[Federal Register: June 15, 2010 (Volume 75, Number 114)]
[Rules and Regulations]
[Page 33705-33708]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jn10-16]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 156
[EPA-HQ-OPP-2005-0327; FRL-8830-7]
RIN 2070-AJ74
Pesticide Management and Disposal; Standards for Pesticide
Containers and Containment; Change to Labeling Compliance Date
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is amending the pesticide container and containment
regulations to provide a 4-month extension of the 40 CFR 156.159
labeling compliance date from August
[[Page 33706]]
16, 2010 to December 16, 2010. This change is being made because there
is insufficient time for pesticide registrants, EPA and states to
complete the label amendments. This change will avoid the temporary
removal of a significant number of pesticides from the market while a
1-year extension proposed elsewhere in today's Federal Register
proceeds through the rulemaking process, and while pesticide
registrants, EPA and states work to update the pesticide labels to
comply with the label requirements in the container and containment
regulations.
DATES: This final rule is effective August 16, 2010.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0327. 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., Confidential Business Information (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 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 Docket
Facility is open 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, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-7385; fax number: (703) 308-2962; e-
mail address: fitz.nancy@epa.gov.
SUPPLEMENTARY INFORMATION:
I. 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 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.
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 Action is the Agency Taking?
EPA is amending the container and containment regulations to
provide a 4-month extension of the 40 CFR 156.159 labeling compliance
date from August 16, 2010 to December 16, 2010. This change is being
made to allow more time for the Agency to propose and solicit comments
on the consideration of a 1-year extension 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 (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
[[Page 33707]]
(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 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 believes that it is appropriate to extend the
Sec. 156.159 compliance date by 1 year, to August 16, 2011, and has
published in the Proposed Rules section of today's Federal Register a
Notice of Proposed Rulemaking soliciting public comment on such a 1-
year extension. Because that rulemaking effort could not become
effective before August 16, 2010, EPA is issuing this final rule
providing for a 4-month extension. As discussed in Unit IV., EPA
believes an additional 4 months will be sufficient to allow the
proposed rule to become final and effective, and that the proposed
additional year (not cumulative with the 4-month extension) 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.
During this 4-month extension, 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.
IV. What is the Agency's Authority for Taking this Action?
This final rule is 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.
Section 553(b)(B) of the Administrative Procedure Act (APA), 5
U.S.C. 553(b)(B), provides that, when an agency for good cause finds
that notice and public procedure are impracticable, unnecessary or
contrary to the public interest, the agency may issue a rule without
providing notice and an opportunity for public comment. EPA has
determined that there is good cause for making today's rule final
without prior proposal and opportunity for comment because such notice
and opportunity for comment is contrary to the public interest, for the
following reasons.
EPA is extending by 4 months the existing August 16, 2010 deadline
for complying with the 40 CFR part 156 subpart H requirements that
pesticide products bear label language to facilitate the safe use,
refill and reuse of containers and the removal of pesticides from
containers prior to their being recycled or discarded. Providing a
comment period would not allow enough time to make the rule change
effective before the compliance deadline. Publishing a proposed rule
for comment would be contrary to the public interest because the August
16, 2010 deadline, if left unchanged, would temporarily remove from the
market a significant number of pesticides important to the protection
of public health and the nation's food supply, without comparable
benefits to public health or the environment.
EPA had anticipated that the August 16, 2010 deadline would allow
an appropriate length of time for new language to be incorporated into
the labels of roughly 15,000 registered products. In order to
facilitate this process, EPA has allowed expedited amendments to
pesticide registrations (per 40 CFR 152.46(a)) for changes that exactly
match the sample language provided in the regulation. EPA has recently
become aware that a disproportionate number of the remaining products
will require individualized review and approval of alternative, and
often unique, label language. Moreover, a majority of the products that
require individualized decisions are public health disinfectants and
sanitizers, which are critical to maintaining safe and sanitary
conditions in hospitals, food preparation areas, and other
institutional settings. While EPA believes that the 40 CFR part 156
subpart H requirements will provide substantial benefits to public
health and the environment over the long term, EPA does not believe
that the public interest is served by removing these products from the
market during the time necessary to approve and implement the new label
language. The statutory and procedural steps required for full notice
and comment rulemaking under FIFRA could not be completed before the
August 16, 2010 compliance date. Therefore, EPA is issuing this final
rule to extend the compliance date by 4 months to give the Agency time
to complete the notice and public comment procedure, which EPA is
initiating with the accompanying Notice of Proposed Rulemaking that is
published in the Proposed Rules section of today's Federal Register.
V. Statutory and Executive Order Reviews
This final rule only amends an existing regulation to extend the
current compliance date, it does not otherwise 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
[[Page 33708]]
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.
Because the Agency has made a ``good cause'' finding that this
action is not subject to notice-and-comment requirements under the APA
or any other statute as stated in Unit IV. of this preamble, it is not
subject to the regulatory flexibility provisions of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.), or to sections 202 and 205 of
the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-1538). 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.
This rule does not have tribal implications, as specified in
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 9, 2000), or
federalism implications as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999).
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 13211, Actions concerning
Regulations that Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001).
This action does not involve technical standards; thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.
This rule 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).
EPA's compliance with these statutes and Executive Orders for the
existing regulations is discussed in the August 16, 2006 and October
29, 2008 Federal Register documents.
VI. FIFRA Mandated Reviews
As provided in FIFRA section 25(a)(2) and (d), the Secretary of
Agriculture and the FIFRA Scientific Advisory Panel waived review of
this final rule. Also in accordance with FIFRA section 25(a), the
Agency transmitted this final rule to the Secretary of the Senate and
the Clerk of the House of Representatives.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 156
Environmental protection, Labeling, Pesticides and pests.
Dated: June 9, 2010.
Lisa P. Jackson,
Administrator.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 156--[AMENDED]
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1. The authority citation for part 156 continues to read as follows:
Authority: 7 U.S.C. 136 through 136y.
0
2. Revise Sec. 156.159 to read as follows:
Sec. 156.159 Compliance date.
Any pesticide product released for shipment by a registrant after
December 16, 2010 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. 2010-14403 Filed 6-14-10; 8:45 am]
BILLING CODE 6560-50-S