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AM ACC Clips Report - November 9, 2018
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Agency Defends Enforcement Record
Nov 8, 2018 | E&E News PM
By Sean Reilly
EPA officials defended the agency's civil enforcement record earlier this year, saying they are focused on "maximizing compliance results," as opposed to the number of individual enforcement actions, according to written responses to questions from Sen. Ed Markey (D-Mass.). -
New EPA Policy For Reviewing State Programs Calls Intervention 'Last Option'
Nov 8, 2018 | Inside EPA
By Dave Reynolds
Acting EPA Administrator Andrew Wheeler has quietly issued new guidance that limits agency oversight of states' delegated programs and calls federal intervention a “last option” even when states allow for significant noncompliance, an approach that is drawing criticism from environmentalists who say it ignores statutory mandates to review some permits. -
Likely House Chairwoman to Fight Moves to ‘Suppress’ Science
Nov 8, 2018 | BNA Daily Environment Report
By Pat Rizzuto
Rep. Eddie Bernice Johnson (D-Texas), who is expected to chair the House science committee after Democrats take control in January, said she will protect scientific research from political pressures and special interests. -
‘No One Is Noticing’ Trump’s Unprecedented Interference With Science
Nov 9, 2018 | The Atlantic
By Robinson Meyer
The Trump administration is breaking with 75 years of precedent by attempting to interfere in how science is practiced by the U.S. government, according to three experts who issued a dire warning to their profession in the journalScience on Thursday. -
Changes Ahead with New U.S. Congress
Nov 9, 2018 | Chemical & Engineering News
By Britt Erickson, Jeff Johnson and Jyllian Kemsley
Following the U.S. elections on Nov. 6, the Democratic Party will gain control over the House of Representatives when the new Congress convenes in January. The Republican Party will retain control of the Senate. -
EPA Declines Growing Calls To Set Surface Water Standards For PFAS
Nov 8, 2018 | Inside EPA
By Suzanne Yohannan
EPA is facing growing calls from states and other stakeholders to set surface water standards for perfluorinated compounds, but the agency currently has no plans to establish such standards, an EPA water official told state waste managers recently. -
EPA's Perchlorate Deadline Extended -- at Least to December
Nov 8, 2018 | Inside EPA
A federal judge has extended until at least December EPA's prior court-ordered Oct. 31 deadline to propose a drinking water standard for the rocket fuel ingredient perchlorate after the judge hearing the case gave the parties until the end of November to complete briefings on EPA's request for an additional 6-month extension. -
Principles of Chemical Regulations – Why Do We Have Them?
Nov 9, 2018 | Chemical Watch - Brief
By Mark Selby
Unless you genuinely have nothing better to do, the reason that this column is read and why it is necessary for organisations like Chemical Watch to go to the effort to produce such articles, is that there is a raft of regulations that we need to follow to comply with the law. -
Cosmetics Without Animal Testing
Nov 9, 2018 | Chemical Watch - Brief
By Andrew Warmington
"There are different types of cosmetic products, different ingredients and different demands from customers and retailers," says Michael Maynard, a board-certified toxicologist who is vice-president of global product sales at small cosmetics firm Beautycounter in the US. -
Echa’s Board of Appeal and Cosmetics Testing on Animals
Nov 9, 2018 | Chemical Watch - Brief
By Katy Taylor
In 2013, the European Commission told European citizens that animal testing of cosmetics in the EU, and the sale here of cosmetics that had been tested on animals elsewhere, were now things of the past. No ifs, no buts. It did not matter whether or not non-animal methods were available. -
Siefs: A New Era for an Old Concept
Nov 9, 2018 | Chemical Watch - Brief
By Caroline Byrne
While substance information exchange forums (Siefs) were supposed to disappear alongside their legal obligations on 1 June, many are forging ahead, spurred on by the many huge challenges their members face. -
‘Eurasia REACH’ – What Do We Know Today?
Nov 9, 2018 | Chemical Watch - Brief
By Olesia Popcharska
Discussions about the possibility of Russia adopting REACH-like regulations have been ongoing for a long time. In 2010, Russia, Belarus and Kazakhstan founded the Eurasian Customs Union (EACU). -
Judge Blocks Keystone XL Pipeline
Nov 8, 2018 | The Hill - E2 Wire
By Timothy Cama
A federal judge blocked the controversial Keystone XL oil pipeline Thursday, saying the Trump administration’s justification for approving it last year was incomplete. -
Judge Tosses Trump’s Keystone XL Approval over Climate Change
Nov 8, 2018 | PoliticoPro
By Alex Guillén
A federal judge ordered both the Trump administration and TransCanada to stop any work on the controversial Keystone XL pipeline on Thursday, saying President Donald Trump’s approval of the project last year violated several key environmental and administrative laws by ignoring facts about climate change. -
EPA Eases Oil Industry Compliance with Refinery Air Rules
Nov 8, 2018 | Inside EPA
EPA has issued a final rule easing industry compliance with refining sector air rules, as the agency completes years of deliberations on various technical aspects of Obama-era Clean Air Act rules for refineries in response to petitions for reconsideration from industry and environmentalists. -
Colorado Vote Paves Way for $7.7 Billion Anadarko Deal
Nov 8, 2018 | BNA Daily Environment Report
By Rachel Adams-Heard and Alex Nussbaum
Anadarko Petroleum Corp.’s first move after Colorado voters rejected an anti-drilling ballot measure was the $7.68 billion combination of two pipeline businesses that will free up more cash for oil and natural gas exploration. -
Energy Companies Triumph by Defeating Carbon, Fracking Initiatives
Nov 7, 2018 | Houston Chronicle
By Rye Druzin
Energy companies won big Tuesday night, beating back a pair of ballot measures that would have severely restricted drilling in Colorado and imposed a carbon fee on refineries, power plants and other industrial faculties. -
Cheniere LNG Expansions Continue with New Poland Contract
Nov 8, 2018 | Houston Chronicle
By Jordan Blum
Cheniere Energy, the Houston liquefied natural gas exporter, said Thursday that it signed a long-term supply contract with Poland's state-run energy company, a deal touted by the Trump administration as helping to reduce Europe's reliance on Russian gas. -
House Democrats Mull Water Infrastructure Options For 2019 Legislation
Nov 9, 2018 | Inside EPA
By Lara Beaven and David LaRoss
House Democratic staff on multiple committees are reaching out to stakeholders for ideas on ways to bolster clean water infrastructure in a possible bipartisan bill in the next Congress -- an effort that could strengthen EPA's water infrastructure funding programs which already face significant demand for funding. -
EPA Eases States’s Ability to Write Off Smog From Other Countries
Nov 9, 2018 | BNA Daily Environment Report
By Amena H. Saiyid
States marginally violating federal ozone limits can blame air pollution blowing in from other countries without first proving they did all they could to control local emissions, the EPA said. -
EPA Expands States' Ozone NAAQS Waivers But Avoids Key Legal Question
Nov 8, 2018 | Inside EPA
By Stuart Parker
EPA's final rule for how states should implement the 2015 ozone national ambient air quality standard (NAAQS) expands their ability to cite international emissions as a reason to waive some emissions control requirements, but the regulation sidesteps key legal questions on weakening air pollution controls raised by an appeals court's ruling. -
State Carbon-Tax Defeat Won’t Halt Federal Push, Exelon CEO Vows
Nov 9, 2018 | BNA Daily Environment Report
By Jennifer A. Dlouhy
Despite Washington state voters’ rejection of a tax on carbon dioxide emissions, there’s still an opening in Congress for a national plan to bolster clean energy and help combat climate change, Exelon Corp. Chief Executive Chris Crane said Nov. 8. -
Appeals Court Grants Trump Admin Request to Stay Youth Climate Lawsuit
Nov 8, 2018 | The Hill - E2 Wire
By John Bowden
A federal appeals court in Oregon on Thursday granted a motion from the Trump administration for a temporary stay in a lawsuit brought forward by a group of young people who argue that the government is violating their rights by not adequately battling climate change.
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Agency Defends Enforcement Record
Nov 8, 2018 | E&E News PM
By Sean Reilly
EPA officials defended the agency's civil enforcement record earlier this year, saying they are focused on "maximizing compliance results," as opposed to the number of individual enforcement actions, according to written responses to questions from Sen. Ed Markey (D-Mass.).
Because the agency was also concentrating on high-impact criminal cases, "the years of incarceration as a result of those cases has also increased," the agency said. "Finally, civil and criminal penalties and the value of injunctive relief all increased in 2017, despite a decrease in the number of cases," according to the letter.
Markey's office released the excerpts from the letter this week following a request from E&E News. Markey had written then-Administrator Scott Pruitt in January inquiring about a reported plunge in new enforcement cases during the Trump administration's first nine months compared with comparable periods for the Obama and George W. Bush administrations.
The EPA inspector general's office mentioned Markey's letter this week in announcing a new audit of EPA enforcement activities (E&E News PM, Nov. 6). Markey's office received the response in May, a spokeswoman for the senator said in an email.
In his January letter, Markey, a member of the Senate Environment and Public Works Committee, had also posed a series of questions about a policy imposed by Pruitt last fall that bars current EPA grant recipients from serving on agency advisory committees. While Pruitt had described the ban as a means of preserving members' objectivity, the agency took a different stance with Markey.
Pruitt's directive "is not an ethics policy intended to address conflicts of interest, but rather is an exercise of the administrator's broad discretion to appoint members to EPA's advisory committees," the response said.
Pruitt's policy is the subject of three pending lawsuits. Agency attorneys have staked out a similar position in arguing the ban is legal.
https://www.eenews.net/eenewspm/2018/11/08/stories/1060105637
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New EPA Policy For Reviewing State Programs Calls Intervention 'Last Option'
Nov 8, 2018 | Inside EPA
By Dave Reynolds
Acting EPA Administrator Andrew Wheeler has quietly issued new guidance that limits agency oversight of states' delegated programs and calls federal intervention a “last option” even when states allow for significant noncompliance, an approach that is drawing criticism from environmentalists who say it ignores statutory mandates to review some permits.
In addition, one state regulator tells Inside EPA that some states are seeking additional specificity from the agency that will maintain existing flexibilities and also to ensure that EPA maintains its role as an arbiter of disagreements that arise from pollution transport issues.
Wheeler issued an Oct. 30 memo to regional officials, “Principles and Best Practices for Oversight of Federal Environmental Programs Implemented by States and Tribes,” which generally calls for EPA to defer to state decision-making in most cases but also lays out situations when regulators should intervene to protect human health and the environment.
“States and tribes have the primary role in state- and tribal-implemented federal programs, and the EPA will generally defer to states and tribes in their day-to-day activities,” Wheeler says describing the first of four principles that will guide regions review of state programs.
“Withdrawal of program implementation authority is a last option to be considered after all other options have been exhausted or when human health and the environment are at risk,” the memo adds.
But an environmentalist, who reviewed the policy obtained by Inside EPA, charges that it focuses on review of state programs as a whole, but ignores requirements under statutes including the Clean Air Act (CAA) and the Clean Water Act (CWA) to review certain permits before they are issued.
“This memo appears to avoid the key issue of whether EPA is still going to do permit reviews” on a case by case basis, Jeffry Fowley, a former EPA official who now consults for the Environmental Integrity Project (EIP) says.
Fowley adds that EPA's authority to conduct up-front reviews of certain state permits is an important mechanism for preventing pollution problems before they occur.
“It doesn't say they are not,” going to review permits before they are issued. “But it doesn't say they will.”
Acting Deputy Administrator Henry Darwin, in a statement to Inside EPA, says the principles outlined in the policy will apply to EPA's permit reviews. While not explicitly noted, Darwin says the policy covers such reviews through a reference to state “activities” that regions will evaluate under the new policy.
Darwin says that EPA has already piloted the new process in oversight of the Title V permitting program and real-time review of state-issued National Pollutant Discharge Elimination System (NPDES) permits, and are evaluating the results of that effort with input from state regulators.
“[T]he two pilots represent both types of EPA oversight - program review and real-time review,” he added.
Cooperative Federalism
The highly-anticipated memo is part of the Trump administration's push for increased cooperative federalism, where states take the lead in implementing federal environmental law while EPA maintains an oversight role and also provides technical assistance and other support where needed.
The policy responds to calls from the Environmental Council of the States (ECOS) for EPA to conduct retrospective reviews of state programs wherever possible, rather than reworking specific decisions, and for a consistent review process, and is one piece of Darwin's broad push for greater efficiency at EPA, which also includes streamlining processes using “Lean” business metrics and reorganizing regional offices in a manner similar to headquarters.
Darwin is a former head of the Arizona Department of Environmental Quality. Former EPA Administrator Scott Pruitt hired Darwin as the agency's chief of operations, but he was elevated to his current role after Pruitt resigned in July and then-Deputy Administrator Wheeler was tapped as the agency's acting chief.
The memo says that EPA headquarters will solicit feedback from regions, states and tribes, though some states are already telegraphing concerns that the policy may not be specific enough and fails to preserve EPA's role mediating interstate disputes.
“States have commented that we need clearer procedures,” John Linc Stine, commissioner of the Minnesota Pollution Control Agency (MCPA) and a past president of ECOS, said in an Oct. 31 interview. “That's the tone of many state comments -- moving away from the principles of cooperative federalism into detailed procedures.”
Specifically, Stine said, states are seeking greater specificity on how to elevate disputes between state and EPA regional staff to ensure timely resolution. He also said that states are seeking clearer definition of EPA and state authorities and a greater emphasis on EPA's role as arbiter of inter-agency disagreements.
Wheeler's memo to staff outlines principles to guide EPA regional officials' work with states in three areas -- formal retrospective reviews of state environmental programs, regular meetings and discussions between regions and states, and matter specific consultations between the parties to address urgent, precedential or high profile matters in the state.
Regions' work in each of those areas should adhere to four principles -- general deference to state decision-making, effective communication, clear standards of review and a predictable process, as well as defining a clear process for elevating disputes from staff to supervisors to ensure prompt resolution of disagreements.
But EIP has pushed back against EPA's development of the policy, arguing in an Aug. 28 letter to Darwin, that streamlining EPA regions' reviews of state programs will allow for issuance of inadequate permits and weak enforcement.
“EPA oversight of state programs has been a critical component of ensuring public health and environmental protection,” the letter said. “After-the-fact audits of state programs inherently come too late to ensure that permits are not issued which violate the minimum federal standards and thus create gaps in what should be nation-wide public health and environmental protection.”
EIP urged EPA to seek public comment before finalizing the policy, but the agency did not take that step.
'Maintain Strong Performance'
In the Oct. 30 memo, Wheeler says the guidelines aim to ensure states “maintain strong performance” in implementing federally delegated environment programs and create greater consistency in program reviews across regions, thereby ensuring a level playing field.
The memo says that reviews should focus on areas that may pose risk to human health or the environment, where there is long-standing implementation issues, or that may set broader precedent. But the memo also suggests that EPA will be loath to revoke state authority even if state implementation is inadequate.
“For most program performance issues identified through oversight evaluation, the EPA anticipates it will be able to help states and tribes return to appropriate performance levels using a variety of tools such as technical support, education, training programs, guidance, work-sharing, evaluations or other appropriate actions,” the memo says.
Before deeming a state program deficient, the memo instructs regions to communicate findings to the state agency and allow an opportunity to respond. “In certain circumstances, such as long-standing program deficiencies, the EPA may conduct enhanced oversight to better understand issues or to ensure that improvements are taking place.”
The memo includes criteria for when direct federal action may be needed and cautions that in such cases, regional officials should engage with states or tribes as early as possible.
The criteria include situations where there is substantial risk to human health or the environment, when a state or tribe lacks sufficient resources or capability to effectively implement programs, when a state decision conflicts with federal requirements, or a state has documented history of inadequate program implementation.
In defining criteria for direct federal action, Wheeler references Jan. 22 interim guidance from enforcement chief Susan Bodine that raises the bar for the agency to bring enforcement actions that states oppose.
“EPA will generally defer to authorized States as the primary day-to-day implementer of their authorized/delegated programs, except in specific situations,” Bodine said. “EPA believes that exceptions to this general practice should be identified through close communication and involvement of upper management of both agencies.”
But Fowley argues that Wheeler's memo fails to address EPA's role in reviewing certain permits up front, which he says is crucial to ensuring environmental protection. And he says that while this and prior memos note federal officials' authority to enforce when states overlook noncompliance, they are not taking that step when problems arise.
Fowley cited as examples, a watchdog group's recent call for EPA Region 4 to take over NPDES permits, alleging that the Florida Department of Environmental Protection has failed to ensure compliance, as well as high lead levels found in drinking water in Newark, NJ.
In an Oct. 29 “overfile” request to EPA Region 4 Administrator Trey Glenn, the group Public Employees for Environmental Responsibility (PEER) urged EPA to take over administration of two NPDES permits issued to the City of Venice.
The request followed a half dozen similar, unanswered requests that PEER's Florida chapter lodged in May, urging EPA to overfile to redress Florida's “chronic nonenforcement” against “longstanding, ongoing and blatant Clean Water Act violations” at a half dozen facilities that discharge wastewater into the St. Johns River near Jacksonville.
https://insideepa.com/daily-news/new-epa-policy-reviewing-state-programs-calls-intervention-last-option
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Likely House Chairwoman to Fight Moves to ‘Suppress’ Science
Nov 8, 2018 | BNA Daily Environment Report
By Pat Rizzuto
Rep. Eddie Bernice Johnson (D-Texas), who is expected to chair the House science committee after Democrats take control in January, said she will protect scientific research from political pressures and special interests.
Among her priorities is blocking political efforts to limit science used in regulations, she said.
Types of government efforts to which Johnson referred are highlighted in a Nov. 8 Science article examining debates about the use of science to inform Environmental Protection Agency regulatory decisions.
Critics content those efforts would undermine the EPA’s ability to set protective limits for air and water pollution and its oversight of chemicals. But some Republicans and the Trump administration claim the efforts are intended to make the EPA’s science easier to understand.
Johnson—the current ranking member of the House Science, Space, and Technology Committee—is expected to chair that panel after the Democrats take the majority in 2019.
‘Fight to Protect Our Scientists’“As chair, I would continue to fight to protect our scientists and engineers from attempts by some in government or the private sector to deny or suppress widely supported and tested scientific findings because of politics, ideology, or financial conflicts of interest,” Johnson told Bloomberg Environment Nov. 7.
The Science article looks at decades of government policy, and most recently an EPA directive last year barring agency grant recipients from serving on EPA advisory boards, an April proposal on science issued by the agency, and the Honest and Open New EPA Science Treatment Act, which the House passed in 2017, but which has not become law.
All three would unnecessarily “control and limit the scientific record” agencies are allowed to rely on in writing regulations and muzzle scientists who have received agency grants, wrote Wendy Wagner, a law professor at the University of Texas School of Law, and her Science co-authors.
Democrats’ Battle Over?But conservative proponents of the efforts to change government science policies said they have already made important gains.
The legislative and EPA efforts are about making sure that all parties understand the scientific data, methods used to gather that data, and policy choices made during the analysis, said Angela Logomasini, a senior fellow at the Competitive Enterprise Institute, which calls itself a nonprofit libertarian think tank.
And Steve Milloy, an environmental health consultant, who said he pushed for the EPA’s science advisers policy while serving on the Trump transition team, told Bloomberg Environment: “The good news is that I’m winning.”
Acting EPA Administrator Andrew Wheeler said in a statement: “I think it’s important to be very transparent, and I think it’s important to make sure people who serve on the science advisory boards don’t have conflicts of interest.”
But a scientist who served in Congress as a Democrat said politicians have no business affecting the science behind regulations.
“Transparency is not the end,” Rush Holt Jr., a physicist who served as a U.S. Democratic Representative for New Jersey from 1999 to 2015, told Bloomberg Environment Nov. 8. Holt is now CEO of the American Association for the Advancement of Science.
“It’s ludicrous for members of Congress to prescribe what the regulations should be, and what the scientific process should be for those regulations,” Holt said.
https://news.bloombergenvironment.com/environment-and-energy/likely-house-chairwoman-to-fight-moves-to-suppress-science
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‘No One Is Noticing’ Trump’s Unprecedented Interference With Science
Nov 9, 2018 | The Atlantic
By Robinson Meyer
The Trump administration is breaking with 75 years of precedent by attempting to interfere in how science is practiced by the U.S. government, according to three experts who issued a dire warning to their profession in the journalScience on Thursday. The administration is empowering political staff to meddle with the scientific process by pushing through reforms disguised to look as though they boost transparency and integrity, the experts say.
“It is tempting to conclude that recent proposals for reforming regulatory science are similar to what has occurred in the past,” they write. “They are not.”
“People who are not scientists are telling us how scientific synthesis and analysis should be done,” says Wendy Wagner, a professor of law at the University of Texas at Austin and one of the authors of the paper. “We’re not even getting scientists’ best work. We’re tying scientists’ hands behind their back and not even giving them a shot.”
“It’s a very dangerous place for science and public policy,” she told me. “Politics has gone to a place that should be off limits, and no one is noticing and calling them on that fact.”
The experts’ warning may prove particularly damaging to the reforms’ success. One of the Trump reforms that most worries Wagner claims to be inspired by a 2009 study from the Bipartisan Policy Center and a 2013 report by the Administrative Conference of the United States. An EPA statement also cited both of those studies for authority.
Wagner actually led and then wrote both of those studies. She said the proposed scientific reform was “extremely problematic.”
In Thursday’s edition of Nature, her warning was co-authored with Liz Fisher, a professor of environmental law at Oxford; and Pasky Pascual, a recently retired data scientist and lawyer for the U.S. Environmental Protection Agency.
The experts are most critical of a so-called scientific-transparency rule first proposed by Scott Pruitt, the former administrator of the Environmental Protection Agency. As I wrote in July, the rule would effectively bar the agency from using public-health research—or any other research that relies on private medical records—when issuing rules to limit water pollution, air pollution, or the use of toxic chemicals. Though Pruitt has resigned, the proposal remains on track to become official EPA policy.
The Pruitt proposal “applies retroactively,” Wagner told me, meaning it would force the EPA to revise—and possibly weaken—nearly every rule protecting human health from air, water, or chemical pollution issued during the agency’s 48-year history.
That proposal has been condemned by nearly 70 scientific and public-health professional organizations, as well as by Harvard; the Association of Public and Land-Grant Universities; and the editors of Science, Nature, and the Proceedings of the National Academy of Sciences.
The experts also criticize an EPA directive issued by Pruitt in 2017 that remains in effect. That memo barred any university scientist who has received a research grant from the EPA from serving on an EPA scientific-advisory board or acting as a peer reviewer of EPA regulatory analysis. Notably, it did not put industry scientists under the same restrictions, even if they are employed by a company that could be financially hurt by EPA regulation.
Since the rule was issued, “at least a few respected scientists have been removed from EPA science-advisory boards because they were not willing to abandon their EPA-funded research,” the authors write. “To our knowledge, there is no precedent for such a unilateral exclusion of federal grantees as peer reviewers” in either federal law or academic practice, they add.
The experts also criticize the honest Act and the EPA Science Advisory Board Reform Act, a pair of bills that would constrain the EPA similarly to the proposals above. Both bills passed the House of Representatives last year but seem unlikely to become federal law during this Congress.
Why are all of these reforms so unprecedented? According to the authors, each of them places some stage of the scientific process under political direction. For decades, they write, the EPA and other federal agencies have followed a “two-step process” when consulting science: First, scientific staff have reviewed existing research and summarized and synthesized it for political staff. Then, that political staff “can accept, ignore, rerun some of the analysis, or reinterpret the results.”
This process essentially erects an apolitical wall between the agency’s scientific staff and its policy makers, and it has been endorsed by the U.S. National Academy of Science, the authors say. But every single one of the proposed EPA reforms breaches that wall, allowing political staff to dictate the terms of scientific analysis and synthesis to scientists.
“It’s extremely problematic to start to limit what the scientific analysis can actually do within the agency. It cuts into the science, a place we’ve never been before,” Wagner told me.
“Of course, science has been under siege in the agencies for decades,” Wagner said. “But it’s never gotten to the point where we’re actually altering the rules to limit the review of the scientific literature.” Since political appointees can issue exemptions to the new policies, they could essentially pick and choose what research scientists are allowed to even consider for synthesis, she said. “So we’ll now be painting a partial picture, and a lopsided picture.”
In the paper, the experts provide a short summary of the use of science in government, demonstrating why the Trump interference is so unprecedented. Wagner told me that the best comparison to the new proposals is when the Indiana state legislature erroneously tried to establish the value of pi as 3.2 at the end of the 19th century: “It’s politics going to a place that should be off-limits. They’re in a place that it shouldn’t be.”
The proposed rules also use terms of great scientific consequence—including “replication” and “transparency”—but fail to define their meaning, the experts say. This could allow federal courts to redefine the terms in ways not conducive to the best interests of science.
Above all, Wagner said she hoped that the broader community of research scientists and technical experts would sit up and pay attention to the EPA proposals and House bills. Many researchers seem to believe the rules set up surmountable obstacles, she said, when they may actually endanger entire swaths of regulation. If the “transparency” proposal becomes law, it would apply to every other EPA rule, Wagner said. Courts could toss out entire agency regulations if the underlying research fails to meet the new, politically-informed standard. “These are mandatory.”
Even if the proposals don’t become law, they point to a depressing “new era” in the federal wars over science, the experts write. As Wagner told me: “What worries us is that we’ve gotten to this point—that this is even on the table.”
https://www.theatlantic.com/science/archive/2018/11/experts-warn-trump-epa-meddling-scientific-method/575377/
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Changes Ahead with New U.S. Congress
Nov 9, 2018 | Chemical & Engineering News
By Britt Erickson, Jeff Johnson and Jyllian Kemsley
Following the U.S. elections on Nov. 6, the Democratic Party will gain control over the House of Representatives when the new Congress convenes in January. The Republican Party will retain control of the Senate.
Among those newly elected to the House are several candidates with science backgrounds, including biochemical engineer and clean-energy entrepreneur Sean Casten (D-Ill.), nuclear engineer Elaine Luria (D-Va.), and nurse Lauren Underwood (D-Ill.). Overall, the House will have at least 18 members with science, technology, engineering, and mathematics (STEM) backgrounds or history of STEM advocacy, according to analysis by Maggie Koerth-Baker of FiveThirtyEight.
The switch in control of the House means leadership changes across the board, including new chairs of committees that handle science legislation and provide oversight of the Trump administration.
A jolting leadership change is expected on the House Committee on Science, Space, & Technology, where Rep. Lamar Smith (R-Texas), a climate change skeptic and vociferous critic of federal research, will likely be replaced by Rep. Eddie Bernice Johnson (D-Texas).
In her first post-election statement, Johnson underscored the importance of climate change research and education, “starting with acknowledging it is real.” She said she would prioritize science innovation; STEM education; robust federally funded R&D; defending scientists from political and ideological attacks; and “challenging misguided or harmful Administration actions.”
Other likely new committee chairs include Rep. Frank Pallone Jr. (D-N.J.) on the Committee on Energy & Commerce, which also covers environment and healthcare; Rep. Raúl Grijalva (D-Ariz.) on the Committee on Natural Resources; and Rep. Nita Lowey (D-N.Y.) on the Committee on Appropriations.
When asked what to expect from the new Congress, Anthony Pitagno, government affairs director for the American Chemical Society, predicted “bunts and singles, but not major legislation.” ACS will be looking to work with Congress on issues likely to gain bipartisan support, such as enhanced protection of critical natural materials, greater support for two-year technical education, and consistency in science research funding, Pitagno says. This funding, he notes, may be more restricted as the 2017 tax relief law goes into full effect and budgets are cut in response. ACS publishes C&EN.
Similarly, the American Association for the Advancement of Science (AAAS) plans to work with Congress where there is general support of science and technology, says Joanne Carney, AAAS’s director of government relations. She predicts that Congress may increasingly examine how science is used in federal government agencies. She expects oversight hearings to probe, for example, new Environmental Protection Agency policies restricting scientists’ participation on advisory boards and Department of Interior proposals to roll back protections of endangered species.
Andrew Rosenberg, director of the Union of Concerned Scientists Center for Science & Democracy, joins Carney in predicting more oversight hearings. The oversight goal is not to uncover scandals but to restore checks and balances across the different branches of government, he says.
Additional probable hearing topics include examination of weakened pollution control and fewer scientists serving in federal agencies, Rosenberg says. “We are losing scientists in government at an alarming rate,” he says. “EPA staff today is at levels not seen since the Reagan years in the 1980s, while the issues remain as complex as ever.”
Another area likely to get oversight hearings is EPA’s implementation of revisions to the Toxic Substances Control Act (TSCA). In the last two years, Democrats on the House Energy & Commerce Committee submitted at least four requests for hearings on EPA’s oversight of commercial chemicals. Republican leaders, however, held no hearings.
“We are extremely concerned that EPA’s increasingly limited review of chemical risk amounts to little more than a rubber-stamping process and does not reflect the higher level of scrutiny for new chemicals required by the TSCA reform law,” Democrats on the committee wrote to Republican leaders in August.
The House will also likely host more action around legalizing cannabis. Congress faces increasing pressure to relax federal cannabis laws: the elections added Utah and Missouri to the dozens of states that allow medical use, while Michigan became the 10th state to legalize recreational use. “With such overwhelming public support for marijuana legalization, even including majorities of Republicans and older Americans, there’s only so long that the federal government can continue to hold out,” says Maria McFarland Sánchez-Moreno, executive director of the Drug Policy Alliance, a group that aims to end criminalization of cannabis.
https://cen.acs.org/policy/legislation-/Changes-ahead-new-US-Congress/96/i45
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EPA Declines Growing Calls To Set Surface Water Standards For PFAS
Nov 8, 2018 | Inside EPA
By Suzanne Yohannan
EPA is facing growing calls from states and other stakeholders to set surface water standards for perfluorinated compounds, but the agency currently has no plans to establish such standards, an EPA water official told state waste managers recently.
During a breakout session of a meeting held by the Association of State & Territorial Solid Waste Management Officials (ASTSWMO) in Bethesda, MD, Chuck Schwer, a waste official with the Vermont Department of Environmental Conservation, said that while regulators and others over the past few years have been focused on addressing drinking water contaminated with the compounds, surface water is also important.
Schwer said discharges of per- or polyfluoroalkyl substances (PFAS) from landfill leachate and wastewater treatment plants are becoming a big issue in his state, and he asked EPA water official Jennifer McLain, a speaker at the session, whether EPA is contemplating a surface water standard for any PFAS.
McLain, deputy director of EPA's Office of Ground Water and DrinkingWater, would not commit to such an action, but acknowledged the interest from stakeholders. "We haven't gotten to the point where we're saying we're going to create a surface water standard, but it's something that we've heard" a desire for from stakeholders, she said.
At the same time, she noted that the agency will be watching what Michigan finds as it undertakes a comprehensive sampling exercise of PFAS in drinking water systems and landfills throughout the state.
"I think that we're going to learn a lot from the work that the state of Michigan is doing in sampling their drinking water and their landfills, and it will be interesting to see the data" that results -- specifically where the state finds the contaminants, with respect to the potential sources it identifies, McLain said at the Oct. 25 ASTSWMO event.
PFAS, used in a host of consumer and industrial applications including in firefighting foam, is a class of thousands of emerging contaminants that is increasingly drawing concerns due to its presence in drinking water systems. They have been linked to several adverse health effects, including certain cancers, ulcerative colitis and thyroid disease.
EPA officials have cited PFAS issues as a top priority as the agency faces continuing pressure to do more than the non-regulatory actions it has taken so far in which it set non-enforceable drinking water health advisories for two of the compounds.
While EPA is considering several actions to address PFAS, including an enforceable drinking water standard, known as a maximum contaminant level, and listing chemicals as "hazardous substances" under the Superfund statute or other laws, EPA's top official leading efforts to address the chemicals earlier this year told lawmakers that if the agency does decide to move forward on such regulations, it would take years to complete.
Surface Water
Surface water, unlike drinking water, has not been at the forefront of issues citizens and environmentalists have flagged as urgent, although the matter has gotten some attention.
In Michigan, the Detroit Free Press recently reported that foam containing PFAS "is coating growing swaths of the surface and shores of waters surrounding the former Wurtsmith Air Force Base in Oscoda, where the foam is now reaching Lake Huron." The article says that while the Air Force is addressing on-base contamination, it is not addressing contaminated groundwater plumes leaving the base that Michigan regulators say is the foam's source.
Federal appeals courts have reached different conclusions on whether the Clean Water Act (CWA) imposes liability for contaminated groundwater that reaches surface water, with parties currently seeking Supreme Court review of the question.
More broadly, the military across the country is facing significant potential cleanup liability for its widespread use of aqueous film-forming foam used for fighting fires.
Michigan's interagency team working to take action on PFAS announced earlier this year that it was undertaking a state-wide study to test PFAS levels in the state's 1,380 public water systems and to test schools operating their own water supplies. In addition, state regulators are also testing groundwater, lakes and streams, soils and sediment, wastewater and PFAS foam accumulating on lakes and rivers, the team's website says.
One step EPA is taking that could lead to regulation of discharges to surface water is its plan to study industrial discharges of PFAS. In May, it released a plan on how it will update its effluent limitation guidelines (ELG) program, saying among the items it will pursue is an industry-wide study on PFAS discharges.
The near-term goal of such a study "is to identify the extent to which these pollutants are discharged from industrial categories," the agency said.
EPA said the study will focus on discharges from industrial categories that may be using long-chain PFAS, as well as industries that may produce or use short-chain PFAS.
ELGs are technology-based standards that are intended to represent the greatest pollutant reductions that are economically achievable for an industry. They are incorporated into CWA discharge permits for direct dischargers.
In contrast, water quality standards include risk-based limits. The standards describe the desired condition of a waterbody and the means by which that condition will be protected or achieved. They include designated uses of a waterbody, such as fishing and/or swimming; risk-based criteria to protect designated uses; and antidegradation requirements to protect existing uses and high quality/high value waters.
PFAS Advisories
Even ahead of any surface water standards for PFAS, several states have issued fish consumption advisories for PFAS, especially perfluorooctane sulfonate (PFOS), due to concerns about surface water contamination. These include Michigan, Alabama, Minnesota, Wisconsin and New Jersey.
And surface water issues appear to have been referenced in some instances at the regional forums EPA held over the past several months to hear from citizens and states on their PFAS concerns. For instance, according to slides presented by Greenland Safe Water Action at EPA's regional PFAS forum in June in Exeter, NH, New Hampshire regulators have found surface water levels at 1,250 parts per trillion (ppt) for the two most common PFAS -- perfluorooctanoic acid and PFOS -- leaching from the Coakley landfill site into surface water. EPA's drinking water health advisories for the two chemicals are set at 70 ppt, combined.
Also, during EPA's regional PFAS forum in July in Pennsylvania, a local redevelopment agency noted in its slide presentation that it is concerned that the lack of standards for surface water, soil and sediment puts its agency "at risk if future standards require remedial actions on property already developed."
https://insideepa.com/daily-news/epa-declines-growing-calls-set-surface-water-standards-pfas
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EPA's Perchlorate Deadline Extended -- at Least to December
Nov 8, 2018 | Inside EPA
A federal judge has extended until at least December EPA's prior court-ordered Oct. 31 deadline to propose a drinking water standard for the rocket fuel ingredient perchlorate after the judge hearing the case gave the parties until the end of November to complete briefings on EPA's request for an additional 6-month extension.
In a Nov. 5 order in Natural Resources Defense Council (NRDC) v. EPA, Judge Edgardo Ramos of the U.S. District Court for the Southern District of New York set a Nov. 16 deadline for NRDC to respond to EPA's 6-month extension request. EPA has a Nov. 30 deadline to reply, should it choose to do so.
EPA last August sought to extend its original settlement agreement deadline with NRDC by six months, to April 30, 2019. The request triggered language in the 2016 agreement allowing an automatic extension when a party requests an extension of a deadline under certain conditions.
The agreement states that the extension “shall remain in effect until the earlier of (i) a dispositive ruling by this Court on such a motion or (ii) [90] days following the date for which modification is sought.”
But NRDC responded with a request for discovery on EPA's motion to delay the deadline, injecting some uncertainty into the new deadline.
In a Nov. 2 letter to Ramos, NRDC's attorney Sarah Fort writes that the group has now deposed Eric Burneson, director of the Standards and Risk Management Division within EPA's Office of Ground Water and Drinking Water, in his personal capacity, “and has obtained sufficient information to properly evaluate Defendants’ Motion to Modify the Consent Decree.”
In its August request, EPA filed a declaration from Burneson explaining its rationale for the deadline extension. Burneson pointed to the agency's efforts to peer review a key perchlorate model as the reason for its delay.
NRDC sued EPA in 2016, charging that EPA missed a two-year Safe Drinking Water Act (SDWA) deadline for proposing a national drinking water goal after then-Administrator Lisa Jackson's 2011 determination that perchlorate should be regulated. EPA's efforts have been hobbled since then by challenges in expanding the model as directed by agency science advisors, and in seeking peer review of the updated model.
Burneson wrote in his August declaration that the two-step peer review of the biologically-based dose-response model took six months longer than EPA anticipated when it reached the settlement with NRDC.
Should EPA comply with the settlement and issue a drinking water standard for the substance it would mark the first such limit the agency has issued since Congress amended SDWA in 1996.
https://insideepa.com/daily-feed/epas-perchlorate-deadline-extended-least-december
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Principles of Chemical Regulations – Why Do We Have Them?
Nov 9, 2018 | Chemical Watch - Brief
By Mark Selby
Unless you genuinely have nothing better to do, the reason that this column is read and why it is necessary for organisations like Chemical Watch to go to the effort to produce such articles, is that there is a raft of regulations that we need to follow to comply with the law.
Whether in Europe, Thailand, the US, China or almost anywhere in the world, the industry needs to do this. These may be generic ‘chemical’ regulations like REACH, those specific to detergents, cosmetics, biocides or another type of chemical, or for specific end uses like toys, vehicles or aircraft, but the principles behind them stay the same. There are rules governing the use of chemicals on their own, in mixtures or in articles.
And in case these regulations are not enough to cover every product type, Europe has the General Products Safety Directive (GPSD), which is intended to protect consumers from anything we have not yet thought of. In other words, there is a requirement to supply only goods that are fit for purpose and do not present a disproportionate hazard to the end user. If there is a hazard, users need to be warned and there is a need to propose risk management measures.
Reflecting on the last paragraph more deeply, the GPSD is the embodiment of the basic principle behind good product stewardship. It is something many organisations have done well over the years and will continue to do, irrespective of the regulations that are thrown at us.
Ideal world
In an ideal world, we would not need regulations, but we cannot rely on everyone applying high standards of product stewardship to all their products. We do need an acceptable set of common standards for the identification and communication of hazards and the Global Harmonized System (GHS) sets out to achieve this.
Even if different countries adopt different parts of a common system, the concept of having one has to be good – as long as it is based on sound science where we agree that, say, a flash point is so many degrees, the substance is flammable, and the methods are standardised within an agreed framework.
When moving to more complex science, such as judging whether the enlarged spleen of an unsuspecting rat that has consumed an unrealistically large amount of a chemical is a toxic effect or not, we are allowed to use ‘expert judgement’.
This term scares many as it cannot be automated into a convenient bit of software, but it is essential that GHS recognises that science has a role in judging the significance of potentially adverse effects. In an ideal situation, scientific judgement, good communication and common sense should prevail.
The real world
Unfortunately, common sense often appears to be in short supply when working in the real world. Ironically, the layers of rules and regulations imposed upon industry are an attempt to protect chemical users and the environment from those who do not observe good practice. Even if they take the ‘spirit of the law’ into account, the legal frameworks attract the attention of legal experts who debate the letter of the law. Sadly, they lose sight of what the law is for.
A key example is the debate over nanomaterials. REACH has this covered already in that the hazards and exposure, and therefore the risk, of a chemical needs to be assessed based on its physical state when manufactured or used. Making a particle smaller will change the properties – for example, iron is very flammable when in small pieces – but when does this change take place? Is it at 1 nm, 10 nm or 3.86 nm?
I made the last number up, but in reality, does the absolute size matter when what science tells is that properties can change when substances are below a certain size, but this will vary according to substance? Legal-minded regulators seem to think that one size fits all and have therefore been demanding a definition.
All over the world, it is unfortunate that, for many, ticking the necessary boxes is the object of the exercise. Like the company that demanded a safety data sheet (SDS) for purified water from its supplier on the basis that it was its policy to obtain an SDS for all chemicals, many in our industry are more concerned with procedures and the letter rather than the spirit of the law.
This adherence to procedure becomes a cycle of bureaucracy with a ‘jobsworth’ approach to chemical regulations. The regulations were set up with the best intentions, to ensure that organisations which fail to work to responsible care meet minimum requirements. But if your objective is to meet these and you have lost sight of the reasons for the controls, then we are in a dangerous place.
It is bad enough for industry to concentrate on the letter of the law. When regulatory agencies focus on procedures and formatting, this makes things even worse.
Letter and spirit
Can we wriggle around the regulations? The simple answer is that we cannot ignore the principles behind them. In Europe, the GPSD is a catch-all backstop that gives power through national enforcement to ensure that whatever is provided to the consumer is fit for purpose and does not pose an unnecessary risk. It is a surprisingly thin Directive, but perhaps this is its strength.
The longest and most impenetrable parts of any legal text are generally written by lawyers for lawyers, such as the section describing the appeals process in the REACH Regulation. When we start to get bogged down in minute details, others come along and find a gap in it. Those familiar with the US Code of Federal Register know only too well how good ideas to promote safety can become a nightmare when it starts to be written in a way to prevent other lawyers from trying to avoid what it sets out to achieve. So, yes there probably are holes in the legal framework that you may be able to exploit, but ultimately, the ideal is to get the science right and to apply good principles.
The future
In the political framework as of 25 October – which may well have changed by the time you read this – politicians in the UK and the rest of Europe are trying to come to some sort of agreement on Brexit that will have major implications for chemical regulation in the EU27 as well as the UK. Whatever happens, the principles of product safety will be upheld, even if politicians fail to agree a legal framework to help us work well together.
If those in the UK who want to see a greater separation of laws get their way, industry will have two sets of rules to follow, instead of a single set of EU Regulations. Although it will make no discernible difference to the requirements for safe handling, there is a real danger that the bureaucratic hassle will be doubled, causing costs that divert funds from better causes.
On a more global scale, many parts of the world are introducing REACH-like regulations and tightening up on environmental and consumer safety. Ideally, this should lead to a converging set of standards for assessment and communication with the same objectives. But there is a danger that the burden of bureaucracy in trying to meet different sets of form-filling will just generate new work for administrators and lawyers.
Irrespective of what may happen with the UK and the EU, those in control have an opportunity to ensure a greater convergence in the regulatory framework, using good science and good product stewardship as the driving force. If a toy is considered safe for a Spanish child, then it must be safe for a child in Canada. Conversely, if an Irish worker needs to follow a specific safety regime to ensure exposure is within acceptable limits, then these methods will equally apply in Australia.
What we can do
Unless you have influence over national or international regulators, perhaps by lobbying through your trade organisation, there is little that most of us can do to affect the direction of international regulations. However, pedantic regulatory checks by national agencies is only a small part of the day-to-day problem.
Like the company insisting on the SDS for water, can we be certain that we are not generating problems for our suppliers and customers due to our internal systems? Examples seen on a regular basis include when recipients of chemicals demand a ‘REACH certificate’ or assurance of compliance from European suppliers, or insist on a declaration that no substances of very high concern (SVHCs) are in their European-sourced articles.
In these cases, the obligation rests with the supplier and declarations are only needed if SVHCs are present in the article. Likewise, if the formatting of the SDS received is not to our liking, is it the best use of everyone’s time complaining to suppliers about trivial details when we should be concentrating on the quality of the information? And if we want our specific use of a registered substance adding to a generic chemical safety report (CSR) for a low hazard substance that has been diluted to below thresholds of concern, need we waste our supplier’s time resubmitting a dossier?
So we can all play a part in making the process easier for others by concentrating on what is important. And this is to ensure that hazards relating to products are fully understood and that we communicate methods to help recipients manage risks effectively or perhaps limit our supply if we think that risk is too great.
https://chemicalwatch.com/71758/principles-of-chemical-regulations-why-do-we-have-them
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Cosmetics Without Animal Testing
Nov 9, 2018 | Chemical Watch - Brief
By Andrew Warmington
"There are different types of cosmetic products, different ingredients and different demands from customers and retailers," says Michael Maynard, a board-certified toxicologist who is vice-president of global product sales at small cosmetics firm Beautycounter in the US. "We need to be creative, as new ingredients become available, about how we conduct safety assessments."
"Current ingredients will no longer have older animal data to rely upon. Many more tools are now available for hazard, safety and risk assessment, and new validated tests have been coming on board – it has been taking off in the last few years. You must get familiar with these and use them, the literature data and literature from other fields. Use good tools, hire good toxicologists and use a weight-of-evidence (WoE) approach to assess the ingredients."
The concept of ‘chemicals of concern’ in cosmetics – which Dr Maynard defines as the hazardous chemicals that sometimes get into a cosmetic product, including new ingredients that have not been tested or have been animal-tested – is driven by retailers, regulators but ultimately by consumers, who are asking for new requirements, claims and results from retailers, with newer and safer ingredients that will have to be tested for safety. Key claims consumers are looking for include, among others: ‘free from’ certain ingredients, such as nuts, soy, gluten, animal-derived ingredients, heavy metals, asbestos and talc;free from child labour;Roundtable on Sustainable Palm Oil (RSPO)-certified;biodegradability, especially of nanoparticles used in sunscreens;non-GMO, organic or vegan;mildness;recyclability; andsustainability.
"We need to discuss how we go about assessing ingredients in cosmetics as we move forward to not being allowed to do animal testing any more, while still getting enough information to conduct safety assessments properly with these requirements," Dr Maynard says. Fortunately more tools, both literature and testing methods, are available for safety assessment than ever before.
"Today, a good toxicologist can and should review all chemical ingredients without animal testing," Dr Maynard says. "He reviews all the data, and its sources – did it come from a good study, carried out to Good Laboratory Practice (CLP) and well-controlled? – and selects the best. Then he reviews exposure. Do the ingredients penetrate the skin and how fast? Are they rinse-off or leave-on? Then he assesses the WoE for decision making and tests when necessary."Using weight-of-evidence
Scientists need to use WoE for all aspects of testing, in his view. More and more cosmetic ingredients are being derived by the innovative use of plants, but these can actually be the most toxic of all and must be managed carefully. Appropriate testing must be carried out on all new ingredients. Those that are becoming increasingly popular include:new actives; natural ingredients; natural preservatives and blends; essential oils;natural fragrances; milder surfactants;tissue culture stem cells that produce biological ingredients; and peptides.
"With chemicals, we should perhaps look to more specific targeted ingredients that will work as we want them to with minimal side effects," Dr Maynard says. "We may also need to group chemicals to manage them efficiently. For example, we may have to use more acids with more activity in peels, to minimise the side effects occurring and still get the activity we want."
There is a vast array of data available in terms of literature sources for substance toxicity, including Scivera, SCCS, Pharos, Toxnet and Toxtree, to name a few. The other aspect of this challenge is risk assessment, based on toxicity and exposure level, to generate a margin of safety and a safe level of exposure which one can calculate and compare.
Similarly, Dr Maynard says, there are many sources for safety endpoints, including from the OECD, the Occupational Health and Safety Administration (Osha), the World Health Organisation (WHO) and Echa, among many others. Likewise, there are many safe levels and reference values, which can be used to assess risk for exposure levels. As well as standard ones like no adverse effect levels (Noaels) and derived no-effect levels (Dnels), these include environmental and occupational safety levels and others from different sectors.Changing the default option
"Testing on animals has historically been very easy," says Dr Maynard. "It’s easy to do with the methods available and everyone accepts them, but as a group we need to seek alternatives. This requires an ethical commitment to finding better solutions, innovation, resources, toxicology expertise and cooperative regulatory bodies.
"Regulators follow the regulations and, until the regulatory agencies allow alternatives to animal testing, companies will be faced with doing the ‘same old same old’ because it’s fast, consistent and the most acceptable approach. Regulations need to change to allow agencies to consider reliable alternatives and I hope that regulators understand that there are validated alternatives to animal testing that can and should be used."
Many non-animal testing regulatory actions are already taking place, he adds. The US EPA, with its ‘acute six-pack’, and California are moving towards in vitro testing. There are testing and marketing bans in the EU and the European Free Trade Area (Efta), India, Turkey and California, and proposed regulations in Argentina, Australia, Brazil, Canada, Chile, Russia and South Korea. Many NGOs, such as Cruelty Free International, the Humane Society and People for the Ethical Treatment of Animals (Peta), have resources that can help industry move in this direction.
More specifically, a committee of the European Parliament has approved a resolution for a global ban on animal testing for cosmetics by 2023. This year, TSCA accepted the skin sensitisation test as an alternative and this is already the default method in EU REACH. Australia is moving in the same direction "and we as an industry should as well", says Dr Maynard.
There is, he agrees, a challenge with non-animal testing approaches: how to assess the hazards of ingredients in development where data is absent. His key advice is that the safety and regulatory functions, along with marketing, have to be involved early in the development process, when claims and the desired products are being established. Companies can also:assess early; run pilot tests;do the Ames test for mutagenicity; and use eye and skin irritation tests, like the bovine Corneal opacity and permeability (BCOP) assay, EpiSkin and EpiDerm, and skin sensitisation tests that have been validated by Interagency Coordinating Committee on the Validation of Alternative Methods (Iccvam) and the European Centre for the Validation of Alternative Methods (Ecvam).
Iccvam itself recently published the National Toxicology Programme (NTP) Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medicinal products in the US and developed computational acute oral toxicity models with the Interagency Centre for the Evaluation of Alternative Toxicology Methods (Niceatm). Acute testing is relatively easy to do, adds Dr Maynard; a bigger challenge will be reproductive and developmental models but efforts are under way on this front too.
"The key is validation with regard to previous animal tests. The EPA also has a strategic plan to promote development and implementation of new approach methodologies (NAMs) in TSCA that was established this June," says Dr Maynard. Many methods exist for non-animal assessment and testing, notably:the ‘3 Rs’(reduce, refine, replace);EPA’s recommended quantitative structure-activity relationship (Qsar) toolbox;EPA Tox21;read-across, which is currently used more in Europe than the US; in vitro methods;in silico and computational methods; and ‘in chemical’ methods, such as chemical reactivity assays and interactions between toxicant and biological macromolecules.
Dr Maynard particularly highlights two major recent developments in the field: multiple organs on a chip (MOC), small cells on which cells from multiple organs can be placed, and a new cheminformatics predictive toxicology software that emerged from an initiative between UL and Johns Hopkins University.
"This is impressive," he says. "It has 70m structures in the database and 300,000 labelled hazard endpoints. It uses machine learning so that it learns from a new structure that is put in the database, targeting chemical features and predicting the hazard probability, with an accuracy of 85-95%." In acute oral toxicity testing, it proved significantly more accurate than many traditional tests. It is also easy to use and produces nine hazard endpoints in one tool.
https://chemicalwatch.com/71747/cosmetics-without-animal-testing
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Echa’s Board of Appeal and Cosmetics Testing on Animals
Nov 9, 2018 | Chemical Watch - Brief
By Katy Taylor
In 2013, the European Commission told European citizens that animal testing of cosmetics in the EU, and the sale here of cosmetics that had been tested on animals elsewhere, were now things of the past. No ifs, no buts. It did not matter whether or not non-animal methods were available.
The EU was taking a moral stance, reflecting public concern. It was willing to take the risk of being challenged by the World Trade Organization (WTO). This was European political leadership at its best – a bold and brave decision, based on doing the right thing and responding to overwhelming public opinion.
It is hard to overestimate the ground-breaking impact of the European cosmetics testing bans. They have been, and continue to be, models for legislation around the world. Despite the doom-mongering of much of industry at the time, the European cosmetics business continues to flourish, investment in non-animal methods for cosmetics has had benefits far beyond that sector and animal suffering has been avoided on a massive scale.
Sadly, over time, interpretation of the law has weakened the bans considerably. In October 2014, the European Commission and Echa published a joint note to the effect that they only applied to ingredients used exclusively in cosmetics (which very few are) and not to tests nominally carried out for worker, as opposed to consumer, safety.
The scientific tests for worker and consumer safety are identical, for the obvious reason that workers, like consumers, are human beings, and worker safety data is needed in just about every case. It is therefore too easy for companies to circumvent the bans by labelling tests as being for worker safety.
Article 18 ban
Cruelty Free International and the European Coalition to End Animal Experiments (ECEAE) have argued that Echa’s approach is clearly contrary to Article 18 of the cosmetics Regulation, which contains the animal testing bans, and to REACH. Importantly, REACH specifically says that its testing requirements have to give way to the cosmetics bans.
In a case brought by the European Federation for Cosmetics Ingredients (EFCI) in 2016, in which Cruelty Free International intervened, the Court of Justice of the European Union (CJEU) ruled that companies cannot rely on animal test data to establish the safety of cosmetics products for the EU market, even if the test is done outside the EU.
It can make no difference in this regard whether a substance is exclusively used in cosmetics or whether a test is nominally for worker safety. It would therefore be self-defeating to carry out animal tests.
The EU legislature has adopted a policy that the suffering of animals is not justified for cosmetics and that, if a new cosmetic ingredient could only be developed safely by testing it on animals, society should forego it. The policy must, as a matter of logic, apply as much to the safety of workers in developing an inessential product as to the safety of consumers in using one.
Unfortunately, the Echa Board of Appeal has recently missed two golden opportunities to give an authoritative ruling. The appellants in these cases were BASF and Symrise; ECEAE and People for the Ethical Treatment of Animals’ (Peta’s) International Science Consortium were given permission to intervene in the appeals.
In each case, the substances are exclusively used in cosmetics and Echa had raised worker safety in its decisions. BASF’s case involved the prenatal developmental toxicity (PNDT) study and Symrise’s the extended one-generation reproductive toxicity study (Eogrts). Each test involves a large number of animals and causes considerable suffering.
The PNDT uses approximately 900 rats or 480 rabbits. The test substance is usually administered daily by gavage to pregnant female animals at least from implantation (around day five post-mating) to one day before partum, at which point they are killed. It is well-documented that gavaging causes distress and occasional serious injury.
An Eogrts involves at least 1,200 animals, more if additional cohorts are needed. They are dosed for at least ten weeks, during which time they are mated. With each test, the substances are given to some of the animals at levels that will almost inevitably cause toxic effects, with all the suffering that is likely to entail.
How to interpret bans
Disappointingly, in each case the board sidestepped the issue of how the cosmetics bans should be interpreted, although in the BASF case it did, as ECEAE had urged, reject Echa’s argument that those bans were not its concern, on the basis that they came from legislation for which it was not responsible. It felt able to sidestep the issues essentially because it found Echa to be in breach of procedural requirements and therefore remitted each case back to the agency.
In BASF’s case, the principal procedural defect the Board of Appeal identified, ironically, was Echa’s failure to consider the relationship between the cosmetics Regulation and REACH, leading to inadequacy in its reasons. The board ordered the company to remedy the defect, but without telling it what the correct legal approach was. In Symrise’s case, which came later, ECEAE pleaded with the board to give general guidance but this fell on deaf ears.
The board has a central role in REACH. It provides a safety net against poor decision making. Its primary role, of course, is to decide the appeal put before it. However, even though its decisions are explicitly not legal precedents, it has a valuable role in providing guidance that goes beyond the facts of the individual case. Echa then generally follows this in other cases.
The problem in these two cases is not so much that the board remitted the cases on procedural grounds but that it failed to give any guidance on the substantive legal principles, which should govern the agency’s considerations second time round. That has two consequences.
First, Echa has no idea what principles it should follow when it reconsiders the two cases. It is likely to adopt the same approach, which could lead to further appeals if it confirms that the animal tests should be carried out. Fresh appeals would cost everyone more money and cause additional delay, which is in no-one’s interest.
The second is that the lack of guidance causes continuing uncertainty about how the law should be applied in other cases. Almost inevitably, Echa will continue to interpret the cosmetics bans in an extremely restrictive manner, because it has not been told that this is wrong.
If we are right about how the bans should be applied, the inescapable result is that thousands of animals are suffering in circumstances where EU legislature intended that they should not. That is damaging to the rule of law.
Opportunity for clarity
By chance, the Board of Appeal has an early chance to redeem itself. Symrise has recently initiated two further appeals. In each, the substance is again exclusively used in cosmetics. Unlike in its previous appeal, the company now argues that it cannot be required to carry out the animal tests in questions – which include the Eogrts, the PNDT and a sub-chronic toxicity study – because it would then not be able to market cosmetic products containing the substances in the EU.
Symrise maintains that it makes no difference whether there are worker safety concerns. In other words, it has adopted ECEAE’s approach. Importantly, with the exception of one of the tests in one of the two appeals, there appear to be no procedural issues to muddy the waters. The board will have to grapple with how the cosmetics bans should be interpreted in the context of REACH.
Cruelty Free International and the ECEAE hope that the board will determine the appeals as soon as possible. It has a heavy workload, no doubt, but there can be no excuse for the more than six months it took to determine the first Symrise appeal after the hearing, particularly given that it did not address the important and substantive legal issues.
Just as importantly, we hope that the board will align the law with the expectations of EU citizens regarding the cosmetics ban and thereby restore a measure of public confidence in the Commission and Echa on animal welfare.
https://chemicalwatch.com/71756/echas-board-of-appeal-and-cosmetics-testing-on-animals
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Siefs: A New Era for an Old Concept
Nov 9, 2018 | Chemical Watch - Brief
By Caroline Byrne
While substance information exchange forums (Siefs) were supposed to disappear alongside their legal obligations on 1 June, many are forging ahead, spurred on by the many huge challenges their members face. High on the list are:Brexit;data-sharing issues; classification and labelling of dossiers; and advocacy and lobbying activities involving substance evaluation with member states and Echa’s Risk Assessment Committee (Rac).
With so much at stake, it does not really make sense for Siefs to dissolve. "Financially, it is not in the interest of companies to leave the Siefs completely out of the activity," says Erwin Annys, REACH director at Cefic. "If you have to restart, you have to set up again. New contract, new agreements, new discussions. This will only cost more money."
Siefs were never supposed to be a long-term alliance. They were a concept established more than a decade ago, so that co-registrants of phase-in substances could build a structure for mandatory data sharing under REACH. As the number of joint submissions ballooned, so did the Siefs, now estimated to number between 16,000 and 16,500.
So, how many actually were dissolved or merged after 1 June? "To the best of my knowledge, we have only seen that in one case," says Eurometaux’s Hugo Waeterschoot, referring to the European Precious Metals Federation’s (EPMF) plan to close its REACH consortium on 31 December and integrate activities back into itself.
Even in that instance, he says, the decision had less to do with the change in REACH legal obligations and more to do with practicalities. "This was an administrative burden that didn’t deliver added value for those that really took the REACH dossiers further."
Pressing the starting button
As the Siefs’ legal obligation ceased on 1 June, the Directors’ Contact Group (DCG) advised industry to replace Sief-based contracts with ‘cooperation contracts’. That did not always happen, however.
"We are not aware of any joint registrants or REACH consortia entering into separate cooperation contracts to fully replace a Sief agreement," says Catherine Manning, a UK-based solicitor at Eversheds Sutherland who focuses on REACH and chemical compliance.
It was not always straightforward to replace Sief contracts, so some companies chose instead to amend their Sief agreements slightly and carry on. "The main issue is that Siefs were focused on registration, whereas activities are now wider, as they relate more to substance evaluation and classification issues," says Claudio Mereu, who heads the competition, regulation and trade, and life sciences groups of law firm Fieldfisher, in Brussels.
"We have amended our clients’ Siefs so as to cover all these activities, including advocacy efforts, in the overall registration context, which includes also evaluation and authorisation, and classification activities," he adds.
Many of the old Siefs’ contracts also did not spell out the lead registrant’s (LR) obligation to inform co-registrants of planned tests, involve them in discussions, or potentially give them rights to the data other than just to refer, says Ruxandra Cana, another Brussels-based litigator and partner at law firm Steptoe & Johnson.It was not always straightforward to replace Sief contracts, so some companies chose instead to amend their Sief agreements slightly and carry on.
While that omission has now been updated in many contracts, financial disputes are still inevitable. "I think the perception for some companies is that they’ve paid in their costs," says Ms Cana.
"So, I think the disputes will be maybe at the less sophisticated level, which is payment for any new type of costs."
Brexit
Although contract negotiations are largely in hand, 29 March 2019, the date on which the UK is scheduled to leave the EU, still looms large for Siefs, big and and small. In the event of a no-deal or ‘hard’ Brexit after the date of withdrawal, any registration by a UK-based company will cease to be valid.
"Brexit is indeed an issue and all registrants based in the UK are moving their registrations to EU-based entities acting as only representatives (ORs) or importers. Echa is issuing guidelines to that effect: these would be regarded as transfers of assets – the registration – to another legal entity," says Mr Mereu.
Lawyers are advising all joint registrants, whether based in the UK or the EU-27, to consider the potential Brexit impact on their REACH registrations. "This will impact how joint registrants agree to future data and cost sharing. How a UK LR or member wants to address this will depend on their no-deal Brexit strategy and the current status of the joint registration dossier - for example, whether Echa has requested the submission of additional data," Ms Manning says.
Nothing is straightforward with Brexit. In mid-October, UK companies were shocked to learn that the Department for the Environment, Food and Rural Affairs (Defra) wanted them to submit a "full" data package to register chemicals under a UK REACH equivalent in the event of a no-deal Brexit.
The request could cost companies hundreds of thousands of pounds and cause problems for Siefs or importers which do not have access to data under commercial agreements. "
I’m not trying to sugarcoat this," James Dancy, head of EU exit – chemicals at Defra, told industry at an official briefing. "This is a difficult area."
By late October, Defra said it would "re-publish" its no-deal Brexit technical notices to address multiple gaps in the information. Siefs were not even addressed in the initial guidance notes for companies.
Marko Sušnik, director of the European Association of Craft, Small and Medium-sized Enterprises (Ueapme), says that, while the June deadline was not a major "game changer", Brexit could have a big impact. "Many SMEs depend on suppliers and ORs based in the UK," he says. "However, it is a bit hard to predict how the UK will proceed in its negotiations.
"This is why we see no point in discussing what the UK should do, or if the UK should stay in the REACH system, and so on. Most of the options are blocked anyway, because of UK’s numerous red lines. What we can do in the EU is to develop options, guidance and tools that allow us to fix as many potential supply disruptions as possible."
‘High alert’
Cefic, the UK’s Chemical Industries Association (CIA) and NGOs CHEMTrust and the European Environmental Bureau (EEB) have jointly urged heads of state and government to ensure EU27 and UK regulatory systems "remain highly aligned" after 29 March.
Cefic and the CIA have also produced a briefing note with advice for companies in the event of Britain leaving EU REACH. "The problem with writing about Brexit is that you can restart your document more or less every week because there is new information coming in," says Cefic’s Mr Annys.
In the midst of the Brexit confusion it appears that Siefs, which were envisioned as a hub to share information among co-registrants, have remained a valid platform via which companies can communicate with each other. "Everyone is realising that this is the only way forward," Mr Annys says. "What we see is that those consortia that are active are working in the same way as they did before."
Cefic has previously warned that "careful consideration" should be given to antitrust issues and to ensuring that members only share information specific to certain agreed tasks. So far, so good, lawyers say. New contracts have been drafted with that in mind. "So what you will see is that they continue activity as a consortia but that they may drop the broader communication towards the Sief," says Eurometaux’s Hugo Waeterschoot.
What is in a name?
The DCG, which consists of directors from the European Commission, Echa and industry associations, has already recommended that co-registrants of phase-in substances carry on cooperating. Exactly how they do that has been largely left up to the Siefs.
The groups have not come up with a new name to describe Siefs and have no plans to do so. Cefic says the chemical sector prefers to stick to terminology everyone already understands. "It is up to industry to get organised," Echa’s director of registration Christel Musset adds. "They can call them ‘Siefs’. They can call them whatever they want. But it is our strong recommendation that they they still have a mechanism to welcome newcomers and to update their dossier jointly."Tackling Brexit: a plan for SMEs
While companies cannot control the day-to-day machinations of Brexit negotiations, Marko Sušnik of Ueapme says they can develop options, guidance and tools to help fix potential supply-disruptions. To that end, Ueapme suggests:the possibility of a simple relocation of ORs to other member states. This is important, because almost 50% of the UK’s registrants are ORs;and transitional periods of three and five years respectively for downstream users who now receive a substance from a UK supplier and who, due to Brexit, decide to register this substance or apply for authorisation themselves.
"What UK registrants and other UK companies can do is to clearly explain to their government, what it means to have a hard Brexit, without sound solutions for resource-availability. This is what the defence industry has done very well in its paper covering three scenarios," Mr Sušnik says.Inside Siefs: The Dow Chemical Company’s perspective
Nicholas Ball, senior toxicology consultant at Dow Chemical, shared his views on Siefs with Chemical Watch:
Q: Have Siefs changed how they operate since 1 June?
A: In many cases there is still communication from the LR to the other members about the various ongoing activities, like the Community Rolling Action Plan (Corap), compliance checks and testing proposals. The Sief or joint submission agreements form the basis for the necessary post-registration collaborations for keeping the dossiers up to date. Siefs were probably more impacted by the publication of the implementing Regulation on data sharing. This led to a need for many Siefs and consortia to revise data-sharing approaches and implement reimbursement schemes. Thus, with the phase-in period, there is a lot of activity involving the re-calculation of letter of access (LoA) costs, reimbursing registrants where necessary and planning out the management of the finances for keeping dossiers up to date.
Q: Have any problems arisen as a result?
A: Dow has not encountered any specific ‘post phase-in’ problems with the Siefs we are a part of.
Q: Do you expect Siefs to carry on as is into the future? Or, if not, what must change?
A: All registrants of the same substance are now tied into working together as long as they want to maintain a REACH registration. Therefore, whether there is a more formally established Sief or consortium, collaboration is critical to the maintenance of the registrations. Industry does need to consider very carefully how it will manage this to continue supporting the registration dossiers. The costs, complexity and administrative burden of this process cannot be underestimated.
Q: Has Brexit caused any particular issues for Siefs and will it?
A: Not yet, but there is a clear concern for those registrants based in the UK. In the worst case, they will likely need to register via an EU legal entity post-Brexit – and thus they will need to submit inquiry dossiers and join the Sief as a new legal entity. Many Siefs and consortia will be pragmatic and allow the ‘new’ registrants to join without mandating additional payments, but this ultimately will come down to the individual Sief and consortium.
Q: Have data-sharing issues caused any particular issues for Siefs post 1 June?
A: Data sharing and dossier compensation is an issue for all Siefs and it is not really limited to the ‘post-phase-in’ status of registrations. There are some specific post-1 June Sief activities, such as the management of the ‘fair and equal share’ aspect of data-sharing and dossier letters of access – now that, for most substances, the ‘final’ number of registrants is known. Many Siefs and consortia are reviewing who has paid what and determining if reimbursements are needed. This can be a very complex and time-consuming activity, made more complicated by factoring in how to fund the future dossier management activities.
In some cases, Siefs and consortia are holding back reimbursement money to cover future costs. In others, registrants receive the full reimbursement they are due, but may be invoiced in the future for dossier update activities. Current experience shows that many registrants did not take into account the possibility that post-registration costs may be associated with being part of a joint submission. This will lead to more challenges when it comes to how registrants work to improve the quality of the dossiers in the future.
Separately, there is a lot of post-registration testing going on as a result of Corap, compliance checks and testing proposals. Registrants need to determine how to split costs for these new studies between them, as well as agree on who owns the studies and what they can do with them. Is each company that funds a study a joint owner? Does contribution vary with tonnage band and how does that affect ownership and access rights? Who can sell the studies to others? And so on.
The industry is also now trying to understand what happens when data starts to become freely available 12 years after registration. Echa and the industry really need to understand how this will work and the implications for data sharing and dossier cost management. Perhaps one of the main takeaways from REACH and the formation of Siefs is that managing joint registrations is almost a new industry in itself, and one that will exist as long as REACH is being implemented.
The industry is also trying to cope with all the other REACH-like legislation appearing in different regions such as South Korea, Taiwan and Turkey. Now we have one Sief for each region and all of these have different data-sharing obligations, compensation models, data requirements, etc. Managing joint registrations is an administrative burden that many stakeholders not involved with preparing registrations do not fully understand or appreciate.
The one activity the industry does need to engage with is data sharing and availability. Through REACH, the EU industry has essentially created the single largest chemical property database in the world and this is an incredibly valuable asset.
If the right approach is taken to managing access to this data, we could vastly simplify how data are made available to those who need it and how it can be used to further advance alternative approaches to animal testing. We are keen to work with Echa and other companies on this, as we see the potential benefits of collaborating on data access far outweighing the cons.
https://chemicalwatch.com/71755/siefs-a-new-era-for-an-old-concept
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‘Eurasia REACH’ – What Do We Know Today?
Nov 9, 2018 | Chemical Watch - Brief
By Olesia Popcharska
Discussions about the possibility of Russia adopting REACH-like regulations have been ongoing for a long time. In 2010, Russia, Belarus and Kazakhstan founded the Eurasian Customs Union (EACU). This was later changed into the Eurasian Economic Union (EAEU, hereafter CU) and extended to Armenia and Kyrgyzstan as well, thus forming a single economic space across five nations.
In order for any products to be placed on the CU market, they have to be compliant with the requirements of CU technical regulations. Since Russia and the CU lacked a horizontal regulation setting requirements for the safety of chemical products, there was clearly a need to adopt a common technical regulation for chemicals.
Probably due to CU member states’ inability to reach an agreement, Russia decided to adopt its own version of REACH. The Technical Regulation on Safety of Chemical Products of 7 October 2016 (Decree No 1019) is scheduled to enter into force on 1 July 2021. Finally, however, in late 2017, CU member states were able to reach an agreement and, thus, the Technical Regulation of Eurasian Economic Union on Safety of Chemical Products No 41 (Eurasia REACH) was approved on 3 March this year.
This will enter into force on the 1 June 2021 if the member states agree on the creation of a chemical inventory and the order in which new substances are notified by adopting separate decrees – second level legislative acts, as they are known – no later than 1 December. The most likely scenario, therefore, is that Russia’s own REACH will be revoked by a separate decree at a later stage and Eurasia REACH will become the single chemicals regulation for the whole CU market.
However, if there are further disagreements between CU member states and a subsequent delay to Eurasia REACH, Russia might go ahead with its own regulation on 1 July 2021. Both regulations are at a very early stage, but currently all of the discussions are directed towards Eurasia REACH, its development and further implementation. What is it all about?
Eurasia REACH consists of 14 chapters and seven annexes. Its purpose is to set out mandatory requirements for chemicals placed on the CU market so as to ensure their safe use. The Regulation covers all types of chemicals products, with the exception of specific products regulated by other Technical Regulations, such as those covered by that on the requirements for automotive and aviation gasoline, diesel and marine fuel, jet fuel and fuel oil (No 13/2011). Even so, these kinds of product have to comply with the requirements for classification, labelling and safety data sheets (SDSs) set out in chapter 1 of Eurasia REACH.
It is also anticipated that, probably in early 2019, companies will be able to contribute to compiling the inventory by notifying chemical substances to it. This procedure will probably be encompassed by the second level legislative act on inventory formation.Registration requirement
The scope of Eurasia REACH covers both substances and mixtures. The Regulation will require companies to submit their registrations to a competent authority in one of the member states (to be confirmed later with the second level legislative act), whereas the type and scope of the registration will depend on whether the status of the chemicals is new or existing.
For existing chemicals, companies will have to submit a ‘record-keeping registration’, which is a simple procedure. For new or restricted chemicals, they will have to apply to the competent authority for an ‘authorised registration’, which, once completed, gives them the right to place a substance on the market.
New substances will also require new substance notification documentation, the requirements for which are set out in chapter 11.
Once the registration information is checked, the authority will issue an individual registration number. Record-keeping registrations are valid indefinitely, while authorised registrations last for five years. After this, an applicant has to re-apply and the registration type will depend on the status of the substance: an authorised registration for a restricted chemical and a record-keeping one for a new chemical.
The SDS will have to be submitted in the registration package, regardless of the registration type, according to GOST Standard No 30333-2007. Under chapter 4, article 13, chemical products compliant with the requirements of Eurasia REACH and other relevant CU technical regulations will be marked with the Eurasian conformity mark.‘Only representative’ concept
Eurasia REACH also foresees a similar mechanism to that of EU REACH in relation to foreign companies and the appointment of an ‘only representative’. At present, the Regulation does not contain any definition of this concept, but there are numerous references to the "representative nominated by the manufacturer" throughout the text.
In contrast with Eurasia REACH, Russia REACH has a definition of the ‘nominated representative’ in the ‘main definitions’ section of chapter 3. Further clarifications on the requirements for the representative will probably come at a later stage. It is, however, clear that foreign companies will be able to submit their inventory notifications and later registrations via one of these.Conclusions
Although the Regulation has been approved, many questions remain for domestic and foreign companies alike. It is still unclear how the inventory will be formed and how much information disseminated, especially in relation to mixtures. It is also unknown which substances will be banned or restricted and who will act as the national competent authorities for Eurasia REACH.
What is already certain is that the Regulation will be entering into force at some point and both local and foreign manufacturers and importers will have to comply with the new requirements in order to place their chemical products on the CU market.
The proverb ‘Forewarned is forearmed’ is used in Russia, as well as in other countries. Our recommendation is to follow the developments of Eurasia REACH closely and take appropriate steps to comply with its requirements, thus ensuring uninterrupted access for your chemicals to the CU market.
https://chemicalwatch.com/71748/eurasia-reach-what-do-we-know-today
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Judge Blocks Keystone XL Pipeline
Nov 8, 2018 | The Hill - E2 Wire
By Timothy Cama
A federal judge blocked the controversial Keystone XL oil pipeline Thursday, saying the Trump administration’s justification for approving it last year was incomplete.
In a major victory for environmentalists and indigenous rights groups, Judge Brian Morris of the District Court for the District of Montana overturned President Trump’s permit for the Canada-to-Texas pipeline, which the president signed shortly after taking office last year.
Morris’s ruling repeatedly faulted the Trump administration for reversing former President Obama’s 2015 denial of the pipeline permit without proper explanation. He said the State Department “simply discarded” climate change concerns related to the project.
The decision once again throws into doubt the future of the 1,179-mile Keystone XL, which for much of the decade since its proposal by TransCanada Corp. has been a lightning rod in national energy policy.
The Trump administration had tried to argue that federal courts didn’t even have the right to review Trump’s approval, saying that it extended from his constitutional authority over border crossings. The court rejected that argument.
In rejecting the permit, Morris relied mainly on arguing that State, the agency that analyzed the project, didn’t properly account for factors such as low oil prices, the cumulative impacts of greenhouse gases from Keystone and the Alberta Clipper pipeline and the risk of oil spills.
“The major spills that occurred between 2014 and 2017 qualify as significant. The department would have evaluated the spills in the 2014 [environmental review] had the information been available,” wrote Morris, whom Obama nominated to the court.
The judge also said that State didn’t properly justify its switch from rejecting the pipeline in 2015 under the Obama administration to approving it in 2017 under Trump.
Such a change isn’t completely prohibited, Morris said, but State needs to better explain changes like its decision to disregard the climate change arguments it made in 2015.
“The department’s 2017 conclusory analysis that climate-related impacts from Keystone subsequently would prove inconsequential and its corresponding reliance on this conclusion as a centerpiece of its policy change required the department to provide a ‘reasoned explanation,’ Morris said, citing court precedent on similar policy changes.
“The department instead simply discarded prior factual findings related to climate change to support its course reversal.”
Morris also ruled that State’s conclusions about the pipeline’s impacts on endangered species need updating, and that State may need to redo some cultural resource examinations along the pipeline’s route.
The Sierra Club, one of the leading groups in the litigation, cheered Morris’s ruling.
“Today's ruling makes it clear once and for all that it's time for TransCanada to give up on their Keystone XL pipe dream,” Sierra Club senior attorney Doug Hayes said in a statement.
“The Trump administration tried to force this dirty pipeline project on the American people, but they can’t ignore the threats it would pose to our clean water, our climate, and our communities.”
TransCanada and State did not respond to requests for comment. The Canadian company had planned to start construction work next year.
The Trump administration or TransCanada could appeal Morris’s ruling to the San Francisco-based Court of Appeals for the Ninth Circuit.
That court is a frequent target of criticism by Trump and Republicans, and has ruled against major Trump policies, including his travel bans for people from certain Muslim-majority countries and his ban on transgender military troops.
https://thehill.com/policy/energy-environment/415862-judge-blocks-keystone-xl-pipeline
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Judge Tosses Trump’s Keystone XL Approval over Climate Change
Nov 8, 2018 | PoliticoPro
By Alex Guillén
A federal judge ordered both the Trump administration and TransCanada to stop any work on the controversial Keystone XL pipeline on Thursday, saying President Donald Trump’s approval of the project last year violated several key environmental and administrative laws by ignoring facts about climate change.
Judge Brian Morris of the U.S. District Court for Montana ruled that the Trump administration almost completely ignored climate change in its analysis supporting the pipeline’s construction, a shift that unlawfully reversed the Obama administration’s 2015 decision rejecting the pipeline’s cross-border permit.
Morris, an Obama appointee, directed the Trump administration in his rulingto prepare a new environmental study before the pipeline can resume construction, leaving the door open to a renewed approval in the future.
“The [State] Department did not merely make a policy shift in its stance on the United States’ role on climate change. It simultaneously ignored” a critical part of the Obama administration’s stance on climate change and foreign relations, Morris concluded. Such a change would require a “reasoned explanation.”
“The Department instead simply discarded prior factual findings related to climate change to support its course reversal,” Morris added.
Morris identified a litany of other flaws that he said will require fixing before the pipeline can move forward.
The administration must incorporate new information about major oil spills that occurred between 2014 and 2017, including a significant incident involving the original Keystone pipeline, he wrote, and the Fish and Wildlife Service will need to update its analysis of impacts on wildlife in the wake of those major spills.
The State Department failed to take a "hard look" at the cumulative climate impacts of Keystone XL alongside the Alberta Clipper pipeline expansion, Morris said, and the analysis failed to review Keystone XL's impacts on "cultural resources" across more than 1,000 acres.
The government must also update the study to examine whether current oil prices affect Keystone XL's viability, he said.
He also blocked the federal government and TransCanada "from engaging in any activity in furtherance of the construction or operation of Keystone and associated facilities until the Department has completed a supplement to the 2014 [Supplemental Environmental Impact Statement] that complies with the requirements of" the National Environmental Policy Act and the Administrative Procedure Act.
Morris previously declined to vacate the Keystone XL permit over questions about the pipeline's path through Nebraska.
https://subscriber.politicopro.com/energy/article/2018/11/judge-tosses-trumps-keystone-xl-approval-over-climate-change-956775
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EPA Eases Oil Industry Compliance with Refinery Air Rules
Nov 8, 2018 | Inside EPA
EPA has issued a final rule easing industry compliance with refining sector air rules, as the agency completes years of deliberations on various technical aspects of Obama-era Clean Air Act rules for refineries in response to petitions for reconsideration from industry and environmentalists.
The final rule released Nov. 8 ahead of its publication in the Federal Register responds to issues raised by the American Petroleum Institute (API) and also the American Fuel and Petrochemical Manufacturers, with the Obama administration's 2015 revisions to air toxics rules setting maximum achievable control technology (MACT) for refineries, and related changes to new source performance standards (NSPS) for the sector.
EPA is easing implementation of the rules, known as MACT 1, MACT 2, and the related NSPS. The rule finalizes changes floated by EPA in two separate proposals, from April 10 and July 10.
“These revisions remove uncertainty associated with the implementation of the December 2015 final rule amendments and simplify compliance, while not affecting emissions reductions projected from the 2015 rules,” EPA says in a Nov. 8 statement that also touted the agency's role in boosting oil production.
“Texas field production of crude oil is at an all-time high, and today’s announcements will only further that progress,” said EPA Acting Administrator Andrew Wheeler.
“This action will reduce annual compliance burdens for the sector by $12 million. The reforms include changes to work practice standards, recordkeeping, and reporting requirements. This action also updates the compliance date for standards for maintenance vents,” the agency adds. The compliance date will now be 30 days after publication of the rule in the Federal Register, rather than Aug. 1, 2017 as in the Obama rule.
API welcomed the final rule, with the group's Senior Director of Regulatory and Scientific Affairs Howard Feldman saying, “EPA’s practical clarification to the language of the refinery rule’s regulatory requirements is a positive step that supports our shared goal of protecting public health, while enhancing investments in cleaner fuels that will reduce our environmental footprint.”
https://insideepa.com/daily-feed/epa-eases-oil-industry-compliance-refinery-air-rules
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Colorado Vote Paves Way for $7.7 Billion Anadarko Deal
Nov 8, 2018 | BNA Daily Environment Report
By Rachel Adams-Heard and Alex Nussbaum
Anadarko Petroleum Corp.’s first move after Colorado voters rejected an anti-drilling ballot measure was the $7.68 billion combination of two pipeline businesses that will free up more cash for oil and natural gas exploration.
Anadarko joins Williams Cos., Energy Transfer LP, and other energy companies in streamlining after U.S. tax changes hammered pipeline partnerships. For Anadarko, the transaction announced Nov. 8 will result in “increased liquidity” while also underpinning buybacks, debt reduction, and future dividend increases, Chief Executive Officer Al Walker said in a statement.
The deal comes two days after Colorado voters rejected a measure that would have imposed costly new restrictions on oil and gas exploration and made some sites all but impossible to drill. In the weeks leading up to the election, Anadarko delayed releasing its 2019 projections to await the outcome of the vote. Spokesman John Christiansen said the company still expects to issue its 2019 outlook this month.
Proposition 112 would have required new drilling sites, processing plants and gathering lines to be more than 2,500 feet (760 meters) from homes, schools and other “vulnerable” areas.
The measure was the “sword of Damocles” hanging over all oil and gas companies in Colorado’s Denver-Julesburg Basin, Guggenheim Securities LLC analyst Matthew Phillips said in an email. “Now that it’s over (for now), they can get some deals done.”
The Nov. 8 deal will likely fuel a new buyback program equivalent to 10 percent of Anadarko’s market value, or about $3 billion, Tudor, Pickering Holt & Co. analysts said in a note to clients. The explorer may also use some of the proceeds to help fund a $20 billion liquefied natural gas project in Mozambique, BMO Capital Markets analysts said in a research note.
Under the terms of the transaction, Western Gas Equity Partners LP will buy all publicly held units of Western Gas Partners LP, which has also agreed to acquire all of Anadarko’s pipeline assets for $4 billion. The deal value is based on Western Gas units outstanding as of Oct. 29. Anadarko did not say whether it’s acquiring any debt as part of the transaction.
https://news.bloombergenvironment.com/environment-and-energy/colorado-vote-paves-way-for-77-billion-anadarko-deal
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Energy Companies Triumph by Defeating Carbon, Fracking Initiatives
Nov 7, 2018 | Houston Chronicle
By Rye Druzin
Energy companies won big Tuesday night, beating back a pair of ballot measures that would have severely restricted drilling in Colorado and imposed a carbon fee on refineries, power plants and other industrial faculties.
The oil and gas industry poured millions of dollars into campaigns aimed at defeating the measures, which had the potential to cost energy companies billions of dollars. In addition, had the measures been approved, they may well have spurred environmentalists in other states to launch similar initiatives, analysts said.
“If either one of these had passed it would have set a precedent and it would have encouraged similar efforts in different states,” Pavel Molchanov, an energy analyst at Raymond James. “Because both of these referendums failed, it’s safe to say that the same approach of going to voters has received setbacks and probably will not be attempted in the immediate future.”Unlimited Digital Access for 99¢Read more articles like this by subscribing to the Houston Chronicle SUBSCRIBE
The initiatives were soundly defeated, with more that 56 percent voters in each state casting “no” ballots.
In Colorado the stakes were potentially high for the oil and gas industry, which warned that tens of thousands of jobs and billions of dollars of investments would be threatened if the Proposition 112 passed. The initiative would have prohibited drilling within about a half-mile of homes and businesses to protect residents and the environment from potentially harmful releases from oil and gas operations and production. It also would have blocked just about all drilling in the state.
John Cavitt, chief executive of Covenant Testing Technologies of Houston, said he and his team were confident going into the election, but stayed up Tuesday night to watch the results come in from their office in Greeley, Colorado, a hub of the state’s oil and gas industry. Cavitt estimated that he would have had to cut about half of his 400 workers in Colorado within six months had the voters approved the measure.
“We were certainly fearful of some worst case scenarios, which is why we worked so hard to get information out to inform the voters,” said Cavitt, whose company does well testing and monitoring.
In Colorado, the campaign against Proposition 112, called Protect Colorado, spent nearly $38 million to defeat the measure. Anadarko Petroleum of The Woodlands and Noble Energy of Houston, which operate the most wells in the state, contributed at least $20 million to defeat the measure, according to campaign finance records.
That spending compared to only $1 million spent by Colorado Rising for Health and Safety, the group that supported the proposition.
Anne Lee Foster of Colorado Rising, said Wednesday that she was still getting her head around the loss.
“We don’t know exactly what the next steps are but we will absolutely keep fighting,” she said. “We really don’t have the option to stop.”
In Washington state, the proposed carbon fee would have started at $15 per ton of carbon and raised billions of dollars that would have allowed for investments in renewable energy projects and helping communities deal with the effects of climate change. Carbon taxes or fees aim to provide an incentive for companies to reduce emissions of carbon dioxide, a greenhouse gas that is a leading contributor to climate change.
The campaign battle over Initiative 1631 cost nearly $45 million, with opponents outspending supporters two-to-one. The oil and gas industry, including BP America and Phillips 66, both of Houston, and San Antonio refiners Valero Energy Corp. and Andeavor, which recently merged with Marathon Petroleum Corp., collectively spent more than $27 million battling the carbon fee measure.
https://www.houstonchronicle.com/business/energy/article/Energy-companies-triumph-by-defeating-carbon-13372933.php
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Cheniere LNG Expansions Continue with New Poland Contract
Nov 8, 2018 | Houston Chronicle
By Jordan Blum
Cheniere Energy, the Houston liquefied natural gas exporter, said Thursday that it signed a long-term supply contract with Poland's state-run energy company, a deal touted by the Trump administration as helping to reduce Europe's reliance on Russian gas.
The value of the 24-year-contract was not disclosed, but Cheniere said it would help support its expansions in Corpus Christi and its Sabine Pass complex in Louisiana, from where the first U.S. shipments of LNG left in early 2016.
European nations have long depended on natural gas shipped via pipeline from Russia, but tensions between the West and Russian President Vladmir Putin have raised concerns that his government could use its control of natural gas supplies as way to pressure Europe. As a result many European nation's are seeking LNG from the United States, Australia and Qatar to diversify their supplies.
U.S. Energy Secretary Rick Perry, who was in Poland as part of a trip to Central and Eastern Europe to promote U.S. energy exports, said Cheniere's deal would help Poland and Europe improve their energy security.
"This is a sign across Europe that this is how your energy security will be developed," Perry said before the deal was signed.
Cheniere has led the burgeoning U.S. LNG industry, fed by record natural gas production from Texas and other U.S. shale plays. Only one other company, Dominion Energy of Richmond, Va., has begun exporting LNG from the United States, but others are expected to follow in the coming months, including two Houston firms, Kinder Morgan, which is completing an export terminal in Georgia, Freeport LNG, which will operate a Gulf Coast terminal at Quintana Island
The Gulf Coast is attracting billions of dollars in investment in LNG processing and export facilities along the Gulf Coast. Several companies, including Sempra Energy of San Diego and Tellurian of Houston, are working on projects expected to start up in the coming years.
In an earnings report Thursday, Cheniere said its fifth LNG processing facility, called a train, at its Sabine Pass terminal near the Texas border is expected to come online in the first quarter of 2019. Cheniere said it contracted with California-based Bechtel Corp. to handle the engineering and construction on a planned sixth train there.
Cheniere said its Corpus Christi LNG export terminal is expected to commence commercial operations in early 2019 when the first train comes online. The second train is slated for startup in the second half of 2019. And a third train won't be completed until the back half of 2021.
Cheniere said it earned $65 million profit in the third quarter, swinging from a $289 million loss a year ago. Cheniere's revenues jumped 30 percent from last year up to $1.82 billion.
https://www.chron.com/business/energy/article/Cheniere-posts-small-profit-as-Sabine-Corpus-LNG-13374525.php
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House Democrats Mull Water Infrastructure Options For 2019 Legislation
Nov 9, 2018 | Inside EPA
By Lara Beaven and David LaRoss
House Democratic staff on multiple committees are reaching out to stakeholders for ideas on ways to bolster clean water infrastructure in a possible bipartisan bill in the next Congress -- an effort that could strengthen EPA's water infrastructure funding programs which already face significant demand for funding.
A wastewater utility source says the requests have come from staff on several House committees, including committees that are not usually major players in infrastructure negotiations, such as the House Ways and Means panel that mainly governs tax policy, according to a wastewater utility source.
That suggests water infrastructure will be among the priorities for the Democratically controlled House.
While it is still too soon to know what provisions lawmakers will include in any bill, sources suggest several measures that have already won bipartisan support could be considered, including calls for a new EPA program to subsidize low-income residents' water bills, eased EPA planning requirements for wastewater utilities and changes to tax provisions that raised the cost of some infrastructure borrowing.
In addition, some environmentalists are already urging policymakers to support “green” infrastructure approaches, such as a reliance on natural systems to limit stormwater runoff.
Top House Democrats and their Senate Republican counterparts have signaled that they hope to address infrastructure in a bipartisan fashion in 2019, when Democrats will control the House and Republicans the Senate.
“We will deliver a transformational investment in America's infrastructure to create more good-paying jobs, rebuilding our roads, bridges, schools [and] water systems,” House Democratic Leader Nancy Pelosi (D-CA), who is expected to be the next House speaker, said early Nov. 7.
And Senate Majority Leader Mitch McConnell (R-KY), who saw his own majority increase in the midterm elections, said at a Nov. 7 press conference that Republicans are already looking at infrastructure as one of their few points of common ground with Pelosi.
“The one issue that Leader Pelosi and I discussed this morning is where . . . there could be a possible bipartisan agreement, would be something on infrastructure,” he said.
Although there are major differences between the parties on how they prefer to fund infrastructure and whether regulatory reform should be part of the conversation, a rural water source says Democrats are motivated to reach consensus on those differences in part because they want to have an affirmative agenda, and see an opportunity for a leading role since the White House's focus on infrastructure has been diffused.
Democrats previously sought to capitalize on Trump's calls for an infrastructure deal, floating a plan in 2017 that included about $1 trillion in federal spending, with massive boosts to drinking water, wastewater, resiliency and clean energy projects, along with transportation and other projects.
That focus never led to a consensus bill, even among Republicans, but with Congress under split control, House and Senate leaders could pursue a more robust negotiation on one of the few topics where they see common ground.
In addition, White House officials have already begun to have initial conversations on the issue with Democrats. Rep. Peter DeFazio (D-OR), who is slated to chair the Transportation and Infrastructure Committee which authorizes EPA infrastructure programs, last month met with Shahira Knight, the White House’s director of legislative affairs, to discuss the issue.
“She is convinced the president wants to do something real and realizes it’s going to require real money,” DeFazio told the Washington Post after the meeting last month.
Water Infrastructure
However, even with Democrats in a stronger negotiating position compared to 2017 any proposal will have to contend with Republicans' long-standing agenda that favors facilitating private infrastructure investment over new federal spending. A key element of any GOP bill will likely be bolstering the administration's effort to streamline permit processes, which Democrats have strongly opposed.
The rural water source and a drinking water utility source also question how much the 116th Congress will be able to accomplish on water infrastructure, noting significant EPA drinking water infrastructure measures that were included in the Army Corps of Engineers authorization legislation enacted in late October.
“Congress considers drinking water done,” the drinking water source says, pointing to a significant overhaul of EPA's drinking water state revolving fund (SRF) program in the Army Corps legislation, known as the Water Resources Development Act (WRDA).
The rural water source notes that funding for EPA's drinking water and wastewater SRFs have increased as has funding for the Agriculture Departments rural development water program. Those funding levels are at “an all-time high other than the Obama stimulus,” the source says.
Additionally, the strong economy blunts to some degree the call for increased infrastructure funding to provide an economic boost, the source says, predicting House Democrats will also direct their attention on oversight issues such as EPA's plan to update the lead and copper drinking water rule, address perfluorinated compounds, and redefine the scope of waters of the United States.
Nevertheless, Rep. Frank Pallone (D-NJ), who is slated to lead the Energy and Commerce Committee, signaled he plans to address drinking water infrastructure issues. In a Nov. 7 statement, he said he plans to put forward proposals to “rebuild America by investing in green energy [and] drinking water,” among other things.
While it is still too early to know what lawmakers plan to consider, the outreach from the Ways and Means Committee could indicate a desire to revisit a controversial provision in the 2017 tax cuts that made interest on advance refunding bonds taxable, thereby eliminating the advantages of using such bonds to fund infrastructure projects.
Advanced refunding refers to the practice of refinancing outstanding bonds within 90 days of when they will mature. This can allow bondholders to take advantage of favorable interest rates to reduce borrowing costs, restructure debt or free up resources for other projects and investments, typically in infrastructure.
Proponents said the ability to issue advance refunding bonds allows state and local governments to issue and have outstanding two sets of federally subsidized debt associated with the same activity when they should only have one set.
But a host of municipal groups, including water and wastewater utility groups, argue that advance refunding saves taxpayers' money due to reductions in interest rates. The groups support bipartisan legislation, H.R. 5003, introduced by Reps. Randy Hultgren (R-IL) and C.A. Dutch Ruppersberger (D-MD), co-chairs of the Municipal Finance Caucus, to reinstate advance refunding of municipal bonds.
The water sector sources say several other issues could be addressed, including recent bipartisan calls to create a new EPA program to subsidize low-income residents' water bills and a separate measure codifying EPA's integrated planning policy, which allows utilities to schedule upgrades under an integrated review of wastewater and stormwater needs.
The wastewater source says that while the bipartisan messages on integrated planning will continue in the next Congress, Democrats in the House are likely to place a new focus on environmental justice and disinvestment in impoverished areas.
'Green' Proposals
Meanwhile, some environmentalists are already signaling they plan to use an infrastructure bill to push for elements of their own agendas that they see as bipartisan -- including broadened support for “green” infrastructure that was a major focus for the Obama administration but has fallen off since the Trump transition.
Conservation groups have long urged the Trump administration and both parties on Capitol Hill to embrace infrastructure techniques that use “green” or natural features -- ranging from cultivated rain gardens to large-scale restored wetlands -- to replace traditional “grey” infrastructure for purposes such as channeling stormwater or bolstering flood resiliency.
“This is something that we've been talking about with the Trump administration since very early on,” Jason Albritton, a senior policy adviser at The Nature Conservancy (TNC), told Inside EPA. “We had hoped in this last Congress that [broad infrastructure legislation] might be an area of bipartisan agreement, but it didn't really turn out that way. Our approach to this won't change in the next Congress, but it might have a better chance of success” in a scenario where control of the government is split among Democrats and Republicans, he said.
“We have long thought that this is an area where you can get bipartisan agreement."
He continued that while the Trump EPA itself has yet to take up its predecessor's push for “green” infrastructure, the initiative has made some headway in Congress -- touting language in WRDA that says the Corps “shall consider . . . a natural feature or nature-based feature” in projects “to restore and protect an aquatic ecosystem or estuary."
That broad language is in line with the pitch Albritton said TNC has delivered to members of Congress from both parties as well as EPA officials -- most recently Acting Administrator Andrew Wheeler, in an Oct. 26 meeting -- that has focused on overall principles rather than specific policies.
He said the group is highlighting projects such as Washington, D.C.'s first-of-its-kind stormwater credit trading program, where facilities receive compliance credits for on-site stormwater retention and other methods of mitigating runoff, as examples of how the philosophy has been applied, but stopped short of pushing for EPA to duplicate that or any other particular policy.
“There was no specific 'ask,'” Albritton said of that meeting. “Stormwater credit trading is one way to bring financing to these projects, but it's definitely not the only one,” he said, adding that EPA's SRFs and Water Infrastructure Finance and Innovation Act (WIFIA) program have become successful models as well. “We think there is no one-size-fits-all approach."
Rather than urging Wheeler to adopt any particular implementation of the natural-infrastructure agenda, he said, “it was more a general education about the body of work.”
Albritton told Inside EPA that his hope is that Republicans in Congress and the Trump administration will back natural infrastructure as a way to reduce costs for regulated entities, which has been a major priority of the current administration.
“These are technologies that can deliver solutions and outcomes more cheaply, which can mean a cost savings for local government.” He added that in the meeting with Wheeler, “[w]e talked about this in a way that shows it doesn't have to be unique to one administration. We think it can meet a lot of different goals.”
https://insideepa.com/weekly-focus/house-democrats-mull-water-infrastructure-options-2019-legislation
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EPA Eases States’s Ability to Write Off Smog From Other Countries
Nov 9, 2018 | BNA Daily Environment Report
By Amena H. Saiyid
States marginally violating federal ozone limits can blame air pollution blowing in from other countries without first proving they did all they could to control local emissions, the EPA said.
That’s a reversal from the Environmental Protection Agency’s original plan to require states—regardless of the severity of their ozone pollution problem—to show they had made every reasonable effort to comply with the ozone limits of 70 parts per billion set in 2015.
The EPA’s final rule, signed Nov. 7, clarifies that only regions that marginally exceed the standards—the lowest category of violation—will be allowed to write off that international pollution before demonstrating all other steps have been taken.
States have awaited the EPA’s guidance while they ready plans to meet the updated ozone standards. Some states, particularly Texas and Arizona, have long complained they can do little to curb the air pollution blowing in from Mexico and as far away as Asia.
The agency’s guidance also clarifies that regions violating the ozone standards don’t need to be located right next to an international border to show they’re affected from pollution blowing in from other countries.
Ozone pollution is caused when nitrogen oxides and volatile organic compounds—both of which are byproducts of fossil fuel combustion—react with sunlight. Even at low levels, ozone can cause respiratory problems, especially in children, people with asthma, and older adults.
The Clean Air Act requires states to demonstrate through air pollution modeling and monitoring that international sources of ozone-forming pollution are contributing factors when cities, towns, and counties violate the 2015 ozone standards.
https://news.bloombergenvironment.com/environment-and-energy/epa-eases-statess-ability-to-write-off-smog-from-other-countries
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EPA Expands States' Ozone NAAQS Waivers But Avoids Key Legal Question
Nov 8, 2018 | Inside EPA
By Stuart Parker
EPA's final rule for how states should implement the 2015 ozone national ambient air quality standard (NAAQS) expands their ability to cite international emissions as a reason to waive some emissions control requirements, but the regulation sidesteps key legal questions on weakening air pollution controls raised by an appeals court's ruling.
Acting EPA Administrator Andrew Wheeler signed the rule on Nov. 7 ahead of its future publication in the Federal Register, finalizing a proposal the Obama administration floated in November 2016.
The rule outlines measures states must include in their state implementation plans (SIPs) to meet the agency's toughened 2015 ozone national ambient air quality standard (NAAQS) of 70 parts per billion, which the Obama EPA tightened from the prior 2008 standard of 75 ppb set by President George W. Bush's EPA. The Trump administration is now reviewing the 2015 standard, and plans to make a final decision on revising it by 2020.
The proposed version of the implementation rule largely echoed a prior regulation for how states should implement the 2008 NAAQS, but the final rule makes several significant changes.
For example, EPA is expanding states' access to a regulatory exemption available to them if they would meet NAAQS “but for” international air pollution. The agency makes the exemption available for all areas of the country that can demonstrate impacts from international emissions, a significant change from the Obama EPA's proposal that solicited comment on only allowing areas bordering Canada or Mexico to qualify for the exemption.
The final rule imposes no geographical limitations on states to make use of the regulatory exclusion contained in Clean Air Act section 179B, which details the scope of the international emissions waiver.
Section 179B does not allow states to escape a nonattainment designation in the first place, a fact criticized by Republican lawmakers and some state air regulators in their deliberations on the issue at House Energy & Commerce Committee panel hearings in the 115th Congress.
In a further concession to states seeking to use the section 179B exclusion, EPA will not as proposed require areas designated in “marginal” nonattainment, the least-serious designation, to impose reasonably available control technology (RACT) or similar reasonably available control measures (RACM) on their industrial pollution sources if they are invoking the waiver. States aim to avoid nonattainment designation as it imposes strict emissions control mandates.
“EPA is choosing to not adopt our proposal for this final rule because the Act does not require states to implement RACM/RACT in Marginal ozone nonattainment areas. For purposes of CAA section 179B demonstrations for the 2015 ozone NAAQS, we are maintaining the approach used for prior ozone standards that only areas classified Moderate and higher must show that they have implemented RACM/RACT,” the agency says in its final rule.
EPA is also “clarifying that a demonstration prepared under CAA section 179B could consider emissions emanating from North American or intercontinental sources and is not restricted to areas adjoining international borders.”
Wheeler in a Nov. 8 press release said, “This final rule grants states the flexibilities they need to incorporate factors that are often outside their control, such as international air pollution” to meet the ozone NAAQS.
Court's Ruling
However, the final rule avoids addressing some key legal questions raised by the U.S. Court of Appeals for the District of Columbia Circuit's Feb. 16 ruling in South Coast Air Quality Management District, et al. v. EPA. The court scrapped important elements of the Obama-era rule for implementing the 2008 ozone air standard.
In that ruling, Judge David Sentelle vacated several aspects of EPA's strategy for revoking an even older NAAQS set in 1997, a strategy that the agency partially relied on in its 2016 SIP requirements proposal.
As a result, the agency is not in this action including any of the measures required to scrap the 2008 standard, including “anti-backsliding” measures to guard against any deterioration in air quality. Under D.C. Circuit precedent, states must apply such measures even when NAAQS get tougher, not weaker.
But EPA does not address the question of revoking the 2008 NAAQS, or anti-backsliding measures, in the Nov. 7 final rule, pushing the issue off into a separate, future rulemaking. “EPA intends to address any revocation of the 2008 ozone NAAQS, and potential anti-backsliding requirements, if any, in a separate future rulemaking,” the agency says in a fact sheet.
The D.C. Circuit, meanwhile, has stayed certain aspects of its ruling until February to allow EPA and states to craft a policy response.
EPA's 2015 ozone NAAQS implementation rule does make final decisions on other issues for how states must craft their SIPs. The agency largely adopts the same methodology it used to implement the 2008 NAAQS, minus the anti-backsliding measures.
The rule contains detailed timelines for states to submit various aspects of their SIPs to EPA, following their designation as either attaining or being in nonattainment with the 2015 NAAQS. It further contains provisions governing the regulation of ozone precursors, among others.
The rule contains detailed requirements for EPA to allow states' programs for inter-precursor emissions trading, a practice opposed by some environmentalists but upheld by the D.C. Circuit.
It also contains limited flexibility in states' choice of “baseline year” from which they must demonstrate “reasonable further progress,” (RFP) an issue tested in South Coast where the court rejected EPA's more-flexible approach for the 2008 NAAQS that allowed states to choose older baseline years, and hence reduce their pollution reduction obligations.
Under the new rule, “the RFP baseline year for the 2015 ozone NAAQS, we are specifying that the baseline year shall be the calendar year for the most recently available triennial emissions inventory preceding the year of the area’s effective date of designation as a nonattainment area.” In effect, that means 2017.
Alternatively, “states may choose to use the year that corresponds with the year of the effective date of an area’s nonattainment designation for the RFP baseline year,” which effectively means 2018.
The rule maintains EPA's position that nonattainment areas cannot count on “out of area” emissions reductions to demonstrate reasonable further progress, consistent with the D.C. Circuit's ruling.
It abandons, however, a proposed tougher measure requiring that areas in the Ozone Transport Commission area of 12 Mid-Atlantic can Northeastern states report nitrogen oxides emissions from industrial sources exceeding 50 tons per year (tpy), keeping the reporting threshold at 100 tpy instead.
Future Guidance
EPA in the final rule also flags some upcoming guidance documents or rules pertinent to ozone NAAQS implementation. EPA says it “is actively evaluating the need for further guidance and/or rules to address” background ozone, which originates from natural or foreign sources and cannot be controlled by state regulators.
The agency also says it “expects to make available” guidance for stratospheric ozone intrusions by the end of 2018 that will guide states on how to account for such events in their “exceptional events” requests to the agency.
EPA's exceptional events rule allows states to exclude from demonstrations of NAAQS attainment air quality data gathered during “exceptional events” such as dust storms or wildfires.
The forthcoming guidance will guide states on how to address data gathered during stratospheric intrusions in the context of exceptional events. Stratospheric intrusions can increase ozone levels in the lower atmosphere in high-altitude locations, primarily in the mountain West.
Once EPA publishes the final rule in the Register it will start a 60-day clock for states, industry groups or environmentalists to file legal challenges to it.
https://insideepa.com/daily-news/epa-expands-states-ozone-naaqs-waivers-avoids-key-legal-question
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State Carbon-Tax Defeat Won’t Halt Federal Push, Exelon CEO Vows
Nov 9, 2018 | BNA Daily Environment Report
By Jennifer A. Dlouhy
Despite Washington state voters’ rejection of a tax on carbon dioxide emissions, there’s still an opening in Congress for a national plan to bolster clean energy and help combat climate change, Exelon Corp. Chief Executive Chris Crane said Nov. 8.
“We can continue to try to do state-by-state programs, but the only way to really accomplish what the scientists say needs to be accomplished is more efficient done at the federal level,” Crane said in an interview.
The Chicago-based power company is putting $2 million behind a campaign to put a national tax on carbon dioxide emissions and redistribute the revenue to U.S. households.
Odds for action have improved in the House, which is set to be controlled by Democrats in January, Crane said. “There is work to do with the Senate,” he allowed.
Exelon, the nation’s largest producer of nuclear power, would benefit because those plants generate carbon-free electricity but are struggling to compete against natural gas.
“Once we close a unit, we can’t bring it back,” Crane said. “Plants are coming off—and they’re not being replaced by carbon-free sources” of power.
Nuclear Power Fleet ClosuresMore than a third of the U.S. nuclear power fleet could close in the next decade, generally replaced by fossil fuels that generate carbon dioxide emissions, the Union of Concerned Scientists said in an analysis released Nov. 8.
The environmental group said federal policies are needed to stave off those closures, especially in light of dire warnings the world will have to rapidly slash carbon dioxide emissions to prevent the most catastrophic consequences of climate change.
Three states already have enacted policies that reward nuclear power. The Washington State initiative rejected by voters Nov. 6 took a different approach in aiming to broadly discourage carbon-intensive energy through a $15 fee on each metric ton of heat-trapping emissions.
But the money raised by that fee would have gone to public transit programs and renewable energy projects—instead of being rebated to consumers. And the Washington plan included highly criticized exemptions for pulp and paper manufacturers, a coal-fired power plant and an aluminum smelter.
Business leaders also warned that a state-based carbon fee would put them at a competitive disadvantage, Crane said.
“I don’t think it’s a mandate that the citizens of Washington don’t believe in global warming; I think they didn’t agree with the framework of a program,” he said.
The defeat shows how important it is to correctly design a federal initiative so it gets broad support and addresses economic concerns, he said. “We can do this in a matter that gets states to their goals” and “gets the country toward what most of the citizens are pushing for.”
https://news.bloombergenvironment.com/environment-and-energy/state-carbon-tax-defeat-wont-halt-federal-push-exelon-ceo-vows
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Appeals Court Grants Trump Admin Request to Stay Youth Climate Lawsuit
Nov 8, 2018 | The Hill - E2 Wire
By John Bowden
A federal appeals court in Oregon on Thursday granted a motion from the Trump administration for a temporary stay in a lawsuit brought forward by a group of young people who argue that the government is violating their rights by not adequately battling climate change.
The Associated Press reported Thursday that the Ninth Circuit Court of Appeals granted a 15-day stay in the case for either it or the Supreme Court to consider a motion by the Trump administration to dismiss the case.ADVERTISEMENT
"As set forth fully in the accompanying memorandum of law, a stay is warranted because...Defendants will be irreparably harmed absent a stay; Plaintiffs will not be harmed by a stay; and the public interest will be well-served by a stay in order to facilitate the review by the Ninth Circuit that the Supreme Court contemplated," the Trump administration wrote in its court filing earlier this week.
Philip Gregory, a co-counsel for the plaintiffs, told the AP that he hoped the temporary stay would be followed by the trial proceeding as planned. The lawsuit argues that the federal government has known about the effects of climate change for 50 years, and is depriving them of life, liberty and property by doing little or nothing to stop it.
“Given the urgency of climate change, we hope the Ninth Circuit will recognize the importance to these young Americans of having a prompt trial date," Gregory said.
“We are pleased this stay is only temporary,” he added. “We want to commence presenting the climate science in court as soon as possible.”
The Supreme Court rejected a request from the Trump administration last week to halt the lawsuit, but wrote that the federal government can still petition a lower court to dismiss the case.
The Obama and Trump administrations have battled the lawsuit for years, arguing that the case would force the federal government to make policy decisions through the court system rather than prescribed legislative processes.
https://thehill.com/policy/energy-environment/415865-appeals-court-grants-trump-admin-request-to-hold-youth-climate
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