[Federal Register Volume 75, Number 114 (Tuesday, June 15, 2010)]
[Proposed Rules]
[Pages 33744-33747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14401]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 156
[EPA-HQ-OPP-2005-0327; FRL-8830-8]
RIN 2070-AJ74
Pesticide Management and Disposal; Standards for Pesticide
Containers and Containment; Proposed Change to Labeling Compliance Date
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to amend the pesticide container and
containment regulations to provide a 1-year extension of the 40 CFR
156.159 labeling compliance date from August 16, 2010 to August 16,
2011. This change is being proposed to address concerns raised by
stakeholders and as a result of further Agency consideration.
DATES: Comments must be received on or before July 15, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0327, 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-
2005-0327. 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: Nancy Fitz, Field and External Affairs
Division (FEAD) (7506P), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-7385; fax
number: (703) 308-2962; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are a
pesticide formulator. Potentially affected entities may include, but
are not limited to:
Pesticide formulators (NAICS code 32532), e.g.,
establishments that formulate and prepare insecticides, fungicides,
herbicides or other
[[Page 33745]]
pesticides from technical chemicals or concentrates produced by
pesticide manufacturing establishments.
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. Submitting CBI. Do not submit CBI 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 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.
II. Background
On August 16, 2006, EPA promulgated a final rule titled ``Pesticide
Management and Disposal; Standards for Pesticide Containers and
Containment'' (71 FR 47330) (container and containment rule),
establishing 40 CFR part 165 and amending 40 CFR part 156. The
container and containment rule established regulations for the safe
storage and disposal of pesticides to reduce the likelihood of
unreasonable adverse effects on human health and the environment. The
container and containment regulations include requirements for
pesticide container design; procedures, standards, and label language
to facilitate removal of pesticides from containers prior to their
being used, recycled, or discarded; and requirements for containment of
stationary pesticide containers and procedures for container refilling
operations. The 2006 rule required that all pesticide products
distributed or sold by a registrant as of August 16, 2009, bear labels
that comply with the rule's label language requirements (40 CFR
156.159). On October 29, 2008, EPA promulgated a final rule that made
various amendments to the container and containment rule, including
extending the original labeling compliance date from August 16, 2009 to
August 16, 2010.
Specifically, 40 CFR part 156, subpart H, titled ``Container
Labeling,'' requires the following information or statements on certain
pesticide product labels:
A statement identifying the container as nonrefillable or
refillable.
On nonrefillable containers, statements providing basic
instructions for managing the container and a batch code.
Cleaning instructions for some nonrefillable containers.
Cleaning instructions for refillable containers at the end
of their useful lives.
In addition, the container and containment rule modified several
existing requirements in 40 CFR 156.10, including allowing for blank
spaces on the labels of some refillable containers for the net contents
and EPA establishment number, and adding a reference to the container
and containment regulations in 40 CFR part 156, subpart H.
The 2008 rule that amended the container and containment rule by
extending the original labeling compliance date to August 16, 2010,
also changed the phrase ``sold or distributed'' to ``released for
shipment'' as associated with all of the compliance dates, and made
several other changes to the label requirements and various minor
editorial changes.
III. What is the Agency's Authority for Taking this Action?
These proposed regulations are issued pursuant to the authority
given the Administrator of EPA in sections 2 through 34 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136-136y.
Sections 19(e) and (f) of FIFRA, 7 U.S.C. 136a(e) and (f), grant EPA
broad authority to establish standards and procedures to assure the
safe use, reuse, storage, and disposal of pesticide containers. FIFRA
section 19(e) requires EPA to promulgate regulations for the design of
pesticide containers that will promote the safe storage and disposal of
pesticides. FIFRA section 19(f) requires EPA to promulgate regulations
prescribing procedures and standards for the removal of pesticides from
containers prior to disposal. FIFRA section 25(a), 7 U.S.C. 136w(a),
authorizes EPA to issue regulations to carry out provisions of FIFRA.
IV. What Action is the Agency Taking?
EPA is proposing to amend the container and containment regulations
to provide a 1-year extension of the 40 CFR 156.159 labeling compliance
date from August 16, 2010 to August 16, 2011. This change is being
proposed to address concerns raised by stakeholders and as a result of
further Agency consideration.
Accomplishing the label amendments required in 40 CFR part 156
subpart H is a multistep process. Registrants must identify the changes
appropriate for their particular products and apply to EPA for an
amended registration. EPA must review the proposed changes and
determine whether they are consistent with the regulations, and advise
the registrant of the Agency's findings. If the EPA approves the
changes, the registrant must then seek approval of the various state
pesticide regulatory agencies. Upon approval of the state agencies, the
registrant must have the new labels printed and applied to its
products.
In March 2010, EPA was contacted by stakeholders with concerns
about being able to have all labels changed by the label compliance
date of August 16, 2010. Some registrants have asserted that they will
not have sufficient time to change all labels for pesticides that are
released for shipment after August 16, 2010 despite efforts by
registrants, EPA's Office of Pesticide Programs
[[Page 33746]]
(OPP) and state agencies. The time constraints are due to several
factors, including:
More antimicrobial product labels than expected require
alternate rinsing instructions, rather than the standard text in the
regulations. Therefore, these amendments cannot be made by
notification, and require more time consuming reviews by EPA.
EPA's position on the appropriate container-related
statements (particularly rinsing and treatment of rinsate) for certain
pesticides has changed over time as a result of experience with
product-by-product label reviews. This has resulted in reconsideration
of some decisions, and has caused some confusion in the regulated
community.
The length of time for states to review and approve labels
is understood to be increasing due to the furlough days for staff in
some states and staffing reductions due to budget shortfalls.
EPA has concluded that there is insufficient time to change all
labels by August 16, 2010. Since registrants can decide which
registered products they wish to market at any given time, the Agency
does not have a precise count of the total number of label changes that
ultimately will be submitted to EPA for review. However, based upon a
review of recent Agency actions and discussions with registrants, EPA
estimates that the majority of label changes already have been
submitted and approved. On the other hand, EPA estimates that there are
at least 1,000 labels and potentially several thousand remaining
pesticide product labels that EPA still needs to review. Even if all of
those applications were submitted immediately, there would not be
enough time for the label changes to be approved by EPA and the states,
printed, and applied to all products that will be released for shipment
after August 16, 2010.
Because EPA actions contributed to the large number of outstanding
label changes, EPA is proposing to extend the compliance date in
Sec. 156.159 by 1 year, so that pesticide products released for
shipment by a registrant after August 16, 2011 would have to bear a
label that complies with the container requirements. EPA believes that
one additional year will provide enough time for EPA and the states to
review the label changes and for registrants to incorporate the changes
into their labels, provided that all applications are submitted soon.
This is based on an evaluation of the resources and the time it would
take for EPA to undertake a concerted effort to complete the review of
these remaining labels and discussions with State regulatory agencies
who estimated a range of 3 to 6 months for them to review and approve
the label revisions. EPA believes that a longer extension is
unjustified because the rule was published 4 years ago so registrants
have had a reasonable amount of time to prepare and submit their label
modification requests and because EPA has already extended the deadline
by 1 year.
Because this proposed 1-year extension could not become final and
effective before the current compliance date of August 16, 2010, EPA is
also issuing in today's Federal Register a final rule providing for a
4-month extension of the Sec. 156.159 compliance date. EPA believes
that 4 months will be sufficient to allow this proposed rule to become
final and effective, and will avoid the temporary removal of a
significant number of pesticides from the market while the rulemaking
process for this 1-year extension is completed.
While this rulemaking process moves forward, pesticide registrants
should continue to submit applications for label changes for their
products prior to the current deadline of August 16, 2010. EPA will
give priority to applications submitted prior to August 16, 2010, with
the goal of processing them to allow sufficient time for the registrant
to obtain state approvals of the new labeling by the revised compliance
date. Applications submitted after August 16, 2010 will be processed on
a non-priority basis only after all applications submitted prior to
that date have been processed. Registrants should carefully consider
this and the timing of their submission to ensure that they have
sufficient time to obtain state approvals by the revised compliance
date.
V. FIFRA Mandated Reviews
In accordance with FIFRA section 25(a) and (d), the Agency
submitted a draft of this proposed rule to the Committee on Agriculture
in the House of Representatives, the Committee on Agriculture,
Nutrition, and Forestry in the United States Senate, the Secretary of
Agriculture, and the FIFRA Scientific Advisory Panel (SAP). The SAP and
the Secretary of Agriculture waived review of this proposed rule.
VI. Statutory and Executive Order Reviews
This action only proposes to amend an existing regulation to extend
the current compliance date, it does not otherwise propose to amend or
impose any other requirements. As such, this action is not subject to
review by the Office of Management and Budget (OMB) as a ``significant
regulatory action'' under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Nor does it impose
or change any information collection burden that requires additional
review by OMB under the provisions of the Paperwork Reduction Act of
1995 (44 U.S.C. 3501 et seq.). The information collection activities
contained in the regulations are already approved under OMB control
number 2070-0133 (EPA ICR No. 1632). An agency may not conduct or
sponsor, and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.
The OMB control numbers for EPA's regulations in 40 CFR are listed in
40 CFR part 9.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed
rule does not have a significant adverse economic impact on a
substantial number of small entities. The proposed extension of the
compliance date is not expected to have any adverse economic impacts on
affected entities, regardless of their size. In general, EPA strives to
minimize potential adverse impacts on small entities when developing
regulations to achieve the environmental and human health protection
goals of the statute and the Agency. EPA solicits comments specifically
about potential small business impacts.
State, local, and tribal governments are rarely pesticide
applicants or registrants, so this proposed rule is not expected to
affect these governments. Accordingly, pursuant to Title II of the
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-1538), EPA has
determined that this action is not subject to the requirements in
sections 202 and 205 because it does not contain a Federal mandate that
may result in expenditures of $100 million or more for State, local,
and tribal governments, in the aggregate, or for the private sector in
any one year. In addition, this action does not significantly or
uniquely affect small governments or impose a significant
intergovernmental mandate, as described in sections 203 and 204 of
UMRA. For the same reasons, EPA has determined that this proposed rule
does not have ``federalism implications'' as specified in Executive
Order 13132, entitled Federalism (64 FR 43255, August 10, 1999),
because it would not have substantial direct effects on the States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various
[[Page 33747]]
levels of government, as specified in the Order. Thus, Executive Order
13132 does not apply to this proposed rule. Nor does it have ``tribal
implications'' as specified in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
22951, November 9, 2000). EPA is not aware of any tribal governments
which are pesticide registrants. Thus, Executive Order 13175 does not
apply to this action.
Since this action is not economically significant under Executive
Order 12866, it is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), and Executive Order 13211, entitled
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). In addition, EPA
interprets Executive Order 13045 as applying only to those regulatory
actions that concern health or safety risks, which is not the case in
this proposed rule.
This action does not involve technical standards that would require
the consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act (NTTAA)
(15 U.S.C. 272).
This action does not have an adverse impact on the environmental
and health conditions in low-income and minority communities.
Therefore, this action does not involve special consideration of
environmental justice related issues as specified in Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).
List of Subjects in 40 CFR Part 156
Environmental protection, Labeling, Pesticides and pests.
Dated: June 9, 2010.
Lisa P. Jackson,
Administrator.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 156--[AMENDED]
1. The authority citation for part 156 continues to read as
follows:
Authority: 7 U.S.C. 136 through 136y.
2. Revise Sec. 156.159 to read as follows:
Sec. 156.159 Compliance date.
Any pesticide product released for shipment by a registrant after
August 16, 2011 must bear a label that complies with Sec. Sec.
156.10(d)(7), 156.10(f), 156.10(i)(2)(ix), 156.140, 156.144, 156.146
and 156.156.
[FR Doc. 2010-14401 Filed 6-14-10; 8:45 am]
BILLING CODE 6560-50-S