Preview Newsletter
ACC AM 2/13/17
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Hearing On Cybersecurity
Feb 14, 2017 | House Science, Space and Technology Subcommittee on Research and Technology
Location: 2318 Rayburn / 10:00 AM -
Hearing on Multi-Modal Transportation
Feb 15, 2017 | Commerce, Science and Transportation Subcommittee on Surface Transportation and Merchant Marine Infr
Location: 253 Russell / 2:30 PM -
Hearing On Energy Infrastructure
Feb 15, 2017 | House Energy and Commerce Subcommittee on Energy
Location: 2123 Rayburn / 10:00 AM -
Hearing On Modernizing Environmental Laws
Feb 16, 2017 | House Energy and Commerce Subcommittee on the Environment
Location: 2123 Rayburn / 10:00 AM -
(ACC Mentioned) Barrasso, Mining Industry Request More Time for Superfund Rule
Feb 13, 2017 | BNA Daily Environment Report
By Sylvia Carignan
Sen. John Barrasso (R-Wyo.) has joined mining industry heavyweights to ask the EPA for more time to review a complex Superfund rule. -
GOP Races Against Time to Roll Back Clock on EPA, Other Rules
Feb 13, 2017 | BNA Daily Environment Report
By Dean Scott
Republicans long supportive of rolling back regulations are making good on their threat to quash Obama era rules after the GOP scored a trifecta by winning the White House and holding control of Congress. -
Regulation Benefits Said to Be at Risk Under Trump Order
Feb 13, 2017 | BNA Daily Environment Report
By Cheryl Bolen
The uncertainty surrounding President Donald Trump's one-in, two-out regulatory order has raised significant concerns among public interest and environmental groups about whether vital health and safety protections will be endangered or eliminated. -
Lawmakers Ask EPA, DOE To Find 'Clear Path' To Savings
Feb 10, 2017 | E&E News PM
By Kevin Bogardus
Republican lawmakers are asking federal agencies, including U.S. EPA and the Department of Energy, to find waste within their agencies. -
(ACC mentioned) No, Chemical Industry, You Can’t Have Your Cake And Eat It Too (Part 2)
Feb 10, 2017 | Environmental Defense Fund
By Richard Denison
We have been watching with growing alarm the rapidly unfolding efforts by leadership in Congress and the Trump Administration to gut health and safety protections that provide millions of Americans with clean air, water and safe products. Support by the American Chemistry Council (ACC) for such efforts, detailed below, gives us profound worry and deep frustration given the trade association’s support of major reforms to the Toxic Substances Control Act last year. -
(ACC Mentioned) US EPA Establishes Science Advisory Committee On Chemicals
Feb 13, 2017 | Chemcial Watch
By Kelly Franklin
The US EPA has named the 18 members that will make up its new Science Advisory Committee on Chemicals (SACC) under the recently reformed TSCA. -
EPA Launches TSCA Risk Evaluation Advisory Committee
Feb 13, 2017 | Inside EPA
EPA has formally launched a new advisory committee of 18 toxicologists, academics, state officials and other experts who will give the agency input on scientific and technical aspects of implementing the revised Toxic Substances Control Act (TSCA), alongside EPA's issuance of its first chemical evaluation report as directed by the toxics law. -
Tensions Flare Over TSCA Section 6 Proposals For TCE
Feb 13, 2017 | Chemical Watch
By Kelly Franklin
The US EPA has extended the consultation deadlines for proposed rules to ban certain uses of trichlorethylene (TCE) under section 6 of TSCA by 30 days. -
Practitioners Insights: Systematic Review in Toxicology—When Is It Worth It?
Feb 13, 2017 | BNA Daily Environment Report
By Dr. Daniele Wikoff
Why Systematic Review? By definition, systematic review is a method for answering specific research questions—it uses a predefined, multistep process to identify, select, critically assess and synthesize evidence from scientific studies to reach a conclusion. It seems like common sense, yet many skeptics question the utility of systematic review: Isn't it what we have always been doing? How does it really apply to toxicology and risk assessment? Why does it take so long? When is it worth it? -
Gore To Drop Waterproofing PFCs
Feb 13, 2017 | Chemical & Engineering News
By Melody M. Bomgardner
Bowing to pressure from activist groups, Gore Fabrics says it is working to eliminate perfluorinated chemicals (PFCs) of environmental concern from its products. Gore supplies water-resistant fabrics to many leading outdoor apparel makers, including Patagonia and The North Face. -
Critics Round On 'Narrow Scope' Of UK's Proposed Microbeads Ban
Feb 13, 2017 | Chemical Watch
By Tammy Lovell
A coalition of NGOs has called for the UK to extend its proposed ban on microbeads in cosmetics. -
State Utility Regulators Eye Next Steps To Cut Carbon Emissions
Feb 13, 2017 | E&E Daily
By Rod Kuckro
U.S. EPA's role in regulating carbon emissions will be on the agenda when state utility regulators meet this week in Washington, although it won't be as prominent an issue as in recent years. -
House To Focus On Building Out Grid, Pipelines
Feb 13, 2017 | E&E Daily
By Hannah Northey
House members keen on seeing new energy projects move forward under the Trump administration will hold a hearing this week. -
PA. Justices Urged To Nix Fracking Rule Injunction
Feb 10, 2017 | Law 360
By Dorothy Atkins
Pennsylvania’s environmental regulators urged the state Supreme Court on Wednesday to overturn an injunction blocking new regulations governing surface areas near gas drilling and hydraulic fracturing, saying the lower court erred when it granted the “extraordinary remedy” of a preliminary injunction. -
(ACC Mentioned) Chemical ISAC Announces Partnership With Defense Group To Expand Membership
Feb 13, 2017 | Inside Cybersecurity
The American Chemistry Council's Chemical Information Technology Center announced that is working with the Defense Security Information Exchange to increase participation in the Chemical Sector Information Sharing and Analysis Center, or Chem-ISAC, which allows chemical companies to share cyber-threat intelligence with each other and the government. -
4 Critical Defects Found In Latest Oil Train Inspections
Feb 12, 2017 | AP (In News 10)
State and federal inspectors found four critical defects and 42 non-critical ones in the latest round of oil train and track inspections across New York state. -
Lawmakers To Mull Self-Driving Cars, Rail Safety
Feb 13, 2017 | E&E Daily
Lawmakers at a pair of hearings this week will consider the challenges of getting people and goods around using both old and new technologies — including self-driving cars. -
Panel To Discuss Changes to Clean Air Act, Brownfields Law
Feb 13, 2017 | E&E Daily
By Sean Reilly
In an organizational reshuffling announced last month, the House Energy and Commerce Subcommittee on Environment picked up jurisdiction over one of the nation's landmark laws: the Clean Air Act. -
States, 'Clean' Utilities Defend Power Plant MACT As Vital For Air Quality
Feb 13, 2017 | Inside EPA
By Stuart Parker
Several states and “clean” utilities that generate power from lower-emitting sources than coal are urging a federal appeals court to uphold EPA's cost assessment that justifies its maximum achievable control technology (MACT) air toxics rule for power plants, saying the rule continues to be vital to ensure good air quality nationwide. -
Advocates’ Air Pollution Suit 20 Years Too Late, EPA Argues
Feb 13, 2017 | BNA Daily Environment Report
By Patrick Ambrosio
The EPA's contention it adequately regulated three air toxic pollutants appears to hinge on whether the court will accept the government's argument that environmental advocates should've raised their concerns more than 20 years ago (Sierra Club v. EPA, D.C. Cir., No. 15-1246, argued 2/10/17). -
Judges Question Trump EPA On Legality Of Obama-Era Air Toxics Regulation
Feb 13, 2017 | Inside EPA
By Stuart Parker
Appellate judges at Feb. 10 oral argument queried the Trump EPA over its defense of an Obama-era rule declaring that the agency has satisfied a Clean Air Act mandate to regulate 90 percent of sources of seven air toxics, questioning the legitimacy of the rule but also raising doubts on whether environmentalists' suit over the finding is timely. -
CEQ's Top Acting Official Pushes GHG Analysis In NEPA Reviews
Feb 10, 2017 | Inside EPA
The acting chairman of the White House Council on Environmental Quality (CEQ), Ted Boling, is urging continued consideration of climate change in National Environmental Policy Act (NEPA) reviews despite the fact that President Donald Trump is expected to target CEQ's recent guidance for agencies on the issue.
Congressional Hearings
Industry and Association News
LCSA News
Chemical Management News
Energy News
Chemical Security News
Transportation News
Environment News
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Feb 14, 2017 | House Science, Space and Technology Subcommittee on Research and Technology
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Hearing on Multi-Modal Transportation
Feb 15, 2017 | Commerce, Science and Transportation Subcommittee on Surface Transportation and Merchant Marine Infr
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Hearing On Energy Infrastructure
Feb 15, 2017 | House Energy and Commerce Subcommittee on Energy
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Hearing On Modernizing Environmental Laws
Feb 16, 2017 | House Energy and Commerce Subcommittee on the Environment
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(ACC Mentioned) Barrasso, Mining Industry Request More Time for Superfund Rule
Feb 13, 2017 | BNA Daily Environment Report
By Sylvia Carignan
Sen. John Barrasso (R-Wyo.) has joined mining industry heavyweights to ask the EPA for more time to review a complex Superfund rule.
The Environmental Protection Agency set a period of 60 days for the public to comment on the proposed rule (RIN:2050-AG61), but the Environment and Public Works Committee chairman has asked for an additional 120 days.
The proposed rule would ensure mining companies have the financial backing to pay for cleanup in the event of an environmental disaster. The rule is intended to reduce the number of Superfund cleanup actions necessary.
In a Feb. 10 letter to EPA Acting Administrator Catherine McCabe, Barrasso notes that the rule is also likely to supersede state requirements for financial assurance, and that states would need more time to review it.
Requesting Extensions
The American Chemistry Council, the American Iron and Steel Institute, ASARCO, Hudbay Minerals and the National Mining Association have also asked for 120-day extensions to the established comment period. The American Petroleum Institute asked for 60 additional days.
In his letter, Barrasso says the 60-day period is “inadequate,” particularly since some documents were added this week, halfway through the comment period. “A meaningful opportunity for comment requires time to adequately review these documents and the complex statistical model that EPA made available to the public only recently,” he said.
But Bonnie Gestring, Northwest program director at Earthworks, said the EPA shouldn't grant any additional time.
“Generally, we're concerned about an extension because we want to make sure that there is no delay in the court-ordered deadline,” she said.
The EPA is currently under a court order to issue a final rule on the matter by Dec. 1.
The American Chemistry Council calls the 60-day comment period “wholly insufficient” to review the EPA's posted material.
The Small Business Administration's Office of Advocacy asked the EPA to withdraw the proposed rule completely.
“The proposed rule would impose costly requirements on hardrock mines owned by small firms, without evidence that a problem exists warranting intervention,” the administration's chief counsel wrote in a Jan. 19 letter.
The 60-day comment period is currently scheduled to end March 13. Nine comments have been submitted as of Feb. 10.
The EPA expects about 200 hardrock mining facilities to be affected by this rule if it is finalized. Hardrock mining incorporates the extraction and processing of metals such as copper, gold, iron and lead as well as non-metallic, non-fuel minerals like phosphate rock, asbestos and sulfur.
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GOP Races Against Time to Roll Back Clock on EPA, Other Rules
Feb 13, 2017 | BNA Daily Environment Report
By Dean Scott
Republicans long supportive of rolling back regulations are making good on their threat to quash Obama era rules after the GOP scored a trifecta by winning the White House and holding control of Congress.
The Republican-controlled House is moving at a rapid clip, voting over the last two weeks to nullify a half-dozen rules issued in the waning months of President Barack Obama's presidency—three of them energy or environment related—under a rarely used 1996 law, the Congressional Review Act.
The Senate also is proving surprisingly agile given its traditionally lumbering pace, voting to nullify two of the regulations the House voted down. Both chambers have passed a resolution that would nullify the Interior Department's stream buffer rule, the coal mining industry's top regulatory target. And any resolutions nullifying regulations that pass Congress will almost certainly be signed into law by President Donald Trump.
“There's plenty of material out there, believe me,” Sen. John Thune (R-S.D.) told Bloomberg BNA. “And I think we could keep very busy just processing CRAs.”
And they are not done yet: on the horizon are resolutions introduced to roll back Environmental Protection Agency rules limiting air pollutants that cross state lines; EPA requirements for risk management plants to prevent chemical releases; and Interior Department rules curbing drilling in the Arctic. Those and other rules being targeted were completed in Obama's last six months, which makes them vulnerable to challenge under the review act's look-back procedures.
It's an extraordinary pace given the Clinton-era law has been used only once, when a Republican-led Congress joined forces with a newly inaugurated Republican president, George W. Bush, to repeal a job safety ergonomics rule in 2001.
Dozens of Rules Now Targeted
The congressional move against regulations, along with executive orders and other deregulatory actions readied by the Trump White House, suggest a roll back of environmental and other regulatory requirements not seen since the Reagan era.
Republicans in both chambers have set their sights higher, introducing dozens more disapproval resolutions over the last few weeks. Some however quietly concede their early plans for taking down hundreds of rules completed in Obama's waning months now seem a bit ambitious in light of the CRA's 60-day window for using its expedited procedures for quick up and down votes on rules.
Thus far, the Senate has slotted in CRA votes on regulations, including as much as 10 hours of debate, in spots between confirmation votes, essentially running those votes in “parallel tracks,” Sen. John Barrasso (R-Wyo.) told reporters recently. But “each of these regulations individually has to take time off” the clock in the Senate, he said.
But the Wyoming Republican maintains Congress can move more than 100 resolutions to repeal major rules under the CRA—essentially those costing the economy $100 million or more annually—even accounting for Democrats who he expects to “throw wrenches in the mix.”
“I would expect that folks that are opposing those [regulatory repeal] efforts, the minority party, may try to throw wrenches in the mix” before the CRA's 60-day deadline for using its fast-track procedures to kill rules, he said.
House and Senate tallies of session or legislative days differ but essentially the chambers have until late May or into June to target regulations using the law's expedited procedures.
“I'm an orthopedic surgeon,” Barrasso said. “I'm used to working nights and weekends. I'm happy to be here all night and all weekend to use” the CRA to repeal rules, he said.
But predictions of college-era all-nighters—like those from Sen. Roger Wicker (R-Miss.), who suggested to Bloomberg BNA in January the Senate might need to work “24/7” and “bring cots in” given the number of rules needing repeal haven't panned out, at least not yet.
Actually, the senators pulling all-nighters of late have been instead Democrats, who have sought to delay many of Trump's top Cabinet picks.
Democrats Largely Sidelined in Debate
Outgunned Democrats and their allies within environmental and public health groups can only watch in dismay at the dismantling of environmental and other regulations that in some cases were developed over eight years of Obama's presidency.
Some environmental groups vow however that they will ultimately challenge the congressional repeal of rules in court, though the law itself includes specific language that was intended to bar judicial review.
Even in the Senate, where Republicans have a slim 52-48 majority, Democrats have few weapons to defend regulations given the CRA allows rules to be voted down with just a 51-vote majority. The Senate's Feb. 2 vote to kill Interior's rule restricting the dumping of mining waste in streams, the chamber's first on a CRA resolutions this year, also saw four Democrats crossing party lines to vote down the rule: Sens. Joe Donnelly (Ind.), Claire McCaskill (Mo.), Heidi Heitkamp (N.D.) and Joe Manchin (W. Va.). A lone Republican, Maine Sen. Susan Collins, voted no on the resolution.
Democrats enter those midterm elections at a huge disadvantage because they will be defending 25 seats; Republicans must defend just eight. Senate Republicans are relishing the prospect of forcing Democrats up for reelection two years from now to vote again and again on regulations their Democratic president moved through the pipeline. All four Democrats voting with Republican to kill the stream protection rule face 2018 reelection contests in states Trump handily won on Election Day.
“The ones that are the most vulnerable, everybody knows who they are,” Republican Sen. Jim Inhofe (Okla.) told Bloomberg BNA last week. “And if you don't know who they are, you can tell—by the way they vote.”
Michigan Sen. Debbie Stabenow, also up for election in two years, is among those vulnerable Democrats in 2018, the bulk of whom still voted no on repealing the stream protection rule. “Our interest is in making sure that public health, the ability to drink the water and breathe the air and enjoy workplace safety” are preserved, she told Bloomberg BNA. “We want to make sure those things are, in fact, protected if at all possible.”
House Democrats have even fewer weapons other than alerting public health and environmental groups of the next round of resolutions or defending the regulations in floor debated.
“We alert all of our environmental friends that this is serious business [and that] they need to keep an ear to the ground” Rep. Grace Napolitano (Calif.), the top Democrat on the House Transportation and Infrastructure Subcommittee on Water Resources and the Environment, told Bloomberg BNA.
But what can Democrats do in the end to repel such attacks, she was asked. “We can keep our fingers crossed and pray.”
Looming Bottleneck?
But House leaders can see the obvious: a bottleneck looming in the Senate. Largely consumed with Trump Cabinet confirmations that have been slowed by Democrats, Senate Majority Leader Mitch McConnell (R-Ky.) has only been able to pass just two resolutions.
Although it's early, at that pace, the Senate is essentially repealing one rule for every three the House has voted to nullify.
House Natural Resources Committee Chairman Rob Bishop (R-Utah) told Bloomberg BNA his committee alone could ready between 50 and 60 resolutions targeting regulations. But even that number may be on the high side, he said, because Republican leaders in the House at some point will grow wary of taking up floor time on resolutions that pile up and may not get a vote over in the Senate.“The question is not necessarily how many [rules] we'd want to roll back. It's how much time the Senate has to pick ‘em up,” said Bishop, who has had a hand in getting the House to roll back several rules already including Interior's stream buffer, methane flaring and land use planning rules.
“It's simply the concept that if the Senate can't handle anymore, we're not going to waste our time passing them over here,” Bishop said.
Mike Long, a spokesman for House Majority Leader Kevin McCarthy, said the Republican leadership is aware of the bottleneck concern. But House Republicans still intend to resume CRA efforts to repeal rules when members return the week of Feb. 13, Long told Bloomberg BNA.
“We're going to [take up] some when we come back, but I don't know that we've finalized the list,” he said, adding House Republicans are “going to do as many as we can” in the months ahead.
Four House Resolutions Coming
On deck are two resolutions: H.J. Res. 69, to repeal Interior Department restrictions on certain hunting practices in National Wildlife Refuges in Alaska, introduced by Rep. Don Young (R-Alaska) and H.J. Res. 43, targeting Health and Human Services requirements related to Title X requirements. Both are slated to be taken up Feb. 14 by the House Rules Committee, essentially the last stop before floor consideration.
Two other resolutions targeting Labor Department regulations (H.J. Res. 66 and H.J. Res 67) are going before the House Rules panel Feb. 13.
Other CRA resolutions to nullify regulations waiting the wings include:
• S.J. Res. 21, introduced Feb. 3 by Sen. Pat Toomey (R-Pa.) to set aside EPA cross state air pollution rules;
• H.J. Res. 59, introduced Feb. 1 by Rep. Markwayne Mullin (R-Okla.) to kill EPA risk management plan requirements for guarding against accidental chemical releases;
• H.J. Res. 47, introduced Jan. 30 by Young, targeting Interior Department limits on exploratory drilling on the Arctic Outer Continental Shelf; and
• H.J. Res. 46, introduced Jan. 30 by Rep. Paul Gosar (R-Ariz.) to repeal Natural Park Service authority to ban oil, gas and mineral drilling in national parks.
To many House Democrats, the Republican focus on repealing regulation after regulation has more to do with rewarding industry allies and messaging than actually helping the economy.“Look, they are going to have to fill floor time with something while working out health care” issues that are complicating GOP efforts to repeal and replace Obamacare, said one Democratic aide with the House Natural Resources Committee. “And it's certainly good for their base.”
Balancing Act Ahead
But House and Senate leaders ultimately will have to balance further demands for regulatory repeal over the next three months or so against other issues competing for floor time, including a mid-March expiration of the debt ceiling limit, always a rancorous issue. There also may be diminishing returns in targeting lesser-known regulations; several of the coal mining industry's top targets for example have already been voted on in either the House or Senate.
Republicans have a ready response: the CRA isn't the only game in town when it comes to rolling back regulations. “We're very much looking at what we can tackle in terms of using the CRA—but just keep in mind there are other tools in our box to address regulatory matters,” AshLee Strong, press secretary for House Speaker Paul Ryan (R-Wis.), told Bloomberg BNA.
“Just to be clear, a president can do relief from regulations through executive action,” she said, noting that White House action on regulatory matters swings both ways.
Much of what Obama put in place, either through executive orders or regulatory actions taken by the EPA and other agencies, will be under close scrutiny by the new administration, Strong said. “Anything put into place from executive action can most likely be undone via executive action.”
Wyoming's Barrasso said the administration will likely have to take the lead in weakening environmental rules ranging from carbon pollution limits for power plants to a Clean Water Act rule expanding federal jurisdiction over certain waterways. “We'll have new cabinet members who may take another look at those regulations and may want to do a different interpretation,” the senator said.
A Welcome Mat at the White House
Whether the campaign to nullify rules using the CRA runs out of steam or not, Republicans and industry groups note that they are almost certain to make history in this sense: The CRA has been deployed successfully only once since its passage more than 20 years ago. The House and Senate together are likely to add scores of rules to that pile in the months ahead.
They couldn't do so without a president who will sign such resolutions, however. Obama's White House repeatedly threatened to veto CRA resolutions advanced by Republicans during his eight-year tenure. Congressional Republicans moved five resolutions, of which three targeted major environmental rules, including EPA limits on power plant carbon pollution. But all ran into a firewall of Obama veto threats.
By contrast, Trump's White House, in its first statement of administration policy on CRA resolutions moving through Congress, put out the welcome mat for the first round of deregulatory measures as they moved through the House. The White House said it “strongly supports” House efforts “to begin to nullify unnecessary regulations imposed” on industries, particularly those viewed as a threat to the coal industry, which Trump vowed to revive during the campaign.
The White House, in its statement of administration policy, stressed that the new administration “is committed to reviving America's coal mining communities, which have been hurting for too long.”
In a sign of things to come, Trump has already issued one executive order calling for the elimination of two existing regulations for every new one brought forth by agencies in his administration. But public interest, environmental and labor groups have already challenged the Jan. 30 order in court, arguing that it is in conflict with and threatens public health and safety protections provided under other laws.
Long Shot or Chink in Armor?
Environmental and public health groups say it may sound like a long shot, but insist there may be a chink in the armor of the congressional rollback strategy now underway: the CRA has been so seldom used, there's no consensus on what the 1996 law meant in declaring that rules once nullified by Congress can't be issued again in “substantially the same form.”
Yogin Kothari, Washington representative with the Union of Concerned Scientists’ Center for Science and Democracy, asks which law the EPA should follow in a situation where Congress sets aside an air pollution regulation: the resolution nullifying the rule, or the Clean Air Act, which specifically directs the agency to address pollutants?
Environmental groups from the Sierra Club to the Environmental Defense Fund to the Natural Resources Defense Council all have been researching the CRA, in some cases for years, poking for vulnerabilities should they have to fight rollbacks in court.
Industry groups argue to the contrary that Congress in drafting the CRA could not have more clear in expressly prohibiting judicial review of congressional actions to nullify regulations. Section 805 of the CRA states that no “determination, finding, action, or omission” [under this chapter] shall be subject to judicial review.”
“Two federal appeals courts and several federal district courts have examined this section and determined that it unambiguously prohibits judicial review of any question arising under the CRA,” according to a Nov. 17, 2016, Congressional Research Service report, “The Congressional Review Act: Frequently Asked Questions.”
Inflated Economic Costs?
Environmental and public interest groups say the campaign to nullify various regulations relies on industry arguments that often inflate compliance costs and economic impacts for regulations and are tallied by the U.S. Chamber of Commerce and conservative think tanks such as the Heritage Foundation and the Competitive Enterprise Institute.
McCarthy, the majority leader, often cites a CEI figure that puts the total cost of rules at about $1.89 trillion—or 10 percent of total gross domestic product—which he notes comes out to a cost of $15,000 for every American household. But those figures don't typically account for benefits provided by rules, or take into account new technologies and industries that emerge as a result of regulations, such as pollution control technologies.
Lisa Heinzerling, professor at Georgetown University Law Center who advised former EPA Administrator Lisa Jackson on climate policy, says unfortunately the debate over regulatory burdens “is often not framed in a reasonable or even honest way. All too often, in fact, the debate recklessly ignores the many benefits of regulation and inaccurately reports its costs,” she said at a Feb. 1 regulatory hearing before the Senate Commerce, Science and Transportation Committee.
“The specific numbers change from time to time, but the game remains the same” for regulatory opponents, Heinzerling said, which is to make regulations “look outlandish by claiming costs and consequences,” she said, “that are not real.”
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=105357594&vname=dennotallissues&fn=105357594&jd=105357594
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Regulation Benefits Said to Be at Risk Under Trump Order
Feb 13, 2017 | BNA Daily Environment Report
By Cheryl Bolen
The uncertainty surrounding President Donald Trump's one-in, two-out regulatory order has raised significant concerns among public interest and environmental groups about whether vital health and safety protections will be endangered or eliminated.
“They may not be alone,” Sally Katzen, professor at New York University School of Law and senior adviser at the Podesta Group, told Bloomberg BNA.
“Some of [the president's] business colleagues may not be enthusiastic about an order that will be understood by the people as the government now having to choose between safe food, safe drugs and clean air—pick one, only one,” Katzen said.
Why Regulations Exist
The new executive order requires agencies to both eliminate two regulations for every one issued and completely offset the cost of the new regulation by reducing existing regulatory costs. That policy has raised many questions about how it will work.
Regulatory costs are typically borne by business, and they may object to those costs, Katzen said. The benefits of regulation are enjoyed by society at large, and those benefits are important, she said.
“Whether it be clean water or safe workplaces or fair competition in the marketplace, they're critically important,” Katzen said. “Many companies wouldn't do them without the regulations. That's why we have regulations.”
It is unclear what this order will mean, for example, in terms of the Food and Drug Administration's approval of labeling new drugs, Katzen said. Are they going to have to yank their approval of other drugs? she asked.
Katzen served as the administrator of the Office of Information and Regulatory Affairs for the first five years of the Clinton administration. OIRA is an office within the White House Office of Management and Budget that reviews all significant agency regulations.
Free Market
In theory, drugmakers could produce whatever they wanted without regulatory approval, Katzen said.
“That could be the outcome of this type of approach,” she said. “But if you bring unsafe or ineffective drugs to the market, you have the potential for another thalidomide.” Thalidomide was used abroad in the 1950s to treat morning sickness, among other uses. But it caused severe birth defects.
Food safety rules are rooted in “The Jungle,” a 1906 novel by Upton Sinclair describing the unsanitary conditions of the meatpacking industry, Katzen said.
Automobiles now have airbags, rollover protection and padded steering wheels because of the 40,000 some deaths a year on the highway, she said.
Reduce Rules by 75 Percent
Trump has said he is seeking a 75 percent reduction in regulation, maybe more. What would that look like?
There might be more lead in the water supply like in Flint, Mich., Katzen said. The river in Cleveland might burn again, or the air in certain areas will look like Beijing's, or there will be widespread E. coli outbreaks, she said.
“These outcomes would not be cost-free,” Katzen said. “Increases would be needed for medical assistance, whether it's for asthma or injuries in the workplace or workman's comp, and the quality of life we have come to enjoy could definitely be adversely affected,” she said.
Hard to Find Regulations to Cut
It is conventional wisdom that there are regulations on the books that could be deleted without a significant impact on anyone, Katzen said.
Presidents since Ronald Reagan have all ordered some form of retrospective review to see what existing regulations could be eliminated, Katzen said.
“It's been very difficult to unearth those,” she said. “Some have really tried hard and still haven't produced very much.”
This is in part because, once a regulation is issued, the affected industries implement it with ingenuity, keeping costs to a minimum, Katzen said. Then, once the rules are implemented, weeding them out does not produce very much savings, she said.
Not Either-Or
The benefits of regulation were raised in a conference call on Feb. 9 hosted by the Federalist Society, where former public policy officials discussed the new executive order and its impact.
Susan Dudley, director of the Regulatory Studies Center at George Washington University, said it is important that agencies continue to calculate the benefits of regulations as well as the costs.
“This order shouldn't replace benefit-cost analysis,” Dudley said. “Instead it adds a budget constraint, and I think agencies would still try to maximize net benefits within that constraint.”
The order does not undermine the ability of the Environmental Protection Agency, for example, to think very much about benefits when it looks at which regulations it wants to introduce and which it might be able to modify, Dudley said.
Same Benefits, Lower Cost
Jitinder Kohli, a former official in the British government and now managing director in Deloitte Consulting LLP's public sector practice, said that in the U.K., agencies are rightly reluctant to take away protections.
Regulators want to protect the environment and workers, and achieve public good, Kohli said on the conference call.
“But they also find that there are ways to achieve those, and often at lower cost to business,” he said.
The way in which regulations evolve can result in complexity and confusion, Kohli said.
“And making it easier and simpler for people to understand, for businesses to understand, can often maintain those protections whilst minimizing costs,” he said.
U.S. agencies will want to bring in regulations when the benefits justify the costs, and overall, they should want the benefits associated with regulation to be as high as possible, and the costs as low as possible, Kohli said.
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Lawmakers Ask EPA, DOE To Find 'Clear Path' To Savings
Feb 10, 2017 | E&E News PM
By Kevin Bogardus
Republican lawmakers are asking federal agencies, including U.S. EPA and the Department of Energy, to find waste within their agencies.
House Energy and Commerce Chairman Greg Walden (R-Ore.) and Rep. Tim Murphy (R-Pa.), who leads the panel's Oversight and Investigations Subcommittee, sent letters today asking agencies if they have any internal studies that identify unnecessary spending.
In their letter to acting EPA Administrator Catherine McCabe, Walden and Murphy said the committee is "examining efforts by federal departments and agencies in its jurisdiction to identify administrative waste and 'a clear path' to achieve significant budget savings in the next five years."
The lawmakers also sent similar letters to the departments of Energy, Commerce, and Health and Human Services.
The letters were sparked by a December Washington Post story. That article reported on an internal Pentagon study that found the Defense Department could save over $125 billion in five years by cutting government waste — without reducing the military and civilian workforce.
Walden and Murphy asked EPA officials and others whether they had any internal studies similar to the Pentagon budget savings report and, if so, to provide them to the committee. If the agencies did not find such a study, the lawmakers asked them to review the Pentagon report and respond to the panel on what lessons they learned from it that could apply to their agencies.
"We look forward to working cooperatively and constructively with you in streamlining administration of programs and achieving significant budget savings," the lawmakers said.
http://www.eenews.net/eenewspm/2017/02/10/stories/1060049906
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(ACC mentioned) No, Chemical Industry, You Can’t Have Your Cake And Eat It Too (Part 2)
Feb 10, 2017 | Environmental Defense Fund
By Richard Denison
We have been watching with growing alarm the rapidly unfolding efforts by leadership in Congress and the Trump Administration to gut health and safety protections that provide millions of Americans with clean air, water and safe products. Support by the American Chemistry Council (ACC) for such efforts, detailed below, gives us profound worry and deep frustration given the trade association’s support of major reforms to the Toxic Substances Control Act last year.
Many of ACC’s member companies worked for many years to move the industry towards strong federal legislation that can restore public and market confidence in the safety of their products. Many of these companies have also been embracing sustainability commitments, and have acknowledged that a strong federal chemicals management system is critical for charting the path to a safer more sustainable future. Those companies with a real commitment to safer chemicals and sustainability should be very alarmed that their trade association has endorsed legislation and the Trump Administration’s deregulatory executive order that would profoundly limit EPA’s and the rest of the Federal government’s ability to protect human health and the environment.
These actions by the executive and legislative branches will or would severely constrain EPA from acting to address chemical risks under the Lautenberg Act as well as other federal laws that protect our air, water, land, workplaces, schools and homes.
Here are the specifics:
· On January 30, President Trump signed an executive order that would require, among other things, all federal agencies to repeal two regulations for every new one they issue and require that any costs (“private expenditures”) of a new regulation are fully offset by cost “savings” from such repealed rules. Benefits, including public benefits, appear to be excluded.
o ACC immediately expressed its support for the executive order, even featuring its support prominently as its “top story” in the next day’s ACC SmartBrief.
· On January 5, the House of Representatives passed the Regulations from the Executive in Need of Scrutiny (REINS) Act. The same bill has been introduced in the Senate. This bill would, among other things, require all new major regulations to be approved by vote in both chambers of Congress. If either chamber did not approve any covered rule within 70 legislative days, the rule could not go into effect or be put forward for another approval vote in that Congress. This effectively gives one chamber of Congress veto power over any new significant public health and safety protection. The bill would subvert the traditional balance of power between the executive and legislative branches of government. House Republicans added amendments requiring costs of any new regulation to be offset through repeal of existing regulations, and mandating that over the next ten years all pre-existing regulations be considered under the REINS Act and require an affirmative vote by both chambers to continue in effect. The REINS Act would apply even to rules mandated by law, which could extend to those in progress under the Lautenberg Act as well as any rules EPA develops using its authority under the new TSCA.
o ACC promptly issued a press release applauding the House for its passage of the REINS Act.
· On January 11, the House passed the Regulatory Accountability Act (RAA). This bill would add more than 80 burdensome and time-consuming hurdles to the rulemaking process, effectively crippling it. Among other things, it would mandate multiple rounds of cost and impact analysis; require that every major rule go through an advanced notice of proposed rulemaking before being proposed; generally require that agencies choose the lowest-cost regulatory option; and require extensive public hearings on rules. To top all this off, the bill would require EPA to finalize a proposed rule within 9 months (18 months for major rules) – a timeframe almost impossible to meet now without all of the additional requirements the Act would impose); if that deadline was not met, the agency would have to start over. (A Senate version of RAA in the last Congress had a slightly less stringent deadline.)
o ACC issued a press release a week before the vote praising the legislation and urging its prompt passage bill by the House. Among many problems with RAA, the requirements that EPA generally choose the “least cost” regulatory option, and allow any party to request a formal public hearing, on many or most regulations are paralyzing mandates that were just removed from TSCA by passage of the Lautenberg Act, but would be re-imposed should RAA pass. So it is ironic that ACC now supports applying these requirements to TSCA as well as many other federal regulations, only months after acknowledging they were detrimental or unnecessary to an efficient regulatory system.
· Members of Congress are expected to reintroduce the Secret Science Reform Act, which was proposed in both the House and the Senate in the last Congress. This bill would require that all underlying data from any study on which EPA relied to support an action would have to be posted online and the results be able to be reproduced. While that sounds nice, the measure would have a crippling effect because, for a host of reasons, all details of studies cannot be made public. For example, large-scale, long-term epidemiological and other studies are not readily reproducible, some industry data are confidential, and certain data underlying some scientifically-important studies cannot be made broadly available in order to protect the privacy of test subjects or intellectual property of researchers. This legislation has been opposed by dozens of scientific associations and universities; see here and here for examples.
o ACC has supported this legislation in the past, and just last month used its SmartBrief to feature a story on its imminent introduction in the House, noting its support.
· Members of Congress are expected to reintroduce the Science Advisory Board Reform Act, which was proposed in both the House and the Senate in the last Congress. This bill would revise the process for selecting members of the EPA’s Science Advisory Board (SAB), which provides scientific advice to the EPA, so as to limit university and other government-funded scientists on the SAB and at the same time make it easier for industry-employed and industry-funded scientists to serve. It would also add burdensome requirements on the SAB, for example requiring it to formally respond to every comment it received, to such an extent that the SAB could be unable to carry out its mandate.
o ACC has endorsed this legislation repeatedly in the past; see for example, here and here.
EDF has long strived to work with both political parties and with the private sector to find common ground and advocate for workable solutions to health and environmental problems that are also economically sustainable. But the current Administration’s and Congress’ efforts to gut health and environmental protections are extreme and present a significant threat to Americans. These efforts will severely undercut our ability to make progress towards a sustainable future. To no small extent, it has been that shared vision of a safer, more sustainable future that has provided common ground upon which we came together to build an improved chemical safety system.
Companies in this industry and those that rely on its products have a choice to make: Stick with their Washington lawyers and trade associations, and further erode the limited trust anyone has in their enterprises, or build on earlier efforts to restore public trust and move toward a more sustainable future. The stakes are high and we are watching.
http://blogs.edf.org/health/2017/02/10/no-chemical-industry-you-cant-have-your-cake-and-eat-it-too-part-2/
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(ACC Mentioned) US EPA Establishes Science Advisory Committee On Chemicals
Feb 13, 2017 | Chemcial Watch
By Kelly Franklin
ACC calls for industry representation
The US EPA has named the 18 members that will make up its new Science Advisory Committee on Chemicals (SACC) under the recently reformed TSCA.
Formation of the committee was required within a year of the Lautenberg Chemical Safety Act's 22 June 2016 passage. By statute, its purpose is to provide "independent advice and expert consultation" with respect to the scientific and technical aspects of implementing the new TSCA.
These duties include reviewing risk assessments, models, tools, guidance documents, chemical category documents and other chemical assessment products, as appropriate.
The 18 panellists comprise nine from academia, three from state or federal government organisations, four from industry and two representing non-governmental organisations. They are:
Academia
· Henry Anderson, MD – University of Wisconsin-Madison
· James Bruckner, PhD – University of Georgia
· Deborah Cory-Slechta, PhD – University of Rochester Medical School
· *William Doucette, PhD – Utah State University
· *Panos Georgopoulos, PhD – Rutgers, the State University
· *Kathleen Gilbert, PhD – University of Arkansas for Medical Sciences
· *John Kissel, PhD – University of Washington (retired)
· Sheela Sathyanarayana, PhD – University of Washington
· *Daniel Schlenk, PhD – University of California, Riverside
State and federal government
· *Holly Davies, PhD – Washington State Department of Ecology
· Melanie Marty, PhD – California Environmental Protection Agency (retired)
· Valentine Schaeffer, PhD – US Occupational Safety and Health Administration
Industry
· Concepcion Jimenez-Gonzalez, PhD – GlaxoSmithKline
· Alan Kaufman – Toy Industry Association (TIA)
· Craig Rowlands, PhD – Underwriters Laboratories
· Christopher Waller, PhD – Merck Research Laboratories
Non-governmental organisation
· *Kenneth Portier, PhD – The American Cancer Society
· Catherine Willett, PhD – The Humane Society of the United States
Those with a star represent members of the EPA Chemical Safety Advisory Committee (CSAC).
The EPA says these members "possess expertise in scientific and technical fields relevant to chemical risk assessment and pollution prevention including human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically-based pharmacokinetics (PBPK) modeling, toxicology, pathology, and chemical exposure to susceptible life stages and subpopulations (including women, children, and others)."
But the American Chemistry Council (ACC) told Chemical Watch that while the selected members "have considerable expertise and represent a diverse set of interests relevant to chemical regulation", it would like the EPA to consider expanding the panel to include chemical industry representation. This, it said, is required under section 26 of TSCA.
As prescribed by the Lautenberg Act, the composition of the SACC is to include "representatives of such science, government, labour, public health, public interest, animal protection, industry, and other groups as the administrator determines to be advisable, including representatives that have specific scientific expertise in the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations."
The SACC is expected to meet three to four times a year.
https://chemicalwatch.com/53512/us-epa-establishes-science-advisory-committee-on-chemicals
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EPA Launches TSCA Risk Evaluation Advisory Committee
Feb 13, 2017 | Inside EPA
EPA has formally launched a new advisory committee of 18 toxicologists, academics, state officials and other experts who will give the agency input on scientific and technical aspects of implementing the revised Toxic Substances Control Act (TSCA), alongside EPA's issuance of its first chemical evaluation report as directed by the toxics law.
The revised TSCA, known as the Frank R. Lautenberg Chemicals Safety Act for the 21st Century and signed into law last June, mandated both the creation of the committee and the publication of the report.
EPA created the Science Advisory Committee on Chemicals (SACC) as directed in Section 17 of the law, which directed EPA to form the panel by this June to provide independent advice and consultation as the agency implements the bipartisan law.
The SACC “supersedes” another relatively new advisory committee, the Chemical Safety Advisory Committee (CSAC), according to EPA's website for the committees.
The Obama EPA created CSAC in 2015 to peer review risk assessments from its TSCA work plan program and to provide advice to EPA's toxics office. The work plan program, Obama EPA officials said, was introduced in 2012 as a way to more strictly enforce TSCA on existing chemicals -- those already on the marketplace when the original TSCA was enacted in 1976 -- and to prepare agency staff should Congress reform the statute.
EPA's new SACC will be chaired by Kenneth Portier, a biostatistician and vice president of the Statistics & Evaluation Center at the American Cancer Society. Portier also served as the chairman of the now superseded CSAC. Portier is not the only panelist to also have been a member of the short-lived CSAC; seven of the 10 members of that panel were named to SACC.
Through the new committee's expanded membership, EPA appears to be targeting some of the unique aspects of the amended TSCA, upon which EPA will likely seek guidance as its works to implement the overhauled statute. For example, the new law requires EPA to consider susceptible sub-populations in its risk evaluations, but does not provide specific definitions or instructions on how EPA should do so.
EPA often considers populations such as children, the elderly, and those with underlying health conditions in its risk assessments, but TSCA also calls on EPA to consider workers' exposures. Among the panelists is Sheela Sathyanarayana, an assistant professor of pediatrics at the University of Washington's medical school and a former chair of the agency's Children's Health Protection Advisory Committee. The panel also includes Valentine Schaeffer, a biochemical toxicologist with the Occupational Safety and Health Administration.
Revisions to TSCA have also directed EPA to make better use of non-animal toxicology and other testing approaches, and the panel's membership includes Catherine Willett, a toxicologist at the Humane Society of the United States who has long led efforts to expand use of non-animal testing methods in the U.S. and abroad.
Three of the panelists are or were state regulators, perhaps responding to concerns leveled at EPA in past years from Republicans and others that EPA's advisory committees do not include enough state experts.
The panel also includes four members representing industry perspectives, viewpoints that industry representatives often argue are overlooked on EPA's advisory panels.
EPA also released Feb. 9 its first annual report on risk evaluations, as directed in Section 26(n)(2) of TSCA. EPA explains that the plan “must identify” chemicals that it will commence and complete evaluation of each year, along with the costs of those tasks. The plan must also describe the status of ongoing evaluations.
Since TSCA was overhauled last June, EPA has identified the first 10 existing chemicals that will begin its new program, selected from the 2014 list of TSCA work plan chemicals, as directed by the statute. EPA indicates that it intends to complete scoping documents of each chemical by June.
The report also points to EPA's ongoing efforts to craft the rules that establish new TSCA's framework, past and upcoming stakeholder meetings, and notes its report to Congress, released last month, regarding the agency's capacity to implement the law and expected costs over the next five years.
https://insideepa.com/daily-feed/epa-launches-tsca-risk-evaluation-advisory-committee
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Tensions Flare Over TSCA Section 6 Proposals For TCE
Feb 13, 2017 | Chemical Watch
By Kelly Franklin
The US EPA has extended the consultation deadlines for proposed rules to ban certain uses of trichlorethylene (TCE) under section 6 of TSCA by 30 days.
The action comes in response to a request from the Halogenated Solvents Industry Alliance (HSIA) on two proposals that would see TCE prohibited as an aerosol degreaser and for spot cleaning in dry cleaning facilities and in vapour degreasing applications. The consultations will now close on 16 March and 19 April, respectively.
The HSIA had written to the agency to make the two comment periods coextensive. It argued both proposals are based on the same risk assessment and "raise many common legal and policy issues". And it asked the agency to extend both deadlines to 20 April.
It said this would allow time for it to submit "significant new scientific information directly relevant to the rulemakings". This would come from a HSIA-sponsored foetal heart development study being undertaken to try to reproduce the cardiovascular effects seen in a study relied upon in the EPA's TCE risk assessment.
"The requested extension will provide time to submit the audited study results which, to date, appear not to support the findings of Johnson et al (2003), along with an interpretation of the results and comparison" to the previous study, it said.
But a coalition of five NGOs submitted comments opposing extending the consultation to 20 April for the purpose of accommodating industry's "untimely and obstructionist 11th hour attempts to yet again challenge the agency's risk findings".
The NGOs – Safer Chemicals, Healthy Families; Earthjustice; Environmental Health Strategy Center; Natural Resources Defense Council; and Toxic-Free Future – said the HSIA's manoeuvres were a last-ditch effort to discredit evidence of TCE's developmental toxicity. This, they said, has "repeatedly been affirmed by agency scientists and external peer reviewers over a lengthy 15-year process."
"We think it would set an unfortunate precedent for EPA to extend comment periods on proposed rules that are needed to protect against unreasonable risks merely because a possibly relevant study is underway that could have been conducted years earlier."
The agency declined to make the consultations concurrent. Instead it issued separate 30-day extensions for each rule.
https://chemicalwatch.com/53513/tensions-flare-over-tsca-section-6-proposals-for-tce
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Practitioners Insights: Systematic Review in Toxicology—When Is It Worth It?
Feb 13, 2017 | BNA Daily Environment Report
By Dr. Daniele Wikoff
Dr. Daniele Wikoff is the Health Sciences Practice Leader for ToxStrategies based in Asheville, North Carolina. She specializes in evaluating human health risks associated with exposures to a wide variety of consumer products, food ingredients and additives, pharmaceuticals and industrial chemicals. Dr. Wikoff has been involved with the application of systematic review, leading multiple projects for the firm involving both protocol development and implementation of evidence-based toxicology assessments using a variety of frameworks. This article does not represent the opinions of Bloomberg BNA, which welcomes other points of view.
Why Systematic Review? By definition, systematic review is a method for answering specific research questions—it uses a predefined, multistep process to identify, select, critically assess and synthesize evidence from scientific studies to reach a conclusion. It seems like common sense, yet many skeptics question the utility of systematic review: Isn't it what we have always been doing? How does it really apply to toxicology and risk assessment? Why does it take so long? When is it worth it?
The objective of this article is to provide insight as to how the use of systematic review (SR) is advancing the field of toxicology, providing objectivity and transparency in the practice of toxicology and risk assessment (i.e., isn't it what we have always been doing?). Its increasing utility as a tool in evidence-based assessments has been endorsed by scientists globally, thereby highlighting the need to establish best practices via the development of methods, frameworks and the conduct of SRs (i.e., how does it apply to toxicology and risk assessment?).
This article also aims to describe some of the remaining challenges with integrating systematic review into standard practice. As experience is gained, such methods will be refined to better fit objectives—whether it be used as a tool for hazard assessment or qualitative and quantitative risk assessments—i.e., when and how it will be applied (and when it may not be appropriate to do so). Development and refinement of software to facilitate the conduct of SRs will aid in efficiency (i.e., why does it take so long?). Nevertheless, these advancements will not negate the need to make expert judgments about the objectives and goals of each assessment, nor will the conduct of SR negate the role of scientific judgment in developing conclusions (i.e., is it worth it?).
Very Brief Introduction to SR
Systematic review is not a new concept; it has been used in the field of clinical medicine for decades. Most systematic review frameworks have common components, including:
• problem formulation and protocol development;
• identification and evaluation of individual studies;
• assessment and integration of the body of evidence (qualitatively or quantitatively); and
• reporting of the SR.
Seemingly, this is a common-sense process. Relative to more traditional narrative reviews currently conducted in the field, however, SRs are differentiated by the a priori process for identifying and evaluating information that is established in the protocol. Higher levels of transparency are achieved via both conducting and reporting the review following the a priori process. Additionally, as established both in SR guidance, and in practice, systematic reviews should be conducted by a multidisciplinary team that includes subject-matter experts, as well as experts in systematic review; librarians; and potentially others, such as epidemiologists, physicians, industrial hygienists, as appropriate to the review. Conflict of interest (COI) statements also are a crucial component of initiating a review, though implementing standard processes for obtaining and managing COI information does not yet appear to be consistently practiced in the field toxicology.Systematic reviews also are differentiated by the overall level of documentation associated with their conduct. Critical elements of documentation include exact reporting of search strategies (including search syntax, databases, etc.) and documentation of study selection, as well as exclusion. Further contributing to the robust level of documentation, two analysts typically screen and critically appraise the literature.
Critical appraisal of each study involves objectively and thoroughly evaluating the quality and relevance of individual studies, often via assessment of risk of bias (RoB). Such assessment is aimed at characterizing each study's internal validity—or how well the study design, conduct and reporting were relative to study hypothesis or objective. Examples of methodological risks of bias include failure to account for confounding variables or failure to adequately randomize exposures. Separately, the external validity, or generalizability, is assessed. The body of evidence also is evaluated, overall, for quality or confidence using parameters such as precision (or imprecision), directness (or indirectness), consistency (or inconsistency), magnitude, dose-response and publication bias. And, in the practice of toxicological systematic reviews, these efforts are done by evidence stream—that is, applied to human, animal and mechanistic datasets separately, as well as overall.
Why Can't We Apply What Other Fields Use?
In clinical medicine, systematic review is a tool that has been used for decades to evaluate an intervention (e.g., a drug treatment or exercise routine) relative to a comparator (e.g., no drug treatment or exercise routine) in a specific population (e.g., adult patients with high blood pressure) relative to a particular outcome (e.g., prevention of heart disease). Specifically, each SR is formed around the PICO statement—population, intervention, comparator and outcome (Table 1).
A common “rule” of a PICO question or statement is to make it as narrow as possible and answerable. So, for example, in a population of adult patients with heart disease, one could specifically clarify that this population also be of a specific race, sex and not be on certain medications. And for an outcome, only measurable parameters would be included, such as blood pressure, time on drug therapy, number of myocardial infarctions, etc. Selected examples from published protocols include:
“To evaluated the value of troponin, brain natriuretic peptide (BNP), and the N-terminal of BNP (NT-proBNP), measured during or directly after treatment with chemotherapy, radiotherapy, or both in women with breast cancer, for predicting the occurrence of cardiac dysfunction.” —Boerman (2014)
“The overarching objective of this review is to examine the short, mid and long term effects of resistance exercise on cardiovascular health outcomes. The effect of resistance exercise on blood borne biomarkers of cardiometabolic health. The effect of resistance exercise on physiological markers of cardiovascular health. The long term effects of resistance exercise on cardiovascular mortality.” —Ashton (2016)
“To determine the diagnostic accuracy of FibroTest, transient elastography method, combined FibroTest and transient elastography method, no matter the sequence, using liver biopsy as reference standard, for assessment of severe hepatic fibrosis and cirrhosis in adults with chronic hepatitis C without any co-infections such as hepatitis B, HIV, and alcoholic liver disease.” —Pavlov et al. (2016)
Generating PICO statements in an SR in clinical medicine, however, seems to be more straightforward than a similar exercise for toxicological applications—much more flexibility is needed. First, it is more accurate to view toxicological research as a whole as an evaluation of exposures compared to interventions. The majority of the practice (though not always, as many substances may also have health benefits) involves unintentional or environmental exposures to chemicals. As a result, the type of data available for assessment is different than that in clinical medicine. Rarely will there be comprehensive information in humans, and when such information is available, it is most often from observational studies (e.g., cohort, case-control, cross-sectional). And, typically, information on adverse events such as lethality in humans will be available, if at all, only from case reports or case series.
As such, assessment of exposure, relative to outcomes, in humans is often more complex, or at a minimum, different,relative to that obtained from randomized control trials available in the field of medicine. The majority of toxicological data, however, typically involve assessment of exposure in animals. The data types available for assessment in themselves present unique challenges. For example, many available frameworks for evaluating evidence (e.g., GRADE, n.d.), rank controlled trials higher (i.e., stronger evidence) than observational studies for a variety of reasons notwithstanding controlled exposure.
In contrast to much of the toxicological evidence in the human evidence stream, assessment of exposure in animal studies is more straightforward, though not without its own complexities, thus often leading toxicologists to a preference for this data type, despite availability of data characterizing potential hazards in humans—a topic that exemplifies the need for a priori approaches for both the critical assessment of individual studies, as well as approaches for integrating the data across evidence streams. Also, related to exposure, assessment of mixtures presents somewhat unique challenges; the definition of the substance (which can be a mixture) and the definition of exposure to a given substance can clearly have a significant approach on a SR.
The second key reason more flexibility is required with SRs in the field of toxicology is the outcome under evaluation is highly dependent on the application of the systematic review. Many may range broadly from defining hazard from many endpoints to narrowly characterizing risk. This is of particular importance when considering the integration of SR as a tool into chemical risk assessment and the practice of evidence-based toxicology. In risk assessment, four primary components are evaluated: hazard, dose-response, exposure and risk-characterization. Systematic review can be used as a tool to facilitate the entire process, or it can be used to facilitate a part of it. This application is likely to dependent on the purpose of the review, the entity conducting the assessment and the resources available to do it. Few efforts to specifically characterize how SR can be integrated into risk assessment have been made. As part of the National Research Council review of the Environmental Protection Agency's (EPA's) Integrated Risk Information System (IRIS), however, it was suggested that systematic review be used as a platform to identify evidence and evaluate studies, the results of which would support the remaining components of the risk process.
Systematic reviews also can be used to integrate the evidence relative to the objective, to select candidate datasets based on the hazard assessment, and to characterize data and approaches for conducing dose-response analysis. Assessment of exposure also can be evaluated systematically; however, its utility is dependent on SR objectives. Thus, unlike the use of systematic reviews in clinical medicine to evaluate interventions, SRs are used in toxicology to assess a broader range of outcomes and applications.
Accordingly, the approach taken, as well as the depth of the assessment, is directly influenced by the volume of data available to assess the outcome(s), as well as resource and time requirements. The key to having flexibility in an SR is that the objectives, both primary and secondary, be clearly stated, and an a priori approach for evaluating the objectives be determined. The need and implementation of flexibility within the application of SR to toxicology can be observed in the following examples of PECO statements from toxicological SRs:
“Develop hazard identification conclusions (‘known,’ ‘presumed,’ ‘suspected,’ or ‘not classifiable’) that exposure to PFOA or PFOS is associated with changes in immune-related measures in humans based on integrating the evidence from human and animal data and considering the evidence for biological plausibility provided by other relevant data (e.g., in vitro or mechanistic studies).” —OHAT, 2013
“Is there an association between fetal growth and maternal glomerular filtration rate (GFR) in humans” —Vesterinen et al (n.d.)
“For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on bone and calcium balance outcomes? Where populations: healthy adults, healthy pregnant women, healthy adolescents (aged 12-19), healthy children (aged 3-12), exposure = 400 mg/day, 300 mg/day, 2.5 mg/kg-bw day, respectively (by population), and comparator = < 400 mg/day, 300 mg/day, 2.5 mg/kg-bw day, respectively (by population).” —Wikoff et al (2015)
Deriving the PECO and the associated rationale can, and often is, more difficult than it appears on the surface. It is made easier via the conduct of rigorous problem formulation efforts. Often undervalued, this component aids in establishing baseline information needed to develop and define the primary and secondary objectives that will support a purposeful review for stakeholders and sponsors. This stage aids in narrowing, where possible, each of the components of the PECO—in the context of risk assessment, narrowing receptors, exposure scenarios and effect types. Well-formulated questions are described as critical, as they have a significant impact on other components of the review—including the literature search strategy, data extraction, synthesis and presentation of findings. In practice, formulation of the topic via PECO questions or statements is an iterative practice, which is best informed by a multidisciplinary team and considerations for the downstream implementation of the entire SR.
Path to Establishing Best Practices
Unlike the field of clinical medicine, which has established, large entities such as Cochrane's—a global independent network of more than 37,000 contributors, or the Agency for Healthcare Research and Quality—the field of toxicology is in the beginning stages of developing methods, guidance and leaders. Closest to such entities is SYRCLE (Systematic Review Centre for Laboratory Animal Experimentation); established in 2012, this organization focuses on the execution of SRs involving animal studies as a means of supporting evidence-based translational medicine. Also in 2012, the National Toxicology Program's Office of Health Assessment and Translation (OHAT) began developing an approach for the implementation of SR methodology to carry out literature-based evaluations to reach conclusions about potential health hazards. In 2014, the group published an approach, followed by the issuance of a handbook and RoB tool in early 2015.
Other independent organizational efforts have made significant efforts to provide direction and examples of the integration of SR into toxicology, highlighted perhaps by those from, the Navigation Guide (http://prhe.ucsf.edu/navigation-guide-selected-milestones), a University of California, San Francisco Program on Reproductive Health and the Environment, as well as the Evidence Based Toxicology Collaboration, based out of the Johns Hopkins School of Public Health. Efforts from a group based out of Lancaster University Environment Centre, including a series of workshops aimed at developing methods and standards for reporting, are helping to move the field forward. Most notably, the lead researcher has developed a tool for evaluating SRs in peer-reviewed journals: Critical Appraisal of Evidence Syntheses in Toxicology (CREST)—a clear need in establishing best practices for the conduct and reporting of SRs.
In the U.S. regulatory arena, efforts are highlighted by a 2011 report by the National Research Council (NRC) recommended that the EPA use a consistent, transparent and systematic approach for the identification, evaluation and integration of data for assessing hazards to human health; these recommendations were further delineated in 2014. As a result, the IRIS program is currently developing and implementing a systematic review process. Related to these efforts, the EPA's IRIS program held a series of workshops on advancing systematic review:
• an August 2013 workshop that focused on methodology and recent developments outside the arena of evidence-based medicine;
• an October 2014 workshop that reviewed recommendations from the NRC related to evaluation of risk of bias, integration of evidence streams and combining quantitative results; and
• a third workshop in December 2015 that examined developments and applications of methods for the identification and evaluation of different types of evidence for use in chemical assessments.
The U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN), which has been advocating the use of evidence-based review methods, held a colloquium in June 2015 with the Society of Toxicology regarding systematic review. Topics were based on integrating SR in human health assessments and included problem formulation and scoping; identification and selection of evidence-based, harmonizing dose-response; and use of mechanistic data. State and other health organizations in the U.S. also are integrating SR; in November 2014, the Texas Commission on Environmental Quality (TCEQ) issued a position paper on Recommendations for Systematic Review and Evidence Integration.SR methods also are being increasingly discussed in toxicological forums. For example, in November 2014, the EBTC hosted a workshop, The Emergence of Systematic Review and Related Evidence-Based Approaches in Toxicology. Topics addressed during the workshop were discussed in a subsequent publication and included: SR methodology as applied to toxicology, agency frameworks and other efforts, antecedents, challenges, and way forward. The experts in this workshop concluded with a recommendation that experts work together to ensure that a harmonized process for how the basic elements of SR methods are applied in toxicology.
Another example, in the 2016 winter session of the Toxicology Forum in Washington, D.C., a session was presented, The Role of Systematic Review in Toxicology—The Rigor, Resources and Tools Required: Implementation Considerations for the Toxicology Community. The goal was to demonstrate the application of SR to the characterization of hazard and risk using a series of case studies, each of which highlighted specific components of the SR process, including development and publication of protocols, individual study assessment, evidence integration, and quantitative assessment of data.
Some Hurdles Still Ahead
Though a number of efforts are underway to aid in developing best practices, there are still some major hurdles before SR is integrated as a common tool in the practice of toxicology. Most broadly, is the acceptance and understanding of what a systematic review is—that the term carries weight and means more than simply doing a literature search systematically. As such, clear differentiation of systematic elements of an effort relative to systematic review are required. The development of guidance and requirements of SR, such as those included in the CREST toolkit discussed previously, will greatly aid in avoiding misuse or overuse of the term. Along with an increased understanding in the meaning of SR, an appreciation for the rigor, resources and time involved also will be gained—and approaches for determining when an SR is appropriate, and when it is not, better developed.
There is clearly a need to balance rigor with efficiency, recognizing that not all SRs will achieve a similar level of detail or comprehensiveness. Key to achieving the balance is selecting tasks with the most value added, and, most importantly, providing transparency to the decisions via a priori documentation and rationale.
With respect to the amount of time, some of the exercises that differentiate the systematic review from a standard narrative review include: development and publication of a protocol, documentation of the literature search (including documentation of all records that were included/excluded), and a critical evaluation of each study using an approach determined a priori. Estimates of time needed to complete problem formulation are highly variable, but are not measured in minutes or hours. Often, resources are dependent on factors such as the number of collaborators, experience of team with SR processes, number of databases (and associated software compliance), establishment of internal processes and procedures, documentation, grading approaches, number of endpoints and outcomes, as well as overall complexity of the topic under investigation. The development of new tools, as well as refinement of existing tools, will greatly enhance the ability to more efficiently conduct SRs. Techniques such as text mining will significantly contribute to these efforts.
With respect to the conduct of a toxicological SR, the evaluation and integration of mechanistic data remain areas of uncertainty. As an evidence stream that is generally unique to evidence-based toxicology fewer frameworks and examples are available. There is also not yet a consensus that mechanistic data should be considered a separate stream—but rather, if such data should or could be considered contextual. An approach for identifying and organizing data associated with cancer outcomes has been proposed, in which the authors provided 10 key characteristics of carcinogens as a basis for organizing data on the mechanisms of carcinogens. This approach is being utilized by IARC, though not as part of a systematic review, as well as within EPA's IRIS program.
Guidance on how these characteristics can be applied beyond organization of data are not yet available, however. For example, some experts do not provide guidance on how to integrate null findings, how quality/validity and relevance are considered, or how the number of characteristics with positive/negative influences the body of evidence. And, importantly, there is not yet a clear vision on how these characteristics can be applied relative to current practices in the assessment of mode of action for carcinogens, or how they could be used to evaluate high throughput data.
So Is It Worth Doing a Systematic Review?
It's worth it. Sometimes. As with any tool, the utility is dependent on the application and purpose—and using the tool correctly. The field of toxicology is repurposing a tool that has been used for decades in the field of medicine. Based on papers indexed by PubMed alone, more than 50 systematic reviews in the field of clinical medicine are published daily. Compare that with fewer than 50 complete systematic reviews with a toxicological focus that have ever been published. Recognizing that systematic review in the context of toxicology is different relative to medicine is critical—while many of the processes and theories apply, they must be adapted to the unique aspects of toxicology. Also critical is the recognition that systematic review is not what we have been doing—the practice of SR bears weight in its enhancement of transparency, objectivity and robustness—but does not omit the need for scientific judgment. Determining when and how SR is used in toxicology and risk assessment is one of the many challenges that lie ahead in the development of best practices.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=105357608&vname=dennotallissues&fn=105357608&jd=105357608
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Gore To Drop Waterproofing PFCs
Feb 13, 2017 | Chemical & Engineering News
By Melody M. Bomgardner
Pressure from Greenpeace bears fruit as the outdoor apparel industry seeks replacement chemicals
Bowing to pressure from activist groups, Gore Fabrics says it is working to eliminate perfluorinated chemicals (PFCs) of environmental concern from its products. Gore supplies water-resistant fabrics to many leading outdoor apparel makers, including Patagonia and The North Face.
High-performance outerwear is commonly coated with a PFC-based barrier to improve water resistance. But those coatings can wear off and escape into the environment.
Greenpeace and other environmental groups have targeted PFCs, a large family of chemicals, because they persist in the environment and have been found in arctic polar bears’ livers and human blood. Some PFCs have been shown to have negative health effects.
Although it is not clear what proportion of PFCs found in the environment come from water-resistant clothing, Greenpeace has been campaigning since 2012 to get outdoor apparel makers to stop using the coatings and switch to alternatives.
For Gore, eliminating all fluorinated chemicals is not on the short-term to-do list because its core water-resistant membrane technology is based on a form of polytetrafluoroethylene (PTFE). PTFE is also the main polymer used in Teflon nonstick coatings. Gore worked with Greenpeace to conclude that PTFE is not of environmental concern because it’s a large, stable molecule and is not bioavailable.
In return, Gore says it will ensure no PFCs of environmental concern are released in the manufacturing, use, and disposal of its products. PFC molecules of environmental concern, according to Gore and Greenpeace, are those that are highly fluorinated, persistent, and small enough to be bioavailable.
One PFC of concern is likely to be perfluorooctanoic acid (PFOA), which was historically used by DuPont to make PTFE. Past releases of PFOA by DuPont polluted drinking water in Ohio and West Virginia and are now the subject of more than 3,500 lawsuits.
Gore intends to eliminate the PFCs of concern from 85% of its products and manufacturing processes by the end of 2020. It will tackle the rest by 2023. Gore says it is working with its suppliers to find fluorinated and nonfluorinated replacements.
That effort also extends to the company’s core PTFE membrane. However, Bernhard Kiehl, Gore’s sustainability leader, points out that “the unique performance and durability of PTFE will make it the preferred choice for many, especially high-demanding, end uses.”
Although firms such as Gore, Patagonia, and The North Face have been exploring and investing in new materials for durable water protection, finding high-performance alternatives to PFCs is a long-term project, according to Joel A. Tickner, director of the Department of Community Health & Sustainability at the University of Massachusetts, Lowell.
“There have been serious efforts, but they’ve been in a holding pattern,” Tickner observes. “So far, nothing works as well as perfluorinated chemicals.”
https://cen.acs.org/articles/95/i7/Gore-drop-waterproofing-PFCs.html
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Critics Round On 'Narrow Scope' Of UK's Proposed Microbeads Ban
Feb 13, 2017 | Chemical Watch
By Tammy Lovell
Makeup, sunscreen and cleaning products should be included, say NGOs
A coalition of NGOs has called for the UK to extend its proposed ban on microbeads in cosmetics.
The UK's environment ministry, and the devolved administrations for Scotland, Wales and Northern Ireland, propose to ban microbeads in 'rinse-off' cosmetics and personal care products. This includes, but is not limited to, exfoliating scrubs, shower gels and toothpastes.
A consultation, launched in December, is also seeking views on the environmental impact of products such as makeup, sunscreens and cleaning products. It says there is currently not enough evidence that microplastic particles from these products are washed down the drain and end up in the marine environment.
But a poll by the Microbeads Coalition found that 42% of people wash makeup down the drain, and 60% do the same with other skin products, such as sun cream.
The coalition claims the results show that if the government excludes these items from a ban, they will continue to enter the ocean.
The coalition, which comprises the Environmental Investigation Agency, Fauna & Flora International, Greenpeace UK and the Marine Conservation Society, is calling on the government to "seize the opportunity to create a world-leading ban".
It says countries around the world, including India, New Zealand and South Korea, are looking to the UK to provide leadership. "By implementing a robust and comprehensive ban of microplastics in all products which can reach drainage, this government can have a truly global impact," it says.
The coalition has compared the UK's proposals to the Microbeads Free-Waters Act. This was passed by the US Senate in December 2015 and requires the phase-out of cosmetic products containing plastic microbeads to begin in July 2017.
"We've already seen the problematic loopholes in the US legislation, which limited the ban to 'rinse-off' products that perform an exfoliating function, and ended up allowing other types of products containing microplastics to keep pouring into our oceans," the coalition says.
The UK cosmetics trade body Cosmetics, Toiletry and Perfumery Association (CTPA) also recently called on the government not to focus its efforts to prevent microplastics polluting the ocean solely on the personal care industry.
The consultation on microbeads ends on 28 February.
https://chemicalwatch.com/53510/critics-round-on-narrow-scope-of-uks-proposed-microbeads-ban
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State Utility Regulators Eye Next Steps To Cut Carbon Emissions
Feb 13, 2017 | E&E Daily
By Rod Kuckro
U.S. EPA's role in regulating carbon emissions will be on the agenda when state utility regulators meet this week in Washington, although it won't be as prominent an issue as in recent years.
On Tuesday, the National Association of Regulatory Utility Commissioners (NARUC) will feature a panel discussion that will look at options the Trump administration would have for evolving the carbon regulations for existing power plants that are pending before the courts.
It will be moderated by Edward Finley of the North Carolina Utilities Commission and Nancy Lange of the Minnesota Public Utilities Commission.
Panelists are Paul Cicio, president of the Industrial Energy Consumers of America; David Doniger, director of the Climate and Clean Air Program at the Natural Resources Defense Council; and Roger Martella, partner with the law firm Sidley Austin.
On Monday, NARUC's Subcommittee on Clean Coal and Carbon Management will hold a session to look at how the Trump administration has upended many of the Obama administration's energy policy priorities.
The moderator will be Jeremy Oden of the Alabama Public Service Commission.
Joseph Giove, director of coal business operations at the Department of Energy, will provide an update on where coal stands and which programs and technologies may receive a higher or lower level of interest during the next four years.
Carey King and Josh Rhodes, both from the Energy Institute at the University of Texas, Austin, will talk about their white paper "New U.S. Power Costs: By County, with Environmental Externalities."
In the paper, they calculate the levelized cost of electricity of new power plants fueled by coal (bituminous and subbituminous, with partial and full carbon capture and sequestration) and other generation sources for each U.S. county under a number of economic scenarios.Other Clean Power Plan notes
Last week, Fitch Ratings analyst Gregory Remec issued a note about why the "likely demise of the CPP does not mean that we are returning to the days when coal-fired generation was the norm."
He said "substantial growth in power generation from natural gas" will displace "much of what's left of coal generation" as a function of simple economics.
"The appetite for renewables is still very strong and there remains a push toward cleaner generation overall even with no statutory mandate," Remec said.
On Capitol Hill, Sen. Shelley Moore Capito (R-W.Va.) will continue serving as chairwoman of the Senate Environment and Public Works Subcommittee on Clean Air and Nuclear Safety during the 115th Congress. The subcommittee oversees EPA regulations established under the Clean Air Act, including rules to curb carbon emissions from coal-fired power plants.
In the last Congress, Capito used the subcommittee to conduct field hearings in her home state about the impact of EPA carbon regulations and what she called "misguided regulations."
In this Congress, Capito may find herself having to conduct oversight on whatever EPA poses as an alternative rule to the Clean Power Plan or even weigh legislative changes to the Clean Air Act to explicitly remove EPA's role in regulating CO2.In case you missed it
· A prominent attorney who represents electric cooperatives against the Clean Power Plan suggested the process of undoing it might not be so cumbersome (Energywire, Feb. 10).
· Former EPA Administrator Gina McCarthy met with Democratic leaders in California and called on states to push forward on climate policy (Climatewire, Feb. 9).
· The number of ideas for replacing the Clean Power Plan is beginning to grow as a group of distinguished Republicans proposed taxing carbon dioxide (Climatewire, Feb. 9).
· Oklahoma Attorney General Scott Pruitt (R), nominated to lead EPA, has laid out some specific thoughts on how he would have written federal carbon regulations for coal plants (Climatewire, Feb. 7).
http://www.eenews.net/interactive/clean_power_plan/column_posts/1060049921
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House To Focus On Building Out Grid, Pipelines
Feb 13, 2017 | E&E Daily
By Hannah Northey
House members keen on seeing new energy projects move forward under the Trump administration will hold a hearing this week.
The House Energy and Commerce Subcommittee on Energy will meet Wednesday to focus on modernizing the nation's energy and electricity delivery system, as well as challenges and opportunities for promoting infrastructure.
Republican Rep. Fred Upton of Michigan, the panel's chairman, said in a statement that infrastructure needs are lagging booming energy production and that new technologies are changing the way energy is consumed.
"While our energy renaissance has provided us the benefits of affordable, reliable energy and jobs, we can do better," Upton said in a statement. "It's time we took a look at barriers to modernizing existing laws so we can improve and expand our infrastructure to maximize the economic potential of our natural resources."
The hearing arrives as states across the country are putting forth lists of energy projects, including pipelines and transmission lines, they hope to advance in coming months and years under the Trump administration.
The top Democrat on Energy and Commerce, Rep. Frank Pallone of New Jersey, said last week that Trump's interest in pushing a major infrastructure bill through Congress could generate bipartisan cooperation and be positive for energy reform legislation (E&E Daily, Feb. 9).
Schedule: The hearing is Wednesday, Feb. 15, at 10 a.m. in 2123 Rayburn.
http://www.eenews.net/eedaily/2017/02/13/stories/1060049928
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PA. Justices Urged To Nix Fracking Rule Injunction
Feb 10, 2017 | Law 360
By Dorothy Atkins
Law360, San Francisco (February 10, 2017, 2:52 PM EST) -- Pennsylvania’s environmental regulators urged the state Supreme Court on Wednesday to overturn an injunction blocking new regulations governing surface areas near gas drilling and hydraulic fracturing, saying the lower court erred when it granted the “extraordinary remedy” of a preliminary injunction.
The state's Department of Environmental Protection and the Environmental Quality Board argued that the lower court improperly granted Marcellus Shale Coalition’s injunction bid, even though the MSC never proved that it is likely to succeed on its merits in challenges to the regulations. The MSC also failed to support its assertions that the new regulations will harm its members and even failed to address how the requested relief would impact the public interest, they said. The regulators added that the injunction is now causing confusion around rules that took the agencies five years to develop.
“This broadened injunction creates confusion in implementing the regulations and harms DEP's ability to effectively protect the environment,” the regulators said.
At issue are a set of new oil and gas rules that were published in October after the public submitted more than 28,000 comments and more than 429 individuals testified during 12 public hearings on the issue. The regulations are the first set of regulations to specifically manage the surface activities associated with the development of "unconventional" natural gas wells, according to court documents.
But MSC launched a suit against the DEP in October claiming that portions of the so-called Chapter 78(a) rules went beyond the scope of the DEP’s regulatory authority or were too vague to justify the purported immense costs they would impose on drillers.
In November, Commonwealth Court Judge P. Kevin Brobson sided with MSC and blocked four out of seven provisions of the rules, citing concerns over costs that might apply to operators.
One blocked provision requires drillers to provide notice when a proposed well could impact publicly accessible areas like playgrounds and schools. Another blocked provision would require drillers to identify and monitor abandoned wells on land surrounding the areas where they plan to drill new wells, even if the operators don’t own those properties.
Additionally, Judge Brobson blocked a provision requiring upgrades to freshwater impoundments that may have been constructed years ago under a different set of standards. He also paused a provision regarding standards for remediating drill sites, which the MSC claimed went improperly above and beyond standards required under the state’s Clean Streams Law.
But on Wednesday, the regulators urged the state high court to reverse the injunction, arguing that Judge Brobson misapplied the essential prerequisites of a preliminary injunction.
MSC had a “heavy burden” of demonstrating that it satisfied those prerequisites, but if failed to do so and relied exclusively on the DEP’s rule-making documents to support its assertions, the regulators said. The ruling also failed to give deference to the government agencies and how they interpreted the 2012 Oil and Gas Act and failed to apply "bedrock principles of statutory construction" that demonstrate no substantial legal questions exist under a plain reading of the statute, they argued.
In December, MSC President David Spigelmyer said the lawsuit was necessary to assert the legal rights of its members directly impacted by the regulations.
Spigelmyer said in a statement that the provisions at issue conflict with DEP’s legal authority granted by the Pennsylvania General Assembly while other provisions are “vague and not clear” about how they will be implemented.
“These shortcomings are immediately harmful to our industry because they affect our ability to conduct business and remain competitive,” he said.
Representatives for the MSC and the regulators did not immediately respond to requests for comment Friday.
The state environmental regulators are represented by Denise Smyler, Nels Taber, Elizabeth A. Davis, Joseph M. Iole and Alexandra Chiaruttini of the Department of Environmental Protection.
The MSC is represented by Jean Mosites and Kevin Garber of Babst Calland Clements & Zomnir PC.
The case is Marcellus Shale Coalition v. Department of Environmental Protection, case number 115 MAP 2016, in the Supreme Court of Pennsylvania, Middle District.
--Additional reporting by Matt Fair. Editing by Kelly Duncan.https://www.law360.com/energy/articles/890818/pa-justices-urged-to-nix-fracking-rule-injunction
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(ACC Mentioned) Chemical ISAC Announces Partnership With Defense Group To Expand Membership
Feb 13, 2017 | Inside Cybersecurity
The American Chemistry Council's Chemical Information Technology Center announced that is working with the Defense Security Information Exchange to increase participation in the Chemical Sector Information Sharing and Analysis Center, or Chem-ISAC, which allows chemical companies to share cyber-threat intelligence with each other and the government.
“Protecting the technology that helps run facilities, as well as the valuable information regarding chemical formulas and customer databases, from a potential cyberattack are mission critical for our industry,”said Ravi Waran, the executive board...
Access to full text unavailable – subscription required. For full story:
https://insidecybersecurity.com/daily-briefs/chemical-isac-announces-partnership-defense-group-expand-membership
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4 Critical Defects Found In Latest Oil Train Inspections
Feb 12, 2017 | AP (In News 10)
ALBANY, N.Y. (AP) – State and federal inspectors found four critical defects and 42 non-critical ones in the latest round of oil train and track inspections across New York state.
Gov. Andrew Cuomo says the targeted inspections of tank cars and tracks are critical to maintaining public safety.
Inspection teams examined 104 crude oil tank cars, 184 miles of track and 89 switches.
The inspections focused on track, track hardware and tank car mechanical safety equipment.
Critical defects involve important maintenance issues that must be addressed immediately, but do not necessarily indicate safety lapses. Non-critical rail defects must be repaired within 30 days.
Since the Democratic governor initiated the inspection campaign in February 2014, the Department of Transportation and federal partners have inspected 11,231 crude oil tank cars and 5,508 miles of track.
http://news10.com/2017/02/12/4-critical-defects-found-in-latest-oil-train-inspections/
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Lawmakers To Mull Self-Driving Cars, Rail Safety
Feb 13, 2017 | E&E Daily
Lawmakers at a pair of hearings this week will consider the challenges of getting people and goods around using both old and new technologies — including self-driving cars.
The Senate and House transportation subcommittees are both set to hold their first hearings of the Congress to discuss rail and autonomous vehicles, with a focus on safety, efficiency and the government's role.
The House Energy and Commerce Subcommittee on Digital Commerce and Consumer Protection, led by Rep. Bob Latta (R-Ohio), invited automaker executives and mobility experts to detail their vision of the federal government's role in deploying self-driving vehicles.
With increasingly more automakers testing their autonomous vehicles on the road and committing to wider rollouts, the lawmakers want to hear how the tests are going. Of particular interest, according to a hearing memo, will be infrastructure needs to facilitate the deployment of the technology, and privacy and security concerns.
The Transportation Department has sought to encourage the technology in the past while ensuring its safety. The National Highway Traffic Safety Administration released guidance for state regulators and automakers last year, including a request for testing data.
Senators on a Commerce, Science and Transportation subcommittee, meanwhile, will ask rail and freight executives how to increase "the efficiency and safety of our nation's multimodal transportation system." The Subcommittee on Surface Transportation and Merchant Marine Infrastructure, Safety, and Security, chaired by Sen. Deb Fischer (R-Neb.), will hold the hearing on "Moving America."
Schedule: The House Energy and Commerce Subcommittee on Digital Commerce and Consumer Protection hearing is Tuesday, Feb. 14, at 10:15 a.m. in Rayburn 2123.
Witnesses: Mike Ableson, vice president of global strategy, General Motors; Nidhi Kalra, co-director and senior information scientist, Rand Center for Decision Making Under Uncertainty; Anders Kärrberg, vice president of government affairs, Volvo Car Group; Joseph Okpaku, vice president of public policy, Lyft; and Gill Pratt, executive technical adviser and CEO, Toyota Research Institute.
Schedule: The Senate Commerce, Science and Transportation Subcommittee on Surface Transportation and Merchant Marine Infrastructure, Safety, and Security hearing is Wednesday, Feb. 15, at 2:30 p.m. in Russell 253.
Witnesses: Matthew K. Rose, executive chairman, BNSF Railway Co.; Christopher B. Lofgren, CEO, Schneider National Inc.; Tom Gurd, vice president of integrated supply chain, Dow Chemical Co.; and Wick Moorman, president and CEO, Amtrak.
http://www.eenews.net/eedaily/2017/02/13/stories/1060049933
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Panel To Discuss Changes to Clean Air Act, Brownfields Law
Feb 13, 2017 | E&E Daily
By Sean Reilly
In an organizational reshuffling announced last month, the House Energy and Commerce Subcommittee on Environment picked up jurisdiction over one of the nation's landmark laws: the Clean Air Act.
The panel is now taking advantage of that added authority, with a Thursday hearing that will look at updating major environmental statutes, with an eye toward pruning any perceived barriers to economic growth.
The hearing "will provide our members an opportunity to consider practical reforms to promote the expansion of domestic infrastructure and manufacturing," Chairman John Shimkus (R-Ill.) said in a news release.
A partial list of confirmed witnesses includes executives of two national business trade groups; a representative from the Pennsylvania Chamber of Business and Industry; and the mayor of a Massachusetts town that has decked out a onetime Superfund site with solar panels.
The hearing will likely focus on the Clean Air Act and the brownfields provisions of the Comprehensive Environmental Response, Compensation and Liability Act, usually dubbed the Superfund law.
Both statutes are now decades old, a point that witnesses are sure to underscore. "When agencies try to adapt laws written in the 1960s and 1970s to modern-day problems, they risk imposing requirements that are not legally justifiable," according to a summary of the points that the National Association of Manufacturers' Ross Eisenberg plans to make.
Among Eisenberg's recommendations: Stop using "the social cost of carbon" in cost-benefit calculations until its validity is confirmed by an impartial third-party review and allow EPA to consider cost and technological feasibility when revisiting ambient air quality standards for ozone and other major pollutants.
Thomas Sullivan, a vice president at the U.S. Chamber of Commerce, will discuss the benefits of involving small businesses early in the regulatory process, according to a spokeswoman.
Kevin Sunday of the Pennsylvania Chamber of Business and Industry plans to touch on an array of issues, such as implementation of the 2008 and 2015 ozone standards and the effect of the National Environmental Policy Act on pipeline and transmission system development.
"It's becoming a challenge to be able to build something new in this country or expand something that's already there," Sunday said in an interview last week.
Jon Mitchell, mayor of New Bedford, Mass., will urge changes to brownfields policy to give cities more flexibility in redeveloping blighted sites with the help of federal money, said his chief of staff, Neil Mello.
One of the city's signature projects involved building a 1.8-megawatt solar generating facility at what had been a hazardous waste landfill.
As of this morning, subcommittee Democrats had not released the names of their witnesses. A Shimkus spokesman had no comment beyond what was in the news release.
Schedule:: The hearing is Thursday, Feb. 16, at 10 a.m. in 2123 Rayburn.
Witnesses:: Ross Eisenberg, vice president of energy and resources policy, National Association of Manufacturers; Thomas Sullivan, vice president of small business policy, U.S. Chamber of Commerce; Kevin Sunday, director of government affairs, Pennsylvania Chamber of Business and Industry; and Mayor Jon Mitchell, New Bedford, Mass. Others TBA.
http://www.eenews.net/eedaily/2017/02/13/stories/1060049925
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States, 'Clean' Utilities Defend Power Plant MACT As Vital For Air Quality
Feb 13, 2017 | Inside EPA
By Stuart Parker
Several states and “clean” utilities that generate power from lower-emitting sources than coal are urging a federal appeals court to uphold EPA's cost assessment that justifies its maximum achievable control technology (MACT) air toxics rule for power plants, saying the rule continues to be vital to ensure good air quality nationwide.
The states and power companies filed briefs Feb. 10 in litigation in the U.S. Court of Appeals for the District of Columbia Circuit case Murray Energy, et al. v. EPA, et al., in which other states and utilities critical of the rule are challenging EPA's revised review of the rule's costs. The agency issued the finding following a Supreme Court ruling in 2015 that faulted it for not considering costs in its initial determination that the rule was necessary.
In their new brief, a coalition of 17 states defending the rule reprises arguments made in the case by the Obama EPA that the revised cost finding is adequate under the Clean Air Act and it need not conduct a new, full-blown analysis of monetized costs and benefits.
Should the Trump EPA decline to further defend the cost finding, these states and environmentalists also intervening in the case will have to continue the rule's defense in lieu of the administration's support.
“Petitioners wrongly claim that EPA was required to consider regulatory approaches under other sections of the Act or to defer regulation to states. The provisions of the Act that Petitioners cite cannot be used to control power-plant hazardous emissions, and individual states, acting alone, cannot adequately protect against the dangers these toxins pose,” the states say, going on to defend EPA's power to issue the rule under the air law's section 112 on air toxics.
“Within section 112(n)(1)(A)’s modest instruction to evaluate 'alternative control strategies' for power-plant hazardous emissions, Petitioners claim to have discovered an expansive command that EPA must explore in its cost-consideration analysis allegedly less costly regulation under other sections of the Act, and even state law,” they say.
The alternatives to the rule that its critics suggest, which include deferring entirely to the states, are insufficient to protect against interstate air pollution, even if some individual states have their own tough mandates, the states say.
Emissions 'Dangers'
“Petitioners’ suggestion that state regulation, alone, is the answer to the dangers of power-plant hazardous emissions is contradicted by recent history. During the two decades that EPA failed to regulate those emissions under section 112, states alone were not able to address them adequately,” resulting in fouling of lakes and other waterways by mercury, among other damages. “National controls are essential to making state waters safe -- and protecting our residents -- from mercury,” the states say. Nor is there any unwarranted erosion of states' rights inherent in the MACT, they argue. “Federal agencies, including EPA, have long exercised concurrent regulatory authority with states over various aspects of power-plant operations,” the states argue in their brief.
In a separate Feb. 10 brief, the clean power utilities Calpine and Exelon say EPA's approach in the revised cost finding is reasonable, and consistent with the high court's holding in the Supreme Court utility MACT case, Michigan v. EPA.
They say industry would be harmed by scrapping the MACT, which “would threaten industry’s ability to recover billions of dollars of capital costs in both competitive and regulated generation markets.”
“EPA applied reasonable metrics to evaluate the costs of regulating, and qualitatively weighed those costs against other relevant factors,” the utilities say. Nor does Michigan demand that EPA ignore the “co-benefits” of regulating non-target pollutants, as the MACT's opponents claim, they argue.
“EPA’s decision to recognize these co-benefits is not strictly a legal interpretation, but a technical judgment commended to the Agency’s expertise. EPA determined that 'fine particulates' are indivisible mixtures of hazardous and criteria pollutants acting together to impact health and are subject to the same treatment technologies, and that acid gas hazardous air pollutants are reduced by the same controls that reduce other acid gases.”
https://insideepa.com/daily-news/states-clean-utilities-defend-power-plant-mact-vital-air-quality
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Advocates’ Air Pollution Suit 20 Years Too Late, EPA Argues
Feb 13, 2017 | BNA Daily Environment Report
By Patrick Ambrosio
The EPA's contention it adequately regulated three air toxic pollutants appears to hinge on whether the court will accept the government's argument that environmental advocates should've raised their concerns more than 20 years ago (Sierra Club v. EPA, D.C. Cir., No. 15-1246, argued 2/10/17).
The Sierra Club and California Communities Against Toxics are challenging a 2015 Environmental Protection Agency finding that the agency met its Clean Air Act obligation to regulate industrial sources responsible for at least 90 percent of the aggregate emissions of various air toxics. The Sierra Club has received funding from Bloomberg Philanthropies, the charitable organization founded by Michael Bloomberg, the majority owner of Bloomberg L.P., parent of Bloomberg BNA.
Section 112(c)(6) of the Clean Air Act requires the EPA to identify sources that account for at least 90 percent of the emissions of seven different hazardous air pollutants and develop emissions standards that control those sources. The advocacy organizations alleged that the EPA improperly claimed to meet that obligation for three air toxics—polycyclic organic matter, hexachlorobenzene and polychlorinated biphenyls—by retroactively claiming that pollutants already regulated by the agency are adequate surrogates for controlling those three substances.
The environmental groups want the U.S. Court of Appeals for the District of Columbia Circuit to vacate the EPA's determination. That could require the agency to set additional emissions limits, though one of the judges who heard arguments Feb. 10 acknowledged the possibility the agency still might be able to show the already regulated pollutants are valid surrogates on remand.
Timing of Lawsuit Questioned
Eileen McDonough, a Justice Department attorney representing the EPA, argued that the advocates’ lawsuit has a timing problem and should be dismissed. She said the organization could've raised claims that the EPA wasn't adequately controlling the three hazardous air pollutants in question back in the 1990s, when the agency set emissions standards on coke ovens, aerospace manufacturing and other industries.
“They should've challenged back then,” McDonough said.
Judge Patricia Millett appeared skeptical of that argument, questioning how the environmental advocates were supposed to know to challenge the adequacy of those rules in controlling polycyclic organic matter and the other two air toxics in question when the EPA didn't say until later that the rules were intended to control those pollutants.
McDonough argued that the EPA is required by another section of the Clean Air Act to set maximum achievable control technology standards for all hazardous air pollutants, including those mentioned in Section 112(c)(6). If the environmental advocates weren't happy with the scope of the 1990s rules the agency is citing as fulfilling its 112(c)(6) responsibilities, they could've sued back when the rules were issued, McDonough said.
However, Neil Gormley, an Earthjustice attorney who represented the environmental petitioners, argued that there is a valid claim against the EPA's 2016 finding because the agency didn't purport to be setting standards to cover the pollutants mentioned in Section 112(c)(6) back when those standards were issued in the 1990s. The EPA later established new surrogacy relationships between the already regulated pollutants and the Section 112(c)(6) pollutants, which fail to meet an established legal test and should be overturned, Gormley argued.
The other two members of the D.C. Circuit panel who heard Sierra Club v. EPA are Judges Judith Rogers and David Sentelle. Rogers questioned whether there was anything in the record of those 1990s EPA rules that would make it obvious that the agency viewed the emissions standards as sufficient to control the 112(c)(6) pollutants, while Sentelle focused his questions on how the court should review the surrogacy relationships if the panel were to disagree with the government's timing arguments.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=105357600&vname=dennotallissues&fn=105357600&jd=105357600
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Judges Question Trump EPA On Legality Of Obama-Era Air Toxics Regulation
Feb 13, 2017 | Inside EPA
By Stuart Parker
Appellate judges at Feb. 10 oral argument queried the Trump EPA over its defense of an Obama-era rule declaring that the agency has satisfied a Clean Air Act mandate to regulate 90 percent of sources of seven air toxics, questioning the legitimacy of the rule but also raising doubts on whether environmentalists' suit over the finding is timely.
In the suit, Sierra Club v. EPA, a three-judge panel of the U.S. Court of Appeals for the District Circuit considered environmentalists' case that EPA's June 3, 2015, finding represents a final agency action, and that it fails D.C. Circuit and air law requirements for use of “surrogate” pollutants to regulate other substances. It marked the first time the Trump Department of Justice (DOJ) has defended an Obama EPA policy in appellate court oral argument.
However, the Trump administration was expected to continue defending the air toxics declaration in court because the finding helps EPA avoid issuing new air toxics rules, in line with Trump's vow to reduce regulations. If EPA had said the agency had not satisfied the air law mandate, it would have to issue new air toxics rules.
As such, it shows that the new administration might continue to defend Obama EPA rules that environmentalists claim are too weak. However, the Trump DOJ is widely not expected to defend other Obama-era rules that environmentalists support, including its power plant climate rules and Clean Water Act jurisdiction rule.
There was no mention of the change in administration during the argument in the Sierra Club air toxics case, and instead the argument focused on the merits of the rule and the timeliness of the suit.
Judges Patricia Millett, Judith Rogers and David Sentelle in their questions tested the agency's argument that environmentalists' suit is an untimely attack on old rules, exploring the possibility that the finding is instead a “new” and potentially unlawful action -- but gave little sign of which way the court will rule.
Millett appeared to lean toward environmentalists' position, while Rogers and Sentelle gave little indication of their views. Although Rogers asked several questions, Sentelle spoke little during the hearing.
Under Clean Air Act section 112 (c)(6), EPA was mandated to list for regulation by 1995 sources accounting for 90 percent of seven hazardous air pollutants (HAPs) that are “persistent” and “bioaccumulative.”
These chemicals are: alkylated lead compounds, polycyclic organic matter (POM), hexachlorobenzene (HCB), mercury, polychlorinated biphenyls (PCBs), 2,3,7,8-tetrachlorodibenzofurans and 2,3,7,8- tetrachlorodibenzo-p-dioxin. Rules regulating then listed sources were required by 2000 under the air law.
The agency for years declined to make a formal finding that it had met the mandate. After protracted litigation, the agency was forced by a legal deadline to issue such a declaration. It ultimately issued its 2015 finding as a formal agency action eligible for judicial review. EPA found that it had, through various rules dating back years, met the 90 percent obligation, in part through use of surrogates to control for the seven HAPs at issue.
'New' Action
If EPA's 2015 finding is considered a “new” regulatory action, the court could find it inadequate if it finds there are flaws in the basis for the declaration, and either remand it, or vacate it as sought by environmentalists.
Alternatively, the court could accept EPA's view that the finding is merely a “summation” of progress made under older rules, and that environmental groups are unlawfully attacking those old rules years too late.
Attorney Neil Gormley, representing Sierra Club and California Communities Against Toxics, told the court that EPA's 2015 finding raises new claims concerning the use of surrogates to regulate three of the seven pollutants: POM, PCBs and HCB.
EPA claimed that a series of existing regulations setting maximum achievable control technology (MACT) for various industry sectors in effect controlled the three HAPs, albeit indirectly, by limiting emissions of other substances. But the old rules made no such claim and made no mention of surrogacy, Gormley said.
The prior rules “did not even purport” to set standards for section 112(c)(6) pollutants, he said, which he argued undermines EPA's reliance on those rules to justify the 90 percent completion claim.
Pressed by Rogers on whether the technical supporting record for those old rules might supply the necessary basis for EPA's claim, even if implicitly, Gormley said no. “We don't believe that the prior rules contain the kind of discussion you are alluding to,” he said.
Gormley further noted that several of the rules in fact pre-date EPA's listing in 1998 of its intended sectors to regulate -- which meant EPA crafted the rules without even knowing they were intended to serve as satisfying the 90 percent mandate.
Questioned by Rogers on whether, if Sierra Club wins, EPA would have to re-open those rules, Gormley said no -- but the agency would have to issue new standards, “either directly, or through a valid surrogate.”
Environmentalists say that EPA's surrogacy claims fail to meet the D.C. Circuit's own test that requires surrogates be “reasonable” and sufficiently correlated with emissions of the target pollutant. The court, however, did not test the substance of this claim.
Timeliness Argument
DOJ attorney Eileen McDonough premised the administration's case largely on the argument that Sierra Club filed its case too late, and if the D.C. Circuit agrees with this claim then it could issue a ruling that rejects the suit on procedural grounds without having to weigh in on the merits of the agency's HAP declaration.
McDonough said Sierra Club knew in 1998 what EPA was planning to regulate with respect to the HAPs, and in fact filed a petition for administrative reconsideration with the agency because it was dissatisfied with the list. After EPA declined that petition, the group abandoned a subsequent legal challenge to the agency's refusal, McDonough noted.
Millet pushed McDonough repeatedly on whether the old rules provided notice that they were intended to satisfy the 90 percent completion requirement.
In response, McDonough conceded that they did not, but also argued that they did not have to. The 1998 list from EPA “put everybody on notice,” she said.
McDonough argued that the section 112(c)(6) provision is not a stand-alone measure, but merely “broadens the universe” of sources of air toxics pollution that have to be subject to MACT regulation for all toxics anyway. This effectively expands MACT regulation from “major” sources of pollution to smaller “area” sources.
Under pressure from Millett, McDonough conceded that several of the earlier MACT rules EPA relies on in its 2015 finding did not meet the D.C. Circuit's standard for use of a surrogate. “Do you agree that some of those prior rules did not meet our standard for establishing a surrogate?” she asked.
McDonaugh replied that “many of them did not,” but argued that the rules' flaws are now immaterial because it is too late to challenge them.
Millet pressed McDonough on whether EPA's 2015 completion finding was a “new” action, to which the DOJ attorney conceded only that it was a “distinct” action.
Millet seemed unimpressed with DOJ's explanation of the adequacy of the old rules and its defense of its recent determination as not subject to judicial review over the surrogacy question, saying there is a “gaping hole here.”
EPA declined to accept public comment on the surrogacy question, Gormley earlier noted.
“It seems to me there is a little bit of whack-a-mole” going on here, Millet said, doubting DOJ's position that EPA did not take “final action” on surrogacy.
https://insideepa.com/daily-news/judges-question-trump-epa-legality-obama-era-air-toxics-regulation
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CEQ's Top Acting Official Pushes GHG Analysis In NEPA Reviews
Feb 10, 2017 | Inside EPA
The acting chairman of the White House Council on Environmental Quality (CEQ), Ted Boling, is urging continued consideration of climate change in National Environmental Policy Act (NEPA) reviews despite the fact that President Donald Trump is expected to target CEQ's recent guidance for agencies on the issue.
Boling told a Feb. 10 American Law Institute-Continuing Legal Education (ALI-CLE) event in Washington, D.C., that it “may be borderline malpractice to not consider the impact of sea-level rise on the useful life of your project” if a project is near a waterbody.
He also referenced CEQ's NEPA greenhouse gas guidance issued last August, which he helped to complete after a long development period, under his prior title of CEQ associate director for NEPA. Boling took over that role last year after Horst Greczmeil retired.
Trump is widely expected to revoke the GHG guidance, which tells agencies to consider broad upstream and downstream impacts of emissions, including, for example, to calculate the GHGs released from coal that is burned when conducting an environmental impact statement (EIS) of a mining approval.
Boling's presentation, “NEPA In Transition,” includes a slide titled “Climate Change Analysis in NEPA,” that discusses proportionality, scoping and agency decision tools available for proper GHG analysis. Those recommendations are contained in the guidance document as well.
Boling said the guidance urges reviewers to use familiar principles of analysis “to make sure climate change is not just a buzz word,” adding that the EIS reviews should provide the “so what” of climate change impacts.
However, he did indirectly reference the new administration's anti-climate policy position, noting first that the link on CEQ's website to the guidance is down and that, “Sometimes a broken hyperlink is just a broken hyperlink.”
Then he added that the entire CEQ website -- along with sites for the White House Office of Management & Budget and the White House Office of Science & Technology Policy -- are also down. That move occurred on the first day Trump took office.
However, Boling said that is “typical” under a new administration and “I expect that we'll have a website up and running soon.”
Speaking at an earlier session at the same ALI-CLE conference, Columbia University law professor and NEPA expert Michael Gerrard said that even if Trump revokes CEQ's climate guide, reviewers must still consider GHGs in an EIS, due to prior case law that requires such analysis.
While the CEQ guide “is something else that may be revoked by Trump . . . there is still underlying law that, even in the absence of guidance on how you do it, will lead to challenges to an EIS that do not have that kind of disclosure.”
The same holds for a climate change disclosure guidance from the Securities & Exchange Commission, Gerrard said.
https://insideepa.com/daily-feed/ceqs-top-acting-official-pushes-ghg-analysis-nepa-reviews
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