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By Pat Rizzuto
Companies importing chemical mixtures would like more than six months to notify the Environmental Protection Agency about the components of those mixtures, according to chemical importers and trade associations.
“We anticipate significant time and effort will be needed to communicate with our suppliers of confidential mixtures that we import into the U.S.,” wrote the Procter & Gamble Co. in comments it submitted for a proposed Toxic Substances Control Act (TSCA) inventory update rule (RIN:2070-AK24) the EPA published Jan. 13 (82 Fed. Reg. 4255).
“Because of this complexity, we request EPA to consider extending the allowable reporting period for importers beyond the first 180-day reporting period,” it wrote.
Missing the deadline would mean a company would violate the rule, and the chemical wouldn’t be on the inventory the EPA will develop listing chemicals that can be active in commerce.
The EPA’s rule, however, offers chemical manufacturers, importers and processors a simple notification process they could use to shift a chemical from the inactive inventory to the active inventory.
Notwithstanding that option, the American Chemistry Council, Japan Chemical Industry Association and a printing equipment and supply company called Videojet Technologies Inc. also urged the EPA to give companies importing chemical mixtures more time to notify it about chemical ingredients in those mixtures in public comments on the rule.
The chemistry council—along with law firms, consultants and other trade groups—backed the EPA’s proposal in several other areas and offered consistent recommendations regarding aspects of the rule they want changed.
But the Environmental Defense Fund, the sole environmental health group to submit comments, raised concerns about some of these industry-backed positions.
The comment period for the inventory update rule closed on March 14.
The proposed inventory update rule would divide the agency’s existing TSCA inventory of more than 85,000 chemicals into two parts: an active inventory of chemicals that have been in commerce during the 10 years that preceded the final rule’s publication and an inactive inventory of chemicals that used to be in commerce, but no longer are.
The proposed rule has two purposes. This article focuses on the first; the goal of giving the EPA a clear understanding of what chemicals are in commerce as that information is missing. The agency has some information about what chemicals are or have been allowed to be in commerce since the TSCA inventory was established in 1982.
The agency can then sort those, decide which raise potential health or environmental concerns warranting closer scrutiny and begin to evaluate those risks.
The process the EPA will use to sort chemicals active in commerce, and the procedures it will use to evaluate chemical risks, are covered in separate rules the agency also has proposed.
Getting a clear, accurate picture of what chemicals are in commerce will help the EPA plan the resources it will need for those subsequent sorting and risk evaluation steps, said Richard Denison, lead senior scientist with the Environmental Defense Fund.
The deadline to notify the EPA about chemicals that should be on the active list is triggered with the EPA’s publication of the final rule.
The TSCA amendments require the EPA to publish a final rule by June. Industry and nonprofit organization officials increasingly are telling Bloomberg BNA that deadline may not be feasible.
Once the rule is final, chemical manufacturers and importers would be required to notify the EPA about the chemicals they have made or imported in the 10 years preceding the final rule.
Domestic manufacturers and chemical importers, which the original and amended chemicals law defines as manufacturers, would have 180 days after the final inventory update rule is published to notify the agency about the chemicals they have made in or imported into the U.S., under the proposed rule.
The 180-day deadline is set by the Lautenberg Chemical Safety Act, which amended TSCA in 2016.
Companies that process chemicals, for example by mixing them to make paint, laundry detergent or car wax, could also notify the agency about the chemicals they use. Processors are not, however, required to notify the EPA.
The proposed rule would give processors up to one year after the final inventory update rule is published to submit their inventory notifications.
The EPA offered a rationale for giving processors more time than manufacturers. Doing so would allow processors to look at a first draft list of chemicals active and inactive in commerce and add additional ones to the active list if omitted, it said.
Procter & Gamble, Videojet, the American Chemistry Council and Japan Chemical Industry Association asked the EPA to give importers of chemical mixtures one year—the same amount of time processors have—to notify it about the chemicals in those mixtures.
That is needed, they said, for reasons including the need to arrange joint submissions authorized by the rule. If an importer or domestic processor cannot provide the specific chemical identity of a substance to the EPA, because its supplier claims that identity confidential, the proposed rule establishes a process by which the companies can file separate, yet joint, submissions directly to the EPA.
Videojet wrote the mixtures it imports may have five to 15 ingredients and some of those “ingredients” themselves may also be mixtures.
“A more complicated formulated product may have over 25 substances and over 30 off-shore suppliers in the supply chain,” it wrote.
The farther removed the importer is from the off-shore chemical manufacturer, the harder it can be to secure information—such as the identity of the chemical it adds to a mixture—from it, Videojet wrote.
If only one off-shore processor or manufacturer is unwilling or unprepared to provide required information, the importer may not be able to meet the 180-day deadline and ensure the chemical is on the active inventory, it said.
P&G said it makes and warehouses some of its finished products in Canada and other countries.
“When we ship these finished products to the U.S. market, we become importers,” it said.
Time is needed to explain the proposed rule’s requirements to some of its foreign and smaller-sized suppliers, P&G said.
“Negotiations likely will be needed with these suppliers to decide whether to pursue joint submission or permit disclosure directly by P&G,” it said.
The law doesn’t allow for that extra time, Denison told Bloomberg BNA.
Read strictly, the law doesn’t even allow the EPA to give processors the extra time the agency proposed to give them, he said. But the EPA’s rationale seemed reasonable, he said.
Expanding the scope of the companies that would have more time to notify EPA is a problem, Denison said. “It’s not what the law provides for.”
Companies know this rule is coming and have time to reach out to their supply chains, he said.
The EPA has the authority to provide importers the additional time and it would make sense to do so, Karyn Schmidt, senior director for chemical regulation, regulatory and technical affairs at the American Chemistry Council told Bloomberg BNA.
“The agency is responsible for a current, accurate inventory,” she said by email.
The additional time would offer an important buffer to address a number of complicated supply chain issues, Schmidt said.
If any domestic manufacturer or importer fails to notify the EPA that a chemical should be on the active inventory the proposed rule will establish, it won’t be onerous to correct that, Dimitrios Karakitsos, an attorney at Holland & Knight LLP, told Bloomberg BNA.
Karakitsos previously served as counsel to the Republicans on the Senate Environment and Public Works Committee. In that role, he served as a principal drafter and negotiator of the amended chemicals law.
“The law intended to only create a simple notification of a substance to move it from the inactive to active list,” Karakitsos said.
Denison echoed Karakitsos’ point: The process the law required, and that EPA has proposed, to move a chemical from the inactive to the active list is simple.
There’s no approval implied by the process, it’s simply designed to make sure the EPA knows what chemicals are in commerce and which are currently not in commerce, Denison said.
On the domestic front, there was significant agreement among chemical manufacturers and processors regarding several parts of the EPA’s rule they supported and the changes they want.
Aspects industry largely supported included the EPA’s proposal to:
Such chemicals may no longer be in commerce, Denison said.
“Given the low burden that inventory notification imposes on companies, the far more prudent approach is to require inventory notification of such chemical substances to verify they are in fact active,” the fund’s comments said.
Chemical manufacturers and processors also largely agreed on several changes they want the EPA to make to its proposed rule. These included asking the EPA to:
Many chemicals are manufactured by more than one company, the council said. That means the EPA will receive multiple reports for a particular chemical.
“Only one notification is needed to identify an active. All subsequent reports are duplicative and unnecessary, and impose an unnecessary burden on industry as well as EPA,” the chemistry council wrote.
The “one and done” concept could introduce challenges for different companies that make the same chemical, Denison said.
One and done would mean that any company—after the first one that had a CBI claim for chemical identity—would not reassert its claim since that subsequent company wouldn’t file its own notification, Denison said.
In short, no other company would make any assertion about information it needed to keep confidential, he said.
Confidential business information claims are company-specific, he said. That means, for example, one company might not claim a chemical’s identity to be confidential. Or if it did and EPA found it invalid, then that chemical’s identity would have to be made public per the new law, Denison said.
Any other company that would have wanted to maintain its claim that the chemical’s identity was confident would have foregone the ability to make that claim, because the company hadn’t asserted it. The confidential status of that chemical would be lost, he said.
To contact the reporter on this story: Pat Rizzuto in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Larry Pearl at email@example.com
The EPA's proposed inventory update rule is available at http://src.bna.com/nf8.
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