The Society of Chemical Manufacturers and Affiliates (Socma) is among groups that have raised concerns over the US EPA’s process for new chemicals under the amended TSCA.
It says delays in approving pre-manufacture notices (PMNs) have caused major disruptions to supply chains.
Socma submitted comments to the EPA following a 14 December stakeholder meeting that discussed the changes implemented to the new chemicals programme following the passage of the Lautenberg Chemical Safety Act.
“Given Congress’s decision to retain the principal features of Section 5, there was great hope among the regulated community that the EPA’s new chemicals program would be able to maintain its historic level of productivity allowing the United States to remain at the forefront of chemical innovation,” Socma wrote in comments. “Those hopes are fading, however”.
Under the amended act the process of bringing a new chemical to the market has changed significantly. TSCA now requires an ‘affirmative finding’ of safety for PMNs. If the agency determines a substance poses an unreasonable risk, it must issue an order to prohibit or restrict it.
In its letter, Socma argues that the new process has greatly reduced the speed PMNs get approved. When the Lautenberg Act was enacted on 22 June 2016, 336 PMNs were awaiting action. In the 90 days that followed, action was taken on only 24 PMNs, Socma says.
The EPA is also “coercing” submitters to voluntarily suspend the 90-day review period under pain of having their submissions found likely to pose an unreasonable risk, it says.
“Socma continues to hear from members that they are getting requests to suspend their cases, sometimes with no clear explanation why, and with no end in sight,” the organisation says.
“This has already caused major disruptions to supply chains. If this continues the resulting uncertainty and delays will likely start to cause serious harm to businesses and companies’ ability to innovate.”
The American Cleaning Institute, along with a number of other industry groups, echoed Socma’s comments on PMN delays.
“Such delays have made the review process unpredictable, untimely, and unnecessarily restrictive, yet without clearly enhancing public safety nor reducing environmental risk,” writes the ACI .
The International Fragrance Association North America (Ifra) called on the EPA to better meet deadlines for PMNs and voiced concern that the notices are being routinely subjected to either consent orders or significant new use rules (Snurs). The association says increased reliance on these restrictions would make the US chemical registration programme similar to REACH, or how the US currently regulates pesticides, drugs and food additives.
“This will dramatically and unnecessarily restrict innovation and market responsiveness in our industry and others.”
Advocacy groups support programme changes
A number of NGOs, however, have broadly supported the changes to the new chemicals programme. They disagree that the changes seen are inconsistent with the intent of the Lautenberg Act.
Dr Jennifer Lowry, writing on behalf of the American Academy of Pediatrics, says the increased wait time for PMNs to be approved is necessary to ensure that the EPA properly vets all chemicals before they reach the market.
“There is a misconception that the finding that 10% chemicals required consent prior to TSCA reform implies that 90% were safe for commercial use, which was not the case,” Dr Lowry writes. “It is the point of the Lautenberg Act to increase evaluation and oversight of new chemicals. Evaluating PMNs with the information supplied without a request for additional data to ensure safety to children and the environment is a gross injustice.”
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