A Ray of Regulatory Sunshine

Posted on April 30, 2020 by Lynn L. Bergeson

We are all desperate for good news.  In my continuing efforts not to become further mired in the quiet despair we are all experiencing, I thought I would pass along some good news, ironically occasioned by the pandemic.

To help alleviate supply chain disruptions by pesticide registrants that manufacture disinfectant products included on List N, the U.S. Environmental Protection Agency (EPA), in March, announced it was taking action to help hasten the availability of EPA-registered disinfectants.  EPA explained that it is temporarily allowing manufacturers of select already-registered EPA disinfectant products to obtain certain active ingredients from any source without obtaining prior EPA approval. The action only applies to products listed on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N). For List N disinfectant manufacturers, EPA’s decision was very good news, and EPA has moved with extraordinary speed in qualifying products to be effective against the virus that causes COVID-19.  As of April 23, EPA now has over 400 such products, up from less than 100 such products pre-pandemic.

Typically, EPA requires disinfectant manufacturers to apply for and receive EPA approval prior to making a change in the source of the active ingredient.  Under EPA’s action, however, manufacturers can source certain active ingredients from alternate suppliers by simply informing EPA of the change.  Once EPA has been notified, the registrant can immediately distribute or sell a product modified according to this temporary amendment, provided that the resulting formulation is chemically similar to the current formulation.  Presumably after the crisis subsides, the program would revert back to the standard approval process.  Registrants would then be disallowed from releasing for shipment new registered product unless that product is produced using a source of active ingredient identified in the product’s approved Confidential Statement of Formula, or otherwise would have complied with relevant requirements in the absence of this temporary amendment.

When announcing its temporary action in March, EPA stated that it intended to assess the continued need for the temporary amendment on a regular basis.  More recently, EPA has done one better, resulting in yet more good news.  EPA Assistant Administrator Alexandra Dunn, our esteemed ACOEL colleague, announced on April 22, 2020, that EPA may well consider permanently dropping certain “administrative hoops” based on a review of the temporary policy after the coronavirus crisis subsides.  EPA’s commitment to review the “value added” of these and perhaps other administrative requirements, consider eliminating them, and possibly institutionalize the streamlined temporary approach could be a great take-away from the crisis and an unexpected benefit.  Any such decision would, of course, be firmly premised on the conclusion that in eliminating these administrative hurdles, there would be no risk to human health or the environment.

Crises have a tendency to sharpen focus and realign priorities.  Maybe this crisis will help distinguish essential requirements to protect health and the environment from non-essential, vestigial ones that we can all live without.

Chronic Pesticide Exemptions May Increase Risks to Our Pollinators

Posted on January 8, 2018 by Stephanie Parent

EPA has the responsibility to protect the public and the environment, including bees and other pollinators, from the use of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Before any pesticide can be sold or distributed in the United States, EPA must register it after determining that its use will not generally cause “unreasonable adverse effects on the environment.” Section 18 of FIFRA allows use of pesticides that have not met this standard if “emergency conditions exist.” Congress intended use of Section 18 emergency exemptions to address urgent pest conditions such as severe and unexpected insect outbreaks. Yet, in some cases, EPA seems to administer the emergency exemption program so that it functions as a shortcut, allowing pesticide use to bypass the registration standard.

EPA’s repeated “emergency” exemptions for use of the insecticide sulfoxaflor on cotton and sorghum over the last six years are a good example of this. Sulfoxaflor is an insecticide, which EPA acknowledges is very highly toxic to bees. In 2015, the Ninth Circuit vacated EPA’s decision to register sulfoxaflor because “[w]ithout sufficient data, the EPA has no real idea whether sulfoxaflor will cause unreasonable adverse effects on bees, as prohibited by FIFRA.” In 2016, EPA registered sulfoxaflor without additional bee data or studies. Instead, EPA explained that the new registration results in “essentially no exposure to bees” because this time it did not allow use on indeterminate blooming crops, such as cotton, or on crops grown for seed. And, the registration restricted applications on certain “bee attractive” crops to post-bloom only.

Despite these restrictions in the registration designed to avoid harm to bees, EPA has exempted the use of sulfoxaflor over 70 times from 2011 through 2017. All but one of these exemptions was for use on cotton, which was retracted from the registration application following the Ninth Circuit’s decision, or on sorghum, which was never included in the registration in the first instance. Most recently, EPA exempted the use on alfalfa grown for seed, even though the registration also prohibits such use to avoid adverse effects to bees. The Center for Biological Diversity, where I work, makes the case that EPA’s chronic approvals of Section 18 exemptions for use of sulfoxaflor no longer reflect “emergency conditions” and are circumventing the FIFRA’s registration standard. We may learn more about sulfoxaflor and other exempted pesticide uses when EPA’s Office of Inspector General concludes its evaluation of whether EPA’s emergency exemption process maintains environmental and human health safeguards. 

40 Years Ago In History

Posted on October 3, 2014 by Andrea Field

The Blog Calendar Gods directed me to post something on September 16, 2014, which just happens to be the 40th anniversary of the date that I first started to practice law.  Not wanting that coincidence to go to waste, I decided to look back 40 years, to a time when the practice of environmental law was far less complex – or, at least, the things that EPA then published in the Federal Register were a lot shorter. 

On September 16, 1974, EPA’s rules and notices took up less than four pages in the Federal Register and consisted of a notice of receipt of applications for pesticide registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); a correction to one line of a previously-published notice of proposed rulemaking under the Clean Water Act; and the approval of a compliance schedule under the State of Kansas’ state implementation plan.   The entire Federal Register on that date was only 104 pages long.   

Fast forward 40 years.  EPA’s fairly typical Federal Register postings on September 16, 2014, include – as was the case 40 years ago – rulemaking proposals and notices under the Clean Air Act, Clean Water Act, and FIFRA; however, the September 16, 2014 proposals and notices from EPA take up more than 125 pages of the Federal Register, and a typical edition of the Federal Register these days is well over 300 pages long.  I could complain that EPA did not celebrate my anniversary with the publication of a splashy huge new rule in the Federal Register – but I think many of my clients would consider that to be a good thing.       

Perhaps the most significant change over the past 40 years, though, is to the overall length and complexity of the rules that are now appear in volume 40 of the Code of Federal Regulations.  (There is that number “40” again.)  In 1974, 40 C.F.R. – the volume of the code containing most of EPA’s regulations – was about 2000 pages long.  In the decades following that time, 40 C.F.R. has steadily increased in size (and complexity).  In 1984, it was approximately 5,800 pages long; by 1993, it topped 11,000 pages; and in 2012, there were over 25,000 pages of regulations in 40 C.F.R.          

For those of you wondering what else was going on 40 years ago (outside of the practice of environmental law), let me share the following tidbits from September 16, 1974.  The big news that day was President Ford’s announcement of his “Program for the Return of Vietnam Era Draft Evaders and Military Deserters.”  In addition, on that day, BART began operations in the Bay area, Bob Dylan recorded Blood on the Tracks, the Royal Canadian Mounted Police swore-in their first female recruits, and Joe Namath was on the cover of Sports Illustrated (he was shown rehabbing his battered knees, hoping to play one more season in his $250,000-per-year contract with the New York Jets).  Also, if I had stopped cutting my hair 40 years ago today, my golden locks would be more than six yards longer than they are today.

I will be thinking about all of this as I lift my glass this evening and toast all of you and begin year 41.