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.

Proposed Rules Federal Register

13286 

Vol. 78, No. 39 

Wednesday, February 27, 2013 

1See 50 FR 38561–38563, ‘‘Policy Statement on 

the Protection of Privileged or Confidential 

Business Information’’ in the Federal Register 

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. 

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 § 340.4, or unless 

APHIS has been notified in accordance 

with § 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 §§ 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 


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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. 

2 7 CFR 340.4(a) and ‘‘USDA–APHIS 

Biotechnology Regulatory Services User’s Guide.’’ 

designated CBI to State or Tribal 

government officials. The APHIS FOIA 

Office oversees any information release 

requested under FOIA. 

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. 

Currently, APHIS shares only ‘‘CBIdeleted’’ 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 

§ 340.4(b)(5)) than do notifications 

(described in § 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, 


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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 CBIdeleted 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 intraagency memorandums or letters which 

would not be available by law to a party 

other than an agency in litigation with 


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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 

§ 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 

§ 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 § 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 § 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 § 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 

§ 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 


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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 § 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 § 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 § 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 § 340.10 

would allow us to share CBI with the 

appropriate State or Tribal officials, we 

would amend § 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 § 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 

§ 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 § 340.3(d) for submission of 

CBI in notifications. The section 

‘‘Procedural requirements for notifying 

APHIS’’ will contain parallel language 

to that in § 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 


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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 nonregulated 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 


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13292 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Proposed Rules 

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 

§ 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 

§§ 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 §§ 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 § 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 


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5APHIS 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. 6See footnote 5 in § 340.3. 

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 

■ 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. 

■ 2. In § 340.3, a new paragraph 

(d)(2)(vi) is added to read as follows: 

§ 340.3 Notification for the introduction of 

certain regulated articles.5

* * * * * 

(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 § 340.10. 

* * * * * 

■ 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. 

§ 340.4 Permits for the introduction of a 

regulated article.6

* * * * * 

(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 § 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 

§ 340.10. 

* * * * * 

■ 4. A new § 340.10 is added to read as 

follows: 

§ 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. 


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13294 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Proposed Rules 

14APHIS’ ‘‘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. 

1See Enhanced Prudential Standards and Early 

Remediation Requirements for Foreign Banking 

Organizations and Foreign Nonbank Financial 

Companies, 77 FR 76628 (December 28, 2012). 

2 Id. 

3See, e.g., Comment letter to the Board from The 

Institute of International Bankers et al. (January 31, 

2013). 

(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; 

(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 

FEDERAL RESERVE SYSTEM 

12 CFR Part 252 

[Regulation YY; Docket No. 1438] 

RIN 7100–AD–86 

Enhanced Prudential Standards and 

Early Remediation Requirements for 

Foreign Banking Organizations and 

Foreign Nonbank Financial Companies 

AGENCY: Board of Governors of the 

Federal Reserve System (Board). 

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: On December 28, 2012, the 

Board published in the Federal Register 

a notice of proposed rulemaking to 

implement the enhanced prudential 

standards required to be established 

under section 165 of the Dodd-Frank 

Act and the early remediation 

requirements established under section 

166 of the Act for foreign banking 

organizations and foreign nonbank 

financial companies supervised by the 

Board. 

Due to the range and complexity of 

the issues addressed in the rulemaking, 

the Board has determined that an 

extension of the public comment period 

until April 30, 2013, is appropriate. This 

action will allow interested persons 

additional time to analyze the proposed 

rules and prepare their comments. 

DATES: The comment period for the 

proposed rule published December 28, 

2012 (77 FR 76628) is extended from 

March 31, 2013 to April 30, 2013. 

ADDRESSES: You may submit comments 

by any of the methods identified in the 

proposed rule.1 Please submit your 

comments using only one method. 

FOR FURTHER INFORMATION CONTACT: 

Molly E. Mahar, Adviser, (202) 973– 

7360, Division of Banking Supervision 

and Regulation; Ann Misback, Associate 

General Counsel, (202) 452–3788, or 

Christine Graham, Senior Attorney, 

(202) 452–3005, Legal Division. 

SUPPLEMENTARY INFORMATION: On 

December 28, 2012, the Board published 

in the Federal Register a notice of 

proposed rulemaking to implement the 

enhanced prudential standards required 

to be established under section 165 of 

the Dodd-Frank Act and the early 

remediation requirements established 

under section 166 of the Act for foreign 

banking organizations and foreign 

nonbank financial companies 

supervised by the Board. The enhanced 

prudential standards include risk-based 

capital and leverage requirements, 

liquidity standards, risk management 

and risk committee requirements, 

single-counterparty credit limits, and 

stress test requirements, and a debt-toequity limit for companies that the 

Financial Stability Oversight Council 

has determined pose a grave threat to 

financial stability. 

In recognition of the complexities of 

the issues addressed and the variety of 

considerations involved with 

implementation of the proposal, the 

Board requested that commenters 

respond to numerous questions. The 

proposed rule stated that the public 

comment period would close on March 

31, 2013.2

The Board has received a request from 

the public for an extension of the 

comment period to allow for additional 

time for comments related to the 

provisions of the proposed rule.3 The 

Board believes that the additional 

period for comment will facilitate 

public comment on the provisions of the 

proposed rule and the questions posed 

by the Board. Therefore, the Board is 

extending the end of the comment 


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