EPA’s Role in Sustainable Products

EPA published a request for comments on its role in advancing sustainable products September 16, 2010.  I submitted the following comments:

Comments on EPA’s Role in Advancing Sustainable Products 75 FR 56528

Georjean L. Adams, EHS Strategies, Inc.

September 30, 2010

I am commenting on the September 16, 2010, notice soliciting comments on the role EPA should play in advancing sustainable products.  I am a professional who has for many years dealt with product environmental marketing claims as a corporate product stewardship manager, as a consultant, and currently as a member of a standard development committee on greener chemical products.

In general, I think the best contribution by EPA in products is to ensure a solid scientific foundation for  development of products that can be made, used and disposed of with the least adverse impact on health and the environment throughout its life cycle.  EPA can also assist with educating government, industry, academia and the general public about sustainability.

But first I must comment on the concept of “a sustainable product.”  I’m not sure there is such a thing.  A product must be considered within the context of the social, economic and physical systems in which it is made, used and disposed of.  Relevant factors include things such as:

– number of different operations

– volumes handled

– the sophistication of the companies, employees and users involved at each life cycle stage of a specific product

– distance from the customers at each transfer point in the supply chain

– ecosystem/resource profiles at each life cycle stage

– raw materials and energy sources used relative to the product

– number and kind of process steps and their associated EHS risk management practices

– local infrastructure at every life cycle stage

– local social and economic systems at every life cycle stage

All of which are undergoing constant change within their business, environmental and social systems over time.

Therefore, except for the very rare product with a single source and limited market niche and geographic use, it doesn’t have much meaning to say a given widget is “sustainable.”

At best we can list some of the attributes that impact sustainability (such as those listed above) and try to collate a series of life cycle snapshots that are more or less relevant to a particular product. Further,  I believe that sustainability is a relative term in comparing alternatives, as opposed to a finite quantitative state of being.  This philosophy is behind the recent GCI-NSF “Greener Chemicals and Processes Information Standard” proposal which attempts to list key metrics for only the chemical manufacturing life cycle stage in the hopes that a customer could compare relative suppliers of a single  chemical product.  See http://standards.nsf.org/apps/group_public/document.php?document_id=9409

It remains to be seen whether this will prove to be practical and meaningful.  I remain concerned that  there are far too many criteria required in the standard. (I was a member of the Joint Committee that developed the proposed standard.)

I offer the following comments on the specific questions raised in the Federal Register notice:

1. What do you see as the major policy and research challenges, opportunities, and trends impacting the development, manufacture, designation, and use of sustainable products?

I’d first recast the question as “…impacting… more sustainable products and processes?”

Policy Challenges:

– the inability to force generation and sharing of perfect information both for practical and proprietary reasons.  How do you determine what information is “enough”?

– value differences among stakeholders.  How do you weight EHS/social/economic costs and benefits?

– lack of understanding and appreciation for systems/life cycle thinking over the long term (by politicians and business and the general public)

– difficulty in communicating uncertainty and risk

– the need to apportion contributions and restrictions for cumulative impacts fairly

– getting consensus on whether “sustainability” is a function of risk or simply inherent hazard of materials. (My bias is that risk has to be a consideration, as there is no product with zero risk.)

Research Challenges:

– understanding the key variables that affect local and global system impacts (preceded by understanding the systems themselves)

– calculating aggregate and cumulative impacts

– how to use representative information for products made and used in different geographic locations (when to use what default assumptions)

– all the challenges in conducting risk characterizations and assessment

2. What do you see as EPA’s overall role in addressing these challenges and opportunities?

– educating the public on ecosystem/resource life cycle impacts

– improving communication of risks

– develop tools to understand and characterize local impacts at each stage of a life cycle.

– such tools could then be used by participants in a product’s supply chain and would help the product manufacturer design better processes, sourcing, products and risk management processes.

– develop tools for the agency to conduct aggregate and cumulative impacts assessments.

– EPA can act as a convener for stakeholders to apportion contributions to cumulative impacts.

I can’t see that a company can deal with cumulative impacts outside of its own products. Cumulative impacts by definition will involved multiple industries, agencies and interest groups across multiple locations.  As EPA has experienced with TMDLs for large water bodies, this is incredibly difficult scientifically and politically where the interests of a wide array of local entities need significant input on who can contribute how much to maintain safe levels.  Compound that difficulty by broadening the scale to nationally or globally acceptable contributions across all media, all chemical uses, large numbers of jurisdictions and the political and technical challenges.  Managing cumulative and aggregate impacts can only be resolved by extensive dialogue among stakeholders.  Perhaps EPA can bring government, business and NGO stakeholders together as a facilitator.

3. In particular, how do you see EPA’s role in:

Assembling information and databases.

– A logical EPA function. The need is also global, so working with other international organizations – UN, OECD, EU – would help to avoid duplication.  The data has to be maintained and subject to rigorous data quality management and well-qualified as to local applicability so that it will be used appropriately in decision-making.

Identifying sustainability “hotspots” and setting product sustainability priorities.

– Insofar as EPA develops a better view of cumulative impacts, it is appropriate to call out “hotspots” or products and processes that have significant inefficiencies and environmental and health adverse impacts.  However, I don’t think EPA is necessarily equipped to deal with the social and economic impacts (pro and con) that also are a necessary part of meeting sustainability goals. EPA has a responsibility to describe potential risks accurately and to focus its role on scientific characterization, as opposed to social acceptability.  EPA can also identify the tools it has available to manage risks through regulatory authorities.

Evaluating the multiple impacts of products across their entire life cycle.

– It is not feasible for EPA to evaluate total life cycle impacts on all products.  Preferably, EPA will develop useful models for individual companies and agencies to use on priority products.   EPA risk management proposals should address those areas where exposure is of concern at points within the life cycle (with total ban on production as a last resort).

Defining criteria for more sustainable products.

– Yes, as commented in #2 above.  The criteria need to be both relevant and reduced in number to as manageable a set of parameters as possible.

Generating eco-labels and/or standards.

– It is not clear that EPA should develop capabilities to evaluate any and all product categories that exist and will exist for the multitude of criteria that exist around the “sustainability” arena. EPA is already hard-pressed to deal with individual pollutant standards without trying to keep up with the ever-changing US industrial, commercial and consumer marketplaces. Even the Energy Star program has shown strains on EPA and DOE keeping up with improving technology and validating claims.

–  EPA should narrowly define product areas only where there is a critical need for nationwide consistent standards that address key environmental concerns and work with other federal agencies to set standards.  EPA should carefully analyze the issues it has in dealing with automobile mileage standards and Energy Star to determine whether those programs are working as intended and what characteristics the product categories and markets have that make them amenable or not to a government operated national standards effort as opposed to 3^rd party standards and certification. Factors such as standardized testing reliability and capability, defined products categories that are fungible, consumer understanding, value of the metric within the context of sustainability goals, market size and variability, etc.

– DfE has been successful in bringing highly motivated stakeholders together to identify and give recognition for safer product designs. I also support improving DfE’s credibility through auditing/certification of claims.  The way EPA has acted as a convener to achieve consensus has been valuable and should continue at some level for product categories where industry wants to collaborate.  However, I do not believe it appropriate for EPA to evolve a more general “green” labeling program.  Non-government activity exists and is proliferating.  Let it. The staff to resource such an ongoing effort would pull away from  core areas where only EPA can perform – regulations and research.

Establishing the scientific foundation for these eco-labels and/or standards.

– Yes, as it would contribute to internal and external programs and is part of understanding life cycle impacts of concern.

– EPA may well be suited to validating 3^rd party standards as appropriately using EHS criteria and metrics.

Verifying that products meet standards

– As stated above, I do not see it feasible for EPA to staff up to be able to review all products making claims.  EPA resources would be better spent accrediting the standard makers.

Stimulating the market.

– Allowing labeling for DfE compliant products is good.

– Providing consultation to federal government procurement may be appropriate, but I do not see it a priority for EPA to maintain resources to be able to catalog all acceptable “sustainable” products.  Rather, resources can be devoted to validating the merits of various 3^rd party standard metrics.

Developing end-of-life management systems (reuse, recycling, etc.).

– EPA should work on modifying regulations that support such systems as opposed to creating and dealing with the logistics of managing them.

– EPA can develop necessary components and considerations (e.g., life cycle impacts) that should be used by developers of end-of-life management systems.

Measuring results, evaluating programs.

– EPA can review and comment on 3^rd party standards programs for whether they are scientific validity and result in appropriate characterization of life cycle environmental and health impacts of products.

– EPA’s primary mission “to protect human health and to safeguard the natural environment — air, water and land — upon which life depends” requires the ability to evaluate the state of the US environment and to identify trends that may show progress or need for further attention.  Highlighting both success and challenges will encourage continued product redesign and invention to assist progress toward sustainability.

Missing from the above list is the EPA role of developing and continually improving education around sustainability concepts and tools.  The audience should be broad-based:  the public, government at all levels, academia and business.  EPA should work with the broad array of stakeholders who are engaged in education efforts around sustainability.

Read Full Post »

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.

Read Full Post »

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).

Read Full Post »

How Safe is…?

Do we really know how to decide what is safe? Are assumptions on the “data” we use to declare something safe or not valid?

Check out this article in C&EN on “How to Define Safe Water”: http://bit.ly/dk0i20

We have to check and re-check the assumptions we make when we make “scientific” declarations.  Bisphenol-A:  is it or isn’t it the cause of every adverse effect (including obesity) just because we can detect minute levels?  I don’t know.  Let the arguments continue – but make sure the best science is being done and reviewed.  Don’t let the uninformed emotion or administrative ease be the only basis for “the answer.”

PS – check out http://www.psychologytoday.com/blog/how-risky-is-it-really for great blogs on risk perception.

Read Full Post »

How Sustainability Fuels Design Innovation – The Magazine – MIT Sloan Management Review

How Sustainability Fuels Design Innovation – The Magazine – MIT Sloan Management Review.

I like this article.  It lines up nicely with my view of product stewardship and life cycle management – we can make products better by thinking of the systems they are part of and how we can better use and handle the materials we make products from and the energy and other resources involved in our processes. See my website for my articles on the topic and other posts on this blog.

It did make me wince to read how he refers to “toxins” – the guy is not a scientist, obviously.  The issue is still basically his theme of materials (chemicals) management.  If we manage materials right we can reduce risk by either reducing hazard or exposure.  If we design products so that everyone in the supply chain can maintain control over chemicals and keep them in the loop for efficient recycle and reuse, we reduce exposure and advance sustainability. (I also don’t think just the product manufacturer can do it all. It takes the whole supply chain down to users and ultimate disposal as well as the governing systems and infrastructure support to work together and share responsibility.)

I also agree that we don’t need to do formal life cycle assessments before we do things and we don’t need to make the perfect product (so there, California).  Instead, if we focus on how continually to knock down significant problem areas we will design better and better systems.

As I’ve said elsewhere on this blog site – sustainability is not an endpoint.  I don’t think there is such a thing as a “sustainable product,” but I do think we can design sustainably.

Read Full Post »

California Safer Consumer Products Alternatives Proposed Rule

California continues to forge ahead with a new complicated regulation intended to eliminate the use of toxic chemicals in products and ensure that alternatives are safer: Safer Consumer Products Alternatives Proposal

First, it’s still misnamed.  It’s not just consumer products, it’s every product that ever was or will be in the state, except for industrial intermediates and R&D.  Looks like exports of Christmas presents to my siblings are still at risk (see previous post: http://wp.me/pzzO5-5a).

Basically, the proposal would allow DTSC to bring product commerce to a halt or, rather, to take over production decisions as they guide companies through the approval process for what chemicals can be in products.  Mostly that’s only for products that show up on the “Products Containing Priority Chemicals” list. Those priority products will trigger mandatory full-blown, professionally produced life cycle assessments of both the existing product and any alternative chemicals to be substituted.  And there must be a plan to find safer alternatives, along with regulations to ensure life cycle management until the alternative is in place.  But wait, that’s comes only after a few other hoops:

Listing “Chemicals Under Consideration” come first.  These will be chemicals that have any shape or form of physical, chemical, toxicity or ecotoxicity properties anyone has ever  thought of (I exaggerate – I don’t see “color” on the list, but the list is only illustrative).  DTSC also “may” consider the factors related to the extent of exposure.  Presumably, DTSC will be coming up with its own chemical list, but the agency also has to respond to petitions to add chemicals.  (It’d be easier to come up with a list of chemicals not under consideration.)  Oh, wait, there is a condition prohibiting listing if every portion of the life cycle is adequately regulated by the feds or the state.  Who is going to believe that?

Once this list is published as final (after public comment), it triggers potential reporting of pretty much anything DTSC wants by anyone who touches a product containing a “chemical under consideration” throughout the supply chain (even my sister if she decides to give my white elephant gift to someone else to use, unless we have a contract that says she can’t). Product composition, markets, properties, analytical methodologies, you name it that DTSC would need to proceed to creating the “Priority Chemicals” list.  The agency can even send requests to out-of-state chemical manufacturers and request info and, since they have no jurisdiction over such companies, DTSC will put up an online dirty-no-goodnik list of non-cooperating companies and their chemical products on a “Failure to Respond List.”

And for those of you trying to avoid getting on the Priority Products list by substituting out (or even reducing the amount of) the “chemical under consideration,” you’ll still have to file a Tier I Alternatives Assessment and a “removed” form.  At least it isn’t a professionally created life cycle assessment.  But it’s close, as you need to explain the relative reduction in adverse health and/or environmental impacts.

So after collecting whatever data it needs on who knows how many “chemicals under consideration,” DTSC will come up with a list of “Priority Chemicals” based on the relative degree of threat to health or the environment, the reliability of the data (won’t that generate interesting comments) and, most importantly, the availability of DTSC resources.  The list is mandated to include carcinogens, reproductive toxins and EPA PBTs.  That ought to keep them busy enough without adding more, but petitions will be hot and heavy.

Priority Chemicals will drive listing of “Products Under Consideration” followed by “Priority Products.”  Both sets will go through public notice and comment, but you have to believe even the proposed PUC is a black list.  DTSC can look at factors that would mitigate exposure in setting under consideration and priority products and companies can file certification of removal or reduction of the priority chemical from their products (along with the Tier I Alternatives Assessment) to get off the list.  There’s also a de minimis level  – 0.1% or lower if there’s a regulatory level (e.g., MCL), but you have to submit proof it applies.  If your product still has a Priority Chemical 60 days after the final list is published, you are in for a world or work:  filing a Tier II Alternatives Assessment work plan (and then do it) to find or argue why you can’t find a safer alternative. These must be conducted by an accredited assessor and essentially are full-blown life cycle assessments.  In addition, you’ll need to have an end-of-life management program as long as a priority chemical is present.

I think DTSC is hoping that consortia and trade associations are going to do  assessments and maybe consolidated reporting on chemicals and product categories to cut down on the cost and paperwork.  Otherwise, the entire supply chain is going to be doing duplicative reporting.  Regardless, there will be an avalanche of demands upstream and downstream to figure out who’s got what chemicals and who’s covering which products.  Not to mention retailers refusing to sell products with chemicals under consideration and, for sure, priority chemicals.

Small businesses (<$1 million in sales) – never fear.  DTSC will provide consultation (for a fee).

After going through all the Tier II assessments, DTSC has to decide what regulatory response if any it needs to take on priority products.  This can go from nothing to a complete ban on the use of a priority chemical and recalls.  At least the proposal will allow public notice and comment on the proposed regulation.  Any retailers of the product must be notified of the regulation by the responsible entity.

Timing: in theory, it will begin with the proposed list of Chemicals Under Consideration in June 2011, and the first set of Priority Products by December 2013.

The only way this is going to conceivably work is if DTSC is starts very slowly in selecting Priority Products it lists – like 1 – 5 narrow categories of products.

Comments on the proposed rule are open until Nov 1, 2010.

Read Full Post »

Landfill Delay by Mark Adams

My brother is an artist, doing his part to reuse paper products: here

Read Full Post »

Greener Chemicals and Processes Standard Proposal

I’m on the joint committee that developed the following proposed standard on “greener” chemicals and processes.  Our intent is to have a standard that can be used by customers of chemical manufacturers to decide who has the “greener” chemical and process.  This is an information standard and does not weight any of the metrics per se, so no total “green score.”  That would be left up to customers. Your comments would be greatly appreciated!

The American Chemical Society, Green Chemistry Institute and NSF International would like to announce the ANSI public comment period has opened for the Greener Chemicals and Processes Information Standard, NSF/GCI 355.  You may view the draft and submit your comments via the link below:

http://standards.nsf.org/apps/group_public/document.php?document_id=9409>http://standards.nsf.org/apps/group_public/document.php?document_id=9409
(Please only comment on the most recent version of the draft)

Consider the standard both as a chemical manufacturer who would claim conformance and as a customer who would look at the information on raw materials. (We started with the chemical transformation life cycle stage and hope to extend the concept to upstream extraction and downstream formulation and fabrication later.)  We ask that you provide feedback specifically on the following items:

1. Chemical Characteristics, section 5 – which are unlikely to have data for most chemicals?
2. Process Mass Efficiency (PME) calculation – ease of use
3. Energy derivation and calculation
4. Inclusion of bio-based input
5. Inclusion or exclusion of Social Responsibility section 7
6. Additional guidance you would like to see provided – calculations, examples, reporting format, algorithms for scoring, etc.
7. Would you use it? If not, why?

The public comment period closes November 16, 2010.

Read Full Post »

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.

Read Full Post »

11 Possible New REACH SVHC Candidates

Chugging right along, ECHA is seeking comments on adding the following 11 chemicals to the Substances of Very High Concern Candidate list.  Pre-candidates (no action needed yet):

Trichlorobenzene isomers

Cobalt(II) compounds: sulfate, dinitrate, carbonate, diacetate

2-Methoxyethanol

2-Ethoxyethanol

Chromium trioxide

Acids generated from chromium trioxide and their oligomers

See http://echa.europa.eu/consultations/authorisation/svhc/svhc_cons_en.asp

Read Full Post »