Wednesday, April 21, 2010

More on the "reasonable certainty of no harm" standard under the new Safe Chemicals Act of 2010

A couple of days ago I asked the question "What does "reasonable certainty of no harm" mean anyway?" and offered some ideas. I want to follow up on that and talk about a definition of "adverse effect" as stipulated in the Senate bill.

‘‘(14) ADVERSE EFFECT.—The term ‘adverse effect’ means a biochemical change, anatomic change, functional impairment, or pathological lesion, or its known precursor, that—
‘‘(A) affects or alters the performance of an anatomic structure of a vital system of an organism or progeny of an organism;
‘‘(B) causes irreversible change in the homeostasis of an organism;
‘‘(C) increases the susceptibility of an organism or progeny of an organism to other chemical or biological stressors or reduces the ability of an organism or progeny of an organism to respond to additional health or environmental challenges; or
‘‘(D) affects, alters, or harms the environment such that the health of humans or other organisms is directly or indirectly threatened.

Again, that is a lot.

Okay, the first bullet "(A)" sounds pretty normal. Does the chemical kill or otherwise cause observable harm to test organisms? That has been the standard for a long time.

The second bullet "(B)" deals with homeostasis, or roughly, the ability of the body to regulate itself through physiological and biochemical means. This has also been used to some extent in the past, but the use here suggests that EPA will have flexibility to include more subtle effects like biomarkers, endocrine disruption, and even some of the new "Toxicology for the 21st Century" enzyme and gene markers currently being developed.

Bullet "(C)" is a little more difficult to pin down. Presumably a chemical that would decrease the body's ability to react to the heat stress of a very hot summer day could fall under this definition. That isn't the intent, of course, but EPA will need to be a lot clearer in defining what this means before it starts to require "minimum data sets" and identify priority chemicals.

The final bullet point "(D)" is interesting because it gets into not what the chemical does to organisms (humans, plants or animals), but what it might do to the ecosystems in which we and they live. This almost sounds like something from the Endangered Species Act, where protection of habitat can be part of the rationale for listing. It's hard to determine exactly what this might mean with respect to the ability to measure environmental impacts without some form of monitoring.

So it looks like EPA will have some work to do before the Safe Chemicals Act will go into force.

More tomorrow.

Tuesday, April 20, 2010

So what happens to the TSCA Inventory under the new Safe Chemicals Act?

As most readers probably know, the current Toxic Substances Control Act (TSCA) has what is called an Inventory of existing chemicals. The list was created soon after TSCA was enacted to "grandfather" the chemicals already in commerce at that time (the late 1970s) onto a list. The idea was that it was simply impossible to assess them all at once for health and safety and that they could be assessed systematically over time. Meanwhile, new chemicals added to the list would undergo a new Premanufacture notice (PMN) procedure to assess their safety. In reality very few of the original 63,000 grandfathered chemicals have received substantive health and safety evaluations. And as the new Safe Chemicals Act anticipates that there will be a "minimum data set" needed for both existing and new chemicals, the fact that the old Inventory was largely made up of chemicals no longer in commerce anyway became evident.

The Lautenberg Safe Chemicals Act of 2010 takes a step towards eliminating the old Inventory and creating a new one. Section 9 of the new act (which amends Section 8 of TSCA, I know, it gets hard to follow), states that "Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, each manufacturer or processor of a chemical substance distributed in commerce shall submit to the Administrator the declaration described in paragraph (2) or (3), accompanied by the certification described in subsection (i)." The declaration noted in paragraph (2) includes information on the chemical identity and characteristics, locations of manufacturing and processing facilities, a list of health and safety studies available, and any other relevant information regarding the physicochemical and toxicological properties and annual production volumes. In essence, the section requires companies to provide information similar to a PMN for new chemicals. The companies would also be required to declare to EPA when they have ceased production.

All of this effectively sets up a new dynamic Inventory where chemicals can be removed as well as added. In the old Inventory once a chemical was on the list it stayed there and anyone could decide to start making it again in the future without any further review. This new system would require there to be the minimum data set produced for any new chemical, which would be defined as any chemical not currently on the list. Companies would be required to update their information every three years, so if no one reports a chemical as being produced after than time presumably it would be removed from the Inventory.

And since EPA would establish a rolling list of 300 chemicals for priority review, presumably from only those chemicals that make the new Inventory list, eventually all chemicals would get reviewed for health and safety. If the new Inventory list of only those chemicals that are currently in commerce is substantially less than the approximately 85,000 chemicals on the current Inventory (some industry figures suggest less than 10,000 are currently in commerce in the US), then the job becomes much more manageable.

I'll take a look at other aspects in upcoming days, including what is meant by the "minimum data set."

Sunday, April 18, 2010

What does "reasonable certainty of no harm" mean anyway? [Safe Chemicals Act]

One of the areas of concern in the new Safe Chemicals Act of 2010 bill is the new "safety standard." The main chemical industry trade group said in its initial response that "the proposed decision-making standard may be 'legally and technically impossible to meet.'"

According to the Senate version of the bill, the standard is a "reasonable certainty of no harm," which is defined as:

The term ‘reasonable certainty of no harm’ means, in establishing whether a chemical substance or mixture meets the safety standard under this subchapter, that aggregate exposure and cumulative exposure of the general population or of any vulnerable population to the chemical substance or mixture presents a negligible risk of any adverse effect on the general population or a vulnerable population.

But if one looks at it closely there is a lot in that one paragraph.

Aggregate exposure: Presumably this would include exposures to a particular chemical or mixture from all sources. But how does one assess that based on the "minimum data set" that is specified in the bill? (more on the minimum data set in future pieces)

Cumulative exposure: So not single exposures but perhaps multiple exposures over time. This would be particularly relevant for chemicals that are persistent or bioaccumulate, and also for chemicals to which people get exposed to over and over.

General or vulnerable populations: So there would have to be specific ways to protect vulnerable populations, which would entail adding additional safety factors to whatever safety margin is assessed. Since children tend to be more sensitive and have less developed immune systems, special safety margins would be necessary to protect them.

Negligible risk: Okay, here is a key question that needs to be addressed. What does "negligible" mean? Some risk is always going to happen. We assume the acceptable risks of driving and flying and even eating new foods. So where is the line drawn for "negligible" when it comes to exposure to chemicals?

All of these pieces of the standard need still to be defined. The bill stipulates that the EPA "shall use the best available science when conducting an assessment," and goes on to say they "shall consider the most recent recommendations of the National Academy of Sciences on ways to better protect people, including pregnant women, infants, children and other vulnerable populations from harm by exposure to toxic substances when assessing such potential risks." This should give EPA the flexibility to accept, and request, studies that are currently still under development, such as those mentioned in the "Toxicity Testing for the 21st Century" report.

The bill also stipulates that an assessment "shall address health or environmental impacts including potential or demonstrated cancer and noncancer endpoints," so the potential is there to also address "new" issues such as endocrine disruption.

All of these will likely be discussed during this period of meetings and negotiations between law makers and industry and advocacy representatives.

Key Areas in Need of Negotiation for new Safe Chemicals Act

Now that the new "Safe Chemicals Act of 2010" has been introduced in the Senate (and a largely mirror version in the House, but with a few important differences), the time for negotiations with stakeholders has begun. All stakeholders expressed the usual "we support the goals" statements, but all also indicated where they feel the bill goes too far, or not far enough.

One of the key chemical trade associations, ACC, issued a statement pointing out three areas of disagreement:

- that the proposed decision-making standard may be "legally and technically impossible to meet"
- that the proposed changes to the new chemicals program "could hamper innovation in new products, processes and technologies"
- that the bill "undermines business certainty by allowing states to adopt their own regulations and create a lack of regulatory uniformity for chemicals and the products that use them"

Another trade association, SOCMA, representing many smaller and medium sized companies, was more worried that the scope of the bill was severely "overreaching." They worry that the requirement for a rolling 300 chemical list of priority substances for closer scrutiny is "overly prescriptive." The "minimum data sets" also were cause for concern.

Meanwhile, environmental and health advocacy groups felt the bill didn't go far enough in some respects, though they applaud the bill for finally "getting serious" about reforming TSCA. EDF thinks that one problem area is the fact that some new chemicals will be allowed to enter the marketplace with "inadequate safety data" if they don't immediately trigger one of the higher concern criteria.

I'll take a look at some of these issues in the following days, including what is really meant by the new risk standard of "a reasonable certainty of no harm" and how the "reset of the TSCA Inventory" has seemingly become a "throw out the old TSCA Inventory and start a new one."