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ACC PM test 19/6/17

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LCSA News

(ACC Mentioned) Controversy Continues on EPA's Stance on New Chemicals
Jun 19, 2017 | Chemical Watch

In implementing the amended TSCA, the EPA has apparently turned its default assumption toward new chemicals upside down, interpreting it as requiring the agency to block manufacture in the absence of definitive evidence that a substance is safe rather than allowing it to proceed unless there is evidence of potential risk.
Robust New Chemical Reviews 'Vital' to Restoring Confidence in TSCA
Jun 19, 2017 | Chemical Watch
By Richard Denison

Imagine a chemical safety system where the government gets notice of a new chemical prior to its manufacture, but can’t require any health and environmental data in the notice and, in the absence of enough information to evaluate potential risks, it must allow the chemical onto the market without any conditions or testing.
REACH Revolution at a Crossroads
Jun 19, 2017 | Chemical WatchM
By Mamta Patel

Businesses are currently preparing to register their substances in time for the third and final REACH registration deadline on 31 May 2018. This milestone marks the end of the ‘phase-in’ period – the time allotted by the Regulation for businesses to register substances that were already on the market when the law was adopted in 2006.
TSCA: Nullify This Hypothesis
Jun 19, 2017 | Chemical Watch
By James Conrad Jr.

The big surprise, since last June’s rewrite of the Toxic Substances Control Act (TSCA), has been the paralysis gripping the EPA’s new chemicals programme.
EPA Preparing State Guidance on TSCA Trade Secret Information Sharing
Jun 19, 2017 | Inside EPA

EPA is preparing a guidance document for states listing the security and policy requirements necessary to protect confidential business information (CBI), requirements that states will have to meet to be able to receive information about chemicals from EPA as outlined in changes enacted in the Toxic Substances Control Act (TSCA) last summer.

Chemical Management News - There are no clips to report at this time.

Masse 'Declares Victory' as Canada Moves to Ban Microbeads
Jun 19, 2017 | CBC

Windsor West MP Brian Masse is declaring victory over microbeads.

Energy News

(ACC Mentioned) Ethane Storage Hub May Bring Investment
Jun 19, 2017 | The Weirton Daily Times
By Casey Junkins

U.S. Sen. Joe Manchin represents West Virginia, but he’ll gladly share $36 billion worth of potential capital investment with Ohio, Pennsylvania and Kentucky — which could become reality if any of these states can land an ethane storage hub.
Chevron Phillips Chemical Wraps up Construction on Old Ocean Polyethylene Units
Jun 19, 2017 | Houston Chronicle
By David Hunn

Chevron Phillips Chemical Co. has finished building two polyethylene units in Old Ocean, southwest of Houston, a “major milestone” in its $6 billion petrochemical expansion along the Gulf Coast.
Fracking Impact? Here's What We Need to Know, Says Elite Texas Shale Task Force
Jun 19, 2017 | Dallas News
By Jeff Mosier

Texas' role as a petroleum powerhouse started with the famed Spindletop oil gusher near Beaumont in 1901. But 116 years later, there's still uncertainty about the industry's impact on the state's people and environment, according a new study released today.

Chemical Security News

Shell Executive: Safety of Workers, Contractors at Forefront of Cracker Project
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Transportation News

Wisconsin US Senator Introduces the Rail Shipper Fairness Act to Reduce Costs and Improve Service
Jun 19, 2017 | RISI Technology Channels

U.S. Senator Tammy Baldwin introduced legislation to address challenges faced by Wisconsin businesses when shipping by rail.
Marcellus Gas Industry Battles State Plan to Regulate Methane
Jun 19, 2017 | E&E Energywire
By Mie Lee

Almost 18 months after it was announced, Gov. Tom Wolf's plan to curb methane emissions from Pennsylvania's natural gas industry is moving slowly.

Environment News

Energy Chief: Carbon Dioxide Not Prime Driver of Warming
Jun 19, 2017 | AP (In The New York Times

Energy Secretary Rick Perry said Monday he does not believe carbon dioxide is a primary contributor to global warming, a statement at odds with mainstream scientific consensus but in line with the head of the Environmental Protection Agency.
The Energy 202: California Scores Its First Big Environmental Victory of the Trump Era
Jun 19, 2017 | The Washington Post
By Dino Grandoni

Between the very little Attorney General Jeff Sessions was willing to say about his conversations with President Trump and the essentially nothing Senate Republicans were willing to say about their health-care bill, there was one revealing bit of testimony on Capitol Hill late last week -- from Environmental Protection Agency Administrator Scott Pruitt.
Ex-Bush Official Expected to Be Deputy EPA Head
Jun 19, 2017 | The Hill E2 Blog
By Timothy Cama

President Trump is likely to nominate former Environmental Protection Agency (EPA) official Jeff Holmstead to be the agency’s deputy administrator, Axios reported Monday.

Industry and Association News - There are no clips to report at this time.

LCSA News

(ACC Mentioned) Controversy Continues on EPA's Stance on New Chemicals

Jun 19, 2017 | Chemical Watch

In implementing the amended TSCA, the EPA has apparently turned its default assumption toward new chemicals upside down, interpreting it as requiring the agency to block manufacture in the absence of definitive evidence that a substance is safe rather than allowing it to proceed unless there is evidence of potential risk.
In opinion pieces in this month's Global Business Briefing, advocates on opposite sides of the issue agree on that, but clash on whether this was what Congress intended and on whether it's a positive development.
Attorney Jamie Conrad, formerly an Assistant General Counsel at the American Chemistry Council, argues that the 2016 Lautenberg Act did not intend to shift the EPA's "null hypothesis," and the new regime is slowing the approval process to a crawl and stifling innovation. Meanwhile,Richard Denison, lead senior scientist at NGO the Environmental Defense Fund, contends that the agency is implementing the new TSCA correctly, and it is a long overdue change needed to restore public confidence.
The key TSCA provisions require the EPA to publish an affirmative "determination" that a new chemical is unlikely to pose an unreasonable risk before it can be manufactured commercially and that the agency consider the "reasonably foreseen" uses of a new chemical. The latter provision has essentially eliminated the use of "non-5(e) Snurs," which the EPA used to issue when it determined that the specific conditions of use and precautions described in a PMN would not pose an unreasonable risk, but for which additional uses may be concerning. In these cases, the agency would ‘drop’ the PMN, allowing the substance to be marketed. The new requirement of an affirmative finding has changed EPA's policy to impose consent orders on the original submitter to address potentially foreseen uses, even if they are not named in the PMN.
While "it must now 'determine' that a new chemical is unlikely to pose an unreasonable risk before it can allow unrestricted manufacture," Conrad writes, "the EPA was effectively making that determination whenever it ‘dropped’ its review of a PMN, or lifted an order after submission of needed information. The agency probably gives these determinations more attention now that it has to publish them. But it is not required to make them any differently.
"When EPA 'Lacks Evidence'
Conrad contends that when EPA lacks the evidence to determine that a substance is definitively safe or unsafe under all conceivable circumstances, the agency can "make these determinations on the basis of the weight of the best available scientific evidence."
He argues that impeding the marketing of new chemicals will prevent improved, possibly more environmentally friendly, substances from replacing older ones and could give nations like China an economic and technological advantage.
Dennison, however, concludes that "the EPA’s implementation to date of the changes to new chemical reviews is not only consistent with the new law, but is mandated by it." Moreover, he contends that the current slowdown in approvals will abate once new procedures are established within the EPA and manufacturers adapt by providing more risk data along with PMNs.
https://chemicalwatch.com/56997/controversy-continues-on-epas-stance-on-new-chemicals

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Robust New Chemical Reviews 'Vital' to Restoring Confidence in TSCA

Jun 19, 2017 | Chemical Watch

By Richard Denison

Imagine a chemical safety system where the government gets notice of a new chemical prior to its manufacture, but can’t require any health and environmental data in the notice and, in the absence of enough information to evaluate potential risks, it must allow the chemical onto the market without any conditions or testing.
That was how the US new chemical programme had to operate until last year’s long-overdue overhaul of the Toxic Substances Control Act (TSCA). And it happened all the time. Historically, 85% of pre-manufacture notices (PMNs) lacked any health data. Of 13,400 valid new chemical notices the EPA reviewed between 1998 and passage of the new TSCA, 68% were ‘dropped’ early on typically due to lack of sufficient information. Between TSCA’s enactment in 1976 and 2015, fewer than 10% of the 40,000 PMNs the EPA reviewed saw any condition applied to the chemical’s commercialisation.
Small wonder, then, that the Lautenberg Act – enacted with overwhelming bipartisan support – made significant enhancements to the EPA’s new chemical reviews. Robust implementation of these reforms by the agency is essential to restoring public and market confidence in our national chemical safety system. Yet they are under threat, with some in industry seeking to restore old practices disallowed under the new law and, most recently, with the placement of a former senior industry official in a position to heavily influence implementation of the new requirements. These actions put at risk the fragile shared objective of restoring confidence that allowed disparate stakeholders and lawmakers to come together to support the reforms to TSCA in the first place.
New chemical reviews under old vs new TSCA
Chemical industry representatives have long asserted and continue to assert that the old law’s new chemicals system – which typically required little of them – worked just fine. And they wishfully add that the new TSCA was meant to largely retain the old system. In fact, the Lautenberg Act substantially reformed that process. Among the major improvements were the following, each of which addressed a critical flaw in the original law:the EPA is mandated both to review each new chemical and make an affirmative finding as to its safety (The old law had neither mandate);if the agency lacks sufficient information to make a reasonable evaluation of a new chemical’s safety, it must now issue an order limiting use of the chemical to mitigate any unreasonable risk, until and unless information sufficient for the agency to make an affirmative finding of safety is provided (The old law lacked such a requirement);the EPA must consider and mitigate unreasonable risks of a new chemical under its "conditions of use". In addition to those intended identified in a PMN, the law explicitly defines the conditions of use to include "reasonably foreseen" circumstances of production, processing, distribution, use, or disposal. (Under the old law, the agency generally had to confine any risk finding to the specific uses identified by the PMN submitter – despite the fact that, once in the marketplace, chemicals can be and often are used for additional purposes); andthe new law requires the EPA to protect against potential risks to "potentially exposed or susceptible subpopulations", explicitly including infants, children, pregnant women, workers, or the elderly. (Such a provision did not exist in the old law.)Support in the law for agency action
In implementing these new requirements, the EPA has taken a number of actions. Firstly, it reset the baseline 90-day clock for new chemicals that were already in progress on the date of enactment. Because the new requirements applied immediately, that decision was both appropriate and necessary.
Secondly, the agency has identified a significant number of new chemicals for which it either lacked sufficient information to "permit a reasoned evaluation" or had information indicating the chemical "may present an unreasonable risk". Here it is proceeding – as required under the new law – to impose testing, or other requirements, through an order, typically a consent order negotiated with the company. As was the case under the old law, the time required for negotiating a consent order typically necessitates an extension of the initial 90-day review period.
Thirdly, the EPA has identified a number of new chemicals for which "reasonably foreseen" conditions of use "may present an unreasonable risk" even if those identified by the company as intended do not. Here again, the law expressly requires the agency to issue an order imposing conditions sufficient to mitigate such risk, typically limiting the PMN submitter to its identified intended conditions of use. Congress recognised that, were the EPA only to examine these, it could miss real concerns arising from uses beyond those identified in the PMN.
Some in industry have suggested that, in such cases, instead of issuing an order, the EPA should only promulgate a significant new use rule (Snur), as it sometimes did under the old law. Doing so would not be consistent with the new law, which requires that the mandatory safety finding be made on the PMN itself. Because consent orders apply to the PMN submitter, the agency is also likely to issue Snurs in order to extend its conditions to other companies.
Fourthly, the EPA has identified a number of new chemicals with characteristics that raise particular concern in relation to workers over potential chronic health effects from long-term inhalation exposures. The agency lacks predictive models for such effects and instead relies, where they exist, on data from structurally-related ‘analogue’ chemicals. However, where no such analogues exist or data is insufficient to establish an exposure benchmark, the EPA is requesting that companies conduct additional testing in order to determine whether the chemical is or is not likely to present an unreasonable risk.
The EPA’s actions to mitigate potential risks in workplaces are mandated by the law’s explicit identification of workers as a "potentially exposed or susceptible subpopulation" that must be protected from unreasonable risks.
In summary, the EPA’s implementation to date of the changes to new chemical reviews is not only consistent with the new law, but is mandated by it.
Congressional intent regarding innovation
In pushing back against EPA implementation of the new requirements, some industry representatives frequently argue that the agency’s actions risk impeding innovation and are at odds with the intent of the law. The claim relies on the only reference to impeding innovation found in all of TSCA, in the law’s list of policy intentions. Industry typically paraphrases this provision as saying the EPA should not act in a manner that impedes innovation. But that is a selective account, which reads in its entirety as follows (emphasis added):
"It is the policy of the United States that— authority over chemical substances and mixtures should be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the primary purpose of this Act to assure that such innovation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment."
Given that new chemicals are a clear source of innovation, the only way to provide an assurance that "innovation and commerce in such chemical substances do not present an unreasonable risk" is through robust scrutiny before commercialisation. Congress understood that innovation without safety is not true and effective innovation.The EPA’s progress and need for a longer-term view
Some of the changes being implemented in the agency’s new chemical review process, while required by the new law, are resulting in more orders and longer review times, compared with under the old law. It is important to note that even then orders often led to longer review times; the difference is that the EPA is now pursuing orders in a larger proportion of cases, a change that is directly rooted in the new requirements.
In the past year under the new law, the agency has reviewed about 1,400 new chemical notices – many more than the average of about 1,000 it did annually before. While a temporary backlog developed at the outset, that is now down to below 150 PMNs, far fewer than the hundreds the industry claims. The EPA has recently added staff to the programme, which is already helping to increase efficiency.
Finally, it needs to be remembered that the new law was passed less than a year ago. Over time, we expect that the EPA’s processes will become more efficient and allow, in many cases, for even more expeditious reviews. As the agency firms up its procedures and practices to meet the new mandates, and companies do a better job at providing the information it needs, the process will become smoother for all parties involved.
In the long run, the new law should deliver a structure which serves efficiency. The EPA has made clear that lack of information in PMNs lengthens the review process, so companies should be motivated to provide more at the outset.
They admit that they often lack knowledge of the full range of uses of chemicals they produce, and may have little control over these once those chemicals are in commercial distribution. Hence it is vital – as well as mandated by the new law – that the EPA considers reasonably foreseen uses of new chemicals in making the required safety findings. Companies should incorporate a broader range of conditions of use into their PMNs and provide the agency with the information it will need to evaluate them.
By acting on these strengthened incentives to provide more information and anticipate future uses, companies can better ensure that the enhanced safety review of new chemicals, mandated by the Lautenberg Act, can be achieved without impeding innovation unduly.
The public has a right to expect that any chemical entering the market is reviewed and managed to provide a reasonable assurance of safety. The most efficient and effective stage at which to provide that is before commercialisation, rather than attempting to mitigate risks that arise, after a new chemical is embedded in the market.
The industry needs to recognise that without a strong new chemicals programme, public and market confidence in our nation’s chemical safety system will not be restored.
https://chemicalwatch.com/56946/robust-new-chemical-reviews-vital-to-restoring-confidence-in-tsca

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REACH Revolution at a Crossroads

Jun 19, 2017 | Chemical WatchM

By Mamta Patel

Scientific agency or regulatory agency?
"The idea of REACH was to speed things up," he notes, "but, instead, the way it is implemented in several ways gives perverse incentives to companies to drag their feet ... Companies are rewarded for having submitted poor data by winning more time to comply. Article 5 of REACH clearly states the principle of no data, no market. What happened to that? Echa has to remember it is not a scientific agency trying to collate the best information but a regulatory agency which has a duty to act."
NGOs are pushing the agency to take tougher action with non-compliant firms. In March, a group of 16 European NGOs wrote another collective open letter to Echa’s executive director, pressing the issue of non-compliant dossiers and asking for hard information on the agency’s understanding of which chemicals need to be tackled because their risks are not adequately controlled. In response, Echa invited the letter’s signatories to a meeting with its board on 6 June.
Speaking the following day, EEB’s Mr Wates commented that Echa had told NGOs that it was not prepared to follow a ‘name and shame’ strategy to oust non-compliant firms because it lacked support for such an approach from its wider community. Mr Wates therefore appealed "over the heads of Echa to member states and industry: why should you defend those companies failing to submit responsibly completed registration applications?"
Speaking to industry contacts who have been working with REACH registration since its inception, none denied the data gap but some questioned its significance. One contact from an EU-headquartered chemicals multinational said: "In Echa’s mind there is a clear conviction that registration dossiers are not complete. I don’t think it is a problem because, in any case, we now have an enormous amount of information that we did not before. It is not perfect but my belief is that this is not a matter of lack of interest by industry, it is the simple fact that in the beginning it was always about registration. We did not know how [the system] worked but just made sure the substance got registered."
Indeed, in the days leading up to the first registration deadline in 2010, the prevailing advice appeared to be to submit dossiers first and deal with any issues later. One Echa official characterises that period as companies having spent a lot of time setting up substance information exchange fora (Siefs) and negotiating contracts and, only in the last six months, paying any attention to the information needed in chemical safety reports and to data requirements.
"It’s true that there is a data quality gap," says Erwin Annys, policy director at the European Chemical Industry Council (Cefic), but he remembers the lead up to the 2010 deadline somewhat differently. Speaking at Chemical Watch’s Global Business Summit in Amsterdam in March, he pointed to the scale of the challenge for companies to register – in some cases up to 2,000 substances – under an unknown regime and using untested IT tools through collaboration with competitors in Siefs, which naturally required a lot of legal discussion. This at a time just after the global economic crisis began, sending budgetary shock waves through many companies.
Moreover, he describes how the compliance process fundamentally changed the way many businesses scrutinised and managed chemicals: "In order to comply with REACH it was an enormous amount of work. First you had to find in the company archive everything that had been done in the past. Finding information on how substances were used was a new challenge. We could use technical datasheets to know how substances were intended to be used but many companies have been surprised how widely and differently certain substances are used in practice." These challenges were unforeseeable, Dr Annys argues.
"In the beginning we saw REACH as something static. This is the biggest underestimate made by industry," Dr Annys says. "It is much more holistic than we thought. The biggest error made by compliance teams and company CEOs was that REACH was to be a programme that ran from 2010 to 2018. Registration was seen by many as the end. But it is really the beginning. One example of this is that, even in order to carry out tests to determine hazard properties, you first have to register to submit a test proposal. Then, if you get permission, you can carry out the test. That means the costs are generated later than the deadline and then, depending on the results of that test, it could completely change your safety assessment for that chemical bringing even more activities."
Dr Rainer Otter, vice-president regulatory affairs/advocacy for industrial petrochemicals Europe at BASF, also cites mitigating circumstances for the poor quality of many companies’ dossiers. He notes the inexperience not only in industry generally but also at Echa in the early days. "When you now take all the evidence you have from the guidance documents and put them together over a decade and then look back and read the registration dossiers put together under time pressure more than ten years ago, of course, you will get frustrated. But that is really unfair."
Are companies ever likely to become the good product stewards that Echa is asking them to be – will they proactively revisit their dossiers to convince themselves as well as the agency of the reliability of the hazard and exposure data and the consequent risk assessments they submitted?
Businesses are currently preparing to register their substances in time for the third and final REACH registration deadline on 31 May 2018. This milestone marks the end of the ‘phase-in’ period – the time allotted by the Regulation for businesses to register substances that were already on the market when the law was adopted in 2006.
It also signals the start of the next phase of chemicals management. Over the last decade, an unprecedented amount of information about chemical hazards and exposure has been collected and stored in the databases of Echa. This includes data for 15,000 chemicals that have been registered either as ‘phase-in’ or new chemicals and many more on its classification and labelling (C&L) inventory.
In the coming years, the agency, businesses and other EU – and non-EU – regulators as well as many other stakeholders will increasingly look to this data to find answers to questions about specific chemicals but also to ask about the big picture: what does all this information tell us about the safety of chemicals on the EU market?
Echa has been drawing attention to a problem at its core over several years of annual evaluation reports. And at a workshop earlier this year for authorities and stakeholders, the agency described its attempt to ‘map its chemical universe’ to see what it really knows. Of the 130,000 substances registered under REACH or notified in the C&L inventory, it identified 4,507 based on the following criteria: substances for which at least one higher tier (Annex IX or Annex X) dossier has been submitted (that is, substances produced or imported over 100 tons per annum (tpa)) and NONS substances (that is, that had been notified under the previous EU new chemicals notification regime) that have been registered and updated.
Of the 4,507, it concluded with some confidence that some 1,250 substances could be confidently categorised as high priority substances with likely hazards and likely exposure during use. Many of these are already regulated or there is enough evidence in the dossier or from other sources to indicate that risk management may be needed. More work is still needed to obtain further information for some of these, which could change their categorisation. Taking a conservative approach, for another 200 or so substances there was enough information to suggest they are unlikely to be of significance in terms of hazard and/or exposure.
This leaves some 3,000 substances in what the agency describes as a ‘grey zone’ where it has insufficient information to make a determination about the risks they pose. For two thirds of these, their registration dossiers suggest some exposure is likely but the hazard properties are not clear. Compliance checks and/or substance evaluations are already underway for some 1,350 substances of these grey zone substances to fill the knowledge gaps.Poor quality dossiers
What concerns the agency is that the missing data pertains to knowing how the chemical is used and to some of the most critical long lasting hazard properties – whether or not a substance is a carcinogen, mutagen or reproductive toxin, whether it is persistent and bioaccumulative or has endocrine disrupting effects.
The high rate of non-compliance has been pointed out in other studies too. In three projects running consecutively from March 2014 to January this year, the German Federal Institute for Risk Assessment (BfR) screened 1,814 registration dossiers for high volume (over 1,000 tpa) substances to assess the human health data provided. It found "a high proportion of non-compliant endpoints" for which no conclusion was given – ranging from 47-73%. It further confirmed that there was a great prevalence of industry providing data-waiving arguments instead of test data for complex endpoints – mainly for developmental and reproductive toxicity – but that a high proportion of these arguments were poorly justified.
The inescapable conclusion is that, under the first two REACH registration deadlines, many companies have done a poor job in providing adequate safety data for their substances. Was this deliberate, due to ineptitude or a lack of sufficient guidance at the time? For instance, the Regulation set a very high bar in terms of "animal testing as a last resort", which may have pushed firms into finding alternative test methods before the science was ready for this.
While the lack of data worries Echa and the European Commission, it should also concern the 28 member states of the EU whose job it is to enforce REACH requirements and protect their citizens and environments. And the business community should be angered because it devalues the efforts of companies that have spent substantial resources on getting compliance right.
Speaking in Helsinki in June, several key stakeholders used the anniversary celebrations to congratulate Echa for pulling off a feat in establishing the REACH infrastructure; creating a globally unprecedented database of information in just ten years; and its timely delivery of more than ten IT systems to ensure consistency and stability in chemicals regulation. Moreover, it has won the cooperation of companies in taking part in registration and trade associations in investing in the tools needed to better measure and manage the hazards and exposure of chemicals through supply chains, for example through the European Network on Exposure Scenarios. Risk management measures have been taken for several hundreds of substances.
Stakeholders noted that many had predicted at the outset it could not be done. At the same time a recurrent theme was that the "glass is still only half full".
Echa executive director Geert Dancet "poured cold water on the celebration" himself by noting that there is "still a way to go" to achieve the objective of having enough information on chemicals to manage them safely. He noted that "the detailed work of member states and Echa can only really begin when we have all the data. Only then can regulators judge whether a substance is of concern or not ... At the moment this is not easy to do."Substance evaluation hindered
The agency has put in place a number of dossier and substance evaluations followed by regulatory follow-ups. Companies also have opportunities to appeal decisions at each step. This process ensures a robust approach is taken, Mr Dancet said. But in some cases it can mean that it takes nearly a decade to conclude on a chemical’s safety. "We are thinking how to accelerate this process but, of course, there is nothing to stop companies from taking the right steps acting from corporate social responsibility," he stressed.
Over the last decade, Echa has published a library of guidance and resources on how to provide adequate safety data. The REACH Regulation itself requires registrants to update their dossiers "whenever there is a material change, or where new information comes to light". But the agency’s repeated public pleas, over the last few years, for companies to do this have fallen on deaf ears. More than two thirds of dossiers have been untouched since they were first submitted. And where dossiers have been reopened and updated, this has usually been due to a prompt by Echa under its compliance check process or other measures.Easy to get a registration number
The patience of some stakeholders with this situation has worn away. Speaking at Echa’s anniversary day, head of the European Environmental Bureau (EEB) Jeremy Wates warned that "there are very real problems with the slow pace of roll-out of REACH". He noted that when companies are awarded a registration number whether or not they have complied with the data requirements then key principles of the Regulation, such as "no data, no market" and "reversing the burden of proof", are failing to be applied.
One impact of putting up with non-compliant data is that it causes severe delays in other processes, such as the substance evaluation processes designed to enlist member states in checking the risks of chemicals of potential concern, says Vito Buonsante of campaign group ClientEarth. When member states select substances to examine, they see the holes in the data and instead send the dossiers for compliance checking. Indeed, in a report to the meeting of Competent Authorities for REACH and CLP (Caracal) last October, Echa concedes that in order to first carry out comprehensive compliance checks, it expects postponement of 15-20 substances scheduled for evaluation in 2017 and further postponements can be expected for 2018. And this for substances suspected of posing a risk.Scientific agency or regulatory agency?
"The idea of REACH was to speed things up," he notes, "but, instead, the way it is implemented in several ways gives perverse incentives to companies to drag their feet ... Companies are rewarded for having submitted poor data by winning more time to comply. Article 5 of REACH clearly states the principle of no data, no market. What happened to that? Echa has to remember it is not a scientific agency trying to collate the best information but a regulatory agency which has a duty to act."
NGOs are pushing the agency to take tougher action with non-compliant firms. In March, a group of 16 European NGOs wrote another collective open letter to Echa’s executive director, pressing the issue of non-compliant dossiers and asking for hard information on the agency’s understanding of which chemicals need to be tackled because their risks are not adequately controlled. In response, Echa invited the letter’s signatories to a meeting with its board on 6 June.
Speaking the following day, EEB’s Mr Wates commented that Echa had told NGOs that it was not prepared to follow a ‘name and shame’ strategy to oust non-compliant firms because it lacked support for such an approach from its wider community. Mr Wates therefore appealed "over the heads of Echa to member states and industry: why should you defend those companies failing to submit responsibly completed registration applications?"
Speaking to industry contacts who have been working with REACH registration since its inception, none denied the data gap but some questioned its significance. One contact from an EU-headquartered chemicals multinational said: "In Echa’s mind there is a clear conviction that registration dossiers are not complete. I don’t think it is a problem because, in any case, we now have an enormous amount of information that we did not before. It is not perfect but my belief is that this is not a matter of lack of interest by industry, it is the simple fact that in the beginning it was always about registration. We did not know how [the system] worked but just made sure the substance got registered."
Indeed, in the days leading up to the first registration deadline in 2010, the prevailing advice appeared to be to submit dossiers first and deal with any issues later. One Echa official characterises that period as companies having spent a lot of time setting up substance information exchange fora (Siefs) and negotiating contracts and, only in the last six months, paying any attention to the information needed in chemical safety reports and to data requirements.
"It’s true that there is a data quality gap," says Erwin Annys, policy director at the European Chemical Industry Council (Cefic), but he remembers the lead up to the 2010 deadline somewhat differently. Speaking at Chemical Watch’s Global Business Summit in Amsterdam in March, he pointed to the scale of the challenge for companies to register – in some cases up to 2,000 substances – under an unknown regime and using untested IT tools through collaboration with competitors in Siefs, which naturally required a lot of legal discussion. This at a time just after the global economic crisis began, sending budgetary shock waves through many companies.
Moreover, he describes how the compliance process fundamentally changed the way many businesses scrutinised and managed chemicals: "In order to comply with REACH it was an enormous amount of work. First you had to find in the company archive everything that had been done in the past. Finding information on how substances were used was a new challenge. We could use technical datasheets to know how substances were intended to be used but many companies have been surprised how widely and differently certain substances are used in practice." These challenges were unforeseeable, Dr Annys argues.
"In the beginning we saw REACH as something static. This is the biggest underestimate made by industry," Dr Annys says. "It is much more holistic than we thought. The biggest error made by compliance teams and company CEOs was that REACH was to be a programme that ran from 2010 to 2018. Registration was seen by many as the end. But it is really the beginning. One example of this is that, even in order to carry out tests to determine hazard properties, you first have to register to submit a test proposal. Then, if you get permission, you can carry out the test. That means the costs are generated later than the deadline and then, depending on the results of that test, it could completely change your safety assessment for that chemical bringing even more activities."
Dr Rainer Otter, vice-president regulatory affairs/advocacy for industrial petrochemicals Europe at BASF, also cites mitigating circumstances for the poor quality of many companies’ dossiers. He notes the inexperience not only in industry generally but also at Echa in the early days. "When you now take all the evidence you have from the guidance documents and put them together over a decade and then look back and read the registration dossiers put together under time pressure more than ten years ago, of course, you will get frustrated. But that is really unfair."
Are companies ever likely to become the good product stewards that Echa is asking them to be – will they proactively revisit their dossiers to convince themselves as well as the agency of the reliability of the hazard and exposure data and the consequent risk assessments they submitted?
It is a tall order, given continuing economic uncertainty and that some companies have already downsized the specialist compliance teams they created to undertake REACH registration. Registration is not the only demand some companies are facing. They are also finding themselves at the receiving end of enquiries through compliance checks and substance evaluation processes. Some firms are additionally caught in the net of needing to obtain authorisation in order to continue to sell or use substances of very high concern (SVHCs) – a hugely demanding process.
Another industry contact made the comparison that companies are used to having to review safety data sheets and put in place management systems to enable them to do this. However, no-one foresaw the need to do this with registration dossiers so there are no management prompts or systems to handle it. "We have to build that system up for registration dossiers. I think the problem will solve itself but Echa must keep up the pressure and remind us what they want to improve."
The hoops that REACH registration required companies to jump through brought unexpected benefits, he says. "I can tell you that after the years you see only the advantages. One of these is that we now have a much better understanding of all the chemical streams we have in our company ... When we started, I thought ‘of course we know them all’ but then you begin to list them and you realise you don’t. You realise one of your companies is using this and another that and you have to look at imports and exports. The flows are much clearer now. I think anyone who is honest will admit that. We now talk about chemicals at a higher level within the company."Forcing the issue
However, an added reality is that not all companies have the resources, motivation or in-house expertise of some multinationals in being able to do robust safety assessments. BASF’s Dr Otter is more frank, given that the vast majority of dossiers have never been updated. "You can only meet that challenge when you put in an obligation in the REACH legal text requiring firms to update their dossiers, otherwise you are spending a lot of money doing something voluntarily that your competitors are not. To be fair it must be in the legislation."
But he also notes the achievements of REACH. "I think it has done a good job already because when we go to the Echa website we can get a lot of knowledge in a very short time on a lot of substances. And the need to comply with REACH has also given us the tools to improve the safe use of chemicals through dialogue with downstream users and even if they do not give you the data."
Looking back at the last three decades of chemicals management in Europe, Dr Otter suggests we are entering a third phase that promises a more harmonious outcome than the first two. In the first phase – under the EC Existing Substances Regulation that preceded REACH – regulators painstakingly collated hazard and exposure data from industry and then put together risk assessments from these which companies very often criticised, leading to a "furious fight" and long delays before any assessments were finalised. In the second phase – under REACH – industry was asked to submit thousands of assessments and now Echa is criticising these. In the third phase that is just beginning, he observes, the agency is now asking industry to help it prioritise the chemicals that need attention: "We do it together and we should get better evaluations."
Echa’s leadership has also suggested that a legal remedy may be needed in order to clarify the circumstances that should drive companies to update their dossiers and the powers of authorities to act if this does not happen. But it is not clear that an implementing Act or some other ‘surgical amendment’ of the REACH Regulation is on the cards in the review of REACH and other EU chemicals legislation under way currently.
The agency is trying a number of approaches to improve the information it holds. It introduced an Integrated Regulatory Strategy in 2014 that includes a ‘common screening’ approach using ‘areas of concern’ algorithms to identify problematic data in dossiers; and an enhanced completeness check programme involving manual checks to follow up suspect data with registrants began in June 2016. In the first six months around a third of incoming new or updated dossiers were queried and for around a fifth of these, registrants were asked to improve aspects of the information they had submitted. In 95% of cases they did so and passed the completeness check. In parallel, and citing a 2013 Board of Appeal decision confirming that the agency is permitted to reopen previously submitted dossiers, it is retrospectively reopening dossiers in batches and asking the registrants to submit more information. This approach, the agency says, is proving successful. But it is time and resource consuming. An estimate is that to address 1,000 substances in this way could take five years.
Other planks of the strategy include early ‘risk management option analysis’ (RMOA) to find the most effective pathway to assess and control the risks of specific chemicals and improved communication of chemicals risks, for example, through the ‘infocards’ and more in-depth ‘brief profiles’ launched in 2016 and other means, thus harnessing public power to ask questions.
A current focus is on a collaborative approach involving Echa, member states and industry in grouping chemicals in evaluation and screening processes in order to reach faster conclusions. The approach would bring economies of scale and allow several member states to pool scant resources in order to achieve a more effective outcome but there are a number of practical hurdles, including member states’ unfamiliarity with it; concern over the methodology for grouping; the reliability of extrapolating findings for all chemicals in a group; and uncertainty about regulatory outcomes for different chemicals within a group.
Another initiative is to try to work with industry sectors. For example, the agency has already undertaken a project with the petroleum and coal sector – known as the Petco working group – to enlist trade body and registration consortia help to identify and assess substances of unknown or variable composition, complex reaction products and biological materials (UVCBs) and how to prioritise them for further regulatory action, such as through authorisation.
In another sector project, the agency has asked the plastics sector, flame retardants manufacturers and others to help them undertake a reality check of a list of more than 1,000 substances which registrants claimed are used as plastic additives, in order to know which to prioritise for further action. According to one source involved in the project which started last November, when industry groups looked at the "gigantic print-out" their assessment was "basically this list is okay but there is a lot that is not right". For example, substances were listed that are not used in plastics and the list was missing some that are known to be used as additives. In a task that is expected to take a few months, substances on the list are now being allocated to various sector groups with expertise in specific areas who are being asked to analyse the data further, including making contact with lead registrants where needed. The group aims to get back to Echa with answers in the autumn.
Echa is also working with the metals and construction sectors in different ways. The aim is not to come up with a universal modus operandi but to learn by trying approaches to find better ways of working and attract other front-runners to work with the agency.
Collaboration is necessary and the vision of companies and regulators reaching agreement on the chemicals of concern on the EU market that need to be substituted is a nice one. But is it enough? Mr Buonsante of ClientEarth says not. He notes that Echa applies a lot of informal processes, giving companies time to get in compliance in order to avoid regulatory sanctions but this all takes time and is done in a culture of secrecy. "Collaboration is a good thing but you need the stick as well as the carrot," he insists, not least to reach those companies which are deliberately evading compliance.
The European Commission’s Environment Directorate is also concerned at the slow pace of progress. For example Bjorn Hansen, head of its chemicals unit, says Echa should view dossiers with inadequate data as non-compliant rather than being of poor quality and use its legal powers to bring them into compliance.
He has suggested to Echa that it could carry out compliance checks in parallel with substance evaluations in order to avoid delays of several years in tackling substances that had already been prioritised for needing scrutiny, due to concerns about their risks. He also explains that the agency and its scientific committees can make the grouping approach more effective by applying its expertise early in the process in order to stipulate the tests that need to be done. "We think this is a step that an agency that aspires to be world leading should be ready to take. An agency working for the public good has a duty to apply that expertise to protect the citizen."
As Echa celebrates its tenth anniversary, it is also a pivotal year for them. Having created the agency from scratch in 2007, Mr Dancet will reach the end of his tenure at the end of the year. The European Commission has already begun the process of shortlisting candidates for his replacement, due to be announced in the autumn. The new executive director will have choices to make on how the hole in the middle of REACH registration data is tackled.
From the evidence of companies which have been through the registration process, it is clear that the REACH machine is working and improving the state of knowledge and safety within many companies – perhaps those that were trying to do the right thing anyway. However, it also appears to need a recalibration with regard to its original goals of protecting human health and the environment and promoting competitiveness and innovation.
The business community, which ten years ago embraced REACH because it promised to improve public confidence in chemicals, provide regulatory certainty and level the EU playing field, also needs to seriously rethink. A Eurobarometer poll for the European Commission’s DG Growth, announced in June, found that still "two thirds of EU citizens are concerned about being exposed to hazardous chemicals" although a half feel that products manufactured in the EU are safer than those imported.
Somewhere along the line, the important goals of REACH became, for many firms, an exercise in obtaining registration numbers instead of being the start of a revolution in which they proactively work with regulators to catch up on decades of missing information about the safety of chemicals on the EU market – for the sake of improving their own intelligence as well as for wider societal goals.
Speaking in Helsinki, Cefic vice-president and BASF board member Saori Duborg pushed for this recalibration. Describing REACH as "more than a regulatory framework" and a "global role model of cooperation", she said it has established a joint language, a currency of trust and stability which is "a cornerstone of integrity – consistently saying what you do and doing what you say".
DG Environment’s Mr Hansen also looked to the bigger picture, particularly for Echa. With 600 people at the agency dealing with REACH, which is a law designed to fill information gaps for another 120 EU laws, he noted that the agency has accumulated expertise that can be expected to be called upon increasingly in the coming years by European and even global society.
But the REACH infrastructure is only as effective as the information it is given. Europe may be leading the way on chemicals safety globally but it is at a crossroads in whether it succeeds in its own objectives to create a more sustainable society by minimising the adverse impact of chemicals. This will now depend on the collective will of Echa, the European Commission and Parliament, member state governments and every sector of industry. Either they enter the next phase to secure the benefits of their investments so far or they squander this effort, missing the prize of chemical safety and innovation that REACH initially promised.
https://chemicalwatch.com/56939/reach-revolution-at-a-crossroads

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TSCA: Nullify This Hypothesis

Jun 19, 2017 | Chemical Watch

By James Conrad Jr.

The big surprise, since last June’s rewrite of the Toxic Substances Control Act (TSCA), has been the paralysis gripping the EPA’s new chemicals programme. Most people thought Congress just codified the agency’s practice under section 5 and did not change its underlying decision-making standard. But important EPA staff have taken the opposite view. They are mistaken, and the agency should clarify this point promptly. New chemicals hold the key to a safer chemical ecology, and the amended TSCA was supposed to help turn that key – not change the locks.
The new chemicals programme was widely seen as the one part of TSCA that worked. The House version of the Frank R Lautenberg Chemical Safety for the 21st Century Act (LCSA) did not address section 5. The final version of the bill did, but it omitted more radical changes sought by TSCA critics. It seemed as though the section 5 programme would carry on essentially as before.Backlog
But things quickly went south. The EPA restarted the 90-day clock on the more than 300 pre-manufacture notices (PMNs) awaiting enactment. For months, approvals trickled out slowly. They have picked up recently, but the backlog is still in the multiple hundreds. This seizing up of the new chemicals programme is little short of a disaster for the US chemical industry.
Career EPA leadership insist that this slow pace derives from the transition to the new law and that approvals will speed up. But the real reason for the programme’s constipation seems to be the view of key EPA staff that, intentionally or not, Congress required them to switch the ‘null hypothesis’ in the threshold question of whether a new chemical is likely to pose an unreasonable risk.
The null hypothesis concept comes from testing in statistics. Since observational data can never guarantee the truth of an empirical hypothesis, hypothesis testing takes the opposite or ‘null’ hypothesis (that is to say, that observed results occurred by chance), and then evaluates how unlikely those results would have been in that case. EPA staff argue that the old section 5 established ‘presume safe’ as the null hypothesis for new chemicals. If the EPA was unable to compile enough data indicating harm, it was (supposedly) compelled to accept the null hypothesis and allow the chemical to be manufactured.Justifying rejection
These staff contend that the LCSA flipped the null hypothesis, requiring the EPA to presume a chemical is unsafe, unless the submitter can provide enough no-adverse-effects data to justify rejecting the new null hypothesis.
The shortest answer is that Congress retained TSCA’s ‘unreasonable risk’ standard, rejecting calls for some assertedly more protective standard like "reasonable certainty of no harm". Congress thus did not intend to change any presumptions about the safety of a new chemical.
The EPA staff’s argument that Congress switched the null hypothesis combines (i) the LCSA’s requirement that the agency publish a ‘determination’ that a new chemical is unlikely to pose an unreasonable risk before the chemical can be manufactured commercially with (ii) the EPA’s greater ability to obtain information on the potential risks of new chemicals. Staff also point to the new requirement that the EPA consider the "reasonably foreseen" conditions of use of a chemical, including effects on "potentially exposed or susceptible subpopulations". Each of these arguments is addressed below.
In effect, EPA staff argue that old TSCA did not give the agency the authority it needed to make informed decisions on PMNs, and so it was forced to allow chemicals about which staff had concerns to proceed to market. This argument has superficial appeal. Before the LCSA, section 5 established what was essentially a delayed ‘notice and go’ mechanism: a would-be manufacturer of a new chemical would submit a PMN on Day 0. Upon Day 90, if the EPA had not initiated a legal process to limit or prohibit manufacture of the chemical in time, the submitter could commence manufacture.
Also, the EPA’s powers to restrict manufacture under section 5 were, on paper, limited. To act permanently, the agency had to conclude that the chemical "presents or will present an unreasonable risk . . ." Even where the EPA concluded that it lacked sufficient information to make such an evaluation, it could not restrain manufacture pending generation of new information, unless it could determine that this "may present an unreasonable risk of injury to health or the environment" – or could make production-related findings that only caught 10% of new chemicals. Thus the Catch 22 rap against old section 5: the EPA had to have information about the potential toxicity of a chemical before it could limit its manufacture on the basis that it did not have such information.Reasoned determination
Now, section 5 requires the EPA to make a reasoned determination that a new chemical is likely either to pose, or not to pose, an unreasonable risk. If it has insufficient information to make either determination, it must issue an order limiting manufacture "to the extent necessary to protect against an unreasonable risk" until it gets such information. It need not make any threshold finding about what risk a chemical "may" pose.
In practice, though, the agency never lacked the ability to adequately evaluate new chemicals. PMN submitters want to start making a new chemical, and have every incentive to get the agency’s OK. Submitters also have limited incentives to challenge the EPA, since any new chemical is generating zero revenue. The more a company has invested in developing it, the more it has to lose if it does not win the agency’s prompt approval.
This has given the EPA tremendous leverage under section 5. Early on, it started asking submitters to "voluntarily suspend" the 90-day limit, so it had as much time as it wanted to review a chemical. A submitter that refused to suspend would find itself facing an order or a proposed rule limiting manufacture.
The agency used the same leverage pre-LCSA to persuade submitters to generate health or environmental effects data, when it felt it had insufficient information to make determinations about potential unreasonable risk.
As a practical matter, therefore, EPA staff were able to get the information they wanted to make determinations about the potential risks of new chemicals. Sometimes the information was supplied informally; sometimes it was generated pursuant to a section 5(e) consent order. But no such order was ever judicially challenged during the 40 years preceding the LCSA. PMN submitters either provided the agency with enough information consensually or threw in the towel.
And while it must now "determine" that a new chemical is unlikely to pose an unreasonable risk before it can allow unrestricted manufacture, the EPA was effectively making that determination whenever it ‘dropped’ its review of a PMN, or lifted an order after submission of needed information. The agency probably gives these determinations more attention now that it has to publish them. But it is not required to make them any differently.
Amended section 5 requires the EPA’s unreasonable risk determinations to take into account any "unreasonable risk to a potentially exposed or susceptible subpopulation, identified as relevant by the administrator under the conditions of use". But its review of PMNs pre-LCSA took into account conditions of use beyond those anticipated in the PMN. The EPA invented "non-5(e)" significant new use rules (Snurs) precisely for cases where it was not concerned about uses described in the PMN, but was worried that the submitter or others might use the chemical in the future in unreasonably risky ways.
By definition, non-5(e) Snurs also took account of "potentially exposed" individuals, since they would not have been exposed by the submitter’s intended uses of the chemical. Certainly the EPA considered workers, as many non-5(e) Snurs have required workplace precautions.
Whatever the default assumption may have been pre-LCSA, amended section TSCA does not establish any null hypothesis or default presumption regarding the safety of a new chemical. Rather, it is agnostic. Section 5(a)(3) lays out the agency’s options symmetrically and even-handedly: subparagraph (A) is "presents an unreasonable risk." At the other end of the continuum, subparagraph (C) is "not likely to present an unreasonable risk". Located in between, subparagraph (B) covers the situation where insufficient information exists to support either (A) or (C) determinations. And sections 26(h) and (i) require the EPA to make these determinations on the basis of the weight of the best available scientific evidence. There are no grounds in any of these provisions for a presumption of unreasonable harm.
The statistical concept most relevant to section 5 determinations is Bayes Theorem. This establishes the rules for determining the likelihood of some proposition to be true, given what one already knows about the probability of it being so. Over TSCA’s first four decades, the EPA reviewed more than 40,000 PMNs under the new chemicals programme and allowed about 90% of them to proceed to manufacture. The accuracy of its predictions under section 5 has been generally confirmed in a variety of ways. The historical trend of new chemicals decisions makes sense, since they tend to be developed because they are either safer or less polluting to manufacture or use than the substances they are intended to replace. The EPA’s experience over 40 years should be leading to faster new chemical reviews, not longer ones.
In the LCSA, Congress intentionally chose not to make the new chemicals programme a registration programme like the frameworks used to regulate pesticides and drugs. But the trend post-LCSA is that PMNs will result in a consent order or Snur in the great majority of cases. Thus, not only does the null hypothesis appear to have been switched, but the output of the new chemicals programme has as well.Shifting leadership?
Congress did not change the "policy of the United States" expressed in TSCA that the EPA’s "authority over chemical substances and mixtures should be exercised in such a manner as to not impede unduly or create unnecessary economic barriers to technological innovation . . ." Historically, the US has been the world leader in chemical innovation, with significant knock-on benefits throughout other areas of the economy and in our standard of living generally. That leadership could easily shift now to places like China. New chemicals are generally preferable to existing chemicals, and the EPA should be interpreting new TSCA to create a bias toward new chemistry, not existing chemicals. Congress did not change the null hypothesis under section 5, and the agency should stop hearing what Congress didn’t say.
https://chemicalwatch.com/56942/tsca-nullify-this-hypothesis

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EPA Preparing State Guidance on TSCA Trade Secret Information Sharing

Jun 19, 2017 | Inside EPA

EPA is preparing a guidance document for states listing the security and policy requirements necessary to protect confidential business information (CBI), requirements that states will have to meet to be able to receive information about chemicals from EPA as outlined in changes enacted in the Toxic Substances Control Act (TSCA) last summer.
"To obtain access to CBI under the new law, because this is new authority, states will have to set up an agreement with EPA," Alexandra Dapolito Dunn, executive director and general counsel of the Environmental Council of the States (ECOS), told Inside EPA in a recent interview, following an American Law Institute webinar late last month where she raised the issue. "EPA will have to agree [that states] have the same level of security as EPA."
To assist states, ECOS asked EPA to provide guidance on what requirements would be necessary to protect CBI, Dunn said. EPA plans to have a draft ready for discussion this summer, with a final version anticipated in the fall, she said. She described the guidance in progress as a checklist of elements that states will need to have in place.
"You can understand that CBI is important to the companies. They want to be sure that states have the ability to protect the information," she said.
One issue that may be a problem for some states and might need a legislative fix is the fact that some states have broad Freedom of Information Act (FOIA) laws, Dunn said. "Some states may need to do a regulatory fix or a [legislative one]."
She added that some states already have experience sharing trade secret information with EPA under the authority granted in other laws, such as the Federal Insecticide, Fungicide and Rodenticide Act.
Dunn said state officials are "really pleased" that EPA is developing the guidance, which she said will save states a great deal of time in preparing to be CBI-compliant. "The alternative is for each state to submit [their application] and be told" that it does or does not meet EPA's requirements.
Those requirements are outlined in new language inserted in TSCA Section 14 through the enacted revisions to the law last summer. Section 14 allows state, tribal and local officials to be one set of entities with certain exemptions to TSCA's CBI requirements.
The changes in the law allow EPA officials for the first time to release "to a State, political subdivision of a State, or tribal government, on written request, for the purpose of administration or enforcement of a law, if such entity has 1 or more applicable agreements with the [EPA] Administrator that are consistent with the guidance developed under subsection (c)(4)(B) and ensure that the entity will take appropriate measures, and has adequate authority, to maintain the confidentiality of the information in accordance with procedures comparable to the procedures used by the Administrator to safeguard the information . . ."
Further, such information "shall be disclosed to a health or environmental professional employed by a Federal or State agency or tribal government or a treating physician or nurse in a nonemergency situation if such person provides a written statement of need and agrees to sign a written confidentiality agreement with the Administrator . . . [and] in the event of an emergency to a treating or responding physician, nurse, agent of a poison control center, public health or environmental official of a State . . . or first responder . . ."
https://insideepa.com/daily-news/epa-preparing-state-guidance-tsca-trade-secret-information-sharing

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Chemical Management News - There are no clips to report at this time.

Masse 'Declares Victory' as Canada Moves to Ban Microbeads

Jun 19, 2017 | CBC

Windsor West MP Brian Masse is declaring victory over microbeads.
The tiny plastic balls often found in cleansers and body scrubs are so small fish can confuse them for food and die of starvation. They also can't be caught by municipal water filtration plants meaning there's a high concentration of microbeads in Canadian waters.
The Canadian government recently prohibited the manufacturing of microbeads in Canadian consumer products starting next year, following Masse's work with companies that make products using the tiny beads.
Selling the plastic products will also be banned starting July 1 and microbeads will be added to Canada's list of toxic substances.
"I am pleased to see that the work I have done, in conjunction with the manufacturers and environmentalists, has finally come to fruition," Masse wrote in a media release. "Microbeads are filling our lakes, streams and oceans and pose a threat to the environment, ecosystems and likely to human health."
http://www.cbc.ca/news/canada/windsor/masse-declares-victory-as-canada-moves-to-ban-microbeads-1.4167068

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Energy News

(ACC Mentioned) Ethane Storage Hub May Bring Investment

Jun 19, 2017 | The Weirton Daily Times

By Casey Junkins

U.S. Sen. Joe Manchin represents West Virginia, but he’ll gladly share $36 billion worth of potential capital investment with Ohio, Pennsylvania and Kentucky — which could become reality if any of these states can land an ethane storage hub.
While meeting with numerous Upper Ohio Valley public officials and industry leaders Friday at the City-County Building in Wheeling, Manchin, D-W.Va., discussed both legislation he recently introduced to help make the ethane storage hub a reality, as well as a recent report from the American Chemistry Council. This study estimates the four-state region could attract $36 billion worth of investment, while generating more than 100,000 jobs, by 2025 — if there are ultimately five ethane crackers and two propane processing facilities.
“People keep talking about diversifying the economy. You have to use what you’ve got,” Manchin said. “I don’t think anyone ever imagined that we would have access to these liquids and to this much natural gas.”
Royal Dutch Shell is moving forward on its ethane cracker in Beaver County, Pa., while Thailand-based PTT Global Chemical continues evaluating the prospects of a similar project along the Ohio River at Dilles Bottom.
According to Manchin, further development of shale natural gas from the Marcellus, Utica, Rogersville and other potential rock formations is one of the region’s best hopes for prosperity.
Manchin is sponsoring legislation to create a “subterranean ethane storage and distribution hub.” This would call for analyzing potential locations based on favorable geology, existing infrastructure and proximity to well sites and end users, such as cracker plants.
“We don’t have to reinvent ourselves. We just have to use what we have,” Manchin said.
Earlier this year, PTT officials said they would wait until the end of 2017 to make a final decision on whether to proceed. On Friday, Belmont County Commissioner Mark Thomas told Manchin and others in attendance the prospects remain “positive.”
About 12 miles south of the Dilles Bottom site, Denver-based Energy Storage Ventures hopes to begin storing ethane before the end of 2018. Officials said the ethane would be pumped into and out of the underground caverns through pipelines.
Some Marcellus and Utica shale ethane is now being shipped out of the region for cracking via pipelines. Manchin said he hopes West Virginia, Ohio, Pennsylvania and Kentucky — as well as Congress, the Department of Energy, the Environmental Protection Agency and other divisions of the federal government — can act before it is too late.
“Once the pipelines are built to take the product out, you’ve got to compete to keep it,” he said. “We can’t blow this opportunity.”
Also during the meeting, Wheeling Mayor Glenn Elliott noted the diverse group on hand, which included officials from Belmont County, Jefferson County, Marshall County, the city of Moundsville, the city of Wellsburg and others.
“It is no longer a zero-sum game. We can’t allow arbitrary borders to divide us anymore,” Elliott said of the need to collaborate in terms of economic development.
https://www.weirtondailytimes.com/news/local-news/2017/06/ethane-storage-hub-may-bring-investment/

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Chevron Phillips Chemical Wraps up Construction on Old Ocean Polyethylene Units

Jun 19, 2017 | Houston Chronicle

By David Hunn

Chevron Phillips Chemical Co. has finished building two polyethylene units in Old Ocean, southwest of Houston, a “major milestone” in its $6 billion petrochemical expansion along the Gulf Coast.
The Woodlands-based company, a joint venture of California’s Chevron Corp.and Houston’s Phillips 66, is now testing the units “to ensure a safe and reliable start-up, and consistent, high-quality production,” the company said in an announcement on Monday. They expect operations to start next quarter.
Each unit will produce at least 500,000 metric tons of product annually.
Chief executive Peter Cella said the expansion allows Chevron Phillips to take advantage of cheap and plentiful natural gas from the U.S. shale boom to meet growing global demand for polyethylene — one of the most common forms of plastic — to make performance films, high-pressure pipe and packaging.
Monday's announcement marks one of the last stops in the massive expansion. The company has already finished a pipeline and storage system for ethylene — a feedstock for the units. It has also built a "state-of-the-art" rail facility with the capacity to store 1,500 rail cars to ship polyethylene pellets to customers around the world.
It is still working on a new ethane cracker in Baytown, just east of Houston, which it expects to finish in the fourth quarter of 2017.
http://www.chron.com/business/energy/article/Chevron-Phillips-Chemical-wraps-up-construction-11229950.php

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Fracking Impact? Here's What We Need to Know, Says Elite Texas Shale Task Force

Jun 19, 2017 | Dallas News

By Jeff Mosier

Texas' role as a petroleum powerhouse started with the famed Spindletop oil gusher near Beaumont in 1901. But 116 years later, there's still uncertainty about the industry's impact on the state's people and environment, according a new study released today.
After spending a year analyzing available studies and research into the topic, the task force set up by The Academy of Medicine, Engineering and Science of Texas issued a 204-page report Monday that found both great economic benefits and reasons to be concerned about the state's latest drilling boom.
Texas leads the nation in oil production and is one of the world's largest producers. The exploration of shale fields -- thanks to hydraulic fracturing and other technology -- has contributed to a 50 percent decrease in gasoline prices, provided local governments with billions of dollars and is responsible for nearly 3.8 million Texas jobs, according to the report.
At the same time, drilling and its related activities have created air pollution, contributed to the increase and severity of traffic accidents near drilling areas and led to earthquakes.
A natural gas industry group pointed to the lack of evidence of groundwater contamination as good news and one data point reinforcing their message.
"This study is yet another indication that the campaign to shut down fracking is based on politics, not science. If fracking were a credible risk to groundwater, we would know about it in Texas, which produces more oil and natural gas than any other state," said Steve Everley, spokesman, Texans for Natural Gas. "The fact that such an incident hasn't been observed here is further confirmation that fracking is safe and well-regulated."
The Environmental and Community Impacts of Shale Development in Texas report calls for greater transparency and more information sharing among government agencies.
The document proposes 25 recommendations, many of which call for new research. Those include studying the effects of exposure from drilling emissions, investigating whether Texas needs a law to protect surface owners who don't own their mineral rights and researching the use of brackish or salty water for fracking.
"This knowledge can be diffuse and difficult to locate and access; furthermore, the sheer number of different sources of information can make it difficult to determine the respective credibility of multiple sources of information," according to the report.
The document, which assembled and analyzed existing peer-reviewed research, was written by experts in oil and gas, engineering, medicine, transportation, economics and the law. The task force included oil executives, academics, an oil and gas regulator and representative from an environmental group.
TAMEST, which created this report, is composed of Texas' nine Nobel laureates and Texas members of the National Academies of Sciences, Engineering and Medicine. In contrast to much fracking debate, the report was measured in its analysis of oil and gas drilling impacts. The authors assumed drilling is part of the long-term energy future but also that there are downsides that need more attention.
The research focused on six issues: geology and earthquakes, land resources, air quality, water quality and use, transportation and economic and social effects.
The study said that drinking water contamination is more likely to occur from surface spills or leaks in well casings close to the surface. The risk contamination is lesser in the aquifers, according to the study.
For air quality, the use of natural gas decreases pollution compared to coal. But high-emitting sources in the production and distribution chain could offset some benefit by accidentally pumping more of the potent greenhouse gas methane into the atmosphere. The report singled out one study finding that two percent of natural gas sites accounted for 50 percent of emissions.
The report also highlighted research showing that trucks related to drilling calculated that the cost of road repair -- mainly on rural road not built for such heavy loads -- was $1.5 billion to $2 billion annually.
Other transportation research found an increase in serious and fatal crashes involving commercial vehicles in drilling areas, such as the Eagle Ford Shale and Permian Basin.
The authors of the study also pointed to a need for more air quality research, although some of the high-quality research hasn't conclusively found negative effects. "Overall, there is limited information concerning exposures to air toxics," according to the report.
The uncertainty points to disparity when comparing the costs and benefits of oil and gas drilling.
The study said that "direct and immediate costs associated with shale oil and gas development and production are easily and regularly measured in dollar terms."
"However, costs related to environmental and socioeconomic impacts tend to be diffuse and difficult to monetize," the report concluded. "Some effects may be less immediate. Others may be difficult to characterize unambiguously or relate conclusively to a specific cause."
https://www.dallasnews.com/news/environment/2017/06/19/fracking-impact-need-know-says-elite-texas-shale-task-force

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Chemical Security News

Shell Executive: Safety of Workers, Contractors at Forefront of Cracker Project

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Transportation News

Wisconsin US Senator Introduces the Rail Shipper Fairness Act to Reduce Costs and Improve Service

Jun 19, 2017 | RISI Technology Channels

U.S. Senator Tammy Baldwin introduced legislation to address challenges faced by Wisconsin businesses when shipping by rail.
The Rail Shipper Fairness Act aims to reduce costs and improve service problems faced by a broad coalition of Wisconsin rail shippers, including farmers, manufacturers and utilities.
“Our Wisconsin businesses need a quality and responsive railroad system to effectively get their goods to market,” said Senator Baldwin. “In order to continue building a strong Made in Wisconsin economy that is fair to farmers, manufacturers, and consumers, we need to give these shippers a seat at the table. This legislation will address the challenges faced by local businesses and help drive our Wisconsin economy forward.”
“Our members, which hail from key state industries including agriculture, forest products and paper, metal casting, chemical, plastics, and electric power providers, rely heavily on rail, even though there are very limited rail options,” said Sarah Barry, Executive Director of the Wisconsin Freight Rail Customer Alliance. “We believe Senator Tammy Baldwin’s Rail Shipper Fairness Act is a critical step in the right direction and the Wisconsin Freight Rail Customer Alliance is very supportive of her efforts to help bring costs down for critical Wisconsin industries.”
The Rail Shipper Fairness Act increases competition, reforms rate case regulations and ends unreasonable practices. The legislation will require railroads to be more responsive to their customers by honoring their contractual obligations. The legislation includes provisions to implement competitive switching, which Senator Baldwin previously called for in a bipartisan letter to the Surface Transportation Board (STB). Additionally, the legislation prohibits railroads from charging customers for fuel in a way that does not correlate with actual fuel costs.
“Packaging Corporation of America commends Senator Baldwin for introducing the Rail Shipper Fairness Act and supporting a level playing field for rail shippers,” said Mark Kowlzan, CEO of Packaging Corporation of America.
https://technology.risiinfo.com/logistics/wisconsin-us-senator-introduces-rail-shipper-fairness-act-reduce-costs-and-improve-service

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Marcellus Gas Industry Battles State Plan to Regulate Methane

Jun 19, 2017 | E&E Energywire

By Mie Lee

Almost 18 months after it was announced, Gov. Tom Wolf's plan to curb methane emissions from Pennsylvania's natural gas industry is moving slowly.
A permit system designed to reduce emissions from gas wells, compressors and other installations has been delayed for months amid pushback from trade groups and the Republican-controlled Legislature. And the state Department of Environmental Protection hasn't submitted a formal proposal for a key part of the plan — regulations to deal with emissions from existing oil and gas wells.
It's important because Pennsylvania is the second-biggest natural gas producer after Texas. And state-led programs to reduce greenhouse gases are likely to take on more importance as the Trump administration retreats from plans to combat climate change (Energywire, June 1).
Any further delays could push the process into 2018, when the Democratic governor is expected to run for re-election. That could mean more delays, and it could also put a final decision on the package in the hands of a new administration, said Rob Altenburg, director of the Energy Center at the environmental group PennFuture.
"If we don't see something start until the fall, it's very possible it doesn't get finalized until after the election anyway," Altenburg said.
Methane, the main component of natural gas, traps more heat than carbon dioxide in the atmosphere, and environmental groups have worried that the United States and other countries can't control rising global temperatures without addressing methane leaks.
Colorado, Wyoming, Ohio and California have also enacted state-level methane controls (Energywire, May 11).
Pennsylvania's gas production has grown thirtyfold in the last 10 years, since drilling began in the region's Marcellus Shale. The DEP estimates that leaks from well sites, compression stations and other equipment have tripled since 1990.
In January 2016, Wolf and then-DEP Secretary John Quigley announced a plan to reduce methane emissions. At the time, Wolf and Quigley expected the permit system for new wells to be in place by the end of 2016 and estimated it would take 18 months to submit the regulations for existing sources to the state Environmental Quality Board, which approves new regulations (Energywire, Jan. 20, 2016).
Wolf was elected in 2014 after promising to tax gas producers and clean up the industry's environmental problems. Since taking office, though, he's been unable to convince the Legislature to pass a gas tax, and he's replaced some of the stronger environmental advocates in his Cabinet.
Quigley, who formerly worked for PennFuture, resigned last year and was replaced by Patrick McDonnell, a longtime DEP employee (Energywire, Sept. 22, 2016).
The permit system would allow gas drillers to get a standardized permit, known as a general permit, if they agreed to use the best available technology to control emissions from wellheads, compressor stations, storage tanks and pipelines. It would replace a system that allows companies to avoid applying for an emissions permit for some wellheads and equipment if they agree to periodically check for and repair leaks.
A group of Republican state senators sent a three-page list of questions to the DEP asking, among other things, whether the agency had an adequate legal basis for controlling methane emissions, why it singled out the shale gas industry and whether the agency conducted a cost-benefit analysis.
The DEP replied that coal beds produce almost as much methane as the oil and gas industry, 30.3 percent of the total compared to 30.5 percent. The state opted not to impose controls on coal mines because there aren't any corresponding federal regulations in place and there's limited technology to reduce methane from mines.
The federal Clean Air Act and Pennsylvania law allow for the regulation of methane, according to the DEP response. And cost-benefit studies from both Colorado and Pennsylvania show it's cost-effective to use leak-detection and repair programs, along with other emissions control methods.
The Marcellus Shale Coalition, which represents 220 companies in the shale gas industry, said the DEP overlooked its own statistics. Methane emissions from the gas industry haven't grown nearly as fast as the industry itself, and they decreased slightly between 2009 and 2013.
The industry group also argued that the permit system, which requires companies to reduce emissions from some types of equipment by 98 percent, amounts to a de-facto regulation and said the DEP should have gone through a formal rulemaking process.
More broadly, the industry group questioned whether methane qualifies as a form of pollution under state law. The DEP has said its primary goal for the methane program is to reduce greenhouse gas emissions, but the state Air Pollution Control Act defines pollution as substances that affect human or animal health or that deprive people of the use of their property.
"The available evidence demonstrates that reducing methane emissions from sources in Pennsylvania to combat global climate change would have no measurable impact on the citizens of Pennsylvania or their environment," the coalition wrote.
The DEP hasn't yet responded to the coalition's comments. Meanwhile, the agency extended the comment period for the permit system by three months to June 5. About 10,000 comments poured in, many of them form letters urging the department to "cut methane pollution from fracking by closing loopholes in the final proposal."
A spokesman for the DEP said it's taking all the comments seriously and hasn't determined when it will finalize the permit system.
https://www.eenews.net/energywire/2017/06/19/stories/1060056207

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Environment News

Energy Chief: Carbon Dioxide Not Prime Driver of Warming

Jun 19, 2017 | AP (In The New York Times

Energy Secretary Rick Perry said Monday he does not believe carbon dioxide is a primary contributor to global warming, a statement at odds with mainstream scientific consensus but in line with the head of the Environmental Protection Agency.
Asked on CNBC's "Squawk Box" whether carbon emissions are primarily responsible for climate change, Perry said no, adding that "most likely the primary control knob is the ocean waters and this environment that we live in."
Perry's view is contrary to mainstream climate science, including analyses by NASA and the National Oceanic and Atmospheric Administration. The EPA under President Donald Trump recently removed a web page that declared "carbon dioxide is the primary greenhouse gas that is contributing to recent climate change."
Taking down the web page came after EPA Administrator Scott Pruitt, appearing on "Squawk Box" in March, said "there's tremendous disagreement about the degree of impact" of carbon dioxide and other greenhouse gases on the planet.
"So, no, I would not agree that (carbon dioxide) is a primary contributor to the global warming that we see," Pruitt said.
The Nobel Prize-winning Intergovernmental Panel on Climate Change, organized by the United Nations, calls carbon dioxide the biggest heat trapping force, responsible for about 33 times more added warming than natural causes.
The panel's calculations mean carbon dioxide alone accounts for between 1 and 3 degrees warming, said MIT atmospheric scientist Kerry Emanuel.
Perry, like Pruitt, rejected the scientific consensus on climate change.
"This idea that science is just absolutely settled and if you don't believe it's settled then you're somehow another Neanderthal, that is so inappropriate from my perspective," he said.
https://www.nytimes.com/aponline/2017/06/19/us/politics/ap-us-perry-global-warming.html?_r=0

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The Energy 202: California Scores Its First Big Environmental Victory of the Trump Era

Jun 19, 2017 | The Washington Post

By Dino Grandoni

Between the very little Attorney General Jeff Sessions was willing to say about his conversations with President Trump and the essentially nothing Senate Republicans were willing to say about their health-care bill, there was one revealing bit of testimony on Capitol Hill late last week -- from Environmental Protection Agency Administrator Scott Pruitt.
On Thursday, Pruitt told a House subcommittee that the EPA is not reviewing California's lone-in-the-country authority to set air-quality standards tougher than those found elsewhere in the nation.
For months, California politicians, led by Democratic Gov. Jerry Brown (D), have aggressively positioned the state as a bulwark against the Trump administration's deregulatory agenda -- for example, striking their own climate pacts with Canada and Mexico.
Since January, one cause for concern among Democrats and environmentalists is a longstanding waiver, written into the 1970 Clean Air Act, that allowed California to impose its own emissions rules for automobiles.
When that federal air pollution law was drafted, smog so choked Los Angeles that California asked Congress and its one-time senator, then President Richard Nixon, to carve out room for the state to set even more stringent air-pollution rules for automobiles than was dictated by federal policy.
But the law simply allows such an exemption to be granted by the federal government -- it doesn't guarantee it. During his confirmation hearing in January, Pruitt suggested that that waiver may come under review.
"I don’t know without going through the process to determine that," Pruitt said when asked by Sen. Kamala Harris (D-Calif.) if he would leave the waiver in place. "One would not want to presume the outcome."
In March, the wheels seemed to be turning toward revoking the waiver. That month, the New York Times reported that the EPA would "begin legal proceedings to revoke a waiver for California that was allowing the state to enforce the tougher tailpipe standards for its drivers."
But the White House left California out of an announcement later that month of a broader review of fuel-efficiency standards issued by the Obama administration.
On Thursday, Pruitt confirmed the Trump administration had indeed backed down on withdrawing the California waiver.
"Currently the waiver is not under review," Pruitt told Congress. He added: "This has been something that's been granted going back to the beginning of the Clean Air Act because of the leadership that California demonstrated."
Why did the EPA back down? There are two possible reasons:
1) California's Democratic governor. The state's leader had signaled it was ready to fight the EPA tooth-and-nail for the right to set its own auto- emissions standards. In January, the state hired former Attorney General Eric Holder to advise it in potential legal battles on climate and other issues with a Justice Department he once ran. Brown's administration thought it had good chance of winning. “In this case we think we have a strong case to be made based on the facts and the history," Xavier Becerra, the state attorney general and a former California congressman, said last month.
"I hope Administrator Pruitt is good to his word," Becerra addedin a statement on Friday. "If at some point down the line our efforts to combat air pollution are threatened, I am prepared to take any and all action necessary to defend our progress.”
The Atlantic explained the strength of California's position in March:
California is written into the Clean Air Act by name: At any time, it can ask the EPA administrator for a waiver to restrict tailpipe pollution more stringently than the federal government. If its proposed rules are “at least as protective of public health and welfare” as the EPA’s, then the administrator must grant the waiver.
2) California's Republican congressmen. While every statewide office in California is held by a Democrat, 14 congressmen in California's 55-person delegation are Republican. These include Ken Calvert (R-Calif.), chair of the House Appropriations' subcommittee on Interior, Environment and Related Agencies, which oversees the EPA's budget. On Thursday, Calvert affirmed his support for allowing California to set its own standards.
"One thing that's important to California is our waiver," he said during the hearing. "We've had these waivers for over 50 years."
Of course, Pruitt said (emphasis added): "Currently the waiver is not under review." Meaning: The Trump administration could always change its mind.
https://www.washingtonpost.com/news/powerpost/paloma/the-energy-202/2017/06/19/the-energy-202-california-scores-its-first-big-environmental-victory-of-the-trump-era/5946ffb2e9b69b2fb981dd77/?utm_term=.3b5d54ef555e

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Ex-Bush Official Expected to Be Deputy EPA Head

Jun 19, 2017 | The Hill E2 Blog

By Timothy Cama

President Trump is likely to nominate former Environmental Protection Agency (EPA) official Jeff Holmstead to be the agency’s deputy administrator, Axios reported Monday.
Holmstead is a partner at the law and lobbying firm Bracewell. Other potential contenders for the post have been ruled out, Axios said, citing two sources.
Trump has allegedly met with the former leader of the EPA’s air pollution office under President George W. Bush and likes him, although no final decision has been made.
Holmstead would be relatively moderate for Trump’s EPA. He has been in Washington for years and has lobbied on behalf of Arch Coal Inc., Duke Energy Corp., Southern Co., the Electric Reliability Coordinating Council and others before de-registering as a lobbyist in December.
He has stated that the Obama administration’s 2009 finding that greenhouse gases are a danger to public health and welfare — the lynchpin for climate change regulation by the EPA — should not be reconsidered, a position that conservatives oppose.
Andrew Wheeler, a lobbyist for various energy and fossil fuel interests at Faegre Baker Daniels, was previously reported to be Trump’s top choice for deputy administrator at the EPA.
But Axios reports that Wheeler is no longer the leading contender.
If nominated, Holmstead would be subject to confirmation by the Senate.
Scott Segal, another partner at Bracewell, said in a statement that he couldn’t confirm Axios’ story, which he called “highly premature.”
“However, we understand why the story is plausible. Jeff’s record in public service is unparalleled,” Segal said, pointing to Holmstead’s experience at the EPA and his earlier role working on environmental issues in the White House under President George H.W. Bush.
Trump has so far nominated only two Senate-confirmed officials for the EPA: Administrator Scott Pruitt and Susan Bodine, the nominee to lead the agency’s office of enforcement and compliance assurance.
http://thehill.com/policy/energy-environment/338409-bush-admin-official-expected-to-be-deputy-epa-head

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