Federal Register, Volume 78 Issue 39 (Wednesday, February 27, 2013)

[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]

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Proposed Rules
Federal Register
________________________________________________________________________

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