ICR Attachment B: 40 CFR 168, Subpart D

§ 167.85

40 CFR Ch. I (7–1–04 Edition)

of establishment registration, civil
and/or criminal penalty assessments.
[53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug.
9, 1989, as amended at 58 FR 34203, June 23,
1993]

Subparts C–D [Reserved]
Subpart E—Recordkeeping and
Reporting Requirements
§ 167.85 Reporting requirements.
(a) Who must report. Each producer
operating an establishment must submit the reports required by this section
concerning any pesticide, active ingredient, or device produced at each establishment. Custom blenders are not required to report production to the
Agency.
(b) Information required. The pesticide
report shall include the following: (1)
Name and address of the establishment; (2) amount of each pesticidal
product: (i) Produced during the past
year; (ii) sold or distributed during the
past year; (iii) estimated to be produced during the current year. The report shall only include those pesticidal
products actually produced at the reporting establishment. Reports submitted by foreign-producing establishments shall cover only those pesticidal
products exported to the United States.
(c) How to report. The reports required by this section must be made on
forms supplied by the Agency. It is the
ultimate responsibility of companies to
obtain, complete, and submit the form
each year.
(d) When to report. A producer operating an establishment must submit an
initial report no later than 30 days
after the first registration of each establishment the producer operates.
Thereafter, the producer must submit
an annual report on or before March 1
of each year, even if the producer has
produced no pesticidal product for that
reporting year.
[53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug.
9, 1989, as amended at 58 FR 34203, June 23,
1993]

§ 167.90 Where to obtain and submit
forms.
(a) Where to obtain forms. Any person
may obtain blank forms for the appli-

cations and reports required by this
part from any EPA Regional Office, or
from the address listed in paragraph (b)
of this section.
(b) Where to submit applications and reports. Each producer operating an establishment, with the exception of
those establishments not found at the
same location as their company headquarters, must submit applications and
reports required by this part to the
EPA Regional Office which serves the
area where the establishment is located. The list of Regional Office addresses is found in 40 CFR 1.7. Applications and reports for those establishments not found at the same location
as their company headquarters to be
submitted by the company headquarters to the Regional Office having
jurisdiction over the State in which
the company headquarters is located. A
foreign producer who exports any pesticide product, device, or active ingredient to the United States must submit
all applications and reports to:
U.S. Environmental Protection Agency, Office of Enforcement and Compliance Assurance, Office of Compliance, Agriculture
and Ecosystems Division (2225A), Ariel
Rios Building, 1200 Pennsylvania Avenue,
N.W., Washington, DC 20460, ATTN: FIFRA
Foreign Establishment Registration Contact.
[53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug.
9, 1989, as amended at 62 FR 49620, Sept. 23,
1997; 65 FR 4577, Jan. 31, 2000]

PART 168—STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS
Subpart A—General Provisions [Reserved]
Subpart B—Advertising
Sec.
168.22 Advertising of unregistered pesticides, unregistered uses of registered
pesticides and FIFRA section 24(c) registrations.

Subpart C [Reserved]
Subpart D—Export Policy and Procedures
for Exporting Unregistered Pesticides
168.65 Pesticide export label and labeling requirements.

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Environmental Protection Agency

§ 168.65

168.75 Procedures for exporting unregistered
pesticides—purchaser acknowledgement
statements.
168.85 Other export requirements.
AUTHORITY: 7 U.S.C. 136–136y.
SOURCE: 54 FR 1125, Jan. 11, 1989.

Subpart A—General Provisions
[Reserved]
Subpart B—Advertising
§ 168.22 Advertising of unregistered
pesticides, unregistered uses of registered pesticides and FIFRA section 24(c) registrations.
(a) FIFRA sections 12(a)(1) (A) and
(B) make it unlawful for any person to
‘‘offer for sale’’ any pesticide if it is unregistered, or if claims made for it as
part of its distribution or sale differ
substantially from any claim made for
it as part of the statement required in
connection with its registration under
FIFRA section 3. EPA interprets these
provisions as extending to advertisements in any advertising medium to
which pesticide users or the general
public have access.
(b) EPA regards it as unlawful for
any person who distributes, sells, offers
for sale, holds for sale, ships, delivers
for shipment, or receives and (having
so received) delivers or offers to deliver
any pesticide, to place or sponsor advertisements which recommend or suggest the purchase or use of:
(1) Any pesticide for a use authorized
under a FIFRA section 5 experimental
use permit (EUP).
(2) Any pesticide for a use authorized
under a FIFRA section 18 emergency
exemption, except for advertisements
that:
(i) Are placed in media which address
primarily persons in the geographical
area to which the exemption applies.
(ii) State the name and address of
one or more retail dealers who stock
the pesticide.
(iii) Contain a prominent notice of
the limitations on use under the section 18 emergency exemption.
(3) Any pesticide for any use authorized only by a FIFRA section 24(c) special local need registration, unless the
advertisement contains a prominent
notice of the limitations on use under
the section 24(c) registrations.

(4) Any unregistered pesticide for any
use unless the advertisement is one
permitted by paragraph (b) (2) or (3) of
this section.
(5) A registered pesticide product for
an unregistered use, unless the advertisement is one permitted by paragraph
(b) (2) or (3) of this section. However, as
a matter of policy, the Agency will not
regard as unlawful the advertisement
of uses permitted by FIFRA section
2(ee) provided the product is not an
antimicrobial
pesticide
targeted
against human pathogens (see 51 FR
19174; May 28, 1986).
(c) For purposes of paragraph (b) of
this section, a ‘‘prominent notice of the
limitations on use’’ is one which sets
forth the limitations on use in a manner reasonably likely to be understood
by persons to whom the advertisement
is addressed. For printed advertising,
this criterion will be met by a legend
in 6-point or larger type.

Subpart C [Reserved]
Subpart D—Export Policy and Procedures for Exporting Unregistered Pesticides
SOURCE: 58 FR 9085, Feb. 18, 1993, unless
otherwise noted.

§ 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 § 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

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§ 168.65

40 CFR Ch. I (7–1–04 Edition)

§ 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
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 § 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 ob-

viously 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.

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Environmental Protection Agency

§ 168.65

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
119, Crystal Mall # 2, 1801 South Bell
St., Arlington, Virginia 22202.)
(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 from the Office
of Pesticide Programs public docket,
Room 119, Crystal Mall #2, 1801 South
Bell St., 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
§ 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 § 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
§§ 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 § 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

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§ 168.75

40 CFR Ch. I (7–1–04 Edition)

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
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]

§ 168.75 Procedures for exporting unregistered
pesticides—purchaser
acknowledgement statements.
This section describes how EPA interprets and will enforce requirements
of FIFRA section 17(a)(2). Section
17(a)(2) provides that any person exporting a pesticide other than a pesticide registered for use under FIFRA
section 3 or sold under FIFRA section
6(a)(1), shall obtain a statement signed

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Environmental Protection Agency

§ 168.75

by the foreign purchaser prior to export, acknowledging that the purchaser
understands that such pesticide is not
registered for use in the United States
and cannot be sold in the United
States. Section 17(a)(2) requires that a
copy of the statement be transmitted
to an appropriate official of the government of the importing country.
(a) Products subject to the requirement.
EPA will not consider an exporter of an
unregistered pesticide to be in violation of FIFRA section 17(a)(2) if, prior
to export of the pesticide, the exporter
submits to EPA a statement signed by
the foreign purchaser which affirms
that the purchaser is aware that the
pesticide is not registered for use in
the United States and cannot be sold
for use in the United States. The exporter must also include with the submission of the purchaser acknowledgement statement to EPA, a certification
signed by the exporter affirming that
the export did not occur until the
statement signed by the foreign purchaser was obtained by the exporter.
Except as provided in paragraph (b) of
this section, all pesticide products produced for export which cannot be sold
for use in the United States in the form
that they are produced for export, are
considered to be unregistered pesticides. This includes pesticides which
are of a different formulation, including composition (except for variation
within certified limits), or type of formulation, and pesticides which are
packaged for use patterns for which
they are not registered, which may be
evidenced by package type or label use
statements. This also includes unregistered products which are under development as pesticidal products and
which are being exported for research
testing.
(b) Exceptions. Under the specific circumstances discussed below, EPA will
not treat a registered product which
has been modified slightly for export
purposes, as unregistered for the purposes of the purchaser acknowledgement statement requirement. Any
changes to the registered product for
export purposes must be documented in
accordance with the record-keeping requirements at § 169.2 of this chapter
and this policy.

(1) Labeling on Immediate Product.
EPA will not treat as unregistered for
the purposes of section 17(a)(2), a registered pesticide product which cannot
be sold or distributed for use in the
United States because its immediate
product container does not bear a label
approved under a FIFRA section 3 registration, but which could be sold or
distributed in the United States with
the approved label attached to the immediate product container, provided
that the 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) Packaging. (i) Certain changes
may be made to a product’s labeling or
packaging without affecting the registration status of the product, as specified in § 152.46(b) of this chapter and
this policy. These changes include any
changes in package size and label net
contents, provided no change in use directions or requirement for child-resistant packaging would be necessary
for the product to be registered for use
in the United States. For example, if
child-resistant packaging is required
for a particular pesticide product in
the United States, and the product will
be exported without child-resistant
packaging, the product would be considered unregistered and therefore subject to all the requirements of FIFRA
section 17(a), as described in § 168.75 of
this chapter including the requirement
for a purchaser acknowledgement
statement.
(ii) If an exporter needed to repackage a product in a size to meet a foreign purchaser’s specifications, that
modification would not affect the registration status of the export product.
Other modifications to the label used
for export purposes which will not affect the export product’s registration
status are: the use of metric units for
net contents, dosages, and other numeric expressions; the use of a different format for the label, provided
that the information does not contradict the U.S. label; revision of nonmandatory U.S. label statements, consistent with 40 CFR part 156, including

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§ 168.75

40 CFR Ch. I (7–1–04 Edition)

additions or changes required by other
Federal statutes or regulations; a
change of the name or address of the
registrant, except for a change resulting from transfer of ownership, which
requires that a registrant keep his
name and address current with the
Agency; and any correction of typographical or printing errors that appeared on the U.S. labeling. (See
§ 152.46(b)).
(3) Labeling statements. The following
statements which appear on any of the
product labels or labeling will not affect the status of the product, provided
that they do not contradict the approved FIFRA section 3 labeling:
(i) It is permissible to add explanatory language which accurately explains the meaning of a use classification. For example, the statement ‘‘restricted use pesticide’’ may be expanded
to read: ‘‘Restricted in the United
States of America to use by certified
applicators’’ or ‘‘Restricted Use Pesticide. In The United States this product is restricted to use by applicators
determined by each state to be competent in pesticide application and the
human health and environmental consequences of misuse.’’ If the explanatory language falsely represents or is
misleading regarding the U.S. use classification, the product will be considered misbranded. In addition, a use
classification can only be listed if one
has been assigned pursuant to the U.S.
registration.
(ii) An exporter who is also the manufacturer of a U.S. registered pesticide
may add new uses to the label of that
product for export purposes, without
triggering the requirements of section
17(a)(2), as long as the new uses are
within the same general use patterns
as those for the registered product.
(Pesticide use patterns are listed in appendix A to 40 CFR part 158—Data Requirements for Registration: Use Pattern Index. The general pesticide use
patterns are: terrestrial food crop and
terrestrial nonfood crop; greenhouse
food crop and greenhouse nonfood crop;
aquatic food crop and aquatic nonfood
crop; indoor use; and forestry use.)
Adding new uses to the label which
change the use pattern, such as
changes from non-food to food use, outdoor to indoor use, or terrestrial to

aquatic use, render the product unregistered and subject to the requirements
of section 17 for unregistered products.
If the new use added to the label is a
food or feed use, a tolerance must already be established for the use of that
pesticide in or on that commodity.
(4) Composition. EPA will not treat a
registered product as unregistered for
the purposes of the purchaser acknowledgement
statement
requirement
under the following specific circumstances:
(i) The formula of the exported product is within certified limits of the formula of the U.S. registered product.
(ii) An exporter, who is also the manufacturer of a U.S. registered pesticide,
may decrease the percentage of the active ingredient(s) of that product by
adding a List 4 inert ingredient, without causing the product to be treated
as ‘‘unregistered’’ and triggering the requirement to obtain a purchaser acknowledgement statement as a condition for export. In EPA’s Policy Statement on Inert Ingredients in Pesticide
Products, EPA included inert ingredients on List 4-a list of inert ingredients
posing minimal hazard or risk-if the
inert ingredients were generally regarded as innocuous. The provisions of
this paragraph do not apply to those
pesticide products intended for public
health uses which are required or conditionally required to submit efficacy
data pursuant to § 158.640 of this chapter. Any differences in formula or composition caused by adding a List 4 inert
must be reflected in records which
show the complete formula of the export product in accordance with the requirements of § 169.2 and this policy.
(iii) 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. 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. The

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Environmental Protection Agency

§ 168.75

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. 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.) Any difference 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
§ 169.2 and this policy.
(5) Research and development products.
An unregistered pesticide product exported only for research and development purposes is subject to the notification requirements of this section, unless its use fits within the criteria described in this paragraph.
(i) An unregistered pesticide product
exported solely for research and development purposes will not be considered
to be in violation of the notification
requirements if the export of the research and development product:
(A) Would not involve land uses of
more than 10 acres (4.05 hectares), or be
used on or affect food or feed crops
which are intended for consumption.
(B) Would not involve aquatic uses of
more than 1 acre (0.405 hectares), or
any aquatic uses which involve water
used for irrigation, drinking or recreation, or be used on or affect plants or
animals taken for food or feed from
such waters.
(C) Would not involve tests on animals intended for food or feed.
(ii) Shipments to different purchasers, to different countries of final
destination, or which occur more than
a calendar year apart will be evaluated
separately. When determining whether
total shipments exceed the criteria described in this paragraph, EPA will
evaluate the total amount of shipments by a single exporter during a
calendar year for use in a particular
country.
(iii) An exporter bears the burden of
demonstrating that the product meets

these criteria before the research product is shipped. This may be met by documenting before the product is shipped
and maintaining records for the time
period required by § 169.2(h) of this
chapter from the date of the last shipment relevant to such records. The
records to be maintained consist of:
(A) The identity of the purchaser and
country of intended use of the research
product.
(B) The amount shipped.
(C) The intended research use by the
purchaser, including the type of application site, rate of application, and
measures taken for protection of humans from direct or dietary exposure.
(c) Procedures. An exporter of an unregistered pesticide product must
submit a purchaser acknowledgement
statement to EPA containing the information stated in paragraph (c)(1) of
this section, and a statement signed by
the exporter certifying that the exportation did not occur until the signed
acknowledgement statement had been
obtained from the purchaser. If the foreign purchaser signs a purchaser acknowledgement statement in their own
language, it must be accompanied by
an English translation when it is submitted to EPA by the exporter. These
statements shall be submitted in accordance with one of the two options
for submission described in paragraph
(c)(2) of this section.
(1) Contents of the purchaser acknowledgement statements. The purchaser acknowledgement statement must include the following information in a
format that is clearly understandable:
(i) Name, address, and EPA identification number, if applicable, of the
exporter.
(ii) Name and address of the foreign
purchaser.
(iii) Identity of the product and the
active ingredient(s), including:
(A) The Chemical Abstract Services
(CAS) Registry number for each active
ingredient.
(B) The chemical nomenclature for
each active ingredient as used by the
International Union of Pure and Applied Chemists (IUPAC).
(C) Other known chemical or common names; or if the export involves a
research product, a code name or identification number that can be used by

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§ 168.75

40 CFR Ch. I (7–1–04 Edition)

EPA to identify the product from the
exporter’s records. If a code name or
identification number is used, additional information must be attached to
the certification statement submitted
with the purchaser acknowledgement
statement which will enable EPA to
identify the product. This attached information may be claimed as confidential, and EPA will not forward this information with the purchaser acknowledgement statement to foreign governments.
(iv) If known or reasonably ascertainable, the country or countries of final
destination of the export shipment,
i.e., where the exported pesticide is intended to be used, if different from the
country of the foreign purchaser’s address.
(v) A statement that indicates that
the foreign purchaser understands that
the product is not registered for use in
the United States and cannot be sold in
the United States.
(vi) The signature of the foreign purchaser.
(vii) The date of the foreign purchaser’s signature.
(2) Reporting options. At the discretion of the exporter, the requirements
of paragraph (c)(1) of this section may
be met on a per-shipment or annual
basis, as stated in paragraphs (c)(2)(i)
and (c)(2)(ii) of this section. If the procedures in paragraph (c)(2)(ii) of this
section are not followed, EPA will consider paragraph (c)(2)(i) of this section,
requiring pershipment purchaser acknowledgement statements, to be applicable in full. Where paragraph
(c)(2)(i) of this section is applicable,
each shipment which does not meet the
requirements of that paragraph will be
considered to be a separate violation of
FIFRA.
(i) Per-shipment purchaser acknowledgment statement. Unless the exporter
chooses to follow the procedures described in paragraph (c)(2)(ii) of this
section for the annual reporting procedures, the exporter must obtain and
submit to EPA, a signed purchaser acknowledgement statement prior to
each shipment of an unregistered pesticide according to the following procedures:
(A) Prior to each shipment in a calendar year of an unregistered pesticide

product to a particular purchaser in a
foreign country, the exporter must provide the foreign purchaser with instructions about the required information on a purchaser acknowledgement
statement, and inform the foreign purchaser that the pesticide product cannot be exported from the United States
until the exporter has received from
the foreign purchaser a properly completed, signed, and dated acknowledgment statement.
(B) The exporter must obtain, prior
to each shipment in a calendar year of
an unregistered pesticide product to a
particular purchaser in a foreign country, a signed purchaser acknowledgment statement which contains the information set forth in paragraph (c)(1)
of this section.
(C) The exporter must sign a statement certifying that export did not
take place until a signed purchaser acknowledgement statement was received. The exporter must also specify
the chemical identity of any research
product which is referred to by code in
the purchaser acknowledgement statement. The information regarding the
specific identity of research products,
which may be included in the statement or consist of an attachment to
the certification, may be claimed as
confidential.
(D) The exporter must submit the
signed acknowledgement statement
from the foreign purchaser, and the accompanying certification by the exporter including attachments, to EPA
within 7 working days of the exporter’s
receipt of the purchaser acknowledgement statement, or by the date of export, whichever occurs first. This information must be transmitted to the following address:
U.S. Environmental Protection Agency,
Office of Pesticide Programs, (H–7501C),
1200 Pennsylvania Ave., NW., Washington,
DC 20460,
Attention:
Purchaser
Acknowledgement
Statement.

(ii) Annual reporting procedures. Unless the exporter chooses to follow the
per-shipment reporting option described in paragraph (c)(2)(i) of this
section, the exporter must follow the
procedures for annual summary reporting which include the requirement of a
purchaser acknowledgement statement

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Environmental Protection Agency

§ 168.75

for the first shipment each calendar
year of an unregistered pesticide product to a particular purchaser, and an
annual summary of shipments to that
purchaser. The annual summary reporting procedures are as follows:
(A) Prior to the first shipment each
calendar year of an unregistered pesticide product to a particular purchaser in a foreign country, the exporter must provide the foreign purchaser with instructions about the required information on a purchaser acknowledgement statement, and inform
the foreign purchaser that the pesticide product cannot be exported from
the United States until the exporter
has received from the foreign purchaser
a properly completed, signed, and dated
purchaser
acknowledgement
statement.
(B) The exporter must obtain, prior
to the first shipment each calendar
year of an unregistered pesticide product to a particular purchaser in a foreign country, a signed purchaser acknowledgement statement which contains the information set forth in paragraph (c)(1) of this section.
(C) The exporter must sign a statement certifying that export did not
take place until a signed purchaser acknowledgement statement was received, indicating that this statement
is for the first shipment to a particular
purchaser in a specific country for that
calendar year, and that the exporter
will meet all the purchaser acknowledgement statement requirements as
described in this paragraph (c)(2)(ii) of
this section. The exporter must also
specify the chemical identity of any research product which is referred to by
code in the purchaser acknowledgement statement. The information regarding the specific identity of research products, which may be included in the statement or consist of
an attachment to the certification,
may be claimed as confidential.
(D) The exporter must submit the
signed acknowledgement statement
from the foreign purchaser, and the accompanying certification by the exporter including attachments, to EPA
within 7 working days of the exporter’s
receipt of the purchaser acknowledgement statement, or by the date of export, whichever occurs first. This infor-

mation must be transmitted to the following address:
U.S. Environmental Protection Agency,
Office of Pesticide Programs, (H–7501C),
1200 Pennsylvania Ave., NW., Washington,
DC 20460,
Attention:
Purchaser
Acknowledgement
Statement.

(E) The exporter, who has chosen to
comply with the requirements of this
paragraph instead of providing pershipment purchaser acknowledgement
statements in accordance with paragraph (c)(2)(i) of this section, must submit an annual summary report to EPA.
An annual summary report is required
for each unregistered pesticide exported within the preceding calendar
year. The report must be in writing,
signed by the exporter, and include the
following information:
(1) Name, address, and EPA identification number if applicable, of the exporter.
(2) Name and address of the foreign
purchaser, and the date the purchaser
acknowledgement
statement,
submitted to EPA during the previous calendar year, was signed by the
purchaser.
(3) The identity of the product and
the active ingredients, including: the
Chemical Abstract Services (CAS) registry number for each active ingredient, the chemical nomenclature for
each active ingredient used by the
International Union of Pure and Applied Chemists (IUPAC), and other
known chemical or common names, or
if the export involves a research product, the code name or identification
number that can be used by EPA to
identify the product from the exporter’s records.
(4) The dates of each shipment of the
pesticide exported to the foreign purchaser during that calendar year.
(5) If known, or reasonably ascertainable, the country or countries of final
destination of the export shipments,
i.e., where the exported pesticide was
intended to be used, if different from
the foreign purchaser’s address.
(F) The exporter shall submit the annual summary no later than March 1st
of the following calendar year. The annual summary shall be sent to the following address:
U.S. Environmental Protection Agency,

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§ 168.85

40 CFR Ch. I (7–1–04 Edition)

Office of Pesticide Programs, H–7501C,
1200 Pennsylvania Ave., NW., Washington,
DC 20460,
Attention: Annual Summary of Exports.

(iii) Confidentiality claims. Persons
submitting the information specified in
the purchaser acknowledgement statement may assert a claim of business
confidentiality by marking the information claimed confidential as ‘‘FIFRA
Confidential Business Information.’’ Information so claimed will not be disclosed, with the exception of disclosure
to the foreign governments, except in
accordance with the procedures set
forth in 40 CFR part 2, 7 U.S.C. 136(h),
and this policy statement. If such
claim is not asserted, EPA may disclose the information to the public
without providing further notice prior
to disclosure or an opportunity to object. Notwithstanding any claim of
confidentiality, the purchaser acknowledgement statement will continue to be forwarded to the appropriate foreign government officials in
its entirety, as required by section
17(a)(2).
(3) Recordkeeping. Except as specifically stated, the requirement to retain
records under part 169 of this chapter
applies to all pesticide producers, regardless of whether a particular product is intended for export. All records
shall be maintained in accordance with
the time period required by § 169.2(h) of
this chapter. Producers must also
maintain certain records pertaining to
pesticide products intended for export.
In addition to the requirement that a
copy of the purchaser acknowledgement statement be kept, as stated at
§ 169.2(h)(3) of this chapter, the following records must be maintained:
(i) Copies of the instructions provided
to foreign purchasers in accordance
with
paragraphs
(c)(2)(i)(A)
and
(c)(2)(ii)(A) of this section.
(ii) Copies of signed purchaser acknowledgement statements obtained
according to paragraphs (c)(2)(i)(B) and
(c)(2)(ii)(B) of this section.
(iii) Copies of the certification from
the exporter; and copies of any accompanying information regarding the
identity of coded R&D products.
(d) Agency transmission of purchaser
acknowledgement statements. EPA will
transmit a copy of each purchaser ac-

knowledgement statement to the appropriate government official in each
of the intended destination countries.
After receipt of the Annual Summary
the following calendar year, EPA will
also transmit a copy of that document
to the appropriate government official
in each of the intended destination
countries. In the case that no Annual
Summary has been received within 30
days of the date at which such summary is required to be submitted, EPA
will send written notification to the
appropriate government official indicating that no summary was submitted, and may also take enforcement
action against the exporter.
[58 FR 9085, Feb. 18, 1993, as amended at 69
FR 23117, Apr. 28, 2004]

§ 168.85 Other export requirements.
This section describes other requirements found in regulations that apply
to exporters of pesticides, devices, and
active ingredients used in producing a
pesticide.
(a) Recordkeeping and inspection. Exporters of pesticides, devices and active
ingredients must keep records and permit inspections of those records in accordance with part 169 of this chapter.
Exporters must keep records of the
product labeling used, including the
EPA registered labeling, any foreign
labeling on or attached to the product
when shipped, and, as applicable, any
supplemental labeling used. Producers
of pesticides for export shall maintain
these records in a manner that shows
exactly which labels and labeling accompanied each shipment of a pesticide
product to a foreign country. As stated
at § 168.75(c), when research product
identity information appears on the labeling in an encoded manner, information translating the code shall be
maintained in records. These records
shall be maintained for the time period
required by § 169.2(h) of this chapter following the last export of such pesticides. All records required by part 169
of this chapter shall be made available
for inspection and copying by EPA or
its duly authorized representatives.
(b) Pesticide production establishment
requirements. Exporters of pesticides,
devices, and active ingredients must
submit annual reports to EPA in accordance with part 167 of this chapter,

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Environmental Protection Agency

§ 169.2

concerning those products that are exported. All products required to be labeled ‘‘Not Registered for Use in the
United States of America’’ must be reported as unregistered production regardless of whether a purchaser acknowledgement statement is required.

PART 169—BOOKS AND RECORDS
OF PESTICIDE PRODUCTION AND
DISTRIBUTION
Sec.
169.1
169.2
169.3

public enemy, fires, floods, epidemics,
quarantine restrictions, strikes, and
unusually severe weather, but in every
case, the failure must be beyond the
control and without the fault or negligence of said person.
(e) Producer. The term ‘‘producer’’
means the person, as defined by the
Act, who produces or imports any pesticide or device or active ingredient
used in producing a pesticide.
§ 169.2

Definitions.
Maintenance of records.
Inspection.

AUTHORITY: 7 U.S.C. 136f and 136w.
SOURCE: 45 FR 54338, Aug. 15, 1980, unless
otherwise noted.

§ 169.1

Definitions.

Terms used in this part shall have
the meanings set forth for such terms
in the Federal Insecticide, Fungicide,
and Rodenticide Act, as amended. In
addition, as used in this part, the following terms shall have the meanings
set forth below:
(a) Amount of pesticide or active ingredient. The term ‘‘amount of pesticide or
active ingredient’’ means the weight or
volume of the pesticide or active ingredient used in producing a pesticide expressed as weight for solid or semisolid products and as weight or volume
of liquid products.
(b) Batch. The term ‘‘batch’’ means a
quantity of a pesticide product or active ingredient used in producing a pesticide made in one operation or lot or
if made in a continuous or semi-continuous process or cycle, the quantity produced during an interval of time to be
specified by the producer.
(c) Device. The term ‘‘device’’ means
any device or class of device as defined
by the Act and determined by the Administrator to be subject to the provisions of the Act.
(d) Inability. The term ‘‘inability’’
means the incapacity of any person to
maintain, furnish or permit access to
any records under this Act and regulations, where such incapacity arises out
of causes beyond the control and without the fault or negligence of such person. Such causes may include, but are
not restricted to acts of God or of the

Maintenance of records.

All producers of pesticides, devices,
or active ingredients used in producing
pesticides subject to this Act, including pesticides produced pursuant to an
experimental use permit and pesticides, devices, and pesticide active ingredients produced for export, shall
maintain the following records:
(a) Records showing the product
name, EPA Registration Number, Experimental Permit Number if the pesticide is produced under an Experimental Use Permit, amounts per batch
and batch identification (numbers, letters, etc.) of all pesticides produced. In
cases where the product is an active ingredient used in producing a pesticide
or where the product is a pesticide
which is not registered, is not the subject of an application for registration,
or is not produced under an Experimental Use Permit, the records shall
also show the complete formula. The
batch identification shall appear on all
production control records. These
records shall be retained for a period of
two (2) years.
(b) Records showing the brand names
and quantities of devices produced.
These records shall be retained for a
period of two (2) years.
(c) Records showing the following information regarding the receipt, by the
producer, of all pesticides, devices, and
active ingredients used in producing
pesticides:
(1) Brand name of the pesticide or device, or common or chemical name of
the pesticide active ingredient;
(2) Name and address of shipper;
(3) Name of delivering carrier;
(4) Date received; and
(5) Quantities received.
These records are not intended to cover
receipt of pesticides used for in-plant

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