[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Notices]
[Pages 13258-13260]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5364]


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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.

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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

[[Page 13259]]

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 Sec.  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\
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    \1\ For more information on the USDA Customer Service Plan, go 
to http://www.usda.gov/open/Blog.nsf/dx/USDA-CSPlan.pdf/$file/USDA-
CSPlan.pdf.
    \2\ For 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.
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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 Sec.  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\
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    \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.
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    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.
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    \4\ This 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.
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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

[[Page 13260]]

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]
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