[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Proposed Rules]
[Pages 18995-19001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7900]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 168
[EPA-HQ-OPP-2009-0607; FRL-8862-2]
RIN 2070-AJ53
Pesticides; Regulation to Clarify Labeling of Pesticides for
Export
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revise the regulations on labeling of
pesticides and devices intended for export. Internal review of the
regulations revealed that the current regulations needed clarification
and restructuring to increase understandability and ease of use.
DATES: Comments must be received on or before June 6, 2011.
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 on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information, The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0607. EPA's policy is that all comments received will be included
in the docket without change and may be made
[[Page 18996]]
available on-line at hitp://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Vera Au, Field and External Affairs
Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-9069; fax number: (703) 305-5884; e-
mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you export a
pesticide product, a pesticide device, or an active ingredient used in
producing a pesticide. 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.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
Section 17(a)(1) of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) requires that unregistered pesticides and
devices intended for export be subject to several provisions that
include labeling, production reports, inspection of establishments, and
reporting and recordkeeping. These provisions are contained in 40 CFR
168.65 and 168.85. FIFRA section 17(a) further requires that exporters
obtain a purchaser acknowledgement statement (PAS) before exporting an
unregistered pesticide (but not a device). The requirements related to
PAS are contained in 40 CFR 168.75.
On February 18, 1993, regulations interpreting the FIFRA
requirements about the export of unregistered pesticides and devices
were published in the Federal Register (58 FR 9085) as subpart D of 40
CFR part 168. Subpart D implements FIFRA sections 17(a) and 17(b).
The current regulations in subpart D have not been changed since
1993. Recently, an EPA internal review determined that the 1993
regulations are not as clear as EPA intended and that the resulting
ambiguity might have led to uncertainty in compliance. To clarify the
regulations in order to aid compliance, EPA decided to propose adding a
more specific labeling requirement. In addition, EPA is restructuring
the regulations to increase ease of use. Clarification and
restructuring of the current regulations are administrative actions
with no significant policy issues.
This proposed rule will supplement the requirements of 40 CFR
168.65 Pesticide export label and labeling requirements.
B. What is the agency's authority for taking this action?
EPA is authorized under FIFRA to regulate the sale, distribution,
and use
[[Page 18997]]
of pesticide products and devices through a licensing (registration)
scheme. This action is issued under the authority of section 17 of
FIFRA (7 U.S.C. 136-136y).
Executive Order 12988, entitled Civil Justice Reform (61 FR 4729,
February 7, 1996), requires agencies that are reviewing existing
regulations take the necessary steps to eliminate drafting errors and
ambiguity, minimize potential litigation, and provide a clear legal
standard for affected conduct.
III. Purpose and Scope of Proposal
EPA is proposing to clarify, restructure, and add specificity to
labeling regulations for the export of unregistered pesticide products
and devices according to Executive Order 12988 to eliminate ambiguity
and simplify EPA regulations. This action is discretionary and is not
subject to a statutory, judicial, or administrative deadline.
Clarification, restructuring, and adding specificity will not change
the substance of the current requirements.
EPA is also proposing to include a specific indication that these
requirements also pertain to unregistered export pesticide products and
devices shipped between registered establishments operated by the same
producer pursuant to 40 CFR 152.30(a). Section 152.30(a) states that an
unregistered pesticide product transferred between registered
establishments operated by the same producer must be labeled according
to 40 CFR part 156. However, there are additional label requirements at
Sec. 168.65 that also apply to a subset of the products covered by
Sec. 152.30(a), specifically, unregistered export pesticide products.
For example, part 156 does not require that the label indicate that the
pesticide product or device is not registered for use in the United
States, while Sec. 168.65 requires the statement ``Not Registered for
Use in the United States'' to appear on the label of any unregistered
export pesticide product or device. This statement may be further
amplified by adding the reason for the unregistered status. For
example:
1. Not Registered for Use in the United States of America because
the product is exempt from registration;
2. Not Registered for Use in the United States of America because
pesticide devices are not required to be registered;
3. Not Registered for Use in the United States of America because
[insert crop name] is not grown in the United States.
EPA believes that including the information required by Sec.
168.65 on the label while an export product moves within the United
States prior to its actual export further protects public health and
the environment by contributing to safer and more appropriate handling
and distribution of unregistered pesticide products and devices. EPA
also believes that unregistered pesticide products and devices intended
for export must be clearly marked with the labeling according to Sec.
168.65 to prevent them from inadvertently entering the U.S. market. EPA
requests comment on the amplifications of the phrase ``Not Registered
for Use in the United States.''
IV. Overview of Proposed Changes
A. Clarification and Restructuring of Current Regulations
The clarifications and added specificity are consistent with
section 1(b)(12) of Executive Order 12866; this section requires each
agency to draft its regulations to be simple and easy to understand,
with the goal of minimizing the potential for uncertainty and
litigation arising from such uncertainty. Certainty can also contribute
to increased compliance with the requirements.
B. Definitions
In order to clarify and distinguish between the labeling
requirements for pesticide products from the requirements for pesticide
devices, two definitions are proposed for 40 CFR part 168, subpart D:
Export pesticide product, and export pesticide device. Export pesticide
products include registered export pesticide products and unregistered
export pesticide products. The requirements for registered export
pesticide products, unregistered export pesticide products, and export
pesticide devices are presented in separate categories. This way the
producer and/or exporter can more easily determine the status of the
product and follow the specific directions for its category.
C. Labeling Export Shipments of Unregistered Pesticides and Devices
Between Establishments Operated by Same Producer
EPA believes the minimal identity and safety information required
for export labeling in FIFRA section 17(a)(1) is important in ensuring
unregistered pesticide products and devices are properly identified
during transportation both within the United States and upon arrival in
the importing country. The current regulations in 40 CFR 152.30(a)
allow the transfer of unregistered pesticide products between
registered establishments operated by the same producer. The
notification of identity and safety measures of products intended for
export is not only important between the time the unregistered
pesticide product or device leaves a U.S. port and the time it arrives
in the importing country; this labeling is equally important while the
unregistered pesticide product or device is shipped between registered
establishments operated by the same producer within the United States.
EPA intended that the labeling requirements in Sec. 168.65 be
followed for each unregistered export pesticide product as it makes its
way towards the importing country. However, the regulations promulgated
in 1993 inadvertently failed to explicitly state that the Sec. 168.65
labeling requirements applied to unregistered pesticide products and
devices intended for export as they move between registered
establishments operated by the same producer in the United States,
including transfers authorized by Sec. 152.30(a).
If the producer exports an unregistered pesticide product or device
directly, then it is clear that the label that must accompany the
unregistered pesticide product or device when it leaves the production
facility must comply with Sec. 168.65.
The requirement to label the unregistered pesticide product and
pesticide device as it begins to move between registered establishments
operated by the same producer may transfer the responsibility for the
label to the producer from the exporter/reformulator/repackager if the
latter was primarily responsible for the label before export.
Therefore, EPA is proposing to explicitly require labeling as
prescribed by Sec. 168.65 to accompany the unregistered export
pesticide product or device at all times, even when they are being
shipped between registered establishments operated by the same
producer. Section 168.65 has been replaced by a proposed new numbering
of sections to accommodate the new categories of products and
accompanying regulations. EPA invites public comment on the requirement
for labeling unregistered pesticide products and devices being shipped
between establishments operated by the same producer.
V. Implementation
This proposal addresses the future labeling of unregistered
pesticide products and devices shipped between establishments operated
by the same producer. The proposed labeling
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requirements, once final, would apply to all pesticide products and
devices intended for export that are produced after the effective date
of the rule. The Agency believes that producers do not frequently
redesign the labels they use on unregistered pesticide products and
devices, so producers will have time to plan and implement any changes
to their current products or practices.
Therefore, the Agency is proposing an effective date of 1 year
after the date of publication of the final rule. The Agency requests
comment on the proposed effective date.
VI. FIFRA Review Requirements
In accordance with FIFRA section 25(a), EPA submitted a draft of
the proposed rule to the FIFRA Scientific Advisory Panel (SAP), the
Secretary of Agriculture (USDA), and appropriate Congressional
Committees. The FIFRA SAP waived its review of this proposal on
December 8, 2010, because this proposal does not raise scientific
issues. USDA waived the opportunity to review the draft proposal on
November 29, 2010, because clarification and restructuring of the
current regulations are administrative actions with no scientific or
policy issues.
VII. Statutory and Executive Order Reviews
A. Regulatory Planning and Review
This action is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget (OMB) under the terms of
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993).
EPA has determined that the cost is minimal to comply with the new
requirement that the unregistered pesticide product or device shipped
between registered establishments operated by the same producer be
labeled with the statement ``Not Registered for Use in the United
States.'' This determination was made given that labeling is already in
place under existing requirements and the burden of adding the
additional statement to unregistered products or devices shipped
between establishments would be negligible. EPA believes that this
labeling change may be easily accomplished using commonly available
word processing software; in addition, this label change does not
require label submission to or approval by EPA, and shall be phased in
as part of normal business operations. EPA concludes that the per firm
and industry level impact of the rule is not significant.
B. Information Collection Burdens
This action does not impose any new information collection burden
that would require additional review or approval by OMB under the
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. OMB previously
approved the information collection requirements contained in the
existing regulations, 40 CFR 168.65, and has assigned OMB control
number 2070-0027 (EPA ICR No. 0161). Burden is defined at 5 CFR
1320.3(b). 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 displayed in the Federal Register and are
listed in 40 CFR part 9.
C. Small Entity Impacts
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., the Agency hereby certifies that this action will
not have a significant adverse economic impact on a substantial number
of small entities.
Under the RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of this proposed rule on small entities, small
entity is defined in accordance with section 601 of the RFA as:
1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201. A small business
that manufactures pesticides and other agricultural chemicals as
defined by NAICS code 325320, has 500 or fewer employees based on the
SBA standards.
2. A small governmental jurisdiction that is a government of a
city, county, town, school district or special district with a
population of less than 50,000.
3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
The small entities directly regulated by this proposed rule are
small manufacturers of pesticides which export unregistered pesticide
products or devices.
EPA has determined that the cost is minimal to comply with the new
requirements that the unregistered pesticide product or device be
labeled with ``Not Registered for Use in the United States.'' This is
because the labeling is already in place under existing requirements
and the burden of adding the additional statement to unregistered
pesticide products or devices shipped between establishments operated
by the same producer would be negligible. EPA believes this labeling
change may be easily accomplished using commonly available word
processing software; in addition, this label change does not require
label submission to or approval by EPA, and shall be phased in as part
of normal business operations. EPA concludes that the per firm and
industry level impact of the proposed rule is insignificant.
Although this proposed rule will not have a significant economic
impact on a substantial number of small entities, EPA believes that
increasing the specificity of the current regulations will minimally
affect all manufacturers of export pesticide products and devices, not
just small entities. The more specific indication that ``Not Registered
for Use in the United States'' will be required while unregistered
pesticides products and devices are shipped between establishments
operated by the same manufacturer; this is the identical information
that is required before the unregistered pesticide product or device is
exported to another country.
The Agency continues to be interested in the potential impacts of
the proposed rule on small entities and welcome comments on issues
related to such impacts.
D. Unfunded Mandates
This rule does not contain a Federal mandate as described in the
Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538, that may
result in expenditures of $100 million or more for State, local, and
tribal governments, in the aggregate, or the private sector in any one
year. This action is expected to only affect producers, transporters,
formulators, packagers, and exporters of unregistered pesticide
products and devices but not resulting in expenditures of $100 million
or more. Since no State, local, or tribal government is known to
produce, transport, formulate, package, or export unregistered
pesticide products or devices, this rule is not expected to affect
State, local, and tribal governments individually, much less in the
aggregate. Thus, this rule is not subject to the requirements of
sections 202 or 205 of UMRA.
This rule is also not subject to the requirements of section 203 of
UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. Since no small
government is known to produce, transport, formulate, package, or
export unregistered pesticide products or devices, this rule is not
[[Page 18999]]
subject to the requirements of section 203 of UMRA.
E. Federalism
This action does not have federalism implications because it is not
expected to have substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). This action is expected to only affect
producers, transporters, formulators, packagers, and exporters of
unregistered pesticide products and devices. Since no State or local
government is known to produce, transport, formulate, package, or
export unregistered pesticide products or devices, there is no effect
on a State, the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Thus, Executive Order 13132 does not
apply to this action.
In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed action
from State and local officials.
F. Indian Tribal Implications
This action 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). This action
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. Thus,
Executive Order 13175 does not apply to this action.
EPA specifically solicits additional comment on this proposed
action from tribal officials.
G. Children's Health Protection
EPA interprets Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997), as applying only to those regulatory actions that
concern health or safety risks, such that the analysis required under
section 5-501 of the Executive Order has the potential to influence the
regulation. This action is not subject to Executive Order 13045 because
it does not establish an environmental standard intended to mitigate
health or safety risks, nor is it an ``economically significant
regulatory action'' as defined in Executive Order 12866. The
clarification and restructuring of current regulations for the export
of unregistered pesticide products and devices do not present a
disproportionate risk to children. Requiring that such unregistered
pesticide products and devices shipped between establishments operated
by the same producer be labeled according to the current regulations in
Sec. 168.65 prevents them from inadvertently entering the U.S. market
and provides compliance assistance. This requirement further protects
public health and the environment by ensuring safe and appropriate
handling and distribution without presenting a disproportionate risk to
children.
H. Effect on Energy Supply, Distribution or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211, entitled Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001), because this action is not likely to have any effect on
the supply, distribution, or use of energy.
I. Technical Standards
Because this action does not involve any technical standards,
section 12(d) of The National Technology Transfer and Advancement Act
of 1995 (NTTAA) (15 U.S.C. 272 note), does not apply to this action.
J. Environmental Justice
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
EPA has determined that this proposed rule 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. This rule is proposing to clarify, restructure, and
add specificity to the current regulations and thus add an extra margin
of safety for all affected populations as shipments of unregistered
pesticides and devices move between establishments operated by the same
producer. Labeling regulations at 40 CFR 152.30(a) currently require
that an unregistered pesticide transferred between establishments
operated by the same producer must follow labeling requirements in 40
CFR part 156. EPA believes that requiring the registration status
information from 40 CFR168.65 on the label further protects public
health and the environment by contributing to safer and more
appropriate handling and distribution of unregistered pesticide
products and devices. EPA believes that unregistered pesticide products
and devices intended for export must be clearly marked with the
labeling according to Sec. 168.65 to prevent them from inadvertently
entering the U.S. market.
List of Subjects in 40 CFR Part 168
Environmental protection, Exports, Labeling, Pesticides and pests.
Dated: March 25, 2011.
Lisa P. Jackson,
Administrator.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 168--STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATION
1. The authority citation for part 168 continues to read as
follows:
Authority: 7 U.S.C. 136-136y.
Sec. 168.65 [Removed and Reserved].
2. Remove and reserve Sec. 168.65.
3. Add Sec. Sec. 168.66 through 168.71 to read as follows:
* * * * *
Sec.
168.66 Labeling of pesticide products and devices for export.
168.67 Definitions.
168.68 Applicability.
168.69 Registered export pesticide products.
168.70 Unregistered export pesticide products.
168.71 Export pesticide devices.
* * * * *
Sec. 168.66 Labeling of pesticide products and devices for export.
(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 sec. 17(a). The
requirements for pesticide production reporting, recordkeeping and
inspection and purchaser
[[Page 19000]]
acknowledgement provisions can be found in the following parts:
(1) Pesticide production reporting requirements under FIFRA sec. 7
are located in part 167 of this chapter (or Sec. 168.85(b));
(2) Recordkeeping and inspection requirements under FIFRA sec. 8
are located in part 169 of this chapter (or Sec. 168.85(a));
(3) Purchaser acknowledgement statement provisions under FIFRA sec.
17(a) are located in Sec. 168.75.
(b) The required label information may be fully met by:
(1) The product label attached to the immediate product;
(2) The product label and supplemental labeling; or
(3) Supplemental labeling that must be:
(i) Attached at all times during shipping or while being held for
shipping; or
(ii) Attached to the immediate product container or to the shipping
container.
Sec. 168.67 Definitions.
Terms used in this subpart have the same meaning as in the Act. The
definitions of terms in Sec. 152.3 of this chapter apply to this
subpart unless defined in this section,
Export pesticide device means a device, as defined in FIFRA sec.
2(h), that is intended solely for export from the United States to
another country.
Export pesticide product means a pesticide product, as defined in
Sec. 152.3 of this chapter, that is intended solely for export from
the United States to another country.
Sec. 168.68 Applicability.
This subpart applies to all export pesticide products and export
pesticide devices regardless of the purpose of the export.
Sec. 168.69 Registered export pesticide products.
(a) Each export pesticide product that is registered under FIFRA
sec. 3 or FIFRA sec. 24(c) must bear a label or be accompanied by
labeling approved by EPA for its registration.
(b) For the purposes of this subpart, a registered export pesticide
product is considered to be any of the following:
(1) A pesticide product of composition, packaging and labeling as
described in its registration under FIFRA sec. 3;
(2) A pesticide product that has been modified in compliance with
the notification or non-notification provisions of Sec. 152.46 of this
chapter, and any associated procedures issued under Sec. 156.10(e) of
this chapter, regardless of whether such modification has been made for
the pesticide product's registration under FIFRA sec. 3;
(3) A pesticide product initially registered by a State under FIFRA
sec. 24(c), and whose Federal registration has not been disapproved by
EPA under Sec. 162.164 of this chapter.
(c) The text of the label or supplemental labeling of the
registered pesticide product must be provided in one of the following
languages besides English:
(1) The language of the country of final destination, if known;
(2) The language predominantly used in the importing country; or
(3) The language in which official government business is conducted
in the importing country.
Sec. 168.70 Unregistered export pesticide products.
(a) Any export pesticide product that does not meet the terms of
Sec. 168.69 is an unregistered export pesticide for purposes of this
subpart.
(b) Each unregistered export pesticide product must bear a label or
be accompanied by supplemental labeling that complies with all
requirements of this section and Sec. 168.66(b).
(1) The label or supplemental labeling must comply with all of the
prominence and legibility requirements of Sec. 156.10(a)(2) of this
chapter.
(2) The label or supplemental labeling must comply with all the
language requirements in Sec. 168.69(c) and Sec. 156.10(a)(3) of this
chapter.
(3) The label or supplemental labeling must bear the following
information:
(i) The name and address of the producer, in accordance with the
requirements of Sec. 156.10(c) of this chapter;
(ii) The net weight or measure of contents, in accordance with the
requirements of Sec. 156.10(d) of this chapter;
(iii) The pesticide producing establishment number, in accordance
with the requirements of Sec. 156.10(f) of this chapter;
(iv) An ingredients statement, in accordance with the requirements
of Sec. 156.10(g) of this chapter, except that:
(A) The ingredients statement need not appear in a second language
besides English if the English language version is likely to be
understood by the ordinary individual in the importing country; and
(B) An export pesticide product intended solely for research and
development purposes, (and which bears the statement ``For research and
development purposes only. Not for distribution, sale or use,'' or
similar language) may bear coded ingredient information to protect
confidentiality.
(v) Human health and precautionary statements in accordance with
the requirements of subpart D of part 156 of this chapter. If a
translated U.S. precautionary statement is inappropriate in the
importing country, an equivalent statement appropriate to the importing
country must be substituted;
(vi) The statement ``Not Registered for Use in the United States of
America,'' which may be amplified by additional statements describing
the reason(s) why the export pesticide product is not registered in the
United States, or is not registered for particular uses.
(c) This section also applies to all unregistered pesticide
products and devices that are transferred, distributed, or sold between
registered establishments operated by the same producer under the
exemptions provided by Sec. 152.30(a) of this chapter if:
(1) The transfer, distribution or sale occurs between a point in
the United States and a point outside the United States, or
(2) The transfer occurs within the United States solely for the
purpose of export from the United States.
Sec. 168.71 Export pesticide devices.
(a) Each export pesticide device sold or distributed anywhere in
the United States must bear a label or be accompanied by supplemental
labeling that complies with all requirements of this section and Sec.
168.66(b).
(b) The label or supplemental labeling of each export pesticide
device must meet all of the prominence and legibility requirements of
Sec. 156.10(a)(2) of this chapter.
(c) The label or supplemental labeling must also comply with all
the language requirements in Sec. 168.69(c) and Sec. 156.10(a)(3) of
this chapter.
(d) The label or supplemental labeling must bear the following
information:
(1) The name and address of the producer, meeting the requirements
of Sec. 156.10(c) of this chapter;
(2) The producing establishment number, meeting the requirements of
Sec. 156.10(f) of this chapter;
(3) The statement ``Not Registered for Use in the United States of
America,'' which may be amplified by additional statements describing
the reason why the export pesticide device is not registered in the
United States.
[[Page 19001]]
(e) An export pesticide device is not required to bear an
ingredients statement.
[FR Doc. 2011-7900 Filed 4-5-11; 8:45 am]
BILLING CODE 6560-50-P