No justification: Substantiations for rampant new chemical CBI claims are deficient or lacking altogether

Stephanie Schwarz, J.D., is a Legal Fellow.  Richard Denison, a Lead Senior Scientist.

We recently started a series of blog posts describing what we did, and did not, get from the EPA Docket Center when we requested the public files on about 70 new chemicals, most of which EPA had determined were “not likely to present an unreasonable risk” under the Toxic Substances Control Act (TSCA), as amended in 2016 by the Lautenberg Act.  To continue our series, we address in this post EPA’s pervasive failure to require companies to adequately substantiate Confidential Business Information (CBI) claims, and its own apparent failure to review such claims, despite clear requirements to do so under § 14 of TSCA. 

Twenty months after passage of the Lautenberg Act, we simply must ask:  When will EPA start carrying out its new responsibilities on CBI claims – which includes compelling companies to comply with the law?

First, to provide some context, let us address a question we were asked based on our first post: whether the PMN situation we are describing is any worse now than it was pre-Lautenberg Act.  We suspect it is not necessarily worse.  However, the purpose of the reforms to CBI in the Lautenberg Act was to fix these problems, by requiring substantiation and EPA review of most CBI claims, including those asserted in premanufacture notifications (PMNs) submitted for new chemicals.  By and large it appears this is simply not happening, 20 months after the law passed and those provisions took effect.

Few of the PMN public files we received included any substantiations, despite massive assertions of CBI claims that require substantiation; instead, companies simply redacted the information.  In addition, nearly all of those submissions that do include a substantiation document are wholly inadequate, routinely claiming information as CBI that is not eligible for nondisclosure or failing to provide justification for information that may be eligible.  The violations are so egregious that they indicate EPA is failing to conduct even a cursory review of the claims and redactions.  

What the law requires

TSCA § 14(c)(3) requires that “a person asserting a claim to protect information under this section shall substantiate the claim . . .” (emphasis added).  EPA has interpreted that section to mean all information submitted to EPA is subject to substantiation unless it falls within the narrow categories of information listed in TSCA § 14(c)(2).  These categories include specific information on chemical processes, uses or functions; marketing and sales information; information that identifies a supplier or customer; specific production or import volumes; and specific chemical identity information for chemicals prior to commercial distribution.  EPA has identified the specific information elements in a PMN that it considers to fall within each of these exempt categories.  Based on this list, a broad range of previously unsubstantiated CBI claims must now be specifically justified at the time the PMN is submitted if the submitter requests CBI protection.

The Lautenberg Act makes clear that certain types of information are not eligible for protection from disclosure at all, however.  Section 14(b)(2) specifically includes in this category, “any health and safety study which is submitted under this Act with respect to . . . any chemical substance or mixture . . . for which notification is required under section 5.”  Under § 2(8), TSCA defines the term “health and safety study” as “any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying information and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological studies of a chemical substance or mixture, and any test performed pursuant to this Act” (emphases added).

EPA has further expanded on this definition in its regulations and provided specific examples of such ineligible information, e.g. surveys, tests, and studies of a substance’s degradation, bioaccumulation and transport and its chemical and physical properties; acute and chronic toxicity tests; monitoring data; and assessments of workplace exposure. Therefore, existing information that is generally required to be submitted with PMNs, such as toxicity studies, information on worker exposure, and the majority of information in Safety Data Sheets, is not protected from disclosure.

What we found

Based on the PMN public files we received, companies are still making excessive CBI claims in most cases, and substantiating them in very few.  As mentioned in our previous blog post, 60% of the documents we received contained no meaningful information because they were wholly or mostly redacted – even when the documents contained information not eligible for protection.

Even beyond these massive redactions, of the 69 PMN files we received, only 19 included a document identified as providing CBI substantiations.

When we examined these “substantiation” documents, however, we found that some in fact did not provide substantiations meeting the law’s requirements, while in others the explanations for the CBI claims were themselves entirely redacted (see P-17-0256).  Here are some specific examples:

  • Despite having no clear connection to “marketing and sales information,” redactions to Safety Data Sheets are generally claimed CBI under this exception and provide no explanation as to how this information constitutes marketing and sales information.
  • Redactions to the worker exposure and environmental release information in the PMNs are claimed as CBI under the “specific process information” exemption, also without any explanation as to how this information is even arguably related to specific process information.
  • A number of substantiations broadly state that all of the redacted information in the PMN and accompanying documents, including information clearly not falling under the § 14(c)(2) exemptions, should be protected indefinitely even though TSCA § 14(e) provides protection only for 10 years absent reassertion and approval.

Also, as alluded to in our previous blog post, based on the documents provided to us, EPA is allowing – whether actively or passively – companies to fully redact documents that the companies themselves identify as health and safety studies.  This is strong evidence that EPA is NOT even taking a cursory look, let alone reviewing those claims, because otherwise it would have caught this type of glaringly illegal redaction.

The rest of this post details what we found.

1. Health and safety studies

In total, we identified 78 health and safety (H&S) studies in the PMN files we received.  These studies do not qualify as CBI under TSCA, yet – as we noted in our earlier post – 55 of the 78 (two-thirds) were fully or partially redacted.  For the great majority of these 55 H&S studies, no substantiation whatsoever was provided for those redactions.  Only four out of the 17 PMN public files with H&S studies, accounting for only six of the 78 H&S studies, provided substantiations that even purported to address the redactions in those studies.  For three of those four PMN files, the reason given for the redactions was to protect the chemical identity (contrary to the law and EPA’s own regulations, as we have previously noted).  In the fourth case, the reason given for the redaction was itself redacted.

The principal takeaway here, however, is that we  received scores of blank or redacted H&S studies, and for nearly all of them the submitter did not even attempt to substantiate the redactions.

All of this is despite the fact that EPA has made clear to the industry on its CBI webpage that H&S information “may not be protected as CBI.”

2. Safety data sheets

H&S information included in Safety Data Sheets (SDS) is also not eligible for CBI protection, so any redactions in SDSs should only be of non-H&S information.  We reviewed the SDSs in the 19 PMN files that included a CBI substantiation document; of these, 17 of the SDS forms were redacted to some extent.  Here are the reasons given (if any) for the redactions:

  • 8 submitters claimed that the SDS redactions did not need to be substantiated because the SDS constituted marketing and sales information exempt from substantiation under TSCA § 14(c)(2)(B). Of these SDSs, 5 were entirely redacted or blacked out.
  • 4 submitters entirely redacted the reason for claiming the SDS as CBI.
  • 2 submitters provided partially redacted SDSs but their substantiation documents did not provide any justification for the SDS redactions.
  • Only 3 submitters provided substantiation for their redaction – and each of them redacted only the company name from their SDSs.

There are a couple of serious concerns with these substantiations.  First, SDS forms contain information regarding hazards and toxicity, accidental release and first-aid measures, fire-fighting methods, handling and storage precautions, needed exposure controls including personal protection, disposal and transport considerations, reactivity and stability, and physical and chemical properties for a chemical substance.  It is difficult to understand how any of this information can be considered “marketing and sales information.”  None of these information elements are identified by EPA as qualifying for this or any of the other TSCA § 14(c)(2) exemptions.  Indeed, as we noted earlier, virtually all of this information constitutes health and safety information not eligible for CBI protection in the first place.  Moreover, even if some of the information in an SDS arguably counted as “marketing and sales information,” that is no basis for redacting or blacking out the entire form as “marketing and sales information” as did some of the submitters of the SDSs we received.

As with the H&S studies, it is important to note that these deficiencies apply to the few PMN files where the submitters at least attempted to substantiate their claims.  Across the rest of the files we received, over 40 SDSs were redacted to varying degrees without any attempt to substantiate those redactions.

Once again, we can only take this as evidence that EPA is not even cursorily reviewing any of these CBI claims, whereas the law requires that EPA must review at least 25% of them (EPA has said it would meet this requirement by reviewing all non-chemical identity CBI claims in every fourth submission it receives that contains one or more such claims).

3. Worker exposure and environmental release information

PMN forms include a section where the submitter must include information on the number of workers potentially exposed to a substance during a particular activity, the duration of exposure, any protective equipment/engineering controls used, and the amount of the new substance released to the environment.  Ten of the 19 substantiations claimed this information CBI, and generally asserted without further explanation that these redactions did not need to be substantiated because they fall under exemption § 14(c)(2)(A), i.e. they constitute “[s]pecific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article.”

Notably, EPA does not identify this information as falling under this exemption – yet companies have been allowed to hide the information from workers and the public.  It is not at all clear how disclosure of this information would reveal any “specific information describing the processes used in manufacture” of a chemical (emphasis added).  Indeed, much of this information arguably constitutes health and safety information not eligible for CBI protection under TSCA.  To the extent it does not, these claims must be substantiated under TSCA, yet none of them were.

Here again, these examples are not the worst of this problem: for the great majority of PMNs we received where this information was redacted, the submitters did not even attempt to claim an exemption applied or provide a substantiation. They just made the redactions.

4. Other types of abuses of the law

a. Additional examples of abusing the exemptions under § 14(c)(2)

We also identified a number of instances where the submitter asserted that information fell under one of the § 14(c)(2) exemptions without demonstrating a logical connection.  For instance, a number of the substantiations claimed that the numbers assigned to their bona fide submissions and pre-notice consultation letters were exempt under § 14(c)(2)(A) because they revealed specific information on a manufacturing process.  While portions of these documents may well include information on such a process, that is not a basis for redacting a number assigned to the submitter.

Additionally, many submitters claimed that disclosing the “number of sites controlled by others” would identify a supplier or customer and hence is exempt under § 14(c)(2)(C).  It is hard to comprehend how that number, on its own, could identify a supplier or customer.  Even if other parts of this section of the PMN form do require the identity of the other sites to be disclosed, TSCA § 14(b)(1) makes clear that if CBI and non-CBI information are included in the same submission, only the CBI information is eligible for protection while the non-CBI information is to be disclosed.  (This is the very reason redactions are supposed to be used in the first place!)

b. More instances of inadequate substantiations

It is also insightful to look at the actual substantiations made by submitters, because in most cases the reasons given are rather perfunctory.  For instance, a number of submitters made sweeping, non-specific claims, such as: “disclosing the information stated above would be harmful to our competitive position. It may provide a useful insight into the direction of our research activities.” (see, for example, P-16-0578).  This is a problem for a few reasons.  First, it lumps together all the information the submitter redacted and provides only one blanket explanation.  Each piece of redacted information needs its own substantiation, however, as it is easier to imagine potential competitive harm from revealing a company name than from revealing a generic description of the chemical’s use – the latter being something TSCA § 5(d)(2)(B) already requires EPA to disclose when it publishes its notices of receipts of PMNs in the Federal Register.

Additionally, while the submitters state that releasing information may provide a “useful insight” into their research and a competitor “may replicate [their] product,” the submitters fail to explain how the redacted information would do so.  Section 14(c)(1)(B)(iii) of TSCA requires that, in order to assert a claim, the submitter must have “a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the [submitter].”  Yet the explanations provided here do not say anything concrete about how disclosure of the specific information being redacted could, let alone is likely to, harm the submitters’ competitive positions.

c. Claiming indefinite protection for information subject to time limits

Of the 19 substantiations we received, six of their submitters requested indefinite CBI protection for information that does not fall under any of the § 14(c)(2) exemptions.  This is contrary to the Lautenberg Act, which permits protection of information subject to qualifying CBI claims for 10 years, at which point the claimant must reassert and re-substantiate the claim, and EPA must approve it, in order for the protection to be maintained.  See TSCA § 14(e)(1)(B), (2).  EPA even reminds submitters about this limitation on its CBI FAQ page.

Statements like these should, at a minimum, flag to the agency that submitters are making claims in their substantiations without any regard to the limitations in the statute.

d. Further flaws revealed in a random sampling of 10 PMNs lacking any substantiations

We randomly selected ten of the PMN files that lacked substantiation documents to review the information that the submitters claimed as CBI on the PMN forms.  We then compared these redactions to EPA’s list of PMN elements that fall under the § 14(c)(2) exemptions.  Here are examples of what we found redacted even though the information does not qualify for any exemption and hence requires substantiation:

  • 7 of the 10 submitters redacted their company names.
  • 6 of the 10 submitters redacted their substances’ generic category of use, which is not “specific” use information under § 14(c)(2)(E) – and which TSCA § 5(d)(2)(B) already requires EPA to disclose when it publishes its notices of receipts of PMNs in the Federal Register.
  • 6 of the 8 submitters that identified the number of sites controlled by others redacted that number.
  • 4 of the 7 submitters that identified the number of workers exposed redacted that number.

Twenty months after passage of the Lautenberg Act, we simply must ask:  When will EPA start carrying out its responsibilities on CBI claims – which includes compelling companies to comply with the law?

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