Page 1 of 5 RESPONSE TO COMMENTS To Regulation to Clarify Labeling of Pesticides for Export proposed April 6, 2011

Docket ID: EPA - HQ - OPP - 2009 - 0607 Summary: EPA is promulgating a final rule to clarify and restructure labeling regulations for the export of pesticide products and devices. A Notice of Proposed Rulemaking was published in the Federal Register on April 6, 2011 (76 FR 18995) and six comments were submitted to the docket . Comment s that EPA believes would be of wide interest are summarized and addressed in the preamble to the final rule. Comments that EPA believes are tangential or of marginal interest are not summarized in the preamble; instead, these are addressed in th is Respon se to Comments document. In several areas of the preamble to the final rule , readers are reminded to access the Response to Comments document for a more complete view of comments and responses. A commenter is identified by the document ID number assigned to the comment in Docket ID EPA - HQ - OPP - 2009 - 0607. Consistency in the use of “label,” “labeling,” and “supplemental labeling” COMMENT: Commenters EPA - HQ - OPP - 2009 - 0607 - 000 9 and EPA - HQ - OPP - 2009 - 0607 - 00 10 pointed out the inconsistencies in the use of “label,” “labeling,” and “supplemental labeling” in the proposed regulations under §§ 168.69, 168.70, and 168.71. Commenter EPA - HQ - OPP - 2009 - 0607 - 00 10 also urged compliance of the proposed regulations in 40 CF R part 1 68 with those in 40 CFR part 156. RESPONSE: EPA attempted to transfer the wording from the current regulations i nto the proposed regulations. EPA might have inadvertently made the proposed regulations more confusing in the transfer . EPA revie wed the current definitions for guidance on how to word the proposed regulations more consistently. FIFRA section 2(p) defines the terms “label” and “labeling” as follows: (1) Label . The term “label” is defined as “the written, printed, or graphic matter on, or attached to the pesticide or device or any of its containers or wrappers.” (2) Labeling . The term “labeling” is defined as “all labels and all other written, printed, or graphic matter: (a) accompanying the pesticide or device at any time; or (b) to which refe rence is made on the label or in literature accompanying the pesticide or device...pesticides. EPA agrees that the phrase “...a label or be accompanied by labeling...” in the proposed regulations m ight be confusing. Since “labeling” according to FIFRA includes l abels and all other written, printed or graphic matter, “labeling” would be most inclusive term to use . Therefore, §§ 168.69, 168.70, and 168.71 will be amended based on the above definitions. EPA also amended §168.66 to more clearly incorporate the requir ements of 40 CFR 156.10 (a)(4) .Page 2 of 5

Foreign language labeling COMMENT: Commenter s EPA - HQ - OPP - 2009 - 0607 - 000 8 and EPA - HQ - OPP - 2009 - 0607 - 000 9 pointed out that the proposed foreign language requirements in § §168.69 and 168.70 do not explicitly allow for an exception when the predominant or official language of the importing country is English. Commenter EPA - HQ - OPP - 2009 - 0607 - 000 9 also believe d that an otherwise registered pesticide product is misbranded if its label differs from its approved label. Therefor e, unless already on the approved label, requirements such as the addition of languages other than English would, by definition, render the pesticide product “Not Registered for Use in the United States of America.” RESPONSE: EPA agrees that the proposed regulation could potentially be interpreted as not permitting English - only labeling when English is also the language of the country of final destination or import. Therefore, section 168.69(c) will be amended to read: 168.69(c) The text of the label ing of the export pesticide product must be provided in Engli s h and, if applicable, the following foreign languages: EPA disagrees with the comment about misbranding discussed by Commenter EPA - HQ - OPP 2009 - 0607 - 000 9 . EPA notes that foreign language labeling is allowed without notification but must be a true and accurate translation of the English text. Guidance on this is provided in the following sources. First, Pesticide Registration Notice ( PR ) 98 - 10, states in IV. Non - notifications under Bilingual L abeling: A registrant may provide bilingual labeling on any product without notification. The foreign text must be a true and accurate translation of the English text. N ote : both language versions of the labeling must appea r on a container. Foreign text may be used on all or part of the labeling. In addition, page 18 - 1 of the Label Review Manual states: Foreign language text, in addition to the full English text, is permitted in part or in its entirety on the product so long as it is a true and accurate translation of the English text (See PR Notice 98 - 10). A registrant may provide bilingual labeling on any product without notification. However, if it is submitted, the Office of Pesticide Programs (OPP) currently does not review the translation for accuracy or stamp/approve it. If the foreign text is inaccurate or goes beyond the reviewed and accepted En glish labeling, the Office of Enforcement and Compliance Assurance (OECA) may take enforcement action. Based on this guidance , EPA concludes that the foreign language requirements in this rule will not cause any misbranded products. Links to both these d ocuments can be found at www.epa.gov/pesticides . Formulation modifications COMMENT: Commenter EPA - HQ - OPP - 2009 - 0607 - 000 8 supported EPA’s proposal to remove the current list of formulation modifications and adop t a broader interpretation of when a product may still be considered as registered, i.e., any changes permitted under notification or non - notification. This commenter also requested better clarity in relation to the permitted changes. RESPONSE: In the c urrent regulations there is a list of modifications to a registered pesticide product that would not render the product “unregistered” for export. EPA proposed removing the list and replacing it with the changes permitted under notification and non - notification in 40 CFR part 152 . EPA believes that Chapter 7 (current as of March 2011) of the Pesticide Registration Manual at www.epa.gov/pesticides/bluebook provides more complete and current inf ormation regarding the changes permitted under notification or non - notification. In addition, PR 98 - 10 entitled “Notifications, Non - Notifications and Minor Formulation Amendments” provides more detailed information and guidance on the permitted changes. Links to both these documents can be found at www.epa.gov/pesticides .Page 3 of 5

Human h azard and precautionary statements COMMENT: Commenter EPA - HQ - OPP - 2009 - 0607 - 000 9 suggested that EPA define the terms “appropriate” an d “inappropriate” in proposed §168.70(b)(3) (v) or use a more proper term since the terms do not provide any useful guidance to exporters. The commenter suggested using the term “legally sufficient.” RESPONSE: EPA agrees that there are no existing defini tions for “inappropriate,” “appropriate,” or even “legally sufficient.” EPA proposed using “inappropriate” and “appropriate” because a literal translation of the U.S. precaution s might not convey a correct level of caution. However, a “legally sufficient ” statement might not even be available in the foreign language. Therefore, EPA has amended 168.70(b) (3) (v) as follows to require “true and accurate” translations of the English statements in the human hazard and precautionary statements : 168.70(b) (3) (v) Human h azard and precautionary statements in accordance with the requirements of subpart D of part 156 of this chapter. The statements must be true and accurate translations of the English statements. Shipping between Registered Establishments Operated by the Same Producer COMMENT: Commenter EPA - HQ - OPP - 2009 - 0607 - 000 8 believes that the proposed labeling in 169.70 [sic] is incompatible with the reality of pesticide manufacturing and formulation . The commenter requests that the labeling requirements be opera tive only when the intent to export is established. This commenter also believes that §168.70 read together with §152.30(b) creates an unintentional consequence by mandating that intermediates and products for export as unregistered products be produced in or transferred only [bold by commenter] between establishments operated by the same producer ; § 152.30(b) permits transfers between registered establishments not operated by the same producer . Commenter EPA - HQ - OPP - 2009 - 0607 - 000 9 suggested that this require ment should be addressed in §152.30(a) instead of §168.70 while Commenter EPA - HQ - OPP - 2009 - 0607 - 00 10 believes the proposed requirement is not necessary to achieve EPA’s goals. RESPONSE: Commenter EPA - HQ - OPP - 2009 - 0607 - 0008 has misinterpreted the proposed l anguage regarding transfer between registered establishments operated by the same producer. The labeling requirement s of FI F RA sec. 17(a)(1) only apply to products that are “intended solely for export to any foreign country.” The exemption found at 40 CFR 152.30(a) can apply to the movement of any unregistered pesticides. In addition, the exemptions may apply to a transfer that is part of a deliberate export manufacturing/distribution chain, in which case the related labeling requirements associated with 40 CFR 168.70 must be met as well as the conditions associated with 40 CFR 152.30(a). However, this does not place any requirement on any producer to ascertain the intent of the transferee of a product; this only applies to a transfer if the product is inten ded solely for export at the time of the transfer; if the transferor does not have that intent at the time of the transfer, then it is not “intended solely for export.” EPA believes that since 40 CFR part 168 contains the labeling requirements for pesticide products intended for export, the proposed requirement should be retained there instead of being addressed in part 152, which contain s pesticide registration and classification procedures. Effective date COMMENT: Commenter EPA - HQ - OPP - 2009 - 060 7 - 00 10 suggested an alternative to the one - year compliance date in the proposed rule : “...the total time allowed between effective date and the compliance date totals 18 months. This timeline corresponds with EPA’s standard policy of existing stocks and th e industry’s established protocols and practices. Less time than 18 months creates and [sic]Page 4 of 5

exception to standard processes which are in place to ensure compliance with changes such as those proposed. ” RESPONSE: EPA acknowledges that adhering to the proposed one - year timeline would not correspond with the compliance date in PR 97 - 7 . EPA believes that a year will be sufficient to comply with the requirement to label unregistered pesticide products intended solely for export tha t are being shipped between registered establishments operat ed by the same producer. Therefore, the rule will become effective 6 0 days after publication in the Federal Register and the compliance date will be 365 days after publication in the Federal Register. Amplification of phrase “Not Registered f or Use in the United States” COMMENT: Commenters EPA - HQ - OPP - 2009 - 0607 - 000 9 and EPA - HQ - OPP - 2009 - 0607 - 00 10 were in agreement that the phrase “Not Registered for Use in the United States” alone would convey the necessary information without further details. RESPONSE: The phrase “Not Registered for Use in the United States of America” is required by FIFRA sec. 2(q)(1)(H) and is sufficient if the exporting company wishes to use it without amplifi cation. The current regulations state: “It is permissible to append explanatory text which qualifies the statement by pointing out the reasons for the unregistered status.” The key word is “permissible.” The amplification is purely voluntary. Label ing of pesticide products for research & development COMMENT: Commenter EPA - HQ - OPP - 2009 - 0607 - 000 8 requested that EPA clarify the labeling of R&D samples for registered as well as unregistered products. RESPONSE: EPA is not changing the applicability of the labeling requirements for exported pesticide products. The previous version of §168.6 5 states “This [export labeling] requirement applies to all such pesticides, devices, or active ingredients, regardless of whether the export is for commercial or research use.” The proposed rule stated in §168.68 “This subpart applies to all export pestic ide products and export pesticide devices regardless of the purpose of the export.” EPA has revised the final rule to clarify that research purposes are encompassed by this phrase, whether the exported is registered or unregistered. Export of pesticide d evices COMMENT: Commenter EPA - HQ - OPP - 2009 - 0607 - 00 11 asked about selling a pes ticide device overseas when his/her product had the phrase “Not Registered for Use in the United States” on the label while a competitor’s product did not have the same phrase. RE SPONSE: 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. Purchaser acknowledgement statements COMMENT: Commenter EPA - HQ - OPP - 2009 - 0607 - 0 0 10 suggested that the definitions for registered pesticide product in the current § 168.65, the proposed § 168.69, and § 168.75 be harmonized into one definition; this commenter believed that this would ensure that there is a uniform understanding of what is considered registered and what is considered to be unregistered . Commenter EPA - HQ - OPP - 2009 - 0607 - 00 10 also suggested a review of the conditions for acquiring Purchaser Acknowledgement Statements (PASs) . This commenter believes that a PAS is not needed for pesticide products which have a composition registered with the EPA, but which bear labeling claims which are not approved in the United States. As a general rule of thumb, when a product can be relabeled and imported back to the United States legally , then a PAS should not be required.Page 5 of 5

RESPONSE: Because the scope of the proposed rule was limited to labeling requirements for exported pesticide products and devices , EPA is not able to consider comments on matters that fall outside this scope , such as foreign purchaser acknowledgement statements. Commenting on www.regulations.gov COMMENT: Commenter EPA - HQ - OPP - 2009 - 0607 - 000 3 tried to comment on the Federal Register notice (December 1, 2010) announcing that EPA had forwarded the draft proposed rule to the Secretary of Agriculture for review. The commenter was not successful in commenting on the notice. RESPONSE: FIFRA sec. 25(a)(2) requires that EPA provide the Secretary of Agriculture with a draft copy of the proposed rule for comment. FIFRA also re quires that EPA notify the public by publishing a notice in the Federal Register that the draft rule has been sent to the U.S. Department of Agriculture for review. Since the draft rule is subject to change and thus not ready for publication, it is not av ailable to the public for comment at the draft stage. That is why Commenter EPA - HQ - OPP - 2009 - 0607 - 000 3 was unable to access that draft for review and comment.