Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

by James V. Aidala

The threat of the Zika Virus grows every day, and the need for clear information is especially pressing if you are pregnant.  How do you prevent getting infected with the Zika Virus, and what insect repellents are best?  The first question is easy to answer:  public health experts agree that women who are pregnant or who might be pregnant should use insect repellents.  The answer to the second question is not so simple.

I am a former senior official at the U.S. Environmental Protection Agency (EPA), and familiar with how the U.S. evaluates and approves pesticides, which include insect repellents.  It is not easy for the average consumer to know what works and what does not work.  Unfortunately, EPA policies have made this question much more complicated, having made important distinctions between some “natural”-type repellents and other products available in the marketplace.

Years ago, EPA de-regulated a number of natural, non-toxic materials from being subject to the registration requirements of the federal pesticide law (the Federal Insecticide, Fungicide, and Rodenticide Act).  This made sense at the time since garlic, pepper, rotten eggs, vinegar, and other common chemicals are sometimes used as pesticides.  Before de-regulation, these products were also subject to the same requirements as synthetic chemical pesticides with long unpronounceable names (e.g., diethyltoluamide, better known as DEET) which EPA requires to have volumes of efficacy and safety test data.  Being natural does not mean a substance is non-toxic; some natural ingredients are fully evaluated and widely used.  But in the interest of efficient use of resources EPA issued a list of products that could be sold as pesticides, but would not be subject to EPA data requirements and review (EPA calls them “minimum risk pesticides”).

This list of pesticides which are not subject to EPA evaluation, and which are not required to have data which proves they are effective, includes a number of botanical ingredients, such as oil of citronella, geranium, rosemary, peppermint, and many others.  Many of these products can be used as pesticides -- some may work better than others -- and many work for the intended use (example:  rotten eggs, or as EPA refers to them -- “putrescent whole egg solids” -- are used as a deer repellent).

Many of these ingredients have been marketed as “natural” insect repellents, and labeled as “safe” or “non-toxic” using words that will not appear on products where EPA reviews and approves the instructions on the product label.

Here is the bureaucratic distinction which matters greatly to EPA, but will not be understood by consumers:

  • If the repellant label includes “public health claims” -- that it repels mosquitoes that may cause a disease (like Zika Virus or West Nile Virus) -- then the product has to have data showing that it works;
  • If the product just says “repels mosquitoes,” it is not required to have data that shows it is effective, and may very well be ineffective.

Few, if any, humans outside of EPA label experts realize this important distinction:  if there is no health claim on the label, then it is, in effect, a situation of “buyer beware.” 

What remains:  EPA’s deregulation of these products means it is legal to sell products which do not work, as long as the ingredients appear on the EPA minimum risk pesticides list.

Consumer Reports (CR) recently reported in May of this year on studies conducted on repellents.  Their results:

  • Using a “natural” mosquito repellent, with active ingredients such as citronella or clove, lemongrass, or rosemary oils, might seem like a good idea, especially if you’re pregnant or planning to be.
  • But five of the six plant-based repellents we tested…lasted one hour or less against Aedes mosquitoes, the kind that can spread Zika.

Not all repellents with the same ingredient are equally effective, and they found that some formulations of the chemical repellents also do not work for very long in their tests.  Some botanical pesticides are effective and have the public health claims on the label (example:  lemon eucalyptus, a botanical ingredient not on the exempt product list, and CR testing did find it to be effective).

To reduce confusion about what works, EPA for years has struggled to correct the situation by trying to impose changes to the requirements for insect repellents.

Unfortunately, to end the confusion about the difference between “repels mosquitoes” and “repels mosquitoes that can cause the Zika Virus,” EPA has to conduct a rulemaking which requires a long and bureaucratic process to complete.  The good news is that EPA is working on such a solution.  The bad news is that they have been working on it for almost ten years and they still have more work to do.  There are details and petitions and proposals and reasons why it has taken so long, but it is the kind of story that gives bureaucracy a bad name.

With the onset and fears about the Zika Virus, however, EPA should make the needed changes immediately to ensure that consumers are not misled into using products which are not proven effective in repelling mosquitoes. 

From a consumer’s point of view, it really is that simple.  Legally, it is more complicated.  In the meantime, EPA should be loud and clear in its communication about the distinction, even if they cannot take immediate action to reduce the confusion.


 

By Lisa M. Campbell and Lisa R. Burchi

In a November 2, 2015, Federal Register notice, the U.S. Environmental Protection Agency (EPA)  issued the final rule revising the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Worker Protection Standard (WPS).  EPA previously announced these revisions on September 28, 2015, and stated that it would issue the final rule in the Federal Register within 60 days. 

The following are important dates:

  • January 4, 2016:  The date when the final WPS rule is effective.
  • January 4, 2017:  The date by which agricultural employers and handler employers will be required to comply with all of the new requirements set forth in the final rule except for the ones listed below.
  • January 4, 2018 (Or 180 Days After An EPA Announcement That Training Materials Are Available, Whichever Is Later):  The date by which agricultural employers and handler employers will be required to comply with certain new requirements for the content of pesticide safety training for workers and handlers and pesticide safety information display (to be codified at 40 C.F.R. § 170.311(a)(3), 40 C.F.R. § 170.401(c)(3), and 40 C.F.R. § 170.501(c)(3)).  EPA states it delayed implementation of the final rule regarding certain training and display materials to provide agricultural employers and handler employers time for such materials to be updated, printed, and distributed as well as to allow time for existing trainers to familiarize themselves with those new materials.
  • January 4, 2018:  The date by which agricultural employers and handler employers will be required to comply with the requirement that the handler performing an application must immediately suspend a pesticide application if any worker or other person, other than an appropriately trained and equipped handler involved in the application, is in the application exclusion zone described in § 170.405(a)(1) or the area specified in column B of the Table in § 170.405(b)(4) (to be codified at 40 C.F.R. 170.505(b)). 

EPA also states that it is “committed to a robust outreach, communications and training effort to communicate the new rule requirements to affected WPS stakeholders.”  EPA has stated its intent to do the following to facilitate implementation:

  • Issue plain language “how to comply” fact sheets and guidance materials.
  • Develop compliance assistance materials that are targeted to specific agricultural sectors and rule requirements, such as respirator requirements or the WPS exemptions and exceptions.
  • Develop and disseminate new worker and handler training materials, conduct outreach to potentially affected parties, and provide assistance and resources to States and Tribes for WPS implementation.
  • Hold Pesticide Regulatory Education Program courses for State and Tribal pesticide program staff that will focus on WPS implementation, and Pesticide Inspector Residential Training courses for State and Tribal pesticide inspectors that will focus on WPS inspection requirements.

The details of the WPS final rule are discussed in Bergeson & Campbell, P.C.’s (B&C®) blog entry EPA Announces Revisions to Its Worker Protection Standard.

For more information, please see B&C’s memorandum Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2015 and James V. Aidala Comments on EPA’s Worker Protection Standards.  More information is also available on EPA’s Worker Protection Standard webpage.


 

By Lisa M. Campbell, Susan Hunter Youngren, Ph.D., and James V. Aidala

On August 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a proposal to revise the Certification of Pesticide Applicators rule.  EPA is proposing stricter standards for people certified to use “restricted use” pesticides (certified applicators).  Restricted use pesticides are not available for purchase by the general public, require special handling, and may only be applied by a certified applicator or someone working under the direct supervision of a certified applicator.

The proposed stricter standards include:

  • Certified applicators must be at least 18 years old;
  • Those working under the supervision of certified applicators would now need training on using pesticides safely and protecting their families from take-home pesticide exposure;
  • Certifications would have to be renewed every 3 years;
  • Additional specialized licensing for certain methods of application that can pose greater risks if not conducted properly, such as fumigation and aerial application; and
  • Updates to the requirements for States, Tribes, and Federal agencies that administer their own certification programs to incorporate the strengthened standards. 

Currently, the majority of certification programs have no renewal requirements.  Thus, this requirement will put additional burdens on States and Tribes administering certification programs to not only strengthen their standards under this new proposal but to incorporate a time-keeping process to ensure applicators’ renewals are kept up to date, and sufficient certification programs are available for re-certifying purposes.  In addition, for some certification programs, the specialized licensing programs will need to be developed, tested, and instituted.

EPA’s proposal to update certification and training requirements comes along with the parallel effort to revise the worker protection standards (WPS), where a final rule updating those requirements are expected sometime in September.  Like the revised WPS, revising the training requirements has been on EPA’s agenda for many years, and this part of the updated requirements for worker protection is expected to be less controversial than some of the changes to the WPS.  In particular, since EPA has emphasized the protection of children as part of its pesticide regulatory program, making the minimum age 18 for pesticide applicators is part of that agenda.

EPA encourages public comment on the proposed improvements.  Comments on the proposal are due November 23, 2015.

More information about certification for pesticide applicators is available here.


 

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On August 11, 2015, the U.S. Court of Appeals for the Ninth Circuit denied a motion for a stay pending review filed on December 18, 2014, by the Natural Resources Defense Council (NRDC), as well as a subsequent stay motion filed on February 6, 2015, by the Center for Food Safety and other petitioners (Case Nos. 14-73353 and 14-73359, consolidated).  Both motions requested that the court stay an October 15, 2014, decision by the U.S. Environmental Protection Agency (EPA) to register Enlist Duo herbicide (a combination of glyphosate and 2,4,-D) for use on corn and soybeans in six Midwestern states.

NRDC and CFS, et al. (Petitioners), filed these stay motions in a case consolidating petitions for review challenging EPA’s decision to register Enlist Duo.  The registrant of Enlist Duo (Dow AgroSciences) has intervened in the consolidated case.  The Petitioners argue that EPA failed to consider the impacts of increased glyphosate use on monarch butterflies, and did not fully assess the potential human health effects from 2,4-D.  In response, both EPA and Dow AgroSciences argue that approval of Enlist Duo will not lead to increased use of glyphosate, and that EPA fully considered all of the human health effects of 2,4-D before granting the registration.

The motions for a stay filed by the Petitioners were effectively motions for preliminary injunctive relief, an extraordinary remedy requiring that those seeking such relief show that they are likely to succeed on the merits, that there is likely to be irreparable harm, that the balance of equities tips sharply in their favor, and that an injunction is in the public interest.  In denying the stay motions, the court cited Winter v. NRDC, 555 U.S. 7 (2008).  In the Winter case, the Supreme Court held that irreparable injury must be likely and that a mere possibility of irreparable injury will not suffice in awarding injunctive relief.  Although the court did not opine further on its rationale for denying the Petitioners’ stay motions, it may be inferred that the court determined that the Petitioners had not satisfied the rigorous prerequisites for injunctive relief.

While this decision avoids an immediate disruption in the marketing of pesticides, the potential for disruption to the registration remains until the court challenge has been resolved.  As Enlist is a new product designed for use with crops genetically modified to be resistant to glyphosate and 2,4,-D, any disruption now would be especially impactful to the registrant and customers of the product.  Further, it could also have a chilling effect on efforts to introduce similar new or pending products if growers perceive too great a risk of uncertainty for this or similar pesticides.