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Posts Tagged ‘TSCA Reform’

The Senate Committee on Environment and Public Works and Subcommittee on Superfund, Toxics, and Environmental Health voice voted (10 to 8) to send the latest version of the Senate Bill 847, Lautenberg’s “Safe Chemicals Act”  for floor vote.  Republicans are not happy and feel they’ve been locked out, but haven’t offered counter-language so the Dems are blowing them off.   Interestingly, Jim Jones, the EPA AA on TSCA, declined to state a position on the bill.  The likelihood of anything coming out of this Congress is slim to none.

The hearing held by Boxer on the 24th ended with her making the panel vote “yes” or “no” only on the question “Do you agree that chemical manufacturers should have to prove, through objective studies, that their products are safe for pregnant women, for infants and children before they can sell their products in the U.S.”  Not surprisingly, the industry reps declined to vote since she wouldn’t let them talk about function (e.g., pharmaceuticals) or risk – hazard and exposure (e.g., industrial intermediates, wine).  It’s this simplistic approach that makes changes to TSCA so challenging.

See previous blogs on TSCA Reform

A summary of changes published by Lautenberg(?) describes:

– allowing a lesser, screening minimum test set on new chemicals

– better prioritization via tiered batches of 6,000 chemicals over 5 year periods with three levels of concern – very low concern, need more info (minimum data set), and very high concern.

– Very High Concern (SVHC in REACH-talk) get expedited safety standards and risk management – which means they can issue administrative orders with no judicial review instead of that messy notice and comment rulemaking process.

– EPA is to rely on existing information first before requiring additional information/testing only to the extent necessary to determine safety.

– CDR is now detailed in law for processors – but only as necessary for implementation of the act and have value commensurate with the burden of reporting.  (At least there’s rulemaking.)

– “Safety” is still defined as “there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance.”

– Confidentiality is supposed to be a little easier to claim now.  There seems to be some convoluted language on allowing chemical identity to be protected for a limited time if the chemical isn’t carcinogen or other “-gen” or a PBT

Watch for my own “markup” later.  That will take awhile, as they’ve replaced 86 pages of the previous version with 174 new pages, making the total bill now 270 pages long – and that’s before anyone gets a chance to add in amendments on the floor.  

Special interests continue to write detailed instructions into law that are de facto regulations that then cause agencies to issue nanoscale detail in their regulations to be later “clarified” by the courts.  Whatever happened to setting goals and allowing experts work together to find the most efficient and effective way to achieve and enforce those goals? 

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Canada periodically puts out mandatory survey on batches of chemicals as it works through its prioritization process. For example in June there were 8 MDA/MDI chemicals of interest.  It’s a pretty comprehensive set of information demanded of manufacturers, importers and processors: volumes, uses available toxicity information and a list of the top 20 customers.  With the possible exception of getting customer lists, such information can be obtained under TSCA section 8 – basically CDR + 8(d) – applied to manufacturers, importers and processors.  

But note that Canada is only going after EIGHT chemicals in this notice – not thousands at a time like EPA does under CDR!  As Canada identifies categories of chemicals they are concerned about, they hold webinars and issue “mandatory surveys” – evaluate the information and go back for more if they need it (link).  Granted, they have far fewer companies and chemicals to cope with than the US, but note how they are being systematic about working through their inventory on a priority basis.

Maybe advocates for TSCA Reform are right – EPA needs the kick in the pants of legislative instructions to actually do something under TSCA.  The trouble is pick-a-number is pretty arbitrary.  But maybe that’s where we are at?  The Agency has had numerous initiatives – like ChAMP, HPV, Chemical Action Plans and now a “Work Plan” – but they always seem to run out of gas.  I still hold there is a ton of authority in the current TSCA for EPA to take action – especially if they tackle chemicals by category (section 26) and not try to do humungous every-test-known-to-man and/or ban-it-all regulations.

I’d certainly recommend looking to Canada as opposed to Europe as a model to emulate.

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EPA revealed another set of chemical identities in health and safety studies June 8, 2011, here.  I think most of them were “voluntary” by companies, but EPA is claiming some were not.

Protect what is legitimate and be ready to back up your claim.  Provide meaningful generic names.  Let it go if you can protect your trade secrets by protecting your company name or if historical information is no longer trade secret.  Quit jeopardizing the ability to protect real trade secrets by being lazy and claiming everything confidential.

EHS Strategies, Inc. can help you with TSCA.

 

 

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Sen. Lautenberg released the 2011 version of the Safe Chemicals Act for TSCA Reform April 14 here.  I’ve blogged about it before and posted a summary pdf here.

The notable changes I see from last year’s version:

– References to mixtures and articles have been deleted here and there.  No PMNs by new mixture makers.  But mixture and article makers with new uses of “existing” chemicals will still have to submit essentially SNUNs (with minimum data set updates)  or proof that the use meets the safety standard (if there is one).  Mixture and article makers are still “processors” under SCA, so there still needs to be clarification in the bill.  Oddly, the new bill drops allegations of adverse effects and information on substantial risk (old 8(c) and (e)) on mixtures.

– Some definitions were dropped or modified.  “Adverse Effect” is gone, as is  “Special Substance Characteristics” because they got incorporated into later language.  “Reasonable Certainty of No Harm” definition is gone but is used in section 6 as a required finding by the Administrator for a determination that a chemical and its use meets a safety standard:

“6(b)(1)(C)(ii)(I)(bb) find that a chemical substance meets the safety standard only if the Administrator finds that there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance.”

[that in addition to required EPA review, but recognized as likely not available, of cumulative exposures. Reminder: “aggregate exposure” means all sources, whether or not TSCA “chemical substances” and “cumulative exposure” means all substances with a similar/same effect.]

The fun part is that manufacturers and processors have to provide EPA with “sufficient information” to make the above finding – with EPA left to decide when they have enough to agree something will have no harm.  EPA manages to deal with no unreasonable risk in today’s PMN calls, but this positive finding?  Of course, the EPA can impose risk management actions to ensure no [aggregate] harm. How precautionary will they be?

– What is to prevent EPA from keeping chemicals and their uses in forever limbo by either failing to set a safety standard or agreeing a company has provided enough “proof”?

– New use notifications won’t be required as long as someone got the use on the inventory of declarations under section 8(a)(2) instead of last year’s version that you had to have declared it.  Of course, it will depend on what gets defined as a significantly increased volume than was first reported.  If there is a safety standard, you must declare you will meet the standard.  If there is no safety standard, you will have to provide the data set to allow EPA to write one.

– The bill expects Minimum Data Sets (that will at a minimum support screening level risk assessment) on all chemicals within 5 years of the effective date of the law. Take that, REACH!

– The biggest change is setting up 3 priority classes of chemicals for safety determinations and risk management action instead of EPA coming up with a standing list of 300 priority chemicals:

Priority Class 1: Require Immediate Risk Management.   EPA has to list 20 – 30 chemicals within the first year.  18 months after listing, EPA imposes conditions “necessary to achieve the greatest practicable reductions in human or environmental exposure.”  It gets a year after that to get rid of residual risk above the safety standard.

Priority Class 2: Chemical Substances That Require Safety Standards. This one puzzles me.  EPA assigns as many chemicals as it can manage to this class based on

“…any more-than-theoretical concern, that there is uncertainty as to whether a chemical substance would satisfy the safety standard in a determination…”

But is this only for chemicals with safety standards already or those that would likely fail a not-yet-promulgated safety standard?  Recall that a new “inventory” of safety declarations will be required for all chemicals; but no way is EPA churning out standards very fast.  I assume this one is the corollary to REACH’s Candidate List of Substances of Very High Concern.

Priority Class 3: No Immediate Action Required.  The title doesn’t match the criteria. This is a list of chemicals with intrinsic properties such that at no stage of their life cycle would there be “any risk of adverse effects” under existing, proposed or anticipated levels of exposure. I doubt there will be many chemicals that will qualify!

– It drops EPA publishing an inventory of chemicals by effects, exposure or lack of data at least.  The agency also gets more time to publish data and decisions on the internet.

-Sneaky big change:  Import requirements will apply to chemicals imported as part of articles as if the chemicals were imported in bulk under the revised bill, unless the EPA or Homeland Security exempts them.  Holy cow!  Since every chemical has some requirements – minimum data sets, safety declarations, eventual safety standards, import certification, etc. – this is going to be a nightmare.  Not sure they thought this one through.

– Minor change on state preemption.  TSCA preempts only if it is impossible to comply with both a state regulation and a TSCA requirement.

The safety standard-driven reporting requirements remain mind-boggling.  The freedom for the Agency to require any information and institute any conditions it wants by order and without judicial review remains of considerable concern.

I assume we are still looking at continued dialog and little action in this Congress.

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EPA declassified confidentiality claims in a batch of 42 health and safety studies (mostly 8(e) notices of substantial risk) March 24, 2011, following through on their promise of transparency.

Certainly there are some old claims out there that are no longer valid (many on what was at the time R&D activity that has either gone commercial or died).  And some claims were pretty bogus to begin with.  But the idea of going back and having to re-substantiate the thousands of claims that have been made over the last 35 years – holy cow!  Believe it or not, some of the claims will still be valid (just like the secret ingredients of Coke).

Certainly there is room for improvements in the generic names companies use so categories of studies can be searched more easily.  Or maybe there are some creative ways to allow 3rd party confidentiality disclosure agreements for limited studies, instead of massive fishing expeditions.  See my other blogs on the topic.

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Proposed bills to reform TSCA have argued to put the burden on chemical manufacturers to prove that there is “reasonable certainty that the substances pose no harm.

But what does this mean, particularly in light of recent EPA positions on dioxin risk and endocrine disruptor tiered screening? [Covered in Feb 23, 2011, InsideEPA.com’s Toxics Regulation News]

In the dioxin IRIS draft, EPA appears to be using a standard that there is no safe level of exposure to dioxin based on linear modeling. EPA cancer risk assessment guidelines indicate its assessors should use the linear modeling when it is unknown how a chemical causes cancer, and when it causes cancer by mutagenic means. Otherwise, a non-linear, or threshold model can be used, which assumes that there is some level of exposure below which no health effects are anticipated to occur.  Therefore, if a chemical has any positive result in a cancer study (at any dose) and a manufacturer can’t prove how, his chemical will be deemed to fail the proposed new TSCA safety standard.  A PMN will be denied and a ban of an existing chemical will be initiated.

Similarly, if the Endocrine Society has it’s way, any effect at any dose seen in any of the eleven Tier I endocrine disruptor screening assays (including in vitro tests) would argue that there is no safe exposure because for EDCs there is no such thing as a threshold effect and even tiny changes can indicate significant effects later appearing in life.  “No harm” would be impossible to prove for chemicals with positive results in these assays – leading to bans.

I am not expert in the pesticide tolerance arena from where this language was lifted.  I’ve heard Richard Denison, EDF, say that “no” doesn’t really mean zero risk.  (Not the least because that is about pesticides that are intended to harm pests or you can’t claim them to be pesticides.)  Well, if “no” doesn’t mean “no,” the language should not be “no harm.”  Actually, the Senate bill did offer a definition:

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.

So “no” means “negligible.”  “Negligible” means “so small or unimportant or of so little consequence as to warrant little or no attention.” [Merriam-Webster]  So are dioxin and EDC’s risks “negligible”?  Not from all the blogging I’ve seen and the bans on BPA cropping up everywhere.

Today the TSCA standard is “presents or will present an unreasonable risk” – also not explicitly defined, but considerations under TSCA section 6 are laid out: effects and exposures, use the least burdensome but still “adequate” control measures,  the availability of substitutes and economic consequences.  Still doesn’t get at how certain and how big the impacts of the chemical uses are and how to determine when we’ve reached acceptable risk and to whom.  That’s what rulemaking is for: EPA publishes its facts and rationale for action, the public comments, EPA responds and maybe somebody sues.

If risk is always going to be unreasonable to someone, is there some place between no (as in zero), negligible and unreasonable? How about “safe enough”  to allow us/society to benefit from a chemical’s use?  Oops – showed my bias.  I think we do need to consider both the costs and benefits in deciding whether a chemical use (emphasis on use and not the inherent properties of a chemical all by itself) is safe enough.  We do need to look at whether appropriate use of risk management (including safety practices, design and training) is happening so that it stays safe enough.  But just because there is a default linear model or a maybe-might-be effect based on a simplistic in vitro assay  shouldn’t mean there is certainty of harm.  I’ve argued before that there is no such thing as life with no risks.

It’s easy to say we should make manufacturers “prove” their products are “safe” – not so easy to really say what that means in practice.  It’s time for stakeholders to quit talking in vague generalities or demanding the impossible and try to work out a rational program that supports beneficial chemical uses and manages risks in practical ways.

EPA says TSCA section 6 is too hard.  It’s too hard to have to explain why the agency is doing what it is doing and too many people complain.  It’s called democracy.

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Steven Owens, Administrator at the EPA Office of Chemical Safety and Pollution Prevention, responsible for implementing the Toxic Substances Control Act says TSCA is:

“… a kind of blob out there.”

[quote from a conference call with the American Bar Association Sept. 16, 2010, reported in Toxics Regulation News Sept. 29, 2010. He was contrasting it with the pesticides programs at EPA and FDA where “There is a lot of back and forth between the agency and companies. It’s well-funded, highly technical and there are deadlines and accountability.”]

No wonder TSCA is in such sad shape.  The agency administrators don’t know how to use the authorities they already have. Except maybe the new chemicals program that works pretty darn well thanks to the work of Blake Biles and the other members of the first EPA staff implementing  TSCA back in the late ’70’s (including me); although you don’t hear Owens being very supportive of the PMN program either.

It would appear that he doesn’t know TSCA.  So he’s waiting for Congress to tell him exactly what to do in new legislation.   Presumably in exquisite detail because rulemaking is such a pain.

And those action plans…well maybe not if Congress revamps TSCA.  I say again, there’s plenty of authority in today’s TSCA and if EPA would get a plan in place and do it.

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