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Posts Tagged ‘Safe Chemicals Act’

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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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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Environment News Service continues the misinformation that current TSCA law is broken:

“Under current policy, the EPA can only call for safety testing after evidence surfaces demonstrating a chemical is dangerous.”  WRONG.

Here’s what the law says today (highlighting mine):

 TSCA Section 4. Testing of chemical substances and mixtures
 (a) Testing requirements
      If the Administrator finds that -
        (1)(A)(i) the manufacture, distribution in commerce,
      processing, use, or disposal of a chemical substance or mixture,
      or that any combination of such activities, may present an
      unreasonable risk of injury to health or the environment,
        (ii) there are insufficient data and experience upon which the
      effects of such manufacture, distribution in commerce,
      processing, use, or disposal of such substance or mixture or of
      any combination of such activities on health or the environment
      can reasonably be determined or predicted, and
        (iii) testing of such substance or mixture with respect to such
      effects is necessary to develop such data; or
        (B)(i) a chemical substance or mixture is or will be produced
      in substantial quantities, and (I) it enters or may reasonably be
      anticipated to enter the environment in substantial quantities or
      (II) there is or may be significant or substantial human exposure
      to such substance or mixture,....

EPA must find there may be an unreasonable risk or there may be significant exposure – why is this impossible to do?

The failure has been in EPA’s reluctance to move test rules forward.  Why? Test rules can cost a bundle ($ millions) and companies are going to fight not to spend their money.  So what? If EPA really wanted to, they can proceed and justify their actions through rulemaking and in court, if necessary. EPA and NGOs whine it takes too long.  Sorry, the rulemaking process is there for a reason – to take comments from the affected public and ensure there are some real benefits for the cost of the action.  EPA has successfully built default mechanisms into testing for new chemicals because they only have one company they can pretty much blackmail into doing whatever EPA wants.  But with some creativity, the same thing can be done for existing chemicals – without overburdening individual companies and testing facilities (not to mention lab animals).

Beware the Jackson EPA: I think they are discovering just how much authority they already have and are willing to use it (without even bending over backwards like CO2 under the Clean Air Act).

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Continuing the review of Lautenberg’s Safe Chemicals Act (SCA), here’s how it appears to treat new uses of existing chemicals:

New uses of chemicals are ones that have not been reported by the company manufacturing or processing the chemical to EPA under the new version of an inventory – the current activity declarations described in earlier an blog – or in a new chemical notice described here.  There are two kinds of new use reports, depending on whether there is a safety standard.

There is No Safety Standard

This will be most existing chemicals until EPA gets around to it in their priority-setting effort.  [I’ll blog another time.]  Processors must report when:

1. the use is “new” (i.e., the use is not ongoing when the SCA gets passed and gets reported by no one)

2. you want to use “significantly increased volumes” above what you reported before [no definition of what that volume is. You get to resubmit even if it’s before the 3 yeat update.] OR

3. the use is new for your company.

There ‘s some convoluted double negatives in §5((a)(2)(A).  I think it reads that if you processed the chemical before the SCA passes but the use was reported by someone else and you resume making or processing it in less than significant volumes, you don’t have to report either for the initial inventory or for this new use notice.  Which makes no sense.

If There IS a Safety Standard

If there is a safety standard and the manufacturer or processor meets the conditions for the standard, no separate notice is required.  Although the company is still covered by the “current activity” reporting requirement every 3 years.

A company has to do the new chemical notice if the use, volume or other conditions of the safety standard will not be met: the current activity information, a minimum data set (with appropriate reimbursement to those who generated it and any updates the company may have) and a declaration that will continue to meet the “reasonable certainty of no harm” safety standard if the use is allowed.  Burden of proof is on the submitter.  EPA will decide if it wants to change the safety standard to encompass the new use.  EPA can also make the default findings as for new chemicals:

If the chemical substance, or a metabolite or degradation product of the chemical substance” is expected to

– be made at < 1 million lbs or released to environment < 100,000 lbs

– present no potential for a long list of toxic endpoints including “other toxicological properties of concern” 

– not be persistent and bioaccumulative

– not be found in humans above natural levels [not clear if EPA is supposed to look at aggregate and cumulative amounts for ALL uses of the chemical] AND

– not be found in food, drinking water, ambient or indoor air, residential soil, or house dust above natural levels. [again all uses?]

Those last two may prevent use of these default findings for new uses of existing chemicals.

In addition to safety standards that are created for new chemicals – for which uses will likely be very narrowly defined – the SCA mandates a priority-setting process to develop standards for existing chemicals at a pace of 300 chemicals/yr.

Processors

These requirements open up reporting on a whole new community that has not focused very hard on TSCA – businesses making products out of chemicals, i.e., processors. See next post.

Update 8/2/10  I’m dropping SCA review and going to focus on the House Bill HR 5820.

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Continuing my review of  Sen. Lautenberg’s Safe Chemicals Act bill, this blog covers the treatment of NEW CHEMICALS.  Today’s PMNs will be converted to “safety declarations.”  Any chemical not reported by a manufacturer or processor in the first round of the “current activity declarations” – see previous blog on the new TSCA Inventory –  will be “new” and require submission of:

1. information as required in the current activity declaration (chemical identity; facility name and location where the chemical is made, processed or distributed and where it will be shipped to; list of health and safety studies and copies not previously submitted to EPA; physical, chemical properties; toxicological properties; annual production; known uses; exposure and fate of the substance)

2. a minimum data set – essentially the same information as #1 and toxicity testing to be determined by rule within 1 year of passage of the Act [which means it will copy REACH because there won’t be time to do anything too novel]

3. a statement that the chemical will meet “the safety standard”

So what is “the safety standard”?

There appears to be no specific definition in the Senate bill.  We’ll assume this was to allow discussion under the House draft:

‘‘§6(b) SAFETY STANDARD DETERMINATIONS.—
‘(1) SAFETY STANDARD.—The Administrator shall apply, as a safety standard under this title, a standard [that] takes into account aggregate and cumulative exposure to a chemical substance or mixture and that provides a reasonable certainty of no harm,  including to vulnerable populations, and protects the  public welfare from adverse effects, including effects on the environment.”

The Senate bill does define  “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.” §3(23)

[‘cumulative’ and ‘aggregate’ is to capture the chemical used for anything, whether regulated as a TSCA/SCA “chemical substance” or not.  Usually moot for a new chemical.]

The bill emphatically says the burden is entirely on the manufacturer or processor to prove that the chemical is safe.  EPA’s duty is to decide if the company met the burden of proof.  The agency can order the company to provide more information to support this proof.

EPA is supposed to make a positive or negative decision within 180 days of receipt of the information and can extend this up to 1 year to get more information from the submitter. If EPA fails to make a determination, the submitter cannot proceed to make or use the chemical in a new way. §5(a)(4)(D).  The company has no recourse to judicial review or challenge.

EPA could lickety-split come up with conditions under which manufacture and use  of a new chemical would constitute a “safety standard” with reasonable certainty of no harm.  In essence, this becomes equivalent to today’s direct final SNUR with workplace, use and disposal restrictions – except these are orders and not rulemaking (or even “consent” orders as with current 5(e)).  EPA issues the safety standard loaded with “conditions” and the manufacturer of a new chemical takes it or leaves it.  These safety standards are not subject to judicial review.  EPA just has to be “transparent” and publish its decisions. (Even REACH authorization requires review!)

On the other hand, there is a default set of findings that the EPA can make to allow new chemical manufacture without doing a safety standard:  

If the new chemical substance, or a metabolite or degradation product of the chemical substance” is expected to

– be made at < 1 million lbs or released to environment < 100,000 lbs [pretty easy to  meet on a new chemical]

– present no potential for a long list of toxic endpoints including “other toxicological properties of concern[EPA’s only requirement is to be “transparent” about its decision-making §6(b)(1)(B)(v).  EPA doesn’t have to do a risk assessment. It just has to decide if the absolute negative has been proven.  Is that possible? ]

– not be persistent and bioaccumulative [the bill codifies EPA’s policies, but allows a very rare authority to do rulemaking to update the definitions.]

– not be found in humans above natural levels [this makes no sense for a new chemical for which there are no natural levels] AND

– not be found in food, drinking water, ambient or indoor air, residential soil, or house dust above natural levels. [again, this makes no sense for a new chemical for which there are no natural levels]

the manufacturer can then make the new chemical.

Since failing any of these criteria will prohibit manufacture, it doesn’t seem too applicable to new chemicals – unless they immediately degrade to whatever is deemed absolutely nontoxic. Water? Oxygen? Elemental carbon?  But even too much water or oxygen or carbon in the wrong place can cause adverse effects….  Plus, that kind of chemical is probably useless commercially as it doesn’t stick around long enough to do anything!  If you can think of any new “green chemicals” that would survive this gauntlet, let me know.

Surely, a more reasonable set of “presumed safe enough” default criteria can be developed. Otherwise, there will be no new chemicals.  Even “green” ones. (Test marketing only has to prove it will “not endanger the health or the environment;” however, EPA can set any restrictions it wants to.)

On the off chance that EPA would let a new chemical be made under whatever safety standard conditions it had deemed appropriate, there is a non-rulemaking public process for petitioning for review of these positive safety findings.  Anyone can petition for “redetermination” of whether a chemical continues to meet the standard of “reasonable certainty of no harm.” EPA publishes that a petition has been received, gets public comment and decides whether or not the chemical/use can continue within 180 days.

This system seems to guarantee no new chemicals will be developed and marketed in the US. If they are, they will be used in very limited niche markets – probably within a single company. Because, as SNUR’d chemical makers can attest to, potential customers don’t want to deal with all the restrictions, recordkeeping and potential for major fines.

I don’t have a big problem with a minimum data set if it is appropriately tiered and if sufficiently similar chemicals toxicity and exposure scenarios can be used (which appear possible under the bill).

I do have a major problem with absolute safety criteria and a demand to prove the “no harm.”  Detection does not mean significant risk. A  transitory biological response is not necessarily adverse.  Nor can society afford to forgo the benefits of new chemicals to guarantee  protecting everyone with extreme health vulnerabilities.  We need reasonable, practical precautions mutually agreed upon to manage risk.

I also have a fairness problem with the cavalier dispensing of the rulemaking process and judicial review. EPA is given too much freedom in the bill to control chemical manufacture and use at the whim of bureaucrats and political appointees. Remember – it’s taken over 30 years to even try to revise TSCA.  Don’t give away due process because you didn’t like the Bush EPA.

Next blog will be about NEW USES of existing chemicals and how they are treated.  The SCA opens a whole new Pandora’s box for processors of chemicals.

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Sen. Lautenberg’s Safe Chemicals Act (SCA) bill throws out the old TSCA Inventory and starts everything anew.   What I think the bill would require is a quasi-“reset” of the TSCA Inventory – with all sorts of additional information well beyond the previous Inventory Update Rule.  See the list below.  Anyone not filing this report will have to file something like a Significant New Use Notification, complete with a minimum test data set and a declaration that proves the “new” chemical and its use(s) will cause “no harm.”  I will cover the new chemical/new use declarations in a separate blog.

Within a year of passage of the act, each manufacturer or  processor shall submit a “declaration” of current commercial activity to EPA containing the following new §8(a)(2) information:

1. chemical identity – which means any name: trade, common, IUPAC, CAS#, molecular structure, and (as determined by rule) size, shape, reactivity or anything else EPA considers “special substance characteristics” [e.g., nanomaterials and who knows what for polymers.  At least this is by rulemaking so there’ll be an opportunity to comment.]

2. Facility name and location where the chemical is made, processed or distributed under the control of submitter [proponents want to be able to map the location of all chemicals]

3. List of health and safety studies and copies not previously submitted to EPA [there’s no more separate 8(d); appears any study is reportable]

4. Physical, chemical properties

5. Toxicological properties which under new definition §(26) means

“actual or potential toxicity or other adverse effects…on… biological functions in humans or nonhuman organisms.“ “Adverse effect” means “…affects or alters the performance of an anatomic structure of a vital system of an organism or progeny of an organism…”  [not sure what isn’t included]

6. Annual production

7. Known uses

8. exposure and fate of the substance

9. Name and location of all ‘ship to’ facilities [not clear how far down the supply chain one goes]

The bill also expands the definition of “chemical substance” to include chemicals contained in or formed into an article (presumably eliminating the current exemption under 40 CFR 710.4(d)(6) and 720.30(h)(6)). It will be interesting to figure out what all that might cover.

R&D remains exempt as are chemicals used only for FDA, pesticide, etc. – regulated uses, at least for SCA declaration purposes.  EPA is to consider all aggregate exposures regardless of TSCA/SCA use in evaluating risk, however.

Updates are required every 3 years.

But a report is due immediately when a manufacturer or processor has “significant new information” regarding:

– physical/chemical or toxicological properties,

– use, and/or

– exposure

that demonstrates a new potential toxic effect or corroborates previous information demonstrating or suggesting a toxic effect or effect at a lower dose. new §8(a)(4)(B)

And if you stop making or processing a chemical you reported, you have to notify EPA within 180 days.

While EPA is required to publish a new Inventory list, the driver for a new chemical declaration (SCA-speak for the new PMN) is whether or not the manufacturer or processor has submitted the above information, not whether a chemical appears on the Inventory list.

The purpose of the new inventory list is to identify currently manufactured and processed chemicals and for EPA to categorize them according to known health/environmental effects, exposure or insufficient data.  New chemicals declared to EPA will be added to the inventory, but that doesn’t change reporting responsibilities.

REPEAT: Each and every manufacturer and PROCESSOR would have to provide the extended information in an inventory “declaration” or stop commercial activity for the chemical.  To make or use a chemical for the first time or in any other way than previously reported, a company will have to file a chemical declaration with a minimum data set and anything else EPA says it needs to prove  that the chemical’s use is safe. Look for my next posts on the new PMN/SNUN -like process in the bill.

This new reporting on commercial activity goes well beyond REACH by including processor reporting (REACH’s downstream users) and collecting potentially unlimited toxicological data and customer location information.  The definition of “process” hasn’t been changed – preparation for distribution in commerce, including as part of an article.   That makes for a lot of new companies who’ve never messed with TSCA Inventory reporting before.

Gone from TSCA §8:

– EPA’s requirement to avoid unnecessary or duplicative reporting.

– Any small business exemption.

– Confidentiality for chemical identity, toxicity information or presence in a consumer article that might expose children.

– A requirement that EPA use rulemaking to obtain information.  EPA will be able to use orders to get any information it wants to administer the SCA.

The scope of this bill is overwhelming. Legislators need to ask questions about this new “declarations of current manufacture and processing” data collection effort:

– how many companies will be subject to the reporting requirements of this new declaration inventory?

– what are the implications of the expansion of the definition of chemical substance to include internationally exempt chemical reaction products formed as part of an article?

– what will be the economic and legal impact on newly regulated processors and small chemical manufacturers?

– how much of this information is “nice to” have vs how much can be reasonably used by EPA (or anyone else)?

– why are there no requirements that EPA must avoid unnecessary and duplicative reporting?

– can EPA administer and enforce this requirement?

And those are just some of the issues around the revision of the TSCA Inventory. Watch for my next blog on safety declarations for new chemicals and uses.

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Senator Lautenberg’s bill “Safe Chemical Act of 2010” sets up a whole new regime for both manufacturers and processors of chemicals that outreaches REACH.

Companies must prove their chemicals and uses are “safe” by providing a minimum data set along with any other data EPA says it wants. EPA may issue by order any restrictions on new chemicals and new uses as it makes findings on “safety standards.”  The new “burden of proof” regime.

EPA is mandated to list “priority” existing chemicals and issue “safety standards” – conditions under which chemicals may be made or used.  Once listed, manufacturers and processors have 30 months to submit a data package to EPA to prove their chemicals and uses are safe. EPA has to be satisfied the chemical and use(s) meet the to-be-developed safety standard. If EPA hasn’t completed a safety standard within 180 days, companies must inform everyone that the standard is pending.  All chemicals must have a minimum data set within 14 years.

The Senate bill does not define “safe.”  It does offer a definition not used elsewhere (though it appears in the House discussion draft) for “reasonable certainty of no harm” – which covers cumulative exposures and negligible risk to vulnerable populations.  (Is anything safe?  It might be easier for EPA to list what meets this standard and ban everything else.)

EPA is also supposed to come up with “Hot Spots” around the country with “disproportionate” exposures and develop action plans to reduce risk.  The public can petition to add locations.

Pesky notice and comment rulemaking and judicial review seem to be largely eliminated. EPA will operate by issuing orders. E.g., no review for listing priority chemicals or hot spot locations, decisions that a chemical or use doesn’t meet a safety standard, and automatic banning of International convention POP and PIC chemicals.

All collected information is to be published on the Internet, with limited confidentiality claims allowed, and EPA is to be “transparent” in its decision-making.

The bill is basically SNURs (Significant New Use Rules) on steroids.  WAKE UP PROCESSORS – companies who use chemicals to make products – you will be consumed by this proposed law.  You will be reporting for the new version of an inventory, paying for data packages, complying with exposure restrictions, and notifying new uses of chemicals.

There will be massive new requirements on companies who aren’t major manufacturers subject to REACH (not that they are going to have a picnic either). There will also be massive requirements on EPA to execute the findings and orders and develop action plans. As both a former company TSCA manager and a former TSCA rule writer, this will be a total nightmare. As a consultant, I’m smiling – this could result in a lot of new business.

More details to come.

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