Labeling of Pesticide Products and Devices for Export, 24347-24350 [2014-09843]
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Federal Register / Vol. 79, No. 83 / Wednesday, April 30, 2014 / Rules and Regulations
not be challenged later in proceedings to
enforce its requirements. See section
307(b)(2) of the CAA.
Dated: April 11, 2014.
W.C. Early,
Acting, Regional Administrator, Region III.
Subpart NN—Pennsylvania
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Nitrogen dioxide, Particulate
matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
2. In § 52.2020, the table in paragraph
(e)(1) is amended by revising the entry
for ‘‘Regional Haze Plan’’ to read as
follows:
■
40 CFR part 52 is amended as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
§ 52.2020
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1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Identification of plan.
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*
(e) * * *
(1) * * *
*
*
Name of nonregulatory SIP revision
Applicable
geographic area
State
submittal
date
EPA
approval date
Additional
explanation
*
*
Regional Haze Plan ..................
*
Statewide .................................
*
12/20/10
12/20/10
*
7/13/12, 77 FR 41279 ..............
4/30/14 [Insert page number
where the document begins].
*
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§ 52.2042; Limited Approval.
Reissuing of Limited Approval.
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BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 168
[EPA–HQ–OPP–2009–0607; FRL–9909–82]
RIN 2070–AJ53
Labeling of Pesticide Products and
Devices for Export
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
EPA is amending the
regulations that pertain to labeling of
pesticide products and devices intended
solely for export. This action will allow
placement of the required information
on collateral labeling attached to the
shipping container of such products
rather than on the immediate package of
each individual product in such a
shipment. This restores provisions that
previously allowed exporters to use
labeling attached to, or accompanying,
the product shipping container of the
export pesticide at all times when
shipped or held for shipment in the
United States.
DATES: This direct final rule is effective
July 29, 2014.
Written adverse comments must be
received on or before May 30, 2014. If
EPA receives adverse comment, EPA
will withdraw this direct final rule
before its effective date.
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SUMMARY:
16:04 Apr 29, 2014
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Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2009–0607, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Kathryn Boyle, Field and External
Affairs Division (7506P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
telephone number: (703) 305–6304;
email address: boyle.kathryn@epa.gov.
SUPPLEMENTARY INFORMATION:
ingredient used in producing a
pesticide. The following North
American Industrial Classification
System (NAICS) code category is not
intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include, but are not limited
to: Pesticide and other agricultural
chemical manufacturing (NAICS code
325320), e.g., pesticide manufacturing,
insecticide manufacturing, herbicide
manufacturing, and fungicide
manufacturing.
I. Executive Summary
D. What are the impacts of this action?
There are no costs associated with
this action, and the benefits provided
are related to avoiding potential costs.
Without these labeling provisions,
registrants would be required to place
ADDRESSES:
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A. Does this action affect me?
You may be potentially affected by
this action if you export a pesticide
product, a pesticide device, or an active
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B. What is the Agency’s authority for
taking this action?
This action is issued under the
authority of section 25(a) of the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA), 7 U.S.C. 136w(a), to carry
out the provisions of FIFRA section
17(a), 7 U.S.C. 136o(a).
C. What action is the Agency taking?
EPA is revising the regulations that
pertain to labeling of pesticide products
and devices intended solely for export.
This action will allow placement of the
required information on collateral
labeling attached to a shipping
container of such products rather than
on the label of each individual product
in such a shipment.
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Federal Register / Vol. 79, No. 83 / Wednesday, April 30, 2014 / Rules and Regulations
export-related labeling on the
immediate package of each individual
pesticide product in a shipping
container that is intended solely for
export. According to stakeholders, the
inability to use the labeling method
allowed under the previous regulations
could significantly increase their costs
and create trade barriers.
II. What are the direct final rule
procedures?
EPA is issuing a direct final rule,
which means that the effective date of
this direct final rule is July 29, 2014.
If EPA receives written adverse
comments on or before May 30, 2014,
EPA will withdraw the direct final rule
before its effective date; issue a
proposed rule to seek public comment
on the issue(s) raised by the adverse
comments received, provide a 30-day
period for public comment on that
issue; and then issue a new final rule.
III. Background
A. Summary of the 2011 Proposed Rule
On April 6, 2011 (76 FR 18995) (FRL–
8862–2), EPA issued a notice of
proposed rulemaking (NPRM) titled,
‘‘Regulation to Clarify Labeling of
Pesticides for Export.’’ EPA proposed to
clarify, restructure, and add specificity
to labeling regulations for the export of
unregistered pesticide products and
devices. In that NPRM, EPA proposed to
explicitly require labeling to accompany
the unregistered export pesticide
product or device at all times, even
when such products are being shipped
between registered establishments
operated by the same producer.
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B. Public Comments on the NPRM
The public comment period for the
April 6, 2011, NPRM closed on June 6,
2011, and six sets of comments were
submitted. Two of the commenters
pointed out several inconsistencies in
the use of the terms ‘‘label,’’ ‘‘labeling,’’
and ‘‘supplemental labeling’’ in the
proposal. One of those commenters also
urged ‘‘that all labeling requirements
should be in compliance with existing
regulations under 40 CFR 156.’’ The
comments are available in the docket
under docket ID number EPA–HQ–
OPP–2009–0607.
EPA analyzed the comments and
prepared a response to comments
document, which is available in the
docket under document number EPA–
HQ–OPP–2009–0607–0016. As part of
analyzing the comment on
inconsistencies in the use of the terms
‘‘label,’’ ‘‘labeling,’’ and ‘‘supplemental
labeling,’’ EPA referred to the FIFRA
definitions of ‘‘label’’ and ‘‘labeling.’’
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FIFRA section 2(p)(1) defines label as
‘‘the written, printed, or graphic matter
on, or attached to, the pesticide or
device or any of its containers or
wrappers.’’ Under FIFRA section
2(p)(2), labeling is a more inclusive term
which includes labels as well as ‘‘all
other written, printed, or graphic
matter’’ that accompanies the product at
any time, or to which reference is made
on a label or in literature accompanying
the pesticide or device. Because the two
terms are not interchangeable, EPA
agreed that inconsistent use could create
confusion. Thus, as EPA began to write
the regulatory text for the final rule, the
Agency carefully evaluated the
regulatory text for possibly confusing
uses of the terms ‘‘label’’ and ‘‘labeling.’’
During that evaluation, and bearing in
mind the comment that ‘‘all labeling
requirements should be in compliance
with existing regulations under 40 CFR
156,’’ EPA analyzed proposed
§ 168.66(b). This section specified that
‘‘the required label information may be
fully met by’’ and then provided several
examples of ways to provide the
required label information. One of the
examples referred to ‘‘supplemental
labeling.’’ At that time, EPA determined
to provide a reference to the existing
label regulations in 40 CFR part 156,
instead of providing examples of ways
to meet the required label information.
Specifically, EPA referred to 40 CFR
156.10(a)(4), which is titled ‘‘Placement
of Label,’’ believing that provision
would provide appropriate and accurate
information.
C. The 2013 Final Rule
The final rule titled ‘‘Labeling of
Pesticide Products and Devices for
Export; Clarification of Requirements’’
published on January 18, 2013 (78 FR
4073) (FRL–9360–8). The rule was
effective on March 19, 2013, with a
compliance date of January 21, 2014.
IV. This Direct Final Rule
Industry stakeholders subsequently
brought to the Agency’s attention their
concern that removing the term
‘‘supplemental labeling’’ resulted in the
removal of a provision stating that such
supplemental labeling can be attached
to a shipping container holding export
pesticides or devices rather than to each
individual product container in a
shipment. They stated that the inability
of registrants to use ‘‘supplemental
labeling’’ in that manner could create
trade barriers and increase costs. The
purpose of this direct final rule is to
address those concerns.
EPA now believes that the term
‘‘supplemental labeling’’ is not the
appropriate term to describe the
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material or documentation used to meet
the requirements of the export labeling
rules. To more accurately describe the
materials other than ‘‘labels’’ that are
acceptable for meeting these
requirements, EPA believes that a better
term is ‘‘collateral labeling.’’ EPA has
already described collateral labeling in
the Label Review Manual (LRM), page
3–2 (see https://www.epa.gov/oppfead1/
labeling/lrm/chap-03.pdf) as follows:
Bulletins, leaflets, circulars, brochures,
data sheets, flyers or other written, printed or
graphic matter which are referred to on the
label or which are to accompany the product
are known in Agency practice as ‘‘collateral
labeling.’’ Such labeling is subject to
applicable requirements of FIFRA and the
Agency’s regulations.
Accordingly, in this direct final rule
EPA is using the term ‘‘collateral
labeling’’ in restoring the ability of
exporters to comply with export
labeling requirements through materials
that are not attached to each individual
export product’s immediate container.
EPA is revising existing 40 CFR 168.66
to remove the reference to 40 CFR
156.10(a)(4), and to restore the
inadvertently eliminated provisions that
allowed exporters to use such collateral
labeling attached to, or accompanying,
the product shipping container of the
export pesticide at all times when
shipped or held for shipment in the
United States. EPA will also restructure
40 CFR part 168, subpart D, by moving
the text in § 168.68 and some of the text
in § 168.66 to new § 168.65.
V. FIFRA Review Requirements
In accordance with FIFRA section
25(a), EPA submitted the draft direct
final rule to the Secretary of Agriculture
(USDA), the FIFRA Scientific Advisory
Panel (SAP), and appropriate
Congressional Committees. On February
10, 2014, the FIFRA SAP waived its
review of this direct final rule because
the changes ‘‘are administrative in
nature and do not contain scientific
issues that require the SAP’s
consideration.’’ On March 12, 2014,
USDA waived review of this direct final
rule, because this action merely
‘‘corrects the regulatory text.’’
VI. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This direct final rule is not a
‘‘significant regulatory action’’ under
the terms of Executive Order 12866 (58
FR 51735, October 4, 1993) and was not,
therefore, submitted to the Office of
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Management and Budget (OMB) for
review under Executive Orders 12866
and 13563 (76 FR 3821, January 21,
2011).
B. Paperwork Reduction Act (PRA)
According to the PRA, 44 U.S.C. 3501
et seq., an agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA regulations in title 40
of the CFR, after appearing in the
Federal Register , are listed in 40 CFR
part 9, and included on the related
collection instrument or form, as
applicable.
The information collection
requirements associated with reporting
under 40 CFR part 168 have already
been approved by OMB pursuant to
PRA under OMB control number 2070–
0027 (EPA ICR No. 0161). This direct
final rule is not expected to involve an
increase in information collection
activities and there are no additional
burdens imposed by this direct final
rule that requires additional review or
approval by OMB.
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C. Regulatory Flexibility Act (RFA)
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA, 5 U.S.C. 601 et seq. In
making this determination, the impact
of concern is any significant adverse
economic impact on small entities,
because the primary purpose of a final
regulatory flexibility analysis is to
identify and address regulatory
alternatives that ‘‘minimize the
significant economic impact on small
entities’’ 5 U.S.C. 604. Thus, an agency
may certify that a rule will not have a
significant economic impact on a
substantial number of small entities if
the rule has no net burden effect on the
small entities subject to the rule. As
indicated previously, EPA is restoring a
provision that was inadvertently
removed from the regulation. We have
therefore concluded that this action will
have no net regulatory burden for all
directly regulated small entities.
D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain any
unfunded mandate as described in
UMRA, 2 U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments. This action imposes no
enforceable duty on any State, local or
tribal governments, because no State,
local, or tribal government is known to
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produce, transport, formulate, package,
or export unregistered pesticide
products or devices. As indicated
previously, EPA is restoring a provision
that was inadvertently removed from
the regulation. As such, the action will
have a net affect on producers,
transporters, formulators, packagers,
and exporters of unregistered pesticide
products and devices intended solely
for export.
E. Executive Order 13132: Federalism
This action will not have substantial
direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999).
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications because it is expected to
only affect producers, transporters,
formulators, packagers, and exporters of
unregistered pesticide products and
devices. Since no Indian tribal
government is known to produce,
transport, formulate, package, or export
unregistered pesticide products or
devices, this action has no tribal
implications. Accordingly, the
requirements of Executive Order 13175
(65 FR 67249, November 9, 2000) do not
apply to this action.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety
This action is not subject to Executive
Order 13045 (62 FR 19885, April 23,
1997), because this action does not
address environmental health or safety
risks disproportionately affecting
children.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 (66 FR 28355, May 22,
2001), because this action is not
expected to affect energy supply,
distribution, or use.
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J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
EPA has determined that this action
will not have disproportionately high
and adverse human health or
environmental effects on minority or
low-income populations because it
increases the level of environmental
protection for all affected populations
without having any disproportionately
high and adverse human health or
environmental effects on any
population, including any minority or
low-income population. As such, this
action does not entail special
considerations of environmental justicerelated issues as delineated by
Executive Order 12898 (59 FR 7629,
February 16, 1994).
VII. Congressional Review Act (CRA)
Pursuant to the CRA, 5 U.S.C. 801 et
seq., EPA will submit a report
containing this direct final 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 direct final rule in the
Federal Register. This action is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 168
Environmental protection,
Administrative practice and procedure,
Advertising, Exports, Labeling,
Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 24, 2014.
James Jones,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
Therefore, 40 CFR chapter I is
amended as follows:
PART 168—[AMENDED]
1. The authority citation for part 168
continues to read as follows:
■
Authority: 7 U.S.C. 136–136y.
2. Revise the heading for subpart D to
part 168 to read as follows:
■
Subpart D—Procedures for Exporting
Pesticides
3. Add § 168.65 to subpart D to read
as follows:
■
I. National Technology Transfer and
Advancement Act (NTTAA)
§ 168.65
Since this action does not involve any
technical standards, NTTAA section
12(d), 15 U.S.C. 272 note, does not
apply to this action.
(a) This subpart describes the labeling
requirements applicable to pesticide
products and devices that are intended
solely for export from the United States
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Applicability.
30APR1
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Federal Register / Vol. 79, No. 83 / Wednesday, April 30, 2014 / Rules and Regulations
under the provisions of FIFRA section
17(a).
(b) This subpart applies to all export
pesticide products and export pesticide
devices that are exported for any
purpose, including research.
(c) Export pesticide products and
export pesticide devices are also subject
to requirements for pesticide production
reporting, recordkeeping and inspection
and purchaser acknowledgement
provisions that can be found in the
following parts:
(1) Pesticide production reporting
requirements under FIFRA section 7 are
located in part 167 of this chapter (as
referenced in § 168.85(b)).
(2) Recordkeeping and inspection
requirements under FIFRA section 8 are
located in part 169 of this chapter (as
referenced in § 168.85(a)).
(3) Purchaser acknowledgement
statement provisions under FIFRA
section 17(a) are located in § 168.75.
■ 4. Revise § 168.66 to read as follows:
■
§ 168.66 Labeling of pesticide products
and devices for export.
AGENCY:
Any label and labeling information
requirements in §§ 168.69, 168.70, and
168.71 that are not met fully on the
product label attached to the immediate
product container may be met by
collateral labeling that is either:
(a) Attached to the immediate product
(container label); or
(b) Attached to or accompanies the
shipping container of the export
pesticide or export device at all times
when it is shipped or held for shipment
in the United States.
§ 168.68
[Removed and Reserved]
5. Remove and reserve § 168.68.
6. Revise § 168.69(a) to read as
follows:
■
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§ 168.69 Registered export pesticide
products.
(a) Each export pesticide product that
is registered under FIFRA section 3 or
FIFRA section 24(c) must bear labeling
approved by EPA for its registration or
collateral labeling in compliance with
§ 168.66.
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■ 7. Revise § 168.70(b) to read as
follows:
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§ 168.70 Unregistered export pesticide
products.
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(b) Each unregistered export pesticide
product must bear labeling that
complies with all requirements of this
section or collateral labeling in
compliance with § 168.66.
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8. Revise § 168.71(a) to read as
follows:
§ 168.71
Export pesticide devices.
(a) Each export pesticide device sold
or distributed anywhere in the United
States must bear labeling that complies
with all requirements of this section or
collateral labeling in compliance with
§ 168.66.
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[FR Doc. 2014–09843 Filed 4–25–14; 4:15 pm]
BILLING CODE 6560–50–P
FEDERAL MARITIME COMMISSION
46 CFR Parts 501 and 503
RIN 3072–ZA03
[Docket No. 14–03]
Requests for Testimony by Employees
Relating to Official Information and
Production of Official Records in
Litigation
ACTION:
Federal Maritime Commission.
Direct final rule.
This regulation amends the
Commission’s provisions for release of
public information and related
delegation of authority by issuing
procedures for requests for testimony by
Federal Maritime Commission
employees and production of official
Commission records in litigation, and
delegating responsibility for
determinations relating to such
procedures to the General Counsel. It
generally provides that Commission
employees may not appear as witnesses
in connection with information
acquired in the course of performing
official duties, or produce Commission
records in litigation, without the
consent of the Commission. The
intended effect of this regulation is to
clarify the Commission’s procedures,
conserve the ability of the Commission
to conduct official business, preserve its
employee resources, minimize
involvement in matters unrelated to its
mission and programs, and maintain its
impartiality. This regulation does not
apply to Congressional inquiries,
Federal court civil proceedings in which
the United States is a party, or Freedom
of Information Act and Privacy Act
requests.
DATES: This rule is effective July 31,
2014 without further action, unless
significant adverse comment is received
by June 2, 2014. If significant adverse
comment is received, the Federal
Maritime Commission will publish a
timely withdrawal of the rule in the
Federal Register.
SUMMARY:
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Submit comments to: Karen
V. Gregory, Secretary, Federal Maritime
Commission, 800 North Capitol Street
NW., Washington, DC 20573–0001 or
email non-confidential comments to:
Secretary@fmc.gov (email comments as
attachments preferably in Microsoft
Word or PDF).
FOR FURTHER INFORMATION CONTACT:
Karen V. Gregory, Secretary, Federal
Maritime Commission, 800 N. Capitol
Street NW., Washington, DC 20573–
0001, (202) 523–5725, Fax (202) 523–
0014, Email: Secretary@fmc.gov.
Tyler J. Wood, Deputy General Counsel,
Federal Maritime Commission, 800 N.
Capitol Street NW., Washington, DC
20573–0001, (202) 523–5740, Fax
(202) 523–5738, Email:
GeneralCounsel@fmc.gov.
SUPPLEMENTARY INFORMATION: At
present, Commission regulations do not
specify procedures for its employees to
respond to subpoenas or produce
Commission records in private
litigation. In the absence of such
procedures, an employee could give
testimony or provide records, diverting
such employee from performing his/her
duties, and potentially creating the
appearance that the Commission is
taking sides in private litigation. This
regulation is intended to address this
situation by generally prohibiting both
appearances and compliance with
subpoenas unless authorized by the
Commission, and setting forth
procedures for handling such requests.
The courts have recognized the
authority of Federal agencies set
procedures for dealing with such
subpoenas. United States ex rel. Touhy
v. Ragen, 340 U.S. 462 (1951); see also
Truex v. Allstate Ins. Co., 233 F.R.D.
188, 190 (D.D.C. 2006); Bobreski v. EPA,
284 F. Supp. 2d 67, 73 (D.D.C. 2003).
This regulation describes procedures
by which the Commission will make its
employees and records available in
response to subpoenas in Federal court
civil proceedings in which the United
States is not a party. The regulation does
not apply to Congressional proceedings,
or to Federal court civil proceedings in
which the United States is a party. This
regulation likewise does not apply to
either Freedom of Information Act or
Privacy Act requests. This regulation
does not restrict the ability of its
employees to appear as private citizens
on their own time or while in an
approved leave status, in proceedings
that do not relate to Commission
policies and programs.
This rule relates to internal agency
management. Therefore, pursuant to 5
U.S.C. 553, notice and comment are not
required and this rule may become
ADDRESSES:
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]]>Agencies
[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Rules and Regulations]
[Pages 24347-24350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09843]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 168
[EPA-HQ-OPP-2009-0607; FRL-9909-82]
RIN 2070-AJ53
Labeling of Pesticide Products and Devices for Export
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is amending the regulations that pertain to labeling of
pesticide products and devices intended solely for export. This action
will allow placement of the required information on collateral labeling
attached to the shipping container of such products rather than on the
immediate package of each individual product in such a shipment. This
restores provisions that previously allowed exporters to use labeling
attached to, or accompanying, the product shipping container of the
export pesticide at all times when shipped or held for shipment in the
United States.
DATES: This direct final rule is effective July 29, 2014.
Written adverse comments must be received on or before May 30,
2014. If EPA receives adverse comment, EPA will withdraw this direct
final rule before its effective date.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0607, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 305-6304; email address:
boyle.kathryn@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action affect me?
You may be potentially affected by this action if you export a
pesticide product, a pesticide device, or an active ingredient used in
producing a pesticide. The following North American Industrial
Classification System (NAICS) code category is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include, but are not limited to: Pesticide and other agricultural
chemical manufacturing (NAICS code 325320), e.g., pesticide
manufacturing, insecticide manufacturing, herbicide manufacturing, and
fungicide manufacturing.
B. What is the Agency's authority for taking this action?
This action is issued under the authority of section 25(a) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136w(a), to carry out the provisions of FIFRA section 17(a), 7 U.S.C.
136o(a).
C. What action is the Agency taking?
EPA is revising the regulations that pertain to labeling of
pesticide products and devices intended solely for export. This action
will allow placement of the required information on collateral labeling
attached to a shipping container of such products rather than on the
label of each individual product in such a shipment.
D. What are the impacts of this action?
There are no costs associated with this action, and the benefits
provided are related to avoiding potential costs. Without these
labeling provisions, registrants would be required to place
[[Page 24348]]
export-related labeling on the immediate package of each individual
pesticide product in a shipping container that is intended solely for
export. According to stakeholders, the inability to use the labeling
method allowed under the previous regulations could significantly
increase their costs and create trade barriers.
II. What are the direct final rule procedures?
EPA is issuing a direct final rule, which means that the effective
date of this direct final rule is July 29, 2014.
If EPA receives written adverse comments on or before May 30, 2014,
EPA will withdraw the direct final rule before its effective date;
issue a proposed rule to seek public comment on the issue(s) raised by
the adverse comments received, provide a 30-day period for public
comment on that issue; and then issue a new final rule.
III. Background
A. Summary of the 2011 Proposed Rule
On April 6, 2011 (76 FR 18995) (FRL-8862-2), EPA issued a notice of
proposed rulemaking (NPRM) titled, ``Regulation to Clarify Labeling of
Pesticides for Export.'' EPA proposed to clarify, restructure, and add
specificity to labeling regulations for the export of unregistered
pesticide products and devices. In that NPRM, EPA proposed to
explicitly require labeling to accompany the unregistered export
pesticide product or device at all times, even when such products are
being shipped between registered establishments operated by the same
producer.
B. Public Comments on the NPRM
The public comment period for the April 6, 2011, NPRM closed on
June 6, 2011, and six sets of comments were submitted. Two of the
commenters pointed out several inconsistencies in the use of the terms
``label,'' ``labeling,'' and ``supplemental labeling'' in the proposal.
One of those commenters also urged ``that all labeling requirements
should be in compliance with existing regulations under 40 CFR 156.''
The comments are available in the docket under docket ID number EPA-HQ-
OPP-2009-0607.
EPA analyzed the comments and prepared a response to comments
document, which is available in the docket under document number EPA-
HQ-OPP-2009-0607-0016. As part of analyzing the comment on
inconsistencies in the use of the terms ``label,'' ``labeling,'' and
``supplemental labeling,'' EPA referred to the FIFRA definitions of
``label'' and ``labeling.'' FIFRA section 2(p)(1) defines label as
``the written, printed, or graphic matter on, or attached to, the
pesticide or device or any of its containers or wrappers.'' Under FIFRA
section 2(p)(2), labeling is a more inclusive term which includes
labels as well as ``all other written, printed, or graphic matter''
that accompanies the product at any time, or to which reference is made
on a label or in literature accompanying the pesticide or device.
Because the two terms are not interchangeable, EPA agreed that
inconsistent use could create confusion. Thus, as EPA began to write
the regulatory text for the final rule, the Agency carefully evaluated
the regulatory text for possibly confusing uses of the terms ``label''
and ``labeling.''
During that evaluation, and bearing in mind the comment that ``all
labeling requirements should be in compliance with existing regulations
under 40 CFR 156,'' EPA analyzed proposed Sec. 168.66(b). This section
specified that ``the required label information may be fully met by''
and then provided several examples of ways to provide the required
label information. One of the examples referred to ``supplemental
labeling.'' At that time, EPA determined to provide a reference to the
existing label regulations in 40 CFR part 156, instead of providing
examples of ways to meet the required label information. Specifically,
EPA referred to 40 CFR 156.10(a)(4), which is titled ``Placement of
Label,'' believing that provision would provide appropriate and
accurate information.
C. The 2013 Final Rule
The final rule titled ``Labeling of Pesticide Products and Devices
for Export; Clarification of Requirements'' published on January 18,
2013 (78 FR 4073) (FRL-9360-8). The rule was effective on March 19,
2013, with a compliance date of January 21, 2014.
IV. This Direct Final Rule
Industry stakeholders subsequently brought to the Agency's
attention their concern that removing the term ``supplemental
labeling'' resulted in the removal of a provision stating that such
supplemental labeling can be attached to a shipping container holding
export pesticides or devices rather than to each individual product
container in a shipment. They stated that the inability of registrants
to use ``supplemental labeling'' in that manner could create trade
barriers and increase costs. The purpose of this direct final rule is
to address those concerns.
EPA now believes that the term ``supplemental labeling'' is not the
appropriate term to describe the material or documentation used to meet
the requirements of the export labeling rules. To more accurately
describe the materials other than ``labels'' that are acceptable for
meeting these requirements, EPA believes that a better term is
``collateral labeling.'' EPA has already described collateral labeling
in the Label Review Manual (LRM), page 3-2 (see https://www.epa.gov/oppfead1/labeling/lrm/chap-03.pdf) as follows:
Bulletins, leaflets, circulars, brochures, data sheets, flyers
or other written, printed or graphic matter which are referred to on
the label or which are to accompany the product are known in Agency
practice as ``collateral labeling.'' Such labeling is subject to
applicable requirements of FIFRA and the Agency's regulations.
Accordingly, in this direct final rule EPA is using the term
``collateral labeling'' in restoring the ability of exporters to comply
with export labeling requirements through materials that are not
attached to each individual export product's immediate container. EPA
is revising existing 40 CFR 168.66 to remove the reference to 40 CFR
156.10(a)(4), and to restore the inadvertently eliminated provisions
that allowed exporters to use such collateral labeling attached to, or
accompanying, the product shipping container of the export pesticide at
all times when shipped or held for shipment in the United States. EPA
will also restructure 40 CFR part 168, subpart D, by moving the text in
Sec. 168.68 and some of the text in Sec. 168.66 to new Sec. 168.65.
V. FIFRA Review Requirements
In accordance with FIFRA section 25(a), EPA submitted the draft
direct final rule to the Secretary of Agriculture (USDA), the FIFRA
Scientific Advisory Panel (SAP), and appropriate Congressional
Committees. On February 10, 2014, the FIFRA SAP waived its review of
this direct final rule because the changes ``are administrative in
nature and do not contain scientific issues that require the SAP's
consideration.'' On March 12, 2014, USDA waived review of this direct
final rule, because this action merely ``corrects the regulatory
text.''
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This direct final rule is not a ``significant regulatory action''
under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993)
and was not, therefore, submitted to the Office of
[[Page 24349]]
Management and Budget (OMB) for review under Executive Orders 12866 and
13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA, 44 U.S.C. 3501 et seq., an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA regulations in title 40 of the
CFR, after appearing in the Federal Register , are listed in 40 CFR
part 9, and included on the related collection instrument or form, as
applicable.
The information collection requirements associated with reporting
under 40 CFR part 168 have already been approved by OMB pursuant to PRA
under OMB control number 2070-0027 (EPA ICR No. 0161). This direct
final rule is not expected to involve an increase in information
collection activities and there are no additional burdens imposed by
this direct final rule that requires additional review or approval by
OMB.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, the impact of concern
is any significant adverse economic impact on small entities, because
the primary purpose of a final regulatory flexibility analysis is to
identify and address regulatory alternatives that ``minimize the
significant economic impact on small entities'' 5 U.S.C. 604. Thus, an
agency may certify that a rule will not have a significant economic
impact on a substantial number of small entities if the rule has no net
burden effect on the small entities subject to the rule. As indicated
previously, EPA is restoring a provision that was inadvertently removed
from the regulation. We have therefore concluded that this action will
have no net regulatory burden for all directly regulated small
entities.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action imposes no enforceable duty on any
State, local or tribal governments, because no State, local, or tribal
government is known to produce, transport, formulate, package, or
export unregistered pesticide products or devices. As indicated
previously, EPA is restoring a provision that was inadvertently removed
from the regulation. As such, the action will have a net affect on
producers, transporters, formulators, packagers, and exporters of
unregistered pesticide products and devices intended solely for export.
E. Executive Order 13132: Federalism
This action will not have substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications because it is
expected to only affect producers, transporters, formulators,
packagers, and exporters of unregistered pesticide products and
devices. Since no Indian tribal government is known to produce,
transport, formulate, package, or export unregistered pesticide
products or devices, this action has no tribal implications.
Accordingly, the requirements of Executive Order 13175 (65 FR 67249,
November 9, 2000) do not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this action does not address environmental
health or safety risks disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not expected to affect energy
supply, distribution, or use.
I. National Technology Transfer and Advancement Act (NTTAA)
Since this action does not involve any technical standards, NTTAA
section 12(d), 15 U.S.C. 272 note, does not apply to this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
EPA has determined that this action will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. As such, this action does not entail special
considerations of environmental justice-related issues as delineated by
Executive Order 12898 (59 FR 7629, February 16, 1994).
VII. Congressional Review Act (CRA)
Pursuant to the CRA, 5 U.S.C. 801 et seq., EPA will submit a report
containing this direct final 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 direct final
rule in the Federal Register. This action is not a ``major rule'' as
defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 168
Environmental protection, Administrative practice and procedure,
Advertising, Exports, Labeling, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 24, 2014.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, 40 CFR chapter I is amended as follows:
PART 168--[AMENDED]
0
1. The authority citation for part 168 continues to read as follows:
Authority: 7 U.S.C. 136-136y.
0
2. Revise the heading for subpart D to part 168 to read as follows:
Subpart D--Procedures for Exporting Pesticides
0
3. Add Sec. 168.65 to subpart D to read as follows:
Sec. 168.65 Applicability.
(a) This subpart describes the labeling requirements applicable to
pesticide products and devices that are intended solely for export from
the United States
[[Page 24350]]
under the provisions of FIFRA section 17(a).
(b) This subpart applies to all export pesticide products and
export pesticide devices that are exported for any purpose, including
research.
(c) Export pesticide products and export pesticide devices are also
subject to requirements for pesticide production reporting,
recordkeeping and inspection and purchaser acknowledgement provisions
that can be found in the following parts:
(1) Pesticide production reporting requirements under FIFRA section
7 are located in part 167 of this chapter (as referenced in Sec.
168.85(b)).
(2) Recordkeeping and inspection requirements under FIFRA section 8
are located in part 169 of this chapter (as referenced in Sec.
168.85(a)).
(3) Purchaser acknowledgement statement provisions under FIFRA
section 17(a) are located in Sec. 168.75.
0
4. Revise Sec. 168.66 to read as follows:
Sec. 168.66 Labeling of pesticide products and devices for export.
Any label and labeling information requirements in Sec. Sec.
168.69, 168.70, and 168.71 that are not met fully on the product label
attached to the immediate product container may be met by collateral
labeling that is either:
(a) Attached to the immediate product (container label); or
(b) Attached to or accompanies the shipping container of the export
pesticide or export device at all times when it is shipped or held for
shipment in the United States.
Sec. 168.68 [Removed and Reserved]
0
5. Remove and reserve Sec. 168.68.
0
6. Revise Sec. 168.69(a) to read as follows:
Sec. 168.69 Registered export pesticide products.
(a) Each export pesticide product that is registered under FIFRA
section 3 or FIFRA section 24(c) must bear labeling approved by EPA for
its registration or collateral labeling in compliance with Sec.
168.66.
* * * * *
0
7. Revise Sec. 168.70(b) to read as follows:
Sec. 168.70 Unregistered export pesticide products.
* * * * *
(b) Each unregistered export pesticide product must bear labeling
that complies with all requirements of this section or collateral
labeling in compliance with Sec. 168.66.
* * * * *
0
8. Revise Sec. 168.71(a) to read as follows:
Sec. 168.71 Export pesticide devices.
(a) Each export pesticide device sold or distributed anywhere in
the United States must bear labeling that complies with all
requirements of this section or collateral labeling in compliance with
Sec. 168.66.
* * * * *
[FR Doc. 2014-09843 Filed 4-25-14; 4:15 pm]
BILLING CODE 6560-50-P
