EPA Clarifies Requirements for Labeling of Pesticide Products and Devices for Export
On January 18, 2013, the U.S. Environmental Protection Agency (EPA) promulgated a final rule revising the regulations on the labeling of pesticide products and devices intended solely for export. EPA states that the final rule restructures the current regulations to clarify which provisions apply under various circumstances. The final rule also provides increased specificity in the regulations by requiring that people who transfer unregistered pesticide products between registered establishments operated by the same producer within the U.S. must also comply with the requirements if those products are intended solely for export at the time of such transfer. According to the notice, EPA “believes that this requirement is necessary to ensure appropriate handling of such products as they move in commerce before they actually leave the United States.” The final rule will be effective March 19, 2013. The compliance date for labeling unregistered pesticide products intended solely for export that are being shipped between registered establishments operated by the same producer is January 21, 2014.
EPA published a notice in the April 6, 2011, Federal Register proposing to revise the regulations on labeling of pesticide products and devices intended solely for export. EPA proposed including a specific indication that these requirements also apply to unregistered pesticide products intended solely for export when shipped between registered establishments in the U.S. operated by the same producer before they are exported.
In the January 18, 2013, Federal Register notice, EPA notes that, with the exception of the modifications discussed below, the final rule is in “essentially the same form as the proposed rule.” EPA received the following key comments:
- Labeling terms: Commenters called attention to inconsistencies in the use of the terms “label,” “labeling,” and “supplemental labeling.” EPA revised the regulatory text according to the definitions of these terms in Section 2(p) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to eliminate the inconsistencies.
- Foreign language labeling: Commenters indicated that the proposed regulations addressing foreign languages on labeling did not explicitly allow for an exception when the predominant or official language of the importing country is English. EPA revised the rule so that labeling text is only required to appear in a foreign language if English is not the predominant or official language in the importing country, as well as the country of final destination, if known.
- Formulation modifications: One commenter supported EPA’s proposal to remove the list of formulation modifications and allow a broader range of changes that can be made to a registered pesticide product intended solely for export while it may still be considered to be “registered” for purposes of FIFRA Section 17(a) (i.e., any changes that are permitted under notification or non-notification). EPA states that the Pesticide Registration Manual and Pesticide Registration Notice 98-10 provide more information and guidance on the permitted changes.
- Human hazard and precautionary statements: One commenter disagreed with the use of “appropriate” and “inappropriate” in the description of the statements. EPA states it selected those terms because a literal translation of the U.S. human health and precautionary statements might not convey the correct level of caution in the importing country. EPA revised the regulatory text to require “true and accurate” translations of the English statements in the human hazard and precautionary statements.
- Amplification of the phrase “Not Registered for Use in the United States”: Several commenters assumed that amplification of the phrase was required and maintained such amplification was unnecessary. EPA states that it agrees that the phrase “Not Registered for Use in the United States,” a FIFRA requirement for unregistered pesticide products, is sufficient to comply with this rule if the exporting company prefers not to use any further optional amplification. Another commenter suggested that including the phrase on device labeling would create a competitive disadvantage in the marketplace. According to the final rule, EPA believes that the ability to include explanatory text such as “because pesticide devices are not required to be registered” should resolve this potential concern.
- Shipping between registered establishments operated by the same producer: Several commenters discussed potential problems associated with the proposed requirement that when unregistered pesticide products intended solely for export are shipped between registered establishments operated by the same producer, the products are required to have labeling that complies with 40 C.F.R. Part 168. One issue related to the many steps in the production process for pesticide products. One commenter suggested the new requirement be added to 40 C.F.R. Section 152.30 instead of Part 168, while another suggested the new requirement was unnecessary. After considering the comments, EPA states that it “believes that it is more appropriate to retain the new requirement in § 168.70 instead of adding it to 40 CFR 152.30.”
EPA intends the revisions to improve clarity in the current regulations. This should either reassure companies that have been operating under such assumptions or allow companies to modify their programs to be in compliance. Although EPA’s regulations state that companies can provide, in addition to the phrase “Not Registered for Use in the United States of America,” any amplification as to why the product is not registered, such amplification is voluntary. EPA intends this to allay concerns raised that required amplification statements would be confusing or irrelevant. There were two comments submitted with regard to the new labeling requirements applicable to unregistered pesticide products shipped between registered establishments operated by the same producer as set forth in 40 C.F.R. Section 152.30(a); one commenter sought to eliminate this provision entirely while the other sought to have any regulatory changes be addressed in 40 C.F.R. Section 152.30(a). While EPA has retained the regulatory provision, it has modified the language in the final rule to clarify that the requirement applies only to products intended solely for export. Specifically, the proposed language stated: “This section also applies to all unregistered pesticide products and devices that are transferred, distributed, or sold between registered establishments operated by the same producer under the exemptions provided by § 152.30(a) of this chapter.” The final language adds the phrase “that are intended solely for export,” stating: “This section also applies to all unregistered pesticide products and devices that are intended solely for export and that are transferred, distributed, or sold between registered establishments operated by the same producer according to § 152.30(a) of this chapter.”
Companies who export pesticides that EPA would consider unregistered under the rule should review the new requirements carefully.