Labeling of Pesticide Products and Devices for Export; Clarification of Requirements, 40040-40043 [2014-16274]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Proposed Rules]
[Pages 40040-40043]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16274]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 168

[EPA-HQ-OPP-2009-0607; FRL-9913-19]
RIN 2070-AJ53


Labeling of Pesticide Products and Devices for Export; 
Clarification of Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing to amend the regulations that pertain to the 
labeling of pesticide products and devices that are intended solely for 
export. These amendments clarify that pesticide products and devices 
that are intended solely for export must meet the Agency's labeling 
requirements by attaching a label to the immediate product container or 
by providing collateral labeling that is either attached to the 
immediate product being exported or that accompanies the shipping 
container of the product being exported at all times when it is shipped 
or held for shipment in the United States. Collateral labeling will 
ensure the availability of the required labeling information, while 
allowing pesticide products and devices that are intended solely for 
export to be labeled for use in and consistent with the applicable 
requirements of the importing country.

DATES: Comments must be received on or before August 11, 2014.

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 list of North American Industrial 
Classification System (NAICS) codes 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., Pesticides manufacturing, 
Insecticides manufacturing, Herbicides manufacturing, Fungicides 
manufacturing, etc.

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 proposing to amend the regulations that pertain to the 
labeling of pesticide products and devices that are intended solely for 
export. These amendments clarify that pesticide products and devices 
that are intended solely for export must meet the Agency's labeling 
requirements by attaching a label to the immediate product container or 
by providing collateral labeling that is either attached to the 
immediate product being exported or that accompanies the shipping 
container of the product being exported at all times when it is shipped 
or held for shipment in the United States. Collateral labeling will 
ensure the availability of the required labeling information, while 
allowing pesticide products and devices that are intended solely for 
export to be labeled for use in and consistent with the applicable 
requirements of the importing country.

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 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. Background

A. The April 30, 2014 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

[[Page 40041]]

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 the direct final rule EPA published 
in the Federal Register of April 30, 2014 (79 FR 24347) (FRL-9909-82) 
was to address those concerns as expeditiously as possible.
    As indicated in the direct final rule, 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), p. 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, the direct final rule used 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. The direct final rule 
provided amendments for 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. The direct final rule also restructures 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.

B. Summary of the April 6, 2011 Proposed Rule

    In the Federal Register of April 6, 2011 (76 FR 18995) (FRL-8862-
2), EPA issued a proposed rule to clarify, restructure, and add 
specificity to labeling regulations for the export of unregistered 
pesticide products and devices. Additionally, that proposed rule 
explicitly requires 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.

C. Public Comments on the April 6, 2011 Proposed Rule

    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 proposed rule. 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 ID 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 FIFRA's definitions of 
``label'' and ``labeling.'' Section 2(p)(1) of FIFRA 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). Proposed 
Sec.  168.66(b) 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), believing that 
provision would provide appropriate and accurate information.

D. The January 18, 2013 Final Rule

    The final rule entitled ``Labeling of Pesticide Products and 
Devices for Export; Clarification of Requirements'' published in the 
Federal Register of January 18, 2013 (78 FR 4073) (FRL-9360-8). This 
final rule was effective on March 19, 2013, with a compliance date of 
January 21, 2014.

III. Withdrawal of the April 30, 2014 Direct Final Rule

    In the preamble to the direct final rule, EPA explained the 
Agency's reasons for these amendments, and that we would withdraw that 
direct final rule if written adverse comment were received within 30 
days of the publication of that direct final rule. Since EPA received 
written adverse comments, elsewhere in this issue of the Federal 
Register, EPA has withdrawn the direct final rule, and the direct final 
rule will not take effect.
    In accordance with the procedures described in the April 30, 2014 
direct final rule, EPA is publishing this proposed rule.

IV. Issues Raised by the Adverse Comments

    EPA received two written adverse comments in response to the direct 
final rule. Both commenters indicated their disagreement with EPA's 
approach on the use of collateral labeling. Their comments indicated 
their belief that individual pesticide products should be properly 
labeled, even if intended solely for export. One commenter indicated 
that this would only ``benefit the large pesticide producers, allowing 
them to cut the cost of production by not properly labeling 
everything.'' The other commenter indicated that labeling ``is critical 
to safe and rational use of pesticides.''
    EPA believes that both commenters misinterpreted the intent of the 
direct final rule and interpreted the direct final rule as removing or 
eliminating requirements. The amendments specified in the direct final 
rule do not remove or eliminate label requirements for individual 
pesticide products or devices that are intended solely for export. The 
amendments would have simply clarified that the label requirements for 
products intended for export can be met with labeling on the individual 
products with the addition of collateral labeling attached to either 
the product or the product shipment container.
    Typically, products that are manufactured in the United States for 
export bear a label which meets the requirements of the importing 
country.

[[Page 40042]]

Since that label may not meet all the FIFRA labeling requirements 
contained in 40 CFR part 168, the regulations previously allowed for 
these products to meet those requirements by labeling attached to the 
shipping container. As an example, a shrink-wrapped pallet of cartons 
would have only one FIFRA export label attached to the shrink-wrap. A 
pallet of unwrapped cartons, on the other hand, would have FIFRA export 
labels attached to each carton. In both cases, the individual products 
in those cartons are individually labeled for use in the importing 
country and in compliance with the applicable labeling requirements of 
that importing country. EPA believes that collateral labeling is 
appropriate for shipping containers holding pesticide products and 
devices that are intended solely for export because it ensures the 
availability of the information provided by the FIFRA export label 
requirements while those products are in transit in the United States.
    The amendments specified in the direct final rule were not to 
establish a new or substantively different requirement from that which 
existed until 2013, when a final rule inadvertently deleted the 
applicable provisions. After considering these adverse comments, EPA 
has determined no changes are needed, and is proposing the same 
regulatory text as that in the April 30, 2014 direct final rule.

V. FIFRA Review Requirements

    In accordance with FIFRA section 25(a), EPA previously submitted 
the draft proposed rule to the Secretary of Agriculture (USDA), the 
FIFRA Scientific Advisory Panel (SAP), and the appropriate 
Congressional Committees. On February 10, 2014, the FIFRA SAP waived 
its review of this proposed 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 proposed 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 proposed 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 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 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 proposed 
rule is not expected to involve an increase in information collection 
activities. There are no additional burdens imposed by this proposed 
rule that requires additional review or approval by OMB.

C. Regulatory Flexibility Act (RFA)

    I certify that this action, if finalized as proposed, will not have 
a significant economic impact on a substantial number of small entities 
under 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 an initial regulatory 
flexibility analysis is to identify and address regulatory alternatives 
``which minimize any significant economic impact of the rule on small 
entities'' 5 U.S.C. 603. 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.

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 proposed rule 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) does not apply to this proposed rule.

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

[[Page 40043]]

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).

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: July 3, 2014.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, it is proposed that 40 CFR chapter I be 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 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. In Sec.  168.69, revise paragraph (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. In Sec.  168.70, revise the introductory text of paragraph (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. In Sec.  168.71, revise paragraph (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. 2014-16274 Filed 7-10-14; 8:45 am]
BILLING CODE 6560-50-P