
person for the introduction.

Related Changes in Part 340

    The regulations in Sec.  340.4(b) and (c) currently state that when 
APHIS determines that a permit application is complete, we will submit 
to the State department of agriculture of the State where an 
introduction is planned a copy of the initial review along with the 
application marked ``CBI Deleted'' or ``No CBI'' for State notification 
and review. Because proposed Sec.  340.10 would allow us to share CBI 
with the appropriate State or Tribal officials, we would amend Sec.  
340.4(b) and (c) to state that when an application contains designated 
CBI, the State or Tribal government will be provided a ``CBI deleted'' 
copy of the application unless the disclosure of certain business 
information to the State or Tribal government has been authorized in 
accordance with Sec.  340.10 and is requested by the State or Tribal 
government.
    The current regulations identify the procedures for a permit 
applicant to identify and mark CBI information in Sec.  340.4(a). CBI 
information submitted in notification applications is identified and 
marked exactly the same way as such information is marked and 
identified in permit applications. However, APHIS neglected to include 
parallel language in the notifications section at the time the 
notifications procedure was added to part 340. APHIS proposes to take 
this opportunity to remedy that oversight by adding a reference in 
Sec.  340.3(d) for submission of CBI in notifications. The section 
``Procedural requirements for notifying APHIS'' will contain parallel 
language to that in Sec.  340.4(a) addressing CBI in permit 
applications.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and equity). Executive Order 13563 
emphasizes the importance of quantifying both costs and benefits, of 
reducing costs, of harmonizing rules, and of promoting flexibility. 
This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    APHIS has prepared an economic analysis for this proposed rule, 
which is set out below. The analysis provides a cost-benefit analysis, 
as required by Executive Order 12866, and an analysis of the potential 
economic effects of this proposed rule on small entities, as required 
by the Regulatory Flexibility Act.
    This proposal would amend APHIS' part 340 regulations regarding 
regulated articles to add provisions concerning the sharing of certain 
business information but only with certain officials of State and 
Tribal government agencies. The proposed provisions would create 
mechanisms for sharing certain business information contained in permit 
applications and notifications that are submitted to APHIS under the 
regulations, while continuing to allow APHIS to protect the 
confidentiality of the information.

Benefits

    The benefits of the proposed rule include improving the 
effectiveness and efficiency of the notification and permitting 
processes of part 340. At the same time, the rule will enhance and 
maintain the rigorous regulation of regulated articles. Specifically, 
State and Tribal government officials could receive information from 
APHIS that APHIS would withhold as CBI under current procedures and 
that applicants may choose not to disclose if requested directly by 
States or Tribes. This would allow those State and Tribal government 
officials to provide more timely and more pertinent information to 
APHIS regarding site-specific issues related to notifications or 
permits. Although APHIS does not envision any efficiencies gained from 
reduced paper handling, efficiencies will derive from

[[Page 13291]]

fewer days required for APHIS to await State or Tribal responses to new 
permit and notification applications. The process and rationale for 
APHIS' decisions regarding introductions (e.g., assignment of permit 
conditions for specific environmental releases, importations and 
interstate movements) would be improved and would be more transparent 
to State and Tribal governments because they would also have certain 
business information APHIS used in its decisionmaking process. In 
addition, new collaborations with the States and Tribes on permit 
issues would be beneficial to the authorized State and Tribal 
authorities as well as to APHIS. A current pilot program that 
authorizes State inspectors to review compliance information for 
approved environmental release sites would be facilitated by making 
available information about regulated articles and the respective 
environmental release sites. Also, future compliance incidents could be 
assessed and remediated under APHIS direction by State employees, if 
provided with appropriate information about permits or notifications. 
By facilitating these actions, APHIS' effectiveness in the continuing 
and evolving oversight of regulated articles and their potential 
attainment of non-regulated status would be enhanced.

Costs

    There would be minimal costs to the States and Tribes associated 
with sharing certain business information between these agencies and 
APHIS. Costs would be the resources required to draft and sign a 
written agreement, and the resources it would take to share the 
information, provide for the appropriate training of those State or 
Tribal officials that would have access to the CBI, and provide the 
appropriate mechanisms for safeguarding the shared CBI. State agencies 
and Tribal officials not currently equipped to handle CBI would incur 
costs of updating or equipping their facilities with secure filing 
systems, provided that they entered into a written agreement with 
APHIS. Because only the storage of paper documents would be authorized, 
not the storage of electronic documents, no computer security costs 
would be incurred. There would be no cost to the biotechnology industry 
as we expect the required measures will protect sensitive information. 
Costs to assess the business information proposed for sharing by APHIS 
are discretionary; if the information is not requested, APHIS would not 
provide it to the States and Tribal governments.
    The cost to APHIS would consist mainly of salary for staff to 
implement the procedures and to carry them out on a continuing basis. 
This should entail less than one full-time staff year during 
implementation, and decrease later as the procedures become routine for 
APHIS, States, and Tribes. We expect the benefits of sharing certain 
business information with State and Tribal agencies would outweigh the 
costs to the Federal government. The proposed rule would add 
transparency to the APHIS review process, as State and Tribal officials 
would have additional information about introductions conducted within 
their jurisdictions. Also, State citizens and Tribal members would have 
greater confidence in their regulatory officials and their ability to 
review permit and notification applications, and APHIS would have an 
additional means to strengthen its regulatory effort through improved 
process efficiency and effectiveness.
    There are no unavoidable costs for States and Tribes under either 
the current application review process or the CBI sharing provisions 
that would be added by this proposed rule because APHIS does not 
require States or Tribes to reply to permit and notification review 
information shared with them. However, the States and Tribes involved 
have indicated they value the opportunity to do so. Frequently, 
information provided to APHIS during these reviews has allowed us to 
improve permit conditions and reduce risks, or to forestall operational 
or administrative problems that might have arisen during a permit 
period due to local conditions that State or Tribal officials explained 
to APHIS. Permit and notification review also allows States to better 
plan their logistics and workloads from year to year. If CBI 
information is shared as described in this proposal, States and Tribes 
would know more about the exact location of planned introductions, the 
methods for confinement of the regulated article, and other planned 
safeguards and mitigation measures. This would allow States to do 
better advance planning of the activities and movements of their 
inspectors who inspect and monitor release sites in accordance with a 
Memorandum of Understanding with APHIS. It would also allow them to be 
better prepared for responses during emergency situations, e.g., 
tornadoes or floods, because they would know well in advance what 
locations they might have to visit to assess possible releases and what 
types of confinement and mitigation systems they will encounter at the 
sites.

Alternatives Considered

    APHIS considered a ``no action'' alternative under which we would 
continue to delete CBI information from notification and permit 
applications, and then share only the CBI-deleted documents with States 
and Tribal governments. This alternative would avoid the implementation 
costs identified for this proposal, but would not accrue any of the 
benefits identified for sharing certain business information. The no 
action alternative could also result in continuing costs to the Federal 
government through reduced effectiveness of the regulatory program.
    APHIS also considered various additional alternatives for how APHIS 
could share business information with the State or Tribal governments. 
These alternatives are discussed in detail above under the heading 
``Mechanisms for Safeguarding Shared Information.''
    In the selected alternative, APHIS proposes to allow sharing of 
paper documents by only certain States or Tribal governments which are 
capable of preventing disclosure of such paper records to the public. 
These States or Tribal governments must also be able to comply with the 
requirements set forth in the proposed rule.

Effects on Small Entities

    APHIS has not identified any private entities, large or small, that 
would be affected by this proposed rule. APHIS would share certain 
business information from both large and small entities with State 
agencies and Tribal officials, as the written agreement would provide. 
There would be no direct economic effect on entities submitting CBI. 
Some such entities might accrue minor savings in time they currently 
spend responding to State or Tribes' requests for information, if 
States or Tribes instead obtain the information through APHIS.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service determined that this action would not 
have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) No State or 
local laws or regulations will be preempted by this rule; (2) no 
retroactive effect will be

[[Page 13292]]

given to this rule; and (3) administrative proceedings will not be 
required before parties may file suit in court challenging this rule. 
State or Tribal agencies must follow their respective State or Tribal 
laws regarding disclosure of information, and a State or Tribe with a 
law that precludes it from signing a written nondisclosure agreement 
with APHIS in accordance with proposed Sec.  340.10 would not be able 
to participate in the business information sharing that would be 
authorized by this proposed rule.

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, Consultation and Coordination with Indian Tribal 
Governments. The review reveals that this rule will not have 
substantial and direct effects on Tribal governments and will not have 
significant Tribal implications.

National Environmental Policy Act

    APHIS, in compliance with the National Environmental Policy Act 
(NEPA) of 1969, as amended (42 U.S.C. 4321 et seq.), categorically 
excluded the proposed sharing of CBI with States and Tribes consistent 
with the USDA Departmental NEPA implementing regulations specific to 
categorical exclusions for the implementation of a procedural policy (7 
CFR 1b.3(1)).

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. APHIS-
2006-0124. Please send a copy of your comments to: (1) Docket No. 
APHIS-2006-0124, Regulatory Analysis and Development, PPD, APHIS, 
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238, 
and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and 
Independence Avenue SW., Washington, DC 20250. A comment to OMB is best 
assured of having its full effect if OMB receives it within 30 days of 
publication of this proposed rule.
    This proposed rule contains certain information collection and 
recordkeeping requirements that would apply to regulatory officials of 
the States that receive APHIS submissions of notifications and permits 
for importations, interstate movements, and environmental releases that 
occur within the State or Tribal lands. The limited information 
presently shared with the States is authorized under Sec. Sec.  
340.3(e) and 340.4(b). The majority of the proposed requirements would 
apply to persons engaged in regulatory activities of regulated articles 
in the States or on Tribal Lands. The reporting burden for these 
officials under the proposed rule would be similar to the burden under 
the current regulations, except in those cases in which the State or 
Tribe desired more information about the details of introductions in 
the States or Tribes beyond that which they have historically been 
provided. Thus, all additional information received would be elective. 
The information is shared because APHIS desires to have States and 
Tribes better informed about introductions that occur in the States or 
Tribes, and because the States or Tribes may be able to provide 
additional assistance to APHIS in issuing the permit or acknowledging 
the notification. In some cases, the additional information would be 
shared with the State's or Tribe's inspectors when they are working 
with APHIS to conduct inspections, or when APHIS requests a State or a 
Tribe's assistance to aid with compliance and mitigation efforts. Major 
emergencies sometimes threaten confinement of a regulated article, and 
APHIS may require assistance in these circumstances.
    Under proposed Sec. Sec.  340.3(d)(2)(vi) and 340.4(b) and (c), 
State or Tribe officials would have available additional information to 
complete their reviews of APHIS notifications and permits. However, 
responses to APHIS would remain voluntary, as they are presently under 
Sec.  340.3(e). Additional reading, assessment, and review writing may 
be required if the official desires to provide comments and information 
to APHIS on the business information shared under this proposed rule.
    For those States or Tribes whose statutes authorize keeping 
business information confidential, and which have signed agreements 
with APHIS to protect the authorized data, additional recordkeeping 
requirements would be needed. As noted in the analysis of costs, 
safeguarding the information would require expenses of time and 
resources to update or establish approved systems to store certain 
business information as well as training the regulatory officials that 
would have access to the CBI. Some States may already have an approved 
mechanism for storing this information, and no additional burden would 
be imposed on them.
    One goal in proposing this rule is to create an efficient and 
streamlined system for information sharing with the State and Tribal 
governments and to ensure that the review process is conducted in a 
timely and effective manner. Permit applications for environmental 
releases may take up to 120 days to assess and review before APHIS 
decides to either issue or deny a permit, while movements (importations 
and interstate movements) alone may take up to 60 days prior to a 
decision. Notifications for environmental releases may take up to 30 
days to assess and review before APHIS decides to either acknowledge or 
deny the notification, movements, importations, or interstate movements 
under notifications may require 10 days after application for an APHIS 
decision regarding them. Certain business information may be provided 
by APHIS directly to the States or Tribal agencies after a written 
agreement is in effect, replacing the necessity that information useful 
to the States or Tribal governments be provided by the applicant. Based 
on this sharing, the States and Tribal governments would review and 
provide comment to APHIS, and APHIS could complete the review process 
for permits and notifications in a timely manner.
    We are soliciting comments from the public (as well as the affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 8 hours for each written 
nondisclosure agreement signed by a State or Tribal government official 
and APHIS. Actual review by States and

[[Page 13293]]

Tribal authorities of CBI documents shared under the proposed rule is 
estimated to average 2 hours per permit and notification application. 
This is a decrease from the current review practice which can take up 
to 2 weeks when a State representative must obtain the business 
information directly from the applicant.
    Respondents: Approximately 49 States or Territories, including the 
Northern Mariana Islands, Guam, Puerto Rico, and the U.S. Virgin 
Islands, as well as approximately 2 Tribes and 69 unique officials in 
these entities.
    Estimated annual number of responses per respondent: Only one in 
the first year, then fewer. The written nondisclosure agreement between 
APHIS and the State or Tribal government is the primary new information 
collection imposed by this rule. Such agreements would presumably be 
signed in the first year of implementation, and be revised or renewed 
infrequently after that. Responses by States to the specific, 
individual permit applications or notifications they review already 
occur, and will continue to do so, and thus are not a new information 
collection.
    Estimated annual number of responses: 51 or fewer written 
agreements.
    Estimated total annual burden on respondents: 408 hours, declining 
over time.
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
851-2908.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

List of Subjects in 7 CFR Part 340

    Administrative practice and procedure, Biotechnology, Genetic 
engineering, Imports, Packaging and containers, Plant diseases and 
pests, Transportation.

    Accordingly, we propose to amend 7 CFR part 340 as follows:

PART 340--INTRODUCTION OF ORGANISMS AND PRODUCTS ALTERED OR 
PRODUCED THROUGH GENETIC ENGINEERING WHICH ARE PLANT PESTS OR WHICH 
THERE IS REASON TO BELIEVE ARE PLANT PESTS

0
1. The authority citation for part 340 continues to read as follows:

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.

0
2. In Sec.  340.3, a new paragraph (d)(2)(vi) is added to read as 
follows:


Sec.  340.3  Notification for the introduction of certain regulated 
articles.\5\
---------------------------------------------------------------------------

    \5\ APHIS may issue guidelines regarding scientific procedures, 
practices, or protocols which it has found acceptable in making 
various determinations under the regulations. A person may follow an 
APHIS guideline or follow different procedures, practices, or 
protocols. When different procedures, practices, or protocols are 
followed, a person may, but is not required to, discuss the matter 
in advance with APHIS to help ensure that the procedures, practices, 
or protocols to be followed will be acceptable to APHIS.
---------------------------------------------------------------------------

* * * * *
    (d) * * *
    (2) * * *
    (vi) If there are portions of the notification deemed to contain 
trade secret or confidential business information (CBI), and if 
submitted through ePermits, then all information entered into the forms 
that is designated CBI should be enclosed in brackets and all 
subsequent copies will be automatically labeled with appropriate CBI 
notations. If submitted on paper, two copies of the written 
notification shall be submitted. On one copy, each page of the 
application containing trade secret or CBI should be marked ``CBI 
Copy.'' In addition, those portions of the notifications which are 
deemed ``CBI'' shall be so designated. The second copy shall have all 
such CBI deleted and shall be marked on each page of the application 
where CBI was deleted, ``CBI Deleted.'' If a notification does not 
contain CBI, then the first page of both copies shall be marked ``No 
CBI.'' When it is determined that a notification is complete, APHIS 
shall submit to the State department of agriculture of the State or the 
appropriate Tribal official of the Tribal land where the introduction 
is planned a copy of the notification for State or Tribal notification 
and review. When the application contains certain business information, 
the State or Tribal government will be provided a CBI deleted copy of 
the notification unless the disclosure of certain business information 
to the State or Tribal government has been authorized in accordance 
with Sec.  340.10.
* * * * *
0
3. Section 340.4 is amended as follows:
    a. In paragraph (b), introductory text, by removing the sixth 
sentence and by adding in its place two new sentences to read as set 
forth below.
    b. In paragraph (c), introductory text, by removing the last 
sentence and by adding in its place two new sentences to read as set 
forth below.


Sec.  340.4  Permits for the introduction of a regulated article.\6\
---------------------------------------------------------------------------

    \6\ See footnote 5 in Sec.  340.3.
---------------------------------------------------------------------------

* * * * *
    (b) * * * When it is determined that an application is complete, 
APHIS shall submit to the State department of agriculture of the State 
or the appropriate Tribal official of the Tribal land where the release 
is planned a copy of the initial review and a copy of the application 
for State or Tribal notification and review. When the application 
contains confidential business information (CBI), the State or Tribal 
government will be provided a CBI deleted copy of the application 
unless the disclosure of certain business information to the State or 
Tribal government has been authorized in accordance with Sec.  340.10. 
* * *
* * * * *
    (c) * * * When it is determined that an application is complete, 
APHIS shall submit to the State department of agriculture of the State 
of destination or to the appropriate Tribal official of the Tribal land 
of destination of the regulated article a copy of the initial review 
and a copy of the application for State or Tribal notification and 
review. When the application contains confidential business information 
(CBI), the State or Tribal government will be provided a CBI deleted 
copy of the application unless the disclosure of certain business 
information to the State has been authorized in accordance with Sec.  
340.10.
* * * * *
0
4. A new Sec.  340.10 is added to read as follows:


Sec.  340.10  Communications with State and Tribal government agencies.

    The Administrator may authorize in accordance with the provisions 
of this section the disclosure of certain business information (CBI) to 
State or Tribal government agencies that has been submitted to APHIS or 
incorporated into Agency-prepared records.

[[Page 13294]]

    (a) Certain business information submitted to APHIS in 
notifications and applications for permits under this part may be 
disclosed to State or Tribal government agencies provided that the 
State or Tribal government agency has entered into a written agreement 
with APHIS that includes:
    (1) A statement establishing the State's or Tribe's authority to 
protect certain business information from public disclosure;
    (2) A statement by the State or Tribal government agency that it 
has suitable procedures in place to ensure the security of the business 
information, and the means to specify and restrict their respective 
officials allowed access to such information. Such procedures must be 
equivalent to those specified in APHIS' policy \14\ on the protection 
of privileged or confidential business information;
---------------------------------------------------------------------------

    \14\ APHIS' ``Policy Statement on the Protection of Privileged 
or Confidential Business Information'' may be viewed on the APHIS 
Web site at http://www.aphis.usda.gov/animal_health/vet_biologics/publications/pel_1_2.pdf. The instructions for submitting CBI 
consistent with this policy are found in the BRS document titled 
``USDA-APHIS Biotechnology Regulatory Services User's 
Guide''(version 2/5/2008) and information may be viewed on the 
Internet at http://www.aphis.usda.gov/brs/pdf/Doc_Prep_Guidance.pdf or obtained from the person listed under FOR FURTHER 
INFORMATION CONTACT.
---------------------------------------------------------------------------

    (3) A statement that the State or Tribal government agency will not 
disclose any business information provided by APHIS without the written 
permission of the submitter of the information or written confirmation 
by APHIS that the information no longer has confidential status;
    (4) A statement that all persons with access to business 
information provided by APHIS will be trained by the State or Tribal 
authority on how to maintain the security of the shared APHIS documents 
before having access to the CBI;
    (5) Any other terms as agreed to by APHIS and the State or Tribal 
government agency.
    (b) The ``certain business information'' that APHIS may authorize 
to be shared under paragraph (a) of this section may include 
information about the regulated article, including details about the 
phenotype as provided by the applicant; the site(s) of the introduction 
including provision of accurate details of the location, acreage (for 
environmental releases), and purpose of the introduction if provided; 
dates of activities, including proposed planting and termination dates 
for the regulated article, actual dates when available; methods of 
confinement, including design protocols if available, and description 
of disposition if provided; and site cooperator, including contact 
information for the responsible person or cooperator, depending upon 
what information the applicant has provided to APHIS. APHIS intends 
that the disclosure of information will be for the purpose of 
facilitating the State or Tribal agency review. In addition, the 
exchange of information may also be made in certain emergency 
situations with States or Tribal government agencies to support better 
disaster responses and maintain confinement of regulated articles. 
Also, information sharing will help facilitate participation in the 
inspection and compliance programs established between the States and 
Tribes and APHIS under specific agreements.
    (c) Information APHIS discloses under this section is not a 
disclosure of information to the public. Disclosures made under this 
section do not waive any FOIA exemption protection.

    Done in Washington, DC, this 20th day of February 2013.
Rebecca Blue,
Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2013-04478 Filed 2-26-13; 8:45 am]
BILLING CODE 3410-34-P