Document ID: EPA-HQ-OPP-2009-0877-0001
Agency: epa
Document Type: Notice
Title: Registration Review; Ethylene Docket Opened for Review and Comment
Posted Date: 2009-12-28T05:00Z

[Federal Register: December 28, 2009 (Volume 74, Number 247)]
[Notices]               
[Page 68615-68617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de09-69]                         

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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: Benmhend.driss@epa.gov.
    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

[[Page 68617]]

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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