[Federal Register Volume 74, Number 247 (Monday, December 28, 2009)]
[Notices]
[Pages 68615-68617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30622]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0877; FRL-8803-6]
Registration Review; Ethylene Docket Opened for Review and
Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA has established a registration review docket for the
pesticide ethylene (case 3071). With this document, EPA is opening the
public comment period for this registration review. Registration review
is EPA's periodic review of pesticide registrations to ensure that each
pesticide continues to satisfy the statutory standard for registration,
that is, the pesticide can perform its intended function without
unreasonable adverse effects on human health or the environment.
Registration review dockets contain information that will assist the
public in understanding the types of information and issues that the
Agency may consider during the course of registration reviews. Through
this program, EPA is ensuring that each pesticide's registration is
based on current scientific and other knowledge, including its effects
on human health and the environment. This document also announces the
Agency's intent not to open a registration review docket for
encapsulated Bacillus thuringiensis proteins. This pesticide does not
currently have any actively registered pesticide products and is not,
therefore, scheduled for review under the registration review program.
DATES: Comments must be received on or before February 26, 2010.
ADDRESSES: Submit your comments identified by docket identification
(ID) number EPA-HQ-OPP-2009-0877, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0877. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: For pesticide-specific information
contact: Driss Benmhend, Biopesticides and Pollution Prevention
Division, Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number: (703) 308-9525; fax number: (703) 308-7026; e-mail
address: [email protected].
For general information contact: Kevin Costello, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-5026; fax
number: (703) 308-8090; e-mail address: costello.kevin @epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
interest to a
[[Page 68616]]
wide range of stakeholders including environmental, human health,
farmworker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the pesticide-specific contact person listed under FOR FURTHER
INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticide
discussed in this document, compared to the general population.
II. Authority
EPA is initiating its review of the pesticide ethylene pursuant to
section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) and the Procedural Regulations for Registration Review at 40
CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other
things, that the registrations of pesticides are to be reviewed every
15 years. Under FIFRA, a pesticide product may be registered or remain
registered only if it meets the statutory standard for registration
given in FIFRA section 3(c)(5). When used in accordance with widespread
and commonly recognized practice, the pesticide product must perform
its intended function without unreasonable adverse effects on the
environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.
III. Registration Review
A. What Action is the Agency Taking?
As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registration for ethylene to assure that it continues to satisfy the
FIFRA standard for registration--that is, it can still be used without
unreasonable adverse effects on human health or the environment. A
pesticide's registration review begins when the Agency establishes a
docket for the pesticide's registration review case and opens the
docket for public review and comment. At present, EPA is opening a
registration review docket for ethylene (case number 3071) (docket ID
number EPA-HQ-OPP-2009-0877).
EPA is also announcing that it will not be opening a docket for
three strains of encapsulated Bacillus thuringiensis proteins (case
6001) because these strains of this pesticide are not included in any
products actively registered under FIFRA section 3 or 24(c). Within
case 6001 there are three different active ingredients holding
exemptions from the requirement of a tolerance, as expressed in 40 CFR
part 180.
1. Delta endotoxin variety San Diego. The registrant, Ecogen Inc.,
held the last registered product (EPA Reg. No. 55638-44) containing the
active ingredient, delta endotoxin of Bacillus thuringiensis variety
San Diego encapsulated into killed Pseudomonas fluorescens. The Ecogen
Inc. product was voluntarily canceled on October 24, 2003, due to non-
payment of maintenance fees (68 FR 62785, November 6, 2003) (FRL-7331-
3). As provided at 40 CFR 180.1108, products containing the delta
endotoxin of Bacillus thuringiensis variety San Diego into killed
Psuedomonas fluorescens are exempt from the requirement of a tolerance
in or on all raw agricultural commodities (56 FR 28325, June 20, 1991)
(FRL-3931-9).
2. Delta endotoxin variety kurstaki. The registrant, Ecogen Inc.,
held the last registered product (EPA Reg. No. 55638-48) containing the
active ingredient, delta endotoxin of Bacillus thuringiensis variety
kurstaki encapsulated into killed Pseudomonas fluorescens. The Ecogen
Inc. product was voluntarily canceled on October 15, 2004, due to non-
payment of maintenance fees (69 FR 62666, October, 27 2004) (FRL-7683-
7). As provided at 40 CFR 180.1107, products containing the delta
endotoxin of Bacillus thuringiensis variety kurstaki into killed
Psuedomonas fluorescens are exempt from the requirement of a tolerance
in or on all raw agricultural commodities (56 FR 28326, June 20, 1991)
(FRL-3931-8).
3. CrylA(c) and CrylC Delta endotoxin. The registrant, Ecogen Inc.,
held the last registered product (EPA Reg. No. 55638-47) containing the
active ingredients, Cry1A(c) and Cry1C derived delta endotoxins of
Bacillus thuringiensis variety kurstaki encapsulated in killed
Pseudomonas fluorescens. The Ecogen Inc. product was voluntarily
canceled on October 15, 2004, due to non-payment of maintenance fees
(69 FR 62666, October, 27 2004) (FRL-7683-7). As provided at 40 CFR
180.1154, products containing the delta-endotoxin of Bacillus
thuringiensis variety kurstaki into killed Psuedomonas fluorescens are
exempt from the requirement of a tolerance when used in or on all raw
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agricultural commodities (60 FR 47487, September 13, 1995) (FRL-4973-
3).
The Agency will take separate actions to propose revocation of any
affected tolerances that are not supported for import purposes only.
B. Docket Content
1. Review docket. The registration review docket contains
information that the Agency may consider in the course of the
registration review. The Agency may include information from its files
including, but not limited to, the following information:
An overview of the registration review case status.
A list of current product registrations and registrants.
Federal Register notices regarding any pending
registration actions.
Federal Register notices regarding current or pending
tolerances.
Risk assessments.
Bibliographies concerning current registrations.
Summaries of incident data.
Any other pertinent data or information.
The docket contains a document summarizing what the Agency
currently knows about the ethylene case and a preliminary work plan for
anticipated data and assessment needs. Additional documents provide
more detailed information. During this public comment period, the
Agency is asking that interested persons identify any additional
information they believe the Agency should consider during the
registration review of the pesticide ethylene. The Agency identifies in
the docket the areas where public comment is specifically requested,
though comment in any area is welcome.
2. Other related information. More information on the ethylene
case, including the active ingredients for the case, may be located in
the registration review schedule on the Agency's website at http://www.epa.gov/oppsrrd1/registration_review/schedule.htm. Information on
the Agency's registration review program and its implementing
regulation may be seen at http://www.epa.gov/oppsrrd1/registration_review.
3. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
Submitters must clearly identify the source of any
submitted data or information.
Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
As provided in 40 CFR 155.58, the registration review docket for
the ethylene case will remain publicly accessible through the duration
of the registration review process; that is, until all actions required
in the final decision on the registration review case have been
completed.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: December 16, 2009.
Keith A. Matthews,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. E9-30622 Filed 12-24-09; 8:45 am]
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