[Title 40 CFR 168.65]
[Code of Federal Regulations (annual edition) - July 1, 1996 Edition]
[Title 40 - PROTECTION OF ENVIRONMENT]
[Chapter I - ENVIRONMENTAL PROTECTION AGENCY--(Continued)]
[Subchapter E - PESTICIDE PROGRAMS]
[Part 168 - STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS]
[Subpart D - Export Policy and Procedures for Exporting Unregistered]
[Sec. 168.65 - Pesticide export label and labeling requirements.]
[From the U.S. Government Publishing Office]
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PROTECTION OF ENVIRONMENT
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1996-07-01
1996-07-01
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Pesticide export label and labeling requirements.
168.65
Sec. 168.65
PROTECTION OF ENVIRONMENT
ENVIRONMENTAL PROTECTION AGENCY--(Continued)
PESTICIDE PROGRAMS
STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS
Export Policy and Procedures for Exporting Unregistered
Sec. 168.65 Pesticide export label and labeling requirements.
(a) General. This section describes how EPA interprets and will
enforce the requirements of FIFRA section 17(a)(1). Every exported
pesticide, device, and active ingredient used in producing a pesticide
(see Sec. 152.3 of this chapter for the definition of ``active
ingredient'' and ``pesticide'') must bear a label or labeling which
meets the requirements of FIFRA section 17(a)(1). This requirement
applies to all such pesticides, devices, or active ingredients,
regardless of whether the export is for commercial or research use. In
the case of unregistered pesticides, including research substances which
are being exported for testing, the labeling requirements of this
section continue to apply independently of whether the exporter must
submit a purchaser acknowledgement statement under FIFRA section
17(a)(2) as described at Sec. 168.75 of this chapter. In addition,
information which will satisfy FIFRA section 2(q)(1)(E), (G), and (H)
and section 2(q)(2)(A) and (D) must appear in English and in the
appropriate foreign languages, on the label or labeling as described in
paragraph (b)(4) of this section. The required label and labeling
statements may be met through either immediate container labels,
accompanying supplemental labeling as described in paragraph (c) of this
section, or a combination of the two.
(b) Specific requirements. The labels and labeling of any exported
pesticides, devices, and active ingredients used in producing pesticides
must meet the requirements regarding label and labeling content, correct
representation, and understandability as stated in this paragraph.
(1) Label contents. The term ``label'' means the written, printed,
or graphic matter on or attached to the immediate container of the
pesticide, device, or active ingredient used in producing a pesticide.
In the case that the immediate container is enclosed in an outer
container or wrapper through which the label cannot be read, the label
must also be on such outer container or wrapper. Except as provided in
paragraph (c) of this section, the immediate container of the pesticide,
device, or active ingredient used in producing a
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pesticide must bear a conspicuous and readable label which includes:
(i) EPA pesticide producing establishment number. The producing
establishment registration number must be present but may appear
anywhere on the label or immediate container in accordance with the
establishment registration labeling requirements set forth in
Sec. 156.10(f) of this chapter.
(ii) Warning or caution statements. Warning or caution statements
must appear on the label and must be adequate for the protection of
persons handling the pesticide, device, or active ingredients including
warnings regarding general toxicological hazards and environmental,
physical, or chemical hazards. Warning and caution statements must
appear in English and in the appropriate foreign languages, as described
in paragraph (b)(4) of this section. Where the U.S. warning or caution
statement, as translated, is obviously inappropriate to protect
residents of the importing country, (for example, where a statement
calls for a gas mask meeting the specification of the U.S. Bureau of
Mines) an equivalent caution must be substituted.
(iii) The statement ``Not Registered for Use in the United States of
America.'' The labels of all pesticides, devices, and active ingredients
which are not registered for use in the United States under FIFRA
section 3 must prominently display the following statement: ``Not
Registered for Use in the United States of America.'' The statement must
appear in English and in appropriate foreign languages, as described in
paragraph (b)(4) of this section. It is permissible to append
explanatory text which qualifies the statement by pointing out the
reasons for the unregistered status. Examples of possible additional
statements are ``Not Registered for Use on...'', ``No Longer Registered
for Use...'', or ``Not Registered...because...'' Such additions must not
be misleading or misrepresent the registration status of the pesticide.
The statement ``Not Registered For Use in the United States of America''
must also be present.
(A) A pesticide is considered registered for the purposes of the
section 17(a)(1) requirement only when:
(1) A label and labeling approved under a current FIFRA section 3
registration for the product is either attached to the immediate product
container or accompanies the product at all times as supplemental
labeling as provided in paragraph (c) of this section.
(2) The formula of the exported product is the same as the formula
of the U.S. registered product (within certified limits). In addition, a
change in the color or fragrance of the export product will not affect
the product's registration status, as long as the following conditions
are met:
(i) The change in color must result only from the addition of a dye
included on the list of the chemicals exempted from the requirement of a
tolerance at Sec. 180.1001, and the dye must not be a List 1 inert.
(List 1 inerts are those inerts which the Agency has identified as
presenting toxicological concerns. The classification of inerts is
explained in EPA's Policy Statement on Inert Ingredients in Pesticide
Products, which can be obtained from the Office of Pesticide Programs
public docket, Room 1128, Crystal Mall 2, 1921 Jefferson Davis Highway,
Arlington, Virginia 22202.
(ii) The change in fragrance must result only from the addition of a
chemical included on the list of chemicals exempted from the requirement
of a tolerance (Sec. 180.1001) and the chemical must not be a List 1
inert.
(iii) The change in fragrance must not result in a pesticide product
containing a food or food-like fragrance. (See ``Food Fragrances in
Pesticide Formulations,'' EPA's Office of Pesticide Programs Policy and
Criteria Notice number 2155.1, November 20, 1975 which can be obtained
from the Office of Pesticide Programs public docket, Room 1128, Crystal
Mall 2, 1921 Jefferson Davis Highway, Arlington, Virginia 22202.).
(iv) Any differences in color or fragrance of the export product in
accordance with this section must be reflected in records which show the
complete formula of the export product in accordance with the
requirements of Sec. 169.2 and this policy.
(3) No statements which appear on any of the product labels or
labeling
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add new uses or claims or in any way contradict the approved FIFRA
section 3 labeling. However, certain minor changes may be made to a
product's labeling or packaging without affecting the registration
status of the product, as specified in Sec. 152.46(b) of this chapter.
(iv) The ingredient statement. The ingredient statement must appear
on the label in English and in appropriate foreign languages (as
described in paragraph (b)(4) of this section). If the English language
description of the ingredients is easily identifiable and likely to be
understood by the ordinary individual, the foreign language ingredient
statement need not be included on the label. In the case of pesticide
products, devices and active ingredients shipped solely for research and
development purposes, it is permissible to use coded identification of
ingredients on the label in order to protect confidentiality, in
accordance with the requirements of Secs. 168.75(c) and 168.85(a).
(v) Identity of parties. The name and address of the producer,
registrant (if any), or the person for whom the pesticide was produced,
must appear on the label.
(vi) Weight or measure. The net weight must appear on the label in
either English or metric units.
(vii) Additional warning for highly toxic pesticides. If the
pesticide, device or active ingredient is highly toxic to humans, the
skull and crossbones, the word ``Poison'', and a statement of practical
treatment must appear on the label. The word ``Poison'' and the
statement of practical treatment shall be in English and in the
appropriate foreign languages, as described in paragraph (b)(4) of this
section. The skull and crossbones may be in red or black. For criteria
on what pesticides are highly toxic, see Sec. 156.10(h) of this chapter.
(2) Use classification statement. In addition to the label contents
described in paragraph (b)(1) of this section, the labeling must include
a use classification statement, if a use classification has been
assigned under a FIFRA section 3 registration. The use classification
shall accurately describe the use classification applicable to the U.S.
registered use of the pesticide, device or active ingredient (e.g.,
``Restricted Use Pesticide''). Summary statements describing the use
classification, e.g., ``For retail sale to and use only by Certified
Applicators...'', or explaining what such terms mean are not required,
but may be included if such statements do not result in false
representation of the U.S. regulatory status of the pesticide. The use
classification information may appear on the product label or on the
labeling accompanying the pesticide product during shipment.
(3) Misrepresentation. The labeling shall not make false or
misleading representations or represent the product as an imitation of
other products.
(4) Understandability. The required statements must be expressed in
such terms as to render them likely to be read and understood by the
ordinary individual under customary conditions of purchase and use. To
satisfy this section, certain information described in paragraph
(b)(4)(i) of this section, which appears on the labeling of all exported
pesticide products, devices and active ingredients must appear in
English, in an acceptable language of the country of import as defined
in paragraph (b)(4)(ii) of this section, and in an acceptable language
of the country of final destination, if known or reasonably
ascertainable by the exporter. When there are several official languages
or dialects in a country, the language which is predominately spoken or
written, or a language in which official government business is
conducted, will be acceptable.
(i) Information required to be multilingual. The following labeling
information must be multilingual:
(A) The warning and caution statements.
(B) Where required, the statement ``Not Registered for Use in the
United States of America.''
(C) The ingredient statement.
(D) Where required in accordance with paragraph (b)(1)(vii) of this
section, the word ``Poison'' and the statement of practical treatment in
case of poisoning.
(ii) Acceptable languages. In all cases, English must be one of the
languages used on the label or labeling. In addition, either the
language which is used
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to conduct official government business, or the predominantly spoken or
written language of the country of import must appear on the labeling.
In each case where a country of final destination is known, the language
which is used to conduct official government business or which is
predominantly spoken in that country, if different from the language of
the country of import, shall also appear on the labeling. In any case
where English is predominantly spoken or written or is the language used
to conduct official government business in a country, no other language
need be included to meet the multiple language requirement of this
paragraph.
(c) Supplemental labeling. A pesticide, device or active ingredient
intended for export will not be considered in violation of the labeling
requirements of FIFRA when the label and/or labeling requirements stated
in paragraph (b) of this section are met by supplemental labeling.
Supplemental labeling must be attached to the immediate product
container or the shipping container of the pesticide, device or active
ingredient at all times when it is shipped or held for shipment to meet
export label requirements. Supplemental labeling must meet all of the
label requirements in paragraph (b) of this section which are not met by
the immediate product labels. Supplemental labeling will satisfy the
labeling requirements of FIFRA only if the following conditions are met:
(1) Applicability. The use of supplemental labeling applies to any
situation where the labeling requirements specified in this section are
not met fully on the product label which is attached to the immediate
product container. Any required label or labeling statement not met on
the immediate container may be met through supplemental labeling.
(2) Labeling contents and relation to shipment. If supplemental
labeling is used to meet any of the labeling requirements of FIFRA
section 17(a)(1), it must meet all of the requirements in paragraph (b)
of this section which are not met by the label on the immediate product
container. Thus, the supplemental labeling, together with the immediate
product container label will meet all of the requirements of paragraph
(b) of this section. Where used, supplemental labeling must be attached
to or accompany the product shipping container of the pesticide, device,
or active ingredient used in producing a pesticide at all times when
shipped or held for shipment in the United States.