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- New chemicals under the new TSCA: Growing pains now, but a stronger system going forward
Richard Denison, Ph.D., is a Lead Senior Scientist.
In the many conversations I have had over these last many years about the Toxic Substances Control Act (TSCA), the single thing that most resonated with people about why the old law didn’t work was about new chemicals. Folks were stunned when they learned that the old law didn‘t require our government to review chemicals and determine they were safe before they were allowed onto the market. People simply assumed this was the case and were shocked to find it wasn’t. I heard repeatedly, what could be a more basic need to ensure protection of the public’s health?
That is why many in Congress worked so hard to drive improvements to the new chemicals provisions in the new law – that, and a clear understanding of the many ways in which the old law hamstrung EPA when it came to new chemicals. In my view, these reforms and robust implementation of them by EPA are absolutely essential to the task of restoring public and market confidence in our national chemical safety system – the shared objective that allowed disparate stakeholders and lawmakers to come together to support the Lautenberg Act.
For too long, economic factors have dominated over the public’s right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety. That has undermined consumer confidence in our chemical safety system. The public understands that the most efficient and effective stage at which to provide assurance of safety is before commercial production and use begins, rather than waiting and then having to try to mitigate risks that arise after a new chemical is embedded in commerce.
I have blogged previously about why the new chemicals reforms in the new law represent a balanced approach, on the one hand, ensuring that the safety of new chemicals is carefully examined and a reasonable assurance of safety is provided before market entry; and, on the other hand, ensuring an efficient process that doesn’t unduly slow or create too high a bar for market entry.
Of course, even as it has supported the new law’s balanced reforms, the chemical industry did and continues to assert that the old new chemicals system worked just fine. I’ve always maintained that’s because it rarely required much of them. It’s not wholly surprising, therefore, that the industry is expressing angst over EPA’s implementation of the new requirements. Change is hard.
Bear in mind also that the new requirements of the law not only changed the status quo significantly, they also became effective immediately upon passage of the law, without any time given to EPA to migrate to the new regimen. That, too, has been a source of the growing pains felt by both EPA and the regulated community. Abrupt change is even harder.
But a broader and longer view of the new law is called for. The bulk of this post will describe why EDF believes that EPA’s implementation to date is not only consistent with the new law but in fact mandated by it, and why, despite initial growing pains, the new system will be a major improvement over the long run for both public health and business. But first …
Playing the “don’t-stifle-innovation” card
But before doing so, I want to briefly address an overarching argument that industry uses to try to lend greater weight to its complaints about EPA’s actions under the new law: that those actions threaten to impede innovation, which they assert is directly at odds with Congress’ intent under TSCA.
This claim relies on the only reference to innovation in all of TSCA, in a list of the law’s policy intentions (section 2(b)(3), same language in both the old and new law). Industry typically paraphrases this provision as saying that, under TSCA, EPA shouldn’t act in a manner that impedes innovation. But that is a selective reading of the actual provision; I quote it in its entirety below (emphasis added):
(b) POLICY.—It is the policy of the United States that—
(3) authority over chemical substances and mixtures should be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the primary purpose of this Act to assure that such innovation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment.
Given that the development and application of new chemicals are a clear source of innovation, how else is that primary purpose of TSCA – providing an assurance that innovation and commerce in chemicals do not present unreasonable risk – to be provided other than through robust scrutiny of new chemicals prior to their commercialization?
Congress clearly got it that innovation without safety doesn’t really qualify as innovation.
New chemical reviews under old vs. new TSCA
The Lautenberg Act made five major improvements to the new chemicals provisions of TSCA, each of which addressed a critical flaw in the original law:
- It mandates that EPA review each new chemical and make an affirmative finding as to its safety. The old law had neither mandate.
- If EPA lacks sufficient information on a new chemical, it must issue an order prohibiting or limiting the chemical in order to mitigate any unreasonable risk. The old law essentially forced EPA to allow manufacture to commence for a new chemical lacking sufficient information – such chemicals typically were simply dropped from further review and manufacture could start at the end of the review period.
- It requires EPA to consider and mitigate unreasonable risks of a new chemical under its “conditions of use,” which the new law defines to include “reasonably foreseen” circumstances of production, processing, distribution use or disposal, as well as those intended by the company providing the new chemical notice to EPA. Under the old law EPA had to confine any risk finding it did make to the specific uses identified by the company.
- It requires EPA to protect against potential risks to “potentially exposed or susceptible subpopulations,” including workers. Such a provision did not exist in the old law.
- Where EPA imposes conditions on the manufacturer of a new chemical, it must consider whether to promulgate a Significant New Use Rule (SNUR) to apply those conditions to other companies making the same chemical. It must either initiate the SNUR rulemaking or publish a statement explaining why it is not doing so. Under the old law taking such action was entirely discretionary and, until recently, was infrequent.
In implementing these new requirements, which took effect immediately upon the law’s enactment, EPA has taken a number of actions. Our understanding of these actions has been informed both through various conversations with companies and EPA staff, and by examination of EPA’s interim recommendations on pre-manufacture notices (PMNs) that are made publicly available here.
Support in the law for EPA’s actions to date
Based on the information available to us, EDF supports each of EPA’s actions described below, both as consistent with or required by the law and as representing sound policy and practice:
First, EPA reset the baseline 90-day clock on reviews that were already in process on the date of enactment. Because the new requirements applied immediately to these new chemicals, that action was both appropriate and necessary. (EPA has explained the legal basis for its decision here [see answer to question 11].)
Second, EPA has identified a number of new chemicals for which it either lacked sufficient information to “permit a reasoned evaluation” or had information that led it to make a finding that the chemical “may present an unreasonable risk.” In such cases, EPA is proceeding, as required under section 5(e) of the new law, to impose testing or other requirements through an order, typically a consent order being negotiated with the company. As was longstanding practice under the old law, the additional time required for testing or negotiating a consent order also typically necessitates an extension of the initial 90-day review period, which is authorized under section 5(c) of the law, or a suspension of the review period done at the request of the PMN submitter.
Third, it appears EPA has identified a number of new chemicals for which it has identified “reasonably foreseen” conditions of use that “may present an unreasonable risk.” This finding may have been reached even where EPA did not find that the intended conditions of use identified by the company may present such risk. Sections 5(e) and 5(f) of the law expressly require that, where EPA finds a new chemical presents or may present an unreasonable risk under its conditions of use – which is defined in the law to include both intended and reasonably foreseen circumstances (section 3(4)) – it must issue an order imposing conditions sufficient to mitigate such risk. It appears that EPA has taken just such action, in some cases by limiting the company to its intended conditions of use – which is necessary to support the affirmative finding that the new chemical is not likely to present an unreasonable risk under its conditions of use, as required to allow manufacture to commence.
Fourth, EPA has identified a number of new chemicals the characteristics of which raise particular concern for workers, especially with regard to the potential for adverse chronic health effects associated with long-term exposures to contaminated air in the workplace. In such cases, we understand EPA is requesting that companies conduct testing to inform its decision as to whether the chemical presents or may present, or is not likely to present, an unreasonable risk. Based on information available to us, EDF believes this is a prudent approach. It is also wholly consistent with the law, which provides EPA with authority to mitigate potential risks posed by new chemicals in workplaces, including where workers represent a “potentially exposed or susceptible subpopulation.”
Looking past growing pains to better incentives and renewed public confidence
EDF recognizes that these changes being implemented in EPA’s new chemicals review process, while fully consistent with and required by the new law, are resulting in development of more orders and longer review times compared to the program under the old law. This outcome is not unexpected as EPA develops and implements new procedures and practices to meet the new mandates under the law. We expect that EPA’s processes will become more efficient over time and allow in many cases for more expeditious reviews.
We also hope that companies will now have greater incentive both to: 1) provide EPA with more information about their new chemicals to facilitate EPA’s mandated review and safety finding; and 2) anticipate when filing new chemical notices that their chemicals may well be produced and used for purposes beyond those they initially intend once those chemicals enter commercial distribution.
Companies have noted repeatedly that they often lack knowledge of the full range of uses of chemicals they make and may have little or no control over such uses once those chemicals are being commercially distributed. Hence it is vital – as well as mandated by the new law – that EPA consider reasonably foreseen uses of new chemicals in making the required safety findings.
Companies concerned that limitations placed on their ability to produce and use a new chemical may impede innovation or competitive position can and should incorporate a broader range of conditions of use into their new chemical notices and provide EPA with the information it will need to evaluate that broader range of conditions of use.
By acting on these strengthened incentives to provide more information and anticipate future uses, companies can better ensure that the much-needed enhanced review of the safety of new chemicals mandated by the Lautenberg Act can be achieved without impeding innovation or the ability to compete.
For too long, economic factors have dominated over the public’s right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety. That has undermined consumer confidence in our chemical safety system. The public understands that the most efficient and effective stage at which to provide assurance of safety is before commercial production and use begins, rather than waiting and then having to try to mitigate risks that arise after a new chemical is embedded in commerce.Source: Main Feed - Environmental Defense | Published: December 2, 2016 - 2:18 pm
- 28 years after Chico Mendes’s death, four environmental challenges still facing the Amazon
I was at home on the evening of December 22nd, 1988 when I got the call from Brazil telling me that Chico Mendes had been murdered a few hours earlier.
Chico Mendes's ideas, his story, and indigenous and forest communities’ fight for land rights that he gave his life for have changed the Amazon, Brazil and the world. But the fight is far from over.
I, and Chico’s other friends, had thought that drawing media attention to his struggle to protect the forest and forest communities against the depredations of land-grabbing cattle ranchers would protect him. We were tragically mistaken.
But the cabal of land grabbers and their hired guns who killed Chico were wrong on a deeper level. They thought that his murder would go unnoticed, and that even if it didn’t everyone would know that cutting down the forest and driving a few poor rubber tappers off the land was the price of progress – inevitable.
The latest New York Times RetroReport, “The Fight to Save the Amazon,” does a very good job of showing both how very much Chico’s ideas, his story, and the indigenous and local forest communities’ fight for their land rights that he gave his life for, have changed the Amazon, Brazil and the world – and how very far from over the fight is. My next post will address what’s changed over the past 28 years, but here I’ll address four things that haven’t.
What hasn’t changed since the fight to save the Amazon began in the 1980s?
1. The frontier is still lawless.
Even though government and state agencies have stepped up enforcement, particularly since the 2004 Plan to Prevent and Control Amazon Deforestation, about 30% of the Amazon is still at risk for illegal logging, deforestation, gold mining and land grabbing.
Deforestation went down from about 27,000 km² in 2004 to a little over 4,000 km² in 2012 – but since then has oscillated around 5,000 km² and now has increased for the last three years, to an alarming near-8,000 km² this year.
It seems that a big part of the residual deforestation is linked to illegal activities, if not organized crime. Environmental/land rights activists like Chico don’t get killed in his home state of Acre, where ten years after he died, his people came to power and have made the state a sustainable development leader. But Brazil is still the world leader in killings of environmental activists, such as Luiz Alberto Araújo, municipal secretary of environment, murdered in Altamira, Pará on October 13th. Dismantling land grabbing and illegal deforestation gangs (as the Federal Police have clearly shown they can do in the last few years) and aggressively prosecuting their leaders need to be high priorities, and gathering the intelligence to do it needs dependable support.
2. The forest is still worth more dead than alive.
Chico’s prescient ideas on the need for forest protection while developing the Amazon economy have won the rhetorical war – but the actual incentives needed to create robust economic alternatives for indigenous peoples and forest communities, compensate good-actor landowners willing to forgo legal rights to clear forest, and fund the shift to high-value, zero-deforestation agriculture for family farmers and agribusiness alike have yet to materialize, and Brazil’s climate negotiators are not helping. Brazil should open up to emerging carbon markets to fund the elimination of deforestation in the Amazon and other biomes, while also pursing public donor funding.
3. Technology and capital to build 21st century supply chains and develop markets for sustainable forest products are still lacking.
After Chico was killed and his story went viral a wave of newly minted MBAs washed over the Amazon, full of passionate conviction that commercially viable sustainable alternatives based on non-timber tropical forest products were there for the taking (Full disclosure: I thought so too, at the time.) Then they figured out that bringing products of highly variable supply and quality to market over continental distances and no infrastructure wasn’t all that good a recipe for business success.
In some places, though, governments and NGOs kept at it, and developed alternatives that yield real benefits for local people. In Acre, for example, the government has invested heavily in things like fish farming on already cleared land, a high-tech condom factory using native rubber latex, and scaled-up Brazil nut processing technology.
In the Xingu indigenous territories and protected areas, NGO Instituto Socioambiental has brought in state-of-the-art technology to add value through local processing of fruits, nuts and oils, while training local people to collect native tree species seeds for sale to famers obliged by law to restore degraded lands. Alternatives like these raise incomes and help the communities get access to the market, and with investment, could help landowners derive sustainable value from the 80% of their holdings they’re required to keep under forest cover. But with over 2 million km² (equal to the size of four Californias) of indigenous territories and protected areas, these innovative pilots will need major investment and a world of new technology to come to scale.
4. The weather in the Amazon is still changing for the worse.
Chico saw before almost anyone else that the weather in the Amazon was changing. The combined effects of climate change and deforestation on regional and global rainfall regimes are provoking more frequent and intense droughts, and causing runaway forest fires in places that were always too moist to burn, even in the dry season. About half the rain that falls in the Amazon is from moisture cycled into the atmosphere by the forest itself – about 20 billion tons of water a day.
If climate change, deforestation and fires continue feeding off of each other, the Amazon ecosystem could unravel, and large parts of the forest could change into savanna. This could affect rainfall patterns as far away as California, and seriously reduce agricultural production in Brazil and other countries.
In one of the last interviews Chico gave before he was killed, he talked about the death threats he was getting and said he wanted to live to save the Amazon. In my next post, I’ll talk about some of the things that have distinctly changed for the better in the last 28 years – in no small measure because of Chico’s life and story – that make saving the Amazon a real possibility.Read more »Source: Main Feed - Environmental Defense | Published: December 2, 2016 - 1:52 pm
- Public Health and Environmental Groups Move to Defend Standards to Reduce Waste of Natural Gas on Public LandsRead more »Source: Main Feed - Environmental Defense | Published: December 2, 2016 - 5:00 am
- More on EPA’s first 10 chemicals up for review
By Lindsay McCormick
Lindsay McCormick is a Project Manager.
As promised in Tuesday’s blog post, we’ve compiled additional information on the 10 chemicals EPA selected as the first to undergo risk evaluations under the new TSCA.
Click on the image to the right to see:
Source: Main Feed - Environmental Defense | Published: December 1, 2016 - 7:33 pm
- EPA’s 2014 rankings on hazard, exposure, and persistence & bioaccumulation characteristics of these chemicals in its TSCA Work Plan for Chemical Assessments;
- Examples of consumer, commercial, and industrial uses; and
- National production volume (i.e., volume produced and imported into the U.S.) for 2011 based on EPA’s 2012 Chemical Data Reporting (CDR) information. (Note the 2012 data are the latest publicly available. EPA recently completed its collection of 2016 data, but they are not yet publicly available.)
- Bipartisan group of Senators urges new Administration to ensure strong implementation of new TSCA
Richard Denison, Ph.D., is a Lead Senior Scientist.
Yesterday a bipartisan group of nine Senators who were deeply involved in passage of the Lautenberg Act wrote to President-Elect Trump’s transition team to urge that EPA under the next Administration “vigorously implement the new law.” The Lautenberg Act amended the Toxic Substances Control Act of 1976 (TSCA) and was signed into law by President Obama on June 22, of this year.
The group went on to state that strong implementation “includes moving expeditiously to identify and address chemicals with the greatest potential impact on public health, especially those affecting vulnerable populations. … Successful implementation of this law will also help ensure there is certainty and restore confidence in the marketplace for manufacturers, consumer product producers, and the public.”
The Senators urged that the transition team work with EPA “to communicate on critical steps that are underway and to get a full appreciation of the new law’s deadlines. We urge that you view appointments, funding and staffing to this office with the utmost importance. It is essential to maintain momentum during the Presidential transition and in the early months of the new Administration to ensure that this new law is successful.”
The signatories to the letter are Sens. Tom Udall (D-NM), James Inhofe (R-OK), Cory Booker (D-NJ), Shelley Moore Capito (R-WV), Tom Carper (D-DE), Mike Crapo (R-ID), Ed Markey (D-MA), Jeff Merkley (D-OR) and Sheldon Whitehouse (D-RI).Read more »Source: Main Feed - Environmental Defense | Published: December 1, 2016 - 3:15 pm
- Making federally-assisted housing lead-safe for children
By Tom Neltner
Tom Neltner, J.D., is Chemicals Policy Director
Housing supported by the Federal Government should not be poisoning children.
That was the simple message Congress delivered to the Department of Housing and Urban Development (HUD) in the Residential Lead-Based Paint Hazard Reduction Act of 1992. Despite some real progress since then, recent cases of lead poisoning in federally-assisted housing in Chicago and Indiana suggest there is still much work to be done.
Thanks to a strong public push to highlight these failings, HUD recently proposed changes to its “Lead Safe Housing Rule.” At the heart of these changes is lowering the level of lead in children’s blood considered “elevated,” the trigger for local housing authorities to conduct detailed inspections of a child’s home for lead. HUD has continued to use a level of 20 µg/dL set in 1999, despite a consensus that lead is harmful to children at much lower levels. HUD is on track to finalize the rule in January 2017 after sending it to the Office of Management and Budget on November 21 for final review.
EDF supports HUD’s proposal to tie its definition of “elevated blood lead level (BLL)” to the Centers for Disease Control and Prevention’s (CDC) reference level, currently 5 µg/dL. This will help ensure that children exposed to lead in federally-assisted housing will receive the services they need to avoid additional exposure.
However, once children are exposed to lead, the neuro-cognitive damage starts accruing and is generally believed to be irreversible. To protect children, we must prevent them from being exposed in the first place. As CDC’s own advisory committee noted in 2012, “Screening children for elevated BLLs and dealing with their housing only when their BLL is already elevated should no longer be acceptable practice.”
EDF joined dozens of other environmental, public health, and housing advocates in submitting public comments that encouraged HUD to heed CDC’s advice and strengthen their rule to do more to prevent exposures in the first place. Suggestions offered to HUD to improve the rule included:
- Eliminate visual-only checks for lead. HUD has said that the dust through which most children are exposed to lead, “…may be so fine that it cannot be seen by the naked eye.” And yet, the department continues to allow programs under its purview, such as Housing Choice Voucher, to use a “visual assessment” to screen for lead. To protect children, many comments noted that HUD should base the determination of safety on quantified measurements of lead dust present in homes.
- Lower the lead threshold for “lead-based paint.” HUD continues to rely on a 1992 definition derived from the limits of portable testing technology available at the time. Relatively inexpensive devices can now quantify lead at much lower levels, and given the amount of lead dust created by disturbing even paint with lower levels of lead, it’s time for HUD to make an update.
- Update the lead in dust standards. We have previously asserted that these standards are outdated. Earthjustice and its partners have thoroughly detailed that HUD should immediately apply lower standards for housing covered by its rules.
- Identify and remove lead service lines that contaminate drinking water. The crises in Flint and other cities have demonstrated that lead exposure from drinking water cannot be ignored. Yet in the proposed rule’s preamble, HUD flatly declares lead in water to not be a “housing hazard,” therefore, beyond the department’s purview to address. We disagree. Lead in water is primarily the result of lead service lines connecting a home to the main. In most communities, the water utility maintains that the homeowner is responsible for the maintenance and replacement of these pipes, just like the lead-based paint on the wall.
- Expand identification and remediation of lead to more categories of assistance. Currently, HUD requires different levels of testing and response depending on the type and amount of federal assistance. A broader range of programs should be covered and disparities addressed.
- Better coordinate with EPA rules. Since EPA promulgated its Renovation, Repair, and Painting Rule in 2008, local housing authorities have had to contend with meeting both HUD’s requirements and a similar, but not identical, set of standards from EPA. While there are good reasons to have both sets of rules, HUD should use this opportunity to build on EPA certification requirements and remove duplicative notifications.
EDF’s full comment, building on a collaboration with the Health Justice Project at the Loyola University Chicago School of Law, highlights many of these topics and addresses additional areas.
We know that prevention works. A recent research article found that residents in federally-assisted housing that have benefited from HUD’s existing Lead-Safe Housing Rule have significantly lower blood lead levels than low-income residents in housing that did not receive federal assistance.Read more »Source: Main Feed - Environmental Defense | Published: November 30, 2016 - 3:35 pm
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