A key reform under the Lautenberg Act is the requirement that the Environmental Protection Agency (EPA) generate an accurate, up-to-date list of all chemicals in active commerce. This is to be accomplished by promulgating a rule to do a full “reset” of the TSCA Inventory that distinguishes between active and inactive chemicals. It is necessary because the 85,000 chemicals on that Inventory represent a cumulative listing of all chemicals that have been in commerce at some point since its establishment in 1979, but no doubt includes many that are not now in commerce.
I have blogged previously about why it is important that EPA and the public know how many and which chemicals are in use today in the U.S. Among other reasons, it is essential that we understand the magnitude of the task that awaits EPA under the new TSCA, with respect to prioritization, risk evaluation, risk management, and substantiation and review of confidential business information (CBI) claims. That has implications for the pace of the program and the resources EPA will need to do its job, which extends ultimately to reviewing the safety of all chemicals in commerce.
EDF provided EPA with our comments on what should be included in EPA’s upcoming rule establishing the Inventory reset. Unfortunately, comments on that rule received from some in industry indicate that they are seeking to limit the Inventory reset in ways that are not allowed under the new law and are short-sighted or even counterproductive to the purpose of the reset. I provide a critique here of three of those proposed limitations.
Proposal to limit the Inventory reset to CDR chemicals
First, some in industry argue that EPA’s Inventory reset rule could or should start with or limit the reset to those chemicals already required to be reported under its Chemical Data Reporting (CDR) rule, which requires manufacturers to report every 4 years to EPA which chemicals they make or import, as well as other information about those chemicals. However, the CDR reaches only a fraction of chemicals in active commerce, between 7,000 and 8,000. That is because of two factors: First, the CDR rule only requires companies to report chemicals they make or import in amounts at or above 25,000 pounds per reporting site per year. Second, numerous exemptions apply that remove whole categories of chemicals (e.g., most polymers) from the reporting requirement.
All evidence points to the likelihood that the number of chemicals produced below the CDR’s 25,000-pound threshold greatly outnumbers those reported under the CDR. Experience under the European Union’s REACH Regulation’s registration process is one such line of evidence. To date, about 8,000 substances produced in amounts above 100 metric tons per year (220,000 pounds/yr) have been registered under REACH. However, REACH officials expect a total of about 35,000 chemicals to be registered when REACH is fully implemented in 2018 and includes all chemicals produced in amounts exceeding 1 metric ton (2,200 pounds) per year. Given the global nature of the chemical industry, there is every reason to expect that similar numbers will apply in the U.S.
The Lautenberg Act’s Inventory reset provision makes no allowance for EPA to impose a reporting threshold or to limit the reset to the CDR chemicals.
Here’s the provision [section 8(b)(4)(A)(i); emphasis added]:
(i) IN GENERAL.—Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator, by rule, shall require manufacturers, and may require processors, subject to the limitations under subsection (a)(5)(A), to notify the Administrator, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the list published under paragraph (1) that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
The “list published under paragraph (1)” is in fact the full TSCA Inventory. Hence, EPA’s rule must require that manufacturers report “each chemical substance” on the full inventory that they make or import.
Now, to be clear, Congress did provide for EPA to use the latest list of CDR-reported chemicals as an interim list of active substances. Section 8(b)(6) states (emphases added):
(6) INTERIM LIST OF ACTIVE SUBSTANCES.—Prior to the promulgation of the rule required under paragraph (4)(A), the Administrator shall designate the chemical substances reported under part 711 of title 40, Code of Federal Regulations (as in effect on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act), during the reporting period that most closely preceded the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, as the interim list of active substances for the purposes of section 6(b).
Had Congress intended the Inventory reset conducted pursuant to the rule to be limited to the CDR chemicals, it would not have included this provision allowing such chemicals to serve as the interim list until the rule is promulgated.
In sum, there is no basis for EPA’s rule to limit the Inventory reset to the CDR chemicals.
Proposal to allow exemptions from the Inventory reset
Some in industry are urging that EPA’s rule extend exemptions provided under other sections of the law to the Inventory reset. Here again, there simply is no basis in the new law to do so. Per section 8(b)(4)(A)(i), EPA’s rule must require manufacturers to notify EPA of each chemical substance on the list published under paragraph (1) they manufacture. There is no mention of or allowance made for any exemptions. This, together with no reporting threshold, is important to ensure that the Inventory reset yields a full list of all chemicals in active commerce.
Proposal to halt the Inventory reset process for a given chemical after receipt of the first notice
Some in industry are also arguing that receipt of a single notice for a given chemical as being active would suffice and that at that point “additional reports for the chemical need not be required.”
Here again, the law is clear this is not allowed. Let’s go back to the Inventory reset provision [section 8(b)(4)(A)(i); emphasis added]:
(i) IN GENERAL.—Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator, by rule, shall require manufacturers, and may require processors, subject to the limitations under subsection (a)(5)(A), to notify the Administrator, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the list published under paragraph (1) that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
Clearly this provision requires each manufacturer of a substance on the Inventory to notify EPA if it is manufacturing it. Nothing in this language allows a subset of such manufacturers to file notices.
Nor would the industry’s proposal work in practice or necessarily be desirable even to them. Part of the notice a manufacturer must file is a reassertion of any existing claim to protect from disclosure the identity of a chemical the company wishes to maintain; see section 8(b)(4)(B)(ii). Such CBI claims and the basis for them are, of course, specific to the company asserting the claim. If the Inventory reset process for a chemical could stop after the first notice is received, that could well mean that only that first notifier’s CBI claim would be asserted – and even then only if that notifier had an existing claim and wished to reassert it. Under this scenario, requests to maintain existing CBI claims originating with other manufacturers of that same chemical might well not be received by EPA.
In this context, the new law is clear that the identity of any active chemical for which no requests are received through the Inventory reset process to extend an existing CBI claim must be disclosed to the public [section 8(b)(4)(B)(iv); emphasis added]:
(B) CONFIDENTIAL CHEMICAL SUBSTANCES.—In promulgating a rule under subparagraph (A), the Administrator shall—
(iv) move any active chemical substance for which no request was received to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance as confidential from the confidential portion of the list published under paragraph (1) to the nonconfidential portion of that list.
I suspect that is not an outcome those in industry urging EPA to stop the process for a chemical after receipt of the first notice would be pleased with.
In sum, the new law is clear that all manufacturers must notify EPA of their active manufacture of a chemical, and that, unless any existing CBI claims are asserted at that time (and later reviewed and found to be warranted), the identity of that chemical is to be made public.
Richard Denison, Ph.D., is a Lead Senior Scientist.
Enviroshop is maintained by dedicated NetSys Interactive Inc. owners & employees who generously contribute their time to maintenance & editing, web design, custom programming, & website hosting for Enviroshop.