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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.

Comments 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 this Response 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-2009-0607-0009 and EPA-HQ-OPP-2009-0607-0010 

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-2009-0607-0010 

also urged compliance of the proposed regulations in 40 CFR part 168 with those in 40 CFR part 156.

RESPONSE: EPA attempted to transfer the wording from the current regulations into the proposed 

regulations. EPA might have inadvertently made the proposed regulations more confusing in the 

transfer. EPA reviewed 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 reference 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 

might be confusing. Since “labeling” according to FIFRA includes labels 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 requirements of 40 CFR 156.10(a)(4).
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Foreign language labeling

COMMENT: Commenters EPA-HQ-OPP-2009-0607-0008 and EPA-HQ-OPP-2009-0607-0009 

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-2009-0607-0009 also believed that an otherwise registered pesticide 

product is misbranded if its label differs from its approved label. Therefore, 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 labeling of the export pesticide product must be provided in 

English and, if applicable, the following foreign languages:

EPA disagrees with the comment about misbranding discussed by Commenter EPA-HQ-OPP2009-0607-0009. 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 Labeling:

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. Note: both language versions of the 

labeling must appear 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 English 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 documents can be found at www.epa.gov/pesticides. 

Formulation modifications

COMMENT: Commenter EPA-HQ-OPP-2009-0607-0008 supported EPA’s proposal to remove the 

current list of formulation modifications and adopt 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 current 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 information 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. 
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Human hazard and precautionary statements

COMMENT: Commenter EPA-HQ-OPP-2009-0607-0009 suggested that EPA define the terms 

“appropriate” and “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 definitions for “inappropriate,” “appropriate,” or 

even “legally sufficient.” EPA proposed using “inappropriate” and “appropriate” because a literal 

translation of the U.S. precautions 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 hazard 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-2009-0607-0008 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 operative 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-2009-0607-0009 suggested that this requirement should be addressed 

in §152.30(a) instead of §168.70 while Commenter EPA-HQ-OPP-2009-0607-0010 believes the 

proposed requirement is not necessary to achieve EPA’s goals.

RESPONSE: Commenter EPA-HQ-OPP-2009-0607-0008 has misinterpreted the proposed language 

regarding transfer between registered establishments operated by the same producer. The labeling 

requirements of FIFRA 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 intended 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 contains pesticide registration and classification procedures. 

Effective date

COMMENT: Commenter EPA-HQ-OPP-2009-0607-0010 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 the industry’s established protocols and practices. Less time than 18 months creates and [sic] 
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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 that are being 

shipped between registered establishments operated by the same producer. Therefore, the rule will 

become effective 60 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 for Use in the United States”

COMMENT: Commenters EPA-HQ-OPP-2009-0607-0009 and EPA-HQ-OPP-2009-0607-0010 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 amplification. 

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. 

Labeling of pesticide products for research & development

COMMENT: Commenter EPA-HQ-OPP-2009-0607-0008 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 §168.65 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 pesticide 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 devices

COMMENT: Commenter EPA-HQ-OPP-2009-0607-0011 asked about selling a pesticide 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.

RESPONSE: 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-2009-0607-0010 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-2009-0607-0010 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.
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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-2009-0607-0003 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 requires 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 available to the 

public for comment at the draft stage. That is why Commenter EPA-HQ-OPP-2009-0607-0003 was 

unable to access that draft for review and comment.