TSCA Reform Latest S. 847 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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Canada’s Mandatory Chemical Surveys v. TSCA CDR

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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More TSCA CBI Revocations

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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TSCA Reform: Safe Chemicals Act 2011

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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TSCA CBI Revocations

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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TSCA Reform: “No Harm”?

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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TSCA: “The Blob”?

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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TSCA – not as broken as claimed

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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HR 5820 Implications: Chemical Processors

What would  TSCA reform bill HR 5820, if it passed as released, do to companies beyond what they have to do today?  This blog deals with my best guess at what the implications are for Chemical Processors and follows on from my previous review for chemical manufacturers/importers.  This blog also deals only with single chemicals being processed and not mixtures as such.  HR 5820′s potential hit on regulating mixtures (“preparations” in EU-speak) will be another potential blog.   The following processing scenarios are reviewed here:

Scenario H: Company processes an existing chemical for the same uses as it has for a number of years.  The chemical isn’t on anybody’s concern list (no safety standard yet).

Scenario I: Company begins to process a chemical it has previously declared for a use that was not included in its previous declaration (whether or not anyone else had declared the use). The chemical isn’t on anybody’s concern list (no safety standard yet).

Scenario J:.  Company processes a chemical that is subject to a newly issued safety standard.

Scenario K: Company wants to begin processing a chemical that is subject to a safety standard.

Chemical processors are those who prepare a chemical substance or mixture after its manufacture, for distribution in commerce, regardless of form or physical state or as part of an article containing the chemical substance or mixture.  EPA has long held that reacting a chemical to form another is also “preparing” a chemical for distribution (which has never made any sense.)  This definition is unchanged in HR 5820.

That means any company that opens a packaged product it got from someone else, does anything to it and then distributes any of its atoms further is a processor. Formulators, repackagers, fabricators.

Not a lot of attention has gone into this TSCA definition for years because most of the tough work (PMNs, testing and reporting) has fallen on manufacturers, with EPA exempting processors as too many, too duplicative and too confusing to deal with.  But HR 5820 fully opens the net by requiring inventory reporting (to be called “declarations”) to processors and making significant new use rules apply to everyone and every chemical.  Maybe EPA will exempt processors if they think they will get all the information they need from manufacturers, but the level of detail to be required will demand processor reporting.

The Scenarios:

Scenario H: Company processes an existing chemical for the same uses as it has for a number of years. The chemical isn’t on anybody’s concern list (no safety standard yet).

1.  DECLARATION.  Company has to file a declaration one year after amendment of TSCA that includes:

-  the chemical identity of the chemical substance or mixture;

-  the name and location of each facility under the control of the processor at which the chemical substance or mixture is manufactured (e.g., if it is contract manufactured for the company) or processed or from which the chemical substance or mixture is distributed in commerce

-  the number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance or mixture in their places of employment and the duration of such exposure

-  a list of health and safety studies reasonably ascertainable by the processor (regardless of whether EPA already knows about it). Also copies of those studies that the company has not previously submitted to EPA.

-  the physical, chemical, and toxicological properties of the chemical substance or mixture, including GHS classification of the toxicity.

-  the categories or proposed categories of intended use

-  the total amount of each substance and mixture processed

-  reasonable estimates of the total amount to be processed

-  the amount processed for each of its categories of use

-  reasonable estimates of the amount to be processed for each of its categories of use or proposed categories of use

-  a description of the byproducts resulting from the processing, use, or disposal of each such substance or mixture

-  exposure information relating to the chemical substance or mixture. EPA will need to define what this means.  Will it be life cycle exposures to any and all media by all users and disposal?  Assume it will be similar to what is asked for in a PMN today – although EPA does a lot of modeling based on process descriptions which are not called out in the bill.  Perhaps EPA will ask for process conditions as a surrogate for exposure information?

-  any conditions currently placed on the chemical substance or mixture due to regulation under any Federal law or due to voluntary action (presumably, this would include conditions set out in safety standards, with which the company must comply and possibly include all uses – even those previously outside current TSCA “chemical substance” jurisdiction)

-  any information indicating that a mixture including the chemical substance has substance characteristics that are different from the substance characteristics in kind or degree.

-  a certification signed by a responsible official of the submitting party that each statement contained in the submission is accurate and reliable; and includes all material facts known to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor.’’

2.  DECLARATION UPDATES

Company has to update the information

- every 3 years whether or not it has made any changes

- immediately if it would indicate “significant new information” of adverse effects or anything relevant to meeting a safety standard.  If this goes the way the old 8(e) did, this will turn out to be any change from that previously reported except for minor volume differences

- No later than 180 days if the company permanently quits processing the chemical.

3.  MINIMUM DATA SET

Company has to provide a minimum data set [to be defined by EPA by rule, but expect the REACH set] depending on volume [to be EPA defined] on a schedule of:

- 3 years for high volume

- 4 years for moderate volume

- 5 years for everyone else  [REACH gives until 2018 and has a 1000 kg cutoff]

Odds are pretty good that processors will be able to rely on – and pay for the privilege – the minimum data set developed by manufacturers.

4.  WHATEVER ELSE EPA WANTS TO KNOW

- EPA has carte blanche to ask for any other records or reports it wants by rule or order.

- Section 4 test rules and orders will also trigger reporting

5.  SIGNIFICANT ADVERSE REACTION ALLEGATIONS AND SUBSTANTIAL RISK INFORMATION

The old 8(c) and 8(e) provisions are unchanged except that allegations records need to be reported annually.   And the bill changes the numbering so that those sections become 8(e) and 8(h), respectively.

6.  DISCLOSURES TO COMMERCIAL PURCHASERS

Companies have to provide “all known commercial purchasers” (whether they buy from the company or someone else?) with each shipment or on request:

- the chemical identity of the chemical substance or, for mixtures, the chemical identity of all chemical ingredients.  Confidentiality for chemical identity appears to be limited to those chemicals with no (known?) health and safety studies and that are not in children’s products or otherwise possibly exposing children.

-all information regarding toxicological properties of the chemical substance or mixture submitted to EPA in the Declaration

- the list of health and safety studies submitted to EPA and copies of the individual studies if requested

- any records of “significant adverse reactions” allegations (e.g., customer complaints) submitted to EPA (but oddly, not substantial risk notifications)

This provision will impact processors the most, as it will challenge the ability to maintain confidential business information.

IMPLICATIONS FOR EXISTING PROCESSORS

INFORMATION MANAGEMENT: A huge multi-disciplinary effort will be needed to create the first declaration.  Records will need to be searched, collated and reported for health and safety studies and toxicity information, sales and marketing current and future will need to be calculated, experts will need to determine how to represent exposure information (which EPA will need to carefully lay out in rulemaking), collating all applicable regulatory standards, chemistry experts to identify byproducts and more.  Likely there will be very extensive communication needed with suppliers to make sure the processor knows what is in the raw materials he uses and what information he can use from the manufacturer or upstream processor.

A jobs bill?  Probably not (at least for the private sector – EPA and consultants will have a hey day, however!).  Resources will have to be reallocated to cover these new reporting requirements, since they will not be revenue generators.

This work will need to continuous – to quickly identify “significant new information” and at a minimum redoing the reporting every 3 years.

MINIMUM TESTING: It’s doubtful any processor would do its own testing on individual chemicals.  The best that can be hoped for is that the manufacturer has already done the testing and will give or sell downstream customers the data at a reasonable cost.  This can be tricky if there are multiple parties in the supply chain before the reporting processor.  One can only hope that EPA will give processors a bye on this one.

RULEMAKING: A lot of work will need to be done to help EPA exercise the provision that declarations  will not be “unnecessary or duplicative.” Much will depend on how fine EPA makes reporting categories of information. Regardless, there will need to be mechanisms for the supply chain to communicate what is and is not being reported by each party.

CBI: There will be loss of proprietary information: No chemical identity confidentiality is allowed if it is subject to a health or safety study or is used in a children’s product.  Processors will be hard-pressed to protect formulation ingredient disclosure (except for percent composition information).  EPA has already begun reversing the historical default of not challenging claims.  Much more care will need to go into upfront substantiation of use, exposure, volumes, etc. information.  Whether or not the link between a company and a chemical is going to be accepted as a valid claim is unclear.

Fees:  Wildcard.  EPA can charge them and, given budget constraints, will.

Scenario I: Company begins to process a chemical it has previously declared for a use not included in its previous declaration (whether or not anyone else had declared the use – the use is new to the company). The chemical isn’t on anybody’s concern list (no safety standard yet).

Submit a declaration as in Scenario H on the new use within 6 months of starting the previously undeclared use.  Update the previously declared information.

IMPLICATIONS FOR PROCESSORS WITH NEW USES OF NONCONTROVERSIAL CHEMICALS:

Same as Scenario H, but with closely monitored new marketing/sales activity to spot changes outside previously reported categories.

Scenario J:.  Company processes a chemical that is subject to a newly issued safety standard.

See blog on Safety Standards here.

As well as dealing with everything from Scenario H, the following will apply:

First, the company will have probably been subject to an extensive reporting rule as EPA tries to collect enough information to be able to do a life cycle assessment of aggregate and cumulative exposures to the chemical.  EPA can do this by rule or order (with less recourse for companies to argue the requirement) on anything it thinks would “assist” (not today’s “necessary”) the agency in doing a safety standard.  Likely this would sweep in uses that are otherwise exempt from today’s TSCA.

Company will need to comply with any conditions set and be able to prove it.  These conditions can be pretty much anything: ban, production limits, use restrictions, hazard communication, monitoring, testing, industrial hygiene measures, disposal, risk reduction plans, etc.

Presumably, EPA will set various recordkeeping, monitoring and other requirements for reporting.

Priority chemicals listed in the bill will be the first to get safety standards (within 18 months of passage) and newly listed (300/yr) within 30 months of listing.

There is a provision for “critical uses” for chemicals that cannot meet the safety standard conditions if the EPA is convinced (the burden of proof is on the company) that the use is “critical or essential” and there is no feasible safer alternative or there is a net benefit to health or the environment compared to alternatives.  Feasible conditions will still be set and purchasers must be informed that the supplied chemical is subject to a safety standard. These exemptions are good for 5 year periods. EPA will publish them.

IMPLICATIONS FOR PROCESSORS WHO BECOME SUBJECT TO SAFETY STANDARDS:

New reporting requirements need to be monitored and responded to.  These will far exceed current PAIR reporting as EPA needs detailed information to create safety standards.

Compliance with conditions set for safety will entail variable and potentially high costs, e.g., relabeling, market restrictions, monitoring, workplace controls, etc.

Constant vigilance to prevent a “significant new use” will be necessary to allow consideration of whether notification is economically warranted and avoid penalties. (90 day pre-notice is required for such new uses.)

New communication to customers about the safety standard and its meaning for the company’s products will be required, along with requests not to initiate new uses without prior consultation.

More export notifications.

Companies will exit manufacture of safety standard chemicals, threatening sources of supply.  Likely only large companies will be able to deal with managing safety standard conditions.

The rate of issuance of safety standards by EPA and the use of categories of chemicals will determine how many companies are affected and the market for the chemicals.

Scenario K: Company wants to begin processing a chemical that is subject to a safety standard.

See Scenario J.

Notification 90 days prior to processing and wait to see what additional conditions EPA may impose.

IMPLICATIONS FOR PROCESSORS ADDING SAFETY STANDARD CHEMICALS TO THEIR PORTFOLIO:

Fewer companies will want to make such chemicals, unless they already have extensive regulated chemical capabilities.  De facto shrinkage of the number of suppliers as existing manufacturers exit and no new ones who will want to deal with the new restrictions.

……………….

Congress is on hold on moving TSCA Reform this year.  But heavy lobbying continues on both sides.  It’s not tough enough, it’s too tough, etc…  And if the Republicans gain more votes in the House….  Meanwhile, EPA is issuing Action Plans under the existing authority of TSCA (which is far broader than is acknowledged and can be quite effective with an aggressive EPA.  See latest here).

Contact EHS Strategies, Inc. for today’s and possibly tomorrow’s TSCA assistance.

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HR 5820 Implications: Safety Standards and New Uses

Part of a series of blogs on the House bill HR 5820 to reform TSCA.

TSCA reform bill HR 5820 sets up requirements for EPA to establish “safety standards” and a new twist on significant new use rules (SNURs).  Here’s a quick summary that applies to scenarios described in related blogs on HR 5820 Implications here.

Safety Standards: EPA has to set a safety standard on the basis of life cycle risk aggregate and cumulative exposures and may set conditions (up to and including a total ban) that would ensure there is “reasonable certainty of no harm” to vulnerable populations throughout the life cycle of a chemical substance.

The number of safety standards will be driven by several prioritization edicts in the bill:

1. EPA must write safety standards for a set of politically identified priority chemicals (BPA, Formaldehyde, phthalates, brominated flame retardants, etc.)

2. EPA must create and work on a steady list of 300 existing chemicals for standards development

3.  EPA must evaluate new chemicals and new uses declared by companies for whether a safety standard is needed

4.  EPA will set significant volume triggers for what will become “new uses” for chemicals covered by safety standards.  Those “new uses” will be considered for whether to modify the standard.

5.  If a use is not listed in a standard, it will be a “new use” and subject to the same reporting as a new chemical.  Safety standards may or may not have specific conditions that apply to manufacture, processing, use and disposal.  Regardless, they will need to contain triggers for what would constitute a new use and require notice (e.g., unlisted uses, significant volume increases).

New Use Rules. Companies proposing to do a “new use” as triggered by the following must submit a notice to EPA that includes the declaration set described in Scenario A (#1) and also the minimum data set (#3) at least 90 days before commencing activity.

1. Significant New Uses Rules (current regulations) still apply

2.  If there is a safety standard and a use is not listed in the standard, it is a “new use” and EPA has to decide if it will modify the safety standard or declare the use to be “critical.”

3.  If there is a safety standard that lists the use, but the volume is significantly higher than considered, it will be a “new use.”  This version of a SNUR would trump the timing of the declaration updates.  [presumably, EPA would designate what would trigger this volume threshold in the standard]

The standard of “reasonable certainty of no harm” is not defined in the House bill. The Senate bill described it as: “…presents a negligible risk of any adverse effect on the general population or a vulnerable population.”  The term comes from pesticides in food tolerances, which doesn’t make a lot of sense for the gamut of commercial chemicals.

But EPA will figure it out.  And issue the safety standards without rulemaking or notice and comment of any kind, except to allow comment on the science it will use in setting standards in general.

But there will be exceptions for “critical uses.”  “Critical uses” are for chemicals that cannot meet the safety standard conditions if the EPA is convinced (the burden of proof is on the company) that the use is “critical or essential” and there is no feasible safer alternative or there is a net benefit to health or the environment compared to alternatives.  Feasible conditions will still be set and purchasers must be informed that the supplied chemical is subject to a safety standard. These exemptions are good for 5 year periods.  EPA will publish them for notice and comment, but not necessarily rulemaking.

Rulemaking is apparently just too cumbersome and such due process gives industry opportunities to  challenge and delay EPA control of chemicals.

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