Preview Newsletter
ACC AM 9/20/16
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(ACC Mentioned) Why Traditional Economic Indicators Failed So Many This Cycle
Sep 19, 2016 | Investment News
By Brett F. Ewing and S. Lance Mitchell
Many economists hold the belief that a recession is still a possibility, which has been stoked by the breakdown in traditionally reliable economic indicators. -
US EPA Moves To Implement TSCA Section 6
Sep 20, 2016 | Chemical Watch
By W Caffey Norman
The US EPA last regulated a chemical under TSCA section 6, which provides for regulation of existing as opposed to new chemicals, in 1989. This 27-year hiatus is coming to an end, as the EPA has indicated that it expects to propose three such rules by late 2016. -
New-Chemical Makers Face More Consent Orders, EPA Says
Sep 20, 2016 | BNA Daily Environment Report
By Pat Rizzuto
The Environmental Protection Agency will be asking manufacturers of new chemicals to sign consent orders that delineate the manufacture and use of their substances more frequently than it did before the Toxic Substances Control Act was amended, a senior agency official told Bloomberg BNA Sept. 19. -
(ACC Mentioned) Chromium-6: 'Erin Brockovich' Chemical Threatens Two-Thirds Of Americans
Sep 20, 2016 | The Guardian
By Tafline Laylin
‘We simply can’t continue to survive with toxic drinking water,’ says Erin Brockovich, as a new report finds 200 million people exposed to chromium-6 -
(ACC Mentioned) Chromium-6 Found Elevated Levels Water 200 Million Americans
Sep 20, 2016 | Newsweek
By Douglas Main
Nationwide tests have detected the carcinogen chromium-6 at levels higher than those recommended by some state agencies in the tap water of more than 200 million Americans. -
(ACC Mentioned) High Levels Of 'Erin Brokovich' Chemical In Many NJ Water Systems, Study Says
Sep 20, 2016 | NJ Spotlight
By Jon Hurdle
Drinking water in more than 150 New Jersey water systems contained the carcinogenic chemical chromium 6 at levels that exceeded a health limit recommended by California scientists when the local systems were tested by the U.S. Environmental Protection Agency, according to a national analysis published on Tuesday. -
(ACC Mentioned) Chemical Manufacturers Get Extra Month to File Data With EPA
Sep 20, 2016 | BNA Daily Environment Report
By Pat Rizzuto
The Environmental Protection Agency announced Sept. 19 a deadline extension until Oct. 31 for chemical manufacturers to submit production volume and other data. -
(ACC Mentioned) EPA Extends CDR Deadline After Chemical Industry Raises Usage Concerns
Sep 19, 2016 | Inside EPA
EPA has extended by a month the deadline for companies to submit data on their manufacture, production and importation of chemicals under the Chemical Data Reporting (CDR) rule, following chemical industry complaints that problems with the agency's web-based electronic reporting tool were making it difficult to meet the original deadline. -
Endocrine Disruptors: Criteria, Testing And Assessment
Sep 20, 2016 | Chemical Watch
By Martina Duft
Endocrine disruptors, their definition and criteria as well as feasible options for testing and assessment, have been extensively worked on and discussed in science and regulatory panels. The debate has engaged the public and national and global political agendas. -
Membrane Coating Could Help Remove Endocrine Disruptors From Wastewater
Sep 19, 2016 | Chemical & Engineering News
By Deirdre Lockwood
Water-stressed communities from California to Singapore have begun reclaiming wastewater for drinking and other uses, but they face a challenge: It’s hard for the treatment process to remove trace organic pollutants, such as endocrine disruptors. -
Where Next For EU Chemicals Policy?
Sep 20, 2016 | Chemical Watch
By Geraint Roberts
Earlier this year, a proposal was made to ban the sale in Europe of consumer products containing any of a group of four phthalates. The proposal, lodged jointly by Echa and the Danish EPA, is unusual because it groups four different chemicals together and seeks to apply the same restriction to them all. -
REACH Data-Sharing: Issues Arise For Lead Registrants
Sep 20, 2016 | Chemical Watch
By Jean-Philippe Montfort
Over six months after the entry into force of the implementing regulation on joint submission and data sharing under REACH, a series of problems have crept in. And REACH lead registrants may face serious difficulties they would be well-advised to anticipate. -
Higher PFOA Restriction Limits 'Unjustified', NGOs Say
Sep 20, 2016 | Chemical Watch
Echa's Risk Assessment and Socio-economic Analysis committees (Rac and Seac) have not justified proposing higher restriction limits on perfluorooctanoic acid (PFOA,) NGOs say. -
Commission Lists EEA Efta Authorisation Decisions
Sep 19, 2016 | Chemical Watch
The European Commission has published a list of authorisation decisions taken by European Economic Area (EEA) European Free Trade Association (Efta) states in the first half of 2015. -
Ohio Supreme Court Blocks Fracking Measures From Ballot
Sep 20, 2016 | BNA Daily Environment Report
By Tripp Baltz
No Ohio residents will vote in the November election on whether to ban fracking locally after the Ohio Supreme Court affirmed that the secretary of state properly blocked ballot measures in four counties ( The state ex rel. Coover v. Husted, Ohio, No. 16-1247, 9/13/16). -
States, Industry Defend Overturning of Fracking Rule
Sep 20, 2016 | BNA Daily Environment Report
By Alan Kovski
The Bureau of Land Management is wrong to cite land management statutes as justification for the agency's 2015 attempt to regulate hydraulic fracturing on federal and Indian lands, the states of Wyoming, Colorado and Utah told an appeals court Sept. 16 (Wyoming v. Jewell, 10th Cir., No. 16-8068, 9/16/16). -
Energy Bill Can Boost American Innovation
Sep 19, 2016 | The Hill - Opinion
By Rich Powell and Christopher Guith
Amid the storm of party-line bickering and election-year hyperbole, it’s easy to lose faith in Congress. Perhaps nowhere is this truer than in our difficult national conversation on energy. -
Clean Power Plan Is Consistent With Law And History
Sep 19, 2016 | The Hill - Pundits
By Richard L. Revesz, Denise A. Grab and Jack Lienke
In a critical federal court hearing this month, challengers of the Clean Power Plan, the Obama administration's signature climate change policy, will characterize the Plan as an "enormous and transformative expansion" of the Environmental Protection Agency's (EPA) regulatory power. -
Will Congress Wade Into Dakota Access Controversy? It can
Sep 20, 2016 | E&E Daily
By Hannah Northey
Congress may soon have a small — and quickly closing — window of opportunity to weigh in on the fight surrounding the $3.7 billion Dakota Access pipeline. -
Dakota Access Pipeline Construction Sits Uneasily in Federal Hands
Sep 19, 2016 | Natural Gas Intelligence
By Richard Nemec
Whether construction of the $3.8 billion, nearly 1,200-mile Dakota Access oil pipeline is completed on schedule early next year will likely be determined by a volatile amalgam of political, regulatory and court actions that should culminate in the next two or three weeks, based on developments in federal court Friday. -
California Law on Climate Pollutants Is Nation's Toughest
Sep 20, 2016 | BNA Daily Environment Report
By Carolyn Whetzel
California must slash emissions of soot, methane and hydroflurocarbon gases from 2013 levels by 2030, according to a bill Gov. Jerry Brown (D) signed Sept. 19. -
California Governor Signs New ‘Super Pollutant’ Bill Into Law
Sep 19, 2016 | The Hill - E2 Wire
By Devin Henry
California Gov. Jerry Brown (D) has signed into law new standards for “super pollutants” like black carbon and methane. -
Hudson River Cleanup Not Complete, N.Y. Attorney General Says
Sep 20, 2016 | BNA Daily Environment Report
By Gerald B. Silverman
The Environmental Protection Agency shouldn't issue a certificate of completion to General Electric Co. for its work dredging polychlorinated biphenyls from the Hudson River until additional steps are taken to ensure that the remedial work was effective, according to a letter from the office of New York Attorney General Eric Schneiderman (D) released Sept. 19. -
UN ‘Confident’ Paris Deal Will Take Effect This Year
Sep 20, 2016 | BNA Daily Environment Report
By John Herzfeld
A Sept. 21 United Nations session on climate change will include announcements by large countries that are expected to fuel momentum toward ratification of the Paris climate agreement by the end of 2016, a UN official said Sept. 19.
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(ACC Mentioned) Why Traditional Economic Indicators Failed So Many This Cycle
Sep 19, 2016 | Investment News
By Brett F. Ewing and S. Lance Mitchell
Many economists believe a recession is still a possibility, which has been stoked by the breakdown in traditionally reliable indicators
Many economists hold the belief that a recession is still a possibility, which has been stoked by the breakdown in traditionally reliable economic indicators. These include economist favorites like the Industrial Production Index (IPI), the Baltic Dry Index (BDIY), the Change in Labor Market Conditions Index (LMCI) and the price of copper.
But are these long standing indicators really accurate?
Consider that we are multi-years into the dollar's rise and still, many economy watchers seemingly can't rework their models to interpret data for the extraordinarily strong U.S. currency and the effects it's having on global interactions and prices.
We believe that indicators like the BDIY and copper have been rendered completely useless by the effects of the dollar, the oversupply of product and the current en vogue switch to service based economies across the world. The two most obvious examples of this significant shift are Chinaand Saudi Arabia. Each of these countries' governments has realized the need and benefit of growing their impoverished middle class through the services sector instead of the highly volatile commodity and manufacturing sectors.
And both countries have now begun the difficult and painful process by moving sovereign investments away from these areas, which only adds to the harm already being created by the dollar on the effectiveness of indicators that capture almost exclusively commodity related growth.
Further, the IPI, which is the stalwart indicator for many economists, has been flashing bright red recession lights for months now. But unfortunately, this index is also disproportionately set towards industries that continue to be in great depression level downturns, yet represent little in the way of the makeup of our current service based economies. And its reliability is further compromised by a shifting and more efficient power grid and the prevalence of utility output as a component.
In contrast, we think that the Chemical Activity Barometer, which was developed by the American Chemistry Council, to now be a far superior leading indicator to industrial production. It grabs items with more pertinent data for the makeup of the economy we now find ourselves in today. The “CAB” has been found to consistently lead the U.S. economy's business cycle given its early position in the supply chain versus a large metal and mining focus in the Industrial Production numbers.
The CAB has been showing strong year-over-year growth and has been accelerating in the past few months. This is a very good sign for an eventual pickup in the more lagging IPI number.
Finally, we come to the recently ugly looking LMCI which is a Fed favorite used to gauge the health of the jobs market. Over the past few months this index has been trending down and worrying many market participants, as well as the Fed.
There are plenty of explanations for this. First, the working-age population is growing very slowly now that the two largest generations, Millennials and Baby Boomers, are very solidly already in the number. Second, the labor force participation rate will have a hard time growing substantially until lower income wages increase enough to get people excited about working again.
That's why we think the trajectory of payroll employment will continue higher at a steady, although slower, pace with 100k plus months being the exception and not the norm.
The bright spot in the employment picture continues to be wage growth,which for the last several years seem to focus on the very skilled higher paying jobs, but is now proliferating down to the lower income works. These higher wages for lower income workers, accompanied by minimum wage increases, could not only put more money in workers' pockets, but also help the labor force participation rate as well.
The economic table as it is currently set, shows a lower growth, but incredibly stable environment, but only if you interpret the data with the strong dollar in mind.
Brett F. Ewing is chief market strategist and S. Lance Mitchell is research director with First Franklin Financial Services
http://www.investmentnews.com/article/20160919/BLOG09/160919949/why-traditional-economic-indicators-failed-so-many-this-cycle
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US EPA Moves To Implement TSCA Section 6
Sep 20, 2016 | Chemical Watch
By W Caffey Norman
The US EPA last regulated a chemical under TSCA section 6, which provides for regulation of existing as opposed to new chemicals, in 1989. This 27-year hiatus is coming to an end, as the EPA has indicated that it expects to propose three such rules by late 2016.
As part of these rulemakings, the EPA convened Small Business Advocacy Reviews (SBARs) on 15 June. Its approach to implementing section 6, disclosed during those meetings, should be of great concern to the commodity chemicals industry.Occupational and consumer exposure
Surprisingly, the EPA’s SBAR presentations concentrated on occupational exposure. Based on workplan assessments, released in June 2014 for trichloroethylene (TCE) and for methylene chloride (dichloromethane or DCM) in August 2014, the EPA identified many occupational exposure scenarios that exceeded its target cancer risk range.
For TCE, the agency derived an acceptable exposure limit (AEL) of 0.4 parts per billion (ppb) as an eight-hour time-weighted average (TWA). This is 250,000 times lower than the current permissible exposure limit (Pel) of 100ppm, set by the Occupational Safety and Health Administration (Osha).
For DCM, the EPA derived a cancer AEL of 0.2ppm, over 100 times lower than the 25ppm limit set by Osha, when it adopted a comprehensive standard under section 6(b)(5) of the Occupational Safety and Health Act (OSH Act) for the substance.
As justification of its emphasis on the workplace, the EPA indicated to the small business representatives that it has authority to regulate occupational hazards. This is because the jurisdiction of Osha does not extend to all state and local government employees, self-employed workers, military personnel and certain other employees.
While true, this has been the case since enactment of the OSH Act in 1970, which preceded that of TSCA by six years. It has not been suggested that this limitation on Osha’s authority gives the EPA jurisdiction over the workplace.
And, according to the agency, the administration has no plans to revise its Pels for these compounds, while the EPA’s TSCA authority includes uses of toxic chemicals that cut across worker, public sector and consumer settings.
The EPA produced a letter from David Michaels, assistant secretary for occupational safety and health, to James Jones, the EPA’s assistant administrator for chemical safety and pollution prevention. This states “[g]iven certain limitations imposed on Osha’s authority under the OSH Act, this agency believes TSCA provides the EPA with a means of eliminating or reducing the risks associated with these chemical uses in a more coordinated fashion, across both consumer and occupational settings.”
The EPA also disclosed in the SBARs that it is considering restricting sales of DCM to 55-gallon drums in order to reduce consumer exposure.
This would eliminate the sale of DCM-based paint strippers to consumers and decimate the commercial refinishing market as well.
The EPA appears to be prepared to act without reference to the Federal Hazardous Substances Act (FHSA), pursuant to which the Consumer Product Safety Commission (CPSC) issued a statement of enforcement policy in 1987. This specifies uniform cautionary labelling for all household products containing methylene chloride.
It is odd that the EPA would choose DCM for one of its inaugural TSCA rulemakings, given that it already conducted a priority review of the risks of human cancer from DCM exposure in 1985. This was under a different, and substantially unchanged, provision of TSCA, section 4(f).
Following referrals from this review, Osha and CPSC took action on the exposures to the substance under their respective jurisdictions, action which the EPA now appears ready to displace.Environmental exposure
Neither the TCE nor the DCM workplan assessment relies upon, or even references, information on the very uses of concern already required to be reported to the EPA.
The TCE assessment uses an incorrect baseline for exposure from vapour degreasing. This is because the data referenced in the assessment predates the May 2010 compliance deadline, established in the 2007 National Emission Standard for Hazardous Air Pollutants (NESHAP) for Halogenated Solvent Cleaning.
Similarly, the EPA’s DCM workplan assessment does not reflect the conditions, following implementation of the EPA’s NESHAP for Paint Stripping and Miscellaneous Surface Coating Operations at Area Sources (or, for that matter, the Osha section 6(b)(5) standard).
It is regrettable that the EPA’s assessments for TCE and DCM fail to start with the detailed study and analysis already carried out by the EPA Air Office in regulating these sources under the Clean Air Act. This requires these NESHAPs to ensure an “ample margin of safety to protect public health”.TSCA section 9
As originally enacted, and updated by the Lautenberg Chemical Safety Act, TSCA requires the EPA to consult and coordinate with other federal agencies “for the purpose of achieving the maximum enforcement of this Act, while imposing the least burdens of duplicative requirements on those subject to [it]...”
Worker and consumer health and safety fall under the jurisdictions, respectively, of Osha and the CPSC. The uses of TCE in vapour degreasing and DCM in paint stripping are adequately regulated under the OSH Act and/or the FHSA.
This framework provides adequate protection with respect to the same potential adverse impacts and potential exposure pathways, targeted by the current EPA initiative.
Taking steps that may lead to the removal of products from the marketplace, because workers or consumers failed to comply with the existing legal requirements, is not consistent with the original or revised version of TSCA.
The basis for the EPA’s broad assertion of jurisdiction over occupational and consumer uses is unclear. The Lautenberg Act eliminated the requirement in TSCA section 6(a) that the agency protect “against [unreasonable] risk using the least burdensome requirements”.
But it did not materially change the existing framework that requires unreasonable risks to be addressed under statutory authority, other than TSCA, wherever possible.
TSCA section 9(a) requires, as it has since 1976, the EPA to refer an unreasonable risk to the agency required to take action on it.
TSCA section 9(b) is the intra-agency counterpart to section 9(a). It requires the EPA to “coordinate” actions taken under TSCA with those taken under other statutes administered by the agency.
If the EPA determines that a chemical risk “could be eliminated or reduced to a sufficient extent by actions taken under the authorities contained in such other Federal laws, the administrator shall use such authorities to protect against such risk,” unless they determine that “it is in the public interest” to proceed under TSCA.
Indeed, the Lautenberg Act strengthened TSCA section 9(b) by including a provision, formerly in TSCA section 6, requiring the EPA to make such a public interest determination. But also to compare “the estimated costs and efficiencies of the actions to be taken under [TSCA] and an action to be taken under such other law.” It was clear from the outset that TSCA is to be used only when other statutes fail to provide a remedy for unreasonable risks. Workplan assessments and TSCA section 6, 26
The EPA appears ready to impose its authority on the workplace and consumer uses, in spite of TSCA section 9’s limits on this.
On the other hand, although significant changes were made to ensure that the agency would employ the “best available science” in its risk assessments, it seems poised to rely on remarkably sketchy and inadequate assessments in its inaugural rulemakings under TSCA section 6.
With regard to the workplan assessments completed prior to passage of the Lautenberg Act, TSCA section 26(l)(4) provides that “the administrator may publish proposed and final rules under section 6(a) that are consistent with the scope of the completed risk assessment for the chemical substance and consistent with other applicable requirements of section 6.”
And so the EPA may base regulation on the pre-enactment risk assessments only to the extent that they comply with the substantive “best available science” requirements of section 26(h) and (i). This includes making decisions based on the weight of the scientific evidence, taking into account peer review and the like.
Following enactment of the Lautenberg Act, it should be clear that a risk evaluation that supports a TSCA section 6 rule must be more robust than the screening level workplan assessments that the EPA conducted for TCE and DCM.
Peer review and public comments identified numerous scientific deficiencies with the draft workplan assessments, including:the inappropriate use of default assumptions;ignoring contrary evidence or “cherry picking”, instead of basing conclusions on the weight of the scientific evidence;reliance on inapposite exposure data;conclusions inconsistent with the evidence cited; andreliance on a study that is not reproducible.
Equally important shortcomings in both the hazard and exposure assessments were noted.
Whatever “best available science” may mean, it cannot include reliance on an unreproducible toxicity study or outdated exposure information.
And certainly the EPA can no longer afford to ignore the conclusions of a peer review it initiated.Implications for other chemicals
There is nothing unique or unusual about TCE or DCM that would limit the EPA’s apparent over-reaching to their uses.
It initially targeted them because of concerns about consumers and small workplaces, but is now looking at much broader regulation.
The agency has derived cancer potency factors for dozens of widely used compounds (see box). Such substances could effectively be banned from the workplace under the approach the EPA is considering.
The table below shows the EPA’s cancer potency factors for six other such chemicals, selected at random.
* Cal Pel for lead and compounds, ACGIH TLV for TCE. The author acknowledges with appreciation the assistance of Rick Reiss and Paul Turnham of Exponent in preparing the table above.
https://chemicalwatch.com/49729/us-epa-moves-to-implement-tsca-section-6
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New-Chemical Makers Face More Consent Orders, EPA Says
Sep 20, 2016 | BNA Daily Environment Report
By Pat Rizzuto
The Environmental Protection Agency will be asking manufacturers of new chemicals to sign consent orders that delineate the manufacture and use of their substances more frequently than it did before the Toxic Substances Control Act was amended, a senior agency official told Bloomberg BNA Sept. 19.
If the production method and uses anticipated by a manufacturer of a new chemical would not be likely to pose an unreasonable risk—but other manufacturing methods or uses of the chemical might—the agency now is requiring the original manufacturer to legally bind itself to the production, worker safety, environmental release restrictions and other conditions it described in its premanufacture notice (PMN), Wendy Cleland-Hamnett, director of the EPA's Office of Pollution Prevention and Toxics, told Bloomberg BNA. Chemical manufacturers that want to make a new chemical—meaning one that has not previously been made in or imported into the United States—must submit premanufacture notices at least 90 days before they intend to make the new molecule.
The need for notice submitters to sign more consent orders is spurred by a requirement in the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182), which amended TSCA as of June 22, Cleland-Hamnett said.
Prior to the Lautenberg Act becoming law, the agency's new chemicals office developed numerous toxicity and environmental fate prediction models to help staff anticipate potential health and environmental concerns and exposures, but now the law mandates those considerations.
Under the Lautenberg Act, however, as the EPA reviews premanufacture notices it is required to consider the “intended, known, or reasonably foreseeable circumstances under which a chemical is manufactured, processed, distributed, disposed of, or used.”
A consent order binds the original manufacturer of a new chemical to making the chemical as it said it would in its premanufacture notice, Cleland-Hamnett said. The agency can then issue a significant new use rule to restrict any other new chemicals manufacture to the same manufacturing and use conditions, she said.
90 Days Since Amended Toxics Act Became Law
Bloomberg BNA requested the interview on Sept. 19 because that day marked 90 days after the Lautenberg Act went into effect. That means the agency was required to take some type of action on the more than 300 premanufacture notices (PMNs) that it was reviewing when the Lautenberg Act became law. The actions available to the EPA include allowing a new chemical to enter commerce, asking the company that wants to make the new chemical for additional toxicity or exposure data, or asking the company to voluntarily suspend the 90-day clock while it and the agency address questions. Under both the original and amended TSCA, the EPA has 90 days to review premanufacture notices.
The agency was unable to provide Bloomberg BNA by Sept. 19 specific numbers to document how many data requests, decisions or other actions it had made regarding the 334 notices that Cleland-Hamnett said were under review on June 22.
The EPA “reset” the 90-day clock on June 22 for each of the 334 notices that was under review the day the Lautenberg Act became law. The agency took that action for two reasons.
First, the agency needed to review the notices using the new “reasonably foreseeable conditions of use” and other criteria focused on preventing unreasonable risks to potentially exposed or susceptible populations.
Second, the agency needed to comply with a new procedure the law requires. Under the original TSCA, if the EPA took no action as it reviewed a new chemical, the substance could enter the market after 90 days.
The Lautenberg Act changes that by requiring the EPA to make a specific, or “affirmative,” finding about each new chemical it reviews. The agency may conclude a new chemical “is not likely to present an unreasonable risk” or, if the chemical does pose an unreasonable risk or might, the law requires the agency to restrict the chemical's manufacture or use in some way to prevent that potential health or ecological harm.
Agency Boosts Staff
Cleland-Hamnett said, after the initial few weeks, the Lautenberg Act did not significantly delay the agency's new chemical reviews. Initially, her office needed to work with the agency's Office of General Counsel to understand how to implement the new law and how to document its conclusion in an “affirmative finding,” she said.
The backlog also built up because, as of June 22, the agency had to re-review PMNs that it had received—but not finished analyzing—before the Lautenberg Act became law while it continued to receive and review new premanufacture notices, Cleland-Hamnett said.
To handle that temporary backlog, the agency recruited some staff working in other parts of the agency to the chemicals office on 4-month details. Staff within OPPT's Risk Assessment Division, who already focus on new and existing chemicals, were asked to focus specifically on new chemicals, Cleland-Hamnett said.
The agency also increased the frequency of new chemical review meetings it holds where multiple staff discuss issues about chemicals under review, she said.
Nevertheless, according to trade associations and law offices Bloomberg BNA spoke with on Sept. 19, the agency has not reached final decisions on many of the premanufacture notices that it has been reviewing.
That's not unusual, Cleland-Hamnett said. The agency often asks chemical manufacturers to voluntarily stop the 90-day clock to address questions that arise during new chemical reviews, and chemical manufacturers typically agree.
When the Lautenberg Act went into effect, companies that wanted to make more than 200 of the 334 new chemicals under review already had voluntarily agreed to stop the 90-day clock, she said.
The agency did not have to immediately ask these manufacturers to keep the clock suspended, since they already had done so, she said. But now that the first 90-day review period is complete, the agency is contacting the manufacturers and making that request, she said.
More Information Helps Agency's Reviews
Chemical manufacturers could reduce the time the agency spends reviewing new chemicals if they provided more information when they submit premanufacture notices, Cleland-Hamnett said.
Neither original TSCA nor the Lautenberg Act imposes any minimum data set on PMN submitters. Companies often have information that would be useful to receive, however, she said.
Many of the agency's decisions about new chemicals, for example, are based on existing analogous substances, she said. If a company that submits a notice thinks there is an analogous chemical, it would be useful to know that and the rationale for that at the time the notice is submitted, Cleland-Hamnett said.
Otherwise, the question of which chemical provides a good surrogate for the new chemical becomes an issue the agency and submitter of the request must address in the midst of the review, she said.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=97506100&vname=dennotallissues&fn=97506100&jd=97506100
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(ACC Mentioned) Chromium-6: 'Erin Brockovich' Chemical Threatens Two-Thirds Of Americans
Sep 20, 2016 | The Guardian
By Tafline Laylin
‘We simply can’t continue to survive with toxic drinking water,’ says Erin Brockovich, as a new report finds 200 million people exposed to chromium-6
In the 2000 biographical film about a legal clerk who brings a major utility company to its knees for poisoning residents of Hinkley, California, Erin Brockovich ended on a Hollywood high note with a $333m settlement from PG&E. But chromium-6 contamination of America’s drinking water is an ongoing battle the US Environmental Protection Agency (EPA) is losing.
Nearly 200 million Americans across all 50 states are exposed to unsafe levels of chromium-6 or hexavalent chromium, a heavy metal known to cause cancer in animals and humans, according to a new report released Tuesday by the nonprofit research and advocacy organization Environmental Working Group (EWG).
Today, Brockovich says Hinkley wasn’t an isolated event.
“The water system in this country is overwhelmed and we aren’t putting enough resources towards this essential resource,” Brockovich wrote in an email to the Guardian. “We simply can’t continue to survive with toxic drinking water.”
We simply can’t continue to survive with toxic drinking water.Erin Brockovich
In their analysis of the EPA’s own data collected for the first nationwide test of chromium-6 contamination in US drinking water, the report’s co-authors Dr David Andrews and Bill Walker, senior scientist and managing editor of EWG, found that 12,000 Americans are at risk of getting cancer.
Drinking water in Phoenix, Arizona, has the highest concentration of chromium-6 contamination. Of the 80 water samples taken across the city – water that serves 1.5 million people – 79 showed average concentrations of 7.853 ppb. California scientists have recommended a public health goal of 0.02 ppb, but industry pressure led to the adoption in 2014 of a legal safe limit of 10 ppb.
“More than two-thirds of Americans’ drinking water supply has more chromium than the level that California scientists say is safe – a number that’s been confirmed by scientists in both New Jersey and North Carolina,” according to Walker.
“Despite this widespread contamination, the US currently has no national drinking water standard for chromium-6.”
Dr Andrews said: “Part of the reason behind writing this report is really highlighting how our regulatory system is broken – in its ability to incorporate new science, and its ability to publish and update drinking water standards.”
Hexavalent chromium is used in a variety of processes: leather tanning, chrome-plating and small cottage industries that use dyes and pigments. But few unleash as much of it into the environment as the electric power industry.
“In 2009, the electric power industry reported 10.6m pounds of chromium and chromium compounds were released to the environment,” according to a 2011 Earthjustice report. “These 10.6m pounds represent 24% of the total chromium and chromium compounds released by all industries in 2009.”
In 2008, the National Toxicology Program, part of the National Institutes of Health, released a report detailing how cancerous tumors developed in mice and rats that drank heavy doses of chromium-6.
According to EWG, based in part on this study, scientists at the California Office ofHealth Hazard Assessment concluded in 2010 that ingestion of tiny amounts of chromium-6 can cause cancer in people.
The Agency for Toxic Substances and Disease Registry, an advisory, non-regulatory agency formed to oversee hyper-toxic Superfund sites, reports long term oral exposure to unsafe levels of chromium-6 compounds are associated with gastrointestinal system cancers.
“The California scientists set a so-called public health goal of 0.02 parts per billion in tap water, the level that would pose negligible risk over a lifetime of consumption,” according to the EWG report.
“But in 2014, after aggressive lobbying by industry and water utilities, the state regulators adopted a legal limit 500 times the public health goal.”
EWG says the California Department of Public Health relied on a flawed analysis that “exaggerated the cost of treatment and undervalued the benefits of stricter regulation”.
The report also details how New Jersey and North Carolina scientists recommended a maximum chromium-6 concentration of 0.06 parts per billion following the 2008 report, meeting similar resistance that has impeded passage of drinking water standards.
In their first major chromium-6 report in 2010, EWG found chromium-6 contamination levels 600 times the public health goal in Norman, Oklahoma – the worst found in 31 of 35 US cities tested. Those tests, and a petition from environmental activists, triggered the EPA to add chromium-6 to the list of chemicals for which local utilities must test under the Unregulated Contaminant Monitoring Rule, according to EWG.
This rule requires the EPA to establish a new list every five years of 30 previously unregulated contaminants to be monitored by public water systems.
In the 20 years since the 1996 Safe Drinking Water Act amendments passed to monitor previously unregulated contaminants, the EPA ordered 81 contaminants to be monitored. To date, only perchlorate, a rocket fuel ingredient, has been recommended for regulation. Though two years behind schedule, implementation has yet to occur.
Asked what steps are necessary to fix the country’s broken drinking water program, Dr Andrews said: “One of the first steps has to occur here: EPA has to be able to complete its health risk assessment about the toxicity of chromium-6.”
EWG reports that in 2010, scientists in the EPA’s Integrated Risk and Information System (Iris) “completed but did not officially release a draft risk assessment that classified oral exposure to chromium-6 as ‘likely to be carcinogenic to humans’”.
But the American Chemistry Council, a powerful lobby for the chemical industry, requested that the EPA withhold the release until after studies funded by the Council and the Electric Power Research Institute could trace the biological mechanisms through which chromium-6 triggers cancer.
Dr Vincent Cogliano, director of Iris, initially resisted industry pressure. In an April, 2011 letter to Ann Mason at the American Chemistry Council, he congratulated their willingness to invest $4m in targeted research on hexavalent chromium, but he denied their request for a delay.
“Without prejudging the outcome of mechanistic studies being written up for publication,” he wrote, “it is entirely possible that granting your request could entail a delay of unknown duration with no public discussion or review of the strong new studies that are now available.”
But then an external review panel, found by the Center for Public Integrity to include three members who consulted for PG&E in the Brockovich case, convinced the EPA to grant the American Chemistry Council time to fund their own studies.
In 2012, the EPA quietly announced it had decided to delay the draft risk assessment following the review panel’s recommendation.
Cogliano wrote in an August 24 email to EWG: “We expect to release a draft health assessment document in 2017, though I wouldn’t use the word ‘early’.”
In an email statement to the Guardian, EPA said: “Ensuring safe drinking water for all Americans is a top priority for EPA.”
The EPA says that less than 2% of the latest national monitoring systems reported hexavalent chromium at levels exceeding California’s enforceable maximum contaminant level of 10ppb.
The EWG report, however, found that “even by that far-too-lax benchmark ... more than seven million Americans are served tap water from supplies that had at least one detection of chromium-6 higher than the only legal limit”.
Erin Brockovich urges Americans to disregard the EPA’s reassurances and to take a more active role in their communities to fix the country’s broken water supply.
“Superman’s not coming,” Brockovich said. “Be informed, ask questions, band together with your community and fight at the local level. And make sure you take your local elections as seriously as the national ones. The issues that most impact the average person are made at the local level.”
https://www.theguardian.com/lifeandstyle/2016/sep/20/chromium-6-erin-brockovich-chemical-threatens-two-thirds-of-americans-erin-brockovich
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(ACC Mentioned) Chromium-6 Found Elevated Levels Water 200 Million Americans
Sep 20, 2016 | Newsweek
By Douglas Main
Hexavalent chromium is known to cause several types of cancer in humans.
Nationwide tests have detected the carcinogen chromium-6 at levels higher than those recommended by some state agencies in the tap water of more than 200 million Americans.
Also called hexavalent chromium, the compound is best known as the pollutant discharged by the Pacific Gas and Electric Company into the drinking water of residents of Hinkley, California. That led to a famous lawsuit, in which environmental activist Erin Brockovich was involved, wherein the company paid $333 million to settle the case in 1996.
A report by the Environmental Working Group first published online September 19 shows that the tap water of 218 million Americans contains levels of chromium-6 above 0.02 parts per billion. California's Office of Environmental Health Hazard Assessment adopted that concentration as its “public health goal” in 2011. This is the level below which the agency believes there is no more than a one-in-a-million risk of a person developing cancer over their lifetime. It’s similar to public health goals set by the states of North Carolina and New Jersey, at 0.07 ppb.
Perry Cohn, a retired environmental epidemiologist with the New Jersey Department of Health, who was involved in setting the state’s standard, said the Environmental Working Group’s conclusions were extremely concerning.
“This is quite shocking, to be honest,” said Brockovich of the level of contamination detailed in the report. She has dealt with issues involving chromium-6 for 25 years, ever since her involvement in the Hinkley case, and said that she knew “it was always lurking around,” and not specific to just that town. But she didn’t know it was this widespread. As a known carcinogen, chromium-6 will lead to avoidable cases of cancers when present at levels above those set by New Jersey and California, she added.
The report estimates that the chemical “will cause more than 12,000 excess cases of cancer by the end of the century," beyond the number of cases that would be expected if the contaminant were uniformly found at 0.02 ppb.
Sam Delson, with California’s Office of Environmental Health Hazard Assessment, said that at 0.02 ppb, “if a million people were to drink water with this level of chromium-6 for a lifetime of 70 years, we would theoretically expect one additional case of cancer,” Delson says. The cancer risk at 10 ppb “would be 500 in one million.”
Hexavalent chromium is a form of chromium that’s produced by and used in a variety of industries, from metalworking to the manufacture of paints and dyes. The chemical is “a well-established carcinogen associated with lung, nasal and sinus cancer,” according to the National Institute for Occupational Safety and Health.
The report relies on tests mandated by the EPA, in which utilities throughout the country took more than 60,000 water samples to look for chromium-6 from 2013 to 2015. The data was made available in April, but hadn’t before been synthesized in a collective whole, say the report’s authors, vice president Bill Walker and senior scientists David Andrews.
The EPA doesn’t have an enforceable standard specific to chromium-6. Rather, the agency caps total levels of chromium (including hexavalent chromium) at 100 ppb. In a statement, the agency said that it is currently working on a risk assessment for chromium-6, which is expects to release for public comment in 2017.
The report argues that chemical companies have stymied the EPA’s progress on regulating this compound, a conclusion with which Cohn and Brockovich agree. Walker and Andrews said that the EPA finished a draft report on the contaminant in 2011, but delayed its finalization after interference from various companies.
This has happened with other chemicals as well, the pair argue. According to a 1996 amendment to the Safe Drinking Water Act, the EPA is required to test up to 30 previously unregulated contaminants every five years, and presumably set new regulations for some of them. In the past two decades, the agency has ordered tests for 81 chemicals and only set new regulations for one chemical, perchlorate. But the agency “is two years behind schedule on finalizing and implementing the regulation” for the chemical, the report notes.
Despite a public health goal of 0.02 ppb, the state of California has adopted an enforceable standard for the chemical at 10 ppb. The Environmental Working Group suggests that this limit is too high to protect human health, and that the standard was softened as the result of intensive lobbying by utilities and chemical companies. Pacific Gas and Electric, one of the companies alleged to be involved in that lobbying process, declined to comment on the report.
The enforceable health standard, also known as the maximum contaminant level, is supposed to be set as close to the public health goal as “technologically and economically feasible” to “avoid any significant risk to public health,” according to the report.
Even still, the report found that more than 7 million Americans have tap water with a reported level of hexavalent chromium above 10 ppb.
Chromium-6 ends up in water via pollution, but also may be naturally occurring. Walker and Andrews said it isn’t yet clear how much of the nation’s chromium is due to pollution versus natural processes.
The American Chemistry Council, a group that represents industry, said in a statement that the report “does not provide any new information about hexavalent chromium in the water supply,” as it relies on data that was publicly available earlier this year. “EPA’s data show that when hexavalent chromium is found in the groundwater, it’s present at low levels that are well below the national drinking water standard set by the EPA,” the group said. It also noted that the council has “supported a third-party research organization to undertake a large, multiple-institution research study.”
The report notes examples of how industry has influenced chromium regulation in the past. As The Wall Street Journal reported in 2005, consultants hired by Pacific Gas and Electric paid for data produced by a Chinese scientist named Zhang JianDong, which demonstrated adverse health effects of chromium-6 pollution. After Zhang retired, the consultants altered the data to be more favorable toward the chemical and published it under Zhang’s name, without disclosing their involvement, according to the Journal. This new conclusion “soon found its way into U.S. regulatory assessments, as evidence that ingested chromium wasn't really a cancer risk,” the publication noted. However, that changed after industry’s involvement was uncovered, and chromium’s status as a carcinogen is not disputed.
Bill Wolfe, with Public Employees for Environmental Responsibility, a group that protects government whistleblowers, says the EPA is “absolutely not” doing its job to protect the public from chromium, and that it’s a case that “illustrates undue influence—agency capture—by major corporate polluters.”
The EPA said in a statement that "ensuring safe drinking water for all Americans is a top priority," but didn’t immediately respond to a request for comment on allegations of industry influence.
http://europe.newsweek.com/chromium-6-found-elevated-levels-water-200-million-americans-500421
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(ACC Mentioned) High Levels Of 'Erin Brokovich' Chemical In Many NJ Water Systems, Study Says
Sep 20, 2016 | NJ Spotlight
By Jon Hurdle
Chromium 6 has been linked to several types of cancer; environmental group says it is unsafe even at low levels
Drinking water in more than 150 New Jersey water systems contained the carcinogenic chemical chromium 6 at levels that exceeded a health limit recommended by California scientists when the local systems were tested by the U.S. Environmental Protection Agency, according to a national analysis published on Tuesday.
The study by the Environmental Working Group, a research and advocacy nonprofit, concluded that 218 million Americans in all 50 states, or some two-thirds of the population, are drinking water that contains the chemical at levels that are above the proposed California health limit but below current limits adopted by both that state and the federal government.
The chemical, best known for having been exposed as a threat to public health by the environmental campaigner Erin Brockovich, a battle depicted in the movie starring Julia Roberts, was found in different concentrations around New Jersey when the U.S. Environmental Protection Agency tested water systems in 1,370 counties across the country from 2013 to 2015.
The EWG combined the previously published the EPA data with a health limit proposed by the California Office of Health Hazard Assessment to calculate the national population that is exposed to the chemical in drinking water at above a limit of 0.02 parts per billion (ppb) recommended by the California panel.
The recommended standard was far stricter than a 10 ppb level that is now set as a legal limit in California, the only state to regulate the chemical so far, EWG said. It argued that the much less-rigorous limit reflected commercial and political pressures that were exerted on regulators in California and other states.
“Federal regulations are stalled by a chemical industry challenge that could mean no national regulation of a chemical state scientists in California and elsewhere say causes cancer even when ingested at extraordinarily low levels,” the EWG report said.
Chromium 6, which is used in steel making, chrome plating, and, as in the Brockovich case, lowering water temperature in the cooling towers of power plants, has been linked to lung cancer, liver damage, and reproductive and developmental problems.
In New Jersey, some of the highest concentrations were found in the Ridgewood Water system in Bergen County, where the chemical was found at above the proposed California level in 56 locations with an average of 0.398 ppb, or almost 20 times the recommended California standard. In Burlington County, the average level was 0.491 ppb in the Mount Holly system operated by New Jersey American Water, according to the EPA data.
A representative of New Jersey American Water did not return a phone call seeking comment.
While many New Jersey utilities exceeded California’s recommended health limit, none topped California’s legal limit of 10 ppb, the data show.
New Jersey’s Drinking Water Quality Institute, a state panel of scientific advisers, considered recommending a chromium 6 health limit of 0.07 ppb in 2010. The proposal never reached the desk of DEP Commissioner Bob Martin because the DWQI stopped meeting at that time because of a shortage of members, according to Larry Hajna, a spokesman for the DEP.
The DWQI resumed its work in 2014 and is due to meet this week to issue its recommendation for a maximum contaminant limit on another toxic chemical, PFOA, which has also been linked to cancer and other illnesses.
New Jersey currently follows the EPA’s recommended guidance limit of 100 ppb for total chromium — a combination of chromium 6 and chromium 3 — in drinking water, Hajna said.
Dr. Keith Cooper, a Rutgers University toxicologist who chairs the DWQI, said he couldn’t comment on what the panel considered in 2010 because he was not involved with it then. But he said chromium 6 could become part of the DWQI’s work in the future.
“The current NJ DWQI in the future will likely review previously proposed levels, if nothing else to see if new information and current exposure warrants the chemical of concern to be assessed,” Cooper wrote in an email.
Bryan Goodman, director of product communications for the American Chemistry Council, said the EWG report contained no new data on chromium 6, also known as hexavalent chromium, in the water supply.
Goodman said that when the chemical is found in ground water, it is present at low levels that are well below the EPA’s national drinking water standard. He said there is limited scientific data on how human health could be affected by low naturally occurring levels of the chemical, and so the council has supported third-party research into the issue.
“This is a positive example of industry supporting independent, peer-reviewed research to inform regulatory decisions about hexavalent chromium and drinking water,” Goodman wrote in an email.
North Carolina’s Department of Environmental Quality recommended a limit of 0.06 ppb, but, like New Jersey, has not set a legal limit for chromium 6 in tap water, EWG said.
“In both states, scientists’ health-based recommendations were at odds with the decisions of politically appointed regulators,” the EWG paper said.
Bill Walker, who wrote the report with the EWG’s Senior Scientist David Andrews, said the group was publishing its analysis as the latest stage of a campaign in which it conducted its own tests for chromium 6 in 35 cities in 2010 and found the chemical in 25 systems at levels exceeding the California health standard.
In its new study, EWG published a list of 22 major metropolitan water systems serving at least 1 million people where the chemical exceeded the recommended California limit. None of the systems exceeded California’s legal limit.
“We want people to be aware that the EPA is dragging its feet on setting a national drinking water standard; that the chemical industry and the electrical power industry have delayed that process, and that as a result of industry influence, the EPA might eventually decide to do nothing,” Walker said.
http://www.njspotlight.com/stories/16/09/19/high-levels-of-erin-brokovich-chemical-in-many-nj-water-systems-study-says/
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(ACC Mentioned) Chemical Manufacturers Get Extra Month to File Data With EPA
Sep 20, 2016 | BNA Daily Environment Report
By Pat Rizzuto
The Environmental Protection Agency announced Sept. 19 a deadline extension until Oct. 31 for chemical manufacturers to submit production volume and other data.
The deadline for chemical manufacturers and importers to submit production volume, worker exposure and other information required by the EPA's Chemical Data Reporting, or CDR, rule was Sept. 30. The EPA said it granted the one month extension in response to concerns the American Chemistry Council voiced in an Aug. 30 letter.
The EPA uses the reporting rule data to assess potential human health and environmental effects of chemicals in commerce.
Problems chemical manufacturers encountered included data being deleted in situations where companies had merged and unannounced outages of the web-based Central Data Exchange through which manufacturers submit their information, the chemistry council said.
Another complication is that as the EPA's help desk has sought to offer “fixes,” it has sometimes directed chemical companies to use servers, such as Google Chrome, that a particular company isn't allowed to use, the chemistry council said.
The challenges these and other problems cause is a larger concern because companies have to submit much more information this year than they have in the past, the council said.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=97506089&vname=dennotallissues&wsn=499101500&searchid=28439593&doctypeid=1&type=date&mode=doc&split=0&scm=DELNWB&pg=0
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(ACC Mentioned) EPA Extends CDR Deadline After Chemical Industry Raises Usage Concerns
Sep 19, 2016 | Inside EPA
EPA has extended by a month the deadline for companies to submit data on their manufacture, production and importation of chemicals under the Chemical Data Reporting (CDR) rule, following chemical industry complaints that problems with the agency's web-based electronic reporting tool were making it difficult to meet the original deadline.
“EPA is amending the Toxic Substances Control Act (TSCA) [CDR] regulations by extending the submission deadline for 2016 reports from September 30, 2016 to October 31, 2016,” according to a notice EPA released Sept. 19 that will soon appear in the Federal Register. “This is a one-time extension for the 2016 submission period only,” the notice says.
The notice adds that “compelling concerns raised by industry include delays in reporting as a result of issues associated with several aspects of electronic reporting. EPA believes it is appropriate to extend the reporting period to allow the regulated community additional time to submit their reports.”
The request comes in an Aug. 30 letter from the chemical industry association American Chemistry Council (ACC), which urged EPA for a 30-day extension.
“The current submission period began June 1, 2016. Since then, and over the course of the summer, our members have reported a wide variety of electronic system issues that have significantly delayed the ability to upload and validate electronic data submissions. Among other things, companies have experienced issues with validation delays, timeouts, program freezes and restarts,” ACC's Vice President Michael Walls writes to the director of EPA's toxics office, Wendy Cleland-Hamnett.
ACC outlines a series of concerns, beginning with “insufficient technical support available,” especially during the last few weeks of the submission period when “it is likely that the demand for EPA help desk, consultant, and staff time with one-on-one support needs will soar.”
The organization says the issues with the electronic reporting tool are compounded by the fact that this is the first time the data covers four years and because “the threshold for reporting has dropped significantly for a number of chemicals undergoing certain regulatory actions. The effect is that the size and scale of the total industry submission has swelled, further stressing the system.”
Concerns with these lowered reporting thresholds dogged the months leading up to the CDR publication, as some trade groups raised concerns that EPA has not provided a list of which chemicals fell subject to these first-time lowered reporting thresholds.
The CDR, in place since 2012, is EPA's main source of exposure information for most industrial chemicals. The rule requires companies to submit information to EPA every four years on the amounts of chemicals greater than 25,000 pounds that they manufactured, imported or processed in certain categories. For the first time in 2016, the rule also requires companies to submit this information for production, processing or importation of more than 2,500 pounds annually of certain other chemicals that may face regulatory action.
But one industry source says that EPA addressed those concerns with a new guidance “on how companies can search for chemicals subject to certain TSCA actions -- which impact the CDR reporting threshold,” addressing the previous concerns.
http://insideepa.com/daily-news/epa-extends-cdr-deadline-after-chemical-industry-raises-usage-concerns
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Endocrine Disruptors: Criteria, Testing And Assessment
Sep 20, 2016 | Chemical Watch
By Martina Duft
Endocrine disruptors, their definition and criteria as well as feasible options for testing and assessment, have been extensively worked on and discussed in science and regulatory panels. The debate has engaged the public and national and global political agendas.
Meanwhile, the WHO/IPCS definition of an endocrine disruptor is unanimously agreed upon:
“An exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse effects in an intact organism, or its progeny, or (sub)populations.”
Consequently, distinct adverse effects and their causal relationship to substance exposure, by a proven endocrine mode of action, need to be established.
By contrast, the scientific criteria for their identification have been the object of fierce and tedious detailed discussions. Finally, on 15 June, the European Commission presented its long-awaited draft scientific criteria to identify endocrine disruptors (EDCs) in the field of plant protection products and biocides.
This announcement was preceded by an expert meeting, organised by the Federal Institute for Risk Assessment (BfR) in Berlin in April. The meeting resulted in a consensus paper, essentially suggesting the presented criteria.
It must be noted that these criteria are not yet adopted. In the context of the plant protection products Regulation, the draft legal text will be voted on by the member states. In that of the biocidal products Regulation, it will be discussed by a group of member state experts before going to the Commission. The legal text may still see further changes before its ultimate adoption, which is foreseen the end of 2016 or early 2017. For the sake of consistency, it is envisaged that both texts will be presented simultaneously to the Parliament and Council by the Commission.
Option two has been selected from four, which were under discussion. The options were:option 1: no policy change (interim criteria);option 2: identification according to WHO/IPCS definition;option 3: WHO definition plus additional categories; andoption 4: WHO definition with the inclusion of potency.
Thus, in principle the WHO definition without consideration of potency is the selected approach. Further, the ground for possible derogations under the plant protection products (PPPs) legislation is expected to be adjusted. This is to take into account the latest scientific knowledge and make the best use of available evidence, including information related to exposure and corresponding risk.
However, overall the hazard-based approach for PPPs and biocides, for the general public, will be maintained, meaning substances can be banned without taking into account exposure or risk assessment. Exceptions for professional uses may be granted. But only if negligible risk can be demonstrated, or the necessity of the substance to combat serious pests, which cannot be contained by other available means (PPPs and biocides); or there are disproportionate negative impacts of non-approval of the substance on society, when compared to the risks (biocides only).
This is in contrast to the position advocated by European industry, which argues that the WHO/IPCS definition alone is not sufficient for making a clear distinction between substances of high concern that pose a risk to human health and environment, and those that don’t. All available and relevant scientific information, including potency, should be considered when evaluating a substance for its potential endocrine-disrupting properties.
However, NGOs say that the burden of proof for a substance to be identified as an EDC seems rather high, and that causality is difficult to prove.
Meanwhile, until final scientific criteria are agreed on and adopted, interim criteria for toxicology still apply for PPPs/biocides. Carcinogenic category 2 and toxic for reproduction category 2 – shall be considered as EDC, or toxic for reproduction category 2 and specific effects on target organs – may be considered as EDC. However none are available for wildlife.Current regulatory developments worldwide
European Union
A community strategy for EDCs was developed by the Commission in 1999. It involves regular updates on implementation, including a priority list of substances for further evaluation. In 2014, the roadmap on “Defining criteria for identifying endocrine disruptors in the context of the implementation of the plant protection products Regulation and biocidal products Regulation” was presented.
It included a public consultation (report published in July 2015) and an impact assessment (IA) (published in June 2016), to evaluate health, socio-economic and environmental impacts of the different options for the criteria and their implementation in the respective legislations.
The IA was supported by two studies, which selected substances and screened them for their potential to be identified as EDCs according to the options. And an assessment of the potential impacts on health, environment, trade, agriculture and socio-economics was made. The screening is guided by a methodology developed by the Commission’s JRC (Joint Research Centre) in 2013.
Several pieces of legislation are relevant with regard to EDCs in the European Union.
In addition to the plant protection products and the biocidal products Regulations, REACH and the cosmetics Regulation are highly important.
Under REACH Article 57f, EDCs are eligible as SVHCs with an equivalent level of concern as for PBT or CMR substances. Thus, generally they might be subject to authorisation, including a socio-economic analysis.
By January, Echa had selected about 300 chemicals for additional manual screening by the national authorities, for further regulatory action. An important focus was substances with endocrine-disrupting potential. Substances were selected by an automated IT screening of any data available, meaning the complete REACH registration database, existing lists and other databases, publications, Qsar model data, and data on exposure and uses.
To this end, a related “screening definition” document was issued in January 2016, specifying the scenarios for identifying potential endocrine disrupting substances. It is emphasised that no single scenario is considered sufficiently robust for selecting a substance for manual screening. Thus the scenarios should be considered in a weight-of-evidence approach. In a nutshell, the following scenario categories were applied:check if the substance itself, or a constituent, impurity or additive can be found in published/external lists of suspected EDCs (Commission, WHO, TEDX or SIN) or are structurally similar to substances in these lists;use of models to predict if the molecular structure of the substance itself, and its constituents, impurities or additives trigger specific structural EDC alerts, such as those based on the Danish Qsar models, developed by the Technical University of Denmark;check the self and harmonised classification, suggesting suspected endocrine disrupting effects, such as the presence of specific target organ toxicity classifications for endocrine organs;analyse information in the registration dossiers and chemical safety reports, by screening text patterns typically associated with evidence for/indications of endocrine disrupting properties (for example, repeated dose toxicity, toxicity to reproduction, fertility and developmental toxicity, long-term aquatic toxicity); andpositive findings in external experimental data generated with assays, for example, ToxCastTM in vitrodata (see further below).
Application of these scenarios led to the selection of more than 100 substances. These were ranked according to total tonnage for full registrations, which resulted in the selection of 75 of them.
The cosmetics Regulation is currently still under review, and so far EDCs are not restricted in any way. Now that the criteria for the identification of EDCs are available, the review should be completed soon.
No precise data requirements are foreseen for any European regulation, but studies can be requested at any time and at any level of the assessment. Requested studies are mostly based on the OECD Conceptual Framework for Testing and Assessment of Endocrine Disruptors, and detailed guidance for the assessment is provided in the comprehensive OECD guidance document No 150: Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption.
In parallel to the process of defining the scientific criteria, individual proposals have been put forward by different European nations. These vary considerably, not least in that some are more risk-based and some are strictly hazard-based. However, in general, European proposals mostly focus on a hazard-based assessment, proposing endocrine disrupting properties as cut-off criterion with few exceptions.
Currently, assessment is mostly conducted on a case-by-case basis.
Americas
In the US, the EPA takes an opposite approach with its comprehensive, two-tiered screening programme, which is still followed by regular risk-based assessment. This Endocrine Disruptor Screening Programme (EDSP) intends to cover oestrogen, androgen and thyroid hormonal systems with respect to human safety and wildlife.
Tier 1 aims at the identification and classification of potential EDCs by in vitro and in vivo assays (series 890, EDSP Test Guidelines). Tier 2 focuses on the establishment of concentration- or dose-response relationships, with several test guidelines finalised in August 2015.
The initial tier 1 list of 67 chemicals to be screened was issued in 2009, followed by list 2 in 2014. This is made up of 109 substances. It is strongly emphasised that the lists are not intended to be lists of suspected chemicals, but instead are based on a potentially high level of exposure (pesticide active ingredients and HPV chemicals, used as pesticide inert ingredients).
Results of tier 1 assays are reviewed together with other scientifically relevant information (Osri), leading to a decision on eventual further tier 2 testing. A review of tier 2 data will, in turn, directly support risk assessments for registration and actions.
In July 2015, the EPA published the first results from screening 52 chemicals from the tier 1 list. This identified a potential for interaction with endocrine pathways (EAT) for 32 of the chemicals, and further required actions on tier 2 testing for 18 chemicals.
It has been recommended that more modern, alternative approaches replace some of the EDSP tier 1 screening assays. Therefore, an efficient and robust screening programme is under development, applying high throughput in vitro screening assays and computational and in silico model alternatives, for example, ToxCast models, especially envisaged to be applied to third draft list of chemicals.
Asia
In China, an agro-industrial standard, Evaluation Method of the Endocrine Disruption Effects of Pesticides, became available in late 2014. It was reviewed by the Ministry of Agriculture, and has been implemented from 1 April. The guidance includes two tiers and seven toxicological study types, and intends to screen for probable endocrine disrupting properties of pesticides, applying methods similar to the ones developed by the US EPA.
An action plan for water pollution prevention by the State Council was implemented in 2015, including a national survey on production and uses of environmental endocrine disruptors before the end of 2017. The aim is to eliminate, restrict or substitute EDCs.In Japan, the Ministry of Environment has, for a long time, been promoting research on the mechanisms of endocrine disruption, environmental monitoring, as well as the development of test methods, hazard and risk assessment, risk management, information sharing and risk communication on the substances.
Several projects have been launched in the country, such as SPEED’98 and ExTEND (Extended Tasks on Endocrine Disruption). The ministry updated this in 2016. If results suggest that a substance has endocrine disrupting properties, it will be regulated under Japan’s Chemical Substance Control Law (CSCL) and can be subject to restrictions or even banned.
In recent years, Japan has been actively collaborating with the US on the development of test guidelines for the US EDSP. Like the US, Japan advocates risk-based assessment.Implications and recommendations for global registrations
The foreseen EU criteria for EDCs will most certainly affect global trade, as they will apply to products imported into the EU, which in turn will trigger a WTO notification.
Although their implementation in the respective EU legislations is not directly linked to other global regulatory programmes, this will influence the overall discussion on the assessment and regulation of EDCs, as part of a larger global policy debate.
The intended Transatlantic Trade and Investment Partnership (TTIP) between the European Union and the US aims to reduce trade barriers, and thus also harmonise approaches to assessment. This is to avoid a situation where the criteria and methods applied under one regulation could lead to a different result under another. In parallel, it had been announced that the US and EU are seeking a harmonised approach on EDCs in a pilot programme.
In conclusion, weight-of-evidence and expert assessments, tailored for respective regulatory programmes, are still required for the evaluation of endocrine disrupting properties of a substance. It is strongly recommended that studies are constructed carefully in order to meet global requirements and avoid redundant testing, not least with regard to animal welfare. Results obtained by studies for one regulatory programme should be considered and dealt with like any other.
https://chemicalwatch.com/49733/endocrine-disruptors-criteria-testing-and-assessment
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Membrane Coating Could Help Remove Endocrine Disruptors From Wastewater
Sep 19, 2016 | Chemical & Engineering News
By Deirdre Lockwood
Adding a hydrophilic coating to a nanofiltration membrane helps clean parabens and bisphenol A from wastewater for recycling
Water-stressed communities from California to Singapore have begun reclaiming wastewater for drinking and other uses, but they face a challenge: It’s hard for the treatment process to remove trace organic pollutants, such as endocrine disruptors. Now researchers have developed a potential solution, coating a commonly used filtration membrane with a material that rejects endocrine-disrupting molecules (Environ. Sci. Technol. Lett. 2016, DOI:10.1021/acs.estlett.6b00263).
Many of the commercially available nanofiltration and reverse osmosis membranes currently used to clean wastewater were optimized for desalination. They’re made with a relatively hydrophobic polyamide composite that rejects salt and other ions. Since many endocrine disruptors, such as bisphenol A (BPA) and parabens, are also hydrophobic, these compounds tend to stick to the membrane and can eventually diffuse through to the other side (Environ. Sci. Technol. 2004, DOI: 10.1021/es034952r).
Chuyang Y. Tang of the University of Hong Kong and his colleagues thought that adding a hydrophilic coating to the membranes might prevent this problem. They tested their hunch with polydopamine, a thin hydrophilic coating researchers are exploring as a way to prevent membrane fouling in wastewater treatment. The researchers coated a commercial polyamide-based nanofiltration membrane, NF90, by shaking it with a solution of dopamine hydrochloride for up to four hours; the dopamine self-polymerizes on the membrane surface. Then they tested the system’s performance in filtering water containing four endocrine disruptors: ethylparaben, propylparaben, benzylparaben, and BPA, at 200 μg/L, which is comparable to or higher than their average concentration in wastewater.
The coated membrane rejected 60 to 70% of the three paraben compounds tested, whereas the untreated membrane rejected 35 to 50%. BPA rejection improved from 96% for the uncoated membrane to 99% for the coated version.
However, the four-hour coating also lowered the membrane’s water permeability by 45%, which Tang says is too much to be practical and something his team wants to improve—a 10% reduction would be more “bearable” for application. Recently, they developed a more hydrophilic coating material that can be applied in very thin layers, minimizing the adverse effect on membrane permeability yet maintaining rejection of endocrine disruptors, according to their preliminary results. What’s more, this approach shortens the coating time from hours to minutes, “an important consideration for industrial upscaling,” Tang says.
Long Nghiem, a membrane engineer at the University of Wollongong, praises the team’s “elegant but simple approach,” while noting that it is a proof-of-concept study. He says the researchers must next assess the impact of the coating on membrane fouling.
https://cen.acs.org/articles/94/web/2016/09/Membrane-coating-help-remove-endocrine.html
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Where Next For EU Chemicals Policy?
Sep 20, 2016 | Chemical Watch
By Geraint Roberts
Earlier this year, a proposal was made to ban the sale in Europe of consumer products containing any of a group of four phthalates. The proposal, lodged jointly by Echa and the Danish EPA, is unusual because it groups four different chemicals together and seeks to apply the same restriction to them all.
In accordance with the way REACH and CLP work, each of the phthalates was registered separately and each has its own official classification. But Echa and the EPA say grouping them together – and thus averting the need to prepare four separate restrictions – is justified because each is classified as a category 1 substance toxic for reproduction. And because each produces a spectrum of effects in rats – caused by suppression of foetal androgen action – known as the “phthalate syndrome”.
The use of grouping in chemicals assessment and classification is rare because we usually lack the scientific evidence to conclusively prove that it is sensible to lump them together. But if the degree of certainty acceptable to policy makers and business groups were lower, the method could reduce cases of “regrettable substitution” – cases where a dangerous chemical which falls under a ban is replaced by users with a structurally similar substance with similar properties which is not covered by the ban.
Grouping is one of the concepts being chewed over in Brussels workshops and public consultations as the Commission orchestrates a number of key chemicals policy reviews. These aim to reassess REACH and other existing legislation, to decide how chemicals management should best interact with issues like worker safety and the need to maximise the recycling of plastics and other materials, and to set out a vision for EU chemicals policy in the decades ahead.
With few conclusions reached so far, it is easy to assume that not much is going on. With the final registration deadline less than two years away, and businesses accustomed to the processes of dossier and substance evaluation, authorisation and restriction, some of the excitement and frenetic lobbying seems to have gone out of the REACH world.
At the same time we now have a Commission that must face the serious threats to its stability posed by immigration and the Brexit vote, and which is more reluctant than ever to place new regulatory obligations on businesses.
Commission initiatives to drive “better” or “smart” regulation are nothing new, but it is worth noting that the second REACH Review – unlike the first – falls under the Commission’s REFIT programme to make existing laws simpler and less costly. And any new regulations must first get their impact assessments approved by the Commission’s Regulatory Scrutiny Board, which has more teeth than its predecessor, the old Impact Assessment Board.
But it would be a mistake to think the chemicals policy reviews won’t lead to any significant new compliance challenges. NGOS, industry groups and member states can all see flaws or limitations that they are keen to rectify.
“So far none of the most relevant actions laid down in the EU seventh Environmental Action Programme (7EAP) have been implemented sufficiently in EU policy and legislation,” says Lisa Anfält of the Swedish Chemicals Agency (Kemi). “Especially the need to deliver results on hazard based and harmonised criteria for endocrine disruptors and information requirements and safe use recommendations for nanomaterials.”
She also singles out grouping, for chemicals such as perfluorinated chemicals (PFCs), as one way to make chemicals legislation more effective than today, calling for an EU-strategy for assessing and managing them.
A “strong and preventive chemicals legislation” is necessary, she says, to achieve non-toxic and resource-efficient material cycles. “Recycling must increase in a safe way, where the goal of a non-toxic environment provides the conditions for eventually achieving a circular economy.”
Michael Warhurst, head of NGO ChemTrust, also wants grouping to be used to prevent companies “moving from one problem chemical to another (less understood) one in the same group”. He says this is “clearly happening” with PFCs, brominated flame retardants and bisphenols.
He also wants more focus on “sensitive” toxic impacts, including endocrine disruption, as well as neurotoxicity and immunotoxicity and on addressing persistent and mobile chemicals. And a “real regulatory response” is needed, he says, to mixture exposures, “rather than just ever more research projects”.
In contrast, Marco Susnik of SMEs trade body Ueapme, warns that REACH may be remembered as a law “that could not be implemented by the majority of small companies”.
“The 2018 deadline will show very soon how well SMEs can cope with the obligations. While I personally hope the deadline will work smoothly, my gut feeling is significantly less positive.”
Rather than regulating everything “to the smallest detail”, he says, resources would be better employed on giving more support to companies or improving enforcement. And “large administrative burdens” are “very efficient mechanisms for selectively harming smaller companies” and thus “used to get rid of competition”.
For Thomas Jakl, deputy director general of the Austrian environment ministry’s chemicals division and former chairman of Echa’s Management Board, “the focus of chemicals management must be widened from assessing hazards and risks towards the monitoring and continuous optimisation of application and use.
“In short, we need to move from ‘using the right chemicals’ to ‘using chemicals right’,” he says. Resource efficiency goals should be added to REACH, for example, by including a new requirement for continuous optimisation in registration chemical safety reports.Another REACH review
The REACH Regulation requires the Commission to conduct a review of its operation every five years. The first should have appeared in 2012 (but wasn’t published until early the following year) so the next is due in 2017.
Work on the review is well under way, with a raft of studies completed or ongoing. Details of these should be published on the chemicals webpages of DGs Environment and GROW this autumn.
Consensus on a number of key issues is emerging among those member states actively engaged in the review and Echa:
Improve the quality of registration dossiers: member states that took part in the Dutch EU presidency’s conference on REACH in June agreed that not only are many dossiers of poor quality, most are not updated by the registrants, as they should be, when new information comes to light. The poor quality of dossier information means that not only is it difficult for companies producing or using chemicals to ensure they have the right risk reduction measures in place, but it is also difficult for authorities and Echa to target the right substances with the right regulatory measures.
The issue was also prominent at a conference organised by a group of member states and Norway last October, and was assessed in Echa’s report on REACH and CLP implementation which came out in May.
Suggestions to overcome the problem include:giving Echa the power to reject inadequate dossiers;strengthening the obligation on registrants to ensure their dossiers are updated; andrequiring registrants to include information on the substance’s uses and exposure.
Level the playing field on SVHCs in imported articles: authorities and industry agree that EU-based article producers are at an unfair disadvantage compared to firms importing articles into Europe when it comes to the obligations and restrictions they face. The sunsetting of substances listed in the REACH Annex XIV list of substances subject to the authorisation process only applies to uses that take place in the EU.
And although REACH restrictions apply equally to domestic and imported articles, the rate at which they are being adopted is too slow, and imported articles containing such banned substances are still appearing in the EU. Moreover, few article importers are bothering to notify Echa, as legally required, when their articles contain SVHCs.
To address these problems, restrictions could have wider scope, both in terms of uses and number of substances. Cefic has suggested that industry organisations should devise a common format for reporting the presence of dangerous chemicals in articles, and do more to encourage their overseas suppliers to provide such information. Echa, meanwhile, says the Commission should conduct a “fundamental” review of the notification process.
Do more to identify SVHCs: Unless the requirements for conducting risk management option analyses are made less onerous for authorities, the Commission’s goal to have all relevant SVHCs on the candidate list by 2020 will not be met.
Minimise exposure to hazardous substances: officials at the June meeting agreed this is of “overarching importance” but current decisions are being made on the basis of limited information. It was proposed that to ensure efficiency, substance data sets should be used across all relevant EU legislation and that exposure to SVHCs could be reduced through controlling emissions to air and water.
Nanomaterials, EDCs and combination effects: although the safe management of all of these is referenced in the 7EAP, the June conference decided none are being addressed adequately. The Commission proposed criteria for identifying EDCs, issued two weeks after the conference, have been severely criticised by some member states, NGOs and industry. The Commission continues to delay publication of proposals for providing registration information for nanomaterials and its report on exposure to mixtures – due last year – has yet to emerge.
Do more to encourage substitution and “benign design” of new chemicals: there is broad agreement that some substances on the REACH candidate list are seeing a resultant drop in demand and that users are seeking substitute substances that seem to have a secure future. But it does not appear that REACH is persuading downstream users to assess different technologies, new business models or the development of new, less hazardous substances.
There is some recognition that this is not within REACH’s purview, and it can only be achieved through economic instruments, R&D and government-led programmes that bring industry, research institutions and NGOs together.
However, it must be remembered that advocacy groups representing the chemical industry and businesses more broadly, especially those representing SMEs, often have different priorities to these member states. As well as ensuring a high level of health and environmental protection, they want REACH to deliver on its goal of enhancing innovation and industry’s competitiveness, and for costs to be minimised. Existing obligations should be better enforced, they say, and the Regulation should be better integrated and be more consistent with other EU chemicals-related law.
Cefic highlights the fact that chemicals policy has been identified by SMEs (which make up most of its members) as one of the top ten more burdensome areas of EU law. With the REACH Regulation now falling under the Commission’s REFIT better regulation drive, it wants it to identify the potential for reducing existing regulatory burdens, and for burden reduction targets to be set.Key policy initiatives
Second REACH Review/REFIT Evaluation
A consultation is due by the year end, with the final report in Q2 2017.
Fitness check of chemicals legislation other than REACH
Study due Q3 2106 and Commission staff working paper by year end. Together, these will form the basis of a stock-taking report on the regulatory fitness of chemicals legislation. Both will also feed into the non-toxic environment strategy.
Circular economy package
Adopted in December 2015. Includes call for policy options “to address the interface between chemicals, products and waste legislation” to be adopted in 2017. Also includes call for strategy on plastics, which will address presence of chemicals of concern, by 2017, and plans to develop, by 2018, “an improved knowledge base and support for SMEs” for the substitution of SVHCs. Will also feed into non-toxic environment strategy.
Non-toxic environment strategy
The seventh EU environmental action programme for 2012 – 2020 calls for such a strategy by 2018 that is “conducive to innovation and the development of sustainable substitutes including non-chemical solutions”. Addressing nanomaterials, endocrine disruptors, the combination effects of chemicals and exposure to chemicals in products, it should promote non-toxic material cycles and reduce indoor exposure to harmful substances.
There is a broad consensus among authorities and industry groups that the REACH authorisation process is too slow and complicated. Some in industry would like risk to take precedence over hazard, and for substances with occupational exposure limits (OELs) to be exempt. At the very least, industry would like OELs and the derived no effect limits (Dnels) used under REACH to have a rational relationship with each other.
The Commission is also conducting a REFIT evaluation of chemicals legislation other than REACH, such as CLP, the RoHS Directive and product-specific Regulations on cosmetics, biocides and food contact materials.
Industry bodies are equally keen for this process to lead to burden reduction targets, but NGOs have also fed in comments. ChemSec points out that different regulations do not necessarily make use of each other’s evaluations, leading to unnecessary work and inconsistent levels of protection. It also says there are regulatory gaps that should be closed to improve efficiency and protection.
For example, the biocide triclosan cannot be used in medical soaps because it is toxic to aquatic organisms and the biocides Regulation takes environmental impacts into account. But it can be used in household soaps or children’s finger paints because neither the cosmetics Regulation or the toy safety Directive consider environmental effects.The next chemicals strategy
Meanwhile, DG environment is leading work to develop, what the head of its green economy directorate, Kestutis Sadauskas calls, a strategy for “what we want to achieve in the next ten years, and where we want to be in the next 50”.
The task of creating an EU strategy for a non-toxic environment is included in the 7EAP. Due in 2018, there is little information about it yet on the DG’s website but it hosted a workshop in June and consultants are busy writing a number of sub-studies that will provide input to an overarching report, due next March.Studies for REACH review
Cumulative costs assessment of chemicals legislation
Impacts of REACH on innovation, competition and SMEs
Impacts of REACH, and corresponding laws in third countries, on the international competitiveness of the EU chemical industry and downstream users
calculation of the indicators of the health and environmental benefits of chemical legislation
fitness check on occupational health and safety legislation
registration requirements for low tonnage substances (1 – 10 tonnes/year)
registration requirements on polymers
development of EU enforcement indicators for REACH and CLP
substance identity in REACH: analysis of SID and substance sameness of complex substances
cumulative health and environmental benefits of the chemicals legislation REACH Baseline study – ten years update
public consultation about the approach to the REACH report 2017 – expected to collect views on any potentially missing elements
socio-economic benefits of chemical legislation
evaluation process of Echa
Eurobarometer survey on the perception of chemicals’ safety
costs and benefits of the REACH authorisation process
REACH contribution to meeting the World Summit Sustainability Development 2020 goals
study on the regulatory fitness of the legislative framework, governing the risk management of chemicals (excluding REACH), in particular CLP and related legislation
Grouping – as mentioned at the beginning of this article – was one of the ideas discussed at the workshop. ChemSec’s Anne-Sofie Andersson told the workshop that chemicals with a similar structure should be assessed and regulated and classified as a group, although exemptions could be granted if non-toxicity can be demonstrated. Testing a product for a group of chemicals, she said, would save money compared to testing different substances individually.
Professor Jim Bridges of Surrey University said he was not sure if grouping was compatible with a weight-of-evidence approach to assessment, and that he “would want the evidence before agreeing they look similar and all have the same action”.
But Professor Philippe Grandjean of Harvard University said “convincing evidence [of that kind] will take decades. We can’t wait that long. Let’s look at probabilities, like we do with climate change, and allow a lower level of proof for something as crucial as brain development.”
Following on from this, Echa’s head of risk management, Jack de Bruin, said testing chemicals individually is a mammoth task. “It will take a long time for REACH data to be assessed [for all substances] and the data will be too basic for many issues like neurotoxicity. We’ll never get them all tested, so how can we better prioritise?”
In response Professor Bridges said assessors “need to look at exposure, groupings – not simply based on structure, but also on changes in physchem properties, in vitro tiered testing to pick out chemicals, and adverse outcome pathways and modes of action.”
Another key issue at the workshop was whether substitution is happening fast enough and enough is being done to help companies find alternatives which are technically and economically feasible. Ms Andersson claimed that “there are some substances that we know a lot about but we still aren’t taking action on” and substitution therefore needs to be encouraged by refusing authorisation applications. Addressing the issue from the opposite side, Ueapme’s Marco Susnik asked: “If all hazardous substances should be substituted or whether exposure control can be okay instead?”
Delegates also discussed whether the chemical industry is doing enough to ensure that new chemicals are less hazardous than those they could replace. Cefic REACH director Erwin Annys said the bigger members in his organisation are starting to use in silico methods much earlier in the design of new chemicals and “things are moving in the right direction”.
But Professor Ian Cousins of Stockholm University, who has studied the effects of the phase-out of long-chain perfluorochemicals, said we are “clearly not seeing it in the whole of the chemical industry”, citing industry’s switch from banned brominated flame retardants to similar substances.Circular economy package
The non-toxic environment strategy is also intended to identify the best opportunities for reducing exposure to hazardous substances from the use and waste management of discarded products and materials. In doing so, it will try to fit with the Commission’s policies for boosting the recycling and recovery of materials – known as the circular economy package.
NGOs would like to see hazardous substances removed from product cycles at source by banning their use but Cefic and other industry groups argue that chemicals of concern can be safely handled by recyclers. Whatever the outcome, it is clear we will need much better information about which chemicals of concern are used in which products.
One place to start, says Echa, is for companies to systematically report any significant volumes of SVHCs in specific articles or parts of articles. The agency could then pass this information onto recyclers, who could then remove such “contaminated” materials from their processes. But this will require a big investment in systems that allow SVHCs to be traced through supply chains.
Whatever the policy actions that flow from these strategies, reviews and packages, fundamental drivers will continue to build the focus on chemicals in products.
Those member states leading the REACH review debate may be disappointed with the final results but Echa will press for better information on chemical uses and exposure. And after the 2018 registration deadline has passed, the agency will be able to focus more on improving registrations and on dossier and substance evaluation.
This data will, in turn, lead to updated substance restrictions and concentration limits in product-specific legislation, as well as new REACH restrictions and additions to the candidate list. Regardless of how radical the Commission’s policy documents turn out to be, chemical companies and those in downstream sectors will find the pace of change doesn’t slacken.
https://chemicalwatch.com/49723/where-next-for-eu-chemicals-policy
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REACH Data-Sharing: Issues Arise For Lead Registrants
Sep 20, 2016 | Chemical Watch
By Jean-Philippe Montfort
Over six months after the entry into force of the implementing regulation on joint submission and data sharing under REACH, a series of problems have crept in. And REACH lead registrants may face serious difficulties they would be well-advised to anticipate.
Some of the essential elements of the data-sharing system, set up under REACH, are being challenged by consultants seeking to sell to their customers, often non-EU companies, low cost access to EU registration, by exploiting gaps in the framework.
These essential elements include:the obligation to share available data and respond to a request for it;the duly justification of those opting out;verification that registrants are in legitimate possession of, or have a right to refer to, studies; andthe protection of the intellectual property rights of data owners.
As in the past, Echa is taking on data-sharing disputes and seeking to verify whether the parties have made “every effort” to reach an agreement on the sharing of data requested and, if not, grant the prospective registrant access.
These discussions are getting more difficult, with potential registrants or their consultants using their right to request an itemisation and justification of the data, and administrative costs incurred for the registration of the substance, as a means to contest such costs and push lead registrants into a corner.
The Regulation requires Echa to ensure the Osor (one substance one registration) principle is upheld, even when a new registrant fully opts out of the joint submission of data. This is causing problems with some companies and consultants not only refusing to pay their share of the costs (normally achieved by obtaining a letter of access) but also requesting the key to the registration dossier, known as a token.
They justify their request on the basis that they will otherwise opt out from all endpoints, where information has been jointly submitted by existing registrants, and have the pretext of a disagreement on the information and/or on its cost.
In what becomes joint submission disputes, once Echa receives a complaint, the agency requests that the parties demonstrate that they have made “every effort” to reach an agreement on access to the joint submission. This must be fair, transparent and non-discriminatory. Echa threatens to grant prospective registrants a token that the lead registrant is refusing to grant them, if the former has made every effort.
This is a very dangerous development, in particular when considering “Wikipedia registrants”, who may receive a token and register in breach of all the principles mentioned above.
This is particularly troublesome when the prospective registrant lacks legitimate rights to refer to full study reports. Indeed, there is no guarantee for the lead registrant that Echa will verify the new registration and, in such situations, the former would need to appeal before the Board of Appeal and/or pursue lengthy and uncertain national proceedings. This is the route to obtain the recognition of a breach of intellectual property rights by dint of the free-rider registration dossier. This cannot be accepted. Why?
Complying with REACH registration requirements for well-intentioned companies is not only about filling information endpoints by providing study data. It also means comprehensive assessment work, including literature search, identification and rating of studies, reading them, reasoning for read-across, a testing strategy and writing study endpoint summaries. This crucial part of the process is resource consuming for companies and/or REACH consortia.
New registrants copying and pasting already submitted information and referring only to published studies through a full opt-out registration, without contributing to the assessment costs, naturally appears unfair to existing registrants. This is because those free riders cherry pick the data served to them on a silver plate.
Registrants that choose to fully opt out, when faced with a letter of access cost they consider excessive, should not be able to receive a token, unless they are able to demonstrate that:they are otherwise in legitimate possession, or have a right of access to, the data in the joint submission; orthey legitimately possess additional data to that in the joint submission, in which case they have an obligation to share it in accordance with Article 30.3 of REACH; orthey have a justifiable waiver for the endpoints in question.
The problem is that, in most cases, they refuse to share such information, leaving the lead registrant with no choice but to refuse to grant the token. Indeed, they are contractually and legally bound to guarantee that data sharing is fair, transparent and non-discriminatory towards all previous registrants. This means that the lead cannot grant a token without such assurances; particularly given that other co-registrants will have paid several thousand euros and accepted to do so in view of the work done.
The latter would also have a claim that the newcomer obtained different, more favourable conditions for accessing the joint submission, and feel discriminated against.
It is also possible that a third-party data owner, identifying that its data is being used by the newcomer, may claim that the lead registrant did not properly ensure that access was made conditional on legitimately obtaining (and paying for) it.
In some cases, the lead registrant could fail to meet its contractual obligations. This is all the more acute in situations where they hold elements which seek to demonstrate that the opt out registration, planned by the potential registrant, will, in fact, be a cut and paste of the joint submission with no legitimate access to the underlying data. The lead registrant may feel powerless.
Now, will Echa control such elements? The agency’s data-sharing dispute is only on the basis of “making every effort”. In other words, it decides which of the parties to the dispute has shown the most willingness to find an agreement.
However, it is not about who is right or wrong about the appropriateness of the charge for a letter of access. And it’s not about who holds legitimate rights to refer to the data submitted. Thus, where Echa mechanically verifies whether there are separate registrations that need to be regrouped into a single joint submission, it does not systematically review the compliance of all registration dossiers, and is reluctant to get into the intellectual property field.
Opt-out dossiers are supposed to be prioritised for compliance checks, but this does not mean a systematic review. Such a registrant will not necessarily indicate in its submission what it is doing. making Echa’s verifying compliance very uncertain. In addition, the agency rarely asks for proof that a registrant is in legitimate possession of, or has a right to refer to, a piece of data. This is because it involves intellectual property considerations that it thinks it is not equipped to deal with. Indeed, Echa is still claiming its inability to assess legitimate possession of data, without a breach being established by a competent national court beforehand. This opens a legal vacuum into which those ill-intentioned consultants are stepping.
This is the very difficult situation in which many lead registrants find themselves today: being forced to spend a lot of their otherwise scarce time in itemising and justifying costs and cost-sharing formula, placed by many co-registrants with consultants. The latter wish to keep their promise to deliver cheap registrations and do anything they can to achieve this. This is at their clients’ risk.
The direction taken is not fulfilling the intentions of the REACH Regulation on data sharing. This was to avoid duplication of testing and ensure a high level of protection of human health and the environment, with relevant and coherent data, backed up by the associated assessment work.
Companies involved in such data-sharing discussions should tread carefully. They need to make sure they make their best effort, despite this costing them time. If Echa eventually grants the token to a new registrant, existing ones should seriously consider challenging it before the Board of Appeal and should take steps in advance to prepare their case. Also, companies that are using these consultants, and eager to cut costs, should think twice because they may lose money in the end.
Echa and the Partner Expert Group (PEG), which the agency consults on any new or revised guidance, should be fully aware of this, when drafting the new data-sharing guidelines. They should find pragmatic solutions so that tokens are not given, without guarantees of the full legitimacy of the new registrations.The option to opt out of registration
While Echa’s guidance on registration is currently under revision, according to that of 2012, a manufacturer or importer may submit certain registration dossier information separately (opt-out), in cases where at least one of the following applies:
(a) it would be disproportionately costly for them to submit this information jointly; or
(b) doing this would lead to disclosure of information that the registrant considers to be commercially sensitive and is likely to cause them substantial commercial detriment; or
(c) the registrant disagrees with the lead on the selection of the information submitted in the lead registration.
In this case, the registrant has to submit, along with their dossier, an explanation of why the costs would be disproportionate, why disclosure of information would be likely to lead to substantial commercial detriment or the nature of the disagreement, as the case may be. Opting out can be partial and refer to just one specific study. However, even when the registrant decides to opt out, they still remain a member of the joint submission and must submit their dossier only after the lead dossier has been accepted for processing. “Hence, a registrant can opt out from certain information requirements but not from the joint submission.”
This article was co-authored by Thomas Delille of Mayer Brown
https://chemicalwatch.com/49730/reach-data-sharing-issues-arise-for-lead-registrants
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Higher PFOA Restriction Limits 'Unjustified', NGOs Say
Sep 20, 2016 | Chemical Watch
Echa's Risk Assessment and Socio-economic Analysis committees (Rac and Seac) have not justified proposing higher restriction limits on perfluorooctanoic acid (PFOA,) NGOs say.
In 2014 Germany and Norway proposed restricting PFOA to 2ppb (2,000 ppt). But, during a public consultation, industry said this limit was too low.
Echa's committees subsequently proposed new limits of:25ppb for PFOA and its salts; and1,000 ppb for PFOA-related substances in constituents of other substances, in mixtures and in articles.
But more than a dozen NGOs say in a letter to Echa's REACH committee that the Rac and Seac "have provided no justification about the impacts of these changes and appear to be merely rubber-stamping industry proposals in contrast to their mandates."
Co-signers to the letter include: the European Environmental Bureau (EEB);CHEM Trust;the Center for International Environmental Law (Ciel);the Health and Environment Alliance (Heal); andIpen.Exemptions
NGOs are also concerned that Seac extended the restriction exemption for PFOA from car spare parts to those for "all industries", including:printing inks;textiles treated for worker protection;nano-coated materials; andfirefighting foams.
"These exemptions include open applications that, if granted, would permit the use of products containing PFOA for up to 20 years in some cases while others are proposed without a time limit," the letter says.
It adds that, if adopted, the exemptions would lack an "appropriate legal basis" due to insufficient justifications provided by the REACH committees. And it would undermine the EU's own proposal for listing PFOA in the Stockholm Convention, the NGOs add.
The co-signers are calling for the proposal to require the labelling of all PFOA-containing articles granted exemptions.
REACH committee members are expected to discuss the draft regulation at its October meeting.
https://chemicalwatch.com/49728/higher-pfoa-restriction-limits-unjustified-ngos-say
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Commission Lists EEA Efta Authorisation Decisions
Sep 19, 2016 | Chemical Watch
The European Commission has published a list of authorisation decisions taken by European Economic Area (EEA) European Free Trade Association (Efta) states in the first half of 2015.
The nine authorisations involved three substances:bis(2-ethylhexyl) phthalate (DEHP);dibutyl phthalate (DBP); anddiarsenic trioxide.
The decisions – by Liechtenstein, Iceland and Norway – are listed in the Official Journal.
https://chemicalwatch.com/49704/commission-lists-eea-efta-authorisation-decisions
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Ohio Supreme Court Blocks Fracking Measures From Ballot
Sep 20, 2016 | BNA Daily Environment Report
By Tripp Baltz
No Ohio residents will vote in the November election on whether to ban fracking locally after the Ohio Supreme Court affirmed that the secretary of state properly blocked ballot measures in four counties ( The state ex rel. Coover v. Husted, Ohio, No. 16-1247, 9/13/16).
Proposed county charters for Athens, Meigs and Porter counties are invalid and don't satisfy threshold requirements of the Ohio constitution, the court said Sept. 13, affirming decisions by Ohio Secretary of State Jon Husted and the respective boards of elections. On Sept. 6 the court denied a writ of certiorari for a similar proposed county charter for Medina County.
The proposed changes in charter for the four counties were designed to give the communities the authority to regulate, up to and including banning, fracking. In Ohio, drilling, management of wastewater from exploration and production, and related activities are regulated by state law, Mike Chadsey, spokesman for the Ohio Oil and Gas Association, told Bloomberg BNA Sept. 19.
No Measures on the Ballot
The ruling means there will be no local fracking measures on any county ballots in Ohio this November, he said.
The Ohio Supreme Court ruling “struck a blow to the people's democratic right to initiative and self-governance,” the Community Environmental Legal Defense Fund, the primary group pushing the county charter changes, said in a Sept. 13 statement. Communities across Ohio are seeing an increase in fracking, use wastewater injection wells, liquified natural gas pipelines and compressor stations, the group said.
“The people's right to alter or reform their government is meaningless when the same government that the people want to alter, acts as gatekeeper, restricting access to direct democracy as they so choose,” said Tish O'Dell, Community Environmental Legal Defense Fund community organizer.
In August, the Colorado Secretary of State said two anti-fracking measures in that state had failed to collect enough signatures to qualify for the ballot. A similar citizens’ campaign in Michigan said in June it had not collected enough signatures for the ballot.
Proposed County Charters Invalid
The petition for Athens County was invalid because it failed to alter the county's form of government, failed to vest powers from the municipalities and townships with the county, and relied on the state's revised code to determine the qualifications and salaries of elected officials, the court said.
The Meigs and Porter county boards of election properly rejected the petitions before them because they failed to provide for a county executive.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=97506101&vname=dennotallissues&fn=97506101&jd=97506101
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States, Industry Defend Overturning of Fracking Rule
Sep 20, 2016 | BNA Daily Environment Report
By Alan Kovski
The Bureau of Land Management is wrong to cite land management statutes as justification for the agency's 2015 attempt to regulate hydraulic fracturing on federal and Indian lands, the states of Wyoming, Colorado and Utah told an appeals court Sept. 16 (Wyoming v. Jewell, 10th Cir., No. 16-8068, 9/16/16).
Those statutes are not laws for environmental regulation, and they especially lack application to the subsurface oil and gas development activity known as fracking, the states told the U.S. Court of Appeals for the Tenth Circuit.
The brief was filed to defend the decision of a district court to overturn the BLM's fracking rule. Briefs also were filed by two industry groups, North Dakota and the Ute Indian Tribe.
The BLM had not previously tried to draft explicit regulations for fracking since passage of the Safe Drinking Water Act in 1974, which gave the Environmental Protection Agency, not the BLM, authority to regulate underground injections, the Independent Petroleum Association of America and the Western Energy Alliance said in their brief.
North Dakota argued that the BLM regulations would upend the state's regulations in a costly violation of state sovereignty. The Ute Indian Tribe argued that the BLM not only has no authority to regulate fracking on Indian lands but that the agency failed to address the tribe's arguments in both the district court and the agency's appeal brief.
State, Federal Authority Argued
The U.S. District Court for the District of Wyoming overturned the BLM hydraulic fracturing rule in June. The court concluded that the Energy Policy Act of 2005 treated federal regulation of fracking as an EPA responsibility and limited the EPA's authority to fracking when diesel fuel is used. All other fracking on public land is regulated under state authority, the court concluded.
The federal government, in its August appeal brief, argued that the Energy Policy Act applied narrowly to the EPA's Underground Injection Control program and was not written to limit the BLM.
The BLM said it had been regulating hydraulic fracturing for decades under the Federal Land Policy and Management Act (FLPMA) and a set of mineral leasing laws, especially the Mineral Leasing Act of 1920. A group of professors and a group of former Interior Department officials filed briefs in support of the government's position, as did environmental activists.
Wyoming, Colorado and Utah said federal lands act provides the bureau with no authority to regulate fracking. FLPMA Section 1712(c)(8) requires the BLM to comply with environmental regulations, not invent them, the states said.
“It does not authorize the Bureau to step into the shoes of the EPA and the states and enact its own regulations on the subject,” the states said.
Record on Regulations Disputed
“BLM misrepresents its regulatory history,” the industry groups said in their brief. They said it is undisputed that under regulations the bureau has had in place since 1982, companies generally treated all hydraulic fracturing operations as routine, and the bureau did not require prior approval for routine operations.
The industry groups also summarized the district court's enumeration of procedural flaws that could be regarded as violations of federal administrative law.
“The district court noted at the preliminary injunction stage that BLM: (i) failed to provide a reasoned explanation for the change in BLM's existing policies; (ii) failed to cite evidence documenting why changes to existing rules were necessary; (iii) did not address evidence contrary to BLM's preferred outcome; and (iv) declined to conduct analyses required to demonstrate the efficacy, cost and value of the final rule,” the industry groups said.
As a result, the BLM was not entitled to court deference to an agency when the agency is interpreting laws and regulations within its area of expertise, the industry groups said.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=97506095&vname=dennotallissues&fn=97506095&jd=97506095
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Energy Bill Can Boost American Innovation
Sep 19, 2016 | The Hill - Opinion
By Rich Powell and Christopher Guith
Amid the storm of party-line bickering and election-year hyperbole, it’s easy to lose faith in Congress. Perhaps nowhere is this truer than in our difficult national conversation on energy. And yet, through the madness of 2016 politics, House and Senate energy leadership have nearly succeeded in the seemingly impossible: crafting substantive, bipartisan legislation that would update our nation’s energy policies for the first time in a decade — and that just might start to mend public faith in a stymied Congress. While the past decade has demonstrated that America’s energy industry leads the world in innovation, the legislation now in conference would further boost America’s engineers and innovators to create jobs in virtually every corner of the energy industry.
Put simply, the world has changed a lot since the last energy bill was passed under the second Bush administration. Then, we were grappling with skyrocketing prices at the pump. Today, gasoline sells at historic lows, thanks to fracking technologies innovated here in the U.S. Behind the scenes, even more fundamental changes have reshaped our energy industries. We’ve overtaken Saudi Arabia to become the top global oil producer and have even outpaced Russia in gas production. Abundant natural gas has supplanted coal as the primary fuel for electricity, significantly lowering emissions along the way. Solar, wind and battery prices are dropping fast — but power grids struggle to incorporate ever larger amounts of “intermittent” renewable energy.
These price declines, driven by prior national commitments to energy innovation, obscure the reality that we still have far to go to achieve stable, economical clean energy to meet the diverse needs of our advanced economy. Failing to do so risks economic opportunities today and American competitiveness in the global economy tomorrow.
A few examples: While we remain complacent with hydropower plant delays and millions in additional costs extracted by anti-dam campaigners, Brazil recently added more hydropower with one plant than America managed in a decade. While 80-year-old bureaucratic hurdles delay American natural gas exports, Vladimir Putin continues to flex his geopolitical influence with Russian natural gas throughout Europe and Asia. And while radical environmentalists oppose all fossil development, including clean coal technologies that could be exported to improve the environment, over 1,200 coal plants are being planned for construction globally.
Congressional leaders have taken note and refused to remain complacent. They recognize that further investment in American energy innovation is imperative to continued prosperity at home and influence abroad.
Last December, the House voted to pass a bill that would bring our energy policies into the 21st century. Later in April, the Senate overwhelmingly passed a bipartisan equivalent. Despite President Obama’s veto threat on certain provisions, members are resolving their differences in bicameral conference. We applaud both chambers of Congress for their initiative. Together, they make key reforms to enable America’s innovators.
Both bills require the Department of Energy to lay the groundwork for the next generation of nuclear technologies. The national labs would begin planning a critical testbed for advanced reactors here in the U.S. Today, our “fourth generation” nuclear entrepreneurs, including a startup backed by Bill Gates, must travel to Russia to test their designs.
On natural gas, the Senate legislation would create a program to explore a potentially revolutionary new resource called “methane hydrates,” gas that’s been trapped in frozen ice or under ocean sediments. Early research shows it could meet America’s gas needs for 4,000 years. The bills also speed permitting for exporting liquefied natural gas.
On coal technologies, the energy bill authorizes over $500 million each year for research and development to address a burgeoning international opportunity that can balance the world’s demands for cheap electricity and clean air. The technology, called “carbon capture” or clean coal, isn’t a pipe dream. First-generation demonstration plants already use captured gases to produce valuable chemicals, increase domestic oil production and make fertilizer.
On hydropower, the Senate bill would authorize $50 million in funding for the National Marine Hydrokinetic Research Center to refine electricity creation from the limitless power of ocean waves. In addition, the bill modernizes key permitting hurdles that should maintain and expand hydropower’s role as our largest on-demand clean energy source.
Lastly, the Senate bill updates our national R&D engine, first by boosting the Energy Department’s Advanced Research Projects Agency-Energy (ARPA-E) budget by $315 million over five years. ARPA-E is a pilot research program that unlocks game-changing breakthroughs with the highest likelihood of private sector application. At the same time, the bill cuts the regulatory burden on our scientists, allowing them more flexibility to partner with the private sector to ensure the relevance of their research in the marketplace.
There’s still plenty of work ahead before these ideas become law. With lawmakers now in position to act, we again urge them to quickly resolve their differences and seize this opportunity. Since the average American’s interactions with electricity start and stop with flipping a light switch, it’s understandable that energy innovation is often not top of mind. But affordable and reliable clean energy is the lifeblood of the modern economy and a vital growth engine.
American ingenuity is by far the world’s most important fuel source. Let’s keep it that way.
Powell is the managing director of policy and strategy for ClearPath Action, whose mission is to accelerate conservative clean energy solutions. Guith is the senior vice president for policy at the U.S. Chamber of Commerce’s Institute for 21st Century Energy (Energy Institute).
http://thehill.com/opinion/op-ed/296720-energy-bill-can-boost-american-innovation
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Clean Power Plan Is Consistent With Law And History
Sep 19, 2016 | The Hill - Pundits
By Richard L. Revesz, Denise A. Grab and Jack Lienke
In a critical federal court hearing this month, challengers of the Clean Power Plan, the Obama administration's signature climate change policy, will characterize the Plan as an "enormous and transformative expansion" of the Environmental Protection Agency's (EPA) regulatory power.
Their legal briefs argue that, in its pursuit of reductions in carbon dioxide emissions from the nation's electric sector, the EPA dramatically exceeded the limits of its Clean Air Act authority and commandeered a regulatory arena — the electricity sector — that has traditionally been managed by the states. They claim there is "no precedent for this invasion of state sovereignty."
But the Clean Power Plan, while certainly a very important rule, is not the boundary-breaking behemoth that the petitioners make it out to be. On the contrary, it explicitly acknowledges and complies with the many constraints that Clean Air Act places on EPA's authority to regulate existing power plants. Furthermore, the plan's basic components have already been used in several prior Clean Air Act regulations, issued under administrations of both parties.
The Clean Power Plan's compliance with statutory limits
The "Clean Power Plan" is EPA's shorthand for a set of "emission guidelines" for power plants that it issued pursuant to Section 111(d) of the Clean Air Act. The text of Section 111 contains eight significant constraints on EPA's authority to craft such guidelines:
1. The EPA must identify the "best system of emission reduction" and calculate the "degree of emission limitation achievable through the application" of that system. Thus, the agency cannot arbitrarily declare that existing sources in the relevant category must reduce their emissions by a particular amount. Instead, it must survey available systems for reducing emissions and calculate the level of reduction achievable using what it considers the best of those systems.
2. In identifying the best system, the EPA must consider the amount of emission reductions it will yield. It goes without saying that a system of emission reduction is unlikely to be "best" if it does a poor job reducing emissions.
3. In identifying the best system, the EPA must consider the system's cost. As explained in U.S. Court of Appeals for the District of Columbia Circuit case law, the EPA cannot adopt standards that can be achieved only at "excessive," "exorbitant" or "unreasonable" expense.
4. In identifying the best system, the EPA must consider "nonair quality health and environmental impacts." For example, the use of a "scrubber" to remove sulfur dioxide emissions from a power plant's smokestack produces coal ash, which can, if improperly stored, contaminate groundwater. The EPA cannot adopt a standard that does more harm than good due to such "cross-media environmental impacts."
5. In identifying the best system, EPA must consider "energy requirements." The EPA cannot deem a system "best" if it imperils access to reliable energy sources.
6. The EPA must find that its preferred method of emission reduction has been "adequately demonstrated." Under D.C. Circuit case law, EPA cannot identify a "purely theoretical or experimental means of preventing or controlling air pollution" as the best system of emission reduction.
7.The EPA's guidelines must be translatable into "standards of performance" for individual sources. Ultimately, states must be able to turn the EPA's guidelines into enforceable standards for individual sources of pollution in the relevant category. This does not mean, however, that the source must meet its standard solely through actions taken within the walls of its own facility.
8. The EPA's guidelines must give states flexibility to account for the "remaining useful life" of their existing sources. The application of certain systems of emission reduction might make less economic sense for facilities on the verge of retirement. The EPA must allow states some way to account for this variation in useful life.
As further explained in our recent report, the EPA acknowledged and complied with each of these constraints when it issued the Clean Power Plan. For example, the EPA reviewed the full range of technological and operational reduction techniques available to regulated plants and engaged in extensive cost and energy impact analysis in identifying the "best system of emission reduction" that underlies its emission guidelines. The agency ultimately concluded that its system could be implemented at a reasonable cost — comparable, on a per megawatt-hour basis, to that of past power-plant regulations targeting other types of pollution — and without reducing overall electricity generation.
The Clean Power Plan's consistency with prior regulations
The petitioners' characterization of the Clean Power Plan as a "transformative" exercise of the EPA's legal authority is further belied by the fact that the EPA has used the plan's core elements in a number of prior Clean Air Act rules, issued under administrations of both parties.
Most notably, while petitioners claim that setting emission limits based on "generation shifting" from higher-polluting to low- or non-polluting sources of electricity is "unambiguously foreclosed by ... nearly a half century of consistent administrative practice," this simply isn't true. Two prior power-sector regulations — the Clean Air Mercury Rule, issued by the George W. Bush administration, and the Cross-State Air Pollution Rule, issued by the Obama administration and upheld by the Supreme Court — took the availability of generating shifting into account when setting emission limits.
Many other rules have been promulgated with the expectation that they would cause generation shifting, even if their emission limits were not set based on that expectation. For example, the 2011 Mercury and Air Toxics Standards were set by reference to reductions that oil- and coal-fired generating units could achieve using on-site controls, but the EPA nevertheless projected that the rule would cause a 1.3 percent decrease in coal-fired generation and a 3.1 percent increase in gas-fired generation between 2009 and 2015.
Similarly, national ambient air quality standards are set solely by reference to pollutants' health impacts, but the EPA has long recognized that they encourage states to increase use of cleaner electricity sources.
Other examples of regulatory precedents for the EPA's approach in the Clean Power Plan abound, as discussed further in our recent article.
The bottom line is this: When crafting the Clean Power Plan, the EPA followed clear statutory protocols and relied on familiar reduction techniques to set achievable emission limits. The result is not, as the challengers claim, an "enormous and transformative" expansion of EPA power, but is instead an eminently reasonable approach to begin addressing one of the most significant public heath threats of our time.
Revesz is dean emeritus and Lawrence King Professor of Law at New York University School of Law and director of the Institute for Policy Integrity. Grab and Lienke are senior attorneys at the Institute for Policy Integrity.
http://thehill.com/blogs/pundits-blog/energy-environment/296598-clean-power-plan-is-consistent-with-law-and-history
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Will Congress Wade Into Dakota Access Controversy? It can
Sep 20, 2016 | E&E Daily
By Hannah Northey
Congress may soon have a small — and quickly closing — window of opportunity to weigh in on the fight surrounding the $3.7 billion Dakota Access pipeline.
Members of the Senate Energy and Natural Resources Committee and House Natural Resources Committee will have 14 days to weigh in "any way they choose" after the U.S. Army Corps of Engineers decides whether to grant the pipeline developer an easement to cross the Missouri River, said Doug Garman, a spokesman for the agency.
Such an opening could allow lawmakers to call for a hearing, give their opinion or ask for more information on the Army Corps' approval of the easement.
Developers of the 1,172-mile-long Dakota Access pipeline, Energy Transfer Partners LP, need the easement to build the project across the Missouri River and ship up to 570,000 barrels a day of Bakken crude through North and South Dakota, Iowa and Illinois.
Whether members of the two committees will have the desire or time to ask for hearings given a tight congressional calendar remains murky.
At least one Democrat on the Senate ENR panel has expressed interest in a hearing but called the opportunity challenging given that Congress is preparing to leave town.
"I think that would be perfectly appropriate," Sen. Martin Heinrich of New Mexico said during an interview on Capitol Hill. "I haven't considered that venue. I have been very concerned about what's going on up there and certainly how people have been treated. I think the challenge is we're all getting ready to leave town here, so as a strategy I don't know how doable that is. I think the more that peoples' attention can be focused on what's going on up there, the better."
Heinrich has expressed concern with the treatment of protesters, calling it "unacceptable." The senator said there's been a "long time of checking the box on tribal consultation rather than truly gaging the tribal consultation" and that he'd like to see local tribes in particular consulted about routes and potential impacts and not just another "we're going to check the box and say we consulted the tribes."
Garman said the Army Corps is required to notify Congress and take input under the Mineral Leasing Act. The agency will provide two weeks unless the committees direct the agency to move ahead earlier, he said.
"Upon notification, committees can provide input or seek additional information in any way they choose," Garman wrote in an email. "We do not have a timeline on when that may occur."
Garman's comments are timely given the corps' statement at a court hearing in Washington, D.C., last week that it would take weeks — not months — considering whether to grant the easement. The court hearing revealed confusion surrounding the easement, with attorneys for Energy Transfer saying that until a few weeks ago they were under the impression the easement had already been approved (E&ENews PM, Sept. 16).
The Obama administration stepped in earlier this month and declared construction of the Dakota Access pipeline beneath and on the shorelines of Lake Oahe would be off-limits while the corps reviewed previous decisions under the National Environmental Policy Act (NEPA) or other federal laws. Construction within 20 miles of the lake, a dammed section of the Missouri River, is also off-limits for now, per a court order.
Activist groups like Bold and 350.org and supporters of Vermont independent Sen. Bernie Sanders are targeting the comment period as a potential flashpoint for "massive demonstrations" on Capitol Hill (E&E Daily, Sept. 9).
While Sanders has called on President Obama to conduct a deeper environmental review of the project, other members of Congress like North Dakota Sens. Heidi Heitkamp (D) and John Hoeven (R) have voiced support for the pipeline while saying all sides should be heard.
Representatives from the International Indigenous Youth Council of Standing Rock and Oceti Sakowin Youth encampment are calling on Sen. John Barrasso (R-Wyo.) to hold a hearing on Dakota Access in the Senate Indian Affairs Committee, which he leads, but have said the senator has so far declined. A spokesman for Barrasso said the chairman is deferring to Hoeven and Heitkamp, who are both members of his committee, and waiting to see how litigation over the pipeline is resolved.
In the lower chamber, Natural Resources Chairman Rob Bishop (R-Utah) has condemned the administration's intervention.
Bishop said during an interview last week that the Obama administration's decision to freeze construction on part of the Dakota Access pipeline was a purely political move that improperly injects the current process with uncertainty.
"It smacks and smells of political gamesmanship," he said. "Literally, if you have a process in place and you went through the process and the courts OK'd the process and upheld it, I expect better from the administration."
Bishop agreed the process should require update and reviews, including NEPA and the Endangered Species Act, even the "damn Antiquities bill." But Bishop said what happened in North Dakota is different from a routine update.
"What happened in North Dakota is simply a violation of their own standards," he said.
Reporters George Cahlink and Cecelia Smith-Schoenwalder contributed.
http://www.eenews.net/eedaily/2016/09/20/stories/1060043084
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Dakota Access Pipeline Construction Sits Uneasily in Federal Hands
Sep 19, 2016 | Natural Gas Intelligence
By Richard Nemec
Whether construction of the $3.8 billion, nearly 1,200-mile Dakota Access oil pipeline is completed on schedule early next year will likely be determined by a volatile amalgam of political, regulatory and court actions that should culminate in the next two or three weeks, based on developments in federal court Friday.
Judge James E. Boasberg of the Federal District Court for the District of Columbia declined to continue a temporary restraining order (TRO) that was in place until a status conference Friday. In that TRO, Dakota Access had voluntarily agreed to halt construction activities within two miles of the western edge of Lake Oahe and 20 miles east of the lake.
"The company’s plans in the wake of the judge’s decision were not made known at the hearing, but it appears that there are no longer any judicial restrictions -- voluntary or involuntary -- that would keep Dakota Access from construction activities not taking place in any area other than the land associated with the U.S. Army Corps of Engineers' (USACE) easement for the utility crossing immediately proximate to Lake Oahe," said Christi Tezak, managing director at ClearView Energy Partners LLC.
In North Dakota on the same day, U.S. District Court Judge Daniel Hovland removed another TRO -- this one against Standing Rock Sioux Tribal Chairman Dave Archambault II, Councilman Dana Yellowfat, and a number of other protesters opposed to the four-state oil pipeline. Dakota Access LLP applied the TRO on Aug. 15 in an effort to cut off demonstrations that they alleged had effectively shut down construction near the Oahe crossing under the Missouri River near the reservation in southcentral North Dakota.
Hovland's action eliminated any federal court prohibition on protests against the pipeline, leaving it up to local authorities and the criminal courts to deal with those accused of violations.
Meanwhile, local authorities are charging as felonies nonviolent actions, such as protesters locking their bodies to stationary equipment. An attorney representing some of the protesters said that while Hovland said he disliked many of the tactics of the protesters, he recognized the limitations of a court injunction in resolving a political contest like the one involved in the pipeline dispute.
Outside of the courts, the USACE's easement for completing the pipeline work under Lake Oahe continues to be a key unknown, although Corps officials reportedly told Boasberg that a decision on the easement is a matter of weeks away -- not months. A quick granting of the easement is thought to be a way for Dakota Access to remain on it most favorable construction completion timetable for early next year.
Tezak noted that the 8th Annual White House Tribal Nation’s conference is scheduled to be held in Washington, DC, Sept. 26-27. "This venue may present an opportunity to at least initiate the 'government-to-government' consultations promised by Justice, Interior and the Army in their joint announcement on Sept. 9.
"At first blush, the Corps statement could suggest that easement could be issued soon, potentially allowing Dakota Access to complete the pipeline section under Lake Oahe this fall," she said.
Tezak said ClearView's analysis remained "cautious," given the precedent of the rejected Keystone XL pipeline, a project which was subject to "several supplemental reviews." In the case of Dakota Access, the Corps could decide to reopen the environmental review of the lake crossing, EPA review or revisit another component of the completed review under either the Clean Water Act, the Rivers/Harbors Act,or the National Historic Preservation Act. Any of those courses would likely delay the USACE easement being issued.
The Corps' response to the Standing Rock Sioux’ complaint is due on Oct. 11, and a further status conference will be held on Nov. 10. In the meantime, the Standing Rock Sioux tribe is still seeking an emergency injunction to overturn Boasberg's past rulings and to halt pipeline construction on a 20-mile portion on either side of Lake Oahe.
Energy industry and construction trades officials have pushed back against the Obama administration's eleventh-hour interference in the Dakota Access project (see Shale Daily, Sept. 13).
http://www.naturalgasintel.com/articles/107794-dakota-access-pipeline-construction-sits-uneasily-in-federal-hands
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California Law on Climate Pollutants Is Nation's Toughest
Sep 20, 2016 | BNA Daily Environment Report
By Carolyn Whetzel
California must slash emissions of soot, methane and hydroflurocarbon gases from 2013 levels by 2030, according to a bill Gov. Jerry Brown (D) signed Sept. 19.
The bill, S.B. 1383, marks the nation's toughest effort to target the short-lived climate pollutants, which have a much higher global warming potential than carbon dioxide.
The bill is part of the state's broader plan to reduce greenhouse gas emissions. On Sept. 9, Brown signed legislation (S.B. 32) establishing a 2030 statewide target to cut emissions 40 percent below 1990 levels. It was sponsored by state Sen. Ricardo Lara (D).
“The super pollutants addressed in this bill—black carbon, methane, and HFC gases—are powerful climate forcers that have a profound effect on climate change and global warming,” said Lara at a Sept. 19 signing ceremony in Long Beach. “They also have detrimental effects on public health. This bill represents a unique opportunity to balance our global vision for the future with a much more local and immediate perspective.”
S.B. 1383 directs the California Air Resources Board to adopt and implement regulations by Jan. 1, 2018, to curb soot by 50 percent. The rules must reduce methane and hydroflurocarbons each by 40 percent. Sources of the emissions include transportation fuels, livestock and dairy waste, organic waste, and fluorocarbon gases used in refrigeration, air conditioning and aerosol products.
The air resources board released a draft plan to tackle the short-lived climate pollutants in April, consistent with the requirements of the new law.
S.B. 1383 includes provisions to help livestock and dairy operations and waste facilities comply with emission reduction deadlines. It also requires the state board to work with other state agencies to encourage the use of biomethane fuels.
“This bill curbs these dangerous pollutants and thereby protects public health and slows climate change,” Brown said at the event.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=97506103&vname=dennotallissues&fn=97506103&jd=97506103
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California Governor Signs New ‘Super Pollutant’ Bill Into Law
Sep 19, 2016 | The Hill - E2 Wire
By Devin Henry
California Gov. Jerry Brown (D) has signed into law new standards for “super pollutants” like black carbon and methane.
The bill signed by Brown on Monday requires a 50 percent reduction in black carbon and 40 percent cuts in methane and hydrofluorocarbons (HFCs) from 2013 levels by 2030.
Black carbon is a component of fine particulate matter formed by the incomplete combustion of fossil fuels. Methane is the primary component of natural gas and a source of pollution at drilling sites. HFCs are chemicals used primarily in air conditioning and refrigeration.
All three pollutants are short-lived when released into the atmosphere, but they have potent impacts on climate change. Methane, for instance, has 25 times the global warming potential of carbon dioxide; HFCs are up to 10,000 times stronger than carbon dioxide.
The Obama administration has looked to crack down on methane and HFCs, instituting new standards on emissions at drilling sites and seeking an international HFC reduction deal by the end of the year.
Brown’s office said the measure he signed on Monday, if applied worldwide, would cut the projected rate of climate change in half by 2050.
“Cutting black carbon and other super pollutants is the critical next step in our program to combat climate change,” Brown said at a signing ceremony on Monday.
“This bill curbs these dangerous pollutants and thereby protects public health and slows climate change.”
The new pollutant standards are one of a handful of climate-related bills approved by the California Legislature this year, including a plan to cut the state’s greenhouse gas emissions by 40 percent by 2030.
http://thehill.com/policy/energy-environment/296670-california-governor-signs-new-super-pollutant-bill-into-law
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Hudson River Cleanup Not Complete, N.Y. Attorney General Says
Sep 20, 2016 | BNA Daily Environment Report
By Gerald B. Silverman
The Environmental Protection Agency shouldn't issue a certificate of completion to General Electric Co. for its work dredging polychlorinated biphenyls from the Hudson River until additional steps are taken to ensure that the remedial work was effective, according to a letter from the office of New York Attorney General Eric Schneiderman (D) released Sept. 19.
The letter said granting GE the certificate of completion would create a legal covenant that releases GE from additional liability in the project.
Schneiderman is joining the chorus of environmental groups, New York state regulators and others who have urged EPA to require additional remedial work on the river.
EPA is undertaking a five-year review of the Superfund project, which was virtually complete in October 2015. The review is scheduled to be complete in April 2017.
$1 Billion Spent
General Electric has spent more than $1 billion to remove 2.7 million cubic yards of sediment and 310,000 pounds of PCBs, the company said.
“When we have completed our demobilization obligations later this year, we expect the project to be declared complete,” Mark Behan, a spokesman for GE, told Bloomberg BNA in an e-mail.
“The U.S. EPA declared the project a success and said no additional dredging was necessary,” Behan said. “EPA is now in the midst of a formal assessment of the results, and we're confident that the assessment will show the dredging project achieved the agency's goals of protecting public health and the environment.”
Larisa W. Romanowski, a spokeswoman for the EPA, said the agency will review the letter from Schneiderman and “consider the points that it makes as part of our ongoing five-year review process.”
Further Steps Urged
Among the steps that Schneiderman is urging the EPA to take are:
• delaying the certificate of completion until it concludes that the remedial work was complete and “fully protective of human health and the environment”;
• determining how long it will take for PCB levels in fish to be reduced so that fish consumption health advisories may be lifted;
• undertaking a comprehensive fish consumption survey; and
• defining the scope and objectives of the five-year review.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=97506096&vname=dennotallissues&fn=97506096&jd=97506096
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UN ‘Confident’ Paris Deal Will Take Effect This Year
Sep 20, 2016 | BNA Daily Environment Report
By John Herzfeld
A Sept. 21 United Nations session on climate change will include announcements by large countries that are expected to fuel momentum toward ratification of the Paris climate agreement by the end of 2016, a UN official said Sept. 19.
Argentina and Brazil are among the countries that will formally register their ratification of the international climate agreement at a Sept. 21 United Nations session on climate change, and Australia and New Zealand will announce their intention to ratify the Paris accord, according to the official, who is involved in Secretary-General Ban Ki-moon's planning for the high-level meeting but requested anonymity in keeping with diplomatic custom.
“We're pretty confident of ratification by the end of the year,” he told Bloomberg BNA. “That's remarkable. No treaties ever go into effect that fast.”
Several possible pathways to ratification suggest themselves in the next few months, the official said on the sidelines of the opening of the annualClimate Week NYC program of policy events in New York.
Russia, India and the European Union are the delegations to watch for the treaty to gain the necessary percentage threshold for ratification, he said.
Moniz Sees Bipartisan Support
In Climate Week keynote remarks, Energy Secretary Ernest Moniz said the past year has marked an “aggressive, more global approach” to the need for long-term investments in innovative technology to implement the Paris Agreement.
He pointed specifically to the Mission Innovation initiative announced at the Paris meeting, a joint project of 20 countries seeking to double clean energy research and development in the next five years. The Paris Agreement calls for limiting global warming to 2 degrees Celsius compared to pre-industrial levels, with a pledge to pursue efforts to limit climate change to 1.5 degrees Celsius.
As part of Mission Innovation, the Obama administration is seeking to boost the $6.4 billion that Congress provided in fiscal year 2016 for clean energy research and development to $12.8 billion in fiscal year 2021.
Moniz said the Mission Innovation plan “has attracted significant bipartisan support” in Congress. Although the appropriations process isn't finished, he said, U.S. budget priorities have been reoriented “to give us an uplift on innovation.”
Calling himself an optimist and a scientist who believes in “rationality,” Moniz added that he has a bet going that Congress will enact simplified, economywide legislation on climate “by the end of this decade.”
Governments must focus on sending “clear signals” on carbon dioxide reduction and financial structures to help businesses make long-term investment decisions for multidecade efforts, he said. Congress has failed for two years to act on Obama administration proposals for tax breaks for carbon capture and sequestration, he said.
Stage Already Set?
Many of the speakers in the Climate Week opener similarly called for signals from governments on cap-and-trade, a carbon tax or other mechanisms to set a price on greenhouse gas pollution. But Jonathan Pershing, the State Department's special climate envoy, said in a panel discussion that the terms of the Paris Agreement, actions by individual countries and the scientific findings of the UN Intergovernmental Panel on Climate Change have set the stage to sufficiently guide future investment.
“The market has shifted in an appreciable way,” Pershing said. “Paris was a turning point, and Marrakech will mark the first step in this new world of implementation.” In November, the Moroccan city will host the first post-Paris Conference of the Parties to the UN Framework Convention on Climate Change.
Efforts to set a price on carbon run into questions of political risk that policy makers haven't been able to overcome, Pershing said, but incremental steps have provided a model or template for private-sector decisions.
“The private sector does well with uncertainty,” he said, calling it “remarkably robust” in coming up with innovation.
‘Political Head Winds.’
Moniz also pointed to U.S. political factors, saying leaders must face up to “distributional issues” of access to energy and jobs. Clean energy will create more jobs, but “not in the same places” as in the fossil fuels economy, he said.
“The political head winds will be greater if we don't address these distributional issues,” Moniz said. “We can't ignore them.”
Asked in the keynote discussion about consistency between administrations as the U.S. presidential election approaches, Moniz told Rachel Kyte, head of the Sustainable Energy for All advocacy group and a special representative of the secretary-general, that the American public increasingly recognizes the need to act on climate change.
“That's not always reflected in the political debate,” he said, adding that “weird weather” has played a role, as the public realizes that we're seeing “extreme weather patterns that have been predicted for decades.”
U.S., China Agreement
Lisa Jackson, the former Environmental Protection Agency administrator who is now an Apple Inc. vice president for environment, policy and social initiatives, told the meeting that the Sept. 7 Paris announcement by the U.S. and China that the two countries had formally joined the agreement marked a moment that “even the most optimistic of us” had worried would never come.
As the world moves toward implementing the pact, she said, governments and businesses are unified and “moving forward with the same vital vision.” But despite all the “painstaking work” it took to achieve that, “this is really where the work begins again,” she said.
Apple has moved to 100 percent renewable energy for its operations and just joined the RE100 group of corporations committed to clean energy, according to Jackson. Now the company is turning its efforts to push renewables in its supply chain, which she said accounts for 77 percent of Apple's carbon emissions.
She joined in the call for government policies that “nudge” businesses “in the right direction.” While not taking a position on choosing between cap-and-trade and carbon tax approaches, she said Apple wants to see “carefully designed, thoughtful policies” to put a price on carbon.
Looking Toward Election
The combination of the Paris accord and the U.S.-China announcement “breeds optimism” for a global transition to clean energy, Amy Davidsen, executive director of the Climate Group, the Climate Week NYC sponsor, said in her opening remarks.
But investors and others around the world are watching the November election carefully to see whether the U.S. “will continue its climate leadership,” she said.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=97506097&vname=dennotallissues&fn=97506097&jd=97506097
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