EPA published six principles Sept 30, 2009, it believes should guide reform of the Toxic Substances Control Act.  On their face, they look reasonable, but as Richard Denison of Environmental Defense Fund says, "the devil's in the details."  Here are the “principles” and what I think about them:

Principle No. 1: Chemicals Should be Reviewed Against Safety Standards that are Based on Sound Science and Reflect Risk-based Criteria Protective of Human Health and the Environment

How safe is safe enough?  Dealing with uncertainty caused by lack of data and lack of understanding of how chemicals cause hazards, what the nature of exposure is  (who is exposed to how much for how long and by what route) remains an art and a source of high emotional content.  The wide spectrum of interpretation and application of the “precautionary principle” makes this a huge political hot button and the reason that nearly all EPA actions to restrict commercial activity are challenged in court.  Whose science do you believe?  How much should we spend or make others spend to protect us from uncertain risks? See an earlier blog of mine on the topic.

EPA still needs to be required to do rulemaking with careful presentation of their rationales for why the safety standards are indeed science and risk-based.  And, yes, be subject to challenge.  It’s the American way.

Principle No. 2: Manufacturers Should Provide EPA with the Necessary Information to Conclude That New and Existing Chemicals are Safe and Do Not Endanger Public Health or the Environment.

EPA wants more data.  In fact, there never is enough data since we will never really be able to totally eliminate uncertainty and those on the extreme end of the precautionary principle are always worried.  In fact, in terms of quickly getting existing data, they have “model” section 8 rules to quickly get it. [I helped write some of these when at EPA.]  They also describe in under this principle that they want data from processors and users.  Processors they can get under current authority, except for tackling “small businesses” – but they haven’t wanted to deal with the large universe of affected companies and the variable quality data they would receive.  Users are another mess.  The administrative and enforcement challenges of identifying and getting comprehensive coverage of users will be a nightmare.  Tread carefully when you open this door, EPA.

What EPA wants most is the ability to require expensive toxicity testing to understand hazards much more easily and quickly than they can under current TSCA authority.  This is probably OK if they maintain a respect for tiered testing that doesn’t immediately jump to the multimillion dollar (yet still equivocal in interpretation) animal cancer tests.  On the other hand, stopping at quick and dirty false-positive plagued screening tests whose meaning is really ambiguous is also bad.  The experiences with voluntary test programs – stimulated by industries fears over complex testing requirements – has been fairly successful and meaningful in generating toxicity information.  The issue has been timing – see Principle 4.

Principle No. 3: Risk Management Decisions Should Take into Account Sensitive Subpopulations, Cost, Availability of Substitutes and Other Relevant Considerations.

Well…sounds good.  Especially “other relevant considerations.”  All the politically correct terminology is listed here (“sensitive subpopulations” = kids).  How much weight will be given to each is another thing.  I am most pleased to see a bow to feasibility – cost and availability of substitutes.  “Relevant” is also what the risks are associated with the substitute – likely not so well known either or risks of a whole different kind.  E.g., shouldn’t EPA have been required to that alternates to asbestos car brakes would work to comparably stop a car?

Risk management is a balancing act and needs to be done in the daylight of public rulemaking.

Principle No. 4: Manufacturers and EPA Should Assess and Act on Priority Chemicals, Both Existing and New, in a Timely Manner.

EPA is always being beat up for being so slow in completing reviews (dioxin review is over 20 years in the making), especially under TSCA.  They get data in and do zip with it.  I’ve written comments to them myself over the fruitlessness of the massive data collection efforts (PAIR, IUR Update, Proposed Inventory Reset) where the data appears to never be used.  This principle is to appease those frustrated with the lack of action – which includes not only NGOs, and Congressmen, but also companies who need a strong EPA to calm public pressures.

But mostly they want companies to be faster in generating test data. There have been laggards in the voluntary programs and seeming endless arguments over what testing should be done.  Maybe.  But EPA remains obligated to justify the efforts they require – both to ensure reasonable costs, but mostly to be sure the data will have utility.

Principle No. 5: Green Chemistry Should Be Encouraged and Provisions Assuring Transparency and Public Access to Information Should Be Strengthened.

Two principles in one.

- Green chemistry – EPA appears to want this to be voluntary not mandated.  Good.  Forcing innovation is not real feasible and, again, can just move you into a different frying pan.

- Confidential Business Information Claims (CBI) – Yes, there are companies who abuse the privilege.  But there are also legitimate claims and valuable business information that EPA is obligated to protect.  I don’t know that EPA needs any new authorities against firms.  It’s more a case of enforcement.  Every situation is somewhat of a case by case and providing substantiation up front is legitimate.  There is also a legitimate need to share information with states.  Unfortunately, while EPA is very conscientious about the handling of CBI, states can be leaky as sieves.  There are some culture changes need at the state level and some well-directed enforcement directed at them as well.

Principle No. 6: EPA Should Be Given a Sustained Source of Funding for Implementation

Congress has not funded the TSCA program at the level necessary. But the sneaky slip in that “manufacturers of chemicals should support the costs of Agency implementation, including the review of information provided by manufacturers” can be a slippery slope – especially given the history of never-ending review at EPA and state agency permit funding games have shown, the costs keep going up with little check on the quality and timeliness of work (see Principle 4).   Some kind of check on the system is necessary so that costs don’t spiral out of control.

We’ll see how the devilish details get worked out….

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