EPA Details Plan to Improve Long-Criticized New Chemical Reviews – Bloomberg Law

By Pat Rizzuto
The EPA outlined new tools and technology it plans to use to review the risks of new chemicals, part of an effort to address criticism about slow assessments, lack of transparency, and deficient consideration of potential hazards.
The goal is to ensure new chemicals’ safety while allowing their innovations “to improve the cars we drive or the chips used in our computers, to create the newest iPhone, or unlock a green energy breakthrough to help solve the climate crisis,” Michal Ilana Freedhoff, EPA’s assistant administrator for chemical safety and pollution prevention, said Monday at a meeting of EPA’s Board of Scientific Counselors, which is reviewing the agency’s proposed approach.
Industry groups allege the Environmental Protection Agency’s new chemicals program is too slow, inconsistent, and demanding. Environmental groups complain it isn’t transparent and doesn’t assure safety. The complaints have engulfed the agency since 2016 when Congress overhauled the program as part of its Toxic Substances Control Act (TSCA) amendments.
TSCA requires the agency to review new chemicals before they’re produced or imported. The amendments forced the EPA for the first time to make public decisions about the risks new chemicals pose.
The agency’s initiatives to address the concerns include a proposed New Chemicals Collaborative Research Program that would let EPA’s staff use new scientific methods to analyze how new chemicals move through the environment and affect people and the natural world.
The Board of Scientific Counselors began to review the program on Monday and will continue to meet Tuesday, next month, and in December, with the goal of providing the agency final recommendations after its December meeting.
The proposed new methods for analysis didn’t exist when the program began in the late 1970s and early 1980s.
The collaborative also aims to help the agency overcome a core challenge built into the law.
TSCA doesn’t require a chemical manufacturer to provide any data on a chemical’s hazards when it asks the EPA to allow it to make or import the chemical for the first time, said Louis “Gino” Scarano, a senior toxicologist in EPA’s chemicals office.
Manufacturers are required to provide details on the atoms used to make the chemical, how those atoms will be connected, proposed production methods, and other information that the agency uses to make predictions. They also must submit any toxicity data they’ve developed.
The US law is different from the requirements in many other countries, which kick in when a new chemical is produced above certain thresholds. In the US, with few exceptions, the EPA’s review occurs before a new chemical is ever made or imported. That means the chemical may not actually exist, but be a computer drawing with predictions made based on existing knowledge about the effects of similar structures.
The new collaborative proposes to use toxicity, exposure, chemical use, and other databases along with computer-based analysis methods that scientists have developed in recent decades, and make this information easier for the EPA’s chemicals office to use, said Katie Paul Friedman, a toxicologist in EPA’s research office.
The EPA’s chemical and research offices stressed that achieving the new collaborative’s goals will take years. The board’s advice on actions that could be taken to improve the program sooner were welcomed.
The EPA would welcome the board’s advice on how to overcome a second challenge, which concerns confidential business information, Scarano said.
Manufacturers include confidential business information (CBI) in in their requests to make new chemicals. That sensitive information is protected in part by the new chemicals program using computer systems not connected to the internet, he said.
“We can’t violate CBI as we build the new program—but it’d be valuable to hear discussions about how to do that” while using the new types of data, Scarano said.
Core changes needed to make this happen include hiring additional staff to build capacity and building a better IT infrastructure system that doesn’t crash as the current one did for two weeks last year, Freedhoff said.
The EPA is offering its chemical risk assessors new training and designing new standard operating practices to help them do their jobs, she said.
For the first time in 12 years, the EPA also is updating a catalog of chemical categories that its staff uses to help their reviews, Freedhoff said. That document also helps industry understand the questions the EPA may raise about their new chemicals, TSCA attorneys have said.
Thirteen new categories will be added to the 56 categories listed in the agency’s 2010 document, Freedhoff said.
These may include groups of similar per- and polyfluoroalkyl substances (PFAS), Friedman said. Concerns about the persistence of some types of PFAS, their ability to move up the food chain, and possible toxicity have spurred federal and state regulations along with thousands of toxic tort lawsuits.
Chemicals enable agriculture, transportation, electronics, and other industries that “are responsible for $5.2 trillion dollars—which is 25% of the US [gross domestic product]—and 4.1 million jobs,” Freedhoff said.
“We want our review of new chemicals to be as modern and innovative as the actual new chemicals we’re reviewing,” she said. “We should be using the latest and greatest technology and tools to do that.”
To contact the reporter on this story: Pat Rizzuto in Washington at prizzuto@bloombergindustry.com
To contact the editor responsible for this story: Renee Schoof at rschoof@bloombergindustry.com
To read more articles log in.
Learn more about a Bloomberg Law subscription


Leave a Comment