EPA TSCA Revision: Casey at Bat

This week, DuPont publicly supported a bipartisan update to the Toxic Substances Control Act or TSCA. This comes only hours after the Chemical Safety Improvement Act was introduced by Senators Frank R. Lautenberg and David Vitter and numerous Republican and Democrat cosponsors.

Swinging for fences… or benches?

The latest attempt to reform chemical management in the United States is not a grand slam home run for the reform team. It’s definitely a compromise compared to the Safe Chemicals Act update that Lautenberg proposed about a month ago. This is called the “Chemical Safety Improvement Act of 2013.” And guess what? The chemical industry likes it! Hey Mikey!

Ken Cook, president of the Environmental Working Group, says the compromise bill fails to give the US Environmental Protection Agency (EPA) firm deadlines or enough funding to review potentially harmful chemicals, and that it doesn’t do enough to protect children and other at-risk populations. The provisions, he said, “make sense for the chemical industry, not kids.”

But Richard Denison, senior scientist at the nonprofit Environmental Defense Fund, has a different point of view. “While this bill isn’t perfect,” he said, it’s a policy and political breakthrough and opens a bipartisan path forward to fix a law that needs a major overhaul.”

Denison went on to say that The Tribune series was a big wake-up call for America, and “there are costs to be paid for a broken system.”

Chemical Safety Improvement Act of 2013 is here. It came suddenly, a surprise to many. It may not be the sweeping reform some environmentalists were hoping for. But what it does have is bipartisan support, which is refreshing to say the least.

As explained by the Washington Post, the Lautenberg-Vitter “Chemical Safety Improvement Act of 2013? would give the EPA new tools such as:

  1. The EPA would review all actively used chemicals and label them as either “high” or “low” priority based on their potential risk to human health and the environment. The agency would then subject high-priority chemicals for further review
  2. Regulators would no longer have to go through a long, protracted rule-making process to get information from companies about their chemicals
  3. The EPA will also have greater flexibility to take action on chemicals deemed unsafe, ranging from labeling requirements to outright bans on things like asbestos

Heavy hitters  “DuPont strongly supports TSCA modernization, and we believe that successful reform requires this sort of bipartisan approach,” said Vice President and Chief Sustainability Officer Linda J. Fisher.

Cal Dooley, president of the American Chemistry Council, commented that this “constructive, balanced proposal” wasn’t perfect, but was a step up.

This may not be bases loaded with Casey at the bat, but even a solo home run would be better than a never-ending partisan stalemate tied at zero. There’s reason for enthusiasm. But, in the words of Joe Walsh, we’ll be taking it play by play.

Why the ISO 14001 revision?

The most widely used Environmental Management System (EMS) standard in the world is the ISO 14001:2004. Over a quarter-million businesses use it worldwide. It was first published in 1996 with a notable update in 2004.

A new and significant revision is underway. It’s expected to be released in summer of 2013 – first draft. Target for final publication is 2015.

Why businesses use ISO standards  A standard is technically a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. In other words, quality. A standard is a practical guide and an ideological benchmark against which to measure systems or products or both. Ideally, ISO standards help assure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors, and increasing productivity. The ISO 14001 EMS standard specifies a process for the control and the continuous improvement of an organization’s environmental performance. The standard encourages a strategic approach to an organization’s environmental policy, plans and actions. A strategic approach is always a good idea.

Why the revision to ISO 14001?  The revision of the ISO standard for Environmental Management Systems (EMS) incorporates a change in document structure. That’s pretty much it. Specifically, there are changes in clause hierarchy, including the nesting area of many subclauses. The adjustments reflect a new universal structure — a standard if you will — recently approved for implementation across all next-generation ISO standards. Best way to approach this new ISO 14001 document is to absorb the new structure. Be mindful that any current processes or products that are ISO 14001:2004 compatible will remain acceptable under ISO 14001:2015. There is no need to rush out and start making changes. However, keep an eye on shuffled clauses in the documentation, as with the following:

Requirements for an EMS will be organized into Clauses 1 – 10:

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Context of organisation
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement

From the intelligence we’ve gathered, there is nothing Quality Professionals need to do differently to remain in compliance with the standard revision. But it might be time to familiarize ourselves with the new structure, and if not today, then bookmark this page for reference later on.

REACH Review Published

So, after 5 years of REACH regulation, what is the public perception of chemicals in Europe?

The European Commission ran a “Eurobarometer” survey on the public perception of chemicals. The target sample size in most countries was 1,000 interviews. In total, 25,557 interviews were conducted.

According to the survey, citizens are generally well aware of the wide application of chemicals. 61% of Europeans say that chemicals on the EU market today are safer than 10 years ago. Furthermore, 69% of Europeans consider chemicals unavoidable for their daily life and 75% relate them to industrial innovations.

More than half of the respondents agree that chemicals can help reduce the use of natural resources. Nevertheless, only 43% of respondents agree that chemicals can contribute to a better environment. In general, Europeans are split on who’s ensuring the safety of chemical substances, thinking it’s either industry who’s responsible or public authorities. Come to think of it, it’s fair to say many insiders are confused about that too!

Chemicals in Europe are safer under REACH. All this because on Feb. 5, ECHA released the published version of the 5-Year REACH Review.

ECHA is saying that the use of chemicals in Europe has become considerably safer since the REACH regulation entered into force. More readily available information about chemical substances on the market and better targeted risk management measures mean that risks from substances registered under REACH have significantly decreased. This trend is expected to continue as industry continues to work towards finding substitutes for the most hazardous chemicals.

Five years after REACH’s entry into force, companies have now registered 30,601 files with the European Chemicals Agency (ECHA), describing the uses and properties of 7,884 chemical substances manufactured or placed on the market.

Public opinion is still warm towards REACH and its effects, according to that Eurobarometer survey published today, mentioned above.

The REACH 5-Year Review upshot. The review concludes that while some adjustments are needed, no major overhaul is required. The main points to consider are as follows:

  1. The report makes recommendations to improve REACH implementation. These include improving the quality of registration dossiers, enhancing intelligent safety data sheet management as a central risk mitigation tool, and addressing issues related to cost sharing within Substance Information Exchange Forums (SIEFs).
  2. The report calls strongly on industry to improve the quality of dossiers submitted. Based on evidence gathered by ECHA relating to the identification of substances and determination of “sameness,” the Commission services will consider options to improve the situation, including legal measures.
  3. The Commission rules out any dramatic changes to the regulation of nanomaterials in the EU in 2013.
  4. There is insufficient information to decide now if certain types of polymers should be registered so no action is expected in 2013.
  5. There are no major overlaps with other EU legislation.
  6. Considerable  efforts to develop alternative methods to animal testing have been made and will continue:  since 2007, the Commission has made available € 330 million to fund research in this area.
  7. Enforcement could be improved. As this is the responsibility of the Member States, the report recommends that Member States reinforce coordination amongst them. See previous blog post on REACH penalties.
  8. Although the report identifies a need for some adjustments to the legislation, the EC wants to ensure legislative stability and predictability for European businesses. No changes to REACH’s main terms are proposed at present.
  9. The report recommends reducing the financial and administrative burden on SMEs in order to ensure the proportionality of legislation and to assist them to fulfil all their REACH obligations.
  10. To promote the competitiveness of the European chemical industry, the Commission will soon propose to reduce registration fees for SMEs.

Next steps. There are a few itemized next steps already moving forward:

  1. The Commission will discuss the outcomes of the REACH review with the Member States and stakeholders.
  2. In cooperation with Member States and ECHA, the Commission is developing a roadmap to assess and identify substances of very high concern (SVHC). It will set out clear milestones, deliverables and the pision of work between the Commission, Member States and ECHA to place all relevant SVHC on the candidate list by 2020.
  3. The Commission will also look into greater fee reductions to SMEs to spread the financial impact of registration more evenly.
  4. The next deadline under the REACH regulation is 31 May 2013, by when industry must register all phase-in substances manufactured or imported in the EU at or above 100 tonnes a year.

Background. REACH is the Regulation on Registration, Evaluation, Authorisation and restriction of CHemicals. The REACH review examines the overall operation of REACH and the attainment of its unique set of objectives – a high level of protection of human health and the environment, the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.

From 1999 to 2009 the EU chemical industry grew slightly higher than the average rate for all manufacturing sectors, and has largely recovered from the crisis of 2008. The industry generates a positive trade balance and is particularly well-performing in high margin sectors of specialty chemicals. In 2003, when REACH was proposed, the EU was the world’s largest chemicals market with approximately 30 % of global chemicals sales. Today it amounts to about 21 %, with China now being the largest chemicals market. However the EU remains the world’s largest exporter of chemicals and over recent years the industry’s turnover has increased in absolute terms.

Review is here: http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/review2012/index_en.htm

CA Cap-and-Trade: It’s Official

Breaking news: the much-discussed greenhouse gas regulation known as “cap-and-trade” has arrived in the US. Chem.Info online reports that California will now require its biggest greenhouse gas offenders/emitters to start purchasing permits for emissions.

Then, the cap, or number of allowances, will decline over time in an effort to drastically reduce greenhouse gas emissions by 2050.

Almost $1 billion. Roughly 39.5 million allowances are being pre-sold Nov. 14 for 2015 emissions. Roughly 23 million allowances will be sold for 2013 emissions.

The California Air Resources Board or ARB has estimated that businesses will pay a total of $964 million for allowances in fiscal year 2012-2013.

CA cap-and-trade  The program addresses refineries, power plants, industrial facilities and transportation fuels. The regulation includes an enforceable GHG cap that will decline over time, reports the AP. California’s ARB will distribute allowances, which are tradable permits, equal to the emission allowed under the cap. The ARB will monitor the program as well.

This “cap-and-trade” system is designed to do four things:

  1. control emissions of heat-trapping gases
  2. spur investment in clean technologies
  3. show that cap-and-trade can be done in the world’s ninth-largest economy
  4. provide a blueprint for other governments, nations and (inevitably) US states to follow

For the first two years of the program, large industrial emitters will receive 90% of their allowances for free. The gentle start hopes to give companies time to reduce emissions through new technologies or software-driven analysis and process improvements or other means.

Environmental laws seem to start in California and trickle eastward.  (Remember how people used to smoke cigarettes in New York City?)  So mind the cap

ECHA Modifies REACH Tonnage Calculations

In REACH news, the European Chemicals Agency (ECHA) has modified its methodology for calculating “total tonnage” bands. Make a note of it if you haven’t already.

The shortcomings in the legacy calculation methodology, ECHA is saying, arose from the fact that the REACH Regulation is based on the concept of legal entities rather than companies. To make a long story short, in some situations the old way could lead to involuntary disclosure of confidential business information.

So the agency has decided to modify the envisaged methodology for calculating aggregated tonnages.

The modification removes the “four registrants rule” before publication of tonnage band data on the ECHA website. As it was, the tonnage data— claimed confidential by a given registrant— would still be included in the calculation of aggregated tonnages if there are four or more registrants in a joint submission. This would threaten the Confidential status.

Tonnage amendment already in place  The publication of tonnage bands on ECHA’s registered substances database that took place for the first time in June.  Repeat: ECHA already took the modifications in the calculation method into account.

The “total tonnage band” is published together with other substance-specific information on ECHA’s website.

Total tonnage bands will be displayed for substances on ECHA’s registered substances database from those listed in the following table:

Table source: courtesy ECHA


Tonnage data will be extracted from the latest disseminated dossier of each full (non-intermediate) registration, aggregated, converted to a total tonnage band, and published on ECHA’s registered substances database. The total tonnage bands will be published for joint submissions and for inpidual submissions. Tonnage data will not be extracted from dossiers for intermediate registrations under REACH Articles 17 or 18. Tonnage data will also not be extracted from dossiers for full (non-intermediate) registrations where the tonnage band is claimed to be confidential in accordance with REACH Article 119(2)(b).

Claiming confidential Registrants have had the facility to claim their tonnage band confidential in accordance with REACH Article 119(2)(b) since June 2008. If registrants have not done so but wish to claim confidentiality for their tonnage band, they should submit an updated dossier with a confidentiality claim on the tonnage band as soon as possible.

For confidentiality claims under REACH, please note that the claim must be justified in accordance with Data Submission Manual 16, and will attract a fee. Confidentiality will only be granted where the claim is accepted as valid by ECHA. Notably, tonnage data will not be extracted from dossiers where the tonnage band is claimed confidential while the confidentiality claim is under assessment.

EPA to Require Companies to Report ‘All Uses’ of PBDEs, HBCD

Printing companies, paint and coatings companies and those using flame retardants in manufactured goods should take note: The US Environmental Protection Agency (EPA) has proposed that companies be required to report to EPA all new uses — including in domestic or imported products — of five groups of potentially harmful chemicals:

  1. polybrominated diphenylethers (PBDEs)
  2. benzidine dyes
  3. a short chain chlorinated paraffin
  4. hexabromocyclododecane (HBCD)
  5. phthalate di-n-pentyl phthalate (DnPP)

The agency is also proposing additional testing on the health and environmental effects of PBDEs.

Although a number of these chemicals are no longer manufactured or used in the U.S. they can still be imported in consumer goods or for use in products,” said Jim Jones, EPA’s acting assistant administrator for the Office of Chemical Safety and Pollution Prevention. Over the years, these chemicals have been used in a range of consumer products and industrial applications, including paints, printing inks, pigments and dyes in textiles, flame retardants in flexible foams, and plasticizers.

The idea appears to be largely one of protecting American consumers from international supply chains with — shall we say — different ideas about the hazards of chemicals in these 5 groupings.

The proposed regulatory actions are known as significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA). The proposed rules would require that anyone who intends to manufacture, import, or process any of the chemicals for an activity that is designated as a significant new use to submit a notification to EPA at least 90 days before beginning the activity. This notification means EPA can evaluate the intended new use and take action to prohibit or limit that activity, if warranted. For PBDEs, the agency will also issue simultaneously a proposed test rule under section 4(a) of TSCA that would require manufacturers or processors to conduct testing on health and environmental effects of PBDEs.

Today’s proposed SNURs were previously identified in action plans the agency issued on these and other chemicals during the last two years.

More:  www.epa.gov/oppt/existingchemicals/ 

Upcoming Chats

SMT process consultant Phil Zarrow’s moderated chat is today at 2pm Eastern.

You don’t need to make the live session in order to ask a question: questions may be submitted in advance.

Future chats will cover data transfer, PCB cleaning, environmental regulations and MSDS tracking, and on March 2 yours truly will take questions on this year’s Apex trade show.

The New RoHS

In RoHS news, the real news is that the RoHS2 is really just RoHS.  We still hear people talking about “RoHS2” and “RoHS Recast”  — and there is simply no such thing:  there is just RoHS.  Yes, there were significant updates to the EU Directive that Restricts Hazardous Substances.  That process occurred over the past year.  Amendments to RoHS have been incorporated into RoHS itself.  So the terms “RoHS recast” and “RoHS2” have no meaning.

RoHS right now. Over the past year, the ban on heavy metals and other dangerous chemicals in electrical and electronic equipment has been extended to a much wider range of products. The changes apply to electronic products such as thermostats, medical devices and control panels.

European Member States have until the end of 2012 to transpose the new rules.  This means most will wait until the last minute (and beyond), but some will not, and to an American mind the order and timing will seem somewhat random.  Since there is no orderly way to hedge your bets here, getting to RoHS compliance in Q1 2012 or (Q2 at the latest) is the path of least risk.

The RoHS Directive will continue to ban lead, mercury, cadmium, hexavalent chromium and the flame retardants Polybrominated biphenyls (PBB) and Polybrominated diphenyl ethers (PBDE). The previous RoHS Directive covered several categories of electrical and electronic equipment including household appliances, IT and consumer equipment, but RoHS has now been extended to all electronic equipment, cables and spare parts.  Exemptions can still be granted in cases where no satisfactory alternative is available.

Updates to RoHS.

  •  A gradual extension of the rules to all electrical and electronic equipment (EEE), cables and spare parts, with a view to full compliance by 2019
  •  A review of the list of banned substances by July 2014, and periodically thereafter
  •  Clearer and more transparent rules for granting exemptions from the substance ban
  •  Improved coherence with the REACH Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals
  •  Clarification of important definitions
  •  CE marking denoting compliance with European norms reserved for electronic products that also respect RoHS requirements

In view of the significant extension of the scope, the new Directive introduces transition periods of up to 8 years for the new products affected by the rules.

Photovoltaic panels are exempted from the new Directive in an effort to help the EU reach its objectives for renewable energy and energy efficiency.  Also included in the new RoHS is a mechanism to make it easier for the Commission to monitor compliance.

RoHS2 background. The revision was launched in 2008. Agreement between the European Parliament and the Council was reached in 2010 and the Directive was adopted in June 2011. Member States have 18 months to transpose the Directive. Until then, RoHS I continues to apply.

Detailed information can be found in the directive here.  See also the Europa.eu site on waste and RoHS.

RoHS is a directive, not a regulation:  A directive is about results, not process.  With RoHS for example, the required result is the restricted use of certain toxic metals in electronics manufacturing & in related disposal and waste.  A regulation, on the other hand, delineates how to get the result, a good example being the REACH regulation, which contains a detailed process for substance registration, use, and data sharing.

This blog is hesitant to recommend specific consultants for RoHS compliance.  However, some software for RoHS compliance such as Material Disclosure from Actio Corp., is worth looking at for RoHS compliance.

EPA Finds More Time for Glymes

There’s now an extension of time allotted for comments on glymes.

In July, the US Environmental Protection Agency (EPA) issued a proposed rule in the Federal Register concerning a proposed significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 14 glymes.

EPA’s list of 14 glymes is here for view or download, in an article written by one of the preeminent Professional Chemical Engineers in the field, Kal Kawar.  The article is called “The Worst of Glymes” (who says chemists can’t be funny?).  This list is easier to read than anything on the EPA site.

Since publication of the proposed rule, EPA has received a request for additional time to submit comments. Now, EPA will extend the comment period for 30 days, from September 12, 2011 to October 12, 2011.

Deadlines for comment: Comments, identified by docket identification (ID) number EPA–HQ–OPPT–2009–0767, must be received on or before October 12, 2011.

In the Federal Register of July 12, 2011 (76 FR 40850) (FRL–8877–8), EPA proposed a SNUR for 14 glymes, designated proposed significant new uses for the 14 glymes, and asked for public comment on several topics. EPA requested comment on whether any of the chemical substances included in the identified glyme category are sufficiently dissimilar from the rest such that they should be removed from the category, or whether any additional chemical substances are sufficiently similar such that they should be added to the category. Comments were also requested on whether any of the additional unconfirmed uses listed in the proposed rule are actual ongoing uses in a consumer product, and whether there are any other ongoing uses in a consumer product of the other chemicals listed in the SNUR.

For further information, see the contact names in the Federal Register here.

Carbon Disclosure, Meet Plastics Disclosure

Environmental Leader and the New York Times are reporting that hundreds of companies and institutions should expect to receive a questionnaire in early October about their use of plastic. The Plastic Disclosure Project, right ahead.


Industry estimates state that 300 million tons of virgin plastic are made every year. If just one percent can be saved through efficiencies, better design, or increased recycling, then 3 million tons could be saved, which is roughly what some conservative estimates say are floating in the middle of the Pacific Ocean. -Plastics Disclosure Project (PDP)

Some companies have already made progress in better managing plastics.  Electrolux, the Swedish appliance maker, for example, introduced a range of vacuum cleaners in February that are made from recycled plastic. Coca-Cola has devised a plastic bottle that contains some plant-based materials, a small step for which the soda company seems to be wringing significant PR traction.

Most interestingly perhaps, as the New York Times points out, Procter&Gamble has the long-term aim of using 100% recycled or renewable material in its products and packaging.

Better managed plastics appeals to some of us as a resource-saver if nothing else — for too long we’ve treated plastic as an almost-infinite supply of cheap material, both raw and article.

Remember the Carbon Disclosure Project — which is not gone but currently forgotten?  Well, this plastics program seeks to inspire organizations to approach plastic consumption in much the same way as we’ve begun to approach carbon consumption:  more awareness, some conservation.  Fair enough.

Targeted big users of plastic include:

  • companies
  • universities
  • hospitals
  • sports groups

This October, the plastics questionnaire will ask organizations to report how much plastic they use and how they recycle.  Further, organizations will be asked what policies they have to:

  • reduce consumption
  • increase recycling
  • increase the use of biodegradable plastic

Plastic Disclosure blog is here, if interested.