Safe Chemicals Act - What is "Expedited Action?"

Yesterday I presented a set of chemicals listed in the House version of the recently introduced TSCA reform bill. These are chemicals for which significant risk has already been documented, and thus the bill provides for "expedited action."

What is "expedited action?"

Oddly enough, it means that manufacturers of the chemical substances listed shall not be required to submit a minimum data set for such chemicals unless and until EPA makes a determination. But it does mean manufacturers must, within 6 months, submit a declaration of safety.

Meanwhile, EPA has 1 year to determine if the manufacturers of the listed substances have established that the substance meets the safety standard. If not, EPA must "take appropriate action" to ensure that the "manufacturing, processing, distribution in commerce, use, and disposal of the chemical meets the safety standard. In other words, if the chemical cannot be determined to meet the safety standard within that time frame, EPA has the authority to severely restrict its use or even ban it.

The idea is to deal with these "low hanging fruit" that have been studied for years and that have been found to be problematic. The Act essentially says "enough is enough" and facilitates their removal, or in some cases, a decision that they aren't as bad as their press.

House version of Safe Chemicals bill has a list of chemicals!

For those who have been following this page you will have noticed that I have used the Senate version of the TSCA Reform bill as my reference point. The Senate bill was introduced by Senator Lautenberg, the sponsor of the previous two Kid Safe Chemical Acts (that never even made it to committee discussion). But there is also a House version of the bill. It is largely the same on the key features, but not completely the same. One point of departure is that the House bill, which Representatives Waxman and Rush issued as a "discussion draft" under the moniker Toxic Substances Safety Act of 2010, has a SEC. 33. EXPEDITED ACTION FOR CHEMICAL SUBSTANCES WITH DOCUMENTED RISKS.

The section states that "In the case of a chemical substance identified in subsection (b) for which risk to health and the environment have been well documented yet sufficient risk management actions have not been taken, expedited action under this title is warranted."

And guess what? Unlike the Senate bill, the House bill names names! Well, chemical names. They pick much of the low hanging fruit, that is, chemicals that have already been identified some place or another to be substances of very high concern. The idea is to deal with these quickly, like while EPA is waiting for companies to notify the chemicals for the new inventory. So the chemicals listed are:

(1) Anthracene, pure
(2) Asbestos
(3) Bisphenol A
(4) Cadmium and cadmium compounds
(5) Chloroalkanes, C10–13 (short-chain chlorinated paraffins)
(6) Decabromodiphenyl ether and congeners in the commercial DecaBDE mixture
(7) p-Dichlorobenzene
(8) Formaldehyde
(9) n-Hexane
(10) Hexabromocyclododecane, including all major diastereomers
(11) Hexachlorobutadiene
(12) Hexavalent chromium
(13) Lead and lead compounds
(14) Methylene chloride
(15) Mercury and mercury compounds
(16) Musk xylene
(17) The following perfluorinated compounds:
(A) Fluorinated telomers
(B) Perfluoroalkyl sulfonates
(C) Perfluorooctane sulfonic acid, its salts, and perfluorooctane sulfonyl fluoride
(D) Perfluorooctanoic acid and related salts
(E) Polyfluoroalkyl phosphoric acid diesters
(18) Phenanthrene
(19) The following phthalates:
(A) Benzylbutyl phthalate
(B) Dibutyl phthalate
(C) Diethylhexyl phthalate
(D) Di-isodecyl phthalate
(E) Di-n-hexyl phthalate
(20) Polybrominated biphenyls
(21) Polychlorinated terphenyls
(22) Tetrabromobisphenol A
(23) 1,2,3–Trichlorobenzene
(24) 1,2,4–Trichlorobenzene
(25) 1,2,3,4–Tetrachlorobenzene
(26) 1,2,4,5–Tetrachlorobenzene
(27) Trichloroethylene
(28) Tris (1,3-dichloro-2-propyl) phosphate
(29) Tris (2-chloroethyl) phosphate
(30) Tris (2,3-dibromopropyl) phosphate
(31) Vinyl chloride

I'm sure many of the chemicals will sound familiar to everyone. I'll talk more about what will happen to these chemicals if the bill passes.

Safe Chemicals and Minimum Data Sets - What Does it Mean? (Part 2)

So the new Safe Chemicals Act institutes what is called a "minimum data set rule." Which states:

"Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall establish, by rule, the data that constitute the minimum data set for chemical substances and mixtures. The rule shall require submission of a minimum data set including information on substance characteristics and on hazard, exposure, and use of chemical substances and mixtures that the Administrator anticipates will be useful in conducting safety standard determinations pursuant to section 6(b) or carrying out any provision of this chapter."

The manufacturers and processors of a chemical must then submit this "minimum data set" to the EPA within "18 months after the date on which the Administrator places the chemical substance on the priority list" or for new chemicals, "the date on which the notice required in section 5(b)(1) is filed [i.e., to notify a new chemical]."

A bit later on the bill specifies "the types of health and environmental information" that EPA could request, including:

- information pertaining to carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and any other effect which may be considered in a safety determination;

- information pertaining to exposure to the chemical substance or mixture, including information regarding the presence of the chemical or mixture in human blood, fluids, or tissue; and

- information pertaining to bioaccumulation, persistence, acute toxicity, subacute toxicity, chronic toxicity, and "any other characteristic which may present an adverse effect."

When you think about it, that is a pretty comprehensive and open-ended list. The REACH program in Europe has very specific data requirements tied to tonnage band. Chemicals produced in smaller quantities have fewer data requirements. Those produced in very large quantities have very extensive requirements. These more extensive data requirements are also necessary if the chemical is considered a "substance of very high concern." But the data requirements under the Safe Chemicals Act bill seems to add the idea of biomonitoring, that is, if a chemical shows up in analyses of people's blood or other bodily fluids it might trigger additional data.

The SCA also seems to add the rather undefined "behavioral disorders," and "cumulative or synergistic effects." It's unclear just exactly how these things might be measured.

And don't forget nanomaterials!!

What goes into a minimum data set for the Safe Chemicals Act? (Part 1)

The new Safe Chemicals Act of 2010 bill introduced by Senator Lautenberg on April 15th (and the companion bill introduced the same day in the House) notes that all chemicals will be required to provide a "minimum data set." But what data are minimum? Will this mean more animal testing?

In this first part I'll introduce some thoughts and then follow up in subsequent posts. It's important to keep in mind that data doesn't mean just hazard data but also use and exposure information. So the minimum data set could include information on the amount of the chemical produced, locations of production, how is it used (e.g., as an intermediate in making other chemicals versus as a component of a consumer product we all use every day), and any specific exposure information.

The minimum data set could also include basic hazard information such as physical-chemical properties (is it soluble in water? high or low pH?), environmental fate (is it persistent in the environment or does it break down quickly? does it end up in the water, the air, sediment, soil?), ecotoxicology (does it kill fish or slow the reproduction of invertebrates or stunt algal growth?), and toxicology (does it kill rats if exposed orally or dermally or via inhalation? does it have more subtle effects on endocrine systems of organisms?), etc., etc., etc.

In short, there is a lot of information that can be needed in a "minimum data set" for EPA to make informed risk assessments and for the appropriate risk management measures to be implemented. So the minimum data set needs to be defined.

It's also important to note that "hazard data" doesn't mean animal testing. In fact, there has been quite a bit of effort put into finding non-animal methods. I'll address that in a subsequent post.

[Please note also the comment and response below for more information]

A change of pace today - It's Earth Day 2010

A bit of a change of pace today. It's Earth Day.



Earth Day 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.

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."

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:

‘‘(23) REASONABLE CERTAINTY OF NO HARM.—
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."

First Summary of New "Safe Chemicals Act of 2010" Introduced by Senator Lautenberg

Well, it's finally here. And it's a doozy. [That's a technical term, trust me] Senator Lautenberg on April 15th introduced the 169-page Safe Chemicals Act of 2010 (SCA) to replace the 1976 Toxic Substances Control Act (TSCA). Meanwhile Congressmen Rush and Waxman introduced a slightly less bulky "discussion document" version in the House. A first look suggests the House bill is pretty close, especially on the main provisions, so any section numbers mentioned below are based on the Senate version.

First thing to notice is that the SCA will require a baseline data set on all chemicals. Some of the major provisions include:

1) The SCA will require EPA to establish a "minimum data set" for all chemicals and mixtures [this mixture thing will need a closer look]. EPA will have the authority to require testing as necessary using rules and orders.

2) Like TSCA, the SCA would require a PMN-type notification, but the data requirements would be more demanding and notifiers would have to demonstrate that their chemical meets the new safety standard.

3) Chemicals would be prioritized based on risk (not just hazard), and EPA would be required to establish a "priority list" within 18 months of enactment of "not less than 300 chemicals" for which safety determinations will first be made. Chemicals can come off the list as they are deemed safe, and new chemicals will be added for priority review so that the list will always have at least 300 substances.

4) EPA would apply a standard of "a reasonable certainty of no harm" in their determinations of safety, for which they will have a 6 month period to complete.

5) EPA would have authority to take immediate action as necessary to deal with chemicals that are deemed to be of "imminent and substantial" hazard. Actions could include banning, stop sale orders, etc.

6) Section 9 requires that within one year all manufacturers and processers must provide a declaration of current production so that an accurate Inventory of chemicals in commerce can be maintained. With this declaration they will be required to submit existing health and safety studies, information on chemical identity, production volume, uses and exposures, etc., and the declaration must be updated every three years.

7) Section 14 allows EPA to require "substantiation" of all claims of confidential business information, and the EPA is required to set standards on what is eligible for CBI.

8) A new section 29 expedites action on chemicals of highest concern.

9) A new section 30 requires the establishment of a Children's Environmental Health Research Program within 90 days after enactment of the law.

10) Section 31 stipulates that great effort should be put into the reduction of animal testing to support data needs, including the use of QSARs, read-across, in vitro methods, etc.

11) Section 32 provides incentives for development of safer chemical alternatives and greener chemistry.

12) Section 35 creates a new section in which EPA is required to identify, assess and develop action plans to address the disproportionate exposures of certain populations and localities (i.e., environmental justice concerns).

13) The cooperation of the US with international efforts to reduce chemical risk is highlighted. Specifically mentioned (as I have noted here previously) are the Stockholm Convention, LRTAP POPs protocol, and Rotterdam Convention, all of which deal with persistent organic pollutants (POPs) and persistent, bioaccumulative and toxic (PBT) chemicals. The US has signed on to all of these in the past but never ratified them, which puts us in the awkward position of not being able to vote on what other countries want to do with chemicals used in the US.

There are many other sections and provisions, of course, that deal with the nuts and bolts and logistics of implementation. In the following days I will take a look at the reactions of NGOs, the EPA, and industry. I'll also dig into the details and see where the main areas of contention will likely be as the bills are discussed over the following months.

Representatives Rush and Waxman have indicated they expect to have a series of meetings with stakeholders over the next month and a half in an effor to fine-tune the bill. While Lautenberg still hopes that the bill will pass in this Congress, there is a general sense by many that it won't be possible given the incredibly busy Congressional docket and the likely contentiousness of this year's mid-term elections. So we'll have to see what happens. While I believe all stakeholders are interested in getting something passed, it could be that the next several months are focused on getting a bill that both protects human health and the environment and is workable.

Download the Senate bill here

Download the House bill here

Download a section-by-section summary of the House bill here

The Safe Chemicals Bill of 2010 is Now Introduced [UPDATED]

The Safe Chemicals Bill of 2010 was introduced minutes ago by Senator Frank Lautenberg.

A copy of the bill, which still does not have a Senate number, can be found here.

From Senator Lautenberg's press release:

“America’s system for regulating industrial chemicals is broken,” said Senator Lautenberg. “Parents are afraid because hundreds of untested chemicals are found in their children’s bodies. EPA does not have the tools to act on dangerous chemicals and the chemical industry has asked for stronger laws so that their customers are assured their products are safe. My 'Safe Chemicals Act' will breathe new life into a long-dead statute by empowering EPA to get tough on toxic chemicals. Chemical safety reform is not a Democratic or Republican issue, it is a common-sense issue and I look forward to building bipartisan support for this measure.”

And also:

The “Safe Chemicals Act of 2010” requires safety testing of all industrial chemicals, and puts the burden on industry to prove that chemicals are safe in order stay on the market. Under current policy, the EPA can only call for safety testing after evidence surfaces demonstrating a chemical is dangerous. As a result, EPA has been able to require testing for just 200 of the more than 80,000 chemicals currently registered in the United States and has been able to ban only five dangerous substances. The new legislation will give EPA more power to regulate the use of dangerous chemicals and require manufacturers to submit information proving the safety of every chemical in production and any new chemical seeking to enter the market.

Meanwhile, Representatives Waxman and Rush have released a "discussion draft" rather than a formal bill. Their version is called the Toxic Chemicals Safety Act of 2010.

Senator Lautenberg & Representative Rush to Introduce TSCA Chemical Reform Bill TODAY [Updated]

Today's the day!

Ever since Senator Frank Lautenberg said over a year ago that he would introduce some version of his Kid Safe Chemical Act to reform TSCA "soon," we've been waiting for "soon" to come. And today it did. Sort of.

By the time you read this the bill may already have "dropped." But word has it that this may be considered somewhat of a "discussion draft" more than a bill that will be pushed through this session of Congress. So this bill will be just the beginning of a long process that realistically will have to continue with the reintroduction (yet again) of a bill in the next session of Congress beginning January 2011.

In a way that is a good thing. It allows more time for a workable law to be developed that reconciles the very different visions put forth by industry and by the advocacy groups. With a contentious mid-term election season and several other major pieces of legislation on the docket, getting TSCA reformed this year seems to be nearly impossible.

More later after it is released.

Oh, Senator Lautenberg will introduce the Senate version and Representative Rush the mirror House version. Rush and Representative Waxman are expected to hold weekly meetings with stakeholders during the rest of April and May in an attempt to reach a consensus on key aspects of TSCA reform.

Meanwhile, an alliance of environmental and labor groups called the Blue Green Alliance also released a set of TSCA reform principles yesterday. Carl Pope, Executive Chairman of the Sierra Club, a co-founder of the BlueGreen Alliance, said: "Knowing what is in these chemicals, and knowing that this law has the teeth to enforce clear health and safety standards, is imperative to ensuring the health of our people and our environment." He added: "Ensuring a cleaner, safer environment as part of a sustainable economy will result in good jobs and safe communities."

Look for more analysis on this spot.

TSCA Chemical Control Bill to be Introduced by Senator Lautenberg - What Happens Next?

Senator Frank Lautenberg has been promising to introduce his new version of the Kid Safe Chemical Act "soon" for over a year now. But now multiple sources suggest that he will do so as early as tomorrow. Once he does, what happens next?

Based on his statements, and the statements of others, during Congressional hearings, it seems likely that his bill will lean more to the liking of the advocacy community and less to the liking of industry. The bill could very well require data to be provided on all chemicals in commerce, which the NGOs want, and not just on a case-by-case basis for an EPA-prioritized short list, which the industries prefer. Since this is a mid-term election year, and expected to be a contentious one at that, it would not be surprising to see Senators and House members stake claims in firm positions at either end of the spectrum, thus setting up the potential for stalemate that keeps any bill from passing during this session. That would be unfortunate since all stakeholders agree that modernization to TSCA is necessary. Advocacy groups and EPA want greater availalibility to data on chemicals, and industry wants the greater certainty of one federal standard rather than a patchwork of state by state regulations.

Based on public statements by various stakeholders, the key areas of likely disagreement include:

1) What chemicals will require data? Industry believes that only a subset of prioritized by risk chemicals should be the subject of data call-ins while NGOs believe data should be provided on all chemicals.

2) What data should be provided? Should there be a base set of data required or should specific data be requested based on EPA's evaluation of what is needed to fill gaps.

3) Who has the burden? NGOs (and EPA) feel that industry must carry the onus of providing the data to prove their chemicals are safe, but that EPA must make the actual safety decision. Industry feels that EPA should do initial assessments and ask questions only on those chemicals for which they have concerns, which industry would then address in a risk based approach.

4) Prioritization? Even if Congress allocates significant new funds to provide EPA with additional resources, all parties understand that any new data and assessment requirements will run into the problem of inadequate resources over the short term. So some way to prioritize the chemicals most of concern is necessary. Here industry again wants EPA to do an initial review and identify a short list of chemicals for which additional data are necessary, while advocacy groups want industry to provide the data first and then the EPA will have the information it needs to prioritize further assessment. One compromise might be to prioritize the low hanging fruit - those chemicals that are PBTs, listed on other "concern lists", or otherwise well known to be substances of very high concern - all while resetting the TSCA Inventory to only those chemicals currently in commerce and having a phased collection of data for only those chemicals that remain.

5) Standard of Regulation? Most stakeholders agree that the current standard is inadequate. EPA has found it difficult to demonstrate that an existing chemical "may present an unreasonable risk of injury to health or to the environment" when in most cases it doesn't have the data on which to base an assessment. But is the "reasonable certainty of no harm" standard lowering the bar for action too much?

6) Jobs? Impacts on jobs will likely be raised by industry, pointing to the current recession as proof that industry is not capable of a REACH-like system. Meanwhile, what provisions will the bill include to ease the disproportionate burden on small and medium sized companies?

7) Confidential Business Information? EPA has taken recent steps to curb what it sees as abuses to the use of CBI claims by industry, but the fact remains that CBI is very important to protect the competitive advantage of companies developing new products.

The list goes on and we could include incentives for green chemistry and innovation, animal welfare issues, logistics of making data public, and many other issues.

Once the bill is introduced I will give a summary of its major provisions, followed in ensuing days with analysis of the specific areas of contention, industry and advocacy proposals, and possible resolutions.

Look for a pretty active next few weeks!!

Industry Representatives Offer "Perspectives on TSCA Modernization"

As I've been talking about for a few days now, the chemical industry held its annual GlobalChem conference in Baltimore in the last week of March. Presentations are available at the website: GlobalChem. I reported the views of the NGO community (while Richard Denison speaks inside, a rubber duck protests outside) and the former head of the EPA toxics office (Charlie Auer). In addition, leaders for the two major chemical manufacturing trade associations, who had sponsored the conference, offered their views.

ACC President Cal Dooley reiterated his organizations guiding principles, while the new President and CEO of SOCMA, Lawrence Sloan, offered what he called a "pragmatic approach" to TSCA modernization. Inlcuded in that approach is:

1) Risk-based prioritization: All priorities should be based on risk, which considers both hazard and exposure, and not just inherent hazard. No exposure means no risk, even if the chemical is hazardous. This prioritization should be "done transparently with clear cut criteria" and decisions by EPA "should be subject to deadlines."

2) EPA should employ proven regulatory mechanisms: Sloan suggested that the "Canadian approach systematically prioritized the nation's inventory" and that the US should do the same to reset the TSCA Inventory to a workable number [note that EPA indicated it doesn't have time to reset the Inventory]. He also suggested we should learn enough from how REACH is unfolding to know that it isn't the way to go in the US.

3) Learn from ourselves: He noted that the EPA's own New Chemicals Program has provided an effective and efficient system for reviewing chemicals, "some 35,000 new chemicals since 1979," while allowing the US to lead the world in innovation.

4) Development of a new safety standard for industrial chemicals: Sloan warned of setting a safety standard that was too restrictive that could easily "black list" any chemicals listed for further study. He noted that industrial chemicals are distinctly different from pesticides, foods, and drugs, which are designed to either be highly toxic (e.g., to kill specific pests) or intentionally exposed to humans (eaten or used as medicine). In contrast, many chemicals see no direct consumer exposure.

5) Avoiding a "one-size-fits-all" approach: Again emphasizing the uniqueness of the specialty chemical sector, Sloan notes that many are small businesses engaging in batch production and not huge corporations, and thus they are "already suffering economy."

6) Adequate funding and oversight: In agreement with all speakers, Sloan emphasized that EPA needs to be adequately resourced to do the job or else it will cause a slow down in reviews and limit innovation.