Environmentalists Poised To Seek EPA Rules To Address Green Chemistry
Environmentalists are poised to call on EPA to introduce new rules and policies to drive the advancement of green chemistry, a stance at odds with top agency officials who have resisted previous calls to regulate green chemistry, saying that EPA's role in the field is a strictly non-regulatory one.
Environment America, a network of citizen-based state environmental groups, is slated Feb. 10 to release its report, "Safer by Design: Businesses Can Replace Toxic Ingredients through Green Chemistry," that studies the efforts of a handful of examples of industry innovation.
It argues that ramping up phaseouts of toxic chemicals and mandatory information-sharing could spur further progress in the field and includes a collection of case studies highlighting the efforts of 14 companies that have used innovative practices to reduce their use of toxic chemicals, according to a press statement.
In the report, Environment America makes the case that "specific polices" are needed to encourage more innovation in the industry sector, a source with the environmental group says. The source says the group would like to see EPA require more phaseouts for toxic chemicals, issue policies requiring businesses to launch studies using green chemistry principles to identify less toxic alternatives and share the findings with other companies, then mandate the use of those safer alternatives through regulation.
"We see a world where Americans are exposed to fewer toxics," the source says.
The case studies feature a wide range of business structures, running the gamut from small, local companies to larger, national ones, the source says.
The report also ties green chemistry principles to economic benefits, saying that the companies which reduced their use of toxic chemicals also created green jobs and boosted the economy, according to a press release from Environment America. "The report shows that with new policies, not only could Americans reap the health benefit of fewer toxic chemicals in our products and environment, business stand to benefit as well," the release says.
The environmental group points out in the press release that the case studies in the report lend support to President Obama's call during the state of the union address to use "American innovation to invigorate the economy."
Some in the chemical industry have previously pushed against the notion of EPA incorporating green chemistry or sustainability principles into its rules. Industry has argued that it has made great strides in those fields, but such innovations have to be driven from the bottom up, rather than done in response to a top-down regulatory mandate.
For example, Len Sauers, Vice President of Global Sustainability for Procter & Gamble, said during a Feb. 2 Toxicology Forum annual meeting in Washington, D.C. that the company's sustainability accomplishments, were "largely borne out of corporate responsibility," not compliance with regulatory requirements.
Sauers gave examples of Procter & Gamble efforts, including producing sustainable products such as cold water use laundry detergent and reducing manufacturing waste sent to landfills. "In many ways we're able to do things the government can't do," Sauers said. Several Proctor & Gamble officials met with EPA Administrator Lisa Jackson and toxics chief Steve Owens Feb. 2 to discuss sustainability issues, Owens told Inside EPA the same day.
EPA officials have largely adopted a similar approach as the consumer products giant. Top agency officials indicated in recent interviews with Inside EPA that they favor voluntary initiatives and educational programs to advance principles for developing safer chemicals and argue that regulation could actually stifle green chemistry innovation.
EPA research chief Paul Anastas, long considered the father of green chemistry and former director of the Yale Center for Green Chemistry and Green Engineering, told Inside EPA last month that the agency's key role is in advancing the science of green chemistry. Anastas has also balked at the suggestion that regulatory measures could serve to stimulate development of safer alternatives to toxic chemicals. "I'm all for a regulatory floor, but I've never seen a regulation that really catalyzed innovation," he said last year.
And Region I Administrator H. Curtis Spalding, who together with Anastas is leading a collaboration of New England academia, industry, state and local government officials and other interested in developing new green chemistry projects, previously said that EPA's strategy is to avoid being "prescriptive" about what parts of green chemistry need enhanced focus. -- Bridget DiCosmo
EPA Declines To Soften Dioxin Absorption Estimates In Cleanup Decisions
Last Updated on Tuesday, 08 February 2011 12:05
EPA has determined that existing data are insufficient to weaken a long-standing default factor for estimating the amount of dioxin that humans and animals absorb from contaminated soil, stymieing an effort that industry groups hoped could have softened EPA's strict new cleanup targets for the contaminants which are stalled at the White House.
But it is not clear whether the agency's latest decision, spelled out in a Jan. 28 memo from EPA's Superfund office to regional managers, will allow the stalled cleanup targets, known as preliminary remediation goals (PRG), to overcome industry and local government concerns about the costly new cleanup requirements and complete review by the Office of Management & Budget.
Environmental Working Group staff met Jan. 31 with EPA and OMB officials where they urged them to quickly complete their review and allow EPA to issue the document that has been pending since Aug. 10. But an OMB official present at the meeting questioned environmentalists on the strict risk-assessment method EPA has proposed using in the risk assessment of dioxin the agency is developing, which will form the basis for future PRGs.
OMB did not return a request for comment regarding the meeting by press time.
In the absence of site-specific data to the contrary, EPA has for years assumed an oral soil bioavailability factor - or relative bioavailability (RBA) of 1, meaning that it assumes 100 percent of dioxins present in contaminated soil could interact with an animal or human that ingested the soil, causing harm. The RBA is part of the equation EPA uses to calculate PRGs, along with the risk estimate from the assessment.
Reducing this default assumption could lead to less stringent assessments of how much cleanup is necessary. Some sources indicated recently that changing the RBA could change dioxin remediation goals by as much as two orders of magnitude.
Last year, EPA launched an effort to reconsider its assumption, asking federal agencies for their views and seeking a contractor review of scientific literature on the issue.
But James Woolford, director of EPA's Office of Superfund Remediation and Technology Innovation, writes in a Jan. 28 memo to regional Superfund policy managers that "available estimates of soil dioxin [relative bioavailability (RBA)] are not adequate and sufficient to estimate a value for RBA for use in risk assessment as an alternative to 100 percent or site-specific values."
Woolford's memo accompanies the contractor's technical report evaluating published studies on dioxin bioavailability in lab animals, which contractor SRC, Inc. wrote for EPA.
The report describes the results of nine published studies whose authors calculated soil bioavailability percentages for polychlorinated dibenzo-p-dioxin or polychlorinated dibenzofuran from contaminated soil in lab rats, pigs or rabbits. The studies varied in the number of doses the animals received and how they were dosed. Each of the RBA values provided in a table at the end of the report is less than 100 percent, ranging from less than 1 percent to 66 percent.
Among the major reasons of variance are the many different congeners of dioxin, as well as the differences in soil type. Bioavailability depends greatly on soil type, since dioxins cling less tightly to sandy soil. In a section describing the uncertainties in the literature, SRC notes that, "The RBA estimates considered in this analysis do not represent a statistical sample of soil in any particular geographic region that is representative of all soil in the U.S. and may or may not adequately represent the variability expected over a wider range of soil types and compositions."
The report also describes other uncertainties, including "large differences" in average RBAs calculated from different species of lab animals exposed to the same test materials, as well as differences in how the animals are exposed to the contaminated soil, with a vehicle of corn oil. "The direct relevance of this type of vehicle to the exposures that formed the bases for the cancer slope factor and/or RfD need to be considered in evaluating their applicability to cancer and non-cancer risk assessment," according to the report.
The cancer slope factor and RfD, or reference dose, are two numerical estimates of risk that are included in the agency's draft assessment of dioxin.
Industry Raises Concerns
EPA's interim PRGs have proven hotly controversial because they are significantly stricter than the agency's existing goals, which are used to determine whether a site requires cleanup. These general values are often used to make initial decisions because of the high cost of performing site-specific risk assessments that could be the basis for cleanup decisions. EPA's new PRGs are interim because they are to be used - when finalized - until the agency completes its long-awaited re-assessment of the risks posed by 2,3,7,8 tetrachlorodibenzo-p-dioxin (TCDD), the most toxic form of dioxin.
EPA used the default RBA to calculate the draft interim PRGs it sent to OMB for review last August. Federal sources say the interim PRGs are 72 parts per trillion (ppt) for residential sites and 950 ppt for industrial and commercial sites, compared with the existing PRGs of 1,000 ppt for residential sites and 20,000 ppt for commercial soil, set in 1998.
In comments on the draft interim PRGs, key groups, including the American Chemistry Council (ACC), which represents chemical manufacturers, the Utility Solid Waste Activities Group (USWAG), which represents power producers, suggested that the agency may be overstating the risks posed by dioxin in part because it relied on the default value.
ACC also presented several studies of RBAs in its April 2010 comments. "Examination of these studies indicates nearly universal estimates of relative bioavailability of less than 50 percent, with 30 percent representing a more reasonable upper end estimate across studies," ACC wrote.
An industry consultant familiar with EPA's decision is puzzled. "All the data supports a conclusion of an oral RBA of less than 100 percent, and likely substantially less. We would all agree on that. The part that is perplexing to me is [their conclusion] that there is too much uncertainty to move off a default of 100 percent" RBA.
The source argues that the conclusion raises scientific concerns, because EPA "could have fit some sort of model to the data" in the report "to come up with an upper bound [RBA] number that would be conservative and protective" but less than 100 percent.
The source also argued that while a change to a smaller RBA could have a large effect in an eventual PRG, it would not greatly increase the uncertainty of the number. While two orders of magnitude is a substantial change in calculating a PRG, two orders of magnitude is small in terms of an overall increase in uncertainty, the source suggests.
"It's just another sign of the tremendous reservation of this agency to ever move off of a default" factor in calculating risk, the source says. "It's perplexing that they're comfortable with some uncertainties" such as the toxicity equivalency factors EPA uses to calculate the overall toxicity of mixtures of different congeners of dioxin - "but with the RBA and the mode of action [by which dioxin causes harm], they're concerned."
Mode of action, or how a chemical causes cancer or other disease, has long been a controversial topic within risk assessment, because it can lead to arguments over whether the effects certain chemicals cause in lab animals are relevant to human risk, or, under EPA's cancer risk assessment guidelines, how stringently the agency assesses risk. The guidelines require agency risk assessors to use strictly health protective linear modeling to assess the risks of chemicals that cause cancer by a mutagenic or unknown mode of action. Linear modeling assumes that there is no safe level of exposure to the chemical even at low doses.
EPA's guidelines have led to much controversy over the agency's assessments, and how much data is necessary in order for EPA to determine an MOA and use a non-linear model. EPA's draft assessment of TCDD uses a linear model, as does the agency's earlier assessment of cancer toxicity that forms the basis for the proposed interim PRG.
And at the Jan. 31 meeting, an OMB staffer asked one of the environmentalists for the activist's views on linear modeling. - Maria Hegstad
States Ask Court To Set July 29 Deadline For EPA To Revise Ozone NAAQS
States and environmentalists are urging a federal appeals court to impose a hard July 29 deadline for EPA to issue its long-pending revision to a Bush-era ozone standard by arguing that further delay will harm human health, marking their latest request for the court to force a deadline for the agency to revise and possibly tighten the standard.
In a Feb. 7 filing with the U.S. Court of Appeals for the District of Columbia Circuit, the states and environmentalists supportive of a stricter standard also oppose industry's request to resume pending litigation over industry's arguments that the Bush EPA ozone limit is too strict. EPA in a separate Feb. 7 filing did not address the July 29 deadline request but does join the states and environmentalists in opposing a resumption of briefing on industry's claims.
Several lawsuits over the Bush EPA's 2008 ozone national ambient air quality standard (NAAQS) are on hold, or in abeyance, in the D.C. Circuit pending the agency's review of the standard, which the Bush administration set at 75 parts per billion (ppb). The Obama EPA has proposed tightening the standard to between 60 and 70 ppb.
EPA is not currently under a legal deadline for issuing the revised NAAQS, but has missed several target dates for issuing a final rule outlined in earlier court briefings. EPA recently asked the court to keep the suits in abeyance until July 29, when the agency says it anticipates being able to finally issue its revisions to the NAAQS.
EPA says it needs the additional time to obtain new input from its Clean Air Scientific Advisory Committee (CASAC) on the data justifying a strict tightening of the Bush-era standard. The committee will hold a Feb. 18 teleconference to address several charge questions from the agency on the adequacy of the data behind a strict NAAQS. The Bush EPA's 75 ppb standard was outside CASAC's recommended 60-70 ppb range.
In the Feb. 7 filing, states and environmentalists agree with EPA's bid for the court to hold the cases in abeyance until July 29 but say that date should be a hard deadline for issuance of a final standard.
"Given that this Court has already properly exercised jurisdiction over the rulemaking at issue, EPA's proposed procedural requirements would do nothing other than cause inefficiency and further delay," according to the 14 states and five environmental groups' filing in State of Mississippi, et al. v. EPA.
The states and environmentalists argue that further delay in issuance of the final NAAQS will result in harm to the public, given that EPA has already proposed a standard within the range of 60-70 ppb and recognizes that ozone exposure above those levels harms human health. "Thus, EPA's delay here has resulted in a de facto circumvention of the agency's statutory duty to review and as appropriate revise the standards every five years. The result is to prolong the exposure of millions of Americans to unsafe ozone levels," the filing says.
EPA has already asked the court not to impose any deadlines on issuing the standard, saying the court lacks authority to impose such a deadline and that litigants must instead seek intervention from federal district court. The states and environmentalists also refute EPA's argument that they should send a citizen suit notice and then wait 180 days before commencing a separate lawsuit in the lower court over the deadline issue.
Bid To Resume Industry Suit
Meanwhile, the filing also asks the court to reject a recent request by several industry petitioners to resume briefing over industry's claims in the ozone litigation. Industry groups that challenged the ozone NAAQS as too strict say that the Obama EPA's proposed tightening of the standard might answer states' and environmentalists' lawsuits if a final rule tightens the NAAQS sufficiently, but will fail to answer industry's push for a weaker NAAQS.
Because there is very little chance that EPA's reconsideration of the NAAQS and pending final standard will be weaker than the one at issue in the suit, industry says briefing on its claims should proceed.
But the states and environmentalists say industry's argument ignores the fact that EPA's rationale and support for strengthening the standards "will undoubtedly be further addressed in its final action. . . . Thus, it is simply incorrect for industry to suggest that EPA's reconsideration will have no relevance to industry's claims."
EPA in its Feb. 7 reply to industry's request also says "the public interest strongly favors a continued deferral of judicial review." The agency argues that new advice it is soliciting from CASAC will be relevant to industry petitioners' assertion that the the 1997 ozone standards should be left unchanged.
"Briefing on all these issues, and this Court's review, therefore, should proceed together, based upon the full administrative record, including CASAC's advice and EPA's decision and explanation upon completing its rulemaking," according to EPA's filing. Artificially severing industry issues from those of other petitioners in the ozone NAAQS litigation would violate principles of judicial economy, the agency says.
Nonetheless, if EPA misses the July 29 target the agency says it "would not oppose a request at that time to establish an appropriate briefing schedule." -- Stuart Parker
Mercury Limits Emerge As Early Test Of Public Health Benefits Of EPA Rules
Last Updated on Tuesday, 08 February 2011 12:09
EPA's pending efforts to curtail mercury emissions are emerging as an early test of the agency's ability to justify the health benefits of costly new regulatory requirements in the face of industry and Republican criticisms that the rules costs do not justify their benefits.
While the agency and its defenders are increasingly citing the health benefits of a host of air, water, waste and greenhouse gas (GHG) regulations to justify their costs, the agency's air toxics rules limiting mercury from cement and power plants and industrial boilers may present the starkest test for the agency as industry and their GOP supporters are attacking EPA over the rule's costly requirements -- even in the case of a known neurotoxin.
Although EPA has historically justified mercury controls due to their benefits in reducing neurological risks, such as reduced IQ, a recent paper that emerged from an agency-sponsored workshop on mercury links exposure to increased risk of heart attack -- potentially offering an even greater benefit from regulations than the well-documented neurological benefits of reduced exposure. But agency sources say uncertainties in the study are complicating efforts to cite it to justify upcoming rules.
For now, though, EPA and its supporters are focusing on the need to limit neurological harms. Representatives of Environment America Jan. 26 unveiled a report, Dirty Energy's Assault on our Health: Mercury, calling on EPA to strictly regulate mercury emissions from power plants. Using data from EPA and recent studies, the report states that power plant emissions from Texas, Pennsylvania, Ohio and West Virginia account for 35 percent of mercury pollution from U.S. power plants, and that "one in six women of childbearing age has enough mercury in her bloodstream to put her child at risk of the health effects of mercury exposure should she become pregnant."
Shelley Vinyard, co-author of the study, said at a Jan. 26 press conference that EPA -- in its forthcoming maximum achievable control technology (MACT) rule for power plants -- should implement a "strong standard that will significantly reduce these harmful pollutants from power plants and specifically cut mercury pollution by more than 90 percent."
When asked how to balance concerns of Republican House leaders and industry on the potential negative economic impacts of the MACT rule and others on the power sector, Vinyard said that "our number one priority should be protecting the future of America by protecting the health of our kids."
Industry lobbyists say they are sensitive to expected accusations that their efforts to curtail EPA's efforts to limit emissions of mercury and other air toxics will damage public health, but are planning to push ahead with attacks on the economic impacts of the agency's proposed and forthcoming rules and to argue that the agency is overestimating benefits the rules would generate.
GOP Introduce Disapproval Resolution
Already, Rep. John Carter (R-TX), a member of the House Republican leadership, has introduced a disapproval resolution under the Congressional Review Act (CRA) to overturn EPA's rule setting MACT standards for the cement industry -- a rule that EPA says will reduce mercury deposition in some states by up to 30 percent. Together with new performance standards EPA is setting for the sector, the agency says its rules will avoid between 960 and 2,500 premature deaths in people with heart disease, 17,000 cases of aggravated asthma and 1,500 heart attacks, among other benefits.
A Carter aide says the congressman is not inherently opposed to regulating mercury emissions from Portland cement facilities, but wants EPA to adopt flexible rules that create new standards in a way that "doesn't cost jobs," an issue of particular concern in Oregon where at least one cement facility will have to shutter due to the rule.
At an event last year, EPA Administrator Lisa Jackson was asked about those impacts but defended the cement MACT as an example of how EPA worked with industry to minimize costs, and she said plant closures that would result from the rule were a consequence of their reliance on high-mercury limestone as feedstock.
"They have feedstock so high in mercury that we really couldn't come up with a solution that didn't require them to either put very, very expensive control technologies on or to stop using that feedstock, and since cement manufacturers tend to be located very near their feedstock, that's a concern," she said during a question-and-answer session at the Nov. 29 Aspen Center event in Washington.
"But again it was because of mercury, so the equation to me is, what is the public health benefit, and how much more does it cost," she continued. "And I think we're still very much in the one-to-20 [costs to benefits] range, especially under the Clean Air Act."
Industry sources acknowledge that mercury regulations may be more difficult to oppose than other rules, because there is essentially no disagreement that mercury is a dangerous neurotoxin, but they still plan to challenge EPA's rules as providing relatively minor improvements to public health that do not justify the potentially massive job losses.
"As a political matter and as a communications challenge, it is different to talk about mercury" than other pollutants such as greenhouse gases, says Scott Segal, a Bracewell & Giuliani lobbyist who represents cement makers, utilities and other industries. "That said, it's not as though mercury is uncontrolled as we sit here now, so one thing you could do is describe the ways in which mercury is currently controlled," he told reporters during a recent event at his firm's Washington office.
Segal added that ambient air concentrations of mercury have been consistently falling. "So the notion that there is a public health crisis that needs to be addressed is not borne out under the facts," he said. "In addition, mercury itself travels in a global cycle, with respect to the way in bioaccumulates in food sources like fish, and if you push productive capacity in the United States -- either by increasing the price of energy or by . . . making the regulatory environment more hostile -- you push people overseas to less efficient, more polluting plants that actually end up releasing more mercury in the atmosphere."
Closer Lawmaker Scrutiny
Republican Capitol Hill aides are beginning to voice similar arguments. Maryam Brown, a majority staffer for the House Energy & Commerce Committee, points to data showing that pollution has fallen in recent decades, even as sources of pollution in the form of factories, power plants and vehicles has grown.
During a Jan. 19 Bipartisan Policy Center forum on environmental regulation, Brown said lawmakers would be closely scrutinizing whether stricter regulations' costs were justified by potentially relatively small benefits. "I think that particularly Republican and some Democratic members across the aisle are going to be asking whether these additional environmental regulations are necessary and do they make good sense . . . whether or not the economic and U.S. competitiveness problems that they may present outweigh incremental health benefits," she said.
But environmentalists say the fact that pollution has fallen while the economy has grown shows EPA regulations work without imposing the massive costs industry says will result, all while improving air quality and lessening public health problems. "The Clean Air Act is a remarkably successful public health law which -- up until now -- has always enjoyed broad bipartisan support. It has saved hundreds of thousands of lives while our economy has continued to grow," Natural Resources Defense Council's David Donniger says in a Jan. 20 blog post. "The further safeguards for soot, smog, mercury, and carbon pollution that EPA is planning to issue will save tens of thousands more lives each year and help us move towards cleaner energy and a stronger economy."