Lecture 8D: After 40 Years, a New Toxic Substances Control Act

So there has been a widespread view that TSCA did not work.

That it did not give EPA the authority it needed to actually identify and

act on chemicals that presented significant risk.

And I think there is a broad view that the Lautenberg Act

addresses all of the major problems in TSCA.

And I'll run through a set of slides that show briefly how it does that.

First, it sets a new safety standard, and

it requires that safety standard be exercised by looking

solely at the affects of chemicals on human health and environmental health.

And it expressly includes a requirement that EPA consider the risks

to vulnerable populations like children, like workers, the elderly.

And to insure that the protections that they enact are sufficient to mitigate

the risk to those populations.

Those are both new features of the law that were not in the old law at all.

In fact, the old TSCA didn't have a health standard at all.

It had a cost benefit standard that required EPA to

ensure that the cost of any regulation were outweighed by the benefits.

And that's what proved to be so,

paralyzing to the agency that it could not even meet that burden for asbestos.

And there was no mention of protecting vulnerable populations under the old law.

So these are both significant improvements.

For the actual mandate for EPA to review chemicals,

both existing and new, is another major reform in the new law.

The old law did not have any mandate to review existing chemicals.

And new chemicals, while EPA has been reviewing them,

they have been doing so on a very cursory basis.

With all of the burden on the agency to find harm in order to prevent

a chemical from getting on to the market.

Under the Lautenberg Act,

not only is there a mandate for EPA to review chemicals, but

it requires an actual affirmative finding as to whether a chemical is safe or not.

And similarly for new chemicals, that affirmative safety finding as a condition

for getting on to the market is another major new feature.

Testing authority, I mentioned the EPA had a very hard time under the old law being

able to conduct testing.

Because it had to first find that chemical presented a risk,

or might present a risk in order to require testing.

And that presented a catch-22,

where EPA didn't have the information in the first place, to make that finding.

And it couldn't test without having that information.

That has been resolved by eliminating that test of a potential risk

as a condition for testing.

And the new law also eliminated

the requirement that the EPA only do testing after promulgating a full

rule-making that took many years for every chemical that it tried to test.

EPA now has the ability simply to order testing, and

that should greatly expedite its ability to get the information it needs.

Confidential business information, or CBI,

was another major area of reform in the new law.

This has to do with the ability of companies to

claim as trade secrets information that they are submitting to the agency.

And under the old law,

companies found that they could virtually claim anything as confidential.

And that EPA had very limited ability and no real mandate to

ever even review those claims to determine if they were legitimate.

And all of that information was denied, not only from the public, but

from state government and from health providers.

That information once it was kept confidential was kept so

indefinitely, with no limit on how long that protection was to apply.

So some of the major reforms under the new law include a requirement that most

claims be justified up front as to why they constitute legitimate trade secrets.

And that EPA review many of those claims enough to keep the system honest and

make sure that only truly

legitimate confidential information is being claimed so.

States and health providers are now given access to

this confidential information if they need it to do their jobs.

And they have to keep that information themselves confidential.

But that allows many more players in the system that regulates chemicals to be able

to get the information they need to do better, to make better decisions.

And then finally most claims actually now have time limits set on them.

A maximum of ten years, after which that information becomes public,

unless a company can make the case for why it still needs to be kept secret.

One of the other major problems with the old law was that EPA

lacked any real, sustained funding to fund the activities.

And it required going back to Congress every year for

a budget that it was entirely dependent upon with no mandates in the law.

And as a result, they ended up very rarely getting enough money to do

even a fraction of what they needed to be doing.

In fact, they could collect some fees for new chemicals, but those fees were

capped at a very low level, and the fees that were collected didn't go to EPA.

They went into the Treasury.

The new law now has a much broader set of activities that are covered

by fees that EPA can collect from industry,

up to $25 million a year can be collected in the early years.

And those fees now go into a dedicated fund that EPA can directly use.

So we are hopeful that this will provide a more sustained source of funding that

helps EPA to do its job and deal with all the new responsibilities it's been given.

Now, finally, let me touch on one of the major controversial areas of the new law.

And that had to do with the extent to which federal authority

would preempt states from acting.

As I mentioned earlier, states were very active in this area.

And they were one of the reasons why the industry decided it

needed to seek federal reform.

Obviously, the industry was interested in getting as much

of that state activity tamped down as possible.

So it was a very controversial part of the debate.

And I would say the outcome was a pretty interesting balance between aspects

of the new law that are more preemptive of state authority than the old law.

But also some aspects that are less preemptive.

So, for example, there was no preemption under the old law

when EPA found that chemical was safe,

that's actually because they never were required to make that determination.

Under the new law, that determination does have some preemptive effect

on states' ability to actually restrict the chemical that EPA has reviewed.

But only if EPA looked at the same uses and

the same risks of a chemical that a state is interested in regulating.

Any other use is fair game for states to regulate.

If EPA only looked at certain risks of a chemical and

not others, those that it did not look at could be looked at by a state.

There are also waivers that states can get

that represent a higher bar than under the old law.

But under the old law, if a state asked for a waiver and didn't get one,

or EPA simply never acted on the request, the state had no recourse.

Under the new law,

states actually can legally challenge a decision by EPA to deny a waiver,

or a failure of EPA to decide on whether to grant a waiver or not.

So, I would say the preemption aspect of the law was mixed.

It increased in some ways and decreased in other ways, the scope of preemption.

Let me finally just add a little bit of context because I mentioned earlier that

the European Union acted about a decade ago,

and put in place a new system that goes by the acronym, REACH.

To regulate chemicals in a very comprehensive manner.

And I want to draw just a couple of comparisons between REACH

and the new TSCA.

One of the hallmarks of REACH was what was called no data, no market.

A requirement that companies provide a certain amount of information up front

in registering their chemicals as a condition for staying on the market.

The reality, unfortunately, has been less clear, as to whether this has succeeded.

In fact, very few new data have been developed, and

there are significant questions being raised about the quality of

the information that companies have developed under that provision.

In the new TSCA, there is not any kind of a minimum set of information.

The industry fought that very hard, however, I've mentioned that

the testing authority that the agency has is much broader than it used to be.

So, we'll see how well that does in terms of bringing more information to Bayer

on chemical risks.

Under REACH, the burden is on industry that shows safety.

That was another hallmark to shift the burden away from government.

However, with that burden came the authority, if you will, of the industry

to do the assessment of a chemical and to decide which risk management was needed.

Government is supposed to police that process, and oversee it.

But in fact very few of the industry assessments have actually been reviewed

to date.

And there are questions being raised about the quality of those assessments.

We have a very different system under the new TSCA,

where EPA now still has to do the assessments.

And it decides what the risk management is that is necessary.

But the shift is banned from EPA having to show harm to EPA having

to determine affirmatively whether a chemical is safe or not.

And that shift and a burden I think is going to be an important thing

that we'll see, again, how it plays out in practice.

I mentioned a couple of other things on this slide that I'll let you read

on your own.

But it's it's an interesting contrast between these two systems and

we'll see how this plays out over time.

Chemicals and Health

Reviews

MK

MP

Taught By

Dr. Megan Weil Latshaw, PhD

Beth A. Resnick, MPH

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