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Businesses Seeking Legal Help to Make Covid-19-Fighting Products

April 14, 2020, 10:00 AM

Attorneys specializing in federal chemical regulations are helping manufacturers get germ-fighters to market amid the coronavirus pandemic.

Companies have been seeking advice on disinfectants, soap, and cleaning products, which are regulated by the Environmental Protection Agency; and hand sanitizers, which fall under the Food and Drug Administration’s jurisdiction, said Martha E. Marrapese, an partner at Wiley LLP in Washington, D.C. whose practice includes environmental protection and chemical control.

Answering the dozens of questions companies have about how they can legally make such products has “been a full time job for three weeks,” Marrapese said. “Everyone is dealing with Covid-19 on top of their normal plate of issues.”

Alcohol and the Law

A lot of companies that can produce ethanol, commonly called alcohol, or purchase it want to use it make hand sanitizers, said Marrapese, and Michael T. Novak, a partner at Keller and Heckman LLP in Washington who specializes in pesticide and chemical regulation.

If the company’s ethanol normally would be used for distilled spirits, then it already meets FDA’s requirement and can easily be used for products like hand sanitizers, Marrapese said.

But companies that produce ethanol for fuel or other purposes may need help to make sure their alcohol can be used under a temporary FDA policy to increase the nationwide supply of hand sanitizers, Marrapese said.

That policy allows different grades of alcohol to be used if certain conditions are met, she said. Many of FDA’s requirements are aimed at ensuring the safety of antiseptic ingredients.

BASF Production

The BASF Corp. doesn’t normally produce hand sanitizers, but it does make various alcohols. And BASF got FDA approval to produce hand sanitizers at its Washington, N.J., and Wyandotte, Mich., plants, said company spokeswoman Katharina Meischen.

The sanitizer will be donated to health care facilities as well as used at BASF locations in the U.S. to protect the company’s workforce, she said.

Companies also want to make disinfectants, said most of the half-dozen attorneys interviewed.

But whether they can could hinge on the specific chemical or chemicals they’d like to use, said Steve Owens, a partner with Squire Patton Boggs whose practice focuses on environmental, safety and health issues.

Owens said some companies believe their cleaning chemical could also be classified as an effective disinfectant. But if that chemical isn’t registered as an antimicrobial under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), there’s no quick path for it to be added to the EPA’s List N, which names disinfectants qualified for use against Covid-19, he said.

EPA’s ‘Magical’ List

“If a product doesn’t have an EPA registration number, then EPA has not reviewed any data on whether the product will kill public health pathogens such as viruses,” the agency’s website says. “EPA will not add products to List N that do not have an EPA registration number because we have no data showing they will work and can be used safely.”

Owens cautions companies against making virus-killing claims. The EPA, the Federal Trade Commission, and the Justice Department are cracking down on fraudulent assertions that a product kills the coronavirus, Owens and other attorneys said.

The EPA’s Emerging Viral Pathogen program is, however, helping companies with FIFRA-registered antimicrobials get qualifying products on List N, Owens said.

Keller and Heckman’s Novak described getting on that list as “magical.” Military, federal, and state agencies, as well as the public, purchase disinfectants based on EPA’s list, he said.

Emergency Exemptions

There’s another type of product that could be useful in the Covid-19 fight, for which Novak said some clients would like EPA’s recognition: an antimicrobial embedded into a textile or hard surface.

Traditionally, the agency has approved antimicrobials such as silver and copper for products like hospital curtains and bed pans. Manufacturers can’t claim these products protect people, but they can say they inhibit the growth of bacteria, mold, and mildew on those products, he said.

Novak is exploring whether the pesticide law’s “Section 18" authority could be used to get antimicrobial-treated products quickly approved as also helping in the Covid-19 fight.

Section 18 of FIFRA allows the EPA to cite emergency conditions in permitting antimicrobial or other pesticide use without undergoing a full registration, which can take more than a year. But a state or other agency must ask the agency to approve the product for an emergency.

“EPA will continue to consider options for expediting certain reviews of additional products that could be effective in responding to this public health emergency,” an agency spokeswoman said.

Shipping Hurdles

Companies making products recognized as essential for Covid-19 have a fairly easy case to make to get those goods shipped, said Manesh K. Rath, a partner with Keller and Heckman LLP who has extensive experience representing industries in occupational safety cases.

But that’s not the case for some chemicals, such as resin, even though that glue-like compound is necessary to make packages for medicines, food, or hand sanitizers, he said.

Truck, rail, air, and other transport carriers have limited space, and they’re under state and company orders to use it for essential goods, Rath said.

One of the tasks Rath said he has taken on during the pandemic is to help clients explain why the chemical, paper, or other product they make is essential.

To contact the reporter on this story: Pat Rizzuto in Washington at prizzuto@bloombergenvironment.com

To contact the editors responsible for this story: Gregory Henderson at ghenderson@bloombergenvironment.com; Rebecca Baker at rbaker@bloombergenvironment.com

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