Preview Newsletter
ACC AM 7/01/2016
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(ACC Blog) What Do A Solar Panel And Pacemaker Have In Common?
Jun 30, 2016 | American Chemistry Matters
From solar panels to medical devices to sports safety equipment to personal care products, silicones are used in thousands of products. https://blog.americanchemistry.com/2016/06/what-do-a-solar-panel-and-pacemaker-have-in-common/ -
(ACC Mentioned) A Call for Action on Toxic Chemicals
Jul 1, 2016 | The New York Times
By Roni Caryn Rabin
Every day, children and adults are exposed to a variety of chemicals found in common household items. -
Amended Law Affecting New Chemicals' Market Entry
Jul 1, 2016 | BNA Daily Environment Report
By Pat Rizzuto
Changes recently made to the Toxic Substances Control Act may delay chemical manufacturers' ability to bring new chemicals to market, policy analysts say. -
EPA to Use Rolling Process to Review Chemicals in Commerce
Jul 1, 2016 | BNA Daily Environment Report
By Pat Rizzuto
The amended U.S. chemicals statute doesn't envision the Environmental Protection Agency reviewing all chemicals in commerce at once to determine whether they are high or low priorities for risk evaluations, a senior EPA official said June 30. -
New Law Brings Confidence in Chemical Safety
Jul 1, 2016 | The Detroit News
By John Dulmes
Last week, a wide range of stakeholders and a vast majority of legislators from both political parties came together to make history: they helped to overhaul a major federal law that hadn’t been updated since it was signed in 1976. -
US EPA Issues First Year Implementation Plan for New Lautenberg Chemical Safety Act
Jun 30, 2016 | Lexology
By Stephen A. Owens
The US EPA has issued a “First Year Implementation Plan” outlining the steps it will take over the next year (and beyond) toward implementing the requirements of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, the legislation signed into law by President Obama on June 22 to modernize the Toxic Substances Control Act (TSCA). -
New Hope for Reducing Children's Risks of Autism, ADHD and Intellectual Disabilities
Jul 1, 2016 | Cleveland.com
By Arthur Lavin
For some time, many families have either feared or dealt with the impact of their children having autism spectrum disorder, ADHD, and/or intellectual disabilities. -
Five Questions: What Chemical Safety Update Means For Public Health
Jul 1, 2016 | The Inquirer (in Philly.com)
By Sandy Bauers
Ten days ago, with President Obama's signing of new chemical safety legislation, the last remaining environmental legislation of the 1970s that had not been updated got a makeover. -
The Chemical Safety Act: Landmark Reforms to a Forty-Year-Old Law and Their Implications for Public Health and the Environment.
Jun 30, 2016 | Environmental Grantmakers Association Blog
By Annie Taylor
Last week, President Obama signed a bill updating the Toxic Substances Control Act (TSCA), a forty-year-old law originally intended to regulate the introduction of new chemicals that posed a threat to public health and the environment. -
The Tricky Business of Regulating Biology
Jun 30, 2016 | Undark
By Brooke Borel
IN 2015, A PLANT PATHOLOGIST at Pennsylvania State University successfully used new gene editing technology to delete a relatively small bit of DNA from the genome of a white button mushroom. -
Compliance, Enforcement Underway For Prop 65 BPA Warnings
Jul 1, 2016 | Chemical Watch
By Kelly Franklin
A month and a half after California's Proposition 65 deadline for providing warning for exposures to bisphenol A (BPA), industry and private enforcement groups continue to adjust to the requirements. -
Common Chemicals Found in Plastic Bottles, Pollution and Even Makeup are 'Damaging Babies' Brains and Lowering Their IQs'
Jul 1, 2016 | Daily Mail
By Madlen Davies
Common chemicals found in plastic bottles, pollution and even makeup are harming the brains of foetuses and growing children, lowering IQs, according to new research. -
Appalachian Basin Lacks Adequate NGL Storage, Pipelines For Demand, More Crackers
Jun 30, 2016 | Natural Gas Intelligence
By Jamison Cocklin
As shale development continues to unfold in Appalachia and with Royal Dutch Shell plc's decision to build a multi-billion dollar ethane cracker in Western Pennsylvania, getting more natural gas liquids (NGL) storage and other infrastructure built is critical, according to several experts who spoke at an industry conference in Pittsburgh this week. -
House Panel Tees Up Floor Action on EPA Spending
Jul 1, 2016 | BNA Daily Environment Report
By Brian Dabbs
The House Rules Committee is aiming to consider legislation to fund the Interior Department and the Environmental Protection Agency the week of July 11, the committee said in a June 30 statement. -
Murray Sues EPA Over Power Plant Reconsideration Denial
Jul 1, 2016 | BNA Daily Environment Report
By Andrew Childers
Murray Energy Corp. is challenging the Environmental Protection Agency's denial of petitions to reconsider its carbon dioxide standards for new power plants in the latest legal broadside on the agency's climate change efforts (Murray Energy Corp. v. EPA, D.C. Cir., No. 16-1218, 6/30/16). -
White House Reviewing Final Part of EPA's Methane Push
Jul 1, 2016 | BNA Daily Environment Report
Guidelines that would help reduce emissions of volatile organic compounds from select existing oil and natural gas industry sources are now under review by the White House Office of Management and Budget. -
Amid Airy Promises, North American Summit Yields Some Sensible Plans On Energy
Jun 30, 2016 | Forbes
By Michael Lynch
The three North American leaders have met and began by addressing, among other things, energy policy and a move to reduce greenhouse gas emissions from that sector (among others). -
IG to Chemical Safety Board: Launch More Investigations
Jul 1, 2016 | BNA Daily Environment Report
By Sam Pearson
The U.S. Chemical Safety and Hazard Investigation Board still needs to boost employee morale, investigate more chemical incidents and promulgate a long-delayed regulation, according to a report from the Environmental Protection Agency's Office of Inspector General. -
(ACC Mentioned) Living Green: Readers Weigh In On Plastic Bags
Jun 30, 2016 | Santa Cruz Sentinel
By Kathryn McKenzie
In last week’s column, I asked for your opinions about local bans of single-use plastic bags, and you didn’t disappoint me. Here are some thoughts on the matter, edited for space and clarity. -
EPA Takes Steps To Advance 'Cumulative' Air Toxics Assessment Policy
Jun 30, 2016 | Inside EPA
By Stuart Parker
EPA is taking steps to advance calls from its Clean Air Act Advisory Committee (CAAAC) to craft a policy on assessing the “cumulative” impacts of air toxics to reduce air pollution in environmental justice (EJ) areas, including updates to its major data screening tools and seeking information on state approaches to the issue.
Industry and Association News
TSCA News
Chemical Management News
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Chemical Security News
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Environment News
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(ACC Blog) What Do A Solar Panel And Pacemaker Have In Common?
Jun 30, 2016 | American Chemistry Matters
From solar panels to medical devices to sports safety equipment to personal care products, silicones are used in thousands of products. This family of high performance materials is crucial to countless industries, including medicine, construction, transportation, fashion, and sports.
A recent socio-economic report released by the Global Silicones Council underscores just how important silicones are to the global economy as well as to the well-being of people in a modern society. Silicones manufacturing is an $11 billion global industry, with 2,122,000 metric tons of formulated silicone products sold every year.
So where is all this silicone being used? Among the most popular uses:Construction materials–$430 million in silicone product sales
Silicone sealants, adhesives and coatings make construction materials work better, last longer, and improve energy efficiency.Specialty consumer and personal care products–$416 million in silicone product sales
Silicones are used in a wide range of products including deodorants, shampoos, sunscreen, and makeup. In laundry detergents, silicones help reduce water and energy use.Transportation–$240 million in silicone product sales
Silicones are used extensively in automotive manufacturing and in components (such as airbags) for cars and other vehicles. Their use contributes to increased strength, durability, reliability and safety.Electronics—$116 million in silicone product sales
Silicones have enabled electronics to become smaller alongside greater functionality. They also enable greater reliability and performance of LEDs, contributing to energy efficiency improvements.Healthcare—$123 million in silicone product sales
Silicones are used in a broad range of medical devices and specialized medical equipment. Silicone-dependent applications include adhesive bandages, syringes, wheel chairs, hearing aids, pacemakers, intelligent contact lenses and artificial limbs.Energy—$52.5 million in silicone product sales
Silicon is used in approximately 90 percent of solar panels and silicones have facilitated larger wind turbines with greater energy potential. A modest quantity of silicone is sufficient to obtain a large increase in the efficiency of processes, energy consumption and use of materials.With such a variety of applications, silicones are a key part of the global economy. In North America alone, silicones manufacturing operations directly employ 10,000 individuals and another 2.3 million individuals throughout the supply chain. To learn more about the socio-economic benefits of silicones, view the Global Silicones Council’s full report here. To learn more about the many uses of silicones, visit siliconesinfo.org.
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(ACC Mentioned) A Call for Action on Toxic Chemicals
Jul 1, 2016 | The New York Times
By Roni Caryn Rabin
Every day, children and adults are exposed to a variety of chemicals found in common household items. Now a growing body of research suggests that many of these chemicals — which are used to make plastic more flexible, fruits and vegetables more abundant and upholstery less flammable — may also pose a threat to the developing brain.
While the link between early chemical exposure and neurodevelopment disorders in children remains a matter of scientific debate, a unique coalition of top doctors, scientists and health advocates is calling for more aggressive regulation. The goal is to protect expectant mothers, infants and children from neurotoxic chemicals by stepping up efforts to curb air pollution, remediate old lead pipes, phase out certain pesticides, ban endocrine-disrupting chemicals used in food packaging and plastics and come up with a plan for getting rid of furniture laden with fire retardants.
The scientists note that neurodevelopmental disorders are complex and have multiple genetic, social and environmental causes. But most chemicals in use today were not adequately tested for safety before being allowed on the market, said Dr. Jeanne Conry, an obstetrician-gynecologist and a past president of the American College of Obstetricians and Gynecologists, which is part of the coalition.
“Before we can prescribe medicine, we have to prove it’s safe,” she said. “So how come with the chemical industry, we assume everything is safe and have to prove there’s harm?”
On Friday the coalition endorsed a first-of-its-kind consensus statement called Project Tendr, which stands for Targeting Environmental NeuroDevelopmental Risks. The statement was published in the scientific journal Environmental Health Perspectives, and related articles are being published over the next few months in endocrinology, nursing, pediatrics and epidemiology journals.
“We as a society should be able to take protective action when scientific evidence indicates a chemical is of concern, and not wait for unequivocal proof that a chemical is causing harm to our children,” the statement says.
The call to action comes just one week after President Obama signed into a law a much-debated overhaul of the nation’s 40-year-old toxic chemical rules. The update to the 1976 Toxic Substances Control Act subjects some 64,000 existing chemicals to eventual safety testing. But critics say the changes don’t go far enough, and the testing of chemicals is far too slow — just 20 chemicals at a time with a deadline of seven years per chemical. And the new law doesn’t cover pesticides used in food production – which critics say are one of the largest sources of childhood chemical exposures.
An official with the American Chemistry Council, which represents companies that make flame retardants, plastics and phthalates, said the new law already addresses the concerns raised by the Tendr coalition. The new rules give more authority to the Environmental Protection Agency and require the agency to take into account vulnerable populations like pregnant women, children and the elderly, she said.
“This new law will give Americans greater confidence that chemicals in commerce are being used safely,” the American Chemistry Council said in a statement.
The Tendr coalition includes pediatric neurologists, several minority physician associations, nurses, learning disability advocacy groups, environmental organizations, and the Endocrine Society, which has compiled several scientific statements documenting adverse health effects linked to endocrine-disrupting chemicals that mimic or disrupt the hormones in our own bodies. Dozens of scientists and health providers have signed the statement, as has Linda Birnbaum, director of the National Institute of Environmental Health Sciences and the National Toxicology Program.
The bottom line: The group wants the chemical industry to prove a chemical is safe, rather than waiting on the medical and scientific community to prove it is harmful. “We’re saying, shift the burden of proof,” Dr. Conry said.
Wading into a potentially contentious issue like regulation of chemicals is unusual for ACOG, a professional medical association for doctors who care for pregnant women. The group has been alarmed by rising rates of neurodevelopmental disorders and other health problems in children, which it linked to toxic exposures in a 2013 scientific paper.
National health surveys show that 15 percent of children had a developmental disability in 2008, up from 12.8 percent in 1996. Researchers say changes in diagnostic criteria and a greater awareness of developmental disorders including autism, attention deficit disorders, and other learning disabilities may explain some of the increase in rates, but not all of it.
The chemicals singled out by the coalition are widely used, and manufacturers and some experts say more research is needed to demonstrate they have harmful effects. They include:Organophosphate Pesticides: Although health concerns led to a ban on residential use of some of these pesticides, they are still permitted on crops like fruit, vegetables, wheat, soy and corn. In one study, women who were pregnant when they lived near areas where these pesticides were in use were up to three times more likely to have a child who developed autism or other developmental disorders. Janet Collins, a senior vice president at CropLife America, which represents pesticide manufacturers, said the studies show only an association between pesticide levels and autism disorders, not a cause-and-effect relationship.Flame Retardants: Recent studies have found that children exposed prenatally to higher levels of flame retardants had lower I.Q.s and higher hyperactivity scores. Similar effects have been found in animal studies. Flame retardants are used in fabric and upholstery padding, plastic casings for televisions and computers and baby products. A major source of exposure is household dust, which can accumulate with residue from treated products. American retailers and manufacturers have phased out one commonly used flame retardant, some of which still lurk in old sofas and other items; some scientists worry that they are being replaced with similar chemicals that may not be any safer.Lead: The government has banned leaded gasoline and household paint, but old homes and pipes often still contain lead that gathers in dust and leaches into water. Lead is so toxic that no level of exposure is considered safe, and even low blood levels are associated with lower intelligence and attention deficits. In 2010,an estimated 535,000 children were identified with alarmingly high levels of lead.Phthalates: These chemicals cross the placenta during pregnancy, and prenatal exposure has been linked in studies to problems with attention and intellectual deficits. The Consumer Product Safety Commission has banned the use of six phthalates in toys and child care products, but they are still widely used in all kinds of products, from food packaging to personal care products and building materials.Combustion-Related Air Pollutants – These include nitrogen dioxide, particulate matter (a mix of small solid particles and liquid droplets) and other toxic chemicals including benzene and formaldehyde, as well as polycyclic aromatic hydrocarbons (or PAHs). Air pollutants can cross the placenta, and prenatal and early childhood exposure to some pollutants has been linked with preterm birth and low birth weight, as well as developmental delays, inattention and reduced I.Q.
Studies show almost all American women have these chemicals circulating in their bodies during pregnancy. A recent study of about 300 women found detectable levels of pesticides, flame retardants, phthalates, PCBs and other chemicals in 99 percent to 100 percent of the women tested.
Gestation is a particularly vulnerable time for the developing fetal brain, because it is growing so rapidly, said Irva Hertz-Picciotto, co-executive director of Project Tendr and director of the MIND Institute Program in Environmental Epidemiology of Autism and Neurodevelopment at the University of California, Davis.
Many chemicals of concern are endocrine disruptors, which can interfere with the activity of the body’s own hormones, like thyroid hormones, estrogen and androgens. These hormones play an important role in healthy brain development, said Heather B. Patisaul, professor at the Center for Human Health and the Environment at North Carolina State University at Raleigh.
“The goal is not to demonize every chemical on the market,” Dr. Patisaul said. “We need to find the group that are harmful, and figure out why, and develop new chemicals that are significantly less harmful.”
How to Limit Your Exposure to Toxic Chemicals
A coalition of doctors, scientists and health advocates says you may be able to reduce your overall exposure to toxic chemicals by taking the following steps:Reduce pesticide exposure by choosing organic strawberries, apples, nectarines, green beans, celery and spinach.Choose seafood low in mercury like salmon, sardines, trout.Breast-feed your baby if you can; if you use formula, make sure the water is lead-free.When buying furniture with padding like a high chair, sofa or mattress, ask for products that are labeled free of toxic flame retardants.Avoid exposing the family to tobacco smoke, wood smoke from fireplaces and wood stoves, idling car exhaust, cooking fumes from stoves and grills.If you’re putting in a new floor, choose either phthalate-free vinyl flooring or wood, bamboo or cork.Avoid plastic toys, backpacks, lunch boxes and school supplies made of polyvinyl chloride (PVC) which can be a source of phthalates.Choose fragrance-free personal care products to avoid phthalates in fragrances .When using stool softeners, laxatives and other time-release capsules, look for phthalates on the list of inactive ingredients so you can avoid them.Use nontoxic alternatives to pesticides in your yard and on your pets.Screen your house for lead. If it was built before 1978, lead paint may place your family at risk. If paint is chipping or peeling, it can build up in house dust and stick to children’s hands.Reduce household dust that may contain lead, flame retardants, phthalates and pesticides. Take shoes off before you come into the house and use a doormat to trap dirt outside and inside the doorway. Damp mop, use a HEPA-filtered vacuum cleaner and dust with a microfiber cloth.
http://well.blogs.nytimes.com/2016/07/01/a-call-for-action-on-toxic-chemicals/
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Amended Law Affecting New Chemicals' Market Entry
Jul 1, 2016 | BNA Daily Environment Report
By Pat Rizzuto
Changes recently made to the Toxic Substances Control Act may delay chemical manufacturers' ability to bring new chemicals to market, policy analysts say.
Lynn Bergeson, managing partner of Bergeson & Campbell PC, told Bloomberg BNA June 30 that because of the changes, the Environmental Protection Agency “reset the clock” and is re-reviewing all new chemical premanufacture notifications (PMNs) that had been submitted to it prior to TSCA being amended. Such an action ignores the law's mandate that supports innovation, Bergeson said.
She was referring to a decision the EPA announced June 23.
The EPA said the 90-day review period the law provides for the agency to review PMNs would begin anew for all new chemicals—even if they had been submitted to the agency prior to President Obama signing the TSCA amendments into law on June 22.
Clients Bergeson's law firm represented had at least 30 PMNs pending at the EPA, which were affected by its decision to re-review all new chemicals under the regulatory standard of the amended law, she said during a June 28 American Bar Association luncheon focused on the TSCA amendments.
Some of the new chemicals the chemical manufacturers sought to make already had been reviewed by the agency, which was ready to let them enter commerce—until the clock was reset, she said.
Restarting the reviews ignores the requirement in Section 2(b)(3), Bergeson said.
Section of Law Ignored
That section of the law “requires EPA to exercise its authority ‘in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the primary purposes 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,’ ” she told Bloomberg BNA in a June 30 e-mail.
Wendy Cleland-Hamnett, director of EPA Office of Pollution Prevention and Toxics, said June 30 the agency is striving to make decisions on all new chemicals submitted to it before the TSCA amendments became law over about the same time frame as before the statute was revised.
“We expect to issue our first determinations late next week,” Cleland-Hamnett said during a webinar the agency hosted June 30 (see related story).
“We're doing everything we can not to hold things up,” she said.
Old, New TSCA Requirements
Prior to the TSCA amendments of 2016, if the EPA took no action during the 90 days the statute gives it to review new chemicals, the substance could enter commerce.
Under the amended TSCA, the agency must review the new chemical in accordance with its intended, known, or reasonably foreseeable uses and issue a specific finding within 90 days.
If the chemical poses or may pose an unreasonable risk, the agency can control that risk through certain orders that would allow the chemical to enter into commerce, Cleland-Hamnett said.
If the chemical doesn't pose an unreasonable risk, the agency publishes that conclusion and the chemical can enter into commerce, she said.
The 90-day review period may be extended up to a maximum of 180 days under the amended law.
Uncertainty Around Legal Interpretations
Ernie Rosenberg, president and chief executive officer of the American Cleaning Institute, told Bloomberg BNA during a recent interview that changes the TSCA amendments have made to the new chemical and new chemical uses provisions of that law (Section 5) could be interpreted as posing an obstacle to innovation.
The EPA has said nothing to suggest it intends to interpret the amended law in a way that would harm innovation, but uncertainty about diverse possible interpretations is raising questions among chemical manufacturers and formulators, he said June 21.
For example, the findings the amended law requires the EPA to make for new chemicals raise the possibility that the agency may routinely impose strict limits on new chemicals and their uses, Rosenberg said.
More 5(e) Rules?
Prior to the amendments, once a new chemical had been reviewed by EPA and entered the market, it could be used in whatever applications for which it proved suitable, he said.
The TSCA amendments require the EPA—prior to completing its review—to evaluate all reasonably foreseeable uses, he said.
The EPA could decide it needs to review uses of a new chemical and accomplish that through what are called Section 5(e) rules, Rosenberg said.
Under 5(e) rules, any chemical manufacturer or company that would like to use a chemical in a new way would have to notify the agency 90 days before doing so. The agency would then review the intended new use and determine whether it posed an unreasonable risk warranting some kind of control.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=92920271&vname=dennotallissues&fn=92920271&jd=92920271
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EPA to Use Rolling Process to Review Chemicals in Commerce
Jul 1, 2016 | BNA Daily Environment Report
By Pat Rizzuto
The amended U.S. chemicals statute doesn't envision the Environmental Protection Agency reviewing all chemicals in commerce at once to determine whether they are high or low priorities for risk evaluations, a senior EPA official said June 30.
The EPA will review chemicals in commerce through a rolling process that meets the law's requirements, Wendy Cleland-Hamnett, director of the agency's Office of Pollution Prevention and Toxics, said during a webinar held by the office.
EPA's webinar reviewed changes the Frank R. Lautenberg Chemical Safety for the 21st Century Act made to the U.S.'s primary chemicals law, the Toxic Substances Control Act. President Barack Obama signed the Lautenberg Act into law on June 22.
More than 1,300 people tried to listen to the first webinar the agency has held on the newly amended law. Not all people who tried to listen were able to do so, because the agency's telephone lines were overwhelmed by the demand. Cleland-Hamnett said the EPA will try to hold another webinar soon.
EPA Plans Meetings
The EPA will hold public meetings in late July or early August to discuss its proposed approach to prioritizing chemicals, she said.
Under the TSCA amendments, the EPA can classify as high priorities chemicals that may present an unreasonable risk of injury to health or the environment due to their hazardous characteristics or the ways or extent to which people or the environment are exposed.
High priority chemicals must have their risks evaluated, which may lead to regulations.
Low priority chemicals, Cleland-Hamnett said, are ones that don't meet the law's standard for high priority.
The TSCA amendments require the agency to issue a final rule describing its process to prioritize chemicals by June 2017.
Proposal to be Issued in December
To meet that goal, the agency intends to propose a rule by mid-December, Cleland-Hamnett said.
A final rule describing the process by which the agency will evaluate chemical risks also is required by June 2017.
The EPA intends to propose that final rule by mid-December as well, meaning it will hold a public meeting on that in late July or early August as well, Cleland-Hamnett said.
Individuals and organizations interested in such meetings and in the agency's implementation of the law should sign up for an e-mail alert the agency offers on its newly established Frank R. Lautenberg Chemical Safety for the 21st Century Act website, she said.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=92920283&vname=dennotallissues&fn=92920283&jd=92920283
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New Law Brings Confidence in Chemical Safety
Jul 1, 2016 | The Detroit News
By John Dulmes
Last week, a wide range of stakeholders and a vast majority of legislators from both political parties came together to make history: they helped to overhaul a major federal law that hadn’t been updated since it was signed in 1976.
This law, the Toxic Substances Control Act, oversees the federal regulation of chemicals in commerce. As more than 96 percent of all manufactured goods are directly touched by the business of chemistry, the TSCA law is an extremely important one for businesses, consumers and the environment.
Much has changed since Congress established these chemicals management rules 40 years ago. Science has produced innovative new substances and materials that have enabled tremendous advancements. Our economy has become much more globalized with the increase in world trade. And new testing methods and understandings of environmental impacts have increased the public awareness of chemical safety.
Under the old TSCA law, however, the Environmental Protection Agency lacked the authority to sufficiently regulate substances of concern. As the shortcomings of this old law became apparent, individual states began to create their own piecemeal regulations, including California’s Proposition 65, responsible for the perplexing warning labels found on many goods sold across the country.
More recently, activist groups have led alarmist campaigns to pressure retailers to remove certain chemicals from their products. While these efforts may have succeeded in shaming such substances, they have not always been based on sound science or reasonable standards.
Fortunately, this new reform, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, will help provide Americans with confidence in the safety of the products they use every day. This new law makes a number of improvements to TSCA that should be applauded:
■It will subject all existing and new chemicals to an EPA safety review.
■It will require the EPA to prioritize its list of chemicals to review based on risk levels, and provide the necessary funding and resources to do so.
■It will require EPA to make an affirmative determination that a chemical is safe before it is allowed to be produced.
■It will provide EPA a range of options to address the potential risks of substances, including labeling, use restrictions, phase-outs or other actions.
■It will reduce the use of animal testing in favor of new digital methods.
Many of these changes have been advocated for years by consumers’ rights and environmental groups, which have widely praised the new law. Many businesses rely on chemicals for the development of their products, and they want to know that their customers can trust their safety. The new law provides strong federal oversight of chemical substances, and it also ensures greater consistency between various states and protects interstate commerce from a patchwork of state-specific rules.
It isn’t every day that industry and environmental groups can both claim victory on an issue like this, or that Congress can overwhelmingly pass a major new law in the middle of a contentious election year. It took nearly a decade of work in Congress to make TSCA reform a reality, but it will be of great benefit to all of us.
John Dulmes is executive director of the Michigan Chemistry Council.
http://www.detroitnews.com/story/opinion/2016/07/01/new-law-brings-confidence-chemical-safety/86586054/
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US EPA Issues First Year Implementation Plan for New Lautenberg Chemical Safety Act
Jun 30, 2016 | Lexology
By Stephen A. Owens
The US EPA has issued a “First Year Implementation Plan” outlining the steps it will take over the next year (and beyond) toward implementing the requirements of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, the legislation signed into law by President Obama on June 22 to modernize the Toxic Substances Control Act (TSCA). The Lautenberg Act imposes a number of new requirements and responsibilities on US EPA, with several major tasks that must be completed with the first twelve months after the law’s enactment, including promulgating several significant rulemakings, initiating risk evaluations on 10 Work Plan chemicals and other efforts.
In announcing the Implementation Plan, US EPA underscored its commitment “to engage partners and stakeholders early in the process, and to be as transparent as possible.” The agency emphasized that the Plan “is not intended to be a comprehensive listing of all requirements in the new law” but instead “is intended to be a roadmap of major activities EPA will focus on during the initial year of implementation.” US EPA also stated that the Plan is a “living document” that will be “further developed over time.”
The Implementation Plan is organized into four broad categories of tasks that US EPA must fulfill: (i) Immediate Actions; (ii) Framework Actions; (iii) Early Mandatory Actions; and (iv) Later Mandatory Actions.
Immediate Actions
US EPA has identified three TSCA program areas for which it is taking “immediate action” under the Lautenberg Act: (i) new chemicals; (ii) confidential business information; and (iii) ongoing TSCA Section 6 rulemakings.
New Chemicals:
On the day that President Obama signed the Lautenberg Act, US EPA announced that the Act’s requirement that US EPA make an affirmative determination on Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs) before the manufacturing, importation or processing of a chemical can commence would be applied to all PMNs and SNUNs, including ones that had been submitted prior to June 22, 2016. US EPA also announced that the Lautenberg Act had “effectively reset” the 90-day review period for PMNs and SNUNs, meaning that the 90-day clock had restarted on June 22.
The Implementation Plan reiterates US EPA’s prior statement that for PMNs and SNUNs submitted prior to enactment and currently undergoing review, US EPA “will make every effort to complete its review and make a determination within the remaining time under the original deadline.”
Confidential Business Information (CBI):
The Implementation Plan notes that US EPA must review — and make a determination on — all new confidentiality claims for chemical identity of chemicals within the 90-day review period and “where claim is upheld, apply a unique identifier to the chemical and any associated information.” The Implementation Plan states that it is US EPA’s goal to meet the 90-day deadline. US EPA also will “create a plan to link associated information” within 30 days, with a target date of mid-July 2016.
The Implementation Plan also notes that US EPA must review and make a determination on “at least 25% of new confidentiality claims for other types of information” within 90 days. US EPA’s goal is to develop an “approach for routine review” of such CBI claims within 30 days, with a target date of mid-July 2016.
Ongoing TSCA Section 6 Rulemakings:
The Implementation Plan points out that for chemicals with risk assessments completed prior to June 22, 2016 (the date of enactment), the Lautenberg Act expressly allows US EPA to publish proposed and final rules consistent with the scope of the risk assessments, “even if they do not cover all conditions of use.” The Implementation Plan states that US EPA will continue to move forward with rulemakings to address the risks it has identified with certain uses of trichloroethylene (TCE), methylene chloride (MC) and N-methylpyrrolidone (NMP), as follows:For TCE use in spot cleaning and aerosol degreasing, US EPA plans to issue a proposed TSCA Section 6 rule by early October 2016, with the final rule anticipated by early October 2017.For TCE use in vapor degreasing, US EPA plans to issue a proposed TSCA Section 6 rule by early December 2016, with the final rule anticipated by early December 2017.For MC and NMP use in paint removers, US EPA plans to issue a proposed TSCA Section 6 rule by early December 2016, with the final rule anticipated by early December 2017.
Framework Actions
The Implementation Plan notes that US EPA also must take several actions during the next several months that will establish “processes to guide longer term program” efforts. These are:
Initial Risk Evaluations:
The Lautenberg Act requires that within 180 days of enactment, US EPA must publish a list of 10 Work Plan chemicals and formally initiate risk evaluation on those chemicals. The Implementation Plan states that US EPA will publish the list by mid-December 2016 and then publish the scope of each risk evaluation within six months after that – i.e., by mid-June 2017. (The Lautenberg Act generally requires US EPA to publish the scope of a risk evaluation no later than six months after the risk evaluation is initiated.)
Prioritization Process Rule:
The Lautenberg Act requires US EPA to publish a final rule establishing the process and criteria for designating chemical as high-priority or low-priority for purposes of risk evaluations within one year after enactment – i.e., by June 22, 2017. The Implementation Plan states that as an “interim milestone” for meeting this requirement, US EPA will publish a proposed rule by mid-December 2016.
Risk Evaluation Process Rule:
The Lautenberg Act also requires US EPA to publish a final rule establishing US EPA’s process for conducting risk evaluations of high-priority chemicals within one year after enactment – i.e., by June 22, 2017. The Implementation Plan states that as an “interim milestone” for meeting this requirement, US EPA will publish a proposed rule by mid-December 2016.
Fees Rule:
The Lautenberg Act gives US EPA the authority to collect fees to help defray the cost of implementing certain provisions in the Act, as well as to fully defray the cost of industry-requested risk evaluations. The Act requires US EPA to issue a rule to put the fees in place. While the Lautenberg Act does not specify a deadline for this rule, the Implementation Plan states that the “authority to require fees will be needed ASAP.” As such, the Plan states that as an “interim milestone,” US EPA will “consult and meet with parties potentially subject to the fees” and publish a proposed rule by mid-December 2016. The Plan also states that US EPA’s goal is to publish the final rule within one year after enactment by mid-June 2017.
Inventory Rule:
The Lautenberg Act requires US EPA to publish a final rule within one year after enactment (i.e., by June 22, 2017) requiring companies to report the chemicals they manufactured (or processed) in the previous 10 years in order to designate chemicals as “active” or “inactive” on the TSCA Inventory. The Implementation Plan states that as an “interim milestone” for meeting this requirement, US EPA will publish a proposed rule by mid-December 2016.
Science Advisory Committee on Chemicals:
The Lautenberg Act also requires that within one year after enactment (i.e., by June 22, 2017) US EPA must establish a committee “to provide independent advice and expert consultation with respect to the scientific and technical aspects of issues related to implementation of the statute.” The Implementation Plan states that it is US EPA’s goal to establish this committee within six months – by mid-December 2016 – instead of taking the full year to do so. Further, the Plan states that as an “interim milestone,” US EPA will publish a Federal Register Notice about formation of the committee in early September 2016, with the comment period ending in early November 2016.
Early Mandatory Actions
The Implementation Plan outlines several additional tasks that US EPA must perform during the first year after enactment:
Scope of Initial Risk Evaluations:
As noted, the Lautenberg Act requires US EPA to publish the scope of a risk evaluation within six months after the evaluation is initiated. The Implementation Plan notes that US EPA must publish the scope of the risk evaluation for the first 10 chemicals (the Work Plan chemicals) by mid-June 2017.
Annual Plan for Risk Evaluations:
The Lautenberg Act requires US EPA to publish a plan at the beginning of each year identifying the chemicals for which risk evaluations are expected to be initiated or completed that year, as well as the resources needed to conduct the evaluations, the status of other chemicals under evaluation, and updated schedules as appropriate. The Implementation Plan notes that US EPA’s first such plan is due in early January 2017.
Additions to Mercury Export Ban:
In addition to the changes it makes to the core TSCA program, the Lautenberg Act also bans the export of mercury compounds (in addition to the pre-existing ban on exports of elemental mercury). The Implementation Plan notes that the Act requires US EPA to publish an initial list of mercury compounds prohibited from export within 90 days of enactment (by mid-September 2016).
Mercury Inventory:
The Implementation Plans notes that the Lautenberg Act also requires US EPA to must publish by April 1, 2017 an inventory of mercury “supply, use, and trade” in the US and update it every three years.
Small Business Definitions:
The Lautenberg Act requires US EPA to review the adequacy of standards for identifying small manufacturers and processors, and to revise those standards as warranted. The Implementation Plan notes that US EPA must determine within 180 days of enactment whether any such revisions are warranted. The Plan also states that US EPA’s goal is publish a plan and schedule for any such revisions at the time it issues its determination.
Report to Congress:
The Lautenberg Act requires US EPA to periodically report to Congress on the agency’s capacity to conduct risk evaluations and to issue rules to address unreasonable risks, along with the resources needed to perform those endeavors. US EPA also must report on its capacity to conduct industry-requested risk evaluations, the likely demand for such requests, and the anticipated schedule for accommodating the demand. The Implementation Plan notes that US EPA first such report must be submitted to Congress within 180 days after enactment (by mid-December 2016) and every 5 years thereafter.
Later Mandatory Actions
Finally, the Implementation Plan identifies several longer-term efforts that US EPA is required to perform by certain deadlines:A rule for reporting by manufacturers and users of mercury and mercury-added products: within two years after enactment (by mid-June 2018)A rule establishing a plan for reviewing CBI claims for active chemicals: within one year after enactment (by mid-June 2017)Guidance document on the development of generic names for CBI chemicals: within two years after enactment (by mid-June 2018)A negotiated rulemaking on byproducts reporting for the Chemical Data Reporting (CDR) rule: proposed rule (if produced by negotiating process) within 3 years from enactment (by mid-June 2019).A strategy for alternative testing methods: within two years after enactment (by mid-June 2018).
Squire Patton Boggs will monitor closely the actions that US EPA takes pursuant to its Implementation Plan, as well as the steps the agency takes toward implementing the numerous other requirements of the Lautenberg Act. The impacts of US EPA’s actions under the Act on the manufacture, importation, processing, distribution and use of chemicals – and products containing chemicals – in the US will be significant and far-reaching. US EPA’s actions over the next months will be critically important and will set the tone for EPA’s long-term approach to the new law.
http://www.lexology.com/library/detail.aspx?g=1118402e-55a0-4cc5-8e21-a54ae7b35930
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New Hope for Reducing Children's Risks of Autism, ADHD and Intellectual Disabilities
Jul 1, 2016 | Cleveland.com
By Arthur Lavin
For some time, many families have either feared or dealt with the impact of their children having autism spectrum disorder, ADHD, and/or intellectual disabilities. Options to reduce the chance of one's child developing such neurodevelopmental disorders have been limited.
But today, a coalition of the nation's experts in the domains of epidemiology, toxicology, exposure science, and a variety of specialists in medicine have published their concerns about a set of six categories of chemicals (lead, mercury, air pollutants, flame retardants, PCBs, and organo-phosphate insecticides) that play a role in causing harm to the developing brain, and play an important role in children developing intellectual disabilities, ADHD, and/or autism spectrum disorder.
This work opens the door to actually reducing the chance that a child could develop one of these neurodevelopmental disorders. As the authors state: "To lower children's risks for developing neurodevelopmental disorders, policies and actions are urgently needed to eliminate or significantly reduce exposures to these chemicals."
The evidence that this statement is true took decades of research, recently synthesized into a set of conclusions. Knowing what chemicals cause which harm depends on complex analyses of possible causes for that harm. This makes discussions about environmental risk often difficult to follow or even believe. Further, when common compounds are found to be harmful, it is very discouraging trying to find actual steps that will help protect from them.
The work done by these scientists to make the case for action makes the moment powerful. #grayscale"); -webkit-filter: grayscale(100%); margin-right: 0px; min-height: 50px; letter-spacing: 0.195px; background: rgb(255, 255, 255);">There is clear scientific consensus on specific chemicals causing harm and on the number of emerging threats.
The group that has put these findings together is called Project TENDR (Targeting Environmental NeuroDevelopmental Risks). Project TENDR was established by Maureen Swanson, director of the Healthy Children Project of the Learning Disabilities Association based in Pittsburgh, and Professor Irva Hertz-Picciotto, director of the MIND Institute at the University of California, Davis, and a leading epidemiologist of autism. I am honored to serve on their Organizing Committee.
The project's Consensus Statement released today is unprecedented in the breadth of science and of health experts coming to agreement that toxic chemicals are increasing American children's risks for neurodevelopmental disorders.
My involvement grew out of my concern observing the rise of neurodevelopmental disorders in my practice of pediatrics in the Cleveland area over the last few decades, and the enormous impact these conditions have on the children and families affected.
The experts include leaders in their fields from universities including Harvard, Columbia, and many others; leading professional societies such as the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists; and the nation's expert agencies in this field, the U.S. Environmental Protection Agency and the National Institutes of Health.
There is clear scientific consensus on both specific chemicals and pollutants causing harm and on the burgeoning number of emerging threats.
For the first time, these leading scientists and health experts have decided to collectively move from research to action. The participants in Project TENDR first gathered in the fall of 2015 near Washington, D.C., to begin the process of synthesizing their findings, and in the spring of 2016 met in Monterey, California, to finalize a formal Consensus Statement.
The experts have concluded that further study is no longer a sufficient response to the clear and present threat these chemicals pose to children. Starting now, with recommendations to address the national health crisis of lead contamination, the TENDR experts will issue a series of recommendations to significantly reduce exposures to chemicals and pollutants that contribute to children's neurodevelopmental disorders.
The TENDR experts also will issue recommendations to establish a new approach to evaluating scientific evidence that will help to identify toxic chemicals and prevent their use before pregnant women and children are widely exposed and harmed.
This news comes at a critical time. Roughly one in 68 of our children now develop autism spectrum disorder, one in 10 develop ADHD, and about one in 6 have a developmental disability. A great and important opportunity now presents itself; for the first time, we can begin to discuss how to keep so many millions of our children protected from compounds that do this to their growing minds.
The Consensus Statement of Project TENDR is published in the journal Environmental Health Perspectives. We are grateful to Sen. Sherrod Brown of Ohio and U.S. Rep. Doris Matsui of California for their leadership and support on the issue of preventing neurodevelopmental disorders in childhood.
I invite all those concerned about their children and grandchildren developing these disorders to support efforts to reduce exposures, to actually decrease the risk to our children. Go to projecttendr.com to learn more and learn what can be done to protect our children.
Dr. Arthur Lavin is a pediatrician who practices at Advanced Pediatrics in the Cleveland area.
http://www.cleveland.com/opinion/index.ssf/2016/07/new_hope_for_reducing_children.html
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Five Questions: What Chemical Safety Update Means For Public Health
Jul 1, 2016 | The Inquirer (in Philly.com)
By Sandy Bauers
Ten days ago, with President Obama's signing of new chemical safety legislation, the last remaining environmental legislation of the 1970s that had not been updated got a makeover.
It had been a long time coming.
More than 80,000 chemicals are in common use, and previously the U.S. Environmental Protection Agency could call for safety testing only after evidence that there was a potential danger. As a result, the EPA has been able to require testing on only about 200 chemicals. It has regulated or banned just five.
Getting new legislation was a priority for U.S. Sen. Frank R. Lautenberg (D., N.J.), who had worked on it since 2005. Shortly before his death in 2013, when it began to look as if political compromise might be possible, he released a statement saying that "American families deserve to know that the chemicals found in everyday products are safe. But because of our broken laws, toxic chemicals that have been linked to cancer and other serious diseases make their way into our homes on a daily basis."
The new law - actually, a series of amendments - pays tribute to him with its name: the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
It passed overwhelmingly, though industry representatives view it as too harsh. Environmental and public health groups say it is too lax.
Michael Gochfeld, professor emeritus in Rutgers University's Environmental and Occupational Health Sciences Institute, recently spoke to us about the act.
Why was it so important to update the original Toxic Substances Control Act, or TSCA?
TSCA was a very important development in the 1970s. It was really landmark in its concept, but unfortunately hamstrung in its implementation. Under TSCA, the National Toxicology Program conducted many studies of many chemicals to assess their carcinogenicity. But the other aspect, which included EPA's promised role in evaluating existing chemicals and new chemicals, simply couldn't materialize. There were too many restrictions with regard to what EPA could actually accomplish - for example, banning chemicals that were considered hazardous.
Everybody seemed to agree that it wasn't an effective law. All the other 1970s environmental laws had been amended or addressed, except for TSCA.
What are some of the most important things the new legislation achieves?
The amendments free up EPA to do many of the things that were promised. It also imposes on EPA the requirement to identify susceptible populations and to make sure that they are protected. That would be children, pregnant women, the elderly and workers. The workers were the particularly novel component that I was surprised to find in the bill. It requires EPA to identify high-priority chemicals and to evaluate their hazards. And, in some cases, to evaluate particular uses of a chemical. So EPA might ban a chemical for one application, while allowing it for another.
Also, the amendment sets up a fund that industry has to pay into to actually fund this function of the EPA. There was no such funding under the original TSCA. This is a major change. I think it will certainly protect this part of EPA's responsibility.
What are the biggest failures of the new legislation?
One of its most controversial provisions is that states that are more restrictive or protective than the federal government might have their actions on hold while the EPA is in the process of evaluating a high priority chemical. They cannot take any new action on a chemical once EPA has said that it is going to list it as a high priority chemical and evaluate it. It's a preemption issue. But although that was very controversial, in reality it doesn't amount to much because EPA can only designate a few chemicals as high priority at one time. Ideally, it would work on about 25 chemicals. Its capacity to go beyond that is limited. It's an expensive, labor-intensive, information-intensive activity. EPA simply doesn't have the staff or the funding.
Another controversial issue - no one knows quite how it will play out, but it allows for some mischief - is that manufacturers can request that EPA review a particular chemical. So that could be a good thing. The manufacturer could learn whether a particular chemical it is proposing to use is problematic. Or, manufacturers could load up EPA's calendar with chemicals that it would not have chosen of its own accord. It seems to be a loophole for nuisance chemicals. Or, suppose I could request that the EPA review a competitor's chemicals. It's not clear whether that would be possible.
The EPA administrator has a lot of leeway in the amended act. So a really good, conscientious, on-top-of-everything administrator could make the act work. A less-good administrator could let the act languish and focus attention on chemicals that aren't really that critical, from a public health perspective.
Ultimately, will Americans be safer because of this act?
In the long run, I think the answer is yes. If it's well-publicized and manufacturers or importers know that people will be watching, then I think there will be less opportunity for importing dangerous pesticide residues, or adding certain compounds to paints or plastics. Some things are not covered: Cosmetics are not included because they are covered by the U.S. Food and Drug Administration. But from a toxic chemical perspective, they could still be important.
But nothing is going to change overnight. The EPA has to identify a certain number of high-priority chemicals for review in the first 18 months. Then it has three years to review them. Then, if it decides the chemical poses a public health or environmental hazard, it has two more years to recommend how to solve the problem. In that, an important benefit of the amendment is that in the previous act, when EPA wanted to regulate something, it had to go through every possible regulatory approach, including taking into account cost. The amended act gives EPA much more latitude in how it can regulate a chemical, based on health alone. That's a really big advance and a big advantage. It frees up the EPA to regulate, where before its hands were very tightly tied.
Is there opportunity for public involvement at this point?
There is clearly a role for public involvement. EPA has to establish policies, it has to come up with a protocol for how it's going to evaluate the chemicals, and it no longer has to know at the outset how dangerous something is. It is allowed to investigate that. Another part of the act is that EPA has to keep the public informed. It has to have a report every year to Congress on its progress in identifying high-priority chemicals and conducting what they're calling a safety assessment. If the public is engaged, the new act will be more effective.
http://www.philly.com/philly/health/20160703_Five_questions__What_chemical_safety_update_means_for_public_health.html
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Jun 30, 2016 | Environmental Grantmakers Association Blog
By Annie Taylor
Last week, President Obama signed a bill updating the Toxic Substances Control Act (TSCA), a forty-year-old law originally intended to regulate the introduction of new chemicals that posed a threat to public health and the environment. At the passage of TSCA, over 62,000 chemicals already existed on the market, making many of them exempt from toxicity testing. Fundamentally, these recent reforms now ensure that all chemicals – both those currently manufactured or used in the U.S. and those being introduced – are safe for people and the environment. In an effort spanning multiple years, Congress drafted and passed The Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576) on June 7th.
In bringing chemical regulations into the present, the law now requires the Environmental Protection Agency to evaluate the toxicity of existing chemicals, prioritized by their potential risk. If a substance or chemical is designated as a high priority, the EPA will face a hard deadline by which to complete a risk evaluation, which will now explicitly consider any risks to susceptible or highly-exposed populations. These enforceable deadlines represent a huge improvement on the past system, which was so slow and burdensome that the EPA could not effectively ban asbestos, a carcinogen that kills as many as 10,000 Americans every year. The law also establishes greater transparency of chemical information, both with regards to the public as well as to health and environmental professionals, and provisions funding to the EPA for implementation.
Many foundations and NGOs began advocating for this type of reform over a decade ago. The bill’s passage marks a landmark achievement, and represents the first major update to an environmental statute in 20 years. Now that the bill has been signed into law, the focus will shift to the EPA’s implementation of these new regulations. In a conversation sponsored by the Health and Environmental Funders Network, the Environmental Grantmakers Association, and Rachel's Network, chemical safety advocates and regulatory implementation experts discussed possible opportunities to ensure effective implementation of the reforms, as well as strong protections for the environment and consumers.
These experts emphasized that the speed and efficacy of priority designation and chemical risk evaluation will matter most to public health. Experts also highlighted the EPA’s new ability to require an affirmative finding of safety before a new chemical hits the market, which now guarantees a common-sense protection against untested chemicals. These advocates will help to hold the EPA accountable to future deadlines, and watchdog any possible exploitation of ambiguous language within the law. In particular, chemicals assigned a low-priority designation will not be immediately subject for review – it is still unclear which substances will qualify, and whether or not this result could be problematic for people or the environment.
Moving forward, funders and advocacy groups will play an essential role in fighting the regulatory battles that undoubtedly exist ahead. Ultimately, the Chemical Safety Act brings the U.S. one step closer to reducing chemicals that pose a significant threat to public health and the environment.
For more information, you can read highlights of the Chemical Safety Act’s key provisions or read the President's remarks at the signing.
https://ega.org/blog/chemical-safety-act-landmark-reforms-forty-year-old-law-and-their-implications-public-health-an
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The Tricky Business of Regulating Biology
Jun 30, 2016 | Undark
By Brooke Borel
IN 2015, A PLANT PATHOLOGIST at Pennsylvania State University successfully used new gene editing technology to delete a relatively small bit of DNA from the genome of a white button mushroom. The result: a mushroom that resists turning brown. The advantages to farmers and distributors seemed obvious, but surely such a biological innovation — one that precisely tweaked the stuff of life itself — would run into a maze of regulatory oversight and examination.
Well, not so much. In April of this year, the USDA said the mushroom would not be regulated because it falls outside the agency’s regulatory role — it only has oversight over engineered plants that have genetic material introduced into their DNA with a plant pathogen, an older technique used to make genetically modified organisms, or GMOs. Direct gene editing doesn’t require a plant pathogen to introduce or change DNA, which means the USDA has no authority over such products.
Similarly, oversight by the Environmental Protection Agency is only triggered by agricultural products engineered to make their own pesticides, which the mushroom does not. And as of this week, the Food and Drug Administration had not published a safety review of the mushroom — avoluntary procedure, anyway.
It’s worth noting that the white button didn’t so much pass a regulatory test as fail to find an agency with the proper authority to administer one.
Biotechnology experts don’t seem particularly worried about the safety of the edited mushroom, and it doesn’t appear to pose major health or environmental concerns. But it’s worth noting that the white button didn’t so much pass a regulatory test as fail to find an agency with the proper authority to administer one — and as such, it begs a simple question: What other biological innovations might slip through these regulatory cracks?
After all, by now, humans have managed to tweak the underlying biology of a growing list of plants and animals, producing everything from high-tech crops to microbes engineered for industrial use. But regulating these entities has turned out to be a complicated affair — particularly because the framework of policies and procedures that would govern advanced biotech were developed long before scientists even conceived of the kind of biological tinkering that produced the white button mushroom.
What’s in place is a framework dating back to 1986, when the federal government decided to regulate new genetically-modified agricultural products under an existing set of policies — many of which were conceived to assess chemical risks from air pollutants, say, or pesticides. Risks are risks, the thinking seemed to be, and the Coordinated Framework for Regulation of Biotechnology was born, with oversight responsibilities delegated to the FDA, the EPA, and the USDA.
Since then, the framework has been updated just once: in 1992.
“The issue has always been the flexibility of the agencies to be able to adapt to emerging technology,” says Todd Kuiken, a senior program associate at the Science and Technology Innovation Program at the Woodrow Wilson Center. “And I won’t even say at the same pace as the technologies are developing, but at least 100 yards behind them.”
Last year, the White House Office of Science and Technology Policyannounced a review of the Coordinated Framework, asking these three agencies “to develop a long-term strategy to ensure that the system is prepared for the future products of biotechnology.”
But how do you govern living things, which, unlike chemical compounds, are apt to be so unpredictable and so different from one case to the next? How to capture all the potential risks when new biological entities are introduced to the wider environmental milieu, or when they pass down variations of their genes from one generation to the next? And can regulation itself — notoriously immovable — ever keep up with biology or the blur of human innovation?
According to the OSTP, updates to the Coordinated Framework will be available for public comment this summer. But unless the new guidance grapples with how to best regulate living things and fast innovation, it may well miss the mark.
“If the OSTP review is going to be truly worthwhile and have really a transformative beneficial impact, it should be asking to reexamine whether the agencies even have the right legal authority,” says Anne Kapuscinski, an ecological risk assessment expert at Dartmouth College, referring mainly to the FDA’s authority over genetically modified animals.
“And secondly,” she adds, “they should be reviewing the scientific scope and quality of the risk assessments they are asking for.”
Innovation can certainly help society by growing food more efficiently, protecting us from getting sick, or providing conveniences that simply make life a little easier. But new technologies introduce new risks, which is why the government has regulatory bodies to begin with. The first seeds of the FDA sprouted in the mid-1800s to protect consumers from mishaps in agriculture and medicine; the EPA launched in 1970, partly in response to the infamous legacy of DDT; and the Animal and Plant Health Inspection Service, the part of the USDA that regulates biotechnology, formalized in 1972 with the conflicting mandate to protect both agriculture and wildlife.
A key policy tool is the risk assessment, a process that proposes to use science to sort out what’s safe and what’s not, and one that is ‘a wholly imperfect exercise.’
In order to protect the public and the environment from a potential hazard, the agencies have to understand that hazard in context. A key policy tool is the risk assessment, a process that proposes to use science to sort out what’s safe and what’s not, and one that is “a wholly imperfect exercise,” says Margaret Mellon, a molecular biologist and independent consultant. “You are never going to surface every possible harm. Nor are you going to be able to assess every possible harm perfectly.”
Still, scientists have worked on providing guidance. In 1983, the National Research Council published a report nicknamed the Red Book, which first codified risk assessment for federal agencies into four steps. First, identify the hazard. Then, determine the dose-response, or how much contact a person needs to have with the hazard in order to see a bad health effect. Then assess the exposure, or how likely a person is to come into contact with it. And finally, determine the actual risk. Other reports followed, including the Blue Book in 1994, which focused on air pollution, and theSilver Book in 2009, which tried to address the holes in existing risk assessments that allowed chemicals to enter the marketplace with little to no oversight.
These reports were written, for the most part, with chemicals in mind, but they eventually served as a framework for assessing risks in living things, too, from GMOs to invasive species. “Risk assessment procedures have largely been derived from and focused on chemical entities,” says Daniel Simberloff, an ecologist at the University of Tennessee Knoxville. “And living organisms have two features that chemicals don’t. One is they evolve in unpredictable ways, and second is they usually have autonomous means of dispersing.”
In other words, a chemical will behave in a fairly predictable way, breaking down into the environment. Organisms have the opportunity to do the opposite: they are able to reproduce.
Norman Ellstrand, an evolutionary geneticist at the University of California at Riverside, puts it like this: “Compare the 24-hour fate of a gram of plutonium to that of a gram of E. coli bacteria under optimal growth conditions. You will have slightly less plutonium and more than a kilogram of bacteria.”
It’s also hard to know how genes might spread, Ellstrand adds. Crops may cross with wild relatives over great distances, while bacteria have been known to swap genes across species, contributing to the spread of antibiotic resistance.
Of course, just because genes can swap among species doesn’t necessarily make them more risky than a product of sexual reproduction. In fact, conventionally grown crops and microbes can do the same thing, and they aren’t regulated at all. Trying to determine which products pose a potential risk if released into the environment, though, is no easy task, and it’ll get no easier as genetic engineering, gene editing, and even synthetic biology — which aims to build new organisms from the DNA up — get faster, cheaper, and easier.
The issue can cut both ways. “The problem is, every time we’ve had to regulate biology since the 1980s, we’ve always picked a chemical precedent,” says Joyce Tait, director of the Innogen Institute at Edinburgh University. According to Tait, this has caused delays in potentially beneficial innovation as regulators have tried to work out how to adapt a chemical-based system to biology. “It’s been true of GMOs, it’s been true of things called biological pesticides — which use microorganisms or complex biological molecules for pest control — that’s had the same problems.”
RATHER THAN A clear set of rules, risk assessments for GMOs usually come from the companies seeking federal approval, and they vary depending on the product, company, and agency.
At the EPA, for example, there is no codified risk assessment, although the process is ongoing, says Chris Wozniak, a biotechnology special assistant with the Biopesticides and Pollution Prevention Division. “We have worked on some rulemaking to try to establish some data requirements,” he says, “and we will be presumably ongoing with that in the future.”
A codified biological risk assessment is certainly possible, but it’s the mishmash of current regulations and risk assessments that’s worrying.
“It’s not that we can’t do biological assessments — we’ve been doing them for a long time. It’s when we piece together such an ad hoc collection of assessments on microbes, plants, animals,” says Jaydee Hanson, a senior policy analyst at the advocacy group Center for Food Safety. “The Obama administration is on the right track, asking for a redo of the Coordinated Framework. The agencies in the main haven’t really wanted to step up to the task, and partly it’s because it’s not an easy task to take on all these technologies with a limited staff.”
Rather than the USDA, or even the Fish and Wildlife Service, the FDA regulates the fish. It’s classified as an animal drug.
Already, the mashing of new technologies into an old regulatory system has led to curious policies. Consider the AquAdvantage Salmon, the first GMO animal approved for food, which scientists genetically engineered to grow faster than its wild counterpart. Rather than the USDA, or even the Fish and Wildlife Service, the FDA regulates the fish. It’s classified as an animal drug.
“They aren’t so naive as to treat the salmon as if it is just a pharmaceutical,” says Peter Jenkins, president of the Center for Invasive Species Prevention. “But the problem is that…it’s being done by an outfit that, while they have some expertise, really doesn’t have the resources or knowledge on regulating a wildlife species like salmon. It’s not a good fit within institutional structure.
There are other examples, too. Microorganisms engineered to make biofuels and other industrial chemicals may be regulated under the Toxic Substances Control Act, primarily intended to oversee chemicals. And then there are gene drives, a new genetic tool that helps to quickly push a specific trait through a population. For example, scientists are working to engineer pathogen-resistant mosquitoes that could breed with a wild population and eventually erase its ability to spread disease. Most regulations try to control the spread of introduced organisms or chemicals; the intention with a gene drive is quite the opposite.
“When you look at it from a legal perspective, you could argue they’re essentially regulating [GMOs] like a chemical,” says Kapuscinski. “But the ecologists and the biologists — and I think even a lot of the staff at the EPA — knew that you can’t really regulate it just like a chemical. And that’s what caused some of the paradoxes and mismatches between the policy and law and regulation, and what the real issues are.”
So what’s the best way to regulate biological innovations? And how should the framework change?
Tait suggests a system-based approach: “I think we need to think quite deeply about the biological entity as a biological system. And how you would regulate a system rather than a molecule.”
Others would like the U.S. to adhere to international food safety standards and risk assessments set by Codex Alimentarius, a collaboration between the World Health Organization and the Food and Agriculture Organization. “We think the U.S. should be leading the world, not at the end,” says Michael Hansen, senior staff scientist at Consumers Union. “And that they should recognize that [new genetic techniques] all do fall under the genetic engineering, and there should be required safety assessments consistent with Codex.”
And a new report from the NRC recommends a tiered U.S. regulatory system, which would focus on the characteristics of a crop regardless of how it was made. The report suggests that crops with novel features should be subject to safety testing, including a full scan of the plant’s genome, or the collection of all of its genetic information, to compare with existing crops or products already on the market.
These tests would presumably catch unexpected differences, including those that pose risks, although the scientists I’ve interviewed who work with gene-editing in the lab say this practice is uncommon mostly due to cost and time.
“Take your plant, look at it, and if there’s no difference, well then you’re in great shape,” says Fred Gould, co-director of the Genetic Engineering and Society Center at North Carolina State University and chairman of recent NRC report. “If you do see a difference, then we’re back to where we have been for years, needing animal testing.”
Of course, another, more drastic approach to address new biological products is to do away with all of the current regulations and start over. “What we would argue that Congress needs to adopt a more plenary, fulsome, appropriate new laws to regulate genetically engineered animals of all kinds,” says Jenkins, “instead of trying to cram them into existing policies and frameworks.”
But is that likely — can we build smart, new, fast-adapting regulations from scratch? When I’ve posed that question to experts, I’ve mostly been met with a laugh.
“No,” says Jenkins. “Not right now.”
http://undark.org/article/tricky-business-regulating-biology-genetic-engineering/
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Compliance, Enforcement Underway For Prop 65 BPA Warnings
Jul 1, 2016 | Chemical Watch
By Kelly Franklin
A month and a half after California's Proposition 65 deadline for providing warning for exposures to bisphenol A (BPA), industry and private enforcement groups continue to adjust to the requirements.
Warning about exposure to BPA has been required since 11 May, a year after the substance was listedas a reproductive toxicant under the state's Prop 65.
During the interim 12 months, the Office of Environmental Health Hazard Assessment (Oehha) enacted an emergency regulation concerning exposure to BPA from canned and jarred foods and beverages. This allowed for a point-of-sale warning in lieu of the traditional on-product labels.Industry database
As part of industry's efforts to comply with the emergency regulation, 16 trade groups came together in May to set up a website to facilitate stores' ordering free point-of-sale warning signs. It also disseminates lists of brands and products whose packaging may contain BPA.
The database contains thousands of products.
But Caroline Cox, research director at the NGO Center for Environmental Health (CEH), points out the site does not say that certain cans contain BPA, but that they might. The language is really vague, she says, and it's "not really helpful" for consumers and their purchasing decisions.
In recent weeks, NGO the Environmental Working Group (EWG) has mined industry data, and published a searchable product list of more than 16,000 products from 926 brands that may contain BPA.
The Grocery Manufacturers Association (GMA), a participant in the industry site, is among the organisations who continue to stand by the safety of the substance’s use in food packaging.
"The current California emergency regulation that necessitated creation of the database to allow companies to list products in packaging that may cause exposure to BPA does not take into account the overwhelming credible science showing that there is no potential for harm from these infinitesimally small exposures", it says.
"If a science-based safe harbour was adopted for BPA by the Oehha, there would be no need for our database to exist, nor for EWG's app to be used to unnecessarily scare grocery shoppers."
Oehha has yet to develop a safe harbour "maximum allowable dose level (MADL)" for oral exposures to BPA.Enforcement begins
Despite continued disagreement on the risks of BPA and the levels of exposure considered safe, the first 60-day notice of an intent to privately enforce a failure to provide warning for exposure to BPA was brought by CEH on 14 June. The complaint, against fast food chain Del Taco, alleges the company had exposed consumers to BPA in thermal receipts above safe harbour levels without providing required warning.
Caroline Cox says that the NGO has been spending "a fair amount of time" since May looking at cash register receipts, particularly in fast food restaurants. This focus has been partially driven by a 2014 study that showed that handling thermal receipts containing BPA, and subsequently eating with one's hands, could result in both dermal and oral exposure to the substance, and increased levels of BPA in urine.
CEH has also served a 60-day notice to Home Depot and bottled water company DS Services of America about an alleged failure to warn for exposures from bottled water in polycarbonate plastic bottles used in water coolers.Compliance confusion
The alleged thermal receipt violation, however, does not tie in with the emergency BPA regulation.
Ms Cox says the emergency regulation changed the landscape in terms of Prop 65 enforcement efforts. It "just makes it a lot harder to determine whether companies are in compliance" in terms of canned and jarred foods and beverages.
Restaurants, for example, have specific prescribed language under Prop 65 for providing warning for when they are exposing consumers to listed substances.
But international law firm Pillsbury Winthrop Shaw Pittman, put out an advisory in May saying it was "appropriate for restaurants that serve bottled or canned beverages or other products to post [the emergency BPA regulation warning].
"Although there is possibly an argument that this generic restaurant warning may be sufficient if a restaurant operator has not received a notice from any suppliers or distributors [of products requiring warning for BPA], the more prudent course of action is to post the BPA-specific sign.”
As a general rule, says attorney Corrie Plant, businesses "can't completely insulate themselves from Prop 65 60-day notices".
She says the firm typically recommends working with clients on a case-by-case basis to determine what they're selling, what types of warnings will be required, and where and how to position those warnings.
https://chemicalwatch.com/48373/compliance-enforcement-underway-for-prop-65-bpa-warnings
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Jul 1, 2016 | Daily Mail
By Madlen Davies
Common chemicals found in plastic bottles, pollution and even makeup are harming the brains of foetuses and growing children, lowering IQs, according to new research.
Now scientists and health practitioners are warning of the dangers as growing evidence shows that many widely available chemicals endanger brain development.
Chemicals that are of most concern include lead and mercury, organophosphate pesticides used in agriculture and gardens, polybrominated diphenyl ethers (PBDEs) found in flame retardants, and phthalates, found in plastic bottles, food containers and beauty products.
Flame retardants, and traffic pollution and from wood smoke can also affect brain development in both the womb and in childhood, according to the new report.
Polychlorinated biphenyls (PCBs), once used as coolants and lubricants in electrical equipment, are also of concern.
Although these were banned in the US in 1977, they can linger in the environment for decades.
Scientists are studying infants and their mothers to determine whether prenatal exposure to phthalates and other chemicals leads to changes in the brain or behaviour.
Professor Susan Schantz, of the University of Illinois, said: 'These chemicals are pervasive, not only in air and water, but in everyday consumer products that we use on our bodies and in our homes.
'Reducing exposures to toxic chemicals can be done, and is urgently needed to protect today's and tomorrow's children.
She continued: 'The human brain develops over a very long period of time, starting in gestation and continuing during childhood and even into early adulthood.
'But the biggest amount of growth occurs during prenatal development.
'The neurons are forming and migrating and maturing and differentiating and if you disrupt this process, you're likely to have permanent effects.'
Professor Frederica Perera, at Columbia University, added: 'There is overwhelming scientific evidence that early-life exposure to neurotoxic chemicals is contributing to a host of developmental problems in children.
'Exposure to these chemicals is pervasive, warranting action now to reduce their production and use.'
Some of the chemicals of concern are known to interfere with normal hormone activity.
Most pregnant women in the US will test positive for exposure to phthalates and PBDEs, both of which disrupt thyroid hormone function.
Professor Schantz said: 'Thyroid hormone is involved in almost every aspect of brain development, from formation of the neurons to cell division.
'It regulates many of the genes involved in nervous system development.'
Studies have linked exposure to certain phthalates with attention deficits, lower IQ and behavioural disorders in children.
The report criticises current regulatory lapses that allow chemicals to be introduced into people's lives with little or no review of their effects on foetal and child health.
Professor Schantz said: 'Phthalates are everywhere, they are in all kinds of different products. We're exposed to them every day.
'For most chemicals, we have no idea what they're doing to children's neurodevelopment. They just haven't been studied.'
He added that if something looks like it may be a risk, scientists feel policymakers should be willing to make a decision that the chemical could be a bad actor and stop its production.
She said: 'We shouldn't have to wait 10 or 15 years, allowing countless children to be exposed to it in the meantime, until we're positive it's a bad actor.'
The research was published in the journal Environmental Health Perspectives.
http://www.dailymail.co.uk/health/article-3669868/Chemicals-pollution-plastic-bottles-make-damage-brains-foetuses-growing-children-lowering-IQ.html -
Appalachian Basin Lacks Adequate NGL Storage, Pipelines For Demand, More Crackers
Jun 30, 2016 | Natural Gas Intelligence
By Jamison Cocklin
As shale development continues to unfold in Appalachia and with Royal Dutch Shell plc's decision to build a multi-billion dollar ethane cracker in Western Pennsylvania, getting more natural gas liquids (NGL) storage and other infrastructure built is critical, according to several experts who spoke at an industry conference in Pittsburgh this week.
Much of the focus at the Northeast U.S. & Canada Petrochemical Construction Conference was about capitalizing on the recent final investment decision announced by Shell and to get similar projects built in the region, developing a more robust chemicals market and getting more NGLs flowing from Ohio, West Virginia and Pennsylvania. The region, speakers agreed, lacks the kind of liquids infrastructure that could seriously help move that process along.
The Appalachian Basin is home to abundant natural gas storage as it has long been a staging area to move gas to the Northeast. But its NGL storage and pipeline options are inadequate. At Mont Belvieu, TX, for example, there is 200 million bbl of NGL storage alone, said Blue Racer Midstream LLC’s Marc Halbritter, senior vice president of business development. In all of the Northeast there's about 5-14 million bbl of NGL storage, he said.
"It depends on how you look at proprietary storage versus publicly available storage, but it doesn't change the fact that there's very little NGL storage in the Northeast relative to the Gulf Coast," Halbritter said.
Shell's Appalachian cracker, which would consume about 100,000 b/d of ethane, is scheduled to come on stream early next decade (see Shale Daily, June 28; June 7). It joins a growing list of midstream options for Marcellus and Utica shale liquids.
It was only in 2014 that some of the basin's first NGL midstream infrastructure projects came online, with the 1,230-mile Appalachia-to-Texas Express ethane pipeline and Sunoco Logistics Partners LP's Mariner West pipeline entering service to move a combined 175,000 bbl of ethane to the Gulf Coast and Canada, respectively.
Sunoco's Mariner East (ME) 1 pipeline entered service earlier this year to deliver ethane and propane from Western Pennsylvania to the Marcus Hook Industrial Complex near Philadelphia for export overseas. The company's 350-mile ME 2 pipeline is also expected to enter service next year to transport NGLs from Ohio, Pennsylvania and West Virginia to Marcus Hook, while it continues to gauge interest in a third pipeline with an ongoing open season (see Shale Daily, Sept. 14, 2015). Kinder Morgan Inc. also has plans for the Utopia Pipeline, which would move ethane products from Ohio to the Sarnia, ON, petrochemical market (see Shale Daily, June 29).
Still, only one NGL storage project has been publicly announced. Mountaineer NGL Storage LLC said in May that it received requests for more than three times its initial planned capacity in Ohio during a nonbinding open season (see Daily GPI, May 25). Mountaineer now plans to offer up to 2 million bbl of initial storage capacity with more than 40,000 b/d of load-in and load-out capacity at its project in Monroe County.
"The one thing I think will really help and allow the market to take off in [Appalachia], will be the creation of storage," Halbritter said. "[Mountaineer] will be tied into the pipeline network, allowing ethane, propane, butane, gasoline to be stored, and I think that will help take some of the fluctuations out and the ethane supply for people like Shell will be more reliable."
"Being able to find the spot, the location for storage of ethane, as well as having the pipeline infrastructure to move it to places where we can manage it, I think, is absolutely critical," said Marcellus Shale Coalition President David Spigelmyer. "I will tell you that there are certainly monies that are going to be invested in liquid storage in Southwest Pennsylvania, Northern West Virginia and Eastern Ohio or some common location there where it makes perfect sense to get gas to the cracker, or crackers, that are built in that region, including Royal Dutch Shell's."
While the commodities downturn has forced many Appalachian producers to retreat to their dry gas acreage and ethane has traded for pennies on the dollar, it has historically been worth more than natural gas and is projected to recover, Halbritter said. Ethane demand is expected to grow as more crackers come online on the Gulf Coast and in the Northeast. Besides Mountaineer's project, other NGL storage projects are rumored to be under consideration in the region, Halbritter said, while midstream companies are even now thinking about more ways to move liquids.
Ethane is a major part of the gas stream in the basin, accounting for 55-62% of a typical NGL barrel there, while propane accounts for about 25%, according to Matt Curry, founder of consultancy Dreadnought Solutions LLC. "It was actually an operational concern," in the early days of the Marcellus, he said, "more than it was a marketing opportunity." But with more demand expected and interstate pipeline specifications that don't typically allow the heat value of gas to be any higher than 1,100 Btu, rejecting ethane is becoming a less desirable option.
Sunoco’s Joseph Colella, senior vice president for business development, said all three Mariner East pipelines would have a combined capacity of 745,000 b/d that could be scaled higher. He added that if ME 2X is constructed, the third pipeline that would run parallel to ME 2, then ME 1 could be converted to natural gas or become a bidirectional line. Marcus Hook already has 900,000 bbl of above ground refrigerated NGL storage, but when ME 2 is completed that would increase to 5 million bbl of combined pressurized and refrigerated storage.
Two other crackers that would be similar in size to Shell's have been proposed by Thailand's PTT Global Chemical pcl in Belmont County, OH, and by Braskem SA in Wood County, WV (see Shale Daily, Sept. 3, 2015; Nov. 14, 2013). While those companies are still deciding whether to construct those facilities, state officials who spoke at the petrochemical conference in Pittsburgh believe they will ultimately be built (see Shale Daily, June 27). Secretary of the West Virginia Department of Commerce Keith Burdette said infrastructure issues in the region recently prompted a coalition of industry companies to match funds for a liquids storage study to see what exactly is still needed. Speakers agreed that additional storage would make the market more stable for producers and consumers alike.
"To be quite honest, I happen to believe that Shell, Braskem and PTT would have been much farther along had there been a storage solution in this part of the country," Burdette said.
http://www.naturalgasintel.com/articles/106934-appalachian-basin-lacks-adequate-ngl-storage-pipelines-for-demand-more-crackers
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House Panel Tees Up Floor Action on EPA Spending
Jul 1, 2016 | BNA Daily Environment Report
By Brian Dabbs
The House Rules Committee is aiming to consider legislation to fund the Interior Department and the Environmental Protection Agency the week of July 11, the committee said in a June 30 statement.
Rules Committee action typically tees up floor consideration for legislation. It's still unclear, however, whether Republican leadership is committed to floor action on the bill, Matt Sparks, a spokesman for House Majority Leader Kevin McCarthy (R-Calif.), told Bloomberg BNA.
Thelegislation, H.R. 5538, would fund the Interior and EPA for fiscal year 2017.
In the Rules Committee notice, Chairman Pete Sessions (R-Texas) asked House members to submit amendments to the committee by early July 7. The committee authorizes the amendment process for floor action.
“I am committed to a structured process that allows for ample debate, while ensuring we can deliver to the American People the legislative solutions they deserve,” Sessions said in the notice.
Divisive Legislation
The $32.1 billion legislation, which would fund the EPA at nearly $8 billion, would prohibit funding for the Clean Power Plan, the Clean Water Rule, Superfund financial assurances and other EPA initiatives.
The bill would slash EPA appropriations by nearly $164 million from current levels. It undercuts the White House request for the agency by more than $290 million.
The Appropriations Committee passed the legislation in mid-June along party lines. Only one Democrat, Rep. Sanford Bishop of Georgia, cast a vote in favor.
More Republican Amendments Possible
An Appropriations Committee minority staffer said Republicans may tack on additional measures.
“I would anticipate [Republicans] passing more amendments on the floor that will be unacceptable to [Democrats],” Matthew Dennis, spokesman for Appropriations ranking member Nita Lowey (D-N.Y.), told Bloomberg BNA.
Rep. Ken Calvert of California, a top Republican appropriator, formally introduced the bill June 21. The committee tacked on a report, accompanied by a dissent section.
“The most significant programmatic cut is to the Environmental Protection Agency, which would receive $164 million less than the FY 2016 enacted level,” wrote top Democratic appropriators in the dissent section. “This cut will impact the Agency's ability to protect public health and the environment, and will jeopardize clean air and water for our families and future generations.”
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=92920275&vname=dennotallissues&fn=92920275&jd=92920275
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Murray Sues EPA Over Power Plant Reconsideration Denial
Jul 1, 2016 | BNA Daily Environment Report
By Andrew Childers
Murray Energy Corp. is challenging the Environmental Protection Agency's denial of petitions to reconsider its carbon dioxide standards for new power plants in the latest legal broadside on the agency's climate change efforts (Murray Energy Corp. v. EPA, D.C. Cir., No. 16-1218, 6/30/16).
The lawsuit, filed June 30 in the U.S. Court of Appeals for the District of Columbia Circuit, is expected to be consolidated with ongoing litigation over the EPA's carbon dioxide new source performance standards (RIN:2060-AQ91). Briefing in those challenges has been placed on hold to allow any additional lawsuits challenging the EPA's denial of petitions for reconsideration to be consolidated (North Dakota v. EPA, D.C. Cir., No. 15-1381, 6/24/16).
The EPA in May denied petitions from the Utility Air Regulatory Group, American Electric Power, Ameren Corp., the Energy and Environmental Legal Institute and Wisconsin seeking reconsideration of various aspects of the performance standards, particularly the standards for new coal-fired units that effectively would require some form of carbon capture to comply. The EPA in its denial defended carbon capture as technologically feasible and commercially viable.
Murray Energy, which already filed a lawsuit over the performance standards, now is challenging the EPA's denial of the petitions.
D.C. Circuit Halted Briefing
The D.C. Circuit—over the objections of the EPA—halted briefing in litigation over the performance standards to allow additional lawsuits over the denial of the petitions for reconsideration to be consolidated. Motions to amend the briefing schedule going forward are due Aug. 4.
Murray Energy is represented by Squire Patton Boggs.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=92920265&vname=dennotallissues&fn=92920265&jd=92920265
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White House Reviewing Final Part of EPA's Methane Push
Jul 1, 2016 | BNA Daily Environment Report
Guidelines that would help reduce emissions of volatile organic compounds from select existing oil and natural gas industry sources are now under review by the White House Office of Management and Budget.
The control techniques guidelines (RIN:2060-ZA22), received at OMB on June 28, are the latest piece of a suite of actions from the Environmental Protection Agency aimed at curbing methane emissions from the oil and gas sector.
Control techniques guidelines are not regulations and do not impose requirements on sources, according to the EPA. They, instead, provide recommendations for state and local air agencies to consider in determining reasonably available control technology for reducing emissions from covered processes and equipment, the agency said.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=92920268&vname=dennotallissues&fn=92920268&jd=92920268
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Amid Airy Promises, North American Summit Yields Some Sensible Plans On Energy
Jun 30, 2016 | Forbes
By Michael Lynch
The three North American leaders have met and began by addressing, among other things, energy policy and a move to reduce greenhouse gas emissions from that sector (among others). The headline takeaway was a call to increase emission-less energy production from 37% to 50% by 2025, which is definitely aggressive. Given that none of the leaders is likely to be in power at that time, it is obviously more aspirational than operational.
Some plans are clearly rational and, to be blunt, appear to be designed by grown-ups. Increased cross-border connections of utility systems will increase reliability on the system and, at least in theory, reduce costs. This is the sort of thing that qualifies as “doing well by dong good,” a policy that makes sense for many reasons beyond reducing emissions or improving prospects for renewables. Climate change advocates will appreciate the improved balancing of variable renewable power generation that this should create, but it is not clear how they will react if major new hydro projects in northern Canada proceed.
Note: Hydro power is no longer ‘green’ to many environmentalists, since the large land needs for some projects raises the blood pressure of many environmentalists. Add the impact on aboriginal peoples and expect outrage in response to new projects. Since activists blocked the Keystone XL pipeline despite the NAFTA treaty, this agreement is unlikely to prevent new hydro exports from becoming the next battleground.
The leaders also called for reduced methane emissions from the petroleum sector, along with those from the agricultural and waste disposal industries. The failure to single out the oil companies as the source of all our ills probably reflects the importance of oil to the Canadian and Mexican economies, but hopefully also an effort to design rational policy rather than score political points.
One weak point is the call to phase out inefficient subsidies on fossil fuels by 2025. This is odd, since there are few such subsidies in North America. Both diesel and gasoline prices in Canada and Mexico are far above those in the U.S., for instance, and Canadian electricity is slightly cheaper than in the U.S., reflecting its availability of cheap hydro. Residential electricity in Mexico is the only spot where prices seem to be subsidized, but raising them is likely to be extremely difficult politically.
Presumably this was a political sop to liberals, who often trot out the large subsidies to fossil fuel industries, especially when justifying support for renewable energy, but their charges are at best misleading. Most fossil fuel subsidies occur outside North America, and are primarily in the form of low petroleum prices in oil producing nations. And while Sen. Elizabeth Warren laments the billions of dollars in oil company tax breaks while students amass a trillion dollars in debt, she doesn’t mention that federal support for college students is roughly twenty times the oil industry tax breaks targeted by Democrats in Congress.
All in all, the agreement has a dual nature, some political feel good talk (more carbon-free energy, less fossil fuel subsidies) largely aspirational, but also some technical, wonky changes, especially the call for better integration of utility grids. The latter will be beneficial and can be expected to proceed, along with some efforts at reducing methane emissions. The good news is that most of the action appears likely to be limited and beneficial, while activists will be satisfied with yet more promises.
http://www.forbes.com/sites/michaellynch/2016/06/30/north-american-summit-yields-agreement-on-energy-again/#5cbedce95169
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IG to Chemical Safety Board: Launch More Investigations
Jul 1, 2016 | BNA Daily Environment Report
By Sam Pearson
The U.S. Chemical Safety and Hazard Investigation Board still needs to boost employee morale, investigate more chemical incidents and promulgate a long-delayed regulation, according to a report from the Environmental Protection Agency's Office of Inspector General.
The June 29 findings come as the CSB is facing criticism for not opening more investigations and failing to resolve long-running personnel disputes. The report also noted the CSB has made improvements since former Chairman Rafael Moure-Eraso resigned in March 2015, though more work is needed for the agency to become more effective.
The OIG noted the House Oversight and Government Reform Committee found in 2014 that a “toxic work environment” and alleged retaliation against whistle-blowers had led to staff departures. The OIG said the CSB is improving in this area since Chairman Vanessa Allen Sutherland was confirmed in August 2015. The agency also fixed problems with its information security and electronic records management programs, the OIG said.
Board Efforts Recognized
“It appears the board is returning to functioning as intended, with open communication between the staff, board and chairperson,” the report said.
The CSB has promulgated a code of conduct for employees and told the White House Office of Management and Budget it wants to improve its standing on the Office of Personnel Management's Federal Employee Viewpoint Survey. In addition, the agency launched an internal staff newsletter and plans to update “all existing board orders” not already revised, the report said.
If the CSB continues these efforts, it is on track for the recommendation to be removed in fiscal year 2017, the OIG said.
The CSB didn't provide a formal response to the OIG report, and the agency didn't respond to a request for comment on the findings.
Lack of Investigations Faulted
The CSB continues to investigate just a small minority of chemical incidents that could fall under its authority, the report said, and hasn't developed a management system to ensure investigations are completed in a timely manner. The board also has failed to create a chemical incident reporting regulation, the report said.
The OIG noted the CSB investigated just one of 27 chemical accidents with fatalities in fiscal year 2015. Since fiscal year 2011, the report said, the CSB has probed only 11 of 241 chemical incidents involving fatalities.
At issue is language in the CSB's authorizing statute specifying the agency “shall” investigate chemical incidents. The OIG contends that means the CSB does not have discretion to select incidents to investigate, while the CSB maintains a 2013 Supreme Court decision grants it discretion (City of Arlington, Tex. v. FCC, 133 S. Ct. 1863, S.C., 11-01545, 11-01547, judgment affirmed5/20/13).
Finalizing Chemical Report Rule
Finalizing a chemical incident reporting regulation, required under the Clean Air Act Amendments of 1990, would set clear rules for when companies must notify the National Response Center of incidents under the purview of the CSB.
The CSB “stated that even if it had already adopted a reporting rule, the agency would have essentially no capacity to collect or interpret much of the data it received, or seek enforcement action against any non-reporters,” the OIG report said.
http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=92920258&vname=dennotallissues&fn=92920258&jd=92920258
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(ACC Mentioned) Living Green: Readers Weigh In On Plastic Bags
Jun 30, 2016 | Santa Cruz Sentinel
By Kathryn McKenzie
In last week’s column, I asked for your opinions about local bans of single-use plastic bags, and you didn’t disappoint me. Here are some thoughts on the matter, edited for space and clarity.
• “Over the last 10 years, I have picked up about 25,000 gallons of litter in a four-block area of Monterey. My schedule is once a week. Prior to the plastic bag ban I would find six to eight plastic bags every collection. Now I find about one bag every three collections. For those saying plastic bags are not a litter problem, may I suggest traveling down one of the interstates, particularly in the desert, pulling off onto a side road and walking through the brush. I have done so and the amount of degrading plastic bags, cups, bottles, etc. is unforgivable. You can also visit the Buena Vista landfill and look at the netting around the site off Harkins Slough Road. The amount of plastic bags collecting on the netting has been greatly reduced.” — Robert Scoles
• “Naturally the California Grocers Association is totally supportive of the plastic bag ban. The stores have always incorporated the cost of bags in their pricing. Now, they are making a ton of extra money also at 25 cents per bag without any reduction in their pricing. I am 77 years old and they load my bags with so much that it is difficult for me to carry and lift them into the car and then into my house. Yesterday I had four of my bags with me. They were filled to capacity and I still had more groceries to be bagged. I totally resent the fact that I had to pay 50 cents for two more bags. My biggest pet peeve concerning plastic ending up in waterways, side of the road, land fills, etc. is PLASTIC DIAPERS. These should definitely be banned. I have seen many in ditches, stuck in bushes, etc. It would be, much better for babies and the environment to return to cloth diapers! Also, they cost so much, families would be able to save a lot of money.” — Beverly Young
• “I’m not sure when Oregon became a front-runner in recycling, but it was indeed in place when I moved to the Portland area in 1977. ... Now back in California since 2000, I am amazed at the folks who don’t get it. I have a longtime friend who owns a condo in Sacramento where they have no recycling bins. The seat of our state government — really? You ended your column asking how the bag ban has affected my life. I guess I’ve been doing it for so long, it’s nearly rote. I have a cache of bags in a basket behind the driver’s seat of my car. I rarely forget to take a shopping bag into a store, but if I do, I push my basket out to the car and load it into a bag. Big deal. I live at the beach, so I am reminded daily of the destruction of the sea and beaches, but when I really think about it, the reasons are clear. It’s the right thing to do.” — Marianne Evans, Capitola
• “I am so glad you wrote the article about the plastic bag ban in California and mentioned the referendum to end the ban. I did not know this was going to be on the ballot. I live in Carmel Valley, but shop around the Peninsula, so there are places that you have to have your own bag, pay for one or carry out your merchandise without a bag. “After visiting foreign countries in the 1980s, we have used our own cloth or canvas shopping bags for all kinds of shopping since that time. We keep a large assortment of bags (stored inside a larger bag) for any shopping need in each trunk of our cars. There are times that a plastic bag is used, such as for restaurant takeout, and in those cases, we try and collect them and recycle the plastic bags at the proper recycling locations. We have been using some of the same canvas bags for over 20 years. It really is not difficult. Other cultures have been doing this for decades.” — Lauren Haase
• “I just read your column in today’s Sentinel about the plastic bag ban and the move by plastic bag makers to overthrow it. “I’m responding because you wrote, ‘I’ve searched numerous websites without seeing much hard data...’ although I wasn’t clear on exactly what type of data you sought. The data you may be looking for, especially showing the seriousness of the plastic bag problem to marine life, are buried in obscure studies, but there is some available. I’m a senior technical editor for an engineering publication. Two years ago after the ban passed I researched and wrote a story on this subject with links to several studies. Two of the studies were sponsored by the American Chemistry Council, an industry trade group for plastics and chemical makers. Both are objective, well-designed, and thorough, even though sponsored by a trade group. And their results are not flattering to trade group members. “According to Table 3 in the first one, slightly more than 10 percent of post-consumer plastic bags were recycled in 2011 in the U.S., compared to slightly less than 10 percent in 2008. That data is based on EPA estimates. It’s a low recycling rate compared to other plastics shown in this table. Plastic bag makers like to talk about how much recycling of bags has increased, but what they don’t say is how huge the amount of waste is, and how low overall recycling rates are and remain, a major reason for the ban. The second study sponsored by the ACC, estimated that the overall U.S. recycling of plastic film increased by only 1 percent in 2012 vs. 2011. This is all in the context of the fact that as much as 80 percent of marine litter, including plastics, comes from land-based sources. That fact has been known for some time. Ocean-going plastic waste causes at least $13 billion worth of damage to marine ecosystems each year, according to a report sponsored by the United Nations Environment Programme.” — Anne Thryft, Boulder Creek
http://www.santacruzsentinel.com/article/NE/20160630/FEATURES/160639987
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EPA Takes Steps To Advance 'Cumulative' Air Toxics Assessment Policy
Jun 30, 2016 | Inside EPA
By Stuart Parker
EPA is taking steps to advance calls from its Clean Air Act Advisory Committee (CAAAC) to craft a policy on assessing the “cumulative” impacts of air toxics to reduce air pollution in environmental justice (EJ) areas, including updates to its major data screening tools and seeking information on state approaches to the issue.
At a June 29 CAAAC meeting in Arlington, VA, Bill Harnett of EPA's Office of Air & Radiation (OAR) said the agency's efforts on cumulative air toxics' risks is just one of several pending steps to address suggestions from the advisory panel on how to potentially improve EPA's federal hazardous air pollutants program.
CAAAC's Urban Air Toxics Workgroup in January sent EPA a report with recommendations on how the agency could improve its air toxics program, addressing a wide-range of issues in response to charge questions from EPA. Among the topics that the report covers includes a suggestion to conduct a “systematic review” of the agency's air toxics program by January 2017, and support local “citizen science” efforts to gather air toxics data.
On cumulative impacts, the report said EPA “should develop a cumulative impacts policy that includes, but goes beyond, participation that results in reducing air pollution in EJ communities and overburdened communities. The EPA should use a screening tool that incorporates a cumulative impacts index to identify EJ communities and communities with high levels of cumulative impacts,” saying a new policy is vital to target exposures.
“While we agree that more cumulative impacts research is warranted, we also strongly recommend that EPA develop a substantive cumulative impacts policy,” the report said. “This type of policy should include, but go beyond, community participation to yield actual reductions in air toxics and other pollution for [EJ] and overburdened communities,” while noting the the panel realizes such a policy is “not easily developed.”
Nevertheless, the panel suggested that a potential policy could be a “place-based” policy suggested by “several” EJ organizations. This approach would have four elements: identify EJ and overburdened communities; include strategies to protect those communities; reduce existing pollution in those areas' and “include incentives that improve other quality of life criteria besides reducing a community’s pollution load,” according to the report.
Cumulative Impacts
At the CAAAC meeting, OAR's Harnett gave a presentation outlining the various steps that the agency is taking to update its screening tools and other measures to better target the cumulative risks of toxics air emissions.
Screening tools that EPA is updating to address cumulative impacts include the agency's National Air Toxics Assessment (NATA) that models air toxics and provides cancer and non-cancer risk estimates at the census tract level. NATA is several years behind, with the latest version released in 2015 covering air toxics data only up to 2011. EPA air official Erika Sasser at a CAAAC permits and toxics subcommittee meeting June 28 in Washington, D.C., said the next NATA, covering 2014 data, should be out in late 2017 or early 2018.
In addition, EPA recently launched its “EJ Screen” tool that aims to integrate evaluation of EJ impacts to communities into EPA decision-making across the board, Harnett said.
The agency this fall will also release the Community-Focused Exposure and Risk Screening Tool which “will support cumulative human exposure and risk screening assessments,” he added.
Harnett cited EPA's Nov. 6 draft Environmental Justice Research Roadmap “that outlines the agency's commitment to building the scientific foundation to conduct such assessments.”
The agency also plans on outreach to the Environmental Council of the States -- representing many state environmental agencies -- for details on how states are addressing cumulative air toxics impacts. “In addition, in recognition that states such as New Jersey are working on cumulative impacts issues, the agency plans to reach out through ECOS to gather information on state approaches,” Harnett's presentation says.
CAAAC's Recommendations
Other recommendations from the CAAAC Urban Air Toxics Workgroup that EPA is already working toward include conducting an analysis of best practices and the provision of training tools to communicate with the public over air toxics' risks; programs to encourage retirement of older diesel vehicles; efforts to better characterize variation in air toxics; use of supplemental environmental projects agreed as part of legal settlements with industry to reduce air toxics; efforts to improve emissions inventories; and others.
Some initiatives require the cooperation of state and local air regulators, Harnett said. Among the many recommendations is a request that EPA work toward the use of personal monitoring devices to measure air toxics. EPA officials at the CAAAC meeting stressed, however, this is a long-term project, given that personal monitoring devices for “criteria” pollutants subject to national ambient air quality standards, such as ozone and particulate matter, are still relatively inaccurate. The agency is nonetheless moving forward with personal sensor evaluation.
However, there are certain requests that CAAAC has made that may prove very difficult to implement because they fall outside the exclusive competence of EPA, Harnett said, and these are still “under review.”
For example, the CAAAC panel asked EPA to better characterize the carcinogenicity of diesel exhaust, but Harnett cautioned this would be a slow task for multiple government agencies, requiring peer-reviewed science and opportunity for public notice and comment.
A recommendation for an executive order to require clean diesel technology in federally funded infrastructure projects would require White House involvement, and recommendations to ensure funding for diesel retrofit programs are dependent on appropriators in Congress, Harnett said.
The CAAAC also seeks recognition of air toxics programs for states and tribes, and for companies, to award them publicly for efforts to clean up toxic pollution, but Harnett said this suggestion is still under review.
http://insideepa.com/daily-news/epa-takes-steps-advance-cumulative-air-toxics-assessment-policy
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