§169.2. Maintenance of records. — Inbound Citations

(b) Under the specific circumstances discussed below, EPA will not treat a registered product which has been modified slightly for export purposes, as unregistered for the purposes of the purchaser acknowledgement statement requirement. Any changes to the registered product for export purposes must be documented in accordance with the record-keeping requirements at § 169.2 of this chapter and this policy.

(1) EPA will not treat as unregistered for the purposes of section 17(a)(2), a registered pesticide product which cannot be sold or distributed for use in the United States because its immediate product container does not bear a label approved under a FIFRA section 3 registration, but which could be sold or distributed in the United States with the approved label attached to the immediate product container, provided that the label and labeling approved under a current FIFRA section 3 registration for the product is either attached to the immediate product container or accompanies the product at all times as supplemental labeling as provided in paragraph (c) of this section.

(i) Certain changes may be made to a product's labeling or packaging without affecting the registration status of the product, as specified in § 152.46(b) of this chapter and this policy. These changes include any changes in package size and label net contents, provided no change in use directions or requirement for child-resistant packaging would be necessary for the product to be registered for use in the United States. For example, if child-resistant packaging is required for a particular pesticide product in the United States, and the product will be exported without child-resistant packaging, the product would be considered unregistered and therefore subject to all the requirements of FIFRA section 17(a), as described in § 168.75 of this chapter including the requirement for a purchaser acknowledgement statement.

(ii) If an exporter needed to repackage a product in a size to meet a foreign purchaser's specifications, that modification would not affect the registration status of the export product. Other modifications to the label used for export purposes which will not affect the export product's registration status are: the use of metric units for net contents, dosages, and other numeric expressions; the use of a different format for the label, provided that the information does not contradict the U.S. label; revision of non-mandatory U.S. label statements, consistent with 40 CFR part 156, including additions or changes required by other Federal statutes or regulations; a change of the name or address of the registrant, except for a change resulting from transfer of ownership, which requires that a registrant keep his name and address current with the Agency; and any correction of typographical or printing errors that appeared on the U.S. labeling. (See § 152.46(b)).

(3) The following statements which appear on any of the product labels or labeling will not affect the status of the product, provided that they do not contradict the approved FIFRA section 3 labeling:

(i) It is permissible to add explanatory language which accurately explains the meaning of a use classification. For example, the statement “restricted use pesticide” may be expanded to read: “Restricted in the United States of America to use by certified applicators” or “Restricted Use Pesticide. In The United States this product is restricted to use by applicators determined by each state to be competent in pesticide application and the human health and environmental consequences of misuse.” If the explanatory language falsely represents or is misleading regarding the U.S. use classification, the product will be considered misbranded. In addition, a use classification can only be listed if one has been assigned pursuant to the U.S. registration.

(ii) An exporter who is also the manufacturer of a U.S. registered pesticide may add new uses to the label of that product for export purposes, without triggering the requirements of section 17(a)(2), as long as the new uses are within the same general use patterns as those for the registered product. The general pesticide use patterns are: terrestrial food crop and terrestrial non-food crop; greenhouse food crop and greenhouse nonfood crop; aquatic food crop and aquatic nonfood crop' indoor use' and forestry use. Adding new uses to the label which change the use pattern, such as changes from nonfood to food use, outdoor to indoor use, or terrestrial to aquatic use, render the product unregistered and subject to the requirements of section 17 for unregistered products. If the new use added to the label is a food or feed use, a tolerance must already be established for the use of that pesticide in or on that commodity.

(4) EPA will not treat a registered product as unregistered for the purposes of the purchaser acknowledgement statement requirement under the following specific circumstances:

(i) The formula of the exported product is within certified limits of the formula of the U.S. registered product.

(ii) An exporter, who is also the manufacturer of a U.S. registered pesticide, may decrease the percentage of the active ingredient(s) of that product by adding a List 4 inert ingredient, without causing the product to be treated as “unregistered” and triggering the requirement to obtain a purchaser acknowledgement statement as a condition for export. In EPA's Policy Statement on Inert Ingredients in Pesticide Products, EPA included inert ingredients on List 4-a list of inert ingredients posing minimal hazard or risk-if the inert ingredients were generally regarded as innocuous. The provisions of this paragraph do not apply to those pesticide products intended for public health uses which are required or conditionally required to submit efficacy data pursuant to § 158.400 or § 161.640 of this chapter, as applicable. Any differences in formula or composition caused by adding a List 4 inert must be reflected in records which show the complete formula of the export product in accordance with the requirements of § 169.2 and this policy.

(iii) A change in the color or fragrance of the export product will not affect the product's registration status as long as the following conditions are met. The change in color must result only from the addition of a dye included on the list of the chemicals exempted from the requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and 180.950, and the dye must not be a List 1 inert. (List 1 inerts are those inerts which the Agency has identified as presenting toxicological concerns. The classification of inerts is explained in EPA's Policy Statement on Inert Ingredients in Pesticide Products. The change in fragrance must result only from the addition of a chemical included on the list of the chemicals exempted from the requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and 180.950, and the chemical must not be a List 1 inert. The change in fragrance must not result in a pesticide product containing a food or food-like fragrance. (See “Food Fragrances in Pesticide Formulations,” EPA's Office of Pesticide Programs Policy and Criteria Notice number 2155.1, November 20, 1975.) Any difference in color or fragrance of the export product in accordance with this section must be reflected in records which show the complete formula of the export product in accordance with the requirements of § 169.2 and this policy.

(5) An unregistered pesticide product exported only for research and development purposes is subject to the notification requirements of this section, unless its use fits within the criteria described in this paragraph.

(i) An unregistered pesticide product exported solely for research and development purposes will not be considered to be in violation of the notification requirements if the export of the research and development product:

(A) Would not involve land uses of more than 10 acres (4.05 hectares), or be used on or affect food or feed crops which are intended for consumption.

(B) Would not involve aquatic uses of more than 1 acre (0.405 hectares), or any aquatic uses which involve water used for irrigation, drinking or recreation, or be used on or affect plants or animals taken for food or feed from such waters.

(ii) Shipments to different purchasers, to different countries of final destination, or which occur more than a calendar year apart will be evaluated separately. When determining whether total shipments exceed the criteria described in this paragraph, EPA will evaluate the total amount of shipments by a single exporter during a calendar year for use in a particular country.

(iii) An exporter bears the burden of demonstrating that the product meets these criteria before the research product is shipped. This may be met by documenting before the product is shipped and maintaining records for the time period required by § 169.2(h) of this chapter from the date of the last shipment relevant to such records. The records to be maintained consist of:

(C) The intended research use by the purchaser, including the type of application site, rate of application, and measures taken for protection of humans from direct or dietary exposure.

(d) Establishments in which pesticide products under State experimental use permits are produced shall be registered as required by 40 CFR 167.2(a) and producers of such products shall maintain books and records as required by 40 CFR 169.2.

(iii) An exporter bears the burden of demonstrating that the product meets these criteria before the research product is shipped. This may be met by documenting before the product is shipped and maintaining records for the time period required by § 169.2(h) of this chapter from the date of the last shipment relevant to such records. The records to be maintained consist of:

(C) The intended research use by the purchaser, including the type of application site, rate of application, and measures taken for protection of humans from direct or dietary exposure.

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

(3) Except as specifically stated, the requirement to retain records under part 169 of this chapter applies to all pesticide producers, regardless of whether a particular product is intended for export. All records shall be maintained in accordance with the time period required by § 169.2(h) of this chapter. Producers must also maintain certain records pertaining to pesticide products intended for export. In addition to the requirement that a copy of the purchaser acknowledgement statement be kept, as stated at § 169.2(h)(3) of this chapter, the following records must be maintained:

(i) Copies of the instructions provided to foreign purchasers in accordance with paragraphs (c)(2)(i)(A) and (c)(2)(ii)(A) of this section.

(ii) Copies of signed purchaser acknowledgement statements obtained according to paragraphs (c)(2)(i)(B) and (c)(2)(ii)(B) of this section.

(iii) Copies of the certification from the exporter; and copies of any accompanying information regarding the identity of coded R&D products.