EPA Seeks Comment on Draft PR Notice on Web-Distributed Labeling
The U.S. Environmental Protection Agency (EPA) published on January 16, 2013, a Federal Register notice announcing the availability of and seeking public comment on a draft Pesticide Registration (PR) Notice entitled “Web-Distributed Labeling for Pesticide Products.” EPA states that the draft PR Notice provides “guidance concerning the process by which registrants can make legally valid versions of pesticide labeling available through the Internet.” According to EPA, web-distributed labeling (WDL) would allow users to retrieve a streamlined version of the pesticide product labeling, which would include directions for use and necessary information related to the user’s specific state and intended site of use. EPA notes that shorter, relevant labeling “could be clearer and easier for the user to understand, improving compliance with pesticide labeling requirements and thereby protecting human health and the environment from unintentional misuse of pesticides. Web-distributed labeling would also allow for more rapid updates to pesticide labeling, meaning risk mitigation measures and new uses can reach the user more quickly than under the current paper-based system.” Comments are due April 16, 2013. The draft PR Notice will be available in the online docket at www.regulations.gov, under Docket Number EPA-HQ-OPP-2012-0906.
In 2010, EPA conducted a “user acceptance pilot,” which involved a simulation of a WDL website. EPA published a December 29, 2010, Federal Register notice seeking comment on issues related to WDL. Based on comments and other feedback received from the Federal Register notice and the user acceptance pilot, EPA is proposing a voluntary approach that would allow registrants to distribute pesticide products with labeling that refers the user to a website from which the user may download legally valid, enforceable labeling. EPA notes that the container “would still be accompanied by a physical copy of the EPA-accepted labeling sufficient for the correct use of the product, but a user could access the most current version of the state- and site-specific labeling” from a website identified on the container label. According to EPA, offering WDL while still retaining the full labeling on or accompanying pesticide containers would allow users, registrants, and EPA to acquire a better understanding of the strengths and limitations of WDL and possibly serve as a transition to a system relying more heavily on the Internet and other technologies to provide users with legally enforceable labeling. More background information is available on EPA’s website.
Issues for Comment
In the Federal Register notice, EPA highlights the following specific areas for comment:
- Would an appendix with sample master labeling and WDL rendered output assist in understanding the PR Notice and how to follow the recommendations in the PR Notice?
- The PR Notice suggests that it “is targeted towards pesticide products marketed primarily to applicators for use in the course of commercial activity.” Please comment on the scope of coverage. Should the EPA expand or contract the targeted products? Are there alternate ways to describe the targeted products?
- Should EPA consider combining the released for shipment date and the unique identifier into a single alpha-numeric combination? If so, why? Please provide suggested definitions for any proposed alternative.
- Should the released for shipment date and unique identifier have a standard location on the container or pesticide labeling? If so, where? If not, why?
- Should EPA approve WDL for one or some, but not all, uses listed on a product’s labeling? If so, how would users know that no WDL was available for their intended use?
- Should EPA consider only accepting WDL submissions for review as electronic files?
- Please provide comments on the WDL statements and their recommended location. Should they be located at the beginning of the directions for use? Should they be a separate section on the labeling, similar to the Agricultural Use Box that conveys information about the Worker Protection Standard? Would either approach make the user more likely to read and comply with the information?
- Please provide comments on the minimum functionality discussed in Unit IV. ix. Are the proposed standards reasonable? If not, please suggest alternative guidelines.
- Please provide any other comments on the PR Notice. If you disagree with or do not understand any aspect of the PR Notice, please describe the area and an alternative that incorporates your suggestions.
This notice seeks comment on a number of practical, administrative elements of the concept of electronic labels. Such “simple” administrative elements are crucial to how any such scheme might be implemented over time, and EPA has made clear its intention of moving towards such a system. At the same time, however, there remain some fundamental issues that have dogged the concept from the start, many centered on the liability and responsibility for ensuring that the “container” has the correct label language. The system for now would be voluntary, but a mandatory scheme is likely over time.
Since it has been axiomatic for decades that under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) “the label is the law,” such a change presents a scenario of “which label?” — the one on the container or the one accessed from the Internet — and who is responsible for making sure this “label,” which is in cyberspace, is the one applicable to the container in the hands of the user or in force at the time of application. Under the old, paper-label-is-on-the-can, one can read it, follow it, and show it to any inspector if that is later relevant. These might be more difficult issues under an electronic label scheme.
This notice is the next step in EPA’s attempt to work out some of the numerous challenges represented by the WDL concept. It is likely inevitable that electronic labels will be used someday, but many issues will continue to evolve, and not all may be readily addressed.