[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR168.65]

[Page 228-231]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 168_STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS--Table of 
 
   Subpart D_Export Policy and Procedures for Exporting Unregistered 
                               Pesticides
 
Sec. 168.65  Pesticide export label and labeling requirements.

    Source: 58 FR 9085, Feb. 18, 1993, unless otherwise noted.


    (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

[[Page 229]]

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 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 40 CFR 180.910, 180.920, 180.930, and 180.950, 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 at the OPP 
Regulatory Public Docket located as set forth in 40 CFR 150.17(c).)

[[Page 230]]

    (ii) The change in fragrance must result only from the addition of a 
chemical included on the list of the chemicals exempted from the 
requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and 
180.950, 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 
at the OPP Regulatory Public Docket located as set forth in 40 CFR 
150.17(c).)
    (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 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 Sec. Sec. 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

[[Page 231]]

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 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.

[58 FR 9085, Feb. 18, 1993, as amended at 69 FR 23117, Apr. 28, 2004; 69 
FR 39864, July 1, 2004; 71 FR 35546, June 21, 2006]