Document ID: EPA-HQ-OPP-2006-1003-0001
Agency: epa
Document Type: Proposed Rule
Title: Plant-Incorporated Protectants; Potential Revisions to Current Production Regulations
Posted Date: 2007-04-04T04:00Z

[Federal Register: April 4, 2007 (Volume 72, Number 64)]
[Proposed Rules]               
[Page 16312-16315]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap07-26]                         

[[Page 16312]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 152, 156, 167, 168, 169, 172, and 174

[EPA-HQ-OPP-2006-1003; FRL-8118-2]
RIN 2070-AJ32

 
Plant-Incorporated Protectants; Potential Revisions to Current 
Production Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Advance Notice of Proposed Rulemaking (ANPRM).

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SUMMARY:  In light of the differences between plant-incorporated 
protectants (PIPs) and other types of pesticides, EPA is considering 
amendments to the current pesticide establishment and production 
regulations promulgated under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), and to other related FIFRA regulations as 
needed for producers of PIPs. PIPs are pesticidal substances that are 
intended to be produced and used in a living plant, or the produce 
thereof, and the genetic material necessary for the production of such 
a pesticidal substance, and also include any inert ingredient contained 
in the plant, or the produce thereof. Given these characteristics, it 
is possible that PIPs may not be produced in the manner contemplated 
when the current establishment and production regulations were 
promulgated for other types of pesticide. In this ANPRM, the Agency 
provides a list of the general regulatory provisions applicable to PIPs 
that EPA is considering amending and solicits public comment on the 
completeness of the list and the scope of any potential changes to 
these regulations. EPA also is soliciting information that may be 
useful to EPA as it reviews these regulations and developing the 
proposed rules. In addition to soliciting comments through this ANPRM, 
EPA intends to solicit stakeholder input through two public meetings 
during the comment period of this ANPRM.

DATES: Comments must be received on or before June 13, 2007.

ADDRESSES:  Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2006-1003, 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'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-
2006-1003. 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 in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 

Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov web 
site to view the docket index or access available documents. 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: Stephen Howie, Hazard Assessment 
Coordination and Policy Division (7202M), Office of Science 
Coordination and Policy, 1200 Pennsylvania Ave., NW., Washington, DC 
20460-0001; telephone number: (202) 564-4146; fax number: (202) 564-
8502; e-mail address: howie.stephen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use PIPs. In order to identify potentially impacted 
industries the analysis relies on North American Industrial 
Classification System (NAICS) codes. Potentially affected entities may 
include, but are not limited to:
     Pesticide and Other Agricultural Chemical Manufacturing 
(NAICS code 325320). This industry comprises establishments that are 
producing PIPs intended for distribution and sale as pesticides.
     Crop Production (NAICS code 111). These are establishments 
such as farms, orchards, groves, greenhouses, and nurseries, primarily 
engaged in growing crops, plants, vines, or trees and their seeds.
     Colleges, Universities, and Professional Schools (NAICS 
code 611310). This industry comprises establishments primarily engaged 
in furnishing academic courses and granting degrees at baccalaureate or 
graduate levels. Furthermore, they may comprise establishments where 
research on PIPs occurs and where PIPs may be grown.
     Research and Development in the Physical, Engineering, and 
Life Sciences (NAICS code 54171). This industry comprises 
establishments primarily engaged in conducting research and 
experimental development in the physical, engineering, or life 
sciences, such as agriculture, environmental,

[[Page 16313]]

biology, botany, biotechnology, forests, and other allied subjects.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Docket. EPA has established a docket for this action under 
docket ID number EPA-HQ-OPP-2006-1003. 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 Office 

of Pesticide Programs (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.
    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.

II. Background

A. What Action is the Agency Taking?

    PIPs are ``pesticidal substances that are intended to be produced 
and used in a living plant, or the produce thereof, and the genetic 
material necessary for the production of such a pesticidal substance. 
PIPs also include any inert ingredient contained in the plant, or the 
produce thereof.'' (40 CFR 174.3) By definition, PIPs are primarily 
distinguished from other types of pesticides because they are intended 
to be produced and used in the living plant. Other types of pesticides 
are primarily produced in a facility and used through physical 
application, e.g., spraying or dusting of the plant. Since PIPs were 
not defined when the existing regulations associated with pesticide 
establishments and pesticide production were promulgated, the existing 
regulations may not adequately address this distinction.
    The Agency is therefore considering amending the current FIFRA 
regulations associated with pesticide establishments and pesticide 
production to better address PIPs and PIP production given the unique 
characteristics of PIPs compared to other types of pesticides.
    EPA is soliciting comments from interested stakeholders on the 
issues and questions identified in this ANPRM. EPA intends to use this 
information in reviewing these regulations and developing its proposed 
rules.

B. What is the Agency's Authority for Taking this Action?

    EPA has regulatory authority to promulgate regulations under FIFRA 
sections 3(a), 8(a), 25(a), and 25(b) (7 U.S.C. 136a(a), 136f(a), 
136w(a), and 136w(b)).
    PIPs are pesticides under FIFRA section 2 because they are 
introduced into plants with the intention of ``preventing, destroying, 
repelling, or mitigating any pest...'' (7 U.S.C. 136(u)).
    Under FIFRA section 7, any person who manufactures, prepares, 
compounds, propagates, or processes any pesticide is a ``producer.'' 
``Produce,'' as further described in in 40 CFR 167.3, also means to 
package, repackage, label, relabel, or otherwise change the container 
of any pesticide. FIFRA section 7 requires that producers of pesticides 
register the establishments where production occurs and requires that 
producers report their annual production (7 U. S. C. 136e). In 
addition, producers of pesticides are required under FIFRA section 8(a) 
to maintain records with respect to their operations, and to make such 
records available for inspection (7 U.S.C. 136f(a)). Under FIFRA 
section 9 appropriately credentialed inspectors have the authority to 
conduct inspections at pesticide producing establishments or other 
places where pesticides are being held for distribution or sale for the 
purpose of inspecting and obtaining samples (7 U.S.C. 136g).

C. Why is the Agency Considering Amending the Regulations?

    EPA believes that the existing regulations need to be amended to 
better address apparent differences between PIPs and other types of 
pesticides in the application of FIFRA's production and production-
related requirements. The existing regulations were written for 
pesticides that are generally produced and used in a more traditional 
manner, e.g., spraying or dusting onto the plants. PIPs are produced 
and used in a living plant, which raises questions regarding how that 
``production'' should be regulated under the existing authorities of 
FIFRA. In general, EPA's experience with PIPs is that they present 
different and potentially lower risk situations compared to chemical 
pesticides. However, EPA needs to ensure that appropriate PIP 
production data are available to manage any potential risk a PIP might 
pose.
    The United States Government published in the Federal Register 
issue of June 26, 1986 (51 FR 23302) a document entitled, Coordinated 
Framework for Regulation of Biotechnology (``Coordinated Framework''), 
which describes in broad terms the Federal Government's approach to 
regulating biotechnology products. In that document, the Federal 
Government concluded that it could appropriately regulate the products 
of biotechnology under existing laws, but recognized that, in some 
cases, new regulations might be needed. Consistent with the Coordinated 
Framework, EPA regulates PIPs under its pesticide authorities. In the 
Federal Register issue of July 19, 2001 (66 FR 37771) (FRL-6057-7), EPA 
published a rule that established a regulatory framework for PIPs. That 
rule clarified the relationship between plants and PIPs under FIFRA, 
exempted from FIFRA requirements PIPs derived entirely through 
conventional breeding between sexually compatible plants, established a 
new part in the Code of Federal Regulations specifically for PIPs (40 
CFR part 174), provided requirements for reporting of adverse effects, 
and set forth certain procedures for CBI. In that Federal Register 
document, EPA also anticipated the future need for proposing 
regulations tailored

[[Page 16314]]

specifically to PIPs so that the regulatory framework would better fit 
their unique characteristics (66 FR 37807). EPA indicated that it would 
continue to apply existing regulations to PIPs, except where superseded 
by the regulations in the July 19, 2001 Final Rule, until the Agency 
could develop additional regulations specifically tailored to PIPs.
    Since the mid-1990s, EPA has approved a number of PIP experimental 
use permits (EUPs) under FIFRA section 5, as well as seed increase and 
commercial use registrations under FIFRA section 3. During this time, 
EPA has registered facilities involved in the production of PIPs as 
pesticide producing establishments under FIFRA section 7. These have 
included, for example, sites of the original transformation (where 
plant tissue was transformed by the insertion of PIP genetic material) 
and seed processing facilities.
    FIFRA section 7 requires that producers of pesticides register the 
establishments where the pesticide is produced and report the amount of 
pesticide produced. EPA's experience to date has demonstrated, 
particularly in the area of pesticide production, that the existing 
regulations (e.g., 40 CFR part 167) may need to be better tailored to 
address PIPs. For example, existing regulations require pesticide 
production quantities to be reported in terms of volume or weight 
(gallons or pounds), measurements that are not useful when considering 
a pesticidal substance produced within a plant. Other questions concern 
the manner in which PIPs are increased within a living plant. Such 
increase occurs at many stages from product development through use, 
which raises questions concerning where pesticide production occurs, 
and what establishments must register and report their production. 
Clarification of this matter would help to ensure that appropriate 
persons comply with production related requirements, and that other 
persons do not face unnecessary regulatory burden. To that end, EPA is 
reviewing the existing regulations in 40 CFR chapter I, subchapter E 
and considering potential regulatory changes to address the apparent 
differences between PIPs and other types of pesticides.

III. Current Regulations Under Review

    EPA is considering amending the following existing regulations 
related to pesticide establishment and production to better address 
PIPs and PIP production:
    1. Registration of establishments where PIPs are produced (FIFRA 
section 7 and 40 CFR 167.20). Current regulations require any producer 
of a pesticide to register the ``production'' site with EPA. The 
statutory and regulatory definitions of ``produce'' include several 
activities, including manufacturing, preparing, compounding, 
propagating, or processing any pesticide or packaging, repackaging, 
labeling, and relabeling the container of any pesticide.
    2. Reporting by registered production establishments (FIFRA section 
7 and 40 CFR 167.85). Current regulations require a producer operating 
a producing establishment to report annually the types and amount of 
each pesticidal product that was produced, sold, or distributed the 
previous year and to estimate the amount that will be produced during 
the current year.
    3. Recordkeeping and inspection authority (FIFRA sections 8 and 9 
and 40 CFR 169.2 and 169.3). EPA's statutory authority under FIFRA 
section 8, and the regulations promulgated thereunder, require 
pesticide producers, registrants, and applicants for registration to 
maintain certain records related to pesticide production (i.e., 
including information regarding the production, receipt, and shipment 
of pesticides) and to provide these records upon request to 
appropriately credentialed inspectors. FIFRA section 8 also provides 
authority for appropriately credentialed inspectors to conduct 
inspections to access such information. Furthermore, under FIFRA 
section 9 appropriately credentialed inspectors have the authority to 
conduct inspections at pesticide producing establishments or other 
places where pesticides are being held for distribution or sale for the 
purpose of inspecting and obtaining samples.
    4. Labeling on PIP containers (FIFRA section 2 and 40 CFR 156.10). 
The statute and current regulations provide requirements for labeling 
of pesticides, including name of the product, identity of the producer, 
net content, product registration number, establishment registration 
number, ingredient statement, hazard and precautionary statements, 
directions for use, and use classification. Currently, PIPs are labeled 
for FIFRA section 5 EUPs and FIFRA section 3 seed increase 
registrations only.
    5. EUPs for field testing of unregistered PIPs (FIFRA section 5 and 
40 CFR part 172). FIFRA allows for field testing of unregistered 
pesticides under an EUP. Any pesticide production activity related to 
an EUP, either the production of a pesticide for use in an EUP or by 
being produced as a result of an EUP, is subject to FIFRA production 
establishment and recordkeeping requirements.
    6. Production of unregistered PIPs for export (FIFRA section 17 and 
40 CFR 168.65-168.85). FIFRA exempts pesticides intended solely for 
export from certain FIFRA requirements, including product registration 
requirements. Products intended for export only are therefore not 
subject to the product safety evaluation required of products intended 
for domestic distribution and sale. However, they must still comply 
with the producer establishment registration, reporting and 
recordkeeping requirements of FIFRA sections 7 and 8 and are subject to 
certain labeling requirements, e.g., their label must include the 
statement: ``Not Registered for Use in the United States of America.''

IV. Request for Comments

    EPA is seeking public comment on the completeness of the list of 
current regulations that need to be reviewed for applicability to PIPs 
and PIP producers (see Unit III.), and is soliciting related 
information to use in reviewing these regulations and developing its 
proposed rules. These issues are especially challenging for PIPs, since 
based on statutory and regulatory definitions, the borders between 
production and use are unclear. EPA is seeking public input to help 
inform decisions on how best to ensure appropriate compliance without 
imposing unnecessarily burdensome reporting or labeling requirements on 
PIP registrants, producers, distributors, and users.
    1. EPA would like comments in response to the following questions 
with respect to the regulations referenced in Unit III.:
    a. Registration of establishments (Unit III.1.). Given that PIPs by 
definition are intended to be produced and used in a living plant, what 
activities should the Agency consider to be part of ``production'' as 
that term is defined in FIFRA (which includes manufacturing, preparing, 
compounding, propagating, or processing any pesticide or packaging, 
repackaging, labeling, and relabeling the container), and what 
establishments should be registered to help EPA manage any potential 
risks associated with PIPs? What other types of facilities, if any 
(e.g., growers involved in seed production), involved in the 
development of PIP-containing varieties should be subject to these 
requirements? Please explain the reason for your response.
    b. Production reporting (Unit III.2.). What production reporting, 
by whom and in what units (e.g., volume, weight, number of seeds, etc.) 
would be

[[Page 16315]]

appropriate? Should reporting units be dependent on the reproductive 
methodology of the crop (e.g., seeds, bulbs, or tubers)? Given your 
response to Unit IV.1.a., what types of production reporting would 
provide the Agency with information valuable for compliance assurance 
purposes and for managing any potential risks associated with a 
violation?
    c. Recordkeeping and inspection (Unit III.3.). What establishments 
or other locations are appropriate to be inspected for records and 
samples, and what records would be appropriate for producers of PIPs to 
maintain?
    d. Labeling (Unit III.4.). Please comment on current labeling 
practices for PIPs. Are current labeling practices sufficient? For 
example, do grower agreements offer sufficient information and 
compliance assurance to ensure registered PIPs are used in a manner 
that protects human health and the environment? Are there circumstances 
where labeling different from that currently in practice for PIPs may 
be appropriate?
    e. Experimental use permits (Unit III.5.). Are there aspects of 
production in association with PIP EUPs that are different from 
production associated with other types of pesticides used in EUPs? If 
there are differences, how should they be addressed for PIP EUPs?
    f. Production for export (Unit III.6.). What conditions would 
ensure that a PIP is intended for export only, and what would be 
necessary for such a PIP to meet the requirements of FIFRA?
    2. Are there other characteristics not described in this document 
unique to PIPs that may affect the application of the existing 
regulations associated with pesticide establishments and pesticide 
production to PIP producers?
    3. Are there additional sections of FIFRA implementing regulations 
related to pesticide establishment and production regulations that 
should be modified to more effectively address the unique 
characteristics of PIPs?

V. Do Any Statutory or Executive Order Reviews Apply to this Action?

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has determined that ANPRMs are considered ``significant 
regulatory actions'' under section 3(f) of the Executive Order. The 
Agency therefore submitted this document to OMB for the 10-day review 
period afforded under this Executive order. Any changes made in 
response to OMB comments during that review have been documented in the 
docket as required by the Executive order.
    Since this ANPRM does not impose or propose any requirements, and 
instead seeks comments and suggestions for the Agency to consider in 
possibly developing a subsequent proposed rule, the various other 
review requirements that apply when an agency imposes requirements do 
not apply to this action.
    As part of your comments on this ANPRM, you may include any 
comments or information that you have regarding this action. In 
particular, any comments or information that would help the Agency to 
assess the potential impact of a rule on small entities pursuant to the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.); to consider 
voluntary consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note); to consider environmental 
health or safety effects on children pursuant to Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997); or to consider human health 
or environmental effects on minority or low-income populations pursuant 
to Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994). The Agency will consider 
such comments during the development of any subsequent notice of 
proposed rulemaking as it takes appropriate steps to address any 
applicable requirements.

List of Subjects in 40 CFR Parts 152, 156, 167, 168, 169, 172, 174

    Environmental protection, Pesticides and pests, Plant-incorporated 
protectants, Reporting and recordkeeping requirements.

    Dated: March 22, 2007.
Stephen L. Johnson,
Administrator.
[FR Doc. E7-6151 Filed 4-3-07; 8:45 am]

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