196 

§ 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 applications 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. 

197 

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 

198 

§ 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 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. 

199 

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 

200 

§ 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 

201 

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 

202 

§ 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 

203 

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 

204 

§ 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 

205 

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 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. 

(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, 

206 

§ 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 acknowledgement 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, 

207 

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 Definitions. 

169.2 Maintenance of records. 

169.3 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 

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 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