Document ID: EPA-HQ-OPP-2009-0607-0017
Agency: epa
Document Type: Rule
Title: Labeling of Pesticide Products and Devices for Export
Posted Date: 2014-04-30T04:00Z

[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.

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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: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://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 http://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