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for Government officials; it is not the final authority on the status of a given pesticide. It is the intent of Congress that the procedures that are followed for notifying foreign governments of the suspension or cancellation of pesticides be those which are also used to inform them that an unregistered pesticide will be entering their country. Therefore, the channel of communication described in this policy is derived from the procedures already used to notify foreign governments of major suspension or cancellation actions.

Comment No. 3. Scope of the FIFRA Section 17 Requirements. A number of commenters addressed the definition contained in this policy statement of an unregistered pesticide. The Agency agrees that clarification on this point is necessary. It is not EPA's intent to limit export of a chemical if it is properly labeled and the exporter complies with the procedures for obtaining and transmitting to EPA a properly executed acknowledgement statement. A more detailed explanation of which products will be regarded as unregistered for the purposes of this policy has been given. One commenter objected to including products with denied or cancelled uses and products with different composition or use patterns with products which contained no registered active ingredient. In drafting this policy statement, EPA adopted a broad interpretation of the registration status of a pesticide.

The Agency could have required exporters of all pesticide products that were not registered under section 3 to acquire an acknowledgement statement from the foreign purchaser. The effect of this would be that an acknowledgement statement would have been required for the overwhelming majority of exported pesticides since most exports differ slightly in formulation or directions for use from the U.S. registered product, or the labels are written in a foreign language. The EPA clearly stated in the proposed policy statement that in its view Congress did not intend that exported products with minor variations from EPA registered pesticides be subject to the export notification procedures. However, products with cancelled uses or with substantial differences in composition or use patterns cannot be considered products with minor variations. The Agency must, therefore, reject this comment.

Comment No. 4. Status of Certain Unregistered Pesticides. One commenter suggested that experimental use products be treated as registered products; another commenter thought that products with temporary tolerances

should be considered as if they were registered. Since registration data for such products are not complete, it has consistently been Agency policy to treat experimental use products and products with temporary tolerances as unregistered products. Products which bear registrations under section 24(c) of FIFRA will, however, be treated as registered products. Products undergoing Rebuttable Presumption Against Registration will be considered in accordance with their registration status at the time of export. It was suggested by one commenter that those pesticides which were registered by a foreign country should not be subject to the requirement for an acknowledgement statement. In order to adequately enforce a policy which took this approach, the EPA would have to evaluate the internal registration procedures conducted by other countries and to regulate exports based upon the policies of the importing country. Thus, EPA policy would be different for similar shipments going to different countries. The Agency rejects this comment. Not only would it be administratively difficult to operate such an export program, but such a policy fails to recognize the point of having the acknowledgement statement: To inform foreign governments of the U.S. registration status of a pesticide.

Comment No. 5. Non-Commercial Exportation. Another commenter requested clarification on the application of the notice provision to pesticides which are exported without a commercial transaction. There are two possible categories of products to which this comment might apply: the first would be small amounts of pesticide exported for research purposes only; the second would be large shipments exported to a foreign establishment of the domestic company which manufactures it. Research quantities are subject to the labeling rules of this policy but not to the acknowledgement statement requirement. Large shipments transferred from a domestic facility to a foreign facility of the same company will be treated in accordance with their U.S. registration status. That is, if the product is registered (in accordance with the use of that term in this policy), no acknowledgement statement is required; if the product is not registered, an acknowledgement statement will be required.

Comment No. 6. Technical and Multiple Use Chemicals. Some commenters asked for clarification of the impact of this policy upon formulated and technical grade products and multi-use products. Formulated and

technical grade products which are subject to FIFRA are subject to this policy. The label on the exported product must comply with section 17 of FIFRA. A multi-use product for which no pesticide claims are made and which is not an active ingredient in any pesticide product in the United States is not subject to this policy, even if it is subsequently processed into a pesticide in another country.

Labeling Comments

Comment No. 7. Use of Bilingual Labeling. A number of commenters stated that the law did not require bilingual labeling. The law states that an exported pesticides, device, or pesticide active ingredient must bear labeling in conformance with FIFRA section 2(g)(1)(E). The FIFRA states in section 2(q)(1)(E) that a pesticide is misbranded

if:

Any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon . . . in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; (Emphasis added.)

The EPA interprets this passage to apply to ordinary individuals in the importing country as well as in the United States. Thus, the bilingual requirements are meant to communicate some basic information about the product to as many handlers of the pesticide as possible. International symbols, suggested by one commenter, could not adequately communicate all the required label elements, although they may be used in addition to the required wording. Commenters asked for guidance regarding EPA's enforcement of the bilingual requirement in two specific instances: when the importing country has several official dialects, or when English is an official government language. Any language in which official government business is commonly conducted in the country, or which is the predominately spoken language of the country, is acceptable as the second language on the label. If English is one of these languages, then a bilingual label is optional, except as may be required by the importing country. One commenter asked if a translation of the U.S. label would be satisfactory. Such a label would be acceptable if the necessary elements appeared both in English and in the foreign language.

Comment No. 8. Foreign Labeling Requirements. Several commenters asked about the application of this policy to labels which comply with the laws of the importing country. It is not

the intention of this policy to supersede the labeling requirements of foreign governments. However, FIFRA now requires that exported pesticides, devices, and pesticide active ingredients bear certain minimal labeling. If the labeling which currently appears on exported pesticides does not meet the minimum FIFRA requirements, even though it may meet the foreign country's requirements, additional labeling must be added to satisfy U.S. law.

Comment No. 9. Supplemental Labeling. Several commenters suggested that supplemental labeling be liberally allowed. The Agency intends to be as flexible as possible in this respect. Exporters will be permitted to use a variety of types of labeling to comply with the FIFRA export requirements. The Agency's principal interest will be to ascertain that products to which this policy applies bear labels or labeling which, taken together, conform to the FIFRA section 17(a)(1) requirements.

Comment No. 10. Establishment Numbers. One commenter requested the option of substituting another code for the EPA Establishment Number on the label. The Act clearly requires that an Establishment Number appear on the label. The Agency must reject this suggestion since permitting other means of identifying the production establishment would negate the usefulness of such numbers.

Comment No. 11. Restricted Use Pesticides. Several commenters requested guidance on label requirements for exported restricted use pesticides. If the product is a restricted use pesticide, then the statement "Restricted Use Pesticide" must appear on the label or labeling. The supplementary statement of the terms and conditions of restriction is not required.

Acknowledgment Statement

Comment No. 12. Prior Possession of Acknowledgement Statements. A number of commenters questioned the requirement that the acknowledgement statements be in the exporter's possession before shipment of the pesticide can take place. Other commenters stated that in their opinion foreign importers, through oversight or bureaucratic inefficiency, will not comply with the acknowledgement statement requirement. In the proposed policy statement, the Agency clearly recognized the problem of noncompliance by foreign importers. For this precise reason, EPA must reject the contention that acknowledgement statements should not be required to be in the exporter's control before shipment can take place. A more liberal

interpretation of what constitutes receipt of the acknowledgement statements has been provided in the final policy statement to facilitate compliance. One commenter suggested that a signed acknowledgement in the hands of a local company representative be considered a receipt by the exporter. The Agency agrees that this would be acceptable so long as the information required on the acknowledgement statement is sent to EPA within the stated time period. If a company anticipates several orders in a year, the acknowledgement statements may be obtained in advance of the actual order. One commenter stated that the requirement that acknowledgement statements be sent to EPA within seven days of receipt by the exporter was too restrictive. This commenter suggested that transmittal of the acknowledgement statement should be tied to the date of shipment. The Agency disagrees. Where possible, acknowledgement statements will be sent to foreign governments as far in advance of shipment as possible. This will provide the government some time to review the information received. The Agency feels more timely notification will occur if transmittal of the acknowledgement statement is tied to date of receipt.

Comment No. 13. Certifications. Some commenters objected to filing, along with the acknowledgement statement, a certification that the order was not shipped before the acknowledgement statement was received. The Agency believes that a certification statement is necessary. While some monitoring of compliance will be through inspection of required books and records, a

certification requirement will serve to remind exporters that shipment must wait until the acknowledgement statement has been received.

Comment No. 14. Destination of Shipment. One commenter suggested that there was no need to include in the acknowledgement statement the destination of the export shipment, if different than the purchaser's address. This comment is rejected because without this information the Agency would be unable to determine if the labeling complied with the bilingual requirements nor would it know the proper place to send the acknowledgement statement.

Comment No. 15. Annual Reporting. Several commenters stated that the requirement that a new

acknowledgement statement be acquired each year that a particular product is exported is overly

burdensome. They point out that the law requires an acknowledgement statement

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only once per country, not once per country, per year. The Agency must reject this comment. Although FIFRA is not clear on this point, the law seems to indicate that an acknowledgement statement should be acquired for each export shipment of an unregistered pesticide. It is the Agency's position that imposing such a requirement would be a burden for all parties concernedexporters, importers, and the U.S. Government, as well as foreign governments-beyond any regulatory purpose it may serve. The requirement to send an acknowledgement statement once per year, which is similar to that being considered under the Toxic Substances Control Act, is not overly burdensome, and yet accomplishes the purpose of regular notification to foreign governments.

Comment No. 16. Notification of Foreign Governments. Several commenters questioned the procedure for notifying foreign governments. It was suggested that either the foreign purchaser or the exporter should directly notify the foreign government. The EPA rejects this proposal. First, it would be difficult, if not impossible, for the Agency to monitor compliance under such a procedure. Second, as previously explained, the procedure for transmitting acknowledgement statements parallels that of the notification of foreign governments of suspended or cancelled registrations. It is the understanding of the Agency that such a procedure, namely governmentto-government contact, was the intent of Congress.

Comment No. 17. Problems with Importing Countries. Two commenters suggested that the policy be different for socialist or communist countries. These commenters cited their experience exporting pesticides to these countries where the "importer" is an agency of the government. These import agencies are said by the commenters to be staffed by very conservative bureaucrats who are reluctant to sign unusual requests. As has been discussed earlier, it is not the intent of this Agency to write a different export policy for different countries. However, should numerous problems arise with any particular country, the Agency will work with industry and the Department of State to solve them.

[FR Doc. 80-22055 Filed 7-25-80; 8:45 am) BILLING CODE 6560-01-M