Preview Newsletter
ACC PM 19/06
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Holmstead Said to be 'Last Man Standing' for EPA No. 2
Jun 19, 2017 | Inside EPA
Jeff Holmstead, the former Bush-era EPA air chief, is now expected to nab the deputy administrator position over Andrew Wheeler, the former aide to Sen. James Inhofe (R-OK) who had long been expected to win the slot. -
(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. -
TSCA: Nullify this Hypothesis
Jun 19, 2017 | Chemical Watch
By James Conrad Jnr
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 -
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. -
US Shakes Up Alternative Test Development
Jun 19, 2017 | Chemical Watch
By Dr. Emma Davies
The way that the US develops, evaluates and validates new alternative test methods is changing. -
REACH Revolution at a Crossroads
Jun 19, 2017 | Chemical Watch
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. -
EU Commission Grants Sodium Dichromate Authorisation Applications
Jun 19, 2017 | Chemical Watch
The European Commission has granted authorisations to five companies for a use of sodium dichromate. -
Pipeline Backer Urges Court to Ditch Lawsuits
Jun 19, 2017 | E&E Energywire
By Ellen M. Gilmer
Keystone XL backers are urging a federal court to toss environmental challenges to the recently revived oil pipeline. -
Week Ahead: Interior, Energy Chiefs to Defend Trump Budget
Jun 19, 2017 | The Hill
By Devin Henry
Two members of President Trump's cabinet are heading to the Senate in the coming week to defend the administration's proposed environment and energy cuts. -
Energy Secretary Rick Perry: Carbon Dioxide is Not ‘Primary’ Driver of Climate Change
Jun 19, 2017 | The Hill
By Devin Henry
Energy Secretary Rick Perry said Monday that carbon dioxide emissions are not the “primary control knob” behind climate change, a statement at odds with nearly every major climate change researcher inside and outside the federal government. -
Marcellus Gas Industry Battles State Plan to Regulate Methane
Jun 19, 2017 | E&E Energywire
By Mike 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. -
Trump Economist has Links to Carbon Taxes and Fossil Groups
Jun 19, 2017 | E&E Climatewire
By Benjamin Hulac
President Trump's nominee to lead a team of White House economists has financial ties to politically right-leaning groups, including some that oppose or downplay benefits of climate regulation, records show. -
Green Groups Worry Budget Process Could Speed ANWR Drilling
Jun 19, 2017 | E&E Greenwire
By Kellie Lunney
Wilderness advocates are concerned that language allowing oil and gas drilling in the Arctic National Wildlife Refuge could end up being included in the fiscal 2018 budget resolution as part of the fast-track reconciliation process. -
Sierra Club Backs EPA in Suit Testing 'Ongoing' NSR Violations
Jun 19, 2017 | Inside EPA
Sierra Club in a new legal brief is backing EPA's claim that violations of the Clean Air Act's new source review (NSR) permitting program are “ongoing” and not subject to the five year statute of limitations, as the group seeks to bolster the agency's appeal of a district court ruling that imposed time limits on filing NSR cases.
Industry and Association News
LCSA News
Chemical Management News
Energy News
Chemical Security News - There are no clips to report at this time.
Transportation News - There are no clips to report at this time.
Environment News
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Holmstead Said to be 'Last Man Standing' for EPA No. 2
Jun 19, 2017 | Inside EPA
Jeff Holmstead, the former Bush-era EPA air chief, is now expected to nab the deputy administrator position over Andrew Wheeler, the former aide to Sen. James Inhofe (R-OK) who had long been expected to win the slot.
Axios, quoting two sources familiar with the decisionmaking process reports that Holmstead, who has represented power and other industry groups since he left EPA, is the “last man standing” for the deputy administrator post.”
The publication adds, “No final decision has been made, but there is no other serious contender for the job at this moment.”
EPA has been awaiting a deputy administrator -- as well as many other top political positions -- and the lack of appointees has stalled Administrator Scott Pruitt’s agenda as he works to roll back key Obama-era climate and other environmental regulations.
For example, several sources say EPA likely will not decide whether to replace the Clean Power Plan greenhouse gas standards for existing power plants until political positions like deputy administrator and air chief are filled. The same is true for EPA’s general deregulatory actions as it implements President Donald Trump’s various executive orders on the issue.
The position has long been expected to go to Wheeler, the former Inhofe aide who is now at Faegre Baker Daniels, though he told Inside EPA in March that he had not been offered the job.
The two men even had an awkward exchange at a recent event, where Wheeler asked Pruitt when he was going to name a deputy administrator nominee.
Others, like Susan Bodine, were said to be considered for the job though she is now awaiting confirmation as EPA's enforcement chief.
Axios notes Holmstead could “represent a moderating tilt inside the agency’s leadership.” Notably, like Pruitt, he has reportedly argued the administration should not target EPA’s greenhouse gas endangerment finding -- which underpins all of the agency’s climate rules and creates an obligation to regulate GHGs -- because the finding would be legally tricky to overturn.
That position is likely to anger hard-line conservatives, who are eyeing EPA’s risk finding as the next step -- now that they have been successful in their efforts to urge Trump to pull the United States from the Paris climate agreement.
It is not clear when Trump might make an announcement about EPA’s No. 2 position, but we’ll keep you updated with any news on this front.
https://insideepa.com/daily-feed/holmstead-said-be-last-man-standing-epa-no-2
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(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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Jun 19, 2017 | Chemical Watch
By James Conrad Jnr
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.
Leadership in world chemical innovation could now shift to places like China
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.
A longer version of this article is available.
https://chemicalwatch.com/56942/tsca-nullify-this-hypothesis
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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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US Shakes Up Alternative Test Development
Jun 19, 2017 | Chemical Watch
By Dr. Emma Davies
The way that the US develops, evaluates and validates new alternative test methods is changing. A new top-down approach sees regulators leading the way, according to a draft US strategic roadmap for alternative approaches, developed by the Interagency Coordinating Committee on the Validation of Alternative Methods (Iccvam).
The approach is being driven by federal agencies, explains Warren Casey, director of the US National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (Niceatm).
Established in 2000, Iccvam now comprises representatives from 16 US regulatory and research agencies that require, use or generate toxicology and safety testing information. Niceatm provides scientific and operational support for the committee’s technical evaluations and related activities. In 2013, Iccvam and Niceatm both made changes to increase the speed and efficiency of regulatory and industry approval of reduce, refine, replace (3Rs) testing methods.
Iccvam’s ‘reinvention’ involved putting control back into the hands of its agencies rather than having Niceatm dictate work plans. "Once we had flipped around to let them determine what they need to work on, things went really fast and that same approach applies to alternative methods," Dr Casey told GBB.
He is buoyed by the US Environmental Protection Agency’s Office of Pesticide Program’s (OPP) decision to "modernise" an acute toxicity "six pack" for oral, dermal, inhalation, eye irritation, skin irritation and skin sensitisation. This sees a move away from animal testing, with support from Iccvam and Niceatm. "I’m confident that by working together with all of our stakeholders, we can have a quick impact on reducing the use of animals in acute effects testing," explained Jack Housenger, OPP director, in a March 2016 letter to stakeholders.
"That’s unheard of speed in the validation world," says Dr Casey. "When the regulators are driving the validation, everything goes really fast."Federal decisions
Instead of academic groups and industry taking the lead on alternative methods, the roadmap suggests that regulators and other federal agencies should decide what needs to be done, Dr Casey told an Iccvam public forum in May. The hope is that the approach will cut dramatically the time it takes a new alternative test to be validated and accepted by regulators and industry.
Currently, methods are first developed, then validated before possible regulatory acceptance and industry use. "This is how it is supposed to work; this is how Iccvam was conceived," said Dr Casey.
However, the model doesn’t reflect reality, he added. "There are not that many alternative methods out there that are ready to be validated. The validation process is not efficient. Just because you have regulatory acceptance, it doesn’t mean you are going to have industry utilisation."
All too often, test method developers first begin with a technology, then try to find a test method to replace, he says. Regulators tend not to be heavily involved in the process, so "we end up with methods that regulators don’t want". "Even if they are accepted by regulators, they are so cumbersome that they don’t really meet the needs of industry."Seven steps
As a result, the entire alternative method process needs to be addressed, he added. Iccvam’s draft roadmap sets out to do just that (see box).
Routinely collecting parallel data from animal studies and alternative methods will be key to "streamlining" processes. "People are going to have to establish confidence in new methods by running them side by side with existing methods," said Dr Casey.
Iccvam also aims to encourage industry to share information on alternative tests that industry already uses for in-house screening. The plan is to set up forums to discuss the best way to fast-track regulatory acceptance of such methods.
Communication and data sharing are also central to developing new methods successfully. "We have got to find ways to start utilising public-private partnerships. We know that we can’t do it on our own. Industry knows that they can’t do it on their own. There are a lot of good opportunities to collaborate," Dr Casey told the forum.
The need for communication between all parties also feeds into the proposed top-down approach. "Probably the most common feedback we hear from test method developers and industry is that agencies aren’t clearly stating what it is they will accept," Dr Casey told GBB.
He is keen to encourage agencies to predict whether they would accept a test method, if validated. "That sounds simple but a lot of regulators aren’t willing to commit to doing that."
Under "resources", Iccvam also plans to look into changing the whole grant review process, which does not currently favour developing alternative methods. "They are reviewed by people that want new and exciting things. A lot of times, what we are doing is not all that new or exciting," said Dr Casey.
The current system has led to a gap between funding for high-tech science and "what we really need", he added.Being human
A key part of the roadmap’s "vision" is to improve alternative test methods’ relevance to human health. At the heart of this is an attempt to move beyond using animal tests to judge alternative tests. Dr Casey questions how test developers can make those that are better at predicting human toxicity when animal tests are still used as the gold standard.
"We are trying to be more human predictive but we don’t have human data to use. We know that animal models can’t produce the results that we need. It’s going to require regulators to have a completely new way of thinking about things," he told the forum.
He is pleased that the Food and Drug Administration and pharmaceutical industry are involved in the roadmap, thanks to their experience with human data and investment in predictive toxicology.
Iccvam has also identified a number of sources of human data. "Pulling those together and getting them in a format that’s suitable for regulators and toxicologists is a different issue," said Dr Casey.
At the forum, Rick Becker from the American Chemistry Council pointed out that "we don’t have human data for a lot of the endpoints that we are interested in." He acknowledged that "we would like to be more predictive of human [adverse effects]," but added that "it is realistic to say that we are going to have to have curated datasets for animal toxicity."
Dr Casey agreed that high quality animal data are still needed to help regulators to establish confidence in alternative test methods.
"If you can’t predict toxicity in a rat, you probably can’t predict toxicity in a human," he said. (It is still not possible to predict reliably toxicity in rodents.)
With organ-on-a-chip devices all the rage, Dr Casey suggested that a "rat-on-a-chip", with clusters of cells representing organs, might be a good idea. "People don’t like to talk about rat-on-a-chip because that’s not sexy and that’s not going to be on the cover of Science."
However, a successful rat-on-a-chip could help industry to believe that human organ-on-a-chip devices may be able to predict human toxicity, he said.
In some areas, such as skin sensitisation, alternative methods can give a quick win, he said. Other tests are going to take a long time and will undeniably need comparisons with animal data, especially for predictive tests for chemicals that may cause cancer and developmental toxicity,
With regulators driving the process, Iccvam also plans to have a "much more representative set of chemicals" tested for validation studies.
Niceatm has contacted agencies and asked them to identify chemicals with associated animal data that could be used to test new methods. The idea is to have different chemicals for different sectors. "Hopefully they will be able to see whether or not these methods work with their specific sector and that will help them to establish confidence," Dr Casey told GBB.International effort
International collaboration and harmonisation is critical for alternative tests to be accepted. Without harmonised methods, industry will always test to the lowest common denominator, said Dr Casey.
He fully expects "institutional resistance" to Iccvam’s plans. One of the biggest obstacles is going to be finding a way to get validation organisations, government agencies and industry to change, he predicts.
A first step is to bring together different groups and resources. "By working with industry and other groups, we can get a lot more done … None of us has the resources to do everything. There is a realisation that we actually need to start working together."
Webcast from Iccvam public forum on 23 May 2017.Iccvam’s draft roadmap outlines seven objectives:Iccvam’s draft roadmap outlines seven objectives are to:communicate the needs of federal agencies;streamline processes for regulatory acceptance of new methods;collaborate with international partners to help global harmonisation;promote communication and data sharing across product sectors;identify and promote resources that help develop and use new approaches;find metrics for monitoring progress; anddevelop a communication plan for distributing information related to acceptance of new methods, data-sharing opportunities etc.
https://chemicalwatch.com/56941/us-shakes-up-alternative-test-development
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REACH Revolution at a Crossroads
Jun 19, 2017 | Chemical Watch
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.
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.
'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,' Geert Dancet, Echa
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.
'The idea of REACH was to speed things up but instead, the way it is implemented in several ways gives perverse incentives to companies to drag their feet …' Vito Buonsante, ClientEarth
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?
'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,' Dr Rainer Otter, BASF
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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EU Commission Grants Sodium Dichromate Authorisation Applications
Jun 19, 2017 | Chemical Watch
The European Commission has granted authorisations to five companies for a use of sodium dichromate.
Solvay Portugal, Kemira Chemicals, Electroquimica De Hernani, Caffaro Brescia and Ercros are permitted to use the substance as: an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorate with or without subsequent production of chlorine dioxide or sodium chlorite.
The recommended review period expires on 21 September 2029.
The Commission has also granted an application from BASF for industrial use of 1,2-dichloroethane (EDC) as a recyclable solvent and extraction agent in a closed system for purification of 1,3,5-trioxane.
The recommended review period expires on 22 November 2024.
https://chemicalwatch.com/56938/eu-commission-grants-sodium-dichromate-authorisation-applications
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Pipeline Backer Urges Court to Ditch Lawsuits
Jun 19, 2017 | E&E Energywire
By Ellen M. Gilmer
Keystone XL backers are urging a federal court to toss environmental challenges to the recently revived oil pipeline.
In Friday filings in the U.S. District Court for the District of Montana, lawyers for TransCanada Corp. argued that a crucial pipeline permit issued by President Trump in March is not within the court's jurisdiction.
Several environmental and tribal groups went to court earlier this year to try to block the pipeline. They say the Trump administration relied on an outdated environmental review when greenlighting the project, in violation of the National Environmental Policy Act.
TransCanada's position echoes one taken by the Trump administration in similar filings a week earlier. Both argue that while the State Department issued Keystone XL's cross-border permit to pass from Canada to the United States, the agency did so under presidential authority that is not reviewable in court (Energywire, June 12).
Company lawyers also note that the permit was issued pursuant to a 2004 executive order that governs certain energy infrastructure border crossings, and the order does not create a private right of action for would-be challengers to go to court.
"Simply put, the issuance of the Presidential Permit and the Department's compliance with NEPA are unreviewable Presidential actions," the company told the court.
A collection of recent case law supports TransCanada's position. Federal district courts in Minnesota; South Dakota; and Washington, D.C., have all rejected challenges to presidential permits for other pipelines, ruling that the permits are not subject to judicial review.
The previous administration cited the same cases last year when defending President Obama's decision to deny a presidential permit for Keystone XL.
Environmental and tribal groups' responses are due next month.
https://www.eenews.net/energywire/2017/06/19/stories/1060056206
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Week Ahead: Interior, Energy Chiefs to Defend Trump Budget
Jun 19, 2017 | The Hill
By Devin Henry
Two members of President Trump's cabinet are heading to the Senate in the coming week to defend the administration's proposed environment and energy cuts.
Ryan Zinke, the secretary of the Interior, will testify about the budget at a Senate Energy and Natural Resources (ENR) Committee hearing on Tuesday. Two days later, he'll speak on the matter before the House Natural Resources Committee on Thursday.
Energy Secretary Rick Perry will testify on Trump's Department of Energy (DOE) spending plan before the House Appropriations Committee on Tuesday, and the Senate energy committee on Thursday. It will be his first testimony before Congress since he took office in February.
Both secretaries are likely to face skeptical lawmakers when they present Trump's budget, which contains deep cuts to both departments. Trump proposed a $1.4 billion, or 10.9 percent, cut to Interior, and he aims to slice DOE's budget by $1.7 billion, or 5.4 percent.
Neither the House nor the Senate are close to writing their own spending targets for Interior or the DOE -- or the Environmental Protection Agency, which found no support for its budget request during a Thursday hearing. But the hearings will be lawmakers' chance to outline their funding priorities for the departments.
When Zinke testified before the House Appropriations Committee last week, even Republicans said they had concerns about the extent of Trump's proposed cuts, pointing to low funding levels for the National Park Service and other environmental programming, while Democrats indicated they would oppose funding cuts for climate change research and policy changes to open up more public lands drilling.
Perry's budget has yet to undergo congressional scrutiny, but members have already said they'll oppose efforts to cut funding for energy research accounts and national labs. The Energy Department confirmed this week that it was aiming to shutter an international green energy office, something likely to anger Democrats.
The House Financial Services Committee will resume marking up several bills meant to reform and reauthorize the National Flood Insurance Program (NFIP). The panel, usually bitterly divided along party lines, has expressed interest in finding a bipartisan solution before the federal flood insurance program expires at the end of September.
Republicans are looking toward a five-year extension of the program, along with various ways to get federally-insured homes covered by private plans. Democrats are eyeing a ten-year reauthorization, while both parties pursue ways to modernize flood mapping and update the process to reduce rates.
Off Capitol Hill in the upcoming week, the Dakota Access Pipeline fight is set to reignite when lawyers return to a federal courthouse on Wednesday.
U.S. District Court Judge James Boasberg handed the tribes opposing the pipeline a major victory on Wednesday when he ruled that federal regulators did not conduct a through enough environmental review for the project.
The ruling, though a win for the pipeline's opponents, wasn't everything the Standing Rock Sioux or the Cheyenne River Sioux tribes had hoped, and Boasberg did not rule that oil should stop flowing through the controversial pipeline. Government, company and tribal lawyers will meet in his courtroom on Wednesday to argue over that question.
Trump approved the Dakota Access project in January, clearing the way for the 1,170-mile pipeline, which kicked up massive opposition from greens and tribal allies last year. Oil began flowing through the pipeline earlier this month.
The fight over Dakota Access so far in 2017 has been mostly contained to the courts. But Boasberg's decision -- and the next stage of the legal fight over the pipeline's future -- is certain to put Dakota Access back on activists' radar, starting next week.
http://thehill.com/policy/energy-environment/338197-week-ahead-interior-energy-chiefs-to-defend-trump-budget
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Energy Secretary Rick Perry: Carbon Dioxide is Not ‘Primary’ Driver of Climate Change
Jun 19, 2017 | The Hill
By Devin Henry
Energy Secretary Rick Perry said Monday that carbon dioxide emissions are not the “primary control knob” behind climate change, a statement at odds with nearly every major climate change researcher inside and outside the federal government.
Asked by CNBC if he believes carbon dioxide is “the primary control knob for the temperature of the Earth and for climate,” Perry said no, and that “most likely the primary control knob is the ocean waters and this environment we live in.”
“This shouldn’t be a debate about is the climate changing, is man having an affect on it? Yeah, we are,” Perry said. “The question should be, just how much and what are the policy changes that we need to make to affect that?”
Federal scientists — including researchers at NASA, the National Oceanic and Atmospheric Administration and the Environmental Protection Agency (EPA) — as well as international and private-sector researchers have concluded that increasing greenhouse gas emissions, driven by human activity such as burning fossil fuels, is the leading cause of climate change around the globe.
Perry’s department is charged, in part, with researching technologies designed to green the energy sector, a leading producer of emissions.
When asked about climate change during his confirmation hearing in January, Perry said that “the climate is changing” but that he believes “some of it is naturally occurring, but some of it is also caused by manmade activity.”
“This idea that the science is absolutely settled and if you don’t believe it’s settled, then you are somehow another Neanderthal, that is so inappropriate from my perspective,” he said on Monday on CNBC's "Squawk Box."
“If you’re going to be a wise, intellectually engaged person, being a skeptic about some of these issue is quite alright.”
EPA Administrator Scott Pruitt said on the same CNBC show in March that he “does not believe carbon dioxide is a primary contributor” to climate change.
http://thehill.com/policy/energy-environment/338415-energy-secretary-perry-carbon-dioxide-is-not-primary-driver-of
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Marcellus Gas Industry Battles State Plan to Regulate Methane
Jun 19, 2017 | E&E Energywire
By Mike 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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Trump Economist has Links to Carbon Taxes and Fossil Groups
Jun 19, 2017 | E&E Climatewire
By Benjamin Hulac
President Trump's nominee to lead a team of White House economists has financial ties to politically right-leaning groups, including some that oppose or downplay benefits of climate regulation, records show.
Trump nominated Kevin Hassett, an economist from the American Enterprise Institute, to chair the Council of Economic Advisers, an agency that assists the president. The Senate Banking Committee voted last week to move his nomination to the full chamber.
Hassett is a well-known tax expert and has supported carbon taxes — a view that places him at odds with Trump and several of the president's Cabinet secretaries, who say climate change is either a fraud or presents minimal risk.
Disclosure records show Hassett gave a speech March 3, 2016, to the National Mining Association, a trade group for the coal industry and a fierce opponent of climate regulation. He was paid $10,800. A spokesman for NMA said he couldn't recall the specifics of Hassett's speech, but didn't think it was about the coal industry.
The files submitted by Hassett also show he was paid $10,000 last year for work with the American Action Forum, a conservative advocacy group that ran advertising against the Obama administration's climate change efforts. A spokeswoman for the group said he consulted about "policy research." She declined to elaborate.
The records also show that Hassett has been an adviser to the Randolph Foundation since 2013. The New York City nonprofit has contributed hundreds of thousands of dollars to political organizations that oppose government policies to cut emissions.
Groups to which the foundation has given money include Donors Trust Inc., the James Madison Institute, and the Property and Environment Research Center. Hassett and the Randolph Foundation did not respond to requests for comment.
"I wouldn't read anything much into a particular speaking engagement," said Adele Morris, an economist and climate change expert at the Brookings Institution.
Think tank researchers and scholars generally maintain a firewall between their work and donor influence, Morris said.
Morris said she has known Hassett for years, adding that he's an "accomplished economist," especially in taxation.
"He's an unqualified expert," she added. "People that have that kind of credibility would guard it very carefully, and rightfully so."
Jeremy Carl, an energy policy researcher at the Hoover Institution, agreed that it would be a mistake to draw conclusions from financial ties.
"I think he's a curious guy with a lot of different relationships," Carl said. "You end up talking to a bunch of people if you're a curious person."
Hassett has the support of economist on both sides of the political aisle. In a recent letter to senators on the Banking Committee, Republicans and Democratic economists expounded on his qualifications.
https://www.eenews.net/climatewire/2017/06/19/stories/1060056215
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Green Groups Worry Budget Process Could Speed ANWR Drilling
Jun 19, 2017 | E&E Greenwire
By Kellie Lunney
Wilderness advocates are concerned that language allowing oil and gas drilling in the Arctic National Wildlife Refuge could end up being included in the fiscal 2018 budget resolution as part of the fast-track reconciliation process.
"We've been in this situation before, and we've won before," Kristen Miller, interim executive director of the Alaska Wilderness League, said during a conference call with reporters today. Still, Miller said environmentalists will need moderate Republicans and Democrats to ensure provisions that pave the way for drilling in ANWR aren't part of the budget process.
President Trump's budget proposal assumes cost savings of $1.8 billion over the next decade by allowing oil and gas drilling in ANWR starting in 2022 — a longtime priority of Senate Energy and Natural Resources Chairwoman Lisa Murkowski (R-Alaska).
But Congress still needs to authorize drilling in the reserve, access that the state's delegation has fought unsuccessfully to obtain for decades. The Alaska congressional delegation is looking to the budget reconciliation process as a vehicle to include revenues related to oil and gas drilling in ANWR, though neither chamber has produced a fiscal 2018 budget resolution yet with guidelines for the appropriations process (E&E Daily, May 24). Budget reconciliation is an expedited maneuver that allows certain budget and fiscal matters to pass by a simple majority in the Senate.
"We are anticipating, possibly as soon as this week, that the House budget resolution will include reconciliation instructions that will tee this up," said Cameron Witten, a budget specialist at the Wilderness Society.
Negotiations have gone on for weeks in the House, but the Budget Committee has yet to schedule a markup — something usually done in April or May. The prospects in the Senate for a budget resolution are even murkier at this point.
The two wilderness groups, and others like them, are hoping to convince lawmakers that it's not in their best interest to support drilling in a portion of the 19-million-acre refuge. The organizations are arguing in part that it doesn't make economic sense right now, said Lydia Weiss, director of government relations at the Wilderness Society, referring to low gas prices and the expense of industrializing the remote ANWR for drilling. Weiss also argued that there's not much constituent demand for it, and she hopes lawmakers will see that. "It's a policy loser, but [also] a political loser," she said.
Drilling in ANWR likely will come up this week during Interior Secretary Ryan Zinke's multiple appearances on Capitol Hill (E&E Daily, June 19).
"On ANWR, we're doing the groundwork to make sure Congress has the information to make the right decision," Zinke told reporters late last month after the administration released its detailed fiscal 2018 budget request. Drilling in ANWR is a major part of the administration's push toward greater energy independence.
https://www.eenews.net/greenwire/2017/06/19/stories/1060056236
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Sierra Club Backs EPA in Suit Testing 'Ongoing' NSR Violations
Jun 19, 2017 | Inside EPA
Sierra Club in a new legal brief is backing EPA's claim that violations of the Clean Air Act's new source review (NSR) permitting program are “ongoing” and not subject to the five year statute of limitations, as the group seeks to bolster the agency's appeal of a district court ruling that imposed time limits on filing NSR cases.
In a June 13 brief filed with the U.S. Court of Appeals for the 5th Circuit in USA, et al. v. Luminant Generation Company, et al., Sierra Club supports EPA's appeal of the district court ruling that largely rejected an EPA enforcement action against power company Luminant for years-old violations of NSR mandates that the lower court found fell under the air law's statute of limitations.
The issue of whether EPA or private citizens can sue over old NSR violations that are outside the five-year window is of central importance to the agency's enforcement of air permits, and courts have a mixed record on the issue. Should EPA win in the 5th Circuit case, it would create a precedent in the states covered by that circuit, but potentially create a split with other judicial circuits, teeing up a potential Supreme Court case.
In a June 6 filing with the appeals court, the Trump Department of Justice (DOJ) on behalf of EPA continued to defend the Obama DOJ's position that NSR violations are ongoing. Further, DOJ claimed that even if fines for NSR violations older than five years are time-barred, injunctive relief is not, contrary to the view of the district court which found injunctive relief also barred, under the “concurrent remedy” doctrine.
The concurrent remedy doctrine provides that when legal and equitable relief are available “concurrently,” based on the same facts, then “equity will withhold its relief in such a case where the applicable statute of limitations would bar the concurrent legal remedy,” under the 1947 Supreme Court ruling in Cope v. Anderson. EPA can legitimately ask courts to mandate overdue emissions controls, the agency claims.
In its brief, Sierra Club makes very similar arguments. The enforcement action relates to two Texas coal-fired power plants either owned or operated by Luminant, the Big Brown and Martin Lake facilities, which EPA alleges failed to obtain prevention of significant deterioration (PSD) permits, and failed to install necessary best available control technology (BACT). PSD permits are required for industrial sources of pollution in areas meeting national ambient air quality standards (NAAQS), while nonattainment NSR permits are required in areas failing to meet the NAAQS.
The district court “misapplied the statute of limitations and the concurrent remedy doctrine to preclude the government and citizens from seeking to protect human health and the environment from harmful emissions by requiring compliance with the Clean Air Act,” Sierra Club says.
“Moreover, the district court departed from controlling precedent and adopted a rule that effectively insulates illegally modified sources from compliance with the Clean Air Act’s pollution control requirements, so long as they commence construction or modification without detection,” the group adds.
Sierra Club says, “even if the PSD claims for civil penalties were barred by the statute of limitations (which they are not), the district court erred by dismissing the government’s claims for injunctive relief.” The court “failed to address well-established precedent” holding that “claims on behalf of the United States in its official enforcement capacity are 'subject to no time limitation in the absence of a congressional enactment clearly imposing one,'” the group argues, citing the Supreme Court's 1924 ruling in E.I. Dupont de Nemours & Co. v. Davis.
Further, “the concurrent remedies doctrine does not apply to government enforcement actions” and “the district court failed to recognize that the concurrent remedies doctrine has no application where, as with the Clean Air Act, a statute provides independent equitable relief to protect against or remedy damage to the public interest.”
The court ignored “numerous [air law] and other environmental enforcement cases in which courts have in fact granted injunctions that serve remedial functions for past violations,” Sierra Club says.
In deciding that an NSR violation occurs only on one day -- the day construction of an industrial project commences without the necessary PSD permit -- “the district court departed from controlling precedent and the text, purpose, and structure of the Clean Air Act, which make clear that operating a modified source without a required PSD permit is an ongoing violation.”
There is also an independent duty on polluters to install BACT, Sierra Club argues. “Moreover, the text and structure of the PSD provisions, its implementing regulations, and the applicable Texas regulations confirm that modified sources have an independent obligation to operate 'subject to” BACT,' with which Luminant must comply. Thus, the statute of limitations does not bar the PSD claims for penalties,” the group says.
https://insideepa.com/daily-feed/sierra-club-backs-epa-suit-testing-ongoing-nsr-violations
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