PART 2: EPA rams through its reckless review scheme for new chemicals under TSCA, your health be damned

Richard Denison, Ph.D., is a Lead Senior Scientist.

Part 1               Part 2               Part 3

I blogged last week about how political appointees at EPA are starting to clear new chemicals to enter commerce based on a new – apparently unwritten and certainly not public – review process that ignores the law and will put the health of the public, workers and the environment at greater risk than even under the weak reviews conducted before Congress’ 2016 overhaul of the Toxic Substances Control Act (TSCA).

In this post I’ll start to take a deeper look at the specific fragrance chemical that is the subject of EPA’s first decision under the new scheme:

Oxirane, 2-methyl-, polymer with oxirane, bis[2-[(1-oxo-2-propen-1-yl)amino]propyl] ether
CAS 1792208-65-1

Recall that, even as it declared the chemical safe, EPA noted its “potential for the following human health hazards: irritation, mutagenicity, developmental/ reproductive toxicity, neurotoxicity, and carcinogenicity.”  I’ll explore those hazard concerns more in a subsequent blog post.  Here, let’s consider use of and exposure to the chemical.[pullquote]Here’s the thing:  None of the parameters of the intended use is binding.  They can be deviated from at any time without consequence.[/pullquote]

With its decision, EPA has allowed this chemical to enter the market without any conditions whatsoever placed on how or how much of it can be produced or used or by whom.  This is in fact the aim of the new scheme and, barring another change in course, we can now expect this outcome for the great majority of new chemicals EPA reviews.  It will be achieved by EPA routinely making determinations that the chemicals are “not likely to present an unreasonable risk.”  

First I need to provide a little context.

While EPA had made some “not likely” determinations before now, for more new chemicals reviewed under the new law EPA had been finding either that:

• EPA had insufficient information to “permit a reasoned evaluation of the health and environmental effects” of a new chemical – not surprising, given that the great majority of new chemical notices include little or no such data; or
• the chemical “may present an unreasonable risk.”

With either determination, the law requires EPA to issue an order specifying binding conditions or testing requirements that have to be met in order to commence manufacture of the chemical.  In addition, within 90 days of issuing the order, EPA has to either commence a rulemaking to require that any company notify EPA before deviating from the terms of that order (through what is called a Significant New Use Rule, or SNUR), or publicly explain why that is not necessary.

That’s what EPA had been doing after the new law passed.  But EPA’s aim now is to avoid making either of the above findings so it won’t have to issue an order and won’t have to promulgate a SNUR.  And because such orders are the primary means by which EPA could require a company to test its new chemical, not issuing orders gets companies out of any testing obligations as well.

In sum, EPA’s new aim is to issue no orders or SNURs and to require no testing – which means unfettered access to the market for any company who wants to make  a chemical in any amount for any use it desires without having to notify EPA of its activities.  EPA apparently intends to pursue this approach even for chemicals, such as this one, which present many potential human health hazards.

In the absence of those binding instruments, the only thing there is to go on is a company’s indication of its intentions for the chemical in the premanufacture notice (PMN) it submits to EPA.  Unfortunately, EPA makes it quite hard for the public to get PMNs.  Despite the fact that EPA’s own regulations require it to make the PMN and associated information publicly available online, EPA rarely does so.

To obtain these documents for this first chemical cleared under EPA’s new scheme, EDF had to do it the old-fashioned way:  We submitted a request to EPA’s docket center and got the “public file” for this chemical, which included the PMN, sent to us on a CD (and then we had to locate a CD reader).  Still, it was worth the trouble in this case.  Here’s what the PMN submitted by International Flavors and Fragrances Inc. said the company intends or expects for this chemical:

• import of the chemical in the amount of approximately 1,000 kilograms/year;
• import of the chemical to its site in New Jersey as a 50% solution of the PMN substance;
• sales of the chemical “to industrial and commercial customers for their incorporation into industrial, commercial, and household consumer products such as floor cleaners, cat litters, fabric refresher sprays, Etc.” “to reduce malodors;” and
• an expectation that its customers will use the chemical in their products at 2% concentration.

EPA’s “not likely” determination document echoes these intended parameters verbatim.  But here’s the thing:  None of this is binding.  It can be deviated from at any time without consequence.  The company could increase the amount imported 10-fold or more, starting day one or any time later.  It could begin manufacturing it domestically.  Or its customers could use it at higher concentrations, or in other products.  Indeed, the “intended use” is left astoundingly wide open by EPA:  Note the “such as” and the “Etc.” in the use description.  And attachments to the PMN reflect the company’s interest in selling it for use in general cleaners, laundry detergents, bar soaps, and other “down-the-drain” products.

Notably, the company could have indicated its willingness to be bound to any of those conditions, but it chose not to do so.  Throughout the PMN form are boxes labeled “Binding option.”  Checking the box by itself doesn’t actually bind the company to anything (see p. 35 of EPA’s “Points to Consider” guidance), but it signals its willingness to accept a limit on, say, production or use in a subsequent order or SNUR.  But that’s all moot in this case, because the company chose not to check any of those boxes and because EPA issued no order and does not plan to promulgate a SNUR.

As I noted, EPA based its review on the intended use as stated by the company.  That summary document provides limited information beyond EPA’s conclusions.  It alludes to EPA’s “risk assessment” – but if it has conducted one, EPA has not elected to make it or any other analyses it did public.  No docket for this decision has been set up.  EDF has requested these documents, and we’ll let you know if we get them.  Meanwhile, the only EPA document is the 5-page summary, which leaves many more questions unanswered than answered.

For starters, did EPA consider the combined exposures to the chemical from a consumer’s use of multiple products containing the chemical?

Let me describe what would likely be a very common sort of consumer:  a cat owner who likes to keep a tidy house, and who has considerable brand loyalty.  He or she could well use a cat litter, wash their clothes with a detergent, clean their floors or other surfaces, “refresh” their upholstered furniture and bedding, and bathe or shower with a bar soap, all made by the same company and containing this chemical.

Here’s another scenario involving commercial products: an employee of a housekeeping service or a building maintenance company who uses multiple cleaning products containing the chemical for many hours every day, five or even six days a week, year-round.  By the way, it’s not at all unusual for commercial versions of such products to contain significantly higher concentrations of a chemical than general consumer versions.  It would not be unreasonable to expect that such an employee might use products containing the chemical at home as well.

So it is curious that EPA’s summary indicates it identified no reasonably foreseen uses of the chemical.  “None,” EPA succinctly states.

EPA’s summary document makes no mention of such users, and without seeing the risk assessment EPA has not made public, there is no way to know whether, in reviewing the chemical’s “intended conditions of use,” EPA analyzed the combined exposures arising from these imminently foreseeable exposure scenarios before it declared the chemical safe.

It is also notable that, while EPA says in its summary that it did consider the possibility that the chemical might be imported in higher than a 50% solution, EPA made no mention of looking at products containing the chemical at greater than 2% concentration.

These are a few of the many concerning questions raised by EPA’s decision that are impossible to answer, at least at this point.

Stay tuned for my next post, where I’ll look deeper at what the company and EPA had to say about the hazards posed by this chemical.

This blog series continues:  Part 3