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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, and 180

[FRL 1546-5]

Statement of Policy on the Labeling Requirements for Exported Pesticides, Devices, and Pesticide Active Ingredients and the Procedures for Exporting Unregistered Pesticides AGENCY: Office of Enforcement, Environmental Protection Agency (EPA or the Agency).

ACTION: Notice of policy statement.

SUMMARY: The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA or the Act) was amended by the Federal Pesticide Act of 1978 on September 30, 1978. Section 17(a) of the Act was modified so that pesticides, devices, and active ingredients used in producing pesticides which are manufactured for export must now bear certain minimal labeling, and the producers of such products are now subject to the requirements of both FIFRA sections 7 (establishment registration) and 8 fbooks and records). In addition, unless a pesticide is registered under section 3 or is being sold under section 6(a)(1) it cannot be lawfully exported unless, prior to export, (1) the foreign purchaser has signed a statement acknowledging that the purchaser understands that the pesticide is unregistered and therefore cannot be sold in the United States, and (2) a copy of that statement has been transmitted to EPA for transmittal to the appropriate officials of the importing country. This foreign purchaser acknowledgement statement must be acquired by the exporter and transmitted to EPA for the first shipment of each unregistered pesticide to a particular purchaser for each importing country, annually.

This notice informs the public of the scope of the new labeling requirements and of the procedures that an exporter of unregistered pesticides must follow to acquire acknowledgement statements which will be transmitted by the U.S. Government to the government of the importing country.

EFFECTIVE DATES: Labeling. Labeling requirements for exported pesticides, devices, and pesticide active ingredients became effective March 29, 1979,

(Federal Pesticide Act of 1978, Pub. L. 95-396, 92 Stat. 833). Therefore, exported products which fall within the purview of this notice must now bear labels which comply with the statutory requirements of FIFRA section 17(a)(1).

Purchaser Acknowledgement Statements. After thirty days from the date of this notice, exporters of unregistered pesticides will be in violation of FIFRA if the foreign purchaser acknowledgement statements have not been acquired before shipment and transmitted to EPA in accordance with this policy.

FOR FURTHER INFORMATION CONTACT: John J. Neylan III, Office of Enforcement, Pesticides and Toxic Substances Enforcement Division (EN-342), EPA, 401 M Street, S.W., Washington, D.C. 20460 (202) 755-1212.

SUPPLEMENTARY INFORMATION: On Wednesday, July 18, 1979, EPA's Office of Enforcement published a proposed statement of policy on the labeling requirements for exported pesticides, devices, and pesticide active ingredients and the procedures for exporting unregistered pesticides, [44 FR 41955). That proposed policy statement explained in some detail what information would be required to appear on the labels or labeling of pesticides, devices, or pesticide active ingredients destined for export in order to be considered in compliance with the law. It also described the procedures for acquiring from a foreign purchaser of unregistered pesticides a statement in which the purchaser acknowledges the registration status of the pesticide. Both of these requirements became effective 180 days after the date of enactment of the Federal Pesticide Act of 1978 (March 29, 1979).1

The July 18 notice invited the public to comment on the proposed policy before September 17, 1979. Twenty-three comments were received. Following is a summary of the major modifications to the policy statement made as a result of the comments.

(1) A more detailed explanation was included of which products will be considered as not registered for use in the United States, for purposes of this policy statement.

(2) The policy statement explains in greater detail what labeling is expected to appear on exported pesticides, devices, and pesticide active. ingredients.

Appendix A contains summaries of the comments made to the July 18, 1979 policy statement and the Agency's response to them.

Accordingly, the Office of Enforcement's general statement of policy on the labeling requirements for exported pesticides, devices, and pesticide active ingredients and the

'Pub. L. 95-396, 92 Stat. 819, September 30, 1978, Section 18(b).

Acting Assistant Administrator for
Enforcement.

L. Summary of Policy

Pesticides, devices, and active ingredients used in producing pesticides which are manufactured for export must now bear labeling which will serve to both identify the product and the producer and to protect persons who come in contact with the product. Certain of the label items must be written in both the English language and in the language of the importing country. These bilingual labeling requirements apply to the product's ingredient statement and its warning and precautionary statements. Exporters of pesticides which are not registered for use in the United States (in accordance with this policy) must obtain a statement from the foreign purchaser of the pesticide in which the purchaser acknowledges the registration status of the product. The pesticide must also bear labeling to indicate that it is not registered in the United States. For purposes of this policy an unregistered pesticide is one which (1) contains an active ingredient not found in a federally registered product; or (2) bears labeling for a use which is currently subject to denial or cancellation of registration; or (3) is not similar in composition and use pattern to a federally registered product.

The acknowledgement statement must (1) identify the purchaser, the exporter, the product's identity and the product's destination; (2) be obtained for the first shipment of a particular pesticide to a particular purchaser for each importing country, annually; (3) be obtained before exportation takes place; and (4) be transmitted to EPA within seven (7) days of receipt by the exporter.

II. Labeling Requirements

Section 17(a) of FIFRA has been amended to provide as follows:

(a) Pesticides and Devices Intended for. Export.-notwithstanding any other provision of this Act, no pesticide or device or active ingredient used in producing a pesticide intended solely for export to any foreign country shall be deemed in violation of this Act

(1) when prepared or packaged according to the specifications or directions of the foreign purchaser, except that producers of such pesticides and devices and active ingredients used in producing pesticides shall be subject to sections 2(p), 2(q)(1)(A), (C), (D), (E). (G), and (H), 2(q)(2)(A), (B). (C)(i) and (iii), and (D), 7, and 8 of this Act;

Every exported pesticide, device, and active ingredient used in producing a pesticide must bear a label or labeling. in English or in the language of the importing country, which meets the requirements of FIFRA section 17(a)(1). In addition, certain information which will satisfy FIFRA sections 2(q)(1)(E). (G), and (H) and 2 (q)(2)(A) and (D) must also appear on the label or labeling so as to provide bilingual (in other words, in English and in the language of the importing country) information to anyone who handles or comes in contact with these products. Any language in which official government business is conducted in the country or which is the predominately spoken language of the country, is acceptable as the second language on the label.

Pursuant to Section 17(a)(1), all exported pesticides, devices, and active ingredients used in producing pesticides must bear labels or labeling which:

(a) bear EPA Establishment Numbers; (b) have ingredient statements; (c) have the name and address of the producer or registrant;

(d) have statements of net weight or

measure;

(e) if highly toxic, bear skull and crossbones and statements of practical treatment in case of poisoning;

(f) include warning and caution statements;

(8) do not make false representations; (h) are not in imitation of other products; and

(i) in the case of unregistered pesticides, bear the statement "Not Registered for Use in the United States of America." All such required statements must be conspicuous and readable.

To satisfy FIFRA section 2(q)(1)(E). the labeling provisions set forth below must appear in the English language and in the language of the importing country. This section specifies that required statements must be represented ". . . in such terms as to render it likely to be read and understood by the ordinary individual..." Therefore, the following information must appear bilingually on exported product labeling:

(a) the warning and caution statements;

(b) the ingredient statement; (c) where required, the word "poison" and the statement of practical treatment; and

(d) the statement "Not Registered for Use in the United States of America."

The following may provide more specific guidance on particular elements which must appear on the label or labeling of each exported product:

a. EPA Establishment Number. The Establishment Number may appear

anywhere on the label or immediate container in accordance with the establishment registration labeling requirements set forth in 40 CFR $182.10(f).

b. Precautionary Statements. Warning or caution statements must be biligual and must be adequate for the protection of persons handling the pesticide, particularly with respect to general toxicological hazards and environmental, physical, or chemical hazards. Where the bilingual translation is obviously inappropriate to protect residents of the importing country, (for example, where a label calls for a gas mask meeting the specification of the U.S. Bureau of Mines) an equivalent caution may be substituted.

c. Unregistered Products. Labels of pesticides which are not registered under FIFRA (See Products Subject to the Requirement for an

Acknowledgement Statement below) must prominently display the following statement: "Not Registered for Use in the United States of America." This statement must appear bilingually. d. Ingredient Statement. The ingredient statement must appear bilingually unless the ingredients are easily identifiable despite their being listed in a foreign language.

e. Use Classification Statement. The statement of use classification (Restricted Use Pesticide or General Use Pesticide) must appear on the labeling of the pesticide; however, summary statements regarding the terms of the restriction, e.g., "For retail sale to and application only by Certified Applicators ..." are not required. f. Identity of Parties. Name and address of the producer, registrant, or person produced for must appear in the labeling.

8. Net Weight. The net weight must appear on the labeling in either conventional English units or metric units.

h. Highly Toxic Pesticides. If the pesticide is highly toxic, the skull and crossbones, the word "Poison", and a statement of practical treatment must appear on the labeling. The word "Poison" and the statement of practical treatment shall be bilingual. The skull and crossbones may be in red or black. For guidance on what pesticides are highly toxic, see 40 CFR § 162.10 (h).

The Agency is concerned that labeling required by FIFRA not conflict with labeling requirements of the importing country. Such a situation might arise, for example, where pesticides are being exported to a foreign country with strict labeling and registration laws such as this country has. To avoid such potential conflicts, yet still meet the statutory

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requirements of FIFRA, exporters may use supplemental labeling. Pesticides, devices, and active ingredients used in producing pesticides may, therefore, bear a label with the appropriate information required by FIFRA section 17(a)(1) or may be accompanied by supplemental labeling in instances where FIFRA required labeling is in contravention of foreign labeling requirements. Supplemental labeling may be attached to or accompany the product container or shipping container. III. Foreign Purchaser Acknowledgment Statement

Section 17 of FIFRA has been further amended to provide as follows:

(a) Pesticides and Devices Intended for Export.-Notwithstanding any other provision of this Act, no pesticide or device or active ingredient used in producing a pesticide intended solely for export to any foreign country shall be deemed in violation of this Act

(2) In the case of any pesticide other than a pesticide registered under section 3 or sold under section 6(a)(1) of this Act, if, prior to export, the foreign purchaser has signed a statement 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 under the Act. A copy of that statement shall be transmitted to an appropriate official of the government of the importing country.

This notice also delineates what pesticide products are affected by this provision and procedures EPA believes would satisfy the purposes of section 17(a)(2).

IV. Products Subject to the
Requirements for an Acknowledgment
Statement

Many pesticides which are produced in the United States solely for export contain active ingredients that are also registered as components of pesticides used within the United States. However, the export formulations in many cases contain slightly different percentages of active ingredients and are labeled differently. Several factors dictate these minor modifications in formulation and labeling, such as different systems of measurement, pests to be controlled which are different from those for which the same or a similar pesticide product is used in the United States, and requirements for labeling in a language other than English.

The Agency believes that Congress did not intend the requirement for obtaining an acknowledgement statement which is applicable to "unregistered" pesticides to apply to products which are minor variations on formulations registered in the United States and which contain only active

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ingredients which are registered in the United States. Rather, it is the Agency's view that the export amendments were meant to apply in cases in which either (1) an adverse decision concerning the use of the pesticide in the United States has been made, or (2) no decision has been made concerning use of the

. pesticide. The requirement for obtaining an acknowledgement statement from a foreign purchaser will apply to pesticide products in which:

(a) The pesticide active ingredient has been judged to pose "unreasonable adverse effects" to man or the environment, and the registrations of products with that active ingredient have been cancelled or denied; or

(b) Either, (1) no assessment or no conclusive assessment of the hazard resulting from use of the pesticide has been made by EPA (while the pesticide may have been used under limited experimental or emergency conditions). (2) the pesticide has never been registered under section 3 because registration for the pesticide active ingredient has not been sought or has not yet been granted, or (3) the pesticide is being exported for a use which is substantially different from any currently registered use of that pesticide (e.g., a pesticide which is registered in this country for use as a termiticide is exported bearing directions for use on food crops).

Consequently, the Agency interprets section 17(a)(2) to apply to:

(a) All pesticide products which contain an active ingredient that is not found in a federally registered product; (b) All pesticide products bearing labeling for a use which is currently subject to denial or cancellation of registration (section 17(a)(2) will also apply to uses not considered by the Administrator dung a cancellation or denial determination); and

(c) All pesticide products which are not similar in composition and use pattern to a federally registered product. To be considered similar in composition and use pattern, a pesticide product must contain only the same ingredient or combination of active ingredients and must have the same category of toxicity as a federally registered product. Also, the use pattern must be similar to the use pattern of the federally registered pesticide to which it is being compared. Registrations involving changes in use patterns such as changes from non-food to food use, outdoor to indoor use, terrestrial to aquatic use, or non-domestic to domestic use, are not considered to qualify as similar use patterns. Pesticide uses which were never reviewed during a cancellation or denial of registration

determination (such as a pesticide use on a crop which is not grown in the United States) also do not qualify as a similar use.

Pesticide products which are subject to the requirements of section 17(a)(2) must also bear the label statement, "Not Registered for Use in the United States of America" stipulated by section 2(g)(1)(H) of this Act.

A pesticide product which has been registered under Section 24(c) of FIFRA will be considered as registered for purposes of this policy. A pesticide product which may be legally used only under an experimental use permit (Section 5) or an emergency exemption (Section 18) will not be considered as federally registered. Nor will a pesticide product whose distribution and use are legal in intrastate commerce because the producer has filed an application for federal registration in accordance with the procedures found in 40 CFR § 162.17. Technical grade and manufacturing use pesticides which are not federally registered will be considered as registered for purposes of this policy, if they qualify as being similar in composition to a registered formulation use pesticide, (i.e., if the products have the same active ingredients and category of acute toxicity).

V. Procedures

Section 17(a)(2) requires that before a pesticide which is not registered for use in the United States can be exported, the foreign purchaser of the pesticide must acknowledge in writing that he understands the registration status of the pesticide and that the pesticide cannot be sold in the United States. An exporter of unregistered pesticides must have received the required

acknowledgement statement before the product is released for shipment. The Agency feels that requiring exporters to have in hand the purchaser acknowledgement statement before exportation takes place is the only way to assure that foreign purchasers comply with these new FIFRA export requirements. The Agency recognizes that this requirement may cause some disruption in the export of pesticides.. However, any such delays will be visited only upon exporters of unregistered pesticides, and then only for the first shipment to a foreign purchaser, in a particular country, annually. The information required on the acknowledgement statement, along with a certification signed by the exporter, must be transmitted to the Environmental Protection Agency within seven days of receipt by the exporter, or by the date of export, whichever occurs first. The certification must state' that

the shipment did not take place before the exporter had the signed acknowledgement statement in hand. The Agency will consider the receipt of purchaser acknowledgement statements by local company representatives in foreign countries to be receipt by the exporter. Nevertheless, the information required by the acknowledgement statement must still be transmitted to EPA within seven days of receipt, or by the date of export, whichever occurs first.

Acknowledgement statements may be acquired at any time in advance of shipment. For example, an exporter that ships to the same foreign purchasers year after year may acquire at the beginning of a year all of the acknowledgement statements which are anticipated to be needed.

The Agency will transmit the acknowledgement statements to appropriate foreign officials through the Department of State. Statements will be transmitted promptly after receipt.

The Agency believes that the purpose of the purchaser acknowledgement statement is to advise foreign governments that pesticides which have been judged by the United States to be hazardous to human health or the environment, or pesticides for which no hazard assessment has been made, are being exported by U.S. producers to their country. Foreign governments may then use such information as they desire, perhaps, for example, in evaluating the risk of continued use of the pesticide in that country versus the benefits that pesticide provides. The Agency does not consider that the acknowledgement statement is primarily intended to serve as preshipment notification to foreign governments in order that they may intercept shipments of such pesticides. Nevertheless, because of the Agency's concern that acknowledgement statements reach foreign governments in a timely manner, the information contained in the acknowledgement statement will be forwarded to foreign governments promptly upon receipt by EPA.

As an information mechanism, the purchaser acknowledgement statement serves the purpose of alerting the foreign government that a certain pesticide is entering its country. The Agency believes that the first notice fulfills this purpose; repetitive notices would be of only marginal value, and in cases of a high volume of exports to a foreign country, might result in a flood of paper. After considering the administrative burdens placed on exporters, EPA, and foreign governments and the value of repetitive notices, the Agency has concluded that each exporter should

complete and have signed a purchaser acknowledgement statement, for the first shipment of a particular product to a particular purchaser for each importing country, annually. A shipment of the same product to a different purchaser or to the same purchaser for disposition to a different importing country would also trigger the requirement for obtaining a signed acknowledgement statement from the foreign purchaser. A second shipment, during the same calendar year, involving the same product, purchaser, and importing country would not trigger this requirement. Any change in the variables different purchaser, different product, different importing countrywill result in the need for obtaining a new purchaser acknowledgement

(a) The exporter must provide the foreign purchaser with instructions about the required information on an acknowledgement statement and inform the foreign purchaser that shipment of the pesticide cannot be undertaken unless the exporter has received from the foreign purchaser a properly completed, signed, and dated acknowledgement statement;

(b) The exporter must secure, prior to shipment, an acknowledgement statement which contains the information outlined in the Required Information section of this notice. Such a statement must be secured for the first purchase each year of a particular pesticide product by a foreign purchaser destined for a particular country;

(c) The exporter must forward the information required on the acknowledgement statement, along with the certification that exportation did not take place until a signed acknowledgement statement was received, within seven (7) days of receipt, or by the date of exportation, whichever occurs first, to the following address: Environmental Protection Agency, Pesticides and Toxic

Substances, Enforcement Division (EN342), 401 M Street SW., Washington, D.C. 20460.

Attention: Export Acknowledgement Statement.

VI. Required Information

As previously stated, a foreign purchaser of a pesticide which is not registered for use in the United States must sign a statement acknowledging his understanding that the product is unregistered and cannot be sold in this

country. The Agency does not intend to prescribe a format for this acknowledgement statement. However, the statement must include the following information:

(a) Name and address of the exporter, (b) Name and address of the foreign purchaser,

(c) Name of the product and the active ingredient and an indication that the purchaser understands that the product is not registered for use in the United States;

(d) Destination of the export shipment, if different than purchaser's address; (e) Signature of the foreign purchaser, and

(f) Date of the foreign purchaser's signature.

VII. Confidentiality

Persons submitting the information specified in Part VI may assert a claim of business confidentiality by marking this information as "FIFRA Confidential Business Information." Information so marked will not be disclosed, with the exception of disclosure to the foreign government, except in accordance with the procedures set forth in 40 CFR Part 2, 7 USC 136h, and this policy statement. If such claim is not asserted, EPA may disclose the information to the public without providing notice of disclosure or an opportunity to object. Notwithstanding any claim of confidentiality, the acknowledgement statement will be forwarded to the appropriate foreign government in its entirety as required by section 17. VIII. Relationship to Other Statutory Requirements

Producers of pesticides, devices, and active ingredients used in producing pesticides which are intended for export are subject to the establishment registration procedures, including the report requirements, as well as the record keeping requirements of FIFRA. The Agency has proposed amendments to the regulations which are promulgated under the authority of those parts of the Act (sections 7 and 8) to bring them into conformity with the newly amended FIFRA. These regulations are found at 40 CFR Part 167 and Part 169, respectively.

Pesticides, devices, and pesticide active ingredients for export are not considered to be in violation of FIFRA when produced according to the directions of the foreign purchaser, when properly labeled and, in the case of unregistered pesticides, when the foreign purchaser has signed a statement in which he acknowledges that he understands the registration status of the pesticide and the exporter

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has forwarded the statement to EPA. Exported pesticides, devices, and active ingredients used in producing pesticides which do not bear labels or labeling in compliance with FIFRA section 17(a)(1) will be considered to be misbranded. Exporters of such products will be subject to civil or criminal liabilities for violation of FIFRA sections 12(a)(1) (D) or (E)-misbranding. Exporters of unregistered pesticides will be subject to civil or criminal liabilities for violation of FIFRA section 12(a)(1)(A)—selling or distributing a pesticide which is not registered-if they fail to secure, prior to export, a properly completed, signed, and dated acknowledgement statement from the foreign purchaser of the pesticide. Falsification of the required certification may subject an exporter to sanctions under 18 U.S.C. 1001.

Appendix A. Significant Comments and Responses

General Comments

Comment No. 1. Applicability of Rulemaking Procedures. Two commenters stated that the Agency should have implemented the export provisions of FIFRA through the procedures established by the Administrative Procedures Act for the promulgation of "substantive" rules. The Agency disagrees. As mentioned previously, these requirements for export labeling and purchaser acknowledgement statements were statutorily effective March 29, 1979, 180 days from enactment of the Federal Pesticide Act of 1978. The law lists the type of information required on an exported pesticide's labeling and the legislative history makes it clear that purchaser acknowledgement statements are to be transferred to foreign governments in the same manner that cancellation notices are furnished. The Agency's position, therefore, is that there is no need for rulemaking but rather there is a need for a general statement of policy on such matters as: (a) what would constitute minimally acceptable labeling, (b) how such labeling could be attached or accompany shipments, and (c) how foreign purchaser acknowledgement statements are to be transmitted to foreign governments.

Comment No. 2. Use of Suspended and Cancelled Pesticides List. Another commenter suggested that foreign countries can be adequately informed of the hazards of U.S. manufactured pesticides through an expansion of the Suspended and Cancelled Pesticides List. This is not the intended function of the Suspended and Cancelled Pesticides List. That list constitutes only a guide