### 196 40 CFR Ch. I (7–1–04 Edition) § 167.85

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 produceroperating an establishment must submit the reports required by this sectionconcerning 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 thepast year; (iii) estimated to be produced during the current year. The report shall only include those pesticidalproducts 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 daysafter 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 personmay 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 thesame 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 besubmitted by the company headquarters to the Regional Office having jurisdiction over the State in which the company headquarters is located. Aforeign 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: FIFRAForeign 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 registeredpesticides 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.

A UTHORITY : 7 U.S.C. 136–136y.

S OURCE : 54 FR 1125, Jan. 11, 1989.



### Subpart A—General Provisions [ Reserved ]

Subpart B—Advertising

§ 168.22 Advertising of unregisteredpesticides, 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 theseprovisions 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 deliverany 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 foran 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

S OURCE : 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 section17(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 alabel or labeling which meets the requirements of FIFRA section 17(a)(1). This requirement applies to all suchpesticides, devices, or active ingredients, regardless of whether the export

is for commercial or research use. Inthe 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 theexporter must submit a purchaser acknowledgement statement under FIFRA section 17(a)(2) as described at


### 198 40 CFR Ch. I (7–1–04 Edition) § 168.65

§168.75 of this chapter. In addition, information which will satisfy FIFRAsection 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 eitherimmediate 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 inproducing 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 producinga 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 containeror 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 mustappear on the label and must be adequate for the protection of personshandling the pesticide, device, or active ingredients including warnings regarding general toxicological hazardsand 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 orcaution 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 ofthe U.S. Bureau of Mines) an equivalent caution must be substituted.

(iii) The statement ‘‘Not Registered for

Use in the United States of America. ’’ Thelabels of all pesticides, devices, and active ingredients which are not registered for use in the United Statesunder FIFRA section 3 must prominently display the following statement:

‘‘Not Registered for Use in the United

States of America. ’’ The statementmust appear in English and in appropriate foreign languages, as described in paragraph (b)(4) of this section. It is permissible to append explanatory textwhich 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 approvedunder 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 asprovided in paragraph (c) of this section.

( 2

) The formula of the exported product is the same as the formula of theU.S. registered product (within certified limits). In addition, a change in the color or fragrance of the export product will not affect the product’sregistration status, as long as the following conditions are met:

( i ) The change in color must resultonly 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 explainedin 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 mustnot 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 minorchanges 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 thelabel in English and in appropriate foreign languages (as described in paragraph (b)(4) of this section). If theEnglish language description of the ingredients is easily identifiable and likely to be understood by the ordinaryindividual, the foreign language ingredient statement need not be included on the label. In the case of pesticideproducts, devices and active ingredients shipped solely for research and development purposes, it is permissibleto 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 (ifany), 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, thelabeling must include a use classification statement, if a use classificationhas 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 suchstatements do not result in false representation of the U.S. regulatory status of the pesticide. The use classification information may appear on theproduct label or on the labeling accompanying the pesticide product during shipment.

(3) Misrepresentation. The labelingshall 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 40 CFR Ch. I (7–1–04 Edition) § 168.75

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, andin an acceptable language of the country of final destination, if known orreasonably ascertainable by the exporter. When there are several official languages or dialects in a country, thelanguage which is predominately spoken or written, or a language in whichofficial 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 accordancewith 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 languagesused on the label or labeling. In addition, either the language which is usedto conduct official government business, or the predominantly spoken orwritten language of the country of import must appear on the labeling. Ineach 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 ofimport, shall also appear on the labeling. In any case where English is predominantly spoken or written or is thelanguage used to conduct official government business in a country, no other language need be included tomeet the multiple language requirement of this paragraph.

(c) Supplemental labeling. A pesticide, device or active ingredient intended forexport 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 ofthe pesticide, device or active ingredient at all times when it is shipped or held for shipment to meet export label requirements. Supplemental labelingmust 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 requirementsof 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 metfully on the product label which is attached to the immediate product container. Any required label or labeling

statement not met on the immediatecontainer may be met through supplemental labeling.

(2) Labeling contents and relation to shipment. If supplemental labeling isused 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 immediateproduct container. Thus, the supplemental labeling, together with the immediate product container label willmeet all of the requirements of paragraph (b) of this section. Where used,supplemental labeling must be attached to or accompany the productshipping 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). Section17(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 transmittedto an appropriate official of the government of the importing country.

(a) Products subject to the requirement. EPA will not consider an exporter of anunregistered 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 thestatement signed by the foreign purchaser was obtained by the exporter. Except as provided in paragraph (b) ofthis 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, areconsidered to be unregistered pesticides. This includes pesticides whichare of a different formulation, including composition (except for variationwithin 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 usestatements. 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 exportpurposes, as unregistered for the purposes of the purchaser acknowledgement statement requirement. Any changes to the registered product for export purposes must be documented inaccordance 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 forthe 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 labelapproved under a FIFRA section 3 registration, but which could be sold or

distributed in the United States withthe approved label attached to the immediate product container, provided that the label and labeling approvedunder 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 asprovided in paragraph (c) of this section.

(2) Packaging. (i) Certain changes may be made to a product’s labeling orpackaging 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 netcontents, 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-resistantpackaging, 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, thatmodification would not affect the registration status of the export product.

Other modifications to the label usedfor export purposes which will not affect the export product’s registration

status are: the use of metric units fornet 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 40 CFR Ch. I (7–1–04 Edition) § 168.75

additions or changes required by other Federal statutes or regulations; a change of the name or address of theregistrant, except for a change resulting from transfer of ownership, which requires that a registrant keep his

name and address current with theAgency; 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 theproduct labels or labeling will not affect the status of the product, providedthat 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 applicatorsdetermined 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 ismisleading 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 aschanges 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 afood 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 forthe purposes of the purchaser acknowledgement statement requirementunder 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 byadding 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 PesticideProducts, EPA included inert ingredients on List 4-a list of inert ingredients posing minimal hazard or risk-if theinert ingredients were generally regarded as innocuous. The provisions of this paragraph do not apply to those pesticide products intended for publichealth uses which are required or conditionally required to submit efficacydata 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 whichshow 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 resultonly 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 explainedin 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 notbe 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 Officeof Pesticide Programs Policy and Criteria Notice number 2155.1, November20, 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 productexported solely for research and development purposes will not be considered

to be in violation of the notificationrequirements 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 waterused 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 whethertotal shipments exceed the criteria described in this paragraph, EPA willevaluate 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 thischapter 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 thepurchaser, including the type of application site, rate of application, andmeasures taken for protection of humans from direct or dietary exposure.

(c) Procedures. An exporter of an unregistered pesticide product must submit a purchaser acknowledgementstatement to EPA containing the information stated in paragraph (c)(1) of this section, and a statement signed bythe exporter certifying that the exportation did not occur until the signed acknowledgement statement had beenobtained from the purchaser. If the foreign purchaser signs a purchaser acknowledgement statement in their own language, it must be accompanied byan 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 theInternational Union of Pure and Applied Chemists (IUPAC).

(C) Other known chemical or common names; or if the export involves aresearch product, a code name or identification number that can be used by


### 204 40 CFR Ch. I (7–1–04 Edition) § 168.75

EPA to identify the product from the exporter’s records. If a code name oridentification number is used, additional information must be attached to

the certification statement submitted with the purchaser acknowledgement

statement which will enable EPA toidentify 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 thecountry 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 thissection 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 exporterchooses to follow the procedures described in paragraph (c)(2)(ii) of thissection for the annual reporting procedures, the exporter must obtain andsubmit to EPA, a signed purchaser acknowledgement statement prior toeach 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 aforeign country, the exporter must provide the foreign purchaser with instructions about the required information on a purchaser acknowledgementstatement, and inform the foreign purchaser that the pesticide product cannot be exported from the United States until the exporter has received fromthe 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 aparticular 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 nottake 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 inthe 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 statementfrom the foreign purchaser, and the accompanying certification by the exporter including attachments, to EPA within 7 working days of the exporter’sreceipt 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 theper-shipment reporting option described in paragraph (c)(2)(i) of this section, the exporter must follow theprocedures for annual summary reporting which include the requirement of a purchaser acknowledgement statement


### 205 Environmental Protection Agency § 168.75

for the first shipment each calendaryear of an unregistered pesticide product to a particular purchaser, and an annual summary of shipments to thatpurchaser. The annual summary reporting procedures are as follows:

(A) Prior to the first shipment eachcalendar 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 informthe 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 datedpurchaser acknowledgement statement.

(B) The exporter must obtain, prior to the first shipment each calendaryear 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 nottake 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 exporterwill meet all the purchaser acknowledgement statement requirements as described in this paragraph (c)(2)(ii) of this section. The exporter must alsospecify the chemical identity of any research product which is referred to bycode 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 statementfrom the foreign purchaser, and the accompanying certification by the exporter including attachments, to EPA within 7 working days of the exporter’sreceipt 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 thisparagraph instead of providing pershipment purchaser acknowledgementstatements in accordance with paragraph (c)(2)(i) of this section, must submit an annual summary report to EPA. An annual summary report is requiredfor 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 purchaseracknowledgement 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: theChemical Abstract Services (CAS) registry number for each active ingredient, the chemical nomenclature for each active ingredient used by theInternational Union of Pure and Applied Chemists (IUPAC), and other known chemical or common names, orif the export involves a research product, the code name or identification number that can be used by EPA toidentify the product from the exporter’s records.

( 4

) The dates of each shipment of thepesticide 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 1stof the following calendar year. The annual summary shall be sent to the following address:

U.S. Environmental Protection Agency,


### 206 40 CFR Ch. I (7–1–04 Edition) § 168.85

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 inthe purchaser acknowledgement statement may assert a claim of businessconfidentiality 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 suchclaim is not asserted, EPA may disclose the information to the public without providing further notice priorto disclosure or an opportunity to object. Notwithstanding any claim ofconfidentiality, 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 chapterapplies 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 acopy 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 fromthe exporter; and copies of any accompanying information regarding the identity of coded R&D products.

(d) Agency transmission of purchaser acknowledgement statements. EPA willtransmit 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 30days of the date at which such summary is required to be submitted, EPA

will send written notification to theappropriate 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 activeingredients 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 showsexactly which labels and labeling accompanied each shipment of a pesticide product to a foreign country. As stated at §168.75(c), when research productidentity 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 periodrequired 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 mustsubmit 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.

A UTHORITY : 7 U.S.C. 136f and 136w.

S OURCE : 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. Inaddition, 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 orvolume 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 aquantity 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 definedby 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 toany records under this Act and regulations, where such incapacity arises outof 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 thecontrol and without the fault or negligence of said person.

(e) Producer. The term ‘‘ producer ’’ means the person, as defined by theAct, 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 producingpesticides subject to this Act, including pesticides produced pursuant to anexperimental use permit and pesticides, devices, and pesticide active ingredients produced for export, shall maintain the following records:

(a) Records showing the productname, EPA Registration Number, Experimental Permit Number if the pesticide is produced under an Experimental Use Permit, amounts per batchand batch identification (numbers, letters, etc.) of all pesticides produced. Incases where the product is an active ingredient used in producing a pesticide or where the product is a pesticidewhich 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