Issue

On a regular basis, pesticide registrants request to add the term “new” to pesticide product labeling when registering a new product or making some change to their product Generally, when EPA has approved the use of “new” on pesticide labeling, EPA has allowed the term to appear for a period of six months following the approval of the labeling. Because there is often a delay between when EPA approves labeling and when a product is first sold and distributed, the six-month period may lapse before the product is available to consumers. This means that despite EPA acceptance of the term “new” on product labeling, registrants may not ever be able to use the term.
The Agency is considering whether to change its practice of approving the use of “new” for only the six months starting at the date EPA approves the product labeling. EPA is interested in receiving comments from pesticide registrants, pesticide regulators, pesticide users, and the general public. Comments will assist the Agency in ensuring pesticide labeling provides accurate and non-misleading information to pesticide users.

Background:

The Federal Trade Commission (FTC) regulates advertising of consumer products generally. In 1967, the FTC issued an advisory opinion concerning the use of the term “new” in advertising. FTC’s advisory opinion stated that “the word ‘new’ may be properly used only when the product so described is either entirely new or has been changed in a functionally significant and substantial respect.” 16 CFR 15.120 (1968). The opinion further states that the Commission would “be inclined to question use of any claim that a product is ‘new’ for a period of time longer than 6 months. This general rule would apply unless exceptional circumstances warranting a period either shorter or longer than 6 months were shown to exist.”
When EPA reviews and approves pesticide labeling, EPA must determine that the labeling is not false or misleading. Consistent with the FTC opinion, EPA’s general practice is to approve the term “new” on product labeling for no more than six months. EPA describes its general practice of allowing the use of “new” for six months following the approval of pesticide labeling in Chapter 12 Part VII of the Label Review Manual (LRM), which states: “The claim ‘new’ may be used on the labeling of a product of new composition for a period of 6 months following approval of the labeling; however, the word ‘new’ may not be a part of the product name of record.” LRM at 12-7.
In cases where EPA approves pesticide labeling through an amendment, there may be a delay before that labeling appears in the marketplace for a variety of reasons including requirements for state registrations, contractual arrangements with retailers, or internal company marketing decisions. In fact, EPA itself generally allows 18 months for registrants to transition to newly-approved labeling. See 40 CFR 152.130(c). This delay can mean that products with labeling approved with the use of new for six months starting at the date of labeling approval will not reach the marketplace before the six months has passed. These products would not be able to make use of the term “new,” even though consumers have yet to be introduced to them.
In contrast, PR Notice 98-10 states that some label changes related to changes in product formulation may be submitted through notification rather than a registration amendment. Specifically, PR Notice 98-10 states: “Truthful statements about alternate formulations or minor formulation changes (such as ‘new’ or ‘new formula’) which have been approved by EPA may be added by notification for a period of six months after EPA’s approval of a revised or alternate formula and beginning when the product with this claim is first sold or distributed.” PRN 98-10 at 6. Claims of “new” added through notification, if appropriate, can be used on products as soon as the Agency has received the notification. 40 CFR 152.46(a)(2).

Suggested Solution:

To provide more consistent treatment between labeling that is approved by amendment and labeling that is changed through notification, EPA is considering to allow registrants seeking to amend their labeling to request the use of “new” with a projected start date for when a six-month time period to use the term would begin. For example, when requesting the use of “new,” a registrant could tell EPA they plan to start marketing the product on a specified date and therefore request to use “new” starting on that date and for six months after. Approving such a request would satisfy EPA’s need to determine that “new” is not used for a period so long that the term would become false or misleading. EPA prefers this approach over approving use of “new” for six months starting at the “first sale or distribution” because EPA generally does not know when the first sale or distribution will take place.

Questions for Public Comment:

What do you think of EPA’s suggestion to change the way the term “new” is approved?
How feasible is it for a registrant to provide an expected sale or distribution date for the new product?

How to Submit Comments:

Comments on this paper should be submitted by November 30, 2012 to: opp_labeling_consistency@epa.gov. Comments may also be posted to the Office of Pesticide Programs label discussion forum at http://blog.epa.gov/enablethelabel/.
Do not submit information considered to be Confidential Business Information or otherwise protected from disclosure. Any comments submitted may be made available to the public.

Editor's Note: The opinions expressed here are those of the author. They do not reflect EPA policy, endorsement, or action, and EPA does not verify the accuracy or science of the contents of the blog.

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