13258 Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 

techniques or other forms of information 

technology should be addressed to: Desk 

Officer for Agriculture, Office of 

Information and Regulatory Affairs, 

Office of Management and Budget 

(OMB), 

OIRA_Submission@OMB.EOP.GOV or 

fax (202) 395–5806 and to Departmental 

Clearance Office, USDA, OCIO, Mail 

Stop 7602, Washington, DC 20250– 

7602. Comments regarding these 

information collections are best assured 

of having their full effect if received 

within 30 days of this notification. 

Copies of the submission(s) may be 

obtained by calling (202) 720–8958. 

An agency may not conduct or 

sponsor a collection of information 

unless the collection of information 

displays a currently valid OMB control 

number and the agency informs 

potential persons who are to respond to 

the collection of information that such 

persons are not required to respond to 

the collection of information unless it 

displays a currently valid OMB control 

number. 

Animal Plant and Health Inspection 

Service 

Title: Emergency Management 

Response System (EMRS). 

OMB Control Number: 0579–0071. 

Summary of Collection: The Animal 

Health Protection Act (AHPA) of 2002 is 

the primary Federal law governing the 

protection of animal health. The law 

gives the Secretary of Agriculture broad 

authority to detect, control, or eradicate 

pests or diseases of livestock or poultry. 

The Secretary may also prohibit or 

restrict import or export of any animal 

or related material if necessary to 

prevent the spread of any livestock or 

poultry pest or disease. Through the 

Foreign Animal Disease Surveillance 

Program, the Animal and Plant Health 

Inspection Service (APHIS) compiles 

essential epidemiological and diagnostic 

data that are used to define foreign 

animal diseases (FAD) and their risk 

factors. The data is compiled through 

the Veterinary Services Emergency 

Management Response System, a webbased database for reporting 

investigations of suspected FAD 

occurrences. 

Need and Use of the Information: 

APHIS collects information such as the 

purpose of the diagnostician’s visit to 

the site, the name and address of the 

owner/manager, the type of operation 

being investigated, the number of and 

type of animals on the premises, 

whether any animals have been moved 

to or from the premises and when this 

movement occurred, number of sick or 

dead animals, the results of physical 

examinations of the affected animals, 

the results of postmortem examinations, 

and the number and kinds of samples 

taken, and the name of the suspected 

disease. APHIS uses the collected 

information to effectively prevent FAD 

occurrences and protect the health of 

the United States. 

Without the information, APHIS has 

no way to detect and monitor foreign 

animal disease outbreaks in the United 

States. 

Description of Respondents: Business 

or other for-profit State, Local or Tribal 

Government. 

Number of Respondents: 471. 

Frequency of Responses: Reporting: 

On occasion. 

Total Burden Hours: 1,884. 

Animal and Plant Health Inspection 

Service 

Title: Importation of Fruits and 

Vegetables. 

OMB Control Number: 0579–0264. 

Summary of Collection: Under the 

Plant Protection Act (7 U.S.C. 7701– 

7772), the Secretary of Agriculture is 

authorized to regulate the importation of 

plants, plant products, and other articles 

to prevent the introduction of injurious 

plant pests. Regulations contained in 

Title 7 of the Code of Federal 

Regulations, Part 319 (Subpart-Fruit and 

Vegetables), Sections 319.56 et seq. 

implement the intent of this Act by 

prohibiting or restricting the 

importation of certain fruits and 

vegetables into the United States from 

certain parts of the world to prevent the 

introduction and dissemination of fruit 

flies and other injurious plant pests that 

are new to the United States or not 

widely distributed within the United 

States. These regulations are enforced 

by the Plant Protection and Quarantine, 

a program with USDA’s Animal and 

Plant Health Inspection Service 

(APHIS). 

Need and Use of the Information: The 

use of certain information collection 

activities including phytosanitary 

certificates, fruit fly monitoring records, 

and cooperative agreements will be used 

to allow the entry of certain fruits and 

vegetables into the United States. 

Without the information all shipment 

would need to be inspected very 

thoroughly, thereby requiring 

considerably more time and would slow 

the clearance of international 

shipments. 

Description of Respondents: Business 

or other for-profit; Federal Government. 

Number of Respondents: 15. 

Frequency of Responses: 

Recordkeeping; Reporting: On occasion. 

Total Burden Hours: 123. 

Ruth Brown, 

Departmental Information Collection 

Clearance Officer. 

[FR Doc. 2012–5326 Filed 3–5–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2011–0129] 

Biotechnology Regulatory Services; 

Changes Regarding the Solicitation of 

Public Comment for Petitions for 

Determinations of Nonregulated Status 

for Genetically Engineered Organisms 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service (APHIS) is 

implementing changes to the way it 

solicits public comment when 

considering petitions for determinations 

of nonregulated status for genetically 

engineered organisms to allow for early 

public involvement in the process. 

Under the updated process, APHIS will 

publish two separate notices in the 

Federal Register for petitions for which 

APHIS prepares an environmental 

assessment. The first notice will 

announce the availability of the 

petition, and the second notice will 

announce the availability of APHIS’ 

decisionmaking documents. This 

change will provide two opportunities 

for public involvement in the 

decisionmaking process. 

FOR FURTHER INFORMATION CONTACT: Dr. 

T. Clint Nesbitt, Chief of Staff, 

Biotechnology Regulatory Services, 

APHIS, 4700 River Road Unit 147, 

Riverdale, MD 20737–1236; (301) 851– 

3917, email: 

Thomas.C.Nesbitt@aphis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Under the authority of the plant pest 

provisions of the Plant Protection Act (7 

U.S.C. 7701 et seq.), the regulations in 

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,’’ 

regulate, among other things, the 

introduction (importation, interstate 

movement, or release into the 

environment) of organisms and products 

altered or produced through genetic 


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Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 13259 

1For more information on the USDA Customer 

Service Plan, go to http://www.usda.gov/open/ 

Blog.nsf/dx/USDA-CSPlan.pdf/$file/USDACSPlan.pdf. 

2For information regarding APHIS’ analysis and 

other internal process changes APHIS is making to 

our petition process, go to http:// 

www.aphis.usda.gov/biotechnology/ 

pet_proc_imp.shtml. 

3 If an EIS is determined to be necessary, APHIS 

completes the NEPA EIS process in accordance 

with Council on Environmental Quality regulations 

(40 CFR part 1500–1508) and APHIS’ NEPA 

implementing regulations (7 CFR part 372) and 

prepares a record of decision prior to either 

approving or denying the petition. 

4This notice describes our process for handling 

most petitions for determinations of nonregulated 

status. APHIS may decide that an EIS is necessary, 

either when we deem the petition to be complete 

or at any time during the EA process, in which case 

APHIS would complete the NEPA EIS process in 

accordance with Council on Environmental Quality 

regulations and APHIS’ NEPA implementing 

regulations. 

engineering that are plant pests or that 

there is reason to believe are plant pests. 

Such genetically engineered (GE) 

organisms and products are considered 

‘‘regulated articles.’’ 

The regulations in § 340.6(a) provide 

that any person may submit a petition 

to the Animal and Plant Health 

Inspection Service (APHIS) seeking a 

determination that an article should not 

be regulated under 7 CFR part 340. 

Paragraph (d) provides that, for petitions 

that meet the submission procedures, 

format, required data, and information 

requirements in paragraphs (b) and (c), 

APHIS will publish a notice in the 

Federal Register to inform the public 

that APHIS will accept written 

comments regarding the petition for a 

period of 60 days from the date of the 

notice. 

As part of the USDA Customer 

Service Plan,1 which seeks to improve 

the Agency’s customer service 

processes, APHIS analyzed the current 

petition process using Lean Six Sigma 

business process techniques. Based on 

this analysis, APHIS is implementing 

changes to improve our process for 

evaluating and responding to petitions 

for determinations of nonregulated 

status. Changes include earlier 

publication of the notice announcing 

the petition’s availability in the Federal 

Register, which will allow early public 

involvement in the process, and changes 

to the way we currently solicit and use 

public comment.2

Current Comment Process for Petitions 

for Determinations of Nonregulated 

Status 

Once APHIS deems a petition to be 

complete (i.e., the petition meets all the 

submission procedures, format, required 

data, and information requirements in 

§ 340.6(b) and (c)), APHIS, in most 

instances, prepares a plant pest risk 

assessment (PPRA) and a draft 

environmental assessment (EA). APHIS 

prepares a PPRA to assess the plant pest 

risk of the article and an EA, in 

accordance with the National 

Environmental Policy Act (NEPA), to 

provide the Agency with a review and 

analysis of any potential environmental 

impacts associated with the petition 

request. After the completion of these 

documents, APHIS typically publishes a 

notice in the Federal Register 

announcing the availability of the 

petition, PPRA, and draft EA for public 

comment. 

After the comment period closes, 

APHIS reviews all written comments 

received during the comment period 

and any other relevant information. 

After reviewing and evaluating the 

comments on the petition, draft EA, 

PPRA, and other data, APHIS prepares 

a final EA, PPRA, and NEPA decision 

document, which can be either a 

Finding of No Significant Impact 

(FONSI) or notice of intent (NOI) to 

prepare an environmental impact 

statement (EIS).3

If APHIS determines, based on the 

PPRA, that the regulated article is 

unlikely to pose a plant pest risk and a 

FONSI is reached, APHIS subsequently 

furnishes a response to the petitioner 

approving the petition. APHIS also 

publishes a notice in the Federal 

Register announcing the regulatory 

status of the GE organism and the 

availability of APHIS’ final EA, PPRA, 

FONSI, and regulatory determination. 

Copies of these documents are made 

available as indicated in the Federal 

Register notice. 

Changes to the Comment Process for 

Petitions for Determinations of 

Nonregulated Status 

Under our updated process, APHIS 

intends to decide whether a petition is 

complete within 3 months of its receipt. 

If APHIS deems that a petition is not 

complete, APHIS will so inform the 

petitioner. For petitions APHIS deems 

complete, APHIS will follow the process 

for public involvement described below. 

EA Comment Process for Petitions for 

Determinations of Nonregulated Status 

For complete petitions, APHIS will 

make the petition available for public 

comment before preparing our EA and 

PPRA.4 APHIS will, therefore, publish 

two separate notices in the Federal 

Register—a notice announcing the 

availability of the petition, with an 

opportunity for public comment, 

followed by a notice announcing the 

availability of APHIS’ EA and PPRA and 

an opportunity for public involvement 

on those documents. This will provide 

two separate and specific opportunities 

for public involvement in the 

decisionmaking process. 

First Opportunity for Public 

Involvement 

The first opportunity for public 

involvement will be a public comment 

period on the petition itself, once it is 

deemed complete by APHIS. APHIS will 

publish a notice in the Federal Register 

to inform the public that APHIS will 

accept written comments regarding a 

petition for a determination of 

nonregulated status for a period of 60 

days from the date of the notice. The 

comment period will provide the public 

with an opportunity to raise any issues 

regarding the petition and will be used 

by APHIS as a scoping opportunity to 

identify potential issues and impacts 

that APHIS would then determine 

should be considered in our evaluation 

of the petition. 

Second Opportunity for Public 

Involvement 

The second opportunity for public 

involvement will come with the 

publication of a notice of availability for 

APHIS’ EA and PPRA in the Federal 

Register. This second notice will follow 

one of two approaches for public 

participation based on whether or not 

APHIS decides the petition for a 

determination of nonregulated status is 

for a GE organism that raises substantive 

new issues. 

Approach 1 

This approach for public participation 

will be used when APHIS decides, 

based on our review of the petition and 

our evaluation and analysis of 

comments received from the public 

during the 60-day comment period on 

the petition, that the petition involves a 

GE organism that raises no substantive 

new issues. This would include 

instances, for example, where APHIS 

decides that the petition involves gene 

modifications that do not raise 

substantive new biological, cultural, or 

ecological issues due to the nature of the 

modification or APHIS’ familiarity with 

the recipient organism. 

Under this approach, APHIS will 

publish a notice in the Federal Register 

announcing APHIS’ preliminary 

regulatory determination and the 

availability of APHIS’ EA, FONSI, and 

PPRA for a 30-day public review. Upon 

completion of the 30-day review period, 

APHIS will review and evaluate any 

information received. If APHIS 

determines that no substantive 

information has been received that 


pmangrum on DSK3VPTVN1PROD with NOTICES
13260 Federal Register / Vol. 77, No. 44 / Tuesday, March 6, 2012 / Notices 

would warrant APHIS altering its 

preliminary regulatory determination or 

FONSI, substantially changing the 

proposed action identified in the EA, or 

substantially changing the analysis of 

impacts in the EA, our preliminary 

regulatory determination will become 

final and effective upon notification of 

the public through an announcement on 

our Web site. APHIS will also furnish a 

response to the petitioner regarding our 

final regulatory determination. No 

further Federal Register notice will be 

published announcing the final 

regulatory determination. 

Should APHIS determine that we 

have received substantive new 

information within 30 days of 

publication of the Federal Register 

notice that would warrant APHIS 

altering our preliminary regulatory 

determination or FONSI, substantially 

changing the proposed action identified 

in the EA, or substantially changing the 

analysis of impacts in the EA, our 

preliminary determination will not 

become effective. In this case, APHIS 

intends to notify the public through an 

announcement on our Web site of our 

intent to conduct additional analysis. 

APHIS will also inform the petitioner of 

our intent. 

Based on the information APHIS 

received and our further analysis, the 

Agency will prepare an amended EA, a 

new FONSI, and/or a revised PPRA, as 

necessary. APHIS will then publish a 

notice in the Federal Register 

announcing the availability of these 

documents for public review and 

APHIS’ preliminary regulatory 

determination. After reviewing and 

evaluating any additional information 

received within 30 days of publication 

of this Federal Register notice, our 

preliminary regulatory determination 

will become final and effective upon 

notification of the public through an 

announcement on our Web site. APHIS 

will also furnish a response to the 

petitioner regarding our final regulatory 

determination. No further Federal 

Register notice will be published 

announcing the final regulatory 

determination. 

Approach 2 

A second approach for public 

participation will be used when APHIS 

determines that the petition for a 

determination of nonregulated status is 

for a GE organism that raises substantive 

new issues. This could include petitions 

involving a recipient organism that has 

not previously been determined by 

APHIS to have nonregulated status or 

when APHIS determines that gene 

modifications raise substantive 

biological, cultural, or ecological issues 

not previously analyzed by APHIS. 

Substantive issues would be identified 

by APHIS based on our review of the 

petition and our evaluation and analysis 

of comments received from the public 

during the 60-day comment period on 

the petition. 

Under this approach, APHIS will 

solicit written comments on a draft EA 

and PPRA for 30 days through the 

publication of a Federal Register notice. 

The draft EA and PPRA will be made 

available as indicated in the Federal 

Register notice. Upon completion of the 

30-day comment period, APHIS will 

review and evaluate all written 

comments received during the comment 

period and any other relevant 

information. After reviewing and 

evaluating the comments on the draft 

EA and PPRA and other information, 

APHIS will revise the PPRA as 

necessary and prepare a final EA. Based 

on the final EA, APHIS will prepare a 

NEPA decision document—either a 

FONSI or NOI to prepare an EIS. If a 

FONSI is reached, APHIS will furnish a 

response to the petitioner, either 

approving or denying the petition. 

APHIS will publish a notice in the 

Federal Register announcing the 

regulatory status of the GE organism and 

the availability of APHIS’ final EA, 

PPRA, FONSI, and our regulatory 

determination. 

These changes to the public 

participation process are effective 

March 6, 2012. All petitions for 

determinations of nonregulated status 

for GE organisms received by APHIS on 

or after this date will be handled using 

the new process for handling petitions 

described in this notice. For petitions 

received before this date and currently 

under consideration by APHIS, our 

ability to transition to the new process 

will depend upon the current status of 

the petition. For those petitions where 

APHIS has not completed a draft EA 

and PPRA, APHIS will follow the new 

process, i.e., the complete petition will 

be published for a 60-day comment 

period followed by later public 

involvement regarding the EA and 

PPRA. For those petitions where APHIS 

has completed or is nearing completion 

of a draft EA and PPRA, APHIS will 

follow our previous process, i.e., the 

petition, draft EA, and PPRA will be 

made available in a single Federal 

Register notice for a 60-day comment 

period. APHIS will notify petitioners 

which process their petition will follow 

and will make this information available 

at http://www.aphis.usda.gov/ 

biotechnology/pet_proc_imp.shtml. 

These public participation process 

changes are consistent with (1) 7 CFR 

part 340, (2) the National Environmental 

Policy Act (NEPA) of 1969, as amended 

(42 U.S.C. 4321 et seq.), (3) regulations 

of the Council on Environmental 

Quality for implementing the 

procedural provisions of NEPA (40 CFR 

parts 1500–1508), (4) USDA regulations 

implementing NEPA (7 CFR part 1b), 

and (5) APHIS’ NEPA Implementing 

Procedures (7 CFR part 372). 

Authority: 7 U.S.C. 7701–7772 and 7781– 

7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 

371.3. 

Done in Washington, DC, this 29th day of 

February 2012. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2012–5364 Filed 3–5–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0005] 

Notice of Availability of a Pest Risk 

Analysis for the Importation of Litchi, 

Longan, and Rambutan From the 

Philippines Into the Continental United 

States 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice of availability and 

request for comments. 

SUMMARY: We are advising the public 

that we have prepared a pest risk 

analysis that evaluates the risks 

associated with the importation into the 

continental United States of fresh litchi, 

longan, and rambutan fruit from the 

Philippines. Based on that analysis, we 

believe that the application of one or 

more designated phytosanitary 

measures will be sufficient to mitigate 

the risks of introducing or disseminating 

plant pests or noxious weeds via the 

importation of fresh fruit of litchi, 

longan, and rambutan from the 

Philippines. We are making the pest risk 

analysis available to the public for 

review and comment. 

DATES: We will consider all comments 

that we receive on or before May 7, 

2012. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0005- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0005, Regulatory Analysis 

and Development, PPD, APHIS, Station 


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